Studies on Quality Standards of Suganning Capsules

LIU Yan-bo1; CHEN Ying-hong2; JIANG Rui-zhi2

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Studies on Quality Standards of Suganning Capsules

更新时间：2024-01-04

- Studies on Quality Standards of Suganning Capsules
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 13, Issue 6, Pages: 18-20(2007)
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- Published：2007
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LIU Yan-bo1, CHEN Ying-hong2, JIANG Rui-zhi2. Studies on Quality Standards of Suganning Capsules[J]. Chinese journal of experimental traditional medical formulae, 2007, 13(6): 18-20.
DOI：

LIU Yan-bo1, CHEN Ying-hong2, JIANG Rui-zhi2. Studies on Quality Standards of Suganning Capsules[J]. Chinese journal of experimental traditional medical formulae, 2007, 13(6): 18-20. DOI：

摘要

目的:完善速感宁胶囊质量标准。控制产品质量。方法:采用TLC法对制剂中大青叶进行了鉴别;大青叶的薄层色谱鉴别采用大青叶为对照药材

以甲苯-三氯甲烷-丙酮(5∶4∶1)为展开剂。采用HPLC法测定制剂中对乙酰氨基酚和马来酸氯苯那敏含量。流动相分别为甲醇-水-冰醋酸(20∶80∶0.5)和甲醇-0.05mol/L

磷酸二氢钾-三乙胺(50∶50:0.02)(用磷酸调pH至5.0)。结果:对乙酰氨基酚平均回收率为99.36%

RSD为1.03%(n=6);马来酸氯苯那敏平均回收率为99.13%

RSD为1.31%(n=6)。结论:鉴别方法专属性强

定量方法准确

稳定

重现性好

可作为速感宁胶囊的质量控制标准。

Abstract

Objective:To develop the quality control standards for Suganning Capsules.Methods: Folium isatidis in the capsules were identified on a thin layer plate of silice gel developed with.toluene-chloroform-acetone(5∶4∶1)with herbal reference substance.The contents of paracetamol and chlorphenamine maleate were determined by HPLC with external standard.The mobile phases were:methanol-water-acetic acid(20∶80∶0.5) and methanol-0.05 mol·L-1 potassium dihydrogen phosphate-triethylamine(50∶50∶0.02)(Adjust to pH 5.0 with phosophoric acid)for the two components respectively.Results:The average recovery of paracetamol was 99.36%(RSD 1.03%

n=6).The average recovery of chlorphenamine maleate was 99.13%(RSD 1.31%

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