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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,5μm),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0.01～0.504μg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 a qualitative and quantitative method of Shenlu Zhuanggu capsule. Methods: Angelica sinensis, Radix Salviae Miltiorrhizae and Rehmannia glutinosa were identified by TLC, the naringin was determined by RP-HPLC and the nitrogen content of the antler was determined by nitrogen determination . LC conditions: C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was acetonitrile-0.4% acetic acid aqueous solution (20:80) at a flow rate of 1.0 mL · min-1 with a detection wavelength of 283 nm and a column temperature of 35 ℃ . Results: Salvia miltiorrhiza, Angelica sinensis and Radix Rehmanniae Preparata were detected in the thin layer chromatography. The naringin injection in the range of 0.01-0.504 μg showed good linearity (r = 0.9998), the average recovery was ( n = 9) was 99.7%. The nitrogen content of 10 batches of samples measured by this method was 8.4% ~ 10.5%. Conclusion: The method is simple, accurate and reliable and can be used for quality control of Shenlu Zhuanggu capsules.