关键词: 牡丹皮, 配方颗粒, 质量评价, 药品监管

Abstract: Objective： To comprehensive evaluate the quality of moutan cortex formula granules sold. Methods： 40 batches of moutan cortex formula granules samples collected from 16 cities in Shandong province were tested according to quality control standards and the current drug quality standards of Shandong province. Stoichiometric methods were used to analyze the test results to evaluate the quality of moutan cortex formula granules. Results： The properties， TLC identification and specific chromatogram of 40 batches of moutan coytex formula granules all conform to the standards. The particle sizes are between 0.3% and 4.2%，and only one patch more than 8% in 40 batches. The moisture test results range from 1.8% to 6.1%.The contents of extract range from 22.3% to 68.8%. The content determination results all conform to the requirements under each standard. The results of exploratory study showed that the content of paeoniflorin and paeonol in moutan cortex formula granules produced by different enterprises varied greatly. The results of stoichiometric analysis showed that there were differences in product quality among enterprises， and the raw materials used for moutan cortes formula granules had the risk of sulfur fumigation. Conclusion： The overall quality of moutan cortex formula granules sold is good. It is suggested to establish a unified， scientific and reasonable national quality standard for moutan cortex formula granules， continuously optimize the production process and strengthen quality supervision.

Key words: Moutan cortex, Formula granules, Quality evaluation,