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The preparation method of anhydrous ampicillin

A technology for ampicillin and ampicillin trihydrate, which is applied in the field of preparation of anhydrous ampicillin, can solve the problems affecting the quality and safety of anhydrous ampicillin as a pharmaceutical intermediate, easily exceeding the standard of heavy metal ions, and accumulating clutter on the production site, etc. Achieve the effect of being conducive to sub-packaging, fast salt formation, and regular production site

Active Publication Date: 2016-01-20
NORTH CHINA PHARM GRP SEMISYNTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Currently commercially available anhydrous ampicillin products mostly use inorganic salt drying process, the product has problems such as incomplete dehydration, moisture content as high as 1%, and heavy metal ions easily exceeding the standard, which seriously affects the quality and safety of the pharmaceutical intermediate anhydrous ampicillin; and this This process is likely to cause dirty and messy accumulation on the production site, which leads to its contradiction with the requirements of the new version of GMP

Method used

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  • The preparation method of anhydrous ampicillin
  • The preparation method of anhydrous ampicillin
  • The preparation method of anhydrous ampicillin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation method of anhydrous ampicillin is as follows:

[0020] 1. Add 300 kg of ampicillin trihydrate and stir in the enamel tank, then add 1000 L of reclaimed isopropanol (water content 13wt%) and mix;

[0021] ②The above-mentioned enamel tank was heated to 50°C in a water bath, heated to reflux and stirred for 40 minutes; cooled to room temperature with cold water, and centrifuged; soaked and washed the solid obtained by centrifugation with acetone for about 3 minutes, and continued to centrifuge and compact;

[0022] ③Hollow drying for 40-60 minutes, the temperature is controlled at 45-50°C, the vacuum degree is <-0.075MPa, and it is turned 1-2 times during the period.

Embodiment 2

[0024] The basic process is the same as in Example 1, except that the water bath is heated to 55° C. in the second step.

Embodiment 3

[0026] The basic process is the same as in Example 1, except that the water bath is heated to 60° C. in the second step.

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Abstract

The invention relates to a preparation method of anhydrous ampicillin, which is characterized by comprising the following steps: (1) adding a dehydration solvent while stirring ampicillin trihydrate, heating to 55-65 DEG C, keeping the temperature for 30-40 minutes, and cooling to 30-40 DEG C; (2) separating, washing with a washing solvent, and separating; and (3) carrying out vacuum drying at 45-50 DEG C under the vacuum degree of greater than -0.075 MPa for 40-60 minutes, wherein the dehydration solvent is anhydrous methanol, ethanol with the water content of 0-4 wt% or isopropanol with the water content of 0-13 wt%. The method for preparing anhydrous ampicillin has the advantages of high safety, high effectiveness and high stability; and since the solvents can be easily recovered, the whole technique has the technical effects of low cost and high economical efficiency.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a preparation method of anhydrous ampicillin. technical background [0002] Anhydrous ampicillin is an important precursor for the preparation of ampicillin sodium for injection raw materials, so the quality of anhydrous ampicillin is directly related to the drug quality and safety of ampicillin sodium for injection. Currently commercially available anhydrous ampicillin products mostly use inorganic salt drying process, the product has problems such as incomplete dehydration, moisture content as high as 1%, and heavy metal ions easily exceeding the standard, which seriously affects the quality and safety of pharmaceutical intermediate anhydrous ampicillin; and this This process is likely to cause dirty and messy accumulation on the production site, which makes it contradict the requirements of the new version of GMP. Contents of the invention [0003] The purpose ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D499/68C07D499/04
Inventor 左丽华严正人桑晓民魏鹏
Owner NORTH CHINA PHARM GRP SEMISYNTECH CO LTD
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