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Carbamaid peroxide freeze dried formulation for injection, its preparation method and uses

A technology of carbonamide peroxide and freeze-dried preparations, applied in the directions of peroxy compound active ingredients, freeze-dried delivery, blood diseases, etc., can solve problems such as difficulty in application and promotion, and achieve the effects of slowing down, avoiding decomposition, and reducing pain.

Active Publication Date: 2008-07-23
JILIN SIHUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are only aseptic subpackaged powders of carboxamide peroxide in the domestic market. The pain caused by the rapid release of oxygen at the injection site during use cannot be overcome, which brings certain difficulties to its application and promotion.

Method used

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  • Carbamaid peroxide freeze dried formulation for injection, its preparation method and uses
  • Carbamaid peroxide freeze dried formulation for injection, its preparation method and uses

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035]A) Take 200 grams of fresh water for injection at 80°C in a concentrated preparation tank, add 10 grams of dextran (molecular weight is 20,000), stir well, add 0.1‰ activated carbon, stir and boil for 20 minutes, cool down to 50°C in circulation, and dissolve the medicine Decarbonize the liquid and filter it into the dilute preparation tank, pass condensed water to cool the liquid to 20°C, add 10 grams of carbonamide peroxide, and start the nitrogen filling device in the preparation system at the same time, so that the entire preparation process can be carried out under airtight conditions , fully stir the liquid medicine, constant volume, intermediate product inspection, filter the liquid medicine through the terminal filter system into the storage tank, to be filled.

[0036] B) According to the content of carboxamide peroxide, the amount is fixed, and the medicinal solution is filled in a vial and sent into a freeze-drying box.

[0037] C) The product is maintained at...

Embodiment 2

[0039] A) Take 1,000 grams of fresh water for injection at 90°C in a concentrated preparation tank, add 100 grams of dextran (molecular weight: 10,000), stir well, add 0.5‰ of activated carbon, stir and boil for 30 minutes, cool down to 60°C in circulation, and dissolve the medicine Decarbonize the liquid and filter it into the dilute preparation tank, pass condensed water to cool the liquid to 25°C, add 0.05 g of carbonamide peroxide, and start the nitrogen filling device in the preparation system at the same time, so that the entire preparation process can be carried out under airtight conditions , fully stir the liquid medicine, constant volume, intermediate product inspection, filter the liquid medicine through the terminal filter system into the storage tank, to be filled.

[0040] B) According to the content of carboxamide peroxide, the amount is fixed, and the medicinal solution is filled in a vial and sent into a freeze-drying box.

[0041] C) The product is maintained...

Embodiment 3

[0043] A) Take 5,000 grams of fresh water for injection at 85°C in a concentrated preparation tank, add 50 grams of dextran (molecular weight is 32,000), stir well, add 1‰ of activated carbon, stir and boil for 25 minutes, circulate the temperature to 65°C, and dissolve the medicine The liquid is decarbonized and filtered into the dilute preparation tank, and the liquid is cooled to 25°C by passing condensed water, and 1500 grams of carbonamide peroxide is added, and the nitrogen filling device in the preparation system is started at the same time, so that the entire preparation process is carried out under airtight conditions , fully stir the liquid medicine, constant volume, intermediate product inspection, filter the liquid medicine through the terminal filter system into the storage tank, to be filled.

[0044] B) According to the content of carboxamide peroxide, the amount is fixed, and the medicinal solution is filled in a vial and sent into a freeze-drying box.

[0045]...

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Abstract

The disclosed freeze-dried preparation for injection comprises carbamide peroxide and dextran by the mass ratio of 0.001-2 : 0.001-2, the invention also discloses the method for preparing the carbamide peroxide freeze-dried preparation and its use, wherein the preparation is prepared through dissolving carbamide peroxide and dextran in water while keeping the condition of filling nitrogen, filtering, recrystallizing during freeze-drying procedure, and slowing down the release speed during clinical application. The invention can be applied for treating various hypoxemia and fetal distress caused by acute anoxia.

Description

technical field [0001] The invention relates to a freeze-dried preparation of carboamide peroxide for injection, its preparation method and its application. Background technique [0002] Oxygen storage in the human body is very small and needs to be continuously supplied from the outside world. Oxygen is now known to be utilized within mitochondria and microsomes. Therefore, hypoxia can be considered as a cellular metabolic disorder caused by insufficient oxygen supply and decreased partial pressure of oxygen in mitochondria. The basic purpose of treating hypoxia is to increase the partial pressure of oxygen in the mitochondria. Gas passes through biological membranes based on the principle of diffusion. These membranes include cell membranes, nuclear membranes, endoplasmic reticulum, Golgi complexes, mitochondrial membranes, and lysosome membranes. The side with the lower lateral partial pressure diffuses, therefore, the gas partial pressure is the main factor determinin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/327A61K9/19A61P7/00A61P43/00
Inventor 郭智华
Owner JILIN SIHUAN PHARM CO LTD
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