Preparation process of microcrystalline cellulose-mannitol compound
A technology of mannitol complex and microcrystalline cellulose, which is applied in the directions of non-active ingredients medical preparations, pharmaceutical formulations, etc., can solve the problems of increasing the difficulty of the direct compression process and the high defective rate of direct compression, and achieves improved dissolution. Efficiency, improved mobility, low sensitivity effects
Pending Publication Date: 2018-09-18
SHENZHEN YOUPUHUI PHARM CO LTD
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Problems solved by technology
[0004] The currently disclosed microcrystalline cellulose and mannitol compositions are highly sensitive to lubricants, which increases the difficulty of the direct compression process and leads to a high rate of direct compression defects
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[0016] A new process for preparing microcrystalline cellulose and mannitol compound
[0017] 1. Selection of raw materials: microcrystalline cellulose filter cake (moisture content 45%, degree of polymerization less than 270, 6.5) and commercially available pharmaceutical grade mannitol are raw materials.
[0018] 2. Mixture ratio: Feed according to the ratio of microcrystalline cellulose: mannitol 1:7.0 (mannitol and microcrystalline cellulose are calculated as dry products), use water as solvent, and the mass ratio of microcrystalline cellulose to solvent is 1 : 3.5.
[0019] 3. Selection of pulping equipment: choose SWFS-400 high-speed disperser
[0020] 4. Pulping: first add water according to the ratio in step 2, then add mannitol, start stirring, and control the stirring speed at 450 rpm. After the mannitol is completely dissolved, reduce the stirring speed and control the stirring speed at 100 rpm Add the microcrystalline cellulose filter cake until all the microcryst...
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Abstract
The invention relates to a preparation process of a microcrystalline cellulose-mannitol compound. The preparation process comprises the following steps: (S1) pulping, namely adding water into a dispersion machine, adding mannitol, starting stirring, controlling the rotation speed at 350r / min-500r / min, after mannitol is completely dissolved, decelerating the stirring, controlling the rotation speedat 80r / min-100r / min, adding microcrystalline cellulose filter cakes, after adding accelerating the stirring, controlling the rotation speed at 350r / min-500r / min, and continuing to stir for 15-30 minutes; and (S2) carrying out spray drying, namely carrying out spray drying by virtue of a spray drying tower GL400, wherein the inlet air temperature is 135-230 DEG C, the outlet air temperature is 70-130 DEG C, the rotation speed of an atomizer is 30Hz-50Hz, the feeding flow is 0.3m<3> / h-0.6m<3> / h, and the negative pressure is 100P-300P. According to the novel process, microcrystalline cellulose and mannitol generate a synergetic function; and compared with traditional microcrystalline cellulose, the compound is capable of improving the fluidity, compressibility and slaking characteristic of asolid preparation, so that the dissolving out efficiency of the soil preparation can be improved, and meanwhile, the compound has extremely low sensibility to a lubricating agent.
Description
technical field [0001] The invention relates to a preparation process of a compound of microcrystalline cellulose and mannitol. Background technique [0002] Individual doses of pharmaceutical compositions suitable for oral administration are conveniently administered in solid dosage form, usually tablets. In addition to one or more therapeutic ingredients (commonly called "active ingredient," "active pharmaceutical ingredient" or "API"), tablets contain pharmaceutically acceptable materials (called excipients) that Not an active ingredient, does not provide a therapeutic effect, but is added to a tablet formulation to impart specific properties independent of the activity of the active ingredient. There are generally three methods of tablet preparation: (1) direct compression or tabletting; (2) dry granulation; and (3) wet granulation. In direct compression, the powdered materials comprising the tablet, including the active ingredient and excipients, are blended together ...
Claims
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IPC IPC(8): A61K47/38A61K47/10
CPCA61K47/10A61K47/38
Inventor 段民英李洪文刘巴宁杨登科
Owner SHENZHEN YOUPUHUI PHARM CO LTD