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Pharmaceutical preparation of cefotaxime sodium compound and preparation method thereof

A technology of cefotaxime sodium and solid sodium bicarbonate is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, which can solve problems such as unstable theoretical properties and achieve good fluidity. Effect

Pending Publication Date: 2022-03-22
上海欣峰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the finally obtained cefotaxime sodium has high fluidity, it also has the defect of unstable theoretical properties.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Weigh the raw material of cefotaxime sodium proliposome, including:

[0066] Cefotaxime sodium 70mg;

[0067] N-(β-D-glucopyranose) octanamide 405mg;

[0068] Octadecylamine 135mg;

[0069] HSPC 1135mg;

[0070] Mannitol 190mg;

[0071] Cholesterol 565mg;

[0072] Tartaric acid 440mg; and,

[0073] Solid sodium bicarbonate granules 110mg. The solid sodium bicarbonate particles are pulverized and classified by a pharmaceutical ball mill to obtain solid sodium bicarbonate particles with a particle size of 280-320 mesh, and dried until the water content is less than 1.7%.

[0074] Dissolve the HSPC, mannitol and cholesterol of prescription quantity in 30mL volume and be 3:1 in the mixed solvent of chloroform-ethanol; Add cefotaxime sodium, N-(β-D-glucopyranose) caprylamide, octadecylamine and tartaric acid, Sonicate to dissolve.

[0075] Add solid sodium bicarbonate particles to react for a certain period of time; the reaction temperature is 60 o C, the reaction t...

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Abstract

The invention discloses a pharmaceutical preparation of a cefotaxime sodium compound. The pharmaceutical preparation comprises the following raw materials: 10 parts of cefotaxime sodium; 57.86 parts of N-(beta-D-glucopyranose) octanamide, and 57.86 parts of N-(beta 19.29 parts of octadecylamine; 162.14 parts of 1-palmitoyl-2-stearoyl lecithin, and 162.14 parts of 1-palmitoyl-2 27.14 parts of mannitol; 80.71 parts of cholesterol; 62.86 parts of tartaric acid; and 15.71 parts of solid sodium bicarbonate particles. In addition, the invention also discloses a preparation method of the medicinal preparation. The cefminox sodium pharmaceutical preparation is better in flowability; meanwhile, after long-time storage (for example, more than three months), the drug encapsulation efficiency is basically kept unchanged.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a pharmaceutical preparation of a cefotaxime sodium compound and a preparation method thereof, in particular to a proliposome of a cefotaxime sodium compound and a preparation method thereof. Background technique [0002] Cefotaxime sodium is (6R,7R)-3-[(acetoxy)methyl]-7-[2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido] -8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, molecular weight 477.45 Daltons; belongs to β-lactam cephalosporins. [0003] Cefotaxime acid is an intermediate of cefotaxime sodium. In theory, cefotaxime acid can achieve curative effect in pharmacology, but it is not sold as a final product in the market because cefotaxime acid is insoluble in water. The powder injection preparations on the market are injected into the human body after cefotaxime acid is dissolved in water, and cefotaxime acid is unstable, difficult to store, ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/546A61K47/26A61P31/04
CPCA61K9/127A61K31/546A61K47/26A61P31/04
Inventor 吴王平张奇刘小彩范海峰卢平平
Owner 上海欣峰制药有限公司
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