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目的比较二黄凝胶贴膏与软膏的体外释放及透皮性能。方法采用Strat-M膜及改进的Franz扩散池进行体外释放及透皮试验,用高效液相色谱法定量分析制剂中君药独活的有效成分蛇床子素含量,测定两种剂型的体外释放度、透皮量及透皮率。结果二黄凝胶贴膏的透皮方程为Ln=0.443 6t+1.350 9,r=0.964 4,体外累积释放度、透皮量、透皮率分别为62.90%、0.067 2 mg/g、20.82%;二黄软膏的透皮方程为Ln=0.205 1t-0.244 7,r=0.995 6,体外累积释放度、透皮量、透皮率分别为77.64%、0.013 1 mg/g、9.36%。结论二黄凝胶贴膏的透皮量、透皮率均优于二黄软膏,透皮性能明显优于原剂型,且凝胶贴膏不易过敏,贴敷方便。
Objective To compare the in vitro release and transdermal properties of two yellow gel patches and ointments. Methods Strat-M membrane and modified Franz diffusion cell were used for in vitro release and transdermal test. The content of Osthole in the preparation was determined by high performance liquid chromatography (HPLC), and the in vitro release of the two dosage forms was determined. Transdermal volume and transdermal rate. Results The transdermal equation of two yellow gel patch was Ln = 0.443 6t + 1.350 9, r = 0.964 4, the cumulative release in vitro, transdermal volume and transdermal rate were 62.90%, 0.067 2 mg / g and 20.82% The transdermal formula of Erhuang Ointment was Ln = 0.205 1t-0.244 7, r = 0.995 6. The cumulative release, transdermal volume and transdermal rate were 77.64%, 0.013 1 mg / g and 9.36% respectively. Conclusion The transdermal volume and transdermal rate of two yellow gel patches are better than that of Erhuang ointment. The transdermal properties of the two yellow gel plasters are obviously better than that of the original one. Moreover, the plaster paste is not easy to be allergic and easy to attach.