Asymmetric cationic lipid having branched piperazine ring

Abstract

The present invention belongs to the field of drug delivery. Provided is an asymmetric cationic lipid containing a branched piperazine ring and having a structure as shown in general formula (1), wherein the definition of each symbol is consistent with that described in the text. In the cationic lipid of the present invention, a degradable group is introduced at an appropriate position, and the presence of the degradable group makes an LNP-pharmaceutical composition prepared therefrom be degraded at an appropriate time in vivo and have a low cytotoxicity, which solves the problems in the prior art that an LNP-pharmaceutical composition prepared from a non-degradable lipid can accumulate in endosomes and acidify the endosomal environment, so that the endosomal escape of a drug (e.g., mRNA) is hindered, and the drug delivered into cells cannot fully function. In the cationic lipid of the present invention, a heterofunctionalized small molecule containing a piperazine ring is used as a raw material. The preparation process is simple and convenient, has a lower cost, and is more environmentally friendly. The LNP-mRNA composition prepared therefrom has the advantages of low toxicity, high biocompatibility, high cell transfection, etc.

Description

An asymmetric cationic lipid branched with a piperazine ring Technical Field The present invention belongs to the field of drug delivery, and particularly relates to a cationic lipid for a pharmaceutical carrier, and more particularly to an asymmetric cationic lipid branched with a piperazine ring, a lipid composition, a lipid drug composition, and a preparation and application thereof containing the cationic lipid. Background Art Nucleic acid drugs are a general term for oligoribonucleotides (RNA) or oligodeoxyribonucleotides (DNA) with different functions, which act at the gene level, including but not limited to: siRNA, miRNA, antisense nucleic acids, aptamers, DNA, messenger RNA (mRNA), etc. Among them, mRNA is a single-stranded ribonucleic acid transcribed from one strand of DNA as a template, carrying genetic information and capable of guiding protein synthesis. In recent years, due to the advantages of mRNA such as translation in the cytoplasm, simple production process, rapid synthesis, low cost, and being conducive to large-scale production when used as a drug or vaccine, mRNA has been applied to the prevention and treatment research of different types of diseases, especially in the field of vaccines. mRNA has disadvantages such as easy degradation, instability, and difficulty in entering cells, and these defects can be overcome by optimizing its own chemical structure and selecting a suitable delivery system. Currently, the mRNA delivery system is one of the most critical technologies restricting the development of mRNA drugs. The mRNA delivery system mainly includes viral vectors and non-viral vectors. Viral vectors have the risk of integrating into the host genome and may produce varying degrees of humoral or cellular immune responses, so their clinical use is restricted. Non-viral vectors mainly include liposomes, lipid nanoparticles (LNP), inorganic nanoparticles, polymers, and proteins. Lipid nanoparticles are the most concerned and studied delivery systems currently. Lipid nanoparticles are usually composed of cationic lipids, neutral lipids, steroid lipids, and polyethylene glycolated lipids compounded under appropriate conditions. Among them, cationic lipids are connected to nucleic acids through electrostatic interactions, and the cationic lipid component has a significant impact on the delivery performance of lipid nanoparticles. Existing maturely applied cationic lipids include MC3, ALC-0315, SM-102, etc. However, the lipid nanoparticle delivery technology for mRNA still faces many challenges, and different research systems will have different optimal cationic lipids and / or lipid formulation ratios. Therefore, there is still a need in the art for improved cationic lipids suitable for conventional therapeutic uses. Summary of the Invention To solve the above problems, the present invention provides a piperazine ring-branched asymmetric cationic lipid and a preparation method thereof, a lipid composition containing the cationic lipid, a lipid drug composition and a preparation thereof containing the lipid composition, and a liposome or lipid nanoparticle containing the lipid composition, in particular an LNP-nucleic acid drug composition and a preparation thereof containing the cationic lipid, which have the advantages of high delivery efficiency, low safety and toxicity, high biocompatibility, and reduced cationic lipid dosage, and can improve the therapeutic and / or prophylactic effects of drugs. The above object of the present invention is achieved by the following technical solutions: An embodiment of the present invention provides a cationic lipid: A cationic lipid, characterized in that the structure is shown in the general formula (1): Or a salt, tautomer, stereoisomer, deuterated compound or solvate thereof; Wherein, L d Is a linking bond, and a is 1; L e Is C 1-12 Alkylene; M is any one of -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH-, -NHC(=O)S-, -C(=S)-, -OC(=S)-, -C(=S)O-, -OC(=S)O-, -NHC(=S)-, -C(=S)NH-, -NHC(=S)NH-, -OC(=S)NH- and -NHC(=S)O-; R is Wherein, tm is an integer from 0 to 6; B1, B2, and B3 are each independently C 1-20 Alkylene; L1, L2, and L3 are each independently selected from -CH(OH)-, -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH- and -NHC(=O)S-, wherein s is 1, 2 or 3; Rg is H or C 1-6 alkyl; R1, R2, and R3 are each independently linear or branched C 5-40 hydrocarbyl group. The present invention also provides a lipid composition, and the embodiments are as follows: A lipid composition containing a cationic lipid having the structure shown in formula (1). The present invention also provides a lipid drug composition, and the embodiments are as follows: A lipid drug composition containing a lipid composition and a drug, and the lipid composition contains a cationic lipid having the structure shown in formula (1), and the drug is selected from any one of nucleic acid drugs, gene vaccines, anti-tumor drugs, small molecule drugs, polypeptide drugs, or protein drugs. The present invention also provides a lipid drug composition preparation, and the embodiments are as follows: A lipid drug composition preparation containing the aforementioned lipid drug composition and a pharmaceutically acceptable diluent or excipient. The present invention also provides a liposome or lipid nanoparticle, and the embodiments are as follows: A liposome or lipid nanoparticle containing a lipid composition, and the lipid composition contains a cationic lipid having the structure shown in formula (1). Compared with the prior art, the present invention has the following beneficial effects: The present invention provides an asymmetric cationic lipid compound with a branched piperazine ring, containing 3-4 saturated or unsaturated fatty hydrophobic tail chains, enriching the types of cationic lipid compounds, and providing more selectable cationic lipids for the delivery of nucleic acid drugs, gene vaccines, small molecule drugs, polypeptides, and protein drugs, etc. The cationic lipid of the present invention introduces a piperazine ring structure in the hydrophilic head, containing multiple ionizable tertiary amines, which can strengthen its interaction with nucleic acids, and thus load more nucleic acids. The piperazine ring-branched asymmetric cationic lipid of the present invention introduces a biodegradable group in the hydrophobic hydrocarbon tail. The presence of the biodegradable group enables the LNP-drug composition prepared therefrom to be degraded in a timely manner in the body, solving the problem that the LNP-drug composition prepared from non-degradable lipids in the prior art will accumulate in endosomes and acidify the endosomal environment, resulting in hindered endosomal escape of drugs (such as mRNA) and the inability of the drugs delivered into cells to fully exert their effects; at the same time, the biodegradable group is degraded into non-toxic metabolites by intracellular enzymes under the action of intracellular enzymes, having the advantages of high safety and low cytotoxicity. The novel ionizable lipid provided by the present invention is positively charged in an acidic environment, hardly charged in a neutral environment, binds to a negatively charged nucleic acid drug through electrostatic interaction in an acidic buffer system, and becomes electrically neutral after entering the neutral environment in the body, which can effectively avoid the adsorption of plasma proteins by the lipid-nucleic acid drug composition, thereby achieving higher delivery efficiency and safety. The cationic lipid containing a piperazine ring in the present invention uses a hetero-functionalized raw material containing a piperazine ring, and the preparation process is simple, with lower cost and more environmentally friendly. The LNP-mRNA composition prepared therefrom has effects such as low toxicity, high biocompatibility, and high cell transfection. Description of the Drawings Figure 1 shows the 1 1H NMR spectrum of the cationic lipid E2-1 prepared in Example 2.1. Figure 2 shows the 1 1H NMR spectrum of the cationic lipid E15-1 prepared in Example 15.1. Figure 3 shows the 1 1H NMR spectrum of the cationic lipid E17-2 prepared in Example 17.2. Figure 4 shows the 1 1H NMR spectrum of the cationic lipid E19-1 prepared in Example 19. Figure 5 shows the 1 1H NMR spectrum of the cationic lipid E20-1 prepared in Example 20. Figure 6 shows the high performance liquid chromatography (HPLC) test results of the cationic lipid E20-1 prepared in Example 20. Figure 7 shows the mass spectrum (MS) of the cationic lipid E20-1 prepared in Example 20. Figure 8 shows the cytotoxicity test results of the LNP-mRNA drug composition L-24 prepared in Example 31. Figure 9 shows the imaging results after injection of the LNP-mRNA drug composition L-24 prepared in Example 31 into mice. Embodiments Term Explanation In the present invention, unless otherwise specified, each term has the following meanings. In the present invention, when the structure involved has isomers, without special specification, any one of the isomers can be used. For example, for a structure with cis-trans isomers, it can be either the cis structure or the trans structure; for a structure with E / Z isomers, it can be either the E structure or the Z structure; when there is optical activity, it can be either the left-handed or right-handed form. In the present invention, the interpretation of a numerical range includes both a numerical range marked with a short dash (such as 1-6) and a numerical range marked with a wavy line (such as (1~6)). In the present invention, in the absence of special instructions, an integer range marked in interval form can represent the set composed of all integers within the range of the interval, and the range includes both endpoints. For example, the integer range 1-6 represents the set composed of 1, 2, 3, 4, 5, and 6. The numerical ranges in the present invention include, but are not limited to, numerical ranges represented by integers, non-integers, percentages, and fractions. Unless otherwise specified, both endpoints are included. In the present invention, the terms “about” or “around” in relation to a numerical value generally refer to a numerical range of ±10%, and in some cases, it can be enlarged to ±15%, but not exceeding ±20%, based on the preset numerical value. For example, if the molar percentage of steroid lipids in total lipids is about 40%, it generally can be considered to include the case where the molar percentage of steroid lipids is 30%-50%. In the present invention, “pharmaceutically acceptable salts” refer to salts of the compounds of the present invention that are recognized for use in animals, and more precisely in humans, including salts formed by the compounds shown in formula (1) and inorganic acids or organic acids. For example, see S.M. Berge et al., “Pharmaceutical Salts”, J. Pharm. Sci. 1977, 66, 1-19. Among them, inorganic acids such as hydrochloric acid, hydrobromic acid, hydroiodic acid, sulfuric acid, phosphoric acid, or nitric acid, etc.; organic acids such as formic acid, acetic acid, acetoacetic acid, pyruvic acid, trifluoroacetic acid, propionic acid, butyric acid, hexanoic acid, heptanoic acid, undecanoic acid, lauric acid, benzoic acid, salicylic acid, 2-(4-hydroxybenzoyl)-benzoic acid, camphoric acid, cinnamic acid, cyclopentanepropionic acid, digluconic acid, 3-hydroxy-2-naphthoic acid, nicotinic acid, barmic acid, pectinic acid, 3-phenylpropionic acid, picric acid, pivalic acid, 2-hydroxyethanesulfonic acid, itaconic acid, aminosulfonic acid, trifluoromethanesulfonic acid, dodecylsulfuric acid, ethanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, methanesulfonic acid, 2-naphthalenesulfonic acid, naphthalenedisulfonic acid, camphorsulfonic acid, citric acid, tartaric acid, stearic acid, lactic acid, oxalic acid, malonic acid, succinic acid, malic acid, adipic acid, alginic acid, maleic acid, fumaric acid, D-gluconic acid, mandelic acid, ascorbic acid, glucoheptonic acid, glycerophosphoric acid, aspartic acid, sulfosalicylic acid, etc. For example, HCl (or hydrochloric acid), HBr (or hydrobromic acid solution), methanesulfonic acid, sulfuric acid, tartaric acid, or fumaric acid can be used to form pharmaceutically acceptable salts with the compounds shown in formula (1). In the present invention, a "solvate" refers to a complex formed by combining a compound of formula (1) or a pharmaceutically acceptable salt thereof and a solvent (such as ethanol or water). It should be understood that any solvate of the compound of formula (1) used in the treatment of a disease or disorder, although it may provide different properties (including pharmacokinetic properties), once absorbed into a subject, the compound of formula (1) will be obtained, such that the use of the compound of formula (1) respectively encompasses the use of any solvate of the compound of formula (1). It should be further understood that the compound of formula (1) or a pharmaceutically acceptable salt thereof can be separated in the form of a solvate, and thus any such solvate is included within the scope of the present invention. For example, the compound of formula (1) or a pharmaceutically acceptable salt thereof can exist in an unsolvated form and in a solvated form formed with a pharmaceutically acceptable solvent (such as water, ethanol, etc.). In the present invention, unless otherwise specified, the terms "comprising", "including", "containing" and similar expressions shall be interpreted in an open and inclusive sense as "including but not limited to" in this specification and the claims. In the present invention, when two or more objects are "each independently preferably", when there are multiple levels of preference, it is not required that they are all selected from the same level of preferred groups. One can be a preference in a large range, one can be a preference in a small range, one can be the maximum range, the other can be any preference case, or they can be selected from the same level of preference. In the present invention, for a "divalent linking group", such as an alkylene group, an alkylidene group, an arylene group, an amide bond, etc., without special limitation, when connecting other groups, either of the two connecting ends can be selected. For example, when using an amide bond as the divalent linking group between C-CH2CH2- and -CH2-D, it can be C-CH2CH2-C(=O)NH-CH2-D or C-CH2CH2-NHC(=O)-CH2-D. In the present invention, when the end groups of the linking group in the structural formula are prone to confusion with the substituents contained in the linking group, is used to label the positions where other groups are connected in the linking group. For example, in the structural formula in, the is used to label the two positions where other groups are connected in the divalent linking group. The above two structural formulas respectively represent -CH(CH2CH2CH3)2- and -CH2CH2CH(CH3)2-CH2CH2-. In the present invention, the range of the number of carbon atoms in a group is marked in subscript form at the subscript position of C, indicating the number of carbon atoms in the group. For example, C 1-12 represents "having 1 to 12 carbon atoms", and C 1-40 represents "having 1 to 30 carbon atoms". "Substituted C1-12 "Alkyl" refers to C 1-12 a group obtained by substituting a hydrogen atom of an alkyl group. "C 1-12 "Substituted alkyl" refers to a group having 1 - 12 carbon atoms obtained by substituting a hydrogen atom of an alkyl group. For example, when a group may be selected from C 1-12 alkylene, it may be selected from any alkylene having a carbon atom number within the range indicated by the subscript, that is, it may be selected from C1, C2, C3, C4, C5, C6, C7, C8, C9, C 10 、C 11 、C 12 any one of the alkylene groups. In the present invention, unless otherwise specified, subscripts marked in the form of an interval all indicate that any integer within the range may be selected, and the range includes both endpoints. In the present invention, "group" may be referred to as "bond" without changing the meaning. For example, an ether group (-O-) may also be referred to as an ether bond, and an ester group (-OC(=O)- or -C(=O)O-) may also be referred to as an ester bond. In the present invention, the "carbon chain length" between two groups refers to the shortest number of carbon atoms excluding the groups themselves. For example, for -OC(=O)CH2CH2OC(=O)- and -OC(=O)CH(CH3)CH2OC(=O)-, the carbon chain length between the two ester bonds is both 2 (which may also be referred to as C2), and the carbon chain length between the two ester bonds of -OC(=O)CH2CH2OCH2CH2OC(=O)- is C4 (which may also be referred to as C4). In the present invention, the heteroatom is not particularly limited and includes, but is not limited to, O, S, N, P, Si, F, Cl, Br, I, B, etc. In the present invention, the heteroatom used for substitution is referred to as a "substituting atom", and any group used for substitution is referred to as a "substituent". In the present invention, "substituted" means that at least one hydrogen atom of any group (for example, an aliphatic hydrocarbon group, a hydrocarbon group, an alkyl group or an alkylene group) is substituted by a bond connected to a non - hydrogen atom, and the non - hydrogen atom is, for example, but not limited to: halogen atoms such as F, Cl, Br and I; an oxo group (=O); a hydroxyl group (-OH); a hydrocarbyloxy group (-OR d , where R d is C 1-12 alkyl); a carboxyl group (-COOH); an amine group (-NR c R c , and the two R c are each independently H, C 1-12 alkyl); C 1-12 alkyl and cycloalkyl. In some embodiments, the substituent is C 1-12Alkyl. In other embodiments, the substituent is cycloalkyl. In other embodiments, the substituent is a halogenated group, such as fluoro. In other embodiments, the substituent is an oxo group. In other embodiments, the substituent is a hydroxyl group. In other embodiments, the substituent is an alkoxy group. In other embodiments, the substituent is a carboxyl group. In other embodiments, the substituent is an amine group. In the present invention, "optional" or "optionally" (e.g., optionally substituted) means that the subsequent described event or situation may or may not occur, and this description includes examples where the event or situation occurs and examples where the event or situation does not occur. For example, "optionally substituted hydrocarbon group" means that the hydrocarbon group may or may not be substituted, and this description includes substituted hydrocarbon groups and unsubstituted hydrocarbon groups. In the present invention, for a compound or a group, it can be substituted and hybridized simultaneously. For example, a nitro phenyl group substitutes a hydrogen atom, or -CH2-CH2-CH2- is replaced by -CH2-S-CH(CH3)-. In the present invention, a "linkage bond" is a connecting part that only serves as a connection and does not contain any atoms. When a certain group is defined as a linkage bond, it also means that this group may not exist. In the present invention, "each independently at each occurrence" not only means that in different groups, each can independently be any option in the definition, but also means that when it appears at different positions in the same group, it can also independently be any option in the definition. For example, in -NR c C(=O)NR c -, the two R c can be the same or different and each independently is a hydrogen atom or C 1-12 alkyl. In the present invention, a "group" contains at least 1 atom and refers to a radical formed by a compound losing one or more atoms. Relative to a compound, a group formed after losing some groups is also called a residue. The valence state of a group is not particularly limited. By way of example, it can be divided into monovalent groups, divalent groups, trivalent groups, tetravalent groups,..., 100-valent groups, etc. Among them, groups with a valence state greater than or equal to 2 are collectively called linking groups. A linking group can also contain only one atom, such as an oxygen group or a sulfur group. In the present invention, "hydrocarbon" refers to a hydrocarbon compound composed of carbon atoms and hydrogen atoms. In the present invention, according to the hydrocarbon group category, hydrocarbons are divided into two types: aliphatic hydrocarbons and aromatic hydrocarbons. A hydrocarbon that does not contain a benzene ring or any structure in which a benzene ring is substituted by a hydrocarbon group is defined as an aliphatic hydrocarbon. A hydrocarbon that contains at least one benzene ring or a benzene ring substituted by a hydrocarbon group is defined as an aromatic hydrocarbon. And an aromatic hydrocarbon can contain an aliphatic hydrocarbon group structure, such as toluene, diphenylmethane, 2,3-dihydroindene, etc. In the present invention, hydrocarbons are classified into saturated hydrocarbons and unsaturated hydrocarbons according to the saturation situation. All aromatic hydrocarbons are unsaturated hydrocarbons. Saturated aliphatic hydrocarbons are also called alkanes. The degree of unsaturation of unsaturated aliphatic hydrocarbons is not particularly limited. By way of example, but not limited to, alkenes (containing double bonds), alkynes (containing triple bonds), dienes (conjugated double bonds), etc. When the aliphatic hydrocarbon part in an aromatic hydrocarbon is a saturated structure, it is also called an arylalkane, such as toluene. In the present invention, there is no particular limitation on the structure of hydrocarbons, and they can be in the form of a straight-chain structure without side chains, a branched-chain structure with side chains, a cyclic structure, a dendritic structure, a comb-like structure, a hyperbranched structure, etc. In the absence of a special definition, a straight-chain structure without side chains, a branched-chain structure with side chains, and a cyclic structure are preferably selected, corresponding to straight-chain hydrocarbons, branched-chain hydrocarbons, and cycloalkanes, respectively. Among them, hydrocarbons without a cyclic structure are collectively called open-chain hydrocarbons, including but not limited to a straight-chain structure without side chains and a branched-chain structure with side chains. Open-chain hydrocarbons belong to aliphatic hydrocarbons. Therefore, straight-chain hydrocarbons can also be called straight-chain aliphatic hydrocarbons. Branched-chain hydrocarbons can also be called branched-chain aliphatic hydrocarbons. In the present invention, a compound formed by substituting a carbon atom at any position in a hydrocarbon with a heteroatom is collectively called a heterohydrocarbon. In the present invention, the "hydrocarbyl group" refers to a residue formed after a hydrocarbon loses at least one hydrogen atom. According to the number of hydrogen atoms lost, it can be divided into a monovalent hydrocarbyl group (losing one hydrogen atom), a divalent hydrocarbyl group (losing two hydrogen atoms, also called a subhydrocarbyl group), a trivalent hydrocarbyl group (losing three hydrogen atoms), and so on. By analogy, when n hydrogen atoms are lost, the valence state of the formed hydrocarbyl group is n. In the absence of a special designation, the hydrocarbyl group in the present invention specifically refers to a monovalent hydrocarbyl group. Unless otherwise clearly stated in this specification, the hydrocarbyl group is optionally substituted. In the present invention, the source of the hydrocarbyl group is not particularly limited. For example, it can be derived from aliphatic hydrocarbons or aromatic hydrocarbons, or from saturated hydrocarbons or unsaturated hydrocarbons, or from straight-chain hydrocarbons, branched-chain hydrocarbons or cycloalkanes, or from hydrocarbons or heterohydrocarbons, etc. From the perspective of saturation, for example, it can be derived from alkanes, alkenes, alkynes, dienes, etc.; for cycloalkanes, for example, it can be derived from alicyclic hydrocarbons or aromatic hydrocarbons, monocyclic hydrocarbons or polycyclic hydrocarbons; for heterocyclic hydrocarbons, for example, it can be derived from aliphatic heterocyclic hydrocarbons or aromatic heterocyclic hydrocarbons. In the present invention, the "aliphatic hydrocarbyl group" refers to a residue formed after an aliphatic hydrocarbon loses at least one hydrogen atom. In the absence of a special designation, the aliphatic hydrocarbyl group in the present invention specifically refers to a monovalent aliphatic hydrocarbyl group. The aliphatic hydrocarbyl group includes saturated aliphatic hydrocarbyl groups and unsaturated aliphatic hydrocarbyl groups. Unless otherwise clearly stated in this specification, the aliphatic hydrocarbyl group is optionally substituted. In the present invention, "alkyl" refers to a hydrocarbon group formed from an alkane. Without specific designation, it refers to a hydrocarbon group formed by removing a hydrogen atom at any position, which can be straight-chain or branched-chain, and can be substituted or unsubstituted. Specifically, for example, propyl refers to either n-propyl or isopropyl, and propylene refers to any one of 1,3-propylene, 1,2-propylene, and isopropylene. Unless otherwise explicitly stated in this specification, the alkyl is optionally substituted. In the present invention, "unsaturated hydrocarbon group" refers to a hydrocarbon group formed by removing a hydrogen atom from an unsaturated hydrocarbon. The hydrocarbon group formed by removing a hydrogen atom from an unsaturated carbon of an unsaturated hydrocarbon can be classified into alkenyl, alkynyl, diene group, etc. In the present invention, "alkenyl" refers to a straight-chain or branched-chain hydrocarbon group containing at least one carbon-carbon double bond formed by removing a hydrogen atom at any position of an alkene. For example, "C 2-15 alkenyl" means a straight-chain or branched-chain alkenyl including 2 - 15 carbon atoms and at least one carbon-carbon double bond, that is, the alkenyl can include one, two, three, four or more carbon-carbon double bonds. Unless otherwise specifically stated, the alkenyl described herein refers to both unsubstituted and substituted alkenyl. Unless otherwise explicitly stated in this specification, the alkenyl is optionally substituted. In the present invention, "alkynyl" refers to a straight-chain or branched-chain hydrocarbon group containing at least one carbon-carbon triple bond formed by removing a hydrogen atom at any position of an alkyne. For example, "C 2-15 alkynyl" means a straight-chain or branched-chain alkynyl including 2 - 15 carbon atoms and at least one carbon-carbon triple bond. The alkynyl can include one, two, three, four or more carbon-carbon triple bonds. Unless otherwise specifically stated, the alkynyl described herein refers to both unsubstituted and substituted alkynyl. Unless otherwise explicitly stated in this specification, the alkynyl is optionally substituted. In the present invention, "subhydrocarbon group" or "subhydrocarbon chain" refers to a straight-chain or branched-chain divalent hydrocarbon chain that connects the remaining part of the molecule to a radical group, which consists only of carbon and hydrogen and is saturated or unsaturated. For example, a subhydrocarbon group (C 1-24 subhydrocarbon group) having 1 to 24 carbon atoms, a subhydrocarbon group (C 1-12 subhydrocarbon group) having 1 to 12 carbon atoms. Specifically, for example, methylene, ethylene, propylene, n-butylene, vinylidene, propenylene, n-butenylene, propynylene, n-butynylene, etc. Unless otherwise explicitly stated in this specification, the subhydrocarbon group is optionally substituted. In the present invention, "alkylene" is also a divalent alkyl, including an open-chain alkylene and a divalent cycloalkyl. The open-chain alkylene refers to a divalent alkyl without a cyclic structure, and the divalent cycloalkyl refers to a divalent alkyl with a cyclic structure. Unless otherwise explicitly stated in this specification, the alkylene is optionally substituted. In the present invention, the aliphatic hydrocarbon derivative is preferably an ether-derivatized aliphatic hydrocarbon, an aliphatic hydrocarbon derivative containing 1 to 2 ether bonds, and more preferably an aliphatic hydrocarbon derivative containing 2 ether bonds. In the present invention, "molecular weight" characterizes the mass of a compound molecule, and "average molecular weight" characterizes the mass of the general formula compound components in a macroscopic substance. When there is no special regulation, the molecular weight of a polymer refers to the "average molecular weight", generally referring to the "number-average molecular weight" Mn. n For the number-average molecular weight, it can be either the molecular weight of a polydisperse block or substance, or the molecular weight of a monodisperse block or substance. When not specifically stated, the measurement unit of "molecular weight" and "average molecular weight" is Dalton, Da. A polymer can be represented by the "degree of polymerization" indicating the number of repeating units (such as ethylene oxide units, EO units in PEG) in the molecule. Correspondingly, the "average degree of polymerization", "number-average degree of polymerization", or "number of EO units" is used to characterize the average value and number average of the number of repeating units; when there is no special regulation, it refers to the number-average degree of polymerization. In the present invention, for the percentage, "about" generally means ±0.5%. In the present invention, the "stable existence" and "degradability" of a group are relative concepts. For detailed examples of stable existence groups and degradable groups, see the

[0134] -

[0145] section in CN113402405A. In the present invention, the "hydroxy protecting group" includes all groups that can be used as the protecting group of a normal hydroxyl group. The hydroxy protecting group is preferably an alkanoyl group (such as acetyl, tert-butylacetyl), an aralkanoyl group (such as benzoyl), benzyl, trityl, trimethylsilyl, tert-butyldimethylsilyl, allyl, acetal group or ketal group. The removal of acetyl is generally carried out under basic conditions, and the most commonly used are the ammonolysis of NH3 / MeOH and the methanolysis catalyzed by methoxide anion; benzyl can be easily removed by palladium-catalyzed hydrogenolysis at room temperature in a neutral solution, and can also be cleaved by reduction with sodium metal in ethanol or liquid ammonia; trityl is generally removed by catalytic hydrogenolysis; trimethylsilyl is usually removed using a fluoride ion-containing reagent (such as tetrabutylammonium fluoride / anhydrous THF, etc.); tert-butyldimethylsilyl ether is relatively stable and can withstand the ester hydrolysis conditions of alcoholic potassium hydroxide and mild reduction conditions (such as Zn / CH3OH, etc.), and can be removed with fluoride ions (such as Bu4N + F - ) in a tetrahydrofuran solution, or can also be removed with acetic acid containing water at room temperature. In the present invention, the "carboxy protecting group" refers to a protecting group that can be converted into a carboxy group through hydrolysis and the deprotection reaction of the carboxy protecting group. The carboxy protecting group is preferably an alkyl group (such as methyl, ethyl, tert-butyl) or an aralkyl group (such as benzyl), and more preferably tert-butyl (tBu), methyl (Me) or ethyl (Et). In the present invention, the "protected carboxyl group" refers to the group formed after the carboxyl group is protected by a suitable carboxyl protecting group, preferably methoxycarbonyl, ethoxycarbonyl, tert-butoxycarbonyl, or benzyloxycarbonyl. The carboxyl protecting group can be removed by hydrolysis under the catalysis of an acid or a base, and occasionally can also be removed by pyrolysis. For example, the tert-butyl group can be removed under mild acidic conditions, and the benzyl group can be removed by hydrogenolysis. The reagent for removing the carboxyl protecting group is selected from TFA, H2O, LiOH, NaOH, KOH, MeOH, EtOH, and combinations thereof, preferably the combination of TFA and H2O, the combination of LiOH and MeOH, or the combination of LiOH and EtOH. The protected carboxyl group is deprotected to produce the corresponding free acid, and the deprotection is carried out in the presence of a base, and the base and the free acid formed by the deprotection form a pharmaceutically acceptable salt. In the present invention, the "amino protecting group" includes all groups that can be used as the protecting group of a normal amino group, such as aryl C 1-6 alkyl, C 1-6 alkoxy C 1-6 alkyl, C 1-6 alkoxycarbonyl, aryloxycarbonyl, C 1-6 alkylsulfonyl, arylsulfonyl, or silyl, etc. The amino protecting group is preferably Boc (tert-butoxycarbonyl), Moz (p-methoxybenzyloxycarbonyl), or Fmoc (9-fluorenylmethyloxycarbonyl). The reagent for removing the amino protecting group is selected from TFA, H2O, LiOH, MeOH, EtOH, and combinations thereof, preferably the combination of TFA and H2O, the combination of LiOH and MeOH, or the combination of LiOH and EtOH. The reagent for removing the Boc protecting group is TFA or HCl / EA; preferably TFA. The deprotecting agent used for the reaction of removing the Fmoc protecting group is a solution of N,N-dimethylformamide (DMF) containing 20% piperidine. In the present invention, "cationic lipid" refers to a lipid that contains a net positive charge or an ionizable lipid. Herein, "cationic" means that the corresponding structure permanently or non-permanently bears a positive charge in response to certain conditions (such as pH). Thus, cations include both permanent cations and cationizable ones. A permanent cation means that the corresponding compound, group or atom bears a positive charge at any pH value or hydrogen ion activity in its environment. Typically, a positive charge is generated due to the presence of a quaternary ammonium atom. When a compound carries multiple such positive charges, it can be referred to as a permanent cation. Cationizable means that a compound, group or atom bears a positive charge at a lower pH and does not bear a charge at a higher pH in its environment. Additionally, in a non-aqueous environment where the pH value cannot be measured, a cationizable compound, group or atom bears a positive charge at a high hydrogen ion concentration and does not bear a charge at a low hydrogen ion concentration or activity. It depends on the individual properties of the cationizable or polycationizable compound, especially the pKa of the corresponding cationizable group or atom, at which pH or hydrogen ion concentration it bears a charge or not. In a dilute aqueous environment, the so-called Henderson-Hasselbalch equation can be used to estimate the fraction of the cationizable compound, group or atom bearing a positive charge, which is well-known to those skilled in the art. For example, in some embodiments, if a compound or moiety is cationizable, preferably, it bears a positive charge at a pH value of about 1 to 9, preferably 4 to 9, 5 to 8 or even 6 to 8, more preferably at a pH value equal to or lower than 9, equal to or lower than 8, equal to or lower than 7, and most preferably at a physiological pH value (such as about 7.3 to 7.4), i.e., under physiological conditions, especially under the physiological conditions of cells in vivo. In other embodiments, preferably, the cationizable compound or moiety is mainly neutral at a physiological pH value (such as about 7.0 - 7.4), but becomes positively charged at a lower pH value. In some embodiments, the preferred range of the pKa of the cationizable compound or moiety is about 5 to about 7. In the present invention, lipid nanoparticles, cationic peptides, proteins, polysaccharides, lipids or polymers are uncharged, have a neutral charge or are electrically neutral under physiological conditions, especially under the physiological conditions of cells in vivo. The cationic peptide or protein preferably contains a relatively large amount of cationic amino acids, such as Arg, His, Lys or Orn in a larger number than other amino acid residues (especially more cationic amino acids than anionic amino acid residues such as Asp or Glu), or contains a component mainly formed by cationic amino acid residues. The term "cationic" can also refer to a "poly-cationic" component / cationic component / compound, and can also refer to a cationic lipid capable of carrying a positive charge. For example, a cationic lipid contains one or more amine groups with a positive charge, and the preferred cationic lipid is ionizable so that they can exist in a positively charged form or a neutral form according to the pH. The ionization of the cationic lipid affects the surface charge of lipid nanoparticles (LNP) under different pH conditions. This charge state can affect plasma protein absorption, blood clearance and tissue distribution, as well as the ability to form a non-bilayer structure crucial for intracellular delivery of nucleic acids. In the present invention, "PEGylated lipid" refers to a molecule containing a lipid moiety and a polyethylene glycol moiety. In the present invention, "neutral lipid" refers to any of a number of lipid substances that exist in an uncharged or neutral zwitterionic form at a selected pH, preferably a phospholipid, which can be synthetic or of natural origin. In the present invention, "steroid lipid" is a steroid or a steroid analogue. In the present invention, a variant form refers to a structural form that can be transformed into a target reactive group through any one of chemical change processes such as oxidation, reduction, hydration, dehydration, electronic rearrangement, structural rearrangement, salt complexation and dissociation, ionization, protonation, deprotonation, substitution, deprotection, change of leaving group, etc. In the present invention, the "variant form of a reactive group" refers to a form that remains active (is still a reactive group) after at least one chemical change process such as oxidation, reduction, hydration, dehydration, electronic rearrangement, structural rearrangement, salt complexation and dissociation, ionization, protonation, deprotonation, substitution, deprotection, change of leaving group, etc., or an inactive form after being protected. In the present invention, "micro-modification" refers to a chemical modification process that can be completed through a simple chemical reaction process. The simple chemical reaction process mainly refers to chemical reaction processes such as deprotection, salt complexation and dissociation, ionization, protonation, deprotonation, change of leaving group, etc. The "micro-variant form" corresponds to "micro-modification" and refers to a structural form that can form a target reactive group after undergoing simple chemical reaction processes such as deprotection, salt complexation and dissociation, ionization, protonation, deprotonation, change of leaving group, etc. The change of the leaving group, such as the transformation from an ester form to an acyl chloride form. In the present invention, the "N / P ratio" refers to the molar ratio of ionizable nitrogen atoms in the cationic lipid to phosphoric acid in the nucleic acid. In the present invention, "nucleic acid" refers to DNA or RNA or a modified form thereof. In the present invention, "RNA" refers to ribonucleic acid that may be naturally occurring or non-naturally occurring. For example, RNA may include modified and / or non-naturally occurring components, such as one or more nucleobases, nucleosides, nucleotides, or linkers. RNA may include a cap structure, chain-terminating nucleosides, stem-loops, polyadenylation sequences, and / or polyadenylation signals. RNA may be a nucleotide sequence encoding a specific polypeptide, and may be messenger RNA (mRNA). Translating mRNA encoding a specific polypeptide, for example, translating mRNA inside mammalian cells in vivo can produce the encoded polypeptide. RNA may be selected from any one of the following: small interfering RNA (siRNA), asymmetric interfering RNA (aiRNA), microRNA (miRNA), Dicer-substrate RNA (dsRNA), small hairpin RNA (shRNA), mRNA, single-stranded guide RNA (sgRNA), self-amplifying RNA (saran), circular RNA (circRNA), cas9 mRNA, and mixtures thereof. In the present invention, FLuc mRNA can express luciferase protein, which emits bioluminescence in the presence of luciferin substrate, so FLuc is commonly used in mammalian cell culture to measure gene expression and cell viability. In the present invention, the methods for determining the expression level of a target gene include, but are not limited to, dot blot, northern blot, in situ hybridization, ELISA, immunoprecipitation, enzymatic action, and phenotypic determination. In the present invention, "transfection" refers to the introduction of a substance (such as RNA) into a cell. Transfection can occur, for example, in vitro, ex vivo, or in vivo. In the present invention, "antigen" refers to a substance that can be recognized by the immune system, preferably by the adaptive immune system, and is capable of triggering an antigen-specific immune response, such as by forming antibodies and / or antigen-specific T cells as part of the adaptive immune response. Typically, an antigen may be or may contain a peptide or protein that can be presented by MHC to T cells. In the context of the present invention, an antigen may be the translation product of the provided nucleic acid molecule (preferably mRNA as defined herein). In this context, fragments, variants, and derivatives of peptides and proteins containing at least one epitope are also understood to be antigens. In the present invention, "delivery" refers to providing an entity to a target. For example, delivering a drug and / or therapeutic agent and / or prophylactic agent to a subject, which is a tissue and / or cell of a human and / or other animal. In the present invention, a "pharmaceutically acceptable carrier" refers to a diluent, adjuvant, excipient or vehicle administered together with a therapeutic agent, and is suitable for contacting the tissues of humans and / or other animals within the scope of reasonable medical judgment without excessive toxicity, irritation, allergic reaction or other problems or complications corresponding to a reasonable benefit / risk ratio. Pharmaceutically acceptable carriers that can be used in the pharmaceutical compositions of the present invention include, but are not limited to, sterile liquids such as water and oils, including those of petroleum, animal, plant or synthetic origin, such as peanut oil, soybean oil, mineral oil, sesame oil, etc. When the pharmaceutical composition is administered intravenously, water is an exemplary carrier. Physiological saline and aqueous solutions of glucose and glycerol can also be used as liquid carriers, especially for injection solutions. Suitable pharmaceutical excipients include starch, glucose, lactose, sucrose, gelatin, maltose, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, skimmed milk powder, glycerol, propylene glycol, water, ethanol, etc. The composition may also optionally contain small amounts of wetting agents, emulsifying agents or pH buffering agents. Oral preparations may contain standard carriers such as pharmaceutical grade mannitol, lactose, starch, magnesium stearate, sodium saccharin, cellulose, magnesium carbonate, etc. Specifically, for example, excipients include, but are not limited to, anti-adhesion agents, antioxidants, binders, coatings, compression aids, disintegrants, dyes (pigments), demulcents, emulsifying agents, fillers (diluents), film formers or coatings, flavoring agents, fragrances, glidants (flow enhancers), lubricants, preservatives, printing inks, adsorbents, suspending or dispersing agents, sweetening agents, and water for hydration. More specifically, excipients include, but are not limited to, butylated hydroxytoluene (BHT), calcium carbonate, dibasic calcium phosphate, calcium stearate, croscarmellose sodium, crospovidone, citric acid, cross-linked povidone, cysteine, ethyl cellulose, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose, magnesium stearate, maltitol, mannitol, methionine, methyl cellulose, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, povidone, pregelatinized starch, phenylparaben, retinyl palmitate, shellac, silica, sodium carboxymethyl cellulose, sodium citrate, sodium starch glycolate, sorbitol, starch (corn), stearic acid, sucrose, talc, titanium dioxide, vitamin A, vitamin E (α-tocopherol), vitamin C, xylitol. In the present invention, the pharmaceutical composition can act systemically and / or locally. For this purpose, they can be administered by suitable routes, such as by injection (e.g., intravenous, intra-arterial, subcutaneous, intraperitoneal, intramuscular injection, including infusion) or transdermal administration; or by oral, buccal, nasal, transmucosal, topical, in the form of ophthalmic preparations or by inhalation. For these administration routes, the pharmaceutical composition of the present invention can be administered in suitable dosage forms. The dosage forms include but are not limited to tablets, capsules, lozenges, troches, powders, sprays, creams, ointments, suppositories, gels, pastes, lotions, ointments, aqueous suspensions, injectable solutions, elixirs, syrups. In the present invention, a "vaccine" is a prophylactic or therapeutic material that provides at least one antigen or antigen function. The antigen or antigen function can stimulate the adaptive immune system of the body to provide an adaptive immune response. In the present invention, "treatment" refers to the treatment and care of a patient to combat a disease, disorder or condition, and is intended to include delaying the progression of the disease, disorder or condition, alleviating or mitigating symptoms and complications, and / or curing or eliminating the disease, disorder or condition. The patient to be treated is preferably a mammal, especially a human. DETAILED DESCRIPTION OF THE INVENTION 1. Cationic Lipids One embodiment of the present invention: A cationic lipid, characterized in that its structure is shown in the general formula (1): Or its salt, tautomer, stereoisomer, deuterated compound or solvate; Wherein, L d Is a linking bond, and a is 1; L e Is C 1-12 Alkylene; M is any one of -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH-, -NHC(=O)S-, -C(=S)-, -OC(=S)-, -C(=S)O-, -OC(=S)O-, -NHC(=S)-, -C(=S)NH-, -NHC(=S)NH-, -OC(=S)NH- and -NHC(=S)O-; R is Wherein, tm is an integer from 0 to 6; B1, B2, B3 are each independently C1-20 Alkylene; L1, L2, and L3 are each independently selected from -CH(OH)-, -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH-, and -NHC(=O)S-, where s is 1, 2, or 3; R g is H or C 1-6 alkyl; R1, R2, and R3 are each independently a linear or branched C 5-40 hydrocarbyl group. 1.1. B1, B2, B3, Le In a specific embodiment of the present invention, preferably, each of B1, B2, and B3 is independently any one of methylene, ethylene, propylene, butylene, pentylene, hexylene, and heptylene. In a specific embodiment of the present invention, preferably L e is C 3-12 alkylene. In a specific embodiment of the present invention, preferably B3 is C 3-20 alkylene. In a specific embodiment of the present invention, preferably L e is C 3-12 alkylene and B3 is C 3-20 alkylene. 1.2. L1, L2, L3 In a specific embodiment of the present invention, L1, L2, and L3 are each independently -CH(OH)-, -OC(=O)-, -C(=O)O-, -C(=O)NH-, -NHC(=O)-, -NHC(=O)O-, -OC(=O)NH-. 1.3. R1, R2, R3 In the present invention, R1, R2, and R3 are each independently a linear or branched C 5-40 hydrocarbyl group, and the hydrocarbyl group is preferably an alkyl group, an alkenyl group, or an alkynyl group. In a specific embodiment of the present invention, the linear C 5-40 hydrocarbyl group is any one of a straight-chain alkyl group, a straight-chain alkenyl group, and a straight-chain alkynyl group; preferably each is independently a C 5-40 straight-chain alkyl group, a C 5-40 straight-chain alkenyl group, a C 5-40 straight-chain alkynyl group; preferably each is independently a C 5-25 straight-chain alkyl group, a C 5-25 straight-chain alkenyl group, a C5-25 Linear alkynyl; the linear C 5-40 hydrocarbyl is more preferably any one of the following structures: In a specific embodiment of the present invention, the branched C 5-40 hydrocarbyl is C 5-40 branched alkyl, C 5-40 branched alkenyl or C 5-40 branched alkynyl, each independently represented as wherein, tn is an integer from 0 to 12; R e , R f are each independently C 1-15 alkyl, C 2-20 alkenyl and C 2-15 alkynyl; preferably each independently selected from any one of methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, decyl, undecyl, dodecyl, pentenyl, hexenyl, heptenyl, octenyl, nonenyl, decenyl, octadecane-6,9-dienyl and their substituted forms; the branched C 5-40 hydrocarbyl is most preferably any one of the following structures: In a specific embodiment of the present invention, R1, R2, R3 are selected from any one of the following situations: Situation (1): R1, R2, R3 are all linear C 5-40 hydrocarbyl; Situation (2): R1, R2, R3 are all branched C 5-40 hydrocarbyl; Situation (3): Any one of R1, R2, R3 is linear C 5-40 hydrocarbyl, and the other two are branched C 5-40 hydrocarbyl; Situation (4): Any two of R1, R2, R3 are linear C 5-40 hydrocarbyl, and the other one is branched C 5-40 hydrocarbyl; preferably R1, R2 are linear C 5-40 hydrocarbyl, and R3 is branched C 5-40 hydrocarbyl. 1.4.-B3-L3-R3 fragment In a specific embodiment of the present invention, the -B3-L3-R3 fragment is each independently selected from any one of the following structures: 1.5.R In a specific embodiment of the present invention, R is each independently selected from any one of the following structures: 1.6. Examples of Structural General Formulas In a specific embodiment of the present invention, M is any one of -OC(=O)-, -C(=O)O-, -OC(=O)O-, -NHC(=O)-, -C(=O)NH-, -OC(=O)NH-, -NHC(=O)O-; the definitions of the other symbols are the same as those in formula (1). In a specific embodiment of the present invention, the structure of the aforementioned cationic lipid preferably satisfies any one of the following general formulas: More preferably, the structure of the cationic lipid satisfies any one of the following general formulas: Preferably, in the aforementioned general formulas (1-1)-(1-22), B1 and B2 are the same and are C 1-12 alkylene; L1 and L2 are the same and are any one of -OC(=O)-, -C(=O)O-, -NHC(=O)-, -C(=O)NH-, -OC(=O)O-; R1 and R2 are the same and are linear C 5-40 hydrocarbon group; R3 is linear C 5-40 hydrocarbon group. 1.7. Examples of Specific Structures In a specific embodiment of the present invention, the cationic lipid is selected from any one of the following structures: Or the structure of the cationic lipid is any one of the following structures: 2. Preparation of Cationic Lipids 2.1 The preparation process is as follows: The intermediates / raw materials involved in the preparation process of the present invention include but are not limited to PIP0, IM-C, IM-C', PIP-C, and PIP-C'. The preparation process of the present invention may involve the initial raw material PIP0 of the piperazine ring and its derivatives, and the PIP0 contains a single reactive group F q or F0, or the functional group pairs F q and F0, and the structure is represented as Among them, F q and F0 are H, Boc, protected or unprotected -OH, protected or unprotected -COOH, and the definitions of the other symbols are the same as those described in general formula (1). In the present invention, PIP0 is selected from any one of the following structures: The preparation process of the present invention may involve an intermediate IM-C containing a reactive group and a carbon-branched and hydrophobic hydrocarbon tail chain, and the structure can be represented as Among them, F2 is a reactive group capable of reacting with F in PIP0 q reaction, and F N is a reactive group capable of reacting with -NH- in PIP0. F2 is preferably protected or unprotected -OH, -COOH, and F N is preferably -F, -Cl, -Br, -CHO, -CH=CH-. B1, B2, L1, and L2 are not all linking bonds, and the definitions of the other symbols are the same as those described in general formula (1). IM-C can be prepared by any suitable chemical reaction, and the any suitable chemical reaction includes single-step or multi-step reactions such as simple esterification, amidation, alkylation, addition, or substitution. For example, in Example 1, S1-1 and S1-2 through an esterification reaction, and then with S1-4 esterified again to obtain the IM-C intermediate In the present invention, IM-C is selected from any one of the following structures: The preparation process of the present invention may involve a small molecule intermediate IM-C' containing a reactive group and a hydrophobic hydrocarbon tail chain, and the structure is represented as F B -B3-L3-R3, F A -R3, where F B is a reactive group capable of reacting with -NH- in PIP0, and F A is a reactive group capable of reacting with F0 in PIP0, and is preferably -OH, -COOH, -Br, -CHO, -CH=CH-, and the definitions of other symbols are consistent with those in the general formula (1). IM-C' can be prepared by any suitable chemical reaction, including simple esterification, alkylation, addition or substitution, etc., in a single step or in multiple steps. For example, in Example 2, S2-9 With S2-10 The small molecule intermediate IM-C' was obtained by substitution reaction. In the present invention, the structure of the aforementioned IM-C' is preferably F B -B3-L3-R3, F B -L3-R3, F A -R3, specifically, IM-C' is selected from any one of the following structures: The preparation process of the present invention may involve an intermediate PIP-C containing a piperazine ring, a secondary amine group and a carbon-branched hydrophobic hydrocarbon tail chain, the structure of which is shown as where F M In order to be able to interact with F in IM-C' A The reactive group is preferably -COOH or -OH, B1, B2, B3, L1, and L2 are not connecting bonds, and the definitions of other symbols are consistent with those in the general formula (1). PIP-C can be obtained by reacting the intermediate IM-C with the initial raw material PIP0. For example, in Example 2, the intermediate IM-C With PIP0 The intermediate PIP-C was obtained by esterification reaction. In the present invention, PIP-C is selected from any one of the following structures: The preparation process of the present invention may involve an intermediate PIP-C' containing a piperazine ring, a reactive group and another carbon-branched hydrophobic hydrocarbon tail chain, the structure of which can be represented as Among them, F CA reactive group capable of reacting with F2 of IM-C, preferably -OH, -COOH; the definitions of the other symbols are the same as those described in the general formula (1). PIP-C' can be obtained by reacting PIP0 with IM-C' in one or more steps. For example, in Example 5, S5-1 and S5-2 The PIP-C' intermediate can be obtained by esterification reaction followed by deprotection In the present invention, PIP-C' is selected from any one of the following structures: In the present invention, the cationic lipid can be prepared by reacting any one of the aforementioned IM-C with any one of PIP0 to obtain PIP-C, and then reacting PIP-C with IM-C'; or by reacting any one of the aforementioned IM-C' with any one of PIP0 to obtain PIP-C', and then reacting PIP-C' with IM-C. 2.2. Description of related raw materials and / or steps in the preparation process 2.2.1. Condensing agent, oxidizing agent, reducing agent In the present invention, the condensing agent used in the reaction is not limited, but preferably N,N'-dicyclohexylcarbodiimide (DCC), 1-ethyl-(3-dimethylaminopropyl)carbodiimide hydrochloride (EDC·HCl, EDCI), 2-(7-azabenzotriazol-1-yl)-N,N,N',N'-tetramethyluronium hexafluorophosphate (HATU), benzotriazol-1-yl-N,N,N',N'-tetramethyluronium hexafluorophosphate (HBTU), and most preferably DCC. An appropriate catalyst (such as 4-dimethylaminopyridine) can be added to this reaction. In the present invention, there is no particular limitation on the oxidant used in the reaction, as long as it is a compound or a combination of compounds that can increase the valence of the substrate. Preferred are phenyl iodide bis(trifluoroacetate), 1,4-benzoquinone, benzyltrimethylammonium tribromide, pyridinium dichromate, potassium dichromate, ozone, oxygen, hypofluorous acid, sodium hypochlorite, cobalt(III) acetate, cobalt(II) acetate, manganese(II) acetate, palladium(II) acetate, copper(II) acetate, monoperoxyphthalic acid, iodine, N-iodosuccinimide, iodobenzene dichloride, 2-iodoxybenzoic acid, dimethyldioxirane, dimethyl sulfoxide - oxalyl chloride, dimethyl sulfoxide - acetic anhydride, DDQ, dichloro(tris(triphenylphosphine))ruthenium, manganese dioxide, diacetoxyiodobenzene, periodic acid, sodium periodate, sodium periodate - osmium tetroxide, potassium permanganate, sodium perborate, peroxybenzoic acid, benzoyl peroxide, nickel peroxide, hydrogen peroxide, cumene hydroperoxide, tert-butyl hydroperoxide, peracetic acid, m-chloroperoxybenzoic acid, N-chlorosuccinimide, pyridinium chlorochromate, palladium(II) chloride - copper(II) chloride, urea hydrogen peroxide complex, triphenylmethyl tetrafluoroborate, tributyltin oxide, cobalt(III) fluoride, vanadium oxytrifluoride, chromium(VI) oxide, manganese(III) acetate, TEMPO, ammonium cerium(IV) nitrate, bromine, N-oxidopyridine, silver oxide, O-ethyl peroxycarbonate, manganese(III) acetylacetonate, vanadyl acetylacetonate, aluminum isopropoxide, potassium hydrogen persulfate, dichloroiodobenzene, etc., or a combination thereof. More preferred is a combination of one or more of oxygen, sodium hypochlorite, hydrogen peroxide, dichloroiodobenzene, potassium hydrogen persulfate, etc. In the present invention, there is no particular limitation on the reducing agent used in the reaction, as long as it can reduce the Schiff base formed from ammonia and an aldehyde or a ketone to an amino group; preferred are sodium borohydride, sodium cyanoborohydride, lithium aluminum hydride, borane, diborane, diisobutylaluminum hydride, diisopinocampheylborane, lithium borohydride, zinc borohydride, borane - pyridine, borane - methyl sulfide, borane - tetrahydrofuran, etc., or a combination thereof; more preferred is sodium cyanoborohydride. In the present invention, the reaction solvent can be a solvent-free or aprotic solvent. Aprotic solvents include toluene, benzene, xylene, acetonitrile, ethyl acetate, ether, methyl tert-butyl ether, tetrahydrofuran, chloroform, dichloromethane, dimethyl sulfoxide, dimethylformamide or dimethylacetamide. Preferred are tetrahydrofuran, dichloromethane, dimethyl sulfoxide, dimethylformamide. In the present invention, the base used in the reaction is an inorganic base or an organic base, preferably an organic base (such as triethylamine, pyridine, 4-dimethylaminopyridine, imidazole or diisopropylethylamine); preferably triethylamine, pyridine. 2.2.2. "Protection" and "deprotection" of relevant groups involved in the reaction process In the present invention, the reaction process also involves the "protection" and "deprotection" processes of related groups. To prevent the influence of related functional groups on the reaction, the functional groups are usually protected. When there are two or more functional groups, only the target functional group is selectively reacted, so other functional groups are protected. The protecting group not only stably protects the functional group to be protected, but also needs to be easily removed as required. Therefore, in organic synthesis, it is important to deprotect only the protecting group bonded to the specified functional group under appropriate conditions. In the present invention, the definitions of "carboxyl protecting group" and "amino protecting group" are the same as those in the "Term Explanation" section, and will not be elaborated here. 2.2.3. Alkylation reaction The alkylation reaction of the present invention is preferably a reaction based on the alkylation of hydroxyl, mercapto or amino groups, corresponding to the formation of ether bonds, thioether bonds, secondary amino or tertiary amino groups in turn. Examples are as follows: 2.2.3.1. Alkylation of substrate alcohol with sulfonate ester and halide In the presence of a base, an ether intermediate is obtained by nucleophilic substitution of the substrate alcohol with a sulfonate ester derivative or a halide. Among them, the molar equivalent of the sulfonate ester and the halide is 1 to 50 times that of the substrate alcohol, preferably 1 to 5 times. When the molar equivalent of the sulfonate ester and the halide is less than 1 times the molar equivalent of the substrate alcohol, the reaction substitution is incomplete and difficult to purify. When the molar equivalent of the sulfonate ester and the halide is greater than 50 times that of the substrate alcohol, the excess reagent brings trouble to purification, may be mixed into the subsequent steps, resulting in an increase in side reactions in the next step and an increase in purification difficulty. The obtained product is a mixture of an ether intermediate and excess sulfonate ester and halide, which can be purified by anion exchange resin, osmosis, ultrafiltration, etc. Among them, there is no particular limitation on the anion exchange resin, as long as the target product can undergo ion exchange and adsorption on the resin, preferably an ion exchange resin of tertiary amine or quaternary ammonium salt with dextran, agarose, polyacrylate, polystyrene, polydiphenylethylene, etc. as the backbone. There is no limitation on the solvent for osmosis and ultrafiltration. Generally, water or an organic solvent can be used. There is no particular limitation on the organic solvent, as long as the product can be dissolved in it, preferably dichloromethane, chloroform, etc. The reaction solvent is not limited, and a non-protic solvent is preferred, such as toluene, benzene, xylene, acetonitrile, ethyl acetate, tetrahydrofuran, chloroform, dichloromethane, dimethyl sulfoxide, dimethylformamide or dimethylacetamide, more preferably dimethylformamide, dichloromethane, dimethyl sulfoxide or tetrahydrofuran. The base includes organic bases (such as triethylamine, pyridine, 4-dimethylaminopyridine, imidazole or diisopropylethylamine) or inorganic bases (such as sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium acetate, potassium carbonate or potassium hydroxide), preferably organic bases, more preferably triethylamine and pyridine. The molar amount of the base is 1 to 50 times the molar equivalent of the sulfonate or halide, preferably 1 to 10 times, more preferably 3 to 5 times. 2.2.3.2. Alkylation of the substrate amine with sulfonate and halide A. Alkylation of the substrate amine with sulfonate and halide In the presence of a base, an ether intermediate is obtained by nucleophilic substitution of the substrate amine with a sulfonate derivative or halide. Among them, the molar equivalent of the sulfonate or halide is 1 to 50 times that of the substrate amine, preferably 1 to 5 times. When the molar equivalent of the sulfonate or halide is less than 1 times the molar equivalent of the substrate amine, the reaction substitution is incomplete and difficult to purify. When the molar equivalent of the sulfonate or halide is greater than 50 times that of the substrate amine, the excess reagent causes trouble in purification and may be mixed into subsequent steps, resulting in an increase in side reactions in the next step and an increase in purification difficulty. The obtained product is a mixture of an amine intermediate and excess sulfonate and halide, which can be purified by column chromatography, anion exchange resin, dialysis, ultrafiltration, etc. Among them, there is no particular limitation on the anion exchange resin, as long as the target product can undergo ion exchange and adsorption on the resin. Ion exchange resins of tertiary amines or quaternary ammonium salts with skeletons such as dextran, agarose, polyacrylate, polystyrene, and polydiphenylethylene are preferred. There is no limitation on the solvent for dialysis and ultrafiltration. Generally, water or organic solvents can be used. There is no particular limitation on the organic solvent as long as the product can be dissolved in it. Dichloromethane, chloroform, etc. are preferred. The reaction solvent is not restricted, and aprotic solvents such as toluene, benzene, xylene, acetonitrile, ethyl acetate, tetrahydrofuran, chloroform, dichloromethane, dimethyl sulfoxide, dimethylformamide or dimethylacetamide are preferred, and dimethylformamide, dichloromethane, dimethyl sulfoxide or tetrahydrofuran are more preferred. The base includes organic bases (such as triethylamine, pyridine, 4-dimethylaminopyridine, imidazole or diisopropylethylamine) or inorganic bases (such as sodium carbonate, sodium hydroxide, sodium bicarbonate, sodium acetate, potassium carbonate or potassium hydroxide), preferably organic bases, more preferably triethylamine and pyridine. The molar amount of the base is 1 to 50 times the molar equivalent of the sulfonate or halide, preferably 1 to 10 times. 2.2.3.3. Alkylation reaction of the substrate amine with aldehyde derivatives After obtaining an imine intermediate from the reaction of a substrate amine with an aldehyde derivative, an amine intermediate is obtained under the action of a reducing agent. Among them, the molar equivalent of the aldehyde derivative is 1 to 20 times that of the substrate amine, preferably 1 to 2 times, more preferably 1 to 1.5 times. When the molar equivalent of the aldehyde derivative is greater than 20 times that of the substrate amine, the excess reagent causes trouble in purification, may be mixed into subsequent steps, and increases the purification difficulty. When the molar equivalent of the aldehyde derivative is less than 1 time that of the substrate amine, the reaction is incomplete and the purification difficulty increases. Among them, the reaction product can be purified by means such as cation exchange resin, osmosis, ultrafiltration, etc. The cation exchange resin has no particular limitation as long as it can exchange with quaternary ammonium cations to achieve a separation effect. The solvents for osmosis and ultrafiltration are not limited. Generally, water or organic solvents can be used. The organic solvents have no particular limitation as long as the product can be dissolved in them. Dichloromethane, chloroform, etc. are preferred. The reaction solvent is not limited. Organic solvents are preferred, such as methanol, ethanol, water, toluene, benzene, xylene, acetonitrile, ethyl acetate, tetrahydrofuran, chloroform, dichloromethane, dimethyl sulfoxide, dimethylformamide or dimethylacetamide, etc.; more preferably water and methanol. The reducing agent has no particular limitation as long as it can reduce the imine to an amine. Sodium borohydride, lithium aluminum hydride, sodium cyanoborohydride, Zn / AcOH, etc. are preferred, and sodium cyanoborohydride is more preferred. Generally, the amount of the reducing agent used is 0.5 to 50 times the amount of the aldehyde derivative in terms of the amount of substance, and more preferably 1 - 10 times. 3.1. Lipid Composition In the present invention, a lipid composition contains any one of the cationic lipids having the structure as shown in the general formula (1) described above. In a specific embodiment of the present invention, preferably, the lipid composition, in addition to containing the cationic lipid having the structure as shown in the general formula (1), further contains one or more of phospholipids, steroid lipids, and polyethylene glycolated lipids, selected from any one of the following situations: Situation (1): Further contains phospholipids; Situation (2): Further contains steroid lipids; Situation (3): Further contains polyethylene glycolated lipids; Situation (4): Further contains phospholipids and steroid lipids; Situation (5): Further contains phospholipids and polyethylene glycolated lipids; Situation (6): Further contains steroid lipids and polyethylene glycolated lipids; Situation (7): Further contains phospholipids, steroid lipids, and polyethylene glycolated lipids; Situation (8): Further contains phospholipids, steroid lipids, polyethylene glycolated lipids, and another cationic lipid; Situation (9): Further contains phospholipids, steroid lipids, polyethylene glycolated lipids, and anionic lipids; More preferably, it also contains three kinds of lipids, namely neutral lipid, steroid lipid and polyethylene glycolated lipid, simultaneously. In a specific embodiment of the present invention, the phospholipid in the lipid composition is preferably any one of 1,2-dilinoleoyl-sn-glycero-3-phosphocholine (DLPC), 1,2-dimyristoyl-sn-glycero-phosphocholine (DMPC), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-doundecanoyl-sn-glycero-phosphocholine (DUPC), 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-di-O-octadecenyl-sn-glycero-3-phosphocholine (18:0 Diether PC), 1-oleoyl-2-cholesteryl succinyl-sn-glycero-3-phosphocholine (OChemsPC), 1-hexadecyl-sn-glycero-3-phosphocholine (C16 Lyso PC), 1,2-dilinolenoyl-sn-glycero-3-phosphocholine, 1,2-diarachidonoyl-sn-glycero-3-phosphocholine, 1,2-didocosahexaenoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine (ME 16.0PE), 1,2-distearoyl-sn-glycero-3-phosphoethanolamine, 1,2-dilinoleoyl-sn-glycero-3-phosphoethanolamine, 1,2-dilinolenoyl-sn-glycero-3-phosphoethanolamine, 1,2-diarachidonoyl-sn-glycero-3-phosphoethanolamine, 1,2-didocosahexaenoyl-sn-glycero-3-phosphoethanolamine, 1,2-dioleoyl-sn-glycero-3-phospho-rac-(1-glycerol) sodium salt (DOPG), dioleoyl phosphatidylserine (DOPS), dipalmitoyl phosphatidylglycerol (DPPG), palmitoyl oleoyl phosphatidylethanolamine (POPE), distearoyl-phosphatidylethanolamine (DSPE), dipalmitoyl phosphatidylethanolamine (DPPE), dimyristoyl phosphoethanolamine (DMPE), 1-stearoyl-2-oleoyl-stearoyl ethanolamine (SOPE), 1-stearoyl-2-oleoyl-phosphatidylcholine (SOPC), sphingomyelin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidic acid, palmitoyl oleoyl phosphatidylcholine, lysophosphatidylcholine and lysophosphatidylethanolamine (LPE) and their compositions. In a specific embodiment of the present invention, the steroid lipid in the lipid composition is preferably any one of cholesterol, coprosterol, sitosterol, ergosterol, campesterol, stigmasterol, brassicasterol, tomatidine, ursolic acid, α-tocopherol and their combinations. In a specific embodiment of the present invention, the polyethylene glycolylated lipid in the lipid composition is preferably any one of polyethylene glycol-1,2-dimyristoyl glycerol (PEG-DMG), polyethylene glycol-distearoyl phosphatidylethanolamine (PEG-DSPE), PEG-cholesterol, polyethylene glycol-diacylglycerol (PEG-DAG), polyethylene glycol-dialkoxypropyl (PEG-DAA), specifically including polyethylene glycol 500-dipalmitoyl phosphatidylcholine, polyethylene glycol 2000-dipalmitoyl phosphatidylcholine, polyethylene glycol 500-distearoyl phosphatidylethanolamine, polyethylene glycol 2000-distearoyl phosphatidylethanolamine, polyethylene glycol 500-1,2-dioleoyl phosphatidylethanolamine, polyethylene glycol 2000-1,2-dioleoyl phosphatidylethanolamine and polyethylene glycol 2000-2,3-dimyristoyl glycerol (PEG-DMG) and their combinations. In a specific embodiment of the present invention, the polyethylene glycolylated lipid in the lipid composition is preferably any one of the following structures and their combinations: Wherein, n1 is an integer from 25 to 300, and more preferably n1 is any one of 44, 45, 46, 47, 48. In a specific embodiment of the present invention, another cationic lipid in the lipid composition is selected from any one of 1,2-dioleoyl-3-trimethylammonium-propane (methyl sulfate) (DOTAP), 1,2-bis(octadecenoxy)-3-methylammonium propane chloride (DOTMA), 1-[2-(oleoyloxy)ethyl]-2-oleyl-3-(2-hydroxyethyl)imidazoline chloride (DOTIM), 1,2-dioleoyl-3-dimethylamino-propane (DODMA), 2,3-bis(tetradecanoyloxy)propyltrimethylammonium chloride (DMTAP), didodecyldimethylammonium chloride (DDAC), didodecyldimethylammonium bromide (DDAB), N,N-dioleyl-N,N-dimethylammonium chloride (DODAC), N-(4-carboxybenzyl)-N,N-dimethyl-2,3-bis(oleoyloxy)prop-1-ammonium (DOBAQ), 3,6-bis{4-[bis(2-hydroxydodecyl)amino]butyl}piperazine-2,5-dione (cKK-E12), 1,1'-((2-(4-(2-((2-(bis(2-hydroxydodecyl)amino)ethyl)(2-hydroxydodecyl)amino)ethyl)piperazin-1-yl)ethyl)azanediyl)bis(dodecan-2-ol) (C12-200), 4-(N,N-dimethylamino)butyric acid (dilinoleoyl) methyl ester (DLin-MC3-DMA), 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine (EPC), ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 8-[(2-hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino]octanoic acid (heptadec-9-yl) ester (SM-102), and ((2-(2-hydroxyethoxy)ethyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (DHA-1). In a specific embodiment of the present invention, the anionic lipid in the lipid composition is selected from any one of 1,2-dioleoyl-sn-glycero-3-phosphate sodium salt (18:1PA), 1,2-dimyristoyl-sn-glycero-3-phosphate sodium salt (14:0PA), bis(monooleoylglycerol) phosphate ammonium salt (18:1BMP), and cardiolipin (CL). In a specific embodiment of the present invention, it contains 20-80% of the cationic lipid shown in formula (1), 5-16% of phospholipid, 25-55% of steroid lipid, and 0.5-10% of polyethylene glycolated lipid, and the percentages are the molar percentages of each lipid in the total lipid. In a specific embodiment of the present invention, any one of the foregoing lipid compositions is preferably selected, and the molar percentage of the cationic lipid in the total lipid is 30-65%; more preferably, it is any one of about 35%, 40%, 45%, 46%, 47%, 48%, 49%, 50%, 55%. In a specific embodiment of the present invention, in any one of the foregoing lipid compositions, the molar percentage of phospholipid in the total lipid is about 7.5-16%; more preferably, it is any one of about 8%, 9%, 10%, 11%, 12%, 16%. In a specific embodiment of the present invention, in any one of the foregoing lipid compositions, the molar percentage of steroid lipid in the total lipid is 35-50%, and more preferably, it is any one of about 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%. In a specific embodiment of the present invention, in any one of the foregoing lipid compositions, the molar percentage of polyethylene glycolated lipid in the total lipid is 0.5-5%; preferably 1-3%; more preferably, it is any one of about 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.5%. 3.2. Preparation of Lipid Composition In the present invention, the lipid composition can be prepared by the following methods, including but not limited to ethanol injection method, microfluidic method, T-tube mixing method, and membrane extrusion method, and preferably the ethanol injection method and the microfluidic method. 4. Lipid Drug Composition and Its Preparation 4.1. Lipid Drug Composition In an embodiment of the present invention, a lipid drug composition contains any one of the foregoing lipid compositions and a drug, wherein the lipid composition contains any one of the foregoing structures of cationic lipid shown in general formula (1), and the drug is selected from any one of nucleic acid drugs, gene vaccines, anti-tumor drugs, small molecule drugs, polypeptide drugs, or protein drugs. In a specific embodiment of the present invention, in the lipid drug composition, the nucleic acid drugs are selected from any one of RNA, DNA, antisense nucleic acid, plasmid, interfering nucleic acid, aptamer, antagomir, and ribozyme, and the RNA is selected from any one of mRNA, saRNA, circRNA, miRNA, and siRNA; preferably, the nucleic acid drugs are any one of DNA, mRNA, miRNA, and siRNA. In a specific embodiment of the present invention, the lipid drug composition is preferably used as a drug and is selected from any one of the following drugs: anti-tumor agent, antiviral agent, antifungal agent, and vaccine. In a specific embodiment of the present invention, the drugs in the lipid drug composition include, but are not limited to, doxorubicin, mitoxantrone, camptothecin, cisplatin, bleomycin, cyclophosphamide, streptozotocin, actinomycin D, vincristine, vinblastine, cytosine arabinoside, anthracycline, nitrogen mustard, thiotepa, chlorambucil, razoxane, melphalan, carmustine, lomustine, busulfan, dibromomannitol, mitomycin C, cis-dichlorodiammineplatinum(II), methotrexate, 6-mercaptopurine, 6-thioguanine, cytarabine, 5-fluorouracil, dacarbazine, dibucaine, chlorpromazine, propranolol, timolol, labetalol, clonidine, hydralazine, imipramine, amitriptyline, doxepin, phenytoin, diphenhydramine, chlorpheniramine, promethazine, gentamicin, ciprofloxacin, cefoxitin, miconazole, terconazole, econazole, isoconazole, butoconazole, clotrimazole, itraconazole, nystatin, naftifine, amphotericin B, antiparasitic agents, hormones, hormone antagonists, immunomodulators, neurotransmitter antagonists, antiglaucoma drugs, vitamins, sedatives, and imaging agents, paclitaxel, cytochalasin B, gramicidin D, ethidium bromide, emetine, mitomycin, etoposide, teniposide, colchicine, daunorubicin, mitoxantrone, mithramycin, 1-dehydrotestosterone, glucocorticoids, procaine, tetracaine, lidocaine, puromycin, maytansinoids. In a specific embodiment of the present invention, it is preferred that the N / P ratio of the lipid composition to the nucleic acid is (0.1 - 100):1, more preferably (0.2 - 30):1, and most preferably (0.5 - 20):1. 4.1. Lipid Drug Composition Preparation In a specific embodiment of the present invention, the drug in the lipid drug composition is a nucleic acid drug, and the working solution of the lipid drug composition preparation is deionized water, ultrapure water, phosphate buffer solution, or physiological saline, more preferably phosphate buffer solution or physiological saline, and most preferably physiological saline; preferably, lipid composition:working solution = (0.05 - 20) g:100 mL, more preferably (0.1 - 10) g:100 mL, and most preferably (0.2 - 5) g:100 mL. In a specific embodiment of the present invention, a lipid drug composition preparation contains the aforementioned lipid drug composition and a pharmaceutically acceptable diluent or excipient, and the diluent or excipient is preferably any one of deionized water, ultrapure water, phosphate buffer solution, and physiological saline, more preferably phosphate buffer solution or physiological saline, and most preferably physiological saline. In the present invention, the preparation of the lipid drug composition preparation includes the following steps: (1) Equilibrate the lipid composition in the diluent or excipient; (2) Add the nucleic acid drug to the mixture of the equilibrated lipid composition and the diluent or excipient for complexation; Among them, preferably, the equilibration time is 0.1 to 12 h, preferably 0.2 to 6 h, more preferably 0.5 to 3 h; preferably, the compounding time is 0.1 to 12 h, preferably 0.2 to 5 h, more preferably 0.5 to 2 h. 5. Liposomes or lipid nanoparticles and their preparation 5.1. Liposomes or lipid nanoparticles In a specific embodiment of the present invention, a liposome or lipid nanoparticle contains any one of the lipid drug compositions described above. In a specific embodiment of the present invention, preferably, the aforementioned lipid nanoparticles are LNP-drug compositions, LPP-drug compositions or PNP-drug compositions; preferably LNP-drug compositions; more preferably LNP-nucleic acid drug compositions; more preferably LNP-mRNA drug compositions. 5.2. Preparation of liposomes or lipid nanoparticles In a specific embodiment of the present invention, liposomes can be prepared by the following methods, including but not limited to thin film dispersion method, ultrasonic dispersion method, reverse phase evaporation method, freeze drying method, freeze-thaw method, multiple emulsion method and injection method, preferably thin film dispersion method, ultrasonic dispersion method and / or reverse phase evaporation method. In a specific embodiment of the present invention, lipid nanoparticles can be prepared by the following methods, including but not limited to microemulsion method, multiple emulsion method, high shear homogenization ultrasonic method, thin film hydration extrusion method, microfluidic method. In a specific embodiment of the present invention, liposomes are prepared by the thin film dispersion method, and the thin film dispersion method includes the following steps: (1) Weigh cationic lipid, steroid lipid, neutral lipid and polyethylene glycolated lipid, dissolve them fully in an organic solvent, shake well, remove the organic solvent by rotary evaporation under reduced pressure to form an oil film, and dry it with a vacuum pump to remove the organic solvent; (2) Add phosphate buffer solution dissolved with cryoprotectant, and perform ultrasonic bath to form a semi-transparent emulsion; (3) Add the emulsion to a high-pressure homogenizer for overpressure, and then add the overpressurized emulsion to a liposome extruder for membrane filtration to form liposomes; (4) Optionally, dry the liposomes in a freeze dryer to form liposome powder; In a specific embodiment of the preparation method of liposomes in the present invention, the ratio of liposomes to phosphate buffer solution dissolved with cryoprotectant can be 1 mg:(0.1 - 100) mL, preferably 1 mg:(0.3 - 50) mL, more preferably 1 mg:(0.5 - 5) mL. In a specific embodiment of the present invention, preferably, the lipid nanoparticles are prepared by a method of microfluidics, vortex or simple mixing, and the steps are as follows: (1) Dissolve each lipid component in an organic solvent to obtain a lipid composition dissolved in the organic phase; the organic phase is preferably ethanol; (2) Add the nucleic acid drug to a buffer solution to obtain an aqueous solution; the aqueous phase is preferably citrate buffer salt or sodium acetate buffer solution; (3) Mix the organic phase solution and the aqueous solution to form a lipid nanoparticle composition by means of a microfluidic device, vortex or pipette, and purify it by ultrafiltration or the like to remove the organic solvent and free nucleic acid molecules. The preparation method of the present invention includes any protection and deprotection processes for specific groups required by the reaction. The intermediates and end products prepared in the present invention can be purified by methods including but not limited to extraction, recrystallization, adsorption treatment, precipitation, antprecipitation, film dialysis, supercritical extraction, column chromatography (including gel column, ion column, silica gel column, etc.). The characterization of the structure, molecular weight and purity of the intermediates and end products can be carried out by methods including but not limited to 1 H NMR, electrophoresis, ultraviolet-visible spectrophotometer, FTIR, AFM, GPC, HPLC, MALDI-TOF MS and circular dichroism spectrometry. In the present invention, the structure of the cationic lipid end product is characterized by nuclear magnetic resonance, and the molecular weight is confirmed by mass spectrometry; the molecular weight (by default, the number-average molecular weight Mn) and polydispersity index (PDI) of the polymer are determined by gel permeation chromatography (GPC), and the degree of polymerization of the polymer (by default, the number-average degree of polymerization) is calculated according to its molecular weight. The preparation methods of the cationic lipid, lipid composition, lipid drug composition, lipid drug composition preparation and the bioactivity test of the lipid drug composition are further described below in conjunction with some specific examples. The specific examples are for further detailed description of the present invention and do not limit the protection scope of the present invention. Example 1: Cationic lipid (E1-1) The preparation process is as follows: Step a: Adsorb glycerol (S1-1, 0.74 g, 8.0 mmol) on silica gel of the same weight by vigorous stirring for 30 minutes, then successively add nonanoic acid (S1-2, 2.53 g, 16.0 mmol), immobilized lipase R. miehei (0.20 g) and molecular sieve (0.55 g) to the preparation, and suspend the mixture in diethyl ether (50 mL), stir and react at room temperature for 48 h, and continuously monitor the reaction by TLC analysis. After the reaction is completed, separate the lipase and silica gel by filtration, concentrate the filtrate, and recrystallize the obtained crude product in methanol to obtain compound S1-3 (2.42 g). Step b: Under nitrogen protection, N,N'-dicyclohexylcarbodiimide (DCC, 2.27 g, 11.0 mmol) was added to a round-bottom flask containing S1-3 (2.24 g, 6.0 mmol), 6-bromohexanoic acid (S1-4, 0.98 g, 5.0 mmol), and 4-dimethylaminopyridine (DMAP, 0.15 g, 1.3 mmol) dissolved in dichloromethane (60 mL). The reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated, and the crude product obtained was purified by column chromatography to obtain S1-5 (2.32 g). Step c: Under nitrogen protection, compound N-hydroxyethylpiperazine (S1-6, 0.39 g, 3.0 mmol) was dissolved in acetonitrile (30 mL). S1-5 (2.15 g, 3.9 mmol) and N,N-diisopropylethylamine (DIPEA, 0.50 g, 3.9 mmol) were successively added under slow stirring, and the reaction was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated, dissolved in dichloromethane, and then extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. The product was purified by column chromatography to obtain S1-7 (1.48 g). Step d: Under nitrogen protection, N,N'-dicyclohexylcarbodiimide (DCC, 0.68 g, 3.3 mmol) was added to a round-bottom flask containing linoleic acid (S1-8, 0.42 g, 1.5 mmol), S1-7 (1.08 g, 1.8 mmol), and DMAP (0.05 g, 0.4 mmol) dissolved in dichloromethane (20 mL). The reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated, and the crude product obtained was purified by column chromatography to obtain cationic lipid E1-1 (1.09 g). 11H NMR (400 MHz, CDCl3) δ: 5.37 - 5.31 (m, 5H; 1H, -C(=O)OCH<; 4H, -CH=CHCH2CH=CH-), 4.38 - 4.29 (m, 2H, >CH(CH2OC(=O))2-), 4.20 (t, 2H, pip-CH2CH2OC(=O)-), 4.19 - 4.14 (m, 2H, >CH(CH2OC(=O))2-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.72 - 2.40 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.32 - 2.27 (m, 8H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 46H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z = 860.7 ([M+H] + )。 Example 2.1: Cationic Lipid (E2-1) The preparation process is as follows: Step a: Add freshly activated magnesium turnings (0.66 g, 27.6 mmol) and 2 mL of anhydrous ether to a clean round-bottom flask. Dissolve the bromide 9-bromo-1-nonene (S2-1, 4.55 g, 22.2 mmol) in anhydrous ether (60 mL) and add it to a dropping funnel. Under an ice bath condition, add the bromide ether solution dropwise to the magnesium turnings. After the addition is complete, react the reaction mixture at 35 °C for 1 h, and then cool it in an ice bath. Dissolve ethyl formate (0.74 g, 10.0 mmol) in anhydrous ether (6 mL), add it to the dropping funnel, and add it to the reaction solution with stirring. After the reaction solution starts to reflux, quickly add the remaining ether solution of the formate. Stir the reaction solution at room temperature for another 1 h. Quench the reaction by dropwise adding 5 mL of acetone and ice water (15 mL). Treat the reaction solution with aqueous H2SO4 (10% by volume, 100 mL) until the solution becomes homogeneous, and let it stand for liquid separation. Extract the aqueous phase with ether (50 mL * 2), combine the organic phases, dry over anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify the crude product by column chromatography to obtain compound S2-2 (2.52 g, 90%). Step b: Dissolve S2-2 (1.96 g, 7.0 mmol) in a mixed solution of dichloromethane (15 mL) and acetonitrile (15 mL), then add ruthenium chloride (RuCl3, 0.26 g, 1.2 mmol). Cool the mixture to 10 °C, and slowly add an aqueous solution of sodium periodate (0.15 g, 0.7 mmol) dropwise, and stir the reaction at 10 °C for 20 h. After the reaction is completed, dilute the reaction solution with water, separate the organic phase and the aqueous phase. Add saturated brine to the organic phase under stirring, and then slowly add 3% sodium sulfide solution dropwise for decolorization. Separate the organic phase and the aqueous phase, dry the organic phase with anhydrous magnesium sulfate, filter, concentrate, and obtain compound S2-3 (1.90 g). Step c: Under a nitrogen atmosphere, add tert-butyldimethylchlorosilane (0.83 g, 5.5 mmol) to a round-bottom flask containing S2-3 (1.58 g, 5.0 mmol) and imidazole (0.85 g, 12.5 mmol) dissolved in DMF (30 mL). Stir the reaction solution at 50 °C overnight. After the reaction is completed, cool to room temperature, dilute the reaction solution with water, extract three times with ethyl acetate, combine the organic phases and wash once with saturated brine, dry the organic phase with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify by column chromatography to obtain the diacid with the hydroxyl group protected by TBS (S2-4, 1.97 g, 91.2%). Step d: Under nitrogen protection, add DCC (3.71 g, 18.0 mmol) to a round-bottom flask containing 2-nonen-1-ol (S2-5, 1.42 g, 10.0 mmol), S2-4 (1.72 g, 4.0 mmol) and DMAP (0.24 g, 2.0 mmol) dissolved in dichloromethane (80 mL), and react at room temperature for 16 h. After the reaction is completed, remove the precipitate by filtration and concentrate the filtrate. Dissolve the residue in tetrahydrofuran (20 mL), then add 20 mL of a 1 M solution of TBAF in tetrahydrofuran, and react overnight to remove the TBS protection. After the reaction is completed, concentrate, extract, and combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, obtain the crude product of S2-6, and purify by column chromatography to obtain compound S2-6 (1.72 g). Step e: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S2-6 (1.36 g, 2.4 mmol), 4-Boc-1-piperazineacetic acid (S2-7, 0.49 g, 2.0 mmol), and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL). The reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, and the filtrate was concentrated to obtain a crude product. The crude product was dissolved in dichloromethane, TFA was added to 0.1 M, and the reaction was carried out for 4 h. The pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and recrystallization was carried out to obtain compound S2-8 (1.04 g). Step f: Under ice bath conditions, linolenyl alcohol (S2-9, 0.80 g, 3.0 mmol) and triethylamine (0.86 g, 8.6 mmol) were added to dichloromethane (20 mL). Subsequently, a dichloromethane (10 mL) solution containing acryloyl chloride (S2-10, 0.41 g, 4.5 mmol) was added dropwise to the reaction system, and the reaction solution was stirred at 20 °C for 2 h. After the reaction was completed, the precipitate was removed by filtration, and the filtrate was washed successively with water and 5% hydrochloric acid by mass. The organic phase was dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and the residue was purified by column chromatography to obtain compound (9Z,12Z)-9,12-dienyloctadecyl acrylate (S2-11, 0.72 g). Step g: S2-8 (0.69 g, 1.0 mmol) was dissolved in isopropanol. Under stirring, a sufficient amount of anhydrous potassium carbonate was added, and the mixture was stirred at room temperature until the reaction solution became alkaline. S2-11 (0.48 g, 1.5 mmol) was added to the reaction solution, and the reaction solution was placed in a reflux device (90 °C) and stirred for an additional 36 h. After the reaction was completed, the reaction solution was concentrated to obtain a crude product, which was purified by column chromatography to obtain cationic lipid E2-1 (0.76 g). 11H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 5.40 - 5.31 (m, 4H, -CH=CHCH2CH=CH-), 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 4.20 (s, 2H, pip-CH2CH2OC(=O)-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.73 - 2.40 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.63 - 1.22 (m, 56H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 9H, -CH2CH3). MS (ESI): m / z = 997.7 ([M+H] + )。 Example 2.2: Cationic Lipid (E2-2) The preparation process is as follows: Step a: Under nitrogen protection, DCC (3.71 g, 18.0 mmol) was added to a round-bottom flask containing 1-nonanol (S2-12, 1.44 g, 10.0 mmol), S2-4 (1.72 g, 4.0 mmol) and DMAP (0.24 g, 2.0 mmol) dissolved in dichloromethane (80 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, and the filtrate was concentrated. The residue was dissolved in tetrahydrofuran (20 mL), and then 20 mL of a tetrahydrofuran solution of TBAF (1 M) was added, and the reaction was carried out overnight to remove the TBS protection. After the reaction was completed, the organic phase was concentrated, extracted, combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated to obtain the crude product of S2-13, which was purified by column chromatography to obtain compound S2-13 (1.73 g). Step b: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S2-13 (1.37 g, 2.4 mmol), S2-7 (0.49 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated to obtain a crude product. The crude product was dissolved in dichloromethane, TFA was added to 0.1 M, the reaction was carried out for 4 hours, the pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, extracted with dichloromethane, the organic phase was dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and recrystallized to obtain compound S2-14 (1.04 g). Step c: S2-14 (0.69 g, 1.0 mmol) was dissolved in isopropanol, an adequate amount of anhydrous potassium carbonate was added with stirring, and the mixture was stirred at room temperature until the reaction solution became alkaline. S2-11 (0.48 g, 1.5 mmol) was added to the reaction solution, and the reaction solution was placed in a reflux device (90 °C) and stirred continuously for 36 h. After the reaction was completed, the reaction solution was concentrated to obtain a crude product, which was purified by column chromatography to obtain cationic lipid E2-2 (0.77 g). 1 H NMR (400 MHz, CDCl3) δ: 5.41 - 5.31 (m, 4H, -CH=CHCH2CH=CH-), 4.95 - 4.87 (m, 1H, -C(=O)OCH<), 4.20 (t, 2H, pip-CH2CH2OC(=O)-), 4.06 (t, 4H, -C(=O)OCH2CH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.73 - 2.41 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 68H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=1000.8 ([M+H] + )。 Example 3: Cationic lipid (E3-1) The preparation process is as follows: Step a: Under nitrogen protection, DCC (3.71 g, 18.0 mmol) was added to a round-bottom flask containing 3-decyn-1-ol (S3-1, 1.54 g, 10.0 mmol), S2-4 (1.72 g, 4.0 mmol) and DMAP (0.24 g, 2.0 mmol) dissolved in dichloromethane (80 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration and the filtrate was concentrated. The residue was dissolved in tetrahydrofuran (20 mL), and then 20 mL of a TBAF tetrahydrofuran solution (1 M) was added, and the reaction was carried out overnight to remove the TBS protection. After the reaction was completed, the organic phase was concentrated, extracted, combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated to obtain the crude product of S3-2, which was purified by column chromatography to obtain compound S3-2 (1.75 g). Step b: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S3-2 (1.41 g, 2.4 mmol), S2-7 (0.49 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration and the filtrate was concentrated to obtain the crude product. The crude product was dissolved in dichloromethane, TFA was added to 0.1 M, and the reaction was carried out for 4 h. The pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated and recrystallized to obtain compound S3-3 (1.07 g). Step c: S3-3 (0.72 g, 1.0 mmol) was dissolved in isopropanol, an adequate amount of anhydrous potassium carbonate was added with stirring, and the mixture was stirred at room temperature until the reaction solution became alkaline. S2-11 (0.48 g, 1.5 mmol) was added to the reaction solution, and the reaction solution was placed in a reflux device (90 °C) and stirred for an additional 36 h. After the reaction was completed, the reaction solution was concentrated to obtain the crude product, which was purified by column chromatography to obtain the cationic lipid E3-1 (0.78 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.32 (m, 4H, -CH=CHCH2CH=CH-), 4.90 - 4.79 (m, 1H, -C(=O)OCH<), 4.20 (s, 2H, pip-CH2CH2OC(=O)-), 4.12 (t, 4H, -C(=O)OCH2CH2C≡C-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.74 - 2.40 (m, 14H; 8H, pip-H; 2H, pip-CH2CH2-; 4H, C(=O)OCH2CH2C≡C-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.16 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 56H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z = 1020.8 ([M+H] + )。 Example 4: Cationic Lipid (E4-1) The preparation process is as follows: Step a: Under ice bath conditions, dissolve S4-1 (0.60 g, 5.0 mmol) in dichloromethane solution, then add DCC (1.13 g, 5.5 mmol) and DMAP (0.31 g, 2.5 mmol). After stirring the mixture for 10 minutes, slowly add t-BuOH (0.66 g, 7.5 mmol), and stir the mixed solution at room temperature overnight. After the reaction is completed, filter the reaction solution through diatomaceous earth, wash it three times with ether and once with saturated brine. Combine the organic phases, dry over anhydrous magnesium sulfate, filter, and concentrate to obtain the crude product of S4-2, which is purified by column chromatography to obtain S4-2 (0.80 g, 91.1%). Step b: Under nitrogen protection, DCC (2.78 g, 13.5 mmol) was added to a round-bottom flask containing S4-2 (0.53 g, 3.0 mmol), S1-8 (2.10 g, 7.5 mmol) and DMAP (0.18 g, 1.5 mmol) dissolved in dichloromethane (60 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, and the filtrate was concentrated to obtain a crude product. In a dry and clean round-bottom flask, a solution of trifluoroacetic acid / dichloromethane (1:2, v / v) was prepared, and the dichloromethane solution of the above crude product was slowly added dropwise under ice bath conditions, and the reaction was carried out at room temperature for 2 h. After the reaction was completed, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and recrystallization was carried out to obtain compound S4-3 (1.58 g). Step c: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing tert-butyl 4-(2-hydroxyethyl)piperazine-1-carboxylate (S4-4, 0.55 g, 2.4 mmol), S4-3 (1.29 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, and the filtrate was concentrated to obtain a crude product. The crude product was dissolved in dichloromethane again, TFA was added to 0.1 M, and the reaction was carried out for 4 h. The pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and recrystallization was carried out to obtain compound S4-5 (1.14 g). Step d: S4-5 (0.76 g, 1.0 mmol) was dissolved in isopropanol, and sufficient anhydrous potassium carbonate was added with stirring, and the mixture was stirred at room temperature until the reaction solution was alkaline. Then S2-11 (0.48 g, 1.5 mmol) was added to the reaction solution, and the reaction solution was placed in a reflux device (90 °C) and stirred for 36 h. After the reaction was completed, the reaction solution was concentrated to obtain a crude product, which was purified by column chromatography to obtain cationic lipid E4-1 (0.81 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 12H, -CH=CHCH2CH=CH-), 4.39 - 4.29 (m, 4H, >CH(CH2OC(=O)2-), 3.02 (q, 1H, >CHC(=O)OCH2-), 4.22 (t, 4H, pip-CH2CH2OC(=O)-), 2.77 (t, 6H, -CH=CHCH2CH=CH-), 2.73 - 2.40 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 12H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 48H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=1062.9 ([M + H] + )。 Example 5: Cationic Lipid (E5-1) The preparation process is as follows: Step a: Under nitrogen protection, to a round-bottom flask containing 2-hexylundecanoic acid (S5-2, 0.77 g, 3.0 mmol), S5-1 (0.88 g, 3.6 mmol, S5-1 was obtained by reacting t-BuOH with the carboxyl terminus of [4-(2-hydroxyethyl)-1-piperazinyl]acetic acid and DMAP (0.09 g, 0.8 mmol) dissolved in dichloromethane (30 mL), add DCC (1.36 g, 6.6 mmol), and react at room temperature for 16 h. After the reaction is completed, remove the precipitate by filtration, concentrate the filtrate to obtain the crude product. In a dry and clean round-bottom flask, prepare a solution of trifluoroacetic acid / dichloromethane (1:2, v / v), and slowly add the dichloromethane solution of the above crude product dropwise under ice bath conditions, and react at room temperature for 2 hours. After the reaction is completed, concentrate the reaction solution, add purified water, extract with dichloromethane, dry the organic phase with anhydrous magnesium sulfate, filter, concentrate the filtrate, and recrystallize to obtain compound S5-3 (1.01 g). Step b: Under nitrogen protection, to a round-bottom flask containing S2-6 (1.36 g, 2.4 mmol), S5-3 (0.85 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), add DCC (0.91 g, 4.4 mmol), and react at room temperature for 16 h. After the reaction is completed, remove the precipitate by filtration, concentrate the filtrate, and purify the obtained crude product by column chromatography to obtain cationic lipid E5-1 (1.59 g).1 1H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 4.94 - 4.88 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 4.21 (t, 2H, pip-CH2CH2-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.72 - 2.40 (m, 11H; 8H, pip-H; 2H, pip-CH2CH2-; 1H, >CHC(=O)O-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 64H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 12H, -CH2CH3). MS (ESI): m / z=972.9 ([M+H] + )。 Example 6: Cationic Lipid (E6-1) The preparation process is as follows: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S3-2 (1.41 g, 2.4 mmol), S5-3 (0.85 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated, and the crude product obtained was purified by column chromatography to obtain cationic lipid E6-1 (1.64 g). 11H NMR (400 MHz, CDCl3) δ: 4.90 - 4.79 (m, 1H, -C(=O)OCH<), 4.19 (t, 2H, pip-CH2CH2-), 4.12 (t, 4H, -C(=O)OCH2CH2C≡C-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.73 - 2.40 (m, 15H; 8H, pip-H; 2H, pip-CH2CH2-; 1H, >CHC(=O)O-; 4H, -C(=O)OCH2CH2C≡C-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.16 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 1.65 - 1.21 (m, 64H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 12H, -CH2CH3). MS (ESI): m / z = 996.9 ([M + H] + )。 Example 7.1: Cationic Lipid (E7-1) The preparation process is as follows: Step a: Under ice bath conditions, add (9Z,12Z)-octadeca-9,12-dienal (S7-1, 2.64 g, 10.0 mmol), DL-proline (0.35 g, 3.0 mmol) and N-chlorosuccinimide to acetonitrile (40 mL), and then stir at 0 °C for 2 h. After the reaction is completed, dilute the reaction solution with absolute ethanol (30 mL), add sodium borohydride (0.53 g, 14.0 mmol), and then continue to stir at 0 °C for 4 h. After the reaction ends, add water (10 mL) to quench the reaction mixture, extract with methyl tert-butyl ether, combine the organic phases, wash with saturated brine, dry over anhydrous magnesium sulfate, filter, and concentrate the filtrate to obtain the target product (9Z,12Z)-2-chloro-octadeca-9,12-dien-1-ol (S7-2, 2.82 g), which is directly used for the next step. Step b: At room temperature, add S7-2 (2.41 g, 8.0 mmol) and aqueous NaOH solution (5 M, 32 mL) to 1,4-dioxane (30 mL). After dropping, stir the mixture at 35 °C for 2 h. After the reaction ends, separate the reaction solution through a separatory funnel, wash with saturated brine, dry over anhydrous magnesium sulfate, filter, and evaporate to concentrate. Purify by column chromatography to obtain the target product S7-3 (1.56 g). Step c: S2-8 (1.54 g, 2.0 mmol) and DIPEA (0.15 g, 1.2 mmol) were successively added to a methanol solution of S7-3 (0.79 g, 3.0 mmol), and the reaction solution was placed in a reflux apparatus (90 °C) and stirred for an additional 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E7-1 (1.39 g). 1 H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 5.40 - 5.31 (m, 4H, -CH=CHCH2CH=CH-), 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 3.68 - 3.60 (m, 1H, -CH(OH)-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 12H; 8H, pip-H; 2H, pip-CH2CH<), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 56H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=954.8 ([M+H] + )。 Example 7.2: Cationic Lipid (E7-2) The preparation process is as follows: S2-14 (1.54 g, 2.0 mmol) and DIPEA (0.15 g, 1.2 mmol) were successively added to a methanol solution of S7-3 (0.79 g, 3.0 mmol), and the reaction solution was placed in a reflux apparatus (90 °C) and stirred for an additional 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E7-2 (1.40 g). 11H NMR (400 MHz, CDCl3) δ: 5.39 - 5.31 (m, 4H, -CH=CHCH2CH=CH-), 4.93 - 4.87 (m, 1H, -C(=O)OCH<), 4.04 (t, 4H, -C(=O)OCH2CH2-), 3.68 - 3.60 (m, 1H, -CH(OH)-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 68H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z = 958.9 ([M+H] + )。 Example 8: Cationic Lipid (E8-1) The preparation process is as follows: Step a: Under ice bath conditions, to a round-bottom flask containing diethyl 3-hydroxyglutarate (S8-1, 2.64 g, 15.0 mmol) dissolved in dichloromethane (80 mL), tert-butyldimethylchlorosilane (TBDMSCl, 2.72 g, 18.0 mmol) and imidazole (2.04 g, 30.0 mmol) were added successively. The reaction mixture was warmed to room temperature and stirred for an additional 17 h. After completion of the reaction, the reaction mixture was filtered and concentrated, and the crude product was purified by column chromatography to obtain compound S8-2 (2.96 g). Step b: Under ice bath conditions, to a round-bottom flask containing S8-2 (2.61 g, 9.0 mmol) dissolved in dichloromethane (30 mL), a solution of diisobutylaluminum hydride (DIBAL-H) in THF (1 M, 7.2 mL, 7.2 mmol) was added. The reaction mixture was warmed to room temperature and stirred for an additional 17 h. After completion of the reaction, the reaction was quenched with MeOH, the reaction mixture was filtered and concentrated, and the crude product was purified by column chromatography to obtain compound S8-3 (1.18 g). Step c: Under nitrogen protection, DCC (3.71 g, 18.0 mmol) was added to a round-bottom flask containing S1-8 (2.80 g, 10.0 mmol), S8-3 (0.94 g, 4.0 mmol) and DMAP (0.24 g, 2.0 mmol) dissolved in dichloromethane (50 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration and the filtrate was concentrated. The residue was dissolved in tetrahydrofuran (20 mL), then 20 mL of a TBAF tetrahydrofuran solution (1 M) was added, and the reaction was carried out overnight to remove the TBS protection. After the reaction was completed, the organic phase was concentrated, extracted and combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated to obtain the crude product of S8-4, which was purified by column chromatography to obtain compound S8-4 (1.99 g). Step d: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S8-4 (1.55 g, 2.4 mmol), S2-7 (0.49 g, 2.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration and the filtrate was concentrated to obtain the crude product. The crude product was dissolved in dichloromethane, TFA was added to 0.1 M, and the reaction was carried out for 4 h. The pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated and recrystallized to obtain compound S8-5 (1.16 g). Step e: S8-5 (0.77 g, 1.0 mmol) and DIPEA (0.10 g, 0.8 mmol) were successively added to a methanol solution of S7-3 (0.40 g, 1.5 mmol), and the reaction solution was placed in a reflux device (90 °C) and stirred for 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E8-1 (0.75 g). 11H NMR (400 MHz, CDCl3) δ: 5.46 - 5.29 (m, 12H, -CH=CH-), 5.17 - 5.08 (m, 1H, -C(=O)OCH<), 4.19 - 4.00 (m, 4H, -C(=O)OCH2-), 3.68 - 3.60 (m, 1H, -CH(OH)-), 3.19 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 6H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 12H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 52H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=1034.9 ([M+H] + )。 Example 9: Cationic Lipid (E9-1) The preparation process is as follows: Step a: Under nitrogen protection, DCC (0.91 g, 4.4 mmol) was added to a round-bottom flask containing S2-5 (0.68 g, 4.8 mmol), S1-4 (0.78 g, 4.0 mmol) and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL), and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated, and the obtained crude product was purified by column chromatography to obtain S9-1 (1.05 g). Step b: Under nitrogen protection, compound S8-5 (1.54 g, 2.0 mmol) was dissolved in acetonitrile (30 mL), and S9-1 (0.83 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) were successively added under slow stirring, and the reaction was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated and dissolved in dichloromethane, and then extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. The cationic lipid E9-1 (1.66 g) was obtained by column chromatography purification. 11H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 1H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 1H, -C(=O)OCH2CH=CH-), 5.46 - 5.29 (m, 8H, -CH=CH-), 5.17 - 5.08 (m, 1H, -C(=O)OCH<), 4.51 (d, 2H, -C(=O)OCH2CH=CH-), 4.19 - 4.00 (m, 4H, -C(=O)OCH2-), 3.19 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 10H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 50H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=1008.8 ([M+H] + )。 Example 10: Cationic Lipid (E10-1) The preparation process is as follows: Dissolve S8-5 (1.54 g, 2.0 mmol) in isopropanol, add a sufficient amount of anhydrous potassium carbonate under stirring, and stir at room temperature until the reaction solution becomes alkaline. Then add S2-11 (0.79 g, 3.0 mmol) to the reaction solution, and place the reaction solution in a reflux device (90 °C) and continue stirring for reaction for 36 h. After the reaction is completed, concentrate the reaction solution to obtain a crude product, and purify it by column chromatography to obtain cationic lipid E10-1 (1.70 g). 11H NMR (400 MHz, CDCl3) δ: 5.46 - 5.29 (m, 12H, -CH=CH-), 5.17 - 5.08 (m, 1H, -C(=O)OCH<), 4.20 - 4.00 (m, 6H, -C(=O)OCH2-), 3.19 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 6H, -CH=CHCH2CH=CH-), 2.74 - 2.40 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 12H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 52H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=1076.9 ([M+H] + )。 Example 11: Cationic Lipid (E11-1) The preparation process is as follows: S4-5 (1.51 g, 2.0 mmol) and DIPEA (0.15 g, 1.2 mmol) were successively added to a methanol solution of 1,2-epoxytetradecane (S11-1, 0.64 g, 3.0 mmol), and the reaction solution was placed in a reflux device (90 °C) and stirred for 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E11-1 (1.41 g). 1 1H NMR (400 MHz, CDCl3) δ: 5.46 - 5.29 (m, 8H, -CH=CH-), 4.39 - 4.29 (m, 4H, >CH(CH2OC(=O)2-), 4.19 - 4.00 (m, 2H, -C(=O)OCH2-), 3.02 (q, 1H, >CHC(=O)OCH2-), 3.70 - 3.61 (m, 1H, -CH(OH)-), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 12H; 8H, pip-H; 4H, pip-CH2-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 54H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=968.9 ([M+H] + )。 Example 12: Cationic Lipid (E12-1) The preparation process is as follows: Step a: Under nitrogen protection, to a round-bottom flask containing S12-2 (0.87 g, 4.8 mmol), S12-1 (1.02 g, 4.0 mmol) and DMAP (0.12 g, 1.0 mmol) dissolved in dichloromethane (50 mL), DCC (1.81 g, 8.8 mmol) was added, and the reaction was carried out at room temperature for 16 h. After the reaction was completed, the precipitate was removed by filtration, the filtrate was concentrated, and the obtained crude product was purified by column chromatography to obtain S12-3 (1.39 g). Step b: Under nitrogen protection, compound S8-5 (1.54 g, 2.0 mmol) was dissolved in acetonitrile (30 mL). Under slow stirring, S12-3 (1.09 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) were successively added, and the reaction was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated and then dissolved in dichloromethane. Then, it was extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then, the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. The cationic lipid E12-1 (1.86 g) was obtained by column chromatography purification. 1 H NMR (400 MHz, CDCl3) δ: 5.46 - 5.29 (m, 8H, -CH=CH-), 5.17 - 5.08 (m, 1H, -C(=O)OCH<), 4.19 - 4.00 (m, 6H, -C(=O)OCH2-), 3.19 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.73 - 2.40 (m, 11H; 8H, pip-H; 2H, pip-CH2CH2-; 1H, >CHC(=O)O-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 68H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 12H, -CH2CH3). MS (ESI): m / z=1109.0 ([M+H] + ) Example 13: Cationic Lipid (E13-1) The preparation process is as follows: Under nitrogen protection, compound S2-14 (1.39 g, 2.0 mmol) was dissolved in acetonitrile (30 mL). Under slow stirring, S12-3 (1.09 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) were successively added, and the mixture was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated, dissolved in dichloromethane, and then extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. The cationic lipid E13-1 (1.71 g) was obtained by column chromatography purification. 1 H NMR (400 MHz, CDCl3) δ: 4.94 - 4.86 (m, 1H, -C(=O)OCH<), 4.05 (t, 6H, -C(=O)OCH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.73 - 2.41 (m, 11H; 8H, pip-H; 2H, pip-CH2CH2-; 1H, >CHC(=O)O-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 1.65 - 1.21 (m, 84H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 12H, -CH2CH3). MS (ESI): m / z=1033.0 ([M+H] + )。 Example 14: Cationic Lipid (E14-1) The preparation process is as follows: Step a: Under nitrogen protection, compound S14-1 (0.56 g, 3.0 mmol) was dissolved in acetonitrile (30 mL). Under slow stirring, S1-5 (2.15 g, 3.9 mmol) and DIPEA (0.50 g, 3.9 mmol) were successively added, and the mixture was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated, dissolved in dichloromethane, and then extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated to obtain a crude product. The crude product was dissolved in dichloromethane again, TFA was added to 0.1 M, and the reaction was carried out for 4 hours. The pH was adjusted to neutral, the reaction solution was concentrated, purified water was added, and the mixture was extracted with dichloromethane. The organic phase was dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. Recrystallization was carried out to obtain compound S14-2 (1.44 g). Step b: Under nitrogen protection, dissolve compound S14-2 (1.11 g, 2.0 mmol) in acetonitrile (30 mL). With slow stirring, sequentially add S12-3 (1.09 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol), and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it in dichloromethane, and then extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then combine the organic phases, dry over anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify by column chromatography to obtain cationic lipid E14-1 (1.48 g). 1 H NMR (400 MHz, CDCl3) δ: 5.37 - 5.31 (m, 1H, -C(=O)OCH<), 4.38 - 4.29 (m, 2H, >CH(CH2OC(=O))2-), 4.19 - 4.13 (m, 2H, >CH(CH2OC(=O))2-), 4.04 (t, 2H, -C(=O)OCH2CH2-), 2.71 - 2.40 (m, 13H; 8H, pip-H; 4H, pip-CH2CH2-; 1H, >CHC(=O)O-), 2.32 - 2.27 (m, 6H, -CH2CH2C(=O)O-), 1.65 - 1.21 (m, 62H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 12H, -CH2CH3). MS (ESI): m / z=892.8 ([M+H] + )。 Example 15.1: Cationic lipid (E15-1) The preparation process is as follows: Dissolve S2-8 (0.69 g, 1.0 mmol) in isopropanol. With stirring, add an adequate amount of anhydrous potassium carbonate and stir at room temperature until the reaction solution becomes alkaline. Add dodecyl acrylate (S15-1, 0.36 g, 1.5 mmol) to the reaction solution, and place the reaction solution in a reflux device (90 °C) and continue stirring the reaction for 36 h. After the reaction is completed, concentrate the reaction solution to obtain a crude product, and purify by column chromatography to obtain cationic lipid E15-1 (0.79 g). 11H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 4.05 (t, 2H, -C(=O)OCH2CH2-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.71 - 2.41 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.37 - 2.25 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 60H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=931.9 ([M+H] + )。 Example 15.2: Cationic Lipid (E15-2) The preparation process is as follows: Dissolve S2-14 (0.70 g, 1.0 mmol) in isopropanol, add a sufficient amount of anhydrous potassium carbonate under stirring, and stir at room temperature until the reaction solution becomes alkaline. Then add S15-1 (0.36 g, 1.5 mmol) to the reaction solution, and place the reaction solution in a reflux device (90 °C) and continue to stir and react for 36 h. After the reaction is completed, concentrate the reaction solution to obtain a crude product, and purify it by column chromatography to obtain cationic lipid E15-2 (0.81 g). 1 1H NMR (400 MHz, CDCl3) δ: 4.94 - 4.88 (m, 1H, -C(=O)OCH<), 4.07 (t, 6H, -C(=O)OCH2CH2-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.71 - 2.41 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.37 - 2.25 (m, 6H, -CH2CH2C(=O)O-), 1.65 - 1.21 (m, 72H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=934.8 ([M+H] + )。 Example 16: Cationic Lipid (E16-1) The preparation process is as follows: S2-8 (1.38 g, 2.0 mmol) and DIPEA (0.21 g, 1.6 mmol) were successively added to a methanol solution of S11-1 (0.64 g, 3.0 mmol), and the reaction solution was placed in a reflux apparatus (90 °C) and continuously stirred for reaction for 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E16-1 (1.32 g). 1 HNMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 3.70 - 3.61 (m, 1H, -CH(OH)-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH<), 2.37 - 2.25 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 62H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=902.8 ([M+H] + )。 Example 17.1: Cationic Lipid (E17-1) The preparation process is as follows: Under nitrogen protection, compound S2-8 (1.38 g, 2.0 mmol) was dissolved in acetonitrile (30 mL), and S17-1 (0.91 g, 2.6 mmol, S17-1 was prepared by reacting undecanol and 6-bromohexanoic acid was prepared by reaction) and DIPEA (0.34 g, 2.6 mmol) were successively added and stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated, dissolved in dichloromethane, extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, the organic phases were combined, dried over anhydrous magnesium sulfate, filtered, the filtrate was concentrated, and purified by column chromatography to obtain cationic lipid E17-1 (1.57 g). 11H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 2H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 2H, -C(=O)OCH2CH=CH-), 4.94 - 4.86 (m, 1H, -C(=O)OCH<), 4.51 (d, 4H, -C(=O)OCH2CH=CH-), 4.05 (t, 2H, -C(=O)OCH2CH2-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.71 - 2.41 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.37 - 2.25 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 64H, -CH2CH2CH2-,-CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=958.8 ([M+H] + )。 Example 17.2: Cationic Lipid (E17-2) The preparation process is as follows: Under nitrogen protection, dissolve compound S2-14 (1.39 g, 2.0 mmol) in acetonitrile (30 mL). Slowly add S17-1 (0.91 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) in sequence under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution in sequence, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E17-2 (1.60 g). 11H NMR (400 MHz, CDCl3) δ: 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.05 (t, 6H, -C(=O)OCH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.70 - 2.42 (m, 8H, pip-H), 2.37 - 2.25 (m, 8H; 2H, pip-CH2CH2-; 6H, -CH2CH2C(=O)O-), 1.70 - 1.63 (m, 4H, >CH(CH2)2-), 1.56 - 1.48 (m, 6H, -C(=O)OCH2CH2-), 1.48 - 0.97 (m, 66H, -CH2CH2CH2-, -CH2CH3), 0.89 (t, 9H, -CH2CH3). MS (ESI): m / z = 963.7 ([M+H] + )。 Example 18: Cationic Lipid (E18-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S2-8 (1.38 g, 2.0 mmol) in acetonitrile (30 mL). Sequentially add S9-1 (0.83 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it in dichloromethane, then extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Then combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E18-1 (1.53 g). 1 1H NMR (400 MHz, CDCl3) δ: 5.80 - 5.72 (m, 3H, -C(=O)OCH2CH=CH-), 5.60 - 5.51 (m, 3H, -C(=O)OCH2CH=CH-), 4.95 - 4.87 (m, 1H, -C(=O)OCH<), 4.51 (d, 6H, -C(=O)OCH2CH=CH-), 3.18 (s, 2H, pip-CH2C(=O)O-), 2.71 - 2.41 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.37 - 2.25 (m, 6H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 6H, -CH=CHCH2CH2-), 1.65 - 1.21 (m, 54H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z = 928.8 ([M+H] + )。 Example 19: Cationic Lipid (E19-1) The preparation process is as follows: Dissolve S3-3 (0.72 g, 1.0 mmol) in isopropanol, add a sufficient amount of anhydrous potassium carbonate under stirring, and stir at room temperature until the reaction solution becomes alkaline. Then add S15-1 (0.36 g, 1.5 mmol) to the reaction solution, and place the reaction solution in a reflux device (90 °C) and continue stirring for reaction for 36 h. After the reaction is completed, concentrate the reaction solution to obtain a crude product, and purify it by column chromatography to obtain cationic lipid E19-1 (0.82 g). 1 H NMR (400 MHz, CDCl3) δ: 4.90 - 4.80 (m, 1H, -C(=O)OCH<), 4.13 (t, 4H, -C(=O)OCH2CH2C≡C-), 4.04 (t, 2H, -C(=O)OCH2CH2CH2-), 2.72 - 2.63 (m, 4H, -C(=O)OCH2CH2C≡C-), 2.62 - 2.36 (m, 16H; 8H, pip-H; 4H, pip-CH2CH2-; 4H, pip-CH2CH2-), 2.30 (t, 4H, -OC(=O)CH2(CH2)6-), 2.17 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 1.65 - 1.21 (m, 60H, -CH2CH2CH2-, -CH2CH3), 0.87 (t, 9H, -CH2CH3). MS (ESI): m / z=969.7 ([M+H] + ) Example 20: Cationic Lipid (E20-1) The preparation process is as follows: Add S3-3 (1.43 g, 2.0 mmol) and DIPEA (0.21 g, 1.6 mmol) successively to the methanol solution of S11-1 (0.64 g, 3.0 mmol), and place the reaction solution in a reflux device (90 °C) and continue stirring for reaction for 24 h. After the reaction is completed, concentrate the reaction solution, and purify the crude product by column chromatography to obtain cationic lipid E20-1 (1.37 g). 11H NMR (400 MHz, CDCl3) δ: 4.90 - 4.79 (m, 1H, -C(=O)OCH<), 4.12 (t, 4H, -C(=O)OCH2CH2C≡C-), 3.70 - 3.61 (m, 1H, -CH(OH)-), 2.70 (t, 4H, -C(=O)OCH2CH2C≡C-), 2.59 - 2.35 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.33 - 2.21 (m, 6H; -OC(=O)CH2(CH2)6-, 4H; pip-CH2CH2-, 2H), 2.16 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 1.64 - 1.20 (m, 62H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 9H, -CH2CH3). MS (ESI): m / z = 942.0 ([M+H] + )。 Example 21: Cationic Lipid (E21-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S3-3 (1.43 g, 2.0 mmol) in acetonitrile (30 mL). Add S17-1 (0.91 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) successively under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E21-1 (1.66 g). 1 1H NMR (400 MHz, CDCl3) δ: 4.90 - 4.79 (m, 1H, -C(=O)OCH<), 4.12 (t, 4H, -C(=O)OCH2CH2C≡C-), 4.04 (t, 2H, -C(=O)OCH2CH2CH2-), 2.72 (t, 4H, -C(=O)OCH2CH2C≡C-), 2.59 - 2.35 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.33 - 2.21 (m, 8H, -OC(=O)CH2-), 2.16 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 1.64 - 1.20 (m, 64H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 9H, -CH2CH3). MS (ESI): m / z = 996.9 ([M+H] + )。 Example 22: Cationic Lipid (E22-1) The preparation process is as follows: S3-3 (1.43 g, 2.0 mmol) and DIPEA (0.21 g, 1.6 mmol) were successively added to the methanol solution of S7-3 (0.79 g, 3.0 mmol), and the reaction solution was placed in a reflux device (90 °C) and continuously stirred for reaction for 24 h. After the reaction was completed, the reaction solution was concentrated, and the crude product was purified by column chromatography to obtain cationic lipid E22-1 (1.45 g). 1 HNMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 4H, -CH=CHCH2CH=CH-), 4.90 - 4.79 (m, 1H, -C(=O)OCH<), 4.12 (t, 4H, -C(=O)OCH2CH2C≡C-), 3.70 - 3.61 (m, 1H, -CH(OH)-), 2.77 (t, 2H, -CH=CHCH2CH=CH-), 2.71 (t, 4H, -C(=O)OCH2CH2C≡C-), 2.59 - 2.35 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.33 - 2.21 (m, 6H, -OC(=O)CH2-), 2.16 - 2.08 (m, 4H, -C≡CCH2(CH2)4-), 2.07 - 2.02 (m, 4H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 56H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 9H, -CH2CH3). MS (ESI): m / z=992.9 ([M+H] + )。 Example 23: Cationic Lipid (E23-1) The preparation process is as follows: Step a: Add freshly activated magnesium turnings (0.26 g, 11.0 mmol) and 2 mL of anhydrous diethyl ether to a clean round-bottom flask. Dissolve brominated linolenol (S23-1, 2.92 g, 8.9 mmol) in anhydrous diethyl ether (30 mL) and add it to a dropping funnel. Under ice bath conditions, slowly add the bromide diethyl ether solution dropwise to the magnesium turnings. After the addition is complete, react the reaction mixture at 35 °C for 1 h, and then cool it in an ice bath. Dissolve ethyl formate (0.30 g, 4.0 mmol) in anhydrous diethyl ether (3 mL), add it to the dropping funnel, and add it to the reaction solution with stirring. After the reaction solution starts to reflux, quickly add the remaining ether solution of formate. Stir the reaction solution at room temperature for another 1 h. Quench the reaction by slowly adding 3 mL of acetone and ice water (10 mL). Treat the reaction solution with aqueous H2SO4 (10% by volume, 50 mL) until the solution becomes homogeneous, and let it stand for phase separation. Extract the aqueous phase with diethyl ether (30 mL * 2). Combine the organic phases, dry over anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify the crude product by column chromatography to obtain compound S23-2 (1.93 g, 91.1%). Step b: Under nitrogen protection, add DCC (0.91 g, 4.4 mmol) to a round-bottom flask containing S23-2 (1.27 g, 2.4 mmol), bromoacetic acid (S23-3, 0.28 g, 2.0 mmol), and DMAP (0.06 g, 0.5 mmol) dissolved in dichloromethane (30 mL). React at room temperature for 16 h. After the reaction is complete, remove the precipitate by filtration, concentrate the filtrate, and purify the obtained crude product by column chromatography to obtain S23-4 (1.07 g). Step c: Under nitrogen protection, dissolve compound S4-5 (0.76 g, 1.0 mmol) in acetonitrile (30 mL). Slowly add S23-4 (0.85 g, 1.3 mmol) and DIPEA (0.17 g, 1.3 mmol) in sequence with slow stirring. Stir and react at room temperature for about 20 h. After the reaction is complete, concentrate the reaction solution, dissolve it in dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Combine the organic phases, dry over anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E23-1 (1.10 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 16H, -CH=CHCH2CH=CH-), 4.94 - 4.88 (m, 1H, -C(=O)OCH<), 4.39 - 4.29 (m, 4H, >CH(CH2OC(=O)2-), 4.23 (t, 2H, pip-CH2CH2OC(=O)-), 3.17 (s, 2H, pip-CH2C(=O)O-), 3.02 (q, 1H, >CHC(=O)OCH2-), 2.77 (t, 8H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.33 - 2.21 (m, 4H, -OC(=O)CH2-), 2.07 - 2.02 (m, 16H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 72H, -CH2CH2CH2-, -CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1325.1 ([M+H] + )。 Example 24: Cationic Lipid (E24-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S2-14 (0.70 g, 1.0 mmol) in acetonitrile (30 mL). Add S23-4 (0.85 g, 1.3 mmol) and DIPEA (0.17 g, 1.3 mmol) successively with slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E24-1 (1.04 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 8H, -CH=CHCH2CH=CH-), 4.93 - 4.87 (m, 2H, -C(=O)OCH<), 4.05 (t, 4H, -C(=O)OCH2CH2-), 3.17 (s, 4H, pip-CH2C(=O)O-), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.59 - 2.35 (m, 8H, pip-H), 2.33 - 2.21 (m, 4H, -OC(=O)CH2-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 92H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1263.1 ([M+H] + )。 Example 25: Cationic Lipid (E25-1) The preparation process is as follows: Step a: Dissolve 9-heptadecanol (S25-1, 2.56 g, 10.0 mmol) in dichloromethane (60 mL), successively add triethylamine (3 mL) and N,N'-carbonyldiimidazole (CDI, 1.62 g, 10.0 mmol), and react at 50 °C for 1.5 h. Then add 6-amino-1-hexanol (S25-2, 1.76 g, 15.0 mmol), and continue to react at 50 °C for 16 h. After the reaction is completed, cool the temperature to room temperature, wash successively with 5% citric acid (30 mL * 2) and saturated brine (30 mL). The organic phase is dried over anhydrous magnesium sulfate, filtered, and concentrated to obtain a crude product. Add dichloromethane (30 mL) to the crude product, stir for 10 min, filter by suction, wash the filter cake with a small amount of dichloromethane, and concentrate to obtain product S25-3 (2.62 g). Step b: Dissolve S25-3 (2.40 g, 6.0 mmol) in dichloromethane (60 mL), add triphenylphosphine (PPh3, 2.36 g, 9.0 mmol), and under ice bath, add carbon tetrabromide (CBr4, 2.98 g, 9.0 mmol) in batches, and react at ice bath for 20 min. Add 10 mL of methanol to quench the reaction, directly concentrate to obtain a crude product, and the crude product is purified by column chromatography to obtain product S25-4 (1.63 g). Step c: Under nitrogen protection, dissolve compound S2-14 (1.39 g, 2.0 mmol) in acetonitrile (30 mL). With slow stirring, add S25-4 (1.20 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) successively, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, dry the organic phase with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E25-1 (1.79 g). 1 H NMR (400 MHz, CDCl3) δ: 4.94 - 4.85 (m, 1H, -C(=O)OCH<), 4.13 - 4.10 (m, 1H, -NHC(=O)OCH<), 4.03 (t, 4H, -C(=O)OCH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 3.15 (t, 2H, -CH2NHC(=O)O-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.33 - 2.21 (m, 4H, -OC(=O)CH2-), 1.64 - 1.20 (m, 88H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1075.9 ([M+H] + )。 Example 26: Cationic Lipid (E26-1) The preparation process is as follows: Step a: Dissolve S12-2 (0.91 g, 5.0 mmol) in 50 mL of dichloromethane, add DMAP (1.29 g, 10.0 mmol), and then add phenyl chloroformate p-nitrophenyl ester (1.11 g, 5.5 mmol) in batches. Stir the reaction at room temperature for 3 h. Add S25-1 (1.43 g, 5.6 mmol) to the reaction solution, and stir the mixture at room temperature overnight. After the reaction is completed, dilute it with 20 mL of dichloromethane, wash it with 30 mL of saturated brine, dry the organic phase with anhydrous magnesium sulfate, filter and concentrate, and purify it by column chromatography to obtain S26-1 (1.67 g). Step b: Under nitrogen protection, dissolve compound S2-14 (1.39 g, 2.0 mmol) in acetonitrile (20 mL). Sequentially add S26-1 (1.21 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E26-1 (1.77 g). 1 H NMR (400 MHz, CDCl3) δ: 4.93 - 4.87 (m, 1H, -C(=O)OCH<), 4.15 - 4.10 (m, 3H, -CH2OC(=O)OCH<), 4.04 (t, 4H, -C(=O)OCH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.59 - 2.35 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.33 - 2.21 (m, 4H, -OC(=O)CH2-), 1.64 - 1.20 (m, 88H, -CH2CH2CH2-, -CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1076.9 ([M+H] + )。 Example 27: Cationic Lipid (E27-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S14-2 (1.11 g, 2.0 mmol) in acetonitrile (30 mL). Sequentially add S26-1 (1.21 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E27-1 (1.55 g). 11H NMR (400 MHz, CDCl3) δ: 5.37 - 5.31 (m, 1H, -C(=O)OCH<), 4.38 - 4.29 (m, 2H, >CH(CH2OC(=O))2-), 4.19 - 4.13 (m, 5H; 2H, >CH(CH2OC(=O))2-; 3H, -CH2OC(=O)OCH<), 2.59 - 2.35 (m, 12H; 8H, pip-H; 4H, pip-CH2CH2-), 2.33 - 2.21 (m, 6H, -OC(=O)CH2-), 1.64 - 1.20 (m, 66H, -CH2CH2CH2-, -CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z = 936.8 ([M+H] + ). Example 28: Cationic Lipid (E28-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S4-5 (1.51 g, 2.0 mmol) in acetonitrile (30 mL). Slowly stir and sequentially add S12-3 (1.09 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol). Stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it in dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. Combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E28-1 (1.81 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 8H, -CH=CHCH2CH=CH-), 4.39 - 4.29 (m, 4H, >CH(CH2OC(=O)2-), 4.20 (t, 2H, pip-CH2CH2OC(=O)-), 4.04 (t, 2H, -C(=O)OCH2CH2CH2-), 3.02 (q, 1H, >CHC(=O)OCH2CH2-pip), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.72 - 2.40 (m, 13H; 8H, pip-H; 4H, pip-CH2CH2-; 1H, >CHC(=O)O-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 64H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1095.0 ([M+H] + ). Example 29: Cationic Lipid (E29-1) The preparation process is as follows: Under nitrogen protection, dissolve compound S4-5 (1.51 g, 2.0 mmol) in acetonitrile (30 mL). Add S23-4 (1.69 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) successively under slow stirring, and stir the reaction at room temperature for about 20 h. After the reaction is completed, concentrate the reaction solution, dissolve it with dichloromethane, extract it successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution, combine the organic phases, dry with anhydrous magnesium sulfate, filter, concentrate the filtrate, and purify it by column chromatography to obtain cationic lipid E29-1 (2.20 g). 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 16H, -CH=CHCH2CH=CH-), 4.96 - 4.87 (m, 1H, -C(=O)OCH<), 4.39 - 4.29 (m, 4H, >CH(CH2OC(=O)2-), 4.20 (t, 2H, pip-CH2CH2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 3.02 (q, 1H, >CHC(=O)OCH2-), 2.77 (t, 8H, -CH=CHCH2CH=CH-), 2.75 - 2.40 (m, 10H; 8H, pip-H; 2H, pip-CH2CH2-), 2.32 - 2.27 (m, 4H, -CH2CH2C(=O)O-), 2.07 - 2.02 (m, 16H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 72H, -CH2CH2CH2-,-CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z=1325.7 ([M+H] + )。 Example 30: Cationic Lipid (E30-1) The preparation process is as follows: Under nitrogen protection, compound S14-2 (1.11 g, 2.0 mmol) was dissolved in acetonitrile (30 mL). S23-4 (1.69 g, 2.6 mmol) and DIPEA (0.34 g, 2.6 mmol) were successively added under slow stirring, and the mixture was stirred at room temperature for about 20 h. After the reaction was completed, the reaction solution was concentrated, dissolved in dichloromethane, and extracted successively with 0.6 M hydrochloric acid / 10% sodium chloride solution and saturated sodium bicarbonate solution. The organic phases were combined, dried over anhydrous magnesium sulfate, filtered, and the filtrate was concentrated. The cationic lipid E30-1 (2.23 g) was obtained by column chromatography purification. 11H NMR (400 MHz, CDCl3) δ: 5.40 - 5.31 (m, 9H; 1H, -C(=O)OCH<; 8H, -CH=CHCH2CH=CH-), 4.94 - 4.87 (m, 1H, -C(=O)OCH<), 4.38 - 4.29 (m, 2H, >CH(CH2OC(=O))2-), 4.19 - 4.13 (m, 2H, >CH(CH2OC(=O))2-), 3.17 (s, 2H, pip-CH2C(=O)O-), 2.77 (t, 4H, -CH=CHCH2CH=CH-), 2.73 - 2.35 (m, 16H; 8H, pip-H; 2H, pip-CH2CH2-; 4H, >CHCH2OC(=O)CH2-; 2H, >CHOC(=O)CH2-), 2.07 - 2.02 (m, 8H, -CH=CHCH2CH2-), 1.64 - 1.20 (m, 70H, -CH2CH2CH2-, -CH2CH3), 0.88 (t, 12H, -CH2CH3). MS (ESI): m / z = 1123.1 ([M+H] + )。 Example 31: Preparation of LNP-mRNA Pharmaceutical Composition and Testing of Its Physicochemical Properties Example 31.1: Preparation of LNP-mRNA Pharmaceutical Composition In this example, an LNP-mRNA pharmaceutical composition (LNP-mRNA) containing Fluc-mRNA was prepared. All the phospholipids it contained were DSPC, all the steroid lipids were cholesterol, and all the polyethylene glycolated lipids were PEG2k-DMG. The difference was the cationic lipid. The preparation method of LNP-mRNA is as follows: Step a: Pipette a certain amount of the stock solutions of cationic lipid, DSPC, cholesterol, and polyethylene glycolated lipid. Dissolve the cationic lipid, DSPC, cholesterol, and polyethylene glycolated lipid in ethanol according to a molar ratio of 50:10:38:1.5 to obtain an ethanol-phase solution (for the control groups LCT-1, LCT-2, and LCT-3, the cationic lipids used were those of the prior art, and for the experimental groups L-1 to L-34, the cationic lipids containing nitrogen heterocycles in Examples 1 - 30 of the present invention were used). Among them, the cationic lipids used in LCT-1 and LCT-2 were C-1 and C-2 respectively, and they were prepared according to the methods disclosed in the reference patent document CN115010681A. The cationic lipid used in LCT-3 was C-3, and it was prepared according to the methods disclosed in the reference patent document WO2023036148A1. The structures of C-1, C-2, and C-3 are as follows: Step b: Add Fluc-mRNA to a 10 - 50 mM citrate buffer (pH = 4) to obtain an aqueous solution. Step c: Mix the ethanol phase solution and the aqueous solution (1:3, v / v) to prepare LNP-mRNA, and wash it by ultrafiltration with DPBS multiple times to remove ethanol and free molecules. Finally, pass it through a 0.2 μm sterile filter and set aside. Example 31.2: Physicochemical property test of LNP-mRNA pharmaceutical composition Determination of encapsulation efficiency: Use the Quant-it Ribogreen RNA quantification kit to determine the encapsulation efficiency of the LNP-mRNA composition. The results show that the lipid compositions (L-1 to L-36) of the present invention have a high encapsulation efficiency for nucleic acid drugs (mRNA), all within the range of 80% - 96%, and most of the encapsulation efficiencies are within the range of 90% - 96%. The results indicate that the cationic lipids containing nitrogen heterocycles in each experimental group can encapsulate mRNA well, showing an encapsulation efficiency equivalent to or better than that of C-1, C-2, and C-3. There are also differences in the encapsulation efficiencies of the cationic lipids containing nitrogen heterocycles with different structures. Particle size determination: In this example, the particle size of LNP-mRNA is determined by dynamic light scattering (DLS). The measured LNP-mRNA has a high size uniformity, and its PDI is less than 0.3. The particle size of LNP-mRNA prepared from the lipid composition of this application is within the range of 90 - 120 nm, meeting the requirements for the particle size of a gene vector. Table 1: Summary table of the formulations of each lipid composition and the particle size and encapsulation efficiency of the LNP-mRNA prepared therefrom Example 32: Biological activity test of LNP-mRNA pharmaceutical composition (1) Serum stability evaluation Add the LNP-mRNA pharmaceutical composition to a medium containing 10% fetal bovine serum (FBS), stir at 37°C, and take samples at regular intervals to measure the particle size change of LNP-mRNA. Analyze the serum stability of the LNP-mRNA pharmaceutical composition preparation by testing its particle size change. The experimental results show that within 7 days, the particle size changes of both the control group and the experimental groups are less than 10%, and the particle size changes of all biological experimental groups are less than 5%. This indicates that the LNP-mRNA pharmaceutical composition preparation prepared from the cationic lipids of the present invention has good serum stability. (2) Study on cytotoxicity (biocompatibility) Prepare DMEM high-glucose complete medium containing 10% FBS. Prepare working solutions of 0.1, 0.15, 0.2, 0.25, and 0.3 μg / 100 μL of the samples (L-1 to L-34 and L-CT1 to L-CT3) using the complete medium and store for later use. Take 293T cells in the logarithmic growth phase and inoculate them into a 96-well plate at 7×10³ cells / well and 100 μL / well. Set 6 replicate wells for both the control group and the experimental group. After incubating in a 5% CO₂, 37 °C constant temperature incubator for 24 h, retain the original medium, add 100 μL / well of the complete medium to the control group, and add 100 μL / well of the working solution to the sample group. After continuing to incubate for 24 h, add 100 μL / well of the medium containing 10% CCK-8 and culture in a 5% CO₂, 37 °C constant temperature incubator for 2 h. Measure the absorbance value at 450 nm using an enzyme-linked immunosorbent assay (ELISA) reader. Calculate the relative viability of the cells according to the following formula: Relative viability % = (absorbance value of the sample group - absorbance value of the background) / (absorbance value of the control group - absorbance value of the background) × 100%; where the absorbance value of the background is the absorbance of adding only the CCK-8 reagent and the medium. The experimental results show that the LNP-mRNA pharmaceutical composition prepared using the cationic lipid of the present invention does not produce obvious cytotoxicity at 5 concentration gradients, and the cell survival rate is greater than 95%. Specifically, for example, the results of the experimental group L-24 are shown in Figure 8. (3) Evaluation of in vitro transfection effect To investigate the mRNA transfection efficiency of each group of LNP-mRNA pharmaceutical compositions prepared in Example 31.1 of the present invention at the cellular level, Luciferase bioluminescence was used for testing. The LNP-mRNA pharmaceutical composition was dissolved in the culture medium to prepare the required dose. Using 293T cells as the cell model, with an inoculation density of 6000 cells / well, 100 μL / well of the cell suspension was inoculated into a 96-well plate with a black-edged transparent bottom. After inoculation, it was incubated in a cell culture incubator for 24 h, and then administered at a dose of 0.2 μg mRNA per well. The blank control group was added with the corresponding dose of free Fluc-mRNA. After 24 h of transfection, the old culture medium was removed and replaced with a new culture medium containing the substrate of sodium D-luciferin (1.5 mg / mL), and after incubating for 5 minutes, the bioluminescence was detected using a microplate reader. The stronger the fluorescence, the more Fluc-mRNA was transported into the cytoplasm and translated into the corresponding fluorescent protein. The experimental results are shown in Table 2. Among them, the relative fluorescence intensity value is the ratio of the fluorescence intensity value of each group to the fluorescence intensity of the blank control group. The results show that the LNP-mRNA pharmaceutical compositions prepared by the present invention all have excellent in vitro transfection effects, that is, the LNPs in the experimental groups are all effective nucleic acid delivery vectors. This may be because the transfection efficiency of the LNPs prepared by the cationic lipids of the present application is better than that of L-CT1 prepared by the cationic lipids of the prior art, and most of them are better than those of the L-CT2 and L-CT3 groups. This may be because C-1 only contains two linear hydrophobic hydrocarbon tail chains, and this structure is not conducive to forming a conical geometry, which in turn leads to a lower transfection rate. There are differences in the types and numbers of degradable groups, the number of hydroxyl groups, and the saturation of the hydrophobic hydrocarbon tail chains between C-2 and C-3 and the cationic lipids of the present application, thus showing different transfection rates. Therefore, the relative fluorescence values of L-8 (E7-1), L-9 (E7-2), L-10 (E8-1), L-16 (E14-1), L-24 (E20-1), L-26 (E22-1), and L-31 (E27-1) in the experimental group are relatively high. This may be because among these cationic lipid compounds, the presence of a larger number of degradable groups can avoid the endosomal accumulation of LNP-mRNA, promote the endosomal escape of LNP-mRNA, and thus improve the delivery effect; and / or the presence of unsaturated hydrophobic hydrocarbon tail chains can improve the membrane fluidity and cell uptake, thus improving the delivery effect; and / or the presence of hydroxyl groups can interact with the phosphate groups on the nucleic acid through hydrogen bonding, thus improving the delivery efficiency. Table 2: Results of cell transfection test (5) Evaluation of in vivo transfection effect Lipid nanoparticles L-24 were delivered to 6-8-week-old female BALB / c mice at a dose of 10 μg / mouse by tail vein injection, and in vivo fluorescence imaging of the mice was performed 6, 12, and 24 hours after administration. After imaging at the last time point, the mice were euthanized, and the main organs heart, liver, spleen, lung, and kidney (from left to right in the figure) were imaged. 0.2 mL of D-luciferin sodium (15 mg / mL) was intraperitoneally injected 10-15 min before imaging. The experimental results (Figure 9) show that the lipid nucleic acid drug composition prepared from the cationic lipid of the present invention can achieve efficient in vivo delivery of nucleic acid drugs, and the LNP-mRNA drug composition delivered into the body is mainly distributed in the liver and spleen. The above are only examples of the present invention, and do not limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the content of the specification of the present invention, or directly or indirectly applied in other related technical fields, shall be equally included in the patent protection scope of the present invention. For those skilled in the art, without departing from the purpose and scope of the present invention and without unnecessary experiments, the present invention can be implemented within a relatively wide range under equivalent parameters, concentrations, and conditions. Although the present invention gives specific examples, it should be understood that the present invention can be further improved. In short, according to the principle of the present invention, this application intends to cover any modification, use, or improvement of the present invention, including those that depart from the scope disclosed in this application and are made by using conventional techniques known in the art.

Claims

1. A cationic lipid, characterized in that, The structure is as shown in the general formula (1): or its salt, tautomer, stereoisomer, deuterated compound or solvate; Among them, L d is a connecting key, and a is 1; L e is C 1-12 an alkylene group; M is any one of -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH-, -NHC(=O)S-, -C(=S)-, -OC(=S)-, -C(=S)O-, -OC(=S)O-, -NHC(=S)-, -C(=S)NH-, -NHC(=S)NH-, -OC(=S)NH- and -NHC(=S)O-; R is wherein, tm is an integer from 0 to 6; B1, B2, and B3 are each independently C 1-20 alkylene; L1, L2, and L3 are each independently selected from -CH(OH)-, -OC(=O)-, -C(=O)O-, -OC(=O)O-, -C(=O)-, -O-, -NH-, -O(CH2) s O-, -S-, -S-S-, -C(=O)S-, -SC(=O)-, -NHC(=O)-, -C(=O)NH-, -NHC(=O)NH-, -OC(=O)NH-, -NHC(=O)O-, -SC(=O)NH-, and -NHC(=O)S-, where s is 1, 2, or 3; R g is H or C 1-6 alkyl; R1, R2, and R3 are each independently linear or branched C 5-40 hydrocarbyl.

2. The cationic lipid according to claim 1, wherein Each of B1, B2 and B3 is independently any one of methylene, ethylene, propylene, butylene, pentylene, hexylene and heptylene.

3. The cationic lipid according to claim 1, characterized in that, Each of L1, L2 and L3 is independently -CH(OH)-, -OC(=O)-, -C(=O)O-, -C(=O)NH-, -NHC(=O)-, -NHC(=O)O-, -OC(=O)NH-.

4. The cationic lipid according to claim 1, wherein The linear C 5-40 hydrocarbyl group is C 5-40 a straight-chain alkyl group, C 5-40 a straight-chain alkenyl group, C 5-40 a straight-chain alkynyl group; preferably each independently is C 5-25 a straight-chain alkyl group, C 5-25 a straight-chain alkenyl group, C 5-25 a straight-chain alkynyl group; the linear C 5-40 hydrocarbyl group is more preferably any one of the following structures: The branched C 5-40 hydrocarbyl group is a C 5-40 branched alkyl group, a C 5-40 branched alkenyl group or a C 5-40 branched alkynyl group, each independently represented as wherein, tn is an integer from 0 to 12; R e , R f are each independently one of C 1-15 alkyl, C 2-20 alkenyl and C 2-15 alkynyl; preferably each independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, decyl, undecyl, dodecyl, pentenyl, hexenyl, heptenyl, octenyl, nonenyl, decenyl, octadeca-6,9-dienyl and their substituted forms; the branched C 5-40 hydrocarbyl is most preferably any one of the following structures:

5. The cationic lipid according to claim 1, wherein R1, R2 and R3 are selected from any one of the following situations: Case (1): R1, R2, and R3 are all linear C 5-40 hydrocarbyl groups; Case (2): R1, R2, and R3 are all branched C 5-40 hydrocarbyl groups; Case (3): Any one of R1, R2, and R3 is a linear C 5-40 hydrocarbon group, and the other two are branched C 5-40 hydrocarbon groups; Case (4): Any two of R1, R2, and R3 are linear C 5-40 hydrocarbon groups, and the other is a branched C 5-40 hydrocarbon group; preferably, R1 and R2 are linear C 5-40 hydrocarbon groups, and R3 is a branched C 5-40 hydrocarbon group.

6. The cationic lipid according to claim 1, wherein, -B3-L3-R3 are each independently selected from any one of the following structures:

7. The cationic lipid according to claim 1, wherein, Each of the Rs is independently selected from any one of the following structures:

8. The cationic lipid according to claim 1, wherein M is any one of -OC(=O)-, -C(=O)O-, -OC(=O)O-, -NHC(=O)-, -C(=O)NH-, -OC(=O)NH-, -NHC(=O)O-; Preferably, the structure of the cationic lipid satisfies any of the following general formulas: More preferably, the structure of the cationic lipid satisfies any of the following general formulas: Preferably, in the foregoing general formulas (1-1)-(1-22), B1 and B2 are the same and are C 1-12 alkylene; L1 and L2 are the same and are any one of -OC(=O)-, -C(=O)O-, -NHC(=O)-, -C(=O)NH-, -OC(=O)O-; R1 and R2 are the same and are linear C 5-40 hydrocarbyl; R3 is linear C 5-40 hydrocarbyl.

9. The cationic lipid according to claim 1, wherein The cationic lipid is selected from any one of the following structures:

10. A lipid composition, characterized in that, containing the cationic lipid described in any one of claims 1-9.

11. The lipid composition according to claim 10, characterized in that, It further contains one or more of phospholipids, steroid lipids and polyethylene glycolated lipids; selected from any one of the following situations: Situation (1): It further contains phospholipids; Situation (2): It further contains steroid lipids; Situation (3): It further contains polyethylene glycolated lipids; Situation (4): It further contains phospholipids and steroid lipids; Situation (5): It further contains phospholipids and polyethylene glycolated lipids; Situation (6): It further contains steroid lipids and polyethylene glycolated lipids; Situation (7): It further contains phospholipids, steroid lipids and polyethylene glycolated lipids; Situation (8): It further contains phospholipids, steroid lipids, polyethylene glycolated lipids and another cationic lipid; Situation (9): It further contains phospholipids, steroid lipids, polyethylene glycolated lipids and anionic lipids; More preferably, it also contains three lipids, namely phospholipids, steroid lipids and polyethylene glycolated lipids, simultaneously.

12. The lipid composition according to claim 11, wherein The phospholipids are selected from any one of 1,2-dilinoleoyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphocholine, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dielaidoyl-sn-glycero-phosphocholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, 1,2-di-O-octadecenoyl-sn-glycero-3-phosphocholine, 1-oleoyl-2-cholesteryl succinyl-sn-glycero-3-phosphocholine, 1-hexadecyl-sn-glycero-3-phosphocholine, 1,2-dilinolenoyl-sn-glycero-3-phosphocholine, 1,2-diarachidonoyl-sn-glycero-3-phosphocholine, 1,2-didocosahexaenoyl-sn-glycero-3-phosphocholine, 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine, 1,2-diphytanoyl-sn-glycero-3-phosphoethanolamine, 1,2-distearoyl-sn-glycero-3-phosphoethanolamine, 1,2-dilinoleoyl-sn-glycero-3-phosphoethanolamine, 1,2-dilinolenoyl-sn-glycero-3-phosphoethanolamine, 1,2-diarachidonoyl-sn-glycero-3-phosphoethanolamine, 1,2-didocosahexaenoyl-sn-glycero-3-phosphoethanolamine, 1,2-dioleoyl-sn-glycero-3-phospho-rac-(1-glycerol) sodium salt, dioleoyl phosphatidylserine, dipalmitoyl phosphatidylglycerol, palmitoyl oleoyl phosphatidylethanolamine, distearoyl phosphatidylethanolamine, dipalmitoyl phosphatidylethanolamine, dimyristoyl phosphoethanolamine, 1-stearoyl-2-oleoyl-stearoylethanolamine, 1-stearoyl-2-oleoyl-phosphatidylcholine, sphingomyelin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidic acid, palmitoyl oleoyl phosphatidylcholine, lysophosphatidylcholine and lysophosphatidylethanolamine and their combinations; or the steroid lipids are selected from any one of cholesterol, coprosterol, sitosterol, ergosterol, campesterol, stigmasterol, brassicasterol, tomatine, ursolic acid, α-tocopherol and their combinations; Or the polyethylene glycolated lipid is selected from polyethylene glycol-1,2-dimyristoyl glycerol, polyethylene glycol-distearoyl phosphatidylethanolamine, PEG-cholesterol, polyethylene glycol-diacylglycerol, polyethylene glycol-dialkoxypropyl, specifically including any one of polyethylene glycol 500-dipalmitoyl phosphatidylcholine, polyethylene glycol 2000-dipalmitoyl phosphatidylcholine, polyethylene glycol-500-distearoyl phosphatidylethanolamine, polyethylene glycol 2000-distearoyl phosphatidylethanolamine, polyethylene glycol 500-1,2-dioleoyl phosphatidylethanolamine, polyethylene glycol 2000-1,2-dioleoyl phosphatidylethanolamine, and polyethylene glycol 2000-2,3-dimyristoyl glycerol and its composition; or the polyethylene glycolated lipid is selected from any one of the following structures and its composition: wherein, n1 is an integer from 25 to 300, and more preferably n1 is any one of 44, 45, 46, 47, 48; or said another cationic lipid is selected from any one of 1,2-dioleoyl-3-trimethylammonium-propane (methyl sulfate), 1,2-bis(octadecenoxy)-3-methylammonium propane chloride, 1-[2-(oleoyloxy)ethyl]-2-oleyl-3-(2-hydroxyethyl)imidazoline chloride, 1,2-dioleoyl-3-dimethylamino-propane, 2,3-bis(tetradecanoyloxy)propyltrimethylammonium chloride, didodecyldimethylammonium chloride, didodecyldimethylammonium bromide, N,N-dioleyl-N,N-dimethylammonium chloride, N-(4-carboxybenzyl)-N,N-dimethyl-2,3-bis(oleoyloxy)prop-1-ammonium, 3,6-bis{4-[bis(2-hydroxydodecyl)amino]butyl}piperazine-2,5-dione, 1,1'-((2-(4-(2-((2-(bis(2-hydroxydodecyl)amino)ethyl)(2-hydroxydodecyl)amino)ethyl)piperazin-1-yl)ethyl)azanediyl)bis(dodecan-2-ol), 4-(N,N-dimethylamino)butyric acid (dilinoleoyl) methyl ester, 1,2-dimyristoyl-sn-glycero-3-ethylphosphocholine, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 8-[(2-hydroxyethyl)(6-oxo-6-(undecyloxy)hexyl)amino]octanoic acid (nonadec-9-yl) ester, and ((2-(2-hydroxyethoxy)ethyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) and their combinations; or said anionic lipid is selected from any one of 1,2-dioleoyl-sn-glycero-3-phosphate sodium salt, 1,2-dimyristoyl-sn-glycero-3-phosphate sodium salt, bis(monooleoylglycerol) phosphate ammonium salt, and cardiolipin and their combinations.

13. The lipid composition according to any one of claims 11-12, characterized in that, comprising 20-80% of cationic lipid, 5-16% of phospholipid, 25-55% of steroid lipid, and 0.5-10% of polyethylene glycolated lipid, and the percentages are the molar percentages of each lipid in the total lipid.

14. The lipid composition according to claim 13, characterized in that, The molar percentage of the cationic lipid in the total lipid is 30-65%; more preferably any one of 35%, 40%, 45%, 46%, 47%, 48%, 49%, 50%, 55%; or the molar percentage of the phospholipid in the total lipid is 7.5-16%; more preferably any one of 8%, 9%, 10%, 11%, 12%, 16%; or the molar percentage of the steroid lipid in the total lipid is 35-50%, more preferably any one of 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%; or the molar percentage of the polyethylene glycolated lipid in the total lipid is 0.5-5%; preferably 1-3%; more preferably any one of 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.5%.

15. A lipid pharmaceutical composition, characterized in that, Containing the lipid composition and drug according to any one of claims 10-14, wherein the drug is selected from any one of nucleic acid drugs, gene vaccines, anti-tumor drugs, small molecule drugs, polypeptide drugs or protein drugs.

16. The lipid pharmaceutical composition according to claim 15, characterized in that, The nucleic acid drug is selected from any one of RNA, DNA, antisense nucleic acid, plasmid, interfering nucleic acid, aptamer, antagomir and ribozyme, and the RNA is selected from any one of mRNA, saRNA, circRNA, miRNA and siRNA; preferably, the nucleic acid drug is any one of DNA, mRNA, miRNA and siRNA.

17. The lipid pharmaceutical composition according to any one of claims 15-16, characterized in that, The pharmaceutical composition is used as a drug and is selected from any one of the following drugs: anti-tumor agent, antiviral agent, antifungal agent and vaccine.

18. A lipid pharmaceutical composition preparation, characterized in that, Containing the lipid drug composition according to any one of claims 15-17 and a pharmaceutically acceptable diluent or excipient, and the diluent or excipient is preferably any one of deionized water, ultrapure water, phosphate buffer solution and physiological saline, more preferably phosphate buffer solution or physiological saline, and most preferably physiological saline.

19. A liposome or lipid nanoparticle, characterized in that, Containing the lipid composition according to any one of claims 10-14.

20. The liposome or lipid nanoparticle according to claim 19, characterized in that, The lipid nanoparticle is an LNP-drug composition, an LPP-drug composition or a PNP-drug composition; preferably an LNP-drug composition; more preferably an LNP-nucleic acid drug composition; more preferably an LNP-mRNA drug composition.

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