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Slow-release preparation of ornithine aspartate and preparation process thereof

A technology of ornithine aspartate and sustained-release preparations is applied in the field of ornithine-aspartate sustained-release capsule formulations, which can solve the problem that the controlled-release preparations of ornithine aspartate cannot be well realized, etc. problems, to achieve a wide range of social and economic benefits, easy to use, less toxic and side effects

Active Publication Date: 2014-04-09
BENGBU BBCA MEDICINE SCI DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The deficiency of current treatment drugs: the ideal drugs for the treatment of hepatic encephalopathy are still lactulose and lactitol
[0011] But

Method used

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  • Slow-release preparation of ornithine aspartate and preparation process thereof
  • Slow-release preparation of ornithine aspartate and preparation process thereof
  • Slow-release preparation of ornithine aspartate and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] (1) Preparation of drug-containing pellet core

[0047] Ornithine Aspartate 200g

[0048] Blank ball core 316g

[0049] 6% PVP solution (solvent is 85% ethanol) 190g

[0050] Preparation Process:

[0051] 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

[0053] (1) Preparation of drug-containing pellet core

[0054] Ornithine Aspartate 200g

[0055] Blank ball core 316g

[0056] 6% PVP solution (solvent is 85% ethanol) 180g

[0057] Preparation Process:

[0058] 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

[0060] (1) Preparation of drug-containing pellet core

[0061] Ornithine Aspartate 200g

[0062] Blank ball core 316g

[0063] 6% PVP solution (solvent is 85% ethanol) 200g

[0064] Preparation Process:

[0065] 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.

[0066] Sustained-release preparation formulation screening test (to determine the type and quantity of optimal sustained-release agent and plasticizer):

[0067] Prescription A:

[0068]

[0069] 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 rotatin...

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PUM

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Abstract

The invention provides a slow-release preparation of ornithine aspartate, the slow-release preparation comprises major components of the ornithine aspartate and an auxiliary additive, and controlled release of active ingredients in the preparation can be realized by the auxiliary additive. The preparation prepared into a capsule preparation formulation overcomes the defects that other ornithine aspartate preparations such as an injection are high in concentration, inconvenient to store and transport, and difficult to use for a patient by oneself, and the preparation has the advantages of convenience for middle and old age patients to take, quick absorption, high biological utilization rate and the like. The slow-release preparation of the ornithine aspartate is suitable for blood ammonia rising caused by acute and chronic liver diseases (such as various types of hepatitis, liver cirrhosis, fatty liver and post-hepatitis syndrome) and treatment of hepatic encephalopathy such as potential or attack-stage hepatic encephalopathy accompanying with or secondary with liver detoxification function damage (such as liver cirrhosis), and is especially suitable for the treatment of consciousness clouding state and other diseases in an early hepatic coma period and a hepatic coma period.

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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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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