布洛芬固体分散体凝胶型中空栓的制备研究

Study on Preparation of Ibuprofen Solid Dispersed Gel Type Hollow Suppository

中空栓是栓剂的一种重要形式,有独特的优势。本实验首先用溶剂法制备布洛芬-PVP固体分散体,然后用半合成脂肪酸酯和卡波姆作基质制备为壳,最后采用热熔法制备成中空栓。制备的布洛芬中空栓在外观、重量差异、融变时限均符合规定,布洛芬质量浓度在4~20μg·mL^-1呈良好的线性关系,高、中、低浓度回收率分别为100.23%、99.08%、100.67%。本方法设计合理,工艺可行,质量检查符合有关规定。

Hollow suppository is an important form of suppository and has unique advantages. The solid dispersion of ibuprofen-PVP was prepared by solvent method, then the shell was prepared with semi-synthetic fatty acid Ester and Capomb as matrixes, and finally the hollow bolt was prepared by thermal melting method. The appearance, weight difference and time limit of the ibuprofen bolt were all in compliance with the regulations. The mass concentration of ibuprofen was well linear at 4~20 μg·mL^-1 , and the recovery rates of high, medium, and low concentrations were 100.23%, 99.08%, and 100.67%, respectively. This method had a sound design and feasible technology, and the examination of ibuprofen solid dispersion gel type hollow suppository met the requirements of Pharmacopoeia.