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复方新诺明(SMZCO)片是合成抗菌药磺胺甲基异恶唑(SMZ)和增效剂甲氧苄氨嘧啶(TMP)联合配方组成应用于临床的。主要用于治疗支气管炎,肺部感染,尿路感染,伤寒等疾病。临床疗效较好,使用广。《中国药典》1985年版,对其质量控制规定了含量测定,崩解时限,重量差异等标准。目前 BP,USP 以及文献资料上都未见有关 SMZCO 片溶出度的规定和报导。为此本文参考有关药典和资料,采用转篮法对其进行溶出度试验。当 TMP和 SMZ 的浓度在6—14μg/ml 时,吸收度符合比尔定律,溶液的 pH 值7.2时,相同浓度的 TMP 和 SMZ 在240.5nm处有一等吸收点,在255nm 波长处SMZ 显最大吸收(见图1)。本厂 SM-ZCO 片在介质中溶出后,是基于这一原理用吸收度比法进行分光光度测定两者溶出量的,从而对本产品的生产工艺,处方组成作了科学的评价。
The compound SMZCO tablet is a combination of the synthetic antibacterial agent sulfamethoxazole (SMZ) and the synergistic agent trimethoprim (TMP) for clinical application. Mainly used for the treatment of bronchitis, lung infections, urinary tract infections, typhoid and other diseases. Clinical efficacy is better, wide use. “Chinese Pharmacopoeia” 1985 edition, its quality control provides content determination, disintegration time limit, weight differences and other standards. At present BP, USP and literature have not seen on the dissolution of SMZCO tablets regulations and reports. To this end, this reference to the Pharmacopoeia and information, the use of spin-basket method for its dissolution test. When TMP and SMZ were in the range of 6-14μg / ml, Beer’s law was obeyed. When the solution pH was 7.2, the same concentration of TMP and SMZ had a first absorption point at 240.5nm and a maximum absorption at 255nm (see picture 1). Our SM-ZCO tablets dissolved in the medium, is based on this principle with the absorbance ratio spectrophotometry dissolution of both, and thus the production process of this product, made a scientific assessment of the composition.