中国临床药学杂志2025，Vol.34Issue(4)：266-271,6.DOI:10.19577/j.1007-4406.2025.04.005
复方维生素纳米乳口腔喷雾剂的制备及其体内外评价
Preparation and evaluation of compound vitamin nanoemulsion oral spray in vitro and in vivo
颜鑫 1刘鸿越 2张琦 1沙先谊 1秦莉2
作者信息
- 1. 复旦大学药学院药剂系,智能化递药教育部重点实验室,上海 201203
- 2. 安利(上海)科技发展有限公司,上海 201203
- 折叠
摘要
Abstract
AIM To address the issues of low bioavailability and slow absorption associated with traditional oral solid dosage forms of vitamin D3 and vitamin K.A compound vitamin nanoemulsion oral spray formulation containing vitamin D3 and vitamin K has been developed by leveraging the advantages of oral spray administration.The in vivo and in vitro effects of this formulation have been evaluated.METHODS A compound vitamin nanoemulsion oral spray containing vitamin D3 and vitamin K was prepared by high-speed shear emulsification.Following pharmaceutical standards,the physical properties of the formulation,including the polydispersity index(PDI),the total number of sprays per bottle,the amount per spray,and the spray load variation were evaluated.Additionally,LC-MS/MS was employed to analyze the main pharmacokinetic parameters and bioavailability of the spray in rabbits.RESULTS The optimized formulation exhibited a particle size of(150.8±10.4)nm with a PDI of 0.112 9±0.011 0.Each spray contains approximately(399±4)U of vitamin D3 and(90±4)μg of vitamin K,meeting the quality requirements for a spray.In vivo pharmacokinetic studies showed that the peak concentration(Cmax)of the main active metabolite(25-OH-VitD3),after oral spray administration was significantly higher than that of the oral tablet group(P＜0.05),and the time to reach the peak concentration(tmax)was significantly faster than that of the oral tablet group(P＜0.01).The oral spray showed 1.83 times greater bioavailability compared to the traditional oral formulation.CONCLUSION The vitamin nanoemulsion oral spray combines the advantages of nanotechnology and oral spray delivery,offering the benefits of convenient administration,rapid drug absorption,and high bioavailability.This innovative form could address slow absorption and low bioavailability issues in traditional vitamin medications,meeting consumer demands for convenience,efficiency,and safety.关键词
复方维生素纳米乳口腔喷雾剂/高速剪切乳化法/生物利用度/药物动力学/给药方式Key words
compound vitamin nanoemulsion oral spray/nanoformulation/bioavailability/pharmacokinetics/drug administration分类
化学工程引用本文复制引用
颜鑫,刘鸿越,张琦,沙先谊,秦莉..复方维生素纳米乳口腔喷雾剂的制备及其体内外评价[J].中国临床药学杂志,2025,34(4):266-271,6.
