仁青芒觉胶囊质量标准的研究.docVIP

仁青芒觉胶囊质量标准的研究 　　摘要：目的 制定仁青芒觉胶囊的质量标准。方法 采用薄层色谱法对西红花、姜黄、丁香、木香、冰片进行定性鉴别。采用高效液相色谱法，CAPCELL PAK MG C18色谱柱（4.6 mm×250 mm，5 μm），流动相为甲醇∶0.01 moL/L磷酸二氢钾溶液（用10%磷酸调节pH值2.5）=25∶75，流速1.0 mL/min，检测波长为254、260 nm，柱温30 ℃，对马钱子碱、士的宁进行定量测定。结果 薄层色谱能定性检出西红花、姜黄、丁香、木香、冰片，斑点清晰，且阴性对照无干扰。马钱子碱在0.012 1～0.072 8 ?g范围内呈良好的线性关系，r=0.999 1，加样回收率为97.27%，RSD=1.20%；士的宁在0.045 4～0.272 4 ?g范围内呈良好的线性关系，r=0.999 8，加样回收率为98.69%，RSD=1.17%。结论 该方法操作简便、专属性、重复性好，可有效控制仁青芒觉胶囊的质量。 　　关键词：仁青芒觉胶囊；质量标准；薄层色谱法；高效液相色谱法；马钱子碱；士的宁 　　DOI：10.3969/j.issn.1005-5304.2014.06.023 　　中图分类号：R284.1 文献标识码：A 文章编号：1005-5304（2014）06-0072-04 　　Abstract：Objective To set up the quality standard of Renqing Mangjue capsules. Methods TLC was used for qualitative identification of Crocus sativus， Zingiberaceae， Syringa oblata， Radix Aucklandiae and Borneolum. The content of Brucine and Strychnine were determined by HPLC， which conducted with CAPCELL PAK MG C18 column （4.6 mm×250 mm， 5 μm）. The mobile phase consisted of methanol∶0.01 moL/L potassium dihydrogen phosphate （with 10% phosphoric acid to adjust the pH 2.5）=25∶75 and the flow rate was 1.0 mL/min. The detection wavelength was set at 254 nm and 260 nm. The column temperature maintained at 30 ℃. Results TLC could detect qualitatively Crocus sativus， Zingiberaceae， Syringa oblata， Radix Aucklandiae and Borneolum. The spots were clear and the negative controls had no interference. HPLC determined that Brucine presented a good linear relationship in the range of 0.012 1-0.072 8 μg （r=0.999 1）. The average recovery was 97.27%， RSD was 1.20%. Strychnine presented a good linear relationship in the range of 0.045 4-0.272 4 μg （r=0.999 8）. The average recovery was 98.69%， RSD was 1.17%. Conclusion The method is simple in operation. The results are accurate， reliable and good in reproducibility. The method can effectively control the quality of Renqing Mangjue capsules. 　　Key words：Renqing Mangjue capsules；quality standard；TLC；HPLC；Brucine；Strychnine 　　仁青芒觉是藏药中的常用名方，始载于十七世纪著名藏医药学家司徒?却吉琼乃编著的《盘德琼