白斑丸的质量标准研究

Improving Quality of Baiban Pills

目的建立白斑丸的质量标准。方法采用TLC法对白斑丸中的当归、何首乌、丹参进行定性鉴别;采用HPLC法测定丹参中丹参酮ⅡA的含量,以十八烷基硅烷键合硅胶为填充剂,流动相为甲醇-水（80∶20）,流速为1 ml·min-1,柱温为30℃,检测波长为270 nm。结果 TLC图谱中,供试品在对照品或对照药材色谱相应位置上显相同颜色的斑点,且阴性无干扰。丹参酮ⅡA在0.6～19.2μg·ml-1范围内呈良好的线性关系（r=0.9999）;平均加样回收率为99.07%,RSD为2.60%（n=9）。结论本研究方法准确可靠,重复性好,可用于白斑丸的质量控制。

Objective To improve the quality standard of Baiban pills. Methods Angelica sinensis,polygoni multiflori and salvia miltiorrhiza were qualitatively identified by TLC. The content of tanshinoneⅡAwas determined by HPLC on an octadecylsilane chemically bonded silica column with the mobile phase composed of methyl alcoholwater（ 80∶ 20） at a flow rate of 1. 0 ml·min- 1. The column temperature was 30 ℃ and the detection wavelength was set at 270 nm. Results TLC spots of test samples had the same color and chromatographic position as the control substance and reference substance,while the negative samples showed no interference. The linear range of TanshinoneⅡAwas 0. 6- 19. 2 μg·ml- 1（ r = 0. 9999） with an average recovery of 99. 07%,RSD = 2. 60%（ n = 9）.Conclusion This method is accurate,reliable,stable,reproducible and precise,which can be used to control the quality of Baiban pills.