Detection method of impurities in polydioxanone

A polydioxanone and detection method technology, applied in the field of analytical chemistry, can solve the problems of inapplicability to routine detection of production samples, high price and high cost of hexafluoroisopropanol, and avoid inaccurate and accurate test results Good effect and low cost

Active Publication Date: 2022-08-09
沈阳恒生医用科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, hexafluoroisopropanol is expensive, and the cost of testing samples as a solvent is high, so it is not suitable for routine testing of production samples

Method used

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  • Detection method of impurities in polydioxanone
  • Detection method of impurities in polydioxanone
  • Detection method of impurities in polydioxanone

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Effect test

Embodiment 1

[0039] Since the amount of impurities remaining in the polydioxanone is very little or not, in order to verify that the detection method of the present invention can effectively detect possible trace impurities, a known amount of impurities was added to the test sample as an additive. Standard test sample, by comparing the detected content of each impurity in the spiked test sample and the known addition amount, calculate the recovery rate, and verify the accuracy of this detection method. Meanwhile, in this embodiment, the detection results of the method of the present invention and the original method are compared to verify the consistency of the detection results of the two methods.

[0040] Polydioxanone sample: provided by Liaoning Yuanda Nuokang Biopharmaceutical Co., Ltd.

[0041] Instrument: Shimadzu gas chromatograph (GC-2010plus, workstation: GC Solution).

[0042]Chromatographic conditions: capillary column (30×0.25mm, 1.4μm) with 6% cyanopropylbenzene+94% methyl p...

Embodiment 2

[0069] Polydioxanone sample: provided by Liaoning Yuanda Nuokang Biopharmaceutical Co., Ltd.

[0070] Instrument: Shimadzu gas chromatograph (GC-2010plus, workstation: GC Solution).

[0071] Chromatographic conditions: capillary column (30×0.25mm, 1.4μm) with 6% cyanopropylbenzene+94% methyl polysiloxane as stationary phase; the column temperature is programmed temperature: the initial column temperature is 40°C, and kept for 5min , the heating rate was 40°C / min, raised to 200°C, and held for 7min; the inlet temperature was 250°C; the hydrogen flame ionization detector was used, and the detector temperature was 260°C; the injection method was direct injection, and the split ratio was 20 : 1, injection volume: 1 μL; carrier gas is nitrogen, column flow: 1.45 mL / min.

[0072] (1) Preparation of the extraction solvent containing the internal standard: take n-hexane, accurately weigh it, dissolve it with propanol and dilute it into a solution containing 0.1 mg of n-hexane per 1 m...

Embodiment 3

[0083] Polydioxanone sample: provided by Liaoning Yuanda Nuokang Biopharmaceutical Co., Ltd.

[0084] Instrument: Shimadzu gas chromatograph (GC-2010plus, workstation: GC Solution).

[0085] Chromatographic conditions: capillary column (30×0.25mm, 1.4μm) with 6% cyanopropylbenzene+94% methyl polysiloxane as stationary phase; the column temperature is programmed temperature: the initial column temperature is 40°C, and kept for 5min , the heating rate was 40°C / min, raised to 200°C, and held for 7min; the inlet temperature was 250°C; the hydrogen flame ionization detector was used, and the detector temperature was 260°C; the injection method was direct injection, and the split ratio was 20 : 1, injection volume: 1 μL; carrier gas is nitrogen, column flow: 1.45 mL / min.

[0086] (1) Preparation of extraction solvent containing internal standard: take n-hexane, accurately weigh, dissolve with ethanol / isopropanol (V / V=1 / 1) and dilute to a solution containing 0.1 mg of n-hexane per 1...

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Abstract

The present invention provides a detection method for the impurities in the polyettetone ketone. This method can not only fully enter the solution into the solution, and avoid the test results caused by the degradation of the sample to meet the accuracy requirements of the test.Methods have strong specialty, high sensitivity, good accuracy, strong reproducibility, good durability, and can be well detected in the impurities in the polyetosterone.Quality control, low cost, and convenient operation.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for detecting impurities in polydioxanone, including a sample processing process and a detection process. Background technique [0002] Poly-p-dioxanone (PPDO) is one of the aliphatic polyester medical absorbable materials with excellent biocompatibility and biodegradability. In vitro, the degradation of polydioxanone is mainly caused by the hydrolysis of ester bonds in the molecule caused by protic solvents. In vivo metabolism studies have shown that PPDO is first hydrolyzed, and then enters the tricarboxylic acid cycle, and the final products are carbon dioxide and water, which are safe and harmless and do not cause any changes in the in vivo environment. At present, it has been developed as passive implantable devices, such as absorbable medical sutures, which are widely used in various departments. [0003] [0004] Polydioxanone, a medical polyme...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 郎洁赵凯华张良陈阳邸伟庆李萍薛雁王宏英薛百忠
Owner 沈阳恒生医用科技有限公司
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