Ketoprofen sustained-release pellet and preparation method thereof

A technology of slow-release pellets and ketoprofen, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve batch-to-batch differences, inter-granular differences cannot be taken in multiple doses, Slow-release pellets have low efficiency and shorten the process time, etc., to achieve the effect of smooth appearance, small difference between particles, and reduced static electricity

Active Publication Date: 2016-10-19
浙江四维医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The invention describes a ketoprofen sustained-release pellet and its preparation method, which reduces the risk of batch-to-batch differences, intergranular differences and inability to take multiple doses of ketoprofen sustained-release tablets due to the small number of units, and solves the problem of sustained-release ketoprofen. The problem of low efficiency, poor repeatability, and difficult control of the release pellets in the coating process also improves the efficiency of drug application, and the commonly used equipment centrifugal granulation coating machine can complete the drug application efficiently And coating process, and the process is stable, good repeatability, good content uniformity, prepared ketoprofen sustained-release pellets with uniform release, solved the disadvantages of similar products that are difficult to reproduce with ordinary equipment, and greatly shortened the process time. suitable for mass production

Method used

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  • Ketoprofen sustained-release pellet and preparation method thereof
  • Ketoprofen sustained-release pellet and preparation method thereof
  • Ketoprofen sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) Preparation of the drug layer for the first time: Take by weighing the prescription amount Eudragit NE30D and purified water according to Example 1, stir for 45 minutes to prepare the suspension as an adhesive for subsequent use, take by weighing the prescription amount of medicinal pellet core (sucrose type ,0.35-0.55mm) placed in a centrifugal granulation coating machine, weighed the prescription amount of ketoprofen raw material, raw material particle size D90<20μm, turned on the machine, adjusted various parameters, the adhesive was sprayed in by spraying, and at the same time Control various parameters according to the actual situation, and control the dosing speed at 100-150g / min. After dosing, dry until the moisture content is ≤3.0%, and collect the required mesh pellets for the next step. (2) Coating preparation for the first time: according to the ratio and prescription of Example 1, take each coating liquid component and stir for 30 minutes first, then shea...

Embodiment 2

[0032] (1) Preparation of the drug layer for the first time: take Eudragit NE30D and purified water according to the prescription amount in Example 2, stir for 45 minutes to prepare a suspension as an adhesive for subsequent use, and take the prescription amount of medicinal pellet core (microcrystalline Cellulose pellets, 0.35-0.55mm) are placed in a centrifugal granulation coating machine, weigh the prescribed amount of ketoprofen raw material, the particle size of the raw material is D90<20μm, turn on the machine, adjust various parameters, and add the adhesive by spraying , while controlling various parameters according to the actual situation, the dosing speed is controlled at 100-150g / min, after the dosing is completed, dry until the moisture content is ≤3.0%, and collect the required mesh pellets for the next step. (2) Coating preparation for the first time: according to Example 1, each coating liquid composition was weighed and stirred for 30 minutes and then sheared fo...

Embodiment 3

[0035] (1) Preparation of the first drug layer: take hypromellose (5cp) and purified water according to the prescription amount in Example 3, stir for 45 minutes to prepare the solution as an adhesive for later use, and weigh the prescription amount of medicinal blank pills The core (starch type, particle size: 0.5-0.6mm) is placed in a centrifugal granulation coating machine, weigh the prescribed amount of ketoprofen raw material, the raw material particle size D90<20μm, turn on the machine, adjust various parameters to bond The agent is added by spraying, and various parameters are controlled according to the actual situation at the same time. The dosing speed is controlled at 100-150g / min. After the dosing is completed, it is dried until the moisture content is ≤3.0%, and the required mesh pellets are collected for the next step. (2) Coating preparation for the first time: according to Example 1, each coating liquid composition was weighed and stirred for 30 minutes and then...

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Abstract

The invention relates to a ketoprofen sustained-release pellet and a preparation method thereof. The pellet comprises a blank pill core, a sustained-release layer and a medicine-feeding layer. The invention adopts a process including twice medicine feeding and twice coating of sustained-release coating. The process not only controls the content proportion and speed of the medicine feeding, but also uses the combination of skeleton and membrane controlled-release; while oil is added in the sustained-release coating, so that the medicine feeding efficiency and coating efficiency are increased, and the content uniformity and reproducibility of process are better, and easy to control; the release is uniform and the release energy curve is basically the same as the preparation on the market. The coating layer has better stability, and reaches in vitro release effect similar to that of the brand-name drug. The invention improves production efficiency and is applicable to large-scale production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing ketoprofen and a preparation method thereof, more specifically to a sustained-release pellet containing ketoprofen and a preparation method thereof. Background technique [0002] Ketoprofen, English name: ketoprofen, chemical name: α-methyl-3-benzoyl-phenylacetic acid, structural formula as follows: [0003] [0004] Molecular formula: C 16 h 14 o 3 , molecular weight: 254.29. [0005] In daily life, pain is one of the most common reasons for patients to seek medical treatment, and rheumatism and arthritis are also common diseases in the existing living environment. And the number of rheumatoid patients exceeds 10 million. [0006] Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID), also known as ketoprofen, which has analgesic and antipyretic properties. Predominant, it is generally believed that NSAIDs play a role by inhibiting cyclooxygenase (cyclooxygenase, COX). St...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/192A61P29/00A61K47/26A61K47/38
Inventor 阮建山丁仲杰韩松陈祥伟张燕
Owner 浙江四维医药科技有限公司
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