摘要
目的：建立阿莫仙胶囊的近红外快速无损检测方法,用于该产品在流通环节的质量追溯及监测。方法：采用近红外一致性检验方法,在5100～9000 cm-1谱段,光谱预处理方法为二阶导数（17点平滑）和矢量归一化,以3批样品在3台仪器上所测量原始光谱建立预测模型。结果：模型阈值为Sum2=0.37（CI=3）,预测8批阿莫仙胶囊分别在3台仪器上所测量光谱的平均光谱、75批内地厂家生产的阿莫西林胶囊的平均光谱,以及经过法定方法确认的6批阿莫西林胶囊假药,正确率均为100%。结论：任意选择某厂家的3批样品在3台仪器上所测量的近红外光谱建立一致性检验模型,可用于对该厂家该药品在流通环节的质量监测。模型阈值根据参照光谱中Sum2最大的结果确定,可以初步将阈值设定为0.6。
Objective： To construct a rapid, non-destructive NIR（Near infrared） detection method of Amoxian capsules for its quality tracking and monitoring in the circulation field. Methods： The conformity test model was built with the original spectra of 3 batches of Amoxian capsules recorded on 3 instruments. The spectral range was 5100 to 9000 cm-1 and all the spectra were pretreated by second derivate with 17-point smoothing followed by vector normalization. Results： The threshold was set to 0.37（CI=3）. The model was challenged with the average spectra from each instrument of 8 independent batches of Amoxian capsules, 75 batches of amoxicillin capsules from other manufacturers and 6 batches of counterfeit amoxicillin capsules. The accuracy was 100%. Conclusion：Our study demonstrated that it could be feasible to build a conformity test model using the original spectra from 3 instruments of 3 random batches from one manufacturer to track the product quality of this manufacturer in the circulation field. The threshold can be set by the maximum Sum2 value of the reference samples. The initial threshold can be set to 0.6 so as to avoid the false positive results for the imitation of Amoxian.
作者
冯艳春
胡昌勤
Feng Yanchun Hu Changqin(National Institutes for Food and Drug Control, Beijing 100050, China)
出处
《中国药事》
CAS
2016年第11期1123-1131,共9页
Chinese Pharmaceutical Affairs
基金
国家公益性行业科研专项资金(编号2012104008)
