铝碳酸镁片及咀嚼片的制酸速度研究

发布时间：2018-03-10 00:20

本文选题：铝碳酸镁片　切入点：铝碳酸镁咀嚼片　出处：《药物分析杂志》2017年11期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:Objective: to establish an acid-making curve method for the determination of acid preparation rate of magnesium bicarbonate tablets and chewable tablets. Methods: the dissolution and release methods (the third method of Chinese Pharmacopoeia, 2015 edition of General Rule 0931) were used to analyze the factors affecting the speed of acid preparation. The fine powder was taken and dispersed evenly in 190ml water. Adding 1 mol 路L ~ (-1) mol 路L ~ (-1) hydrochloric acid titrate to 10 mL, stirring at a speed of 200r 路min ~ (-1) per min to record the pH of the solution in real time within 60 min, drawing the acid-making curve with X axis as the time axis and using the Y axis as the solution. Results: there was great difference in the rate of acid preparation among different manufacturers. Only 3 samples from 6 manufacturers of tablets comply with the regulations, and only 4 samples from 15 manufacturers of chewable tablets comply with the regulations. Conclusion: the speed of preparation of magnesium bicarbonate tablets and chewing tablets is affected by raw materials and fillers, The influence of disintegrating agent, disintegration time and wettability of the preparation were directly related to the rate of acid preparation.
【作者单位】：黑龙江省食品药品检验检测所;
【分类号】：R927.1

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