双氯芬酸钠乳膏的微生物限度检查方法验证试验研究

Research on the determination of validation method for microbial limits test in Diclofenac Sodium Cream

目的:建立双氯芬酸钠乳膏的微生物限度检查方法并对其进行验证,保证微生物限度检查方法的科学性以及检验结果的正确性和可靠性。方法:采用《中国药典》2005年版一部附录微生物限度检查法项下方法进行方法验证。结果:确认了双氯芬酸钠乳膏的微生物限度检查方法。结论:用常规法检查双氯芬酸钠乳膏的细菌、霉菌和酵母菌;控制金黄色葡萄球菌采用稀释法检查、铜绿假单胞菌用常规法检查。

Objective:To establish and determinate a validate method for microbial limits test in Diclofenac Sodium Cream and ensure the scientificity of the test and the accuracy and reliability.Methods:Using Chinese Pharmacopoeia 2005 Edition 1 Appendix microbial limits test,the methods were validated.Results:The microbial limit test methods were confirmed for diclofenac sodium cream.Conclusion:It is reliable that bacteria,mold and yeast can be tested by using conventional test method for diclofenac sodium cream.Control of staphylococcus and aureus bacteria can be tested by using dilution test and pseudomonas aeruginosa can be tested by using the conventional method.