Dissolution Test Of Some Drugs With In Situ Fiber-optic Dissolution Test System(fodt)

Objective: Dissolution testing played an important role in drug preparation technology evaluation and quality control and new drug RD (research and development), especially in imitate drug and origin drug bioequiavailability testing and new pattern drug product quality and curative effect control. Fiber-optic dissolution test system(FODT) is an optical, mechanical and electronical dissolution analytical apparatus that comes into being in response to sci-tech development in the new period, real-time mensuration drug dissolution and online providing with drugs stripping curve. To obtain comprehensive information of drug products internal quality. In order to overall extend its utilize in quality controlled of drugs, to study dissolution assay in narcotic drugs, narrow therapeutic index drugs and new preparation of orally disaggregation tablets, to evaluate drug product technology and quality. Method: To set up in situ dissolutive assay method of warfarin sodium tablets by FODT with coefficient multiplying factors method to eliminate accessories interference. And using UV spectrophotometry for comparison.In situ assay dissolution of codeine phosphate tablets and pethidine hydrochloride tablets which frequently used in clinically, at the same time getting out dissolution paramete(rTd,T50)to statistics analysis, to overall evaluate internality quality of drugs and product technology . To study dissolution rate of high dissolvability drugs ambroxol hydrochloride orally disaggregation tablets in artificial saliva and insolubility drugs ibuprofen orally disaggregation tablets in two kinds of dissolution medium(artificial saliva and pH7.2 phosphate buffer), to supply advice of such drugs dissolution test. Result: FODT in situ assay dissolution of warfarin sodium tablets by coefficient multiplying factors method eliminating accessories interference. There was no distinct difference when compared with UV method(P>0.05). Codeine phosphate tablets and pethidine hydrochloride tablets both have more difference between each tablets in dissolution homogeneity, and preparation technology imperfect. Compared with traditionally dissolutive assay method, FODT have more superiority in drug product technology evaluation of special control drugs and narrow therapeutic index drugs. FODT assay ambroxol hydrochloride orally disaggregation tablets in artificial saliva accumulated dissolution above 90% within 2min, ibuprofen orally disaggregation tablets in artificial saliva accumulated dissolution need 360min, but in pH7.2 phosphate buffer only need 6min. Conclusion: coefficient multiplying factors method can be used to eliminate accessories interference and each wavelength absorbance inequality of drugs with in situ dissolution testing. FODT can provid with stripping curve and be used to quality control and preparation technology evaluation of codeine phosphate tablets and pethidine hydrochloride tablets. With artificial saliva as medium to assay ambroxol hydrochloride orally disaggregation tablets'dissolution more approach to it's dissolution process. And ibuprofen orally disaggregation tablets has great differencd in two kinds of dissolution medium .It can not dissolution in oral cavity but main in intestinal tract.