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制备了盐酸曲美他嗪渗透泵片,并采用单因素试验考察了渗透压促进剂种类、包衣材料和增重以及致孔剂用量对药物在水中释放的影响。优化后制品在水、0.1 mol/L盐酸和pH 6.8磷酸盐缓冲液中的释放行为相似。以市售盐酸曲美他嗪片(商品名万爽力)为参比制剂,考察了自制渗透泵片在Beagle犬体内的药动学。结果表明,参比制剂和自制品的t_(max)为(0.75±0.29)和(5.50±1.00)h,MRT为(4.8±0.2)和(13.0±0.7)h,可见自制品表现出明显的缓释行为。
Trimetazidine hydrochloride osmotic pump tablets were prepared, and the effects of different types of osmotic pressure enhancers, coating materials and weight gain, and the amount of porogen on drug release in water were investigated by single factor test. The release behavior of the optimized product in water, 0.1 mol / L hydrochloric acid and pH 6.8 phosphate buffer was similar. Trimetazidine hydrochloride tablets (trade name Wan Shuangli) as a reference preparation, investigated the self-made osmotic pump tablets in Beagle dogs pharmacokinetics. The results showed that the t_ (max) of reference preparations and self-made products were (0.75 ± 0.29) and (5.50 ± 1.00) h and MRT was (4.8 ± 0.2) and (13.0 ± 0.7) Slow release behavior.