山银花提取物泡腾片的制备及质量评价

Preparation and Quality Evaluation of Lonicerae Flos Effervescent Tablets

本研究采用正交试验优选山银花提取物泡腾片的处方工艺,并建立其质量评价的方法。优化后的制备工艺为山银花提取物干膏粉4.5%,崩解剂碳酸氢钠24%,酒石酸16%,黏合剂聚乙烯吡咯烷酮(K30)9%,润滑剂聚乙二醇60005%,矫味剂阿斯巴甜1.5%。采用高效液相色谱法测定泡腾片中绿原酸的含量,每片泡腾片中含绿原酸不低于2.0mg,崩解时限,重量差异、硬度、脆碎度检查符合规定。结果表明山银花泡腾片处方组成合理,制备方法简便可行,质量可控。

The preparation of Lonicerae Flos effervescent tablets was optimized by the orthogonal experiment and its quality was evaluated.The optimal preparation contained 4.5% Lonicerae Flos extract,24% sodium bicarbonate,16% tartaric acid as effervescent disintegrating ageng,9% PVP (K30 ) as adhesive,5% PEG 6000 as lubricants and 1.5% aspartame as sweet excipient.The content of chlorogenic acid in the tablets was not less than 2.0 mg and determined by HPLC.The disintegration time limit,weight difference,hardness and brittleness met the requirements.The results showed that the formulation of Lonicerae Flos effervescent tablets was rational and the manufacturing technology was simple and convenient,and the quality was controllable.