【摘要】

    目的:对化学药品由口服给药方式改为注射给药后的非临床安全性因素进行分析。方法:抽取110例在我院就诊期间将口服用药改为静脉用药的临床患者病例，对其在用药过程中的相关资料进行整理分析，并对相关的非临床安全性因素进行总结。结果:分析结果表明，给药途径发生改变后可以导致活性物质发生改变、制剂相关改变、暴露程度发生改变，对给药途径改变后的非临床安全性进行评价的项目应该包括药理学试验、药毒性试验、致癌性试验。结论:对化学药品由口服给药方式改为注射给药后的非临床安全性因素和对非临床安全性进行评价的主要途径进行充分了解，可以保证今后临床在对患者进行治疗的过程，选择更加合理有效的给药途径，使患者临床治疗效果得到保证的同时使其非临床安全性进一步提高。

    【关键词】化学药；口服；注射；非临床安全性

    Chemical medicine oral to intravenous administration of non clinical safety analysis

    Lv Ping

    【Abstract】Purpose On chemical medicine by oral administration to injection after administration of non clinical safety factors. Method Selected 110 cases in our hospital during oral medication was changed to intravenous medication in patients with clinical cases. The medication process related data consolidation analysis. And the relevant nonclinical safety factors were summarized. Result The analysis results show that. The route of administration changes can lead to the active material.preparation changes change.exposure level change. On the route of administration after the change of non clinical safety evaluation project should include pharmacological test.drug toxicity.carcinogenicity tests. Conclusion On chemical medicine by oral administration to injection after administration of non clinical safety factors and non clinical safety evaluation of main ways of understanding. Can guarantee the future clinical in patients on treatment process. Choose a more reasonable and effective administration route. The clinical treatment effect are guaranteed at the same time the non clinical safety further improve. ......