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纳米结晶制剂产业化研究进展

Progress in the industrialization of nanocrystal technology

  • 摘要: 随着10种纳米结晶制剂先后上市,纳米结晶技术逐渐发展成为一种成熟的技术工艺,该技术能提高药物的饱和溶解度、改善药物的溶出速率从而提高其在体内的生物利用度。随着新设备、新材料的出现,纳米结晶制剂技术也逐步呈现可控化和产业化,不同给药方式的纳米结晶制剂先后上市或进入临床研究阶段。本文综述了纳米结晶制剂的产业化生产技术、生产过程中关键工艺参数、稳定剂对产品的影响,以及利用纳米结晶技术上市或进入临床研究的药物等。

     

    Abstract: In the past decade, more maturing nanocrystal technology brought about commercial marketing of ten kinds of nanocrystal formulation. The saturated solubility, dissolution rate and oral bioavailability could be improved. Emergence of new equipments and materials ensured the controllability and industrialization in the adaptation of nanocrystal technology. Nanocrystal formulations for the different routes of administration are available or in clinical investigation. This paper summarized the industrial production methods, the key processing parameters, the effects of stability-enhancer on the nanocrystal formulations, and the drugs on the market or in clinical study.

     

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