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Pharmaceutical composition containing cefotiam hydrochloride compound and preparation method thereof

A technology of cefotiam hydrochloride and compounds, which is applied in the field of compositions containing cefotiam hydrochloride compounds and its preparation, can solve the problems of affecting the quality of freeze-dried powder injections, the content of active ingredients, the large amount of amino acids used, and the high production cost. To achieve the effect of avoiding the waste of medicine and hidden dangers of medicine, reducing the content of impurities and reducing the production cost

Active Publication Date: 2011-10-05
福建康成医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN101559040A discloses a composition of cefotiam hydrochloride and basic amino acids and the freeze-dried powder injection of the composition, which can improve the stability of cefotiam hydrochloride, but the amino acid usage is large and the production cost is also high
If cefotiam hydrochloride freeze-dried powder injection is prepared in this conventional method, because cefotiam hydrochloride and sodium carbonate are mixed and dissolved before freezing, cefotiam hydrochloride will be affected by the CO released by sodium carbonate. 2 Although the freeze-dried powder injection has good stability, the decomposition during the preparation process will seriously affect the quality and active ingredient content of the freeze-dried powder injection.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Weigh 50g of anhydrous sodium carbonate, put it in a sterilized container, add water for injection, stir to dissolve it, and filter it through a 0.22μm microfiltration membrane until the filtrate is clear and transparent. , freezing for 20 hours, then sublimation drying, vacuum degree of 15KPa, heating rate of 10°C / h, stop when the temperature rises to 25°C, continue drying for 10h, and obtain freeze-dried sodium carbonate powder for later use.

Embodiment 2

[0033] Weigh 5 g of cefotiam hydrochloride and 60 g of mannitol, place them in a sterilized container, add water for injection, stir to dissolve them, add activated carbon for decolorization, filter through a 0.22 μm microfiltration membrane until the filtrate is clear and transparent, and the filtrate is first vacuum-frozen at low temperature, Temperature -30°C, vacuum degree 20KPa, freezing time 10h, then sublimation drying, vacuum degree 20KPa, heating rate 10°C / h, stop after warming up to room temperature, continue drying for 3h, obtain freeze-dried powder, and then implement with 0.3g The sodium carbonate freeze-dried powder prepared in Example 1 was mixed evenly, divided into 1 mL brown vials according to the usual amount, dried at normal temperature and pressure for 7 hours, capped, inspected for quality, and packaged.

Embodiment 3

[0035] Weigh 8 g of cefotiam hydrochloride and 150 g of mannitol, place them in a sterilized container, add water for injection, stir to dissolve them, add activated carbon for decolorization, filter through a 0.22 μm microfiltration membrane until the filtrate is clear and transparent, and the filtrate is first vacuum-frozen at low temperature, Temperature -45°C, vacuum degree 15KPa, freezing time 15h, then sublimation drying, vacuum degree 15KPa, heating rate 12°C / h, stop after warming up to room temperature, continue drying for 3h, obtain freeze-dried powder, and then implement with 0.4g The sodium carbonate freeze-dried powder prepared in Example 1 was mixed evenly, divided into 1mL brown vials according to the usual amount, dried at normal temperature and pressure for 10 hours, capped, inspected for quality, and packaged.

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PUM

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Abstract

The invention provides a pharmaceutical composition containing a cefotiam hydrochloride compound, which is a powder injection and is composed of, by weight, 3-10 parts of cefotiam hydrochloride, 0.1-0.5 parts of sodium carbonate and 20-150 parts of mannitol. The invention also provides a method for preparing the pharmaceutical composition, comprising steps of: mixing the cefotiam hydrochloride and the mannitol to produce freeze-drying powders, making soda ash into a freeze-drying powder, and mixing the freeze-drying powders, followed by drying. According to the invention, the stability of the pharmaceutical composition powder injection is raised, the storage time of the pharmaceutical composition is prolonged, and simultaneously medication waste and medication hidden troubles caused by the medicine instability are avoided. The preparation method provided by the invention, wherein cefotiam hydrochloride and sodium carbonate are respectively prepared into freeze-drying powders and then the freeze-drying powders are mixed, avoids the influence of CO2 released from the dissolved sodium carbonate on the decomposition of the cefotiam hydrochloride, reduces the content of impurities in the freeze-drying powder injection, makes the best use of active ingredients, and is suitable for large scale production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a composition containing cefotiam hydrochloride compound and a preparation method thereof. Background technique [0002] Cefotiam is a semi-synthetic second-generation cephalosporin. Cefotiam hydrochloride for injection is commonly used as its dihydrochloride, the chemical name is (6R-trans)-7-[[(2-amino-4-thiazolyl)acetyl]amino]-3-[[[1- [(2-(Dimethylamino)ethyl]-1H-tetrazol-5-yl]thiomethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]octane- 2-ene-2-carboxylic acid dihydrochloride, white or light yellow powder, belongs to powder injection. It can be used to treat infections caused by sensitive bacteria, such as pneumonia, bronchitis, biliary tract infection, peritonitis, urinary tract infection and surgery Infection and sepsis etc. caused by trauma. Cefotiam market share has increased rapidly since 2005, and the sales scale in 2008 has become the first in antibiotics. Cefotiam hydrochl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/19A61K47/02A61K47/10A61P31/04
Inventor 罗诚
Owner 福建康成医药有限公司
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