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目的:筛选苯磺酸氨氯地平分散片的处方及工艺。方法:以崩解时限为指标对崩解剂进行选择和采用直接压片法制备苯磺酸氨氯地平分散片,以微粉硅胶作助流剂;对影响因素进行研究,并进行了放大试验和质检。结果:经筛选所得处方制备的样品外观光洁,30秒内能崩解完全并能全部通过2号筛,溶出快,稳定性好。结论:此分散片崩解迅速,溶出度高,制备工艺简单。
Objective: To screen prescription and process of amlodipine besylate dispersible tablets. Methods: According to the disintegration time as the index, the disintegrant was selected and the direct-tablet method was used to prepare amlodipine besylate dispersible tablets. Silica gel was used as the glidant. The influencing factors were studied, Quality inspection. Results: The samples prepared by the screening showed a bright appearance, which could disintegrate completely within 30 seconds and passed through No.2 sieve completely. The dissolution was rapid and the stability was good. Conclusion: The dispersible tablets disintegrate rapidly, high dissolution, preparation process is simple.