复方红景天口服液微生物限度检查方法的验证.

Objective To establish a method of microbial limit tests for compound Hongjingtian oral liquid and to perform the validation of the method. Methods The validation on the microbial limit test method was conducted according to the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the appendix of China pharmacopoeia (２０１０ edition）. Results The recoveries were over ７０％ when culture diluting method was used for staphylococcus aureus and routine test method was used for Escherichia coli, Bacillus subtilis, Candida albicans and A spergillus niger. In the test of positive control bacteria, the growth was detected, while the negative control was no growth detected. Conclusion The microbial limit test for compound Hongjingtian oral liquid is validated in this study. The amount of staphylococcus aureus can be determined using diluted culture method ; while the amounts of Escherichia coli, Bacillus subtilis, Candida albicans, A spergillus niger can be determined by conventional method. [ABSTRACT FROM AUTHOR]