CN112933109A - Vagina pH regulator and preparation method and application thereof - Google Patents
Vagina pH regulator and preparation method and application thereof Download PDFInfo
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- CN112933109A CN112933109A CN202110151375.8A CN202110151375A CN112933109A CN 112933109 A CN112933109 A CN 112933109A CN 202110151375 A CN202110151375 A CN 202110151375A CN 112933109 A CN112933109 A CN 112933109A
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- vaginal
- vagina
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- stirring
- urea
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- 210000001215 vagina Anatomy 0.000 title abstract description 40
- 238000002360 preparation method Methods 0.000 title abstract description 13
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims abstract description 87
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 81
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 78
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims abstract description 60
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims abstract description 60
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 36
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 30
- 239000004202 carbamide Substances 0.000 claims abstract description 30
- 239000008103 glucose Substances 0.000 claims abstract description 30
- 239000004310 lactic acid Substances 0.000 claims abstract description 30
- 235000014655 lactic acid Nutrition 0.000 claims abstract description 30
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 29
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 29
- 229960001631 carbomer Drugs 0.000 claims abstract description 29
- 235000011187 glycerol Nutrition 0.000 claims abstract description 29
- 239000003755 preservative agent Substances 0.000 claims abstract description 28
- 230000002335 preservative effect Effects 0.000 claims abstract description 28
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000011975 tartaric acid Substances 0.000 claims abstract description 27
- 235000002906 tartaric acid Nutrition 0.000 claims abstract description 27
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 15
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims abstract description 14
- 235000015165 citric acid Nutrition 0.000 claims abstract description 12
- 238000003756 stirring Methods 0.000 claims description 58
- 239000011259 mixed solution Substances 0.000 claims description 22
- 239000012153 distilled water Substances 0.000 claims description 11
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 7
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 7
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 7
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 5
- 239000003002 pH adjusting agent Substances 0.000 claims description 5
- 239000001540 sodium lactate Substances 0.000 claims description 5
- 229940005581 sodium lactate Drugs 0.000 claims description 5
- 235000011088 sodium lactate Nutrition 0.000 claims description 5
- ZCTXEAQXZGPWFG-UHFFFAOYSA-N imidurea Chemical compound O=C1NC(=O)N(CO)C1NC(=O)NCNC(=O)NC1C(=O)NC(=O)N1CO ZCTXEAQXZGPWFG-UHFFFAOYSA-N 0.000 claims description 4
- 229960002216 methylparaben Drugs 0.000 claims description 4
- IXMINYBUNCWGER-UHFFFAOYSA-M sodium;4-propoxycarbonylphenolate Chemical compound [Na+].CCCOC(=O)C1=CC=C([O-])C=C1 IXMINYBUNCWGER-UHFFFAOYSA-M 0.000 claims description 3
- 244000052616 bacterial pathogen Species 0.000 abstract description 10
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- 210000000582 semen Anatomy 0.000 abstract description 5
- 241000894006 Bacteria Species 0.000 abstract description 4
- 241000700605 Viruses Species 0.000 abstract description 4
- 230000002378 acidificating effect Effects 0.000 abstract description 4
- 244000005700 microbiome Species 0.000 abstract description 3
- 230000004083 survival effect Effects 0.000 abstract description 3
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- 239000000243 solution Substances 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 6
- 241000283973 Oryctolagus cuniculus Species 0.000 description 5
- 230000002421 anti-septic effect Effects 0.000 description 5
- 239000012530 fluid Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 229910019142 PO4 Inorganic materials 0.000 description 3
- 230000000813 microbial effect Effects 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 3
- 239000010452 phosphate Substances 0.000 description 3
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Chemical compound CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 235000014633 carbohydrates Nutrition 0.000 description 2
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 description 2
- 210000002919 epithelial cell Anatomy 0.000 description 2
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 description 1
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical compound COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 description 1
- 206010015150 Erythema Diseases 0.000 description 1
- 229920002527 Glycogen Polymers 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 241000186660 Lactobacillus Species 0.000 description 1
- 241000186783 Lactobacillus vaginalis Species 0.000 description 1
- 241000736262 Microbiota Species 0.000 description 1
- 206010067482 No adverse event Diseases 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- 206010058679 Skin oedema Diseases 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- 206010046555 Urinary retention Diseases 0.000 description 1
- 208000032159 Vaginal inflammation Diseases 0.000 description 1
- 201000008100 Vaginitis Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 210000003756 cervix mucus Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 230000003749 cleanliness Effects 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000002357 endometrial effect Effects 0.000 description 1
- 229940011871 estrogen Drugs 0.000 description 1
- 239000000262 estrogen Substances 0.000 description 1
- 210000000416 exudates and transudate Anatomy 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 235000019253 formic acid Nutrition 0.000 description 1
- 230000000762 glandular Effects 0.000 description 1
- 229960002442 glucosamine Drugs 0.000 description 1
- 229940096919 glycogen Drugs 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000009545 invasion Effects 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 239000002085 irritant Substances 0.000 description 1
- 231100000021 irritant Toxicity 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 229940039696 lactobacillus Drugs 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 210000003101 oviduct Anatomy 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 239000006041 probiotic Substances 0.000 description 1
- 230000000529 probiotic effect Effects 0.000 description 1
- 235000018291 probiotics Nutrition 0.000 description 1
- 235000019260 propionic acid Nutrition 0.000 description 1
- WXSLOYPZKHFWII-UHFFFAOYSA-N propyl 4-hydroxybenzoate;sodium Chemical compound [Na].CCCOC(=O)C1=CC=C(O)C=C1 WXSLOYPZKHFWII-UHFFFAOYSA-N 0.000 description 1
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000004404 sodium propyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010230 sodium propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 244000052613 viral pathogen Species 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
Classifications
-
- 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
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
- A61K31/78—Polymers containing oxygen of acrylic acid or derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
Abstract
The invention relates to the technical field of medicines, and discloses a vagina pH regulator and a preparation method and application thereof. The pH regulator for vagina contains glucose, urea, potassium hydroxide, carbomer, glycerol, lactic acid, citric acid, tartaric acid, preservative and water. The pH regulator of the vagina can regulate the pH value of the vagina within a normal range of 3.5-4.5, resist and inhibit the growth of pathogenic bacteria, maintain the healthy environment of microorganisms in the vagina, and effectively regulate the pH value even in the presence of semen, thereby maintaining an acidic environment which is not suitable for the survival of sperms and virus and bacterial pathogens related to sexually transmitted infection but is essential for the survival of healthy bacteria in the vagina.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a vagina pH regulator and a preparation method and application thereof.
Background
Vaginal fluid consists of plasma exudate from the vaginal wall, glandular secretions, cervical mucus, endometrial and fallopian tubes fluid, as well as residual urine and exfoliated epithelial cells, the nature and composition of which largely determines the interaction between the microbiota and urogenital pathogens. The vaginal fluid contains water organic matters, inorganic salts, urea, carbohydrates, mucin, fatty acids, albumin, immunoglobulin and other macromolecules, the carbohydrates of the vaginal fluid contain a small amount of mannose and glucosamine besides main glucose, the organic acids also contain a small amount of ions such as formic acid, succinic acid, propionic acid, butyric acid, sodium, potassium, chlorine, calcium and the like besides main lactic acid and acetic acid, and the secretions cooperate with microbial flora to maintain vaginal environment balance. Lactic acid is a main substance for maintaining a weak acid environment with a pH value less than or equal to 4.5 in the vagina, and is beneficial to the growth and the propagation of probiotic lactobacillus vaginalis under the acidity, resists and inhibits the growth of pathogenic bacteria, and maintains the health of the microbial environment in the vagina.
Affected by age, pregnancy and external factors, the microbial community in the vagina of a woman is changed, the vaginal cleanliness and pH are changed, vaginal flora is imbalanced, and further vaginal inflammation is caused; or due to the fact that some factors cause the estrogen level to be reduced, the glycogen content in the epithelial cells is reduced, the generation of lactic acid is reduced, the pH value of the vagina is increased, when the pH value in the vagina is larger than 5.0, the growth and the reproduction of lactobacillus in the vagina are inhibited, and finally, pathogenic bacteria invade and reproduce, so that inflammation is caused; and after sexual life, in the presence of semen in the vagina (which generally raises the vaginal pH to 7.0-8.0), healthy bacteria lose their dominance, leading to the invasion of certain viral and bacterial pathogens associated with sexually transmitted infections, which in turn causes a range of diseases.
Therefore, it is necessary and urgent to develop a product for adjusting the pH of female vagina safely and effectively.
Disclosure of Invention
The invention aims to overcome the problem of lacking a product capable of safely and effectively adjusting the pH value of a female vagina in the prior art, and provides a vagina pH adjusting agent, a preparation method and application thereof, wherein the vagina pH adjusting agent can adjust the vagina pH value within a normal range of 3.5-4.5, and can effectively adjust the pH value even in the presence of semen, so that an acidic environment which is not suitable for sperms and certain virus and bacterial pathogens related to sexually transmitted infection but is essential for healthy bacterial survival in the vagina is maintained.
In order to achieve the above objects, according to one aspect of the present invention, there is provided a vaginal pH adjustor comprising glucose, urea, potassium hydroxide, carbomer, glycerin, lactic acid, citric acid, tartaric acid, a preservative and water.
Preferably, the vaginal pH regulator comprises 4-6 wt% of glucose, 2-3 wt% of urea, 2-5 wt% of potassium hydroxide, 34-42 wt% of carbomer, 2.5-6.5 wt% of glycerin, 2.5-4 wt% of lactic acid, 4-5.5 wt% of citric acid, 1.5-3 wt% of tartaric acid, 1.5-2.5 wt% of preservative and 30-40 wt% of water.
Further preferably, the vaginal pH regulator comprises 4.5-5 wt% of glucose, 2.5-2.75 wt% of urea, 2.5-4.5 wt% of potassium hydroxide, 35-41 wt% of carbomer, 3-6.25 wt% of glycerin, 2.75-3.8 wt% of lactic acid, 4.5-5.2 wt% of citric acid, 1.75-2.3 wt% of tartaric acid, 1.75-2.25 wt% of a preservative, and 31-39 wt% of water.
Preferably, the preservative is at least one of methylparaben, sodium propylparaben, imidazolidinyl urea and sodium lactate.
Preferably, the water is distilled water.
In a second aspect, the present invention provides a method for preparing the above-mentioned vaginal pH adjustor, comprising the steps of:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and a preservative into the mixed solution obtained in the step (2) and stirring to obtain the vaginal pH regulator.
Preferably, in step (1), the temperature of the stirring is 22 to 28 ℃.
Preferably, in step (1), the stirring time is 30-40 min.
Preferably, in step (1), the stirring speed is 55-65 rpm.
In a third aspect, the present invention provides the use of a vaginal pH modifier as hereinbefore described for modifying the pH of the vagina.
The pH regulator of the vagina can regulate the pH value of the vagina within a normal range of 3.5-4.5, resists and inhibits the growth of pathogenic bacteria, maintains the healthy environment of microorganisms in the vagina, is safe and effective, and can also effectively regulate the pH value even in the presence of semen, thereby maintaining an acidic environment which is not suitable for the existence of sperms and virus and bacterial pathogens related to sexually transmitted infection but is essential for the existence of healthy bacteria in the vagina.
Detailed Description
The following describes in detail specific embodiments of the present invention. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.
The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value, and such ranges or values should be understood to encompass values close to those ranges or values. For ranges of values, between the endpoints of each of the ranges and the individual points, and between the individual points may be combined with each other to give one or more new ranges of values, and these ranges of values should be considered as specifically disclosed herein.
The invention provides a vagina pH regulator, which contains glucose, urea, potassium hydroxide, carbomer, glycerol, lactic acid, citric acid, tartaric acid, a preservative and water.
Preferably, the vaginal pH regulator comprises 4-6 wt% glucose, 2-3 wt% urea, 2-5 wt% potassium hydroxide, 34-42 wt% carbomer, 2.5-6.5 wt% glycerol, 2.5-4 wt% lactic acid, 4-5.5 wt% citric acid, 1.5-3 wt% tartaric acid, 1.5-2.5 wt% preservative and 30-40 wt% water.
Further preferably, the vaginal pH regulator comprises 4.5-5 wt% of glucose, 2.5-2.75 wt% of urea, 2.5-4.5 wt% of potassium hydroxide, 35-41 wt% of carbomer, 3-6.25 wt% of glycerin, 2.75-3.8 wt% of lactic acid, 4.5-5.2 wt% of citric acid, 1.75-2.3 wt% of tartaric acid, 1.75-2.25 wt% of a preservative, and 31-39 wt% of water.
In the present invention, there is no particular requirement for the selection of the preservative, and it may be a routine choice in the art. In a preferred embodiment, the preservative is at least one of methylparaben, sodium propylparaben, imidazolidinyl urea and sodium lactate.
In the present invention, the water is distilled water.
In a second aspect, the present invention provides a method for preparing the above-mentioned vaginal pH adjustor, comprising the steps of:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and a preservative into the mixed solution obtained in the step (2) and stirring to obtain the vaginal pH regulator.
In the present invention, in the step (1), the temperature of the stirring is 22 to 28 ℃. Specifically, the temperature of the stirring may be 22 ℃, 23 ℃, 24 ℃, 25 ℃, 26 ℃, 27 ℃ or 28 ℃.
In the invention, in the step (1), the stirring time is 30-40 min. Specifically, the stirring time may be 30min, 31min, 32min, 33min, 34min, 35min, 36min, 37min, 38min, 39min, or 40 min.
In the present invention, in the step (1), the stirring speed is 55 to 65 rpm. Specifically, the stirring speed may be 55rpm, 56rpm, 57rpm, 58rpm, 59rpm, 60rpm, 61rpm, 62rpm, 63rpm, 64rpm, or 65 rpm.
In a third aspect, the present invention provides the use of a vaginal pH modifier as hereinbefore described for modifying the pH of the vagina.
The pH regulator of the vagina can regulate the pH value of the vagina within a normal range of 3.5-4.5, resists and inhibits the growth of pathogenic bacteria, maintains the healthy environment of microorganisms in the vagina, is safe and effective, and can also effectively regulate the pH value even in the presence of semen, thereby maintaining an acidic environment which is not suitable for the existence of sperms and virus and bacterial pathogens related to sexually transmitted infection but is essential for the existence of healthy bacteria in the vagina.
The present invention will be described in detail by way of examples, but the scope of the present invention is not limited thereto.
Example 1
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and antiseptic (methyl parahydroxybenzoate) into the mixed solution obtained in step (2), stirring (stirring temperature is 22 deg.C, stirring time is 40min, and stirring speed is 60rpm) to obtain vaginal pH regulator A1;
wherein the vaginal pH regulator A1 contains 4.89 wt% glucose, 2.6 wt% urea, 4 wt% potassium hydroxide, 40 wt% carbomer, 5 wt% glycerin, 3 wt% lactic acid, 5 wt% citric acid, 2 wt% tartaric acid, 1.81 wt% preservative, and 31.7 wt% water.
Example 2
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and preservative (sodium propyl p-hydroxybenzoate) into the mixed solution obtained in the step (2), and stirring (stirring temperature is 28 ℃, stirring time is 35min, and stirring speed is 55rpm) to obtain a vaginal pH regulator A2;
wherein the vaginal pH regulator A2 contains 4.89 wt% glucose, 2.66 wt% urea, 3.1 wt% potassium hydroxide, 37 wt% carbomer, 3.4 wt% glycerin, 2.75 wt% lactic acid, 5.2 wt% citric acid, 2 wt% tartaric acid, 2 wt% preservative and 37 wt% water.
Example 3
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and preservative (imidazolidinyl urea) into the mixed solution obtained in the step (2), and stirring (the stirring temperature is 25 ℃, the stirring time is 30min, and the stirring speed is 65rpm) to obtain a vaginal pH regulator A3;
wherein the vaginal pH regulator A3 comprises 4.89 wt% glucose, 2.54 wt% urea, 2.9 wt% potassium hydroxide, 35 wt% carbomer, 5.59 wt% glycerol, 3.8 wt% lactic acid, 4.5 wt% citric acid, 1.75 wt% tartaric acid, 2.01 wt% preservative and 37.02 wt% water.
Example 4
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and antiseptic (sodium lactate) into the mixed solution obtained in step (2), and stirring (stirring temperature is 24 deg.C, stirring time is 38min, and stirring speed is 57rpm) to obtain vaginal pH regulator A4;
wherein the vaginal pH regulator A4 contains 4.91 wt% glucose, 2.62 wt% urea, 3.7 wt% potassium hydroxide, 36 wt% carbomer, 4.77 wt% glycerin, 2.98 wt% lactic acid, 4.75 wt% citric acid, 2.3 wt% tartaric acid, 2.02 wt% preservative and 35.95 wt% water.
Example 5
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and antiseptic (sodium lactate) into the mixed solution obtained in step (2), and stirring (stirring temperature is 26 deg.C, stirring time is 33min, and stirring speed is 61rpm) to obtain vaginal pH regulator A5;
wherein the vaginal pH regulator A5 comprises glucose 4.54 wt%, urea 2.52 wt%, potassium hydroxide 4.02 wt%, carbomer 39 wt%, glycerol 6.08 wt%, lactic acid 3.59 wt%, citric acid 4.66 wt%, tartaric acid 2.01 wt%, preservative 2.19 wt% and water 31.39 wt%.
Comparative example 1
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding citric acid, tartaric acid and antiseptic (methyl p-hydroxybenzoate) into the mixed solution obtained in step (2), and stirring (stirring temperature is 22 deg.C, stirring time is 40min, and stirring speed is 60rpm) to obtain vaginal pH regulator D1;
wherein the vaginal pH regulator D1 contains 4.89 wt% of glucose, 2.6 wt% of urea, 4 wt% of potassium hydroxide, 40 wt% of carbomer, 5 wt% of glycerol, 5 wt% of citric acid, 2 wt% of tartaric acid, 1.81 wt% of preservative and 34.7 wt% of water.
Comparative example 2
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, tartaric acid and antiseptic (methyl p-hydroxybenzoate) into the mixed solution obtained in step (2), and stirring (stirring temperature is 22 deg.C, stirring time is 40min, and stirring speed is 60rpm) to obtain vaginal pH regulator D2;
wherein the vaginal pH regulator D2 contains 4.89 wt% of glucose, 2.6 wt% of urea, 4 wt% of potassium hydroxide, 40 wt% of carbomer, 5 wt% of glycerol, 3 wt% of lactic acid, 2 wt% of tartaric acid, 1.81 wt% of preservative and 36.7 wt% of water.
Comparative example 3
The preparation method comprises the following steps:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into distilled water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid and preservative (methyl p-hydroxybenzoate) into the mixed solution obtained in the step (2), and stirring (stirring temperature is 22 ℃, stirring time is 40min, and stirring speed is 60rpm) to obtain a vaginal pH regulator D3;
wherein the vaginal pH regulator D3 contains 4.89 wt% of glucose, 2.6 wt% of urea, 4 wt% of potassium hydroxide, 40 wt% of carbomer, 5 wt% of glycerol, 3 wt% of lactic acid, 5 wt% of citric acid, 1.81 wt% of preservative and 33.7 wt% of water.
Test example 1
Skin irritation test
Test subjects: selecting 50 healthy adult rabbits, dividing into 5 groups of 10 rabbits, and shaving 4 parts of the back of each rabbit by 9cm2。
The test method comprises the following steps: the vaginal pH regulators prepared in examples 1 to 5 were applied to the shaved area of 10 rabbits every 8 hours, and the applied area was observed for 8 hours, 16 hours, 24 hours, 48 hours, and 72 hours.
And (3) test results: no local irritation reactions such as skin erythema, edema and the like appear in 50 tested rabbits, which shows that the vagina pH regulator prepared by the invention is safe and non-irritant and has no adverse reaction.
Test example 2
Test for pH-adjusting ability
100mL of the vaginal pH adjustor in each of examples 1 to 5 and comparative examples 1 to 3 was taken, the pH value thereof was measured, 5mL of a phosphate solution having a pH of 5.5 was added thereto each time several times, and the pH of the solution after each addition was measured each time.
TABLE 1
As can be seen from the results in Table 1, the pH regulator for vagina prepared in the examples can effectively maintain stable pH, which shows that the pH regulator for vagina of the invention can better maintain the pH within the normal physiological range.
Test example 3
Test for pH-adjusting ability
100mL of the vaginal pH adjustor in each of examples 1 to 5 and comparative examples 1 to 3 was taken, the pH value thereof was measured, 5mL of a phosphate solution having a pH of 6.5 was added thereto each time several times, and the pH of the solution after each addition was measured.
TABLE 2
As can be seen from the results in Table 2, the pH regulator for vagina prepared in the examples can effectively maintain the pH to be stable, which shows that the pH regulator for vagina of the invention can better maintain the pH to be in a normal physiological range even under the condition of weak pathological alkaline environment.
Test example 4
Test for pH-adjusting ability
100mL of the vaginal pH adjustor in each of examples 1 to 5 and comparative examples 1 to 3 was taken, the pH value thereof was measured, 5mL of a phosphate solution having a pH of 7.8 was added thereto each time several times, and the pH of the solution after each addition was measured.
TABLE 3
As can be seen from the results in Table 3, the pH regulator for vagina prepared in the examples can effectively maintain stable pH, which indicates that the pH regulator for vagina of the present invention can better maintain the pH within the normal physiological range.
The preferred embodiments of the present invention have been described above in detail, but the present invention is not limited thereto. Within the scope of the technical idea of the invention, many simple modifications can be made to the technical solution of the invention, including combinations of various technical features in any other suitable way, and these simple modifications and combinations should also be regarded as the disclosure of the invention, and all fall within the scope of the invention.
Claims (10)
1. A vaginal pH regulator is characterized by comprising glucose, urea, potassium hydroxide, carbomer, glycerol, lactic acid, citric acid, tartaric acid, a preservative and water.
2. The vaginal pH regulator according to claim 1, wherein the vaginal pH regulator comprises 4 to 6% by weight of glucose, 2 to 3% by weight of urea, 2 to 5% by weight of potassium hydroxide, 34 to 42% by weight of carbomer, 2.5 to 6.5% by weight of glycerin, 2.5 to 4% by weight of lactic acid, 4 to 5.5% by weight of citric acid, 1.5 to 3% by weight of tartaric acid, 1.5 to 2.5% by weight of a preservative, and 30 to 40% by weight of water.
3. The vaginal pH adjustor of claim 2, wherein the vaginal pH adjustor comprises 4.5-5 wt% of glucose, 2.5-2.75 wt% of urea, 2.5-4.5 wt% of potassium hydroxide, 35-41 wt% of carbomer, 3-6.25 wt% of glycerin, 2.75-3.8 wt% of lactic acid, 4.5-5.2 wt% of citric acid, 1.75-2.3 wt% of tartaric acid, 1.75-2.25 wt% of preservative, and 31-39 wt% of water.
4. The vaginal pH adjustor of claim 1, wherein the preservative is at least one of methylparaben, sodium propylparaben, imidazolidinyl urea and sodium lactate.
5. The vaginal pH adjustor of claim 1, wherein the water is distilled water.
6. A method for preparing the vaginal pH adjustor of any one of claims 1-5, wherein the method comprises the steps of:
(1) adding glucose, urea, potassium hydroxide, carbomer and glycerol into water, and stirring to obtain a mixed solution;
(2) adding lactic acid, citric acid, tartaric acid and a preservative into the mixed solution obtained in the step (2) and stirring to obtain the vaginal pH regulator.
7. The method according to claim 6, wherein in step (1), the temperature of the stirring is 22-28 ℃.
8. The method according to claim 6 or 7, wherein in step (1), the stirring time is 30-40 min.
9. The method according to claim 8, wherein in step (1), the stirring speed is 55-65 rpm.
10. Use of the vaginal pH modifier of any one of claims 1-5 for the adjustment of vaginal pH.
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