| Objective: Dissolution/release rate test is a method of evaluating preparation component, production technology, biological availability and preparation continuity. It is one of important test items for ensuring the safety of medicine, effective, good quality. The varieties of dissolution test are increasing quickly in many countries pharmacopoeia. Ch.P 2005 edition have 330 pieces medicine requiring dissolution test. The apparatus of drug dissolution test has improved greatly in these years, but the conventional manual sampling is still a usual analysis method. This method is very troublesome, and errors are produced easily by the withdrawal of sampling aliquots, filter, dilution et al. This will affect the accuracy of dissolution test. The automatic sampling analysis exists filter, washing, adsorption and the foam of surfactant et al some interference factors. Therefore, study of high sensitive, fast, automatic Fiber Optic in Situ Drug Dissolution Test System and test technology has become a hot spot of Pharmaceuticals analysis workers studying i n our country and other countries.We has studied and created Fiber Optic in Situ drug Dissolution Test System supported by two funds of our country and xinjiang. It omits the the withdrawal of sampling aliquots, filter, dilution et al operation. However, some drug preparation need to change the test condition fromsampling analysis to FODT. This is a very difficult job and need to do a I }t of work. For example, some smaller or bigger content drug preparation , compound preparation and traditional medicine preparation -t al, there are many difficulties to realize FODT of these drug preparation. This thesis have study mainly FODT of some drug preparation by physical, chemical, mathematical method and changing est conditions, thus made some drugs realize FODT.Methods:(l)This thesis used DT-601 Fiber-optic in Situ Dissolution Testing System (FODT) and tested the release rate of Metronidazole Oral sticking Tablets and Indometacin Enteric-coated Tablets, and realized the orocess analysis of Paracetamol Tablets dissolution by changing pH of solution and test wavelength, the process analysis of Pyrazinamide Tablets by changing test wavelength, and the process analysis of Dipyidamole Tablets, Phenoxymethylpenicillin Potassium Tablets, Ooxycycline Hyclate Tablets by changing light distance, and the process inalysis of Domeridone Tablets without changing test condition in uandard method. In order to evaluate the suitability of this apparatus, osults of FODT compared with those of Ch.P and standard methods, vleasures methods include precision and recovery of these methods, omparison of drug dissolution parameters et al.(2) This thesis studied the dissolution of Sodium Danshensu in Fufang Janshen Diwan by derivative (3D) spectrum, and compared with HPLC. I his will provide method fundament for FODT of Fufang Danshen Diwan lissolution.Results: (1) FODT can test the release rate of Metronidazole Oral Sticking Tablets and Indometacin Enteric-coated Tablets, and the dissolution of Paracetamol Tablets, Pyrazinamide Tablets, Phenoxymethylpenicillin Potassium Tablets, Doxycycline Hyclate Tablets, Uipyidamole Tablets, Domeridone Tablets, compared with the standard methods. Results of two methods have no difference^ > 0.05).(2)Derivative spectrum method can test the dissolution of Danshensu in Fufang Danshen Diwan, compared with HPLC. Results of two methods have no difference (P>0.05).Conclusion: FODT omits the withdrawal of sample solution, filter, dilution, supplementary solution et al operation , and increased the precision, accuracy of drug dissolution/ release rate test results. FODT have very important meaning to immediate release and sustained release preparation especially. The component of traditional medicine preparation is very complicated, and exists usually interference of other components. Experiment results has proved that derivative spectrum can eliminate the interference of some components, thus realize FODT of traditional medicine preparation.
|
PDF Full Text Request