Establishment Of The Calibration Of The Probes With The Fiber-optic In-situ Dissolution Test System And Analysis The Resourse Of Errors During The Dissolution Test

Objective: Calibrate the path-length of probes according to the absorption coefficient of potassium dichromate at different concentrations determined with UV to test the drug dissolution with the method of absorption coefficient; Investigate the effects of different factors on dissolution test of Aspirin Enteric-Coated Tablets and the effect of temperature on the standard curves, as well as, affect the dissolution test of Cimetidine Tablets and Metformin Hydrochloride Tablets; Traditionally, the dissolution test is a test of a limitation, but determined by the fiber-optic dissolution system, it can give a complete dissolution curves, so how to evaluate the similarity of dissolution curve is very important. Methods: 1,The probes had four kinds of path lengths, the light path were 1.0, 2.0, 4.0, 10.0 mm, respectively. The absorption coefficient of potassium dichromate given by Ch.P only at the concentration of 60.0μg/ml and the light path of 10.0mm. If calibrate other three path length of probes, there was need to determine the absorption coefficient of potassium dichromate at different concentrations. 2,Make standard curves at room temperature and 37℃, respectively, to investigate the effect of temperature on the dissolution test of Cimetidine Tablets and Metformin Hydrochloride Tablets. 3,Employed the methods of f2,Chow and Ki's and the uniformity of dissolution rate to evaluate the similarity of dissolution curve. Results: According to improve the methods of calibration of probes, the error was reduced when determined the drug dissolution test with the method of absorption coefficient. The average effects of temperature on Cimetidine Tablets and Metformin Hydrochloride Tablets was 13% left and right. When employed the evaluation method of f2, there was phenomenon of false positive, the shortcoming of Chow and Ki's was low sensitivity, the method of uniformity of dissolution rate can give an accurate result. Conclusion : According to improve the calibration of probes, the usage of fiber-optic dissolution system was expanded and is powerful to establish a more scientific and effective evaluation method of the drug quality.