糜蛋白酶微生物限度检查法的验证

目的：对糜蛋白酶微生物限度检查法进行验证。方法：选用适宜的稀释剂溶解糜蛋白酶作为供试液，分别用平皿法与薄膜过滤法对糜蛋白酶进行微生物限度检查法的验证。结果：两种方法的回收率均≥70%。由于薄膜过滤法的取样量是平皿法的10倍，故微生物的检出率高于平皿法。结论：薄膜过滤法适用于糜蛋白酶微生物限度检查。

Validation of microbial limit test method for chymotrypsin

Objective：To establish a method for microbial limit tests of chymotrypsin. Methods： An appropriate diluent was selected to dissolve chymotrypsin. The microbial limit were tested by both plate and iflm methods. Results：Microbial recoveries in two methods were ≥70%, which showed that no inhibition of chymotrypsin to microbial growth. Microbial detection rate was higher in the iflm method than in the plate method since the sampling volume in the iflm method was 10 times larger than that in the plate method. Conclusion：The iflm method is suitable for the microbial limit test of chymotrypsin.