A kind of quality evaluation method of ceftriaxone sodium butyl rubber stopper for injection

A technology for quality evaluation of ceftriaxone sodium, which is applied in the field of quality evaluation of ceftriaxone sodium for injection, can solve problems such as non-compliance with the inspection items of "clarity of solution", drug dissolution becoming turbid, and affecting drug quality, etc., to achieve accurate High performance, simple steps, and convenient operation

Active Publication Date: 2022-07-08
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the case of high temperature, the compounding agent in the rubber stopper may precipitate, and the contact between the precipitate and the drug may affect the quality of the drug and pose a risk of harming human health
[0003] Ceftriaxone sodium is the third-generation cephalosporin antibiotic, a national essential drug, and its injection powder is widely used clinically. At present, the outstanding quality problem of ceftriaxone sodium for injection is that the inspection item "clarity of solution" is not correct. Conforms to the regulations, manifested as gradual turbidity when the drug dissolves during storage

Method used

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  • A kind of quality evaluation method of ceftriaxone sodium butyl rubber stopper for injection
  • A kind of quality evaluation method of ceftriaxone sodium butyl rubber stopper for injection
  • A kind of quality evaluation method of ceftriaxone sodium butyl rubber stopper for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The present embodiment relates to a method for evaluating the quality of ceftriaxone sodium butyl rubber stopper for injection, comprising the following steps:

[0041] 1) Determine the volatiles hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2 in the butyl rubber stopper in the sample to be tested by headspace gas chromatography 6-di-tert-butyl-p-cresol;

[0042] The detection conditions are: chromatographic column: 5% phenyl-95% methyl siloxane;

[0043] Carrier gas: nitrogen; flow rate 1.0ml / min;

[0044] Column temperature program: 50°C maintained for 10min, 10°C / min raised to 170°C, maintained for 20min;

[0045] Headspace conditions: 121°C for 30min; use methane to determine the dead time of the chromatography system (t 0 );

[0046] 2) Select octamethylcyclotetrasiloxane concentration 0.0518mg / ml as detection standard;

[0047] Four batches of butyl rubber stoppers produced by the same manufacturer were analyzed acco...

Embodiment 2

[0052] The present embodiment relates to a method for evaluating the quality of ceftriaxone sodium butyl rubber stopper for injection, comprising the following steps:

[0053] 1) Measure the volatiles hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and BHT in the butyl rubber stopper in the sample to be tested by headspace gas chromatography;

[0054] The detection conditions are: chromatographic column: 5% phenyl-95% methyl siloxane;

[0055] Carrier gas: nitrogen; flow rate 1.0ml / min;

[0056] Column temperature program: 50°C maintained for 10min, 10°C / min raised to 170°C, maintained for 20min;

[0057] Headspace conditions: 121°C for 30min; use methane to determine the dead time of the chromatography system (t 0 );

[0058] 2) Select the octamethylcyclotetrasiloxane concentration as 0.0518mg / ml as the detection standard;

[0059] Three batches of butyl rubber stoppers produced by the same manufacturer were analyzed according to the...

experiment example

[0063] The rubber stoppers of Example 1 and Example 2 were used for the production of ceftriaxone sodium for injection. The turbidity of the turbidity solution was compared, and it was found that the turbidity of the turbidity solution was lower than that of No. 1 turbidity solution, which proved that the quality of the rubber stoppers of Examples 1 and 2 met the requirements.

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Abstract

The invention belongs to the field of quality evaluation of rubber stoppers, and in particular relates to a quality evaluation method for ceftriaxone sodium butyl rubber stoppers for injection, comprising the following steps: determining the volatility of ceftriaxone sodium for injection by headspace gas chromatography Ingredients, with hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2,6-di-tert-butyl-p-cresol as ceftriaxone sodium clouding agents For the target to be measured, the quality of the butyl rubber stopper is judged by detecting the concentration of the above-mentioned target to be measured. The method of the invention has simple steps and convenient operation, and can realize relatively accurate detection in less steps.

Description

technical field [0001] The invention belongs to the field of quality evaluation of rubber stoppers, in particular to a quality evaluation method of ceftriaxone sodium for injection. Background technique [0002] For injection medicines, medicinal butyl rubber stopper is one of the necessary sealing materials, and it needs to add a variety of compounding agents during processing, including vulcanizing agents, vulcanization accelerators, antioxidants, fillers, anti-scorch agents, active agents And lubricants, and must go through vulcanization, cleaning and other processes to produce products with good physical and chemical properties. In the case of high temperature, the compounding agent in the rubber stopper may be precipitated, and the contact between the precipitate and the drug may affect the quality of the drug and pose a risk to human health. [0003] Ceftriaxone sodium is a third-generation cephalosporin antibiotic, a national basic drug, and its injection powder is w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/86G01N30/06
CPCG01N30/02G01N30/8675G01N30/06
Inventor 崇小萌王立新田冶刘颖朱俐邹文博张斗胜姚尚辰尹利辉许明哲
Owner NAT INST FOR FOOD & DRUG CONTROL
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