我院制剂的微生物限度检查方法学验证

目的:应用微生物验证试验建立我院制剂的微生物限度检查方法。方法:按照药典方法对我院自制制剂进行微生物验证试验,并对其结果进行探讨。结果:大多数我院制剂可以用常规方法进行微生物检查,但对于有部分抑菌作用的制剂,我们采取了不同的方法进行验证,确立了微生物试验的方法。结论:由于制剂中所含有的成分不同,其抑菌作用也不相同,为了真实反映制剂的微生物情况,保证微生物检验方法的可靠性,必须对制剂进行微生物试验方法学验证。

Valitation Method for Microbial Limit Test of Drugs

Objective:To establish the method of microbial limit test of the drugs,by the valitation method for microbial limit test.Method:According to the method described in the Pharmacapeia of China 2005.the valitation test was held on the hospital’ s preparations,and the results were discussed.Results:Most of the preparations could do the microbial limit test in a normal way,but some preparations with bacteriostasis sould take other methods to establish the microbial limit test.Conclusion:It is necessary to establish a valitation method for microbial limit test of the preparations to reflact the real microbial situation,because the bacreriostasis of the preparation is different with the compositions.