枳壳及其制剂归芎养骨合剂的质量标准探讨

Discussion on Quality Standard of Aurantii Fructus and Its Preparation Guixiong Yanggu Mixture

目的:探讨枳壳及其制剂归芎养骨合剂现行质量标准。方法:采用薄层色谱法及HPLC法,分别对归芎养骨合剂中的枳壳及药材枳壳进行定性鉴别。结果:药材及制剂现行标准中的薄层色谱鉴别均易产生假阳性结果,不能准确地对枳壳进行定性鉴别,采用HPLC法进一步验证,结果显示,制剂中未检出柚皮苷,所收集3批枳壳均不含有其指标性成分柚皮苷及新橙皮苷。结论:建议枳壳及其制剂的质量标准增加HPLC鉴别项,从而可以更加快速、准确、有效地对目前市场上植物来源品种繁多的枳壳药材、饮片及其制剂进行监管。

Objective： Discussion on two current official standards of Aurantii Fructus and its preparation Guixiong Yanggu Mixture. Methods： Qualitative identification was carried out by TLC and HPLC for Aurantii Fmctus and Guixiong Yanggu Mixture. Results： The current official qualitative methods were liable to give false positive results for Aurantii Fruetus and its preparation. Further verification with HPLC method, naringin cannot be found in Guixiong Yanggu Mixture. Also, naringin and neohesperidin were both absent in all Aurantii Fructus collected, which were the two index components of Aurantii Fructus in official standard. Conclusion： It is suggested that HPLC methord should be added into the official standard of Aurantii Fmctus and the Guixiong Yanggu Mixture, and then to evaluate and supervise the gualitative of crude herbs and its preparations of Aurantii Fructus.