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A sustained-release preparation of ornithine-aspartate and its preparation process

A technology of ornithine aspartate and sustained-release preparations is applied in the field of ornithine aspartate sustained-release capsule dosage forms, which can solve the problems of difficult use, high concentration, inability to achieve controlled release or sustained release, etc. , to achieve a wide range of social and economic benefits, less toxic and side effects, and long acting time.

Active Publication Date: 2016-08-17
BENGBU BBCA MEDICINE SCI DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Insufficiency of current treatment drugs: At present, the ideal drugs for the treatment of hepatic encephalopathy are still lactulose and lactitol
However, the current existing preparations cannot achieve controlled release or sustained release, and for common preparations of ornithine aspartate, such as injections, its specification is 5g: 10ml, which has a large concentration and is inconvenient to store and transport; Difficulty using it on your own
[0011] But at present there is no preparation that can well realize the controlled release of ornithine aspartate. In view of this, the present invention is proposed

Method used

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  • A sustained-release preparation of ornithine-aspartate and its preparation process
  • A sustained-release preparation of ornithine-aspartate and its preparation process
  • A sustained-release preparation of ornithine-aspartate and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] (1) Preparation of drug-containing pellet core

[0045] Ornithine Aspartate 200g

[0046] Blank ball core 316g

[0047] 6% PVP solution (solvent is 85% ethanol) 190g

[0048] Preparation Process:

[0049] Pass ornithine aspartic acid through an 80-mesh sieve, weigh the prescribed amount, pour it into the lower hopper of the granulation coating machine, set the air inlet pressure and the rotating speed of the turntable, and then pour it into blank pellet cores for granulation. Spray 6% PVP solution (solvent is 85% ethanol), dry at 40°C, granulation is completed, and 500g of material is discharged.

Embodiment 2

[0051] (1) Preparation of drug-containing pellet core

[0052] Ornithine Aspartate 200g

[0053] Blank ball core 316g

[0054] 6% PVP solution (solvent is 85% ethanol) 180g

[0055] Preparation Process:

[0056] Pass ornithine aspartic acid through an 80-mesh sieve, weigh the prescribed amount, pour it into the lower hopper of the granulation coating machine, set the air inlet pressure and the rotating speed of the turntable, and then pour it into blank pellet cores for granulation. Spray 6% PVP solution (solvent is 85% ethanol), dry at 50°C, granulation is completed, and 495g of material is discharged.

Embodiment 3

[0058] (1) Preparation of drug-containing pellet core

[0059] Ornithine Aspartate 200g

[0060] Blank ball core 316g

[0061] 6% PVP solution (solvent is 85% ethanol) 200g

[0062] Preparation Process:

[0063] Put ornithine aspartic acid through 80 mesh sieve, weigh the prescription amount, pour it into the lower hopper of the granulation coating machine, set the air inlet pressure and the rotating speed of the turntable, then pour into the blank pellet core, spray 6% PVP solution ( The solvent is 85% ethanol), granulated. Dry at 45°C, the granulation is completed, and 508g is discharged.

[0064] Sustained-release preparation formulation screening test (to determine the type and quantity of optimal sustained-release agent and plasticizer):

[0065] Prescription A:

[0066]

[0067] Preparation process: Weigh the pill core containing the prescription amount, pour it into the lower hopper of the granulation coating machine, set the air inlet pressure and the rotating...

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Abstract

The invention provides a sustained-release preparation of ornithine aspartate, which contains ornithine aspartate as the main component and an auxiliary additive, and the auxiliary additive can realize the controlled release of the active ingredient in the preparation of the invention . After the preparation is prepared into a capsule dosage form, it overcomes other preparations of ornithine-aspartate, such as injections, which have high concentration, inconvenient storage and transportation; it is difficult for patients to use themselves, and it is convenient for middle-aged and elderly patients to take. It has the advantages of fast absorption and high bioavailability. The ornithine-aspartate slow-release preparation is applicable to the elevation of blood ammonia caused by acute and chronic liver diseases (such as various types of hepatitis, liver cirrhosis, fatty liver, post-hepatitis syndrome) and the treatment of hepatic encephalopathy, such as with Potential or episodic hepatic encephalopathy occurring or secondary to impaired liver detoxification function (such as liver cirrhosis), especially suitable for the treatment of early hepatic coma or confusion state during hepatic coma.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and provides a method suitable for the prevention, treatment and protection of hepatic encephalopathy, in particular to a sustained-release capsule dosage form of ornithine aspartate. Background technique [0002] Hepatic encephalopathy (hepatic encephalopathy, HE) is a syndrome of central nervous system dysfunction caused by severe liver disease and based on metabolic disorders. . According to clinical manifestations, hepatic encephalopathy is divided into four stages. Phase 1 (prodromal phase) is characterized by mild changes and behavioral disturbances, and sometimes the symptoms are not obvious and vary and are ignored. The second stage (pre-coma) is mainly characterized by confusion, sleep disorders, and behavioral disorders. The third period is the drowsy period, and the fourth period is the coma period. The treatment orientation of the present invention is the elevation of bl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/205A61P25/00A61P1/16
Inventor 戴荣欢吴言俊陈文婕徐正秀
Owner BENGBU BBCA MEDICINE SCI DEV
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