The New Indication of Trisofen Ceftriaxone Sodium Drug Preparation in the Treatment of Bacterial Endometritis

A ceftriaxone sodium and solvent technology, which is applied in the field of drug preparation, can solve problems such as hidden safety hazards, insufficient stability of ceftriaxone sodium, poor stability of ceftriaxone sodium preparations, etc., and achieve improved use safety and storage stability and outstanding solubility, reducing the risk of clinical sensitization

Active Publication Date: 2021-01-22
广东金城金素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Based on the consideration of ceftriaxone sodium impurities on the efficacy and safety of the drug, it is necessary to study the production process and formulation form of ceftriaxone sodium preparations to solve the problem of insufficient stability of ceftriaxone sodium during storage and the impact of ceftriaxone caused by impurities. Poor stability and potential safety hazards of pine sodium preparations

Method used

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  • The New Indication of Trisofen Ceftriaxone Sodium Drug Preparation in the Treatment of Bacterial Endometritis
  • The New Indication of Trisofen Ceftriaxone Sodium Drug Preparation in the Treatment of Bacterial Endometritis
  • The New Indication of Trisofen Ceftriaxone Sodium Drug Preparation in the Treatment of Bacterial Endometritis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-2

[0126] The synthesis of embodiment 1-2 ceftriaxone sodium

[0127] The same as the synthesis process of Example 1-1, the only difference is: in step 1), 15gAlCl is added dropwise to the reaction system 3 -BF3-dimethyl carbonate solution [(wBF 3 )=18%] (wherein, AlCl 3 0.66g (0.005mol), BF 3 2.7g (0.04mol)), namely AlCl 3 -BF 3 AlCl in dimethyl carbonate composite catalyst 3 and BF 3 The molar ratio is 1:8.

[0128] The synthesis of embodiment 1-3 ceftriaxone sodium

[0129] Identical to the synthetic technique of embodiment 1-1, difference is only: in step 2), reaction solvent is by V 乙腈 :V 二氯甲烷 =5:1 mixed solvent, changed to acetonitrile, crystallization solvent is acetone.

Embodiment 1-4

[0130] The synthesis of embodiment 1-4 ceftriaxone sodium

[0131] The synthesis process is the same as in Example 1-1, except that in step 2), 192.7 g (0.55 mol) of AE-active ester, that is, the mass ratio of 7-ACT to AE-active ester is 1:1.0.

Embodiment 1-5

[0132] The synthesis of embodiment 1-5 ceftriaxone sodium

[0133] The synthesis process is the same as in Example 1-1, the only difference is that in step 2), the catalyst is changed from tri-n-butylamine and pyridine to triethylamine of the same molar amount. The color of the crude product of ceftriaxone sodium obtained is light yellow.

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Abstract

The invention relates to the technical field of pharmaceutical preparing, and discloses a novel indication of a Rocephin (ceftriaxone sodium) pharmaceutical preparation for treating bacterial intimitis. Ceftriaxone sodium provided by a specific production process has an extremely low impurity content and significant medical effects, is of a novel crystal form different from present crystal forms,improves quality of a preparation product, ensures safety and effectiveness of the preparation product, and can be used for preparing medicines treating bacterial intimitis.

Description

technical field [0001] The invention relates to medicine preparation technology, in particular to a ceftriaxone sodium composition, a preparation method and an application thereof. Background technique [0002] Ceftriaxone Sodium is a third-generation cephalosporin antibiotic. Originally researched and marketed by Roche, the trade name is Rocephin. The internationally recognized brands include: Traxofen, Junbizhi, Acantex, and Cefaxone. The chemical name is (6R,7R)-7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5, 6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thio-1-azabicyclo[4.2 .0] Oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate. Its chemical structural formula is as follows: [0003] [0004] The possibility of adverse drug reactions may occur during drug use. Common factors include dosage, dosing regimen, course of treatment, demographic characteristics, combination medication, efficacy characteristics, etc., ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/06C07D501/36A61K31/546A61K31/43A61K31/431A61P31/04
CPCA61K31/43A61K31/431A61K31/546A61P31/04C07B2200/13C07D501/06C07D501/36A61K2300/00
Inventor 伊茂聪吴丰喆傅苗青马庆双周白水朱旭伟李秋荣
Owner 广东金城金素制药有限公司
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