多维合剂的微生物限度检查方法验证

Validation of Microbial Limit Tests of Mixture Polyvitamin

目的建立多维合剂的微生物限度检查方法。方法按《中华人民共和国药典》2010年版的规定,用常规法测定多维合剂对5种验证菌株的回收率,并对控制菌检查法进行验证。结果多维合剂无明显抑菌作用。结论多维合剂可直接取样并采用常规法进行微生物限度检查。

Objective To establish a method of microbial limit test for Mixture Polyvitamin. Methods According to the People＇ s. Republic of China pharmacopoeia 2010 edition, the recovery rates of 5 tested strains treated by Mixture Polyvitamin were determined by common method. The test method of the control bacteria was verified. Results Mixture Polyvitamin had no obvious bacteriostatic effect. Conclusion The common method of the microbial limit tests may be used for Mixture Polyvitamin by direct sampling.