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Dopamine hydrochloride injection and preparation method thereof

A technology of dopamine hydrochloride and injection, applied in the field of dopamine hydrochloride injection and its preparation

Inactive Publication Date: 2016-10-05
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

[0003] The current preparation process of dopamine hydrochloride injection cannot meet the requirements of the above-mentioned "Notice", so we need a new preparation process to make the quality of dopamine hydrochloride injection meet the requirements of the above-mentioned "Notice"

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A dopamine hydrochloride injection,

[0023] 10000mL of water for injection contains the following components by volume ratio:

[0024] Dopamine Hydrochloride 1%

[0025] Sodium bisulfite 0.05%.

Embodiment 2

[0027] A dopamine hydrochloride injection,

[0028] 10000mL of water for injection contains the following components by volume ratio:

[0029] Dopamine Hydrochloride 1%

[0030] Sodium bisulfite 0.08%.

Embodiment 3

[0032] A preparation method for dopamine hydrochloride injection, comprising the following steps:

[0033] (1) Take water for injection of 60% of the configured volume, and feed carbon dioxide until saturated;

[0034] (2) dopamine hydrochloride and sodium bisulfite are added in the water for injection of step (1) by the formula described in claim 1;

[0035] (3) adjust the pH value of the solution of step (2), make the pH value between 3.3;

[0036] (4) Add water for injection to the full amount and stir evenly;

[0037] (5) After filtration and potting, sterilize at 121° C. for 12 minutes or at 115° C. for 30 minutes.

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PUM

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Abstract

The invention provides a dopamine hydrochloride injection and a preparation method thereof. A formula of the dopamine hydrochloride injection contains, by volume, dopamine hydrochloride 1% and sodium bisulfite 0.05%-0.10% in 10000 ml water for injection. The quality of the dopamine hydrochloride injection meets the stipulations of 'Notification' issued by State Food and Drug Administration in 2008.

Description

technical field [0001] The invention relates to a production method of dopamine hydrochloride injection. Background technique [0002] In 2008, the Evaluation Center of the State Food and Drug Administration issued the State Food and Drug Administration [2008] No. 7 document - "Notice on Issuing the Basic Technical Requirements for Chemical Drug Injections and Multi-component Biochemical Drug Injections" (hereinafter referred to as "Notice"), which stipulates that small-volume injections should adopt a terminal sterilization process, and it is recommended that the overkill method be preferred (F 0 ≥12), if the product cannot tolerate overkill conditions, the survival probability method (8≤F 0 <12), but it should be ensured that the SAL (sterility assurance level) of the product after sterilization is not greater than 10 -6 . Use other F 0 Processes with terminal sterilization conditions whose value is less than 8 are not approved in principle. If there is sufficient ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137
Inventor 卜宇倩
Owner 上海禾丰制药有限公司