粉末直接压片制备苯磺酸氨氯地平片

Preparation of Amlodipine Besylate Tablets by Direct Powder Compression

目的探讨苯磺酸氨氯地平片的制备工艺改进方法。方法采用高效液相色谱法(high performance liquid chromatography,HPLC)测定其中氨氯地平的含量,并对其性状、鉴别、重量差异、溶出度、含量均匀度、脆碎度等进行检测。结果制得的苯磺酸氨氯地平片表面光滑美观、剂量准确、服用方便、溶出度>85%,硬度>80N,脆碎度<0.2%,符合片剂质量要求。结论将原湿法制粒压片法改进为粉末直接压片法,简化了制剂流程,提高了生产效率,稳定性好,临床疗效好。

Objective To explore the improved preparation process methods of Amlodipine besylate Tablets.Methods High performance liquid chromatography （HPLC） method was used to determine content of amlodipine. Its character, distin- guish, weight deviation, solubilit, content uniformity, friability were tested.Results The amlodipine besylate tablets could be obtained with smooth-surface,dose accuracy, easy taking, solubilit 〉85%, hardness〉80N, friability 〈0.2%, which was in accordance with the requirements for quality of tablets. Conclusion Compared with wet granulation compression tablets method,the direct power compressing tablets method can simplify the process, improve the efficiency and quality stability, and has good clinical effect.