CAJ | 학술논문

目的：比较《中国药典》2015年版（通则公示稿）中的微生物限度检查法与《中国药典》2010年版对不同药物的检测结果。方法：以灵芝孢子红景天胶囊、小蓟炭配方颗粒两种中成药和孟鲁司特钠颗粒、双氯芬酸钠贴片两种化学药为研究对象，分别按照《中国药典》2010年版及《中国药典》2015年版（通则公示稿）中所给出的微生物限度检查法进行方法学建立和验证，并对药品中微生物的含量进行检测。结果：两种方法的方法学建立和验证过程不尽相同，但所获的检测结果一致，2015年版拟修订的微生物限度检查法比2010年版更为灵敏。结论：《中国药典》2015年版拟修订的微生物限度检查法比2010年版更为合理，更具优越性。
목적：비교《중국약전》2015년판（통칙공시고）중적미생물한도검사법여《중국약전》2010년판대불동약물적검측결과。방법：이령지포자홍경천효낭、소계탄배방과립량충중성약화맹로사특납과립、쌍록분산납첩편량충화학약위연구대상，분별안조《중국약전》2010년판급《중국약전》2015년판（통칙공시고）중소급출적미생물한도검사법진행방법학건립화험증，병대약품중미생물적함량진행검측。결과：량충방법적방법학건립화험증과정불진상동，단소획적검측결과일치，2015년판의수정적미생물한도검사법비2010년판경위령민。결론：《중국약전》2015년판의수정적미생물한도검사법비2010년판경위합리，경구우월성。
Objective:To compare the two microbial limit test methods proposed by Chinese Pharmacopoeia 2010 Edition appendix and Chinese Pharmacopoeia 2015 Edition ( general rules in public draft ) for microbes determination in various pharmaceuticals .Methods:Two Chinese patent medicines: Spores of Ganoderma LucidumRhodiola Capsules and Herba Cirsii Carbonisatus Granules , and two chemical medicines:Montelukast Sodium Granules and Diclofenac Sodium Patch , were selected as the subjects for investigation .Their microbial limit test methods were established and validated according to Chinese Pharmacopoeia 2010 Edition and 2015 Edition, respec-tively.The established methods were then applied for determination of microbes presented in the investigated pharmaceutical samples . Results:Similar detection results were obtained by using the microbial limit test methods proposed by Chinese Pharmacopoeia 2010 E-dition and 2015 Edition, although their method establishment and validation processes were slightly different .In addition, the method proposed by Chinese Pharmacopoeia 2015 Edition ( general rules in public draft ) was more sensitive than that of 2010 Edition appen-dix.Conclusion:The microbial limit test method proposed by Chinese Pharmacopoeia 2015 Edition ( general rules in public draft ) is more reasonable and superior than that proposed by Chinese Pharmacopoeia 2010 Edition appendix.