注射制剂药品说明书印制标准化研究

目的 分析注射制剂药品包装及说明书印制现状,为规范我国药品包装和说明书印制提供参考。方法 以上海交通大学医学院附属上海儿童医学中心为样本医院,系统分析其静脉用药调配中心(PIVAS)提供的药品说明书的药品品种,最小包装材质及含说明书的最小包装药品中药品数量及最小包装材质,并测量说明书尺寸。结果 样本医院PIVAS配备的品种覆盖面广,具有较强代表性;共收集到190种药品说明书,最小包装材质88种(46.32%)为西林瓶,65种(34.21%)为安瓿瓶。164种(86.32%)药品说明书尺寸在A4范围内。结论 注射制剂采用大包装装盒,并采用标准化尺寸印制药品说明书是可行的。

Standardization of Package Inserts for Injection Preparations

Objective To analyze the current situation of pharmaceutical packaging and instruction printing for injection preparations to provide references for standardizing pharmaceutical packaging and instruction printing in China.Methods Taking Shanghai Children’s Medical Center affiliated to Shanghai Jiao Tong University School of Medicine as the sample hospital,we systematically analyzed the distribution of instructions in the Pharmacy Intravenous Admixture Services(PIVAS)of the sample hospital,the number of drug in minimum packaging material with instructions,and measured the size of instructions.Results The PIVAS in the sample hospital had a wide coverage of drugs and were highly representative.A total of 190 kinds of drug instructions were collected in this study.There were88 kinds of minimum packaging materials in cillin bottles(46.32%),65 kinds(34.21%)in ampoules bottles.The specifications of164 drugs(86.32%)were within the size of A4 paper.Conclusion It is feasible to pack injection preparations in large packages and print pharmaceutical instructions with standardized size.