What are the specific factors that affect the granulated product when using a wet mixing granulator

The wet mixing granulator is a kind of mixing granulator, which can be used to mix pharmaceutical ingredients In terms of technology, the wet mixed granulator combines the two-step processes of mixing and granulation, which not only saves time but also meets the GMP requirements, reduces cross pollution and improves efficiency It is a more quick, better and more economical method, which is welcomed by users However, compared with the requirements of the development of preparations, the traditional technology of wet granulation has obvious deficiencies It is reported that the traditional auxiliary materials used in wet granulation are usually limited to sugar powder, starch, dextrin, etc Among them, sugar powder has obvious hygroscopicity; starch will gradually hydrolyze and lose expansion when meeting acid, alkali, or in wet and heated state; dextrin interferes with the content determination of some drugs, so the traditional wet granulation has obvious limitations In addition, the traditional technology often uses the empirical judgment of the proportion and consistency of the extract to determine the amount of auxiliary materials, which affects the quality control standard of the preparation For hygroscopic drugs and excipients, if the particles are prepared by wet granulation technology, the particles will be squeezed together, resulting in adhesion, strip like soft material, sticky net and other phenomena The prepared particles are too hard and have poor solubility and unstable quality With the increasing demand of pharmaceutical industry for pharmaceutical technology, wet granulation technology also needs to keep pace with the times Only more, more energy-saving, more environmentally safe granulation methods can be applied in the market The researchers found that the combination of dynamic and static drying method, namely two-step drying method, can shorten the drying cycle and improve the production efficiency It is understood that the particles made by wet mixed granulation have irregular shape, uniform particle size distribution, and perfect structure compared with other traditional granulation processes, but their granulation products will be affected by many factors First, the rotation speed of the mixing paddle and the cutting knife According to the industry, the size and distribution of particle size are directly related to the speed of the impeller and the cutter When the speed of the cutter is slow, the particle size becomes larger, while when the speed is fast, the particle size becomes smaller; when the speed of the impeller is slow, the particle size is small, and when the speed is fast, the particle size is large, which plays the opposite role
Second, the influence of mixing and granulating procedures and time In the operation of the high-speed mixing granulator, the rotation of the mixing paddle makes the materials in the pot roll to the space, so that the materials at the bottom of the pot are thrown up along the wall of the pot This action pushes the soft materials one after another to the fast cutting knife, and they are cut into particles of different sizes As the particles roll over with each other for a period of time, they are rounded and gradually spherical 。 It can be seen that the speed and time of the impeller and the cutter affect the particle size Third, the influence of material and concentration In the production of wet mixed granulation, alcohol granulation or dextrin adhesive granulation are often used, but there are some differences between them It is common to use alcohol to make granules Because alcohol does not have viscosity, and it has a loose effect, this method is ideal for making granules of high viscosity traditional Chinese medicine If dextrin is used to make granules, because dextrin is viscous and polymerizable, the granules are large and coarse, and the drying is slow This method is ideal for western medicine without viscosity In addition, whether the concentrated extract is diluted as the material, or the dextrin or other adhesive materials are used, the slurry concentration of the material can be a little thinner when producing smaller particles, and a little thicker when larger particles are needed