微生物法测定利福霉素钠注射液含量的方法学验证

Study on the method of microbial assays of antibiotics in Rifamycin Sodium Injection

目的对微生物法测定利福霉素钠注射液含量的方法学进行考察。方法以藤黄微球菌[MCC（B）28001]为测定菌，使用培养基Ⅱ（pH6．5—6．6），采用该微生物法二剂量管礤法测定利福霉素钠注射液的含量，并对其方法学进行建立与验证。结果抑菌圈直径（Y）对利福霉素钠溶液浓度（C）对数值的线性回归方程为Y=9．0113 logC＋20．884，r=0．9981（n=5），在0．1μ·mL^-1～1．2μ·mL^-1范围内抑菌圈直径与利福霉素钠浓度的对数值呈良好的线性关系。空白辅料对测定无任何干扰，平均回收率为100．1％，RSD为0．87％（n=9）。结论本实验为微生物法测定利福霉素钠注射液含量的方法学建立及验证提供了参考。

OBJECTIVE To study on the method of microbial assays of antibiotics in Rifamycin sodium Injection. METHOD The test organism was micrococcus luteus[MCC（B）28001] and the culture medium Ⅱ （pH6.5-6.6） .To establish and study the method of microbial assays of antibiotics in Rifamycin sodium injection. RESULTS The linear regression equation of bacteriostasis circle diameter（Y） and logarithm concentration of Rifamycin Sodium（C） was Y = 9. 0113 logC ＋ 20. 884, r = 0. 9981 （n = 5）, the linear range of the method was 0.1μ·mL^-1- 1.2μ· mL^-1, the assist materials had no interference to the assays, the recovery was 100.1% with RSD of 0. 87 % （n = 9）.CONCLUSION The results provide reference for the method of microbial assays of antibiotics in Rifamycin Sodium Injection.