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Levocarnitine composition for injection and preparation method of levocarnitine composition

A technology for composition and injection, which can be used in pharmaceutical combinations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc. , the effect of increasing the lower limit temperature and prolonging the freeze-drying time

Active Publication Date: 2012-01-25
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the present invention also solves the very difficult problem of decarbonization and filtration of levocarnitine preparation liquid

Method used

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  • Levocarnitine composition for injection and preparation method of levocarnitine composition
  • Levocarnitine composition for injection and preparation method of levocarnitine composition
  • Levocarnitine composition for injection and preparation method of levocarnitine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] prescription:

[0087] Levocarnitine 10Kg

[0088] Mannitol 10Kg

[0089] Add water for injection to 80Kg

[0090] Preparation: Weigh levocarnitine and mannitol, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH to 6.0 with 0.1mol / L hydrochloric acid solution;

[0091] 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, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0092] Aseptic subpackaging: subpackage the levocarnitine solution filtered into the sterile room into 8ml / bottles into vials, and half-stopper;

[0093] Vacuum Freeze Drying:

[0094] a. Pre-freezing: Put the sub-packaged levocarnitine liquid into the freeze dryer, quickly lower the product temperature, a...

Embodiment 2

[0101] prescription:

[0102] Levocarnitine 10Kg

[0103] Mannitol 11Kg

[0104] Add water for injection to 80Kg

[0105] Preparation: Weigh levocarnitine and mannitol, 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 0.1mol / L hydrochloric acid solution;

[0106] 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, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0107] Aseptic subpackaging: subpackage the levocarnitine solution filtered into the sterile room into 8ml / bottles into vials, and half-stopper;

[0108] Vacuum Freeze Drying:

[0109] a. Pre-freezing: Put the sub-packaged levocarnitine liquid into the freeze dryer, quickly lower the product temperature, a...

Embodiment 3

[0116] prescription:

[0117] Levocarnitine 10Kg

[0118] Mannitol 7.5Kg

[0119] Add water for injection to 80Kg

[0120] Preparation: Weigh levocarnitine and mannitol, 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 0.1mol / L hydrochloric acid solution;

[0121] 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, connect a titanium rod filter and a 0.22 μm microporous filter in series, and decarbonize Simultaneously carry out sterile filtration;

[0122] Aseptic subpackaging: subpackage the levocarnitine solution filtered into the sterile room into 8ml / bottles into vials, and half-stopper;

[0123] Vacuum Freeze Drying:

[0124] a. Pre-freezing: Put the sub-packaged levocarnitine liquid into the freeze dryer, quickly lower the product temperature, ...

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Abstract

The invention relates to a levocarnitine composition for injection and a preparation method of the levocarnitine composition; the levocarnitine composition is lyophilized powder containing levocarnitine and mannitol, wherein the weight ratio of the levocarnitine to the mannitol is 1:(0.75-1.25); the average particle diameter of the lyophilized powder is 90-130 nm, and the porosity is 94-98%. The preparation method comprises the steps of: 1) preparing: weighing levocarnitine and mannitol, putting the levocarnitine and the mannitol in a preparing tank, adding injection water, agitating to enable the levocarnitine and the mannitol to be completely dissolved and uniformly mixing, regulating the pH to 5.7-6.3 through a 0.1mol / L hydrochloric acid solution; 2) decarburizing and sterile filtering; 3) sterile packaging; 4) vacuum freeze drying to obtain the levocarnitine composition . The levocarnitine composition has the advantages of simple preparation, advanced technique, uniform quality, excellent stability, better redissolution capability and clinic medicine application safety.

Description

technical field [0001] The invention relates to a levocarnitine composition for injection and a preparation method thereof. The levocarnitine composition for injection prepared by the method can be used to promote fatty acid oxidation and energy supply. Background technique [0002] The chemical name of levocarnitine is (R)-3-carboxy-2-hydroxyl N,N,N-trimethyl-1-propanamine hydroxide. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 7 h 15 NO 3 [0006] Molecular weight: 161.20. [0007] Malnutrition is a common complication of uremic hemodialysis (hemodialysis) patients, and it is one of the main causes of morbidity and death in patients. In recent years, studies have found that hemodialysis patients have significant carnitine deficiency, which is an important factor causing malnutrition. Levocarnitine is a substance necessary for the metabolism of long-chain fatty acids in the human body to produce energy. Normal human L-carnitine comes...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/205A61K47/10A61P3/00
Inventor 赵俊叶东蔡继兰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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