泮托拉唑钠药物-树脂液体缓释混悬液的制备及体内外评估

IF 0.7 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Xinyi Tang, Xianghuan Meng, Ke Li, Zhannuan Yin, Haibing He, Hongfei Liu
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引用次数: 0

摘要

为提高儿童、老年人和吞咽困难患者消化性溃疡治疗的有效性、便利性和安全性,本研究制备了泮托拉唑钠药物-树脂液体缓释混悬液(PAZ-Na)。泮托拉唑钠药物-树脂复合物(PAZ-Na-DRC)采用浴法制备。采用流化床包衣法将其包衣,然后加入辅料制成干混悬液备用。对体外释放实验条件的参数进行了优化,药物释放曲线显示延迟释放。大鼠经胃内给药服用商品 PAZ-Na 肠溶颗粒胶囊和 PAZ-Na 缓释混悬液。结果表明,与 PAZ-Na 肠溶颗粒胶囊相比,PAZ-Na 缓释混悬液的 Tmax 从 2 小时增加到 4 小时。同样,Cmax 也从 6.162μg/mL 降至 3.244μg/mL,与商品胶囊相比,浓度-时间曲线非常平缓。口服后,PAZ-Na 缓释混悬液的相对生物利用度(AUC0-24 为 19.578 μg-h-mL-1)比商品药(AUC0-24 为 17.388 μg-h-mL-1)高 112.67%。研究结果表明,口服 PAZ-Na 缓释混悬液配制成功,药代动力学指标得到极大改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preparation and in vitro/in vivo evaluation of a pantoprazole sodium drug-resin liquid delayed release suspension.

A drug-resin liquid delayed-release suspension of pantoprazole sodium (PAZ-Na) was prepared to improve the effectiveness, convenience and safety of peptic ulcer treatment in children, the elderly and patients with dysphagia. Pantoprazole sodium drug-resin complexes (PAZ-Na-DRC) were prepared using the bath method. The fluidized bed coating method is used to coat it and then add excipients to make a dry suspension prepared before use. The parameters of the in vitro release experimental conditions were optimized and the drug release curve showed delayed release. Rats were given commercial PAZ-Na enteric-coated pellet capsules and the PAZ-Na delayed release suspension via intragastric administration. The results showed that the Tmax of the PAZ-Na delayed release suspension was increased from 2h to 4h compared with the PAZ-Na enteric-coated pellet capsules. Similarly, the Cmax was reduced from 6.162μg/mL to 3.244μg/mL with the concentration-time curve is very gentle compared with the commercial drug capsules. After oral administration, the relative bioavailability of PAZ-Na delayed release suspension (AUC0-24 of 19.578 μg•h•mL-1) compared with the commercial drug (AUC0-24 of 17.388 μg•h•mL-1) was 112.67%. The findings showed that the PAZ-Na delayed release suspension for oral administration was successfully formulated with highly improved pharmacokinetic indices.

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来源期刊
CiteScore
1.40
自引率
12.50%
发文量
211
审稿时长
4.5 months
期刊介绍: Pakistan Journal of Pharmaceutical Sciences (PJPS) is a peer reviewed multi-disciplinary pharmaceutical sciences journal. The PJPS had its origin in 1988 from the Faculty of Pharmacy, University of Karachi as a biannual journal, frequency converted as quarterly in 2005, and now PJPS is being published as bi-monthly from January 2013. PJPS covers Biological, Pharmaceutical and Medicinal Research (Drug Delivery, Pharmacy Management, Molecular Biology, Biochemical, Pharmacology, Pharmacokinetics, Phytochemical, Bio-analytical, Therapeutics, Biotechnology and research on nano particles.
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