郝娟娟 杨斯斯 王倩颖 李哲 王娇 李菲

【摘 要】 目的：优化曲克芦丁片的制粒及包衣的工艺过程及工艺参数。方法：制粒工艺选择粘合剂的浓度、粘合剂的加入方式、湿混搅拌时间、制粒目数为考察因素，采用正交试验L9（34）进行正交试验设计，优化制粒工艺参数;通过正交试验设计对薄膜包衣工艺过程及工艺参数进行研究。结果：粘合剂的浓度、粘合剂的加入方式对制粒工序具有极显著的影响;包衣过程中片芯脆碎度及片床温度对包衣成品率有较显著的影响。结论：经过3批次的工艺验证，中间控制项目符合工艺要求且重现性良好，经检验，产品各项检验指标均符合法定质量标准要求。证明该工艺参数稳定可靠，可应用于生产。

【关键词】 曲克芦丁;制粒;薄膜包衣;工艺;正交试验设计

【中图分类号】R943 【文献标志码】A 【文章编号】1007-8517（2021）15-0027-05

Abstract：Objective Optimize the pelleting and coating process and process parameters of Troxerutin tablets. Methods The concentration of the binder， the adding mode of the binder， the wet mixing time and the Screen mesh were selected as factors for the granulation process. Orthogonal test L9（34） was used for the orthogonal test design to optimize the granulation process parameters. The process and parameters of film coating were studied by orthogonal test design. Results The concentration of the adhesive and the way of adding the adhesive had a significant effect on the pelletizing process. In the process of coating， the tablets friability and the temperature of the pills have a significant effect on the yield of coating. Conclusion Through the process verification of three batches， the intermediate control items meet the process requirements and have good reproducibility. Through the inspection， all the inspection indexes of the products meet the statutory quality standards. It is proved that the process parameters are stable and reliable and can be used in production.

Keywords：Roxerutin; Granulation; Film Coating; Technology; Orthogonal Experimental Design

曲克芦丁片为中国药典收载品种，是临床治疗心脑血管疾病的基本药物，又名维脑路通片。曲克芦丁能抑制红细胞和血小板的凝聚，防止血栓形成，疏通血管，改善微循环，促进新血管生成以增进侧支循环，增加血中氧的含量，主要用于闭塞综合征、血栓性静脉炎、毛细血管出血等。本品原料为曲克芦丁，是芦丁经羟乙基化的半合成产物，是以三羟乙基芦丁为主，同时含有单羟乙基芦丁、二羟乙基芦丁和四羟乙基芦丁等组分的多组分混合物，是临床治疗心脑血管疾病的基本药物。曲克芦丁为黄色或黄绿色粉末，无臭，有引湿性，在水中易溶[1-3]。……