3种医院制剂微生物限度检查方法研究  

Study on microbial limit test for three kinds of hospital preparations

作　　者：方剑儒 张燕 赵翠琴 FANG Jianru;ZHANG Yan;ZHAO Cuiqin(Zhangye Institute of Quality Inspection and Testing in Gansu Province,Zhangye Gansu 734000,China)

机构地区：[1]甘肃省张掖市质量检验检测研究院,甘肃张掖734000

出　　处：《中兽医医药杂志》2023年第5期81-85,共5页Journal of Traditional Chinese Veterinary Medicine

摘　　要：根据3种医院制剂的剂型和处方特性,建立相适应的微生物限度检查方法。按照《中华人民共和国药典》(2020年版)要求,采用常规平皿计数法和增加培养基体积法进行需氧菌总数检查、霉菌和酵母菌计数,接种5种试验菌验证,分别计算各试验菌的回收比值;根据品种不同,采用常规法和增加培养基体积法进行控制菌检查。结果显示,用常规法检验,复方甘草合剂对5种菌株的回收比值均在0.5~2.0之间;佛香胶囊和紫露烧伤膏对部分菌株有抑制作用,采用增加培养基体积法可有效消除佛香胶囊和紫露烧伤膏的抑菌活性。说明复方甘草合剂可以采用常规法进行微生物计数和控制菌检查;佛香胶囊和紫露烧伤膏对部分菌株有抑菌作用,可采用增加培养基体积的方法进行微生物计数和控制菌检查。According to the formulation and prescription characteristics of three kinds of hospital preparations,a suitable microbial limit test method was established.The total number of aerobic bacteria,mould and yeast were counted by conventional plate counting method and increasing medium volume method according to the requirements of pharmacopoeia.The recovery ratio of each test strain was calculated by inoculating 5 test strains,and the positive indicator bacteria could be detected by using the conventional method and increasing the medium volume method according to the different strains.The results showed that the recovery ratios of compound Radix Glycyrrhizae mixture to 5 strains were all between 0.5 and 2.0 by routine method,while Foxiang capsule and Zilu burn ointment had inhibitory effects on some strains,the method of increasing diluent volume could effectively eliminate the bacteriostatic activity of Foxiang capsule and Zilu burn ointment.Compound Radix Glycyrrhizae mixture can be used to count microorganisms and control bacteria by routine method,Foxiang capsule and Zilu burn ointment have bacteriostatic effect on some strains,therefore,the method of increasing diluent volume can be used to count microorganisms and control bacteria.

关 键 词：医院制剂 微生物限度检查 常规法 增加培养基体积法 

分 类 号：S853.7[农业科学—临床兽医学]