微生物比浊法测定注射用替考拉宁的效价含量

Determination of Content of Teicoplanin for Injection by Microbiological Turbidimetric Method

目的：建立比浊法测定注射用替考拉宁效价含量的方法,以用于其质量控制。方法：分别采用微生物比浊法和管碟法对注射用替考拉宁的效价进行检定,比较2种方法的效果。结果：替考拉宁线性范围为5.0~15.0 u/ml,浓度的对数与吸光度成良好的线性关系,线性方程为A=1.372-0.792 6l g C（r=0.997）,平均回收率为100.46%,RSD为0.85%。结论：比浊法和管碟法测定注射用替考拉宁效价含量的结果无显著差异。微生物比浊法灵敏、准确、可靠、重现性好,可用于注射用替考拉宁的质量控制。

OBJECTIVE： To establish a microbiological turbidimetri method for the determination of content of teicoplanin for injection,so as to control its quality. METHODS： Microbiological turbidimetri method and cup-plate method were respectively adopted to detect and compare the the potency of teicoplanin for injection,and the effects of two methods were compared. RESULTS： The calibration curve was linear with the logarithm of concentration range of5. 0-15. 0（ μ / ml） of teicoplanins,the linear equation was A = 1. 372- 0. 792 6l g C（ r = 0. 997）,the average recovery was 100. 46%,RSD was 0. 85%. CONCLUSIONS： There was no significant difference in the determination of content of teicoplanin for injection between turbidimetric method and cup-plate method. Microbiological turbidimetri method is sensitive,accurate,reliable and reproducible,suitable for quality control of teicoplanin for injection.