WO2017193509A1 - Lotion gynécologique bionique et son procédé de préparation - Google Patents

Lotion gynécologique bionique et son procédé de préparation Download PDF

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Publication number
WO2017193509A1
WO2017193509A1 PCT/CN2016/097615 CN2016097615W WO2017193509A1 WO 2017193509 A1 WO2017193509 A1 WO 2017193509A1 CN 2016097615 W CN2016097615 W CN 2016097615W WO 2017193509 A1 WO2017193509 A1 WO 2017193509A1
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Prior art keywords
vaginal
gynecological lotion
bionic
cell debris
gynecological
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PCT/CN2016/097615
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English (en)
Chinese (zh)
Inventor
陈松彬
易萍
张爱萍
倪彦艳
吴纯玲
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广东科玮生物技术股份有限公司
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Publication of WO2017193509A1 publication Critical patent/WO2017193509A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1767—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants

Definitions

  • the invention belongs to the field of personal cleaning articles, and particularly relates to a bionic gynecological lotion and a preparation method thereof.
  • Vaginitis is inflammation of the vaginal mucosa and submucosal connective tissue and is the most common disease in gynecology.
  • the vagina has a natural defense function against the invasion of pathogens.
  • the pathogen will invade and cause vaginal inflammation. According to statistics, more than 80% of married women of childbearing age in China are plagued by this disease.
  • Vaginitis is mainly caused by dysbacteriosis in the vagina, that is, the micro-ecological balance (bacteria) that is normally parasitic in the vagina, the beneficial bacteria such as lactobacilli in the vagina are reduced, and other bacteria are multiplied, and anaerobic bacteria are produced at the same time.
  • bacteria micro-ecological balance
  • the products for the treatment of vaginitis are mainly based on sterilization, on the one hand commonly used antibiotics and a variety of antibacterial washing liquid.
  • the dominant flora Lacobacillus, Bifidobacterium vaginalis
  • the symptoms are relieved during the treatment, once the other drugs are stopped, they will quickly grow and cause inflammation. Repeatedly appear alternately.
  • Long-term use of antibiotics and antibacterials can also cause drug resistance in various pathogens and exacerbate the imbalance of flora in the vagina.
  • the existing lotion and vaginal secretions are completely different in composition. Repeated lavage of the vagina will accelerate the aging of the vagina and easily dry the vagina.
  • Chinese Patent Application No. 201310062784.6 discloses a bionic gynecological care solution comprising an antimicrobial peptide and an artificial vaginal secretion having a pH of 3.3 to 4.4, and a preparation method thereof, the anti-bacterial solution
  • the content of the bacterial peptide in the artificial vaginal secretion is 0.1 to 10.0 g / L;
  • the artificial vaginal secretion liquid comprises an artificial body fluid and a thickening agent, and the content of the thickening agent in the artificial body fluid is 0.5 to 5.0 g. /L.
  • the bionic gynecological care solution of the invention adopts a bionic design, uses artificial body fluid as a solvent, adds a thickener to adjust its viscosity, adjusts the pH value with acid and alkali, and obtains artificially close to the vaginal secretion component, viscosity and pH of the human body.
  • Vaginal secretion, and then use antibacterial peptide as a fungicide there will be no drawbacks of chemical bactericidal agent to chronically erode vaginal viscosity, will not excessively change the vaginal microenvironment and damage the physiological balance of the vagina, can be used to treat refractory vaginitis and daily vagina Health care and disease prevention.
  • the product has the following disadvantages: 1 is due to the high salt environment of artificial body fluids, which reduces the biological activity of the antimicrobial peptide, and ultimately leads to a significant decrease in its antimicrobial capacity; 2 is the composition of the artificial body fluid and human vaginal secretions; There is a big difference, it is not a true bionics, so its compatibility with the vagina is poor; 3 is that the product mainly aims to cure vaginitis by killing vaginal harmful bacteria, but it is against vaginal flora.
  • vagina There is no balance, and it can not repair the damage caused by vaginitis to the vagina, so it is easy to relapse vaginitis, the population with a history of vaginitis is still a high incidence of vaginitis; 4 is due to the shorter residence time of the lotion in the vagina
  • the action time of the antibacterial peptide is too short, so in order to achieve the desired antibacterial effect, the vagina needs to be repeatedly irrigated every time, and the relationship of many times easily destroys the micro environment of the vagina.
  • biomimetic gynecological lotion that has bactericidal, vaginal flora, and vaginal function.
  • the object of the present invention is to overcome the above drawbacks of the prior art, and to provide a bionic gynecological lotion having bactericidal, vaginal flora and vaginal function, which has significant effects on different types of vaginitis.
  • the invention provides a bionic gynecological lotion, comprising a housefly antibacterial peptide, a xylooligosaccharide, a xanthan gum and an artificial simulated vaginal secretion having a pH of 3.3 to 4.8, the housefly antibacterial peptide and the xylooligosaccharide
  • the content of xanthan gum in artificial simulated vaginal secretions is 0.1-10.0 g/L, 5-10.0 g/L and 0.05-0.15 g/L, respectively.
  • the contents of the housefly antimicrobial peptide, xylooligosaccharide and xanthan gum in artificial simulated vaginal secretions are 0.1 g/L, 6.0 g/L and 0.1 g/L, respectively.
  • the artificial simulated vaginal secretion is composed of the following components: NaCl 5-10 g/L, KCl 0.3-0.5 g/L, CaCl 2 0.1-0.2 g/L, NaHCO 3 0.3-0.45 g/L, MgCl.
  • the artificial simulated vaginal secretion is composed of the following components: NaCl 8.0 g/L, KCl 0.45 g/L, CaCl 2 0.15 g/L, NaHCO 3 0.4 g/L, MgCl 2 ⁇ 6H 2 O 0.015 g /L, MgSO 4 ⁇ 7H 2 O 0.05g / L, KH 2 PO 4 0.06g / L, Na 2 PHO 4 ⁇ 12 H 2 O 0.06g / L, glucose 2g / L, urea 1.5g / L, Gram Positive bacterial cell debris 0.002 g / L and the balance of deionized water.
  • the Gram-positive bacterial cell debris consists of a Bifidobacterium cell fragment and a Lactobacillus cell debris in a weight ratio of 1:1.
  • the biomimetic gynecological lotion further comprises a vaginal repairing agent
  • the vaginal repairing agent is contained in the artificial simulated vaginal secretions in an amount of 0.1 to 2 g/L
  • the vaginal prosthetic is selected from the group consisting of water-soluble VE, One or more of natural moisturizing factors and free amino acids.
  • the vaginal repairing agent is composed of a water-soluble VE, a natural moisturizing factor and a free amino acid in a weight ratio of 1:0.5 to 1:1 to 2.
  • the vaginal repair agent consists of a water-soluble VE, a natural moisturizing factor and a free amino acid in a weight ratio of 1:0.5:1.
  • the free amino acid is selected from one or more of glycine, alanine, aspartic acid and serine.
  • the present invention also provides a preparation method of the above-mentioned bionic gynecological lotion, comprising the following steps:
  • the step B) further comprises adding a vaginal restorative agent after adding the housefly antimicrobial peptide.
  • the invention simulates the composition of human vaginal secretions to the greatest extent, and adds urea and Gram-positive bacterial cell debris on the basis of artificial body fluid, preferably adding bifidobacterial cell debris and Lactobacillus cell debris, which can induce Bifidobacterium in the vagina And the production of Lactobacillus, the addition of xylooligosaccharide specifically promotes the proliferation of the beneficial bacteria Lactobacillus and Bifidobacteria, and the propagated Lactobacillus and Bifidobacteria can colonize, compete for nutrition, and secrete H 2 O 2
  • bacteriostatic substances such as bacteriocin inhibit the growth and reproduction of pathogenic microorganisms in the vagina and intestine of women, and additionally produce a large number of short-chain fatty acids such as acetic acid, propionic acid and butyric acid by fermentation of xylo-oligosaccharides by lactobacilli and bifidobacteri
  • the antimicrobial ability is significantly reduced.
  • Musca domestica antimicrobial peptides maintain excellent biological activity at high salt concentrations, and Good thermal stability, which is conducive to the subsequent high-temperature sterilization operation; due to the short residence time of the washing liquid in the vagina, the antibacterial peptide has a short action time, so in order to achieve the desired antibacterial effect, the vagina needs to be repeatedly irrigated every time, the applicant It was found that the xanthan gum was first coupled with the antibacterial peptide, and the bioadhesive property of xanthan gum was used to adhere to the mucosa and cells for a long time, prolonging the action time of the antibacterial peptide, thereby reducing the number of lavage, and the two synergistically increased the washing. The antibacterial effect of the liquid.
  • the present invention utilizes the coupling of Musca domestica antibacterial peptide xanthan gum to greatly improve the antibacterial effect and reduce the number of lavage, and utilizes Gram-positive bacterial cell debris to induce the production of Bifidobacteria and Lactobacillus in the vagina.
  • the xylo-oligosaccharide has a powerful function of regulating the vaginal flora and vaginal acidity.
  • vaginal secretion component of the human body is supplemented with a solvent close to the vaginal secretion component of the human body and a component that has a repairing effect on the vagina.
  • the distribution of each group is reasonable, the primary and secondary are distinct, and a combination is formed. Sterilization, balance of vaginal flora, vaginal acidity and a stable system for repairing vaginal damage.
  • the bionic gynecological lotion of the present invention has the following advantages:
  • the bionic gynecological lotion of the invention adopts a bionic design, has little influence on the vaginal microenvironment and vaginal physiological balance, and does not cause cell resistance, and has an outstanding bactericidal effect compared with the existing gynecological lotion.
  • bacterial vaginitis, candida vaginitis, trichomonas vaginitis, and mixed yin Daoyan has a significant therapeutic effect.
  • the invention utilizes the coupling of Musca domestica antibacterial peptide xanthan gum to greatly improve the antibacterial effect and reduce the number of lavage, and utilizes Gram-positive bacterial cell debris to induce the production of Bifidobacteria and Lactobacillus in the vagina and synergistic oligomeric wood.
  • the powerful function of regulating the vaginal flora and vaginal acidity is finally supplemented by the solvent close to the vaginal secretion component of the human body and the component which has the repairing effect on the vagina.
  • the distribution of each group is reasonable, the primary and secondary are distinct, and the composition is both bactericidal and balanced. Vaginal flora, vaginal acidity, and a stable system for repairing vaginal damage.
  • composition of the invention is safe and non-toxic, and the preparation method is simple.
  • Example 1 A bionic gynecological lotion
  • the bionic gynecological lotion of the first embodiment is composed of the following components: Musca domestica antimicrobial peptide 0.1g, xylooligosaccharide 6.0g, xanthan gum 0.1g, NaCl 8.0g, KCl 0.45g, CaCl 2 0.15g, NaHCO 3 0.4 g, MgCl 2 ⁇ 6H 2 O 0.015 g, MgSO 4 ⁇ 7 H 2 O 0.05 g, KH 2 PO 4 0.06 g, Na 2 PHO 4 ⁇ 12H 2 O 0.06 g, glucose 1.0 g, urea 1.5 g, gram 0.002 g of positive bacterial cell debris, which was made up to 1 L with deionized water, wherein the growth factor consisted of recombinant human epidermal growth factor and recombinant human basic fibroblast growth factor in a weight ratio of 1:1.
  • Gram-positive bacterial cell debris consists of Bifidobacterium cell debris and Lacto
  • the cell debris and glucose are dissolved in 800 ml of deionized water, stirred and mixed uniformly, and water is added to 1000 ml to adjust the pH to 3.4, that is, the artificial vaginal secretion is artificially simulated;
  • Example 2 A bionic gynecological lotion
  • the bionic gynecological lotion of the present embodiment 2 is composed of the following components: Musca domestica antimicrobial peptide 0.1g, xylooligosaccharide 6.0g, xanthan gum 0.1g, NaCl 8.0g, KCl 0.45g, CaCl 2 0.15g, NaHCO 3 0.4 g, MgCl 2 ⁇ 6H 2 O 0.015 g, MgSO 4 ⁇ 7 H 2 O 0.05 g, KH 2 PO 4 0.06 g, Na 2 PHO 4 ⁇ 12H 2 O 0.06 g, glucose 1.0 g, urea 1.5 g, gram Positive bacterial cell debris 0.002g, water soluble VE0.4g, natural moisturizing factor 0.2g and free amino acid 0.4g, up to 1L with deionized water, wherein the growth factor consists of recombinant human epidermal growth factor and recombinant human base
  • the fibroblast growth factor is composed of a weight ratio of 1:1
  • Example 1 The preparation method is referred to Example 1.
  • Example 3 a bionic gynecological lotion
  • the bionic gynecological lotion of the present embodiment 3 is composed of the following components: Musca domestica antimicrobial peptide 0.2g, xylooligosaccharide 5.0g, xanthan gum 0.1g, NaCl 8.0g, KCl 0.45g, CaCl 2 0.15g, NaHCO 3 0.4 g, MgCl 2 ⁇ 6H 2 O 0.015 g, MgSO 4 ⁇ 7 H 2 O 0.05 g, KH 2 PO 4 0.06 g, Na 2 PHO 4 ⁇ 12H 2 O 0.06 g, glucose 1.0 g, urea 1.5 g, gram Positive bacterial cell debris 0.001g, water soluble VE 0.4g, natural moisturizing factor 0.2g and free amino acid 0.4g, up to 1L with deionized water, wherein the growth factor consists of recombinant human epidermal growth factor and recombinant human base
  • the fibroblast growth factor is composed of a weight ratio of
  • Example 2 The preparation method is referred to in Example 2.
  • Example 2 The component urea was removed, and the remaining components and their amounts were as in Example 2.
  • Example 2 The preparation method is referred to in Example 2.
  • This comparative example 3 biomimetic gynecological lotion consists of the following components: Musca domestica antibacterial peptide 0.1g, xylooligosaccharide 6.0g, xanthan gum 0.2g, NaCl 8.0g, KCl 0.45g, CaCl 2 0.15g, NaHCO 3 0.4 g, MgCl 2 ⁇ 6H 2 O 0.015 g, MgSO 4 ⁇ 7 H 2 O 0.05 g, KH 2 PO 4 0.06 g, Na 2 PHO 4 ⁇ 12H 2 O 0.06 g, glucose 1.0 g, urea 1.5 g, gram Positive bacterial cell debris 0.002g, water soluble VE0.4g, natural moisturizing factor 0.2g and free amino acid 0.4g, up to 1L with deionized water, wherein the growth factor consists of recombinant human epidermal growth factor and recombinant human base The fibroblast growth factor is composed of a weight ratio of 1:1, and
  • Example 2 The preparation method is referred to in Example 2.
  • Comparative Example 3 differs from Example 2 in that the amount of xanthan gum is increased.
  • Test example 1 stability test
  • Test articles Bionic gynecological lotions of Examples 1 to 3 and Comparative Examples 1 to 3 of the present invention.
  • Test method The above groups of the washing liquid were placed at a constant temperature of 45 ° C for two weeks, and then the changes of the gynecological lotion properties were observed. The test results are shown in Table 1 below.
  • Test 1 bactericidal effect of the gynecological lotion of the invention on Neisseria gonorrhoeae, Staphylococcus aureus and Candida albicans
  • Test article Inventive Examples 1 to 3 and Comparative Examples 1 to 2 Bionic gynecological lotion.
  • the filter paper sheets were placed on the above-mentioned nutrient agar medium plates coated with different strains, and 5 pieces were placed on each nutrient agar medium plate, and the gynecological cleanings of Examples 1 to 3 and Comparative Examples 1 to 2 were respectively dropped.
  • Examples 1-3 have excellent killing effects against Staphylococcus aureus, Staphylococcus aureus and Neisseria gonorrhoeae, especially in Group 2; Comparative Examples 1 and 2 and Example 2 In comparison, its killing effect on all three bacteria is reduced.
  • Test 2 the gynecological lotion of the present invention kills Trichomonas vaginalis test
  • Test drugs Take the gynecological lotion of the invention in the first to third and comparative examples 1 to 2 of the present invention, and after the test drug is autoclaved, the mixture is diluted by aseptic dilution, and the highest dilution is 1:16. 1 to 3 and Comparative Example 1 to 2 dilutions, respectively, take 2 ml of the above dilution into a test tube, and mark it for use.
  • Trichomonas vaginalis Trichomonas vaginalis, 30 strains isolated and cultured from the vaginal secretions of Trichomonas vaginalis patients provided by the Department of Obstetrics and Gynecology, Third Clinical Hospital of China Medical University.
  • Trichomonas vaginalis medium prepared with liver culture soup medium according to the clinical medical test manual (published by Jilin Science and Technology Press).
  • Test method 0.05 ml of the culture solution after subculture for 48 hours was added to the above test tube, gently shaken, and then 8 ml of sterile liver immersion culture medium was added to the above tube, and placed in a 37 ° C incubator. At 24 h, the tube bottom culture was taken for microscopic examination, and the test was carried out for three days. The mortality of the worms was counted after the action of the light drug solution, and the trichomoniasis mortality was counted. The statistical results are shown in Table 3.
  • the treatment group received the gynecological lotion lavage and vagina for 5 minutes, 1 day, 7 days for a course of treatment.
  • Candida vaginitis was washed with 3% sodium bicarbonate solution, and then placed in the vagina with 200 mg of Dakening suppository; bacterial vaginitis was washed with vulva and vagina with 1% compound iodine, and 500 mg of metronidazole was placed.
  • vagina In the vagina; trichomonas vaginitis with 0.5% acetic acid rinse vulva, vagina, placed 400mg metronidazole in the vagina; mixed vaginitis with a combination of drugs. All treatments were performed once a day for 7 days for a course of treatment. Before treatment, on the 7th day after the end of treatment Check the patient's clinical symptoms, signs and changes in vaginal secretions. Observed indicators include: vulvar discomfort, vaginal discharge, odor and traits, vulva/vaginal congestion, edema, vaginal cleanliness, pH, vaginal pathogen examination, etc.
  • the treatment of different types of vaginitis is best in the group of Example 2, and the total effective rate of the treatment of trichomonas vaginitis in the group 2 is as high as 100%, which illustrates the first to third embodiments of the present invention. It has significant therapeutic effects on bacterial vaginitis, candida vaginitis, trichomonas vaginitis and mixed vaginitis.

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  • Pharmacology & Pharmacy (AREA)
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  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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  • Reproductive Health (AREA)
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Abstract

La présente invention concerne une lotion gynécologique bionique et un procédé de préparation de celle-ci. La lotion comprend un peptide antibactérien Musca domestica , un xylooligosaccharide, une gomme de xanthane et une sécrétion vaginale simulée artificielle ayant un pH de 3,3 à 4,8, les teneurs en peptide antibactérien Musca domestica , en xylooligosaccharide et en gomme de xanthane dans la sécrétion vaginale simulée artificielle étant de 0,1 à 10,0 g/L, de 5 à 10,0 g/L et de 0,05 à 0,15 g/L
PCT/CN2016/097615 2016-05-11 2016-08-31 Lotion gynécologique bionique et son procédé de préparation WO2017193509A1 (fr)

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