摘要
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。
The trimetazidine dihydrochloride osmotic pump tablets were prepared. The effects of osmotic pressure promoting agents, coating materials, coating levels and contents of porogenic agent on drug release in water were investigated by single factor experiment. The drug release behaviors of the optimized tablets in water, 0.1 mol/L hydrochloric acid and pH 6.8 phosphate buffer were similar. The pharmacokinetics in Beagle dogs of the products was investigated with the trimetazidine dihydrochloride tablets （Vasorel） as the reference preparation. The pharmacokinetic parameters for the reference and test tablets were tmax（0.75±0.29） and （5.50±1.00）h, MRT （4.8±0.2） and （13.0±0.7）h, respectively. It indicated that the osmotic pump tablets perform an obvious sustained-release hehnvinr.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2011年第10期752-756,共5页
Chinese Journal of Pharmaceuticals
关键词
盐酸曲美他嗪
渗透泵
体外释放
药动学
trimetazidine dihydrochloride
osmotic pump tablet
release
pharmacokinetics
