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Method for determining ceftazidime polymer for injection

A technology for ceftazidime and its determination method, which is applied in the field of determination of ceftazidime polymer for injection, and can solve the problems of ceftazidime self-polymerization reaction and threat to drug safety

Pending Publication Date: 2021-02-09
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, ceftazidime for injection is prone to self-polymerization, which generates polymer impurities and induces allergic reactions, threatening people's drug safety. Therefore, its polymer content must be strictly controlled.

Method used

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  • Method for determining ceftazidime polymer for injection
  • Method for determining ceftazidime polymer for injection
  • Method for determining ceftazidime polymer for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] see Figure 1-6 Shown, present embodiment is a kind of ceftazidime polymer assay method for injection, comprises the following steps:

[0037] Step 1: Inject deionized water into the water storage tank 102 of the purification equipment, add concentrated hydrochloric acid into the acid solution chamber 126, add sodium hydroxide solution into the alkali solution chamber 127, and close the sealing cover 124;

[0038] Step 2: Start the stretching cylinder 130, the movable rod of the stretching cylinder 130 is extended to push the filter plate 129 to move down until it fits with the bottom of the inner cavity of the purification box 108, and ceftazidime pentahydrate is added to the purification box 108 from the feeding port 111 In the inner chamber of the purification tank, the delivery liquid pump 103 is started, and the delivery liquid pump 103 runs to extract the deionized water in the water storage tank 102 and transport it to the inner cavity of the purification tank 10...

Embodiment 2

[0046] see Figure 1-6 As shown, the purification equipment in this embodiment includes an installation frame 101, a water storage tank 102, a liquid delivery pump 103, a vacuum pump 104, a plate condenser 105, a first installation plate 106, an air delivery pump 107, a purification box 108, a drain Feed trough 109, mediation box 110, feeding port 111, second mounting plate 112, driving motor 113, discharging motor 114, water storage tank 102 and vacuum pump 104 are respectively installed at both ends of the inner chamber bottom of described mounting frame 101, The installation frame 101 is sequentially installed with a delivery liquid pump 103 and a plate condenser 105 between the water storage tank 102 and the vacuum pump 104, and a first installation plate 106 is installed at the bottom of one side of the installation frame 101. The top of the installation plate 106 is equipped with a delivery air pump 107, the top of the installation frame 101 is equipped with a purificati...

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Abstract

The invention discloses a method for determining a ceftazidime polymer for injection, which comprises the following steps: adding concentrated hydrochloric acid into ceftazidime pentahydrate water todissolve the ceftazidime pentahydrate, adding a sodium hydroxide solution to regulate the pH value of the ceftazidime aqueous solution to precipitate, and peforming filtering to remove the precipitate, and continuously adjusting the pH value of the obtained filtrate by using a sodium hydroxide solution, and finally carrying out vacuum drying to separate out crystals so as to obtain purified ceftazidime. Compared with unpurified ceftazidime pentahydrate, the purified ceftazidime has the advantages that precipitates in the purification process are removed, polymers in the ceftazidime pentahydrate are fully removed, and the ceftazidime is obtained; and the content of ceftazidime is increased, and the safety of the medicine is guaranteed; according to the determination method, the ceftazidimepentahydrate is purified by using the purification equipment, and the purification equipment is high in automation degree, so that the working efficiency of purifying the ceftazidime pentahydrate is effectively improved.

Description

technical field [0001] The invention relates to the field of ceftazime, in particular to a method for determining a ceftazidime polymer for injection. Background technique [0002] Ceftazidime is a third-generation cephalosporin antibiotic with strong antibacterial activity and broad antibacterial spectrum, and has strong effects on Gram-positive or negative bacteria. It has high stability to the β-lactamase produced by Gram-positive bacteria and negative bacteria, and is resistant to Pseudomonas aeruginosa, Escherichia coli, Klebsiella, Proteus, Enterococcus, Salmonella, Shigella, and Neisseria gonorrhoeae Bacteria, Neisseria meningitidis, Staphylococcus aureus, hemolytic streptococcus, pneumococcus and Bacillus aerogenes have strong antibacterial activity. Ceftazidime is suitable for respiratory tract infection, urinary tract infection, skin and soft tissue infection, gastrointestinal, biliary tract and abdominal infection, bone and joint infection, complicated infection ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14
CPCG01N30/02G01N30/06G01N30/14
Inventor 马莉李珠珠史权杰
Owner HAINAN WEI KANG PHARMA QIANSHAN