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Sodium ilaprazole powder injection and preparation method thereof

A technology of ilaprazole sodium and powder injection, which is applied in the field of ilaprazole sodium powder injection and its preparation, and can solve problems such as allergic reactions and accelerated instability

Active Publication Date: 2016-07-20
LIVZON GROUP LIVZON PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After analysis by the research technicians, the reasons for the allergy may be as follows: 1. The ilaprazole sodium in the preparation is still not stable enough, and the preparation needs to be stored in an environment below 4°C. During the storage and transportation links of production and sales, it may accelerate its instability
2. The influence of impurities in the preparation itself
During the preparation process of the preparation, impurities may inevitably be introduced due to raw materials and other reasons, causing allergic reactions

Method used

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  • Sodium ilaprazole powder injection and preparation method thereof
  • Sodium ilaprazole powder injection and preparation method thereof
  • Sodium ilaprazole powder injection and preparation method thereof

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Effect test

Embodiment 1

[0031] Embodiment 1: Preparation of ilaprazole sodium freeze-dried powder injection (batch number S001)

[0032] The present embodiment is to adopt the method of the present invention to prepare 1000 bottles of ilaprazole sodium freeze-dried powder injection (marked amount: containing 10 mg ilaprazole sodium, edetate disodium content 0.05%, mannitol content 2.4%), specifically The process consists of the following steps:

[0033] 1) Pre-cool 900ml of water for injection to below 25°C.

[0034] 2) First weigh about 800ml of water for injection, add 0.5g of edetate disodium and 24g of mannitol, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Add 10g of ilaprazole sodium crude drug, fully dissolve, add water for injection to 1000g, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Close the lid of the ingredient jar after dissolving.

[0035] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0036] 4) Use ...

Embodiment 2

[0038] Embodiment 2: Preparation of ilaprazole sodium freeze-dried powder injection (lot number S002)

[0039]The present embodiment adopts the method of the present invention to prepare 1000 bottles of ilaprazole sodium freeze-dried powder injection (marked amount: containing 10 mg ilaprazole sodium, edetate disodium content 0.15%, mannitol content 4.6%), specifically The process consists of the following steps

[0040] 1) Pre-cool 900ml of water for injection to below 25°C.

[0041] 2) First weigh about 800ml of water for injection, add 1.5g of edetate disodium and 46g of mannitol, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Add 10g of ilaprazole sodium crude drug, fully dissolve, add water for injection to 1000g, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Close the lid of the ingredient jar after dissolving.

[0042] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0043] 4) Use an automa...

Embodiment 3

[0045] Embodiment 3: the preparation of ilaprazole sodium freeze-dried powder injection (lot number S003)

[0046] 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 10 mg ilaprazole sodium, edetate disodium content 0.10%, mannitol content 2.8%), The specific process includes the following steps

[0047] 1) Pre-cool 900ml of water for injection to below 25°C.

[0048] 2) First weigh about 800ml of water for injection, add 1.0g of edetate disodium and 28g of mannitol, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Add 10g of ilaprazole sodium crude drug, fully dissolve, add water for injection to 1000g, and then adjust the pH to 11.5-12.0 with 5mol / L sodium hydroxide. Close the lid of the ingredient jar after dissolving.

[0049] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0050] 4) Use an automatic ...

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Abstract

The invention provides a sodium ilaprazole powder injection and a preparation method thereof. The powder injection is prepared from, by weight volume, 0.8-1.2% of sodium ilaprazole, 2.4-4.6% of mannitol and 0.05-0.15% of disodium edotato.

Description

technical field [0001] The invention relates to a powder injection of proton pump inhibitor sodium salt and a preparation method thereof, in particular to a powder injection of ilaprazole sodium and a preparation method thereof. Background technique [0002] Ilaprazole Sodium (Ilaprazole Sodium), the chemical name is: 5-(1 hydrogen-pyrrol-1-yl)-2~[[(4-methoxy-3-methyl)-2-pyridyl]-methanol Base]-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 pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
CPCA61K9/19A61K31/4439A61K47/183
Inventor 侯雪梅陆文岐孔祥生赵梨陈嘉璐张象娜谌红丹王涛涂增清张华萍
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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