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目的:建立灯盏花素滴丸的溶出度测定方法。方法:采用Agilent TC-C18色谱柱(4.6 mm×250 mm,5μm),以甲醇-四氢呋喃-0.1%磷酸溶液(14∶14∶72)为流动相,流速0.8 mL.min-1,检测波长335 nm。应用桨法,以磷酸盐缓冲液(pH6.8)为溶出介质,转速为50 r.min-1,对灯盏花素滴丸中野黄芩苷进行了溶出度测定。结果:野黄芩苷的线性范围为20.8～416μg.L-1(r=0.999 9),平均回收率(n=6)为99.92%(RSD 0.43%)。采用试验确定的方法,灯盏花素滴丸在20 min时累积溶出率可达70%。结论:灯盏花素滴丸批内和批间样品的累积溶出率差异较小,说明所建立的方法重复性较好,可用于灯盏花素滴丸的质量控制。
Objective: To establish a method for the determination of the dissolution of breviscapine drip pills. METHODS: The mobile phase was acetonitrile-tetrahydrofuran-0.1% phosphoric acid solution (14:14:72) with a flow rate of 0.8 mL · min-1 on an Agilent TC-C18 column (4.6 mm × 250 mm, 5 μm) nm. The paddle method was used to determine the dissolution of wild baicalin in the Breviscapine Dropping Pills by using phosphate buffer solution (pH6.8) as the dissolution medium and rotating speed of 50 r.min-1. Results: The linear range of baicalin was 20.8 ~ 416μg.L-1 (r = 0.999 9). The average recovery (n = 6) was 99.92% (RSD 0.43%). Using the method determined by experiment, the elution rate of breviscapin dropping pills at 20 min can reach 70%. Conclusion: The difference of cumulative dissolution rates of erigeron dropping pills between batches and batches is small, which shows that the established method has good reproducibility and can be used for the quality control of erigeron dropping pills.