Study on Improvement of Quality Standard of Yishen Jiangu Pills

CHEN Zhangong; ZHAO Xiaowei; WU Jiankun; XIA Xuezhu; MAO Kechen

doi:10.14009/j.issn.1672-2124.2021.05.002

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Study on Improvement of Quality Standard of Yishen Jiangu Pills

更新时间：2022-10-08

- Study on Improvement of Quality Standard of Yishen Jiangu Pills
- Vol. 21, Issue 5, Pages: 517-521(2021)
- 作者机构：
  
  首都医科大学附属北京中医医院药学部
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.05.002
  CLC： R286.0
- Published：2021，
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[1]陈占功,赵小伟,吴剑坤,夏雪竹,毛克臣.益肾坚骨丸质量标准提高研究[J].中国医院用药评价与分析,2021,21(05):517-521.

CHEN Zhangong, ZHAO Xiaowei, WU Jiankun, et al. Study on Improvement of Quality Standard of Yishen Jiangu Pills. [J]. 21(5):517-521(2021)
[1]陈占功,赵小伟,吴剑坤,夏雪竹,毛克臣.益肾坚骨丸质量标准提高研究[J].中国医院用药评价与分析,2021,21(05):517-521. DOI： 10.14009/j.issn.1672-2124.2021.05.002.

CHEN Zhangong, ZHAO Xiaowei, WU Jiankun, et al. Study on Improvement of Quality Standard of Yishen Jiangu Pills. [J]. 21(5):517-521(2021) DOI： 10.14009/j.issn.1672-2124.2021.05.002.

摘要

目的:提高益肾坚骨丸的质量标准。方法:对熟地黄、菟丝子、茯苓、山药和泽泻进行显微鉴别

对山茱萸、苍术和丹参进行薄层色谱鉴别

采用高效液相色谱法对制剂中的莫诺苷和马钱苷进行定量分析。结果:熟地黄、菟丝子、茯苓、山药和泽泻的显微鉴别特征明显

山茱萸、苍术和丹参的薄层鉴别色谱图斑点清晰。莫诺苷在0.368～0.828μg范围线性关系良好

r2=0.999 9（n=6）

平均回收率达97.55%

RSD=1.57%;马钱苷在0.392～0.882μg范围线性关系良好

r2=0.999 9（n=6）

平均回收率达97.29%

RSD=0.82%。结论:本方法全面、准确

有效提高了该制剂的质量控制水平。

Abstract

OBJECTIVE: To improve the quality standard of Yishen Jiangu pills. METHODS: To conduct microscopic identification on radix rehmanniae

semen cuscutae

poria

rhizoma dioscoreae and rhizoma alismatis

to preform thin-layer chromatographic identification on cornus officinalis

rhizoma atractylodis and salviae miltiorrhizae

and the high performance liquid chromatography was adopted to carry out quantitative analysis on monosidine and strychnine in the preparation. RESULTS: The characteristics of microscopic identification of radix rehmanniae

semen cuscutae

poria

rhizoma dioscoreae and rhizoma alismatis were obvious

the spots of thin-layer chromatograms of cornus officinalis

rhizoma atractylodis and salviae miltiorrhizae were clear. The morroniside showed good linearity in the range of 0. 368-0. 828 μg

with r2= 0. 999 9（ n = 6）

the average recovery was 97. 55%

and the RSD = 1. 57%;strychnine showed good linearity in the range of 0. 392-0. 882 μg

with r2= 0. 999 9（ n = 6）

the average recovery was97. 29%

and the RSD = 0. 82%. CONCLUSIONS: This method is comprehensive and accurate

which has effectively improved the quality control of this preparation.

关键词

益肾坚骨丸显微鉴别薄层色谱法高效液相色谱法

Keywords

Yishen Jiangu pillsMicroscopic identificationThin layer chromatographyHPLC

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