五味子泡腾片的制备工艺及质量评价

研究五味子泡腾片的制备工艺,并对其进行质量评价。以崩解时限、产气量、pH值为评价指标,采用单因素和正交试验优化泡腾崩解剂配比、泡腾崩解剂质量分数、聚乙二醇(polyethylene glycol,PEG)6000的用量,并通过片剂重量差异、崩解时限、pH值、产气量、硬度及脆碎度和五味子醇甲的含量对产品进行质量控制。结果表明,柠檬酸∶碳酸氢钠最佳配比为1∶0.7(质量比),泡腾崩解剂的最佳质量分数为55%,五味子水提物浸膏质量分数26%,PEG 6000的最佳质量分数为5%,甜菊糖苷2%,氯化钠2%,乳糖10%。最优工艺条件下制备的泡腾片,外表呈浅粉色,片剂表面光滑,可迅速溶于水中,产生丰富气泡,汤色呈浅粉色,并伴有五味子特有香气,口味酸甜适中,口感良好,每片泡腾片中五味子醇甲的含量为(9.79±0.18)mg,平均片重(500±20)mg,崩解时限为(87.42±1.91)s,pH值平均值为4.63±0.071,崩解时限、pH值均符合药典规定。

Preparation Technology and Quality Evaluation of Schisandra chinensis Effervescent Tablets

The preparation technology of Schisandra chinensis effervescent tablets and its quality evaluation were researched in this study.The dosage of effervescent disintegrating agent,effervescent disintegrating agent mass fraction and polyethylene glycol(PEG 6000)were optimized by single factor and orthogonal test with disintegration time,gas production and pH value as the evaluation index.The product was carried out by weight difference of tablets,disintegration time,pH value,gas production,hardness,brittleness and content of schisandol quality control.The results showed that the optimal ratio of citric acid∶sodium bicarbonate was1∶0.7,the best mass fraction of effervescent disintegrating agent was 55%,the mass ratio of extract of Schisandra chinensis water extract was 26%,the best mass fraction of PEG 6000 was 5%,stevioside 2%,sodium chloride 2%,and lactose 10%.The effervescent tablets prepared under the optimum conditions were pale pink and smooth on the surface of the tablets,which could quickly dissolve in the water and produce rich bubbles.The soup color was light pink,accompanied by the special aroma of Schisandra chinensis and moderate sweet and sour taste.The content of schisandrin in each effervescent tablet was(9.79±0.18)mg,with an average table weight of(500±20)mg,disintegration time of(87.42±1.91)s,and the average pH value of4.63±0.071.The disintegration time and pH value of the prepared effervescent tablets met the requirements of pharmacopoeia.