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Method for inspecting microbial limit of nifuratel and nysfungin vaginal soft capsules

A nifuratel nystatin, microbial limit technology, applied in the directions of biochemical equipment and methods, microbial determination/inspection, etc., to achieve the effects of simple operation process, elimination of nifuratel, and reduction of bacteriostatic properties

Inactive Publication Date: 2018-07-24
BEIJING JINCHENG TAIER PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There is no report on the microbial limit test method of Nifuratel Nystatin Vaginal Soft Capsules

Method used

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  • Method for inspecting microbial limit of nifuratel and nysfungin vaginal soft capsules
  • Method for inspecting microbial limit of nifuratel and nysfungin vaginal soft capsules
  • Method for inspecting microbial limit of nifuratel and nysfungin vaginal soft capsules

Examples

Experimental program
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Effect test

Embodiment 1

[0041] (1) Bacterial liquid preparation

[0042] ① Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis

[0043] Take fresh cultures of Pseudomonas aeruginosa, Staphylococcus aureus, and Bacillus subtilis that have been cultured at 30-35°C for 18-24 hours, and use 0.9% sterile sodium chloride solution to make 50-100 cfu per 1ml bacterial suspension.

[0044] ②Candida albicans

[0045] Take the fresh culture of Candida albicans cultured at 20-25°C for 2-3 days, and use 0.9% sterile sodium chloride solution to make a bacterial suspension containing 50-100 cfu per 1 ml.

[0046] ③Aspergillus niger

[0047] Take the fresh culture of Aspergillus niger cultured at 20-25°C for 5-7 days, add 3-5ml of 0.9% sterile sodium chloride solution containing 0.05% (ml / ml) polysorbate 80, elute the spores, and suck out Put the spore suspension into a sterile test tube, and use 0.9% sterile sodium chloride solution to make a spore suspension containing 50-100 cfu of spores per 1 m...

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Abstract

The invention belongs to the technical field of drug detection, and particularly relates to a method for inspecting microbial limit of nifuratel and nysfungin vaginal soft capsules. The method comprises the following steps: preparing bacterial liquid; preparing a test solution; measuring a total quantity of aerobic bacteria, molds and yeasts; determining that a ratio of a value of the quantity ofbacteria in a test group minus the quantity of bacteria in a test sample group to the quantity of bacteria in a bacterial liquid group is qualified in a range of 0.5-2; inspecting control bacteria. The sample treatment adopted in the invention can better eliminate nifuratel, reduces bacteriostasis, has simple operation process and low pollution probability, prevents samples from false negative during inspection, and improves medication safety of patients.

Description

technical field [0001] The invention belongs to the technical field of drug testing, and in particular relates to a microbial limit testing method for nifuratel nystatin vaginal soft capsules. Background technique [0002] Symptoms of bacterial vaginosis are increased leucorrhea with a foul smell, which worsens after sexual intercourse, and may be accompanied by genital itching or burning. However, 10% to 40% of patients do not have any symptoms and are only discovered during physical examination. [0003] Symptoms of candidal vaginitis are vulva itching, vulva and vaginal burning pain, leucorrhea increased in the form of bean curd residue, sometimes accompanied by frequent urination, dysuria, and dyspareunia, and white membranes can be seen on the inner side of the labia minora and vaginal mucosa during gynecological examination , After erasing, the red and swollen mucosal surface is exposed, and the damaged erosion surface can be seen in the acute stage. [0004] Nifurat...

Claims

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Application Information

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IPC IPC(8): C12Q1/18
CPCC12Q1/18
Inventor 翟卫东张静
Owner BEIJING JINCHENG TAIER PHARMA CO LTD
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