市售抗骨增生丸中淫羊藿苷含量比较及其相关问题的探讨

Comparison on the Content of Icariin in Kanggu Zengsheng Pills on Sale

目的建立HPLC法测定9个不同厂家的市售抗骨增生丸中淫羊藿苷的含量,探讨可能影响抗骨增生丸产品质量的因素。方法HPLC法测定。色谱柱为Alltima C18(5μm,250 mm×4.6 mm);流动相为乙腈-水(30∶70);检测波长270 nm;流速1.0 ml.min-1;柱温:30℃。结果淫羊藿苷色谱峰分离度良好,系统适应性试验和方法学考察结果符合《中国药典》要求,市售抗骨增生丸中淫羊藿苷的含量差异较大。结论淫羊藿药材和抗骨增生丸的制备工艺对其质量具有重大影响,建议新版《中国药典》对其进行一定的控制,切实保障临床用药的合理性和安全性。

Objective To establish an HPLC method for quantifying icariin in Kanggu Zengsheng pills on sale manufactured by 9 different enterprises and discussed the relative matters which possibly affect its quality. Methods The methanolic extract of this preparation was injected into an HPLC system for qualitative analysis of icariin. An Alhima C18 （5 μm, 250 mm× 4.6 mm） column was used with a mixture of acetonitrile water （30：70） as the mobile phase. The measuring wavelength was set at 270 nm. The flow rate was 1.0 ml · min^ -1 and the column temperature was maintained at 30℃. Results The icariin peak was base - lined separated with interference peaks. The system suitability test and method validation data meet the Chinese pharmacopoeia criterion. The disparity in icariin content in Kanggu Zengsheng pills on sale was large. Conclusion The quality of Kanggu Zengsheng pills was correlative with the quality of Herba Epimedii and the produced process Kanggu Zengsheng pills. It is suggested that the next edition of Chinese Pharmacopoeia should control its quality.