Abstract:
OBJECTIVE To establish a method for the dissolution determination of compound ganmaoling tablet, and to evaluate the inherent quality differences of different batches of Compound Ganmaoling tablet from different domestic enterprises by researching its dissolution.
METHODS The dissolution test was carried out with basket method, and using 0.1 mol·L
-1 hydrochloric acid solution as the dissolution medium, the rotation speed of 100 r·min
-1, and the sample dissolution time was 30 min. The dissolution test of paracetamol, caffeine and chlorphenamine maleate in preparations were performed on HPLC, then similarity factor method was adopted to detect the similarity of dissolution profiles of 3 batches of products from 3 domestic enterprises.
RESULTS The dissolution profiles and similarity factor method evaluation results showed that the dissolution curve of paracetamol and caffeine in 3 batches of compound ganmaoling tablet from 3 domestic enterprises was relatively high;but the chlorphenamine maleate had certain difference, overall similarity was relatively low.
CONCLUSION The difference of dissolution of compound ganmaoling tablet may affect the preparation's efficacy, the production process and quality control in domestic enterprises shall be managed strictly. Moreover, the current quality standard of this preparation has not been set up dissolution inspection item, which needs to be improved urgently.