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Powder injection for treating peptic ulcers and preparation method thereof

A technology for peptic ulcer and powder injection, which is applied to the digestive system, medical preparations without active ingredients, and medical preparations containing active ingredients, etc.

Active Publication Date: 2012-07-25
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such enteric-coated tablets and enteric-coated pellets are only suitable for the treatment of peptic ulcers with benign ulcerative damage to the gastric and duodenal mucosa due to the action of gastric acid and pepsin

Method used

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  • Powder injection for treating peptic ulcers and preparation method thereof
  • Powder injection for treating peptic ulcers and preparation method thereof
  • Powder injection for treating peptic ulcers and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1 : the formula selection of ilaprazole sodium freeze-dried powder injection of the present invention

[0057] 1. Selection of excipients

[0058] Experiments have shown that when the mass fraction of the excipient exceeds 30 parts, the excipient cannot be completely dissolved in the solution containing ilaprazole sodium; when the mass fraction of the excipient is less than 10 parts, the ilaprazole Sodium azole is relatively unstable in the solution and is prone to precipitation; when the mass fraction of the excipient exceeds 18 parts, mannitol will precipitate out after the solution is left for several hours.

[0059] In the aqueous solution containing one part of ilaprazole sodium, add 0, 3, 6, 9, 12, 15, 18 parts of mannitol and 0, 0.1, 0.2, 0.3 parts of edetate disodium respectively, and combine according to the arrangement According to the stability of each prescription under dark conditions, it was determined that when 18 parts of mannitol and 0.3 part...

Embodiment 2

[0068] Example 2 : Preparation and detection of ilaprazole sodium freeze-dried powder injection

[0069] 1. Preparation of ilaprazole sodium freeze-dried powder injection

[0070] refer to figure 1 As shown in the process flow diagram, 1000 bottles of ilaprazole sodium freeze-dried powder injection (marked amount: containing 10g ilaprazole sodium) are prepared by the method of the present invention, and the specific process comprises the following steps:

[0071] 1) Take materials according to the following weight: mannitol 180.0g, sodium thiosulfate 4.0g, edetate disodium 2.0g, ilaprazole sodium 11.0g;

[0072] 2) Dissolve mannitol, sodium thiosulfate, and edetate disodium in 1300g water for injection at 4°C, adjust the pH value to 10.5 with 2mol / L sodium hydroxide solution, add ilaprazole sodium, dissolve fully and then Use 2mol / L sodium hydroxide solution to adjust the pH value to 10.5, and finally add 4°C water for injection to 1500g;

[0073] 3) Sterilize by filterin...

Embodiment 3

[0081] Example 3 : Preparation and detection of ilaprazole sodium freeze-dried powder injection

[0082] This embodiment is to adopt the method of the present invention to prepare 1000 bottles of ilaprazole sodium freeze-dried powder injection (marked amount: containing 10g ilaprazole sodium), and the specific process includes the following steps:

[0083] 1) Take materials according to the following weight: xylitol 150.0g, ilaprazole sodium 11.0g;

[0084] 2) Dissolve xylitol with 1200g, 10°C water for injection, adjust the pH value with 2mol / L sodium hydroxide solution, add ilaprazole sodium, fully dissolve and then adjust with 2mol / L sodium hydroxide solution pH value to 11.5, finally add water for injection at 10°C to 1500g;

[0085] 3) Sterilize by filtering 3 times with a filter membrane with a pore size of 0.2 μm;

[0086] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG~300 linear semi-dropper aseptic filling machine) to dispense the fil...

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Abstract

The invention provides an injection for treating a peptic ulcers and a preparation method thereof. The powder injection provided by the invention comprises the active ingredients of Ilaprazole sodium and excipient, wherein the ratio of the both in parts by weight is (1:1)-(1:30), and the preferable ratio is (1:10)-(1:18). The preferable prescription of the powder injection provided by the invention comprises 1 part of Ilaprazole sodium, 1-30 parts of excipient, 0-10 parts of antioxidant and / or 0-0.3 part of metal ion complexing agent; and a right amount of inorganic base is added to regulate the pH value to 9.0-12.0. The Ilaprazole sodium freeze-dried powder injection provided by the invention has stable quality, and is suitable for treating peptic ulcer bleeding and stress ulcers and preventing upper gastrointestinal bleeding caused by serious diseases.

Description

technical field [0001] The invention relates to an injection for treating peptic ulcer and a preparation method thereof, in particular to an injection of ilaprazole sodium and a preparation method thereof. Background technique [0002] Ilaprazole Sodium (Ilaprazole Sodium), chemical name: 5-(1H-pyrrol-1-yl)-2~[[(4-methoxy-3-methyl)-2-pyridyl]- Methyl]-sulfinyl-1 hydrogen-benzimidazole sodium salt. Ilaprazole (Ilaprazole, IY~81149, Eriprazole) is a new type of proton pump inhibitor for treating ulcers invented by Ilyang Pharmaceutical Co., Ltd. in Korea in 1988. It has been patented in 26 countries (including China). Because the toxic and side effects, safety and curative effect of ilaprazole are all superior to other 4 other prazoles medicines listed on the market at present (its curative effect of 5mg is equivalent to omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg , rabeprazole 20mg), is the strongest acid-suppressing proton pump inhibitor. [0003] In December 20...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61K47/26A61K47/36A61P7/04A61P1/04
Inventor 侯雪梅王燕清徐乐意杨伦杨春苏日佳王翔
Owner LIVZON PHARM GRP INC
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