脂质纳米颗粒药物制造系统/GMP微流控/微流控制备仪MPE-P1

微流控制备仪 MPE-P1

Microfluidic Preparation Equipment: MPE-P1

微流控制备仪描述：

MPE-P1型微流控制备仪，是中试型制备系统，可用于脂质纳米颗粒LNP、聚合物纳米颗粒、脂质体Liposome、微乳Emulsion等微纳米制剂中试规制备工艺开发，助力核酸药物、小分子药物DDS系统的产业化研究。设备采用集成式触屏操作，系统配置批次记录、数据导出等功能，便捷高效。MPE-P1中试型微流控制备仪，支持高浓度和高流速下LNP、Liposome等微粒的制备，结果稳定，重现性高，可为生产放大提供详实、可靠、全面的工艺数据。

功能应用：

Functional application

化学药品脂质体（Liposome）制备，如多柔比星脂质体、伊立替康脂质体等； 

Preparation of chemical  liposomes, such as doxorubicin liposomes, iritecan liposomes, etc;

生物类脂质纳米颗粒颗粒（LNP）制备，如mRNA脂质体、siRNA-LNP等； 

Preparation of biological lipid nanoparticles (LNP), such as mRNA liposomes, siRNA LNP, etc;

聚合物纳米颗粒/微球等制备，如PLGA微球、PEG-PLGA纳米颗粒等； 

Preparation of polymer nanoparticles / microspheres, such as PLGA microspheres and peg-plga nanoparticles;

乳剂（Emulsion）的制备，如疫苗佐剂、脂肪乳制剂等； 

Preparation of emulsion, such as vaccine adjuvant, fat emulsion preparation, etc;

有机/无机纳米粒，如金纳米等； 

Organic / inorganic nanoparticles, such as gold nanoparticles;

其他相关微纳米制剂。

Other related micro nano preparations.

微流控技术

Microfluidic Technology

微流控（Microfluidic）技术是一种基于（微）流体力学理论，在管线中实现样品制备与加工的技术。完美的将微流体的理化模型与流体力学理论相结合，可实现样品的混合、乳化及分离纯化等功能。

Microfluidic technology is a kind of technology based on the theory of （Microfluidics）fluid mechanics, which can realize the sample preparation and processing in the pipeline. The perfect combination of the physical and chemical model of microfluidics and the theory of hydrodynamics can realized the functions of sample mixing, emulsification, separation and purification.

微流控技术将过程控制技术（Process Control Technology，PCT）与过程分析技术（Process Analytical Technology，PAT）相结合，可实现良好的在线样品制备技术（On-line Preparation Technology，OPT）。样品在连续化制备的过程中，工艺过程中参数完全可控，且具备良好重现性，所以较传统分步割裂式制备、分批次生产的方法来说更具有可放大性。

Microfluidic technology combines process control technology (PCT) with process analytical technology (PAT) to realize good on-line preparation technology (OPT). In the process of continuous preparation, the parameters in the process are completely controllable and have good reproducibility, so it can be better applied applied to production than traditional method of step-by-step split preparation and batch production.

可实现样品的初乳化、复乳化、粒径控制功能。

Can realize the functions of initial emulsification, re-emulsification and particle size control. 

微流控制备系统通过制备泵和高压输送泵与微流控芯片相连接，A相和B相可按照一定的比例恒速的输送至芯片中进行混合，乳化。在微流控芯片中通过设计不同的流道结构，控制不同的速度，使得样品在微流控芯片中达到湍流、层流或雾化状态，可以实现样品的初乳化或复乳化的要求。

Microfluidic preparation system is connected with microfluidic chip by fabricating pump and high-pressure conveying pump. Phase A and phase B can be mixed and emulsified at constant speed in a certain proportion. In microfluidic chips, different runner structures are designed and different velocities are controlled to make the samples turbulent, laminar or atomized in the microfluidic chips, which can meet the requirements of pre-emulsification  or re-emulsification.

制备好的样品通过高压泵输送至高压微流控芯片中，通过撞击力和剪切力来控制粒径，使其达到所需范围内。粒径最小可达到100nm以内，PDI至0.1以下。

The prepared samples were transported to the high pressure microfluidic chip by high-pressure pump, and the particle size was controlled by impact force and shear force to reach the required range. The smallest particle size can be less than 100nm, and PDI can be less than 0.1.

微流控芯片 

Microfluidic Chips

微流控芯片是基于应用工艺的定制型特殊流道结构部件，其通道结构和尺寸均与项目工艺需求相结合，属定制型结构件。具体来说可实现以下四种功能：

Microfluidic chip is a customized special channel structure component based on the application process. Its channel structure and size are combined with the process requirements of the project. Specifically, the following four functions can be realized:

（1）     两相的混合、乳化；

Mixing and emulsification of two phases;

（2）     微粒形成后的孵育；

Incubation after particle formation;

（3）     微粒形成后的粒径控制；

Particle size control after particle formation;

（4）     二次混合或乳化。

Secondary mixing or emulsification after particle formation.

技术参数：