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以甲壳系作为辅料采用湿颗粒压片法制备了双氯灭痛缓释片。体外溶出实验显示了双氯灭痛在0.1mol/L盐酸中极少溶出。在磷酸盐缓冲液(pH 6.8)中 0~10 h释药呈一级线性相关。含量测定等结果符合中国药典各有关规定,动物实验结果表明本品比其肠溶片抗炎作用延长且毒性较小,可望作为临床的更新产品。
Diclofenac sustained-release tablets were prepared by wet granulation method using the carapace as an excipient. In vitro dissolution experiments showed that diclofenac sodium rarely dissolves in 0.1mol / L hydrochloric acid. In phosphate buffered saline (pH 6.8) 0-10 h release of drug showed a linear correlation. Content determination and other results in line with the relevant provisions of Chinese Pharmacopoeia, animal experiments show that the product than its enteric coated anti-inflammatory effect of prolonged and less toxic, is expected as a clinical update products.