祝倩倩1,萧 伟2*,王振中2,孙永成2,杨绪芳2,李力龙2.注射用芪红脉通微滤液的超滤工艺适用性研究[J].中草药,2013,44():
注射用芪红脉通微滤液的超滤工艺适用性研究
Adaptability research of ultrafiltration process of microfiltrated Qihong Maitong Injection
  
DOI:
中文关键词:  关键词:芪红脉通注射剂  超滤  膜材质  黄芪甲苷  羟基红花黄色素A
英文关键词:Key words: Qihong Maitong Injection  ultrafiltration  membrane material  astragaloside IV  hydroxy safflower yellow A
基金项目:
作者单位
祝倩倩1,萧 伟2*,王振中2,孙永成2,杨绪芳2,李力龙2 1. 南京中医药大学江苏 南京 210000 2. 江苏康缘药业股份有限公司江苏 连云港 222001 
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中文摘要:
      摘 要:目的 以注射用芪红脉通微滤后药液为研究对象,考察4 种不同材质的中空纤维超滤膜对注射用芪红脉通药液体系 的适用性。方法 分别选取截留相对分子质量为100 000 的聚砜、聚醚砜、聚丙烯、混纺复合4 种材质的超滤膜进行超滤, 测定不同膜材质超滤过程的膜通量、指标成分黄芪总皂苷、黄芪甲苷、羟基红花黄色素A(hydroxy safflower yellow A,HSYA) 透过率、固含物减少率、蛋白质减少率、有关物质及热原检查,筛选适宜本产品的超滤膜。结果 相同截留相对分子质量的 4 种不同材质超滤膜对同一药液体系的适用性存在差异:聚丙烯、聚醚砜和混纺复合材质的膜纯水通量恢复率均较高,而聚 砜材质的膜通量和膜纯水通量恢复率较低;聚丙烯与聚醚砜材质的指标成分透过率较高,聚砜与混纺复合材质的固含物与蛋 白质去除率较高;对于本产品,截留相对分子质量为100 000 超滤膜可有效去除热原。结论 聚丙烯-100 000 超滤膜既能有 效去除固含物与高分子物质,又能保留有效成分,适用于注射用芪红脉通的精制。
英文摘要:
      Abstract: Objective To study the application of four different materials hollow fiber ultrafiltration membrane by taking Qihong Maitong Injection microfiltered liquid as the research object. Methods Polysulfone, polyether sulfone, polypropylene and blended composite membrane with the same entrapment of relative molecular mass of 100 000 for ultrafiltration were selected to determine the best appropriate ultrafiltration membrane material. Adopting the membrane flux of ultrafiltration, the content of effectual ingredients, solids reduction rate, protein reduction rate, related substances and pyrogen inspection of different membrane materials as the evaluation index. Results The suitability of four different kinds of ultrafiltration membrane material with the same entrapment relative molecular mass was different. The pure water flux recovery rate of polypropylene, polyether sulfone and blended composite material are higher than polysulfone material. The component permeation rate of polypropylene and polyether sulfone material was higher, while the solid and protein reduction rate of polysulfone and blend compound material was higher. For Qihongmaitong injection, the entrapment relative molecular mass of 100 000 ultrafiltration membrane could effectively remove pyrogen. Conclusion The polypropylene-100 000 ultrafiltration membrane not only could effectively remove the solid and high polymer material, but also keep components. It is suitable for the purification of Qihong Maitong injection.
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