运用近红外光谱法对缬沙坦胶囊进行一致性评价的研究

发布时间：2018-10-21 11:57

【摘要】：目的:利用近红外光谱技术建立缬沙坦胶囊的一致性快速检验模型,考察和评估缬沙坦胶囊制剂工艺的一致性。方法:对抽取的175批建立胶囊内容物粉末和除铝塑包装无损一致性检验模型。并采用主成分分析法研究不同企业的样品在主成分空间的分布情况。结果:采用胶囊内容物积分球漫反射模式和胶囊除铝塑包装光纤模式建立的2种模型的预测正确率高;各企业光谱在主成分空间的分布状况很好地印证了各厂家胶囊制剂工艺,并与一致性模型相对应。结论:近红外光谱能够成功应用于缬沙坦胶囊的快速检验和筛查,具有模型稳健可靠、检测快速无损的优势;并能够对制剂工艺的一致性进行研究和考察。
[Abstract]:Aim: to establish a rapid test model of valsartan capsule by near infrared spectroscopy (NIR) and to evaluate the consistency of valsartan capsule preparation. Methods: the nondestructive consistency test model was established for 175 batches of capsule contents powder and dealuminium-plastic packaging. Principal component Analysis (PCA) was used to study the distribution of samples in principal component space in different enterprises. Results: the prediction accuracy of the two models, which were established by the integrated sphere diffuse reflection model of capsule contents and the fiber model of capsule dealuminium-plastic packaging, was high, and the distribution of each enterprise spectrum in the principal component space was very good to confirm the capsule preparation process of various manufacturers. And corresponding to the consistency model. Conclusion: Near-infrared spectroscopy can be successfully applied to the rapid detection and screening of valsartan capsules, which has the advantages of robust model and fast nondestructive detection, and can be used to study and investigate the consistency of preparation process.
【作者单位】： 中国食品药品检定研究院;
【分类号】：R927;O657.33
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本文编号：2285022