荔枝草泡腾片的制备工艺及质量评价

研究荔枝草提取物泡腾片的制备工艺及质量评价。以感官评分、崩解时限、pH及产气量为指标,采用单因素实验和正交试验优选荔枝草提取物添加量、泡腾崩解剂添加量、泡腾崩解剂配比(碳酸氢钠:柠檬酸)、甜味剂添加量进行感官评分;最终以泡腾片的重量差异、崩解时限、硬度及脆碎度、总黄酮含量为指标,对产品进行质量评价。结果表明,荔枝草泡腾片的最佳配方为荔枝草提取物18.0%,泡腾崩解剂的最佳质量比是1:1.9(共计40.0%),甜菊糖苷2.75%,聚乙二醇6000 4.0%,氯化钠2.0%,乳糖33.25%。最佳工艺下制得的荔枝草泡腾片口感良好,感官评分(4.79±0.02)分,且外观良好,崩解迅速,汤色呈黄褐色澄清透明,平均片重(500±12) mg,片重差异、崩解时限、硬度及脆碎度均符合《中国药典》规定,每片总黄酮含量为(7.52±0.06) mg。

Preparation Technology and Quality Evaluation of Salvia plebeia R.Br.Effervescent Tablets

The preparation process and quality evaluation of Salvia plebeia R.Br. extract effervescent tablets were studied. Sensory score, disintegration time limit, pH and gas production were used as indicators. Single factor experiments and orthogonal test were used to optimize the amount of Salvia plebeia R.Br. extract, the amount of effervescent disintegrant, and the ratio of effervescent disintegrant (sodium bicarbonate:citric acid), the amount of sweetener. Finally, the quality of the production was evaluated by the difference in weight of the effervescent tablets, the time limit of disintegration, the hardness and friability, and the total flavonoid contents. The results showed that, the best formula of Salvia plebeia R.Br. effervescent tablets was 18.0% of Salvia plebeia R.Br. extract, the best mass ratio of effervescent disintegrant 1:1.9 (total 40.0%), stevioside 2.75%, polyethylene glycol 6000 4.0%, sodium chloride 2.0%, lactose 33.25%. The Salvia plebeia R.Br. effervescent tablets prepared under the best process had a good taste, sensory score (4.79±0.02) points, rapid disintegration, a yellow-brown clear liquid and a good appearance. The average weight of the effervescent tablets were (500±12) mg. Tablets weight difference, disintegration time limit, hardness and friability were in accordance with the provisions of the"Chinese Pharmacopoeia". And the total flavonoid content was (7.52±0.06) mg per tablet.