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Enteric-coated preparation containing mycophenolic acid and salts thereof, and preparing method thereof

A technology of mycophenolate mofetil and enteric-coated preparations, which is applied in anti-inflammatory agents, antiviral agents, and pharmaceutical formulations, and can solve problems such as complex processes and inconvenience for patients to take, and achieve simple processes, stable drug effects, and simplified processes The effect of the process

Inactive Publication Date: 2014-06-11
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The purpose of the present invention is to provide a new preparation method of mycophenolic acid or its salt enteric-coated granules, so as to overcome the shortcomings of the enteric-coated preparations prepared by the prior art methods such as inconvenient taking for patients and complicated process.

Method used

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  • Enteric-coated preparation containing mycophenolic acid and salts thereof, and preparing method thereof
  • Enteric-coated preparation containing mycophenolic acid and salts thereof, and preparing method thereof
  • Enteric-coated preparation containing mycophenolic acid and salts thereof, and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 prepares mycolate sodium enteric-coated granules

[0043] (1) Prescription:

[0044]

[0045] A total of 1000 bags were made

[0046] (2) Preparation method:

[0047] 1) Mix sodium mycophenolate mofetil (calculated as mycophenolic acid as 650g), 690g acrylic resin No. Ⅱ, and 460g acrylic resin No. Ⅲ, pulverize with a pulverizer to obtain fine powder, and set aside;

[0048] 2) Put the micropowder in a high-efficiency wet granulator, add 6.5g triacetin, then add an appropriate amount of 95% ethanol, shear and stir, and mix well;

[0049] 3) Add 4225g of microcrystalline cellulose and 325g of croscarmellose sodium to the above-mentioned homogeneously mixed material, after stirring, add 189g of povidone K30 and appropriate amount of water, and continue stirring to make a soft material.

[0050] 4) Put the soft material into the single-screw extruder, extrude it into strips, and then transfer it to the spheronizer for spheronization to obtain wet granules...

Embodiment 2～6

[0052] Examples 2-6: The prescription is shown in Table 1, and the preparation method is the same as that of Example 1, but the raw materials and adjuvants added are shown in the following table.

[0053] Prescription used to prepare enteric-coated granules in table 1 embodiment 1~6

[0054]

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PUM

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Abstract

A preparing method of an enteric-coated preparation containing mycophenolic acid and salts thereof is disclosed. The method is characterized in that: the method includes directly mixing an enteric coating material and active components, adding a wetting agent suitable for medicinal preparations, uniformly mixing and granulating; and the enteric coating material is acrylic resin II and / or acrylic resin III. The method simplifies processes for preparing the enteric-coated preparation, and an independent coating process is not needed. Experiments show that: the preparation has better enteric properties than enteric-coated preparations in the prior art, release of the active components is not influenced by gastric emptying and foods, and the preparation provided by the invention has faster releasing speed. The preparation is stable in medicine effect, is in a form of granules and is convenient to take.

Description

Technical field: [0001] The invention relates to a preparation method of an enteric-coated preparation containing mycophenolic acid or mycophenolic acid salt and the enteric-coated preparation prepared according to the method. Background technique: [0002] Mycophenolic acid (MPA) or its salt is a drug with various activities such as antitumor, antiviral, immunosuppressive, and anti-inflammatory. In order to exert its medicinal effect and improve bioavailability, most of its preparations are enteric-coated preparations. Enteric-coated preparation is a preparation with enteric properties, that is, the active ingredient in the preparation is not released in the stomach, but is released in the intestinal tract. [0003] For example, in CN97193760.5, Novatis Company prepared mycophenolate mofetil into granules, pellets, tablets, etc., and then used acetic acid phthalic acid, cellulose trimellitate or methacrylic acid as coating materials. , coated with an enteric coating, and ...

Claims

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Application Information

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IPC IPC(8): A61K31/365A61K9/16A61K47/32A61K47/38A61P35/00A61P31/12A61P37/06A61P29/00
Inventor 徐飞虞忠杨春维
Owner CHONGQING HUAPONT PHARMA
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