扶正固本颗粒质量标准研究  

Study on Quality Standard of Fuzheng Guben Granules

作　　者：李学涛 王为[1,2] 符敏[2] 刘晶晶 王晓波 LI Xuetao;WANG Wei;FU Min;LIU Jingjing;WANG Xiaobo(The 967 Hospital of the Logistic Support Force of the Chinese People's Liberation Army,Dalian 116000,Liaoning,China;Liaoning University of Traditional Chinese Medicine,Dalian 116600,Liaoning,China)

机构地区：[1]中国人民解放军联勤保障部队第九六七医院,辽宁大连116000 [2]辽宁中医药大学,辽宁大连116600

出　　处：《辽宁中医药大学学报》2019年第12期17-20,共4页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家自然基金面上项目（81874347）;辽宁省“兴辽英才计划”项目（XLYC1807132）

摘　　要：目的:建立扶正固本方颗粒剂的质量标准。方法:颗粒剂中炙甘草的薄层色谱展开剂为乙酸乙酯-甲酸-冰醋酸-水(15∶1∶1∶2),显色剂是10%硫酸乙醇溶液;黄芪的薄层色谱展开剂是三氯甲烷-甲醇-水(13∶7∶2)的下层溶液,显色剂也是10%硫酸乙醇溶液;五味子的薄层色谱以环己烷-乙酸乙酯(3∶2)为展开剂,应用硅胶GF254薄层板,检视条件是紫外光灯254 nm。实验采用C18条件色谱柱,乙腈-水(29∶71)的流动相,和203 nm的检测波长,对扶正固本颗粒人参皂苷Rb1的量进行测定。结果:实验所建立的TLC方法,各斑点清晰,Rf值较适中,且分离度良好。以人参皂苷Rb1为指标成分进行方法学研究,其对应的线性范围分别0.89~4.45μg,平均加样回收率为96.59%,方法的稳定性与重复性良好。结论:该方法准确灵敏,易于操作,专属性强,重复性好,可用于扶正固本方的质量控制。Objective:To establish quantitative methods for the quality of Fuzheng Guben granules. Method:Thin layer chromatography identification conditions of Licorice was Ethyl acetate-formic acid-glacial acetic acid-water(15:1:1:2)as developing agent,10% sulfuric acid ethanol solution as chromogenic reagent;TLC identification conditions of Astragalus was a lower solution of chloroformmethanol-water(13:7:2)as developing solvent;a 10% sulfuric acid ethanol solution as chromogenic reagent;TLC identification conditions of schisandrae chinensis was cyclohexane-ethyl acetate(3:2)as a developing solvent,a thin layer of silica gel GF254 was applied and examined under a UV lamp(254 nm). Results:The established TLC method had clear spots,moderate Rf value and good separation. The results of methodological study of ginsenoside Rb1 showed that the linear range was 0.89~4.45 μg,the average recovery was 96.59%,and the method has good stability and repeatability. Conclusion:The method is accurate,sensitive and easy to operate which had strong specificity and good repeatability. Therefore,it could be used for the quality control of the Fuzheng Guben granules.

关 键 词：扶正固本颗粒 质量标准 薄层色谱 人参皂苷RB1 

分 类 号：R284[医药卫生—中药学]