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Method for detecting vulcanizing agent SP1045 phenolic resin in rubber plug

A technology of phenolic resin and detection method, which is applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of lack of SP1045 phenolic resin detection, influence of content results, complicated preparation steps, etc., so as to improve the safety of use and drug safety. , Improve quality control, good test results

Active Publication Date: 2020-12-25
广西中恒创新医药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To sum up, the complex sample preparation steps will easily cause operational errors and affect the content results. p-tert-octylphenol is one of the raw materials for the synthesis of SP1045 phenolic resin, and SP1045 phenolic resin itself is a complex compound. During use, there may be other Degradation products of components are produced, and there is no report on the detection of SP1045 phenolic resin in rubber stoppers
[0004] At present, there is no method for the detection of SP1045 phenolic resin, and it is impossible to detect the content of the vulcanizing agent SP1045 phenolic resin in the rubber stopper and whether there is migration of the drug during use.

Method used

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  • Method for detecting vulcanizing agent SP1045 phenolic resin in rubber plug
  • Method for detecting vulcanizing agent SP1045 phenolic resin in rubber plug
  • Method for detecting vulcanizing agent SP1045 phenolic resin in rubber plug

Examples

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Effect test

Embodiment 1

[0033] A kind of detection method of vulcanizing agent SP1045 phenolic resin in rubber stopper, comprises the following steps:

[0034] Step 1, prepare the test solution: cut the rubber stopper into pieces, weigh 1g of the rubber stopper by precise weighing, place it in a stoppered Erlenmeyer flask, add 20ml of ethyl acetate as a solvent, ultrasonically treat it for 30min, let it cool, Filter, wash the Erlenmeyer flask and filter residue with absolute ethanol, transfer the filtrate and washing liquid to a 25ml volumetric flask, add absolute ethanol to the mark, shake well, filter, and take the subsequent filtrate to obtain the test product solution;

[0035] Step 2, preparation of the migration test product solution: take 0.4g of Xueshuantong (freeze-dried) powder for injection after being ground and mixed by precise weighing, place it in a stoppered Erlenmeyer flask, and precisely add 10ml of ethyl acetate- The mixed solution of absolute ethanol is used as a solvent, plugged...

Embodiment 2

[0041] A kind of detection method of vulcanizing agent SP1045 phenolic resin in rubber stopper, comprises the following steps:

[0042] Step 1, preparation of the test solution: cut the rubber stopper into pieces, weigh 2g of the rubber stopper by precise weighing, place it in a stoppered Erlenmeyer flask, add 20ml of ethyl acetate as a solvent, ultrasonically treat it for 60min, let it cool, Filter, wash the Erlenmeyer flask and filter residue with absolute ethanol, transfer the filtrate and washing liquid to a 25ml volumetric flask, add absolute ethanol to the mark, shake well, filter, and take the filtrate to obtain the test product solution;

[0043] Step 2, prepare the migration test solution: take 0.5g of Xueshuantong (freeze-dried) powder for injection after being ground and mixed by precise weighing, place it in a stoppered Erlenmeyer flask, and accurately add 10ml of ethyl acetate- The mixed solution of absolute ethanol is used as a solvent, plugged tightly, weighed,...

Embodiment 3

[0049] A kind of detection method of vulcanizing agent SP1045 phenolic resin in rubber stopper, comprises the following steps:

[0050] Step 1, preparation of the test solution: cut the rubber stopper into pieces, weigh 2g of the rubber stopper by precise weighing, place it in a stoppered Erlenmeyer flask, add 20ml of ethyl acetate as a solvent, ultrasonically treat it for 70min, let it cool, Filter, wash the Erlenmeyer flask and filter residue with absolute ethanol, transfer the filtrate and washing liquid to a 25ml volumetric flask, add absolute ethanol to the mark, shake well, filter, and take the subsequent filtrate to obtain the test product solution;

[0051] Step 2, prepare the migration test solution: take 0.5 g of Xueshuantong (freeze-dried) powder for injection after being ground and mixed by precise weighing, place it in a stoppered Erlenmeyer flask, and accurately add 10 ml of ethyl acetate- The mixed solution of absolute ethanol is used as a solvent, plugged tigh...

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Abstract

The invention discloses a method for detecting a vulcanizing agent SP1045 phenolic resin in a rubber plug. The method comprises the following steps of: preparing a test solution; preparing a migrationtest solution; preparing a control solution; and performing liquid chromatography determination analysis: adopting high performance liquid chromatography, wherein the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is taken as a filler; acetonitrile is taken as a mobile phase A, and water is taken as a mobile phase B for gradient elution; the detection wavelength is 190-400nm; and the column temperature is 25-35 DEG C. According to the method disclosed by the invention, the raw material SP1045 phenolic resin is taken as a control, the content of the vulcanizing agent SP1045 phenolic resin in the coated rubber plug is detected, whether the vulcanizing agent migrates to a drug is detected in the using process, and the long-term use safety of the drug packaging material and the safety of the drug are ensured.

Description

technical field [0001] The invention relates to the technical field of phenolic resin detection, in particular to a method for detecting vulcanizing agent SP1045 phenolic resin in rubber stoppers. Background technique [0002] As a vulcanizing agent, SP1045 phenolic resin has a good vulcanization effect and can effectively improve physical and chemical properties, so it is widely used. The vulcanizing agent is included in the prescription of Xueshuantong (freeze-dried) drug packaging material for injection, chlorinated butyl rubber stopper covered with polytetrafluoroethylene / ethylene copolymer film for freeze-dried sterile powder for injection. [0003] Chlorobutyl rubber stoppers covered with PTFE / ethylene copolymer film for injection freeze-dried sterile powders are in direct contact with drugs during use, and the good sealing and chemical stability of the rubber stoppers make them less likely to contact with drugs effect and affect the quality of the drug. However, dur...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/88G01N30/06G01N2030/027G01N2030/884
Inventor 韦日伟招丽君黄展文梁云飞蒙永明蒋腾川兰星蒙思宇
Owner 广西中恒创新医药研究有限公司
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