水合氯醛口服溶液的处方筛选研究
Study on formulation screening of chloral hydrate oral solution
-
摘要: 水合氯醛是儿科临床检查前常用的中枢镇静药物, 但因其稳定性、适口性差, 严重影响临床使用的安全性和依从性。本文在考察不同处方稳定性前提下, 联用人体感官和仿生电子舌2种评价技术, 对水合氯醛口服溶液的适口处方进行筛选, 其中人体感官测试已按照药物临床试验质量管理规范的伦理要求经所有受试者知情同意。结果表明, 山梨醇、三氯蔗糖的添加可有效保障该口服溶液的稳定性; 山梨醇是主要的掩味成分, 40%山梨醇、0.5%三氯蔗糖配比下可有效掩蔽10%水合氯醛的苦味、涩味、辛辣味。感官评价与电子舌评价结果具有良好的相关性和互补性, 2种评价方式相互结合更有利于得到客观合理的结论。Abstract: Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.
下载: