Study Of Dissolution Test On Progress Analysis For Three Antibiosis Drug Preparation

Objective:Drug Dissolution is rate and degree of dissolution which is from solid dosage forms such as tablets and capsules so on. Dissolution testing is an important tool for quality control and an aid in developing pharmaceutical formulations. It measures changes in the stability of the product. Traditionally,Dissolution testing has been conducted by manually or automatically removing samples from dissolution vessels,and then bringing the samples either to a UV/VIS spectrometerfor determination of the analyte concentration. Manual sampling can not reflect the real dissolution behavier which is difficult to evaluate preparation technology for fast release preparation. FODT became a good way to moniter dissolution for fast release preparation.It is a important and urgent task to develop the methods monitoring by FODT for fast release preparation. Methods: This thesis developed FODT methods for Amoxicillin Dispersible Tablets, Cefixime Dispersible Tablets and cefalexin granules three antibiosis drug fast release preparation. Using two wavelength method and multiplying factor methods eliminate excipient interference.Experiment method include precision and recovery etc. The dissolution of Cefixime Dispersible Tablets from six mufacturers were test by FODT.Results:to establish two wavelength method eliminate excipient interference of Amoxicillin Dispersible Tablets. The dissolution results of measurement using the instrument have not significant Difference compared with the ChP; to establish multiplying factor methods eliminate excipient interference of Cefixime Dispersible Tablets. The dissolution results of measurement using the instrument have not significant Difference compared with the United States Pharmacopoe (USP30-NF25);The experiment show different dissolution behavier for Cefixime Dispersible Tablets of six mufacturers.Conclusion:The parameters were obtained directly from the dissolu-tion profile. And the control experiment was conducted as described by the Chinese Pharmacopoeia. No difference was found between the two methods (P>0.05). The system is more accurate, precise, and easier to set up than conventional manual sampling or automated sipper-sampling systems and analysis using spectrophotometry. FODT eliminates the withdrawal of sample aliquots and provides the in-situ measurement of drug concentrations eliminates the problems inherent in withdrawing sample from the vessel for further analysis. The in-situ system also eliminates the need tore place media and the resulting volume correction calculations. It is very important for immediate release experiment and sustained release preparation especially.