十批脉络宁注射液的质量考察

Quality evaluation of Mailuoning Injection from 10 batches

目的:对十批脉络宁注射液进行质量考察。方法:采用高效液相色谱法测定脉络宁注射液中绿原酸的含量。色谱柱为Phenomenex C18柱(150mm×4.6mm,5μm);流动相为乙腈-0.4%磷酸溶液(13∶87);检测波长为327nm;流速为1ml/min;柱温为25℃;进样量为10μl。结果:绿原酸的回归方程为Y=595.86X+1.451(r=0.9999),绿原酸在0.025～0.250mg/ml范围内具有良好的线性关系。平均回收率为99.60%,RSD为0.78%。结论:本文建立的测定方法稳定、可行,可用于检验脉络宁注射液,作为评价该制剂的质量标准。

Objective： To evaluate the quality of Mailuoning Injection from 10 batches. Methods： HPLC method was used to determine the content of chlorogenic acid in Mailuoning Injection. The column was Phenomenex C18（150 mm ×4.6 mm, 5 μm） ; the mobile phase was acetonitrile-0.4% phosphoric acid （ 13：87） ; the detective wavelength was 327 nm ; the flow rate was 1 ml/min ;the column temperature was 25℃ ;the injection volume was 10 μl. Results： The linear range was 0.025- 0.250 mg/ml （n=6, r=0.999 9）,the average recovery was 99.60%（n=9）with RSD of 0.78%.Conclusion： This method is accurate, quick and has a good reproducibility. It can be used for the quality control of Mailuoning Injection.