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Low-dose non-steroidal anti-inflammatory drug composition and preparation process thereof

A non-steroidal anti-inflammatory, low-dose technology, used in drug combinations, anti-inflammatory agents, antipyretics, etc., can solve problems such as unsafe and unfavorable

Inactive Publication Date: 2017-01-04
苏州朗易生物医药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, poorly soluble active substances are often unfavorable or even unsafe for intravenous administration due to the risk of drug particles blocking blood flow through capillaries

Method used

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  • Low-dose non-steroidal anti-inflammatory drug composition and preparation process thereof
  • Low-dose non-steroidal anti-inflammatory drug composition and preparation process thereof
  • Low-dose non-steroidal anti-inflammatory drug composition and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Suspension Prescription:

[0039]

[0040] Suspension Prescription:

[0041]

[0042] The preparation technology of low-dose diclofenac pharmaceutical composition comprises the following steps:

[0043] a) Weigh 10g of povidone k90, add 1000ml of purified water to prepare a 1% povidone k90 aqueous solution; weigh 40g of diclofenac, add it to a 1% povidone k90 aqueous solution, stir at 4000rpm for 30min, and prepare a uniformly dispersed Suspension: The suspension is homogenized using a D-6L high-pressure homogenizer, pretreated once under a pressure of 15000 psi; homogenized twice under a pressure of 23000 psi to obtain an emulsion;

[0044] b) The emulsion is spray-dried with a 6000Y spray dryer, the air inlet temperature is 55-60°C, the outlet air temperature is 50-55°C, the feed rate is 1000ml / h, the nozzle diameter is 0.7mm, and the pressure is 0.2Mpa to obtain dry powder;

[0045]c) Weigh 43.8g of dry powder, 8g of sodium carboxymethylcellulose, 4g of polox...

Embodiment 2

[0048] Suspension Prescription:

[0049]

[0050]

[0051] Prescription for granules:

[0052]

[0053] The preparation technology of low-dose diclofenac pharmaceutical composition comprises the following steps:

[0054] a) Weigh 10g of povidone k90, add 1000ml of purified water to prepare a 1% povidone k90 aqueous solution; weigh 40g of diclofenac, add it to a 1% povidone k90 aqueous solution, stir at 4000rpm for 30min, and prepare a uniformly dispersed Suspension: The suspension is homogenized using a D-6L high-pressure homogenizer, pretreated once under a pressure of 15000 psi; homogenized twice under a pressure of 23000 psi to obtain an emulsion;

[0055] b) The emulsion is spray-dried with a 6000Y spray dryer, the air inlet temperature is 55-60°C, the outlet air temperature is 50-55°C, the feed rate is 1000ml / h, the nozzle diameter is 0.7mm, and the pressure is 0.2Mpa to obtain dry powder;

[0056] c) Weigh 43.8g of dry powder, 354.1g of mannitol, 0.12g of sodi...

Embodiment 3

[0059] Suspension Prescription:

[0060]

[0061] Tablet prescription:

[0062]

[0063]

[0064] The preparation technology of low-dose diclofenac pharmaceutical composition comprises the following steps:

[0065] a) Weigh 10g of povidone k90, add 1000ml of purified water to prepare a 1% povidone k90 aqueous solution; weigh 40g of diclofenac, add it to a 1% povidone k90 aqueous solution, stir at 4000rpm for 30min, and prepare a uniformly dispersed Suspension: The suspension is homogenized using a D-6L high-pressure homogenizer, pretreated once under a pressure of 15000 psi; homogenized twice under a pressure of 23000 psi to obtain an emulsion;

[0066] b) The emulsion is spray-dried with a 6000Y spray dryer, the air inlet temperature is 55-60°C, the outlet air temperature is 50-55°C, the feed rate is 1000ml / h, the nozzle diameter is 0.7mm, and the pressure is 0.2Mpa to obtain dry powder;

[0067] c) Weigh 12g of sodium carboxymethylcellulose, add it to 100ml of pur...

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Abstract

The invention discloses a low-dose non-steroidal anti-inflammatory drug composition and a preparation process thereof, belonging to the technical field of drugs. The drug composition contains low-dose non-steroidal anti-inflammatory drugs and other auxiliary materials which are suitable for the drug composition and include oral suspensions, granules, tablets and capsules. Submicron diclofenac is obtained by taking diclofenac as a model drug and adopting the high pressure homogenization technology, thus increasing in vitro dissolution and improving the bioavailability. The drugs are used at the lowest effective dose so that the duration of the drugs in vivo is the shortest, thus reducing the risk of severe cardiovascular events and gastrointestinal problems accompanying high-dose non-steroidal anti-inflammatory drugs and improving the compliance of patients.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a low-dose non-steroidal anti-inflammatory pharmaceutical composition and a preparation process thereof. Background technique [0002] NSAIDs (Nonsteroidal Antiinflammatory Drugs, NSAIDs) are a class of anti-inflammatory drugs that do not contain a steroidal structure. Since aspirin was first synthesized in 1898, more than 100 kinds of NSAIDs have been listed on the market for more than 100 years. , such drugs include aspirin, acetaminophen, indomethacin, naproxen, naproxen, diclofenac, ibuprofen, nimesulide, rofecoxib, celecoxib, etc. It has anti-inflammatory, anti-rheumatic, analgesic, antipyretic and anti-coagulant effects, and is widely used clinically to relieve osteoarthritis, rheumatoid arthritis, various fevers and various pain symptoms. NSAIDs are one of the most used drugs in the world. About 30 million people use it every day around th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K31/196A61P29/00
CPCA61K45/00A61K31/196
Inventor 张胜华杨艳丽徐宁
Owner 苏州朗易生物医药研究有限公司
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