Full
Outline
To develop the first batch of standardized reagents for the potency assay of heparin, low-molecular-weight heparin (LMWH) anti-factor Xa and anti-factor Ⅱa.
Fibrinogen coagulation method was used for factor Ⅱa reagent to assign the potency, which was calculated with the national standard of thrombin. Chromogenic substrate method was used for antithrombin Ⅲ to assign the potency, which was calculated with the WHO international standard. The potency of facor Xa was measured using a fully automatic hemagglutination instrument, calculated with the national standard of human coagulation factor. The purity and free pNA content of chromogenic substrates S-2765 and S-2238 were analyzed by reversed-phase chromatography. The separation was obtained by the column Agela Technologies Venusil XBP RP C18 (250 mm×4.6 mm, 5 μm) using mobile phase A of 20% acetonitrile solution which contained 0.1% trifluoroacetic acid and phase B of 60% acetonitrile solution which contained 0.1% trifluoroacetic acid in a gradient elution. The wavelength was set at 313 nm. The constant Km was calculated to evaluate the enzyme and substrate affinities.
The standard reagent potency of factors Ⅱa, Factor Xa, and Antithrombin III were 40 IU, 76.3 nKat, and 10 IU per vial, respectively. The limit of quantification (LOQ) and detection limit of detection (LOD) of pNA were 7.6 ng·mL-1 and 2.3 ng·mL-1; the linear range is 0.005~100 μg·mL-1(r=1.0); the sample recovery rate is in the range of 98.5%~102.3%. The contents of chromogenic substrates, S-2765 and S-2238, are 96.2% and 97.3%. There is no statistical difference in Km between imported reagents and standard reagents.
According to the quality test results of standard reagents in this study, it can be seen that standard reagents can completely replace imported reagents, and the value of standard reagents is much accurate compared to imported reagents.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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