オザグレルナトリウム注射剤の品質比較試験

抄録

A pharmaceutical study was carried out to evaluate the quality of five Sodium Ozagrel (OZG) injection products. The quality of these products initially and after 12 weeks and 24 weeks of accelerated stability testing was evaluated based on characteristics such as pH, foreign insoluble matter, content and impurities. One brand name injection and four generic injections were evaluated. The brand name product and one generic product were in freeze-dried form and the other three generic injections were in liquid form.
The pH of one generic injection was higher than that of the others. No foreign insoluble matter was observed in any product during the period of the study. The OZG content of the freeze-dried injections was approximately equal to that indicated on the labels but that of the liquid injections was appreciably higher, one of them having at least 15 % more than the indicated content. In the accelerated stability testing, the OZG content was still around 100% of the initial content after 24 weeks, showing that it was very stable. Quaternary salts were detected in the brand name injection but the concentration was only 0.02%. The cis form of OZG was detected in one generic injection but the concentration was only 0.03%. Accelerated stability testing did not increase the quantities of these impurities. Two unknown impurities were detected in one generic injection and one of them was detected in the other three generic injections.
Our study showed that there was a difference in quality between the generic injections and the brand name OZG injections in terms of pH, content and impurities, suggesting that not only cost but also quality should be considered when deciding whether to use generics or not.