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目的建立脑得生固体分散体胶囊(三七、川芎、红花、葛根、山楂)的质量控制方法。方法采用薄层色谱法对该复方制剂中三七、川芎、红花、葛根、山楂进行定性鉴别,同时采用比色法测定三七总皂苷的含量,并采用高效液相法测定羟基红花黄色素A的含量。结果供试品色谱中,在与对照品、对照药材色谱相应的位置上,显相同颜色的斑点,阴性样品无干扰;三七总皂苷对照品在0.042~0.119mg·ml~(-1)(r=0.9995)范围内线性关系良好,加样回收率均值为99.47%,RSD为2.43%;羟基红花黄色素A在0.259~1.554μg(r=0.9999)范围内线性关系良好,加样回收率均值为99.33%,RSD为1.03%。结论所建立的方法操作简便,准确,重复性好,能够有效地控制脑得生固体分散体胶囊的质量。
Objective To establish a quality control method for brain solid dispersion capsules (notoginseng, Chuanxiong, safflower, Pueraria lobata, hawthorn). Methods The TLC, TLC, HPLC, HPLC, HPLC and HPLC were used to identify the contents of Panax notoginseng, Rhizoma Chuanxiong, Safflower, Pueraria lobata and Hawthorn. The content of Panax notoginseng saponins was determined by colorimetric method. Pigment A content. Results for the test product chromatography, with the reference substance, the corresponding position of the reference drug chromatography, was the same color spots, negative samples without interference; notoginseng total saponin reference substance in the 0.042 ~ 0.119mg · ml -1 ( r = 0.9995), the average recovery was 99.47% and the RSD was 2.43%. The linearity of hydroxysafflor yellow A was good in the range of 0.259 ~ 1.554μg (r = 0.9999) The mean was 99.33% with a RSD of 1.03%. Conclusion The established method is simple, accurate and reproducible, and can effectively control the quality of brain solid dispersion capsules.