Abstract:Based on the national drug sampling results data, to analyze and evaluate the quality of Chinese patent medicine products in my country, and provide references for relevant regulatory authorities and drug manufacturers. Methods:The drug sampling notices issued by the national and provincial drug administrations from 2014 to 2018 were collected. Classification and statistics of 5 433 unqualified batch data were conducted. And we focused on the quality problems of oral solid and oral liquid Chinese patent medicine preparations. Results:There were many unqualified batches of Chinese patent medicine tablets and capsules, accounting for 47.60% and 26.47% of the total number of unqualified batches of oral dosage forms, followed by pills and granules. The inspection items were the most common unqualified items of oral Chinese patent medicines, and the unqualified contents were mainly the difference in loading (weight), moisture and microbial limits. Conclusion:In the past five years, the quality of Chinese patent medicines in my country is generally optimistic. The review of the results of periodic drug inspections is conducive to discovering the trend of drug quality problems and provides a useful reference for the improvement of the level of drug quality supervision and the level of quality control of the entire drug industry chain.