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Urapidil large volume injection, its preparation method and application

A technology of urapidil and injection, applied in the field of urapidil injection, can solve the problems of inconvenience in clinical use, unqualified heat source, influence on curative effect, etc., and achieve the effect of convenient medication

Active Publication Date: 2007-12-12
杨立新
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN1079147A discloses a sustained-release preparation, but when urapidil is used for oral administration, the absorption rate is low, and the curative effect is not obvious
[0004] 1. Not safe enough
Small injections need to be further diluted with glucose isotonic liquid after intravenous injection, and the speed of injection is not easy to control, and the speed of injection directly affects the curative effect. Danger
[0005] 2. Easy to pollute
During the dilution process of small injections, it is very easy to be contaminated by bacteria due to foreign substances, improper operation and other factors, resulting in unqualified heat source
[0006] 3. Inconvenient clinical use
Small injections need to be prepared when used, resulting in a delay in the use of this product in acute and severe cases
[0007] 4. The scope of application is narrow
[0008] 5. Small injections are packaged in extremely thin glass ampoules, which are easily damaged and inconvenient for storage and transportation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Weigh 9.0g of sodium chloride, add 100ml of water for injection, add 0.1% activated carbon, boil for 15 minutes, filter while hot; take another 0.5g of urapidil, add 100ml of water for injection, adjust the pH value to 2.5 with 1mol / L hydrochloric acid solution , heated and stirred to make the solution pass through the charcoal layer of filtered sodium chloride solution, mix the filtrate with sodium chloride solution, add water for injection to 800ml, mix well, adjust the pH value to 5.0 with 0.1mol / L sodium hydroxide solution, add water for injection To 1000ml, mix well, measure the content of intermediates, filter with a microporous membrane after passing the test, potting, sterilize at 115°C for 30 minutes, light inspection, and pack in glass bottles, each independent packaging specification is 100ml / bottle. .

Embodiment 2

[0060] Weigh 50g of glucose, add 100ml of water for injection, add 0.1% activated carbon, boil for 15 minutes, and filter while hot; take another 0.5g of urapidil, add 100ml of water for injection, adjust the pH value to 2.0 with 1mol / L hydrochloric acid solution, heat and stir to make The solution passes through the charcoal layer of the glucose solution, the filtrate is mixed with the glucose solution, add water for injection to 800ml, mix well, adjust the pH value to 4.6 with 0.1mol / L sodium hydroxide solution, add water for injection to 1000ml, mix well, and measure the middle After passing the test, filter it with a microporous membrane, seal it, sterilize it at 115°C for 30 minutes, inspect it with light, and pack it in a glass bottle. The specification of each independent package is 100ml / bottle.

Embodiment 3

[0062] Weigh 30g of dextran, add 100ml of water for injection, add 0.1% activated carbon, boil for 15 minutes, and filter while hot; take another 0.6g of urapidil, add 100ml of water for injection, adjust the pH value to 2.3 with 1mol / L hydrochloric acid solution, heat and stir to make The solution passes through the charcoal layer of the filtered dextran solution, mix the filtrate with the dextran solution, add water for injection to 800ml, mix well, adjust the pH value to 5.4 with 0.1mol / L sodium hydroxide solution, add water for injection to 1000ml, mix well, and measure the middle After passing the test, filter it with a microporous membrane, seal it, sterilize it at 115°C for 30 minutes, inspect it with light, and pack it in a glass bottle. The specification of each independent package is 50ml / bottle.

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PUM

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Abstract

The invention provides a Urapidil large volume injection, its preparation method and use in making medicament for treating hypertension, wherein the preparation comprises Urapidil, isotonic conditioning agent, pH regulator and water for injection, wherein the isotonic conditioning agent is selected from sodium chloride, glucose, dextran, mannitol or sorbierite, the pH regulator is selected from hydrochloric acid and sodium hydroxide.

Description

technical field [0001] The present invention relates to a kind of urapidil injection, its preparation method and its application, in particular to a kind of urapidil large-capacity injection, its preparation method and its application in the preparation of medicine for treating hypertension. Background technique [0002] Urapidil, a uracil derivative substituted by phenylpiperazine, is a highly selective α-receptor blocker with dual mechanisms of action both peripheral and central. Mainly by activating 5-hydroxytryptamine receptors, reducing the sympathetic feedback regulation of the medullary cardiovascular control center to reduce blood pressure, without common reflex tachycardia; the peripheral effect is mainly to block post-synaptic α 1 Receptors, which reduce peripheral resistance and dilate blood vessels. Urapidil can expand the arteries and veins in a balanced manner, and can be used clinically for various types of hypertension. Its intravenous administration is use...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/513A61K9/08A61P9/12
Inventor 杨立新
Owner 杨立新
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