Project name: Application of high shear granulator in the field of traditional Chinese medicine

Project start and end date: March 2018 to March 2020

Purpose of project development:

Due to the backward production method of Chinese medicine tablets and granules, a large amount of ethanol is used in preparing granules, and the yield is low, the mixing uniformity is poor, the energy consumption is high, the labor intensity is high, and the environment of the production site is poor. Therefore, traditional Chinese medicine is gradually developing from casserole boiling to mechanized pharmaceuticals. But this mechanization process does not refine the research and purification of the active ingredients of Chinese medicine.

The production method of Chinese medicine tablets and granules is relatively backward, and a large amount of ethanol is used in the preparation of granules, and the yield is low, low efficiency, high energy consumption, high labor intensity, and poor environment at the production site.

With the in-depth research of CHANSE Technology in the process, this project adopts high shear granulator to make uniform granules directly, and then adopts vertical fluidized bed drying, which makes Chinese medicine granules with high yield and stability, saves energy and labor, has good mixing homogeneity, and greatly reduces the dust pollution.

The main content of the project development:

  (1) Greatly improve the mixing uniformity.

  (2) Greatly improve the yield.

  (3) Intelligent production process control.

  (4) Significantly reduce energy consumption, labor costs, time costs.

  (5) Reduce the dust in the production process, improve the environment, and meet the GMP requirements.

  (6) Make product quality safe and controllable.

  (7) The scientific application of the perfect chemical production model in the production of traditional Chinese medicine.

The technical innovation of the project:

High mixing uniformity, which can reach 1:0.0009, depends on the overall design of the equipment to ensure the effect of mixing; Uniform particles are prepared directly by high shear granulator, avoiding repetitive labor, improving the production efficiency and reducing energy consumption; High particle uniformity, high yield, easier control of the production process, and safe and reliable products.

Main technical or economic indicators:

(a) For different processes, the use of high shear granulator, scientific design adjustment, mixing uniformity can be greatly improved to 1: 0.0009.

(b)The traditional swing granulator is prone to the rupture of the metal mesh wire falling off, resulting in a great risk of product quality and safety, the use of high shear granulator after the production process is safe and controllable, can ensure the quality and safety of the product.

(c) the whole production process automation degree is high, realize the closed transfer, can save a lot of labor input, cost savings.

(d) Compared with the traditional process, the process is simple and efficient, which can save a lot of energy consumption and improve economic efficiency.

(e)The appearance of the finished product in the traditional way is irregular in shape, the uniformity of the particles is not high, and the requirements for the later packaging are higher, and the finished product made after adopting the high shear granulator has a regular appearance and good uniformity of the particles, which reduces the requirements for the later packaging and saves the cost.

(f) The use of traditional equipment reproduces poor drug reproducibility, product quality is not stable, the use of high shear granulator, equipment stability, batch to batch reproducibility is good, product quality is stable.

(g) the use of traditional tank-type mixer is easy to produce a lot of dust, the workshop production environment does not meet the GMP requirements, the use of high-shear granulator, the production process using a continuous line, the material to achieve the transfer of airtight, the workshop environment in line with the GMP requirements