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Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof

A temperature-sensitive gel and temperature-sensitive gel matrix technology, applied in the field of vaginal gel preparations, can solve the problems affecting the feasibility of the product, poor mechanical strength, short action time, etc. The effect of convenient medication

Inactive Publication Date: 2014-01-22
SAIKE SAISI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, research has found that the temperature-sensitive gel skeleton material in this technical solution is only composed of poloxamers, and there are some disadvantages in using poloxamers alone as the temperature-sensitive gel matrix, such as poor mechanical strength, low adhesion, and short action time. , which directly affects the feasibility of the product

Method used

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  • Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof
  • Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof
  • Acidic buffer temperature-sensitive gel preparation for vagina as well as preparation method and application thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0035] In the preparation method of the acid-buffered thermosensitive gel preparation for vagina, the reaction temperature in step 2) is preferably 4°C, and the reaction time is preferably 72 hours.

[0036] The sterilization method in the step 2) is preferably irradiation sterilization, and the irradiation method can be 60 For Coγ-rays or high-energy electron beams, the irradiation time is 10-40min, and the irradiation dose is 10K-70K.

[0037] The acid-buffered temperature-sensitive gel preparation for vagina prepared in step 2) can be packaged in single-dose disposable aluminum tubes, plastic tubes or plastic bottle-level vaginal injectors. The acid-buffered temperature-sensitive gel preparation for vagina of the present invention is applied to the vaginal vault of the human body by means of a vaginal injector to ensure that it can maintain the pH value of the vagina not greater than 4.5 for more than 72 hours.

[0038] The application of the acid-buffered temperature-sens...

Embodiment 1-8

[0040] Example 1-8, preparation of acid-buffered temperature-sensitive gel preparation for vagina

[0041] The formulations and preparation process parameters of Examples 1-4 (using compound poloxamers) and Comparative Example 1 vaginal acid-buffered thermosensitive gel preparations are shown in Table 1. Examples 5-8 (using single poloxamers) and The formula of comparative example 2 vaginal acid-buffered temperature-sensitive gel preparations and the preparation process parameters are as shown in Table 2:

[0042] Table 1 Example 1-4 and Comparative Example 1 The formula and preparation process parameters of the acid-buffered thermosensitive gel preparation for vagina

[0043]

[0044]

[0045] Table 2 Example 5-8 and Comparative Example 2 The formula and preparation process parameters of the acid-buffered thermosensitive gel preparation for vagina

[0046]

preparation Embodiment 1-8

[0047] The method for preparing the acid-buffered temperature-sensitive gel preparation for vagina of Example 1-8 comprises the following steps:

[0048] 1) Measure the temperature-sensitive gel matrix and acid buffer system according to the formula shown in Table 1 or Table 2;

[0049] 2) Add the temperature-sensitive gel matrix into the acid buffer system and stir evenly, place it at 2-4°C (preferably 4°C) for 24-72h (preferably 72h), fully swell and defoam, then irradiate and sterilize. by 60 Coγ-rays or high-energy electron beam rays, the irradiation time is 10-40min, and the irradiation dose is 10K-70K, to obtain acid-buffered temperature-sensitive gel preparations for vagina, using single-dose disposable aluminum tubes, plastic tubes or plastic bottles. Vaginal injectors are packaged.

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Abstract

The invention discloses an acidic buffer temperature-sensitive gel preparation for vagina as well as a preparation method and application thereof. A material formula of the gel preparation comprises the following components in percent by weight: a temperature-sensitive gel substrate consisting of 17wt%-35wt% of poloxamer and 0.04wt%-0.3wt% of auxiliary materials, and 64.8wt%-82.85wt% of an acidic buffer system. A test proves that the acidic buffer temperature-sensitive gel preparation disclosed by the invention has a certain buffer capacity, and the pH value of 3.5-4.5, can be used for correcting and keeping a normal acid environment of the female vagina and has in-vivo retention time not less than 3 days, so that dosing frequency can be reduced, patient compliance is improved, a gelatinization temperature is moderate, and the gel preparation is good in mobility before entering into the body and quickly changed into solid after entering into the body. The acidic buffer temperature-sensitive gel preparation is used for adjusting pH value of the female vagina, and convenient and sanitary to medicate.

Description

technical field [0001] The invention relates to a gel preparation for vagina, in particular to an acid-buffered temperature-sensitive gel preparation for vagina, a preparation method thereof and its application in regulating the pH value of female vagina. Background technique [0002] In women of childbearing age, under the action of estrogen, the vaginal mucosa periodically sheds glycogen, and the normal flora decomposes these glycogen to produce acidic components such as lactic acid, making the environment in the vaginal canal an acidic state (pH3.5-4.5). The acidic environment of the vagina is conducive to maintaining the status of dominant flora such as Lactobacillus, and can inhibit the growth of various pathogenic microorganisms. And when the vaginal microecological flora is in a state of imbalance, some endogenous flora or conditional pathogenic microorganisms and other anaerobic flora significantly increase, when a certain type of flora (or trichomonas, mycoplasma) i...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/32A61K47/34A61K47/36A61K47/38A61P15/02A61P31/02
Inventor 张雯雯白云峰马爱青王聪聪
Owner SAIKE SAISI BIOTECH CO LTD
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