赖氨酸磷酸氢钙颗粒评价性抽验结果及质量评价  

Sampling results and assessment quality of Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules

作　　者：咸瑞卿[1,2] 王聪聪 巩丽萍 石峰 XIAN Ruiqing;WANG Congcong;GONG Liping;SHI Feng(School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东大学药学院,山东济南250012 [2]山东省食品药品检验研究院,山东济南250101

出　　处：《药学研究》2020年第4期205-212,232,共9页Journal of Pharmaceutical Research

摘　　要：目的评价国产赖氨酸磷酸氢钙颗粒质量现状及存在问题,为提高质量标准及临床用药安全提供参考。方法对全国范围内抽取的167批样品采用法定标准检验与探索性研究结合的方法进项检验,并对检验结果进行统计分析,用于风险评估。结果按法定标准检验,167批样品结果均符合规定;探索性研究中,合格率为83.8%,不合格项目为干燥失重及未按批准处方投料。结论本次抽检的赖氨酸磷酸氢钙颗粒整体质量状况差,现行质量标准存在缺陷,需进一步完善。Objective To evaluate the quality status and existing problems of Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules and provide references for the improvement of quality standard and clinical medication safety.Methods Totally 167 batches of samples from all over the country were examined by statutory testing methods combined with the exploratory research methods.The detection results were statistically analyzed for evaluating the quality status of Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules.Results All the samples were qualified according to the statutory standard.The qualified rate was 83.8%by exploratory research methods.The unqualified items were loss on drying and unapproved prescription.Conclusion The overall quality of Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules was poor.The current statutory standard was defective which should be further improved.

关 键 词：赖氨酸磷酸氢钙颗粒 评价性抽验 质量评价 

分 类 号：R927.11[医药卫生—药学]