Piribedil sustained-release tablet and preparation method thereof

A technology of piribedil and sustained-release tablets, which is applied in the field of medicine, can solve problems such as poor effect, poor stability, and decreased drug efficacy, and achieve the effects of avoiding motor complications, improving stability, and improving compliance

Active Publication Date: 2013-04-03
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the existing piribedil administration effects are not good, and the stability is poor, and there are shortcomings such as that the curative effect of the drug decreases due to the fluctuation of the plasma drug concentration.

Method used

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  • Piribedil sustained-release tablet and preparation method thereof
  • Piribedil sustained-release tablet and preparation method thereof
  • Piribedil sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0019] Meanwhile, in a typical embodiment of the present invention, the preparation method of the above-mentioned piribedil sustained-release tablets includes the following preparation steps in order: (1) mixing the piribedil, framework material and filler after crushing uniform; (2) adding binder to make soft material, granulating, and drying; (3) adding lubricant to the dried granules, mixing, and tableting to obtain the piribedil sustained-release tablet. The method is simple and easy to implement, and the prepared piribedil sustained-release tablet has good dissolution rate and stability.

[0020] The specific implementation of each step in the preparation method of the above-mentioned piribedil sustained-release tablet will be given below.

[0021] Preferably, in the preparation method of the above-mentioned piribedil sustained-release tablets, the preparation step (1) further includes: pulverizing each raw material, passing through a 60-80 mesh sieve, and setting aside; ...

Embodiment 1

[0025] Raw materials and equipment:

[0026]

[0027] Preparation Process:

[0028] (1) pass the raw and auxiliary materials through an 80-mesh sieve, and set aside;

[0029] (2) Weigh the piribedil of the prescribed amount, the skeleton material, and the filler and divide them into 20 equal parts respectively, add and mix them successively, and vibrate for 10 minutes at a frequency of 10 times / s;

[0030] (3) Add an appropriate amount of binder to make a soft material, pass through a 26-mesh sieve to granulate, and dry in a 60-degree oven for 1 hour;

[0031] (4) Pass through a 26-mesh sieve for granulation, add an appropriate amount of lubricant, mix evenly, compress into tablets, and check. The dissolution data are shown in Table 1.

[0032] The release test results of the piribedil sustained-release tablets prepared in Table 1 Example 1

[0033] Labeled cumulative release %

Embodiment 2

[0035] Raw materials and ratio:

[0036]

[0037] Preparation Process:

[0038] (1) pass the raw and auxiliary materials through a 60-mesh sieve, and set aside;

[0039] (2) Weighing the piribedil of the prescribed amount, the skeleton material, and the filler are divided into 10 equal parts respectively, added and mixed successively, and shaken for 30 minutes at a frequency of 20 times / s;

[0040] (3) Add an appropriate amount of binder to make a soft material, pass through a 25-mesh sieve to granulate, and dry in an oven at 50 degrees for 1 hour;

[0041] (4) Pass through a 25-mesh sieve for granulation, add an appropriate amount of lubricant, mix evenly, compress into tablets, and check. The dissolution data are shown in Table 2.

[0042] The dissolution test result of the piribedil sustained-release tablet prepared by the embodiment 2 of table 2

[0043] Labeled cumulative release %

[0044] 2#

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PUM

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Abstract

The invention provides a piribedil sustained-release tablet and a preparation method thereof. The piribedil sustained-release tablet comprises the following raw material components in percent by weight: 10-80% of piribedil, 1-70% of framework material, 10-80% of filler, 0.1-5% of lubricating agent and an appropriate amount of adhesive. The piribedil sustained-release tablet provided by the invention has the advantages that releasing rate of piribedil is increased, drug stability is improved, the defects that a drug therapeutic effect is reduced owning to fluctuation of plasma drug concentration is overcome, stable plasma drug concentration is maintained for a long time, motion complication caused by a dopamine receptor stimulated by fluctuation of drug concentration is avoided, the requirement of a continuous activated dopamine receptor is met, compliance of a patient is improved and a clinical effect of the piribedil sustained-release tablet is guaranteed.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a piribedil sustained-release tablet and a preparation method thereof. Background technique [0002] Pirabedil is a central dopamine receptor agonist that acts on postsynaptic D2 and D3 receptors. Increase the excitability of dopamine receptors, thereby increasing the binding level of receptors and dopamine, and restore the balance between acetylcholine and dopamine systems to play an effective role. [0003] Motor dysfunction in Parkinson's disease arises from loss of dopaminergic neurons in the substantia nigra. Although there is no cure so far, levodopa, as the precursor of dopamine, can improve clinical symptoms and is still the most widely used drug for the treatment of Parkinson's disease. However, the fluctuation of plasma drug concentration affects the clinical application of such drugs, and the long-term use of levodopa often leads to the decline of curative effect, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/506A61K47/38A61K47/36A61K47/32A61P25/16
Inventor 杨亚军何仲贵马建国
Owner KANGYA OF NINGXIA PHARMA
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