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Levocarnitine injection and preparation method thereof

A technology for injection and water for injection, which is applied in the field of medicine and can solve problems such as hidden dangers in application

Pending Publication Date: 2022-08-02
湖北海浈医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Therefore, the technical problem to be solved by the present invention is that the levocarnitine injection prepared by the existing levocarnitine injection preparation method contains a relatively high content of trimethylamine, which leads to the problem of hidden dangers in application, and then provides a levocarnitine injection Carnitine injection and preparation method thereof

Method used

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Examples

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Effect test

Embodiment 1

[0034] The present embodiment provides a preparation method of L-carnitine injection, comprising the following steps:

[0035] 1) add 240L water for injection in the dosing tank, control the temperature of the water for injection to be 60 ° C, then add 60kg of levocarnitine to this water for injection, stir to make the levocarnitine dissolve completely, obtain the levocarnitine solution ;

[0036] 2) adjusting the pH of the levocarnitine solution to 6.0 with a mass fraction of 10% hydrochloric acid solution, then adding the remaining water for injection until the levocarnitine solution is 300L, stirring evenly to obtain a crude levocarnitine solution;

[0037] 3) The crude L-carnitine solution was filtered for the first time with a microporous membrane with a pore size of 0.45 μm (the microporous membrane was purchased from Hangzhou Kebaite Filtration Equipment Co., Ltd., the model is SCS92SG71S) (the filtration temperature was 25° C.). , the pressure is 0.1MPa), the obtained...

Embodiment 2

[0039] The present embodiment provides a preparation method of L-carnitine injection, which is different from Embodiment 1 in that the temperature of the water for injection is controlled to be 40° C. in step 1).

Embodiment 3

[0041] This embodiment provides a preparation method of L-carnitine injection, which is different from Embodiment 1 in that the temperature of the water for injection is controlled to be 25° C. in step 1).

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a levocarnitine injection and a preparation method thereof. The preparation method of the levocarnitine injection provided by the invention comprises the following steps: controlling the temperature of part of water for injection to be below 60 DEG C, then adding levocarnitine into the water for injection, and stirring to dissolve levocarnitine to obtain a levocarnitine solution; adjusting the pH value of the levocarnitine solution, then adding the residual water for injection, and stirring to obtain a levocarnitine crude solution; the crude levocarnitine solution is filtered for the first time through a microfiltration membrane with the pore diameter being 0.45-0.8 micron, the obtained filtrate is filtered for the second time through a microfiltration membrane with the pore diameter being smaller than 0.22 micron, and the filtrate obtained through the second time of filtration is subjected to filling, nitrogen charging and sealing to obtain the finished levocarnitine injection. The preparation method of the levocarnitine injection provided by the invention can greatly reduce the content of trimethylamine in the injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a levocarnitine injection and a preparation method thereof. Background technique [0002] Levocarnitine, the chemical name is (R)-3-carboxy-2-hydroxy-N,N,N-trimethyl-1-propylammonium hydroxide inner salt, its molecular weight is 161.2. L-carnitine is an essential natural substance in mammalian energy metabolism. Its main function is to promote lipid metabolism. It can not only bring long-chain fatty acids into the mitochondrial matrix, promote its oxidative decomposition, provide energy for cells, but also The short-chain fatty acyl groups produced in the mitochondria are exported. L-carnitine injection is suitable for chronic renal failure and long-term hemodialysis patients with a series of complications caused by secondary carnitine deficiency, clinical manifestations such as cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, and hypotension and musc...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/205A61P13/12A61P9/00A61P21/00A61P9/06A61P3/06A61P9/02A61P21/02
CPCA61K9/08A61K9/0019A61K31/205A61P13/12A61P9/00A61P21/00A61P9/06A61P3/06A61P9/02A61P21/02
Inventor 陈艳明梁蒸冷玉欢
Owner 湖北海浈医药科技有限公司
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