摘要
目的探讨影响天然植物抗菌液(PAMs)凝胶膏剂性能的处方因素并进行初步药效评价。通过研究不同温度、时间以及主要组分对凝胶膏剂表观成型性、流变学特性及对大鼠烫伤修复程度的影响,为PAMs凝胶膏剂基质处方的筛选提供一种新的评价方法。方法采用正交试验、流变学特性及建立大鼠烫伤模型,综合评估PAMs凝胶膏剂的性能。结果3种不同处理温度与时间下,50℃恒温固化24 h后室温(25℃)静置2 d形成的PAMs凝胶膏剂强度最大,其线性黏弹区(LVR)、储能模量(G′)、损耗模量(G″)、复数模量(G~*)值均最大;感官感受与流变学分析显示,正交试验各处理样品中Viscomate NP-700、酒石酸的浓度越高,凝胶膏剂强度越大;EDTA浓度越高,凝胶膏剂黏性越大;促透剂含3.0%丙二醇时,对大鼠烫伤修复效果较好,结果与LVR、G′、G″、G~*、相位角(δ)值变化一致。权重和综合分析表观成型性、黏弹性以及动物模型结果,初步确定该PAMs凝胶膏剂的优化基质配方为Viscomate NP-7004.0%、酒石酸0.2%、氮酮3.0%、丙二醇3.0%,不含EDTA。结论该体外、体内共同评价的方法为PAMs凝胶膏剂基质处方的筛选和优化提供了一种思路,同时对建立凝胶膏剂可行的测量指标和评价体系具有重要的参考价值。
Objective To explore the formulation factors affecting the performance and preliminary efficacy evaluation of natural plant antimicrobial solution(PAMs)gel paste.By studying the effects of different temperatures,time and major components on the apparent formability,rheological properties of gel paste as well as the capacity of scald remediation in rats,a new evaluation method was provided for the selection of PAMs gel paste matrix prescriptions.Methods The performance of PAMs gel paste was evaluated by orthogonal experiment,rheological properties and rat scald model.Results It was found that the strength of PAMs gel paste was the highest when the condition stood at room temperature(25℃)for 2 days after 50℃for 24 hours under processing conditions,and its LVR,G′,G″,G~*values were the largest.Sensory perception and rheological analysis showed the concentration of Viscomate NP-700 and tartaric acid was positively correlated with the hydrogel strength.The concentration of EDTA was positively correlated with the hydrogel viscosity.When the penetration enhancer contained 3.0%propylene glycol,it had better effect on scald remediation in rats,which was consistent with the changes of LVR,G′,G″,G~*,δvalues.Weight and comprehensive analysis of apparent formability,viscoelasticity and animal model results suggested that the optimized matrix formulation of the PAMs gel paste was composed of 4.0%Viscomate NP-700,0.2%tartaric acid,3.0%azone and 3.0%propylene glycol without EDTA.Conclusion This method of co-evaluation in vitro and in vivo provides a method for the selection and optimization of the matrix formulation of PAMs gel paste,and it is of great importance for the establishment of the feasible measurement indexes and evaluation system of the gel paste.
作者
杨飘
付鹏德
韦乐华
郝静
向飞丹州
茆灿泉
YANG Piao;FU Pengde;WEI Lehua;HAO Jing;XIANGFEI Danzhou;MAO Canquan(School of Life Science and Engineering,Southwest Jiaotong University,Chengdu 610031,China;Yunnan PuerDanzhou Pharmaceutical Co.Ltd,Ninger 655199,China)
出处
《广东药科大学学报》
CAS
2019年第6期719-725,共7页
Journal of Guangdong Pharmaceutical University
基金
国家科技部自然保护区生物标本整理、整合共享试点项目(2005DKA21404)
