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Adrenaline hydrochloride injection and preparation method thereof

A technology of epinephrine hydrochloride and epinephrine, which is applied in the field of medicine and can solve problems such as high cost, serious product quality problems, and harsh conditions

Active Publication Date: 2021-09-03
上海葆隆生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Further, Chinese invention patent application CN108078917A (a preparation method of epinephrine hydrochloride injection) believes that the method of sterilization at 100°C for 30 minutes adopted by CN105982851A will cause enantiomers of epinephrine hydrochloride injection due to high temperature, thus The aseptic production process and terminal non-sterilization method are adopted; similarly, the conditions of the aseptic production process are harsh and the cost is high. If the sterilization method is not used at the terminal, if there are any mistakes in the production process, it will lead to deterioration of product quality. Serious Problem

Method used

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  • Adrenaline hydrochloride injection and preparation method thereof
  • Adrenaline hydrochloride injection and preparation method thereof
  • Adrenaline hydrochloride injection and preparation method thereof

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Experimental program
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Effect test

Embodiment 1-4

[0034] Components and proportioning ratio of embodiment 1-4 are shown in table 1:

[0035] Table 1 embodiment 1-4 component and proportioning

[0036] components Example 1 Example 2 Example 3 Example 4 adrenaline 1mg / ml 1mg / ml 1mg / ml 1mg / ml Sodium chloride 6.5mg / ml 6.0mg / ml 7.3mg / ml 8mg / ml Sodium metabisulfite 0.6mg / ml 0.8mg / ml 0.457mg / ml 0.2mg / ml L(+)-Tartrate 4.0mg / ml 3.5mg / ml 2.25mg / ml 0.1mg / ml Edetate disodium 0.4mg / ml 0.01mg / ml 0.2mg / ml 0.3mg / ml sodium hydroxide 2.1mg / ml 1.5mg / ml 1mg / ml 0.1mg / ml Hydrochloric acid solution qs to pH 3.0 qs to pH 3.5 qs to pH 3.9 qs to pH 4.5 Water for Injection Appropriate amount to 1ml Appropriate amount to 1ml Appropriate amount to 1ml Appropriate amount to 1ml

Embodiment 1

[0039] (1) Add 95% water for injection of the total amount in the preparation container, feed nitrogen to make the oxygen content less than or equal to 2ppm: vacuumize and discharge the air in the configuration container and pipeline, then feed nitrogen, after 3 cycles, Add water for injection to 95% of the total volume, pass nitrogen until the oxygen content in water for injection is less than or equal to 2ppm;

[0040] (2) Sodium hydroxide is dissolved with an appropriate amount of water for injection, and set aside;

[0041] (3) adding sodium chloride, sodium metabisulfite, L-(+) tartaric acid, disodium edetate, and the sodium hydroxide solution obtained in the above step (2) to the water for injection prepared in the above step (1);

[0042] (4) Add hydrochloric acid to adjust the pH of the solution obtained in step (3) to be 3.0, add epinephrine and stir to dissolve, add hydrochloric acid to keep the pH of the solution at 3.0, add water for injection to the total amount, ...

Embodiment 2

[0046] (1) Add 90% water for injection of the total amount in the preparation container;

[0047] (2) Sodium hydroxide is dissolved with an appropriate amount of water for injection, and set aside;

[0048] (3) Add sodium chloride, sodium pyrosulfite, L-(+) tartaric acid, disodium edetate, and the sodium hydroxide solution obtained in the above step (2) to the water for injection in the preparation container in the above step (1) ;

[0049] (4) Add hydrochloric acid to adjust the pH of the solution obtained in step (3) to be 3.5, add epinephrine and stir to dissolve, add hydrochloric acid to keep the pH of the solution at 3.5, add water for injection to the total amount, and feed nitrogen to control the oxygen content of the injection to be less than or equal to 2ppm ;

[0050] (5) The injection obtained in step (4) is filtered through a 0.45 μm microporous membrane once, and then twice through a 0.22 μm microporous membrane;

[0051] (6) The injection liquid obtained in th...

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Abstract

The invention belongs to the field of biomedical chemistry, and particularly relates to an adrenaline hydrochloride injection and a preparation method thereof. The preparation method comprises the following steps of: controlling the oxygen content in the injection to be less than or equal to 2ppm and controlling the volume content of headspace oxygen in an ampoule bottle to be less than or equal to 3% during filling and sealing, and sterilizing at 121 DEG C for 12 minutes after filling and sealing to obtain a final product. The adrenaline hydrochloride injection prepared by the preparation method meets the national drug standard; compared with the standard requirement of China Pharmacopoeia 2020 edition, the stability of the adrenaline hydrochloride injection is remarkably improved, the growth of adrenaline sulfonic acid and D-adrenaline can be more stably controlled, and the potential safety hazard of medication brought to patients due to the increase of impurities and isomers is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to an injection and a preparation method thereof, in particular to an epinephrine hydrochloride injection and a preparation method thereof. Background technique [0002] Epinephrine is (R)-4-[2-(methylamino)-1-hydroxyethyl]-1,2-benzenediol, which acts directly on the α and β adrenergic receptors of the adrenal medulla and The active ingredient of endogenous catecholamines is mainly suitable for severe dyspnea caused by bronchospasm, and can quickly relieve anaphylactic shock caused by drugs, etc. Stop the main rescue drug for cardiac resuscitation. [0003] Adrenaline has the following structural formula: [0004] [0005] Molecular formula of epinephrine: C 9 h 13 NO 3 , Molecular weight: 183.21. [0006] Both natural and synthetic drugs use the L configuration as the active body. The structure of epinephrine contains the skeleton of β-phenylethylamine. The L configuration w...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/02A61K47/12A61K47/18A61P9/02
CPCA61K31/137A61K9/08A61K47/02A61K47/18A61K47/12A61K47/183A61K9/0019A61P9/02
Inventor 黄平刘勇齐月月仝云董真秀朱高军
Owner 上海葆隆生物科技有限公司
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