Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof

A technology of sodium chloride injection and preparation, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., and can solve the problems of high dosage of acid-base adjustment, low safety, opalescent opacity, etc., and achieve Increase safety and stability, high safety, reduce the effect of dosage
CN103565733AInactive Publication Date: 2014-02-12南京帝易医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
南京帝易医药科技有限公司
Publication Date
2014-02-12
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides an ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and a preparation method thereof. The injection contains 1-10 mg / ml of ibuprofen, and injection water, wherein the pH is adjusted to 6.0-6.5 by an acid-base modifier; the dosage of the required acid-base modifier accounts for about 2-6% by weight / volume of the injection; the sodium chloride content of an isoosmotic adjusting agent is 0.70-0.90% by weight / volume. The preparation technology comprises the following steps: firstly, dissolving the acid-base modifier and the ibuprofen; adding the injection water to 20% of total mass; adding sodium chloride to stir and dissolve; adding activated carbon, filtering and decarburizing; adding water to 90% of total mass, adjusting the pH to 6.0-6.5, and adding water to total mass; filtering by 0.45 microns and 0.22 microns of microfiltration membranes; and filling and sealing and sterilizing at 121 DEG C for 8-20 minutes.
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Description

technical field

[0001] The invention relates to a large-capacity injection of ibuprofen sodium chloride injection with a pH of 6.0-6.5 and a preparation method thereof. Background technique

[0002] Ibuprofen, also known as α-methyl-4-(2-methylpropyl)phenylacetic acid, is a non-steroidal anti-inflammatory and analgesic drug with strong anti-inflammatory, anti-rheumatic, antipyretic and analgesic effects , and its efficacy and other effects are greater than aspirin. Ibuprofen has no obvious side effects on the liver and hematopoietic system. Its mechanism of action is the same as other propionic acid derivatives. It is a powerful inhibitor of cyclooxygenase. By inhibiting cyclooxygenase, it can reduce the production and release of prostaglandins. Play anti-inflammatory, antipyretic, analgesic effect.

[0003] At present, the formulations of ibuprofen listed at home and abroad include ordinary tablets, chewable tablets, sustained-release tablets, capsules, suspensions, drops...

Claims

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