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目的:对大活络丸及其同系列品种中牛黄的质量进行分析研究,增加其中贵细药材牛黄的监控方法,为完善其质量标准、规范生产及加强监管力度提供依据。方法:采用Kromasil C_(18)(4.6 mm×150 mm,5μm)色谱柱,以乙腈-1%醋酸水溶液(95∶5)为流动相,检测波长450 nm,建立大活络丸及其同系列品种中游离胆红素和总胆红素的高效液相色谱测定方法,对其中所含牛黄的各成分指标进行综合分析及制定合理限量,有效评价和控制其中牛黄的质量。结果:大活络丸及其同系列品种中部分样品所含的牛黄中的游离胆红素和总胆红素的含量有很大的不同,可能存在牛黄投料量不足,以人工牛黄或游离胆红素替代牛黄投料的情况。结论:综合分析不同类型胆红素的含量及比例可较好地评价大活络丸及其同系列品种中投料用牛黄的质量。该方法操作简便,质量可控性高,可为其他含牛黄制剂中牛黄的质量评价提供借鉴。
OBJECTIVE: To analyze and study the quality of bezoar in Dayuanluo Pills and the same series of varieties, and to increase the monitoring method of bezoar, which is a precious and detailed medicine, to provide basis for improving its quality standards, regulating production and strengthening supervision. Methods: Kromasil C18 (4.6 mm × 150 mm, 5 μm) column was used with a mobile phase of acetonitrile-1% acetic acid aqueous solution (95: 5) Midstream free bilirubin and total bilirubin high performance liquid chromatography method, the contents of each component contained in bezoar comprehensive analysis of indicators and to develop a reasonable limit, which effectively evaluate and control the quality of bezoar. Results: The content of free bilirubin and total bilirubin in the bovine bezoar contained in some samples of Dayouluo Pills and its homologous series are quite different. There may be insufficient amount of bovine bezoar feeding, with artificial bezoar or free bile Prime instead of cattle feed situation. Conclusion: The contents and proportions of different types of bilirubin can be used to evaluate the quality of dyestuff in Dayouluo pills and its homologous series. The method has the advantages of simple operation, high quality controllability, and can provide reference for the quality evaluation of bezoar in other bezoar-containing preparations.