温湿度记录器分段修正在药品稳定性试验箱验证中的应用  

The Application of Temperature and Humidity Recorder Segmented Correction in the V alidation of Drug Stability Test Chamber

作　　者：姜辉 张翔宇 曾冰梅 周文 赵丹丹 彭战 姜萌 JIANG Hui;ZHANG Xiangyu;ZENG Bingmei;ZHOU Wen;ZHAO Dandan;PENG Zhan;JIANG Meng

机构地区：[1]哈尔滨誉衡制药有限公司,黑龙江哈尔滨150025 [2]成都市计量检定测试院,四川成都610001 [3]海南科瑞计量技术服务中心,海南571100 [4]武汉市计量测试检定(研究)所,湖北武汉430050 [5]绍兴市质量技术监督检测院,浙江绍兴312000 [6]四川远大蜀阳药业责任有限公司,四川成都610214 [7]北京林电伟业电子技术有限公司,北京100097

出　　处：《计量与测试技术》2020年第9期56-58,共3页Metrology & Measurement Technique

摘　　要：药品稳定性试验箱广泛应用于制药行业,用于药品的稳定性试验或加速试验,其温湿度的稳定性和可靠性直接影响到药品的质量。制药厂普遍配备温湿度记录器定期对药品稳定性试验箱进行验证。本文根据药品稳定性试验箱验证过程中发现的问题,提出了一种分段修正方法,经验证,可提高温湿度记录器在全量程范围内测量的准确性,使得温湿度记录器能够更加精准可靠地对药品稳定性试验箱进行验证。Drug stability test chamber is widely used in pharmaceutical industry,used for drug stability test or accelerated test,its temperature and humidity stability and reliability directly affect the quality of drugs. The pharmaceutical factory is generally equipped with a temperature and humidity recorder to periodically verify the stability of the drug t stability test chamber. Based on the problems found in the validation process of drug stability test chamber,this paper proposes a segmented correction method,which is verified to improve the accuracy of temperature and humidity recorder measurement in the full range,so that the temperature and humidity recorder can verify the drug stability test chamber more accurately and reliably.

关 键 词：药品稳定性试验箱 验证 温湿度记录器 多段修正 

分 类 号：V444.34[航空宇航科学与技术—飞行器设计]