Preparation method for rapid-disintegrating directly-pressed particle mannitol preparation

Abstract

The invention relates to a preparation method for a rapid-disintegrating directly-pressed granular mannitol preparation. The preparation method comprises the following steps of: 1) weighing the following raw materials in percent by weight according to a particle mannitol formula: 0.2-5.0 percent of adhesive and 8-2 percent of purified water, pouring the adhesive into the purified water and preparing adhesive slurry for future use; 2) putting crushed or uncrushed mannitol and 0.2-5.0 percent of disintegrating agent in a high-speed agitating and granulating machine, starting up the high-speed agitating and granulating machine, adding the slurry and preparing high-quality soft materials; 3) transferring the product wet granules into a fluidized drying machine for drying, screening the dried materials and completely tidying the granules; and 4) mixing the screened and tidied materials with lubricating agent, pressing the mixture into tablets and conducting hardness and disintegration tests. By adopting the preparation method, widely applicable directly-pressed granules with different content and fineness can be produced, have a rapid disintegrating characteristic and satisfy the American standard that the disintegrating time of sublingual tablets is less than or equal to 30 seconds. Moreover, the preparation method has the advantages of easiness in operation, low production cost, simple technology and high product quality.

Description

Technical field: [0001] The invention relates to the technical field of health foods, in particular to a preparation method of a quick-disintegrating direct-pressure granular mannitol preparation. Background technique: [0002] Mannitol is a hexanol with a melting point of 166°C and a relative density of 1.52. 1g of this product is soluble in about 5.5ml of water (25°C) and more soluble in hot water. It absorbs heat when dissolved and has a sweet taste. It is comfortable to the oral cavity and has very low hygroscopicity, so it is more widely used in the manufacture of chewable tablets such as sobering medicines and mouth refreshing agents, and has a wide range of uses in the pharmaceutical and food fields. However, the commonly used mannitol in the domestic market is needle-like crystals, which has poor fluidity. It is often necessary to use more lubricants and glidants to help release the tablet during tablet compression, which affects the content and taste of the tablet, and t...

AI Technical Summary

Problems solved by technology

However, the commonly used mannitol in the domestic market is needle-like crystals with poor fluidity. When tableting, it is often necessary to use more lubricants and glidants to help release the mold, thereby affecting the content and taste of the tablet, and the crystal structure is not easy to compress directly. , the dissolution rate is also slow

[0003] The existing granulated mannitol is mainly imported. It is obtained by heating mannitol or mannitol with a binder above the melting point to melt it into a liquid, and then cooling, agglomerating, pulverizing or extruding granules. Granular mannitol, this method has a high heating temperature, which is easy to cause the material to change color at high temperature, which affects the quality and use, and the melting time is difficult to grasp, the technical requirements are high, the operation control is difficult, the pass rate is low, the yield is low, the manufacturing cost is high, and the sales The price is also high

Another Guangxi Nanning patent number is CN200610019626.2 method: add 25%-35% water or water with a binder to the mannitol put into the mixer and mix it, and then input it into the rotary vacuum dryer after forming a mass , high-temperature and high-vacuum drying, and then cooling, crushing and sieving. This method is difficult to transfer materials. A large proportion of water is used to fuse and then dry, which consumes more energy. Large, the yield is not high, and the yield is not high. According to its introduction, the yield is only 50-60%, so the quality of the finished product is not stable

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