摘要
分别以pH6.8 磷酸盐缓冲液和0.1mol/L HCl及其含0.1%、0.5%、1.0%十二烷基硫酸钠、10%乙醇的改性溶液作溶出介质,评价枸橼酸托瑞米芬片的溶出特性。测定结果显示,本品在pH6.8 磷酸盐缓冲液中几乎不溶出,60min时在后5种溶液中的溶出百分率分别为(44.26±13.00)%、(27.72±12.58)%、(46.20±9.68)%、(87.15±1.16)%和(78.27±9.38)%。后两者溶出参数b、T0.2、T0.3存在统计学差异(P<0.05)。
Dissolution properties of toremifene citrate tablets in pH 6.8 phosphate buffer solution and 0.1mol/L HCl,modified 0.1mol/L HCl (containing 0.1%, 0.5%, 1.0% SDS or 10% ethanol, respectively)were examined by HPLC method.A C18 column was used with the mobile phase of methanol-100mmol/L ammonium acetate solution-triethylamine (90∶10∶0.05), at the detection wavelength of 277nm. Toremifene citrate didn't release in pH 6.8 phosphate buffer solution.The dissolution rates in 0.1 mol/L HCl and its four modified mediums were(44.26±13.00)%, (27.72±12.58)%, (46.20±9.68)%, (87.15±1.16)%, (78.27±9.38)%, respectively. Weibull's model was used to analyze the different dissolu-tion properties in the latter two modified mediums. The result showed that the Weibull's parameters b, T0.2 and T0.3 weresignificant different(P<0.05).
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2004年第6期345-347,共3页
Chinese Journal of Pharmaceuticals