滚球法测试可乐定透皮贴片初黏力的优化研究  

Optimization of Test Method for Tack of Clonidine Transdermal Patches by Rolling Ball

作　　者：贺婕 海燕 赵超越 李肖青 HE Jie;HAI Yan;ZHAO Chao-yue;LI Xiao-qing(China National Pharmac-eutical Group Shanxi Rfl Pharmaceutical Co.,Ltd,Taiyuan 030032,China)

机构地区：[1]国药集团山西瑞福莱药业有限公司,山西太原030032

出　　处：《海峡药学》2023年第9期43-47,共5页Strait Pharmaceutical Journal

摘　　要：目的研究滚球法测试可乐定透皮贴片初黏力的影响因素,提高检测结果的精密度。方法考察分别在不同温度(18℃、20℃、22℃、24℃、26℃、28℃)、不同湿度(30%、40%、50%、60%、70%、80%)按中国药典2020版通则0952所规定的助滚段距离、样品黏贴面长度和国标GB/T4852-2002所规定的条件下产品的初黏力变化。并采用响应曲面法考察温度、湿度、样品黏贴面长度及助滚段距离对检测结果精密度的影响。结果最优检测条件为:温度23℃,相对湿度60%,样品黏贴面长度8 cm,助滚段距离50 mm。结论优化的检测条件可明显改善可乐定透皮贴片初黏力检测结果的精密度,为其它贴剂和贴膏剂初黏力检测提供参考。OBJECTIVE To investigate the influencing factors of test method for tack of clonidine trandermal patches by rolling ball,improve the precision of quality control in the tests.METHODS Comparing Ch.P2020〈0952〉adhesion test method 1 to GB/T4852-2002 test method for tack of pressure sensitive adhesive tapes by rolling ball method,the respective results were investigated under different temperatures(18℃、20℃、22℃、24℃、26℃、28℃),humidities(30%、40%、50%、60%、70%、80%),respectively.The response surface methodology was used to investigate the effects of temperature,humidity,the length of adhesive,starting distance on the precisions of results.RESULTS The optimal conditions were:temperature 23℃,humidity 60%,the adhesive sample length 8 cm,starting distance 50 mm.CONCLUSION The optimized conditions can improve the precision of tack test,and provide reference value for further detecting tack test of other patches and plasters.

关 键 词：初黏力 滚球法 可乐定透皮贴片 

分 类 号：R927[医药卫生—药学]