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目的:本文采用研磨法制备了对乙酰氨基酚-β-环糊精(β-CD)包合物,熔融法制备了其固体分散体。方法:建立了对酰氨基酚包合物及其固体分散体外溶出度测定方法。结果:对乙酰氨基酚包合物(1:1W/W)(A)和PEG6000固体分散体(1:2W/W)(B)的体外溶出参数Kr、T(50)、Td分别(A):0.833min(-1)、3.9min和4.4min;(B):0.506min(-1)、4.4min和5.1min。结论:经t检验,对乙酰氨基酚包合物及固体分散体与胶囊剂之间的T(50)、Td均有极显著性差异(P<0.01)。
OBJECTIVE: In this paper, acetaminophen-β-cyclodextrin (β-CD) inclusion complex was prepared by grinding method and its solid dispersion was prepared by melt method. Methods: A method for the determination of the dissolution of amidophenol inclusion complex and its solid dispersion was established. Results: Dissolution parameters Kr, T (50), Td (A) in vitro for acetaminophen inclusion complex (A) and PEG 6000 solid dispersion (1: 2 W / W) : 0.833 min (-1), 3.9 min and 4.4 min; (B): 0.506 min (-1), 4.4 min and 5.1 min. Conclusion: The T (50) and Td between acetaminophen inclusion complex, solid dispersion and capsule have significant difference (P <0.01) by t test.