Preparation method of high-purity direct-compression mannitol particles

Abstract

The invention belongs to the field of sugar alcohol processing, relates to a preparation method of high-purity direct-compression mannitol particles and particularly discloses a method for producing high-purity direct-compression mannitol particles by use of a multifunctional fluidized bed. A high-concentration mannitol solution is subjected to spraying granulation by use of the multifunctional fluidized bed, and fine mannitol powder is contained in a boiling pot of the multifunctional fluidized bed to prevent wall sticking. The high-concentration mannitol solution is easy to concentrate and dry, the multifunctional fluidized bed is used for granulation, energy consumption can be reduced, and the yield of finished large mannitol particles can be increased.

Description

technical field [0001] The invention relates to a preparation method of sugar alcohol granules, in particular to a preparation method of high-purity mannitol direct-pressed granules, which belongs to the technical field of sugar alcohol processing. Background technique [0002] Mannitol (Mannitol) is also called mannitol, molecular formula C 6 h 8 (OH) 6 , molecular weight 182.17, white crystal, white needle crystal. Most of the hexahydric alcohols have strong hygroscopicity. Unlike other hexahydric alcohols, mannitol has no hygroscopicity at all. , Mannitol is widely used as excipients, sweeteners, fillers, etc. In terms of physical form, mannitol can be divided into three forms: micropowder, crystal and granule. Currently, the commonly used mannitol in China is needle-like crystals with poor fluidity, and the crystals cannot be directly used for tablet compression, and the dissolution rate of crystals is slower than that of granules. Domestic tablet manufacturers main...

AI Technical Summary

Problems solved by technology

But the mannitol product yield of this method is too low, is about 60%

The patent CN201310154224.3 of Shandong Tianli Pharmaceutical Co., Ltd. is granulated by multifunctional fluidized bed, and granulated by spraying binder. The content of binder is 1-3wt%, and the content of mannitol is 97-99wt%. Due to the addition of binders, the clarity and heavy metal content of the produced mannitol cannot be detected during product testing, and the unknown components exceed the standard, which meets the national standard, but does not meet the requirements of USP and EP; French Roquette's patent FR:2016051820:W Disclosed is a method for producing mannitol direct-pressed granules by a spray drying method. The method is to spray and dry a relatively high-concentration mannitol solution through a multi-nozzle spray gun in a certain humidity environment, and the produced mannitol direct-pressed granules have good Fluidity and compressibility, but this method consumes a lot of energy, and the yield is relatively low; Jiangsu Jiangshan Pharmaceutical’s patent 201110340624.4 discloses a preparation method of a fast-collapsing direct-pressure mannitol preparation. The method is to mix 0.2-5% The binder is prepared as an 8-20% aqueous solution, then stirred and granulated with crushed mannitol powder, and then sieved, wherein the binder used in this method includes starch, maltodextrin, hypromellose Cellulose, Polyvinylpyrrolidone

This method is relatively easy to operate, but too many granules need to be granulated, and the granules are easy to produce powder, which reduces the overall fluidity and is difficult to mix with other excipients.

However, the particle size produced by the existing fluidized bed granulation technology cannot meet the standards of national standards, EP and USP due to the addition of binders and unidentified impurities. Directly compressible mannitol particles produced by spray drying , the cost is too high, and there are many fine powders