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High-purity mezlocillin sodium preparation and method for preparing same

A technology of mezlocillin sodium and mezlocillin dry powder, which is applied in the directions of organic chemistry methods, organic chemistry, active ingredients of heterocyclic compounds, etc. Slow speed, product safety risks and other problems, to achieve the effect of good fluidity and dissolution speed, process optimization, and low insoluble particles

Active Publication Date: 2016-08-31
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Mezlocillin sodium for injection belongs to penicillin preparations, and there is still a large gap between the quality of the domestic product and the production method of the same kind abroad: the dissolution rate of mezlocillin sodium for injection is slow, which makes clinical use inconvenient; the fluidity of raw materials is poor , not easy to pack; the finished product of mezlocillin sodium has high content of polymers and impurities, which can easily cause allergic reactions; there are many insoluble particles, which make the product a safety risk

Method used

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  • High-purity mezlocillin sodium preparation and method for preparing same
  • High-purity mezlocillin sodium preparation and method for preparing same
  • High-purity mezlocillin sodium preparation and method for preparing same

Examples

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Embodiment 1

[0032] This example provides a kind of preparation method of high-purity mezlocillin dry powder, the steps include the preparation of ampicillin sodium solution, the preparation of mezlocillin sodium condensation liquid, the preparation of mezlocillin dry powder three steps. Specifically:

[0033] 1-1) Preparation of ampicillin sodium solution.

[0034] According to the molar ratio of ampicillin and sodium hydroxide being 1:1 to 1:1.25, 20 g of the reaction raw materials ampicillin and 1.98 to 2.48 g of sodium hydroxide were weighed. Wherein, the purity of ampicillin is 98%, and the purity of sodium hydroxide is 99%. Sodium hydroxide is dissolved in water to prepare a sodium hydroxide solution with a mass concentration of 3.9-4.0%, which is ready for use.

[0035] Add 200g of water to the reaction kettle, dissolve the weighed ampicillin in the water, then add sodium hydroxide solution to the reaction kettle, control the adding speed of the sodium hydroxide solution, and carr...

Embodiment 2

[0049] This embodiment provides a kind of preparation method of high-purity mezlocillin sodium preparation, with the mezlocillin dry powder prepared in Example 1 as raw material, and then through the preparation of ampicillin sodium solution and the preparation of mezlocillin sodium condensation liquid 1. Three steps of preparing the mezlocillin sodium preparation to obtain the mezlocillin sodium preparation. Specifically:

[0050] 2-1) Preparation of mezlocillin sodium solution.

[0051] According to the mol ratio of mezlocillin and sodium bicarbonate is 1: 1~1: 2, take by weighing the mezzlocillin 100g that embodiment 1 makes, sodium bicarbonate 15g, sodium bicarbonate is dissolved in water, configures mass concentration 10% sodium bicarbonate solution, ready to use.

[0052] Slowly add the dry powder of mezlocillin into the sodium bicarbonate solution, control the pH at the end point of the feed solution to be 5.5-7.0, control the reaction temperature at 20-25°C, and cont...

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Abstract

The invention discloses a high-purity mezlocillin sodium preparation. The high-purity mezlocillin sodium preparation comprises uniform granules with the grain sizes smaller than 50 micrometers. The content of total impurities in the high-purity mezlocillin sodium preparation is lower than or equal to 0.68%, and the content of polymers in the high-purity mezlocillin sodium preparation is lower than or equal to 0.06%. The invention further discloses a method for preparing the high-purity mezlocillin sodium preparation. The method includes six steps of preparing ampicillin sodium solution; preparing mezlocillin sodium condensation liquid; preparing mezlocillin dry powder; preparing mezlocillin sodium solution; preparing mezlocillin sodium active compounds; preparing the high-purity mezlocillin sodium preparation. The high-purity mezlocillin sodium preparation and the method have the advantages that existing problems can be solved by the aid of the high-purity mezlocillin sodium preparation prepared by the aid of novel crystallization technologies, and the quality of the high-purity mezlocillin sodium preparation can be greatly improved; the high-purity mezlocillin sodium preparation is high in dissolving rate and purity, low in impurity content and insoluble particle content, good in flowability and easy to separately package, and the like.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a high-purity mezlocillin sodium preparation and a preparation method thereof. Background technique [0002] Mezlocillin sodium, English name Mezloeillin Sodium, molecular formula C 21 h 24 N 5 NaO 8 S 2 , CAS No. 59798 30 0, chemical name 3,3-dimethyl-6-[(R)-2-[3-(methylsulfonyl)-2-oxo-1-imidazolidinecarboxamido]-2 -Sodium phenylacetamido]-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylate. Mezlocillin sodium was discovered in 1968 by the Bayer Company of the Federal Republic of Germany in the study of ampicillin a-aminophthalated derivatives. It was first listed in the Federal Republic of Germany in 1977. In 1981, the US FDA officially approved the drug to be launched in the United States. Since the 1980s, it has been listed in the United States, Japan, Italy, the Netherlands, Switzerland and other countries. [0003] Mezlocillin sodium is a semi-synthet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/431C07D499/68C07D499/16
CPCC07B2200/13C07D499/16C07D499/68
Inventor 高任龙胡卫国郝瑞霞左丽华仇俊新严正人刘慧勤周捷刘丹张彩霞李玉琢张艳慧秦宏亮陈利明王欣王秋颖李兰涛
Owner NORTH CHINA PHARMA COMPANY
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