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同一药物,虽然剂型、剂量相同,但不同厂家生产的产品,其溶出速度和生物利用度可能不同,此已由许多药品所证实(例如泼尼松、甲基磺丁脲、地高辛等).若溶出速度与生物利用度有一定相关关系,通常可用溶出速度控制药剂质量.本文作者用药物在水中的分散程度代替溶出速度试验,方法简便省时.采用A,B,C,D四个不同厂家生产的烟酸生育酚酯(TN)硬胶囊剂为样品,分别将药粉轻轻地撒在100ml水面上,立即观察其分散的快慢和程度,结果表明C立刻分散,10min后仍甚均匀混悬,D则10min后仍飘浮在水面上.四个样品的分散程度依C,B,
The same drug, though of the same dosage form and dosage, may differ in its dissolution rate and bioavailability from products produced by different manufacturers and has been demonstrated by many medications (eg prednisone, methylbutamide, digoxin, etc.) If the dissolution rate and bioavailability have a certain relationship, usually the dissolution rate can be used to control the quality of the drug.In this paper, the drug dispersion in the water instead of the dissolution rate test, the method is simple and time-saving using A, B, C, D four Different manufacturers of tocopherol nicotinate (TN) hard capsules as a sample, respectively, the powder sprinkled gently on 100ml of water, immediately observe the speed and degree of dispersion, the results show that C immediately dispersed, even after 10min even Suspended, D is still floating on the water after 10min.The degree of dispersion of the four samples according to C, B,