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May 28, 2021
What factors affect the granulated products of the high-speed mixing granulator?
High-speed mixing granulator is a kind of mixing and granulating equipment, which can be used to mix medicine ingredients. In terms of technology, the high-speed mixing granulator combines the two-step process of mixing and granulation, which not only saves time but also meets GMP requirements, reduces cross-contamination, and improves efficiency. The method is well received by users.
However, compared with the requirements of current formulation development, the traditional technology of high-speed mixing and granulation has obvious shortcomings. It is reported that the auxiliary materials used in traditional wet granulation are often limited to powdered sugar, starch, dextrin and so on. Among them, powdered sugar has obvious hygroscopicity; starch will gradually hydrolyze and lose its swelling effect when encountering acid, alkali, or under humid and heated conditions; dextrin interferes with the determination of the content of certain drugs, so the traditional wet granulation Has obvious limitations.
In addition, the traditional process often uses empirical judgments on the proportion of the extract and the consistency of the extract to determine the amount of excipients, which affects the quality control standards of the preparation. For hygroscopic drugs and excipients, if wet granulation technology is used to prepare granules, the granules will be squeezed together, causing adhesion, strip-like soft materials, sticky nets and other phenomena. The prepared granules are too hard and have poor solubility and poor quality. stable.
As the pharmaceutical industry has higher and higher requirements for pharmaceutical technology, wet granulation technology also needs to keep pace with the times. Only more energy-saving, more environmentally safe and safe granulation methods can be applied in the market. The researchers found that the combination of dynamic and static drying, that is, the two-step drying method used in the drying process of wet granulation, can shorten the drying cycle of the wet granules and increase the production efficiency.
It is understood that the granules produced by high-speed mixing and granulation have irregular shapes, uniform particle size distribution, and better structures than other traditional granulation processes, but their granulated products will be affected by many factors.
First, the speed of the stirring blade and the cutting knife. According to the industry, the size and distribution of the particle size is directly related to the speed of the stirring blade and the cutting knife. When the speed of the cutting blade is slow, the particle size becomes larger, and when the speed is fast, the particle size becomes smaller; when the speed of the stirring blade is slow, The particle size is small, and the faster the speed is, the larger the particle size is. The two functions are opposite.
Second, the influence of mixing and granulating procedures and time. During the operation of the high-speed mixing and granulating machine, the rotation of the stirring paddle causes the materials in the pot to roll to the space, so that the bottom materials are thrown up along the wall of the pot, and this action is successively soft. The soft material is pushed to the fast cutting knife and cut into particles of different sizes. As the particles roll over for a period of time, they are rounded and gradually become spherical. It can be seen that the speed and time of the stirring blade and the cutting knife affect the granulation granularity.
Third, the influence of material and concentration. In the production of wet mixed granulation, alcohol granulation or dextrin binder granulation is commonly used, but there are certain differences between the two types of granulation. Alcohol is commonly used for granulation. Because alcohol does not have viscosity and it has a loosening effect, this method is ideal for granulating traditional Chinese medicines with high viscosity. If dextrin is used for granulation, since dextrin is viscous and has a polymerization effect, the particles produced are large and coarse, and the drying is slow. This method is ideal for western medicine without viscosity.
In addition, whether it is used as a material after dilution of concentrated extract, or using dextrin or other binder materials, when producing smaller particles, the slurry concentration of the material can be thinner, and when larger particles are required, the material The slurry concentration can be slightly thicker.