Measuring method for detecting gel chromatography of high molecular weight materials in Qingkailing injection

A high-molecular-weight, gel-chromatographic technology, applied in the field of gel-chromatographic determination of high-molecular-weight substances in Qingkailing injection, to save clinical emergency time, ensure safety and effectiveness, and shorten the time

Active Publication Date: 2014-04-23
广东省药品检验所
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However, the skin test can only predict the immediate type I allergic reaction, and the positive coincidence rate is only 30%. Even if the skin test is negative, it cannot explain that no allergic reaction will occur in the future. The clinically possible allergic reactions include II, Type III and IV allergies, which cannot be predicted by skin tests

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  • Measuring method for detecting gel chromatography of high molecular weight materials in Qingkailing injection
  • Measuring method for detecting gel chromatography of high molecular weight materials in Qingkailing injection
  • Measuring method for detecting gel chromatography of high molecular weight materials in Qingkailing injection

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Embodiment Construction

[0015] The present invention will be further described below in conjunction with the accompanying drawings of the description.

[0016] Preferably, a gel chromatography assay method for detecting high molecular weight substances in Qingkailing injection, the method comprises the following steps: a, preparation of contrast solution: as figure 1 As shown, take 1ml each of ribonuclease A, human insulin, thymosin α, and human somatostatin reference substance solution, put it in a 25ml measuring bottle, add water to dilute and set the volume to the mark, and then obtain reference substance solution I; Get contrast solution I 2.5ml, be settled to 25ml, obtain contrast solution II; B, preparation of need testing solution: get need testing solution 10ml, in the ultrafiltration centrifuge tube of 20ml, the present invention adopts Millipore ultrafiltration Centrifuge the tube at 10,000 rpm for 15 minutes, take the residue and add water to dilute to 1ml to obtain the test solution. ins...

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Abstract

The invention provides a measuring method for detecting gel chromatography of high molecular weight materials in Qingkailing injection, wherein the method comprises the following steps: a, preparing a reference solution; b, preparing a test article solution; c, measuring: respectively and precisely absorbing 20 microliter of the reference solution and test article solution; injecting the two solutions into a liquid chromatograph; making a linear regression equation of a standard curve with the logarithm of the molecular weight of each reference substance and the corresponding retention time, and calculating the retention times of the substances with molecular weights at 10000, 5000 and 1000 by a standard curve regression equation, taking the retention times as the limit to calculate the accumulated peak area value of the test article in each section; d, measuring the lowest detection limit; e, detecting influences of sample matrix interferences; f, simulating the test; and g, measuring the sample. In the method provided by the invention, the high molecular weight materials in Qingkailing injection products are detected, and the high molecular weight materials which are possibly brought in are effectively monitored; and the method has very important significance.

Description

technical field [0001] The invention relates to the technical field of detection of traditional Chinese medicine injections, in particular to a gel chromatography determination method for detecting high molecular weight substances in Qingkailing injections. Background technique [0002] The study of macromolecular substances is the main content of this exploratory study. There are many adverse reactions in Qingkailing injection, and the focus of literature reports is mostly on macromolecular substances such as high molecular weight. Due to method limitations, such high molecular weight determinations have not been carried out. For Qingkailing injection products containing high molecular weight substances, from the perspective of safety, patients need to undergo skin tests when applying them. However, the skin test can only predict the immediate type I allergic reaction, and the positive coincidence rate is only 30%. Even if the skin test is negative, it cannot explain that ...

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 杨立伟李泳雪肖树雄刘潇潇胡珂
Owner 广东省药品检验所
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