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目的:建立准确快速地识别不同交联剂的改性明胶注射液以及不同厂家生产的琥珀酰明胶注射液的近红外定性分析模型。方法:以全国范围内不同企业生产的改性明胶注射液为分析对象,用光纤测定近红外漫反射光谱,结合OPUS软件建立近红外定性分析模型。结果:选择合适的谱段,采用一阶导数(或二阶导数)结合矢量归一化预处理方法,平滑点数选择9,分两层建立的定性分析模型,正确识别率为100%。结论:模型准确地区分不同交联剂的改性明胶注射液,可以用于监控厂家生产工艺,控制制剂的质量,适合药品现场快速筛查,有效的打击假劣药品。
OBJECTIVE: To establish a near-infrared qualitative analysis model for identifying gelatin injection with different cross-linking agents accurately and rapidly and succinylated gelatin injection produced by different manufacturers. Methods: The modified gelatin injection produced by different enterprises nationwide was taken as the analysis object. The near-infrared diffuse reflectance spectra were measured by optical fiber, and the qualitative analysis model of near-infrared was established by OPUS software. Results: The first order derivative (or second derivative) and vector normalized preprocessing method were selected. The number of smoothing points was chosen as 9, and the qualitative analysis model was established by two layers. The correct recognition rate was 100%. Conclusion: The model can accurately distinguish modified gelatin injection with different cross-linking agents, which can be used to monitor the production process of manufacturers and control the quality of preparations. It is suitable for rapid screening on the drug site and effectively counterfeit counterfeit drugs.