响应面法优化甘草泡腾片制备工艺及其质量评价

Optimization on Preparation Process and Quality Evaluation of Effervescent Tablet for Glycyrrhiza Effervescent Tablet by Response Surface Method

中药泡腾片作为一种新的固体剂型,携带方便,可定量服用.本研究以感官评分、崩解时限和发泡量为指标,通过单因素实验以及响应面优化实验优化甘草泡腾片的制备工艺,并采用酸碱分开制粒压片法制备片剂.结果表明:最佳工艺条件为阿斯巴甜添加量5%,酸碱比例0.67︰1,柠檬酸添加量24%,碳酸氢钠添加量36%,PEG6000添加量4%.在此工艺条件下进行3次验证实验,得到的甘草泡腾片感官评分为89.5分.其崩解时限、发泡量、硬度及脆碎度均符合《中国药典》2020年版对泡腾片的质量要求.泡腾片颜色呈浅棕色,表面光滑,酸甜适度,冲调后澄清度良好.

As a new solid dosage form,effervescent tablets in Chinese herbal medicine are convenient for carrying and can be taken in quantitative quantities.In this study,the use of sensory evaluation,disintegration time and foaming amount were taken as indices;the preparation technology of glycyrrhiza effervescent tablets was optimized through single factor experiment and response surface optimization experiment,and acid alkali separation granulation was used to prepare tablets.The results show that the optimal technological condition was 5%of aspartame,0.67︰1 of acid alkali ratio,24%of citric acid,36%of NaHCO_(3) and 4%of PEG6000.Three verification experiments were conducted under this technological condition,and the sensory score of glycyrrhiza effervescent tablets was 89.5 points.The disintegration time,foaming amount,hardness and fragility all meet the quality requirements of the effervescent tablets in the 2020 edition of Chinese Pharmacopoeia.The effervescent tablet is light brown in color,smooth in surface,exhibiting moderate acidity and sweetness and good clarity after blending.