儿童常用注射用冻干粉空瓶体积及负压与产气体积相关性研究  

Correlation between Empty Bottle Volume,Negative Pressure and Gas Production Volume of Freeze-dried Powder Commonly Used in Children

作　　者：李浩 施芳红[2] 王永庆 王学贤 张顺国 陈敏玲 魏继福 

机构地区：[1]上海交通大学医学院附属上海儿童医学中心药剂科,上海200127 [2]上海交通大学医学院附属仁济医院药剂科 [3]南京医科大学第一附属医院药学部

出　　处：《中国药师》2017年第12期2273-2276,共4页China Pharmacist

基　　金："重大新药创制"科技重大专项项目(编号:2011ZX09302-003-02);九三学社上海市委参政议政课题(编号:zb064);上海交通大学中央高校基本科研业务费资助项目(编号:17JCYB11)

摘　　要：目的:研究儿童医院门急诊输液药房常用的注射用冻干粉针空瓶体积及负压与产气体积相关性,为药品生产提供参考。方法:利用20 ml注射针筒测量30种儿童医院门急诊输液药房常用的注射用冻干粉针空瓶体积,具有负压的药品瓶内负压体积,溶解后产生气体的药品产气体积,比较各体积与药品理论溶解体积及实际溶解体积之间的关系,提出药品生产时的注意事项。结果:30种药品中,实际溶解体积为理论溶解体积1/2的共计6种,瓶内具有负压的药品共计8种,溶解后产生气体的药品共计3种。药品的空瓶体积大于药品理论溶解体积4 ml以上为宜。药品的负压体积略大于药品的理论溶解体积为宜。产气的药品需在溶解后仍保持瓶内负压为宜。结论:现有部分注射用冻干粉针在出厂设计时存在缺陷,造成一定的药品冲配困难。Objective： To study the correlation between the empty bottle volume, negative pressure and gas production of the freeze-dried powder in the out-patient pharmacy intravenous admixture center of a children＇ s hospital in order to provide reference for the drug production. Methods： 20 ml Syringes were used to measure the volume of empty bottles, negative pressure and produced gas. The relationship between the theoretical drug dissolution volume and the actual dissolution volume was compared, and the precautions for the drug production were put forward, Results ： Among the tested 30 drugs, 6 ones were with the actual dissolution volume half of the theoretical dissolution volume, 8 ones were with negative pressure in the bottles, and 3 ones were with produced gas after dissol- ving. It was appropriate that the empty bottle volume be 4 ml larger than the theoretical dissolution volume, and it was appropriate that the negative pressure volume of drugs was slightly larger than the theoretical dissolution volume. Negative pressure should be still kept in the bottles after the gas production. Conclusion： The design of part of freeze-dried powder injection needle shows defects resulting in dru- mixing difficulties to a certain extent.

关 键 词：注射用冻干粉 空瓶 负压 产气 药品冲配 

分 类 号：R942[医药卫生—药剂学]