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目的:通过对比盐酸氨溴索片和参比制剂在不同PH溶出介质中的体外溶出度测定,找出各制剂处方工艺和质量差异。方法:应用《盐酸氨溴索片一致性评价参比制剂/溶出曲线测定》方法,转速每分钟50转、溶出介质900ml。结果:在水、0.1mol/L盐酸、PH4.5醋酸缓冲液和PH6.8磷酸盐缓冲液中测定溶出度曲线,与参比制剂比较有显著差异。
OBJECTIVE: To compare the dissolution rate of ambroxol hydrochloride tablets and reference preparations in different PH dissolution media to find out the difference of prescription and quality of each formulation. Methods: The method of “reference formulation / dissolution curve determination of ambroxol hydrochloride tablets consistency” was used. The speed of rotation was 50 revolutions per minute, and 900 ml of dissolution medium was dissolved. Results: Dissolution curves were measured in water, 0.1 mol / L hydrochloric acid, pH 4.5 acetate buffer and pH 6.8 phosphate buffer with significant differences compared to the reference formulation.