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Method for preparing mezlocillin sodium for injection

A technology for mezlocillin sodium and injection is applied in the field of preparation of mezlocillin sodium for injection, which can solve the problems of inability to accurately guarantee and remove dissolved substances, and achieve the effect of good drug stability

Active Publication Date: 2013-01-30
SICHUAN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, in the existing preparation process, since the water is sublimated by freeze-drying, although the impurity and insoluble particles in the aqueous solution are removed by means of filtration in the previous step, the dissolved particles in the aqueous solution cannot be removed. Therefore, for various important parameters such as the pH value of the product, specific rotation, related substances, and mezlocillin polymer, it is impossible to accurately ensure that the above parameters of the prepared mezlocillin sodium for injection can be in a better parameter. within the range

Method used

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  • Method for preparing mezlocillin sodium for injection
  • Method for preparing mezlocillin sodium for injection
  • Method for preparing mezlocillin sodium for injection

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Embodiment 1

[0020] The specific steps of the preparation method of the present embodiment mezlocillin sodium for injection are as follows:

[0021] 1. Bottle washing process, pretreatment of injection bottles for sterilization:

[0022] The bottle washing process is as follows: send the injection bottle with qualified quality into the bottle washing track, firstly let the injection bottle enter the ultrasonic cleaning area and make the bottle mouth face down, use ultrasonic wave for initial washing, the frequency of ultrasonic cleaning is 40kHz, and use water after the initial washing is completed. Rinse with purified water with a pressure of 0.25Mpa, then rinse with water for injection filtered through a 0.22μm filter with a water pressure of 0.3Mpa, and finally blow dry with 0.4Mpa of compressed air filtered and purified through a 0.22μm filter. Finally, turn the mouth of the injection bottle upside down and take out the bottle; under the protection of 100-level laminar flow, it is sen...

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Abstract

The invention relates to a method for preparing mezlocillin sodium for injection, comprising the following steps of introducing nitrogen filtered by a 0.22 micrometer membrane filter to an injection bottle subjected to sterilization pretreatment, separately loading mezlocillin sodium with the specific rotation of +190-(+195) DEG into the injection bottle, introducing nitrogen to the separately-loaded drug, covering the bottle with a pretreated rubber plug, finally putting into a bottle capping chamber, capping the bottle by using an aluminium cap and obtaining mezlocillin sodium for the injection. According to the invention, the injection preparation is prepared by selecting mezlocillin sodium with the specific rotation of +190-(+195) DEG and the pH value of 7.0-7.5, therefore, mezlocillin sodium for the injection is better in drug stability and safer when serving as the injection preparation.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of mezlocillin sodium for injection. Background technique [0002] Mezlocillin sodium is a semi-synthetic broad-spectrum antibiotic obtained from cyclic urea penicillins. Its active ingredient is mezlocillin, which exists as a water-soluble monohydrate sodium salt. The chemical name is: (2S, 5R, 6R)-3, 3-Dimethyl-6-[(R)-2[3-(methylsulfonyl)-2-oxo-1-imidazolidinecarboxamido]-2-phenylacetamido]-7-oxo-4 -Thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid sodium salt. [0003] Mezlocillin sodium is mainly used clinically for respiratory system, urinary system, digestive system, gynecology and reproductive organs and other infections caused by sensitive strains of Gram-negative bacilli such as Escherichia coli, Enterobacter, and Proteus, such as Indications for sepsis, suppurative meningitis, peritonitis, osteomyelitis, skin and soft tissue infections, and ey...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/431A61P31/04A61L2/20B08B3/12
Inventor 周燕伟
Owner SICHUAN PHARMA
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