中国药业2023，Vol.32Issue(23)：18-23,6.DOI:10.3969/j.issn.1006-4931.2023.23.004
处方工艺对阿普唑仑片混合均匀度及含量均匀度的影响
Effect of Formulation Technology on the Blend Uniformity and Content Uniformity of Alprazolam Tablets
摘要
Abstract
Objective To investigate the effects of excipients and processes in the formulation on the blend uniformity and content uniformity of Alprazolam Tablets.Methods Low-dose Alprazolam Tablets were prepared by direct compression method.With the blend uniformity and content uniformity of the total mixed materials as evaluation indicators,the effects of the types and dosages of excipients,the blend technology and tablet technology on the blend uniformity and the content uniformity were investigated by the single factor test.Results The RSD of the blend uniformity of the formulation with round shape and rough surface of spray-dried lactose(11SD,F100),types of microcrystalline cellulose(PH 102,PH200,TLF935),dosages of corn starch(3％,5％,7％),dosages of colloidal silica(0.8％,1.2％)was far lower than 5％,and the content uniformity(A+2.2 SS)was far lower than 15.0.The particle size D90 of the active pharmaceutical ingredients(API)was no more than 35 μm,the alprazolam and lactose were pre-blended by a wet granulator of 600 r/min for 10 min,and then transferred to a three-dimensional moving mixer,where microcrystalline cellulose,corn starch and colloidal silica were added and mixed at blending frequency of 12 Hz for 15-25 min,the RSD of blend uniformity was lower than 2.5％.The content uniformity(A+2.2 S)of tableting speed(10-20 r/min)was lower than 7.2.Conclusion The optimal formulation process is suitable for the content uniformity and quality control of Alprazolam Tablets,which can be used for industrial production.关键词
阿普唑仑片/直接压片法/混合均匀度/含量均匀度Key words
Alprazolam Tablets/direct compression/blend uniformity/content uniformity分类
医药卫生引用本文复制引用
郭金秀,曾令高,高梓真,许向阳,陈醒,王家辉..处方工艺对阿普唑仑片混合均匀度及含量均匀度的影响[J].中国药业,2023,32(23):18-23,6.基金项目
国家"重大新药创制"科技重大专项资助项目[2015ZX093001002007,2017ZX09101001]. （）
