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采用一测多评法对大黄不同制剂颗粒的质量进行了评价。

Variation in quality of the different prepared formulation granules of rhubarb was evaluated by quantitative analysis of multicomponents with single marker.

机构信息

Department of Pharmacy, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, Zhejiang Province, PR China.

Laboratory of Chinese herbal medicines, Jiaxing Institute for Food, Drug and Product Quality Control, Jiaxing, Zhejiang Province, PR China.

出版信息

Pak J Pharm Sci. 2022 Jul;35(4):1095-1101.

Abstract

Rhei Radix et Rhizoma formula granule (RRFG) , Winy Rhei Radix et Rhizoma formula granule(WRFG) and Rhubarb charcoal formula granules (RCFG) are the three most popular and effective formula granules of rhubarb in China and anthraquinone components are their main active ingredients. In order to discuss the difference in anthraquinone components of these three drugs, a simultaneous quantitative analysis method of multicomponents by single-marker (QAMS) was developed. Emodin was chosed as the internal reference standard, the relative correction factors (RCFs) of aloe-emodin, rhein, chrysophanol and physcion were established and the contents of the four components were calculated based on the RCFs, respectively. Meanwhile, the contents of these components was determined by external standard method (ESM) and compared with QAMS to verify its rationality, feasibility and repeatability. The results showed that there were no significant difference between QAMS and ESM (RSDs≤2.26%). The contents of anthraquinone components showed a wide variation in these three drugs. All of 5 components were higher in RRFG than that in the others and RCFG had the lowest content. This method was successfully applied for the evaluation on difference of these drugs and the wide variation in anthraquinone components indicated there were different pharmacodynamic basis.

摘要

大黄配方颗粒(RRFG)、酒大黄配方颗粒(WRFG)和大黄炭配方颗粒(RCFG)是中国最常用且最有效的三种大黄配方颗粒,其主要活性成分为蒽醌类成分。为了探讨这三种药物中蒽醌类成分的差异,建立了一种同时测定多成分的单标志物定量分析方法(QAMS)。选择大黄素作为内标,建立了芦荟大黄素、大黄酸、大黄酚和大黄素甲醚的相对校正因子(RCFs),并分别基于 RCFs 计算了这四个成分的含量。同时,采用外标法(ESM)测定了这些成分的含量,并与 QAMS 进行比较,以验证其合理性、可行性和重复性。结果表明,QAMS 和 ESM 之间无显著差异(RSDs≤2.26%)。这三种药物中蒽醌类成分的含量差异较大。RRFG 中 5 种成分的含量均高于其他两种,而 RCFG 中含量最低。该方法成功应用于评价这三种药物的差异,蒽醌类成分的广泛变化表明其具有不同的药效学基础。

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