参鹿壮骨胶囊定性定量方法研究

目的: 建立参鹿壮骨胶囊定性定量方法。 方法: 采用薄层色谱法对当归、丹参、熟地黄进行鉴别,采用反相高效液相色谱法测定处方中骨碎补的有效成分柚皮苷,采用氮测定法测定处方中鹿角胶的氮含量。LC条件:采用C₁₈色谱柱(4.6 mm×250 mm,5 μm),流动相为乙腈-0.4%醋酸水溶液(20:80),流速1.0 mL·min^-1,检测波长为283 nm,柱温35℃。 结果: 在薄层色谱中可检出丹参、当归、熟地黄;骨碎补含量测定中柚皮苷的进样量在0.01~0.504 μg范围内线性关系良好(r=0.9998),平均回收率(n=9)为99.7%;用该方法测得10批样品的含氮量为8.4%~10.5%。 结论: 该方法简便、准确、可靠,可用于参鹿壮骨胶囊的质量控制。

Objective: To establish qualitative and quantitative methods for Shenlu Zhuanggu capsules. Methods: Angelicae Sinensis Radix,Salviae Miltiorrhizae Radix et Rhizoma and Radix Rehmanniae Preparata were identified by TLC.HPLC method was used to determine the conte nt of the active ingredient naringin in Drynariae Rhizoma.Chromatographic conditions:HPLC method was carried on a C₁₈ column(4.6 mm×250 mm,5 μm)with acetonitrile-water(20: 80)as the mobile phase at the flow rate of 1.0 mL·min^-1,and the detection wavelength was 283 nm,and the temperature of column was 35℃.The nitrogen in antler glue was determined by nitrogen determination method. Results: Angelicae Sinensis Radix,Salviae Miltiorrhizae Radix et Rhizoma and Radix Rehmanniae Preparata could be detected by TLC.Naringin showed a good linear relationship(r=0.9998)in the range of 0.01-0.504 μg,and the average recovery(n=9)was 99.73%.The nitrogen of the ten batches of samples was between 8.4%-10.5%. Conclusion: This method is simple,reliable,and accurate,which can be used to control the quality of Shenlu Zhuanggu capsules.

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