Levocarnitine injection preparation and preparation method thereof

A technology for injection preparations and injections, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of poor stability of preparations and failure to meet quality requirements, and achieve low product cost. High potential safety, effect of reducing drug costs

Active Publication Date: 2019-07-02
HARBIN GLORIA PHARMA +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 q

Method used

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  • Levocarnitine injection preparation and preparation method thereof
  • Levocarnitine injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0032] Example 1

[0033] Formulation prescription:

[0034] L-carnitine 1000g;

[0035] L-Proline 150g;

[0036] pH=2.4 Glycine-HCl buffer appropriate amount.

[0037] The preparation method is as follows:

[0038] Take 4500mL of water for injection, add L-proline, dissolve completely, add L-carnitine, add water for injection to 5000mL, add pH adjuster to adjust the pH value to 6.0, filter with 0.22μm filter element, fill into vials, freeze-dried , 1000 injection preparations were obtained.

Example Embodiment

[0039] Example 2

[0040] Formulation prescription:

[0041] L-carnitine 1000g;

[0042] L-proline 350g;

[0043] pH=2.4 Glycine-HCl buffer appropriate amount.

[0044] The preparation method is as follows:

[0045] Take 4500mL of water for injection, add L-proline, dissolve completely, add L-carnitine, add water for injection to 5000mL, add pH adjuster to adjust the pH to 6.5, filter with 0.22μm filter element, fill into vials, freeze-dried , 1000 injection preparations were obtained.

Example Embodiment

[0046] Example 3

[0047] Formulation prescription:

[0048]L-carnitine 1000g;

[0049] L-proline 250g;

[0050] pH=2.4 Glycine-HCl buffer appropriate amount.

[0051] The preparation method is as follows:

[0052] Take 4500 mL of water for injection, add L-proline, dissolve completely, add L-carnitine, add water for injection to 5000 mL, add pH adjuster to adjust the pH value to 6.2, filter with 0.22 μm filter element, fill into vials, freeze-dried , 1000 injection preparations were obtained.

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Abstract

The invention belongs to the technical field of a biomedicine, and particularly relates to a levocarnitine injection preparation and a preparation method thereof, the levocarnitine injection preparation is prepared from the following raw materials: levocarnitine and a pH adjuster; further, the injection preparation is prepared from the following raw materials: levocarnitine, proline, and the pH adjuster. The preparation can solve the problems of poor stability in the preparation and impurity generation due to long-term placement in the prior art, and cannot meet the quality requirements in aneffective period. The levocarnitine injection preparation and the preparation method thereof solve the above problems and provide more reliable technical support for the use of levocarnitine for injection.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a levocarnitine injection preparation and a preparation method thereof. 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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/205A61K47/18A61P3/06A61P9/00A61P9/02A61P9/06A61P21/00
CPCA61K31/205A61K9/08A61K9/0019A61K47/183A61P9/00A61P21/00A61P9/06A61P3/06A61P9/02
Inventor 朱吉满何利群夏瑞雪宁夏王帆
Owner HARBIN GLORIA PHARMA
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