复方芪麻胶囊的质量标准研究
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篇名: | 复方芪麻胶囊的质量标准研究 |
TITLE: | |
摘要: | 目的:建立复方芪麻胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中黄芪、天麻、化橘红和川芎进行定性鉴别;采用高效液相色谱法测定制剂中天麻素和对羟基苯甲醇的含量:色谱柱为Waters XBridge C18,流动相为乙腈-0.05%磷酸溶液(3 ∶ 97,V/V),流速为1.0 mL/min,检测波长为220 nm,柱温为25 ℃,进样量为10 μL。结果:黄芪、天麻、化橘红和川芎的TLC图斑点清晰,分离度好,阴性对照无干扰。天麻素、对羟基苯甲醇检测质量浓度线性范围分别为7.97~59.76 μg/mL(r=0.999 5)、4.27~32.04 μg/mL(r=0.999 9);精密度、稳定性、重复性试验的RSD<1.0%;加样回收率分别为98.98%~100.11%(RSD=0.35%,n=9)、98.74% ~100.23%(RSD=0.43%,n=9)。结论:该研究所建标准可用于复方芪麻胶囊的质量控制。 |
ABSTRACT: | OBJECTIVE: To establish the quality standard for Compound qima capsules. METHODS: TLC was used for the qualitative identification of Radix astragali, Gastrodia elata, Pummelo Peel and Ligusticum chuanxiong. HPLC method was adopted for the contents determination of gastrodin and gastrodigenin. The determination wasp performed on Waters XBridge C18 column with mobile phase consisted of acetonitrile-0.05% phosphoric acid (3 ∶ 97,V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm, column temperature was 25 ℃ and sample size was 10 μL. RESULTS: The TLC spots of R. astragali, G. elata, Pummelo Peel and L. chuanxiong were clear and well separated without the interference of negative samples. The linear ranges of gastrodin and gastrodigenin were 7.97-59.76 μg/mL(r=0.999 5),4.27-32.04 μg/mL(r=0.999 9). RSDs of precision, stability and repeatability tests were all lower than 1.0%. Recoveries of them were 98.98%-100.11%(RSD=0.35%,n=9), 98.74%-100.23%(RSD=0.43%,n=9), respectively. CONCLUSIONS: Established method can be used for quality control of Compound qima capsules. |
期刊: | 2017年第28卷第18期 |
作者: | 孙冬梅,林晓燕,李素梅,江洁怡,罗文汇,陈雪 |
AUTHORS: | SUN Dongmei,LIN Xiaoyan,LI Sumei,JIANG Jieyi,LUO Wenhui,CHEN Xue |
关键字: | 复方芪麻胶囊;质量标准;薄层色谱法;高效液相色谱法 |
KEYWORDS: | Compound qima capsules; Quality standard; TLC; HPLC |
阅读数: | 454 次 |
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