Study On The Application Of Fiber-optic Dissolution Test System In Medicine Quality Evaluation And Bioequivalence

Objective: Dissolution test is a method in vitro tests to simulate disintegration and dissolution of solid dosage forms in gastrointestinal tract. In Many countries like china, origin medicine is a leader of clinical medication, while imitation products is main body in medical treatment and public health, the same type of which is manufactured by many enterprises. Preparation level, manufacture technology and quality control differ from country to country and region to region. How to take effective measures to ensure drug product quality, therapeutic effect and bioequivalence thus becomes the focus of work for medical workers. Scientific and technological progress, analysis set to become automatic and intellectual and demand for improving drug quality monitoring makes it inevitable to have drug dissolution monitoring. Fiber-optic dissolution test system, an optical, mechanical and electronical dissolution analytical apparatus that comes into being in response to sci-tech development in the new period, features real time, on-line, rapid and whole-process monitoring. While launching an overall evaluation of its specifications and performance, it is also a arduous and practical job to research into its application in medicine internal quality evaluation, Process monitoring immediate dosage forms, sustained release preparation(controlled release preparation), drug products identification, bioequivalence, prescription bolting and optimization and to establish automation test methods. Method: After establishing drug testing technology, an overall assessment of internal quality of medicine can be provided by comparing different manufacturers, adopting CHP method and BP method and analyzing dissolution curves and dissolution parameters in way of statistics. We may also tell whether a medicine is genuine or not and learn about its deterioration caused by photolysis of medicine by comparing real time spectrum to standard spectrum. The data of dissolution profile of solid medicine can be obtained by fiber-optic dissolution test system automatically, and then a similarity factor (f2) be used to assess the bioequivalence of it in vitro. Among a great deal of indexes in prescription bolting and optimization, release rate is chosen as the subject index. Main factors which impact release rate of tablet will be tried randomly to bolt and pick out a prescription. Results: While monitoring dissolution of drug products, one can tell the difference of Amoxicillin and Dimenhydrinate and identify photolysis products of Extended Release Nifedipine Tablets by absorption spectrum displayed in a real-time manner. An assessment of internal quality of Gliclazide Tablets, a primary product in diabetes treatment, is completed by analyzing dissolution curves and dissolution parameters by statistics and a process analysis method has also been established in immediate dosage forms and sustained release preparation. In combination with a similarity factor method, dissolution data obtained by fiber-optic dissolution test system may help evaluate bioequivalence of Nimodipine Tablets in vitro. With release rate as the indicator, the optimal prescription of Extended Release Deferiprone Tablets has been defined by random trial of multiple factors at multil evel. Conclusion: When applied to pharmaceutics, Fiber-optic dissolution test system is both advanced and practical in drug products internal quality control and prescription bolting and optimization. It is irreplaceable or even incomparable by traditional method in process monitoring of immediate dosage forms and sustained release preparation(controlled release preparation). By telling whether a medicine is genuine or not while monitoring dissolution, we can not only obtain comprehensive information of drug products internal quality, but also detect deterioration of small amounts of drug product caused by photolysis or improper manufacturing, transportation, storage and so on, thus ensuring people's safe and effective access to medication. Despite some gap between evaluation of bioequivalence from actual application in vitro, establishment scientific and effective evaluation system of bioequivalence in vitro is of innovative significance for launching a more people-centered and effective work of. bioequivalence. Dissolution (release) process information and an effective statistical method makes prescription screening and optimization work fast and detailed.