美洲大蠊提取物泡腾片制备及质量评价

Preparation and Quality Analysis of Periplanet Americana Extract Effervescent Tablets

采用单因素实验和响应面试验对美洲大蠊提取物泡腾片的处方工艺进行探究及质量评价。以崩解时间、pH、发泡量及感官评价为指标,最佳工艺为:美洲大蠊提取物5.0%、酸碱比例1∶1.21、PVP-K301.35%、PEG60005.37%、矫味剂10%、填充剂38.28%。工艺验证试验其崩解时间、片重差异、pH、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标准,泡腾片表面光滑呈淡黄色,甜度适中,冲调后澄清度良好。

Single factor experiments and response interviews were used to explore the prescription and technology of Periplaneta americana.effervescent tablets and evaluate its quality.Based on the indicators of disintegration time,pH,foaming amount,and sensory evaluation,the optimal process was as follows:Periplaneta americana.was 5.0%,acid-base ratio was 1∶1.21,PVP-K30 was 1.35%,PEG6000 was 5.37%,flavoring agent was 10%,and filling agent was 38.28%.In the process validation test,the disintegration time,tablet weight difference,pH,foaming amount,hardness and friability of the effervescent tablets met the quality requirements of Pharmacopoeia of the People s Republic of China 2020.The surface effervescent tablets were light yellow,with moderate sweetness and good clarity after preparation.