Di-acetyl-aminoethyl-ethylenediamine powder injection and its preparation method

A technology of diacetaminoacetate ethylenediamine powder and diacetamidoacetate ethylenediamine, which is applied in the field of medicine, can solve the problems of harming the probability of infusion reaction, increasing the number of particles, unreasonable unit dose, etc., so as to increase the probability of infusion reaction , Improve stability, and facilitate transportation and preservation.

Inactive Publication Date: 2004-11-03
武汉安士医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, this not only wastes more than 2 times of packaging materials, but also a great waste of social wealth! Moreover, it is extremely inconvenient to use; more importantly, the unreasonable unit dosage of this drug will inevitably lead to the need to fold and open the ampoule many times during the clinical infusion process, which will increase the number of particles in the infusion, greatly increasing the risk of causing great harm. Chance of infusion reaction, which can endanger the life of the patient in severe cases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Under clean conditions, take ethylenediamine diacetamidoacetic acid 200g, sorbitol 40g, sodium sulfate 2g, arginine 25g, 2-hydroxypropyl β-cyclodextrin 5g, sodium bisulfite 0.12 g in an appropriate amount of water for injection at 20°C, stir and dissolve; use gluconic acid and sodium hydroxide to adjust the acidity to about pH=4.5, add 0.1g of activated carbon for needles, stir for 20min, filter and decarbonize with a 10μm titanium filter rod, pH value and content After the determination is qualified, filter with a 0.45-0.8um microporous membrane, and then filter with a 0.2um-0.22um microporous membrane; sterilize and remove pyrogens, and pack them into vials according to the dose, so that the diacetylamine in each vial The unit dose of ethylenediamine acetate is 0.2g, with a rubber stopper, put the subpackaged vials in a freeze dryer, freeze for 2 hours, make the temperature reach -40°C, and make the vacuum degree in the machine 10Pa. Dry for 18 hours, raise...

Embodiment 2

[0027] Example 2: Under clean conditions, take ethylenediamine diacetamidoacetic acid 400g, sodium chloride 10g, lysine 50g, 2-hydroxypropyl β-cyclodextrin 5g, nicotinamide 25g, L-cysteine Amino acid hydrochloride 0.12g is dissolved in an appropriate amount of water for injection at 20°C, stirred and dissolved; the acidity is adjusted to about pH=4 with glucuronic acid and sodium hydroxide, filtered through a 5μm titanium filter rod, and water for injection is added to wait for the pH value and content After the determination is qualified, two times of ultrafiltration to sterilize, remove the pyrogen, and pack in the vials according to the dose, so that the unit dose of ethylenediamine diacetamidoacetic acid in each vial is 0.4g, add a rubber stopper, and pack the vials , put it in a freeze dryer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum inside the machine 10Pa, dry in low temperature vacuum for 30 hours, raise the temperature to 10°C, dry in vacuum...

Embodiment 3

[0028] Example 3: Under clean conditions, 600g of ethylenediamine diacetate, 10g of glucose, 10g of disodium hydrogen phosphate, 15g of arginine, 5g of 2-hydroxypropyl β-cyclodextrin, 20g of nicotinamide, Dissolve 0.12g of sodium metabisulfite in an appropriate amount of water for injection at 20°C; use hydrochloric acid and sodium hydroxide to adjust the acidity to about pH=4.5, filter through a 10μm titanium filter rod for decarburization, add water for injection, stir well, and measure the pH value and content After passing the test, two times of ultrafiltration to sterilize, remove pyrogens, and pack in vials according to dosage, so that the unit dose of ethylenediamine diacetamidoacetic acid in each vial is 0.6g, add a rubber stopper, and pack the vials , put it in a freeze dryer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum inside the machine 10Pa, dry in low temperature vacuum for 30 hours, raise the temperature to 10°C, dry in vacuum for 10 hour...

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PUM

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Abstract

The diaceto ethylenediamine acetate powder for injection contains diaceto ethylenediamine acetate, at least one kind of pharmaceutically acceptable excipient, pH regulator, antioxidant, stabilizer, etc., and is provided in unit dosage inside some container. Compared with water diaceto ethylenediamine acetate injection, the present invention is convenient in storing and transportation. The present invention is used in preventing and treating hemorrhage caused by various causes.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a diacetylethylenediamine powder injection preparation and a preparation method thereof. Background technique [0002] Xinningling (ethylenediamine diacetylaminoacetate) is a hemostatic drug developed in China, which is clinically used to prevent and treat various causes of bleeding. It has a good curative effect on surgical bleeding, surgical bleeding, respiratory bleeding, facial bleeding, gynecological bleeding, hemorrhoid bleeding, urinary tract bleeding, cancer bleeding, gastrointestinal bleeding, and cerebral hemorrhage. However, at present, only water needles are available in the market, and the water needles are less stable, and their storage and transportation are inconvenient. And there are only 0.2g / 2ml, 0.4g / 2ml specifications (National Drug Administration National Drug Standard WS-10001-(HD-0011)-2002), and in clinical use, intravenous infusion, each 600m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/195A61P7/04
Inventor 刘力刘珍
Owner 武汉安士医药科技有限公司
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