无针注射器论文.docVIP

GB-03无针注射器对重组人胰岛素注射液生物活性的影响 祝清芬 魏霞山东省药品检验所药理室，济南 250101 摘要：目的　。方法　结果　结论　关键词 The influence of the GB-03 Needle-free Injector on the Biological Activity of Recombinant Human Insulin Injection Zhu Qingfen, Guo Ming, Wei Xia Department of Pharmacology, Shandong Institute for Drug Control, Jinan 250101, China ABSTRACT: OBJECTIVE To evaluate the influence of the GB-03 needle-free injector NFI on the biological value of recombinant human insulin injection rHI ; to examine whether the NFI administration is bioequivalent to the traditional S.C. administration for rHI. METHODS A twin cross-over designed biological assay method in mice was carried out to determine the potency of the NFI treated rHI the untreated rHI as the standard ; the concentration of serum glucose was measured in 6h after needle-free or traditional S.C. administration of 0.4 unit/kg rHI in rabbits. RESULTS The estimated potency of rHI was 108% of the labeled potency in mice. There were no significantly difference between the concentration of the serum glucose of the needle-free group and the S.C. group. CONCLUSION The GB-03 needle-free injector has no significant influence on the biological value of rHI; the NFI administration is bioequivalent to the traditional S.C. administration for rHI in rabbits. KEY WORDS: needle-free injector; recombinant human insulin injection; serum glucose 无针注射器是一种通过压力注射的设备。它的原理是通过高压使液体药品通过一个极细的孔后，产生一个液体柱，穿透皮肤喷射到皮下。它的优点是消除了被注射者对针头的恐惧，消除了疼痛。美国和欧洲医疗器械厂商J-Tip、Biojector 2000、Cool.click、SeroJet、Med-Jet、mhi-500等无针注射器目前大量应用于胰岛素，干扰素，疫苗等小量液体药品的注射。 1.1 试剂试药 重组人胰岛素注射液，规格10ml：400单位，批号1003001，通化东宝药业股份有限公司。.2 动物 小鼠，昆明种，体重20～23g，由山东大学实验动物中心提供，许可证号：SCXK（鲁）座机电话号码。，，体重20～g，山东省农科院畜牧兽医研究所提供，许可证号SCXK（鲁）座机电话号码。 1.3 仪器GB-03无针注射器，潍坊筑金吾真注射医疗器械有限公司提供。7020全自动生化分析仪，日立公司生产。方法 2.1无针注射器重组人胰岛素注射液生物效价 药品经无针注射器处理方法：将药品原样吸入无针注射器所附一次性注射器中，经无针注射器喷出后，收集用于实验。 以含有苯酚0.2g并用盐酸调节p值为2.5的0.9％氯化钠溶液作为稀释液。精密量取重组人胰岛素注射液高剂量组配成每1ml中含0.10单位，高低剂量比值 r 为1:0.5。取健康无伤、同一来源、出生日期相近成年雄性小鼠，体重相差不得超过3g，按体重随机分成4组，每组12只逐只编号, 各组小鼠分别自皮下