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Phenylephrine hydrochloride injection and preparation process thereof

A technology of phenylephrine hydrochloride and injection, applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, cardiovascular system diseases, etc., to achieve the effect of cost reduction

Active Publication Date: 2012-07-04
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

[0005] There is no relevant report about the formula and preparation method of phenylephrine hydrochloride injection preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Phenylephrine Hydrochloride Injection contains the following ingredients:

[0042] Each 10000ml injection contains,

[0043] Phenylephrine Hydrochloride 100g

[0044] Sodium chloride 60g

[0045] Sodium metabisulfite 10g

[0046] Edetate Disodium 1g

[0047] Add water for injection to 10000ml.

[0048] The preparation technology of described phenylephrine hydrochloride injection comprises the following steps:

[0049] (1) Add 90% of the total volume of water for injection in the preparation container, cool to 30°C, and pass through CO 2 15 minutes to make it saturated;

[0050] (2) Dissolve edetate disodium with a small amount of hot water for injection and set aside;

[0051] (3) Add sodium chloride, sodium pyrosulfite, phenylephrine hydrochloride and the edetate disodium solution obtained in step (2) respectively into the water for injection obtained in step (1), and stir to dissolve;

[0052] (4) Add water for injection to the total amount and stir well;

[...

Embodiment 2

[0061] Phenylephrine Hydrochloride Injection contains the following ingredients:

[0062] Each 10000ml injection contains,

[0063] Phenylephrine Hydrochloride 100g

[0064] Sodium chloride 40g

[0065] Edetate Disodium 0.8g

[0066] Add water for injection to 10000ml.

[0067] The preparation process of the described phenylephrine hydrochloride injection is carried out in a closed environment, comprising the following steps:

[0068] (1) Add 90% of the total volume of water for injection in the preparation container, cool to 30°C, and pass through CO 2 15 minutes to make it saturated;

[0069] (2) Dissolve edetate disodium with a small amount of hot water for injection and set aside;

[0070] (3) Add sodium chloride, phenylephrine hydrochloride and the disodium edetate solution obtained in step (2) into the water for injection obtained in step (1), and stir to dissolve;

[0071] (4) Add water for injection to the total amount and stir well;

[0072] (5) Sampling the s...

Embodiment 3

[0080] Phenylephrine Hydrochloride Injection contains the following ingredients:

[0081] Each 10000ml injection contains,

[0082] Phenylephrine Hydrochloride 100g

[0083] Sodium chloride 60g

[0084] Edetate Disodium 1g

[0085] Add water for injection to 10000ml.

[0086] Its preparation technology is identical with embodiment 2.

[0087] The obtained phenylephrine hydrochloride injection is carried out quality inspection, and its result is as follows:

[0088] detection item Sterilize at 100°C for 30 minutes Sterilize at 121°C for 12 minutes Content of Phenylephrine Hydrochloride qualified qualified relative substance qualified qualified sulfonate peak not detected not detected

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PUM

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Abstract

The invention discloses a formula of phenylephrine hydrochloride injection and a preparation process thereof. The phenylephrine hydrochloride injection contains, per 10000 mL, 100 g of phenylephrine hydrochloride, 40 g to 80 g of sodium chloride, 0.8 g to 1.2 g of disodium ethylenediaminetetraacetate, and water for injection added up to 10000 mL. The invention provides a low-cost prescription of phenylephrine hydrochloride injection and a preparation process thereof. The quality of the phenylephrine hydrochloride injection conforms to the regulations of notice on issue of chemical injection and multi-component biochemical injection basic technical requirements ([2008] No.7 file) issued by State Food and Drug Administration in 2008.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to chemical drug injections. 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") puts forward new requirements for the sterilization conditions of injections, 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 conditi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P9/06A61K47/02A61K31/137A61P9/00A61K9/08A61K47/18
Inventor 孙克刚
Owner 上海禾丰制药有限公司
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