Production method of tazobactam sodium for injection

A technology of tazobactam sodium and a production method, which is applied in the field of medicine, can solve the problems of slow drying speed, prolonged production cycle, large resistance to water sublimation, etc., and achieves the effects of increasing acidity stability and good grain consistency

Inactive Publication Date: 2018-06-01
山东安信制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the small grains, the gaps left by ice crystals after sublimation are narrow, the resistance of water sublimation is large, the drying speed is slow, the production cycle is prolonged, and the dried products are particularly easy to absorb moisture, which brings difficulties to storage. This is the shortcoming of quick freezing.
[0006] 2. The drying design is unreasonable, making it difficult to dry the product after quick freezing
However, it is difficult to dry after quick-freezing, and the existing technology does not give a reasonable drying method, which affects the application of quick-freezing technology

Method used

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  • Production method of tazobactam sodium for injection
  • Production method of tazobactam sodium for injection
  • Production method of tazobactam sodium for injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1. Salt formation

[0036] Raw materials and dosage: 132kg of tazobactam, 36.8kg of sodium bicarbonate.

[0037] ① Add 200ml of bottom water to the reaction tank, turn on the interlayer refrigerant water to cool down, and turn off the refrigerant water when the temperature drops to 5-10°C.

[0038] Then the sodium bicarbonate 36.8g that has weighed is added water and is mixed with the sodium hydroxide solution that concentration is 25% (w / v) for subsequent use, reserves the sodium bicarbonate solution to adjust the pH value usefulness, and all the other sodium bicarbonate solutions are ready to be added dropwise .

[0039] ② Put the weighed tazobactam into the reaction tank, and start to drop the prepared lye at the same time, keep the lye in a suspension state without precipitation during the alkali addition process, and maintain the temperature in the reaction tank at 5 -10°C.

[0040] ③ Turn on the vacuum to remove carbon dioxide gas.

[0041] ④Adjust the pH to 6...

Embodiment 2

[0055] After step ④ is completed, add 38 mg of EDTA solution and stir for 20 minutes, then re-evacuate the carbon dioxide gas and maintain the pH at 6.0-6.5.

[0056] All the other are with embodiment 1.

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Abstract

The invention discloses a production method of tazobactam sodium for injection. The method comprises the following steps: salifying tazobactam and sodium hydrogen carbonate, then putting feed liquid into a tray, placing the tray on a spacer plate and freeze-drying; cooling the spacer plate of a freeze dryer to -30 DEG C in advance, controlling the time for 15min and cooling to -42 DEG C, then controlling the time for 10min and cooling to -45 DEG C, and stabilizing for 2-4h; after pre-freezing is finished, carrying out sublimation drying in three stages under the vacuum condition; heating the spacer plate of the freeze dryer up to 35 DEG C from -45 DEG C, wherein the heating time is 70-90min; then, heating the spacer plate of the freeze dryer up to 40 DEG C from 35 DEG C, wherein the heating time is 400-600min; heating the spacer plate of the freeze dryer up to 55 DEG C from 40 DEG C, wherein the heating time is 50-70min; finally, carrying out analytical drying, cooling and discharginggas out of a box. The method changes the freeze-drying curve of the tazobactam sodium, enables the design of the freeze-drying curve of the product to be more reasonable, enables the crystal form of the product to be more stable, and avoids frequent occurrence of material melting.

Description

technical field [0001] The invention relates to a production method of tazobactam sodium for injection, which belongs to the technical field of medicine. Background technique [0002] Tazobactam sodium is a new type of penicillane sulfone β-lactamase inhibitor developed by Japan Dapeng Pharmaceutical Co., Ltd. It is one of the best β-lactamase inhibitors in clinical application, with high stability, Low activity, low toxicity, strong enzyme inhibitory activity and so on. Tazobactam sodium, the chemical name is [2S-(2a,3b,5a)]-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl Base)-4-thio-1-azabicyclo[3,2,0]heptane-2-carboxylate sodium 4,4-dioxide, molecular formula: C 10 h 11 N 4 NaO 5 S, the chemical structural formula is as follows: [0003] [0004] Tazobactam sodium for injection is made by reacting tazobactam acid and alkaline sodium salt. After the reaction is completed, it is pre-frozen, then sublimated and dried, and decomposed and dried to obtain the original p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/02A61K47/18A61K31/431A61P31/04
CPCA61K9/0019A61K9/19A61K31/431A61K47/02A61K47/18
Inventor 康宁曲景静
Owner 山东安信制药有限公司
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