摘要
目的建立地肤子配方颗粒质量标准。方法以地肤子皂苷Ic为对照品,采用薄层色谱法(TCL)进行定性鉴别;采用高效液相色谱法(HPLC)对地肤子配方颗粒中的地肤子皂苷Ic进行含量测定,并在此基础上建立地肤子配方颗粒的指纹图谱;对地肤子配方颗粒各项指标进行检查。结果 TLC中地肤子配方颗粒在地肤子皂苷Ic相应位置,显示相同颜色的斑点;醇溶性浸出物含量27.44%～30.95%;地肤子皂苷Ic在18.768 2～600.582 4 mg·L-1呈良好的线性关系(R2=0.999 5),平均回收率102.04%(RSD为0.98%,n=9),指纹图谱相似度系数大于0.95;地肤子配方颗粒水分、溶化性、粒度等均达到2015年版《中华人民共和国药典》颗粒剂的要求。结论该实验建立的定性及定量方法简单可行,重复性好,准确度高,可用于地肤子配方颗粒的质量控制。
Objective To establish the quality standards of Kochia Scoparia . Methods The marker component momordin Ic in the samples were identified by qualitative TLC. The determination of momordin Ic were conducted by HPLC, and on the basis of that, the HPLC fingerprints were established.The content of moisture, particle size, and solubility of Kochia Scoparia dispensing granules were determined. Results The TLC showed the spots developed clearly, with good resolution. The alcohol soluble extractive moisture from 10 batches of Kochia Scoparia dispensing granules were 27.44%-30.95 %. The concentration of momordin Ic showed a good linear relationship in the range of 18.768 2-600.582 4 mg·L^-1 ( R 2 =0.999 5), and the average recovery was 102.04 %, with RSD was 0.98%( n =9), the similarity coefficient of fingerprint was greater than 0.95. The moisture, particle size, and solubility were conformed according to the China Pharmacopoeia (2015) requirement. Conclusion The established methods are accurate, with strong specificity and good reproducibility, which can be used for the quality control of Kochia Scoparia dispensing granules.
作者
胡辉
翟红伟
刘源才
HU Hui;ZHAI Hongwei;LIU Yuancai(Jing Brand BIO-Medicine Co., Ltd, Huangshi 435000 , China;Jing Brand Co., Ltd,Daye 435100, China;Jingpai Research Institute, Huangshi 435000, China;Hubei Provincial Key Lab for Quality and Safety of Traditional Chinese Medicine Health Food, Daye 435100 , China)
出处
《医药导报》
CAS
北大核心
2019年第5期626-631,共6页
Herald of Medicine
基金
湖北省技术创新专项重大项目(2016ACA142)
关键词
地肤子
配方颗粒
地肤子皂苷Ic
指纹图谱
质量标准
Kochia Scoparia
Dispensing granules
Momordin Ic
HPLC fingerprints
Quality standards
