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目的研究丹酚酸缓释滴丸的制备方法。方法通过固体分散技术,以聚乙二醇6000(polyeth-ylene-glycol 6000,PEG-6000)和聚乙二醇400(polyethylene-glycol 400,PEG-400)为滴丸基质制备滴丸丸心,以乙基纤维素(ethyl cellulose,EC)、丙烯酸树脂高渗(eudragit RL100)、丙烯树脂低渗(eud-ragit RS100)、邻苯二甲酸二乙酯(diethyl phthalate,DEP)为包衣材料,体积分数为95%的乙醇溶液为包衣溶剂进行包衣,利用均匀设计优化处方,制得具有良好缓释效果丹酚酸缓释滴丸。结果以PEG-6000和PEG-400为固体分散辅料可制得外观圆整,质地均匀的丹酚酸滴丸,包衣处方中以乙基纤维素3.0 g、丙烯酸树脂RL100和RS100 1.0 g、邻苯二甲酸二乙酯2.5 mL、体积分数为95%的乙醇溶液100 mL、包衣增质量分数为3%能达到最佳的释放效果。结论所制备的丹酚酸缓释滴丸具有良好的释放效果。
Objective To study the preparation of salvianolic acid sustained-release dropping pills. Methods Droplets pellets were prepared by solid dispersion technique with a drop base of polyethylene glycol 6000 (PEG-6000) and polyethylene glycol 400 (PEG-400) Ethyl cellulose (EC), eudragit RL100, eud-ragit RS100, and diethyl phthalate (DEP) were used as coating materials. The volume 95% ethanol solution for the coating of the coating solvent, using uniform design and optimization of prescription, prepared with good sustained-release salvianolic acid sustained-release dropping pills. Results PEG-6000 and PEG-400 were used as solid dispersing excipients to obtain salicylic acid dropping pills with uniform appearance and uniform texture. The coating prescription consisted of ethyl cellulose 3.0 g, acrylic resin RL100 and RS100 1.0 g, 2.5 mL of diethyl phthalate, 100 mL ethanol solution with volume fraction of 95%, and 3% coating mass fraction to achieve the best release effect. Conclusion The prepared salvianolic acid sustained-release dropping pills has a good release effect.