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Compound diclofenac sodium slow-release preparation and preparation method thereof

A technology of diclofenac sodium and sustained-release preparations, applied in anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc., can solve problems such as adverse reactions, gastrointestinal bleeding, and increased bleeding risk of gastrointestinal ulcers

Inactive Publication Date: 2012-07-04
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although diclofenac sodium is an NSAIDs drug with high clinical safety, it still has gastrointestinal adverse reactions, such as epigastric discomfort, nausea, vomiting, etc., and gastrointestinal bleeding may occur in severe cases
Long-term use of diclofenac sodium may even increase the risk of gastrointestinal ulcer bleeding

Method used

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  • Compound diclofenac sodium slow-release preparation and preparation method thereof
  • Compound diclofenac sodium slow-release preparation and preparation method thereof
  • Compound diclofenac sodium slow-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] a. Weigh the following components:

[0039] Diclofenac sodium 28.5g, omeprazole 7.6g, mannitol 8.0g, talcum powder 8.0g, polyvinylpyrrolidone K30 1.5g, sodium dihydrogen phosphate 1.2g, lactose 10.4g, hydroxypropyl methylcellulose 5.0g, 25g of microcrystalline cellulose, 2.4g of casing material, and 2.4g of insulating material. The casing material is a mixture of acrylic resin No. II and diethyl phthalate in a ratio of 100:4 by weight. The insulating material is hydroxypropyl methylcellulose.

[0040] b. The polyvinylpyrrolidone K30 described in step a is prepared into an aqueous solution with a mass ratio concentration of 10% for subsequent use;

[0041] c. Mix diclofenac sodium with lactose, hydroxypropyl methylcellulose, and microcrystalline cellulose evenly, add 1 / 2 amount of polyvinylpyrrolidone K30 aqueous solution prepared in step b, make it into pellets, and dry them for backup use;

[0042] d. Omeprazole is mixed with mannitol, talcum powder, and sodium dih...

Embodiment 2

[0048] a. Weigh the following components:

[0049] Diclofenac sodium 28.5g, omeprazole 7.6g, mannitol 6.0g, talc 8.0g, polyvinylpyrrolidone K302g, sodium dihydrogen phosphate 1.2g, starch 12g, hydroxypropyl methylcellulose 12g, microcrystalline cellulose 19.1g, casing material 1.8g, insulation material 1.8g. The enteric coating material is a mixture of acrylic resin No. II and diethyl phthalate in a proportion of 100:8 by weight. The insulating material is hydroxypropyl methylcellulose.

[0050] B, the polyvinylpyrrolidone K30 described in a step operation is mixed with the aqueous solution that mass ratio concentration is 10% for subsequent use;

[0051] C, mix diclofenac sodium with starch, hydroxypropyl methylcellulose, microcrystalline cellulose, add the polyvinylpyrrolidone K30 aqueous solution of 1 / 2 amount prepared by b step operation, make it into granules, after drying for subsequent use ;

[0052] D, omeprazole is mixed with mannitol, talcum powder, sodium dihydr...

Embodiment 3

[0058] a. Weigh the following components:

[0059] Diclofenac sodium 35g, omeprazole sodium salt 4.2g, mannitol 7g, talc 8.0g, polyvinylpyrrolidone K302g, sodium bicarbonate 1.2g, pre-interleaved starch 10g, magnesium stearate 2g, sodium carboxymethyl starch 12. Microcrystalline cellulose 15g, casing material 1.8g, isolation material 1.8g. The enteric coating material is a mixture of acrylic resin No. II, diethyl phthalate and polysorbate in a ratio of 100:8:2 by weight. The insulating material is hydroxypropyl methylcellulose.

[0060] B, the polyvinylpyrrolidone K30 described in a step operation is mixed with the aqueous solution that mass ratio concentration is 10% for subsequent use;

[0061] c, mix diclofenac sodium with pre-interleaved starch methyl starch sodium, microcrystalline cellulose, add the polyvinylpyrrolidone K30 aqueous solution of 1 / 2 amount prepared by step b, make it into granules, add hard Magnesium fatty acid for use;

[0062] D, omeprazole sodium sa...

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Abstract

The invention discloses a compound diclofenac sodium slow-release preparation and a preparation method of the compound diclofenac sodium slow-release preparation. The compound preparation consists of the following ingredients in percentage by mass: 20 to 30 percent of diclofenac sodium, 4 to 8 percent of omeprazole or sodium salt of the omeprazole and the balance of auxiliary materials allowed on the pharmacy. The preparation method of the compound preparation comprises the steps that: the diclofenac sodium and the omeprazole are respectively prepared into enteric granules or pellets, the prepared omeprazole enteric granules or pellets are mixed with the diclofenac sodium enteric granules or pellets, and the tabletting or the capsule filling is carried out. In compound diclofenac sodium enteric slow-release tablets or enteric slow-release capsules prepared by the preparation method, the medicine release of the main omeprazole medicine is carried out at the normal release speed, but the diclofenac sodium is slowly released from the preparation. Therefore, the omeprazole or the sodium salt of the omeprazole is firstly released for realizing the effect of protecting the gastrointestinal mucosa, the diclofenac sodium is prevented from irritating the gastrointestinal mucosa of a patient in the medicine release process, and the gastrointestinal tract adverse reaction occurrence rate of the diclofenac sodium is reduced.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a compound diclofenac sodium sustained-release preparation and a preparation method thereof. Background technique [0002] Diclofenac sodium is a third-generation nonsteroidal anti-inflammatory drug (Nonsteroidal Anti-inflammatory Drugs, NSAIDs), its analgesic effect is 2 to 2.5 times that of indomethacin, 26 to 50 times that of aspirin. It is clinically used to treat inflammation caused by rheumatism, rheumatoid arthritis, frozen shoulder, trauma and surgery. Although diclofenac sodium belongs to NSAIDs with high clinical safety, it still has gastrointestinal adverse reactions, such as epigastric discomfort, nausea, vomiting, etc., and gastrointestinal bleeding may occur in severe cases. Long-term use of diclofenac sodium can even increase the risk of gastrointestinal ulcer bleeding. Contents of the invention [0003] The object of the present ...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K31/196A61K9/24A61K9/52A61P29/00A61P1/00
Inventor 张纲孔德宪姜海刘军锋
Owner SHINEWAY PHARMA GRP LTD
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