马晓璇,李汶,温玉莹
MA Xiao-xuan, LI Wen, WEN Yu-ying(Shantou Institute for drug control

• 1:汕头市药品检验所

摘要(Abstract)：

目的建立硫软膏和复方硫磺洗剂2种含硫磺的医院制剂的微生物限度检查方法。方法采用常规法、培养基稀释法、离心沉淀结合培养基稀释法及薄膜过滤法对样品进行微生物限度检查,根据对5种标准试验菌株的回收率进行数理统计。结果硫软膏细菌计数采用一次离心沉淀方法结合培养基稀释法,霉菌、酵母菌计数及控制菌检查采用一次离心沉淀方法;复方硫磺洗剂为混悬制剂,采用一次离心沉淀法结合薄膜过滤法可有效去除抑菌成分。结论经验证的上述微生物限度检查方法,可以客观地反映硫软膏、复方硫磺洗剂中微生物的污染状况,可行性强,能达到检测目的。
Objective To establish a valid microbacterial limit test for sulfur compounds. Methods Different methods: traditional method, diluted medium, and combination of diluted medium and membrane filtration, were adopted to test the microbaterial limit on the selected samples. Data were then collected and analyzed based on 5 groups of bacteria with positive reaction. Results Diluted medium by centrifugating once was most effective in bacteria control in sulfur ointment; centrifugating once could be used in the calculation and control of mould and microzyme; recovery of membrane filtration by centrifugating once could be used to effectively eliminate bacteriostasis in the sulfur compound lotion. Conclusion In conclusion, the above tests can objectively reflect the pollution level of microbateria found in sulfur ointment and sulfur compound lotion. It is proved to be a feasible and valid test.

关键词(KeyWords)： 硫软膏;复方硫磺洗剂;微生物限度检查;方法验证
sulfur ointment; sulfur compound lotion; microbacterial limit test; validation of the methodology. Assaying determination of Tinidazole Buccal Tablets by HPLC

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作者(Author): 马晓璇,李汶,温玉莹
MA Xiao-xuan, LI Wen, WEN Yu-ying(Shantou Institute for drug control

参考文献(References)：

• 1国家药典委员会.中华人民共和国药典.2005年版二部.北京:化学工业出版社,2005,附录XIJ93-101.