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Medicinal composition containing cefotiam hydrochloride

A cefotiam and composition technology, applied in the field of new pharmaceutical preparation compositions, can solve the problems of unsatisfactory dissolution rate, increase dissolution rate, stability problems, etc., achieve rapid dissolution, ensure stability, and tolerate good effect

Active Publication Date: 2012-10-10
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, cefotiam is mainly in the form of powder injection, but due to the influence of various factors, the dissolution rate of existing products is not satisfactory. Since it does not contain preservatives, it must be used immediately after dissolution
For this reason, it is beneficial for patients to develop a convenient cefotiam freeze-dried injection preparation to increase the dissolution rate and avoid stability problems caused by long-term storage.

Method used

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  • Medicinal composition containing cefotiam hydrochloride
  • Medicinal composition containing cefotiam hydrochloride
  • Medicinal composition containing cefotiam hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Cefotiam 500g;

[0052] Anhydrous sodium carbonate 100g;

[0053] Mannitol 150g;

[0054] Vitamin C1.5g,

[0055] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4,

[0056] Add water for injection to 4000ml

[0057] 1000 bottles

[0058] Preparation: First mix 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above-mentioned amount of cefotiam, mannitol, vitamin C and dissolve in citric acid buffer solution, then dilute to 4000ml with water for injection, pass through the aperture Filtrate through a 0.22um filter membrane, after the clarity is qualified, fill, half-tighten, freeze-dry in a box, pack, and get ready. Wherein, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh disodium hydrogen citrate 13g, trisodium citrate 60g and dissolve in 2000ml water for injection to obtain a buffer solution with a...

Embodiment 2

[0060] Cefotiam 1000g;

[0061] Anhydrous sodium carbonate 200g;

[0062] Mannitol 200g;

[0063] Vitamin C 2g,

[0064] Disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4 2000ml

[0065] Add water for injection to 4L

[0066] 1000 bottles

[0067]Preparation: first mix 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above amount of cefotiam, mannitol, EDTA calcium, vitamin C and citric acid buffer solution to dissolve, and then dilute to 4000ml with water for injection , filtered through a filter membrane with a pore size of 0.22um, and after the clarity is qualified, it is filled, half-pressed, put into a box for freeze-drying, and packaged to obtain the product. Wherein, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh disodium hydrogen citrate 13g, trisodium citrate 60g and dissolve in 2000ml water for injectio...

Embodiment 3

[0069] Cefotiam 500g;

[0070] Anhydrous sodium carbonate 120;

[0071] Mannitol 100g;

[0072] Vitamin C1g,

[0073] Disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4 2000ml

[0074] Add water for injection to 4L

[0075] 1000 bottles

[0076] Preparation: First mix 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above-mentioned amount of cefotiam, mannitol, vitamin C and dissolve in citric acid buffer solution, then dilute to 4000ml with water for injection, pass through the aperture Filtrate through a 0.22um filter membrane, after the clarity is qualified, fill, half-tighten, freeze-dry in a box, pack, and get ready. Wherein, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh disodium hydrogen citrate 13g, trisodium citrate 60g and dissolve in 2000ml water for injection to obtain a buffer solution with a pH value of 7....

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Abstract

The invention relates to a new medical preparation composition, in particular to an injection preparation containing cefotiam hydrochloride, and application of the injection preparation. The composition comprises cefotiam hydrochloride, anhydrous sodium carbonate, mannitol, vitamin C, and a sodium hydrogen citrate and trisodium citrate buffering solution.

Description

Technical field: [0001] The invention relates to a new pharmaceutical preparation composition, in particular to an injection preparation of cefotiam, its prescription, application and preparation method. Background technique: [0002] Cefotiam, English name: Cefotiam Hydrochloride. Its 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]oct-2- En-2-carboxylic acid dihydrochloride. Molecular formula: C18H23N9O4S3 2HCl, molecular weight: 598.6. This product is white to light yellow crystalline powder, odorless. It has a wide range of antibacterial effects on Gram-negative bacteria and positive bacteria. Especially for Escherichia coli, Klebsiella, Proteus mirabilis, influenza bacillus, etc., it shows stronger antibacterial activity. For enterobacteria, Citrobacter, indole-positive common Proteus, Rettger Proteus morganii and Proteus morganii also showed good antibact...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K47/12A61K47/22A61P31/04
Inventor 孙志嘉杨新春王喜军陈桂芹徐丹
Owner 哈药集团股份有限公司
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