【摘要】：目的:利用近紅外光譜技術(shù)建立纈沙坦膠囊的一致性快速檢驗(yàn)?zāi)Ｐ?考察和評估纈沙坦膠囊制劑工藝的一致性。方法:對抽取的175批建立膠囊內(nèi)容物粉末和除鋁塑包裝無損一致性檢驗(yàn)?zāi)Ｐ�。并采用主成分分析法研究不同企業(yè)的樣品在主成分空間的分布情況。結(jié)果:采用膠囊內(nèi)容物積分球漫反射模式和膠囊除鋁塑包裝光纖模式建立的2種模型的預(yù)測正確率高;各企業(yè)光譜在主成分空間的分布狀況很好地印證了各廠家膠囊制劑工藝,并與一致性模型相對應(yīng)。結(jié)論:近紅外光譜能夠成功應(yīng)用于纈沙坦膠囊的快速檢驗(yàn)和篩查,具有模型穩(wěn)健可靠、檢測快速無損的優(yōu)勢;并能夠?qū)χ苿┕に嚨囊恢滦赃M(jìn)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.
【作者單位】： 中國食品藥品檢定研究院;
【分類號(hào)】：R927;O657.33
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本文編號(hào)：2285022