己酮可可碱巴布剂的研制及质量评价

Preparation and quality evaluation of the pentoxifylline transdermal delivery system of poultice

目的制备己酮可可碱巴布剂并按照《中华人民共和国药典》(2 0 0 0版 )的有关规定对其进行体外质量评价。方法通过正交实验确定己酮可可碱巴布剂的优化处方 ,利用Franz扩散池研究己酮可可碱的体外经皮渗透性 ,用HPLC法测定药物的经皮渗透量。结果己酮可可碱巴布剂经皮行为呈零级模式 ,2 4h累积渗透量为 1 98mg·cm-2 ,质量考察结果表明各项指标均符合要求 ;5 %NMP的增渗倍数最大 ,为 2 61。结论己酮可可碱巴布剂质量可控 ,刺激性小 ,是一种安全。

Objective To prepare the pentoxifylline poultice and evaluate its quality.Methods Optimized formulation of pentoxifylline poultice was determined by using the orthogonal experiment.The Franz diffusion cell was used to study the in vitro permeation behavior.Samples were assayed by the HPLC method. Results The skin permeation conformed to the zero-order behavior.The 24 h cumulative permeated amounts of pentoxifylline from optimized poultice across the excised rat′s skin were 1.98 mg·cm -2.The quality evaluation of pentoxifylline poultice showed that each item was up to the scratch.The ER of 5% NMP was as high as 2.61.Conclusion The pentoxifylline poultice is well qualified without skin irritation,which is a safe and effective transdermal delivery system.