5种维药蜜膏制剂微生物限度检查法的 建立与结果分析
5种维药蜜膏制剂微生物限度检查法的 建立与结果分析
目的建立5种维药蜜膏制剂微生物限度检查方法。方法按《中国药典2015年版四部附录通则》1105、1106对5种维药蜜膏进行微生物限度检查, 并进行方法适用性试验, 通过比较回收比值确定合适的检查方法。结果需氧菌总数及霉菌及酵母菌总数计数采用1:10供试液按平皿法测定, 回收比值为0.5~2.0, 说明5种维药蜜膏无抑菌作用。结论5种维药制剂及酵母菌总数计数的方法适用性可采用1:10供试液按平皿法进行测定, 此方法符合药典要求且有效可行。
ObjectiveTo establish a microbial limit test method for 5 kinds of Uygur honey paste preparation. MethodsAccording to 1105, 1106 of the Chinese Pharmacopoeia 2015 Edition Four Appendices General Rules, the microbial limit test of 5 kinds of Uygur honey paste preparation were conducted, the method suitability test was carried out, and the appropriate inspection method was determined by comparing the recovery ratios. ResultsThe total number of aerobic bacteria and the total number of molds and yeasts were determined by the 1:10 test solution according to the plate method. The recovery ratio was 0.5~2.0, indicating that the 5 kinds of Uygur honey paste preparation were not bacteriostatic. ConclusionThe applicability of the 5 kinds of Uygur honey paste preparation and the total number of yeast counts can be determined by using the 1:10 test solution according to the plate method, which is in compliance with the requirements of the pharmacopoeia and is effective and feasible.
标题：5种维药蜜膏制剂微生物限度检查法的 建立与结果分析
英文标题：Establishment and result analysis of microbial limit test for 5 kinds ofUygur honey paste preparation
作者：
顾金花 新疆维吾尔自治区食品药品检验所
袁凤娟 新疆维吾尔自治区食品药品检验所;新疆维吾尔自治区乌鲁木齐市第一人民医院分院药剂科
张明君 新疆维吾尔自治区食品药品检验所
李海芳 新疆维吾尔自治区食品药品检验所
马建军 新疆维吾尔自治区乌鲁木齐市第一人民医院分院药剂科
中文关键词:维药蜜膏制剂,微生物限度检查法,方法验证,
英文关键词:Uygur honey paste preparation,microbial limit test,method validation,
发表日期：2018-11-12
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