竹叶提取物泡腾片的制备工艺优化及其质量分析

Optimized Preparation and Quality Analysis of Bamboo Leaf Extract Effervescent Tablets

目的:制备竹叶提取物泡腾片并对其进行质量分析。方法:以崩解时限、p H值、硬度为指标,采用正交试验设计筛选竹叶提取物泡腾片中泡腾剂(柠檬酸、碳酸氢钠)的最佳组成和润滑剂(聚乙二醇6000)的使用方法,并考察泡腾产品的总黄酮含量、崩解时限、p H值、硬度和发泡量。结果:泡腾剂的最佳组成为柠檬酸质量分数20%、碳酸氢钠质量分数20%,制备工艺采用聚乙二醇6000包裹碳酸氢钠后实施粉末直接压片。最优工艺所得泡腾片呈弱酸性,可迅速崩解,发泡量为13.7 m L/g,总黄酮含量为52 mg/g。结论:该工艺所制备的竹叶提取物泡腾片外观良好,崩解迅速,溶解后溶液澄清透明、呈弱酸性。

Objective：To optimize the preparation process of bamboo leaf extract effervescent tablets and to evaluate their quality attributes.Methods：An orthogonal array design was used to optimize the formulation of effervescent tablets including the usage of lubricant（polyethylene glycol 6000）and effervescent agent composition（i.e.ratio of sodium bicarbonate to citric acid）based on p H,disintegration time and hardness.Total flavonoids content and foaming capacity of the optimized effervescent tablets were also analyzed.Results：The optimum combination of effervescent agents was citric acid 20% and sodium bicarbonate 20%.Sodium bicarbonate was wrapped with polyethylene glycol 6000 before direct powder compression.The obtained tablets were slightly acidic and rapidly disintegrated.Foam volume of the tablets was 13.7 m L/g and the content of total flavonoids was 52 mg/g.Conclusion：The obtained effervescent tablets displayed good appearance,rapid disintegration,and clear solution without precipitation after dissolution.