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Preparation method of levocarnitine injection preparation

A technology for injection preparations and water for injection, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve problems such as failure to meet quality requirements and poor stability of preparations, and achieve high potential safety High reliability, low product cost, and guaranteed stability

Active Publication Date: 2019-07-09
哈尔滨誉衡制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Based on the above reasons, in order to solve the deficiencies of the prior art, solve the problems of poor stability of the preparation of levocarnitine for injection prepared by the prior art, long-term placement of impurities, and the inability to meet the quality requirements within the effective period, etc., the present invention Provide a preparation method of levocarnitine injection preparation, solve the above problems, and provide more reliable technical support for the use of levocarnitine for injection

Method used

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  • Preparation method of levocarnitine injection preparation
  • Preparation method of levocarnitine injection preparation

Examples

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Effect test

Embodiment 1

[0029] Preparation prescription:

[0030] Levocarnitine 1000g;

[0031] L-proline 150g;

[0032] pH value=2.4 Glycine-HCl buffer in proper amount.

[0033] Preparation method is:

[0034] Take 4500mL of water for injection, add L-proline, dissolve completely, add levocarnitine, add water for injection to 5000mL, add a pH regulator to adjust the pH value to 6.0, filter with a 0.22μm filter element, fill into a vial, and freeze-dry , to obtain 1000 injection preparations.

Embodiment 2

[0036] Preparation prescription:

[0037] Levocarnitine 1000g;

[0038] L-proline 350g;

[0039] pH value=2.4 Glycine-HCl buffer in proper amount.

[0040] Preparation method is:

[0041] Take 4500mL of water for injection, add L-proline, dissolve completely, add levocarnitine, add water for injection to 5000mL, add a pH regulator to adjust the pH value to 6.5, filter with a 0.22μm filter element, fill into a vial, and freeze-dry , to obtain 1000 injection preparations.

Embodiment 3

[0043] Preparation prescription:

[0044] Levocarnitine 1000g;

[0045] L-proline 250g;

[0046] pH value=2.4 Glycine-HCl buffer in proper amount.

[0047] Preparation method is:

[0048] Take 4500mL of water for injection, add L-proline, dissolve completely, add levocarnitine, add water for injection to 5000mL, add a pH regulator to adjust the pH value to 6.2, filter with a 0.22μm filter element, fill into a vial, and freeze-dry , to obtain 1000 injection preparations.

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Abstract

The invention belongs to the technical field of biomedicine, and particularly relates to a preparation method of a levocarnitine injection preparation. The injection preparation is prepared from raw auxiliary materials including levocarnitine, proline and a pH adjuster; the preparation method solves the problems that in the prior art, in the process of preparing injection levocarnitine, the stability of a preparation is poor, impurities are generated after long-term placement, and the quality requirements in the duration of validity cannot be met; a more reliable technical support is providedfor the use of injection levocarnitine.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a preparation method of levocarnitine injection preparation. Background technique [0002] Levocarnitine: (R)-3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanamine hydroxide, inner salt. L-carnitine (also known as L-carnitine) is a natural substance widely present in the body tissues of mammals. It is an essential nutrient for mammalian energy metabolism. Humans can ingest it from animal food or synthesize it by themselves. It is mainly distributed in In human cardiac and skeletal muscles. The main function of L-carnitine is to promote lipid metabolism. For ischemia and hypoxia in various tissues, L-carnitine improves the energy supply of tissues and organs by increasing lipid metabolism and energy production, especially myocardial cells, brain, kidneys, etc. Multiple tissues and organs, thereby improving the function of tissues and organs in ischemia and hypoxia. ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/18A61K47/22A61K31/205A61P9/00A61P9/06A61P21/00A61P3/06A61P9/02A61P21/02
CPCA61K9/0019A61K9/19A61K31/205A61K47/183A61K47/22A61P3/06A61P9/00A61P9/02A61P9/06A61P21/00A61P21/02
Inventor 朱吉满何利群夏瑞雪宁夏王帆
Owner 哈尔滨誉衡制药有限公司