复方磺胺甲噁唑片溶出度研究

Study on the dissolubility of compound sulfamethoxazole tablets

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。

BJECTIVE: To establish the standard of compound sulfamethoxazole tablets on its dissolubility. METHODS: The dissolability of compound tablets was measured in 0.1 molL-1 hydrochloride acid as medium.According to the method described in Chinese Pharmacopoeia 1995 appendix XC,the rotational speed was 100rmin-1,and the temperture (370.5).The absorbency was measured at 278nm. RESULTS: The calibration curve was linear,A=0.089354c-0.138526(r=0.99990,n=5).The average recovery of the assay was 100.30% with standard deviation of 1.4% (n=5).The accumulation percentage of compound sulfamethoxazole tablets in 45 minutes was more than 90%. CONCLUSION: The results indicated that this method may satisfy with the requirement of the Chinese Phamacopeia.The method is sensitive and reliable,and it may be used for the quantitative detaminatation of the tablets.