双氯芬酸钠肠溶片的制备及其处方优化

Preparation and optimization of the formulation of enteric coated diclofenac sodium tablets

目的制备更优质的双氯芬酸钠肠溶片。方法采用粉末直接压片及高效包衣机包衣法制备了双氯芬酸钠肠溶片,从片芯及包衣层两方面对处方进行筛选及优化。结果所制得的双氯芬酸钠肠溶片在人工胃液中耐酸力良好,在人工肠液中的溶出迅速且完全。结论研制了双氯芬酸钠肠溶片,解决了双氯芬酸钠对胃部刺激较大的问题,重现性好,工艺可行。

Objective Develop the diclofenac sodium enteric coated tablets.Methods Diclofenac sodium enteric coated tablets were prepared with direct powder compression method and coated using high efficiency coating machine and the formulation was screened and optimized from tablet core and the coating layer.Results The resistance to acid was good and the dissolution of the tablets was quick in artificial intestinal liquid. Conclusion Diclofenac sodium enteric-coated tablets was developed and the problem of stimulating to stomach by the diclofenac sodium was solved .The preparation process was feasible and replicable.