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以篮法和往复筒法测定自制盐酸普拉克索蜡质缓释骨架片的体外释放度(F),采用HPLC法测定释放介质中的药物。采用HPLC-MS/MS法测定Beagle犬单剂量口服市售片或自制片后血浆中的药物浓度。根据市售片血药浓度的拟合结果确定采用Loo-Riegelman法计算自制片的体内吸收百分数(X)。将两法得到的F分别与X进行线性回归,用所得线性方程的相关系数与临界值进行比较。结果表明,两个方程的相关系数为0.97和0.99,均大于临界值r(0.001,6)=0.92,表明两法建立的体内外相关性(IVIVC)均具有显著意义,且采用往复筒法建立的IVIVC更显著,因此更适合考察缓释片的体外释放度以建立良好的IVIVC。
In vitro release (F) of homemade Pramipexole Wax sustained-release matrix tablets was determined by basket method and reciprocating tube method, and the drug release medium was determined by HPLC. The concentration of drug in the Beagle dog single-dose oral commercial tablet or self-made plasma was determined by HPLC-MS / MS. The percentage absorption (X) in vivo of the self-made tablets was calculated using the Loo-Riegelman method based on the fitting results of the commercially available blood plasma concentrations. The linear regression of F obtained from the two methods with X and the correlation coefficient of the linear equation obtained are compared with the critical values. The results showed that the correlation coefficients of the two equations were 0.97 and 0.99, both of which were greater than the critical value r (0.001,6) = 0.92, indicating that IVIVC established by the two methods had significant significance and established by reciprocating cylinder method Of IVIVC is more significant, so it is more suitable to investigate the release of sustained release tablets in vitro to establish a good IVIVC.