改性明胶注射液近红外定性分析模型的建立

Establishment of near-infrared qualitative model for modified gelatin injection

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 model for accurate and rapid identification of modified gelatin injection and succinylated gelatin injection produced by different manufacturers with different crosslinking agents. Methods：With the modified gelatin injection produced by different manufacturers as sam- ples, combining with the OPUS software, and using near - infrared spectroscopy method, the near - infrared spectroscopy qualitative model was established. Results ： Appropriate spectra were selected, and the first deriva- tive （ or second derivative） was adopted combined with vector normalization pretreatment methods with 9 - point smoothing,to establish the qualitative analysis model which was divided into two levels, and 100% accuracy was obtained. Conclusion：The established near - infrared spectroscopy qualitative model can precisely distin- guish modified gelatin injections of different crosslinking agents, and can be used for production process monito- ring, the drug quality control which is suitable for rapid on - site screening inspection, so as to effectively con- trol counterfeit drugs.