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Acid vagina lubricant and preparation method and use thereof

A technology of lubricant and acid buffer, applied in the field of pharmaceutical excipients gel, can solve the problems of difficulty in accurate loading and difficulty in production, etc.

Inactive Publication Date: 2010-12-08
SHANGHAI INST OF PLANNED PARENTHOOD RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, all lubricants currently on the market remain gelatinous at room temperature, and their viscosity is between 60-85Pa·s. It is difficult to accurately fill the amount during production, and GMP large-scale production is extremely difficult.

Method used

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  • Acid vagina lubricant and preparation method and use thereof
  • Acid vagina lubricant and preparation method and use thereof
  • Acid vagina lubricant and preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Preparation of Vaginal Acid Gel I

[0071] Put 19.5 kilograms of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) and 8 kilograms of HPMC (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) into a stirrer, add 60 L of pure water, and stir at 20-22 ° C Evenly, stir at 100-300rpm to make it dissolve completely. The process is about 3-4 hours. After finishing, add 35L glycerin (purchased from Shanghai Yangjia Economic and Trade Development Co., Ltd.) and 3L 0.6M acetate buffer, stir for 1-2 hours, let stand overnight, centrifuge for 15min, remove air bubbles, and finally add pure water to 100L, measure the pH and viscosity of the gel.

[0072] Results: pH is 3.5, measured by NDJ-1 rotary viscometer (purchased from Shanghai Hengping Instrument Factory), the viscosity at 22°C is 20-32Pa·s, and the viscosity at 30°C is 36-53Pa·s.

Embodiment 2

[0074] Preparation of Vaginal Acid Gel II

[0075] Put 18.5 kg of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) and 10 kg of HPC (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) into a stirrer, add 60L of pure water, and stir well at 20-22°C , Stirring speed 100-300rpm, make it dissolve completely, the process is about 3-4 hours, after finishing, add 25L aloe vera (purchased from Shanghai Yangjia Economic and Trade Development Co., Ltd.), and 5L 0.4M phosphate buffer, stir for 1-2 hours , let stand overnight, centrifuge for 15min to remove air bubbles, and finally add pure water to 100L. Measure the pH and viscosity of the gel.

[0076] Results: pH is 3.7, measured by NDJ-1 rotary viscometer (purchased from Shanghai Hengping Instrument Factory), the viscosity at 20°C is 18-31Pa·s, and the viscosity at 31°C is 49-62Pa·s.

Embodiment 3

[0078] Preparation of Vaginal Acid Gel III

[0079] 20 kilograms of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) and 10 kilograms of sodium hydroxymethylcellulose (CMC-Na) (purchased from Shanghai Changwei Pharmaceutical Excipient Technology Co., Ltd.) were placed in the stirrer, and 60L of Pure water, stir well at 20-22°C, stirring speed 100-300rpm, make it completely dissolved, the process is about 3-4 hours, after that, add 25L glycerin (purchased from Shanghai Yangjia Economic and Trade Development Co., Ltd.) and 6L 0.2M Acetate buffer solution, stirred for 1-2 hours, let stand overnight, centrifuged for 15 minutes, removed air bubbles, and finally added pure water to 100L. Measure the pH and viscosity of the gel.

[0080] Results: pH is 4.2, measured by NDJ-1 rotary viscometer (purchased from Shanghai Hengping Instrument Factory), the viscosity at 21°C is 20-35Pa·s, and the viscosity at 32°C is 41-58Pa·s.

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Abstract

The invention discloses an acid vagina lubricant and a preparation method and use thereof. Based on the total weight of the lubricant, the acid vagina lubricant comprises the following components in percentage by weight: (a) 15 to 30 percent of substrate excipient, (b) 5 to 15 percent of viscous agent, (c) 20 to 40 percent of wetting agent and (d) 1 to 7 percent of acid buffer, wherein the substrate excipient is selected from polyoxyethylene polyoxypropylene polymer, carbomer, alginic acid or chitosan; the viscous agent is selected from xanthan gum, hydroxy propyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC) and sodium carboxymethylcellulose (CMC-Na); the wetting agent is selected from asparagus, glycerin, polysorbate, polyethylene glycol, propylene glycol or triacetin; and the acid buffer is selected from an acetic acid buffer pair, a boric acid buffer pair, a carbonic acid buffer pair, a phosphoric acid buffer pair or a citric acid buffer pair; and the acid vagina lubricant has the properties that: pH is between 3.0 and 4.5; and the lubricant is in liquid state at the temperature of less than or equal to 25 DEG C and in gel state at the temperature of more than or equal to 30 DEG C.

Description

technical field [0001] The invention relates to the field of reproductive health and health care, in particular to a pharmaceutical excipient gel and its preparation method and application. Background technique [0002] Gel has been applied to vaginal lubricants in many countries, and there are many varieties of gel lubricants produced in batches in developed countries. The requirements for currently commercially available gel lubricants are to maintain a gelatinous state at room temperature, not to dry or liquefy, and to have a pH of about 4.5. [0003] Vaginal lubricants refer to lubricants mainly used for sexual life, suitable for vaginal dryness caused by endocrine changes, menopause, gynecological surgery or mental factors, and also suitable for lubrication of vaginal dilators during gynecological examinations. Female vaginal lubrication is an important physiological manifestation at the beginning of sexual life. Insufficient vaginal lubrication is medically called sex...

Claims

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Application Information

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IPC IPC(8): A61L31/12A61L31/06A61L31/04A61L31/02
Inventor 李卫华王健吴蕴琦胡晓晴王玉柱田芳丁训诚
Owner SHANGHAI INST OF PLANNED PARENTHOOD RES
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