关键词: font-size:medium, ">维酶素片；质量评价；阿氏假囊酵母菌；黄曲霉毒素

Abstract: Objective： To evaluate the quality of vitacoenzyme tablets， and improve the quality standards. Methods： According to the combination of legal standard tests and the exploratory research， 224 batch samples from national drug plan and samples collected from survey enterprises were tested. The quality of vitacoenzyme tablets was analyzed and evaluated by the identification of fermentation strains(Eremothecium ashbyii guilliermond)， the study of the characteristic map， the determination of aflatoxin content and the investigation of vitamin B2 content. Results： The qualified rate of 224 batches of vitacoenzyme tablets was 99.1%. The exploratory study results showed that there were significant differences in the properties of vitacoenzyme tablets produced by different manufacturers. The reason was that there were differences in the fermentation strains and prescriptions used by the three API manufacturers. Aflatoxin B1 was detected in a total of 10 batches of samples， indicating potential drug safety risks. Conclusion： The quality of vitacoenzyme tablets was generally general based on the examination of legal standards and exploratory experiments. It is suggested that relevant enterprises improve raw material standards， increase the identification of aflatoxin test. It is suggested that relevant enterprises investigate and optimize the prescription production process to improve the quality of the preparation. It is suggested that the quality standard should be updated to increase the identification of fermenting strains (Eremothecium ashbyii guilliermond) and the check item of characteristic chromatogram， so as to ensure that the standard is controllable and the drug is safe and effective.
  

Key words: font-size:medium, ">Vitacoenzyme tablets； Quality evaluation； Eremothecium ashbyii guilliermond； Aflatoxin