双黄平喘颗粒中的成分鉴别及含量测定研究

Ingredient Identification and Content Determination in Shuanghuang Pingchuan Granules

目的探索建立双黄平喘颗粒中矮地茶、黄芩、淫羊藿、女贞子的薄层鉴别,岩白菜素及盐酸麻黄碱等的含量测定方法,为制订双黄平喘颗粒的质量标准提供参考。方法矮地茶、黄芩等的鉴别采用薄层色谱法,盐酸麻黄碱、伪麻黄碱、岩白菜素的含量测定采用高效液相色谱法(HPLC)。结果所用的薄层方法鉴别矮地茶、黄芩、淫羊藿、女贞子,在与对照品色谱相应的位置上,显相同颜色的荧光斑,阴性对照在对应位置无此斑点。含量测定中盐酸麻黄碱在范围0.040 8~1.020 0μg内线性关系良好(r=0.999 8),加样回收率为99.67%;伪麻黄碱在范围0.029 4~0.560 8μg内线性关系良好(r=0.999 9),加样回收率为98.88%;岩白菜素在范围0.0564 3~1.128 6μg内线性关系良好(r=0.999 8),加样回收率为98.82%。结论该薄层鉴别方法操作简便、重现性好、专属性强,含量测定方法准确、稳定、可靠,可用作控制双黄平喘颗粒质量的方法。

Objective To discuss the thin- layer chromatographic identification of herba ardisiae japonicae,radix scutellariae,epimedium and fructus ligustri lucidi and the content determination of bergenin and ephedrine hydrochloride so as to develop the quality standard of shuangguang pingchuan granules. Methods The thin layer chromatography was used for the identification of herba ardisiae japonicae,radix scutellariae,etc. HPCL was used for the content determination of ephedrine hydrochloride,pseudoephedrine and bergenin. Results In response to the chromatography of the reference,the thin- layer chromatographic identification of herba ardisiae japonicae,radix scutellariae,epimedium and fructus ligustri lucidi showed the same color fluorescent spots and absence of spot correspondingly in the negative reference. The linear relationship of ephedrine hydrochloride was good in the range of 0. 040 8 to 1. 020 0 μg( r = 0. 999 8) and the sample recovery was 99. 67%. The linear relationship of pseudoephedrine was good in the range of 0. 029 4 to 0. 560 8μg( r = 0. 999 9) and the sample recovery was 99. 88%. The linear relationship of bergenin was good in the range of 0. 056 43 to 1. 128 6μg( r = 0. 999 8) and the sample recovery was 98. 82%. Conclusion The thin- layer chromatographic identification is sample in operation,good in reproducibility and strong in exclusivity. The content determination is accurate,stable and reliable. All of them are applicable for controlling the quality of shuanghuang pingchuan granules.