万通炎康滴丸制备工艺及含量测定

Preparation and determination of Wan Tong Yan Kang dripping pills

目的优选万通炎康滴丸制备工艺及其含量测定方法。方法按照正交实验设计,分别以圆整度和溶散时限为指标考察了聚乙二醇PEG4000与PEG6000比例,药物和基质的比例,物料温度对处方工艺的影响;以丸重合格率(%)为指标,考察了滴距、滴速、冷却液温度对滴丸制备的影响。建立了异嗪皮啶HPLC含量测定法。结果优选出最佳制备法为PEG4000:PEG6000为7:2,药物:基准为1:4,物料温度C(℃)为90℃,冷却液温度为5℃,滴距10cm,滴速30d/min。异嗪皮啶含量测定在0.852~4.260μg/mL范围内线性关系良好。结论该滴丸制备方法简便可行,含量测定法灵敏度高,重复性好,可为滴丸制备及质量控制提供依据。

Objective To Prepare and prefer method for the determination Wan Tong Yan Kang dripping pills. Methods Based on the Orthogonal test,the roundness and dissolution time were regarded as the index,the proportion of PEG4000 and PEG6000,the ratio of drug and matrix and material temperature were investigated. The pill weight pass rate (%)was regarded as the index to prepare dropping pills,the distance,dropping speed and temperature were investigated.Established isofraxidin content assay by HPLC. Results The best preparation method for drugs is:PEG4000 PEG6000 is 72,rugs:standard is1:4;the material temperature is 90 ℃;the cooling liquid temperature is 5 ℃;dropping distance is 10cm,dropping speed is 30 d/min. Isofraxidin regression equation is Y=26842X-835,R2 =0.998. Isofraxidin has good linear relationship in the range of concentrations 0.852-4.26 μg/mL. Conclusion The dripping pill preparation method is simple and feasible. Determination method has high sensitivity and good repeatability. The experiment provides a basis for the preparation of dripping pills and establishment of quality standards.