CAJ | 학술논문

目的：建立比较不同厂家的注射用头孢曲松钠抑菌效力的方法。方法以测定效价为反应值，按照《中国药典》2010年版（二部）附录Ⅺ A 抗生素微生物检定法中管碟法的二剂量法设计试验，对不同厂家的注射用头孢曲松钠的抑菌效力进行比较。结果对于金黄色葡萄球菌，A、B 厂样品与原研样品抑菌效果基本相同。对于大肠埃希菌，两个厂家样品的抑菌效果与原研样品基本一致，对于肺炎克雷伯菌，两个厂家样品的抑菌效果无显著性差异，原研样品抑菌效果更好。结论该方法能用于比较不同厂家的注射用头孢曲松钠的抑菌效力。
목적：건립비교불동엄가적주사용두포곡송납억균효력적방법。방법이측정효개위반응치，안조《중국약전》2010년판（이부）부록Ⅺ A 항생소미생물검정법중관설법적이제량법설계시험，대불동엄가적주사용두포곡송납적억균효력진행비교。결과대우금황색포도구균，A、B 엄양품여원연양품억균효과기본상동。대우대장애희균，량개엄가양품적억균효과여원연양품기본일치，대우폐염극뢰백균，량개엄가양품적억균효과무현저성차이，원연양품억균효과경호。결론해방법능용우비교불동엄가적주사용두포곡송납적억균효력。
Objective To establish a method for comparing the antimicrobial potency of Ceftriaxone Sodium Injection from different manufactures. Methods With the potency determined as response value,the test was designed by the two dose method of antibiotic bioassay cup - plate method in the appendix Ⅺ A of Chinese Pharmacopoeia(edition 2010,part 2),then compared the antibacterial effect of Ceftriaxone Sodium Injection from different factories. Results As to Staphylo-coccus aureus,samples of A,B factories and samples of original research had the same antibacterial effect. As to Escherichia coli,the antibacterial effect was same between the samples of different factories and samples of original research. As to Kleb-siella pneumoniae,the antibacterial effect was no difference between samples from different factories,while the effect of the original research sample was relatively stronger. Conclusion The method could be used for testing the antimicrobial poten-cy of Ceftriaxone Sodium Injection from different manufacturers.