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

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

Example Embodiment

[0069] Example 1

[0070] Preparation of Vaginal Acid Gel I

[0071] Put 19.5 kg of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) and 8 kg of HPMC (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) in a mixer, add 60 L of pure water, and stir at 20-22 °C. Evenly, the stirring speed is 100-300rpm to make it completely dissolved. The process is about 3-4 hours. After completion, add 35L glycerol (purchased from Shanghai Yangjia Economic and Trade Development Co., Ltd.) and 3L 0.6M acetate buffer, and stir for 1-2 hours, left standing overnight, centrifuged for 15 min, removed air bubbles, and finally added pure water to 100 L, and measured the pH and viscosity of the gel.

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

Example Embodiment

[0073] Example 2

[0074] Preparation of Vaginal Acid Gel II

[0075] Put 18.5 kg of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) and 10 kg of HPC (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) in a mixer, add 60 L of pure water, and stir at 20-22 °C. , the stirring speed is 100-300rpm to make it completely dissolved, the process is about 3-4 hours, after the completion, 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, remove air bubbles, and finally add pure water to 100L. The pH and viscosity of the gel were determined.

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

Example Embodiment

[0077] Example 3

[0078] Preparation of Vaginal Acid Gel (Acid Gel) III

[0079] 20 kilograms of Poloxamer127 (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) and 10 kg of sodium hydroxymethylcellulose (CMC-Na) (purchased from Shanghai Changwei Pharmaceutical Excipients Technology Co., Ltd.) were placed in a mixer, and 60L of Pure water, stir evenly at 20-22 ℃, stirring speed 100-300rpm, make it completely dissolved, the process is about 3-4 hours, after completion, add 25L glycerol (purchased from Shanghai Yangjia Economic and Trade Development Co., Ltd.) and 6L 0.2M acetic acid buffer, stir for 1-2 hours, let stand overnight, centrifuge for 15 minutes, remove air bubbles, and finally add pure water to 100L. The pH and viscosity of the gel were determined.

[0080] Results: pH was 4.2, measured with NDJ-1 rotational viscometer (purchased from Shanghai Hengping Instrument Factory), the viscosity at 21°C was 20-35 Pa·s, and the viscosity at 3...

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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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