化学药品仿制药凝胶贴膏药学研究关注点探讨OA
Discussion on pharmaceutical research concerns of chemical generic drugs cataplasms
凝胶贴膏系指原料药物与适宜的亲水性基质混匀后涂布于背衬材料上制成的贴膏剂,具有使用方便、给药剂量准确、避免肝脏首过效应、皮肤刺激性小等优势.本文结合凝胶贴膏药典标准及已上市药品情况,对凝胶贴膏处方工艺、质量研究和质量控制、稳定性和包装等方面进行探讨,希望有助于凝胶贴膏的开发,助推更多高质量凝胶贴膏产品上市.
Cataplasm is made by mixing drug substances with a suitable hydrophilic matrix and then coating it on the backing material.Cataplasm has the advantages of convenient use,accurate dosage,avoidance of the first-pass effect of the liver and little skin irritation.Discussions on formulation and manufacturing process,quality research and quality control,stability and packaging of cataplasm were based on the marketing drug and pharmacopoeia standards.These discussions are expected to guide the development of cataplasm,and promote marketing of high-quality cataplasms.
张钊瑞;冯雪;胡延臣
国家药品监督管理局药品审评中心,北京 100076国家药品监督管理局药品审评中心,北京 100076国家药品监督管理局药品审评中心,北京 100076
医药卫生
凝胶贴膏处方工艺质量控制稳定性和包装
CataplasmFormulation and manufacturing processQuality controlStability and packaging
《药学研究》 2026 (5)
536-541,6
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