维生素E乳膏微生物限度检查方法验证

摘要

OBJECTIVE To establish a microbial limits test of Vitamin E cream and to ensure the scientificity of the test and the accuracy and reliability of the reault.METHODS The methods were validated according to Chi-nese Pharmacopoeia 2010 Edition 2 Appendix microbial limits test.RESULTS The microbial limit test methods were confirmed for Vitamin E cream.CONCLUSION The bacteria、mildew and yeast counting bacteria controlling both can be tested by using the conventional method ,which is reliable.%目的：建立维生素E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》2010年版二部附录微生物限度检查法项下方法进行方法验证。结果确认了维生素 E 乳膏的微生物限度的检查方法。结论维生素E乳膏的细菌、霉菌、酵母菌计数，控制菌检查均可采用常规法，结果可靠。