枸橼酸钾缓释片的制备.docx

枸橼酸钾缓释片的制备
作者：陈龙浩，邹江冰，孟静，蒋琳兰
【摘要】 目的制备枸橼酸钾缓释片并考查其体外释放机制。方法 采用正交试验，以体外累积释放率为指标，筛选枸橼酸钾缓释片的处方工艺。结果 100 g素片中加入聚丙烯酰***树脂5 g、 g，所制得的枸橼酸钾缓释片在体外按higuchi模式释药;、、3 h累积释放度分别为(±)%、(±)%、(±)%，符合2010年版《中国药典》相关规定。结论 所制备缓释片工艺合理，体外试药效果良好。
【关键词】 枸橼酸钾;缓释片;聚丙烯酰***树脂;处方工艺;累积释放度
abstract:objectiveto prepare potassium citrate sustained-release tablets and study its in-vitro release technological parameters of tablets were screened through the orthogonal test with the accumulative releasing rate as the optimized parameters were as follows:polyacrylamide resin 5 g/100 g potassium citrate tablets,talc g/100 g potassium citrate rate of potassium citrate from tablets was demonstrated in accordance with higuchi releasing rates of h,1 h,3 h are (±)%,(±)%,(±)% respectively,which were consistent with chinese pharmacoeia(2010 edition).conclusion this process of sustained-release tablets is reasonable with a good performance in-vitro release effect.

key words:potassium citrate; sustained-release tablet; polyacrylamide resin; technology; accumulative releasing
枸橼酸钾于1985年被美国fda批准为单味药治疗远端肾小管酸中毒、低枸橼酸尿性草酸钙结石及尿酸结石伴或不伴有含钙结石，对泌尿系各类结石均有防治作用[1]。由于枸橼酸钾属于极易水溶性药物，每片剂量很大，采用通常的骨架缓释技术，片重会达到1 g左右，导致患者吞服困难;而且骨架缓释片制备工艺复杂，缓控释材料用量大