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目的设计一种适用于冻干法制备口腔崩解片的崩解检查试验。方法根据冻干法制备口腔崩解片的特点和口腔内实际环境设计装置和实验方法,考察冻干法制备含不同配方和活性药物的口腔崩解片的崩解行为和崩解时限,并与志愿者体内(口腔内)崩解行为进行对比。结果可以有效检查口腔崩解片的崩解行为和时限,与体内试验比较,具有较强的相关性(r=0．91)。结论该法能体现冻干法口腔崩解片崩解行为体内外试验的一致性,可作为处方筛选和质量检查的参考方法之一。
Objective To design a disintegration test for oral preparation of lyophilized tablets. Methods The disintegration behavior and disintegration time of oral disintegrating tablets with different formulations and active drugs prepared by lyophilization were investigated according to the characteristics of the orally disintegrating tablets prepared by lyophilization and the practical environment design device and experimental method in oral cavity. Volunteers in vivo (oral) disintegration behavior comparison. The results can effectively check the disintegration behavior of oral disintegrating tablets and the time limit, compared with the in vivo test, has a strong correlation (r = 0.91). Conclusion The method can reflect the consistency of in vitro and in vivo tests of lyophilized oral disintegration tablets and can be used as one of the reference methods for prescription screening and quality inspection.