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Levocarnitine pharmaceutical composition for injection

A composition and a technique for injection, which are applied in the field of pharmaceuticals in the field of medicine, can solve problems such as inconvenience in the production process, and achieve the effects of stable quality, good stability, and simple and easy methods

Active Publication Date: 2013-06-12
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The present invention adopts citric acid aqueous solution (pH=6.2), and improves the pH stability of the drug, and the storage stability period can reach 36 months. pH5.5-7.0), levocarnitine injection with citric acid aqueous solution and sodium chloride as auxiliary materials has better stability than foreign commercially available levocarnitine injection, and it is proved by pharmacological experiments that according to the formula The prepared injection has no hemolysis, vascular irritation and allergic reaction, and the levocarnitine injection produced by the prior art has very strict requirements on storage and light protection, and the pH changes obviously after being irradiated by sunlight. There are inconveniences in the production process

Method used

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  • Levocarnitine pharmaceutical composition for injection
  • Levocarnitine pharmaceutical composition for injection
  • Levocarnitine pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] For every 1000 pieces of the L-carnitine pharmaceutical composition, the formula is as follows:

[0069] L-Carnitine 1000g

[0070] Citrate buffer (pH=6.2) 2.5L

[0071] Sodium chloride 30g

[0072] The water for injection is increased to 5L.

[0073] Preparation Process:

[0074] 1) Weigh sodium chloride, add citrate buffer solution, and add appropriate amount of water for injection to dissolve it completely;

[0075] 2) Add 0.1% medicinal charcoal of the volume of water for injection, heat for 5 minutes to remove pyrogen, filter and decarbonize to obtain filtrate;

[0076] 3) Cool to 40-50℃, then add L-carnitine, dissolve it, add water for injection to the full amount, if necessary, adjust the pH range 5.5-7.0 with citric acid solution or sodium hydroxide solution;

[0077] 4) The resulting solution is finely filtered with a mixed cellulose ester microporous filter membrane to obtain the filtrate, which is filled and sealed in an ampoule, and autoclaved at 121°C for 15 minutes to o...

Embodiment 2

[0079] For every 1000 pieces of the L-carnitine pharmaceutical composition, the formula is as follows:

[0080] L-Carnitine 1000g

[0081] Citrate buffer (pH=6.2) 3L

[0082] Sodium chloride 30g

[0083] The water for injection is increased to 5L.

[0084] Preparation process: the same as in Example 1.

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Abstract

The invention relates to a stable levocarnitine pharmaceutical composition, and the injection specifically comprises levocarnitine or pharmaceutically acceptable salts thereof and additives for injection, wherein the additives at least contain citrate buffer solution (pH is 6.2), and the other additive is selected from sodium chloride. The levocarnitine injection is good in light resistance, stable in pH, small in skin irritation and easy to realize industrialization.

Description

technical field [0001] The invention relates to medicines in the medical field, in particular to a stable levocarnitine pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Chronic renal failure (CRF, referred to as renal failure) refers to the chronic progressive renal dysfunction caused by chronic kidney disease (CKD) or systemic diseases involving the kidney, and the resulting Syndrome composed of various clinical symptoms and metabolic disorders. A retrospective epidemiological survey of 976 patients with chronic renal failure admitted from 1997 to 2003 showed that: in mainland China, Hong Kong, Macao, Taiwan, Southeast Asia, Europe and the United States, the primary cause of chronic renal failure is chronic renal failure. Glomerulonephritis. Most glomerulonephritis is an immune-mediated inflammatory disease, and only a small number of chronic nephritis is caused by the development of acute nephritis. The exact etiol...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/205A61K47/12A61P9/00A61P19/08A61P21/00A61P9/06A61P3/06A61P9/02A61P21/02
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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