单因素考察结合Box-Behnken响应面法优化脑络欣通颗粒制备工艺及对脑卒中大鼠的影响  

Optimization of the Preparation Process of Naoluo Xintong Granules(脑络欣通颗粒)and Its Effect on Stroke Rats by Single-factor Study Combined with Box-Behnken Response Surface Method

作　　者：洪璐 范冰冰 胡青华 操雪萍 刘雨晴 陈卫东[1,2,3,4] 何玲 HONG Lu;FAN Bingbing;HU Qinghua;CAO Xueping;LIU Yuqing;CHEN Weidong;HE Ling(Anhui University of Chinese Medicine,Hefei 230012,Anhui,China;Anhui Province Key Laboratory of Chinese Medicinal Formula,Hefei 230012,Anhui,China;Institute of Traditional Chinese Medicine Resources Protection and Development,Hefei 230012,Anhui,China;Anhui Province Key Laboratory of Traditional Chinese Medicine Decoction Pieces of New Manufacturing technology,Hefei 230012,Anhui,China;Key Laboratory of Xin’an Medicine,Ministry of Education,Hefei 230012,Anhui,China;Research Institute of Science,Technology and Humanities,Shanghai University of traditional Chinese Medicine,Shanghai 200120,China)

机构地区：[1]安徽中医药大学,安徽合肥230012 [2]中药复方安徽省重点实验室,安徽合肥230012 [3]中药资源保护与开发研究所,安徽合肥230012 [4]中药饮片制造新技术安徽省重点实验室,安徽合肥230012 [5]新安医学教育部重点实验室,安徽合肥230012 [6]上海中医药大学科技人文研究院,上海200120

出　　处：《辽宁中医药大学学报》2024年第1期47-54,共8页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(82204671);安徽省高校自然科学研究重点项目(KJ2019A0452,KJ2021A0574);安徽中医药大学探索项目(2021zxts51)。

摘　　要：目的 完善脑络欣通颗粒的生产制造工艺考察研究,筛选出最佳辅料构成和最佳制备工艺条件,为脑络欣通颗粒的开发和应用提供理论和实验基础。方法 通过对脑络欣通颗粒干燥工艺的研究,考察辅料种类、辅料用量以及进风温度。在单因素实验的基础上研究脑络欣通颗粒最佳药物辅料构成,利用综合评分筛选出最佳的辅料种类、最佳的药辅比及最佳的乙醇浓度,再通过使用Box-Behnken响应面法对制备工艺设计进行优化。根据所得工艺进行制粒,对脑卒中模型大鼠进行脑络欣通颗粒剂灌胃给药,初步观察脑络欣通颗粒对脑卒中大鼠的疗效。结果既得颗粒剂干燥工艺研究考察结果中,辅料种类为糊精,辅料用量为5%,进风温度为145℃。脑络欣通颗粒最佳制备工艺:辅料种类为糊精,药辅比为1∶0.5,乙醇体积分数为95%,在此条件下综合评分值为0.872 946。相比脑卒中模型组大鼠,脑络欣通颗粒剂组神经元细胞数目有明显增加,初步推断颗粒剂对脑卒中大鼠有治疗作用。结论采用响应面法优选脑络欣通颗粒的制备工艺结果可靠,稳定性较高,方法简单可行,颗粒剂药效显著,可为脑络欣通颗粒剂的工业化生产提供依据。Objective To improve the process investigation of the manufacturing of Naoluo Xintong Granules(脑络欣通颗粒),to screen out the best excipient composition and the best preparation process conditions.To provide a theoretical and experimental basis for the development and application of Naoluo Xintong Granules.Methods Through the study of the drying process of Naoluo Xintong Granules,the types of excipients,the number of excipients and the inlet air temperature were investigated.The optimal drug excipient composition of the granules was investigated on the basis of single-factor tests,and the optimal excipient type,the optimal drug to excipient ratio and the optimal ethanol concentration were screened out by using a comprehensive score,and then the preparation process design was optimized by using the Box-Behnken response surface method.The pellets were granulated according to the obtained process and administered by gavage to rats in a middle cerebral artery occlusion(MCAO)model to observe the efficacy of Naoluo Xintong Granules on rats.Results In the results of the study of the drying process of the obtained granules,the excipient type was dextrin,the amount of excipient was 5%,and the inlet air temperature was 145℃.The best preparation process for the granules was dextrin,with an excipient ratio of 1∶0.5 and a volume fraction of ethanol of 95%,and the overall score was 0.872946.Compared with the rats in the MCAO model group,the number of neuron cells in the Naoluoxintong granules group increased significantly,and it was tentatively concluded that the granules had a therapeutic effect on the MCAO rats.Conclusion The results of the preparation process of Naoluo Xintong Granules were reliable,stable,simple and feasible,and the granules were effective,which can provide a basis for the industrial production of Naoluo Xintong Granules.

关 键 词：脑络欣通颗粒 制备工艺 BOX-BEHNKEN设计 响应面法 颗粒成型性 

分 类 号：R285.5[医药卫生—中药学]