正交设计法优化富马酸喹硫平口服混悬液处方工艺  被引量:3

Optimization of formulation process of quetiapine fumarate oral suspension by orthogonal test

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作  者:袁雨冰 张登山[1] YUAN Yu-bing;ZHANG Deng-shan(Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing 210029,China)

机构地区:[1]南京中医药大学附属医院,江苏南京210029

出  处:《中国药物应用与监测》2023年第1期19-23,共5页Chinese Journal of Drug Application and Monitoring

摘  要:目的:采用正交设计法对富马酸喹硫平口服混悬液处方工艺进行优化。方法:以含量均匀度、溶出度、综合评分为评价指标,采用单因素试验考察处方中富马酸喹硫平粒径,处方中絮凝剂用量,高剪切时间对含量均匀度、溶出度的影响;根据单因素试验结果,采用L_(9)(3^(4))正交试验法对各因素进行优化,并对优化处方工艺进行验证。结果:优化后的处方工艺:富马酸喹硫平粒径7μm<D_(90)≤51μm;絮凝剂枸橼酸用量18.14 mg·mL^(-1)、磷酸氢二钠用量87.27 mg·mL^(-1);高剪切时间为25 min。优化后制得混悬液的含量均匀度(A+2.2S)分别为2.8、3.0、2.9,均呈快速溶出(5 min溶出度>标示量85%)。结论:优化后的富马酸喹硫平口服混悬液处方工艺具有很好的可行性、可控性及耐用性,且稳定性好。Objective:To optimize the formulation process of quetiapine fumarate oral suspension by orthogonal test.Methods:The evaluation indicators included the content uniformity,the dissolution rate and the comprehensive score.A single factor test was used to investigate the effect of particle size,flocculant dosage,high-speed shearing time on the content uniformity and the dissolution rate of quetiapine fumarate.And the L9(3~4)orthogonal test was used to optimize the evaluation indicators and verify the formulation process according to single factor test results.Results:The optimized formulation process of quetiapine fumarate oral suspension were confirmed as follows:the particle size was 7-51μm(D_(90)).The dosage of citric acid and disodium hydrogen phosphate were 18.14 mg·mL^(-1)and 87.27 mg·mL^(-1)respectively.The high-speed shearing time was 25 min.The content uniformity(A+2.2S)of the suspension with the optimized formulation process were 2.8,3.0,2.9,which all showed rapid dissolution(>85% labelled amount,5 min).Conclusion:The optimized formulation process of quetiapine fumarate oral suspension were feasible,controllable and durable with good stability.

关 键 词:富马酸喹硫平 处方工艺优化 正交试验 含量均匀度 综合评分 

分 类 号:R917[医药卫生—药物分析学] R971.4[医药卫生—药学]

 

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