仁青芒觉胶囊质量标准研究

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,5μm),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 8μg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 4μg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。

Study on Quality Standard for Renqing Mangjue Capsules

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, 5μm）. 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.