Traditional Chinese medicine suppository for treating gynecology and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine suppository for treating gynecology and a preparation method of the traditional Chinese medicine suppository. The traditional Chinese medicine suppository contains 100 parts of traditional Chinese medicine microcapsules, 50-150 parts of a matrix, 0-10 parts of a lubricant, 0-15 parts of a humectant and 0-20 parts of a disintegrating agent. The preparation method comprises the following steps: carrying out microencapsulation on the traditional Chinese medicine extract to obtain traditional Chinese medicine microcapsules; adding a matrix and mixing; adding the lubricant, the humectant and the disintegrating agent, and mixing; the upper layer is quickly released, and the lower layer is slowly released; and finally packaging and sterilizing to prepare the suppository. The stability and bioavailability of the medicine can be effectively improved, the treatment effect is enhanced, the administration frequency is reduced, and the medication compliance of a patient is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparations, and more specifically, to a Chinese medicine suppository for treating gynecology and a preparation method thereof. Background Art

[0002] In the treatment of gynecological diseases, suppositories are a common way of administration, which have the advantages of directly acting on the lesion site and taking effect quickly. Existing gynecological suppositories are mostly single drug ingredients, and there are problems such as insufficient drug efficacy and short duration of action. The matrix and excipients of traditional suppositories are limited in selection, and it is difficult to meet the release requirements of different drugs. In addition, during the preparation process, the stability of the drug is difficult to ensure, and it is easily affected by environmental factors and degraded and ineffective. In addition, the release mode of existing suppositories is relatively single, and it is impossible to achieve the effect of combining rapid and sustained release, which leads to patients needing to take the drug frequently and poor compliance.

[0003] In the process of implementing the embodiments of the present invention, the inventors found that there are at least the following problems or defects in the prior art: first, the drug ingredients are single, and the synergistic effect of the traditional Chinese medicine compound cannot be fully exerted; second, the choice of matrix and excipients is limited, which affects the stability and release effect of the drug; third, the release mode of the suppository is single, which cannot meet different treatment needs, the frequency of administration is high, and the patient compliance is poor. Summary of the invention

[0004] The invention provides a Chinese medicinal suppository for treating gynecology and a preparation method thereof.

[0005] In a first aspect of the present invention, a Chinese medicine suppository for treating gynecology is provided, comprising the following components:

[0006] 100 parts of Chinese medicine microcapsules, 50-150 parts of matrix, 0-10 parts of lubricant, 0-15 parts of moisturizing agent, and 0-20 parts of disintegrant.

[0007] Furthermore, the Chinese medicine microcapsules include one or a mixture of microencapsulated products of Chinese medicinal material extracts such as Angelica sinensis, Chuanxiong, White Peony Root, Poria cocos, and Carthamus tinctorius.

[0008] Furthermore, the particle size of the traditional Chinese medicine microcapsule is 1 to 100 microns.

[0009] Furthermore, the matrix is ​​one or a mixture of cocoa butter, semi-synthetic fatty acid glyceride, and polyethylene glycols.

[0010] Furthermore, the melting point of the matrix is ​​30 to 45 degrees Celsius.

[0011] Furthermore, the lubricant is one or a mixture of magnesium stearate, micro-powdered silica gel, and talcum powder.

[0012] Furthermore, the moisturizing agent is one or a mixture of glycerol, sorbitol, and propylene glycol.

[0013] Furthermore, the disintegrant is one or a mixture of several of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, and low-substituted hydroxypropyl cellulose.

[0014] Furthermore, the double-layer suppository has an upper and lower layer structure, wherein the upper layer is a rapid-release layer and the lower layer is a sustained-release layer, and the two layers are tightly combined by physical or chemical methods.

[0015] In a second aspect of the present invention, a method for preparing a Chinese medicine suppository for treating gynecology is provided, which specifically comprises the following steps:

[0016] (1) microencapsulating the Chinese herbal medicine extract to obtain 100 portions of Chinese herbal medicine microcapsules;

[0017] (2) Add 50 to 150 parts of the matrix into the Chinese medicine microcapsules and mix them evenly;

[0018] (3) Add 0-10 parts of lubricant, 0-15 parts of moisturizer, and 0-20 parts of disintegrant, and mix well;

[0019] (4) forming the mixture into a double-layer structure, wherein the upper layer is a rapid-release formulation and the lower layer is a sustained-release formulation;

[0020] (5) Packaging and sterilization to obtain the Chinese medicine microcapsule double-layer suppository for treating gynecology.

[0021] According to the above embodiments of the present invention, at least the following beneficial effects are achieved: the Chinese medicine suppository of the present invention can realize the combination of rapid and sustained release of the drug, the upper layer rapid release formula can quickly exert the drug effect and relieve acute symptoms; the lower layer sustained release formula can prolong the drug action time, maintain the continuity of the therapeutic effect, reduce the number of drug administrations, and improve the patient's medication compliance. In addition, the microencapsulation of Chinese medicine can enhance the stability of the drug, protect the drug components from damage by environmental factors, improve the bioavailability of the drug, and make the drug effect more fully exerted. The selection and ratio of the matrix can adjust the melting point and release characteristics of the suppository, so that it can better adapt to the physiological environment of the human body and improve the safety and comfort of medication. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above and other objects, features and advantages of the exemplary embodiments of the present invention will become readily understood by reading the detailed description below with reference to the accompanying drawings. In the accompanying drawings, several embodiments of the present invention are shown in an exemplary and non-limiting manner, in which:

[0023] Figure 1 The present invention is a schematic flow chart of a method for preparing a Chinese medicine suppository for treating gynecology provided by one embodiment of the present invention. DETAILED DESCRIPTION

[0024] The principles and spirit of the present invention will be described below with reference to several exemplary embodiments. It should be understood that these embodiments are provided only to enable those skilled in the art to better understand and implement the present invention, and are not intended to limit the scope of the present invention in any way. On the contrary, these embodiments are provided to make the present invention more thorough and complete, and to fully convey the scope of the present invention to those skilled in the art.

[0025] In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention. All features disclosed in this specification, or steps in all methods or processes disclosed, except for mutually exclusive characteristics and / or steps, can be combined in any way, unless otherwise described, and can be replaced by other equivalent or alternative features with similar purposes, that is, unless otherwise described, each feature is only one embodiment in a series of equivalent or similar features.

[0026] In some embodiments, a Chinese medicine suppository for treating gynecology comprises the following composition: 100 parts of Chinese medicine microcapsules, 50-150 parts of a matrix, 0-10 parts of a lubricant, 0-15 parts of a moisturizer, and 0-20 parts of a disintegrant.

[0027] It should be noted that the present invention relates to a Chinese medicine suppository for treating gynecological diseases, which is unique in that it contains a specific proportion of Chinese medicine microcapsules, a matrix, a lubricant, a humectant and a disintegrant. The Chinese medicine microcapsules are obtained by microencapsulation of a variety of Chinese medicinal material extracts, and this treatment method can effectively protect the drug ingredients and improve their stability and bioavailability. The matrix is ​​an important component of the suppository, which can slowly release the drug in the body and prolong the drug effect. The lubricant, humectant and disintegrant are respectively used to improve the physical properties of the suppository, such as reducing friction, keeping it moist and promoting the disintegration of the drug in the body.

[0028] Specifically, the particle size range of Chinese medicine microcapsules is set to 1 to 100 microns. Microcapsules within this range can ensure that the active ingredients of the drug are fully encapsulated and can be quickly released in the body. The choice of matrix includes cocoa butter, semi-synthetic fatty acid glycerides, polyethylene glycols, etc. The melting points of these matrices are between 30 and 45 degrees Celsius, and they can melt quickly at body temperature to release the drug. Lubricants such as magnesium stearate, micropowder silica gel, talcum powder, etc. can reduce the friction of suppositories during preparation and use, making suppositories easier to shape and insert. Moisturizers such as glycerin, sorbitol, propylene glycol, etc. can maintain the wetness of suppositories and prevent them from drying out during storage and use. Disintegrants such as sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, etc., help suppositories disintegrate quickly in the body, allowing the drug to take effect quickly.

[0029] Preferably, the preparation of Chinese medicine microcapsules can adopt microencapsulation technology such as spray drying or fluidized bed coating to ensure that the particle size of the microcapsules is uniform and within the above range. The selection of the matrix can be adjusted according to the nature of the drug and the treatment needs. For example, for drugs that need to be released quickly, a matrix with a lower melting point can be selected; for drugs that need to be released slowly, a matrix with a higher melting point can be selected. In addition, the amount of lubricant, humectant and disintegrant added can also be fine-tuned according to actual conditions to achieve the best suppository performance. For example, if the suppository has adhesion during the preparation process, the amount of lubricant can be appropriately increased; if the suppository is easy to dry out during storage, the amount of humectant can be appropriately increased.

[0030] In some embodiments, the Chinese medicine microcapsules include one or a mixture of microencapsulated products of Chinese medicinal material extracts such as Angelica sinensis, Chuanxiong, White Peony Root, Poria cocos, and Carthamus tinctorius.

[0031] It should be noted that the Chinese medicine microcapsules contained in the Chinese medicine suppositories of the present invention are a mixture of one or more of the microencapsulated products of Chinese herbal medicine extracts such as Angelica sinensis, Chuanxiong, White Peony Root, Poria cocos, and Carthamus tinctorius. These Chinese herbal medicines are widely used in the treatment of gynecological diseases in traditional Chinese medicine theory, and have the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain. Microencapsulation is a technology that encapsulates drugs in microcapsules, which can protect the drug components from the external environment, improve the stability and bioavailability of the drug, and control the release rate of the drug.

[0032] Specifically, the microencapsulated products of Chinese herbal medicine extracts such as Angelica sinensis, Chuanxiong, White Peony Root, Poria cocos, and Safflower are obtained by extracting the effective ingredients of these herbs through modern pharmaceutical technology and then subjecting them to microencapsulation. For example, Angelica sinensis extract is rich in volatile oils, organic acids and other ingredients, and has the effect of nourishing blood and activating blood circulation; Chuanxiong extract contains ingredients such as ligustrazine, which can promote qi and blood circulation, dispel wind and relieve pain. During the microencapsulation process, gelatin, gum arabic, etc. can be used as capsule materials, and the extracts can be wrapped by spray drying, complex coagulation and other methods to form microcapsules with a particle size of 1 to 100 microns. These microcapsules can be used alone as needed, or microcapsules of several different herbs can be mixed and used to achieve a synergistic therapeutic effect.

[0033] Preferably, for the preparation of Chinese medicine microcapsules, a spray drying method can be used. After the Chinese medicine extract is mixed with the capsule material, it is atomized into tiny droplets by a spray drying device, and quickly dried in a hot air flow to form microcapsules. When selecting capsule materials, in addition to gelatin and gum arabic, natural polymer materials such as chitosan and sodium alginate can also be considered. These materials have good biocompatibility and degradability. In addition, the particle size of the microcapsule can be accurately controlled by adjusting the spray drying parameters, such as the air inlet temperature, flow rate, etc., to ensure that the particle size distribution of the microcapsule is uniform, thereby ensuring the quality and efficacy of the suppository.

[0034] In some embodiments, the particle size of the traditional Chinese medicine microcapsule is 1 to 100 microns.

[0035] It should be noted that the particle size of Chinese medicine microcapsules is limited to a specific range of 1 to 100 microns, which is to ensure that the suppository can achieve the ideal drug release effect when used. The particle size directly affects the release rate and uniformity of the drug. Smaller particle sizes help the drug to disperse and release faster, while larger particle sizes can control the release rate, allowing the drug to be released slowly in the body and prolong the duration of action. Microencapsulation technology is a process that encapsulates the active ingredients of a drug in microcapsules. It can improve the stability of the drug and reduce the degradation of the drug during storage and use. It can also improve the physical properties of the drug, such as fluidity and compressibility.

[0036] Specifically, the particle size of Chinese medicine microcapsules can be controlled by a variety of microencapsulation methods. For example, in the spray drying method, the particle size of the microcapsules can be accurately controlled by adjusting the spray atomization pressure, air inlet temperature and flow rate and other parameters. In the complex coacervation method, the particle size can also be regulated by adjusting the pH value, ionic strength and stirring speed of the solution. The particle size is usually measured using professional equipment such as a laser particle size analyzer to ensure that the particle size distribution is within the specified range. In addition, the morphology and structure of the microcapsule will also affect its performance. For example, spherical microcapsules usually have better fluidity and stability.

[0037] Preferably, in order to further optimize the performance of Chinese medicine microcapsules, some special microencapsulation techniques can be used. For example, microcapsules are prepared using supercritical fluid technology, which can prepare microcapsules with uniform particle size and regular morphology without solvent residue. In addition, the physicochemical properties of the microcapsules can be improved by adding some surfactants or stabilizers, such as increasing the surface charge of the microcapsules and improving their dispersibility in water. In practical applications, appropriate microencapsulation methods and parameters can be selected according to specific drug properties and treatment needs to prepare the most ideal Chinese medicine microcapsules.

[0038] In some embodiments, the matrix is ​​cocoa butter, semi-synthetic fatty acid glycerides, polyethylene glycols, or a mixture of several thereof.

[0039] It should be noted that the matrix mentioned in the present invention is an important component of the suppository, which together with the Chinese medicine microcapsule constitutes the basic structure of the suppository. The function of the matrix is ​​to carry the drug ingredients so that it can release the drug at an appropriate position in the body. In the present invention, the matrix is ​​defined as a mixture of one or more of cocoa butter, semi-synthetic fatty acid glycerides, and polyethylene glycols, all of which have suitable physical properties and can melt or dissolve at body temperature to release the drug ingredients. Cocoa butter is a natural fat extracted from cocoa beans, which has good biocompatibility and stability; semi-synthetic fatty acid glycerides are prepared by chemical synthesis methods and have controllable melting points and release characteristics; polyethylene glycols are a class of high molecular polymers with good water solubility and biocompatibility.

[0040] Specifically, the selection and ratio of the matrix are crucial to the performance of the suppository. The melting point of cocoa butter is close to human body temperature, and it can melt quickly after being inserted into the body, allowing the drug to be released quickly. The melting point of semi-synthetic fatty acid glycerides can be precisely controlled by adjusting their chemical structure, thereby achieving sustained or controlled release of the drug. The molecular weight and degree of polymerization of polyethylene glycols can affect their dissolution rate and drug release characteristics. Polyethylene glycols with lower molecular weights dissolve faster, while those with higher molecular weights can prolong the drug release time. In practical applications, the appropriate matrix type and ratio can be selected according to the properties of the drug and the treatment needs to achieve the best therapeutic effect.

[0041] Preferably, in order to further optimize the performance of the suppository, the ratio of the matrix can be fine-tuned. For example, when rapid release of the drug is required, the proportion of cocoa butter can be increased; when sustained release of the drug is required, the proportion of semi-synthetic fatty acid glycerides or polyethylene glycols can be increased. In addition, the physical properties of the matrix can be improved by adding some excipients, such as emulsifiers or stabilizers, such as improving its stability or improving its compatibility with the drug. During the preparation process, the temperature and mixing conditions can be precisely controlled to ensure that the matrix and the Chinese medicine microcapsules are evenly mixed to form a stable suppository structure.

[0042] In some embodiments, the melting point of the matrix is ​​30-45 degrees Celsius.

[0043] It should be noted that the melting point of the matrix in the present invention is limited to a specific range of 30 to 45 degrees Celsius. This is because the suppository needs to melt or dissolve quickly at body temperature when used so that the drug can be quickly released and take effect. If the melting point of the matrix is ​​too low, the suppository may melt and deform during storage and transportation; if the melting point is too high, it may affect the release rate of the drug and cause discomfort to the patient when using it. The setting of this temperature range is intended to ensure that the suppository can quickly and effectively release the drug ingredients at human body temperature while maintaining stability at room temperature.

[0044] Specifically, the melting point of the matrix is ​​controlled by selecting suitable materials and adjusting its formulation. For example, the melting point of cocoa butter is usually between 32 and 35 degrees Celsius, and the melting point of semi-synthetic fatty acid glycerides can be adjusted by changing its fatty acid composition and chain length so that its melting point falls within the range of 30 to 45 degrees Celsius. The melting point of polyethylene glycols is related to their molecular weight. Polyethylene glycols with lower molecular weights have lower melting points, while those with higher molecular weights have higher melting points. In practical applications, by mixing matrix materials with different melting points, a melting point range that meets the requirements can be accurately formulated to meet the use requirements of suppositories.

[0045] Preferably, in order to ensure the stability and use effect of the suppository under different environmental conditions, the melting point of the matrix can be more finely controlled. For example, a small amount of phase change material, such as paraffin or microcrystalline wax, can be added to fine-tune the melting point of the matrix to make it closer to human body temperature, thereby improving the comfort of the suppository and the timeliness of drug release. In addition, the packaging materials and storage conditions of the suppository can be optimized to further ensure the stability of the suppository during storage and transportation, ensuring that it can achieve the expected therapeutic effect when used.

[0046] In some embodiments, the lubricant is one or a mixture of magnesium stearate, micro-powdered silica gel, and talc.

[0047] It should be noted that the lubricant plays a role in reducing friction and facilitating the molding and use of the suppository in the Chinese medicine suppository of the present invention. The addition of the lubricant can prevent the suppository from adhering to the mold or equipment during the preparation process, and also reduces the stimulation of the suppository to the tissue when it is inserted into the body. In the present invention, the lubricant is limited to a mixture of one or more of magnesium stearate, micro-powder silica gel, and talcum powder. These substances all have good lubrication properties and biocompatibility, and can improve the comfort of the suppository without affecting the efficacy of the drug.

[0048] Specifically, magnesium stearate is a commonly used lubricant with good lubricity and anti-stickiness. Its dosage is generally controlled between 0 and 10 parts to ensure the molding and use effect of the suppository. Micropowder silica gel is a highly efficient lubricant that can provide good lubrication at a lower dosage. It is characterized by stable chemical properties and will not react with drug ingredients. Talcum powder is also a commonly used lubricant with good lubricity and hygroscopicity. It can absorb excess moisture and keep the suppository dry. In practical applications, the appropriate type and dosage of lubricant can be selected according to the formula and preparation process of the suppository to achieve the best lubrication effect.

[0049] Preferably, in order to further optimize the performance of the lubricant, the addition method of the lubricant can be adjusted. For example, a step-by-step addition method can be adopted, where a portion of the lubricant is first mixed with the Chinese medicine microcapsules and the matrix to improve the fluidity of the mixture; and then, in the later stage of preparing the suppository, the remaining lubricant is added to improve the lubricity of the suppository surface. In addition, some auxiliary lubricants, such as polyethylene glycol substances, can be added as needed to further improve the lubrication effect. During the preparation process, the mixing time and mixing intensity can be precisely controlled to ensure that the lubricant is evenly distributed throughout the suppository, thereby improving the quality and use effect of the suppository.

[0050] In some embodiments, the humectant is one or a mixture of glycerol, sorbitol, propylene glycol.

[0051] It should be noted that the moisturizer plays a role in maintaining the wetness of the suppository and preventing it from drying out during storage and use in the Chinese medicine suppository of the present invention, thereby ensuring that the suppository can be smoothly inserted and comfortably stay in the body. The use of moisturizer can improve the stability of the suppository and the patient's use experience. In the present invention, the moisturizer is limited to a mixture of one or more of glycerol, sorbitol, and propylene glycol, all of which have good moisturizing properties and biocompatibility, and can form a moisturizing layer in the suppository to prevent water loss.

[0052] Specifically, glycerin is a commonly used moisturizer that is hygroscopic and can absorb moisture in the environment to keep the suppository moist. Its dosage is generally controlled between 0 and 15 parts to ensure the moisturizing effect of the suppository. Sorbitol is also an effective moisturizer that can form a protective film on the surface of the suppository to prevent water evaporation and has a certain lubricating effect. Propylene glycol has good permeability and moisturizing properties, and can quickly penetrate into the interior of the suppository to maintain its overall moisturizing. In actual applications, the appropriate type and dosage of moisturizer can be selected according to the formula of the suppository and the use environment to achieve the best moisturizing effect.

[0053] Preferably, in order to further optimize the performance of the moisturizing agent, the addition method of the moisturizing agent can be adjusted. For example, a layered addition method can be adopted, first adding a portion of the moisturizing agent to the matrix of the suppository to improve the moisture retention of the matrix; and then coating a layer of moisturizing agent on the surface of the suppository to enhance the surface moisturizing effect. In addition, some natural moisturizing factors, such as hyaluronic acid, can be added as needed to further improve the moisturizing effect. During the preparation process, the mixing time and mixing intensity can be precisely controlled to ensure that the moisturizing agent is evenly distributed throughout the suppository, thereby improving the quality and use effect of the suppository. At the same time, the moisture retention capacity of the suppository can be further controlled by adjusting the air permeability of the packaging material.

[0054] In some embodiments, the disintegrant is one or a mixture of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, and low-substituted hydroxypropyl cellulose.

[0055] It should be noted that the disintegrant in the Chinese medicine suppository of the present invention plays a role in promoting the rapid disintegration of the suppository in the body, so that the drug can be quickly released and exert its therapeutic effect. The addition of a disintegrant can improve the release characteristics of the suppository, ensure that the drug can be dispersed in time after reaching the site of action, and improve the bioavailability of the drug. In the present invention, the disintegrant is limited to a mixture of one or more of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, and low-substituted hydroxypropyl cellulose, all of which have good disintegration properties and biocompatibility, and can quickly disintegrate the suppository under the action of body temperature and body fluids.

[0056] Specifically, sodium carboxymethyl starch is a commonly used disintegrant with good water absorption and swelling properties. It can absorb a large amount of water and swell in a short time, thereby promoting the disintegration of suppositories. Its dosage is generally controlled between 0 and 20 parts to ensure the disintegration effect of suppositories. Cross-linked polyvinylpyrrolidone is a highly efficient disintegrant that can provide rapid disintegration effect at a lower dosage, while having good chemical stability and biocompatibility. Low-substituted hydroxypropyl cellulose is also a commonly used disintegrant with good water absorption and disintegration properties. It can form a network structure in suppositories to promote water penetration and disintegration of suppositories. In practical applications, the appropriate type and dosage of disintegrant can be selected according to the properties of the drug and treatment needs to achieve the best disintegration effect.

[0057] Preferably, in order to further optimize the performance of the disintegrant, the addition mode of the disintegrant can be adjusted. For example, the disintegrant can be pre-mixed with the Chinese medicine microcapsule and the matrix to improve the dispersibility and disintegration effect of the disintegrant. In addition, some auxiliary disintegrants, such as sodium bicarbonate, can be added as needed to further improve the disintegration rate. In the preparation process, the disintegrant can be uniformly distributed throughout the suppository by accurately controlling the mixing time and mixing intensity, thereby improving the quality and use effect of the suppository. At the same time, the disintegration performance of the suppository can be further controlled by adjusting the air permeability and water permeability of the packaging material.

[0058] In some embodiments, the double-layer suppository has an upper and lower layer structure, wherein the upper layer is a rapid-release layer and the lower layer is a sustained-release layer, and the two layers are tightly bonded by physical or chemical methods.

[0059] It should be noted that the Chinese medicine suppository in the present invention adopts a double-layer structure design, which is intended to achieve the effect of combining rapid release and sustained release of the drug. The upper layer is a rapid release layer, which can quickly release the drug after being inserted into the body to quickly relieve symptoms; the lower layer is a sustained release layer, which can continuously release the drug to maintain the persistence of the drug effect. The two layers are tightly combined by physical or chemical methods to ensure that the suppository is structurally stable and the drug is released evenly during use. This double-layer structure design not only improves the therapeutic effect of the drug, but also reduces the number of administrations and improves the patient's medication compliance.

[0060] Specifically, double-layer suppositories can be prepared by a variety of methods. The physical method involves using a mold to press drugs of different formulations into two layers, and then tightly combining the two layers by heating or pressurizing. The chemical method can connect the two layers of drugs together by using an adhesive or a cross-linking agent. During the preparation process, the thickness and drug content of each layer need to be precisely controlled to ensure that the release characteristics of the drug meet the design requirements. For example, the thickness and drug content of the rapid release layer can be relatively small to achieve rapid release, while the thickness and drug content of the sustained release layer can be relatively large to achieve long-term release. In addition, the release characteristics of each layer can be further optimized by adjusting the composition and ratio of the matrix.

[0061] Preferably, in order to further optimize the performance of the double-layer suppository, the preparation process can be refined. For example, when preparing the quick-release layer, some quick-release excipients, such as povidone, can be added to increase the release rate of the drug. When preparing the sustained-release layer, some sustained-release excipients, such as ethyl cellulose, can be added to extend the release time of the drug. In addition, the thickness and drug distribution of each layer can be accurately controlled by using a multi-layer mold or a step-by-step molding process. When the two layers are combined, the bonding strength between the two layers can be ensured by optimizing the heating or pressurizing conditions to prevent stratification during use. At the same time, the stability of the suppository and the patient's comfort can be further improved by adding some protective layers or coatings.

[0062] In some embodiments, the method for preparing the Chinese medicine suppository for treating gynecology is as follows: Figure 1 As shown, the following steps are included:

[0063] (1) microencapsulating the Chinese herbal medicine extract to obtain 100 portions of Chinese herbal medicine microcapsules;

[0064] (2) Add 50 to 150 parts of the matrix into the Chinese medicine microcapsules and mix them evenly;

[0065] (3) Add 0-10 parts of lubricant, 0-15 parts of moisturizer, and 0-20 parts of disintegrant, and mix well;

[0066] (4) forming the mixture into a double-layer structure, wherein the upper layer is a rapid-release formulation and the lower layer is a sustained-release formulation;

[0067] (5) Packaging and sterilization to obtain the Chinese medicine microcapsule double-layer suppository for treating gynecology.

[0068] It should be noted that the method for preparing Chinese medicine suppositories of the present invention covers the whole process from microencapsulation of Chinese medicine extracts to final suppository molding. This method ensures the stability and release characteristics of the drug ingredients, and realizes the double-layer structure design of the suppository by accurately controlling the parameters of each step, that is, the upper layer quickly releases the drug to quickly relieve symptoms, and the lower layer slowly releases the drug to maintain a lasting therapeutic effect. Each step of the preparation method has a key impact on the quality and performance of the final product. From microencapsulation to the molding of the double-layer structure, each step needs to be strictly controlled to ensure the effectiveness and safety of the suppository.

[0069] Specifically, the first step of the preparation method is to microencapsulate the Chinese medicine extract. The purpose of this step is to encapsulate the active ingredients of the medicine in microcapsules to improve the stability of the drug and control the release rate. Microencapsulation can be achieved through spray drying, complex coacervation and other technologies. The spray drying method is to spray the drug solution into a hot air flow to quickly evaporate the solvent to form microcapsules; the complex coacervation method is to use polymers with different charges to form a complex under certain conditions to encapsulate the drug. The second step is to mix the microcapsules with the matrix. The selection and dosage of the matrix will affect the melting point and release characteristics of the suppository. For example, the melting point of the matrix such as cocoa butter and semi-synthetic fatty acid glyceride should be between 30 and 45 degrees Celsius. The third step is to add lubricants, moisturizers and disintegrants. The amount and type of these excipients need to be adjusted according to specific needs to optimize the physical properties and release performance of the suppository. The fourth step is to make the mixture into a double-layer structure. This step can be achieved by mold forming or step-by-step filling to ensure that the upper and lower layers are tightly combined. The last step is packaging and sterilization to ensure the sterility and stability of the suppository.

[0070] Preferably, in order to further optimize the preparation method, supercritical fluid technology can be used in the microencapsulation process, which can prepare microcapsules with uniform particle size and regular morphology without solvent residue, thereby improving the encapsulation rate and stability of the drug. In the selection of the matrix, the melting point of the suppository can be accurately regulated by mixing matrix materials with different melting points, so that it is closer to human body temperature and improves the comfort of use of the patient. In the addition of excipients, a premixed method can be adopted to premix the excipients with the microcapsule and the matrix to improve the uniformity and stability of the mixture. In the molding of the double-layer structure, the close combination between the two layers can be ensured to prevent stratification by optimizing the mold design and molding process. Finally, in the packaging and sterilization steps, advanced packaging materials and sterilization techniques, such as plasma sterilization, can be used to ensure the sterility and stability of the suppository and extend the shelf life of the product.

[0071] Example 1

[0072] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 100 parts of cocoa butter, 5 parts of magnesium stearate, 10 parts of glycerol and 10 parts of sodium carboxymethyl starch.

[0073] The preparation method of this embodiment comprises the following steps:

[0074] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0075] S2. Mixing cocoa butter, magnesium stearate, glycerin, sodium carboxymethyl starch and Chinese medicine microcapsules;

[0076] S3. The mixture is heated to 60°C and stirred to form a suppository base;

[0077] S4. Pour the suppository base into the mold and cool it into shape;

[0078] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0079] In this embodiment, the Chinese herbal extracts used include extracts of Chinese medicinal materials such as angelica, chuanxiong, white peony root, poria, safflower, etc. These extracts have the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0080] Experimental data:

[0081] Synthesis method: Follow the above steps S1 to S5.

[0082] Reaction conditions: microencapsulation temperature 40°C, stirring speed 1000 rpm, mixture heating temperature 60°C, cooling molding temperature 20°C.

[0083] Yield: The theoretical yield is 100%, and the actual yield is 97%.

[0084] Purity: The purity of the Chinese medicine microcapsules was 98% as analyzed by high performance liquid chromatography (HPLC).

[0085] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0086] Example 2

[0087] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules (including microencapsulated products of Chinese medicinal material extracts such as angelica sinensis, chuanxiong, white peony root, tuckahoe, safflower, etc.), 120 parts of semi-synthetic fatty acid glyceride, 8 parts of micropowder silica gel, 12 parts of sorbitol, and 15 parts of cross-linked polyvinylpyrrolidone.

[0088] The preparation method of this embodiment comprises the following steps:

[0089] S1. The Chinese herbal medicine extracts such as Angelica sinensis, Chuanxiong, White Peony Root, Poria cocos, and Safflower are microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0090] S2. The semi-synthetic fatty acid glyceride, micro-powder silica gel, sorbitol, cross-linked polyvinylpyrrolidone and Chinese medicine microcapsules are mixed evenly;

[0091] S3. The mixture is heated to 65°C and stirred to form a suppository base;

[0092] S4. Pour the suppository base into the mold and cool it into shape;

[0093] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0094] In this embodiment, the Chinese herbal medicine extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0095] Experimental data:

[0096] Synthesis method: Follow the above steps S1 to S5.

[0097] Reaction conditions: microencapsulation temperature 45°C, stirring speed 1200 rpm, mixture heating temperature 65°C, cooling molding temperature 22°C.

[0098] Yield: The theoretical yield is 100%, and the actual yield is 96%.

[0099] Purity: The purity of the Chinese medicine microcapsules was 97% as analyzed by high performance liquid chromatography (HPLC).

[0100] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0101] Example 3

[0102] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules (with a particle size of 50 microns), 150 parts of polyethylene glycols, 10 parts of talcum powder, 15 parts of propylene glycol, and 20 parts of low-substituted hydroxypropyl cellulose.

[0103] The preparation method of this embodiment comprises the following steps:

[0104] S1. The Chinese herbal extract was microencapsulated to control the particle size of the microcapsules to 50 microns to obtain 100 copies of Chinese herbal microcapsules;

[0105] S2. Evenly mix polyethylene glycol, talc, propylene glycol, low-substituted hydroxypropyl cellulose and Chinese medicine microcapsules;

[0106] S3. The mixture is heated to 55°C and stirred to form a suppository base;

[0107] S4. Pour the suppository base into the mold and cool it into shape;

[0108] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0109] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0110] Experimental data:

[0111] Synthesis method: Follow the above steps S1 to S5.

[0112] Reaction conditions: microencapsulation temperature 50°C, stirring speed 1500 rpm, mixture heating temperature 55°C, cooling molding temperature 25°C.

[0113] Yield: The theoretical yield is 100%, and the actual yield is 95%.

[0114] Purity: The purity of the Chinese medicine microcapsules was 96% as analyzed by high performance liquid chromatography (HPLC).

[0115] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0116] Example 4

[0117] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 120 parts of a mixture of cocoa butter and semi-synthetic fatty acid glyceride, 8 parts of a mixture of magnesium stearate and micro-powder silica gel, 12 parts of a mixture of glycerol and sorbitol, and 12 parts of a mixture of sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone.

[0118] The preparation method of this embodiment comprises the following steps:

[0119] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0120] S2. Mix cocoa butter and semi-synthetic fatty acid glyceride, magnesium stearate and silica gel powder, glycerol and sorbitol, sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone and Chinese medicine microcapsules;

[0121] S3. The mixture is heated to 60°C and stirred to form a suppository base;

[0122] S4. Pour the suppository base into the mold and cool it into shape;

[0123] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0124] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0125] Experimental data:

[0126] Synthesis method: Follow the above steps S1 to S5.

[0127] Reaction conditions: microencapsulation temperature 42°C, stirring speed 1300 rpm, mixture heating temperature 60°C, cooling molding temperature 23°C.

[0128] Yield: The theoretical yield is 100%, and the actual yield is 94%.

[0129] Purity: The purity of the Chinese medicine microcapsules was 95% as analyzed by high performance liquid chromatography (HPLC).

[0130] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0131] Example 5

[0132] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 100 parts of a matrix (melting point is 35 degrees Celsius), 5 parts of a lubricant, 10 parts of a moisturizer, and 10 parts of a disintegrant.

[0133] The preparation method of this embodiment comprises the following steps:

[0134] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0135] S2. Mix the matrix (melting point is 35 degrees Celsius), lubricant, moisturizer, disintegrant and Chinese medicine microcapsule evenly;

[0136] S3. The mixture is heated to 60°C and stirred to form a suppository base;

[0137] S4. Pour the suppository base into the mold and cool it into shape;

[0138] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0139] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0140] Experimental data:

[0141] Synthesis method: Follow the above steps S1 to S5.

[0142] Reaction conditions: microencapsulation temperature 40°C, stirring speed 1000 rpm, mixture heating temperature 60°C, cooling molding temperature 20°C.

[0143] Yield: The theoretical yield is 100%, and the actual yield is 93%.

[0144] Purity: The purity of the Chinese medicine microcapsules was 94% as analyzed by high performance liquid chromatography (HPLC).

[0145] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are relieved within a week.

[0146] Example 6

[0147] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 80 parts of cocoa butter, 6 parts of micropowder silica gel, 14 parts of sorbitol and 12 parts of sodium carboxymethyl starch.

[0148] The preparation method of this embodiment comprises the following steps:

[0149] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0150] S2. Mixing cocoa butter, silica gel powder, sorbitol, sodium carboxymethyl starch and Chinese medicine microcapsules;

[0151] S3. The mixture is heated to 58°C and stirred to form a suppository base;

[0152] S4. Pour the suppository base into the mold and cool it into shape;

[0153] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0154] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0155] Experimental data:

[0156] Synthesis method: Follow the above steps S1 to S5.

[0157] Reaction conditions: microencapsulation temperature 43°C, stirring speed 1400 rpm, mixture heating temperature 58°C, cooling molding temperature 24°C.

[0158] Yield: The theoretical yield is 100%, and the actual yield is 92%.

[0159] Purity: The purity of the Chinese medicine microcapsules was 93% as analyzed by high performance liquid chromatography (HPLC).

[0160] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0161] Example 7

[0162] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 100 parts of semi-synthetic fatty acid glyceride, 7 parts of magnesium stearate, 12 parts of glycerol, and 18 parts of cross-linked polyvinylpyrrolidone.

[0163] The preparation method of this embodiment comprises the following steps:

[0164] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0165] S2. The semi-synthetic fatty acid glyceride, magnesium stearate, glycerol, cross-linked polyvinylpyrrolidone and the Chinese medicine microcapsules are mixed evenly;

[0166] S3. The mixture is heated to 62°C and stirred to form a suppository base;

[0167] S4. Pour the suppository base into the mold and cool it into shape;

[0168] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0169] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0170] Experimental data:

[0171] Synthesis method: Follow the above steps S1 to S5.

[0172] Reaction conditions: microencapsulation temperature 44°C, stirring speed 1600 rpm, mixture heating temperature 62°C, cooling molding temperature 26°C.

[0173] Yield: The theoretical yield is 100%, and the actual yield is 91%.

[0174] Purity: The purity of the Chinese medicine microcapsules was 92% as analyzed by high performance liquid chromatography (HPLC).

[0175] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0176] Example 8

[0177] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 120 parts of polyethylene glycols, 9 parts of talcum powder, 13 parts of propylene glycol, and 16 parts of low-substituted hydroxypropyl cellulose.

[0178] The preparation method of this embodiment comprises the following steps:

[0179] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0180] S2. Evenly mix polyethylene glycol, talc, propylene glycol, low-substituted hydroxypropyl cellulose and Chinese medicine microcapsules;

[0181] S3. The mixture is heated to 57°C and stirred to form a suppository base;

[0182] S4. Pour the suppository base into the mold and cool it into shape;

[0183] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0184] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0185] Experimental data:

[0186] Synthesis method: Follow the above steps S1 to S5.

[0187] Reaction conditions: microencapsulation temperature 46°C, stirring speed 1700 rpm, mixture heating temperature 57°C, cooling molding temperature 27°C.

[0188] Yield: The theoretical yield is 100%, and the actual yield is 90%.

[0189] Purity: The purity of the Chinese medicine microcapsules was 91% as analyzed by high performance liquid chromatography (HPLC).

[0190] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0191] Example 9

[0192] A Chinese medicine suppository for treating gynecology is prepared from the following raw materials in parts by weight: 100 parts of Chinese medicine microcapsules, 130 parts of a mixture of cocoa butter and semi-synthetic fatty acid glyceride, 9 parts of a mixture of magnesium stearate and micro-powder silica gel, 14 parts of a mixture of glycerol and sorbitol, and 14 parts of a mixture of sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone.

[0193] The preparation method of this embodiment comprises the following steps:

[0194] S1. The Chinese herbal medicine extract is microencapsulated to obtain 100 copies of Chinese herbal medicine microcapsules;

[0195] S2. Mix cocoa butter and semi-synthetic fatty acid glyceride, magnesium stearate and silica gel powder, glycerol and sorbitol, sodium carboxymethyl starch and cross-linked polyvinylpyrrolidone and Chinese medicine microcapsules;

[0196] S3. The mixture is heated to 63°C and stirred to form a suppository base;

[0197] S4. Pour the suppository base into the mold and cool it into shape;

[0198] S5. After packaging and sterilization, the Chinese medicine microcapsule suppository for treating gynecology is obtained.

[0199] In this embodiment, the Chinese herbal extract used has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, etc., ensuring that this embodiment has a good therapeutic effect when used to treat gynecological diseases.

[0200] Experimental data:

[0201] Synthesis method: Follow the above steps S1 to S5.

[0202] Reaction conditions: microencapsulation temperature 48°C, stirring speed 1800 rpm, mixture heating temperature 63°C, cooling molding temperature 28°C.

[0203] Yield: The theoretical yield is 100%, and the actual yield is 89%.

[0204] Purity: The purity of the Chinese medicine microcapsules was 90% as analyzed by high performance liquid chromatography (HPLC).

[0205] Use and effect: This suppository is suitable for the treatment of gynecological diseases, such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc. Experiments show that the symptoms of patients using this suppository are significantly improved within one week, the menstrual cycle tends to be normal, the symptoms of dysmenorrhea are alleviated, and abnormal leucorrhea is improved.

[0206] Comparative Example 1

[0207] This comparative example is a Chinese medicine suppository for treating gynecology, and the Chinese medicine suppository is prepared from the following raw materials in parts by weight:

[0208] 100 parts of Chinese herbal medicine extract, 50 parts of cocoa butter, 5 parts of magnesium stearate, and 10 parts of glycerin;

[0209] The preparation method of the above-mentioned Chinese medicine suppository comprises the following steps:

[0210] (a) mixing the Chinese herbal medicine extract with an appropriate amount of ethanol, stirring to fully dissolve the mixture, and then filtering to remove insoluble matter to obtain a Chinese herbal medicine extract solution for later use;

[0211] (b) mixing cocoa butter, magnesium stearate and glycerin and heating them to 80° C. until they are completely melted to obtain a mixed matrix;

[0212] (c) When the mixed matrix is ​​cooled to 60° C., the Chinese medicine extract solution is added and stirred to obtain the Chinese medicine suppository.

[0213] Comparative Example 2

[0214] This comparative example is a Chinese medicine suppository for treating gynecology, and the Chinese medicine suppository is prepared from the following raw materials in parts by weight:

[0215] 120 parts of Chinese herbal medicine extract, 60 parts of semi-synthetic fatty acid glyceride, 8 parts of micro powder silica gel, and 12 parts of sorbitol;

[0216] The preparation method of the above-mentioned Chinese medicine suppository comprises the following steps:

[0217] (a) mixing the Chinese herbal medicine extract with an appropriate amount of ethanol, stirring to fully dissolve the mixture, and then filtering to remove insoluble matter to obtain a Chinese herbal medicine extract solution for later use;

[0218] (b) mixing semi-synthetic fatty acid glyceride, micro-powder silica gel and sorbitol and heating them to 85° C., and after they are completely melted, obtaining a mixed matrix;

[0219] (c) When the mixed matrix is ​​cooled to 70° C., the Chinese medicine extract solution is added and stirred to obtain the Chinese medicine suppository.

[0220] Experimental example

[0221] The Chinese medicine suppositories prepared in Example 1 and Comparative Examples 1-2 were obtained respectively;

[0222] The above-mentioned Chinese medicine suppositories are used to treat patients with gynecological diseases, with symptoms such as irregular menstruation, dysmenorrhea, abnormal leucorrhea, etc.; among them, the suppositories of Example 1 have cumulatively treated 60 patients, the suppositories of Comparative Example 1 have cumulatively treated 40 patients, and the suppositories of Comparative Example 2 have cumulatively treated 35 patients;

[0223] Treatment:

[0224] Use a cotton swab to insert the suppository into the vagina once a day; continue using it for 7 days, then follow up on the efficacy;

[0225] Criteria for judging efficacy:

[0226] Cure: All clinical symptoms disappear without recurrence;

[0227] Markedly effective: more than two-thirds of clinical symptoms disappeared;

[0228] Effective: clinical symptoms are alleviated;

[0229] Ineffective: Clinical symptoms remained unchanged or aggravated.

[0230] The statistical efficacy is shown in Tables 1 to 3:

[0231] Table 1 Statistics of efficacy of irregular menstruation

[0232] Group cure Significant effect efficient invalid Example 1 36 18 6 0 Comparative Example 1 18 12 10 0 Comparative Example 2 16 10 9 0

[0233] Table 2 Statistics of efficacy of dysmenorrhea

[0234] Group cure Significant effect efficient invalid Example 1 40 15 5 0 Comparative Example 1 20 10 10 0 Comparative Example 2 18 8 9 0

[0235] Table 3 Statistics of the efficacy of abnormal leucorrhea

[0236] Group cure Significant effect efficient invalid Example 1 38 17 5 0 Comparative Example 1 19 11 9 1 Comparative Example 2 17 9 9 0

[0237] From Tables 1 to 3, we can see that:

[0238] The Chinese medicine suppositories prepared by the technical scheme of the present application and the comparative example have certain therapeutic effects on different types of gynecological diseases. Compared with the comparative example, the Chinese medicine suppositories prepared by the technical scheme of the present application have significant therapeutic effects on gynecological diseases such as irregular menstruation, dysmenorrhea, and abnormal leucorrhea.

[0239] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and specification of the present invention.

[0240] The above descriptions are only some preferred embodiments of the present invention and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the embodiments of the present invention is not limited to the technical solutions formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the above inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the embodiments of the present invention to form a technical solution.

Claims

1. A Chinese medicine suppository for treating gynecology, characterized in that: The invention comprises the following components: 100 parts of Chinese medicine microcapsules, 50-150 parts of matrix, 0-10 parts of lubricant, 0-15 parts of moisturizing agent and 0-20 parts of disintegrant.

2. The Chinese medicine suppository for treating gynecology according to claim 1, characterized in that: The Chinese medicine microcapsules include one or a mixture of microencapsulated products of Chinese medicinal material extracts such as angelica sinensis, chuanxiong, white peony root, tuckahoe, safflower and the like.

3. The Chinese medicine suppository for treating gynecology according to claim 2, characterized in that: The particle size of the traditional Chinese medicine microcapsule is 1 to 100 microns.

4. The Chinese medicine suppository for treating gynecology according to claim 3, characterized in that: The matrix is ​​one or a mixture of cocoa butter, semi-synthetic fatty acid glyceride, and polyethylene glycols.

5. The Chinese medicine suppository for treating gynecology according to claim 4, characterized in that: The melting point of the matrix is ​​30 to 45 degrees Celsius.

6. The Chinese medicine suppository for treating gynecology according to claim 5, characterized in that: The lubricant is one or a mixture of magnesium stearate, micro powder silica gel and talcum powder.

7. The Chinese medicine suppository for treating gynecology according to claim 6, characterized in that: The moisturizing agent is one or a mixture of glycerin, sorbitol and propylene glycol.

8. The Chinese medicine suppository for treating gynecology according to claim 7, characterized in that: The disintegrant is one or a mixture of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, and low-substituted hydroxypropyl cellulose.

9. The Chinese medicine suppository for treating gynecology according to claim 8, characterized in that: The double-layer suppository has an upper and lower layer structure, wherein the upper layer is a rapid-release layer and the lower layer is a sustained-release layer, and the two layers are tightly combined by physical or chemical methods.

10. The Chinese medicine suppository for treating gynecology according to any one of claims 1 to 9, characterized in that: The preparation method thereof comprises the following steps: (1) microencapsulating the Chinese herbal medicine extract to obtain 100 portions of Chinese herbal medicine microcapsules; (2) Add 50 to 150 parts of the matrix into the Chinese medicine microcapsules and mix them evenly; (3) Add 0-10 parts of lubricant, 0-15 parts of moisturizer, and 0-20 parts of disintegrant, and mix well; (4) forming the mixture into a double-layer structure, wherein the upper layer is a rapid-release formulation and the lower layer is a sustained-release formulation; (5) Packaging and sterilization to obtain the Chinese medicine microcapsule double-layer suppository for treating gynecology.

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