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Piribedil, levodopa and benserazide compound sustained-release three-layer tablet and preparation method thereof

A technology for piribedil and sustained-release tablets, which is applied in coatings, pill delivery, and pharmaceutical formulations. It can solve the problems of mutual influence between active ingredients, difficult long-term release of active ingredients, and increased impurity content, and achieve guaranteed Long-term release, guaranteed stability, good stability effect

Pending Publication Date: 2020-05-01
山西卫生健康职业学院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The applicant's previous research found that there is a phenomenon of mutual influence between active ingredients when piribedil, levodopa and benserazide are mixed and stored. It is difficult to release the ingredients for a long time, so it is urgent to invent a compound preparation of piribedil, levodopa and benserazide that can ensure long-term drug release and stable properties

Method used

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  • Piribedil, levodopa and benserazide compound sustained-release three-layer tablet and preparation method thereof
  • Piribedil, levodopa and benserazide compound sustained-release three-layer tablet and preparation method thereof
  • Piribedil, levodopa and benserazide compound sustained-release three-layer tablet and preparation method thereof

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Embodiment 1

[0054]

[0055]

[0056] Its preparation method is:

[0057] (1) Mix the piribedil crude drug of the formula amount with the first layer of croscarmellose sodium, sucrose and calcium carbonate in a mixer, add the prepared adhesive containing polysorbate 80 After the wet granules are dried and granulated, colloidal silicon dioxide and magnesium stearate are added and mixed uniformly to obtain the first layer of granules after mixing;

[0058] (2) after mixing the second sheet of polyoxyethylene, sodium chloride, red iron oxide, and hypromellose in a mixer, dry granulation, adding magnesium stearate and mixing uniformly to obtain a second lamellar particles;

[0059] (3) The levodopa bulk drug, benserazide hydrochloride bulk drug and the third lamella lactose, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, hypromellose, and colloidal silicon dioxide in the formula amount are mixed in Mix evenly in a mixer, dry granulate, add colloidal silicon dioxide and ...

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Abstract

The present invention discloses a piribedil, levodopa and benserazide compound sustained-release three-layer tablet and a preparation method thereof. The piribedil, levodopa and benserazide compound sustained-release three-layer tablet is characterized in that the tablet is a three-layered sustained-release tablet, an active ingredient of a first layer is piribedil, a second layer is an isolationlayer, and active ingredients of a third layer are levodopa and benserazide. The preparation process is as follows: wet granulation of the first layer, dry granulation of the second layer and the third layer, tableting by a three-layer tableting machine, sustained-release semi-permeable membrane covering, perforating, and then quick-release coating film wrapping. The piribedil, levodopa and benserazide compound sustained-release three-layer tablet can be prepared, feasibility of simultaneous administration is realized, stability of each active ingredient can be guaranteed and at the same timestable release of the effective ingredients is ensured.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a compound sustained-release three-layer tablet of piribedil, levodopa and benserazide and a preparation method thereof. Background technique [0002] Pirbedil is a dopaminergic agonist, which can stimulate the post-synaptic D2 receptors in the nigrostriatal and midbrain cortex, and D2 and D3 receptors in the mesolimbic pathway, providing potent dopaminergic effects. Clinical pharmacology studies have clarified its mechanism of action: 1. Stimulate dopaminergic cortical electrogenesis in waking and sleeping states. 2. Different clinical functions under the control of dopamine, as demonstrated by testing on behavioral or psychometric scales. In addition, piribedil increased femoral arterial blood flow (the presence of dopaminergic receptors in the femoral vascular bed explains the effect of piribedil on the peripheral circulation). For the treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K9/36A61K9/24A61P25/16A61P25/00A61P9/10A61K31/198A61K31/165
CPCA61K31/506A61K31/198A61K31/165A61K9/209A61P25/16A61P25/00A61P9/10A61K9/2081A61K9/2866A61K2300/00
Inventor 李彩艳
Owner 山西卫生健康职业学院
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