2021年枸橼酸钾缓释片的制备.docx

枸橼酸钾缓释片的制备

　　陈龙浩，邹江冰，孟静，蒋琳兰
　　摘要 目标制备枸橼酸钾缓释片并考查其体外释放机制。方法 采取正交试验，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2021年版《药典》相关要求。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 sustainedrelease tablets and study its invitro 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(2021 Edition).Conclusion This process of sustainedrelease tablets is reasonable with a good performance invitro release effect.
　　Key words:potassium citrate; sustainedrelease tablet; polyacrylamide resin; technology; accumulative releasing
　　枸橼酸钾于1985年被美国FDA同意为单味药诊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，对泌尿系各类结石都有防治作用[1]。因为枸橼酸钾属于极易水溶性药品，每片剂量很大，采取通常的骨架缓释技术，片重会达成1 g左右，造成患者吞服困难;而且骨架缓释片制备工艺复杂，缓控释材料用量大、成本高。 mm的球状异型缓释片[2]的文件报道，该制剂片重符合要求，但每次需服用6片，1日3次