Abstract
In the present study, according to the standardized methods, we tried to evaluate the quality and efficacy of oral kallidinogenase preparations, which were manufactured under the new quality standard, and the stabillity and purity tests by using HPLC-post-column analysis.Results obtained by the standardized methods showed that all of the specimens were in compliance with standards.The purity test by HPLC-post-column analysis revealed that many specimens were found to have enzyme activities other than kallidinogenase.The stability test showed that most specimens were stable enough under the storage conditions at 50°C for 2 months, but one particular specimen reduced to 30% of the labeled activity under the same conditions.These results suggest that although the products have been manufactured and marketed under the standardized criteria, the qualities of kallidinogenase preparations are found considerably different among manufactures.
