Sodium ilaprazole freeze-dried powder injection

A technology of ilaprazole sodium and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of proton pump inhibitor sodium salt, which can solve the problems of venous blood vessel injury, granulation tissue, hyperplasia, and irritation

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

[0006] In addition, researchers found that in animal experiments, when the ilaprazole sodium powder injection disclosed in CN102038648B was used as an experimental animal in Beagle dogs, the injection site would become hard, and the pathological manifestations were venous vascular injury and granulation tissue hyperplasia, which manifested as Slightly irritating when injected

Method used

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  • Sodium ilaprazole freeze-dried powder injection
  • Sodium ilaprazole freeze-dried powder injection
  • Sodium ilaprazole freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] 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 10mg ilaprazole sodium, 0.2% edetate disodium), the specific process includes the following steps

[0041] 1) Pre-cool 900ml of water for injection to below 25°C.

[0042] 2) First weigh about 800ml of water for injection, add 2.0g of edetate disodium, 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.

[0043] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0044] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG~300 linear semi-dropper aseptic filling machine) to pack the filtrate into 1000 bottles (specification: 10...

Embodiment 2

[0047] 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 10mg ilaprazole sodium, 0.15% edetate disodium), the specific process includes the following steps

[0048] 1) Pre-cool 900ml of water for injection to below 25°C.

[0049] 2) First weigh about 800ml of water for injection, add 1.5g of edetate disodium, 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.

[0050] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0051] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG~300 linear semi-dropper aseptic filling machine) to pack the filtrate into 1000 bottles (specification: 1...

Embodiment 3

[0054] 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 10mg ilaprazole sodium, 0.10% edetate disodium), the specific process includes the following steps

[0055] 1) Pre-cool 900ml of water for injection to below 25°C.

[0056] 2) First weigh about 800ml of water for injection, add 1.0g of edetate disodium, 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.

[0057] 3) The solution is filtered through two 0.2um filter membranes to the batching room.

[0058] 4) Use an automatic filling machine (Nanjing Bojian Technology Co., Ltd. KFG~300 linear semi-dropper aseptic filling machine) to pack the filtrate into 1000 bottles (specification: 1...

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Abstract

The invention aims at providing a sodium ilaprazole freeze-dried powder injection which has few adverse reactions and is stable in character and suitable for clinic requirements. The sodium ilaprazole freeze-dried powder injection is prepared from, by weight volume, 0.8-1.2% of sodium ilaprazole, mannitol and 0.05-0.15% of disodium edotato.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of proton pump inhibitor sodium salt, in particular to a freeze-dried powder injection of ilaprazole sodium. Background technique [0002] Ilaprazole sodium (Ilaprazole Sodium) is a new type of proton pump inhibitor for ulcer treatment 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] Chinese patents CN1184970C and CN1225240C respectively disclose ilaprazole oral tablet and its microparticle preparation. However, oral administration of such enteric-coated tablets and enteric-coated pell...

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陈嘉璐张象娜谌红丹王涛涂增清赵梨汪华
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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