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作 者:陈海清 李后如 谢俊俊 CHEN Haiqing;LI Houru;XIE Junjun(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330001,China;The Yintao Pharmaceutical of Jiangxi Co.,Ltd,Fuzhou,Jiangxi,344100,China.)
机构地区:[1]江西省药品检查员中心,江西南昌330001 [2]江西银涛药业有限公司,江西抚州344100
出 处:《药品评价》2022年第8期453-456,共4页Drug Evaluation
摘 要:目的:探索β-环糊精(β-CD)包合肉桂挥发油的最佳工艺,并对包合效果进行特征鉴别。方法:选取3个对包合效果有主要影响的单因素,考察不同水平单因素对包合效果的影响,最终包合效果根据包合物收得率和挥发油包合率进行评价,通过正交试验选出最佳包合工艺,采用优选工艺制备肉桂挥发油β-CD包合物,并采用紫外扫描和薄层色谱法进行包合物特征鉴别。结果:L_(9)(3^(4))正交试验结果显示最佳工艺为投料比1∶5,包合温度40℃,包合时间80 min。验证试验显示优选的包合工艺稳定可靠,特征鉴别显示优选工艺制备的包合物已形成。结论:该正交试验优化出的工艺稳定可靠,特征鉴别显示包合物出现新物相。Objective:To optimize the inclusion process of cinnamon oil withβ-cyclodextrin,andthe inclusion complex prepared by the preferred process is characterized.Methods:Three single factors were selected to have a major impact on the inclusion effect,three levels were investigated for each single factor,the inclusion rate of volatile oil and the yield of inclusion compound were selected as the evaluation indexes of inclusion effect,the best inclusion process of volatile oil was determined by orthogonal test,β-CD inclusion compound of cinnamomum volatile oil was prepared by optimum process.and the quality of inclusion complex was verified by UV scanning and TLC.Results:The L_(9)(3^(4))orthogonal test results show that the best inclusion process wasβ-Cyclodextrin and cinnamon volatile oil at 1:5,and 80 min was encapsulated at inclusion temperature of 40℃.The stability and reliability of the optimized process are verified by the validation experiments,the formation of inclusion complex was confirmed by UV scanning and TLC.Conclusion:The optimized inclusion process of cinnamon volatile oil is stable and reliable,the new phase of inclusion complex was confirmed by characteristic identification.
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