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Adrenaline hydrochloride injection and preparation process thereof

A technology of epinephrine hydrochloride and epinephrine, applied in anesthetics, blood diseases, extracellular fluid diseases, etc., can solve problems such as unguaranteed and difficult to meet the quality standards of epinephrine hydrochloride injection

Inactive Publication Date: 2012-02-01
上海禾丰制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the prior art, epinephrine hydrochloride injection is sterilized at 100°C for 30 minutes, which cannot guarantee that the SAL of the product after sterilization is not greater than 10 -6 , so it is necessary to seek a more advanced preparation process. Since the product is sterilized at 121°C for 12 minutes, the indicators are difficult to meet the quality standards of the Chinese Pharmacopoeia 2010 Edition II Epinephrine Hydrochloride Injection, so it is now used aseptic Production

Method used

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  • Adrenaline hydrochloride injection and preparation process thereof

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0030] (1) Add 90% of the total amount of water for injection below 30°C in the preparation container, and pass CO 2 15 minutes to make it saturated;

[0031] (2) Sodium chloride is dissolved in an appropriate amount of water for injection below 30°C, and the appropriate amount accounts for about 5% of the total preparation amount;

[0032] (3) Dissolve edetate disodium with boiled water for injection;

[0033] (4) Dissolve the sodium chloride solution obtained in step (2), the edetate disodium solution obtained in step (3), sodium metabisulfite and epinephrine in the water for injection obtained in the above step (1), stir to dissolve ;

[0034] (5) Measure the intermediate pH of the solution obtained in step (4), adjust the pH to 3.6-4.0 with 1mol / L hydrochloric acid, add water for injection until the total amount is stirred;

[0035] (6) filter the solution obtained in step (5) with a filter membrane of 0.45um and 0.22μm;

[0036] (7) The solution obtained in step (6) i...

preparation Embodiment 2

[0038] (1) Add 900g of water for injection below 30°C to the preparation container, pass through CO 2 15 minutes to make it saturated;

[0039] (2) Dissolve 7.944g of sodium chloride in 50g of water for injection below 30°C;

[0040] (3) Dissolve edetate disodium 0.298g with 10g of boiled water for injection;

[0041] (4) The sodium chloride solution obtained in step (2), the edetate disodium solution obtained in step (3), 0.993 g of sodium metabisulfite and 0.993 g of adrenaline were dissolved in the water for injection obtained in the above step (1) , stir to dissolve;

[0042] (5) Measure the pH of the solution obtained in step (4), adjust the pH to 3.6-4.0 with 1mol / L hydrochloric acid, add water for injection to 1000g and stir well;

[0043] (6) filter the solution obtained in step (5) with a filter membrane of 0.45um and 0.22μm;

[0044] (7) The solution obtained in step (6) is subjected to aseptic potting according to the potting operation procedure, and N is connec...

preparation Embodiment 3

[0046] (1) Add 1800g of water for injection below 30°C to the preparation container, pass through CO 2 15 minutes to make it saturated;

[0047] (2) Dissolve 15.888g of sodium chloride in 100g of water for injection below 30°C;

[0048] (3) Dissolve edetate disodium 0.596g with 20g of boiled water for injection;

[0049] (4) Dissolve the sodium chloride solution obtained in step (2), the edetate disodium solution obtained in step (3), sodium metabisulfite 1.986g and epinephrine 1.986g in the water for injection obtained in the above step (1) , stir to dissolve;

[0050] (5) Measure the pH of the solution obtained in step (4), adjust the pH to 3.6-4.0 with 1mol / L hydrochloric acid, add water for injection to 2000g and stir well;

[0051] (6) filter the solution obtained in step (5) with a filter membrane of 0.45um and 0.22μm;

[0052] (7) The solution obtained in step (6) is subjected to aseptic potting according to the potting operation procedure, and N is connected in the...

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Abstract

The invention discloses an adrenaline hydrochloride injection and a preparation process thereof. The preparation process comprises the following steps: (1) adding water for injection in a container and inserting CO2 for 15 min, wherein, the volume of the water is 90% of the total volume, and the temperature of the water is less than 30 DEG C; (2) dissolving sodium chloride in proper amount of water for injection having a temperature of below 30 DEG C; (3) dissolving disodium edetate with boiled water for injection; (4) dissolving sodium chloride solution, disodium edetate solution, sodium pyrosulfite and epinephrine respectively in water for injection; (5) measuring the pH value of the solution, regulating the pH value to 3.6-4.0 with 1 mol / L hydrochloric acid, adding water for injection to reach the total amount, and uniformly stirring; (6) filtering; and (7) carrying out aseptic filling and sealing, and inserting N2 in ampoules when filling and sealing; or carrying out filling and sealing according to operating procedures of filling and sealing, inserting N2 in the ampoules when filling and sealing , and carrying out disinfection for 30 min at the temperature of 100 DEG C. The process realizes aseptic production, and products produced by the preparation process satisfy the national medicine quality standards.

Description

【Technical field】 [0001] The invention relates to the field of pharmacy, in particular to chemical drug injections. 【Background technique】 [0002] The Evaluation Center of the State Food and Drug Administration issued the State Food and Drug Administration [2008] No. 7 document in 2008 - "Notice on Issuing Basic Technical Requirements for Chemical Drug Injections and Multi-component Biochemical Drug Injections", which stipulates : Small-volume injections should be terminally sterilized, 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 evidence to prove that the terminal sterilizati...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/18A61P9/00A61P11/00A61P23/00A61P7/08
Inventor 吴雯君
Owner 上海禾丰制药有限公司
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