车载抗病毒类化学药粉针剂定性分析模型的验证及优化

目的: 对车载近红外模型库SFDA_Ident(2.6.4)中抗菌抗病毒类化学药粉针剂定性分析模型进行验证并优化。 方法: 采集国家评价抽验品种注射用阿昔洛韦、更昔洛韦、炎琥宁、穿琥宁共计455批次样品的近红外漫反射光谱,对模型进行验证;在模型中增加注射用喷昔洛韦,并对建模品种、谱段、因子谱等参数进行调整,建立优化模型;同时采集阿昔洛韦、更昔洛韦、利巴韦林、脱水穿心莲内酯琥珀酸半酯、苦参碱的对照品近红外光谱,建立上述粉针剂二级串联模型。 结果: 模型验证总的正确识别率为62.9%。优化后模型的正确识别率为100%;建立的5个串联模型正确识别率为100%。 结论: 模型优化后更加科学合理,增加了使用范围,提高了准确率,适合药品现场快速筛查。

Objective: To validate and optimize the identity models of antiviral drugs for injection. Method: NIRDRS of totally 455 batches of national evaluation examination varieties were collected and validated,such as aciclovir for injection,ganciclovir for injection,potassium dehydroandrographolide succinate for injection and potassium sodium dehydroandrographolide succinate for injection;Then penciclovir for injection was added to the models,the parameters were adjusted such as regions of frequency,and the optimized models were constructed;NIRDRS of the reference substances of aciclovir,ganciclovir,ribavirin,dehydroandrographolide succinate,matrin were collected and the secondary series models for these varieties were constructed. Results: The correct recognition rate of the original models is 62.9%,and the rate of the optimized models is 100%;the rate of 5 secondary series models is 100%. Conclusion: The reasonability,the usable range and the accuracy of the optimized models are all highly improved.

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