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Method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection

A technique for retinal pigment and dimethyl sulfoxide, which is applied in the field of determination of dimethyl sulfoxide residues in human retinal pigment cell injection, can solve the problem of interference, low concentration, accuracy, precision and sensitivity that cannot meet regulatory requirements and other problems to achieve the effect of improving sensitivity and accuracy and reducing interference effects

Inactive Publication Date: 2019-08-30
EYECURE THERAPEUTICS INC JIANGSU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the above two methods are applied to actual biological samples, due to the low concentration of dimethyl sulfoxide, there is endogenous interference, and the sample size provided for detection is small, so when the above methods are applied to such products, Its accuracy, precision and sensitivity will not meet the regulatory requirements

Method used

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  • Method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection
  • Method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection
  • Method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Method validation for determination of residual solvent dimethyl sulfoxide in human retinal pigment epithelial cell injection:

[0081] Dimethyl sulfoxide reference substance and human retinal pigment epithelial cell injection (201805029RCY-QC1). The injection should be centrifuged before use to obtain the supernatant, and then prepared with ethanol as solvent to prepare the system applicability, specificity, and limit of quantitation respectively. And detection limit, linearity and range, accuracy, repeatability, solution stability, intermediate precision and durability test samples. Each verification item is sampled and tested according to the established standard, and the specific operation is as follows:

[0082] (1) Reference substance solution (two parallel configurations)

[0083] Diluent / Blank Solution: Ethanol

[0084] Reference substance stock solution 1-1: Accurately weigh 50.19mg of DMSO and place it in a 10ml volumetric flask, add diluent to make up the vol...

Embodiment 2

[0133] Human retinal pigment epithelial cell injection, the manufacturer is Jiangsu Aierkang Biomedical Technology Co., Ltd., batch number: 201708093RCY-1; using dimethyl sulfoxide chromatographic separation and mass spectrometry qualitative and quantitative analysis method:

[0134] Dimethyl sulfoxide reference substance is configured with ethanol as solvent

[0135] Reference substance stock solution 1-1: Take 51.36mg of dimethyl sulfoxide reference substance and place it in a 10ml volumetric flask, dilute to volume with ethanol, and shake well.

[0136] Reference substance stock solution 1-2: take 50.48 mg of dimethyl sulfoxide reference substance and place it in a 10ml volumetric flask, dilute to volume with ethanol, and shake well.

[0137] Reference substance stock solution 2-1: Precisely pipette 0.5ml of reference substance stock solution 1-1 into a 50ml volumetric flask, dilute to volume with ethanol, and shake well.

[0138] Reference substance stock solution 2-2: Pr...

Embodiment 3

[0151] Human retinal pigment epithelial cell injection, the manufacturer is Jiangsu Aierkang Biomedical Technology Co., Ltd., batch number: 201710097RCY-1, using dimethyl sulfoxide chromatography separation and mass spectrometry qualitative and quantitative analysis methods:

[0152] The configuration process of reference substance solution 1,2 is the same as embodiment 2

[0153] The test solution configuration:

[0154] Take human retinal pigment epithelial cell injection into a centrifuge tube, centrifuge at 702 g for 5 minutes, and take the centrifuged supernatant to obtain the sample to be tested.

[0155] Test solution SPL-3: Accurately weigh 24.08mg of the sample to be tested into a 5ml volumetric flask, dilute to volume with ethanol, and shake well.

[0156] Test solution SPL-4: Accurately weigh 25.31mg of the sample to be tested into a 5ml volumetric flask, dilute to volume with ethanol, and shake well.

[0157] The above-mentioned test solution SPL-3, SPL-4 and ref...

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Abstract

The invention discloses a method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection. The method comprises steps of (1) pre-treatment of the human retinal pigment epithelial cell injection: centrifuging the injection and then obtaining supernate and detecting; (2) taking a certain amount of supernate and adding proper amount of diluent and mixing uniformly;(3) analyzing residuals in the mixed solution by both gas phase chromatography and mass spectrometry, searching an optimal color spectrum condition and performing methodology verification; and (4) measuring residual dimethyl sulfoxide in the injection by using a verified method. The feasible method of measuring residual dimethyl sulfoxide in human retinal pigment epithelial cell injection is simple, rapid and effective, and delivers reliable and accurate results.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for determining the residue of dimethyl sulfoxide in human retinal pigment cell injection. Background technique [0002] The retinal pigment epithelium (RPE) is a continuous monolayer of cells located on the outer retina, named for its sieve-like shape and abundant melanin in the cytoplasm, they play important functions in the maintenance and self-renewal of retinal cells, such as: phagocytosis Digest the OS of exfoliated photoreceptor cells; promote the regeneration of 11-cis-retinal, an important mediator in the visual cycle; regulate the immune response in the eye; participate in the formation of the retina-vascular barrier, etc. This abnormal physiological function of RPE cells is considered to be closely related to the occurrence of related eye diseases. For example, abnormal RPE cell barrier function can easily lead to Best vitelliform macular dystrophy (BVMD) a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 戴舒春方攀峰王志刚冷晓燕刘辉王云娟
Owner EYECURE THERAPEUTICS INC JIANGSU
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