关键词: font-size:medium, ">药品监管；酒石酸美托洛尔制剂；国家评价性抽验；质量分析

Abstract: Objective： The quality status of metoprolol tartrate preparation in 2018 were analyzed， in order to provide reference for itsproduction， quality control and supervision.Methods： 281 batches of samples were inspected according to the current official standards， and the results of important inspection items were collected for statistical analysis. The original tablets were used as the reference preparation to carry out the exploratory test， and pharmaceutical consistencies of product samples from domestic enterprises were evaluated. Results： According to the official standard inspection， one batch of the 281 batches of samples was unqualified for the items of dissolution (tablet)； the exploratory research study showed that the dissolution curves of some imitated samples had a large difference between batches， and were not similar to the original reference preparation， suggesting that there was a large instability in the formulation and production process. Conclusion： The quality of domestic metoprolol tartrate preparations is generally satisfactory， but there is much more can be done for improvement compared with the original preparation. The current standard is basically feasible， but it still needs to be perfected to control the production process and improve the quality of preparations.

Key words: font-size:medium, ">Drug monitoring； Metoprolol Tratrate preparations； National assessment programs； Quality analysis