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目的:研究长春西汀自微乳化释药系统(VIN-SMEDDS)的体外释药特性。方法:进行了体外释放度实验,考察释放度实验方法学、释放介质、转速和制剂因素对药物释放特性的影响。结果:释放度实验方法学、释放介质、转速和制剂处方因素都会对药物释放测定结果造成影响。采用反相透析技术能较好地模拟口服后的体内生理情况,在人工肠液中,转速50r·min~(-1)下,VIN-SMEDDS 累积释放百分率3h 达到68.45%。SMEDDS 制剂的电性对释放基本无影响,VIN-SMEDDS 的体外释放比长春西汀自乳化释药系统(VIN-SEDDS)好。结论:长春西汀自乳化释药系统显著提高了药物的释放速度和程度。体外反相透析释放实验的透膜限速过程属于被动扩散过程。
Objective: To study the in vitro release characteristics of vinpocetine self-microemulsifying drug delivery system (VIN-SMEDDS). Methods: The in vitro release test was carried out to investigate the effects of experimental methods, release medium, rotational speed and formulation factors on drug release characteristics. Results: The release assay methodology, media release, rotational speed, and formulation prescriptions all have implications for the drug release assay. Reverse dialysis was used to simulate the in vivo physiological conditions after oral administration. The cumulative release percentage of VIN-SMEDDS reached 68.45% at 50r · min -1 in artificial intestinal juice. The electrical properties of SMEDDS formulations had virtually no effect on release, and the release of VIN-SMEDDS in vitro was better than that of Vinpocetine self-emulsifying drug delivery system (VIN-SEDDS). CONCLUSION: Vinpocetine self-emulsifying drug delivery system significantly increases the rate and extent of drug release. In vitro anti-phase dialysis release experiment of the rate-limiting process is a passive diffusion process.