中国药典膜剂通则修订的考量

Considerations for the Revision of General Requirements of Pharmaceutical Films in the General Chapter of the Chinese Pharmacopoeia

膜剂系指采用流延或挤出等方法将药物分散在成膜材料中制备的薄膜状制剂,由于给药方便、患者依从性好,近年来发展迅速,日益受到关注。该文梳理了上市的膜剂品种及其质量标准和贮存要求,调研了膜剂溶化时限和溶出度等质量检查项目的测定方法,结合《美国药典》《欧洲药典》和《日本药局方》要求,对《中华人民共和国药典》膜剂通则的修订做简要说明。

The pharmaceutical films are thin sheets formed by various methods such as casting or extrusion,which results in a dispersion of the active pharmaceutical ingredients through the film.They are subject to growing research and have received increasing interests recently due to their convenient administration and improved patient compliance.This review summarizes the marketed products of film dosage form,their quality standards,and storage requirements.Besides,the testing methods of quality inspection items including disintegration time and dissolution are discussed.Finally,brief explanations are provided for the revision of general requirements of pharmaceutical films in the general chapter of the Chinese Pharmacopoeia by comparing with the United States Pharmacopoeia,European Pharmacopoeia,and Japanese Pharmacopoeia.