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Pantoprazole sodium enteric mini-tablet capsule and preparation method thereof

A pantoprazole sodium and enteric-coated technology, which is applied in the field of pantoprazole sodium enteric-coated micro-tablet capsules and its preparation, can solve the problems of low bioavailability, complex preparation process, poor long-term storage stability, etc., and achieve simple process , stable quality, blood concentration consistent with the original research effect

Inactive Publication Date: 2019-12-20
WUHAN RUNXIN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, based on reasons such as prescription composition, preparation process, the pantoprazole sodium enteric-coated capsule in the prior art still has related substance content higher, long-term storage stability is poor, preparation process is complicated (as CN104523648A has adopted double barrier layer design) , low bioavailability

Method used

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  • Pantoprazole sodium enteric mini-tablet capsule and preparation method thereof
  • Pantoprazole sodium enteric mini-tablet capsule and preparation method thereof
  • Pantoprazole sodium enteric mini-tablet capsule and preparation method thereof

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preparation example Construction

[0036] A preparation method for pantoprazole sodium enteric-coated microtablet capsules, comprising the following steps:

[0037] S1, the preparation method of described pantoprazole sodium tablet core comprises: first take by weighing pantoprazole sodium, Pearlitol 200SD, anhydrous sodium carbonate, PVPP, PVP.K30 and magnesium stearate cross 80-100 mesh sieve standby ; Then mix Pearlitol 200SD, anhydrous sodium carbonate, PVPP, PVP.K30 and magnesium stearate evenly for later use; then mix pantoprazole sodium with the above mixed powder in equal proportions; finally choose 3mm or 5mm, 7mm Punch, the hardness of the tablet is about 40N-60N, and the pantoprazole sodium tablet is prepared by powder direct compression or wet granulation process. In tablet compression, the surface of the tablet is smooth, no sticking, no cracks, and good fluidity.

[0038] S2, spray the prepared barrier layer on the pantoprazole sodium tablet core again, the preparation method of the barrier layer...

Embodiment 1

[0042] The invention provides a method, and each capsule is embedded with four pantoprazole sodium enteric-coated microtablets, calculated in 1000 tablets.

[0043] Pantoprazole sodium tablet core contains the following components:

[0044]

[0045] The isolation layer includes the following components:

[0046]

[0047]

[0048] Add water and be mixed with 5% solid content solution, and isolation layer accounts for 5% of the mass of pantoprazole sodium enteric-coated microtablet;

[0049] The enteric layer includes the following components:

[0050]

[0051] Water is added to prepare a solution with a solid content of 10%, and the enteric layer accounts for 10% of the mass of the pantoprazole sodium enteric-coated microtablets.

Embodiment 2

[0053] The invention provides a method, and each capsule is embedded with four pantoprazole sodium enteric-coated microtablets, calculated in 1000 tablets.

[0054] Pantoprazole sodium tablet core contains the following components:

[0055]

[0056] The isolation layer includes the following components:

[0057]

[0058] Add water and be mixed with 8% solid content solution, and isolation layer accounts for 15% of the mass of pantoprazole sodium enteric-coated microtablet;

[0059] The enteric layer includes the following components:

[0060]

[0061] Water is added to prepare a solution with a solid content of 20%, and the enteric layer accounts for 20% of the mass of the pantoprazole sodium enteric-coated microtablets.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a pantoprazole sodium enteric mini-tablet capsule and a preparation method thereof. The pantoprazole sodium enteric mini-tablet capsule comprises a pantoprazole sodium enteric mini-tablet placed in the capsule. The pantoprazole sodium enteric mini-tablet sequentially comprises a pantoprazole sodium tablet core,an isolation layer and an enteric layer from inside to outside. The pantoprazole sodium tablet core comprises the following components in percentage by mass: 20-60% of pantoprazole sodium, 10-46% of Pearlitol 200 SD, 15-20% of anhydrous sodium carbonate, 5-15% of PVPP, 3-5% of PVP.K30 and 0.5-2% of magnesium stearate. According to the invention, the stability of the product is improved, the bioavailability is basically consistent with that of reference listed drugs, and the acceleration stability is better than that of the reference listed drugs.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pantoprazole sodium enteric-coated microtablet capsule and a preparation method thereof. Background technique [0002] Pantoprazole sodium is sensitive to temperature, extremely unstable in an acidic environment, and prone to degradation, so it is generally made into enteric-coated preparations. CN104523648A, CN1321642C, CN101596165B, CN104644616A, CN105310999A and other existing technologies have carried out a lot of research on pantoprazole sodium enteric-coated preparations including enteric-coated capsules and enteric-coated tablets. But, based on reasons such as prescription composition, preparation process, the pantoprazole sodium enteric-coated capsule in the prior art still has related substance content higher, long-term storage stability is poor, preparation process is complicated (as CN104523648A has adopted double barrier layer design) and low bioavail...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/20A61K9/36A61K9/32A61K47/32A61K47/38A61K31/4439
CPCA61K9/2027A61K9/2095A61K9/2846A61K9/2866A61K9/2886A61K9/2893A61K9/4808A61K9/4866A61K31/4439
Inventor 姜松涛桑安国何全斌
Owner WUHAN RUNXIN TECH
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