Pancreatic enzymes enteric coated pellets and preparation

An enteric-coated pellet and pancreatin technology, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, and digestive systems, etc., can solve the problems of adhesion, pancreatin globules that easily drop powder, and slow pancreatin speed. To achieve the effect of simple method, no decrease in potency, and high drug release rate

Inactive Publication Date: 2008-10-08
CHANGZHOU NO 4 PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the above-mentioned patented technology, the produced trypsin spheres are easy to drop powder during coating, and adhesion occurs in the coating process, and the release of trypsin from the obtained pellets is not fast.

Method used

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  • Pancreatic enzymes enteric coated pellets and preparation
  • Pancreatic enzymes enteric coated pellets and preparation
  • Pancreatic enzymes enteric coated pellets and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Preparation of trypsin pellets

[0026] Pancreatin pellet prescription

[0027] Name of main drug and excipients

Weight / grams)

trypsin powder

150

Mannitol

40

Sodium carboxymethyl starch

10

purified water

100

[0028] Preparation of trypsin pellets

[0029] At normal temperature, dry mix 150 grams of trypsin powder, 40 grams of mannitol and 10 grams of sodium carboxymethyl starch. Transfer the dry-mixed material to a small fluidized bed used in the laboratory, and spray 100 grams of purified water on the top under a low fluidization state; extrude the material wetted by water on a single-screw machine with a mesh diameter of 1.0mm ; spheronization; drying at 40°C; screening with 24 mesh to 18 mesh to obtain 181 grams of trypsin pellets.

Embodiment 2-4

[0030] Example 2-4 Pancreatin pellet prescription

[0031]

[0032]

[0033] Example 2-4 The preparation process of trypsin pellets was the same as Example 1 . Example 2 , Reality Example 3 and Example 4 The finished product yields are respectively: 91%, 94% and 96%.

[0034] Press Chinese Pharmacopoeia 2005 edition two appendices XD first method to measure the release degree of pancreatin pellet in the solution of pH=6.5, measuring condition is: phosphate buffered saline (get potassium dihydrogen phosphate 6.8g, add water 900ml and make dissolving, Use sodium hydroxide test solution to adjust the pH value to 6.5, add water to 1000ml) 900ml, and the rotating speed is 100r / min, and take samples for analysis at 20, 30 and 45 minutes respectively. According to the Chinese Pharmacopoeia, the potency of pancreatic lipase in the released pancreatic enzymes was determined. The results are as follows:

[0035] Release of trypsin pellets in pH=6.5 solution

[0036...

Embodiment 5

[0038] Example 5 Preparation of trypsin pellets

[0039] Pancreatin pellet prescription

[0040] Name of main drug and excipients

[0041] Example 5 The preparation process of trypsin pellets was the same as Example 1 . Example 5 The finished product yield is: 95%.

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PUM

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Abstract

The invention discloses a medicine preparation of trypsin enteric coated pellets. The preparation consists of active trypsin powder, a polyol medical excipient, a disintegrant and an enteric coating material containing an anti-adhesion agent. The pellet medicine preparation of the invention is prepared by an extruding-rolling technique. The preparation is used for treating dyspepsia, gastricism caused by pancreatic diseases and dyspepsia of diabetic patients, etc.

Description

Technical field: [0001] The invention relates to pharmaceutical preparations, in particular to a pancreatin enteric-coated pellet and a preparation method thereof. The enteric-coated pellets are very stable in human gastric juice, can quickly disperse in human intestinal solution, and have high biological activity. Background technique: [0002] Pancreatin is a mixture of various enzymes obtained from the pancreas of healthy animals, mainly containing trypsin, pancreatic amylase and pancreatic lipase, which can decompose protein, convert starch into glucose or maltose, and have the ability to digest fat. Pancreatin loses activity quickly under acidic conditions, but has higher activity under neutral or slightly alkaline conditions. It is clinically used for indigestion and digestive disorders caused by pancreatic diseases and indigestion in diabetic patients. [0003] Medicinal pancreatin is white or off-white or slightly yellow powder, slightly smelly, but has no rotten o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/46A61K9/16A61K47/10A61K47/34A61K47/36A61K47/38A61P1/14A61P1/18A61K47/26A61K47/44
Inventor 葛纪龙屠永锐葛旭东刘建安房燕冬
Owner CHANGZHOU NO 4 PHARMA FACTORY
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