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A kind of cefuroxime sodium raw material and injection and preparation method thereof

A technology of cefuroxime sodium and cefuroxime acid, which is applied in the field of medicine and can solve problems such as rapid growth and poor control of related substances 2

Active Publication Date: 2021-12-31
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There is little research on related substance 2 in the prior art, and the country requires strict control of this impurity. After research, it is found that the above-mentioned patented technology products do not control related substance 2 well, and the growth rate is relatively fast during the accelerated test process.

Method used

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  • A kind of cefuroxime sodium raw material and injection and preparation method thereof
  • A kind of cefuroxime sodium raw material and injection and preparation method thereof
  • A kind of cefuroxime sodium raw material and injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0039] Embodiment 1 prepares cefuroxime sodium raw material of the present invention

[0040] (1) Preparation of cefuroxime acid solution: add methanol (50L), dehydrated ethanol (98L) and water (2L) respectively in a clean stainless steel batching tank A, stir and control the liquid temperature in the stainless steel tank A to 10 -15°C, then add cefuroxime acid (15kg) weighed in advance, control the temperature at 10-15°C and completely dissolve to obtain a cefuroxime acid solution, and set aside;

[0041] (2) Preparation of salt-forming agent solution: Measure and add 95% ethanol (150L) into the clean stainless steel batching tank B, stir and control the liquid temperature in the stainless steel tank B to 10-15°C, and then add the mixture that has been weighed in advance Sodium acetate trihydrate (5.29kg), temperature control 10-15 ℃ and after dissolving completely, obtain salt-forming agent solution, standby;

[0042] (3) Salt-forming reaction: Methanol (10L), absolute etha...

Embodiment 2

[0044] Embodiment 2 prepares cefuroxime sodium raw material of the present invention

[0045] (1) Preparation of cefuroxime acid solution: add methanol (55L), absolute ethanol (108L) and water (2L) into a clean stainless steel batching tank respectively, stir and control the liquid temperature in the stainless steel tank to 10-15 ℃, then add cefuroxime acid (15kg) weighed in advance, after temperature control 10-15 ℃ and completely dissolved, cefuroxime acid solution is obtained for subsequent use;

[0046] (2) Preparation of salt-forming agent solution: Measure and add 95% ethanol (165L) respectively in a clean stainless steel batching tank, stir and control the liquid temperature in the stainless steel tank to 10-15°C, then add the pre-weighed three Water sodium acetate (5.29kg), temperature control 10-15 ℃ and after completely dissolving, obtain salt-forming agent solution, standby;

[0047] (3) Salt-forming reaction: Methanol (11L), absolute ethanol (21.6L), water (0.4L),...

Embodiment 3

[0049] Embodiment 3 prepares cefuroxime sodium raw material of the present invention

[0050] (1) Preparation of cefuroxime acid solution: Methanol (60L), dehydrated ethanol (118L) and water (2L) were metered into clean stainless steel batching tank A respectively, stirred and the liquid temperature in stainless steel tank A was controlled to 10 -15°C, then add cefuroxime acid (15kg) weighed in advance, control the temperature at 10-15°C and completely dissolve to obtain a cefuroxime acid solution, and set aside;

[0051] (2) Preparation of salt-forming agent solution: Measure and add 95% ethanol (180L) into the clean stainless steel batching tank B respectively, stir and control the liquid temperature in the stainless steel tank B to 10-15°C, then add the Sodium acetate trihydrate (5.29kg), temperature control 10-15 ℃ and after dissolving completely, obtain salt-forming agent solution, standby;

[0052] (3), salt-forming reaction: Methanol (12L), absolute ethanol (23.6L), wa...

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Abstract

The invention relates to a cefuroxime sodium raw material, an injection and a preparation method thereof, belonging to the technical field of medicine. The cefuroxime sodium raw material of the present invention is passed in a specific solvent environment, with a special dropping rate, dropwise adding cefuroxime acid solution and a 95% ethanol solution of sodium acetate trihydrate prepared according to a specific mixed solvent ratio and a specific concentration at the same time Prepared. The product quality and stability of cefuroxime sodium for injection prepared from this raw material through special process control has been significantly improved, especially the production of related substance 2 has been reduced, and the product quality has been strictly controlled, thereby ensuring the safety and effectiveness of the drug.

Description

technical field [0001] The invention relates to a cefuroxime sodium raw material, an injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefuroxime sodium was developed by the GlaxoSmithKline company of the United Kingdom, and was first listed in Germany, Ireland, the United Kingdom, and Italy (trade name Curoxim) in 1978. In 1980, it was launched in Japan by Shin Nihon Jitsugyo Company, under the trade name "Zinacef", only in oral dosage form. In October 1983, it was approved by the U.S. FDA by Teligent, and its trade name was Zinacef. The injection was launched in China in 1987 under the trade name Xilixin, and the tablet was launched in China in 1989. Cefuroxime sodium has been on the market at home and abroad for many years, and has been included in Chinese, British, American, and European pharmacopoeias, with clear safety and efficacy. [0003] Cefuroxime sodium is a second-generation cephalosporin, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/34C07D501/04A61K9/14A61P31/04A61K31/546
CPCC07D501/34C07D501/04A61K9/0019A61K9/14A61P31/04C07B2200/13
Inventor 王杰马慧丽王晨光
Owner 石药集团中诺药业(石家庄)有限公司
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