Method for preparing high shearing force microcrystal lactose

A high-shear force and lactose technology, applied in the preparation of sugar derivatives, chemical instruments and methods, disaccharides, etc., can solve the problems that do not involve the preparation of drug carrier microcrystalline lactose, do not have adsorption, separation characteristics, and crystal morphology To achieve the effects of excellent fluidity and dispersion, concentrated particle size distribution, and complete crystal planes

Active Publication Date: 2008-08-13
SOUTH CHINA UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] (1), the surface of the crystal is destroyed, and the crystal shape is very different;
[0005] (2) The crystal particle size is not uniform, and the product particle size distribution is very wide;
[0006] (3) It is easy to produce amorphous particles. Due to the small contact angle of amorphous particles, they do not have the adsorption and separation characteristics required as a carrier;
None of the foregoing relates to the preparation method of the drug carrier microcrystalline lactose for dry powder inhalation

Method used

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  • Method for preparing high shearing force microcrystal lactose
  • Method for preparing high shearing force microcrystal lactose

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Mix industrial lactose powder and water in a crystallizer at a ratio of 1.5:1, stir and heat up to 90°C to dissolve lactose completely, let it stand, and slowly cool to 25°C to obtain a lactose supersaturated solution with a supersaturation of 6; at 200Pa The crystals were crystallized at high speed for 3 minutes under a certain shear force, and then the lactose crystals were quickly separated from the mother liquor by a continuous centrifuge. The obtained lactose crystals were freeze-dried, vibrated and dispersed through a 150-mesh sieve, and the lactose with the size distribution shown in Figure 2 was obtained. Crystals, lactose crystals are 3 μm.

Embodiment 2

[0039] Mix industrial lactose powder and water in a crystallizer at a ratio of 3:1, stir and heat up to 90°C to dissolve lactose completely, let it stand, and slowly cool to 30°C to obtain a lactose supersaturated solution with a supersaturation of 7; at 500Pa The crystals were crystallized at high speed for 1 minute under a certain shear force, and then the lactose crystals were quickly separated from the mother liquor by a continuous centrifuge. The obtained lactose crystals were microwave-dried, vibrated and dispersed through a 150-mesh sieve, and the lactose with the size distribution shown in Figure 3 was obtained. Crystals, lactose crystals are 16μm.

Embodiment 3

[0041] Mix industrial lactose powder and water in a crystallizer at a ratio of 2:1, stir and heat up to 90°C to dissolve lactose completely, let it stand, and slowly cool to 40°C to obtain a lactose supersaturated solution with a supersaturation of 5; at 300Pa The crystals were crystallized at a high speed for 2 minutes under a certain shear force, and then the lactose crystals were quickly separated from the mother liquor by a continuous centrifuge. The obtained lactose crystals were freeze-dried, vibrated and dispersed through a 150-mesh sieve, and the lactose crystals with the size distribution shown in Figure 2 were obtained. Crystals, lactose crystals are 20μm.

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Abstract

The invention discloses a high shearing force preparation of microcrystalline lactin, including steps of: (1) mixing solid lactin and water with a certain proportion, stiring and heating until the latin is fully dissolved; (2) cooling the latin solution to a predetermined temperature to obain hypersaturate solution of latin; (3) turn on a shear in a crystallizer, to stimulate crystallization of the solution by high shear force; (4) fast separating latin crystal from mother liquid by continuous centrifuge; (5) drying obtained latin crystal; (6) product of microcrystalline lactin is obtained by screening. The invention not only stimulate crystallization of mother liquid by shearing force, in order to realize control of the crystal forming process, and obtain product with centralized grain-size distribution, but also avoids mechanical crushing in the preparation, so that crystal structure is protected, and generation of non-crystal granular is also avoided. Further, the invention combines centrifugal and vibrating drying, thus crystal exhibit excellent fluidity and dispersity, and crystallization time is short.

Description

technical field [0001] The invention relates to a method for preparing lactose, in particular to a method for preparing high-shear force microcrystalline lactose. Background technique [0002] Dry powder inhalation aerosols (DPIs for short) is a new respiratory drug delivery method. Many methods for treating respiratory diseases are administered directly through the respiratory tract, which has the advantages of relatively low dosage, small side effects, and quick onset of action. The traditional inhalation drug delivery method using propellants has certain toxicity and can cause bronchoconstriction and arrhythmia, etc., and has been gradually replaced by more advanced DPIs. The DPIs method usually mixes the drug particles with the carrier, and then the drug enters the respiratory tract and lungs in the form of a powder mist through a special drug delivery device, and the drug is separated from the carrier under the action of the respiratory airflow, and reaches the target ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H3/04C07H1/06A61K47/26A61K9/72
Inventor 曾新安于淑娟秦贯丰张庆
Owner SOUTH CHINA UNIV OF TECH
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