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Preparation method of levocarnitine freeze-dried powder for injection

A technology for freeze-dried powder and injection, which is applied in the field of preparation of levocarnitine freeze-dried powder for injection, which can solve the problem of uneven quality of levocarnitine freeze-dried powder, not very standardized process control, and inaccurate parameter control and other issues, to achieve the effect of being suitable for promotion, improving the shelf life, and standardizing the process

Inactive Publication Date: 2014-03-12
HAINAN GENERAL & KANGLI PHARMA
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Problems solved by technology

For ischemia and hypoxia in various tissues, L-carnitine improves the energy supply of tissues and organs by increasing energy production. Clinically, L-carnitine for injection is mainly used for cardiomyopathy, arrhythmia, hyperlipidemia, hypotension, etc. Disease prevention and treatment. At present, levocarnitine for injection is mainly stored in the form of freeze-dried powder. During the preparation process of levocarnitine freeze-dried powder for injection, the process control is not very standardized, and the parameter control is not precise enough, etc. Problems, resulting in uneven quality and inconsistent shelf life of the obtained levocarnitine freeze-dried powder for injection

Method used

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Embodiment Construction

[0026] For a better understanding of the present invention, the present invention will be further specifically described below through the following examples, but it should not be construed as a limitation of the present invention. For some non-essential improvements and adjustments made by those skilled in the art according to the above-mentioned content of the invention, It is also considered to fall within the protection scope of the present invention.

[0027] According to the method provided by the invention, proceed as follows:

[0028] First, prepare the following components in parts by weight:

[0029] Levocarnitine 500g, mannitol 600g, water for injection 3500g, activated carbon 7g, then adopt the following steps:

[0030] a. Weigh 70% water for injection of the prepared amount and add it to the liquid mixing tank and cool to room temperature.

[0031] b. Then add the approved dosage of mannitol and levocarnitine, stir until completely dissolved, and adjust the pH v...

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Abstract

The invention provides a preparation method of levocarnitine freeze-dried powder for injection. Process steps are adjusted, for example, a medicine adding sequence is adjusted, temperature, duration, pressure and other parameters are precisely controlled, and the filtering process is controlled multiply, so that the quality of a finished product is greatly improved, the storage life is prolonged, the process is more standard, and the preparation method is suitable for popularization.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of levocarnitine freeze-dried powder for injection. Background technique [0002] L-carnitine is a natural substance in the body needed 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 membranes, and the accumulation of fatty acyl-CoA can cause changes in membrane structure, disintegration of membrane phases, and cell death. In addition, during hypoxia, the anaerobic glycolysis of sugar is the main method, and the accumulation of fatty acids leads to acidosis, ion disturbance, and cell autolysis and death. A sufficient amount of free ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/205A61P9/00A61P9/06A61P3/06A61P9/02
Inventor 王志涛林密林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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