Polypeptide compounded traditional Chinese medicine extract antibacterial and antiviral preparation and preparation method thereof

Abstract

The invention relates to the technical field of antibacterial and antiviral preparations, and particularly discloses a polypeptide compounded traditional Chinese medicine extract antibacterial and antiviral preparation and a preparation method thereof. The dosage form of the polypeptide compound traditional Chinese medicine extract antibacterial and antiviral preparation is one of gel, ointment and lotion. The composition comprises the following raw materials in percentage by mass: 0.01-1% of azalophenon polypeptide or stability-increasing azalophenon polypeptide, 0.2-5% of a traditional Chinese medicine extract and the balance of dosage form auxiliary materials, the traditional Chinese medicine extract comprises a radix sophorae flavescentis extract, a liquorice extract, a radix stemonae extract and a chamomile extract. When the dosage forms of the polypeptide compound traditional Chinese medicine extract antibacterial and antiviral preparation are respectively gel, ointment and lotion, the preparation is prepared by adopting respective corresponding steps. The invention has broad-spectrum antibacterial effect, can effectively inhibit and kill various pathogenic microorganisms, diminish inflammation, resist bacteria and virus, can be used for internal filling or external smearing, can also be used for vaginal perfusion and daily vulva cleaning and flushing, and has high safety.

Description

Technical Field

[0001] The present invention relates to the technical field of antibacterial and antiviral preparations, and in particular to an antibacterial and antiviral preparation of a polypeptide-compounded traditional Chinese medicine extract and a preparation method thereof. Background Art

[0002] Medical topical preparations are products that are absorbed through the skin or mucous membranes and are used for the examination and treatment of skin, gynecological and other diseases. They mainly use the viscosity and softness of ointments and gels to form a protective film in the skin or gynecological cavities to relieve pain, lubricate, and remove foreign matter.

[0003] Medical external preparations mainly include ointments, gels, lotions and other products. Currently, gel and ointment dosage forms have made major breakthroughs in drug dosage form design, overcoming many shortcomings of traditional drug dosage forms. This is because they can quickly form a thin film that covers the surface of the skin or gynecological cavity, providing a good carrier for the drug, increasing the local concentration and duration of action of the drug, and especially focusing on the regulation of drug delivery and controlled release, which greatly improves the safety and effectiveness of clinical applications.

[0004] Alloferon peptide is used in Russia as an injectable drug for Alloquine-Alpha, drug registration number: PN002829 / 01, trade name: Alloquine-Alpha, dosage form: lyophilisate for preparation of subcutaneous injection. Pharmacotherapeutic group: antiviral, immunomodulator.

[0005] Alofilon peptide is an oligopeptide with pharmacological effects very similar to interferon α. ​​Alofilon peptide is an effective inducer of endogenous interferon synthesis and an activator of the natural killer system, which can stimulate cytotoxic lymphocytes to recognize and lyse defective cells. Experiments have shown that it has a high efficacy against infections caused by influenza A and B viruses, hepatitis B and C, herpes type 1 and 2, and human papilloma (carcinogenic type).

[0006] Alofilon peptide has no general toxicity, no allergy, no mutagenicity, no carcinogenicity, no embryotoxicity, and no effect on reproductive function. It can quickly penetrate into the blood and interact with immune cells, and then its metabolites are very similar in structure to serum proteins. An increase in interferon concentration was found 2 hours after administration and remained at a high level (2-2.5 times the normal background level) for 6-8 hours, reaching the baseline value at the end of the day. An increase in the functional activity of natural killer cells was observed within 7 days after administration. However, there is currently no product with dual antibacterial and antiviral effects of Alofilon peptide.

[0007] On this basis, the development of a gel or ointment dosage form for the treatment of skin and gynecological diseases that can be absorbed through the skin or mucosa, and the use of alofilon peptide for antibacterial and antiviral purposes through local administration has excellent research prospects. Summary of the invention

[0008] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a polypeptide compound Chinese medicine extract antibacterial and antiviral preparation and a preparation method thereof.

[0009] A polypeptide compounded Chinese herbal medicine extract antibacterial and antiviral preparation, the dosage form of which is one of a gel, an ointment and a lotion; the raw materials thereof include by mass percentage: 0.01-1% of alophillon polypeptide or stabilized alophillon polypeptide, 0.2-5% of a Chinese herbal medicine extract, and the remainder is dosage form excipients; the Chinese herbal medicine extract includes: sophora flavescens extract, licorice extract, stemona extract, chamomile extract, and the mass ratio of sophora flavescens extract, licorice extract, stemona extract, and chamomile extract is 5-10:2-10:0-10:2-10.

[0010] Preferably, when the dosage form of the preparation is a gel, the dosage form excipients include: a natural antibacterial agent, a moisturizer, a thickener, and water; the natural antibacterial agent is at least one of tea tree essential oil, chitosan, lactic acid, and citric acid; the moisturizer is at least one of decyl glucoside, glycerin, sorbitol, polyethylene glycol 600, vaseline, and lanolin; the thickener is at least one of hydroxymethyl cellulose, xanthan gum, and carbomer.

[0011] Preferably, when the dosage form of the preparation is a gel, the raw materials include, by mass percentage: 0.01-1% of alophillon polypeptide or stabilized alophillon polypeptide, 0.2-5% of traditional Chinese medicine extract, 0.5-1.5% of natural antibacterial agent, 1-6% of moisturizer, 1-2% of thickener, and the balance is water.

[0012] Preferably, when the dosage form of the preparation is an ointment, the dosage form excipients include: base oil, moisturizer, emulsifier, preservative, water; the base oil is at least one of evening primrose oil and tea tree essential oil; the moisturizer is at least one of decyl glucoside, glycerin, sorbitol, polyethylene glycol 600, vaseline, and lanolin; the emulsifier is sorbitan fatty acid ester and / or polyoxyethylene sorbitan fatty acid ester.

[0013] Preferably, when the dosage form of the preparation is an ointment, the raw materials include, by mass percentage: 0.01-1% of alofilone polypeptide or stabilized alofilone polypeptide, 0.2-5% of traditional Chinese medicine extract, 5-20% of base oil, 10-20% of moisturizer, 3-23% of emulsifier, 0.003-0.03% of preservative, and the balance is water.

[0014] Preservatives are commonly used additives in the cosmetics field to inhibit the growth and reproduction of microorganisms in products, such as ethylparaben, sodium benzoate, sodium salicylate, etc.

[0015] Preferably, when the dosage form of the preparation is a lotion, the dosage form excipients include: sorbitol, saccharin sodium, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, anhydrous ethanol, flavor, solubilizer, water, and base oil.

[0016] The raw materials of the above-mentioned polypeptide compounded traditional Chinese medicine extract antibacterial and antiviral preparation include, by mass percentage: 0.01-1% of alofilon polypeptide or stabilized alofilon polypeptide, 0.2-5% of traditional Chinese medicine extract, 1-10% of sorbitol, 0.01-0.05% of saccharin sodium, 0.01-0.05% of sucralose, 0.01-0.05% of xylitol, 0.01-1% of poloxamer, 0.01-1% of sodium benzoate, 0.01-1% of disodium ethylenediaminetetraacetic acid, 0.01-10% of anhydrous ethanol, 0.01-1% of essence, 0.01-1% of solubilizer, 50-95% of water, and the balance is base oil.

[0017] ‌Fragrance is a commonly used additive in the cosmetics field that has the functions of masking the odor of the product matrix, giving the product fragrance, and attracting consumers.

[0018] More preferably, the base oil is at least one of evening primrose oil, glycerin and tea tree essential oil.

[0019] Preferably, the stabilized alofilone polypeptide is prepared by the following specific operation: adding the hyperbranched polyamidoamine to water and stirring evenly, adding methyl thioglycolate thereto under stirring, stirring at 60-70° C. for 1-2 hours, cooling to 2-6° C., adding the alofilone polypeptide and stirring for 5-10 minutes, adding 1-ethyl-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinimide and continuing to stir for 1-2 hours, centrifuging, washing, and vacuum drying.

[0020] The present invention grafts hyperbranched polyamidoamine onto the alophyllon polypeptide. The polyamidoamine is a highly branched macromolecule with a quasi-spherical structure. The polyamidoamine can effectively prevent the alophyllon polypeptide from being hydrolyzed through a steric hindrance effect, has excellent stability, and is positively charged due to having more amino groups, while bacteria generally have a negative charge on their surface. The two can be combined through the mutual attraction of positive and negative charges, further enhancing the antibacterial effect.

[0021] More preferably, the hyperbranched polyamidoamine has a generation number of 2.0 to 4.0.

[0022] More preferably, the mass ratio of hyperbranched polyamidoamine, methyl thioglycolate, alophilon polypeptide, 1-ethyl-(3-dimethylaminopropyl)carbodiimide, and N-hydroxysuccinimide is 1-2: 0.1-0.5: 0.1-1: 0.01-0.1: 0.1-0.2.

[0023] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation comprises the following steps: i , adding the thickener into water, heating to 40-60° C. and stirring to obtain the first material; ii , adding the Chinese herbal medicine extract into water to dissolve, then adding the natural antibacterial agent and mixing evenly, then slowly adding into the first material, stirring evenly to obtain the second material; iii , adding the alophillon polypeptide or the stabilized alophillon polypeptide into water and completely dissolving it to obtain an alophillon polypeptide aqueous solution; iv , add the aqueous solution of Alofilon polypeptide to the second material and mix evenly, then add the moisturizer and mix evenly.

[0024] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation comprises the following steps: S1. Add the preservative into water and mix evenly, then add the alophillon polypeptide or stabilized alophillon polypeptide and the Chinese medicine extract in sequence and mix evenly to obtain an aqueous phase; S2, mixing the base oil and the emulsifier evenly, and then adding the moisturizer and mixing evenly to obtain an oil phase; S3. Mix the water phase and the oil phase, evacuate to a vacuum degree of 0.08-0.09 MPa, heat and stir, homogenize and emulsify, cool, and return to normal pressure.

[0025] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation comprises the following steps: (1) Add sorbitol, sodium saccharin, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide or stabilized alophyllon polypeptide, and Chinese herbal medicine extract into water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil phase, stir until completely dissolved, then add the solubilizer, and continue stirring for at least 30 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for at least 30 minutes after the oil phase is completely added. Adjust the pH value of the system to 4.5-6.5.

[0026] Beneficial effects: The patent related to the Alloferon alpha polypeptide compound (the original application number is RU19990127725, and the application date is 1999-12-27) has expired in China, so the polypeptide raw material can be synthesized, used, added, and extended to develop medical products.

[0027] Therefore, the applicant has developed gynecological drugs for gynecological diseases based on the alofilon polypeptide, which are mainly used to treat gynecological diseases such as vaginitis, cervicitis, HPV, HSV, etc. The polypeptide compound Chinese medicine extract antibacterial and antiviral preparation obtained by the present invention can be prepared into functional preparations such as gel, lotion, ointment, etc. by local administration, using alofilon polypeptide in combination with raw materials such as sophora flavescens extract, licorice extract, stemona extract, chamomile extract, tea tree essential oil, chitosan, lactic acid, etc., and using carbomer, hydroxyethyl cellulose, lanolin, vaseline, carrageenan, glycerin, purified water, etc. The preparation directly acts on the lesion site to play the role of anti-inflammatory and sterilization, tissue repair, antifungal, antiviral, antipruritic, cervical erosion repair, etc.

[0028] As an oligopeptide that activates natural killer cells, alofilone peptide can stimulate cytotoxic lymphocytes to recognize and lyse defective cells; it can also induce the synthesis of endogenous interferon (mainly INF-γ) and the activation of cytotoxic CD3+HLA-DR+T cells, even when the absolute number of CD3+CD8+ cells is reduced. In the comprehensive treatment of high-grade cervical epithelial dysplasia and cervical cancer, the use of alofilone peptide can significantly reduce TGF-β and FOXP3 immunosuppressive proteins.

[0029] Sophora flavescens has the effects of clearing away heat and dampness, antibacterial and anti-inflammatory, cooling blood and removing dampness; it can treat abnormal leucorrhea and trichomonas vaginitis in women. Stemona has antibacterial effects and has obvious inhibitory effects on Shigella dysenteriae, Staphylococcus aureus, paratyphoid, Escherichia coli, and Proteus. It is suitable for addition to the composition of this formula to play a synergistic and synergistic role in inhibiting bacteria. The ingredients of licorice are relatively mild, and it can clear away heat and detoxify, and has antibacterial and anti-inflammatory effects. The application of chamomile can play the role of promoting blood circulation and removing blood stasis, relieving pain during menstruation, and playing an auxiliary and synergistic role in the formula. Tea tree essential oil is widely used, especially for various skin inflammations. It has a good therapeutic effect. In addition to its bactericidal and anti-inflammatory effects, it also has the effect of assisting in improving dysmenorrhea. This technology uses tea tree essential oil, which has excellent efficacy and safety in the British Pharmacopoeia, and chitosan prepared from shell raw materials is used for tissue repair.

[0030] At the same time, there are many normal flora in the vagina of healthy women, the main one being lactobacillus, which can decompose the glycogen of the vaginal epithelium and convert it into lactic acid, thereby maintaining the vaginal pH value at 3.8-4.5. The weakly acidic environment can effectively inhibit the growth of harmful bacteria. This is the self-cleaning ability of the vagina, which is the natural defense function of the vagina.

[0031] Therefore, in the composition of the formula, we have added a portion of lactic acid as one of the formula matrix components according to the actual efficacy requirements. While assisting in adjusting the pH value, it can also promote the health of the female vaginal environment.

[0032] The present invention adopts alofilon polypeptide in combination with sophora flavescens extract, licorice extract, stemona extract, chamomile extract, tea tree essential oil, chitosan, lactic acid and other ingredients as main active ingredients, has a broad-spectrum antibacterial effect, can effectively inhibit and kill a variety of pathogenic microorganisms (such as bacteria, fungi, viruses, etc.), and has anti-inflammatory, antibacterial and antiviral effects.

[0033] The gel, ointment, lotion and other dosage forms of the present invention can be used for internal filling or external application, as well as for vaginal irrigation and daily vulva cleaning and flushing. On the one hand, they have good permeability and adhesion, and can quickly form a protective film on the surface of the vaginal mucosa, cervix and other surfaces, making the drug ingredients easier to absorb and utilize; on the other hand, they can be administered locally to quickly relieve symptoms such as itching and pain caused by gynecological inflammation, while inhibiting the reproduction of pathogenic microorganisms and the replication of viruses, thereby achieving the purpose of antibacterial and antiviral.

[0034] At the same time, the present invention adopts alophilon polypeptide combined with sophora flavescens extract, licorice extract, stemona extract, chamomile extract, tea tree essential oil, chitosan, lactic acid and other ingredients as main active ingredients, does not contain hormones and antibiotics, has no toxic side effects on the human body, and is highly safe. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The figure is a comparison chart of the virus inhibition rates of the polypeptide compounded Chinese herbal extract antibacterial and antiviral gel obtained in Example 2 and the polypeptide compounded Chinese herbal extract antibacterial and antiviral ointments obtained in Examples 3 and 6.

[0036] Figure 2 This is a comparison chart of the antibacterial and antiviral rates of the polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6 after dilution 100 times.

[0037] Figure 3 This is a comparison chart of the antibacterial and antiviral rates of the polypeptide compounded Chinese herbal extract antibacterial and antiviral ointments obtained in Examples 3 and 6 after being stored for 90 days and then diluted 100 times.

[0038] Figure 4This is a comparison chart of the antibacterial and antiviral lotions of polypeptide-compounded Chinese herbal extracts obtained in Example 9 and Example 10 after being diluted 100 times.

[0039] Figure 5 This is a comparison chart of the antibacterial and antiviral wash solutions of polypeptide-compounded Chinese herbal extracts obtained in Examples 9 and 10, which were stored for 90 days and then diluted 100 times. DETAILED DESCRIPTION

[0040] The present invention will be further explained below in conjunction with specific embodiments.

[0041] The following Alofilon polypeptide was purchased from Hangzhou Sinoda Pharmaceutical Technology Co., Ltd.; tea tree essential oil was purchased from Guangzhou Wuyuan Essential Oil Co., Ltd.; essence was purchased from Shenzhen Qingchulan Biotechnology Co., Ltd.; the remaining raw materials can be purchased from commercial channels.

[0042] Example 1 A polypeptide compounded Chinese medicine extract antibacterial and antiviral gel, the raw materials of which include, by mass percentage, 0.5% alophilon polypeptide, 1% sophora flavescens extract, 1% liquorice extract, 1% stemona extract, 1% chamomile extract, 0.5% tea tree essential oil, 1.5% carbomer, 5% glycerin, 0.5% lactic acid, and 88% water.

[0043] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral gel comprises the following steps: i , adding carbomer into water, heating to 45° C. and stirring to obtain the first material; ii , add Sophora flavescens extract, Licorice extract, Stemona extract and Chamomile extract into water to dissolve, then add Tea Tree essential oil and lactic acid, mix well, then slowly add into the first material, stir well to obtain the second material; iii 3. Adding the Alofilon polypeptide into water and completely dissolving it to obtain an Alofilon polypeptide aqueous solution; the mass ratio of the Alofilon polypeptide to water is 1:5; iv , add the aqueous solution of Alofilon polypeptide to the second material and mix evenly, then add glycerol and mix evenly.

[0044] Example 2 A polypeptide compounded Chinese medicine extract antibacterial and antiviral gel, the raw materials of which include, by mass percentage, 0.01% alophilon polypeptide, 1% sophora flavescens extract, 0.2% liquorice extract, 0.2% chamomile extract, 0.5% tea tree essential oil, 0.5% chitosan, 1.5% glycerol, 0.035% citric acid, 1.4% hydroxyethyl cellulose, and 94.655% water.

[0045] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral gel comprises the following steps: i , adding hydroxyethyl cellulose into water, heating to 40-60° C. and stirring to obtain the first material; ii , add Sophora flavescens extract, Licorice extract and Chamomile extract into water to dissolve, then add Tea Tree essential oil, chitosan and citric acid, mix well, then slowly add into the first material, stir well to obtain the second material; iii , adding the Alofilon polypeptide into water to completely dissolve it to obtain an Alofilon polypeptide aqueous solution; iv , add the aqueous solution of Alofilon polypeptide to the second material and mix evenly, then add glycerol and mix evenly.

[0046] Example 3 A polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment, the raw materials of which include, by mass percentage, 0.5% of alophilon polypeptide, 1% of sophora flavescens extract, 0.2% of liquorice extract, 0.2% of stemona extract, 0.2% of chamomile extract, 5% of vaseline, 10% of lanolin, 10% of evening primrose oil, 10% of polysorbate 80, 3% of Span 80, 0.03% of ethylparaben, and 59.87% of purified water.

[0047] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment comprises the following steps: S1. Add ethyl paraben to water and mix evenly, heat to 60°C and stir for 20 min, then add alofilon polypeptide, Sophora flavescens extract, Licorice extract, Stemona extract, and Chamomile extract in sequence and stir for 2 h to obtain an aqueous phase; S2, evening primrose oil, polysorbate 80 and Span 80 were mixed, the temperature was raised to 80°C, and the mixture was stirred for 3 minutes, and lanolin and vaseline were added, and the stirring was continued for 30 minutes after the lanolin was dissolved to obtain an oil phase; S3, evacuate the emulsifying pot until the internal vacuum degree reaches 0.08MPa, and draw the water phase and oil phase into the emulsifying pot; adjust the vacuum degree in the emulsifying pot to 0.09MPa, adjust the temperature in the emulsifying pot to 60°C, stir the emulsifying pot with a scraper for 45min, and the stirring speed is 60rpm, and then homogenize and emulsify for 5min; stop stirring, turn on the cooling water for cooling, and when the paste temperature cools to 40°C, close the cooling water valve; evacuate the emulsifying pot again until the vacuum degree in the emulsifying pot is 0.09MPa, remove the bubbles in the paste, open the vent valve, and return to normal pressure.

[0048] Example 4 A polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment, the raw materials of which include, by mass percentage, 0.5% of stabilized alophilone polypeptide, 1% of sophora flavescens extract, 0.2% of liquorice extract, 0.2% of stemona extract, 0.2% of chamomile extract, 5% of vaseline, 10% of lanolin, 10% of evening primrose oil, 10% of polysorbate 80, 3% of Span 80, 0.03% of ethylparaben, and 59.87% of purified water.

[0049] The stabilized Alofilon polypeptide was prepared by the following specific operation: 1 g of 2.0 generation hyperbranched polyamidoamine was added to 30 g of water and stirred evenly, 0.1 g of methyl thioglycolate was added thereto under stirring, and the mixture was stirred at 70° C. for 1 h, cooled to 6° C., 0.1 g of Alofilon polypeptide was added, and stirred for 10 min, 0.01 g of 1-ethyl-(3-dimethylaminopropyl)carbodiimide and 0.2 g of N-hydroxysuccinimide were added, and stirring was continued for 1 h, centrifuged, washed 3 times with ultrapure water, and dried in vacuo.

[0050] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment comprises the following steps: S1. Add ethyl hydroxybenzoate to water and mix evenly, heat to 60°C and stir for 20 minutes, then add stabilizer alofilon polypeptide, Sophora flavescens extract, Licorice extract, Stemona extract, and Chamomile extract in sequence and stir for 2 hours to obtain an aqueous phase; S2, evening primrose oil, polysorbate 80 and Span 80 were mixed, the temperature was raised to 80°C, and the mixture was stirred for 3 minutes, and lanolin and vaseline were added, and the stirring was continued for 30 minutes after the lanolin was dissolved to obtain an oil phase; S3, evacuate the emulsifying pot until the internal vacuum degree reaches 0.08MPa, and draw the water phase and oil phase into the emulsifying pot; adjust the vacuum degree in the emulsifying pot to 0.09MPa, adjust the temperature in the emulsifying pot to 60°C, stir the emulsifying pot with a scraper for 45min, and the stirring speed is 60rpm, and then homogenize and emulsify for 5min; stop stirring, turn on the cooling water for cooling, and when the paste temperature cools to 40°C, close the cooling water valve; evacuate the emulsifying pot again until the vacuum degree in the emulsifying pot is 0.09MPa, remove the bubbles in the paste, open the vent valve, and return to normal pressure.

[0051] Example 5 A polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment, the raw materials of which include, by mass percentage, 0.5% of stabilized alophilone polypeptide, 1% of sophora flavescens extract, 0.2% of liquorice extract, 0.2% of stemona extract, 0.2% of chamomile extract, 5% of vaseline, 10% of lanolin, 10% of evening primrose oil, 10% of polysorbate 80, 3% of Span 80, 0.03% of ethylparaben, and 59.87% of purified water.

[0052] The stabilized Alofilon polypeptide was prepared by the following specific operation: 2 g of 4.0 generation hyperbranched polyamidoamine was added to 20 g of water and stirred evenly, 0.5 g of methyl thioglycolate was added thereto under stirring, and the mixture was stirred at 60° C. for 2 h, cooled to 2° C., 1 g of Alofilon polypeptide was added, and stirred for 5 min, 0.1 g of 1-ethyl-(3-dimethylaminopropyl)carbodiimide and 0.1 g of N-hydroxysuccinimide were added, and stirring was continued for 2 h, centrifuged, washed once with ultrapure water, and dried in vacuo.

[0053] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment comprises the following steps: S1. Add ethyl hydroxybenzoate to water and mix evenly, heat to 60°C and stir for 20 minutes, then add stabilizer alofilon polypeptide, Sophora flavescens extract, Licorice extract, Stemona extract, and Chamomile extract in sequence and stir for 2 hours to obtain an aqueous phase; S2, evening primrose oil, polysorbate 80 and Span 80 were mixed, the temperature was raised to 80°C, and the mixture was stirred for 3 minutes, and lanolin and vaseline were added, and the stirring was continued for 30 minutes after the lanolin was dissolved to obtain an oil phase; S3, evacuate the emulsifying pot until the internal vacuum degree reaches 0.08MPa, and draw the water phase and oil phase into the emulsifying pot; adjust the vacuum degree in the emulsifying pot to 0.09MPa, adjust the temperature in the emulsifying pot to 60°C, stir the emulsifying pot with a scraper for 45min, and the stirring speed is 60rpm, and then homogenize and emulsify for 5min; stop stirring, turn on the cooling water for cooling, and when the paste temperature cools to 40°C, close the cooling water valve; evacuate the emulsifying pot again until the vacuum degree in the emulsifying pot is 0.09MPa, remove the bubbles in the paste, open the vent valve, and return to normal pressure.

[0054] Example 6 A polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment, the raw materials of which include, by mass percentage, 0.5% of stabilized alophilone polypeptide, 1% of sophora flavescens extract, 0.2% of liquorice extract, 0.2% of stemona extract, 0.2% of chamomile extract, 5% of vaseline, 10% of lanolin, 10% of evening primrose oil, 10% of polysorbate 80, 3% of Span 80, 0.03% of ethylparaben, and 59.87% of purified water.

[0055] The stabilized Alofilon polypeptide was prepared by the following specific operation: 1.5 g of 3.0 generation hyperbranched polyamidoamine was added to 25 g of water and stirred evenly, 0.3 g of methyl thioglycolate was added thereto under stirring, and the mixture was stirred at 65° C. for 1.5 h, cooled to 4° C., 0.8 g of Alofilon polypeptide was added, and stirred for 8 min, 0.05 g of 1-ethyl-(3-dimethylaminopropyl)carbodiimide and 0.15 g of N-hydroxysuccinimide were added, and stirring was continued for 1.5 h, centrifuged, washed twice with ultrapure water, and dried in vacuo.

[0056] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment comprises the following steps: S1. Add ethyl hydroxybenzoate to water and mix evenly, heat to 60°C and stir for 20 minutes, then add stabilizer alofilon polypeptide, Sophora flavescens extract, Licorice extract, Stemona extract, and Chamomile extract in sequence and stir for 2 hours to obtain an aqueous phase; S2, evening primrose oil, polysorbate 80 and Span 80 were mixed, the temperature was raised to 80°C, and the mixture was stirred for 3 minutes, and lanolin and vaseline were added, and the stirring was continued for 30 minutes after the lanolin was dissolved to obtain an oil phase; S3, evacuate the emulsifying pot until the internal vacuum degree reaches 0.08MPa, and draw the water phase and oil phase into the emulsifying pot; adjust the vacuum degree in the emulsifying pot to 0.09MPa, adjust the temperature in the emulsifying pot to 60°C, stir the emulsifying pot with a scraper for 45min, and the stirring speed is 60rpm, and then homogenize and emulsify for 5min; stop stirring, turn on the cooling water for cooling, and when the paste temperature cools to 40°C, close the cooling water valve; evacuate the emulsifying pot again until the vacuum degree in the emulsifying pot is 0.09MPa, remove the bubbles in the paste, open the vent valve, and return to normal pressure.

[0057] Example 7 A polypeptide compound Chinese medicine extract antibacterial and antiviral lotion, the raw materials of which include, by mass percentage, 0.01% alophilon polypeptide, 0.5% sophora flavescens extract, 0.2% liquorice extract, 0.3% stemona extract, 0.1% chamomile extract, 1% sorbitol, 0.01% saccharin sodium, 0.01% sucralose, 0.01% xylitol, 0.01% XBL-A, 0.01% poloxamer, 0.01% sodium benzoate, 0.01% disodium ethylenediaminetetraacetic acid, 0.01% anhydrous ethanol, 0.01% flavor (BF908951), 0.01% solubilizer SF-410, 95% purified water, and the balance is glycerol.

[0058] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral lotion comprises the following steps: (1) adjusting the temperature of purified water to 40° C., adding the alofilon polypeptide to completely dissolve it, wherein the mass ratio of the alofilon polypeptide to the purified water is 1:5, and obtaining an alofilon polypeptide aqueous solution; Add sorbitol, sodium saccharin, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide aqueous solution, sophora flavescens extract, licorice extract, stemona extract, and chamomile extract into purified water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil, stir until completely dissolved, then add the solubilizer SF-410, and continue stirring for at least 30 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for at least 30 minutes after the oil phase is completely added. Adjust the pH value of the system to 4.5-6.5.

[0059] Example 8 A polypeptide compound Chinese medicine extract antibacterial and antiviral lotion, the raw materials of which include, by mass percentage, 1% alophilon polypeptide, 1% sophora flavescens extract, 1% liquorice extract, 1% stemona extract, 1% chamomile extract, 10% sorbitol, 0.05% saccharin sodium, 0.05% sucralose, 1% xylitol, 1% poloxamer, 1% sodium benzoate, 1% disodium edetate, 10% anhydrous ethanol, 1% flavor (BF908951), 1% solubilizer SF-410, 50% purified water, and the balance being base oil.

[0060] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral lotion comprises the following steps: (1) The temperature of purified water is adjusted to 45° C., and the alofilon polypeptide is added to completely dissolve, wherein the mass ratio of the alofilon polypeptide to the purified water is 1:10, to obtain an alofilon polypeptide aqueous solution; Add sorbitol, sodium saccharin, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide aqueous solution, sophora flavescens extract, licorice extract, stemona extract, and chamomile extract into purified water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil, stir until completely dissolved, then add the solubilizer SF-410, and continue stirring for at least 30 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for at least 30 minutes after the oil phase is completely added. Adjust the pH value of the system to 4.5-6.5.

[0061] Example 9 A polypeptide compound Chinese medicine extract antibacterial and antiviral lotion, the raw materials of which include, by mass percentage, 0.5% alophilon polypeptide, 0.9% sophora flavescens extract, 0.4% liquorice extract, 0.7% stemona extract, 0.2% chamomile extract, 5% sorbitol, 0.02% saccharin sodium, 0.03% sucralose, 0.5% xylitol, 0.5% XBL-A, 0.5% poloxamer, 0.5% sodium benzoate, 0.5% disodium edetate, 5% anhydrous ethanol, 0.5% flavor (BF908951), 0.5% solubilizer SF-410, 72.5% purified water, and the balance evening primrose oil.

[0062] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral lotion comprises the following steps: (1) The temperature of purified water is adjusted to 45° C., and the alophillon polypeptide is added to completely dissolve, wherein the mass ratio of the alophillon polypeptide to purified water is 1:8, to obtain an alophillon polypeptide aqueous solution; Add sorbitol, sodium saccharin, sucralose, xylitol, XBL-A, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide aqueous solution, sophora flavescens extract, licorice extract, stemona extract, and chamomile extract into purified water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil, stir until completely dissolved, then add the solubilizer SF-410, and continue stirring for 60 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for 60 minutes after complete addition and adjust the pH value of the system to 4.5-6.5.

[0063] Example 10 A polypeptide compound Chinese medicine extract antibacterial and antiviral lotion, the raw materials of which include, by mass percentage, 0.5% of stabilizer alophilon polypeptide, 0.9% of sophora flavescens extract, 0.4% of liquorice extract, 0.7% of stemona extract, 0.2% of chamomile extract, 5% of sorbitol, 0.02% of saccharin sodium, 0.03% of sucralose, 0.5% of xylitol, 0.5% of XBL-A, 0.5% of poloxamer, 0.5% of sodium benzoate, 0.5% of disodium ethylenediaminetetraacetic acid, 5% of anhydrous ethanol, 0.5% of flavor (BF908951), 0.5% of solubilizer SF-410, 72.5% of purified water, and the balance of tea tree essential oil.

[0064] The stabilized Alofilon polypeptide was prepared by the following specific operation: 1.5 g of 3.0 generation hyperbranched polyamidoamine was added to 25 g of water and stirred evenly, 0.3 g of methyl thioglycolate was added thereto under stirring, and the mixture was stirred at 65° C. for 1.5 h, cooled to 4° C., 0.8 g of Alofilon polypeptide was added, and stirred for 8 min, 0.05 g of 1-ethyl-(3-dimethylaminopropyl)carbodiimide and 0.15 g of N-hydroxysuccinimide were added, and stirring was continued for 1.5 h, centrifuged, washed twice with ultrapure water, and dried in vacuo.

[0065] The preparation method of the above polypeptide compounded Chinese medicine extract antibacterial and antiviral lotion comprises the following steps: (1) The temperature of purified water is adjusted to 45° C., and the alophillon polypeptide is added to completely dissolve, wherein the mass ratio of the alophillon polypeptide to purified water is 1:8, to obtain an alophillon polypeptide aqueous solution; Add sorbitol, sodium saccharin, sucralose, xylitol, XBL-A, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide aqueous solution, sophora flavescens extract, licorice extract, stemona extract, and chamomile extract into purified water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil, stir until completely dissolved, then add the solubilizer SF-410, and continue stirring for 60 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for 60 minutes after complete addition and adjust the pH value of the system to 4.5-6.5.

[0066] The polypeptide compound Chinese medicine extract antibacterial and antiviral gel obtained in Example 2 and the polypeptide compound Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6 were used for antiviral test, with HSV-2 virus as the test virus and 10 μM ganciclovir (GCV) as the positive control. The results are as follows Figure 1 As shown, the virus inhibition rate of the gel obtained in Example 2 is relatively low, while the virus inhibition rate of the ointments obtained in Examples 3 and 6 is better; at the same time, the virus inhibition rate of Example 6 is slightly higher than that of Example 3, but there is no significant difference between the two (P>0.05).

[0067] The polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6 was tested as follows: 1.1 The appearance of the two groups of polypeptide compounded Chinese medicine extract antibacterial and antiviral ointments were evaluated and tested according to Q / IDE008-2023. The polypeptide compounded Chinese medicine extract antibacterial and antiviral ointments obtained in Example 3 and Example 6 were in the form of pastes with uniform color and met the requirements.

[0068] 1.2 According to 2.2.1.4 of the Technical Specification for Disinfection of the Ministry of Health in 2002, a pH meter (model: SevenMulti) was used to detect the pH values ​​of the two groups of polypeptide compound Chinese medicine extract antibacterial and antiviral ointments in an environment with a temperature of 23°C and a relative humidity of 46%.

[0069] The pH value of the polypeptide compound antibacterial and antiviral ointment of traditional Chinese medicine extract obtained in Example 3 is 4.8±0.01, and the pH value of the polypeptide compound antibacterial and antiviral ointment of traditional Chinese medicine extract obtained in Example 6 is 4.8±0.01.

[0070] 1.3 In accordance with Chapter 4, 1.6 of the 2015 edition of the "Technical Specifications for Safety of Cosmetics", the contents of lead, arsenic and mercury in two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments were determined in an environment with a temperature of 23°C and a relative humidity of 46%.

[0071] In the polypeptide compound Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6, the lead content is ≤0.10 mg / kg, the arsenic content is <0.0033 mg / kg, and the mercury content is <0.0033 mg / kg, which meets the limit requirements in GB 27951-2021 "General Requirements for Skin Disinfectants".

[0072] 1.4 According to the Appendix 2 of the Health Supervision (2009) No. 56, Determination of Antibiotics in Disinfection Products - Liquid Chromatography-Tandem Mass Spectrometry, the content of antibiotics in the two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments was tested. The test environment temperature was 23°C and the relative humidity was 49%.

[0073] In the polypeptide compound Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6, 7 antibiotics (metronidazole, chlortetracycline hydrochloride, oxytetracycline dihydrate, minocycline hydrochloride, erythromycin, cephradine, and tetracycline hydrochloride) were not detected.

[0074] 1.5 In accordance with 2.3.3.3.3 of the Technical Specifications for Disinfection (2002 edition) and 6.6 (3) of the Regulations on Inspection of Disinfection Products, multiple complete skin irritation tests were conducted on two groups of peptide compound Chinese herbal extract antibacterial and antiviral ointments.

[0075] Test subjects: 2.46-2.59 kg ordinary grade New Zealand rabbits [purchased from Jiashan County Jintu Rabbit Industry Professional Cooperative, production license number: SCXK (Zhejiang) 2020-0006], regardless of gender (female animals were selected from those that were not pregnant and had not given birth).

[0076] Before the test, the hair on both sides of the spine of the experimental animals were cut off, and the hair removal area was 3cm×3cm. Take 0.5g of the test sample and apply it on one side of the skin, and the other side was used as a control. 4 hours after application, remove the residue with warm water once a day for 14 consecutive days. From the second day, the hair should be cut before each test. Observe the results 24 hours after each application, and score and grade according to the relevant requirements in the specification. The treatment method of the control area is the same as that of the test area.

[0077] The results of multiple skin irritation tests are shown in Tables 1 and 2.

[0078] Table 1 Results of multiple skin irritation tests on rabbits using the polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3

[0079] Table 2 Results of multiple skin irritation tests on rabbits using the polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment obtained in Example 6

[0080] As shown in Tables 1 and 2, the skin of the test animals was observed for 14 consecutive days, and the average score of the irritation reaction of each animal per day was 0.00, indicating that the results of multiple skin irritation tests on rabbits of the polypeptide compound Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6 were non-irritating, and the test results met the requirements of the "Technical Specification for Disinfection" (2002 edition).

[0081] 1.6 According to Appendix B of GB15979-2002 “Hygiene Standards for Disposable Hygiene Products”, two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments were tested for microorganisms.

[0082] The test results of the polypeptide compounded Chinese medicine extract antibacterial and antiviral ointment obtained in Example 3 and Example 6 were the same, which were: total bacterial colony count <4 cfu / g, total fungal colony count <4 cfu / g, while coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, and hemolytic Streptococcus were not detected.

[0083] 1.7 According to Appendix C of GB15979-2002 “Hygiene Standards for Disposable Hygiene Products”, the antibacterial rates of two groups of peptide compounded Chinese medicine extract antibacterial and antiviral ointments were determined.

[0084] Test strain: Escherichia coli 8099 , Staphylococcus aureus ATCC6538 Provided by China Industrial Microbiological Culture Collection Center, 4th to 8th generation fresh slant culture; Candida albicans ATCC10231 Provided by China Industrial Microbiological Culture Collection Center, 5th-6th generation fresh slant culture. Test temperature: 19-21℃.

[0085] After three repeated tests, the results showed that the average antibacterial rates of the two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments on Escherichia coli, Staphylococcus aureus, and Candida albicans for 2min, 5min, 10min, and 20min were all >99.9%. It was confirmed that the two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments had strong antibacterial effects on Escherichia coli, Staphylococcus aureus, and Candida albicans, and met the requirements of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0086] 1.8 The two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments were diluted 100 times, and the antibacterial rate of the diluted ointment samples was measured again according to Appendix C of GB15979-2002 "Hygiene Standards for Disposable Hygiene Products". The detection steps are the same as 1.7.

[0087] After 3 repeated tests, Figure 2As shown, it was found that the antibacterial and antiviral ointment of the polypeptide compounded Chinese medicine extract obtained in Example 6 had a better inhibition rate against Escherichia coli, Staphylococcus aureus and Candida albicans after 5 minutes of action than that of Example 3 (P<0.05).

[0088] 1.9 The two groups of polypeptide compound antibacterial and antiviral ointments of traditional Chinese medicine extracts were stored in a constant temperature and humidity incubator at 37°C and 80%RH for 90 days, and the antibacterial rates of the two groups of polypeptide compound antibacterial and antiviral ointments of traditional Chinese medicine extracts were measured again according to Appendix C of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0089] After three repeated tests, the results showed that the average antibacterial rates of the two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments on Escherichia coli, Staphylococcus aureus, and Candida albicans for 2min, 5min, 10min, and 20min were all >99.9%. It was confirmed that the two groups of peptide compound Chinese medicine extract antibacterial and antiviral ointments had strong antibacterial effects on Escherichia coli, Staphylococcus aureus, and Candida albicans after being stored for 90 days, and the effective period of the antibacterial effect was at least 2 years at room temperature, which met the requirements of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0090] 1.10 After being stored for 90 days in 1.9, the two samples were diluted 100 times, and the antibacterial rate of the diluted ointment sample was measured again according to Appendix C of GB15979-2002 "Hygiene Standard for Disposable Sanitary Products".

[0091] After 3 repeated tests, Figure 3 As shown, the antibacterial and antiviral ointment of the polypeptide compounded Chinese medicine extract obtained in Example 6 after dilution against Escherichia coli, Staphylococcus aureus and Candida albicans for 5 minutes was still better than that of Example 3 after dilution (P<0.05).

[0092] The polypeptide compounded Chinese medicine extract antibacterial and antiviral lotions obtained in Example 9 and Example 10 were tested as follows: 2.1 The appearance of the two groups of polypeptide compounded Chinese medicine extract antibacterial and antiviral lotions were evaluated and tested according to Q / IDE006-2023. The polypeptide compounded Chinese medicine extract antibacterial and antiviral lotions obtained in Example 9 and Example 10 were liquid with uniform color and met the requirements.

[0093] 2.2 According to 2.2.1.4 of the Technical Specification for Disinfection of the Ministry of Health in 2002, a pH meter (model: SevenMulti) was used to detect the pH values ​​of the two groups of polypeptide compound Chinese medicine extract antibacterial and antiviral washes in an environment with a temperature of 23°C and a relative humidity of 46%.

[0094] The pH value of the polypeptide compound antibacterial and antiviral lotion of traditional Chinese medicine extract obtained in Example 9 was 6.41±0.01, and the pH value of the polypeptide compound antibacterial and antiviral lotion of traditional Chinese medicine extract obtained in Example 10 was 6.35±0.01.

[0095] 2.3 In accordance with Chapter 4, 1.6 of the 2015 edition of the "Technical Specification for Safety of Cosmetics", the contents of lead, arsenic and mercury in two groups of peptide compound Chinese medicine extract antibacterial and antiviral lotions were determined in an environment with a temperature of 23°C and a relative humidity of 46%.

[0096] In the polypeptide composite Chinese medicine extract antibacterial and antiviral wash obtained in Example 9 and Example 10, the lead content is ≤0.09 mg / kg, the arsenic content is <0.0033 mg / kg, and the mercury content is <0.0033 mg / kg, which meets the limit requirements in GB 27951-2021 "General Requirements for Skin Disinfectants".

[0097] 2.4 In accordance with 2.3.3.3.3 of the Technical Specifications for Disinfection (2002 edition) and 6.6 (3) of the Regulations on Inspection of Disinfection Products, two groups of peptide compound Chinese herbal extract antibacterial and antiviral lotions were subjected to multiple complete skin irritation tests.

[0098] Test subjects: 2.34-2.41kg common New Zealand rabbits [purchased from Tongxiang Yinhai Animal Husbandry Professional Cooperative, production license number: SCXK (Zhejiang) 2018-0002], female (non-pregnant and non-parous). Raised in a normal rabbit room, room temperature 21.7-22.4℃, relative humidity 49.5-60.2%.

[0099] Before the test, check the animals' vaginal opening for secretions, congestion, edema and other injuries, and discard animals with inflammation or (and) injuries. Divide into Example 9 Group, Example 10 Group and Control Group, 3 animals in each group.

[0100] The rabbit was fixed on its back, and the perineum and vaginal opening were exposed. The catheter (disposable rectal administration tube with a length of about 6 cm connected to a 2 mL syringe) was moistened with the test substance and gently inserted into the vagina (4 cm). 2 mL of the test substance was slowly injected with a syringe, and the catheter was withdrawn. The animals in the control group were treated in the same way with sodium chloride injection.

[0101] 24 hours after exposure, the animals were killed by gas embolism, and the intact vagina was removed by laparotomy. The vagina was opened longitudinally and observed with the naked eye to see if there were any signs of congestion or edema. The vagina was then fixed in 10% formalin solution for 48 hours. Tissues from the two ends and three middle parts of the vagina were selected for preparation and stained with HE for histopathological examination.

[0102] The results of histopathological examination were scored. The stimulation response scores of the three sites of the three animals in each group were added together and then divided by the total number of observations (number of animals × 3) to obtain the average score of the vaginal mucosal stimulation response of the test group. The stimulation intensity was graded by subtracting the average score of the control group from the average score of the Example 9 group / the Example 10 group.

[0103] The scores of vaginal mucosal irritation reactions are shown in Table 3.

[0104] Table 3 Vaginal mucosal irritation response score summary

[0105] Note: 1) Average score = sum of the stimulation response scores of 3 parts of 3 animals / total number of observations (number of animals × 3); 2) Irritation index = average score of the poisoned group - average score of the negative control group.

[0106] As shown in Table 3, the irritation indexes of the polypeptide compounded Chinese medicine extract antibacterial and antiviral washes obtained in Example 9 and Example 10 on the vaginal mucosa of rabbits were 0.67 and 0.45, respectively, and the vaginal mucosal irritation reaction intensity was no vaginal mucosal irritation. The test results met the requirements of the Technical Specifications for Disinfection (2002 Edition).

[0107] 2.5 According to Appendix B of GB15979-2002 “Hygiene Standards for Disposable Hygiene Products”, the microorganisms in the two groups of peptide compound Chinese medicine extract antibacterial and antiviral washes were detected.

[0108] The test results of the polypeptide compounded Chinese medicine extract antibacterial and antiviral wash obtained in Example 9 and Example 10 were the same, both of which were: total bacterial colony count <4 cfu / g, total fungal colony count <4 cfu / g, while coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, and hemolytic Streptococcus were not detected.

[0109] 2.6 According to Appendix C of GB15979-2002 “Hygiene Standards for Disposable Hygiene Products”, the antibacterial rates of two groups of peptide compounded Chinese medicine extract antibacterial and antiviral washes were determined.

[0110] Test strain: Escherichia coli 8099 , Staphylococcus aureus ATCC6538 Provided by China Industrial Microbiological Culture Collection Center, 4th to 8th generation fresh slant culture; Candida albicans ATCC10231 Provided by China Industrial Microbiological Culture Collection Center, 5th-6th generation fresh slant culture. Test temperature: 19-21℃, After three repeated tests, the results showed that the average antibacterial rates of the two groups of peptide compound Chinese medicine extract antibacterial and antiviral washes on Escherichia coli, Staphylococcus aureus, and Candida albicans for 2min, 5min, 10min, and 20min were all >99.9%. It was confirmed that the two groups of peptide compound Chinese medicine extract antibacterial and antiviral washes had strong antibacterial effects on Escherichia coli, Staphylococcus aureus, and Candida albicans, and met the requirements of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0111] 2.7 The two groups of peptide compound Chinese medicine extract antibacterial and antiviral wash solutions were diluted 100 times, and the antibacterial rate of the diluted wash solution samples was measured again according to Appendix C of GB15979-2002 "Hygiene Standards for Disposable Hygiene Products". The detection steps are the same as 2.6.

[0112] After 3 repeated tests, Figure 4 As shown, the antibacterial and antiviral lotion of the polypeptide compounded Chinese medicine extract obtained in Example 10 had a better inhibition rate on Escherichia coli, Staphylococcus aureus and Candida albicans after 5 minutes of action than that in Example 9 (P<0.05).

[0113] 2.8 The two groups of polypeptide compound antibacterial and antiviral lotions prepared from traditional Chinese medicine extracts were stored in a constant temperature and humidity incubator at 37°C and 80%RH for 90 days. The inhibition rates of the two groups of polypeptide compound antibacterial and antiviral lotions prepared from traditional Chinese medicine extracts against Candida albicans were measured again according to Appendix C of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0114] Candida albicans ATCC10231 Provided by China Industrial Microbiological Culture Collection Center, 5-6th generation fresh slant culture.

[0115] After three repeated tests, the results showed that the two groups of polypeptide compound antibacterial and antiviral washing solutions with Chinese herbal extracts had an average inhibition rate of 2min, 5min, 10min, and 20min against Candida albicans after being stored at 37°C for 90 days, which was >99.9%, confirming that the two groups of polypeptide compound antibacterial and antiviral washing solutions with Chinese herbal extracts had a strong antibacterial effect on Candida albicans after being stored for 90 days. The effective period of the antibacterial effect is at least 2 years when stored at room temperature, which meets the requirements of GB15979-2002 "Hygiene Standards for Disposable Sanitary Products".

[0116] 2.9 After the two samples in 2.8 were stored for 90 days, they were diluted 100 times and the antibacterial rate of the diluted washing liquid samples was measured again according to Appendix C of GB15979-2002 "Hygiene Standard for Disposable Sanitary Products".

[0117] After 3 repeated tests, Figure 5As shown, the antibacterial and antiviral lotion of the polypeptide compounded Chinese medicine extract obtained in Example 10 after dilution against Escherichia coli, Staphylococcus aureus and Candida albicans for 5 minutes was still better than that of Example 9 after dilution (P<0.05).

[0118] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation, characterized in that: The dosage form of the preparation is gel, ointment, and lotion; The raw materials include, by mass percentage: 0.01-1% of alofilone polypeptide or stabilized alofilone polypeptide, 0.2-5% of Chinese herbal medicine extract, and the remainder is dosage form excipients; The Chinese medicine extracts include: sophora flavescens extract, liquorice extract, stemona extract and chamomile extract. The mass ratio of the sophora flavescens extract, liquorice extract, stemona extract and chamomile extract is 5-10:2-10:0-10:2-10.

2. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 1, characterized in that: When the dosage form of the preparation is a gel, the dosage form excipients include: natural antibacterial agent, moisturizer, thickener, water; The natural antibacterial agent is at least one of tea tree essential oil, chitosan, lactic acid and citric acid; The moisturizer is at least one of decyl glucoside, glycerin, sorbitol, polyethylene glycol 600, petrolatum, and lanolin; The thickener is at least one of hydroxymethyl cellulose, xanthan gum and carbomer; The raw materials include, by mass percentage: 0.01-1% of alophilone polypeptide or stabilized alophilone polypeptide, 0.2-5% of Chinese herbal extract, 0.5-1.5% of natural antibacterial agent, 1-6% of moisturizing agent, 1-2% of thickener, and the balance of water.

3. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 2, characterized in that: When the dosage form of the preparation is an ointment, the dosage form excipients include: base oil, moisturizer, emulsifier, preservative, water; The base oil is at least one of evening primrose oil and tea tree essential oil; The moisturizer is at least one of decyl glucoside, glycerin, sorbitol, polyethylene glycol 600, vaseline, and lanolin; The emulsifier is sorbitan fatty acid ester and / or polyoxyethylene sorbitan fatty acid ester; The raw materials include, by mass percentage: 0.01-1% of alofilone polypeptide or stabilized alofilone polypeptide, 0.2-5% of Chinese herbal medicine extract, 5-20% of base oil, 10-20% of moisturizer, 3-23% of emulsifier, 0.003-0.03% of preservative, and the balance of water.

4. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 1, characterized in that: When the dosage form of the preparation is a lotion, the dosage form excipients include: sorbitol, saccharin sodium, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, anhydrous ethanol, flavor, solubilizer, water, base oil; The raw materials of the polypeptide compounded Chinese herbal medicine extract antibacterial and antiviral preparation include, by mass percentage: 0.01-1% of alofilone polypeptide or stabilized alofilone polypeptide, 0.2-5% of Chinese herbal medicine extract, 1-10% of sorbitol, 0.01-0.05% of saccharin sodium, 0.01-0.05% of sucralose, 0.01-0.05% of xylitol, 0.01-1% of poloxamer, 0.01-1% of sodium benzoate, 0.01-1% of disodium ethylenediaminetetraacetic acid, 0.01-1% of flavor, 0.01-1% of solubilizer, 50-95% of water, and the balance of base oil.

5. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 4, characterized in that: The base oil is at least one of evening primrose oil, glycerin and tea tree essential oil.

6. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 1, characterized in that: The stabilized Alophillon polypeptide is prepared by the following specific operation: adding hyperbranched polyamidoamine to water and stirring evenly, adding methyl thioglycolate thereto under stirring, stirring at 60-70° C. for 1-2 hours, reducing the temperature to 2-6° C., adding Alophillon polypeptide and stirring for 5-10 minutes, adding 1-ethyl-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinimide and continuing to stir for 1-2 hours, centrifuging, washing, and vacuum drying.

7. The polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to claim 6, characterized in that: The mass ratio of hyperbranched polyamidoamine, methyl thioglycolate, alophilon polypeptide, 1-ethyl-(3-dimethylaminopropyl)carbodiimide and N-hydroxysuccinimide is 1-2: 0.1-0.5: 0.1-1: 0.01-0.1: 0.1-0.

2.

8. A method for preparing the polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation as claimed in any one of claims 2, 6 and 7, characterized in that: The steps include: i. Add the thickener into water, heat it to 40-60°C and stir to obtain the first material; ii. Add the Chinese herbal medicine extract into water and dissolve it, then add the natural antibacterial agent and mix well, then slowly add it into the first material and stir well to obtain the second material; iii. adding the alophillon polypeptide or the stabilized alophillon polypeptide into water and completely dissolving it to obtain an alophillon polypeptide aqueous solution; iv. Add the aqueous solution of Alofilon polypeptide to the second material and mix evenly, then add the moisturizer and mix evenly.

9. A method for preparing the polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation as claimed in any one of claims 3, 6 and 7, characterized in that: The steps include: S1. Add the preservative into water and mix evenly, then add the alophillon polypeptide or stabilized alophillon polypeptide and the Chinese medicine extract in sequence and mix evenly to obtain an aqueous phase; S2, mixing the base oil and the emulsifier evenly, and then adding the moisturizer and mixing evenly to obtain an oil phase; S3. Mix the water phase and the oil phase, evacuate to a vacuum degree of 0.08-0.09 MPa, heat and stir, homogenize and emulsify, cool, and return to normal pressure.

10. A method for preparing the polypeptide compounded Chinese medicine extract antibacterial and antiviral preparation according to any one of claims 4 to 7, characterized in that: The steps include: (1) Add sorbitol, sodium saccharin, sucralose, xylitol, poloxamer, sodium benzoate, disodium edetate, alophyllon polypeptide or stabilized alophyllon polypeptide, and Chinese herbal medicine extract into water and stir until completely dissolved to obtain an aqueous phase liquid; (2) Add anhydrous ethanol and essence to the base oil, stir until completely dissolved, then add the solubilizer, and continue stirring for at least 30 minutes to obtain an oil phase liquid; (3) Continue stirring the aqueous phase and slowly add the oil phase during stirring. Continue stirring for at least 30 minutes after the oil phase is completely added. Adjust the pH value of the system to 4.5-6.5.

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