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Stable levocarnitine compound

A technology of compounds and hydrates, applied in the field of stable levocarnitine compounds, which can solve problems such as affecting use and poor stability of levocarnitine

Active Publication Date: 2012-05-09
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The poor stability of levocarnitine, especially its strong hygroscopicity, affects its use, so it is made into pharmaceutically acceptable salts, such as sodium salt, hydrochloride, nitrate, tartrate, fumarate acid, mucate, etc., but there are still some defects

Method used

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  • Stable levocarnitine compound
  • Stable levocarnitine compound
  • Stable levocarnitine compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052]In a 2000ml reaction bottle equipped with stirring, thermometer and condenser, add 200g of levocarnitine and 1000ml of isopropanol-acetonitrile-water (5:3:2) mixture, start stirring, and heat up to 70°C -75°C, wait until it is completely dissolved, and filter while it is hot. The filtrate was naturally cooled to room temperature, and then kept warm for 8 hours to precipitate crystals, filtered, and dried indoors to obtain 181.6 grams of levocarnitine white crystals, with a melting point of 183.1°C-184.6°C, a content of 99.36%, and a specific rotation [a] 20 D is -31.1 (c=1,H 2 o). Determined by Karl Fischer method, it contains 14.30% (weight percent) of water.

[0053] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° .

[0054] Microparticles or microspheres are prepared by combining the compounds of the present invention wit...

Embodiment 2

[0056] Granules containing levocarnitine sesquihydrate

[0057] Prescription: 100 grams of levocarnitine sesquihydrate, 650 grams of lactose, 80 grams of crospovidone, 50 grams of PEG-4000, 88 grams of hydroxypropyl methylcellulose, appropriate amount of distilled water, made into 1000 bags.

[0058] Process: PEG-4000 and levocarnitine sesquihydrate are crushed together, passed through an 80-mesh sieve, mixed with other materials, made into soft materials with distilled water, granulated, dried at low temperature, and then packed into granules.

Embodiment 3

[0060] Capsules containing L-carnitine sesquihydrate

[0061] Prescription: 50 grams of levocarnitine sesquihydrate, 5 ml of propylene glycol, 200 grams of starch, made into 1000 capsules.

[0062] Process: Moisten levocarnitine sesquihydrate and starch with 15% propylene glycol aqueous solution, mix well, sieve and granulate, dry at 60°C, granulate, and fill capsules.

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Abstract

The invention specifically relates to a levocarnitine sesquihydrate, which belongs to the technical field of medicines. The levocarnitine sesquihydrate obtained in the invention contains one and a half crystal water and has the advantages of a high purity and good stability, having non-obvious moisture absorption and weight gain even under the condition of high humidity. The invention also relates to application of the levocarnitine sesquihydrate in preventing and mitigating myocardial damage, in mitigating and alleviating symptoms of chest pain, in treating coronary heart disease, angina pectoris, heart failure, myocardial infarction and cerebral infarction, in auxiliary treatment of renal disease, chronic pulmonary heart disease, male sterility, acquired immune deficiency syndrome, intermittent claudication, as well as acute and chronic hepatitis, cirrhosis, chronic hepatic insufficiency, muscular atrophy, diabetes and bad postpartum uterus contraction, etc.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicine, and specifically relates to levocarnitine hydrate and a preparation method thereof. The invention also relates to the use of the hydrate to prevent and alleviate myocardial damage, alleviate and alleviate chest pain symptoms, and treat coronary heart disease, angina pectoris, heart failure, Myocardial infarction, cerebral infarction, kidney disease, chronic pulmonary heart disease, male infertility, acquired immunodeficiency syndrome, intermittent claudication, etc., as well as acute and chronic hepatitis, cirrhosis, chronic liver disease, etc. Adjuvant treatment for insufficiency, muscle atrophy, diabetes, postpartum uterine contraction, etc. Background technique [0003] Carnitine was first discovered in muscle extracts by two Russian scientists in 1905. Its molecular structure is 3-hydroxy-4-aza-trimethylaminobutyric acid, which exists in two forms: left-handed and right-handed. But...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C229/22C07C227/42A61K31/205A61P9/00A61P9/10A61P9/04A61P13/12A61P15/08A61P37/00A61P21/00A61P1/16A61P21/02A61P3/10A61P15/04
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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