The wet mixed granulation machine is a kind of mixed granulation equipment, which can be used for the mixing of drug components.In terms of technology, the wet mixed granulator combines the two steps of mixing and granulating, which not only saves time but also meets the requirements of GMP, reduces cross pollution and improves efficiency. It is a way of saving money more quickly and deeply welcomed by users.
However, compared with the requirement of preparation development, the traditional process of wet granulation has obvious shortcomings.It is reported that the traditional wet granulation materials are usually limited to sugar powder, starch, dextrin and so on.Sugar powder has obvious hygroscopicity.Starch in acid, alkali, or in the state of moisture and heating, will gradually hydrolyze and lose expansion;Dextrin can interfere with the determination of some drugs, so the traditional wet granule method has obvious limitations.
In addition, the traditional technology often determines the dosage of excipients by empirical judgment on the proportion and consistency of the extract, which affects the quality control standard of the preparation.As for hysteretic drugs and excipients, if the particles are prepared with the wet granulation technology, the particles will be squeezed together, resulting in adhesion, strip of soft materials, sticky mesh and other phenomena. The prepared particles will be very hard but have poor solubility and unstable quality.
With the increasingly high requirements of the pharmaceutical industry on the pharmaceutical process, wet granulation technology also needs to advance with The Times, only more efficient, more energy saving, more environmentally safe granulation method can be applied in the market.The researchers found that the combination of dynamic and static drying, the two-step drying method, could shorten the drying period and improve the production efficiency.
It is known that the granule made by wet mixed granulation is irregular in shape, uniform in size distribution and more perfect in structure than other traditional granulation processes.
First, the agitator paddle and the cutter speed.According to the industry, the size and distribution of particle size are directly related to the stirring paddle and the cutting tool speed. When the cutting tool speed is slow, the particle size increases, while when the speed is fast, the particle size decreases.When the speed of agitator is slow, the particle size is small, while the speed is increasing, the particle size is large.
Second, the influence of the mixing, granulating process and time due to the high speed mixing system in the operation of the machine, the rotation of the impeller the pot material into space back, so that the bottom of the pot material along the wall and threw up the pot, this act a barrage of soft soft wood into fast cutting knife, and is cut into different size particles, as the roll each other for a period of time between particles is rounded spherical gradually.It can be seen that the speed and time of agitator and cutter affect the grain size of granulation.
Third, the effect of material and concentration.In the production of wet mixed granulation, wine granulation or dextrin binder are commonly used to granulate.It is common to use wine to refine granule, because alcohol does not take viscosity, and it has loose effect, it is ideal to use this method to prepare granule of traditional Chinese medicine with high viscosity.If using dextrin granulation, because dextrin viscosity, polymerization, the prepared particles for large and coarse, drying slow, no viscosity of western medicine with this method is more ideal.
In addition, whether the use of concentrated extract after dilution as a material, or using dextrin or other adhesive materials, in the production of smaller particles, the material slurry concentration can be a little thinner, need larger particles, the material slurry concentration can be a little stronger.