本品为醇剂型血液促凝剂，以无水乙醇为溶剂，搭配多种有效促凝成分，专为快速凝血、高效分离血清设计，适用于医用采血管制备及临床检验。
本品主要成分为硅藻土、高岭土、硅微粉、无水乙醇等，各成分比例科学配比，确保促凝效果稳定，且不干扰临床检测。
本品为淡黄色浑浊液体，静置后会出现沉淀，摇匀后呈均匀悬浊液；具有快速加速血液凝固的作用，对临床生化项目检测无任何影响，且醇剂成分易挥发，烘干后无残留。
适用范围
可用于制备真空采血管及注射式采血管，广泛应用于临床医学检验工作中。化验人员可在同一器皿中，完成血样采集、快速分离血清及样品传递等操作，简化检验流程，提高工作效率。
促凝原理
通过激活血浆及血小板中的部分凝血因子，促进凝血活酶和纤维蛋白凝块的生成，加速血球凝块收缩，从而达到快速分离血清的目的；其中无水乙醇可辅助分散促凝成分，增强促凝效果的均匀性。
促凝能力
在25℃环境下，取15-20µl本品（醇剂），可使5mL血样快速凝固；血液初始凝固后，静置30分钟左右即可上机离心（离心力：1200-1500g，离心时间：8-10分钟），顺利分离出血清。离心后血块收缩良好，血清析出量大，分离状态佳，无杂质残留，不干扰血液标本检测结果。当环境温度低于20℃时，可适当延长采血后静置时间，确保促凝充分，以达到最佳血清分离效果。
用法与用量
添加方式：采用机器喷雾法加入采血管，添加过程中须不断搅拌，保持悬浊液均匀，确保各有效成分添加量一致，避免因醇剂分层影响促凝效果。
搅拌方式：可采用机械搅拌、电磁搅拌、气动搅拌等方式维持悬浊液均匀，搅拌速度根据实际设备及操作场景调整，以无明显沉淀、悬浊均匀为准。
烘干处理：本品为醇剂，添加完成后需进行烘干处理（水剂促凝剂无需此步骤）。建议采用热风烘干，温度控制在160-180℃，通过两组热风管热风烘干3次，每次2秒，以彻底烘干、无醇剂残留为准。
辐照灭菌：如需进行辐照灭菌，建议辐照剂量控制在8-25kGy，灭菌后需检查产品性状，确保无异常。
用量标准：一般情况下，15-20µl本品可快速促凝5mL血样，用量误差范围控制在±10%。具体推荐用量如下表所示：
血样体积
| 建议添加剂量
|
3-4 mL
| 15 μL
|
5-7 mL
| 20 μL
|
8-15 mL
| 30 μL |
注意事项
- 若血液凝血不充分，会导致血球及纤维蛋白丝挂壁，甚至出现轻度溶血；部分患者血液若一次凝血不完全，可能出现凝血过程中止、纤维蛋白析出，或离心后无血清分离等情况，需及时检查操作流程及用量。
- 若凝血时间少于15分钟即上机离心，可能导致纤维蛋白丝二次析出，漂浮在血清中，极易造成检测探针堵塞，影响检验进度。
- 本品为醇剂，具有挥发性，储存及使用时需密封，避免乙醇挥发导致成分比例失衡，影响促凝效果；操作时避免接触明火，远离高温环境。
- 添加过程中若出现悬浊液分层严重，需重新充分搅拌后再使用，确保促凝成分均匀分布。
- 密封保存，放置于阴凉干燥处，环境温度不得超过35℃；因醇剂特性，低温（0-10℃）储存效果更佳，可有效延缓成分变质，保持促凝性能稳定；避免阳光直射及潮湿环境。
- 自生产之日起，有效期为三年；逾期不得使用，若发现产品出现浑浊异常、异味或沉淀无法摇匀，需立即丢弃。
This product is an alcohol-based blood coagulant, using anhydrous ethanol as a solvent, combined with a variety of effective coagulation-promoting components. It is specifically designed for rapid blood clotting and efficient serum separation, suitable for the preparation of medical blood collection tubes and clinical testing.
Ingredients
The main components of this product include diatomaceous earth, kaolin, silica powder, anhydrous ethanol, etc. The proportions of each component are scientifically formulated to ensure stable coagulation-promoting effects without interfering with clinical test results.
Properties
This product is a light yellow turbid liquid. Sedimentation occurs upon standing, but it forms a uniform suspension after shaking. It rapidly accelerates blood coagulation without affecting clinical biochemical tests. The alcohol-based components are volatile and leave no residue after drying.
Scope of Application
It can be used for preparing vacuum blood collection tubes and syringe-based blood collection tubes, widely applied in clinical medical testing. Laboratory personnel can complete blood sample collection, rapid serum separation, and sample transfer in the same vessel, simplifying the testing process and improving work efficiency.
Coagulation Principle
By activating certain coagulation factors in plasma and platelets, it promotes the generation of thromboplastin and fibrin clots, accelerating blood clot contraction to achieve rapid serum separation. Anhydrous ethanol aids in dispersing the coagulation components, enhancing the uniformity of the coagulation effect.
Coagulation Capacity
At 25°C, adding 15-20µl of this product (alcohol-based) can rapidly coagulate 5mL of blood. After initial blood clotting, allow it to stand for about 30 minutes before centrifugation (centrifugal force: 1200-1500g, centrifugation time: 8-10 minutes) for smooth serum separation. After centrifugation, the clot contracts well, yielding a large amount of serum with excellent separation, free from impurities, and does not interfere with blood sample test results. When the ambient temperature is below 20°C, the standing time after blood collection can be appropriately extended to ensure full coagulation and achieve the best serum separation effect.
Usage and Dosage
- Addition Method: Add to blood collection tubes using machine spraying. Continuous stirring is required during the addition process to maintain the uniformity of the suspension, ensuring consistent addition of effective components and avoiding分层 (stratification) that may affect the coagulation effect.
- Stirring Method: Mechanical stirring, electromagnetic stirring, or pneumatic stirring can be used to maintain the uniformity of the suspension. The stirring speed should be adjusted according to the actual equipment and operation scenario to ensure no significant sedimentation and uniform suspension.
- Drying Treatment: As an alcohol-based product, drying is required after addition (not necessary for water-based coagulants). Hot air drying is recommended, with the temperature controlled at 160-180°C. Dry three times through two sets of hot air tubes, each for 2 seconds, ensuring thorough drying and no alcohol residue.
- Irradiation Sterilization: If irradiation sterilization is required, the recommended dose is 8-25kGy. After sterilization, check the product properties to ensure no abnormalities.
- Dosage Standard: Generally, 15-20µl of this product can rapidly coagulate 5mL of blood, with a dosage error range controlled within ±10%. The recommended dosage is as follows
Blood Sample Volume
| Recommended Dosage
|
3-4 mL
| 15 μL
|
5-7 mL
| 20 μL
|
8-15 mL
| 30 μL |
Precautions
- If blood coagulation is insufficient, it may cause blood cells and fibrin strands to adhere to the tube wall, or even mild hemolysis. If blood coagulation is incomplete in some patients, it may result in the cessation of coagulation, fibrin precipitation, or no serum separation after centrifugation. The operation process and dosage should be checked promptly.
- If centrifugation is performed less than 15 minutes after coagulation, secondary precipitation of fibrin strands may occur, floating in the serum and potentially blocking detection probes, affecting testing progress.
- This product is alcohol-based and volatile. During storage and use, ensure sealing to avoid ethanol evaporation, which may disrupt component ratios and affect the coagulation effect. Avoid contact with open flames and keep away from high-temperature environments.
- If severe stratification of the suspension occurs during addition, stir thoroughly before use to ensure uniform distribution of coagulation components.
- Store sealed in a cool, dry place, with the ambient temperature not exceeding 35°C. Due to its alcohol-based nature, low-temperature storage (0-10°C) is more effective in delaying component deterioration and maintaining stable coagulation performance. Avoid direct sunlight and humid environments.
- The shelf life is three years from the production date. Do not use beyond the expiration date. If abnormal turbidity, odor, or sedimentation that cannot be redispersed by shaking is observed, discard immediately.
ZJ26F0434463
危险品化学品经营许可证（带存储）