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目的:建立当归芍药胶囊的质量标准。方法:采用薄层色谱法对当归、白芍、白术、泽泻和川芎进行定性鉴别,采用HPLC法对当归芍药胶囊中的芍药苷进行含量测定,以十八烷基硅烷键合硅胶为固定相,以乙腈-磷酸二氢钾溶液(16∶84)为流动相,测定波长230 nm;流速为1.0ml·min-1。结果:薄层色谱中,供试品溶液在与对照药材相应位置上出现相同颜色的斑点,斑点清晰,阴性对照无干扰;高效液相色谱中,芍药苷进样量在0.208~1.872μg范围内有良好的线性关系(r=0.999 95),平均回收率为98.45%,RSD%为0.75%(n=6)。结论:方法可靠,操作简便,重复性良好,可用于该制剂的质量控制。
Objective: To establish the quality standard of Danggui Shaoyao Capsule. Methods: The Angelica, Radix Paeoniae Alba, Atractylodes macrocephala, Alisma orientalis and Chuanxiong Rhizome were qualitatively identified by TLC. The content of paeoniflorin in Danggui Peony Herbal Capsule was determined by HPLC. The octadecylsilane bonded silica gel was used as the stationary phase , The mobile phase was acetonitrile-potassium dihydrogen phosphate solution (16:84) with the wavelength of 230 nm and the flow rate of 1.0 ml · min-1. Results: In the TLC, the same color spots appeared on the corresponding position of the reference drug solution, the spots were clear and the negative control had no interference. In the HPLC, the injection of paeoniflorin was in the range of 0.208 ~ 1.872μg There was a good linear relationship (r = 0.999 95) with an average recovery of 98.45% and a RSD% of 0.75% (n = 6). Conclusion: The method is reliable, easy to operate, reproducible and can be used for the quality control of the preparation.