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比较了国内某一厂家3批卡马西平缓释片(受试制剂)与Tegretol(参比制剂)在不同pH介质中的体外释放度。采用桨板法,转速75 r/min,分别考察了受试制剂和参比制剂在不同释放介质(水、pH 4.5乙酸盐缓冲液和pH 6.8磷酸盐缓冲液)900 ml中的释放行为。结果显示,在上述3种介质中,受试制剂的批间差异显著,同批产品在不同介质中的释放行为也有显著差异。受试制剂的内在品质不如参比制剂。
The in vitro release of 3 batches of carbamazepine (test preparation) and Tegretol (reference preparation) in different pH media in a certain domestic manufacturer was compared. The propeller plate method was used at a rotational speed of 75 r / min to investigate the release behavior of test and reference preparations in 900 ml of different release media (water, pH 4.5 acetate buffer and pH 6.8 phosphate buffer) respectively. The results showed that among the above three media, there was significant difference between the test preparations and between the same batch of products in different media. The internal quality of the test preparation is inferior to the reference preparation.