今日药学

2019, v.29(03) 186-188+191

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近红外光谱法快速筛查维D_2磷酸氢钙片
Application of Near Infrared Spectroscopy in Rapid Qualitative Detection of Vitamin D_2 and Calcium Hydrogen Phosphate Tablets

韩莹;曾文珊;欧淑芬;刘红果;阮玮婷;
HAN Ying;ZENG Wenshan;OU Shufen;LIU Hongguo;RUAN Weiting;Guangzhou Institute for Drug Control;

摘要(Abstract):

目的建立维D_2磷酸氢钙片一厂一品一规近红外快速定性分析方法,用于该厂家的产品在流通环节的质量追溯及监测。方法以聚类分析方法选取建模样本,选取10 500~7 500 cm~(-1)、6 900~5 600 cm~(-1)及5 000~4 200 cm~(-1)谱段,光谱预处理方法为矢量归一化加二阶导数(17点平滑),采用近红外一致性检验方法建立单一厂家模型。结果模型最大CI限度为6,预测7批同厂家样品通过模型,预测6批同厂家样品(但不同片重)、18批其他厂家样品以及3批相似品种,结果为不通过,按照样品实际情况,识别正确率为100%。结论利用近红外光谱法按厂家建立维D_2磷酸氢钙片一厂一品一规近红外快速筛查模型,具有较好的专属性和耐用性,可在现场快速筛查产品质量,监控产品质量的一致性。
OBJECTIVE To establish a rapid detection method of Vitamin D_2 and calcium hydrogen phosphate tablets for one manufacturer and one regulation by Near infrared( NIR),which can be used in quality tracking and monitoring in the circulation field.METHODS The conformity test model was built with the modeling samples selected by cluster analysis. The spectral range was 4 200-5 000 cm~(-1),5 600-6 900 cm~(-1) and 7 500-10 500 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 6( CI = 6). Seven batches of Vitamin D_2 and calcium hydrogen phosphate tablets from the same manufacturer were identical by the model prediction,but 6 batches from the same manufacturer( with different weight of tablets),18 batches from another manufacturers and 3 batches of similar varieties were failed. The predicted results of this model accord well on the realities of samples. CONCLUSION This study demonstrated that it can be feasible to build a conformity test model of vitamin D_2 and calcium hydrogen phosphate tablets from one manufacturer,which has good specificity and durability to track the product quality in the circulation field,and to ensure the consistency of product quality.

关键词(KeyWords): 维D_2磷酸氢钙片;近红外;一致性检验;定性;质量监控
Vitamin D_2 and calcium hydrogen phosphate tablets;near-infrared;conformity test;qualitative;quality control

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作者(Author): 韩莹;曾文珊;欧淑芬;刘红果;阮玮婷;
HAN Ying;ZENG Wenshan;OU Shufen;LIU Hongguo;RUAN Weiting;Guangzhou Institute for Drug Control;

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