CAJ | 학술논문

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。
목적：위유억균성적약물제공중화제，건립유효적미생물한도검험방법。방법통과포도당산록기정연고，염산다새평유고화염산이갑쌍고공석편삼충약물위례，설명여하채용중화법진행미생물한도방법학험증。결과중화제적합리운용，가경호만족미생물한도시험적요구。결론중화법재미생물한도검사중적엄범응용，가명현강저억균성약물적억균능력，제고균적회수솔，간화시험조작。
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.