Studies and comparison on the process monitoring of dissolution of simvastatin tablets
Ping Wang · Yaowu fenxi zazhi · 2008
Objective:To compare the qualities of Simvastatin tablets from different manufactures through the method of fiber-optic real time dissolution test.To establish a valuable testing way of dissolution to evaluate the difference between Simvastatin tablets from different manufactures.Methods:Taking the dissolution tests according to the specifications in WS_1-(X-240)- 2004Z and WS_1-(X-066)-2003Z.Results:There are much more clearly diversities between domestic Simvastatin tablets than imported Simvastatin tablets in two different dissolution condi- tions.Furthermore,much obvious difference can be found in the same batch of some domestic manufactures.These results show that domestic Simvastatin tablets don't have the similar nature.Conclusion:It is impossible to com- pletely control and test the dissolution of some solid oral preparation by one single time.It suggests that we should take the fiber-optic real time dissolution test to strengthen the treatment and improve the quality.