血栓通滴丸生产工艺及质量标准研究

Study on Preparation and Quality Standard of Xueshuantong Drop Pills

目的：研究血栓通滴丸最佳制备工艺并确定其质量标准。方法：以滴丸成型率为评价指标,对药物与不同基质的配比、冷却剂进行选择试验,优选出最佳滴制条件;采用HPLC法,色谱柱采用迪马-C18（200 mm×4.6mm,5μm）,以乙腈为流动相A,水为流动相B,0 min20%A,14 min40%A,15 min60%A,16 min20%A,流速为1.0 mL/min,检测波长203nm。结果：药物与聚乙二醇4000 1∶2比例熔融,80℃保温滴制,滴头内径为2.3 mm,外径为4.8mm。滴速20滴/min,冷却剂液体石蜡的温度为5℃。三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1分别在0.51~4.08μg/mL、3.75~30.00μg/mL、3.75~30.00μg/mL范围内线性关系良好,r均为0.9999,方法重复性及回收率均符合要求。结论：制备出的血栓通滴丸能很好的达到中国药典滴丸剂通则的要求及本品定性、定量方法质量标准的有关规定。

Objective： To optimize the best technical parameters and establish the quality standard for Xueshuantong Drop Pills.Methods： Using moulding probability of drop pill as the evaluation to choose the best dropping condition.Using parallel experimentation for the choice of proportion of drug and matrix,and refrigerant;HPLC method was employed on ODS column which was used with a mobile phase of acetontrile-water,0 min 20% A,14min40%A,15 min 60%A,16 min 20%A.The wavelength of detexter was set at 203 nm.Drug-PEG4000（1∶2） was melt at 80℃.Liquid-paraffin was refrigerated with 5℃.Internal and external diameter of buretteare equal to 2.3 mm and 4.8 mm.The linear ranges of notoginsenoside R1 ginsenoside,Rg1 and Rb1were 0.51～4.08 μg/mL,3.75～30.00 μg/mL,3.75～30.00 μg/mL,respectively.Their coefficients of determination（r） were all 0.9999.Conclusion： The moulding technics of drop pills have high finished product rate and good quality.