Production method for dopamine hydrochloride injection

A technology for dopamine hydrochloride and injection, which is applied in the field of production of dopamine hydrochloride injection, which can solve the problems of low sterility assurance level of sterilization conditions and inability to guarantee the safety of preparations, and achieves difficult decomposition, definite curative effect and good stability Effect

Inactive Publication Date: 2011-01-26
上海禾丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using carbon powder in the production process, although there is a filtration procedure, it cannot completely avoid the absence of carbon powder residue in the preparation, and the sterilization condition at 100°C for 30 minutes has a very low level of sterility assurance. These two problems make the preparation safe sex is not guaranteed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] A kind of preparation method of dopamine hydrochloride injection, its step is: take the water for injection of 50% preparation amount, pass CO 2 15 minutes to make it saturated; take 1% dopamine hydrochloride and 0.15% sodium bisulfite in weight-volume ratio and add the above-mentioned CO 2 Stir to dissolve in saturated water; use sodium hydroxide or hydrochloric acid to adjust the pH of the injection to 3.5, add water for injection to the full amount and stir evenly; filter, pot, and sterilize at 115°C for 30 minutes to prepare a A kind of dopamine hydrochloride injection.

Embodiment 2

[0014] A kind of preparation method of dopamine hydrochloride injection, its step is: take the water for injection of 60% preparation amount, pass CO 2 20 minutes to make it saturated; take 1% dopamine hydrochloride and 0.2% sodium bisulfite in weight-volume ratio and add the above-mentioned CO 2 Stir to dissolve in saturated water; use sodium hydroxide or hydrochloric acid to adjust the pH of the injection to 4.0, add water for injection to the full amount and stir evenly; filter, pot, and sterilize at 121°C for 12 minutes to prepare a A kind of dopamine hydrochloride injection.

Embodiment 3

[0016] A kind of preparation method of dopamine hydrochloride injection, its step is: take the injection water of 70% preparation amount, pass CO 2 25 minutes to make it saturated; take 1% dopamine hydrochloride and 0.25% sodium bisulfite in the weight-volume ratio and add the above-mentioned CO 2 Stir to dissolve in saturated water; use sodium hydroxide or hydrochloric acid to adjust the pH of the injection to 4.3, add water for injection to the full amount and stir evenly; filter, pot, and sterilize at 121°C for 15 minutes to prepare a A kind of dopamine hydrochloride injection.

[0017] The sources of ingredients used in the present invention are commercially available.

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PUM

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Abstract

The invention relates to a production method for dopamine hydrochloride injection, which comprises the following steps of: taking 50 to 80 percent of water for injection in a preparation amount, and introducing CO2 for 15 to 30 minutes to make the water saturated; adding 1 weight volume percent of dopamine hydrochloride and 0.15 to 0.25 weight volume percent of sodium hydrogensulfite into the saturated water into which the CO2 is introduced, and stirring for dissolution; and adjusting the pH value of the injection to be between 3.2 and 4.3 by using sodium hydroxide or hydrochloric acid, adding the water for injection to the full amount, and uniformly stirring; and filtering, filling and sealing, and sterilizing at the temperature of between 115 and 121 DEG C for 12 to 30 minutes. The production method has the advantages of high product stability, exact curative effect, difficult decomposition and precipitation, high sterility assurance level (F0 is more than or equal to 12), and suitability for large-scale industrial production.

Description

technical field [0001] The invention relates to a production method of dopamine hydrochloride injection. Background technique [0002] The dopamine hydrochloride injection in the prior art adds carbon powder during the production process, uses a 0.45 μm filter membrane, and sterilizes at 100° C. for 30 minutes. Using carbon powder in the production process, although there is a filtration procedure, it cannot completely avoid the absence of carbon powder residue in the preparation, and the sterilization condition at 100°C for 30 minutes has a very low level of sterility assurance. These two problems make the preparation safe Sex cannot be guaranteed. Contents of the invention [0003] The technical problem that the present invention needs to solve is to provide a kind of production method of dopamine hydrochloride injection, aim to solve above-mentioned problem; [0004] In order to solve the problems of the technologies described above, the present invention is achieved ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/02A61P9/00
Inventor 孙克刚施建国吴浩萍
Owner 上海禾丰制药有限公司
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