摘要
目的探讨中药饮片“置干燥处”贮藏的具体要求、执行现状及现存问题的解决方案。方法统计2020年版《中国药典(一部)》收载的616种中药饮片对“置干燥处”贮藏的要求及其他法规对干燥的贮藏要求,分析全国31个主要城市自然环境下达标情况,并以某医院1个月的温控系统数据为例,分析在冷库、冰箱、阴凉库、常温库等贮藏环境人工干预后的达标(相对湿度35%~75%)情况。结果自然环境下,各主要城市贮藏环境相对湿度达标率为70.97%(22/31),部分南方城市年平均相对湿度超标情况较常见,难以达到有效的干燥贮藏条件;在室内或有药品贮藏设备设施的贮藏环境内,平均相对湿度可达标,但阴凉库的平均相对湿度仍较高且高于专家的建议相对湿度(70%),可导致中药含水量增加,冰箱及冷库的湿度控制略优于普通环境,除湿机对房间内平均相对湿度影响不大,且各种设备设施均无法达到美国药典提出的干燥标准(相对湿度低于40%)。结论中药饮片储藏对温度的要求可通过设备解决,对光照、空气中异物、水分等的要求可通过包装容器或避免日光直射解决。在保证中药饮片水分达标及符合贮藏温度前提下,使用包装(特别是小包装)有助于保持其干燥状态。
Objective To investigate the specific requirements for storage,implementation status and solutions to existing problems of Chinese medicine decoction pieces on’’placing in a dry place’’.Methods The storage requirements for 616 kinds of Chinese medicine decoction pieces which included in Chinese Pharmacopoeia(VolumeⅠ,2020 Edition)in’’placing in a dry place’’and the dry storage requirements in other regulations were analyzed.The compliance in the natural environment of 31 major cities in China was analyzed,and taking the temperature control system data of a hospital for one month as an example,the compliance(the relative humidity of 35%-75%)after manual intervention under the storage environments such as in the cold storage,refrigerator,shade storage and normal temperature storage was analyzed.Results Under the natural environment,the relative humidity compliance rate of the storage environment in major cities was 70.97%(22/31),and the annual average relative humidity exceeded the standard in some southern cities was more common,which was difficult to achieve effective dry storage conditions.In the indoor or storage environment with drug storage equipments and facilities,the average relative humidity could reach the standard,but the average relative humidity in the shade storage was still high and higher than the relative humidity(70%)recommended by experts,which could lead to the increase of water content in traditional Chinese medicine(TCM).The humidity control of the refrigerator and cold storage was slightly better than that in the ordinary environment,and the dehumidifier had little effect on the average relative humidity in the room.All kinds of equipments and facilities could not meet the drying standard proposed by United States Pharmacopeia(the relative humidity was less than 40%).Conclusion The temperature requirements for the storage of Chinese medicine decoction pieces can be solved by equipments,and the requirements on light,the foreign matter in the air,the water content and so on ca
作者
范丽霞
张庆业
蔡庆群
唐洪梅
李学林
FAN Lixia;ZHANG Qingye;CAI Qingqun;TANG Hongmei;LI Xuelin(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China 510405;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou,Henan,China 450004)
出处
《中国药业》
CAS
2022年第8期9-12,共4页
China Pharmaceuticals
基金
国家重点研发计划项目[2017YFC1703400]。
关键词
中药饮片
置干燥处
贮藏
包装
药房管理
Chinese medicine decoction pieces
placing in a dry place
storage
packaging
pharmaceutical management
