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。
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 （ ChP 2015.Vol IV 0931 the third method ）. Weigh a quantity of the powder, evenly disperse in 190 mL of water, then add 10 mL of Hydrochloric acid titration solution （ 1 mol· L-1 ）, and mix at 200 r· min-1. Record the pH of the solution in real-time within 60 minutes, and draw the acid curve （ the X axis is time, the Y axis is the pH 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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2017年第11期2087-2092,共6页
Chinese Journal of Pharmaceutical Analysis
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
hydrotalcitetablets
hydrotalcite chewable tablets
neutralisingspeed
acidcurve
Analysis of influencing factors
fillers
disintegrating agent
disintegration time
wettability
