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Hersey(1969),Wagner(1971)和Baun及Walker(1969)等曾先后介绍过各种片剂溶化度检查用的装置,以反映药物在固体剂型中的生理有效性,其中以连续流动式装置较其他各种方法为好。本文在Walker(1969)和Lagenbucher(1969)建议的流动型的基础上对连续流动式溶化装置作了研究。对不同处方的甲苯磺丁脲的溶化率进行了测定并与美国药典18版溶化度检查法进行了比较。测定时以三羟甲氨甲烷(THAM 1:40,以盐酸调节成pH7.6)作为溶解介质。文中附图介绍装置并给出了用连续流动式装置溶化甲苯磺丁脲的典型曲线,列出了五种牌号,四个批号的甲苯磺丁脲处方的药片变化情况。结果发现,其中有半数牌号的各药片之间的变化范围很大。各
Various devices for tablet dissolution testing have been introduced by Hersey (1969), Wagner (1971), Baun and Walker (1969) and others in order to reflect the physiological effectiveness of the drug in solid dosage forms, with continuous flow devices Better than other methods. In this paper, based on the flow patterns proposed by Walker (1969) and Lagenbucher (1969), a continuous flow type melting apparatus was studied. The solubilities of tolbutamide in different prescriptions were determined and compared with the 18th edition of the United States Pharmacopeia method. Trimethylamine (THAM 1:40, adjusted to pH 7.6 with hydrochloric acid) was used as the dissolution medium. The accompanying drawings illustrate the device and give a typical curve for the dissolution of tolbutamide by a continuous flow device, listing changes in the tablets of tolbutamide in five or four lot numbers. The results showed that there was a wide range of variation among the tablets with half of the grades. each