运用近红外光谱法对缬沙坦胶囊进行一致性评价的研究

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.

Objective: To establish near infrared spectroscopy(NIRS)models for the rapid identification and uniformity evaluation of valsartan capsules from various manufacturers. Methods: NIRS models for capsule content powders and capsules without aluminum plastic packaging were built for 175 batches of products from 7 manufacturers.Principal component analysis(PCA)was used to analyze the distribution of samples from different manufacturers in PCA space. Results: Two types of uniformity models(integrating the sphere diffuse reflection pattern for capsule content powders and the solid fiber pattern for capsules without aluminum plastic packaging)for valsartan capsules were built with high prediction accuracy.The distribution in PCA space for 7 individual manufacturers was coincident with the preparation process and the distribution of uniformity models. Conclusion: NIRS was successfully utilized in the rapid uniformity test and screening of valsartan capsules.These models were found to be robust,reliable,rapid and nondestructive,which demonstrated the potential of being a rapid and highly effective method in site tests and a useful tool for uniformity inspection of preparation process.

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