现代医药卫生2025，Vol.41Issue(7)：1555-1559,5.DOI:10.3969/j.issn.1009-5519.2025.07.004
2种外用制剂微生物限度检查方法的建立
Establishment of microbial limit test methods for two kinds of external preparations
杨晓峰 1秦利芬 1李聃 1李惠英1
作者信息
- 1. 昆明市儿童医院,云南 昆明 650000
- 折叠
摘要
Abstract
Objective To establish a method for microbial limit test of two kinds of external prepara-tions(0.9%sodium chloride nasal drops and white lotion).Methods According to the 2020 edition of The Chinese Pharmacopoeia(General 9202),the applicability test of counting method and control bacteria test method was carried out for three batches of two preparations by plate method.The total count of aerobic bac-teria,molds and yeasts was analyzed by Minitab21,and the recovery rate was calculated.Results The recovery rate of each test bacteria in the applicability test of aerobic bacteria,mold and yeast counting method was 0.62-0.91.According to the conventional method,the control bacteria grew well.Conclusion The re-covery rate of the method applicability test reaches the standard range of 0.5-2.0,and the plate method can truly reflect the microbial test results of the two preparations.The test samples of 0.9%sodium chloride na-sal drops and white lotion were prepared by 1∶10 dilution method.The plate method can be applied to the daily microbial limit test of two kinds of external preparations.关键词
微生物限度检查/滴鼻剂/洗剂/平皿法/回收率Key words
Microbial limit test/Nasal drops/Lotion/Plate method/Recovery rate分类
医药卫生引用本文复制引用
杨晓峰,秦利芬,李聃,李惠英..2种外用制剂微生物限度检查方法的建立[J].现代医药卫生,2025,41(7):1555-1559,5.
