自制无针粉末注射给药系统药物导入率的体外评价

目的 建立体外吸收评价方法，考察自制无针粉末注射给药系统的给药性能。方法 以人体皮肤为研究材料，荧光素钠作为模型药物，高效液相-荧光法检测，以透皮吸收率为指标，采用正交试验设计优选无针粉末注射的载药喷射参数。结果 建立的方法分析时间小于3min，在0．2304-9．216ng范围内呈线性关系，绝对回收率大于99．8％，RSD〈0．8％；自制无针粉末注射给药系统的最高透皮吸收率可达到40％，超过普通透皮途经400倍以上，与国外同类产品的药物导入效率（33％）相当；正交试验分析表明气源压力、喷管型号、药物剂量、药粉粒径均对无针粉末注射的效果有影响。结论 建立的研究方法简便、快速、准确、可靠，可用于无针粉末注射系统的体外研究；自制无针粉末注射给药系统的药物导入效率较高，值得进一步推广应用。

The in Vitro Evaluation on the Drug Delivery Rate of the Serf-Designed Powder Needle free Injection System

Aim To establish an in vitro method to evaluate the capability of drug delivery of the self-designed Powder Needleless Injection (PNI) system.Methods Fluoresceinsodium was selected as the model drug to evaluate the human skin absorption rate of PNI in vitro by orthogonal experiments using the HPLC-FLD method.Results The determination time of the method was within 3 minutes.A linear relationship of fluoresceinsodium was good between 0.230 4 and 9.216ng and the recovery of the method was larger than 99.8% ( RSD <0.8%).The max skin absorption rate of self-designed PNI system exceeded 40%,which was over 400 times the rate of normal transdermal delivery route and approximated the rate (33%) of foreign products of the same kind in some degree.The results of orthogonal experiments showed that the efficiency of self-designed PNI system can be influenced by air pressure,nozzle type,doses and particle size.Conclusion The established determination method is simple,fast,accurate and reliable for the evaluation of PNI system.The capability of drug delivery of the self-designed PNI system was high,making it worthy to be popularized.