双黄连口腔崩解片的制备及质量检查

Preparation and Quality Examination of Shuanghuanglian Orally Disintegrating Tablets

目的:探讨双黄连口崩片制备工艺,优化口崩片处方。方法:以黄芩、金银花、连翘提取物为主药制备口崩片,采用单因素试验,考察崩解剂、起泡剂和压力对制备工艺的影响,以外观、崩解时限和黄芩苷、绿原酸、连翘苷的溶出度为指标考察制剂质量。结果:处方中各成分的质量分数分别为黄芩提取物14.7%、金银花提取物15.7%、连翘提取物16.3%、微晶纤维素18.0%、交联聚维酮15.7%、微粉硅胶0.43%、硬脂酸镁0.43%、甘露醇14.6%、无水枸橼酸2.5%、薄荷脑0.29%、碳酸氢钠0.63%、阿斯帕坦0.57%;制备的口崩片为褐色圆形片,崩解时限和溶出度均符合要求。结论:该制备工艺简便、准确,缓释效果理想,可为该制剂进一步研究提供理论依据。

OBJECTIVE： To investigate the preparation technology of Shuanghuanglian orally disintegrating tablets and to optimize the prescription of them. METHODS： Orally disintegrating tablets were prepared using extracts of Scutellaria baicalensis, Lonicera japonica and Forsythia suspensa as main components. The effects of disintegrating agent, foaming agent and pressure on preparation technology were investigated by single factor test. The quality of orally disintegrating tablets was investigated with appearance, disintegrating time, dissolution rate of baicalin, chlorogenic acid and phillyrin as index. RESULTS： The tablets were composed of 14.7% S. baicalensis extract, 15.7% L. japonica extract, 16.3% F. suspensa extract, 18.0% MCC, 15.7% PVPP, 0.43% micronization silica gel, 0.43% magnesium stearate, 14.6% mannitol, 2.5% citric acid, 0.29% menthol, 0.63% sodium bicarbonate, 0.57% aspartame. The orally disintegrating tablets were brown round tablet, and disintegrating time and dissolution were up to the requirements. CONCLUSION： The method is simple, accurate and sound sustain-released effect in preparation. It also provides basis for further study of preparation.