陈香露白露片微生物限度检查方式验证研究
【摘要】 目的：成立陈香露白露片微生物限度检查方式。方式：依照该样品的微生物限度标准，按《中国药典》2005年版一部附录微生物限度检查法的验证实验指导原那么，用委托厂家3个批号的陈香露白露片进行验证实验，以考察确信陈香露白露片微生物限度的检查方式。第一用常规法进行预实验，初步考察该样品对实验菌检测的阻碍，然后依照预实验结果，用离心沉淀集菌法进行再实验。结果：常规法实验时，大肠埃希菌、白色念珠菌的回收率均大于70%，而金黄色葡萄球菌、枯草芽孢杆菌的回收率小于70%，操纵菌检查检出实验菌。采纳离心沉淀集菌法实验时，能够有效排除抑菌作用，使金黄色葡萄球菌、枯草芽孢杆菌的回收率大于70%。结论：采纳离心沉淀集菌法能够有效排除抑菌作用，简便、准确。
【关键词】 微生物限度检查 验证实验 离心沉淀集菌法
Validation of Microbial Limit Test for Chenxianglubailu Tablets
YIN Chun
（The Institute of Food and Drug Control, Yunnan Chuxiong 675000, China; Yunnan Longfa Pharmaceutical Limited Company,
rong, SUN Ping, XIAO Ju
li
Yunnan Chuxiong 675000, China）
［Abstract］ Objective: To establish a microbial limit test method for Chenxianglubailu tablets. Methods: The microbial limit test for Chenxianglubailu tablets was studied according to the guidance of the microbial limit standard for this product and the principle of the validation of microbiological test in “Chinese Pharmacopoeia” (2005), and tested in three batches of Chenxianglubailu tablets. The test was conducted with routine and centrifugal precipitation methods. Results: When doing routine test the rate of recovery of escherichia coli and candida albicans was over 70%, but the rate of recovery of staphylococcus aureus and bacillus subtilis was below 70%. Test organism was obtained by controlled bacteria detection test. The results showed that centrifugal precipitation test could eliminate bacteriostasis effectively. Conclusions: Centrifugal precipitation test could eliminate bacteriostasis effectively and the test was simple and accurate.
［Key words］ Microbial limit test; Verification test; Centrifugal precipitation methods
陈香露白露片是一复方中成药制剂，由川木香、大黄、石菖蒲、陈皮、甘草、次硝酸铋、氧化镁、碳酸氢钠组成，用于胃溃疡、糜烂性胃炎、胃酸过量等疾病［1］。《中国药典》2005年版规定，在进行药品微生物限度检查时，应付所用方式进行验证，以确认所采纳的方式适合于该药品的微生物限度检查。为此，笔者对陈香露白露片的微生物限度检查方式进行了验证实验。
1 实验材料
样品
陈香露白露片（云南龙发制药有限公司；规格：100片/瓶；批号：06040一、06040二、060403）。
稀释剂及培育基
pH 无菌氯化钠蛋白胨缓冲液、%无菌氯化钠溶液、TTC营养琼脂培育基、玫瑰红钠琼脂培育基、胆盐乳糖培育基、MUG培育基、胆盐乳糖发酵培育基、营养肉汤培育基、改良马丁培育基。
菌种
陈香露白露片微生物限度检查方式验证研究
