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目的 :对两厂家生产的酒石酸美托洛尔片进行评价。方法 :对两厂家生产的药物的体外溶出度及人体相对生物利用度进行研究 ,比较不同厂家产品的差异 ,并考察溶出度与人体吸收的相关性。溶出度研究的含量测定采用UV法 ,生物利用度研究的样本采用HPLC法测定。结果 :香港默克雅柏有限公司生产的酒石酸美托洛尔片 ,与其相应的参比制剂均生物等效 ,酒石酸美托洛尔片的体外溶出度与体内吸收的相关性不明显。结论 :片剂的体外溶出度试验结果能基本上反映药物在人体内的吸收及制剂的生物等效性。
Objective: To evaluate the production of metoprolol tartrate tablets by two factories. Methods: The in vitro dissolution rate and the relative bioavailability of drugs produced by the two factories were studied. The differences of different manufacturers’ products were compared. The correlation between dissolution and absorption was also investigated. The content of dissolution study was determined by UV method, and the samples of bioavailability study were determined by HPLC method. Results: Metoprolol tartrate tablets produced by Merck Abbott Co., Ltd. in Hong Kong were bioequivalent to their corresponding reference preparations. The dissolution of metoprolol tartrate tablets in vitro was not significantly correlated with the absorption in vivo. Conclusion: The in vitro dissolution test results of tablets can basically reflect the absorption of drugs in the human body and the bioequivalence of the preparation.