基于Kalman滤波-紫外分光光度法六味地黄丸(浓缩丸)物质组释放动力学特征及可视化评价  

Kalmanfilter-UV spectrophotometry of release kinetic characteristics and visual evaluation for concentrated Liuwei Dihuang Pill substance group

作　　者：陈文静 江丽慧 俎龙辉 禹海燕[4] 于蓓蓓[3] 孙丹丹[3] 闫雪生[3] CHEN Wen-jing;JIANG Li-hui;ZU Long-hui;YU Hai-yan;YU Bei-bei;SUN Dan-dan;YAN Xue-sheng(Shandong University of Traditional Chinese Medicine,Shangdong Jinan 250355,China;Shangdong Vocational College of Science&Technology,Shangdong Weifang 261053,China;Shandong Academy of Traditional Chinese Medicine,Shandong Jinan 250014,China;Affiliated Hospital,Shandong University of Traditional Chinese Medicine,Shandong Jinan 250011,China)

机构地区：[1]山东中医药大学,山东济南250355 [2]山东科技职业学院,山东潍坊261053 [3]山东省中医药研究院,山东济南250014 [4]山东中医药大学附属医院,山东济南250011

出　　处：《中国医院药学杂志》2021年第4期353-359,共7页Chinese Journal of Hospital Pharmacy

基　　金：山东省中医药科技发展计划项目(编号:2017-089);山东省泰山学者工程专项经费资助项目(编号:ts201511107)。

摘　　要：目的:利用Kalman滤波-紫外分光光度法考察加入辅料聚乙二醇(PEG)6000和交联聚维酮(PVPP)的六味地黄丸(浓缩丸)物质组释放特征,并对其进行可视化评价。方法:利用Kalman滤波-紫外分光光度法对采用优化辅料处方制备的模型组、自制普通组、市售组的六味地黄丸(浓缩丸)进行物质组释放动力学研究,测定3组丸剂的物质组释放度,并绘制模型组的物质组紫外吸收图谱,可视化评价3种不同浓缩丸的物质组释放动力学特征。结果:以优化辅料处方制备的模型组单一成分丹皮酚(难溶性成分)及化合物为整体物质组,2个指标释放曲线进行f2相似因子拟合,结果为53.21(f2>50),2组释放曲线无显著性差异。两指标均遵循weibull释放机制,组分释放较同步。模型组丸剂在120 min内释放量均达90%,超市售组约15%,释放量增加显著。结论:利用Kalman滤波-紫外分光光度法评价辅料处方丸剂的释放动力学特征符合实验要求,可视化的评价方法可以直观地表达出不同制剂物质组释放的差异。OBJECTIVE To explore the release characteristics of concentrated Liuwei Dihuang Pill with excipients(polyethylene glycol(PEG)6000 and cross-linked povidone(PVPP))and conduct visual evaluation.METHODS Kalmanfilter-ultraviolet spectrophotometry was employed for examining the substance group release kinetics of concentrated Liuwei Dihuang Pill of model group,self-prepared ordinary group and commercially available group prepared with optimized excipient prescriptions.The release degrees of three groups of pills were determined and the ultraviolet absorption spectrum was plotted for visually evaluating the release kinetic characteristics of three different concentrated pills.RESULTS The single component paeonol(insoluble component)and the compound of model group prepared by optimized excipient formulation were used as overall substance group.Two index release curves were fitted with f2 similarity factors.The result was 53.21(f2>50).No significant inter-group difference existed in release profile.Both indicators followed the Weibull release mechanism and the release of components was more synchronized.The release of pills in model group reached 90%within 120 min and about 15%in commercially available group and the release increased significantly.CONCLUSION Kalman filter-ultraviolet spectrophotometry may be employed for evaluating the release kinetic characteristics of excipient prescription pill.The experimental requirements are fulfilled.And visual evaluation may intuitively express the difference in the release of different formulations.

关 键 词：六味地黄丸(浓缩丸) Kalman滤波-紫外分光光度法 可视化评价 

分 类 号：R917[医药卫生—药物分析学]