常用中成药说明书贮藏项标示问题分析  

Problems with specifications of storage conditions in common proprietary Chinese medicine instructions

作　　者：王岩 张鹏 王思惠 姜德春 WANG Yan;ZHANG Peng;WANG Sihui;JIANG Dechun(Department of Pharmacy,Beijing Millennium Temple Hospital,Capital Medical University,Beijing 100038;State Key Laboratory for Quality Assurance and Sustainable Use of Dao-di Herbs,Beijng 100700,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药学部,北京100038 [2]道地药材品质保障与资源持续利用全国重点实验室,北京100700

出　　处：《空军航空医学》2024年第6期506-510,共5页AVIATION MEDICINE OF AIR FORCE

基　　金：北京市第三批中药骨干人才培养项目(京中医科字[2022]59号);中央本级重大增减支项目(2060302)。

摘　　要：目的通过对常用中成药说明书贮藏项标示问题分析并提出相关建议,进一步规范中药储藏条件以确保药品质量和用药安全。方法统计分析首都医科大学附属北京世纪坛医院药品目录中的291种中成药药品说明书中贮藏项内容,并评价观察结果。结果291种中成药分为31类,其中扶正剂有49种(16.84%),位列第1,清热剂42种(14.43%),祛瘀剂37种(12.71%);其说明书中贮藏项未对温度做出要求的是215种(73.88%),占比最大,不超过20℃或阴凉处有67种(23.02%)。不超过25℃或30℃以下涉及药品比较少;说明书中贮藏条件为密封的有259种(89.00%),占比最大,其中占比最高的是胶囊剂,为33.59%,其次是颗粒剂和丸剂,占比均为16.22%;药品说明书中大部分未对光照提出要求,有279种(95.88%);贮藏项中对湿度有要求的有68种(23.37%),223种(76.63%)未对湿度做出要求。结论应确保药品的正确贮藏条件,规范药品说明书贮藏项术语的表达,如温湿度的具体范围,有利于药品保存的实际操作。Objective To standardize the storage of traditional Chinese medicines to ensure the quality and safety of drugs.Methods The specifications about storage in the instructions of 291 types of proprietary Chinese medicines in the drug catalog of Beijing Shijitan Hospital Affiliated to Beijing Medical University were statistically analyzed before the results of observation were evaluated.Results According to the functional classification by the National Basic Medical Insurance,Industrial Injury Insurance and Maternity Insurance Drug Catalogue(2023),the 291 drugs were divided into 31 categories,among which 49 were immunity-boosting agents,accounting for 16.84%,42 were heat-clearing agents,accounting for 14.43%,and 37 were blood-stasis removing agents,accounting for 12.71%.The required temperature was not specified in the instructions of 215 of these drugs,accounting for the largest proportion(73.88%),and the instructions of 67 drugs specified that the storage temperature was up to 20℃or in cool place,accounting for 23.02%.In the instructions of 259 drugs,sealing was required for storage,accounting for the largest proportion(89.00%).Capsules made up the majority of these drugs,accounting for 33.59%,followed by granules and pills,accounting for 16.22%.The technical terms related to light storage of drugs were shading and avoiding light.In most of these drug instructions(279),lighting conditions were not mentioned,accounting for 95.88%.There were 68 storage items that specified requirements for humidity,accounting for 23.37%,while 76.63%did not.Conclusion It is critical to ensure the correct storage conditions of drugs and standardize the descriptions of storage terms in drug instructions,such as temperature and humidity.

关 键 词：药品说明书 中成药 贮藏条件 合理用药 用药安全 

分 类 号：R28[医药卫生—中药学]