冻干口崩片的质量评价研究  

Quality evaluation of lyophilised orally disintegrating tablets

作　　者：李思潼[1] 薛婉莹 李红鑫 孙常胜 吴婧楠 邱旖 吴雪纯 蒋巧萍 宇泉霖 孙腾跃 张欣悦 张金玲 蔡程科[1] 王洪飞 LI Si-tong;XUE Wan-ying;LI Hong-xin;SUN Chang-sheng;WU Jing-nan;QIU Yi;WU Xue-chun;JIANG Qiao-ping;YU Quan-lin;SUN Teng-yue;ZHANG Xin-yue;ZHANG Jin-ling;CAI Cheng-ke;WANG Hong-fei(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488;Beijing Quantum Hi-tech Pharmaceutical Co.,Ltd,Beijing 102200)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京量子高科制药科技有限公司,北京102200

出　　处：《中南药学》2022年第6期1274-1279,共6页Central South Pharmacy

基　　金：国家科技重大专项研发项目(No.2011ZX09201-201-15);北京市科技计划专项研发项目(No.Z16010101390)。

摘　　要：目的寻找评价冻干口崩片质量的方法,准确客观地评价冻干口崩片的质量。方法筛选出10种具有代表性的冻干口崩片,通过外观、片重差异、崩解时限、水分、真密度、比表面积、孔隙率、引湿性试验等方面对其进行质量评价,使用SPSS 20.0对评测结果进行相关性分析。结果除百荷冻干含化糖外,其余9种冻干口崩片各检测项目均合格;相关性分析显示,水分含量与比表面积成负相关;水分含量与引湿性成正相关;崩解时限与孔隙率成负相关;真密度与比表面积成正相关。结论本研究建立了评价冻干口崩片质量的方法,方法简单可行,结果可靠,为后续冻干口崩片质量评价体系的建立奠定了基础。Objective To evaluate the quality of lyophilised orally disintegrating tablets,and the quality of freeze-dried orally disintegrating tablets accurately and objectively.Methods Ten representative lyophilised orally disintegrating tablets were screened out,and their quality was evaluated from appearance,difference in tablet weight,disintegration time limit,moisture,true density,specific surface area,porosity,and hygroscopicity test.SPSS 20.0 was used for the correlation analysis of the evaluation results.Results Except for the Baihe lyophilized sugar,all test items of the others 9 lyophilised orally disintegrating tablets were qualified.The correlation analysis showed that the moisture content was negatively correlated with the specific surface area.The moisture content was positively correlated with the hygroscopicity.The disintegration time is negatively correlated with the porosity.The true density was positively correlated with the specific surface area.Conclusion The methods to evaluate the quality of freeze-dried orally disintegrating tablets are established.The methods are simple,feasible,and reliable,which lays a foundation for establishment of the subsequent quality evaluation system for lyophilised orally disintegrating tablets.

关 键 词：口腔崩解片 冻干法 质量评价 相关性分析 加速试验 

分 类 号：R944[医药卫生—药剂学]