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Levocarnitine composition for injection and its preparation method

A composition and injection technology, applied in the field of medicine, can solve the problems of long freeze-drying cycle, collapse of skeleton freeze-dried microstructure, influence, etc., and achieve the effects of avoiding adverse effects, improving freeze-drying efficiency, and excellent freeze-drying structure.

Active Publication Date: 2019-06-04
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Due to the high liquid solid content of levocarnitine preparation, it is difficult to form a complete water vapor channel, which is not conducive to the sublimation of water vapor in the product, so the freeze-drying cycle is also longer. Skeleton and freeze-drying microstructure collapse will inevitably occur when freeze-drying according to the prior art. In terms of these defects, the longer freeze-drying cycle only limits the improvement of the production efficiency of the levocarnitine composition for injection. According to the existing The collapse of the skeleton and freeze-dried microstructure that occurs during freeze-drying is directly related to the quality of the final product, because the collapse of the skeleton and freeze-dried microstructure directly affects or even does not meet the requirements of the Pharmacopoeia, resulting in the scrapping of the entire batch of drugs.
Even for the levocarnitine composition for injection with good reconstitution performance at the factory, due to the existence of skeleton and freeze-dried microstructure collapse, the microstructure collapse continues to extend during the placement process, resulting in further damage to the entire freeze-dried pore structure, making The resolubilization performance gradually deteriorates

Method used

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  • Levocarnitine composition for injection and its preparation method
  • Levocarnitine composition for injection and its preparation method
  • Levocarnitine composition for injection and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0037] prescription:

[0038]

[0039] Preparation: Weigh levocarnitine, tranexamic acid, mannitol and glycine, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH to 5.7 with a pH regulator to obtain a medicinal solution;

[0040] Decarbonization and sterile filtration: add 0.01% activated carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 45°C and keep it warm for 30 minutes, perform coarse filtration with a titanium rod, and fine filtration with a 0.22 μm microporous membrane;

[0041] Aseptic subpackaging: subpackage the filtered medicinal solution in 8ml / bottle into vials, and half-stopper;

[0042] Vacuum freeze-drying: pre-freeze at -45°C to -40°C for 3 to 5 hours, keep at -10°C for 7 to 8 hours, keep at 10°C for 6 to 7 hours, and then dry at 50°C for 5 hours;

[0043] Plugging, capping, packaging, full inspection, storage.

Embodiment 2

[0045] prescription:

[0046]

[0047]

[0048] Preparation: Weigh levocarnitine, tranexamic acid, mannitol and glycine, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH to 6.3 with a pH regulator to obtain a medicinal solution;

[0049] Decarbonization and sterile filtration: add 0.3% activated carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 45°C and keep it warm for 30 minutes, perform coarse filtration with a titanium rod, and fine filtration with a 0.22 μm microporous membrane;

[0050] Aseptic subpackaging: subpackage the filtered medicinal solution in 8ml / bottle into vials, and half-stopper;

[0051] Vacuum freeze-drying: pre-freeze at -45°C to -40°C for 3 to 5 hours, keep at -10°C for 7 to 8 hours, keep at 10°C for 6 to 7 hours, and then dry at 50°C for 5 hours;

[0052] Plugging, capping, packaging, full inspection, storage.

Embodiment 3

[0054] prescription:

[0055]

[0056] Preparation: Weigh levocarnitine, tranexamic acid, mannitol and glycine, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH to 6.1 with a pH regulator to obtain a medicinal solution;

[0057] Decarbonization and sterile filtration: add 0.1% active carbon for needles by weight of the liquid medicine, continue to stir, heat the liquid medicine to 45°C and keep it warm for 30 minutes, perform coarse filtration with a titanium rod, and fine filtration with a 0.22 μm microporous membrane;

[0058] Aseptic subpackaging: subpackage the filtered medicinal solution in 8ml / bottle into vials, and half-stopper;

[0059] Vacuum freeze-drying: pre-freeze at -45°C to -40°C for 3 to 5 hours, keep at -10°C for 7 to 8 hours, keep at 10°C for 6 to 7 hours, and then dry at 50°C for 5 hours;

[0060] Plugging, capping, packaging, full inspection, storage.

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a levocarnitine composition for injection and a preparation method thereof. The levocarnitine composition for injection comprises levocarnitine, tranexamic acid, mannitol and glycine. The levocarnitine composition for injection has the remarkably-excellent freeze-drying structure, average grain diameter and porosity, the redissolution performance of the levocarnitine composition for injection can be effectively improved, and the stability and consistency of the performance within the period of validity of a preparation are guaranteed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a levocarnitine composition for injection and a preparation method thereof. Background technique [0002] The chemical name of levocarnitine is (R)-3-carboxy-2-hydroxyl N,N,N-trimethyl-1-propanamine hydroxide. It is a white crystalline powder with strong hygroscopicity. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 7 h 15 NO 3 [0006] Molecular weight: 161.20. [0007] Pharmacological effects L-carnitine is a natural substance in the body required in mammalian energy metabolism, and its main function is to promote lipid metabolism. During hypoxia and ischemia, fatty acyl-CoA accumulates, long-chain fatty acyl-carnitine in mitochondria also accumulates, and free carnitine decreases due to massive consumption. Ischemia and hypoxia lead to a decrease in ATP levels, an increase in the permeability of cell membranes and subcellular ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/205A61K47/18A61K47/26A61P3/00A61P9/10
CPCA61K9/0019A61K9/19A61K31/205A61K47/18A61K47/183A61K47/26
Inventor 苗得足胡清文王宏光王海于志波
Owner REYOUNG PHARMA
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