WO2021036294A1 - Gel tampon vaginal à base d'acide et procédé de préparation - Google Patents

Gel tampon vaginal à base d'acide et procédé de préparation Download PDF

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Publication number
WO2021036294A1
WO2021036294A1 PCT/CN2020/085844 CN2020085844W WO2021036294A1 WO 2021036294 A1 WO2021036294 A1 WO 2021036294A1 CN 2020085844 W CN2020085844 W CN 2020085844W WO 2021036294 A1 WO2021036294 A1 WO 2021036294A1
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WO
WIPO (PCT)
Prior art keywords
acid
base
vaginal
purified water
sodium
Prior art date
Application number
PCT/CN2020/085844
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English (en)
Chinese (zh)
Inventor
魏民
黄波
贾芳
刘淑敏
Original Assignee
南京天朗制药有限公司
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Publication of WO2021036294A1 publication Critical patent/WO2021036294A1/fr

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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
    • A61K31/74—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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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

Definitions

  • the invention belongs to the field of pharmacy, and specifically relates to a vaginal acid-base buffer gel and a preparation method.
  • vaginal pH of women of normal childbearing age is between 3.8 and 4.5. This acidic environment is formed because of the glycogen of the vaginal epithelial tissue and the presence of lactobacilli in the vaginal flora of women of childbearing age. Lactobacillus uses glycogen to produce lactic acid to maintain the acidic environment of the vagina while inhibiting the growth of pathogens, which is called vaginal self-purification. Lactobacillus is also called vagina guard.
  • vaginal pH can be the cause of vaginal disease, or it can be the result of disease. Maintaining a normal vaginal pH is an important guarantee for vaginal health; there are many microorganisms in the normal vagina, but due to the formation of the ecological balance between these microorganisms in the vagina, it does not cause disease. Once the ecological balance is broken or foreign pathogens invade, That is, inflammation occurs. Lactobacillus, vaginal pH, and estrogen are the most important factors in maintaining the ecological balance of the vagina;
  • buffer gels are currently used for treatment, but the existing buffer gels have the following shortcomings: 1.
  • the appearance of the product gel is soft, not shaped, cannot stay in the body for a long time, and is easy to flow out and pollute. Underwear; 2.
  • the product is not effective in use, and the auxiliary treatment effect of vaginitis is quite poor; 3.
  • Patients with damaged vaginal mucosa have a temporary irritation and pain during use; 4.
  • the price is too high; the performance of the product is relatively high Poor; the preparation process takes a long time, which easily causes the product to be easily oxidized and discolored;
  • the product prepared by the present invention can effectively adjust the vaginal environment of original inflammation, remove vaginal odor, and improve symptoms such as increased vaginal discharge and itching.
  • the purpose of the present invention is to provide a vaginal acid-base buffer gel and a preparation method.
  • the product prepared by the present invention can effectively adjust the vaginal environment of original inflammation, remove vaginal odor, and improve symptoms such as increased vaginal discharge and itching.
  • a vaginal acid-base buffering gel which is characterized in that it is composed of the following mass components: oil phase base 1% to 39%, water phase base 60% to 99%, acid base regulator 0.001% to 2% and Bacteriostatic agent 0.05% to 5%;
  • the oil phase-based component is a mixture of one or more of white petrolatum, liquid paraffin, glyceryl behenate, Span, Tween, glycerin or propylene glycol;
  • the water-based components are hydroxypropyl methyl cellulose, carbomer, sodium carboxymethyl cellulose, polycarbophil, polyethylene glycol, azone, gelatin or a mixture of one or more of purified water ;
  • the acid-base regulator is a mixture of one or more of citric acid, sodium citrate, sodium hydroxide, hydrochloric acid, triethanolamine, boric acid, borax, sodium dihydrogen phosphate or disodium hydrogen phosphate;
  • the bacteriostatic agent is a mixture of one or more of benzoic acid, sodium benzoate, benzyl alcohol, benzalkonium bromide, benzalkonium chloride, sorbic acid, potassium sorbate or parabens.
  • the formula is 39% oil phase base, 60% water phase base, 0.6% acid-base regulator and 0.4% bacteriostatic agent;
  • the oil phase base component is composed of white petrolatum, Span 60 and Tween 80;
  • the water phase base component is composed of hydroxypropyl methyl cellulose and purified water
  • Acid-base regulator is composed of sodium citrate
  • the bacteriostatic agent is composed of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate.
  • 39% of the oil phase base is composed of 36% white petrolatum, 1% Span 60 and 2% Tween 80;
  • 60% of the water phase base is composed of 1% hydroxypropyl methylcellulose, 1% polycarbophil and 58% purified water;
  • the acid-base regulator is composed of 0.6% sodium citrate
  • the antibacterial agent 0.4% is composed of 0.3% methyl p-hydroxybenzoate and 0.1% propyl p-hydroxybenzoate.
  • a method for preparing vaginal acid-base buffer gel the steps are as follows:
  • the sterilization time is 30 to 60 minutes.
  • steps S3 and S5 a homogenizer is used for mixing and stirring.
  • Vaginal acid-base buffer gel is a polymer gel product.
  • a process of polymer material swelling is required.
  • the time of polymer swelling often determines the success or failure of the finished product; in the traditional process During the preparation process, it is necessary to swell the polymer materials and other raw materials with purified water one day in advance, and then mix and reprocess the materials the next day. This greatly increases the probability of contamination of the sample and also causes oxidation reaction between the gel and the stainless steel container.
  • polycarbophil is added to the traditional formula, and the molecular chain of polycarbophil has many hydroxyl groups, which endows the gel product with excellent acid-base buffering capacity and unique bioadhesiveness, which can promote activity
  • the ingredients are transported to various mucosal surfaces and pressed onto the damaged mucosal surface with small wounds in the form of spherical molecules, which has the effect of relieving pain and hemostasis; and polycarbophil has significant water absorption and water retention, and can absorb its own weight of 600 It swells but does not dissolve, forming a hydrogel with high water content.
  • This can solve the problem of the formation of the vaginal acid-base buffer gel.
  • the gel can fit the vaginal mucosa 100% in an all-round way, is not easy to undercut, prolongs the time the product stays in the body, and enhances the product's auxiliary treatment effect.
  • a vaginal acid-base buffer gel comprising the following quality components: 19% oil phase base is composed of 16% white petrolatum, 1% Span 60 and 2% Tween 80;
  • 80% of the aqueous phase is composed of 1% carbomer, 1% polycarbophil, and 78% purified water;
  • Acid-base regulator is composed of 0.6% sodium hydroxide
  • the bacteriostatic agent consists of 0.4% benzalkonium bromide.
  • vaginal acid-base buffer gel The preparation method of a vaginal acid-base buffer gel is as follows:
  • a vaginal acid-base buffer gel including the following quality components: 39% of the oil phase base is composed of 36% white petrolatum, 1% Span 60 and 2% Tween 80;
  • 60% of the water phase base is composed of 1% hydroxypropyl methylcellulose, 1% polycarbophil, and 58% purified water;
  • Acid-base regulator is composed of 0.6% sodium citrate
  • the antibacterial agent 0.4% is composed of 0.3% methyl p-hydroxybenzoate and 0.1% propyl p-hydroxybenzoate.
  • a preparation method of vaginal acid-base buffer gel is as follows:
  • vaginal acid-base buffer gel including the following mass components: oil phase base 29% composed of white petrolatum 26%, 1% Span 60 and 2% Tween 80 composition;
  • 70% of the water phase base is composed of 1% carbomer, 1% polycarbophil, and 68% purified water;
  • the acid-base regulator 0.6% is composed of 0.3% sodium citrate and 0.3% sodium hydroxide
  • the antibacterial agent 0.4% consists of benzalkonium chloride.
  • vaginal acid-base buffer gel In the setting of the pH value of the vaginal acid-base buffer gel, attention should be paid to establishing the micro-balance of the vaginal environment.
  • the setting of pH value needs to break the conventional neutrality, and choose a pH value (4.0 to 5.5) that is neutral and acidic, so that the gel can effectively regulate the vaginal environment of the original inflammation, remove vaginal odor, and improve Symptoms such as increased vaginal discharge and itching;
  • the A1, A2, and A3 groups use the original prescription product vaginal pH buffer gel according to the instructions;
  • the B1, B2 and B3 groups use the formulas of Example 1, Example 2, and Example 3 respectively according to the instructions.
  • the vagina pH buffering gel, the corresponding drugs are used continuously, and once a day, 14 days after the drug, the statistics are as follows:

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un gel tampon vaginal à base d'acide et un procédé de préparation, le gel étant constitué des composants suivants en masse : 1 % à 39 % d'une base en phase huileuse, 60 % à 99 % d'une base en phase aqueuse, 0,001 % à 2 % d'un régulateur de pH et 0,05 % à 5 % d'un agent bactériostatique, la base en phase huileuse étant du pétrolatum blanc, de la paraffine liquide, du béhénate de glycéryle, du Span, du Tween, du glycérol ou du propylène glycol ; la base en phase aqueuse étant de l'hydroxypropylméthylcellulose, un carbomère, de la carboxyméthylcellulose sodique, du polycarbophile, du polyéthylène glycol, de l'azone, de la gélatine ou de l'eau purifiée ; le régulateur de pH étant de l'acide citrique, du citrate de sodium, de l'hydroxyde de sodium, de l'acide chlorhydrique, de la triéthanolamine, de l'acide borique, du borax, du dihydrogénophosphate de sodium ou de l'hydrogénophosphate disodique ; et l'agent bactériostatique étant de l'acide benzoïque, du benzoate de sodium, de l'alcool benzylique, du bromure de benzalkonium, du chlorure de benzalkonium, de l'acide sorbique, du sorbate de potassium ou de la nipagine. Le produit préparé peut réguler efficacement l'environnement vaginal d'origine d'une inflammation, éliminer l'odeur vaginale et soulager des symptômes tels que l'augmentation des sécrétions vaginales ou des démangeaisons.
PCT/CN2020/085844 2019-08-28 2020-04-21 Gel tampon vaginal à base d'acide et procédé de préparation WO2021036294A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910803584.9A CN110575431B (zh) 2019-08-28 2019-08-28 一种阴道酸碱缓冲凝胶及制备方法
CN201910803584.9 2019-08-28

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WO (1) WO2021036294A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110575431B (zh) * 2019-08-28 2021-08-03 南京天朗制药有限公司 一种阴道酸碱缓冲凝胶及制备方法
CN110882211A (zh) * 2019-12-31 2020-03-17 深圳市瀚德标检生物工程有限公司 一种羟苯酯类凝胶剂及其制备方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050276836A1 (en) * 1997-06-11 2005-12-15 Michelle Wilson Coated vaginal devices for vaginal delivery of therapeutically effective and/or health-promoting agents
CN102170860A (zh) * 2008-08-14 2011-08-31 Incrementha医药研发创新有限公司 粘膜粘附组合物和其用途
CN102688182A (zh) * 2012-06-04 2012-09-26 王洪明 一种阴道pH值缓冲抗菌凝胶及其制备方法
CN106075446A (zh) * 2016-06-24 2016-11-09 青岛中腾生物技术有限公司 一种缓释妇科凝胶及其制备方法
CN108498876A (zh) * 2018-05-06 2018-09-07 李志军 抑菌润滑凝胶
CN108853004A (zh) * 2018-07-24 2018-11-23 株洲千金药业股份有限公司 一种制备甲硝唑阴道凝胶的方法
CN110269835A (zh) * 2019-08-05 2019-09-24 江苏开源康达医疗器械有限公司 一种卡波姆妇科抑菌修复性凝胶及其制备方法
CN110575431A (zh) * 2019-08-28 2019-12-17 南京天朗制药有限公司 一种阴道酸碱缓冲凝胶及制备方法

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050276836A1 (en) * 1997-06-11 2005-12-15 Michelle Wilson Coated vaginal devices for vaginal delivery of therapeutically effective and/or health-promoting agents
CN102170860A (zh) * 2008-08-14 2011-08-31 Incrementha医药研发创新有限公司 粘膜粘附组合物和其用途
CN102688182A (zh) * 2012-06-04 2012-09-26 王洪明 一种阴道pH值缓冲抗菌凝胶及其制备方法
CN106075446A (zh) * 2016-06-24 2016-11-09 青岛中腾生物技术有限公司 一种缓释妇科凝胶及其制备方法
CN108498876A (zh) * 2018-05-06 2018-09-07 李志军 抑菌润滑凝胶
CN108853004A (zh) * 2018-07-24 2018-11-23 株洲千金药业股份有限公司 一种制备甲硝唑阴道凝胶的方法
CN110269835A (zh) * 2019-08-05 2019-09-24 江苏开源康达医疗器械有限公司 一种卡波姆妇科抑菌修复性凝胶及其制备方法
CN110575431A (zh) * 2019-08-28 2019-12-17 南京天朗制药有限公司 一种阴道酸碱缓冲凝胶及制备方法

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CN110575431B (zh) 2021-08-03

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