青连宁心胶囊的质量标准研究
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篇名: 青连宁心胶囊的质量标准研究
TITLE:
摘要: 目的:建立青连宁心胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中黄连、青蒿进行定性鉴别;采用高效液相色谱法测定制剂中青蒿素的含量:色谱柱为Diamonsil C18,流动相为甲醇-磷酸盐缓冲液(45 ∶ 55,V/V),流速为1.0 ml/min,检测波长为260 nm,柱温为30 ℃,进样量为10 μl。结果: 黄连、青蒿的TLC斑点清晰,分离度好,阴性对照无干扰。青蒿素检测质量浓度线性范围为5.62~56.2 μg/ml(r=0.999 4);精密度、稳定性、重复性的RSD<1.0%;加样回收率为97.46%~99.72%(RSD=0.75%,n=6)。结论:该研究所建标准可用于青连宁心胶囊的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Qinglian ningxin capsule. METHODS: TLC was adopted for the qualitative identification of Coptis chinensis and Artemisia carvifolia. HPLC was used for the content determination of artemisinin: column was Diamonsil C18 with mobile phase of methanol-phosphate buffer solution (45 ∶ 55,V/V) at a flow rate of 1.0 ml/min, detection wavelength was 260 nm, column temperature was 30 ℃,and injection volume was 10 μl. RESULTS: The TLC spots of C. chinensis and A. carvifolia were clear and well separated, negative control without interference. The linear range of artemisinin was 5.62-56.2 μg/ml(r=0.999 4);RSDs of precision, stability and reproducibility tests were lower than 1.0%; recovery was 97.46%-99.72% (RSD=0.75%,n=6). CONCLUSIONS: The satandard  can be used for the quality control of Qinglian ningxin capsule.
期刊: 2016年第27卷第33期
作者: 司席席,孙洪胜,曹广尚,陈倩倩,刘丹
AUTHORS: SI Xixi,SUN Hongsheng,CAO Guangshang,CHEN Qianqian,LIU Dan
关键字: 青连宁心胶囊;青蒿素;高效液相色谱法;薄层色谱法;质量标准
KEYWORDS: Qinglian ningxin capsule; Artemisinin; HPLC; TLC; Quality standard
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