CAJ | 학술논문

目的：：评价国产珍珠明目滴眼液抑菌剂效力是否符合《中国药典》2010年版要求。方法：结合2014年度国家药品抽验计划,参照《中国药典》2010年版附录《抑菌剂效力检查法指导原则》,并增加6h和24h两个检测点,对国内7家企业各1批产品进行抑菌剂效力检查。结果：细菌计数,企业e的产品对于金黄色葡萄球菌的抑菌效力为7 d菌数下降值为0.6lg,14 d菌数下降值为1.0lg；其他6个厂家的产品7 d细菌数下降值均大于1.0 lg,14 d菌数下降值均大于3.0 lg,14~28 d菌数未增加。真菌计数,7家企业的产品与初始值比较均未增加。结论：尽管国产珍珠明目滴眼液使用的抑菌剂相同,含量基本一致,但是其抑菌效力存在差异,其中1家企业生产的产品抑菌剂效力不符合《中国药典》2010年版Ⅰ类产品的判断标准,其他6个厂家的产品符合规定。
목적：：평개국산진주명목적안액억균제효력시부부합《중국약전》2010년판요구。방법：결합2014년도국가약품추험계화,삼조《중국약전》2010년판부록《억균제효력검사법지도원칙》,병증가6h화24h량개검측점,대국내7가기업각1비산품진행억균제효력검사。결과：세균계수,기업e적산품대우금황색포도구균적억균효력위7 d균수하강치위0.6lg,14 d균수하강치위1.0lg；기타6개엄가적산품7 d세균수하강치균대우1.0 lg,14 d균수하강치균대우3.0 lg,14~28 d균수미증가。진균계수,7가기업적산품여초시치비교균미증가。결론：진관국산진주명목적안액사용적억균제상동,함량기본일치,단시기억균효력존재차이,기중1가기업생산적산품억균제효력불부합《중국약전》2010년판Ⅰ류산품적판단표준,기타6개엄가적산품부합규정。
Objective:To evaluate the antimicrobial effectiveness of Zhenzhu Mingmu eye drops according to the requirements de-scribed in Chinese pharmacopoeia (2010 edition). Methods:Totally 7 batches of Zhenzhu Mingmu eye drops from 7 enterprises were evaluated. All the samples were tested according to the requirements described in Chinese pharmacopoeia, and the testing points of 6h and 24h were added. Results:As for bacteria, the reduction value of staphylococcus aureus in 7 days treated with Zhenzhu Mingmu eye drops from enterprise e was 0. 61g, and that in 14 days was 1. 01g. That in 7 days treated with the eye drops from the other enter-prises was all above 1. 01g, that in 14 days was above 3. 01g, and that in 14-28 days kept stable. As for fungi, the number was stable from the beginning with the treatment of the eye drops from the seven enterprises. Conclusion:Although the type and content of bacte-riostatic agent in domastic Zhenzhu Mingmu eye drops are the same, there is difference in the antimicrobial effectiveness of the product from different enterprise. The eye drops from one enterprise can't meet the requirements for type I product described in Chinese pharma-copoeia,and the others meet the requirements.