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通过对肝苏缓释胶囊在狗体内的PK—PD研究,考查肝苏缓释胶囊PK—PD相关性,评价肝苏缓释胶囊的内在质量。方法:采用以有效成分没食子酸为指标的药代动力学与以药理效应强度ALT为指标的药效动力学相结合的方法。结果:肝苏缓释胶囊在体内有较好的缓释作用,在狗体内的PK—PD有较好的相关性。结论:PK—PD能更客观地反映该制剂的内在质量,对临床给药方案的设计具有一定的指导意义。
Through the PK-PD study of Gansu Sustained-Release Capsules in dogs, the relevance of PK-PD in Gansu Sustained-release capsules was examined and the intrinsic quality of Gansu Sustained-release capsules was evaluated. Methods: The pharmacokinetics with the active ingredient gallic acid as the index and the pharmacodynamics with the pharmacological effect intensity ALT as the index were combined. RESULTS: Liver Su sustained-release capsules had better sustained release in vivo, and PK-PD in dogs had better correlation. Conclusion: PK-PD can more objectively reflect the intrinsic quality of the preparation, and has certain guiding significance for the design of clinical dosing regimen.