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Composition and preparation method of metaraminol bitartrate injection

A technology of meta-hydroxylamine bitartrate and meta-hydroxylamine tartrate, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pharmaceutical formulas, and can solve the problems of high safety risk, easy oxidation of products, loss of active ingredients, etc. question

Active Publication Date: 2022-05-10
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amount of residual oxygen determines the quality of the product, which requires high levels of personnel and technology for filling equipment. If the amount of residual oxygen is high, the product is easily oxidized, and some or all of its active ingredients are lost, which affects the treatment of patients.
[0009] Chinese patent CN107157925A discloses a metaraminol tartrate injection and a preparation method thereof, wherein the prescription consists of metaraminol tartrate, sodium chloride, sodium bisulfite, calcium sodium edetate, lipoic acid and water. The composition is complex, containing sodium bisulfite, edetate calcium sodium, and lipoic acid as antioxidants. The interaction between various materials and the toxicity of degradation products have extremely high safety risks under the injection route of administration.
[0010] Chinese patent CN106389312A discloses a pharmaceutical composition of metaraminol bitartrate injection, which consists of metaraminol bitartrate, sodium chloride, sodium metabisulfite, edetate and water. The prescription is also composed of various antioxidants. Higher safety risk from degraded impurities
Although the sodium metabisulfite in this prescription can play an anti-oxidation effect, the anti-oxidation effect is weak, unstable, and easy to degrade. There are certain hidden dangers in the safety of degraded impurities produced during the degradation process.

Method used

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  • Composition and preparation method of metaraminol bitartrate injection
  • Composition and preparation method of metaraminol bitartrate injection
  • Composition and preparation method of metaraminol bitartrate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Per 10000mL of metahydroxylamine bitartrate injection:

[0036] metaraminol bitartrate 189g Sodium chloride 85g L-Carnosine 20g Add water for injection to 10000mL

[0037] Sodium chloride, L-carnosine, and m-hydroxylamine bitartrate in the prescribed amounts were added to water for injection in turn, and after stirring and dissolving, 0.22 µm was filtered, the ampoules were filled and sealed, and sterilized by autoclaving at 121°C for 12 minutes.

Embodiment 2

[0039] Per 10000mL of metahydroxylamine bitartrate injection:

[0040] metaraminol bitartrate 189g Sodium chloride 85g L-Carnosine 40g Add water for injection to 10000mL

[0041] Sodium chloride, L-carnosine, and m-hydroxylamine bitartrate in the prescribed amount were added to water for injection in turn, and after stirring and dissolving, 0.22µm was filtered, the ampoules were filled and sealed, and sterilized by autoclaving at 121°C for 15 minutes.

Embodiment 3

[0043] Per 10000mL of metahydroxylamine bitartrate injection:

[0044] metaraminol bitartrate 189g Sodium chloride 85g L-Carnosine 50g Add water for injection to 10000mL

[0045] Sodium chloride, L-carnosine, and m-hydroxylamine bitartrate in the prescribed amounts were added to water for injection in turn, and after stirring and dissolving, 0.22 µm was filtered, the ampoules were filled and sealed, and sterilized by autoclaving at 121°C for 12 minutes.

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Abstract

The invention discloses a composition and a preparation method of metaraminol bitartrate injection. The prescription is composed of metaraminol bitartrate, sodium chloride, L-carnosine and water for injection, wherein the dosage of L-carnosine is 2-8 mg / ml. The metaraminol tartrate injection disclosed by the invention has simple composition, stable quality, simple and efficient preparation process, no need for special equipment and inert gas filling, and the finished product after terminal sterilization (F0≥12) has low impurity level and good safety .

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a meta-hydroxylamine bitartrate injection and a preparation method thereof. Background technique [0002] The chemical name of metahydroxylamine bitartrate is (-)-α(1-aminoethyl)-3-hydroxybenzyl alcohol bitartrate, which is an adrenergic and dopaminergic drug. [0003] Chemical Structure: [0004] [0005] Molecular formula: C 9 H 13 NO 2 ·C 4 H 6 O 6 [0006] Molecular weight: 317.29 [0007] Metahydroxylamine Bitartrate Injection was first marketed in Japan, and is mainly used clinically to prevent and treat acute hypotension during intravascular block anesthesia. Adjuvant symptomatic treatment of hypotension; can also be used to treat hypotension caused by cardiogenic shock or sepsis. It mainly acts on α receptors and directly excites α receptors. Its effect on cardiovascular is similar to that of norepinephrine, which is weaker but more durable than nor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/22A61P9/02
CPCA61K31/137A61K9/0019A61K47/22A61K9/08A61P9/02
Inventor 徐成朱亚芳刘馨忆谢晓燕
Owner 南京泽恒医药技术开发有限公司