L-瓜氨酸泡腾片的制备及其质量检测

Preparation and Quality Determination of L-citrulline Effervescent Tablets

以外观、崩解时限、硬度、口感为考察指标,采用正交试验优化了L-瓜氨酸泡腾片的配方;采用高效液相色谱-蒸发光散射法建立了L-瓜氨酸的含量测定方法。结果表明L-瓜氨酸泡腾片的最佳配方为:L-瓜氨酸30%,甘露醇32%,柠檬酸19.1%,碳酸氢钠15.9%,三氯蔗糖0.5%,甜菊糖苷0.4%,聚乙二醇6000 2%,PVPk30 0.1%。采用优化处方制备的泡腾片各项指标均符合《中国药典》2010年版标准,崩解迅速、口感良好、服用方便。测定方法简单快速,灵敏,可靠,专属性强,可作为L-瓜氨酸泡腾片的质量控制方法之一。

The preparation of L-cilrulline effervescent tables was op ＂ttmized by orthogonal design with appearance, disintegration time, hardness and tastes as indexes. HPLC-ELSD was adopted to determine the content of L-citrulline. The results showed that the best formula of effervescent tablets was composed of 30% L-citrtflline, 32% mannitol, 19.1% citric acid and 15.9% bicarbonate Sodium, 0.5% sucralose, 0.4% stevioside, 2% polyethylene glycol 6000, 0.1% polyvinylpyrrolidone （PVPk30）. The quality of the tablets prepared by the optimal formulation was complied with the requirement of＂ChP 2010＂. The L-citrulline effervescent tablets disintegrated rapidly, tasted good and easy to take. The analysis method was fast, sensitive and reliable and it was a most suitable for quantitative determination of L-citrulline effervescent tablets.