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 黑龙江省食品药品检验检测所 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 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。 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@ 收稿日期：2016年11月16日 Study on neutralising speed of hydrotalcite tablets and hydrotalcite 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 release test (Ch P 2015.VolⅣ0931 the third method) .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-1) , and mix at 200 r·min-1.Record the p H of the solution in real-time within 60 minutes, and draw the acid curve (the X axis is time, the Y axis is the p H of the solution) .Results: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 hydrotalcitc tablets and hydrotalcite chewable tablets was affected by raw materied, fillers and disintegrating agent.The dismtegration time and wettability of preparation are directly related to the neutralising speed. Keyword： hydrotalcitetablets; hydrotalcite chewable tablets; neutralisingspeed; acidcurve; An