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Method for preparing metronidazole vaginal gel

A technology of vaginal gel and metronidazole, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of microbial contamination and unsatisfactory safety, and achieve safety High, no reduction in drug efficacy and skin permeability

Inactive Publication Date: 2018-11-23
ZHUZHOU QIANJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the existing metronidazole topical preparations are prone to microbial contamination during storage and use, and their safety is not ideal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The present embodiment provides a kind of method for preparing metronidazole vaginal gel, specifically:

[0029] (1) Dissolve 40g edetate disodium in 44g water, disperse and add 1.6kg carbomer 974P after the dissolution is complete, put the material into the vacuum homogeneous emulsifier, control the speed at 20r / min, stir for 4h, and control the temperature during this process at 40°C to obtain a gel matrix;

[0030] (2) Add sodium hydroxide to the gel matrix, adjust the pH value to about 4.0, control the rotation speed at 20r / min, and stir for 30min to obtain a blank gel;

[0031] (2) Add 64g of methyl p-hydroxybenzoate and 16g of propyl p-hydroxybenzoate into 2.4kg of propylene glycol, heat and dissolve to obtain a propylene glycol solution; take 30g of water, heat to 50°C, add the propylene glycol solution, and then add 600g of formazan Nitazole was dissolved at 50°C to obtain a mixed solution; the mixed solution was cooled to 40°C, mixed with the blank gel, added ...

Embodiment 2

[0033] The present embodiment provides a kind of method for preparing metronidazole vaginal gel, specifically:

[0034] (1) Dissolve 32g edetate disodium in 37.4g water, disperse and add 1.52kg Carbomer 974P after the dissolution is complete, put the material into the vacuum homogeneous emulsifier, control the speed at 20r / min, stir for 4h, during this process the temperature Control at 40°C to obtain a gel matrix;

[0035] (2) Add sodium hydroxide to the gel matrix, adjust the pH value to about 4.0, control the rotation speed at 20r / min, and stir for 30min to obtain a blank gel;

[0036] (2) Add 56g of methyl p-hydroxybenzoate and 16g of propyl p-hydroxybenzoate into 2.24kg of propylene glycol, heat and dissolve to obtain a propylene glycol solution; take 25.6g of water, heat it to 50°C, add the propylene glycol solution, and then add 592g Metronidazole was dissolved at 50°C to obtain a mixed solution; after the mixed solution was cooled to 40°C, mixed with the blank gel, ad...

Embodiment 3

[0038] The present embodiment provides a kind of method for preparing metronidazole vaginal gel, specifically:

[0039] (1) Take 56.2g of water to dissolve 48g of edetate disodium, and after the dissolution is complete, add 1.68kg of carbomer 974P, add the material to the vacuum homogeneous emulsifier, control the speed at 20r / min, and stir for 4h. During this process, the temperature Control at 40°C to obtain a gel matrix;

[0040] (2) Add sodium hydroxide to the gel matrix, adjust the pH value to about 4.0, control the rotation speed at 20r / min, and stir for 30min to obtain a blank gel;

[0041] (2) Add 72g methyl p-hydroxybenzoate and 16g propyl p-hydroxybenzoate to 2.4kg propylene glycol, heat and dissolve to obtain a propylene glycol solution; take 38.4g water, heat to 50°C, add the propylene glycol solution, and then add 608g Metronidazole was dissolved at 50°C to obtain a mixed solution; after the mixed solution was cooled to 40°C, mixed with the blank gel, added to a ...

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PUM

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Abstract

The invention relates to a method for preparing metronidazole vaginal gel. The method comprises the following steps that (1) edetate disodium is mixed with water, then carbomer 974P is added, the mixture is subjected to sufficient swelling and vacuum homogenous emulsification, and a gel substrate is obtained; (2) the pH value of the gel substrate is conditioned to be 4.0-4.5, and blank gel is obtained; and (3) methyl parahydroxybenzoate and propyl p-hydroxybenzoate are mixed at the mass ratio of (2 to 6) to 1 and added into propylene glycol, and a propylene glycol solution is obtained; the propylene glycol solution is mixed with water, metronidazole is added to be sufficiently dissolved, the mixture is sufficiently mixed with the blank gel, and the metronidazole vaginal gel is obtained. The method provided by the invention optimizes the preparation technology of the metronidazole vaginal gel, the adding order and the mixing mode of the raw materials, particularly carbomer 974P is adopted to replace carbomer 934P commonly applied in the prior art, the condition that the drug efficacy performance is not declined after the ingredient is replaced is ensured, and the safety is higher.

Description

technical field [0001] The invention relates to the field of treatment of gynecological diseases and related medicines, in particular to a method for preparing metronidazole vaginal gel. Background technique [0002] Bacterial vaginosis (BV) is a mixed infection caused by Gardnerella vaginalis and some anaerobic bacteria, which leads to the imbalance of microecological balance in the vagina, resulting in increased vaginal secretions, vaginal discharge with fishy smell and genital itching and burning. syndrome. Can be divided into Haemophilus vaginitis, Corynebacterium vaginitis, Anaerobic vaginitis, Gardnerella vaginitis and so on. [0003] As the most commonly used drug for bacterial vaginosis, metronidazole has a high degree of clinical acceptance; the preferred option in the "2010 Guidelines for the Treatment of Vaginitis by the US Centers for Disease Control" and the "Guidelines for the Diagnosis and Treatment of Bacterial Vaginosis (Draft)" drafted by the Chinese Medic...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/32A61K31/4164A61P15/02A61P31/04
CPCA61K9/0034A61K9/06A61K31/4164A61K47/32A61P15/02A61P31/04
Inventor 凌勇根白璐刘逆夫龚云李伏君袁莉张英帅
Owner ZHUZHOU QIANJIN PHARMA
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