【摘要】 目的:考查现时零售药店所使用的清肺抑火片的质量情况,以完善其质量控制方法.方法:对5个厂家8批次样品及3批自制产品进行了研究,采用高效液相色谱法测定不同厂家清肺抑火片中黄芩苷的含量,色谱柱为Ul-trasphereTM-ODS柱(4.6mm×250mm,5μm),流动相为甲醇-0.4%磷酸溶液(32:68),流速为1.0mL/min,检测波长为282nm.结果:黄芩苷在0.1～2.0μg范围内与峰面积积分值呈良好的线性关系(r=0.999 9),平均回收率为101.38%,RSD为2.80%(n=9).不同厂家清肺抑火片中黄芩苷的含量差异较大.结论:结合中国药典黄芩含量测定项下规定和黄芩苷的实际转移率情况,建议本品每片含黄芩以黄芩苷计应不得少于5.70mg.更多还原

【Abstract】 Objective: To improve the method of quality control by determining baicalin content in Qingfei Yihuo tablets from different retail pharmacies.Methods: HPLC was performed to determine the baicalin content of 3 batches of self-made Qingfei Yihuo tablets and 8 batches of Qingfei Yihuo tablets from 5 different manufacturers,using an UltrasphereTM-ODS column(4.6 mm×250 mm,5 μm).The mobile phase consisted of methanol and 0.4 % phosphoric acid solution(32∶68) at a detection wavelength of 282 nm and a velocity of 1.0 mL/min.Results: The linear range of baicalin was 0.1~2.0 μg(r=0.999 9),and the average recovery was 101.38 % with an RSD of 2.80 %(n=9).The contents of baicalin in Qingfei Yihuo tablets from different pharmaceutical factories were in considerable disparity.Conclusion: According to Chinese Pharmacopoeia(2010 edition) of the content determination of Radix Scutellariae items and the actual transfer rate of baicalin,it is recommended that the content of Radix Scutellariae in each Qingfei Yihuo tablet should be no less than 5.70 mg of baicalin.更多还原