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目的:建立制酸曲线法测定铝碳酸镁片及咀嚼片的制酸速度,对制酸速度的影响因素进行分析。方法:采用溶出度与释放度测定法(中国药典2015年版四部通则0931第三法)装置。取本品细粉,均匀分散于190 m L水中后,加盐酸滴定液(1 mol·L~(-1))10 m L,以每min 200 r·min~(-1)的转速搅拌,60 min内实时记录溶液的p H,绘制制酸曲线(X轴为时间,Y轴为溶液p H)。结果:不同厂家间产品制酸速度差异大;片剂6个生产厂家只有3个厂家的样品全部符合规定;咀嚼片15个生产厂家只有4个厂家的样品全部符合规定。结论:铝碳酸镁片及咀嚼片的制酸速度受原料、填充剂、崩解剂的影响,制剂的崩解时限和润湿性与制酸速度有直接相关性。
OBJECTIVE: To establish an acid-forming curve method for the determination of acid-forming rate of aluminum magnesium carbonate tablets and chewable tablets, and to analyze the influencing factors of acid-forming rate. Methods: Dissolution and release determination (Chinese Pharmacopoeia 2015 edition of the four rules 0931 third method) device. Take the fine powder of this product and disperse it evenly in water of 190 m L, add 10 mL of hydrochloric acid titration solution (1 mol·L -1) to stir at a speed of 200 r · min -1 every minute, Record the pH of the solution in real time within 60 min and plot the acidity curve (time on X-axis and solution pH on Y-axis). Results: There was a big difference in the rate of acid production among different manufacturers. Only 3 samples from 6 manufacturers in tablets were in compliance with the regulations; only 4 samples from 15 manufacturers in chewable tablets all met the requirements. CONCLUSION: The speed of acidification of aluminum magnesium carbonate tablets and chewable tablets is affected by the raw materials, fillers and disintegrants. The disintegration time and wettability of the tablets are directly related to the speed of acid production.