低分子肝素钙注射液的动态浊度法检测研究

Study on Kinetic Turbidimetric Assay of Low Molecular Weight Heparins Calcium Injection

目的:建立低分子肝素钙注射液细菌内毒素定量测定方法,控制药品质量。方法:采用动态浊度法,对低分子肝素钙注射稀释液进行干扰预实验、干扰实验定量检测。结果与结论:低分子肝素钙注射液在32倍稀释时无干扰作用。因此用动态浊度法定量检查低分子肝素钙注射液细菌内毒素的含量,结果准确,在实际应用中完全可行。

The analytical method for quantita tive detection of the bacterial endoterial in Low Molecular Weight Heparins Calcium Injection was established. The kinetic turbidimetric assay was used for dilutions of Low Molecular Weight Heparins Calcium Injection. No interference action was found in the 32 -- fold dilution. Quantitative detection of bacterial endotoxin in Low Molecular Weight Heparins Calcium Injection by kinetic turbidimetric assay is entirely feasible in practice.