| Summary: | 碩士 === 中國醫藥學院 === 藥物化學研究所 === 88 === Diclofenac sodium is a phenylacetic acid derivatives of the NSAIDs, which is used in in the treatment of rheumatic disorders. In this study, the bioavailability of two sustained-release dosage form of diclofenac sodium: DSSR and VoltarenR SR (Ciba-Geigy) in eight healthy male volunteers, and the bioavailability of two enteric-coated beads dosage form of diclofenac sodium: WerenR EMC (Yu Sheng) and Diclo-purenR (Yung Shin) in twelve healthy male volunteers were evaluated. From calculated pharmacokinetic parameters, the possible bio-equivalency of these two groups formulations were determined.
We used high performance liquid chromatography method to analysis the plasma samples. The HPLC conditions are included RP-18 column, mobile phase is methanol:0.1% ortho-phosphoric acid=78:22, internal standard is Mefenamic acid, and monitoring at UV 280 nm. This method showed good linearity, the intra- and inter-day validation is reasonably with the C.V. less than 10 %. The relative recovery ratio is above 90 %.
We found that two sustained-release dosage form of diclofenac sodium: DSSR and VoltarenR SR were not equal.The two enteric-coated beads dosage form of diclofenac sodium: WerenR EMC and Diclo-purenR, By coparing the pharmacokinetics included AUC, Cmax, Tmax, T1/2, there are no significant statistic difference between each pair of the parameter (P >0.05), This indicated that this two products were equal.
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