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Pulullan polysaccharide empty hard capsule and preparation method thereof

A pullulan polysaccharide, hollow hard capsule technology, applied in the directions of capsule delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Market prospects and practical value, high gas barrier properties and impact strength, and the effect of small molecular weight changes

Inactive Publication Date: 2009-11-18
金斐嘉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, as the rubber of hollow hard capsules, gelatin is basically used as the main gelling agent at present, and the water content of hard capsules prepared from gelatin has a certain range (12.5% ​​to 17.5%). The friability of the capsule increases, which is not conducive to drug filling. For hygroscopic drugs (some Chinese herbal medicines), the moisture in the capsule is easily absorbed by the filling, and the filled drug capsules are easy to crack during storage; Stable drugs also affect the expiration date of the drug. Gelatin is prone to aldehyde drug reactions, producing insoluble substances, prolonging the disintegration time of the capsule, and changing the color of the capsule
[0004] Hollow capsules and capsule medicines made of gelatin should be stored in a constant temperature and humidity environment. Because the temperature is too high, the capsules are easy to soften and deform, and the temperature is too low, the capsules are easy to crack. Store gelatin hard capsules at 0°C for three months. Unqualified friability
Gelatin is an animal protein colloid and contains certain animal fat. Generally, the animal fat content in gelatin is about 2.2%, which is easy to cause pollution (foot-and-mouth disease, mad cow disease, etc.), these shortcomings restrict the popularization and application of hollow hard capsule products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] First, prepare the following raw materials: 8000g of pullulan, 80g of red alginate, 12g of sorbitol, 8g of sodium lauryl sulfate, 8060g of polybehenate, and 25000g of water.

[0024] Then, prepare capsules according to the following steps: (1) 25000g water is added in the heating and stirring tank that can be vacuumized, and the mixer is run at a speed of 45 rpm; (2) 8000g of pullulan, 80g of red alginate, Sorbitol 12g, sodium lauryl sulfate 8g, and polybehenate 8060g are dropped into tank respectively, after feeding, the stirring speed is adjusted to 80 rev / min, and the raw material components are stirred until they are evenly mixed and completely dissolved; (3 ) Turn on the heating switch, raise the temperature in the tank to 70°C, and keep it for 1.2h; (4) Vacuumize to eliminate air bubbles; (5) Release the glue, and filter it with a 250-mesh filter bag; (6) Fill the filtered glue solution Put it in an insulated container at a heat preservation range of 65° C., and l...

Embodiment 2

[0026] First, prepare the following raw materials: 10,000 g of pullulan, 100 g of gellan gum, 20 g of potassium chloride, 10 g of sucrose stearate, 30 g of low-substituted hydroxypropyl cellulose, 8,040 g of polysorbate, and 40,000 g of water.

[0027] Then, prepare capsules according to the following steps: (1) 40000g water is added in the heated mixing tank that can be vacuumized, and the mixer is run at a speed of 40 rpm; (2) 10000g of pullulan, 100g of gellan gum, Potassium chloride 20g, sucrose stearate 10g, low-substituted hydroxypropyl cellulose 30g, and polysorbate 8040g are put into the tank respectively, after feeding, the stirring speed is adjusted to 100 rpm, and the raw material components are stirred to Mix evenly and dissolve completely; (3) Turn on the heating switch, raise the temperature in the tank to 80°C, and keep it for 1 hour; (4) Vacuumize to eliminate air bubbles; (5) Release the glue and filter it with a 300-mesh filter bag; (6) ) put the filtered glu...

Embodiment 3

[0029] First, prepare the following raw materials: 15000g of pullulan, 50g of starch, 80g of cellulose gum, 20g of sorbitol, 50g of sodium hydroxymethyl starch, 30g of calcium hydroxymethylcellulose, 8040g of polysorbate, and 58000g of water.

[0030] Then, prepare capsules according to the following steps: (1) 58000g of water is added in the heated mixing tank that can be vacuumized, and the mixer is run at a speed of 50 rpm; (2) 15000g of pullulan, 50g of starch, cellulose Put 80g of glue, 20g of sorbitol, 50g of sodium hydroxymethyl starch, 30g of calcium hydroxymethylcellulose, and 8040g of polysorbate into the tank respectively. After feeding, adjust the stirring speed to 110 rpm, and stir the raw materials Mix until uniform and completely dissolved; (3) Turn on the heating switch, raise the temperature in the tank to 90°C, and keep it for 1.5 hours; (4) Vacuumize to eliminate air bubbles; (5) Release the glue, and filter with a 300-mesh filter bag; (6) Put the filtered g...

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PUM

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Abstract

The invention discloses a polullan polysaccharide empty hard capsule and a preparation method thereof. The preparation method comprises the following steps: mainly adopting polullan polysaccharide, gel agent, plasticizer, emulsifying agent, latent solvent, water, and the like as raw materials; stirring and dissolving the raw materials in a heating-stirring tank which is vacuumized, heating to form glue, filtering, conveying glue solution into a capsule making machine for making a capsule and finally obtaining the polullan polysaccharide empty hard capsule. The empty hard capsule has the advantages of good quality stability, uneasy friability, stable breakdown index, difficult hydrolysis, no misty and yellowing appearance on the surface while in long-term deposition and can hold solids, oily liquid, semisolids and pasty materials; especially, as the water content of the capsule is lower than that of a gelatine capsule, the capsule is more suitable for being filled with moisture-absorption medicines and aldehydes-containing medicines and has wide market prospect and practical value.

Description

technical field [0001] The invention relates to the technical field of capsules, in particular to a pullulan hollow hard capsule with pullulan as the main raw material, and also relates to a preparation method of the hard capsule. Background technique [0002] Hollow hard capsule is a new dosage form developed in the fields of medicine, food, health care products, chemical products, etc. in recent years. , good uniformity, beautiful appearance and so on. [0003] However, as the rubber of hollow hard capsules, gelatin is basically used as the main gelling agent at present, and the water content of hard capsules prepared from gelatin has a certain range (12.5% ​​to 17.5%). The friability of the capsule increases, which is not conducive to drug filling. For hygroscopic drugs (some Chinese herbal medicines), the moisture in the capsule is easily absorbed by the filling, and the filled drug capsules are easy to crack during storage; Stable medicine also affects the validity pe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/36A61K47/38A61J3/07
Inventor 蔡猛
Owner 金斐嘉
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