| Dissolution means the rate and the degree that solid preparation release in certain media. Release rate of drug means that takes orally the medicine puts off to a later time to release the product and control to release the preparation, lately releasing the preparation and deeply the skin releases the medicine system waits in prescriptive melting agent releasing with the degree. Dissolution/ Release rate test is an effective method which control the drugs quantity and investigate the products. The instrument which measurement the medicine releases is similar to the method which been used to measurement dissolution in addition to having another provision. In different country, the kinds of drug which been accepted in Pharamacopoeia and used for Dissolution/ Release rate of drug test is increasing continuously. The instrument and the measurement method develop gradually to using the machine or moving the pump to take the products and to analysis, instead of be taken by hand. The 90's of last century, the fiber-optic chemical sensor appeared and it can monitor the dissolution and release rate of drug on-line, on -time.In our test, we use Fiber-Optic Chemical Sensing Drug Dissolution Test, FOCSDT, which was made by ourselves and have one or six channels, to measurement the Dissolution/ Release rate of Rifampine capsules, Ferrous sulfate sustained release tablets, Chloroquine Phosphate tablets, Clonazepam tablets, Theophylline sustained-release tablets. We evaluate the reliability and accuracy of drug on-line method by compared with the Chinese Pharamacopoeia method.The experiment investigated whether three different positions of thefiber optic probe can influence the Dissolution/ Release rate. Establish the Fiber-optic process monitor of Clonazepam tablets, compared with the Pharamacopoeia method, the parameter of the Pharmacy dynamic and all result of measurement using instrument have no signification difference (P>0.05). The result of Release process monitoring of Theophylline sustained -release tablets in accordance with handicraft, save the labor strength. Establish the Fiber-optic process monitor of Clonazepam tablets, Compared with the Pharamacopoeia method, the parameter of the Pharmacy dynamic and all result of measurement using instrument have no signification difference (P>0.05), 10 hours measurement process explain that the system of FOCSDT stability.The research display that the Fiber-Optic Chemical Sensing Drug Dissolution Test( FOCSDT), can measurement Dissolution/ Release rate and the method is accurate and dependable. The system has good stability. |
