阿立哌唑口服溶液的工艺摸索研究  

Research on the process exploration of aripiprazole oral solution

作　　者：黄冬强 战崇轩 HUANG Dongqiang;ZHAN Chongxuan(Wante Pharmaceutical(Hainan)Co.,Ltd,Haikou 570314,China)

机构地区：[1]万特制药(海南)有限公司,海南海口570314

出　　处：《天津药学》2025年第1期120-124,共5页Tianjin Pharmacy

摘　　要：目的通过不同的考察指标,对阿立哌唑口服溶液配制参数进行摸索,确定最佳制备工艺。方法选取参比制剂进行对比研究,考察影响阿立哌唑口服溶液制备的关键工艺参数,采用确定的工艺参数进行样品制备,参比制剂和自制制剂同步进行影响因素考察,检测关键项目进行质量评价。结果自制制剂与参比制剂在影响因素条件下,含量、有关物质、pH值等无显著差异。结论阿立哌唑口服溶液小试制备工艺合理,可为后期批量放大提供支持性依据。Objective To explore the preparation parameters of aripiprazole oral solution through different evaluation indicators and determine the optimal preparation process.Methods A comparative study was conducted by selecting reference formulations to investigate the key process parameters affecting the preparation of aripiprazole oral solution.The determined process parameters were used for sample preparation,and the influencing factors of the reference formulation and self-made formulation were simultaneously investigated.Key items were tested for quality evaluation.Results There were no significant differences in content,related substances,pH value,etc.between the homemade formulation and the reference formulation under the influencing factors.Conclusion The smallscale preparation process of aripiprazole oral solution is reasonable and can provide supporting evidence for later batch scaling up.

关 键 词：阿立哌唑口服溶液 关键工艺参数 影响因素考察 参比制剂 

分 类 号：R971.1[医药卫生—药品]