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Method for detecting content of polyethyleneimine in treatment product

A polyethyleneimine and detection method technology, applied in the field of instrumental analysis, to achieve accurate detection, high sensitivity, and low detection limit

Inactive Publication Date: 2021-01-22
OBIO TECH SHANGHAI CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is currently no PEI content detection method, therefore, there is an urgent need to develop a detection method that can accurately detect the content of polyethyleneimine in therapeutic products

Method used

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  • Method for detecting content of polyethyleneimine in treatment product
  • Method for detecting content of polyethyleneimine in treatment product
  • Method for detecting content of polyethyleneimine in treatment product

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0090] The preparation method of the sample to be tested is as in step S103, which will not be repeated here.

[0091] S202: Using high performance liquid chromatography-charged aerosol detector combination technology to quantify the polyethyleneimine in the test product;

[0092] The quantitative method of step S202 can be quantified by the following methods:

[0093] S2021: Obtain polyethyleneimine reference substance;

[0094] Step S2021 is the same as step S101, and will not be repeated here.

[0095] S2022: Use high performance liquid chromatography-charged aerosol detector to detect the reference substance;

[0096] Step S2022 is the same as step S102, and will not be repeated here.

[0097] S2023: Use high performance liquid chromatography-charged aerosol detector combined technology to detect the product to be tested;

[0098] Step S2023 is the same as step S104, and will not be repeated here.

[0099] S2024: Comparing the detection results of the reference substa...

Embodiment 1

[0111] Investigate the linearity of the CAD detector to the corresponding signal of different PEI injection volumes

[0112] experimental method:

[0113] (1) Mobile phase preparation: Measure 100ml of acetonitrile, add 800ml of water, add 6ml of formic acid, and mix well.

[0114] (2) Take 50 μl of Polyplus PEI (1mg / ml), add 950 μl of mobile phase, mix well, and obtain the reference substance;

[0115] (3) Inject the reference substance into the high performance liquid chromatograph sequentially according to the injection volume shown in Table 1 below, and use a charged aerosol detector to detect. Among them, the chromatographic conditions are: the flow rate of the mobile phase is 1ml / min, the chromatographic column is MabPAC SEC-1, 300A5μm 300*7.8mm, and the temperature is 22°C; CAD detection conditions: frequency 5MHz, filter 3.6s, run time 8min.

[0116] Table 1

[0117]

[0118] From figure 1 and figure 2 It can be seen that the correlation coefficient R of the s...

Embodiment 2

[0120] Spike Recovery Test

[0121] Test sample: same as embodiment 1

[0122] Test method: test according to the method of embodiment 1 and the amount of scalar shown in table 2, and the test results are as shown in table 2;

[0123] Table 2

[0124]

[0125] As can be seen from Table 2, the above-mentioned method has a higher rate of recovery, illustrating that the method of the present invention has higher accuracy.

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Abstract

The invention relates to a method for detecting the content of polyethyleneimine in a treatment product. The method for detecting the content of polyethyleneimine in the treatment product comprises the following steps: obtaining a polyethyleneimine reference substance; detecting a reference substance by adopting a high performance liquid chromatography-electrospray detector combined technology; obtaining a to-be-detected product; detecting the to-be-detected product by adopting the high performance liquid chromatography-electrospray detector combination technology; and comparing the detectionresults of the reference substance and the to-be-detected substance to obtain the content of polyethyleneimine in the to-be-detected substance. The method can accurately detect the content of polyethyleneimine in the treatment product.

Description

technical field [0001] The invention relates to the technical field of instrumental analysis, in particular to a detection method for polyethyleneimine content in therapeutic products. Background technique [0002] In recent years, gene therapy has developed rapidly as a new type of therapy, and several gene therapy products such as Luxturna, Yescarta, T-vec, Strimvelis, etc. have been launched on the market one after another. The therapeutic effect of gene therapy products largely depends on the gene transfection system, that is, the vector carrying the target gene is delivered into the cells by using specific transfection reagents. [0003] Currently, the most widely used transfection reagents include cationic liposomes and cationic polymers. Among them, cationic liposome has high efficiency in gene transfection in vitro, but in vivo, it will be cleared rapidly and accumulate in lung tissue, induce strong anti-inflammatory response, and has toxicity, so the application is...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/72
CPCG01N30/02G01N30/7266
Inventor 党金玲郑琳松贾国栋由庆睿潘讴东吴周凯凯陈井波
Owner OBIO TECH SHANGHAI CORP LTD
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