CAJ | 학술논문

面向制药结晶中的清洁生产,针对目前国内制药结晶存在的毒性溶剂使用、VOC 排放、结晶母液处理、晶体质量、连续工艺等问题,从绿色结晶、晶体工程、连续结晶、智能设备 4 个方面,结合相关案例,总结了国内外的制药结晶中清洁生产的设计思路和技术手段,探讨了制药结晶中的清洁生产发展方向.对制药工业清洁生产具有一定的实际意义.
면향제약결정중적청길생산,침대목전국내제약결정존재적독성용제사용、VOC 배방、결정모액처리、정체질량、련속공예등문제,종록색결정、정체공정、련속결정、지능설비 4 개방면,결합상관안례,총결료국내외적제약결정중청길생산적설계사로화기술수단,탐토료제약결정중적청길생산발전방향.대제약공업청길생산구유일정적실제의의.
Pharmaceutical industry has been listed as one of the serious pollution industries in China. As the important and necessary part of pharmaceutical industry, crystallization technology should be optimized and updated to meet the clean production requirement. The pollution and waste caused by crystallization include toxic solvent applied, VOC emission, waste of mother liquor, bad properties of crystal product, and out-dated batch operation, etc. In face of these problems, the design methods and technology of clean production of pharmaceutical crystallization are reviewed and summarized. (a) Green crystallization. The solvent should be clean and effective. Single type of solvent and little consumption should be considered. Reduce the waste (gas, liquid and solid) emission by increasing crystal yield. Crystalline mother liquor and by-products should be reused and recycled. (b) Crystal engineering. Simplify the processes of filtering, washing, drying and tableting by optimizing crystal shape and interfacial properties. Solvates should be avoided to reduce the VOC emission. (c) Continuous crystallization. Compared with batch operation, novel continuous crystallization technology takes more advantages. (d) Intelligent device. Crystallization device should be optimized based on fluid dynamics to the benefit of crystal nucleation and growth. Integration of devices could reduce materials and energy consumption.