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Ibuprofen granules and preparation method thereof

A technology of granules and disintegrants, applied in the field of ibuprofen granules and its preparation, to achieve a simple and reliable preparation process

Pending Publication Date: 2021-08-31
哈尔滨华瑞生化药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the technical problems that the ibuprofen pharmaceutical ingredients prepared by the method provided by the related technology are prone to segregation and poor solubility due to the difference in particle density, the invention provides an ibuprofen granule and a preparation method thereof

Method used

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  • Ibuprofen granules and preparation method thereof
  • Ibuprofen granules and preparation method thereof
  • Ibuprofen granules and preparation method thereof

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preparation example Construction

[0038] On the other hand, the embodiment of the present application also provides a method for preparing ibuprofen granules, the method for preparing ibuprofen granules comprises:

[0039] S101. Crushing step of the crude drug: pulverize the ibuprofen crude drug to a preset fineness to obtain the first crude drug.

[0040] S102. The step of sieving raw and auxiliary materials: sieving the binder, the first bulk drug and the filler to obtain raw and auxiliary materials with a predetermined mesh number.

[0041] S103. Mixing step: adding the first bulk drug, binders of preset meshes, fillers and disintegrants into the mixer for dry powder mixing, and adding the mixed liquid for wet mixing to obtain a soft material.

[0042] S104. Granulating step: extruding the soft material through a granulator to obtain wet granules.

[0043] S105. Drying step: drying the wet granules to obtain dry granules.

[0044] S106. Grain sizing step: removing large particles and fine powder in the dr...

Embodiment

[0074] (1) Crushing of raw materials: set the current of the classifying motor of the airflow pulverizer to 2A, the frequency of the classifying wheel to 80 Hz, and the frequency of feeding to 20 Hz. The raw material should reach the preset fineness (the particle size test report of the ibuprofen raw material: the fineness is 2μm≤D50≤18μm, 4μm≤D90≤56μm).

[0075] (2) Screening of raw and auxiliary materials: hydroxypropyl cellulose and pulverized ibuprofen raw materials are sieved by hand with a mesh number of 20; 20 mesh.

[0076] (3) Ingredients: Check the names, serial numbers and weights of raw and auxiliary materials before ingredients, and put them in double-layer low-density polyethylene bags according to the batch amount.

[0077] (4) Preparation of fumaric acid and sodium saccharin mixed solution: Fumaric acid, sodium saccharin, and purified water are prepared in a ratio of 1:1:1200 to make a solution for later use (dissolve fumaric acid and sodium saccharin with a s...

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Abstract

The invention provides ibuprofen granules and a preparation method thereof. The method comprises the following steps of: a step of crushing raw material medicines: crushing ibuprofen raw material medicines to specified fineness to obtain a first raw material medicine; a step of sieving raw and auxiliary materials: sieving an adhesive, the first raw material medicine and a filling agent to obtain the raw and auxiliary materials with a preset mesh number; a step of preparing a mixed solution: dissolving a flavoring agent and a flavoring agent in purified water according to a prescription; a step of mixing: adding the raw and auxiliary materials with the preset mesh number and a disintegrating agent into a mixer, mixing dry powder, adding the mixed solution, and performing wet mixing to obtain a soft material; a step of granulating: extruding the soft material through a granulator to obtain wet granules; a step of drying: drying the wet granules to obtain dry granules; and a step of straightening the granules: removing large granules and fine powder in the dry granules to obtain the target ibuprofen granules. The method provided by the invention improves the combination degree between the raw material medicines and the raw and auxiliary materials as well as the adhesive, thereby improving the uniformity and dissolution performance of the medicines.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to ibuprofen granules and a preparation method thereof. Background technique [0002] Ibuprofen is a non-steroidal anti-inflammatory drug, which mainly inhibits the synthesis of cyclooxygenase and prostaglandins to achieve anti-inflammatory and analgesic effects, and plays an antipyretic effect through the hypothalamic thermoregulation center, which has a greater promotional effect. It has a greater role in popularization and application. Clinically, it is generally applicable to relieve rheumatoid arthritis, osteoarthritis, spondyloarthropathy, gouty arthritis, rheumatoid arthritis and other diseases. [0003] The preparation method of ibuprofen commonly used at present comprises preparation quick-release part, is about to mix ibuprofen, disintegrant, binding agent, wet granulation and drying to obtain quick-release granule; Prepare slow-release part, ibuprofen, slow-release Erosion agen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/192A61K47/38A61K47/12A61K47/26A61P29/00
CPCA61K31/192A61K9/1652A61K9/1623A61K9/1617A61P29/00A61K9/1682
Inventor 孟祥奎宋洋邹继文景凤云张琳潘雪丹张家蕾高闯
Owner 哈尔滨华瑞生化药业有限责任公司
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