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Levocarnitine freeze-dried composition for injection and preparation method thereof

A composition and technology for injection, applied in the field of levocarnitine freeze-dried composition for injection and its preparation, and in the field of injections, can solve the problems of increasing the dextrorotatory product of levocarnitine, achieve simple preparation process and avoid degradation , Ease of industrial production

Inactive Publication Date: 2014-08-13
广东泽盛药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] By searching the existing technologies at home and abroad, it is found that there is currently no literature on how to avoid the increase of the dextrorotatory product of L-carnitine.

Method used

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  • Levocarnitine freeze-dried composition for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] L-Carnitine 1000g

[0026] Fructose Bisphosphate 600g

[0027] Lactic acid amount

[0028] Add water for injection to 3000ml

[0029] Preparation Process:

[0030] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0031] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0032] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0033] Preparation of medicinal solution: Weigh the prescribed amount of levocarnitine and sodium fructose diphosphate and add them to the water for injection, stir to dissolve, circulate and filter, adjust the pH to 5.0 with lactic acid, send samples to tes...

Embodiment 2

[0037] L-Carnitine 1000g

[0038] Fructose Bisphosphate 1800g

[0039] Lactic acid amount

[0040] Add water for injection to 3000ml

[0041] Preparation Process:

[0042] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0043] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0044] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0045] Preparation of medicinal solution: Weigh the prescribed amount of levocarnitine and sodium fructose diphosphate and add them to the water for injection, stir to dissolve, circulate and filter, adjust the pH to 5.5 with lactic acid, send samples to te...

Embodiment 3

[0049] L-Carnitine 1000g

[0050] Fructose Bisphosphate 1000g

[0051] Lactic acid amount

[0052] Add water for injection to 3000ml

[0053] Preparation Process:

[0054] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0055] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0056] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0057] Preparation of medicinal solution: Weigh the prescribed amount of levocarnitine and sodium fructose diphosphate and add them to the water for injection, stir to dissolve, circulate and filter, adjust the pH to 6.0 with lactic acid, send samples to te...

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Abstract

The invention discloses a levocarnitine freeze-dried composition for injection and a preparation method thereof. The composition contains levocarnitine, fructose diphosphate and lactic acid. Preferably, the weight ratio of levocarnitine to fructose diphosphate is 1:(0.6-2.0). By adding a proper freeze drying propping agent, a stable levocarnitine freeze-dried powder injection is provided. By using the preparation, the transformation of levocarnitine into a dextroisomer side product can be retrained to the maximum extent, degradation of medicaments is avoided, and the stability of the preparation is enhanced.

Description

technical field [0001] The invention belongs to the technical field of chemical preparations, and in particular relates to an injection, in particular to a levocarnitine freeze-dried composition for injection and a preparation method thereof. Background technique [0002] L-carnitine, also known as L-carnitine, is an essential natural substance in the energy metabolism of mammals. Its main function is to promote lipid metabolism. For ischemia and hypoxia in various tissues, L-carnitine can improve energy production by increasing energy production. Energy supply of tissues and organs. Other functions of levocarnitine include oxidation of medium-long chain fatty acids, oxidation of fatty acid peroxidase, buffering of the ratio of bound coenzyme A to free coenzyme, and protection from ketones, pyruvate, amino acids ( Including branched-chain amino acids) to generate energy, remove the toxicity of excessive coenzyme A, and regulate the concentration of ammonia in the blood. Le...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/205A61K47/26A61K47/12A61P3/00A61P9/00A61P21/00A61P9/06A61P3/06A61P9/02A61P21/02
Inventor 严白双
Owner 广东泽盛药业有限公司
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