一种双氯芬酸钠控释片的制备及体外释放研究

The preparation and in vitro release of a controlled release diclofenac sodium tablet

目的：制备双氯芬酸钠控释片，并对其药物释放机制进行了研究。方法：采用硬脂酸和乙基纤维为释放阻滞剂，以羧甲基淀粉钠等为崩解剂，制粒干燥后制备控释片，根据中国药典１９９５年版所载的溶出方法测定其释放度。结果：所制备的控释片在ｔ０．９之前的释放为零级动力学过程；片剂中主药含量（在３５％～６０％范围内）、片剂形状及硬度（５～１０ｋｇ）等对该控释片的药物溶出无明显影响。结论：改变该控释片中崩解剂或阻滞剂用量均可改变其药物释放的ｔ１／２。

OBJECTIVE:To prepare diclofenac sodium controlled release tablet,and to evaluate the mechanism of drug release.METHODS:Stearic acid and ethyl cellulose were used as blocking agents and sodium carboxylmethyl starch was used as disintegrating agent.Tablets were made after drying the granules prepared.The dissolution rates were acquired according to Chinese Pharmacopoeia(1995).RESULTS:Drug release from the tablets prepared was of zero-order release before 90% of drug released.No significant influences were observed from the dissolution rates of the different pressure of tablet(5～10kg),amount of drugs contained in the tablet(35%～60%)and different geometry of the tablets,respectively.The remarkable difference waw observed between the disintegrating and blocking agents contained in the tablets.CONCLUSION:The time of 50% of durg released could be changed as the amount of disintegrating or blocking agents were changed.