Preparation and application in pharmacy field of silica medical microsphere

A technology of silica and microspheres, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, microcapsules, etc., which can solve the problems of large coating weight gain, low product yield, and high breakage rate. problems, achieve the effect of reducing coating loss, high product yield and low breakage rate

Inactive Publication Date: 2016-12-07
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Medicinal blank cores are the necessary mother cores for the production of micropill preparations. At present, the commonly used blank cores for micropill preparations mainly include: sugar pills (sucrose type), microcrystalline cellulose pellet cores, starch pellet cores, and lactose pellet cores. , silica ball cores, etc., which are mainly used for drug application and coating of pellets. The particle size range is 300-800 μm, and different types of ball cores have different stability, bulk density, and friability, so they cannot be applied to pellets smaller than For the coating of 150μm granules, the existing blank cores (≤150μm) have many defects when using wuster coating technology, because the existing blank cores (≤150μm) have small particle size and large specific surface area. Moreover, there are irregularities and inhomogeneities in the granules themselves, the coating is difficult, the weight of the coating is large, the breakage rate is high, and the product yield is very low. Some blank cores cannot be realized at all, and the coating granules also have inhomogeneity. Satisfactory results cannot be achieved when applied to taste-masking and sustained-release preparations, such as uneven taste-masking, uneven release, or even burst release or broken
This greatly limits the application of wuster coating technology in the pharmaceutical field of particles smaller than 150 μm

Method used

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  • Preparation and application in pharmacy field of silica medical microsphere
  • Preparation and application in pharmacy field of silica medical microsphere
  • Preparation and application in pharmacy field of silica medical microsphere

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of embodiment 1 silica microsphere

[0033] Take 1 kg of silicon dioxide microspheres (80 mesh) prepared by melting prepared silicon dioxide microspheres or crystal ore with a silicon dioxide purity of 99.0% and grind them with a ball mill, put them into 10% hydrochloric acid solution, stir for 1 hour, and let stand , pour off the supernatant, add 1mol / L sodium hydroxide to the remaining concentrated silica microspheres to adjust the pH to 7, filter, wash with purified water, dry and sieve to obtain 80 mesh carbon dioxide Silica microspheres.

Embodiment 2

[0034] The preparation of embodiment 2 silica microspheres

[0035] Take 1 kg of silicon dioxide microspheres (100-120 mesh) prepared by melting prepared silicon dioxide microspheres or crystal ore with a silicon dioxide purity of 99.9% and grind them into 10% hydrochloric acid solution, and stir for 1 hour , stand still, pour off the supernatant, add 1mol / L sodium hydroxide to the remaining concentrated silica microspheres to adjust the pH to 7, filter, wash with purified water, dry and sieve to obtain 120 Silica microspheres.

Embodiment 3

[0036] The preparation method of embodiment 3 azithromycin dry suspension

[0037] Prepare the azithromycin drug-containing pellets first, coat the isolation layer, and then coat the slow-release layer to prepare the azithromycin taste-masking pellets, add auxiliary materials according to the characteristics of the dry suspension, and mix evenly.

[0038] (1) Preparation process of azithromycin drug-containing pellets

[0039] The prescription of azithromycin-containing pellets: silica microspheres (particle size: 0.075-0.10mm) 300g, azithromycin 150g (100 mesh), HPMC (E5) 10g, talcum powder 5g, 85% ethanol 2000mL.

[0040] Preparation process of medicinal solution: Add 10.0 g of HPMC (E5) to 2000 mL of 85% ethanol under stirring, dissolve until clear, add 150 g of azithromycin, continue stirring for 1 hour, add 5 g of talcum powder, and stir for 15 minutes to obtain a drug-containing solution.

[0041] Preparation of drug-containing pellets: Take 150-200 mesh silica microsph...

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Abstract

A silica microsphere is prepared by melting or grinding high purity silica; the silica microsphere is purified then to reach the requirements of pharmaceutical adjuvant and has good roughness and mechanical strength; the particle size is in a range of 40 to 250 [mu]m, and the bulk density is in a range of 1.2 to 1.6 g/cm3. The silica medical microsphere can be applied to the pharmacy field, is taken as a blank pill core for wuster coating, can be used to coat particles with a size smaller than 150 [mu]m, can cover the odor, and is capable of achieving the sustained-release and control-release functions. Based on the proper particle size distribution, high bulk density and mechanical strength, and good roughness, the yield of coated particles with a size smaller than 150 [mu]m is largely increased, and the coating yield is more than 90%.

Description

technical field [0001] The invention relates to a silicon dioxide pharmaceutical microsphere, their preparation and pharmaceutical purification method, and the application of the silicon dioxide pharmaceutical microsphere in the field of particle coating preparations smaller than 150 μm. Background technique [0002] Medicinal blank cores are the necessary mother cores for the production of micropill preparations. At present, the commonly used blank cores for micropill preparations mainly include: sugar pills (sucrose type), microcrystalline cellulose pellet cores, starch pellet cores, and lactose pellet cores. , silica ball cores, etc., which are mainly used for drug application and coating of pellets. The particle size range is 300-800 μm, and different types of ball cores have different stability, bulk density, and friability, so they cannot be applied to pellets smaller than For the coating of 150μm granules, the existing blank cores (≤150μm) have many defects when using...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/04A61K9/50A61K9/52A61K31/7052A61K31/545A61K31/7048A61K31/7056
CPCA61K9/5073A61K31/545A61K31/7048A61K31/7052A61K31/7056A61K47/02A61K9/0095A61K9/5026A61K9/5078A61K31/00A61K9/1676A61K9/5089
Inventor 孙卫东董永生李锐马丽
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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