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Preparation method of functional fine micro pills

A functional pellet technology, applied in the field of pharmaceutical preparations, can solve problems such as difficult preparation of fine pellets, low output rate, difficult process control, etc.

Inactive Publication Date: 2017-01-11
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The existing technology usually adopts the method of preparing microspheres or microcapsules to realize the preparation of fine pellets. However, due to the difficulty in large-scale production of microsphere (capsule) technology, and the involvement of many organic solvents, the process is not easy to control, and the production It is not easy to realize the preparation of fine pellets due to the low yield rate and other reasons.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The preparation method of embodiment 1 Roxithromycin dry suspension

[0030] First prepare roxithromycin drug-loaded fine pellets, coat the isolation layer, and then coat the taste-masking layer to obtain fine particles, then add auxiliary materials according to the characteristics of the dry suspension, and mix evenly to obtain the roxithromycin dry suspension agent.

[0031] (1) Preparation process of silica microspheres

[0032] Take 1 kg of silica microspheres (100-120 mesh) prepared by melting, put them into 10% hydrochloric acid solution, stir for 1 hour, let stand, pour off the supernatant, and add the remaining concentrated silica microspheres Adjust the pH to 7 with 1mol / L sodium hydroxide, filter, wash with purified water, dry and sieve to obtain 120-mesh silica microspheres.

[0033] (2) Preparation process of roxithromycin drug-loaded fine pellets

[0034] Roxithromycin drug-loaded fine pellets formula: silica microspheres (particle size: 0.10-0.15mm) 200...

Embodiment 2

[0047] Example 2 Preparation method of lincomycin sustained-release fine pellets

[0048] Lincomycin drug-loaded fine pellets are firstly prepared, coated with an isolation layer, and then coated with a slow-release layer to prepare fine pellets, and then mixed evenly with appropriate characteristic auxiliary materials.

[0049] (1) Preparation process of silica microspheres

[0050] Take 1 kg of silica microspheres (80 mesh) prepared by grinding the crystal ore with a silica purity of 99.0% with a ball mill, put it into a 10% hydrochloric acid solution, stir for 1 hour, let it stand, pour off the supernatant, and put the remaining Add 1 mol / L sodium hydroxide to the silica microsphere concentrate to adjust to pH = 7, filter, wash with purified water, dry and sieve to obtain 80-mesh silica microspheres.

[0051] (2) Preparation process of lincomycin-loaded pellets

[0052] The prescription of lincomycin-loaded fine pellets: silica microspheres (particle size: 0.10-0.15mm) 20...

Embodiment 3

[0064] Example 3 Preparation of clarithromycin enteric-coated capsules

[0065] First prepare clarithromycin drug-loaded fine pellets, coat the isolation layer, and then coat the enteric layer to prepare the fine pellets, and then fill the capsules.

[0066] (1) Preparation process of silica microspheres

[0067] Take 1 kg of silica microspheres (80 mesh) prepared by grinding the crystal ore with a silica purity of 99.0% with a ball mill, put it into a 10% hydrochloric acid solution, stir for 1 hour, let it stand, pour off the supernatant, and put the remaining Add 1 mol / L sodium hydroxide to the silica microsphere concentrate to adjust to pH = 7, filter, wash with purified water, dry and sieve to obtain 80-mesh silica microspheres.

[0068] (2) Preparation process of clarithromycin-loaded fine pellets

[0069] The prescription of clarithromycin drug-loaded pellets: silica microspheres (particle size: 0.10-0.15mm) 300g, clarithromycin 250g, hyprolose 60g, talcum powder 12g, ...

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PUM

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Abstract

The invention relates to a preparation method of functional fine micro pills. The method comprises the following steps of (1) preparing silicon dioxide micro balls with the particle diameter being smaller than 0.15mm; (2) spraying and covering medicine active ingredients onto the surfaces of the silicon dioxide micro balls in a solution or suspension mode to obtain medicine carried fine micro pills; (3) sequentially covering an insulation layer and a function layer on the surfaces of the medicine carried fine micro pills to obtain the functional fine micro pills. The method has the advantages that the control is easy; the large-scale production can be performed; the particle diameter of the obtained fine micro pills is small enough; the palatability is good; the method is widely applicable to the preparation of medicine preparation such as ordinary tablets and slow release preparations, particularly oral suspension liquid and oral dry suspensions.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of functional fine pellets. Background technique [0002] At present, some oral solid forms such as tablets have proven difficult and even dangerous for children and the elderly, in which case we usually need more suitable dosage forms, such as chewable or disintegrating in the mouth tablets, and granules that can be dispersed and suspended in water. When it comes to such uses, it is usually necessary to prepare particles with a particle size small enough to avoid the drug formulation causing the user a gritty feeling or difficulty swallowing during oral administration. The preparation of particles with a sufficiently small particle size is also conducive to the development of more pharmaceutical preparations. For example, fine pellets with a taste-masking effect can be used for ordinary oral tablets, orally disintegrating tablets, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/04A61J3/07
CPCA61K9/5078A61J3/078A61K47/02
Inventor 赵军霞孙卫东钱勇臧利敏
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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