应用近红外技术建立注射用盐酸氨溴索一致性检验模型

摘要

Objective Using near infrared technology for a speciifc"Plant a product of a regulation"of drugs to establish near-infrared consistency test models. Methods NIR spectra of samples collected to establish consistency test model through the OPUS software and maps to compare and analyze. Results The consistency test model can well distinguish different pharmaceutical companies in the production of Ambroxol Hydrochloride for injection. Conclusion The method consistency test models can be created quickly and accurately distinguish different manufacturers ambroxol hydrochloride for injection, for rapid identiifcation of drugs from different manufacturers have a certain reference value.%目的：运用近红外技术对具体的某“一厂一品一规”的药品建立近红外一致性检验模型。方法用近红外光谱仪采集样品光谱，通过OPUS软件建立一致性检验模型，并对图谱进行比对分析。结果建立的一致性检验模型可以很好地区分不同制药企业生产的注射用盐酸氨溴索。结论建立的一致性检验模型的方法能快速、准确地区分不同厂家生产的注射用盐酸氨溴索，对快速鉴定不同厂家生产的药品具有一定的参考价值。