氯化钾注射液质量综合评价分析

Comprehensive Evaluation and Analysis of the Quality of Potassium Chloride Injection

目的:考察国内氯化钾注射液质量状况。方法:依据《中国药典》相关标准对23个生产厂家的132批次氯化钾注射液进行质量检测,并对各批次氯化钾注射液p H、微粒及含量进行综合评价分析。结果:所检测的132批次氯化钾注射液全部合格,不同厂家生产的氯化钾注射液中氯化钾含量、平均装量和p H检查结果无统计学差异,但微粒检查结果具有统计学差异(P<0.01)。结论:不同生产厂家对氯化钾注射液的质量监控水平参差不齐,氯化钾注射液生产工艺有待改善。

OBJECTIVE： To inspect and analyze the quality of Potassium chloride injection in China. METHODS： According to related standard of Chinese Pharmacopeia, the quality of 132 batches of Potassium chloride injection from 23 manufacturers was detected, and these batches of injections were evaluated comprehensively in terms of pH, particle and content. RESULTS： All the tested 132 batches of Potassium chloride injection met the quality requirement, but there was no statistical difference in the content of potassium chloride, average load capacity and pH of Potassium chloride injection from different manufacturers; there was statistical significance in results of particle test （P〈0.01）. CONCLUSIONS： There is uneven quality control level of Potassium chloride injection from different manufacturers, and the production process of Potassium chloride injection needs to be improved.