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Pancreatin microspheres and production method thereof

A production method, pancreatin technology, applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, digestive system, etc., can solve the problems of unfavorable enzyme stability, loss of enzyme activity, low industrial cost, etc., and achieve high bioavailability , high activity persistence, and the effect of reducing process costs

Pending Publication Date: 2019-08-02
江苏麦德森制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is detrimental to the stability of the enzyme and involves high industrial costs; moreover, there is a serious problem of loss of enzyme activity during extrusion in the presence of solvents
According to the prior art, there is currently lack of an efficient process with low industrial cost to produce very fine particle size without causing denaturation of trypsin and loss of enzyme activity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0019] This embodiment provides a trypsin microsphere, which is composed of a mixture of trypsin, corn starch and sucrose, and polyethylene glycol (PEG 4000); wherein, the weight percentage of trypsin is 56.7%, The weight percentage of polyethylene glycol is 26.7%, and the weight percentage of the mixture of cornstarch and sucrose is 16.6%.

[0020] The production method of above-mentioned trypsin microsphere is as follows:

[0021] A mixture of 680.0 grams of pancreatin, 320.0 grams of polyethylene glycol, and 200.0 grams of cornstarch and sucrose was added to the reactor and heated to 70°C, mixed for 40 minutes, and then transferred to the basket with the rotor inserted in the fluidized bed. The disc is knurled type, the rotating speed is 1200rpm / min, and at the same time, the hot air is blown to 70°C, and it runs at a speed of 1-2 m / s. The filter hose is shaken for 5 seconds in 6 seconds. After heating and spheroidizing for 20 minutes, the temperature of the air that was ...

Embodiment approach 2

[0023] This embodiment provides a pancreatin microsphere, which is a pharmaceutical composition composed of pancreatin, microcrystalline cellulose and polyethylene glycol; the weight percentage of pancreatin is 71.8%, polyethylene glycol The weight percent of microcrystalline cellulose is 19%, and the weight percent of microcrystalline cellulose is 9.2%.

[0024] The production method of above-mentioned trypsin microsphere is as follows:

[0025] Add 717.8 g of trypsin, 190.8 g of polyethylene glycol, and 91.4 g of microcrystalline cellulose to a high-energy mixer tank. The blade running speed of the machine is 900 rpm, and the heating jacket is 70°C. After spheroidizing for 45 minutes, the heating is turned off, the blade speed is reduced to 120 rpm, and the jacket is cooled by the water flow in the pipeline. After cooling for 15 minutes, the pellets were unloaded. The total process time is 60 minutes. The enzyme activity of the prepared trypsin microspheres was 23.5u / mg,...

Embodiment approach 3

[0027] This embodiment provides a pancreatin microsphere, which is a pharmaceutical composition composed of pancreatin, a mixture of colloidal silicon dioxide, triethyl citrate and talcum powder, and polyethylene glycol; pancreatin The percentage by weight of polyethylene glycol is 40%, the percentage by weight of polyethylene glycol is 50%, and the percentage by weight of the mixture of colloidal silicon dioxide, triethyl citrate and talc is 10%.

[0028] Add 400.0 grams of pancreatin, 500.0 grams of polyethylene glycol, and 100.0 grams of colloidal silicon dioxide, triethyl citrate and talcum powder into the reactor, mix for 20 minutes at 70°C and transfer to a in the basket of the fluidized bed. The disc is knurled type, the rotating speed is 1200rpm / min, and at the same time, the hot air is blown to 70°C, and it runs at a speed of 1-2 m / s. The filter hose is shaken for 5 seconds in 6 seconds. After 20 minutes of spheroidization, the temperature of the incoming air was lo...

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Abstract

The invention relates to microsphere production of the field of pharmacy, and discloses pancreatin microspheres and a production method thereof. The microspheres are prepared from pancreatin, a medicinal auxiliary and one or more hydrophilic low-melting-point polymer, wherein the weight percentage of the pancreatin is 40%-85%, the weight percentage of the hydrophilic low-melting-point polymer is 15%-50%, and the rest is the medicinal auxiliary. The production method of the pancreatin microspheres comprises the step that without solvents, through high-energy granulation and a spheroidization technology, the pancreatin microspheres are produced; and no solvents are used in the production process, the prepared microspheres have high enzymatic activity, bioavailability and stability, and compared with existing production methods, the production method is more effective.

Description

technical field [0001] The invention relates to the technical field of microsphere production, in particular to a trypsin microsphere and a production method thereof. Background technique [0002] The reduction of pancreatic secretory enzymes may be due to different pathological conditions, especially the decrease of digestive enzymes due to mucoadhesive disorders (cystic fibrosis), common bile duct obstruction, pancreatic cancer, and inflammatory states of the pancreas (chronic pancreatitis) reduced or absent. As a result, people affected by these disorders are unable to break down food into molecules that can be absorbed by the gastrointestinal tract. The disease causes weight loss and can have fatal consequences. Oral administration of animal-derived pancreatic enzymes is an effective treatment for such diseases. The most suitable and effective preparations for trypsin are microspheres or pellets. Since pancreatin is easily inactivated by the acidic pH of the stomach,...

Claims

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Application Information

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IPC IPC(8): A61K38/43A61K9/14A61K47/10A61P1/16A61P35/00A61P1/18
CPCA61K38/43A61K9/146A61P1/16A61P35/00A61P1/18
Inventor 刘榜惠
Owner 江苏麦德森制药有限公司
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