雷奈酸锶干混悬剂溶出度方法的建立

发布时间：2019-03-09 10:26

【摘要】：目的:建立雷奈酸锶干混悬剂溶出度测定方法。方法:选用318 nm作为检测波长,用分光光度法对雷奈酸锶主成分进行测定。采用桨法考察不同转速(50、75、100 r·min-1)和不同溶出介质(0.05 mol·L-1盐酸溶液、p H 4.5醋酸盐缓冲液、p H6.8磷酸盐缓冲液、水)对雷奈酸锶干混悬剂溶出行为的影响,建立雷奈酸锶干混悬剂的溶出度测定方法。并对所建立方法进行方法学考察。结果:分光光度法测定雷奈酸锶方法可行。方法学验证结果表明,溶液在室温条件下放置12 h其RSD仍小于2%,证明溶液在室温下稳定;雷奈酸锶质量浓度在4.425~26.549μg·m L-1范围内呈良好的线性;平均回收率98.6%,RSD为1.4%,该方法准确度良好;重复性试验RSD小于10%,证明方法精密度良好。0.05 mol·L-1盐酸溶液作为溶出介质溶出速度快且较为平缓。利用所建立的溶出度测定方法对2批市售制剂进行测定,30min内2批样品的溶出度分别为98.4%和98.3%。结论:所建立的溶出度测定方法经方法学考察,可对雷奈酸锶干混悬剂进行溶出度测定。
[Abstract]:Objective: to establish a method for the determination of dissolution of strontium rhenate dry suspension. Methods: the principal components of strontium rhenate were determined by spectrophotometry with 318 nm as the detection wavelength. Different speeds (50,75100 r 路min-1) and different dissolution media (0.05 mol 路L-1 hydrochloric acid solution, p H 4.5 acetate buffer solution, pH 6.8 phosphate buffer solution) were investigated by paddle method. The effect of water on the dissolution behavior of strontium rhenate dry suspension was studied. A method for the determination of dissolution of strontium rhenate dry suspension was established. The methodology was investigated. Results: it is feasible to determine strontium ranate by spectrophotometry. The results of methodology verification showed that the RSD of the solution was still less than 2% at room temperature for 12 h, which indicated that the solution was stable at room temperature, and the concentration of strontium ranate was linear in the range of 4.425 ~ 26.549 渭 g 路mL ~ (- 1). The average recovery is 98.6%, RSD is 1.4%, the accuracy of this method is good, the repeatability test RSD is less than 10%, the precision of the method is good, and the dissolution rate of 0.05 mol 路L-1 hydrochloric acid solution as dissolution medium is fast and smooth. The dissolution rates of two batches of commercial preparations in 30min were 98.4% and 98.3%, respectively. Conclusion: the method established for the determination of dissolution can be used to determine the dissolution of strontium rhenate dry suspension.
【作者单位】：北京中医药大学中药学院;中国食品药品检定研究院中药民族药检定所;
【分类号】：R927.2;O657.32

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