苯磺酸左旋氨氯地平片的制备和质量控制

摘要

目的：研究苯磺酸左旋氨氯地平片的制备及其质量控制方法。方法：制剂处方中加入微晶纤维素、乳糖、硫酸钙作为填充剂，羟丙纤维素作为黏合剂以及崩解剂，硬脂酸镁作为润滑剂；含量测定采用高效液相色谱法。结果：苯磺酸左旋氨氯地平片在浓度为13.6~20.4µg/ml浓度范围内线性关系良好(r=0.9990)，考察3批样品，平均回收率和RSD分别为：99.0%和0.42%；含量为99.3%、99.2%、99.3%。结论：本制备方法简单，易于操作；含量测定方法简便、准确、回收率高，可用于苯磺酸左旋氨氯地平片的质量控制。%　　Objective:To study the preparation and quality control of levoamlodipine besylate tablets. Methods:In pharmaceutical formulations, microcrystalline cellulose, lactose and calcium sulfate were added as a filler, hydroxypropyl cellulose as a binder and disintegrant and magnesium stearate as a lubricant. An HPLC was used for the determination of contents. Results:The calibration curve of levoamlodipine besylate tablets was linear over the range of 13.6~20.4 µg/ml ( r=0.999 0). The average recovery rate and RSD value were 99.0%and 0.42%and the contents in three batches of samples were 99.3%, 99.2%and 99.3%. Conclusion:The method for preparation is simple and easy to operate and the method for the determination of contents is accurate and simple with high recovery rate, which can be used for the quality control of levoamlodipine besylate tablets.