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引用本文:张雅秋,乔俊缠,孙晓琦,王来兵,渠弼.和辉胶囊的质量标准研究[J].中国现代应用药学,2019,36(10):1240-1243.
ZHANG Yaqiu,QIAO Junchan,SUN Xiaoqi,WANG Laibing,QU Bi.Study on Quality Standard for Hehui Capsule[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(10):1240-1243.
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和辉胶囊的质量标准研究
张雅秋, 乔俊缠, 孙晓琦, 王来兵, 渠弼
内蒙古医科大学药学院, 呼和浩特 010110
摘要:
目的 建立和完善和辉胶囊的质量标准。方法 利用盐酸-镁粉反应鉴定沙棘中的总黄酮;采用薄层色谱法对丹参中的丹参酮ⅡA、荜茇中的胡椒碱以及制大黄中的大黄素分别进行鉴别;使用HPLC测定制剂中丹酚酸B的含量。结果 盐酸-镁粉反应呈阳性;薄层色谱斑点清晰,阴性对照无干扰;丹酚酸B在0.2029~1.622 9 μg内呈现良好的线性关系,r=0.999 8,平均加样回收率为98.83%,RSD为1.73%。结论 建立和完善的质量标准具有简便、可行、重复性好的特点,可用于该制剂的质量控制。
关键词:  和辉胶囊  质量标准  理化鉴别  薄层色谱  高效液相色谱
DOI:10.13748/j.cnki.issn1007-7693.2019.10.014
分类号:R944.5
基金项目:
Study on Quality Standard for Hehui Capsule
ZHANG Yaqiu, QIAO Junchan, SUN Xiaoqi, WANG Laibing, QU Bi
School of Pharmacy, Inner Mongolia Medical University, Hohhot 010110, China
Abstract:
OBJECTIVE To establish and improve the quality standard for Hehui capsule. METHODS The total flavonoids in Hippophae rhamnoides were identified by hydrochloric acid-Mg reaction. The tanshinoneⅡA in Salvia miltiorrhiza Bge, the piperine in Piper longum, and the emodin in Rhubarb were identified by TLC, and the content of salvianolic acid B in the preparation was determined by HPLC. RESULTS The hydrochloric acid-Mg reaction was positive; the TLC spots were clear and the negative control had no interference. The salvianolic acid B showed a good linear relationship in the linear range of 0.202 9~1.622 9 μg, r=0.999 8, the average recovery rate was 98.83%, and RSD was 1.73%. CONCLUSION The established and improved quality standard is simple, feasible and reproducible, and can be used for the quality control of the preparation.
Key words:  Hehui capsule  quality standard  physical and chemical identification  TLC  HPLC
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