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Preparation method of adenosine triphosphate coenzyme insulin freeze-dried powder injection

A technology of adenosine triphosphate coenzyme and disodium adenosine triphosphate, which is applied in freeze-dried transportation, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve problems such as appearance collapse, poor product stability, and long freeze-drying time , to achieve the effect of full appearance, good clarity and stable product quality

Active Publication Date: 2012-12-26
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, excessive use of excipients not only increases the cost of the product, but more importantly, introduces unnecessary impurities into the product, thereby affecting the drug safety of patients
In addition, the traditional freeze-drying process is used to prepare ATP-coenzyme insulin freeze-dried powder injection. Its appearance is collapsed, the frozen shape is poor, and the freeze-drying time is long, the reconstitution and clarity are not easy to control, and the product stability is poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Weigh the main ingredient and auxiliary materials according to the following process formula:

[0031] Disodium Adenosine Triphosphate 20mg

[0032] Coenzyme A 50 units

[0033] Insulin 4 units

[0034] L-Arginine 6mg

[0035] Disodium ethylenediaminetetraacetic acid (EDTA) 0.36mg

[0036] Low Molecular Dextran 5mg

[0037] Calcium Gluconate 1mg

[0038] Cysteine ​​Hydrochloride 0.5mg

[0039] Water for injection 0.5ml;

[0040] The specific preparation process is:

[0041] (a) Add an appropriate amount of water for injection into the stainless steel barrel, adjust the pH value to about 2.5 with 10% hydrochloric acid, add insulin, stir evenly, and prepare solution I for later use.

[0042] (b) Add an appropriate amount of water for injection into a stainless steel bucket, add L-arginine and EDTA, stir evenly, add 2% (g / ml) activated carbon and stir for 30 minutes, and decarbonize. Add disodium adenosine triphosphate, stir evenly, and prepare solution II for lat...

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PUM

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Abstract

The invention discloses a preparation method of an adenosine triphosphate coenzyme insulin freeze-dried powder injection, comprising the following steps of: adjusting injection water with diluted hydrochloric acid until the pH value is 2.5-3.5, adding insulin and uniformly mixing to obtain a solution I; adding L-arginine and disodium ethylene diamine tetraacetate in the injection water, uniformly stirring, adding carbon and stirring; after removing carbon, adding adenosine disodium triphosphate and uniformly stirring to obtain a solution II; adding calcium gluconate, low molecular weight dextran and cysteine hydrochloride in the injection water, adding carbon and removing the carbon and uniformly stirring to obtain a solution III; mixing three solutions, uniformly stirring, adjusting the pH value to be 5.7-6.2 with a 2-4 percent NaOH solution, adding coenzyme A and supplementing the balance of injection water; and sterilizing, measuring the content, subpackaging and freezing dry. The adenosine triphosphate coenzyme insulin freeze-dried powder injection prepared by the method has the advantages of favorable redissolution, clearness and quality stability of products and is saturated in appearance.

Description

Technical field: [0001] The invention relates to a preparation method of medicines, in particular to a preparation method of adenosine triphosphate coenzyme insulin freeze-dried powder injection. Background technique [0002] Adenosine triphosphate coenzyme insulin freeze-dried powder injection is a sterile freeze-dried powder injection made of adenosine triphosphate disodium, coenzyme A and insulin as the main ingredients. The adenosine triphosphate disodium in the drug can improve the metabolism of the body and participate in the substitution of fat protein, sugar, nucleic acid and nucleotide in the body. The role of Xie, but also the source of energy in the body. Coenzyme A is a coenzyme that metabolizes acetylation in the body and plays an important role in the metabolism of sugar, fat and protein. It is closely related to the synthesis of acetylcholine in the body, the accumulation of glycogen in the liver, the reduction of cholesterol and the regulation of blood lipi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/19A61K47/36A61K47/18A61K47/12A61K47/20A61P1/16A61P13/12A61P9/04A61K31/7076
Inventor 宋亮李晓斌路玉锋赵霞刘书睿
Owner NORTH CHINA PHARMA COMPANY
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