鲑鱼降钙素可溶微针贴片的制备与评价  

Preparation and Evaluation of Salmon Calcitonin Dissolving Microneedle Patches

作　　者：沈瑞雪[1] 朱壮志[1] 童想柳 武余波[1] 罗华菲[1] SHEN Ruixue;ZHU Zhuangzhi;TONG Xiangliu;WU Yubo;LUO Huafei(National Pharmaceutical Engineering Research Center,China State Institute of Pharmaceutical lndustry Shanghai 201203)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2018年第9期1264-1271,共8页Chinese Journal of Pharmaceuticals

摘　　要：初步研究鲑鱼降钙素可溶微针的体外评价和体内降血钙作用。制备的可溶微针大小均一,针体完整,药物完全分布于针体。鲑鱼降钙素透明质酸可溶微针具有足够的机械强度穿透角质层,到达真皮层的上层,并在2 min内迅速完全释放药物。采用大鼠降血钙试验考察鲑鱼降钙素可溶微针贴片的药效,结果显示可溶微针的降血钙效应为(22.2±5.9)%,与皮下注射相比,相对药理活性为(78.6±21.7)%。大鼠皮肤屏障恢复试验验证了可溶微针的安全性。本研究提示可溶微针贴片有望成为注射的无痛替代给药方式。The study was to assess the feasibility of salmon calcitonin（s CT）-hyaluronic acid（HA） dissolving microneedle patches for osteoporosis（OP） treatment. The dissolving microneedles were fabricated using micromold casting method. In vitro characteristics including morphology, mechanical strength and dissolution profile were investigated. The results showed that the prepared dissolving microneedles were able to penetrate the stratum corneum to the depth of the top of dermis and completely dissolved within 2 min resulting in the rapid release of the loaded s CT. The animal study showed a similar hypocalcemic effect in rats receiving a dissolving microneedle patch and subcutaneously injecting of Miacalcic. The relative pharmacological activity of s CT in the prepared microneedle patches was（78.6±21.7）%, implying that dissolving microneedle patches might be a painless alternative to conventional injection.

关 键 词：鲑鱼降钙素 可溶微针 贴片 机械强度 降血钙 安全性 

分 类 号：R944.9[医药卫生—药剂学]