参仙灵颗粒的成分鉴别及冬凌草甲素和人参皂苷Rg1的含量测定

Ingredient identification of Shenxianling granules and content determination of oridonin and ginsenoside Rg1

目的:修订提高解放军第八一医院院内制剂参仙灵颗粒的质量标准,保障在消化道肿瘤病人辅助治疗中的疗效和安全性。方法:在对参仙灵颗粒原有检测方法验证的基础上,完善了仙鹤草、乌梅、甘草、绞股蓝、人参、灵芝的薄层色谱(TLC)鉴别方法;采用HPLC法测定参仙灵颗粒中冬凌草甲素和人参皂苷Rg1的含量。结果:TLC斑点清晰,阴性对照无干扰,专属性强。参仙灵颗粒中冬凌草甲素在0.015 6~2.00μg范围内线性关系良好(r=0.999 8),平均回收率为96.0%~99.5%(RSD=1.08%,n=6)。人参皂苷Rg1在0.000 9~0.24μg范围内线性关系良好(r=0.999 6),平均回收率为99.1%~104.7%(RSD=2.62%,n=6)。结论:本方法简便,专属性强,重现性好,结果准确,可作为参仙灵颗粒的质量控制标准。

Objective： To revise and improve the quality standards of Shenxianling granules produced in No, 81 Hospital, so as to ensure the efficacy and safety of the patients with digestive tract tumor, Methods： Based on the existing detection results, thin layer chromatography （TLC） was used to improve the identification of agrimony, plum, licorice, ginseng, Ganoder ma lucidum and gynostemma in Shenxianling granules. At the same time, HPLC method was used to determine the levels of oridonin and ginsenoside Rg1, Results： The TCL spots were clear, without interference in the negative control. The calibration curve for oridonin of Shenxianling granules displayed good linearity within the range of 0. 015 6-2. 00 g （r=0. 999 8）. The average recovery rate of oridonin was 96. 0%-99.5% （RSD= 1.08%, n= 6%）. The calibration curve for ginsenoside Rg1 of Shenxianling granules also displayed good linearity （r=0, 999 6） within the range of 0. 000 9-0, 24μg, with an average recovery rate of 99. 1 %-104.7% （RSD= 2. 62%, n = 6 %）, Conclusion： This method is simple, specific, reproducible and accurate, therefore, it could be used as the control standards for the quality of Shenxianling granules.