阿托品眼膏微生物限度检查方法的验证

Validation of microbial limit test for atropine eye ointment

目的对阿托品眼膏的微生物限度检查进行方法验证。方法在阿托品眼膏中加入5种阳性对照菌,测定其回收率,验证常规法测定阿托品眼膏中菌数方法的可靠性。结果各试验组阳性对照菌的回收率和稀释剂对照组的回收率均达到70%以上。结论对阿托品眼膏的微生物限度检查可按常规法进行。

Objective To verify the microbial limit test for atropine eye ointment. Methods 5 bacterial liquids as positive controls were respectively added into atropine eye ointment and the relative recovery rates were determined. Results The recovery rates of each positive control and diluent control were higher than 70%. Conclusion The microbial limit test of atropine eye ointment could be investigated by conventional method.