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Medical preparation containing levocarnitine and dihydroxybenzenesulphonic acid salt and preparation method of medical preparation

A technology for dobesilate and solid pharmaceutical preparations, which is applied in the field of pharmaceutical preparations containing levocarnitine and dobesilate and its preparation, and can solve problems such as affecting production, difficulty in large-scale production, and large tablet discrepancy

Inactive Publication Date: 2012-06-27
LIAONING THINKING DECKER MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, Chinese patent application 201010215998.9 uses conventional technology to prepare pharmaceutical compositions, and there are some problems, such as: directly mixing the drug powder and then granulating, the poor fluidity of the particles leads to large tablet differences, and it is easy to cause sticking of the tablet machine and affect production. Normal operation; moisture absorption during the mixing process of the drug powder, resulting in mottled granules during tablet compression; unsatisfactory dissolution of sustained-release and controlled-release tablets (especially slow-release and controlled-release coated tablets)
These problems lead to difficulties in large-scale production, thus limiting its application

Method used

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  • Medical preparation containing levocarnitine and dihydroxybenzenesulphonic acid salt and preparation method of medical preparation
  • Medical preparation containing levocarnitine and dihydroxybenzenesulphonic acid salt and preparation method of medical preparation
  • Medical preparation containing levocarnitine and dihydroxybenzenesulphonic acid salt and preparation method of medical preparation

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preparation example Construction

[0051] In the preparation method of the pharmaceutical preparation of the present invention, the granulation may adopt dry granulation, wet granulation or spray granulation. Preferably, the granulation adopts wet granulation. Various granulation techniques are well known to those skilled in the art, for example, refer to the fourth edition of "Pharmacy" (Bi Dianzhou, People's Health Publishing House).

[0052] The third aspect of the present invention relates to the preparation of levocarnitine and dobesilate for the treatment and / or prevention of diseases affecting renal function such as primary nephritis, secondary nephritis, renal ischemia / reperfusion injury, Renal insufficiency (eg, chronic renal insufficiency), nephrotic syndrome, renal failure (eg, chronic renal failure), uremia and diabetic nephropathy, and complications from diseases affecting renal function such as cardiovascular disease (eg, myocardial Ischemia / reperfusion and chronic cardiac insufficiency) and diab...

Embodiment 1

[0057] Example 1 - Tablets

[0058] formula:

[0059]

[0060]

[0061] Preparation Process:

[0062] Mix levocarnitine, microcrystalline cellulose and calcium sulfate, add an appropriate amount of binder to make a soft material, and dry at 50°C for 3 hours, as part A. Mix calcium dobesilate and microcrystalline cellulose, add an appropriate amount of binder to make a soft material, and dry at 50°C for 2 hours, as part B. Mix part A and part B, add crospovidone and low-substituted hydroxypropyl cellulose, mix well, then add magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0063] Example 2 - Sustained Release Tablets

[0064] formula:

[0065]

[0066] Preparation Process:

[0067] Mix levocarnitine, hydroxypropyl methylcellulose, microcrystalline cellulose and calcium sulfate, add an appropriate amount of binder to make a soft material, dry at 50°C for 3 hours, and use it as part A. Mix calcium dobesilate, hydroxypropyl methylcellulose and microcrystalline cellulose, add an appropriate amount of binder to make a soft material, dry at 50°C for 2 hours, and use it as part B. Mix part A and part B, add magnesium stearate, mix well, and press into tablets.

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Abstract

The invention relates to medical preparation containing levocarnitine and dihydroxybenzenesulphonic acid salt and a preparation method of the medical preparation, and particularly relates to an orally taken solid medical preparation. The medical preparation contains the levocarnitine, the dihydroxybenzenesulphonic acid salt and pharmacologically receivable excipient, and the levocarnitine and the dihydroxybenzenesulphonic acid salt are separately granulated in a preparation process of the preparation. The invention further relates to the preparation method for the orally taken solid medical preparation and application for treating and / or preventing diseases affecting renal functions, such as primary nephritis, secondary nephritis, renal ischemia / reperfusion injury, renal insufficiency (for example, chronic renal insufficiency), nephrotic syndrome, renal failure (for example, chronic renal failure), uremia and diabetic nephropathy, and complications caused by the diseases affecting the renal functions, such as cardiovascular disease (for example, myocardial ischemia / reperfusion and chronic cardiac insufficiency) and diabetes mellitus.

Description

technical field [0001] The invention relates to a pharmaceutical preparation comprising levocarnitine and dobesilate and a preparation method thereof. In particular, the present invention relates to oral solid pharmaceutical formulations comprising levocarnitine and dobesilate. Background technique [0002] Chronic renal failure (CRF) is the late manifestation of a variety of common renal diseases in clinical practice. End-stage renal failure and its series of complications seriously threaten people's life and health. Dialysis treatment in end-stage renal failure often brings a heavy economic burden to patients. Nephrologists have been discussing how to reduce multi-system complications, better save residual renal function, reduce dialysis times, prolong dialysis intervals, and maintain a good quality of life for patients. [0003] Dobesylate is 2,5-dihydroxybenzenesulfonate with the formula (C 6 h 5 o 5 S) x M, the structural formula is as follows: [0004] [000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/205A61K31/185A61P13/12A61P13/00A61P3/10A61P9/00
Inventor 王勇王淑君陈斌关玉晶刘莹王惠姝田宁
Owner LIAONING THINKING DECKER MEDICAL TECH
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