Sampling Results and Quality Assessment of Recombinant Human Interferon α2 a Injections
- VernacularTitle:重组人干扰素α2a注射剂评价性抽验结果与质量分析
- Author:
Dening PEI
;
Ying GUO
;
Yonghong LI
;
Chunmei HAN
;
Youxue DING
;
Xiang LI
- Publication Type:Journal Article
- Keywords:
Recombinant human interferon α2a;
Evaluative sampling;
Quality evaluation
- From:
China Pharmacist
2015;(1):52-54,55
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the quality status of recombinant human interferon α2a injections and find out some quality problems. Methods:The statutory testing methods combining with the exploratory studies were used to examine the samples, and the quality status of recombinant human interferon α2a injections was evaluated by statistical analysis of the results. Results: All 28 bat-ches of the injections were qualified using the statutory testing methods. The exploratory studies showed that if the specific activity was determined, the qualified rate was only 87. 0%. All 7 batches of drug substances were qualified using the statutory testing methods. The exploratory studies showed that if the related protein was determined, the qualified rate was 57. 1%. Conclusion:At present the quality of recombinant human interferonα2a injections is generally good. The current standards are feasible;however, improvement is still needed. Specific activity determination should be supplemented the standards for drug products and related protein determination should be supplemented the standards of drug substances.
