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Pancreatin enteric coating pellet and preparation method therefor

A technology of enteric-coated pellets and pancreatic enzyme pellets, which is applied in the fields of pharmaceutical formulations, medical preparations containing active ingredients, and the digestive system, can solve the problems of poor stability and large particles of pancreatic lipase, and achieve a simple and easy preparation method OK, high safety factor, reliable quality

Inactive Publication Date: 2015-09-16
SOUTHWEST UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the large size of the multi-enzyme tablet, it cannot enter the duodenum through the pylorus synchronously with the digested chyme, which may easily lead to poor stability of pancreatic lipase

Method used

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  • Pancreatin enteric coating pellet and preparation method therefor
  • Pancreatin enteric coating pellet and preparation method therefor
  • Pancreatin enteric coating pellet and preparation method therefor

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preparation example Construction

[0050] The present invention also provides a preparation method of pancreatin enteric-coated pellets, including the preparation of pancreatin enteric-coated pellets, the preparation of enteric liquid and the preparation of pancreatin enteric-coated pellets, specifically comprising the following steps:

[0051] Step 1: Pass the formulated amount of active pancreatin powder, diluent, disintegrant, and binder through a 100-mesh sieve, mix well, and add an appropriate amount of water to make a moist, uniform and plastic soft material;

[0052] Step 2: put the soft material prepared in step 1 into an extruder, and extrude thin strips of equal diameter;

[0053] Step 3: Quickly add the equal-diameter strip-shaped extrudates prepared in step 2 into the spheronizer in batches, and set the parameters of the spheronizer so that the drug particles are rounded;

[0054] Step 4: Dry the spherical drug granules prepared in Step 3 at 37°C for 12-20 hours to obtain pancreatin pellets;

[005...

Embodiment 1

[0066] The preparation of embodiment 1 trypsin pellet

[0067] Table 1 Prescription of trypsin pellets

[0068]

[0069] The preparation method of trypsin pellet

[0070] 1. After mixing active pancreatin powder, microcrystalline cellulose and croscarmellose sodium evenly, use 3% hydroxypropyl methylcellulose solution to make it into a moist, uniform and plastic soft material.

[0071] 2. Put the above-mentioned soft material into an extruder, and extrude (with a sieve plate aperture of 1.0mm) a thin strip-like extrudate of equal diameter through the extruder.

[0072] 3. Quickly add the extruded product into the spheronizer in batches, adjust the parameters of the spheronizer to make the drug granules completely spheroidized and dry at 37°C for 20 hours, take out the pellets and granulate to obtain the product.

Embodiment 2

[0073] The preparation of embodiment 2 trypsin pellets

[0074] Table 2 Prescription of trypsin pellets

[0075]

[0076] The preparation method of trypsin pellet

[0077] 1. After mixing active pancreatin powder, mannitol and croscarmellose sodium evenly, use 5% polyvinylpyrrolidone solution to make it into a moist, uniform and plastic soft material.

[0078] 2. Put the above-mentioned soft material into an extruder, and extrude (with a sieve plate aperture of 1.0mm) a thin strip-like extrudate of equal diameter through the extruder.

[0079] 3. Quickly add the extruded product into the spheronizer in batches, adjust the parameters of the spheronizer to make the drug granules completely spheroidized and dry at 40°C for 15 hours, take out the pellets and granulate, and the product is ready.

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Abstract

The invention belongs to the pharmaceutical preparation technology field and discloses a pancreatin enteric coating pellet. The pancreatin enteric coating pellet is prepared from a pancreatin pellet, a separant and an enteric coating liquid. The formula of the pancreatin pellet comprises pancreatin powder, diluents, disintegrating agents and adhesives. The formula of the enteric coating liquid comprises enteric coating materials, antitackiness agents, plasticizers and purified water. The invention also provides a preparation method for the pancreatin enteric coating pellet. The pancreatin enteric coating pellet is advantaged by high stability, low irritability, high safety factor and rapid drug release degree. The preparation method is simple and practicable, the quality is reliable, and the method can be implemented and worthy of further industrial popularization.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pancreatin enteric-coated pellet and a preparation method thereof. Background technique [0002] Pancreatin is a mixed enzyme extracted from the pancreas of pigs, cattle, sheep and other animals. Pancreatin contains a variety of enzymes, mainly including trypsin, pancreatic amylase, pancreatic lipase, trypsin, carboxypeptidase and so on. Among them, trypsin can decompose protein, pancreatic amylase can convert starch into maltose or glucose, and pancreatic lipase has the ability to digest fat. Clinically, pancreatic enzymes are mainly used for diseases such as indigestion and digestive disorders caused by the pancreas. [0003] Pancreatin will quickly lose its activity under acidic conditions, but has higher activity under neutral and alkaline conditions. Therefore, pancreatic enzyme preparations should be acid-resistant and have a high releas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/54A61K9/16A61P1/14A61P1/18
Inventor 陈章宝冯洋洋赵海霞邓琴何成陈禹恺
Owner SOUTHWEST UNIVERSITY
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