铝碳酸镁片及咀嚼片的制酸速度研究

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水中后，加盐酸滴定液（1 mol·L^-1）10 mL，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pH）。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.

[1] 孙儒品,薛淑英,于中麟,等.铝碳酸镁-新一代抗酸药[J].中国药学杂志,1995,30(2):122 SUN RP,XUE SY,YU ZL,et al.hydrotalcite-a new generation of antacids[J].Chin Pharm J,1995,30(2):122
[2] PLAYLE AC,GUNNING SR.The in vitro antacid and antic-pepsic activity of hydrotalcite[J].Pharm Acta Helv,1974,49:298
[3] 周晓平,钟柏松,仇炏.铝碳酸镁药理研究进展及临床应用[J].西北药学杂志,2001,16(4):183 ZHOU XP,ZHONG BS,CHOU Y.Pharmacology research progress and clinical application of hydrotalcite[J].Northwest Pharm J,2001,16(4):183
[4] 施昕磊,黄绳武.咀嚼片的研究进展[J].中国药业,2008,17(14):17 SHI XL,HUANGSW.Resarch progress in chewing tablets[J].China Pharm,2008,17(14):17
[5] 张筱红,刘天扬.抗酸药制酸力检验项目的规范化[J].中国药品标准,2011,12(5):323 ZHANG XH,LIU TY.Critical quality attributes,quality metrics and quality evaluation of antacids[J].Drug Stand China,2011,12(5):323
[6] 刘天扬,于新颖,寻延滨,等.抗酸药关键质量属性表征与质量评价[J].中国药品标准,2017,18(1):13 LIU TY,YU XY,XUN YB,et al.Antacids critical quality attributes and quality metrics,characterization and application of quality assessment[J].Drug Stand China,2017,18(1):13
[7] CHIAKI I,TOSHIAKI K,AYA K,et al.The quality evaluation of magnesium oxide tablets using and neutralization test and dissolution Test[J].Pharm Soc Jpn,2007,127(12):2085
[8] BP 2016[S].2016:676
[9] 中国药典2015年版.四部[S].2015:121 ChP 2015.Vol Ⅳ[S].2015:121
[10] 国家食品药品监督管理局国家药品标准WS1-(317)-2003Z[S] The National Drug Standards of China Food and Drug Administration WS1-(317)-2003Z[S]
[11] 国家食品药品监督管理局国家药品标准WS1-(284)-2003Z[S] The National Drug Standards of China Food and Drug Administration WS1-(284)-2003Z[S]
[12] 崔福德.药剂学[M].北京:人民卫生出版社,2011:126 CUI FD.Pharmacy[M].Beijing:People's Medical Publishing House,2011:126
[13] 敖玲玲,张晨芳,徐凯敏,等.几种常用崩解剂的理化性能及应用效果[J].中国医药指南,2015,13(16):20 AO LL,ZHANG CF,XU KM,etal.Properties and application of commomly useddisintegrants[J].Guide China Med,2015,13(16):20
[14] 陈和生.铝碳酸镁及其伪品的结构鉴定[J].分析仪器,2010, (5):36 CHENG HS.Structural identification of hydrotalcite and its counterfeit[J].Anal Instrum,2010(5):36
[15] 华东东,李鹤然,杨白雪,等.药用辅料接触角的测定及表面活性剂对辅料润湿性的调节作用[J].药学学报,2015,50(10):1342 HUA DD,LI HR,YANG BX,et al.Determination of contact angle of pharmaceutical excipients and regulating effect of surfactants on their wettability[J].Acta Pharm Sin,2015,50(10):1342