Biomolecular film composition, skin external preparation as well as preparation method and application of biomolecular film composition and skin external preparation

Abstract

The invention discloses a biomolecular film composition, a skin external preparation as well as a preparation method and application of the biomolecular film composition and the skin external preparation. The composition comprises the following components: 5%-30% of bisabolol; 2%-20% of oryzanol; 0-60% of grease; 0.3%-6% of ethyl cellulose and / or 5%-40% of a rape / tung oil copolymer; 0.5% to 8% of C20-40 acid; 0.1%-1% of a neutralizer; 0.025% to 0.225% of silk fibroin; 0.05% to 0.45% of glucomannan; and 0.1%-1.6% of a preservative. Water-soluble active molecules and oil-soluble active molecules are combined together through hydrophobic chains and hydrophilic chains in fibroin, the composition is prepared through high-pressure homogenization, and the composition has the effects of oxidation resistance, UV damage repair, UV light protection and inflammation resistance and can be adsorbed on the skin surface to form a film; the composition can be used together with a sun-screening agent, so that the sun-screening efficiency and stability of the sun-screening agent are improved, and relatively good water-resistant and sweat-resistant performance is provided.

Description

Technical Field

[0001] The present invention specifically relates to a biomolecular film composition, a topical skin preparation, a preparation method thereof, and an application thereof. Background Art

[0002] In sunlight, in addition to visible light, there are also light waves in bands such as ultraviolet (UV), infrared, and blue light. According to current life science research, photoaging and photodamage caused by UV are important exogenous factors for skin aging and are also one of the inducing factors for skin diseases such as skin cancer and melasma; although infrared and blue light are less harmful than UV, they can also cause skin inflammation, pigmentation and other problems. With the development of modern medicine, photoelectric therapy is an effective treatment method for improving skin acne, scars, pigmentation, and hair removal. Some of the light waves used in photoelectric therapy include bands such as ultraviolet, infrared, and blue light, which will also cause damage to the skin while treating skin diseases. Especially after treatment, if the skin is exposed to sunlight again, it is easy to cause lesions such as pigmentation and swelling.

[0003] In conventional topical skin preparations, liquid dressings such as two types of medical devices of hyaluronic acid and collagen or special-purpose cosmetics with sunscreen function are used to care for or prevent skin damage caused by natural light and after photoelectric treatment. However, medical device-based topical skin preparations can only mainly play effects such as moisturizing and antibacterial, and cannot directly provide the effect of light protection, and can only be used for nursing after photodamage; while special-purpose cosmetics with sunscreen function are mainly for shielding UV and are only suitable for use on normal skin to prevent damage caused by UV. Due to the safety and irritation problems of the sunscreen itself, it is not suitable for use within one week after photoelectric treatment. Once there is skin breakage or damage, the disadvantages outweigh the advantages.

[0004] Considering the usage scenarios and habits, the use of topical skin preparations with light protection or light repair effects will be affected by skin physiological and pathological processes. For example, sweating or exudation due to skin damage will cause loss of the retention of the topical preparation. Therefore, it is also very important that the preparation form can be better fixed on the skin surface, and usually a polymer film-forming agent is used to achieve this.

[0005] A film-forming agent is a commonly used component in topical skin preparations, which can increase adhesion and persistence, and endow functions such as moisturizing, sunscreen, sweat resistance, waterproofing, and shaping, and prevent the preparation from falling off and smudging during use; the function of the film-forming agent is relatively single, generally only having effects related to film-forming performance, and due to problems such as impurities introduced during the synthesis process, its safety, biocompatibility, and biodegradability are relatively poor, and it cannot provide effects such as antioxidant free radical damage and light damage repair.

[0006] Silk fibroin, also known as sericin, is a protein with excellent biological activity and material functionality, rich in high β-sheet structures; silk protein in dilute (aqueous) solutions mainly exists in a random coil conformation. Although using silk fibroin alone has certain properties, it can also cause problems such as pilling and discomfort caused by the accumulation of external fibers on the skin.

[0007] Chinese patent document CN118236283A discloses a sunscreen composition that uses a heat-strengthening agent composed of silk fibroin and an acyl peptide-based biosurfactant, which can form a film after application, and as the skin temperature or ambient temperature rises, the film gradually transforms into a denser layered structure. However, it has two deficiencies: First, only the factor of temperature is considered, without considering that after the skin temperature rises, there will also be sweating problems. Sweat will dilute the sunscreen product on the skin mask and carry away the externally applied sunscreen preparation through flowing, thereby leading to a decline in the UV protection function and causing skin damage. If this heat-strengthening agent needs to improve the water and sweat resistance performance, other chemical film-forming agents still need to be used, such as styrene / acrylic acid (ester) copolymers in the examples; Second, this heat-strengthening agent itself has no efficacy and cannot provide effective UV protection for the skin without a sunscreen agent. Summary of the Invention

[0008] The technical problem actually solved by the present invention is to overcome the defects of the existing film-forming agents, sunscreen products or externally applied skin agents with single functions, which cannot have functions such as film-forming, sweat and water resistance, sunscreen enhancement, anti-inflammatory, and photo-protection effects at the same time. The present invention provides a biomolecular film composition, an externally applied skin preparation, its preparation method, and application. The present invention uses the hydrophobic chain and hydrophilic chain in the silk fibroin structure to combine water-soluble and oil-soluble active molecules, and through high-pressure homogenization, a composition with UV protection and water resistance functions is formed. The composition of the present invention can promote the formation of β-sheets to form a film structure loaded with active substances, which can independently exert antioxidant, UV damage repair, UV photo-protection, and anti-inflammatory effects, and can also adsorb and form a film on the skin surface; it can also be used together with a sunscreen agent to enhance the sunscreen efficacy and stability of the sunscreen agent, and provide good water and sweat resistance performance.

[0009] The present invention solves the above technical problems through the following technical solutions.

[0010] The present invention provides a biomolecular film composition, which includes the following components:

[0011] Bisabolol 5%-30%;

[0012] Oryzanol 2%-20%;

[0013] Oil 0-60%;

[0014] Ethyl cellulose 0.3%-6% and / or rapeseed / tung oil copolymer 5%-40%;

[0015] C 20-40 0.5% - 8% acid;

[0016] 0.1% - 1% neutralizing agent;

[0017] 0.025% - 0.225% fibroin;

[0018] 0.05% - 0.45% glucomannan;

[0019] 0.1% - 1.6% preservative;

[0020] Among them, the above percentages are all mass percentages of each component relative to the total amount of the composition.

[0021] In the present invention, the oil and fat can be conventional in the art, such as vegetable oil and / or synthetic oil.

[0022] The vegetable oil can be conventional in the art, preferably one or more of camellia seed oil, sunflower seed oil, macadamia nut oil, etc.

[0023] The synthetic oil can be conventional in the art, preferably one or more of coco-caprylate / caprate, neopentyl glycol di(ethylhexanoate), caprylic / capric triglyceride, diisopropyl sebacate, isononyl isononanoate, etc., and more preferably diisopropyl sebacate.

[0024] In the present invention, the average molecular weight of the ethyl cellulose is preferably 0.5 - 5×10 5 Da. If the molecular weight is less than the lower limit, the film-forming effect is weak; if the molecular weight is greater than the upper limit, the solubility in oil and fat is low.

[0025] In the present invention, the ethoxy content of the ethyl cellulose is preferably 45 - 55%. If the ethoxy content is lower than the lower limit, the solubility in oil and fat is low; if it is higher than the upper limit, it will cause a decrease in the tensile strength of the film formed by ethyl cellulose, making it easy to break and not resistant to friction.

[0026] In the present invention, the neutralizing agent can be conventional in the art, such as one or more of sodium hydroxide, potassium hydroxide, aminomethyl propanol, tromethamine, arginine, etc., and preferably arginine.

[0027] In the present invention, the fiber length of the fibroin is preferably 0.05 - 2.5 μm. In the present invention, if the fiber length of the fibroin is less than 0.05 μm, the film-forming performance is relatively poor; if the fiber length is greater than 2.5 μm, the dispersion and dissolution performance in water is poor, the consistency is high, and the uniform stability is slightly poor.

[0028] In the present invention, the β-sheet content of the fibroin is preferably greater than 30%. In the present invention, if the β-sheet content of the fibroin is lower than 30%, the intermolecular force of the fibroin fiber is weak and the film-forming property is weak.

[0029] In the present invention, the average molecular weight of the glucomannan is preferably 1.0×10 6 -8.0×10 6 Da. If the average molecular weight is less than the lower limit, the film-forming effect is not good; if the average molecular weight is greater than the upper limit, the stickiness on the skin surface is too strong and the usability is not good.

[0030] In the present invention, the preservative can be conventional in the art, such as raspberry ketone and / or 1,2-hexanediol.

[0031] When the biomolecular film composition contains raspberry ketone, the dosage of the raspberry ketone is preferably 0.05-0.6%, such as 0.3%, 0.4% or 0.5%.

[0032] When the biomolecular film composition contains 1,2-hexanediol, the dosage of the 1,2-hexanediol is preferably 0.05%-1%, such as 0.3%, 0.4%, 0.5%, 0.6% or 0.8%.

[0033] In the present invention, the dosage of the bisabolol is preferably 7%-25%, such as 7.5%, 10%, 15%, 18%, 20% or 22.5%.

[0034] In the present invention, the dosage of the oryzanol is preferably 3%-18%, such as 5%, 8%, 10%, 12% or 15%.

[0035] In the present invention, the dosage of the ethyl cellulose is preferably 0.5%-4%, such as 1%, 1.5%, 2%, 2.5% or 3%.

[0036] In the present invention, the dosage of the oil is preferably 0.01%-50%, such as 2%, 3%, 4.5%, 6%, 7%, 9.5%, 11%, 13.5%, 14.5%, 15.5%, 18.5%, 20.5%, 27%, 29%, 31%, 32%, 37%, 42% or 43%.

[0037] In the present invention, the dosage of the rapeseed / tung oil copolymer is preferably 5%-30%, such as 8%, 10%, 15%, 20% or 25%.

[0038] In the present invention, the dosage of the C 20-40 acid is preferably 0.5%-4%, such as 1%, 1.5%, 2%, 2.5% or 3%.

[0039] In the present invention, the dosage of the neutralizing agent is preferably 0.2% - 0.6%, such as 0.3%, 0.4% or 0.5%.

[0040] In the present invention, the dosage of the fibroin is preferably 0.04 - 0.15%, such as 0.05%, 0.075%, 0.09%, 0.1% or 0.125%.

[0041] In the present invention, the dosage of the glucomannan is preferably 0.08 - 0.30%, such as 0.10%, 0.15%, 0.18%, 0.20% or 0.25%.

[0042] In the present invention, the dosage of the preservative is preferably 0.2% - 1.5%, such as 0.3%, 0.5%, 0.8%, 1% or 1.2%.

[0043] In the present invention, the biomolecular film composition preferably further contains water. The dosage of water is preferably 29.775%, 34.725%, 34.75%, 39.675%, 39.7%, 39.725%, 44.65% or 49.625%.

[0044] In a preferred embodiment, the bisabolol is purchased from Yili Chuanning Biotechnology Co., Ltd.

[0045] In a preferred embodiment, the oryzanol is purchased from Shanghai Shunfeng Chemical Technology Co., Ltd.

[0046] In a preferred embodiment, the ethyl cellulose is purchased from Ashland Group.

[0047] In a preferred embodiment, the diisopropyl sebacate is purchased from The Good Light LLC.

[0048] In a preferred embodiment, the rapeseed / tung oil copolymer is purchased from TRI-K Industries.

[0049] In a preferred embodiment, the C20-40 acid is purchased from Shanghai Aoyuan Biotechnology Co., Ltd.

[0050] In a preferred embodiment, the arginine is purchased from Hannin Chemistry (Shanghai) Co., Ltd.

[0051] In a preferred embodiment, the fibroin aqueous solution is purchased from Sinet (Suzhou) Biotechnology Co., Ltd.

[0052] In a preferred embodiment, the glucomannan aqueous solution is purchased from Nanjing Nanfangyuan Biotechnology Co., Ltd.

[0053] In a preferred embodiment, the raspberry ketone is purchased from Lipoid.

[0054] In a preferred embodiment, the 1,2 - hexanediol is purchased from Ashland Group.

[0055] In a preferred embodiment, the sunflower seed oil is purchased from Suzhou Luxiangyuan Food Co., Ltd.

[0056] The present invention also provides a method for preparing the biomolecular film composition, which comprises the following steps: in a high - pressure homogenizer, homogenize each component of the biomolecular film composition to obtain the biomolecular film composition.

[0057] In a preferred embodiment, the high - pressure homogenizer can be a micro - jet super - high - pressure homogenizer, produced by Genizer, model MixGenizer 30K.

[0058] In the present invention, the fibroin is preferably added in the form of an aqueous solution.

[0059] Among them, in the aqueous solution containing fibroin, the mass fraction of fibroin is preferably 0.4% - 0.6%.

[0060] The dosage of the aqueous solution containing fibroin is preferably 8% - 30%, such as 10%, 15%, 18%, 20% or 25%.

[0061] In the present invention, the glucomannan is generally added in the form of an aqueous solution. In the aqueous solution containing glucomannan, the mass fraction of glucomannan in the aqueous solution is preferably 0.9 - 1.1%.

[0062] The dosage of the aqueous solution containing glucomannan is preferably 8% - 30%, such as 10%, 15%, 18%, 20% or 25%.

[0063] In the present invention, before homogenization, each component of the biomolecular film composition is generally stirred and mixed evenly. The temperature of the stirring and mixing is preferably 85 - 90°C.

[0064] In the present invention, a uniform emulsion - like mixture can generally be obtained after homogenization.

[0065] In the present invention, after homogenization, conventional filtration is generally also carried out.

[0066] In the present invention, the pressure of homogenization is preferably 20 - 300 MPa, preferably 100 MPa;

[0067] In the present invention, the temperature of homogenization is preferably 25 - 80°C, such as 80°C.

[0068] In the present invention, the time of homogenization is preferably 5 - 30 min, such as 15 min.

[0069] The present invention provides a topical skin preparation, which comprises 0.1%-10% of the above-mentioned biomolecular film composition, and the above percentages are the mass percentages of the composition in the topical skin preparation.

[0070] In the present invention, the dosage of the biomolecular film composition is preferably 0.2-8%, more preferably 0.2-5%, such as 0.5%, 1% or 2%.

[0071] In the present invention, the topical skin preparation preferably comprises 0.1-0.3% of carbomer, such as 0.25% of carbomer.

[0072] In the present invention, the topical skin preparation preferably comprises 0.2-0.80% of 1,2-hexanediol, such as 0.50% of 1,2-hexanediol.

[0073] In the present invention, the topical skin preparation preferably comprises 0.01-0.05% of disodium EDTA, such as 0.02% of disodium EDTA.

[0074] In the present invention, the topical skin preparation preferably comprises 2-10.0% of butanediol, such as 5.0% of butanediol.

[0075] In the present invention, the topical skin preparation preferably comprises 1.0-2.0% of bis-ethylhexyloxyphenol methoxyphenyl triazine, such as 1.5% of bis-ethylhexyloxyphenol methoxyphenyl triazine.

[0076] In the present invention, the topical skin preparation preferably comprises 1.0-3.0% of ethylhexyl triazone, such as 2.0% of ethylhexyl triazone.

[0077] In the present invention, the topical skin preparation preferably comprises 2.0-4.0% of diethylamino hydroxybenzoyl hexyl benzoate, such as 3.5% of diethylamino hydroxybenzoyl hexyl benzoate.

[0078] In the present invention, the topical skin preparation preferably comprises 5.0-15% of ethylhexyl methoxycinnamate, such as 9.5% of ethylhexyl methoxycinnamate.

[0079] In the present invention, the topical skin preparation preferably comprises 5.0-15% of diisopropyl sebacate, such as 9.5% of diisopropyl sebacate.

[0080] In the present invention, the topical skin preparation preferably comprises 0.5-5% of polysiloxane-15, such as 1.0% of polysiloxane-15.

[0081] In the present invention, the topical skin preparation preferably comprises 1.0-2% of polyglyceryl-6 stearate, such as 1.5% of polyglyceryl-6 stearate.

[0082] In the present invention, the topical skin preparation preferably comprises 0.3 - 1% cetearyl alcohol, for example 0.6% cetearyl alcohol.

[0083] In the present invention, the topical skin preparation preferably comprises 0.1 - 0.5% arginine, for example 0.25% arginine.

[0084] In the present invention, the topical skin preparation preferably comprises 40.0 - 80.0% water.

[0085] The above percentages are all mass percentages of each component relative to the topical skin preparation.

[0086] The present invention also provides a method for preparing the topical skin preparation, which comprises the following steps: uniformly mixing the oil phase component, the water phase component, the neutralizing agent and the biomolecular film composition.

[0087] In the present invention, it is preferred to first prepare the oil phase mixture and the water phase mixture separately. After mixing the oil phase mixture and the water phase mixture, then mix them with the preservative and the biomolecular film composition.

[0088] Among them, the oil phase mixture can be prepared by conventional methods in the art. For example, add each component of the oil phase to an oil pan, heat to 80 - 85 °C, stir evenly, and the stirring speed is 150 - 400 rpm (for example, 250 rpm).

[0089] In a preferred embodiment, the oil phase mixture is prepared by the following steps: Add bis - ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl triazone, diethylamino hydroxybenzoyl benzoic acid hexyl ester, ethylhexyl methoxycinnamate, diisopropyl sebacate, polysiloxane - 15, polyglyceryl - 6 stearate and cetearyl alcohol to an oil pan, heat to 80 - 85 °C, stir evenly, and the stirring speed is 250 rpm.

[0090] Among them, the water phase mixture can be prepared by conventional methods in the art. For example, add each component of the water phase to a water pan, heat to 80 - 85 °C, stir evenly, and the stirring speed is 150 - 400 rpm (for example, 250 rpm).

[0091] In a preferred embodiment, the water phase mixture is prepared by the following steps: Add carbomer, 1,2 - hexanediol, disodium EDTA, butanediol and water to a water pan, heat to 85 - 90 °C, stir evenly, and the stirring speed is 250 rpm.

[0092] Among them, when the oil phase mixture and the water phase mixture are mixed, it is preferred to carry out homogeneous mixing. The time of homogenization is preferably 5 minutes. The homogenization speed is preferably 3000 rpm.

[0093] After the homogeneous mixing, heat preservation is generally carried out, for example, heat preservation for 30 min

[0094] In the present invention, the neutralizing agent can be conventional in the field, such as arginine.

[0095] In the present invention, generally when the system is cooled to 50 °C, the biomolecular film composition is added.

[0096] The present invention provides an application of the biomolecular film composition in external medical devices, external drugs for treating skin damage caused by optoelectronic therapy, or the field of daily chemical skin care.

[0097] The external medical devices mainly refer to Class II and Class III medical devices, such as liquid dressings, cold compress patches, cold compress gels, etc.

[0098] The biomolecular film composition preferably has a light protection effect, and the light protection effects include sun protection, anti-photoaging, repair and other effects.

[0099] In the external medical devices and external drugs for treating skin damage caused by optoelectronic therapy, the dosage of the composition can be 0.1-10%, preferably 0.2-8%, more preferably 0.2-5%. The above percentages are the mass percentages of the composition in the external drugs.

[0100] In the preparation process of the external medical devices and external drugs for treating skin damage caused by optoelectronic therapy, excipients are generally added.

[0101] The external medical devices and external drugs for treating skin damage caused by optoelectronic therapy can be conventional dosage forms prepared by conventional methods in the art.

[0102] Among them, the conventional dosage forms generally include but are not limited to the following dosage forms: lotions, liniments, films, ointments, sprays, gels, cataplasms, patches, ointments, microneedle transdermal absorbers or liposomes.

[0103] In the field of daily chemical skin care, the dosage of the composition can be 0.1%-10%, preferably 0.2-8%, more preferably 0.2-5%. The above percentages are the mass percentages of the composition in the skin external preparations.

[0104] The biomolecular film composition can be used as a sunscreen product or a post-sun repair product in the field of daily chemical skin care. In the sunscreen product or post-sun repair product, it can significantly improve the water resistance, sun protection performance, anti-free radical ability, anti-UV damage, anti-inflammatory and soothing effects of the product.

[0105] On the basis of conforming to the common knowledge in the art, the above preferred conditions can be combined arbitrarily to obtain various preferred examples of the present invention.

[0106] The reagents and raw materials used in the present invention are all commercially available.

[0107] The positive and progressive effects of the present invention are as follows:

[0108] 1. When used in combination with a sunscreen agent, the amount of the sunscreen agent used is reduced, the risk of skin irritation caused by the sunscreen agent is lowered, and the problem of skin irritation risk existing in existing sunscreen products is solved.

[0109] 2. When used in combination with a sunscreen agent, the weakening of the sunscreen effect is slowed down, the sunscreen time is extended, and the durability of the sunscreen product is improved, solving the problem of short sunscreen time in existing sunscreen products.

[0110] 3. When used in combination with a sunscreen agent, the waterproof ability is improved, and the sunscreen film is not easily damaged by friction of sweat and water, solving the problem that the existing sunscreen film is easily damaged by friction of sweat and water.

[0111] 4. When used alone, it has the effects of resisting oxidation damage caused by UV, anti-inflammatory and soothing, and being mild, meeting the skin care needs of consumers for daily production or after UV damage or photoelectric surgery. When used in combination with a sunscreen agent, the problem that existing sunscreen products lack skin care effects such as antioxidant is solved.

[0112] 5. The homogeneous mixture prepared by the high-pressure homogenization technology adopted in the present invention has a homogeneous material and uniform particle size under this condition, and achieves the effect of encapsulating the active ingredients, which is beneficial to uniform spreading on the skin surface, has a good skin feel, forms a uniform oil film, water film and water-oil two-way breathable film on the skin surface, improves the spreading uniformity of the sunscreen film, and solves the problem of uneven spreading in existing film-forming technologies.

[0113] 6. The unique molecular structure of fibroin in the composition endows it with excellent biological activity and material functionality, enhancing the repair, soothing, antioxidant and other functions of the composition.

[0114] 7. The composition of the present invention can form a sandwich molecular fishnet structure on the skin surface, in which an oil film is formed by ethyl cellulose and rapeseed / tung oil copolymer, a water-oil two-way breathable film is formed by fibroin, a water film is formed by glucomannan, and active ingredients such as C20-40 acid, bisabolol and oryzanol are embedded in the fishnet structure, making the sandwich fishnet structure more stable.

[0115] The synergistic effect of various components of the composition improves the film-forming performance, solves the problems of poor performance and single function of existing film-forming agents, forms an oil film, a water film and a water-oil two-way breathable film on the skin surface, can well unify the oil and water, is beneficial to forming a thin film on the skin surface, and enhances the water resistance, sunscreen ability and other properties of the product. Detailed implementation mode

[0116] The present invention will be further described below by way of examples, but the present invention is not limited to the scope of the described examples. For the experimental methods without specific conditions noted in the following examples, they are carried out according to conventional methods and conditions, or selected according to the product specifications.

[0117] In the examples and comparative examples, the high-pressure homogenizer is a microfluidic ultra-high pressure homogenizer, produced by Genizer, model MixGenizer 30K.

[0118] In the examples and comparative examples, the raw material sources are as follows: Bisabolol is purchased from Yili Chuanning Biotechnology Co., Ltd.; Oryzanol is purchased from Shanghai Shunfeng Chemical Technology Co., Ltd.; Diisopropyl Sebacate is purchased from The Good Light LLC; Rapeseed / Tung Oil Copolymer is purchased from TRI-K Industries; C20-40 Acid is purchased from Shanghai Aoyuan Biotechnology Co., Ltd.; Arginine is purchased from Hannin Chemistry (Shanghai) Co., Ltd.; Raspberry Ketone is purchased from Lipoid; 1,2-Hexanediol is purchased from Ashland Group; Sunflower Seed Oil is purchased from Suzhou Luxiangyuan Food Co., Ltd.; Synthetic Oil GTCC is purchased from Shanghai Shunfeng Chemical Technology Co., Ltd.

[0119] Ethylcellulose is purchased from Ashland Group, with an average molecular weight of 0.5 - 5×10 5 Da, and the ethoxy content is 45 - 55%.

[0120] The aqueous solution of silk fibroin is purchased from Sinat (Suzhou) Biotechnology Co., Ltd., with a fiber length of 0.05 - 2.5 μm, a β-sheet content of more than 30%, and the mass fraction of silk fibroin is preferably 0.5%.

[0121] The aqueous solution of glucomannan is purchased from Nanjing Nanfangyuan Biotechnology Co., Ltd., with an average molecular weight of 1.0×10 6 -8.0×10 6 Da, and the mass fraction of glucomannan in the aqueous solution is 1%.

[0122] Examples 1 - 20

[0123] Examples 1 - 20 and Comparative Examples 1 - 3 disclose a biomolecular film composition, and the components and mass ratios are shown in Table 1. Among them, each percentage is the mass percentage of each component relative to the total amount of the composition.

[0124] Table 1

[0125]

[0126] In Examples 19 - 20, ethylcellulose and rapeseed / tung oil copolymer are respectively removed. These removed components are all oil-soluble components, and the removed components are replaced with an equal amount of the oil-soluble substance diisopropyl sebacate.

[0127] In Comparative Example 1, the oil-soluble component oryzanol was replaced with an equal amount of the oil-soluble component diisopropyl sebacate.

[0128] In Comparative Examples 2-3, the aqueous silk fibroin solution and the aqueous mannan solution were removed respectively. These removed components are all water-soluble substances, and the removed components were replaced with an equal amount of water.

[0129] The preparation method of the composition comprises the following steps:

[0130] S1 At 85-90 °C, 11 components such as bisabolol, oryzanol, ethyl cellulose, diisopropyl sebacate, rapeseed / tung oil copolymer, C 20-40 acid, arginine, aqueous silk fibroin solution, aqueous glucomannan solution were added in sequence and stirred and mixed evenly;

[0131] S2 The material obtained in step S1 was added to a microfluidic high-pressure homogenizer for homogenization to obtain a uniform emulsion-like mixture, which was filtered to obtain the biomolecular film composition. Among them, the homogenization pressure was 100 MPa, the homogenization temperature was 80 °C, and the homogenization time was 15 min.

[0132] Example 21

[0133] Compared with Example 2, the difference is only that diisopropyl sebacate was replaced with an equal amount of synthetic grease GTCC, and other operations and conditions are the same as those in Example 2.

[0134] Example 22

[0135] Compared with Example 2, the difference is only that diisopropyl sebacate was replaced with an equal amount of vegetable oil high-oleic sunflower oil, and other operations and conditions are the same as those in Example 2.

[0136] Comparative Example 4

[0137] Compared with Example 2, the difference is only that: in step S2, the microfluidic high-pressure homogenizer was not used for homogenization, and the composition was only prepared by filtration, and other operations and conditions are the same as those in Example 2.

[0138] The product prepared in Comparative Example 4 will show oil-water stratification after standing at room temperature.

[0139] Application Example Preparation of sunscreen milk

[0140] The biomolecular film compositions prepared in Examples 1-22 and Comparative Examples 1-4 were added with other components to prepare sunscreen milk, and the sunscreen milks corresponding to Examples 1-22 and Comparative Examples 1-4 were obtained.

[0141] The formula of the sunscreen lotion (mass percentage) is as follows: 5% of the biomolecular film composition prepared in the example or comparative example, 0.25% of carbomer, 0.50% of 1,2 - hexanediol, 0.02% of disodium EDTA, 5.0% of butanediol, 1.5% of bis - ethylhexyloxyphenol methoxyphenyl triazine, 2.0% of ethylhexyl triazone, 3.5% of diethylamino hydroxybenzoyl benzoic acid hexyl ester, 9.5% of ethylhexyl methoxycinnamate, 9.5% of diisopropyl sebacate, 1.0% of polysiloxane - 15, 1.5% of polyglyceryl - 6 stearate, 0.6% of cetearyl alcohol, 0.25% of arginine, and the rest is water.

[0142] The preparation method of the sunscreen lotion includes the following steps:

[0143] A1 Weigh each component. Add the aqueous phase components carbomer, 1,2 - hexanediol, disodium EDTA, and butanediol into the water pot (already added with component water) in sequence, heat to 85 - 90 °C, stir evenly, and the stirring speed is 250 rpm;

[0144] A2 Add the oil phase components bis - ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl triazone, diethylamino hydroxybenzoyl benzoic acid hexyl ester, ethylhexyl methoxycinnamate, diisopropyl sebacate, polysiloxane - 15, polyglyceryl - 6 stearate, and cetearyl alcohol into the oil pot in sequence, heat to 80 - 85 °C, stir evenly, and the stirring speed is 250 rpm;

[0145] A3 Mix the oil phase components and the aqueous phase components, homogenize (the homogenization time is 5 minutes and the homogenization speed is 3000 rpm), and then keep warm (the warming temperature is 80 - 85 °C and the warming time is 30 minutes);

[0146] A4 When starting to cool down, add arginine. When the temperature drops to 50 °C, add the biomolecular film composition, stir evenly, and then discharge the material.

[0147] Comparative Example 5 Blank control group sunscreen lotion

[0148] When preparing the sunscreen lotion, in Comparative Example 5, except for not adding the biomolecular film composition of the present invention, other components, dosages, and preparation methods are the same as those of the sunscreen lotion prepared in the application example.

[0149] Effect Example 1

[0150] Perform water resistance and sunscreen enhancement tests on the sunscreen lotions prepared in the examples and comparative examples.

[0151] 1. Water resistance test

[0152] Testing method: Use leather with a size of 5 cm × 5 cm, weigh it and record as m0. Take 0.04 g of the composition and evenly coat the entire leather. After drying in an oven at 37 °C for 0.5 h, weigh it and record as m1. Then immerse the leather carrying the composition in 0.9% physiological saline and soak for 30 min. After rinsing with 0.9% NaCl saline, dry it in an oven at 45 °C for 6 h and weigh it and record as m2. Water resistance (%) = (m2 - m0) / (m1 - m0) × 100.

[0153] Testing results: The sunscreen lotions prepared in Examples 1-22 and Comparative Examples 1-5 were subjected to water resistance testing, and the results are shown in the following table.

[0154] Table 2

[0155]

[0156] The results show that: (1) Compared with Comparative Example 5 (basic formula), all examples and comparative examples have water resistance, especially Examples 1, 2, and 7 are particularly significant. (2) Compared with Example 2, the water resistance effects of Examples 19, 20, Comparative Examples 1-3 are significantly worse than that of Example 2. Based on this, it shows that the sunscreen lotion prepared from the biomolecular film composition of the present invention has good water resistance.

[0157] The water resistance effect of Example 19 is close to that of Example 14, and the water resistance of Example 20 is similar to that of Examples 3, 4, 5, and 11, and even better than that of Examples 5, 11, 14, and 22. Based on this, it shows that in this composition, ethyl cellulose and rapeseed / tung oil copolymer are at least added one kind, and the influence of ethyl cellulose on water resistance is greater than that of rapeseed / tung oil copolymer.

[0158] The water resistance of Example 22 has a slight advantage over the comparative example. The main reason is that vegetable oils contain unsaturated fatty acids, which affect the emulsification performance and then affect the stability of the molecular film. At the same time, oleic acid and linoleic acid in vegetable oils may cause changes in the structure of fibroin, affect the structure of the molecular film, and are not conducive to the formation of the molecular film of this composition, thus affecting its water resistance.

[0159] 2. Sunscreen enhancement testing

[0160] Test method: Use a special syringe to suck the sunscreen by the pressure method or the suction method, and evenly apply it on the surface of a PMMA plate with a size of 5 cm × 5 cm. Then use a finger wearing a latex medical finger cot to smear the sample to make it a uniform surface. The actual sample application amount on each plate should be between 0.03 g ± 0.0025 g. Use a load bar to add a 3M film or a quartz plate of polymethyl methacrylate as a blank calibration for instrument calibration and measurement according to the instrument instructions. Subsequently, the samples coated according to the above steps are placed at room temperature (20°C - 30°C) and 40% - 60% relative humidity for 20 min, and then measured on a SPF meter. The number of measurement points on each sample piece shall not be less than 5 points. Each sample is coated on 3 plates respectively, and the average value is taken to obtain the initial SPF value and PA value. Then the tested plates are irradiated under lab365 ultraviolet light for 30 minutes, and then measured on a SPF meter. The number of measurement points on each sample piece shall not be less than 5 points. Each sample is coated on 3 plates respectively, and the average value is taken to obtain the SPF value and PA value after 30 min of ultraviolet irradiation.

[0161] The equipment used is the ultraviolet transmittance analyzer UV-2000s.

[0162] Test results: The sun protection factor (SPF) / protection grade of UVA (PA) synergistic tests were carried out on the sunscreens prepared in Examples 1 - 22 and Comparative Examples 1 - 3, Comparative Example 5, and the results are shown in the following table.

[0163] Table 3

[0164]

[0165] The results show that: (1) Compared with Comparative Example 5 (basic formulation), all examples and comparative examples have sun protection synergistic effects, especially Examples 1, 2, and 17 are particularly significant. At the same time, the sun protection effects of Examples 1, 2, 7, and 17 are still very significant after 30 min of UV irradiation. (2) Compared with Example 2, there are significant differences in the SPF and PA values of Examples 19, 20, and Comparative Examples 1 - 3. The biomolecular film composition of the present invention has functions such as sun protection performance, sun protection synergism, and slowing down the weakening of sun protection effect.

[0166] The sun protection synergism of Example 22 is worse than that of the comparative examples, which further shows that vegetable oil is not conducive to the formation of the molecular film of the composition, thereby affecting its sun protection synergism.

[0167] 3. Verification of the high-pressure homogenization process on the water resistance and sun protection synergistic effect of the composition

[0168] The sunscreen lotions (A - F) prepared in Example 2 and Comparative Example 4 were subjected to a water resistance test, and at the same time, the influence of different concentrations of the composition in the sunscreen lotion on water resistance was investigated. The results are shown in the following table. Among them, in the preparation method of the sunscreen lotion, except for the amount of the composition as shown in the following table, other components and their amounts and the preparation process were the same as those of the sunscreen lotion mentioned in the application example.

[0169] Table 4

[0170]

[0171] The results show that: in the sunscreen lotion, when the amount of the biomolecular film composition is the same, the water resistance effect of Example 2 is significantly higher than that of Comparative Example 4, and the more the addition amount, the better the effect.

[0172] By comparing Table 4 and Table 2, it can be seen that the water resistance effects of sunscreen lotions D, E, and F added with the composition of Comparative Example 4 are worse than those of Comparative Example 5 (blank control group sunscreen lotion). Thus, it can be seen that the composition of Comparative Example 4 is more unfavorable to the water resistance of the sunscreen lotion due to instability (oil - water separation).

[0173] The sunscreen lotions (A - F) prepared in Example 2 and Comparative Example 4 were subjected to a sunscreen synergistic effect test, and at the same time, the influence of the composition concentration on the sunscreen synergistic effect was investigated. The results are as follows:

[0174] Table 5

[0175]

[0176] The results show that: in the sunscreen lotion, when the amount of the biomolecular film composition is the same, the sunscreen effect of Example 2 is significantly higher than that of Comparative Example 4, and the more the addition amount, the better the effect.

[0177] Effect Example 2

[0178] The biomolecular film composition prepared in the example was subjected to an anti - free radical test.

[0179] Test method: DPPH is a dark purple prismatic crystal, showing a deep purple color in an anhydrous ethanol solution. The DPPH free radical has a strong absorption peak at 517 nm. This method involves the pairing and combination of a stable DPPH free radical provided by DPPH with an electron pair provided by the antioxidant, causing the characteristic purple color of the DPPH free radical to disappear and turn colorless or light yellow. The absorbance after the reaction was measured using an ultraviolet - visible spectrophotometer. The antioxidant ability was reflected by the change in the absorbance of DPPH before and after the reaction.

[0180] (1) Prepare the sample solution:

[0181] Weigh 0.02 g, 0.05 g, 0.1 g, and 0.2 g of the biomolecular membrane composition of Example 17, make up the volume with primary water. First dissolve them in dimethyl sulfoxide (DMSO) (1 g) respectively, and then make up the volume to 10 g with distilled water to prepare sample solutions with concentrations of 0.2%, 0.5%, 1.0%, and 2.0%.

[0182] (2)Prepare the vitamin C solution: Take 0.025 g of vitamin C and gradually dilute it into a 10 mg / L vitamin C solution for standby;

[0183] Prepare the DPPH solution: Take 0.025 g of DPPH and make up the volume to 50 mL with absolute ethanol to prepare a solution with a concentration of 0.5 mg / mL for standby.

[0184] (3)Conduct three parallel tests for each sample concentration, numbered 1, 2, and 3 respectively. Add reagents according to the combinations in the following table for each group of experiments.

[0185] Table 6

[0186]

[0187] (4)After mixing them evenly respectively, react in the dark at room temperature for 30 min, and measure the absorbance value with a UV spectrophotometer under the condition of 517 nm.

[0188] (5)If the sample becomes turbid after the reaction, centrifuge the sample at a speed of 10000 rpm for 10 min.

[0189] (6)Calculate according to the formula (1) for the DPPH radical scavenging rate (%):

[0190] P = (1 - (As - Ac) / Ab) x 100% (1)

[0191] Calculate according to formula (1), where:

[0192] P--Scavenging rate;

[0193] As---Absorbance of the mixed solution of the test solution and the DPPH solution;

[0194] Ac---Absorbance of the mixed solution of the test solution and the absolute ethanol solution;

[0195] Ab---Absorbance of the mixed solution of the DPPH solution and the sample solution.

[0196] The test solutions represented by As and Ac are respectively: vitamin C solution, Example 17 with a concentration of 0.2%, Example 17 with a concentration of 0.5%, Example 17 with a concentration of 1%, and Example 17 with a concentration of 2%)

[0197] The results of the free radical scavenging performance of the biomolecular film composition solutions with different addition amounts in Example 17 are shown in the following table.

[0198] Table 7

[0199]

[0200] The results show that the biomolecular film composition of the present invention has antioxidant activity. When the addition amount of the composition is 0.2%, the DPPH removal rate can reach 56.1%. At the same time, as the addition amount increases, the ability to scavenge free radicals becomes stronger. When the addition amount of the biomolecular film composition of the present invention is 0.5%, the DPPH removal rate is 79.4%; when the addition amount is 1.0%, the DPPH removal rate is 91.2%; when the addition amount is 2.0%, the DPPH removal rate is 94.6%.

[0201] The biomolecular film compositions of Examples 2, 5, 7, and 17 were all formulated into sample solutions with a concentration of 0.5% according to the method shown above, and their free radical scavenging abilities were tested. The results are shown below.

[0202] Table 8

[0203]

[0204] The results show that Examples 2, 5, 7, and 17 all have excellent DPPH free radical scavenging rates. Among them, Example 5 has the best effect.

[0205] Effect Example 2

[0206] The biomolecular film compositions prepared in the examples and comparative examples were tested for UV-induced skin inflammatory factors using a 3D skin model.

[0207] From the results of the water resistance and sunscreen synergistic experiments, Examples 2 and 17 with better effects were selected for anti-inflammatory tests to verify whether the biomolecular film composition has anti-inflammatory effects in addition to its water resistance and sunscreen effects.

[0208] Test method: Full-thickness 3D skin model (Archgene, Shanghai, CN), with an area of approximately 3.14 cm 2It includes an epidermis layer and a dermis layer, has a structure similar to that of human real skin, and is an in vitro model that can better reflect skin physiological responses. This model has a good response to ultraviolet (UV) irradiation. Under normal circumstances, under the stimulation of UV, this model will secrete a large amount of IL-1α. IL-1α is an important inflammatory mediator. It can induce the expression of a variety of inflammation-related genes, such as inducing vascular endothelial cells to express adhesion molecules (such as E-selectin, ICAM-1, etc.), enabling white blood cells to adhere to and cross the vascular wall and migrate to the inflammation site. At the same time, it can also stimulate monocytes, macrophages, etc. to produce more inflammatory factors, such as IL-6, TNF-α, etc., amplifying the inflammatory response. UV can induce a large amount of secretion of IL-1α in skin cells, thereby causing skin inflammation and damage; and inhibiting the increase of IL-1α caused by UV indicates that it can inhibit skin inflammation and damage caused by UV.

[0209] In this experiment, the skin model was continuously irradiated with UV for three days, and the irradiation dose each time was UVB 50 mJ / cm 2 UVA 5 J / cm 2 Before irradiation, each skin model was thoroughly rinsed on the surface with 15 mL of PBS (Gibco, Paisley, UK) with a pH of 7.4. After carefully sucking dry the surface moisture, 200 μL of the sample was applied, and the solvent control group was 200 μL of water. The model culture medium was collected 24 h after each irradiation, and the secretion amount of IL-1α was detected respectively. The secretion amounts of IL-1α for three days were accumulated and obtained as shown in the following table.

[0210] Table 9

[0211]

[0212] In the table, the experimental conditions of the blank control were: not irradiated with UV and not smeared with any substance;

[0213] The experimental conditions of the solvent control were: applying 200 μL of water each time.

[0214] The experimental conditions of other experiments were: applying 200 μL of an aqueous solution with a composition concentration of 5% each time.

[0215] Compared with the solvent control, Examples 2, Comparative Example 4, and Example 17 all had good effects of inhibiting IL-1α at a concentration of 5%.

[0216] The component ratios of Comparative Example 4 and Example 2 were the same, only the process was different (Comparative Example 4 did not undergo the microfluidic high-pressure homogenization process). The efficacy of Comparative Example 4 was significantly inferior to that of Example 2. Thus, it shows that the high-pressure homogenization process has a good effect of inhibiting IL-1α.

[0217] The effect of Example 17 is significantly inferior to that of Example 2 and Comparative Example 4. This shows that the component ratios of Example 2 and Comparative Example 4 have a better effect on suppressing the secretion amount of IL-1α.

[0218] The above examples are only the preferred embodiments of the present invention and should not be construed as limitations on the present invention. Those skilled in the art can make various changes, modifications, and substitutions under the inspiration of the present invention without departing from the spirit and scope of the present invention, and these changes, modifications, and substitutions should all be included within the protection scope of the present invention.

Claims

1. A biomolecular film composition, characterized in that: It includes the following components: Bisabolol 5%-30%; Oryzanol 2%-20%; Grease 0%-60%; Ethyl cellulose 0.3%-6% and / or rapeseed / tung oil copolymer 5%-40%; C 20-40 Acid 0.5%-8%; Neutralizer 0.1%-1%; Silk fibroin 0.025%-0.225%; Glucomannan 0.05%-0.45%; Preservatives 0.1%-1.6%; The above percentages are the mass percentages of each component relative to the total amount of the composition.

2. The biomolecular film composition according to claim 1, characterized in that The biomolecular film composition satisfies one or more of the following conditions: (1) The amount of bisabolol is 7%-25%; (2) The dosage of oryzanol is 3%-18%; (3) The amount of ethyl cellulose is 0.5%-4%; (4) The amount of the oil is 0.01%-50%; (5) The amount of the rapeseed / tung oil copolymer is 5%-30%; (6) C 20-40 The dosage of acid is 0.5%-4%; (7) The amount of the neutralizing agent is 0.2%-0.6%; (8) The amount of the silk fibroin is 0.04%-0.15%; (9) The amount of glucomannan is 0.08%-0.30%; and, (10) The amount of the preservative is 0.2%-1.5%.

3. The biomolecular film composition according to claim 1, characterized in that The biomolecular film composition satisfies one or more of the following conditions: (1) The amount of bisabolol is 7.5%, 10%, 15%, 18%, 20% or 22.5%; (2) The amount of oryzanol is 5%, 8%, 10%, 12% or 15%; (3) The amount of ethyl cellulose is 1%, 1.5%, 2%, 2.5% or 3%; (4) The amount of the oil is 2%, 3%, 4.5%, 6%, 7%, 9.5%, 11%, 13.5%, 14.5%, 15.5%, 18.5%, 20.5%, 27%, 29%, 31%, 32%, 37%, 42% or 43%; (5) The amount of rapeseed / tung oil copolymer is 8%, 10%, 15%, 20% or 25%; (6) C 20-40 The amount of acid used is 1%, 1.5%, 2%, 2.5% or 3%; (7) The amount of the neutralizing agent is 0.3%, 0.4% or 0.5%; (8) The amount of the silk fibroin is 0.05%, 0.075%, 0.09%, 0.1% or 0.125%; (9) The amount of glucomannan is 0.10%, 0.15%, 0.18%, 0.20% or 0.25%; and, (10) The amount of the preservative is 0.3%, 0.5%, 0.8%, 1% or 1.2%.

4. The biomolecular film composition according to claim 1, characterized in that The biomolecular film composition satisfies one or more of the following conditions: (1) The oil is vegetable oil and / or synthetic oil; The vegetable oil is preferably one or more of camellia seed oil, sunflower seed oil and macadamia nut oil; The synthetic oil is preferably one or more of coconut oil caprylate / caprate, neopentyl glycol di(ethylhexanoate), caprylic / capric triglyceride, diisopropyl sebacate and isononyl isononanoate, more preferably diisopropyl sebacate; (2) the neutralizing agent is one or more of sodium hydroxide, potassium hydroxide, tromethamine, aminomethyl propanol and arginine, preferably arginine; and, (3) The preservative is raspberry ketone and / or 1,2-hexanediol; When the biomolecular film composition contains raspberry ketone, the amount of raspberry ketone is preferably 0.05%-0.6%, such as 0.3%, 0.4% or 0.5%; When the biomolecular film composition contains 1,2-hexanediol, the amount of 1,2-hexanediol is preferably 0.05%-1%, such as 0.3%, 0.4%, 0.5%, 0.6% or 0.8%; (4) The average molecular weight of the ethyl cellulose is 0.5~5×10 5 Da; (5) The ethoxy content of the ethyl cellulose is 45%-55%; (6) The fiber length of the silk fibroin is preferably 0.05-2.5 μm; (7) The β-folding content of the silk fibroin is preferably greater than 30%; (8) The average molecular weight of the glucomannan is 1.0×10 6 -8.0×10 6 Da; and, (9) The biomolecular film composition further contains water, and the amount of water is preferably 29.775%, 34.725%, 34.75%, 39.675%, 39.7%, 39.725%, 44.65% or 49.625%.

5. A method for preparing a biomolecular film composition according to any one of claims 1 to 4, characterized in that: The method comprises the following steps: homogenizing the components of the biomolecular membrane composition in a high-pressure homogenizer to obtain the biomolecular membrane composition; The high-pressure homogenizer is preferably a microfluidizer; Before the homogenization, the components of the biomolecular film composition are preferably stirred and mixed uniformly; the stirring and mixing temperature is preferably 85-90° C.; The homogenization pressure is preferably 20-300 MPa, preferably 100 MPa; The homogenization temperature is preferably 25-80°C, for example 80°C; The homogenization time is preferably 5-30 min, for example 15 min; The fibroin is preferably added in the form of an aqueous solution; in the aqueous solution containing fibroin, the mass fraction of fibroin is preferably 0.4%-0.6%; the amount of the aqueous solution containing fibroin is preferably 8-30%, for example 10%, 15%, 18%, 20% or 25%; The glucomannan is preferably added in the form of an aqueous solution; in the aqueous solution containing glucomannan, the mass fraction of glucomannan in the aqueous solution is preferably 0.9%-1.1%; the amount of the aqueous solution containing glucomannan is preferably 8%-30%, for example 10%, 15%, 18%, 20% or 25%.

6. A skin external preparation, characterized in that: It comprises 0.1%-10% of the biomolecular film composition according to any one of claims 1 to 4, and the above percentage is the mass percentage of the composition in the skin external preparation.

7. The external skin preparation according to claim 6, wherein The skin external preparation meets one or more of the following conditions: (1) The biomolecular film composition is used in an amount of 0.2-8%, preferably 0.2-5%, such as 0.5%, 1% or 2%; (2) The topical skin preparation comprises 0.1-0.3% carbomer, such as 0.25% carbomer; (3) The topical skin preparation comprises 0.2-0.80% 1,2-hexanediol, for example 0.50% 1,2-hexanediol; (4) The topical skin preparation comprises 0.01-0.05% disodium EDTA, for example 0.02% disodium EDTA; (5) The topical skin preparation comprises 2-10.0% butylene glycol, for example 5.0% butylene glycol; (6) The topical skin preparation comprises 1.0-2.0% bis-ethylhexyloxyphenol methoxyphenyl triazine, for example 1.5% bis-ethylhexyloxyphenol methoxyphenyl triazine; (7) The topical skin preparation comprises 1.0-3.0% ethylhexyl triazone, for example 2.0% ethylhexyl triazone; (8) The topical skin preparation comprises 2.0-4.0% diethylaminohydroxybenzoyl hexyl benzoate, for example 3.5% diethylaminohydroxybenzoyl hexyl benzoate; (9) The topical skin preparation comprises 5.0-15% ethylhexyl methoxycinnamate, such as 9.5% ethylhexyl methoxycinnamate; (10) The topical skin preparation comprises 5.0-15% diisopropyl sebacate, for example 9.5% diisopropyl sebacate; (11) The topical skin preparation comprises 0.5-5% polysilicone-15, for example 1.0% polysilicone-15; (12) The topical skin preparation comprises 1.0-2% polyglyceryl-6 stearate, for example 1.5% polyglyceryl-6 stearate; (13) The topical skin preparation comprises 0.3-1% cetearyl alcohol, for example 0.6% cetearyl alcohol; (14) The topical skin preparation comprises 0.1-0.5% arginine, for example 0.25% arginine; and, (15) The skin external preparation comprises 40.0-80.0% water; The above percentages are all the mass percentages of each component relative to the skin external preparation.

8. A method for preparing the external skin preparation according to claim 6 or 7, characterized in that: The method comprises the following steps: uniformly mixing an oil phase component, an aqueous phase component, a neutralizing agent and the biomolecular film composition according to any one of claims 1 to 4; Preferably, an oil phase mixture and an aqueous phase mixture are prepared separately, and the oil phase mixture and the aqueous phase mixture are mixed, and then mixed with the preservative and the biomolecular film composition; The oil phase mixture is preferably prepared by the following steps: adding the components of the oil phase into an oil pan, heating to 80-85° C., stirring evenly at a stirring speed of 150-400 rpm; The oil phase mixture is preferably prepared by the following steps: adding bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl triazone, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl methoxycinnamate, diisopropyl sebacate, polysilicone-15, polyglyceryl-6 stearate and cetearyl alcohol into an oil pan, heating to 80-85° C., stirring evenly, and stirring at a speed of 250 rpm; The aqueous phase mixture is preferably prepared by the following steps: adding the aqueous phase components into a water pot, heating to 80-85° C., stirring evenly at a stirring speed of 150-400 rpm; The aqueous phase mixture is preferably prepared by the following steps: adding carbomer, 1,2-hexanediol, disodium EDTA, butylene glycol and water into a water pot, heating to 85-90° C., stirring evenly at a stirring speed of 250 rpm; Wherein, when the oil phase mixture and the water phase mixture are mixed, preferably, homogenization is performed; the homogenization time is preferably 5 minutes; and the homogenization speed is preferably 3000 rpm.

9. Use of the biomolecular film composition according to any one of claims 1 to 4 in external medical devices, external medicines, or daily skin care fields for treating photoelectric skin damage.

10. The use according to claim 9, characterized in that The application meets one or more of the following conditions: (1) The biomolecular film composition has a photoprotective effect, and the photoprotective effect includes sun protection, anti-photoaging and photodamage, and repair effects; (2) In the external medical device and external medicine for treating photoelectric skin damage, the amount of the composition is 0.1-10%, preferably 0.2-8%, more preferably 0.2-5%, and the above percentage is the mass percentage of the composition to the external medicine; (3) The dosage form of the external medical device or external medicine for treating photoelectric skin damage is lotion, liniment, film, cream, spray, gel, cataplasm, patch, ointment, microneedle transdermal absorption agent or liposome; (4) In the field of daily chemical skin care, the amount of the composition is 0.1%-10%, preferably 0.2-8%, more preferably 0.2-5%, the above percentages being the mass percentage of the composition in the skin external preparation; and, (5) The biomolecular film composition is used as a sunscreen product or after-sun repair product in the field of daily chemical skin care.

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