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目的:建立安替可胶囊的质量标准。方法:采用薄层色谱法对方中的当归、蟾皮进行定性鉴别;采用HPLC法对制剂中华蟾酥毒基和脂蟾毒配基进行定量分析。结果:薄层色谱鉴别分离效果好,专属性强;华蟾酥毒基在50~250 mg·L-1范围内线性关系良好(r=0.9999);脂蟾毒配基在44~220 mg·L-1范围内线性关系良好(r=0.9999);华蟾酥毒基平均加样回收率为99.79%,RSD%=0.56%;脂蟾毒配基平均加样回收率为100.08%,RSD%=0.47%。结论:该方法简单、准确、专属性强、重复性好,可有效控制安替可胶囊的质量。
Objective: To establish the quality standard of Anti-capsule. Methods: Angelica sinensis and toad skin were qualitatively identified by TLC. The contents of cinobufagin and resibufogenin were quantitatively analyzed by HPLC. Results: TLC showed good separation and specificity, and the concentration of cinobufagin was linear in the range of 50 ~ 250 mg · L-1 (r = 0.9999). The content of bufalin was 44 ~ 220 mg · L (R = 0.9999). The average recoveries of snake venom were 99.79%, RSD% = 0.56%. The average recoveries of resibufogenin were 100.08%, RSD% = 0.47 %. Conclusion: The method is simple, accurate, specific and reproducible, which can effectively control the quality of Antipyrine capsules.