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A kind of three-dimensional porous lactose particle and its preparation method and application

A three-dimensional porous, lactose technology, applied in the field of medicine, can solve the problems of unfavorable scale-up production, low yield, residual ammonia or sodium ions, etc., achieve good fluidity and uniformity, uniform particle size distribution, and improve wall sticking phenomenon Effect

Active Publication Date: 2021-04-20
JIANGXI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing pore-forming process is mainly through the use of ammonium bicarbonate and sodium bicarbonate to produce gas, which will produce residual ammonia or sodium ions, which is not conducive to large-scale production, and the yield is low, and the prepared lactose particles have fluidity and Poor particle size uniformity, poor sustained release effect

Method used

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  • A kind of three-dimensional porous lactose particle and its preparation method and application
  • A kind of three-dimensional porous lactose particle and its preparation method and application
  • A kind of three-dimensional porous lactose particle and its preparation method and application

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Take lactose and povidone K30 with a weight ratio of 10:1, mix lactose, povidone K30 and water to form a solution with a solid content of 12%, and spray dry to make composite particles. The conditions for spray drying are: air intake The temperature is 140°C, the air outlet temperature is 80°C, and the material pumping speed is 6mL / min; after mixing 50g of the obtained composite particles and 300mL of absolute ethanol, stir magnetically at a speed of 300r / min for 12h, centrifuge, and remove the supernatant The precipitate was obtained, blown and dried to constant weight at 60° C. to obtain three-dimensional porous lactose particles, and the obtained three-dimensional porous lactose particles were tested by scanning electron microscope, and the test results were as follows: figure 1 shown, and tested the fluidity (Carr index, Housen ratio and angle of repose), particle size distribution (uniformity), and yield of three-dimensional porous lactose particles. The test result...

Embodiment 2

[0038] Three-dimensional porous lactose particles were prepared using a preparation method similar to that of Example 1. The difference between this example and Example 1 is that the weight ratio of lactose and povidone K30 is different. In this example, lactose and povidone K30 The weight ratio of the obtained three-dimensional porous lactose particles is 10:2; the scanning electron microscope test is carried out to the obtained three-dimensional porous lactose particles, and the test results are as follows figure 2 shown, and tested the fluidity (Carr index, Housen ratio and angle of repose), particle size distribution (uniformity), and yield of three-dimensional porous lactose particles. The test results are shown in Table 1; drug powder, and determine the active ingredient content and dissolution behavior of the drug-loaded powder, and evaluate its drug release behavior. The measurement results are as follows: Figure 6 Shown in the S2 curve.

Embodiment 3

[0040] Three-dimensional porous lactose particles were prepared using a preparation method similar to that of Example 1. The difference between this example and Example 1 is that the weight ratio of lactose and povidone K30 is different. In this example, lactose and povidone K30 The weight ratio of the obtained three-dimensional porous lactose particles is 10:3; the scanning electron microscope test is carried out to the obtained three-dimensional porous lactose particles, and the test results are as follows: image 3 shown, and tested the fluidity (Carr index, Housen ratio and angle of repose), particle size distribution (uniformity), and yield of three-dimensional porous lactose particles. The test results are shown in Table 1; drug powder, and determine the active ingredient content and dissolution behavior of the drug-loaded powder, and evaluate its drug release behavior. The measurement results are as follows: Figure 6 Shown in the S3 curve in.

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Abstract

The invention discloses a three-dimensional porous lactose particle, its preparation method and application. The present invention uses povidone K30 as a porogen, mixes and dissolves povidone K30 and lactose, then sprays drying, eluting, and drying to obtain three-dimensional porous lactose particles, and the addition of povidone K30 in the spray drying process is beneficial Improving the wall sticking phenomenon is conducive to improving the yield of three-dimensional porous lactose particles; the particle size distribution of the three-dimensional porous lactose particles prepared by the present invention is uniform, and it is in a spherical or quasi-spherical structure. The three-dimensional porous lactose particles with this structure have good flow and homogeneity, which is beneficial to the later preparation processing, such as filling of capsules and tablets; the surface of three-dimensional porous lactose particles is distributed with needle-like porous structures, which is conducive to the rapid release of insoluble drugs; for example, the loaded curcumin The cumulative dissolution percentage of the drug powder can reach more than 95% within a dissolution time of 90 minutes.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a three-dimensional porous lactose particle and its preparation method and application. Background technique [0002] Lactose is a natural disaccharide present in most mammalian milk consisting of galactose and sucrose. Lactose is widely used as a filler or diluent for tablets and capsules, and sometimes in freeze-dried products and baby food formulas. Lactose is also used as a diluent in powder inhalers. Various grades of lactose are available in the market, as are products with different physical properties such as particle size and fluidity. For example, the choice of lactose particle size range for capsule filling depends on the model of capsule filling machine. In general, when wet granulating tablets and accompanied by grinding and mixing, it is better to choose lactose with fine particle size, which is easier to mix with other ingredients. Other applications include: ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K47/26A61K47/32A61K31/12
CPCA61K9/145A61K9/146A61K31/12A61K47/26A61K47/32
Inventor 朱卫丰李哲明良山朱琳
Owner JIANGXI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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