Production process of compound preparation of ceftriaxone sodium and tazobactam sodium for injection

A technology of ceftriaxone sodium and tazobactam sodium, which is applied in the field of compound preparations of ceftriaxone sodium and tazobactam sodium for injection, which can solve the problem of poor mixing uniformity, different specific volumes, and effects on the content of sterile products and the color level of the solution And other problems, to achieve high safety, good mixing uniformity, and improve the effect of purity

Active Publication Date: 2009-09-23
HAIKOU QILI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional compound preparations are produced by mixing ceftriaxone sodium and tazobactam sodium aseptic powder and subpackaging. The clarity of the sterile product not only affects the solution clarity of the sterile prod

Method used

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  • Production process of compound preparation of ceftriaxone sodium and tazobactam sodium for injection
  • Production process of compound preparation of ceftriaxone sodium and tazobactam sodium for injection
  • Production process of compound preparation of ceftriaxone sodium and tazobactam sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A kind of production technology of ceftriaxone sodium tazobactam sodium compound preparation for injection, this production technology comprises steps as follows:

[0023] 1. Choice of prescription

[0024] Prescription 1, and ratio: specification 1.0g

[0025] Material name

prescription

Proportion

Ceftriaxone Sodium

894.0g (equivalent to 750g ceftriaxone)

3

Tazobactam Sodium

294.0g (equivalent to 250g tazobactam)

1

Sterile water for injection

500g

2

Ethyl acetate and isopropanol mixture (1:2)

1250

5

Absolute ethanol

2250

9

co-production

1000 bottles

[0026] Prescription 2, and ratio: specification 1.0g

[0027] Material name

prescription

Proportion

Ceftriaxone Sodium

894.0g (equivalent to 750g ceftriaxone)

3

Tazobactam Sodium

294.0g (equivalent to 250g tazobactam)

1

Sterile water fo...

Embodiment 2

[0066] A kind of production technology of ceftriaxone sodium tazobactam sodium compound preparation for injection, this production technology comprises steps as follows:

[0067](1), raw material: press ceftriaxone sodium: tazobactam sodium: sterile water for injection: ethyl acetate and isopropanol mixed solution: the weight ratio of dehydrated alcohol is 5: 1: 2: 5: 9, Weigh the above raw materials respectively;

[0068] Wherein, the mixed solution of ethyl acetate and isopropanol is that ethyl acetate and isopropanol are mixed in a volume ratio of 1:2;

[0069] (2) Dissolving and filtering: add sterile water for injection into the dissolving tank, 8°C to 12°C, then add ceftriaxone sodium and tazobactam sodium and stir to dissolve, add activated carbon, and the amount added is 0.2% of the liquid weight in the tank , and filtered after stirring for 30 minutes: pass the mixed solution through a 0.45 micron titanium rod filter, 0.22 micron and 0.01 micron filter elements for u...

Embodiment 3

[0077] A kind of production technology of ceftriaxone sodium tazobactam sodium compound preparation for injection, this production technology comprises steps as follows:

[0078] (1), raw material: press ceftriaxone sodium: tazobactam sodium: sterile water for injection: ethyl acetate and isopropanol mixed solution: the weight ratio of dehydrated alcohol is 5: 1: 2: 5: 9, Weigh the above raw materials respectively;

[0079] Wherein, the mixed solution of ethyl acetate and isopropanol is that ethyl acetate and isopropanol are mixed in a volume ratio of 1:4;

[0080] (2) Dissolving and filtering: add sterile water for injection into the dissolving tank, 8°C to 12°C, then add ceftriaxone sodium and tazobactam sodium and stir to dissolve, add activated carbon, and the amount added is 0.2% of the liquid weight in the tank , and filtered after stirring for 30 minutes: pass the mixed solution through a 0.45 micron titanium rod filter, 0.22 micron and 0.01 micron filter elements for ...

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Abstract

The invention discloses a production process of compound preparation of ceftriaxone sodium and tazobactam sodium for injection, comprising the steps of weighing raw materials of ceftriaxone sodium, tazobactam sodium, sterilized water for injection, mixed liquid of ethyl acetate and isopropanol, and anhydrous ethanol based on the weight ratio of 3-5:1:2:5:9; conducing dissolution and filtration; crystallizing and washing; and lyophilizing to obtain the compound preparation of ceftriaxone sodium and tazobactam sodium for injection. The invention is applicable to the compound preparation of ceftriaxone sodium and tazobactam sodium for injection, which is produced according to the ratio of 3:1-5:1 of ceftriaxone to tazobactam; and the invention adopts evenly mixing of liquid phase, can achieve good mixing uniformity, effectively increase the purity of the preparations simultaneously, and further guarantee the advantage of high safety of clinic use.

Description

technical field [0001] The invention relates to a production process of a compound preparation of ceftriaxone sodium and tazobactam sodium for injection. Background technique [0002] Ceftriaxone sodium is a third-generation cephalosporin with broad-spectrum antibacterial effects. With the widespread clinical application of cephalosporin antibiotics, bacteria undergo genetic mutations under the genetic pressure of antibiotics. Over the past two decades, the number of drug-resistant strains has increased, and the number of cases of severe and refractory infections, especially respiratory infections, is facing severe challenges of bacterial drug resistance clinically. At present, it has been developed for the production and use of compound preparations. In the second part of the "Pharmacopoeia of the People's Republic of China" in 2005, it is stipulated that ceftriaxone sodium and the like should be checked for "clarity and color of the solution". Therefore, it is an importan...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/431A61P31/04
CPCA61K31/549A61K9/0019A61K31/43A61P31/00A61P31/04A61K2300/00
Inventor 韩宇东韩克胜许礼贵
Owner HAIKOU QILI PHARMA
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