探针法测定吲哚美辛凝胶剂粘附力的方法研究  

Study on the adhesion of indomethacin cataplasm by probe method

作　　者：李玉凤 邢绍荣 左宁[1] 陈华[1] LI Yu-feng;XING Shao-rong;ZUO Ning;CHEN Hua(National Institutes for Food and Drug Control,Beijing 102629,China;China Pharmaceutical University,Nanjing 211100,China;Parexel International,Beijing 100020,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]中国药科大学,南京211100 [3]精鼎医药研究开发(上海)有限公司,北京100020

出　　处：《药物分析杂志》2020年第5期948-951,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重大新药创制(2015ZX09303001002)。

摘　　要：目的:建立探针法测定吲哚美辛凝胶膏剂黏附力的方法,并考察影响贴剂黏附力检测的因素。方法:采用多功能材料试验机测定,以1 cm^2酚树脂板作为接触介质,接触时施加100克力(gf)于样品上,以300 mm·min^-1的速度进行分离,测定分离产生的最大作用力,同时与2015年版《中华人民共和国药典》(简称《中国药典》)通则<0952>黏附力测定法第一法测定结果进行比对。测定不同储存条件下凝胶膏剂含水量对黏附力的影响。结果:探针法测量结果与滚球法有一定的对应关系,即黏住较大球号的凝胶膏剂其对应的探针法粘附力也较大。高温或者低湿的存储条件下,凝胶膏剂的水分与黏附力呈负相关,Y=-3.3872X+376.18(R2=0.8825),水分与初黏力之间线性关系良好。结论:探针法具有较好的可操作性和重现性,比滚球法有更好的质量区分性。该法可以作为凝胶膏剂黏附力质量控制的方法。Objective:To establish a method for the determination of the adhesion of indomethacin cataplasm by probe method,and to investigate the influencing factors of patch adhesion.Method:With a multifunctional material testing machine,100 gf was applied to the cataplasm within 1 cm^2 contact surface that is made of phenol resin.The maximum force generated by separation at a speed of 300 mm·min^-1 was recorded.These results were compared to those from the Chinese Pharmacopoeia 2015(ChP 2015)<0952>adhesion test method 1.The effect of the water content of the cataplasm on adhesion was investigated.Results:There exists a correlation between the results from rolling ball method and probe method.The adhesion of the batches that the larger ball size was adhered corresponds to the greater observed values in the probe method.There exists an obvious negative correlation between water content and adhesion with a good linearity of Y=-3.3872 X+376.18(R2=0.8825).Conclusion:Given that the probe method has a good practicability and reproducibility,especially a better quality discrimination than the rolling ball method,it can be used as a quality control method for the adhesion of the cataplasm.

关 键 词：探针法 滚球法 黏附力 凝胶膏剂 吲哚美辛 透皮给药 

分 类 号：R917[医药卫生—药物分析学]