Activity determination method of low concentration Ulinastatin
A technology for ulinastatin and activity determination, which is applied in the direction of material analysis by observing the effect on chemical indicators, and analysis by chemical reaction of materials, etc., can solve the problem of high cost of inspection reagents, inability to sample detection, and equipment requirements Advanced problems, to achieve the effect of high sensitivity, high equipment requirements and low cost
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Embodiment 1
[0024] Take a sample during the purification process of ulinastatin, the concentration of which was determined to be 61U / ml according to the method described in the Chinese Pharmacopoeia 2010 edition, and accurately add 5 times the volume of water to dilute the sample to obtain a low-concentration ulinastatin sample. Carry out ulinastatin concentration determination according to the method of the present invention:
[0025] A low-concentration ulinastatin activity assay method, comprising the steps:
[0026] 1) Take 3 test tubes, tube A 0 , Tube A S , Tube A T , and to A 0 Add 3ml of 0.2 M triethanolamine buffer solution to the tube, and add 2.8ml of the triethanolamine buffer solution to the other two tubes;
[0027] 2) to tube A S Add 0.2ml of 10U / ml ulinastatin reference substance to tube A T Add 0.2ml of the sample solution to be tested, mix well, add 0.2ml of 0.01mg / ml trypsin solution to each tube (the final concentration of trypsin in the reaction system is 0.0005...
Embodiment 2
[0039]The sample of 61U / ml in embodiment 1 is diluted 61 times, detects according to the method of the present invention:
[0040] A low-concentration ulinastatin activity assay method, comprising the steps:
[0041] 1) Take 3 test tubes, tube A 0 , Tube A S , Tube A T , and to A 0 Add 3ml of 0.2 M triethanolamine buffer solution to the tube, and add 2.8ml of the triethanolamine buffer solution to the other two tubes;
[0042] 2) to tube A S Add 0.2ml of 1U / ml ulinastatin reference substance to tube A T Add 0.2ml of the sample solution to be tested, mix well, add 0.2ml of 0.001mg / ml trypsin solution to each tube (the final concentration of trypsin in the reaction system is 0.000058mg / ml), mix immediately and place in a 37°C water bath keep warm for 10 minutes;
[0043] 3) Add 0.2ml of 20mg / ml BAPNA substrate solution to each tube, mix immediately and keep warm in a 37°C water bath for 60 minutes, add 0.6ml of 20% trichloroacetic acid stop solution to each tube, mix imme...
Embodiment 3
[0054] The sample of 61U / ml in embodiment 1 is diluted 3 times, detects according to the inventive method:
[0055] A low-concentration ulinastatin activity assay method, comprising the steps:
[0056] 1) Take 3 test tubes, tube A 0 , Tube A S , Tube A T , and to A 0 Add 3ml of 0.2 M triethanolamine buffer solution to the tube, and add 2.8ml of the triethanolamine buffer solution to the other two tubes;
[0057] 2) to tube A S Add 0.2ml of 20U / ml ulinastatin reference substance into tube A T Add 0.2ml of the sample solution to be tested, mix well, add 0.2ml of 0.1mg / ml trypsin solution to each tube (the final concentration of trypsin in the reaction system is 0.0058mg / ml), mix immediately and place in a 37°C water bath keep warm for 10 minutes;
[0058] 3) Add 0.2ml of 20mg / ml BAPNA substrate solution to each tube, mix immediately and keep warm in a 37°C water bath for 10 minutes, add 0.6ml of 20% trichloroacetic acid stop solution to each tube, mix immediately to stop ...
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