中医方药可塑性脐贴膏制备及其安全性评价  

Study on the technology of preparation of the plastic XEFXQTG

作　　者：施峰[1] 贾晓斌[1] 高成林[1] 蒋俊[1] 

机构地区：[1]江苏省中医药研究院中药新型给药系统重点实验室国家中医药管理局中药释药系统重点研究室,江苏南京210028

出　　处：《中国医院药学杂志》2011年第2期91-93,共3页Chinese Journal of Hospital Pharmacy

基　　金：国家"十一五"科技支撑计划项目(编号:2008BAI53B072);江苏省中医药局科研项目(编号:HL07091)

摘　　要：目的:选择确有疗效的中医方药为样本,进行可塑性脐贴膏制备的共性技术研究,并做相关评价。方法:通过正交试验法对可塑性脐贴膏空白基质辅料进行筛选,筛选出的空白基质按30%载药量制备脐贴膏,并采用溶出仪法对贴剂的体外释放度进行测定,通过家兔敷贴对脐贴膏的安全性进行评价。结果:正交试验筛选出空白基质制备的最佳工艺参数为:PVP-K30用量为0.5g,海藻酸钠0.8g,氧化锌4g,甘油6.3g,水10mL,按30%载药量可制备可塑性的脐贴膏;脐贴膏具有较好的释放度,并且无急性毒性,对完整皮肤无刺激性,对破损皮肤有轻度刺激性。结论:若工艺参数得当、辅料合理,中医方药可制备成可塑性的脐贴膏,且适用于完整皮肤给药,并能很快将药物释放到皮肤表面。OBJECTIVE To study the technology of preparation of the plastic Xiao Er Fu Xie Qi Tie（XEFXOTG） ,and inves tigate the safety-evaluation of the preparation. METHODS Orthogonal test was used to optimize the matrix excipients, the plastic umbilicus patch was made with a drug loading rate of 30%, and safety evaluation was undertaken by rabbit application model. RFNULTS The optimal matrix formulation was.. PVP K30 0. 5 g,sodium polymannuronate 0. 8 g,zinc oxide 4 g,glycerol 6. 3 g, water 10 mL, drug-loading rate was 30% ; umbilicus patch had no acute toxicity,it was nonirritant to intact skin and slightly stimulatory to damaged skin. CONCLUSION the optimized matrix formulation could be used to prepare plastic umbili- cus patch which may be applied to intact skin.

关 键 词：可塑性脐贴膏 制备工艺 共性技术 释放度 安全性 

分 类 号：R283.69[医药卫生—中药学]