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[摘要]
目的 制定沈阳红药气雾剂的质量控制标准。方法 采用薄层色谱法对制剂中的三七、当归、川芎、白芷、冰片、薄荷脑进行定性鉴别,采用高效液相色谱法测定制剂中人参皂苷Rg1。色谱柱为Diamonsil C18柱(200 mm×4.6 mm,5 μm);流动相为乙腈–0.5%磷酸水溶液(20∶80);体积流量为1.0 mL/min;检测波长203 nm。结果 三七、当归、川芎、白芷、冰片、薄荷脑薄层色谱斑点清晰,重现性好,无干扰;人参皂苷Rg1在0.05~0.50 mg线性关系良好,平均回收率为100.6%,RSD为1.07%(n=6)。结论 所建立的定性和定量方法结果准确、可靠、重现性好,可用于沈阳红药气雾剂的质量控制。
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[Abstract]
Objective To establish the quality standard of Shenyang Hongyao Aerosol. Methods TLC was applied to identifying Notoginseng Radix et Rhizoma, Angelicae Sinensis Radix, Chuanxiong Rhizoma, Angelicae Dahuricae Radix, Borneolum Syntheticum, and Menthae Haplocalycis Herba. HPLC was applied to determining the content of ginsenoside Rg1 in the prescription. Diamonsil C18 column (200 mm×4.6 mm, 5 μm) was used, the mobile phase consisted of acetonitrile-0.5% phosphoric acid (20:80) solution, and the flow rate was 1.0 mL/min with detection wavelength at 203 nm. Results The spots on TLC plates of above mentioned six material medica were clear with good reproducibility and without interference in the blank reference. The linearity range of ginsenoside Rg1 was 0.05—0.50 mg, the average recovery rate was 100.6%, and RSD was 1.07% (n=6). Conclusion The established method is accurate, feasible, and reproducible. It can be used for the quality control for Shenyang Hongyao Aerosol.
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