What factors affect the finished granulation product of a high-speed mixer?

  High-speed mixing granulator is a kind of mixing and granulation equipment, which can be used for mixing pharmaceutical ingredients. In the process, high-speed mixing granulator is in the mixing, granulation two-step process together, not only to save time and meet the GMP requirements, reduce cross-pollution, improve efficiency, is a kind of faster and better way to save money, by the user welcome.

 

  However, compared with the requirements of the current development of the preparation, high-speed mixing and granulation of the traditional process there are obvious shortcomings. It is reported that the traditional wet granulation excipients used are often limited to icing sugar, starch, dextrin and so on. Among them, icing sugar has obvious hygroscopicity; starch in the presence of acid, alkali, or in the state of humidity and heating, will gradually hydrolyse and lose the swelling effect; dextrin on the determination of the content of certain drugs have interference, so the traditional wet granulation has obvious limitations. In addition, the traditional process is often used to determine the amount of excipients by empirical judgement of the proportion of extracts, consistency of extracts, etc., which affects the quality control standards of the preparations. As for hygroscopic drugs and excipients, if the particles are prepared by wet granulation technology, the particles will be extruded together, and there will be phenomena such as adhesion, striped soft material, sticky net, etc., and the resulting particles will be too hard and poorly dissolved, and the quality will be unstable.



  With the pharmaceutical industry on the pharmaceutical process requirements are becoming more and more high, wet granulation technology also needs to keep pace with the times, only more energy efficient, more environmentally safe granulation method can be applied by the market. Researchers have found that the dynamic, static drying method, that is, two-step drying method used in wet granulation drying process, can make the resulting wet particles to shorten the drying cycle, improve production efficiency. It is understood that high-speed mixing granulation made of particles, irregular shape, uniform particle size distribution, structure than other traditional granulation process is perfect, but its granulation of finished products and will be affected by many factors.

 

  1, mixing paddle and cutting knife speed. It can be said that the size and distribution of particle size and mixing paddle and cutting knife speed is directly related to when the cutting knife speed is slow, the particle size becomes large, while the speed of the speed of the particle size becomes small; when the mixing paddle speed is slow, the particle size is small, while the speed of the speed by the speed of the particle size is large, and the two play opposite roles.

 

  2, mixing, granulation procedures and the impact of time. Because in the high-speed mixing granulator operation, the rotation of the stirring paddle so that the pot of material to space tumbling, so that the bottom of the pot material along the pot wall rotation thrown up, this action one after another softly soft material pushed to the fast cutting knife, and was cut into different sizes of particles, with the particles rolling each other for a period of time to be rounded and gradually be spherical. From this, we can see that the stirring paddle and cutting knife speed and time on the granulation of the particle size effect.

 

  3, the influence of the material and concentration. In the wet mixing granulation production, commonly used alcohol granulation or dextrin binder granulation, and these two are certain differences. Commonly used alcohol granulation, the particles made of small and fine, easy to dry, which is due to alcohol does not bring viscosity, and it has a loosening effect, the viscosity of high Chinese medicine granulation with this method is ideal. If you use dextrin granulation, the particles made of large and coarse, slow drying, due to dextrin viscosity, polymerisation, no viscosity of Western medicine with this method is ideal.

 

  In addition, whether it is used as a concentrated extract after dilution of the material, or the use of dextrin or other adhesive materials, in the production of smaller particles, the material can be thinner slurry concentration, the need for larger particles, the material can be slightly thicker slurry concentration.