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Pantoprazole sodium combined drug

A technology of pantoprazole sodium and drugs, applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve the problems of unprotected adverse reactions, physical damage, drug oxidation hazards, etc., to achieve protection from being Oxidation and peroxidation, improvement of internal quality, and stable drug properties

Active Publication Date: 2010-07-07
安徽延寿堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-dried injection of pantoprazole sodium in the prior art still adopts the activated carbon depyrogenation process in the preparation production, resulting in activated carbon microparticles and heavy metal ions remaining in the medicinal liquid, which are brought into the blood of the human body during infusion of Jingmai , bring medicinal damage to the body, and the research of the present invention finds that the pyrogen in the activated carbon adsorption liquid is not thorough. ; Second, activated carbon itself does not depyrogenize and activate
This study also found that the heavy metal ions and iron ions brought by activated carbon are oxidative hazards to the drug; the auxiliary excipient of the freeze-dried injection prepared by the prior art uses low-molecular dextran-40, which has allergic effects on the human body, and some people After dripping a few drops of low-molecular-weight dextran-40 infusion, an allergic reaction occurred. The amount of low-molecular-weight dextran used as an excipient for pantoprazole sodium has reached the minimum amount of allergies, and mannitol is generally used as an excipient. Mannitol has a stimulating adverse reaction to blood vessels; the preparation of pantoprazole sodium in the prior art does not protect the group with sulfur atoms from oxidation, peroxidation, and light in the process of manufacture, storage, transportation, use, and entry into the body. Adverse reactions of this drug caused by oxidation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The pantoprazole sodium combination medicine provided by the invention is made up of following medicinal composition weight ratio:

[0026] Pantoprazole sodium: 35

[0027] Tiopronin 15

[0028] Calcium glutamate 90

[0029] Edetate Disodium 15

[0030] Preparation Process:

[0031] 1. Dissolve Pantoprazole Sodium, Tiopronin, Calcium Glutamate, and Disodium Edetate respectively with water for injection 50-150 times the weight of Pantoprazole Sodium under normal speed stirring;

[0032] 2. Add activated carbon that has been depyrogenated through dry heat at 180° C. for 2 hours to the combined medicinal liquid prepared in the first step, and the ratio of the weight of activated carbon to the volume of the liquid is 0.15%.

[0033] 3. The combined drug liquid is sterilized at 121° C. for 20 minutes, and when the temperature of the liquid is 60-70° C., it is filtered with a two-layer superimposed membrane with an upper layer of 0.45 μm and a lower layer of 0.22 μm.

[...

Embodiment 2

[0040] The pantoprazole sodium combination medicine provided by the invention is made up of following medicinal composition weight ratio:

[0041] Pantoprazole sodium: 100

[0042] Tiopronin 35

[0043] Calcium Glutamate 200

[0044] Edetate disodium 25

[0045] Preparation Process:

[0046] 1. Dissolve Pantoprazole Sodium, Tiopronin, Calcium Glutamate, and Disodium Edetate respectively with water for injection 50-150 times the weight of Pantoprazole Sodium under normal speed stirring;

[0047] 2. Add activated carbon that has been depyrogenated through dry heat at 180° C. for 2 hours to the combined medicinal liquid prepared in the first step, and the ratio of the weight of activated carbon to the volume of the liquid is 0.15%.

[0048] 3. The combined drug liquid is sterilized at 121° C. for 20 minutes, and when the temperature of the liquid is 60-70° C., it is filtered with a two-layer superimposed membrane with an upper layer of 0.45 μm and a lower layer of 0.22 μm.

...

Embodiment 3

[0055] The pantoprazole sodium combination medicine provided by the invention is made up of following medicinal composition weight ratio:

[0056]Pantoprazole sodium: 65

[0057] Tiopronin 23

[0058] Calcium glutamate 123

[0059] Edetate disodium 19

[0060] Preparation Process:

[0061] 1. Dissolve Pantoprazole Sodium, Tiopronin, Calcium Glutamate, and Disodium Edetate respectively with water for injection 50-150 times the weight of Pantoprazole Sodium under normal speed stirring;

[0062] 2. Add activated carbon that has been depyrogenated through dry heat at 180° C. for 2 hours to the combined medicinal liquid prepared in the first step, and the ratio of the weight of activated carbon to the volume of the liquid is 0.15%.

[0063] 3. The combined drug liquid is sterilized at 121° C. for 20 minutes, and when the temperature of the liquid is 60-70° C., it is filtered with a two-layer superimposed membrane with an upper layer of 0.45 μm and a lower layer of 0.22 μm.

[...

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PUM

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Abstract

The invention discloses a pantoprazole sodium combined drug and a preparation method thereof. The pantoprazole sodium combined drug contains the following active ingredients in parts by weight: 35-100 parts of pantoprazole sodium, 15-35 parts of tiopronin, 90-200 parts of calcium glutamate and 15-25 parts of edetate disodium. The pantoprazole sodium combined drug has the functions of preventing damages caused by pantoprazole sodium to liver and other adverse reactions. The invention has the advantages of high drug quality, stable curative effect and advanced preparation method.

Description

technical field [0001] The invention relates to a combination medicine of pantoprazole sodium and a preparation process thereof. Background technique [0002] The gastric and duodenal mucosa has a natural and perfect mechanism to resist the erosion of gastric acid and pepsin, but when it is damaged by Helicobacter pylori and non-steroidal anti-inflammatory drugs, peptic ulcer disease will occur. Australian scholars Warren and Marshall reveal the etiology, and have H 2 Receptor antagonist therapy drugs are effective in treatment, and 22 years later, the two were awarded the 2005 Nobel Prize in Medicine. In the 1980s, proton pump inhibitor drugs were used to treat peptic ulcer disease, which were more powerful and durable than H2 inhibitors. Pantoprazole sodium is a typical representative drug, which is currently one of the first-line first-line drugs for the treatment of peptic ulcer disease. However, the freeze-dried injection of pantoprazole sodium in the prior art still...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K47/20A61K47/16A61P1/04
Inventor 邓学峰蔡海德
Owner 安徽延寿堂药业有限公司
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