摘要
目的利用近红外漫反射光谱技术建立硝酸咪康唑栓剂一致性检验方法,快速鉴别筛查假劣药品。方法以西安杨森制药有限公司54批硝酸咪康唑栓为分析对象,首先用近红外漫反射法采集样品的近红外光谱,然后采用一致性检验方法建立模型。建模谱段为10000~4500cm^(-1);预处理方法为一阶导数结合矢量归一化;平滑点为17;CI指数为7。结果所建立的模型可以快速鉴别区分其他8个厂家的硝酸咪康唑栓。结论所建方法快速、简便、有效,可准确筛查假劣药品,保护品牌药,保障人民用药安全。
OBJECTIVE To establish the conformity test of miconazole nitrate suppository using near infrared diffuse reflectance spectroscopy technology. METHODS A total of 54 batches of miconazole nitrate suppository from Xi＇an Janssen Pharmaceutical Ltd were chosen for analysis. First, the near infrared spectrum of the samples was collected. Then,the model was constructed by conformity test. The spectra range was 10000 -4500cm-1 ;The pretreatment method was first derivation and vector normalization with the smooth point 17;CI index was 7. RESULTS Miconazole nitrate suppositories from other 8 manufacturers could be quickly identified and differentiated by our model. CONCLUSION The method constructed by us is rapid, simple and effective and can screen the counterfeit and inferior drugs accurately with protecting the brand of medicine and safeguarding the people＇s medication safety.
出处
《海峡药学》
2015年第11期34-36,共3页
Strait Pharmaceutical Journal
关键词
近红外
硝酸咪康唑栓
一致性检验
Near-infrared
Miconazole Nitrate Suppository
Conformity test
