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Ticarcillin sodium clavulanic acid potassium freeze-dried powder as well as preparation and preparation method thereof

A technology of carcillin sodium clavulanate potassium and ticarcillin sodium, which is applied in the field of medicine, can solve the problems of increased risk of bacterial contamination and unqualified visible foreign matter, difficulty in mixing uniformly, difficulty in process control, etc., and achieves good product uniformity , High safety in clinical use, good solubility effect

Active Publication Date: 2011-05-18
福安药业集团重庆博圣制药有限公司 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method is relatively simple to operate, it has strong potential safety hazards: first, clavulanic acid is a hygroscopic and explosive substance. In a dry, aseptic environment, clavulanic acid potassium has the danger of explosion. There are many examples of casualties and production stoppages caused by potassium clavulanate explosions at home and abroad; secondly, it is usually difficult to ensure that the two components have the same particle size and bulk density by using the method of physical packaging. It is precisely because of these reasons that the process control is difficult. And it is not easy to mix evenly; thirdly, the method of physical mixing is adopted, and the two components need to be aseptic and have no heat source, which will increase the cost of raw materials; in addition, the environmental requirements are relatively high, and the packaging process needs to strictly control the relative humidity and Sterile conditions, thus increasing the risk of contamination and visible foreign material failure

Method used

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  • Ticarcillin sodium clavulanic acid potassium freeze-dried powder as well as preparation and preparation method thereof
  • Ticarcillin sodium clavulanic acid potassium freeze-dried powder as well as preparation and preparation method thereof
  • Ticarcillin sodium clavulanic acid potassium freeze-dried powder as well as preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Get content and be 100kg of ticarcillin sodium aqueous solution of 20% (ticarcillin content), add gac 5kg in reaction tank, and content be 78% (clavulanic acid content, moisture: 0.9%) potassium clavulanate 1.78kg , after stirring for 25 minutes, flush the pressing system, sweep the thread, filter for sterilization, and start the freeze dryer. Rapidly lower the temperature to -45°C to solidify. Under 10 mbar vacuum, raise the temperature to 10°C within 6 hours, maintain this temperature for 3 hours, and then raise the temperature to 30°C in 5 hours, and maintain this temperature to continue vacuum drying. 8 hours, get ticarcillin sodium clavulanate potassium lyophilized powder, measure content: ticarcillin 82.0%, clavulanic acid 5.7% (the content determination method of ticarcillin, clavulanic acid is with reference to import drug registration standard (standard No. JX20050203) execution, the same below).

Embodiment 2

[0045] Get content and be 100kg of ticarcillin sodium aqueous solution of 20% (ticarcillin content), add gac 5kg in reaction tank, and content be 78% (clavulanic acid content, moisture: 0.9%) potassium clavulanate 1.72kg , after stirring for 25 minutes, flush the pressing system, sweep the thread, filter for sterilization, and start the freeze dryer. Rapidly lower the temperature to -40°C to solidify. Under 10 mbar vacuum, raise the temperature to 10°C within 4 hours, maintain this temperature for 3 hours, and then raise the temperature to 30°C in 5 hours, and maintain this temperature to continue vacuum drying After 8 hours, the freeze-dried powder of ticarcillin sodium and potassium clavulanate was obtained, and the measured content was: 83.5% of ticarcillin and 5.6% of clavulanic acid.

Embodiment 3

[0047] Getting content is 100kg of ticarcillin sodium aqueous solution of 20% (ticarcillin content), adds gac 5kg in reaction tank, content is 0.85kg of potassium clavulanate of 78% (clavulanic acid content, moisture: 0.9%), After stirring for 25 minutes, flush the pressing system, sweep the thread, sterilize and filter, and start the freeze dryer. Rapidly lower the temperature to -30°C to solidify, then raise the temperature to 10°C within 4 hours under a vacuum of 10 mbar, maintain this temperature for 2 hours to freeze-dry, then raise the temperature to 40°C within 5 hours, and maintain this temperature to continue vacuum drying After 8 hours, the freeze-dried powder of ticarcillin sodium and potassium clavulanate was obtained, and the measured content was: 94.2% of ticarcillin and 3.1% of clavulanic acid.

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Abstract

The invention discloses ticarcillin sodium clavulanic acid potassium freeze-dried powder. The freeze-dried powder is prepared from the following components in percentage by weight: 75.2-96.4 percent of ticarcillin and 2.70-7.50 percent of clavulanic acid, wherein the bulk density of the freeze-dried powder is between 0.4 g / ml and 0.85 g / ml, and the repose slope is between 25 degrees and 40 degrees. The invention also provides a preparation method of the ticarcillin sodium clavulanic acid potassium freeze-dried powder, which has the advantages of no potential safety hazard, good product equality, less production link, high safety in clinical use, and the like and is particularly suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a freeze-dried powder of ticarcillin sodium and clavulanate potassium, its preparation and a preparation method. Background technique [0002] Ticarcillin Sodium Clavulanate Potassium was successfully developed by GlaxoSmithKline, and its preparation was named TIMENTIN It was launched in the United States, New Zealand, Switzerland, and the United Kingdom in 1986, and the ticarcillin sodium and clavulanate potassium preparation with a ratio of 15:1 (based on effective acid) was imported into my country in 2000. At present, my country has domestic ticarcillin sodium and clavulanate potassium preparations on the market, and the ratio is also 15:1 (based on effective acid). [0003] A compound composed of clavulanate potassium and ticarcillin sodium, in which clavulanate potassium can protect ticarcillin sodium from being degraded by β-lactamase, and extend the antibacterial spect...

Claims

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Application Information

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IPC IPC(8): A61K31/424A61K31/431A61K9/19A61P31/04
Inventor 陈小勇冯秀梅张稳稳沈渝徐霞张黎黎
Owner 福安药业集团重庆博圣制药有限公司
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