ABSTRACT
OBJECTIVE: To compare the in vitro dissolution of ursodeoxycholic acid capsules prepared by different grinding methods and screen the best grinding method. METHODS: Using the large cup method, HPLC was used to investigate the similarity of dissolution behaviors between the reference preparation Ursofalk® (the original drug) and the self-made ursodeoxycholic acid capsules in four dissolution media. The grinding method which obtained product with qualified similarity factor f2 was determined as the best technology. RESULTS: The ursodeoxycholic acid capsules made with raw material micronized by ball grinder for 3 min had similar dissolution curve to the original drug. CONCLUSION: Rational preparation process is established for ursodeoxycholic acid capsules.