A kind of linezolid dry suspension and preparation method thereof

A technology of linezolid and dry suspension, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of reducing product safety and instability, and achieve reduction The use of excipients, increasing the number of applicable people, and the effect of simple preparation methods

CN111728944BActive Publication Date: 2022-04-01SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD +1
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Publication Date
2022-04-01

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Abstract

The invention provides a dry suspension of linezolid and a preparation method thereof. The dry suspension is composed of linezolid, a filler, a suspending agent, a buffer, a preservative, a flavoring agent, a lubricant, etc.; The new carboxylated nanocellulose replaces the traditional suspending agent. At the same time, the carboxyl group on the carboxylated nanocellulose is used to hydrogen bond with linezolid to achieve the taste-masking effect, and the use of suspending agent and other auxiliary materials is reduced. The drug compliance and safety of children are improved while ensuring product quality; the preparation method is simple and suitable for industrial production.
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Description

technical field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a linezolid dry suspension and a preparation method thereof. Background technique

[0002] Linezolid is a synthetic oxazolidinone antibiotic approved by the US FDA in 2000 for the treatment of complicated skin and skin soft tissue infections, community-acquired pneumonia and associated bacteremia, and nosocomial pneumonia , suitable for children from birth to 11 years old and adolescents and adults aged 12 and above. The chemical structure of linezolid is as follows:

[0003]

[0004] Linezolid was imported into my country by Pfizer of the United States in 2006, and the dosage forms that have been listed in China include tablets, injections, and dry suspensions. Patent CN201210525618.0 discloses a linezolid oral tablet and its preparation Method, using the conventional wet granulation preparation method, but the tablet has poor drug compliance for children...

Examples

example 1

[0061]

[0062] Process:

[0063] (1) Prepare materials according to the prescription of Example 1, and pass 80 mesh sieves of mannitol for subsequent use.

[0064] (2) Add linezolid, mannitol, carboxylated nanocellulose, citric acid, and sodium citrate into a wet granulator and mix for 5 minutes to obtain a mixture. Then 35g of water was added into the wet granulator through an atomizer, and stirred for 60s to prepare a soft material. Pass the soft material through a 30-mesh sieve and granulate to obtain drug-containing granules.

[0065] (3) Put the drug-containing granules into a vacuum drying oven to dry for 4 hours at a temperature of 60° C., and use a 30-mesh sieve to sieve the granules.

[0066](4) Add the drug-containing granules together with sodium benzoate, orange flavor and silicon dioxide into a multi-sport mixer, mix for 20 minutes, and mix well.

example 3

[0076]

[0077] According to the above formula, the same preparation method as in Example 1 was adopted to obtain the finished product 3.