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目的：建立复方磺胺甲唑片的溶出度试验方法。方法：以０．１ｍｏｌ·Ｌ－１盐酸为溶出介质，采用“转篮法”进行溶出度测定，转速为１００ｒ·ｍｉｎ－１，温度为（３７±０．５）℃，进行累积溶出度百分率测定。采用紫外分光光度法测定含量，λｍａｘ为２７８ｎｍ，以０．１ｍｏｌ·Ｌ－１盐酸作为参比，该方法线性关系良好，回收方程为Ａ＝０．０８９３５４ｃ－０．１３８５２６，ｒ＝０．９９９０（ｎ＝５），平均回归率为１００．３０％，ＲＳＤ为１．４％。结果：经测定４５ｍｉｎ后，市售复方新诺明片溶出度大于７０％，符合中国药典１９９５年版附录中溶出度测定方法的结果判断标准。结论：本方法准确可靠、简便适用，可用于控制复方新诺明片溶出度，建议以此方法来控制产品的质量，保证临床疗效，修订标准时，采用此方法。
Objective: To establish a dissolution test of compound sulfamethoxazole tablets. Methods: The dissolution rate was determined by “basket spinning method” with 0.1mol·L-1 hydrochloric acid as dissolution medium. The rotational speed was 100r · min-1 and the temperature was (37 ± 0.5) ℃. The cumulative dissolution rate Determination. The UV-vis spectrophotometry was used to determine the content of the compounds. The maximum λmax was 278 nm. The linear relationship was good with 0.1 mol·L-1 hydrochloric acid as reference. The recovery equation was A = 0.089354c-0.138526, r = 0.9990 n = 5). The average rate of regression was 100.30% and RSD was 1.4%. Results: After 45min, the dissolution rate of the commercial cotrimoxazole tablets was more than 70%, which accorded with the judgment standard of the result of dissolution method in the appendix of Chinese Pharmacopoeia 1995 edition. Conclusion: This method is accurate and reliable, simple and convenient, and can be used to control the dissolution of cotrimoxazole tablets. It is suggested that this method should be used to control the quality of products and ensure the clinical curative effect. When this standard is revised, this method is adopted.