研发背景

南京格利诺2023-11-30 15:14:35

中药提取生产过程,是依据GMP 规范,按给定的配方,生产一定数量产品的过程、中药提取生产采用批量生产方式,也叫间歇生产方式。其主要特点是:小批量、多品种,其特征是:物料流动的不连续性、物料和设备的非稳态性、产品及其工艺的不确定性和设备资源的动态调度分配。不连续性是指物料输入、输出是断续的,单元操作是按顺序进行的,没备运行是间断的,非稳态性是指生产过程中物料和设备都时常处于变化状态。不确定性指的是要根据市场需求生产不同产品,和增加新产品。   


   为了提高设备对不同产量和类似工艺的适应能力,中药提取生产设备需要具有良好的柔性,能生产多种工艺相近似的产品。产品生产完成,对设备进行清洗后,即可生产别一种产品。中药提取过程单元,一般安装多台操作设备(如提取罐、浓缩器),配置大小不同的多组兼用设备(如:缓冲罐、储罐),设备按串联和并联结构排布,组成串、并联结构提取过程单元,设备单元之间采用固定管道连接或非固定软管连接。设备以连续、半连续、间歇方式工作。   


    中药提取过程单元按生产的产品划分,可单品种过程单元、多品种单流程过程单元,多品种多流程过程单元单品种过程单元的生产工艺流程、原料配比和工艺参数都是确定的。多品种单流程过程单元可以生产一族不同规格的产品,产品生产工艺流程相同,参数变化。多品种多流程过程单元可以生产不同品种的产品,产品生产流程和工艺参数都可以改变。除此之外,还有中试过程单元,中试过程单元采用多品种多流程形式。   


    常用的中药提取单元设备主要包括:多功能提取罐、热回流提取装置、外循环真空减压浓缩器、内循环真空减压浓缩器、球形浓缩器、搅拌沉淀罐、冷沉罐、离心机、板框过滤器、精馏塔、溶剂配置罐、脱色罐、结晶罐、大孔树脂吸附洗脱装置、膜分离/ 膜浓缩装置、超临界萃取装置、微波提取装置、超声波萃取装置、储罐等。 


The production process of Chinese medicine extraction, is based on the GMP standard, according to the given formula, produced by the batch production process, the production of Chinese traditional medicine extract a certain number of products, also called a batch mode of production. Its main features are: small volume, multi species, its features are: dynamic scheduling and allocation of materials flow discontinuities, material and equipment, non steady state of product and process uncertainty and equipment resources. The discontinuity is refers to the material input, output is intermittent, unit operation is sequential, equipment operation is intermittent, non steady state refers to the production process in the material and equipment are often in the state of changing. Uncertainty refers to according to the market demand the production of different products, and the addition of new products.


In order to improve the ability to adapt to the different and similar equipment production process, production equipment needs to have good flexibility of traditional Chinese medicine extraction, can produce a variety of process similar products. The product is finished, the cleaning equipment, can produce another kind of products. The process of Chinese medicine extraction unit, generally installed multiple operating equipment (such as extracting tank, concentrator), multiple groups of different size and configuration of equipment (such as: buffer tank, tank), equipment according to series and parallel structures, composition series, parallel structure extraction process unit, using a fixed or non fixed pipeline connecting hose connection unit between the equipment. Equipment in a continuous, semi continuous, intermittent work mode.


The process of extracting unit according to production products division of Chinese medicine, can be a single variety of process unit, many varieties of a single process unit, multi variety and multi process unit single variety process unit production process, the ratio of raw materials and process parameters are determined. Many varieties of a single process unit can produce a family of products with different specifications, the technological process for production of the same products, parameter changes. More and more varieties of process unit can produce a variety of products, production processes and process parameters of product can change. In addition, test process and test process of unit, unit adopts multi variety and multi process.


Commonly used traditional Chinese medicine extraction unit equipment mainly includes: multifunctional extraction pot, heat reflux extraction device, the external circulation vacuum concentrator, internal circulation vacuum concentrator, spherical concentrator, stirring settling tank, cold precipitation tank, centrifuge, filter, distillation, solvent configuration tank, decolorization tank, crystallizer, macroporous adsorption resin elution device, membrane separation / film concentrating device, supercritical extraction device, microwave extraction device, ultrasonic extraction device, tanks etc

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