纯尼索地平混悬液与尼索地平双螺旋混悬液药代动力学参数的比较评估

Ghada Hamid Naji, Fatima Jalal Al-Gawhari
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引用次数: 0

摘要

胆糖体是一种纳米载体,在其囊状双层中含有胆汁盐,从而增强了其在胃肠道中的灵活性和耐久性。与传统的囊泡系统不同,它们具有明显的优势,如简化生产程序、节约成本和提高稳定性。本研究的主要目的是比较尼索地平(NSD)在服用普通 NSD 悬浮液和 NSD 双糖体悬浮液后的药代动力学参数。研究使用了 60 只体重为 200±15 克的瑞士白化大鼠,分为两组(每组 30 只)。第一组大鼠服用 2.2 mg/kg 剂量的普通 NSD 悬浮液,第二组大鼠服用相同剂量的 NSD 双糖体悬浮液。采用高效液相色谱法测定大鼠血浆中的 NSD 含量。结果显示,纯悬浮剂的Cmax、Tmax和AUC0-36分别为51.47±0.94 ng/mL、2±0.3 h和323.33±21 ng×h/mL,双糖体悬浮剂的Cmax、Tmax和AUC0-36分别为116.41±1.22 ng/mL、4±0.7 h和916±64.09 ng×h/mL。单剂量 NSD 给药 36 h 后,纯悬浮剂和双糖体制剂的最大浓度有明显差异(P<0.05),而纯悬浮剂的相对生物利用度是双糖体悬浮剂的 2.9 倍。总之,制备的双糖体混悬液提高了NSD的生物利用度,可被视为一种重要的给药系统。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative evaluation of pharmacokinetic parameters between a pure nisoldipine suspension and a nisoldipine-loaded bilosome suspension
Bilosomes are nanocarriers that contain bile salts in their vesicular bilayer, thereby enhancing their flexibility and durability in the gastrointestinal tract. Unlike conventional vesicular systems they provide distinct advantages such as streamlined manufacturing procedures, cost efficiency, and improved stability. The main objective of this study was to attain a comparison of the pharmacokinetic parameters of nisoldipine (NSD) after administering an ordinary NSD suspension and an NSD-loaded bilosome suspension. The study used 60 Swiss albino rats weighing 200±15 g and divided into two groups (n=30 each). A dose of 2.2 mg/kg of NSD was administered from the ordinary NSD suspension to the rats of the first group and the same dose of NSD-loaded bilosome suspension was administered to the rats of the second group. NSD levels were determined in the rat plasma by using high-performance liquid chromatography. Our results showed that the Cmax, the Tmax, and the AUC0-36 were 51.47±0.94 ng/mL, 2±0.3 h, and 323.33±21 ng×h/mL for the pure suspension, and 116.41±1.22 ng/mL, 4±0.7 h, and 916±64.09 ng×h/mL for the bilosome suspension, respectively. The maximum concentration was significantly different between the pure and the bilosomal preparation (P<0.05), while the relative bioavailability of the pure suspension was 2.9 times that of the bilosomal suspension, 36 h after a single-dose NSD administration. In conclusion, the prepared bilosomal suspension enhanced the bioavaila¬bility of NSD, and could be considered as a vital delivery system.
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