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目的:改进保肾片的质量控制标准,为制剂生产提供质量保障。方法:采用TLC法对制剂中的大黄进行定性鉴别;采用HPLC法对制剂中的大黄酸、大黄素、大黄酚总含量进行测定,其色谱条件为:色谱柱为Lichrospher-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(70∶30),流速为1.0 ml·min-1,柱温为30℃,检测波长为254 nm。结果:TLC鉴别色谱斑点清晰,阴性无干扰;大黄酸在0.001 3~0.010 6 mg·ml-1范围内有良好的线性关系(r=0.999 9),大黄素在0.002 7~0.021 3 mg·ml-1范围内有良好的线性关系(r=0.999 9),大黄酚在0.007 6~0.060 5 mg·ml-1范围内有良好的线性关系(r=0.999 9),平均回收率分别为100.18%、100.31%、100.09%,RSD分别为1.08%、0.67%、1.11%(n=9)。结论:该方法准确易行,便于质量控制。
Objective: To improve the quality control standard of Baoshen Tablet and provide quality assurance for the preparation production. Methods: TLC was used to identify the rhubarb in the preparation. HPLC was used to determine the total contents of rhein, emodin and chrysophanol in the preparation. The chromatographic conditions were as follows: column of Lichrospher-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.1% phosphoric acid solution (70:30), the flow rate was 1.0 ml · min-1, the column temperature was 30 ℃ and the detection wavelength was 254 nm. Results: There was a good linear relationship between rhein (0.001 3 ~ 0.010 6 mg · ml-1) and rhamnoides (r = 0.999 9) in the range of 0.002 7 ~ 0.021 3 mg · ml (R = 0.999 9). There was a good linear relationship between the concentration of chrysophanol in the range of 0.007 6-0.060 5 mg · ml-1 (r = 0.999 9) and the average recoveries were 100.18% , 100.31% and 100.09%, respectively. RSD was 1.08%, 0.67% and 1.11% respectively (n = 9). Conclusion: The method is accurate and easy to facilitate quality control.