采用定时释药技术制备复方中药舒胸缓释制剂的研究.pdf

1 采用定时释药技术制备复方中药 舒胸缓释制剂的研究 宋洪涛 1 郭涛 1 姜鹏 1 陈大为 2 何仲贵 2 1. 沈阳军区总医院药剂科 辽宁 沈阳 110016 2. 沈阳药科大学 辽宁 沈阳 110016 摘要 目的 以防治冠心病确有疗效的复方中药舒胸片为模型药物 制备具有不同时滞的定时控释片 将之与片芯组合制备成复方中药缓释制剂 方法 以崩解时间 加水后膨胀体积和吸湿后片芯增重 片径 片高变化率为指标 确定了片芯处方 采用压制包衣技术 选用聚乙二醇 6000 氢化蓖麻油和 乙烯 醋酸乙烯共聚物作为包衣材料制备定时控释片并考察了处方 工艺 不同体外溶出条件对控时 效果的影响 结果 经过筛选确定片芯处方为原药 30 微晶纤维素 50% 羧甲基淀粉钠 20 包衣 层中聚乙二醇 6000 用量 包衣层用量 压片压力对定时控释片的释药时滞具有显著影响 溶出介质 粘度和搅拌速度对时滞影响不大 但对时滞期后的释药速率有一定影响 结论 本文所确定的片芯处 方具有较好的膨胀性和崩解能力 通过调整包衣处方和包衣层用量可实现不同控时效果 由片芯 3h 和 6h时滞的定时控释片组合后在体外可于 0h 3h 6h依次释药 从而达到了缓释效果 关键词 复方中药 舒胸片 定时释药 缓释 Studies on preparation of Shuxiong sustained-release formulation of traditional Chinese medicine compound recipe by adopting time-controlled release techniques SONG Hong-tao1, GUO Tao1, JIANG Peng1, CHEN Da-wei2, HE Zhong-gui2 ( 1. Department of Pharmacy, the General Hospital of Shenyang Military Region, Shenyang 110016, China; 2. Shenyang Pharmaceutical University, Shenyang 110016, China) ABSTRACT: OBJECTIVE To prepare a sustained-release formulation of traditional Chinese medicine compound recipe (TCMCR) which contained core tablet and two kinds of time-controlled release tablets with shuxiongpian as model drug. METHODS The prescription and technology of core tablets were formulated by selecting disintegrating time and swelling volume of core tablets in water, and the weight, diameter as well as high of core tablets after moisture absorption as index. The time-controlled release tablets was prepared by adopting press-coated techniques, and selecting PEG6000, HCO and EVA as coating material. The influences of prescription, technology and dissolution condition in vitro on the time of drug release were investigated. RESULTS The prescription of core tablet was confirmed as follow: 30% original drug, 50% MCC and 20% CMS-Na. The lag time of drug release from time-controlled release tablets was influenced remarkably by PEG6000 contents of the outer layer, the amount of outer layer and pressure. The viscosi