摘要
透皮贴剂作为一种特殊的剂型,其药物释放的程度和速度与贴剂和皮肤接触的面积、紧密程度和持续时间直接相关,所以黏附力是直接影响使用效果的一项重要的质控指标。国外不少生产企业已经针对透皮贴剂开发了专属性很强的检测项目。为适应贴剂黏附力检测的发展需要,中国药典2015年版附录草案中拟增加对贴剂黏附力的检测要求。本文简要介绍透皮贴剂黏附力的原理,分别针对初黏力、持黏力和剥离强度各自的检测方法进行简单的概述,并且对中国药典现行标准、中国药典2015版附录草案和国外相关检测标准进行详细的比对。通过比对各种方法的装置及优缺点,探讨目前提高中国药典贴剂黏附力检测方法的紧迫性和发展方向。
Transdermal delivery system（ TDS） is a kind of special dosage form. The release content and speed are closely relevant to the area,tightness and during- time of contact between skin and patches. So the adhesive power is an important test in quality control. A lot of industries have developed special test item for TDS. In order to comply with the need to measure the adhesive power of patch,there are new specifications in the draft of Appendixin Chinese Pharmacopeia 2015（ ChP 2015）. This paper briefly introduced the principle of the formation of adhesive power,and the adhesive test for quick stick power,shear strength and peel force of the TDS. The authors compared the testing methods from ChP 2010,draft of ChP 2015 and related specifications in foreign countries. After comparing the apparatuses in different methods and their advantages and disadvantages,the authors discussed the urgency and targets to improve the adhesion tests of TDS in ChP.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第8期1343-1347,共5页
Chinese Journal of Pharmaceutical Analysis
基金
重大新药创制课题--化学新药质量标准研究与评价技术平台(2011ZX09303-001)
关键词
透皮贴剂
黏附力
初黏力
持黏力
剥离强度
压敏胶
检测方法
药典
transdermal delivery system（TDS）
adhesion
quick stick power
shear strength
peel force
pressure-sensitive adhesive
test method
pharmacopeia
