Abstract: Objective: To evaluate the quality of olopatadine hydrochloride oral preparations in our country. Based on the problems
found in the study, some suggestions were put forward to solve the problems. Methods: The research was carried out according to the
current standards, then the results were counted and analyzed. Based on the concept of risk control, new methods of related substances
were established and exploratory studies on genotoxic impurities were carried out. Results: The qualified rate was 100.0% based on the
current quality standard. In the exploratory study, the defects of the quality standard including related substances method and
dissolution method were pointed out, and then the suggestions were given. Conclusion: The overall quality evaluation of the domestic
olopatadine hydrochloride oral preparations is "fairly good", but the quality standard should be improved.

Key words: olopatadine hydrochloride oral preparations, evaluation sampling test, risk control