物性测试仪用于制剂软材特征物理性质的表征方法研究  

Evaluating method of the characteristic physical properties of the wetting mass using texture analyser

作　　者：高雅[1,2] 洪燕龙[1,3] 鲜洁晨[1,3] 张宁 冯怡[1,3] 杨秀娟[1,3] 

机构地区：[1]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [2]上海中医药大学科技实验中心,上海201203 [3]上海张江中药现代制剂技术工程研究中心,上海201203

出　　处：《药学学报》2012年第8期1049-1054,共6页Acta Pharmaceutica Sinica

基　　金：上海市教委创新项目(10YZ57),上海市教委重点学科资助项目(J50302);上海市自然科学基金资助项目(09ZR1429600);上海市科委中药现代化专项资助项目(10DZ1973000);上海高校选拔培养优秀青年教师科研专项基金资助项目(szy09006)

摘　　要：为建立制剂软材特征物理性质的表征方法,以蒸馏水为黏合剂,将微晶纤维素制备成软材,采用物性测试仪的质构曲线解析法测试硬度、黏附性、弹性、内聚性、咀嚼性和回复性等物理性质,优选出可以表征制剂软材特征物理性质的方法与条件,并进行方法学考察,同时采用此方法对不同型号的微晶纤维素及聚乙烯吡咯烷酮所制备的软材进行测试。当执行触发力为1 500 g时,质构曲线解析法得到的数据相对标准偏差小于10%,各特征物理性质随着润湿剂的增加,其变化趋势与理论结果相符。同一辅料的相同含水率的软材,其测定结果的精密度较高,而同一辅料的不同含水率的软材以及不同辅料所制备的软材各特征物理性质间的结果有较大差异性。用物性测试仪对软材物理性质进行测试,各特征物理性质随加水量增加的变化趋势与理论结果基本一致,且具有较好的精密度、准确性和灵敏度,能够较好表征制剂软材的特征物理性质。To build the evaluating method of the characteristic physical properties of the wetting mass,this study reported the preparation of wetting mass by adding water into microcrystalline cellulose,and using texture analyser texture profile analysis to test its physical properties,including hardness,adhesiveness,springness,cohesiveness,chewiness,resilience and so on,then finding out the better method and parameters.The method was evaluated and used to test wetting mass,which was made of microcrystalline cellulose of different types and polyvinylpyrrolidone.When running texture profile analysis whose trigger force was 1 500 g,the relative standard deviation was under 10%,and the trend of every characteristic physical property tallied with the theory result by water ratio increase.Testing result of the same excipient with the same water ratio had a higher precision,while characteristic physical properties of wetting mass who was made of the same excipient with different water ratios and different excipients had a great difference.Using texture analyser to test physical properties of wetting mass could get a result which tallied with the theory by water ratio increase,and had a well precision,accuracy and sensitivity,and thus it could also evaluate the characteristic physical properties of wetting mass relatively well.

关 键 词：物性测试仪 软材 物理性质 

分 类 号：R943[医药卫生—药剂学]