A kind of preparation technology of microcrystalline cellulose ball core

A technology of microcrystalline cellulose pills and microcrystalline cellulose, which is applied in the field of preparation technology of microcrystalline cellulose pill cores, can solve the problems of low surface finish and roundness, reduced cellulose purity, influence of drug properties, etc. The effect of improving coating efficiency, low viscosity and reducing coating cost

Active Publication Date: 2018-09-04
珠海市东辰制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, medicinal microcrystalline cellulose ball cores have been produced at home and abroad, but the performance of the existing microcrystalline cellulose ball cores has the following defects: such as low true sphericity, low surface finish and roundness, and high friability At the same time, in order to improve the friability and surface finish of microcrystalline cellulose cores, many companies use binders such as starch, sodium carboxymethyl cellulose or hypromellose, polyvinylpyrrolidone to prepare microcrystalline cellulose cores. , ethyl cellulose and other semi-synthetic macromolecular substances, because the existence of these substances will reduce the purity of cellulose in the microcrystalline cellulose pellet core, and too many related impurities in it will have a certain impact on the properties of the drug

Method used

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  • A kind of preparation technology of microcrystalline cellulose ball core

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039]Commercially available paper pulp (purchased from Shandong Rizhao Senbo Pulp and Paper Co., Ltd.) was hydrolyzed for 60 minutes in a 0.1mol / L hydrochloric acid solution with a temperature of 100°C and a pressure of 0.5Mpa, and filtered and washed to obtain a filter with a solid content of 45wt%. cake. After stirring the filter cake for 1 hour with a mixing mixer (RW 28 type, manufactured by IKA), a microcrystalline cellulose filter cake with a volume average particle diameter of 75 microns was obtained. After drying off 30 wt% of the water, the stirred filter cake was fed into an extrusion spheronizer (Mini 250 type, manufactured by Shenzhen Xinyite), the diameter of the orifice plate was 0.5mm. Dry the spheronized microcrystalline cellulose pellets in an oven at 60°C for 2 hours, remove large particles with a sieve with a pore size of 500 μm, and then remove small particles through a sieve with a pore size of 400 μm to obtain a volume average particle size of 400 to 500...

Embodiment 2

[0041] With the filter cake of embodiment 1, adopt shearing machine (FA 30 type, prepared by FLUKO) to shear 10 minutes, shear 6 to 8 times, the outlet of shearing equipment will be controlled in the first 2 shearing processes Below 12 mm, the outlet of the last 4 to 6 shearing equipment is controlled below 24 mm. After drying off 30% of the moisture, the sheared microcrystalline cellulose filter cake was fed into an extrusion spheronizer (Mini250 type, manufactured by Shenzhen Xinyite), with a diameter of orifice plate of 0.8 mm. Dry the spheronized microcrystalline cellulose pellets in an oven at 60°C for 2 hours, use a sieve with a pore size of 800 μm to remove large particles, and then pass through a sieve with a pore size of 700 μm to remove small particles to obtain a volume average particle size of 700 to 800 μm Table 1 shows the relevant physical characterization parameters of the microcrystalline cellulose pellet core.

Embodiment 3

[0043] Add water to the stirred filter cake in Example 1 to obtain a dispersion with a solid content of 25 wt%, and grind for 60 minutes with a ball mill (GTM 60, manufactured by Shenzhen Leitong). After drying off 40 wt% of water, the ground microcrystalline cellulose filter cake was fed into an extrusion spheronizer (Mini 250 type, manufactured by Shenzhen Xinyite), the diameter of the orifice plate was 0.3 mm. Dry the spheronized microcrystalline cellulose pellets in an oven at 60°C for 2 hours, use a sieve with a pore size of 300 μm to remove large particles, and then pass through a sieve with a pore size of 200 μm to remove small particles to obtain a volume average particle size of 200 to 300 μm Table 1 shows the relevant physical characterization parameters of the microcrystalline cellulose pellet core.

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Abstract

The invention discloses a technology for preparing microcrystalline cellulose pellets, and relates to pharmaceutical excipients. The technology includes the steps that microcrystalline cellulose filter cakes are mechanically treated to have the volume average particle diameters smaller than 100 micrometers; after moisture accounting for 30wt% to 50wt% of the weight of the microcrystalline cellulose filter cakes is removed through drying, the dried microcrystalline cellulose filter cakes are added into an extruding rounder to be rounded; after rounding, drying and screening are carried out, and the microcrystalline cellulose pellets are prepared. As for the microcrystalline cellulose pellets prepared with the technology, the true sphere degree (about 1.1 to 1.3) is high, water absorption (about 0.5 ml / g to 1.3 ml / g) is adjustable, friability is zero, and mechanical strength is ultrahigh (the pellets are not disintegrated when being soaked in water for 24 h); meanwhile, the technology can be used for preparing the microcrystalline cellulose pellets with different particle diameter ranges to meet different requirements of customers.

Description

technical field [0001] The invention relates to a pharmaceutical auxiliary material, in particular to a preparation process of a microcrystalline cellulose ball core. Background technique [0002] With the development of international excipients, more and more new drug dosage forms are displayed in front of consumers. At the same time, domestic pharmaceutical companies have put forward many new requirements for the functions of excipients under the premise of continuous progress in various processes and equipment. The same is true for cellulose pellet cores, which have been widely used in the fields of slow-release capsules, pellets, suspensions, etc. The focus of users' attention, microcrystalline cellulose pellets are mainly used as core materials for enteric-coated pellets and sustained-release pellets. [0003] Sustained-release pellets are a multi-unit dosage form. Due to their small particle size, they are evenly distributed in the gastrointestinal tract, which can re...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/38
Inventor 段民英刘武先
Owner 珠海市东辰制药有限公司
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