Full scan analysis method for organic matter in medical device extracts

Abstract

The present invention discloses a full-scan analysis method for organic matter in a medical device extract, comprising the following steps: (1) sample mother solution preparation: (2) standard curve solution A preparation; (3) adding an extractant to the sample mother solution of step (1) and the standard curve solution A of step (2), respectively, and obtaining the solution A to be tested, and then respectively measuring the solution using GC-MS. The sample solution in the present application is used as an acidic extract to simulate the use environment of the medical device when it is in contact with an acidic drug. With a specific chromatographic column and temperature and heating program, the organic matter in the extract can be well separated, avoiding the overlap of the peak position and the interference of impurities. Moreover, the full-scan analysis method is used for the detection of volatile organic compounds and semi-volatile organic compounds, and has high specificity, linearity, sensitivity, precision, accuracy, and low detection limit, and can be widely used for the detection of volatile organic compounds and semi-volatile organic compounds in an acidic extract with a pH of 3 in a closed drug transfer device (CSTD).

Description

Technical Field

[0001] The present invention relates to the field of chemical analysis and detection, G01N30 / 02, and in particular to a full-scan analysis method for organic matter in a medical device extract. Background Art

[0002] Nowadays, many medical devices are made of polymers with different properties. Their components are complex, and different types of medical devices have different functions and are used in different places. When they come into contact with drugs or even blood, they will interact to a large extent, and residual organic solvents and other substances in the preparation process will also exist, which will cause serious toxic effects after entering the blood. Therefore, the biological evaluation of medical devices should be taken seriously. Closed drug transfer devices can be used to transfer dangerous drugs, mechanically organize the transfer of environmental pollutants into the system, and prevent harmful drugs or vapor concentrations from escaping the system. During use, they will come into contact with blood and different liquid medicines, and the analysis and detection of volatile organic compounds and semi-volatile organic compounds in their acid extracts is essential.

[0003] At present, the main methods for detecting organic solvent residues in medical device products are titration, liquid-solid extraction, and gas chromatography. Patent CN202010244336.8 discloses a kit and method for rapid detection of the total amount of ethylene oxide and 2-chloroethanol in medical devices. The kit includes reagent A, reagent B, reagent C, reagent D, reagent E, reagent F and reagent G, colorimetric tubes, measuring cylinders and standard colorimetric cards. Finally, standard colorimetric cards are prepared through various standard color scale solutions, and the content of the analyte is finally determined. It is free from expensive instruments and has low cost, but this method is time-consuming. Patent CN201811057690.9 discloses a method for determining the residual diphenylmethane-4,4′-diisocyanate in a hemodialyzer. After the hemodialyzer sealing layer is leached with a mixture of an organic solvent, a derivatizing agent, and an internal standard, the residual amount of diphenylmethane-4,4′-diisocyanate in the hemodialyzer is calculated and detected using a high-performance liquid chromatography-fluorescence-internal standard method. The sensitivity and accuracy of this detection method have been improved. However, these methods have high detection limits and poor accuracy and precision. Summary of the invention

[0004] In order to solve the above problems, the first aspect of the present invention provides a full scan analysis method for organic matter in a medical device extract, which comprises the following steps:

[0005] (1) Preparation of sample mother solution: add the prepared KCl aqueous solution to a solvent bottle, then add the acid solution and purified water, and adjust the pH of the solution to obtain the sample mother solution;

[0006] (2) Preparation of standard curve solution A;

[0007] S1. Preparation of mixed standard mother solution A: prepare a methanol solution of deuterated naphthalene and a methanol solution of methyl palmitate, measure the methanol solution of deuterated naphthalene and the methanol solution of methyl palmitate, mix them, dilute to scale with acetonitrile, shake well, and obtain a mixed standard mother solution A;

[0008] S2. Prepare standard curve solution A: Take the prepared KCl aqueous solution in a sample bottle and add the mixed standard solution A to obtain;

[0009] (3) Adding an extractant to the sample mother solution of step (1) and the standard curve solution A of step (2) to obtain a sample solution to be tested and a standard curve solution A to be tested, and then measuring them by GC-MS respectively.

[0010] In step (1)

[0011] As a preferred embodiment, the molar concentration of the KCl aqueous solution is 0.1-0.3M; preferably, the molar concentration of the KCl aqueous solution is 0.2M;

[0012] As a preferred embodiment, the acidic solution is selected from one or more of phosphate buffer, hydrochloric acid solution, sulfuric acid solution, nitric acid solution, glacial acetic acid solution, and carbonate buffer; preferably, the acidic solution is hydrochloric acid solution;

[0013] As a preferred embodiment, the molar concentration of the acidic solution is 0.05-0.4M; preferably, the molar concentration of the acidic solution is 0.2M;

[0014] As a preferred embodiment, the pH of the sample solution is 2 to 3.5; preferably, the pH of the sample solution is 3;

[0015] In the present application, the sample mother solution in step (1) is used as an extracting solution, which is an acidic extracting solution. It simulates the use environment of medical devices when they are in contact with acidic drugs, and replaces the drug solution for extraction research. With the help of a specific chromatographic column and temperature and heating program, the organic matter in the extracting solution can be well separated, avoiding the overlap of peak positions and interference from impurities.

[0016] The applicant has found that when the acidic solution used is a hydrochloric acid solution, its polarity can improve the solubility of the solution, so that harmful organic substances in the medical device are well dissolved. In particular, when the hydrochloric acid concentration is 0.2M and the pH value of the acidic solution is 3, the extraction capacity of the solution can be further improved. It is speculated that the concentration of the acid solution, the pH value and the ionic strength of the hydrochloric acid solution and other factors work together to increase the solubility of the volatile organic substances and semi-volatile organic substances contained in the medical device in the hydrochloric acid solution. At the same time, the polymer structure of the medical device will not be destroyed, and the residue of the extract will not cause adverse effects on subsequent biological determinations. However, impurities will be precipitated, affecting the accuracy and precision of the detection method. The applicant unexpectedly discovered that after extraction with dichloromethane, ethyl acetate and ethanol in a volume ratio of 2.5:2:1, the specificity, sensitivity, precision and accuracy of the detection method of volatile organic compounds and semi-volatile organic compounds were improved with the coordinated cooperation of the chromatographic column and the temperature program setting, especially the detection of volatile organic compounds and semi-volatile organic compounds in the acidic extract with a pH of 3 in a closed drug transfer device (CSTD).

[0017] Preferably, the specific operation of preparing the sample mother solution is:

[0018] Weigh KCl and add purified water to dissolve and dilute to obtain a 0.2M KCl aqueous solution. Then measure 250mL of 0.2M KCl aqueous solution into another 1000mL solvent bottle, add 5.3mL of acidic solution, add purified water to 1000mL, adjust the pH with acidic solution, mix well, and obtain the sample mother solution.

[0019] In step (2)

[0020] As a preferred embodiment, in step S1, deuterated naphthalene is an extractable volatile organic compound having an aromatic structure; methyl palmitate is an extractable semi-volatile organic compound having an aliphatic hydrocarbon structure;

[0021] As a preferred embodiment, the concentrations of deuterated naphthalene and methyl palmitate are both 90.0 to 120 μg / mL; preferably, the concentrations of deuterated naphthalene and methyl palmitate are both 100 μg / mL;

[0022] Preferably, the specific operation of preparing the mixed standard mother solution A in step S2 is:

[0023] Prepare 1.106 mg / mL of deuterated naphthalene methanol; prepare 1.017 mg / mL of methyl palmitate methanol solution; respectively measure the above deuterated naphthalene methanol solution and methyl palmitate methanol solution, mix them, and dilute them with acetonitrile to obtain a mixed standard mother solution A with a concentration of both deuterated naphthalene and methyl palmitate of 100.0 μg / mL.

[0024] As a preferred embodiment, in step S2, six series of standard curve solutions A of gradient deuterated naphthalene and methyl palmitate are prepared;

[0025] As a preferred embodiment, the concentrations of deuterated naphthalene and methyl palmitate in the six gradient series of standard curve solutions A mixed with deuterated naphthalene and methyl palmitate are 40.0 μg / L, 100.0 μg / L, 200.0 μg / L, 300.0 μg / L, 500.0 μg / L, and 750.0 μg / L, respectively;

[0026] In step (3)

[0027] As a preferred embodiment, the specific operation of the extractant treatment is: respectively measure the sample mother solution obtained in step (1) and the standard curve solution A obtained in step (2) into a sample bottle, add the extractant, cover the bottle cap, shake, let stand, then add NaCl and shake, let stand, take the lower layer solution, add the desiccant, shake, let stand, and take the upper layer solution;

[0028] As a preferred embodiment, the extractant is selected from one or more of benzene, dichloromethane, chloroform, ethyl acetate, kerosene, gasoline, ether, carbon tetrachloride, n-hexane, and petroleum ether; preferably, the extractant is dichloromethane, ethyl acetate, and ether;

[0029] As a preferred embodiment, the volume ratio of dichloromethane, ethyl acetate and ethanol is (2-3): (1-3): 1; preferably, the volume ratio of dichloromethane, ethyl acetate and ethanol is 2.5:2:1;

[0030] The applicant has found that when the extractant is a single component, its ability to extract and separate organic matter from medical devices is relatively weak. When the extractant is a mixture of dichloromethane, ethyl acetate and ether with a volume ratio of 2.5:2:1, it is not only beneficial to improve the extraction ability, but also can accelerate the extraction and separation speed.

[0031] As a preferred embodiment, the desiccant is selected from one or more of anhydrous sodium sulfate and anhydrous magnesium sulfate; preferably, the desiccant is anhydrous sodium sulfate;

[0032] As a preferred embodiment, the shaking time is 0.2 to 0.8 minutes, and the standing time is 3 to 7 minutes; preferably, the shaking time is 0.5 minutes, and the standing time is 6 minutes;

[0033] Preferably, the specific extraction operation of the extraction product of the sample mother solution is:

[0034] Measure 10.00mL of sample mother solution into a sample bottle, add 10.00mL of extractant, cover the bottle cap, shake for 0.5min, let stand for 5min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to draw about 5mL of the lower layer solution into another 20mL sample bottle, then add desiccant until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to draw about 1mL of the upper layer solution into the injection bottle;

[0035] Preferably, the specific extraction operation of the extraction product of the standard curve solution A is:

[0036] Measure 10.00 mL of 0.05 M KCl aqueous solution into a 20 mL sample bottle, and respectively measure mixed standard solution A of deuterated naphthalene and methyl palmitate with a concentration of 100.0 μg / mL into the bottle to prepare standard curve solution A;

[0037] As a preferred embodiment, the GC-MS test chromatographic conditions are: the injection port temperature is 270-290°C; the injection mode is pulse non-divided flow; the purge flow rate is 24.0-26.0psi; the injection volume is 1.0-3.0μL; the carrier gas is high-purity helium (99.999%); the transmission line temperature is 290-310°C; the column flow rate is 0.5-2.0mL / min; the chromatographic column is HP-5MSUI, 30m×0.25mm×0.25μm; the heating program is: initial temperature: 40°C, maintained for 2-4min, increased to 300°C at 7-10°C / min, maintained for 4-6min;

[0038] Preferably, the GC-MS test chromatographic conditions are: injection port temperature is 280°C; injection mode is pulse non-divided flow; purge flow is 25.0psi; injection volume is 2.0μL; carrier gas is high-purity helium (99.999%); transmission line temperature is 300°C; column flow rate is 1.2mL / min; chromatographic column is HP-5MS UI, 30m×0.25mm×0.25μm; heating program is: initial temperature: 40°C, hold for 3min, increase to 300°C at 8°C / min, hold for 5min;

[0039] The GC-MS test mass spectrometry conditions are: ion source temperature: 230° C.; quadrupole temperature: 150° C.; solvent delay: 4 min; scanning range: 29-550 m / z.

[0040] The second aspect of the present invention provides an application of a full scan analysis method for organic matter in a medical device extract, which can be used to detect the content of organic matter in a medical device extract. DETAILED DESCRIPTION

[0041] Embodiment 1:

[0042] 1. A full scan analysis method for organic matter in medical device extracts, comprising the following steps:

[0043] (1) Preparation of sample stock solution: Weigh KCl and add 1000 mL of purified water to dissolve and dilute to obtain a 0.2 M KCl aqueous solution. Then, measure 250 mL of 0.2 M KCl aqueous solution into another 1000 mL solvent bottle, add 5.3 mL of acidic solution, add purified water to 1000 mL, adjust the pH to 3 with acidic solution, mix well, and obtain the sample stock solution.

[0044] Extraction agent treatment: measure 10.00mL of sample mother liquor into a sample bottle, add 10.00mL of extraction agent, cover the bottle cap, shake for 0.5min, let stand for 5min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to absorb 5mL of the lower solution into another sample bottle, then add desiccant until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to absorb 1mL of the upper solution (i.e., the sample solution to be tested) into the injection bottle.

[0045] (2) Preparation of standard curve solution A;

[0046] S1. Prepare mixed standard stock solution A: prepare 1.106 mg / mL of deuterated naphthalene methanol; prepare 1.017 mg / mL of methyl palmitate methanol solution; respectively measure the above-mentioned deuterated naphthalene methanol solution and methyl palmitate methanol solution, mix them, dilute with acetonitrile, and obtain a mixed standard stock solution A with a concentration of 100.0 μg / mL for deuterated naphthalene and methyl palmitate.

[0047] S2. Prepare standard curve solution A: measure 10.00mL of 0.05M KCl aqueous solution into a 20mL sample bottle, add mixed standard solution A, prepare a series of standard curve solutions A, the concentrations of deuterated naphthalene and methyl palmitate are 40.0μg / L, 100.0μg / L, 200.0μg / L, 300.0μg / L, 500.0μg / L, 750.0μg / L respectively;

[0048] Extraction agent treatment: 10.00 mL of 0.05 M KCl aqueous solution was measured in a sample bottle, and the mixed standard mother solution A with the concentration of deuterated naphthalene and methyl palmitate both being 100.0 μg / mL was measured in the bottle, and then 10.00 mL of the extraction agent was added, the bottle cap was covered, and the mixture was shaken for 0.5 min, and the mixture was allowed to stand for 5 min. Then, NaCl was added until the bottom of the bottle was in the form of quicksand, and the mixture was shaken for 0.5 min, and the mixture was allowed to stand for 5 min. 5 mL of the lower layer solution was drawn into another sample bottle with a glass dropper, and then desiccant was added until the bottom of the bottle was in the form of quicksand, and the mixture was shaken for 0.5 min, and the mixture was allowed to stand for 5 min. 1 mL of the upper layer solution was drawn into the injection bottle with a glass dropper to prepare the standard curve solution A to be measured;

[0049] (3) The extraction products of steps (1) and (2) are measured by GC-MS.

[0050] The acidic solution is a hydrochloric acid solution;

[0051] The substance concentration of the acidic solution is 0.2M;

[0052] The extractant is dichloromethane, ethyl acetate, or ether;

[0053] The volume ratio of dichloromethane, ethyl acetate and ethanol is 2.5:2:1;

[0054] The desiccant is anhydrous sodium sulfate;

[0055] In step (1) and step (3), the shaking time is 0.5 min and the standing time is 6 min;

[0056] The GC-MS test chromatographic conditions are as follows: injection port temperature is 280°C; injection mode is pulse splitless; purge flow is 25.0psi; injection volume is 2.0μL; carrier gas is high-purity helium (99.999%); transfer line temperature is 300°C; column flow rate is 1.2mL / min; chromatographic column is HP-5MS UI, 30m×0.25mm×0.25μm; heating program is: initial temperature: 40°C, hold for 3min, increase to 300°C at 8°C / min, hold for 5min;

[0057] The GC-MS test mass spectrometry conditions are: ion source temperature: 230°C; quadrupole temperature: 150°C; solvent delay: 4 min; scanning range: 29-550 m / z;

[0058] 2. Application of full scan analysis method for organic matter in medical device extracts, which can be used to detect the content of organic matter in medical device extracts.

[0059] Embodiment 2:

[0060] 1. The full scan analysis method of organic matter in the medical device extract is different from that in Example 1 in that the volume ratio of dichloromethane, ethyl acetate and ethanol is 3:1.5:1;

[0061] 2. Application of the full scan analysis method for organic matter in medical device extracts, same as in Example 1.

[0062] Comparative Example 1:

[0063] 1. The full scan analysis method of organic matter in the medical device extract is different from that in Example 1 in that the volume ratio of dichloromethane, ethyl acetate and ethanol is 4:4:1;

[0064] 2. Application of the full scan analysis method for organic matter in medical device extracts, same as in Example 1.

[0065] Comparative Example 2:

[0066] 1. The full scan analysis method for organic matter in the medical device extract is different from that in Example 1 in that: the chromatographic column is ACQUITY UPLC BECH C18, 2.1 mm×50 mm, 1.7 μm;

[0067] 2. Application of the full scan analysis method for organic matter in medical device extracts, same as in Example 1.

[0068] Comparative Example 3:

[0069] 1. The full scan analysis method of organic matter in the extract of medical devices is different from that in Example 1 in that: the temperature program is as follows: initial temperature: 40°C, maintained for 3 min, increased to 300°C at 12°C / min, maintained for 5 min;

[0070] 2. Application of the full scan analysis method for organic matter in medical device extracts, same as in Example 1.

[0071] Performance Test:

[0072] 1. Accuracy: Take low concentration level accuracy solution, medium concentration level accuracy solution and high concentration level accuracy solution as accuracy samples, inject and analyze them respectively, and calculate the recovery rate and relative standard deviation RSD;

[0073] Preparation of low-concentration level accuracy solution: Measure 10.0 mL of sample mother solution into a sample bottle, add it to the sample bottle, add 10.0 μL of mixed standard mother solution A, then add 10.00 mL of extractant, cover the bottle, shake for 0.5 min, let stand for 5 min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add anhydrous sodium sulfate until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle;

[0074] The extractant is the same as the extractant in each embodiment / comparative example;

[0075] Three low concentration level accuracy solutions were prepared in parallel using the same method, and low concentration level accuracy solutions 1 to 3 were obtained in sequence;

[0076] Preparation of medium concentration level accuracy solution: Measure 10.0mL of sample mother solution into a sample bottle, add it to the sample bottle, add 30.0μL of mixed standard mother solution A, then add 10.00mL of extractant, cover the bottle, shake for 0.5min, let stand for 5min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to draw 5mL of the lower layer solution into another sample bottle, then add anhydrous sodium sulfate until the bottom of the bottle becomes quicksand, shake for 0.5min, let stand for 5min, use a glass dropper to draw 1mL of the upper layer solution into the injection bottle;

[0077] The extractant is the same as that in Example 1;

[0078] Three medium concentration level accuracy solutions were prepared in parallel using the same method, and medium concentration level accuracy solutions 1 to medium concentration level accuracy solutions 3 were obtained in sequence;

[0079] Preparation of high-concentration horizontal accuracy solution: Measure 10.0 mL of sample mother solution into a sample bottle, add it to the sample bottle, add 50.0 μL of mixed standard mother solution A, then add 10.00 mL of extractant, cover the bottle, shake for 0.5 min, let it stand for 5 min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5 min, let it stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add anhydrous sodium sulfate until the bottom of the bottle becomes quicksand, shake for 0.5 min, let it stand for 5 min, use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle;

[0080] The extractant is the same as that in Example 1;

[0081] Three high concentration horizontal accuracy solutions were prepared in parallel using the same method, and high concentration horizontal accuracy solutions 1 to 3 were obtained in sequence;

[0082] 2. Specificity test: using the reagent blank solution, sample solution, standard curve solution A, and quantitative limit spike solution as specificity solutions, observe whether there is interference at the peak position according to step (3) in Example 1;

[0083] (1) Preparation of reagent blank solution: 10 mL 0.05 M KCl aqueous solution;

[0084] (2) Preparation of standard curve solution: Measure 10.00 mL of 0.05 M KCl aqueous solution into a sample bottle, add 30.0 μL of mixed standard mother solution A, then add 10.00 mL of extractant dichloromethane, ethyl acetate, and ether (volume ratio of 2.5:2:1), cover the bottle cap, shake for 0.5 min, let stand for 5 min, then add NaCl until the bottom of the bottle becomes a quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add desiccant until the bottom of the bottle becomes a quicksand, shake for 0.5 min, let stand for 5 min, and use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle;

[0085] (3) Quantitation limit spike solution: low concentration level accuracy solution 1;

[0086] 3. Linear analysis: The linear regression equation and correlation coefficient are automatically calculated by the instrument software;

[0087] 4. Detection limit: The signal-to-noise ratio of the target in the detection limit solution is calculated and reported;

[0088] Preparation of detection limit solution: Measure 10.00 mL of 0.05 M KCl aqueous solution into a sample bottle, add 4.0 μL of mixed standard mother solution A, then add 10.00 mL of extractant dichloromethane, ethyl acetate, and ether (volume ratio is 2.5:2:1), cover the bottle cap, shake for 0.5 min, let stand for 5 min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add desiccant until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle, and configure it into standard curve solution A;

[0089] 5. Precision (repeatability): prepare repeatable solution for sampling and analysis, and calculate RSD;

[0090] Preparation of precision (repeatability) solution: Measure 10.00 mL of sample mother solution into a sample bottle, add 30.0 μL of mixed standard mother solution A, then add 10.00 mL of extractant, cover the bottle cap, shake for 0.5 min, let stand for 5 min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add desiccant until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle;

[0091] The extractant is the same as the extractant in each embodiment / comparative example;

[0092] Three precision (repeatability) solutions were prepared in parallel using the same method.

[0093] 6. Precision (intermediate precision): prepare precision (intermediate precision) solution for sampling and analysis, set up three parallel samples, and calculate RSD;

[0094] Preparation of precision (intermediate precision) solution:

[0095] Prepare a 1.045 mg / mL methanol solution of deuterated naphthalene; prepare a 1.0028 mg / mL methanol solution of methyl palmitate; measure the methanol solution of deuterated naphthalene and the methanol solution of methyl palmitate, mix them, and dilute them with acetonitrile to obtain a mixed standard mother solution B with a concentration of both deuterated naphthalene and methyl palmitate of 100.1 μg / mL;

[0096] Measure 10.00 μL of sample mother solution into a sample bottle, add 30.0 μL of mixed standard mother solution B, then add 10.00 mL of extractant, cover the bottle cap, shake for 0.5 min, let stand for 5 min, then add NaCl until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 5 mL of the lower layer solution into another sample bottle, then add desiccant until the bottom of the bottle becomes quicksand, shake for 0.5 min, let stand for 5 min, use a glass dropper to draw 1 mL of the upper layer solution into the injection bottle;

[0097] The extractant is the same as the extractant in each embodiment / comparative example.

[0098] Table 1 Example 1 Test results

[0099]

[0100] Table 2 Test results of Example 1 and Comparative Examples 1 to 3

[0101]

Claims

1. A full scan analysis method for organic matter in medical device extracts, characterized in that: The following steps are involved: (1) Preparation of sample mother solution: Take the prepared KCl aqueous solution and add it into the solvent bottle, then add the acid solution and purified water, and adjust the pH of the solution to obtain the sample mother solution; (2) Preparation of standard curve solution A; S1. Preparation of mixed standard solution A: prepare a methanol solution of deuterated naphthalene and a methanol solution of methyl palmitate, measure the methanol solution of deuterated naphthalene and the methanol solution of methyl palmitate, mix them, dilute to the mark with acetonitrile, and shake well to obtain a mixed standard solution A; S2. Prepare standard curve solution A: Take the prepared KCl aqueous solution in a sample bottle and add the mixed standard solution A to obtain; (3) adding an extractant to the sample mother solution of step (1) and the standard curve solution A of step (2), respectively, to obtain a sample solution to be tested and a standard curve solution A to be tested, and then measuring them by GC-MS respectively; The acidic solution is a hydrochloric acid solution; The molar concentration of the acidic solution is 0.05-0.4M; The pH of the sample solution is 2-3.5; The extractant is dichloromethane, ethyl acetate, and ether in a volume ratio of 2.5:2:1; The GC-MS test chromatographic conditions are as follows: the injection port temperature is 270~290°C; the injection mode is pulse non-divided flow; the purge flow rate is 24.0~26.0psi; the injection volume is 1.0~3.0μL; the carrier gas is high-purity helium; the transmission line temperature is 290~310°C; the column flow rate is 0.5~2.0mL / min; the chromatographic column is HP-5MS UI, 30m×0.25mm×0.25μm; the heating program is as follows: initial temperature: 40°C, maintained for 2~4min, increased to 300°C at 7~10°C / min, and maintained for 4~6min.

2. A full scan analysis method for organic matter in a medical device extract according to claim 1, characterized in that: The molar concentration of the KCl aqueous solution is 0.1-0.3M.

3. The full scan analysis method for organic matter in a medical device extract according to claim 1, characterized in that: The GC-MS test mass spectrometry conditions are: ion source temperature: 230° C.; quadrupole temperature: 150° C.; solvent delay: 4 min; scanning range: 29-550 m / z.

4. An application of the full scan analysis method for organic matter in a medical device extract as claimed in any one of claims 1 to 3, characterized in that: Used for detecting the content of organic matter in medical device extracts.

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