碳酸锂片的制备及体外溶出行为考察  

Preparation and in vitro dissolution behavior of lithium carbonate tablets

作　　者：胥骞 戴慧 李鸣 端木彦涛 王福东[1] 彭东明[1] 袁秀菊 罗隽 向大佐 XU Qian;DAI Hui;LI Ming;DUAN-MU Yan-tao;WANG Fu-dong;PENG Dong-ming;YUAN Xiu-ju;LUO Juan;XIANG Da-zuo(School of Pharmacy,Hunan University of Chinese Medicine,Changsha 410208;Hunan Qianjin Xiangjiang Pharmaceutical Co.,Ltd.,Zhuzhou Hunan 412003)

机构地区：[1]湖南中医药大学药学院,长沙410208 [2]湖南千金湘江药业股份有限公司,湖南株洲412003

出　　处：《中南药学》2023年第5期1177-1182,共6页Central South Pharmacy

基　　金：湖南省自然科学株洲联合基金资助项目(No.2019JJ60071);湖南省药学一流学科开放基金(No.科函[2021]8号-2021YX12)。

摘　　要：目的制备碳酸锂片,并考察其体外溶出行为。方法以马铃薯淀粉、小麦淀粉、羧甲基淀粉钠和硬脂酸镁为辅料制备碳酸锂片;采用单因素试验,以水含量、休止角、硬度、脆碎度、崩解时限和溶出度为指标筛选片剂处方,比较自制片剂与参比制剂(进口片剂)在pH 1.0、pH 4.5、pH 6.8和水4种不同介质中的体外溶出曲线。结果确定了碳酸锂片的制备工艺,最佳处方为75.3%的碳酸锂片原料药、15%的马铃薯淀粉(淀粉浆浓度10%)、2%的羧甲基淀粉钠、7.2%的小麦淀粉、0.5%的硬脂酸镁;在4种介质中,自制片剂与进口片剂溶出行为均相似。结论自制的碳酸锂片处方合理、工艺可行、质量可控,其体外溶出行为与进口片剂相似。Objective To prepare lithium carbonate tablets and determine their in vitro dissolution behaviors.Methods Lithium carbonate tablets were prepared with potato starch,wheat starch,sodium carboxymethyl starch and magnesium stearate as excipients.The formulation of tablets was selected by single factor test based on the moisture,resting angle,hardness,brittleness,disintegration time and dissolution.The in vitro dissolution profiles of prepared tablets and the reference formulations(imported tablets)were compared in 4 media wuth pH 1.0,pH 4.5,pH 6.8,and water.Results The preparation process of lithium carbonate tablets were established.The optimal prescription by singlefactor test included:75.3%lithium carbonate API,15%potato starch slurry(10%concentration),2%sodium carboxymethyl starch(addititon),7.2%wheat starch and 0.5%magnesium stearate.The dissolution behaviors of prepared tablets and the imported tablets were similar in the 4 media.Conclusion The prepared lithium carbonate tablets have feasible process,reasonabl prescription and controllable quality,and their in vitro dissolution behaviosr are similar to those of imported tablets.

关 键 词：碳酸锂片 制备工艺 单因素试验 体外溶出 

分 类 号：R943[医药卫生—药剂学]