龟鹿二胶丸微生物限度检查方法学验证

Verification of Methodology on Microorganism Limitation Test of Guilu Erjiao Pills

目的：探讨龟鹿二胶丸微生物限度检查方法的准确性和可靠性，并对该品种的微生物限度检查方法进行方法学验证。方法：采用菌液组、供试品对照组、试验组、稀释剂对照组进行3次独立平行试验，分别计算各试验菌每次试验的回收率。结果：各试验菌的回收率均高于70％，稀释剂对5种试验菌的回收率均高于70％。结论：采用常规法即可进行本品的微生物限度检查。

Aim：To investigate the accuracy and reliability of the method for microorganism limitation test of Guilu Erjiao Pill and verify the methodology for the test. Methods： Parallel tests were independently carried out to the vaccine group, sample control group, testing group and solvent control group for three times, recovery rate for each test bacteria was calculated separately. Results ：The recovery rate of each test bacteria and was aver 70%. Conclusion： Conventional method for microorganism limitation test of the product was available.