| 陶明,周艳梅,李勇,师俊萍.司他夫定胶囊近红外一致性检验模型建立及验证[J].中国药品标准,2018,19(5):376-381 |
| 司他夫定胶囊近红外一致性检验模型建立及验证 |
| Construction and validation of conformity test model for Stavudine capsule by near infrared reflectance spectroscopy |
| 投稿时间：2018-06-05 修订日期：2018-09-28 |
| DOI： |
| 中文关键词: 近红外光谱分析技术 司他夫定胶囊 一致性检验 快速检测 |
| 英文关键词: : Near-infrared spectroscopy(NIRS) Stavudine capsule Conformity test rapid testing |
| 基金项目:河南省开封市科技攻关计划项目 |
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| 摘要点击次数: 380 |
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| 中文摘要: |
| 目的：本实验以司他夫定胶囊为研究对象,应用近红外光谱分析技术,建立司他夫定胶囊的近红外一致性检验模型,快速无损进行司他夫定的真伪鉴别。方法：以司他夫定为研究主体,收集上海迪赛诺生物医药有限公司多批次数量样品,采集原始建模光谱160张,不同人员验证光谱80张,不同仪器验证光谱80张,应用OPUS7.0分析软件,采取一阶导数+矢量归一化法在12000~4000 cm-1范围内对司他夫定胶囊采集光谱进行预处理,选择最佳建模谱段为9000 cm-1～7500cm-1、6900 cm-1～5600 cm-1和5000 cm-1～4250 cm-1,平滑点为17,CI限度设为7,建立一致性检验模型并进行验证。结果：本方法CI限度值设为7,意味着本厂生产的样品CI限度值应＜7,结果建模样品光谱的CI限度值均＜7,非本厂生产的样品CI限度值均＞7,与事实相符,代表本模型具有很好鉴别本厂产品的能力。同时,不同仪器及不同人员测定的相同批次样品验证光谱CI值均＜7,证明该模型分别通过了不同仪器、不同人员的验证。结论：使用一致性检验模型可正确区分正品及伪品司他夫定胶囊,并通过了不同人员和不同仪器的光谱验证,从而实现了精确有效的模型传递,大大提高了近红外校正模型的通用性。该方法快速、简便、准确,适用于药品快检车对司他夫定胶囊的一致性快速筛查。 |
| 英文摘要: |
| Objective: This experiment took Stavudine Capsules as the object of study,applied Near infrared spectroscopy analysis technique to establish a conformity test model for inspecting Stavudine capsule by near infrared reflectance spectroscopy fastly and losslessly. Methods: Took Stavudine as the research subject, collected multiple batches of samples of Shanghai Diseno Biopharmaceutical Co.Ltd., gathered 160 pieces of original spectral modeling, 80 pieces of verified spectrum by different personnel,80 pieces of verified spectrum by different instruments,applied analysis software of OPUS 7.0.The method of first derivative and vector normalization was employed respectively to pretreat the corresponding near spectroscopy spectral of Stavudine capsule with the spectral ranges of 12000~4000 cm-1, the optimum modeling band is 9000 cm-1～7500cm-1、6900 cm-1～5600 cm-1and 5000 cm-1～4250 cm-1,the smoothing point is 17 and CI being 7, The conformity test model was constructed on the basis of the above parameters and was validated. Results: The CI of the method is 7, which means that the CI of the samples produced by our factory should be less than 7. The results show that the CI of the sample spectrum was 7, and the CI of the samples produced in other factory was more than 7, which was consistented with the facts,which indicated that this model had a good ability to identify our products. At the same time, The verified spectrum CI of the same batch samples by different personnel and instruments were all less than 7, This model was proved to be validated by different personnel and instruments respectively.Conclusion: Using the conformity test model can distinguish the authentic from inauthentic Stavudine capsule, and can be validated by different inspectors and near infrared instruments. Realizing the model transfering accurately and effectively and improving the universality of NIR calibration model. The conformity test model is quickly, accurate, simple, and suitable for the drug examination of Stavudine capsule. |
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