Piribedil hydrophilic gel membrane controlled and sustained release reparation and preparation method thereof

A technology of hydrophilic gel and sustained-release preparation, applied in the field of medicine, can solve the problems of poor effect, decreased drug efficacy, poor stability, etc., and achieve the effects of improving compliance, improving drug efficacy and stable release

Inactive Publication Date: 2016-05-04
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This new type of medicine called pibildrils was developed earlier than other types of drugs that were previously available for use or had been given up due to their side effectiveness on patients who took them outdoors without being able to take it again after they are taken back into place. By controlling this slow releasing process, these dosage forms made sure there wasn't any sudden changes during treatment periods when compared to previous methods like tablets or capsules. Additionally, they improved patient acceptance and correlation between treatments overtime.

Problems solved by technology

This patented technical problem addressed by this patents relates to improving the efficacy and safety of medicines called pimobendibiols (PD), specifically those containing certain substances like piperidinium, lithium nitroprussone, etc., while also addressing their instabilities during storage over time caused by fluctuasis in platelets associated with high levels of impurities present within these materials.

Method used

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  • Piribedil hydrophilic gel membrane controlled and sustained release reparation and preparation method thereof
  • Piribedil hydrophilic gel membrane controlled and sustained release reparation and preparation method thereof
  • Piribedil hydrophilic gel membrane controlled and sustained release reparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] (1) Prescription:

[0039]

[0040]

[0041] (2) Preparation method:

[0042] (1) Micronizing the piribedil so that the particle size is 10-50 μm;

[0043] (2) each auxiliary material is crossed 80 mesh sieves, for subsequent use;

[0044] (3) Weigh the prescribed amount of piribedil, divide the filling agent into 20 equal parts, add and mix in turn, and shake at a frequency of 10 times / s for 10 minutes;

[0045] (4) Add an appropriate amount of adhesive to make a soft material, pass through a 26-mesh sieve to granulate, and dry in a 60-degree oven for 1 hour;

[0046] (5) Pass through a 26-mesh sieve for granulation, add skeleton materials and mix evenly; add an appropriate amount of lubricant, mix evenly, and compress into tablets to obtain tablet cores.

[0047] (6) Dissolve the slow-release coating material in ethanol, stir to dissolve completely, put the plain tablet in the coating pan, adjust the temperature (50-60°C) and rotation speed (5-15rpm), and inc...

Embodiment 2

[0051] (1) Prescription:

[0052]

[0053]

[0054]

[0055] (2) Preparation method:

[0056] (1) Micronizing the piribedil so that the particle size is 10-50 μm;

[0057] (2) each auxiliary material is crossed 80 mesh sieves, for subsequent use;

[0058] (3) Weigh the prescribed amount of piribedil, divide the filling agent into 20 equal parts, add and mix in turn, and shake at a frequency of 10 times / s for 10 minutes;

[0059] (4) Add an appropriate amount of adhesive to make a soft material, pass through a 26-mesh sieve to granulate, and dry in a 60-degree oven for 1 hour;

[0060] (5) Pass through a 26-mesh sieve for granulation, add skeleton materials and mix evenly; add an appropriate amount of lubricant, mix evenly, and compress into tablets to obtain tablet cores.

[0061] (6) Dissolve the slow-release coating material in ethanol, stir to dissolve completely, put the plain tablet in the coating pan, adjust the temperature (50-60°C) and rotation speed (5-15rpm...

Embodiment 3

[0066] (1) Prescription:

[0067]

[0068]

[0069] (2) Preparation method:

[0070] (1) Micronizing the piribedil so that the particle size is 10-50 μm;

[0071] (2) each auxiliary material is crossed 80 mesh sieves, for subsequent use;

[0072] (3) Weigh the prescribed amount of piribedil, divide the filling agent into 20 equal parts, add and mix in turn, and shake at a frequency of 10 times / s for 10 minutes;

[0073] (4) Add an appropriate amount of adhesive to make a soft material, pass through a 26-mesh sieve to granulate, and dry in a 60-degree oven for 1 hour;

[0074] (5) Pass through a 26-mesh sieve for granulation, add skeleton materials and mix evenly; add an appropriate amount of lubricant, mix evenly, and compress into tablets to obtain tablet cores.

[0075] (6) Dissolve the slow-release coating material in ethanol, stir to dissolve completely, put the plain tablet in the coating pan, adjust the temperature (50-60°C) and rotation speed (5-15rpm), and inc...

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Abstract

The invention provides a piribedil hydrophilic gel membrane controlled and sustained release preparation and a preparation method thereof. The piribedil sustained release tablet comprises a hydrophilic gel framework material, a filling agent, a lubricating agent, an adhesive and a sustained release coating material. The piribedil hydrophilic gel membrane controlled and sustained sustained release preparation is prepared through the following steps that 1, main drug piribedil is micronized; 2, the micronized main drug piribedil and the filling agent are evenly mixed, a proper amount of the adhesive is added, and pelletizing, drying and grain finishing are carried out; 3, the dry particles in the step 2 and the hydrophilic gel framework material are evenly mixed, then the lubricating agent is added, and even mixing and tabletting are carried out; 4, tablet cores in the step 3 are placed in a coating pan, the sustained release coating material is subjected to coating, and the hydrophilic gel membrane controlled and sustained sustained release tablet is obtained. The hydrophilic gel framework material and the sustained release coating material are adopted in the piribedil sustained release tablet, release of piribedil is delayed, release of the drug is more stable, and the drug effect is improved. The compliance of a patient is improved, and meanwhile good in vitro-in vivo correlation is achieved.

Description

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Claims

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Application Information

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Owner KANGYA OF NINGXIA PHARMA
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