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 study the preparation method of amlodipine besylate tablets. Methods The content of amlodipine was determined by high performance liquid chromatography (HPLC), and its traits, identification, weight difference, dissolution, content uniformity and friability were tested. Results The obtained amlodipine besylate showed smooth and beautiful appearance, accurate dosage and convenient taking. The dissolution rate was> 85%, the hardness was> 80N, the friability was <0.2%, which accorded with the tablet quality requirements. Conclusion The wet granulation tablet method was improved to powder direct tabletting method, which simplified the preparation process, improved the production efficiency, good stability and good clinical curative effect.