中和法在微生物限度检查中的应用

Application of Neutralization in microbial limit test

目的为有抑菌性的药物提供中和剂,建立有效的微生物限度检验方法。方法通过葡萄糖酸氯己定软膏,盐酸多塞平乳膏和盐酸二甲双胍控释片三种药物为例,说明如何采用中和法进行微生物限度方法学验证。结果中和剂的合理运用,可更好满足微生物限度试验的要求。结论中和法在微生物限度检查中的广泛应用,可明显降低抑菌性药物的抑菌能力,提高菌的回收率,简化试验操作。

Objective To provide neutralizer for neutralization of antibacterial activity of drugs and establish a simple and effective method for microbial limit test. Methods The article take Chlorhexidine Gluconate Ointment, Doxepin Hydrochloride Cream and metformin hydrochloride controlled release pellet as examples to explain neutralization for antibacterial activity of drugs for microbial limit test. Results The method of using properly neutralizer passed the microbial limit validation test of Chinese pharmacopoeia 2010 version. Conclusion Neutralization is widely used in the microbial limit ,obviously inhibiting the antibacterial activity of drugs, obviously increasing the recovery rate of microbial and simplifying operation.