铝碳酸镁片及咀嚼片的制酸速度研究.docVIP

铝碳酸镁片及咀嚼片的制酸速度研究 刘天扬 杨杨 吴雨川 于新颖 刘利群 白政忠 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 mL水屮后，加盐酸滴定液仃 mol ? L ［） 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pH,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。 关键词： 铝碳酸镁片;铝碳酸镁咀嚼片;制酸速度;制酸曲线;影响因素分析;填充剂; 崩解剂;崩解时间;润湿性; 作者简介:刘天扬 Tel: （0451）E-mail: liutianyang@sina. com 收稿日期：2016年11月16日 Study on neutralising speed of hydrotalcite tablets and hydrotaleite chewable tablets LIU Tian-yang YANG Yang WU Yu-chuan YU Xin-ying LIU Li-qun BAI Zheng-zhong Heilongjiang Institute for Food and Drug Control; Abstract： Objective:To establish an acid curve method for the neutralising speed of hydrotalcite tablets and hydrotalcite chewable tablets, and analyze the influencing factors of the neutralising speed. Methods:Carry out the device of the dissolution and drug releeise test (Ch P 2015. VolIV0931 the third met hod) . Weigh a quantity of the powder, evenly disperse in 190 m L of water, then add 10 m L of Hydrochloric acid titration solution (1 mol ? L , and mix at 200 r ? min l. Record the p H of the solution in real-time with in 60 min utes, and draw the acid curve (the X axis is time, the Y axis is the p 11 of the solution) ? ResuIts:The neutralising speed was a large difference among the different productor. There were only 3 of 6 tablets producters met the requirments and only 4 of 15 chewable tablets producters met the requirments. Conclusion:The neutralising speed of hydrotalcite tablets and hydrotalci te chewable tablets was affected by raw mater ied, fillers and disintegra ting age nt. The disintegration time and wettability of preparation arc directly related to the neutralising speed. Keyword： hydrotalcitetablets; hydrotalcite chewable tablets; neutmlisingspeed; acidcurvc; Analysis of influencing factors; fillers; disintegrating agent; disintegration time; wet