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目的比较参术益肠丸细粉和超微粉中主要活性成分葛根素、芍药苷和甘草苷溶出情况,为其生产工艺优化提供实验依据。方法采用高效液相色谱法分别对参术益肠丸中主要活性成分在不同溶出介质中相对累积溶出率进行定量研究。色谱条件:Agilent Eclipse XDB-C18色谱柱(150 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸水溶液(11︰89);体积流量1.5 m L/min;检测波长230 nm;进样量10μL。结果细粉中葛根素和甘草苷在水和人工胃液中相对累积溶出率大于超微粉,而细粉中芍药苷在水和人工胃液中相对累积溶出率小于超微粉。人工肠液中超微粉和细粉的溶出行为相似。结论适度的微粉化能促进参术益肠丸有效成分的溶出,其溶出行为还受到不同溶出介质的影响,超微粉碎技术应用于参术益肠丸还需进一步研究。
OBJECTIVE To compare the dissolution of puerarin, paeoniflorin and glycyrrhizin, which are the main active components in YiZheng pill and ultrafine powder, and provide experimental basis for the optimization of its production technology. Methods The relative cumulative dissolution rates of the main active ingredients in Yishengchangchang pill in different dissolution media were quantitatively determined by high performance liquid chromatography. Chromatographic conditions: Agilent Eclipse XDB-C18 column (150 mm × 4.6 mm, 5 μm); acetonitrile-0.1% phosphoric acid solution (11:89); mobile phase volume 1.5 mL / min; Amount of 10 μL. Results The relative cumulative dissolution rates of puerarin and glycyrrhizin in water and artificial gastric juice were higher than that of superfine powder, while the relative cumulative dissolution rate of paeoniflorin in water and artificial gastric juice was smaller than that of superfine powder. Artificial intestinal fluid ultrafine powder and the dissolution behavior of similar. Conclusions Appropriate micronization can promote the dissolution of the active ingredient in the Shaoyi Yichang pill. The dissolution behavior of the tablet is also influenced by different dissolution media. The application of the ultrafine grinding technology to the Shaoyi Yichang Pill needs further study.