双氯芬酸钠亲水凝胶骨架片及其释药影响因素的研究  

Diclofenac sodium hydrophilic matrix tablet and the factors affecting dissolution rates

作　　者：徐惠南[1] 陶雅菊[1] 吴涓 张建芳[1] 

机构地区：[1]上海医科大学药学院药剂教研室

出　　处：《中国药学杂志》1997年第1期34-36,共3页Chinese Pharmaceutical Journal

摘　　要：目的：制备双氯芬酸钠（ＤＣＦ）亲水凝胶骨架片，并对其释药影响因素进行了研究。方法：采用羟丙甲基纤维素（ＨＰＭＣ）为骨架材料，以粉末直接压片法制备ＤＣＦ亲水凝胶骨架片。所用ＨＰＭＣ分别为ＭｅｔｈｏｃｅｌＥ４Ｍ，Ｋ４Ｍ，Ｋ１５Ｍ和Ｋ１００Ｍ。根据中国药典１９９０年版所载的溶出度测定方法测定其释放度，并与国外同类缓释片的释药行为进行比较。结果：ＨＰＭＣ在片剂中含量升高或粒度减小，释药速度变慢。ＨＰＭＣ的粘度对释药的影响因品种和其在片中的用量不同而有不同表现。在所试４种ＨＰＭＣ中，除Ｅ４Ｍ的缓释作用较差外，其余３种只要选择合适条件，均可制成所需释放度的ＤＣＦ缓释骨架片。结论：丙烯酸树脂包衣的ＤＣＦ骨架片（ＤＣＦ∶ＨＰＭＣ＝１∶１．４）与国外同类缓释片具类似的释药行为。OBJECTIVE:To make diclofenac sodium(DCF) hydrophilic matrix tablets and examine the factors affecting their dissolution rates.METHODS:Four kinds of hydroxypropylmethylcellulose(HPMC) were used as matrix materials.They were Methocel K4M,K15M,K100M and E4M.Direct compression technique was employed.According to Chinese Pharmacopoeia(1990),dissolution rates acquired were compared with control samples abroad.RESULTS:The dissolution rates became slow with the increase of HPMC content or the decrease of HPMC particle size.The effect of HPMC viscosity differed when HPMC sort or content changed.Desirable dissolution rates were obtained by applying the above mentioned HPMC to DCF sustained release tablets,except for methocel E4M,which shows poor retarding function.CONCLUSION:No significant difference was observed between the dissolution rates of the control samples abroad and the acrylic resin coated tablet(DCF∶HPMC=1∶1.4).

关 键 词：双氯芬酸钠 HPMC 亲水凝胶骨架片 释放度 消炎药 

分 类 号：R971.1[医药卫生—药品]