Rapid blood coagulation additive, vacuum blood collection tube and application

Abstract

The invention relates to the technical field of biological medicine, and particularly discloses a rapid blood coagulation additive, a vacuum blood collection tube and application. The additive is obtained by mixing a coagulation-promoting active component, an alkaline regulator, an amino acid stabilizer, a protein protective agent, a saccharide protective agent, an osmotic pressure regulator, a serum protein stabilizer, a high-molecular polymer, an antioxidant and a PBS buffer solution and then performing filtration operation, has an efficient and rapid coagulation effect, and can realize rapid coagulation of blood within 5 minutes; meanwhile, the additive also has excellent environmental anti-interference capability, can maintain the effectiveness of the blood coagulation function under long-term high-temperature and high-humidity conditions, has no interference on the detection result of clinical serum indexes, and effectively solves the technical defect that in the prior art, blood coagulation is difficult to quickly realize to efficiently obtain serum.

Description

Technical Field

[0001] This application relates to the field of biomedical technology, and in particular to a rapid coagulation additive, a vacuum blood collection tube, and its application. Background Technology

[0002] Serum and plasma are both products of blood centrifugation and are important subjects in clinical hematological testing and diagnosis. Plasma is the supernatant obtained by centrifugation of blood without clotting under the action of certain anticoagulants; serum, unlike plasma, is the supernatant obtained by centrifugation of blood after it has undergone clotting under normal conditions. Compared to plasma, serum has advantages in clinical hematological diagnosis, such as ease of acquisition, less cell contamination, and more stable test indicators. However, because serum collection requires a blood clotting process, which typically takes 1-2 hours, it significantly delays the clinical blood testing process.

[0003] In existing technologies, negatively charged substances such as silica are often added to blood collection tubes to activate clotting factors in the blood and accelerate the blood clotting process. However, this clotting process still requires a clotting waiting time of 20 to 30 minutes. Therefore, in special scenarios such as emergency departments and intensive care units where rapid serological test results are required, this clotting time is difficult to meet actual clinical needs.

[0004] Given the above, these departments typically use plasma tubes for blood collection. While plasma tubes can avoid a prolonged clotting process, for patients with specific conditions such as acute myocardial infarction or acute pancreatitis, the reliability of plasma test results is lower than that of serum test results. Therefore, developing a technology that can rapidly perform clotting and obtain serum is of significant practical importance. Summary of the Invention

[0005] In view of this, the purpose of this application is to provide a rapid coagulation additive and a vacuum blood collection tube and its application, in order to solve the defects of the prior art in that it is difficult to achieve rapid coagulation to obtain serum.

[0006] To achieve the above-mentioned technical objectives, this application provides a rapid coagulation additive, using a buffer solution with a concentration of 1× to 10× as a solvent, and further comprising the following components at mass concentrations:

[0007] The active ingredient for coagulation is 1~100 IU / mL; the alkalinity regulator is 0.001~0.1 mol / L; the amino acid stabilizer is 1~10 mg / mL; the protein protectant is 1~5 mg / mL; the carbohydrate protectant is 10~100 mg / mL; the osmotic pressure regulator is 0.5~5% (w / v); the serum protein stabilizer is 5~50 mg / mL; the polymer is 0.5~10% (w / v); and the antioxidant is 1~20 mg / mL.

[0008] Furthermore, using a 1× buffer solution as the solvent, the product also includes the following components at the following mass concentrations: coagulant active ingredient 2-50 IU / mL; alkalinity regulator 0.005-0.05 mol / L; amino acid stabilizer 2-5 mg / mL; protein protectant 1-3 mg / mL; carbohydrate protectant 30-60 mg / mL; osmotic pressure regulator 1-3% (w / v); serum protein stabilizer 10-30 mg / mL; polymer 1-5% (w / v); and antioxidant 2-10 mg / mL.

[0009] Further, the procoagulant active ingredient is selected from at least one of thrombin, snake venom thrombin, and fibrinogen activator; and / or, the alkalinity regulator is selected from at least one of sodium hydroxide, potassium hydroxide, and sodium bicarbonate; and / or, the amino acid stabilizer is selected from at least one of glycine, alanine, and lysine; and / or, the protein protectant is selected from at least one of gelatin, collagen, and casein; and / or, the carbohydrate protectant is selected from at least one of trehalose, sucrose, and glucose; and / or, the osmotic pressure regulator is selected from at least one of mannitol, sorbitol, and sodium chloride; and / or, the serum protein stabilizer is selected from at least one of bovine serum albumin, human serum albumin, and recombinant albumin; and / or, the polymer is selected from at least one of PEG-8000, PEG-6000, and PVP K30; and / or, the antioxidant is selected from at least one of reduced glutathione, cysteine, and lipoic acid; and / or, the buffer solution is selected from at least one of PBS, Tris-HCl, and HEPES.

[0010] This application provides a method for preparing a rapid coagulation additive, comprising the following steps: mixing a procoagulant active ingredient, an alkaline regulator, an amino acid stabilizer, a protein protectant, a carbohydrate protectant, an osmotic pressure regulator, a serum protein stabilizer, a polymer, an antioxidant, and a buffer solution, followed by filtration to obtain the rapid coagulation additive.

[0011] This application provides an application of a rapid coagulation additive for coagulation treatment of isolated blood samples; or for the preparation of products with rapid coagulation effects.

[0012] This application provides a vacuum blood collection tube, which also includes a separating gel containing an acrylate polymer.

[0013] Furthermore, the volume ratio of the rapid coagulation additive to the volume of the vacuum blood collection tube is 1: (1000~2000).

[0014] This application provides a method for preparing a vacuum blood collection tube, comprising the following steps: adding a rapid coagulation additive to the blood collection tube, and sequentially subjecting the blood collection tube to vacuuming and sterilization to obtain a vacuum blood collection tube;

[0015] When the vacuum blood collection tube also includes a separating gel, the separating gel is first added into the blood collection tube. After the separating gel has settled at the bottom of the blood collection tube, a rapid coagulation additive is added.

[0016] This application provides an application of a vacuum blood collection tube for coagulation treatment of isolated blood samples.

[0017] In summary, this application provides a rapid coagulation additive, which is obtained by filtering a mixture of procoagulant active ingredients, alkaline regulators, amino acid stabilizers, protein protectants, glycoprotectants, osmotic pressure regulators, serum protein stabilizers, polymers, antioxidants, and buffer solutions. This additive possesses highly efficient rapid coagulation performance, achieving rapid blood coagulation within 5 minutes. Furthermore, it exhibits excellent environmental resistance, maintaining effective coagulation function under prolonged high temperature and humidity conditions.

[0018] Compared with existing technologies, the rapid coagulation additive described in this application can complete the coagulation process in a short time and has excellent long-term resistance to extreme environments. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 The following are comparative charts showing the coagulation time analysis of the vacuum blood collection tubes provided in the embodiments and comparative examples of this application during the coagulation operation; wherein, Figure A is a coagulation time chart; and Figure B is a bar chart showing the coagulation time comparison analysis.

[0021] Figure 2 Serum quality diagram during coagulation operation of vacuum blood collection tubes provided in the embodiments and comparative examples of this application. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. Based on the embodiments in this application specification, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection claimed in this application.

[0023] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0024] Unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0025] The raw materials used in this invention are not particularly restricted in their source; they can be purchased on the market or prepared using conventional methods known to those skilled in the art.

[0026] This application provides a rapid coagulation additive, using a buffer solution with a concentration of 1× to 10× as a solvent, and comprising the following components at mass concentrations:

[0027] The formula contains: coagulant active ingredient 1~100 IU / mL; alkalinity regulator 0.001~0.1 mol / L; amino acid stabilizer 1~10 mg / mL; protein protectant 1~5 mg / mL; carbohydrate protectant 10~100 mg / mL; osmotic pressure regulator 0.5~5% (w / v); serum protein stabilizer 5~50 mg / mL; polymer 0.5~10% (w / v); antioxidant 1~20 mg / mL; and a 1× to 10× buffer system.

[0028] It should be noted that the rapid coagulation additive provided in this application has a highly efficient rapid coagulation effect, which can achieve rapid coagulation of blood within 5 minutes; at the same time, the additive still has good stability under long-term high temperature and high humidity conditions (temperature of 50±1℃ and humidity of 50±10%), and its coagulation effect is not significantly affected.

[0029] In some embodiments, a 1× buffer solution is used as the solvent, comprising the following components at the following mass concentrations: coagulant active ingredient 2-50 IU / mL; alkalinity regulator 0.005-0.05 mol / L; amino acid stabilizer 2-5 mg / mL; protein protectant 1-3 mg / mL; carbohydrate protectant 30-60 mg / mL; osmotic pressure regulator 1-3% (w / v); serum protein stabilizer 10-30 mg / mL; polymer 1-5% (w / v); antioxidant 2-10 mg / mL; and a 1× buffer system.

[0030] In some preferred embodiments, a 1× buffer solution is used as the solvent, comprising the following components at the following mass concentrations: 5-10 IU / mL of procoagulant active ingredient; 0.01-0.02 mol / L of alkalinity regulator; 3-4 mg / mL of amino acid stabilizer; 2-3 mg / mL of protein protectant; 50-55 mg / mL of carbohydrate protectant; 1.5-2% (w / v) of osmotic pressure regulator; 15-25 mg / mL of serum protein stabilizer; 2-3% (w / v) of polymer; 3-4 mg / mL of antioxidant; and a 1× buffer system.

[0031] In some embodiments, the procoagulant active ingredient is selected from at least one of thrombin, snake venom thrombin, and fibrinogen activator; and / or, the alkalinity regulator is selected from at least one of sodium hydroxide, potassium hydroxide, and sodium bicarbonate; and / or, the amino acid stabilizer is selected from at least one of glycine, alanine, and lysine; and / or, the protein protectant is selected from at least one of gelatin, collagen, and casein; and / or, the carbohydrate protectant is selected from at least one of trehalose, sucrose, and glucose; and / or, the osmotic pressure regulator is selected from at least one of mannitol, sorbitol, and sodium chloride; and / or, the serum protein stabilizer is selected from at least one of bovine serum albumin (BSA), human serum albumin (HSA), and recombinant albumin; and / or, the polymer is selected from at least one of PEG-8000, PEG-6000, and PVP K30; and / or, the antioxidant is selected from at least one of reduced glutathione, cysteine, and lipoic acid; and / or, the buffer solution is selected from at least one of PBS, Tris-HCl, and HEPES.

[0032] This application provides a method for preparing a rapid coagulation additive, comprising the following steps: mixing a procoagulant active ingredient, an alkaline regulator, an amino acid stabilizer, a protein protectant, a carbohydrate protectant, an osmotic pressure regulator, a serum protein stabilizer, a polymer, an antioxidant, and a buffer solution, followed by filtration to obtain the rapid coagulation additive.

[0033] This application provides an application of a rapid coagulation additive for coagulation treatment of isolated blood samples; or for preparing products with rapid coagulation effects.

[0034] This application provides a vacuum blood collection tube containing a rapid clotting additive.

[0035] In some embodiments, the volume ratio of the rapid coagulation additive to the volume of the vacuum blood collection tube is 1: (1000~2000).

[0036] In some preferred embodiments, the volume ratio of the rapid coagulation additive to the volume of the vacuum blood collection tube is 1:(1000~1800).

[0037] In some preferred embodiments, the volume ratio of the rapid coagulation additive to the volume of the vacuum blood collection tube is 1:(1000~1500).

[0038] In some embodiments, a separating gel is also included, the separating gel containing an acrylate polymer.

[0039] In some embodiments, the volume ratio of the separating gel added to the volume of the vacuum blood collection tube is 1: (11~22).

[0040] In some preferred embodiments, the volume ratio of the separating gel added to the volume of the vacuum blood collection tube is 1: (12.5~16.5).

[0041] In some embodiments, the vacuum negative pressure inside the vacuum blood collection tube is ≥13.0 kg / cm². 2 .

[0042] In some preferred embodiments, the vacuum negative pressure inside the vacuum blood collection tube is 14.0~18.6 kg / cm². 2 .

[0043] This application provides a method for preparing a vacuum blood collection tube, comprising the following steps: adding a rapid coagulation additive to the blood collection tube, and sequentially subjecting the blood collection tube to vacuuming and sterilization to obtain a vacuum blood collection tube;

[0044] When the vacuum blood collection tube also includes a separating gel, the separating gel is first added into the blood collection tube. After the separating gel has settled at the bottom of the blood collection tube, a rapid coagulation additive is added.

[0045] This application provides an application of a vacuum blood collection tube for coagulation treatment of isolated blood samples.

[0046] The applicant further provides the following specific embodiments to describe the present invention. It should be noted that these embodiments are merely descriptive and do not limit the present invention in any way.

[0047] Example 1

[0048] This embodiment provides a rapid coagulation additive that uses 1× PBS buffer as a solvent and also includes the following components at mass concentrations:

[0049] The active ingredient for coagulation is thrombin 10 IU / mL, the alkalinity regulator is sodium hydroxide 0.01 mol / L, the amino acid stabilizer is glycine 3.6 mg / mL, the protein protectant is gelatin 2.4 mg / mL, the carbohydrate protectant is trehalose 50 mg / mL, the osmotic pressure regulator is mannitol 1.5% (w / v), the serum protein stabilizer is bovine serum albumin 20 mg / mL, the high molecular weight polymer is PEG-8000 2.0% (w / v), and the antioxidant is glutathione 3 mg / mL.

[0050] This embodiment provides a method for preparing a rapid coagulation additive, including the following steps: using 1× PBS buffer as a solvent, adding a procoagulant active ingredient, an alkaline regulator, an amino acid stabilizer, a protein protectant, a carbohydrate protectant, an osmotic pressure regulator, a serum protein stabilizer, a polymer, and an antioxidant to the solvent, mixing evenly, and then filtering through a 0.22 μm filter membrane to obtain the rapid coagulation additive.

[0051] This embodiment provides a vacuum blood collection tube, which is prepared as follows:

[0052] Step S1, Add separating adhesive: Use a dispensing machine to inject the separating adhesive containing acrylate polymer into the sampling tube. The volume ratio of the acrylate polymer to the volume of the sampling tube is 1:15. Centrifuge the sampling tube at 1800g for 5 minutes to allow the separating adhesive to settle smoothly at the bottom of the tube.

[0053] Step S2: Using a spray drying device, the rapid coagulation additive is sprayed into the PET blood collection tube in the form of a spray. The ratio of the volume of the rapid coagulation additive to the volume of the sampling tube is 1:1200.

[0054] Step S3: Assemble the sampling tube with the matching rubber stopper and safety cap to obtain the blood collection tube, and then perform vacuum treatment to make the negative pressure inside the blood collection tube 15 kg / cm². 2 ;

[0055] Step S4: Sterilize the vacuum blood collection tubes by irradiation; the irradiation dose is 14~30kGy.

[0056] Example 2

[0057] The difference from Example 1 lies in the concentration of the rapid coagulation additive, specifically as follows: This additive uses 1× PBS buffer as a solvent and also includes the following components at different mass concentrations:

[0058] The active ingredient for coagulation is thrombin (5 IU / mL), the alkalinity regulator is sodium hydroxide (0.01 mol / L), the amino acid stabilizer is glycine (2 mg / mL), the protein protectant is gelatin (1 mg / mL), the carbohydrate protectant is trehalose (30 mg / mL), the osmotic pressure regulator is mannitol (1% w / v), the serum protein stabilizer is bovine serum albumin (BSA) (10 mg / mL), the polymer is PEG-8000 (1.0% w / v), and the antioxidant is glutathione (2 mg / mL).

[0059] Example 3

[0060] The difference from Example 1 lies in the composition of the rapid coagulation additive, specifically as follows: This additive uses 1× Tris-HCl buffer as a solvent and also includes the following components at different mass concentrations:

[0061] The active ingredients for coagulation include fibrinogen activator 10 IU / mL, alkalinity regulator sodium bicarbonate 0.01 mol / L, amino acid stabilizer alanine 3.6 mg / mL, protein protectant casein 2.4 mg / mL, carbohydrate protectant glucose 50 mg / mL, osmotic pressure regulator sodium chloride 1.5% (w / v), serum protein stabilizer human serum albumin (HSA) 20 mg / mL, high molecular weight polymer PEG-6000 2.0% (w / v), and antioxidant cysteine ​​3 mg / mL.

[0062] Comparative Example 1

[0063] This comparative example provides a vacuum blood collection tube, specifically a disposable vacuum blood collection tube from Guangzhou Yangpu Medical—a separation gel coagulation tube. The separation gel composition in this separation gel coagulation tube is the same as that provided in Example 1.

[0064] Comparative Example 2

[0065] This comparative example provides a vacuum blood collection tube, specifically the BD Vacutainer SST.

[0066] Comparative Example 3

[0067] The difference from Example 1 is that the components of the rapid clotting additive are different.

[0068] In this comparative example, the rapid coagulation additive used 1× PBS buffer as a solvent and also included the procoagulant active ingredient—thrombin 10 IU / mL.

[0069] Performance Comparison Test: To simulate interference from extreme environments, all blood collection tubes provided in the examples and comparative examples were stored in a constant temperature and humidity incubator at 50±1℃ and 50±10% for one month after irradiation sterilization before performance testing. The test items were the accuracy of coagulation time, serum mass, and clinical analyte concentration. The specific steps and results of each test are as follows:

[0070] Test 1: Clotting Time

[0071] Test method: Blood was collected from 24 healthy volunteers using the vacuum blood collection tubes provided in the above embodiments and comparative examples. The time of needle removal was taken as T1. Immediately afterwards, the vacuum sampling tube was gently inverted 6-8 times to mix the blood. After mixing, the tube was kept vertical and stationary. The vacuum blood collection tube was tilted at intervals and the blood flow was observed. After each observation, the tilt angle of the tube was slowly increased until the tube was completely inverted. The state of no blood flow was recorded as the coagulation time T2. The coagulation time T = T2 - T1.

[0072] Test results: Figure 1 Coagulation time diagrams for coagulation operations using vacuum blood collection tubes provided in the examples and comparative examples (A: coagulation time diagram; B: coagulation time comparison analysis diagram, **** represents p < 0.0001).

[0073] like Figure 1 As shown in Figure A, the average clotting speed of Experimental Example 1 was 67.35 seconds, which was 86.6% higher than that of Comparative Example 1 and 91.2% higher than that of Comparative Example 2. Similarly, the clotting times of Examples 2 and 3 were significantly lower than those of the Comparative Examples. Paired t-tests were performed on the Examples and Comparative Examples, and the results are as follows: Figure 1 As shown in B, the clotting speed of Examples 1-3 was significantly faster than that of the comparative examples (p<0.0001).

[0074] Test 2: Serum quality

[0075] Test method: Blood was collected from 24 healthy volunteers using the vacuum blood collection tubes provided in the above examples and comparative examples. In Examples 1-3 and Comparative Example 3, the blood was centrifuged 5 minutes after collection, and in Comparative Examples 1-2, the blood was centrifuged 20 minutes after collection. After centrifugation, the serum status was observed. The centrifugation conditions were 1800g for 10 minutes.

[0076] Test results: Figure 2The images show serum quality during coagulation procedures using the vacuum blood collection tubes provided in the examples and comparative examples. Serum samples obtained by centrifugation after 5 minutes using the vacuum blood collection tubes provided in Examples 1-3 were all clear and transparent, consistent with the serum quality obtained by centrifugation after 20 minutes in Comparative Examples 1-2, and no secondary fibrin precipitation was observed. However, significant secondary fibrin precipitation was observed in the serum of Comparative Example 3 (without the addition of the rapid coagulation additive). This indicates that the rapid coagulation additive and vacuum blood collection tubes provided in this application have the advantages of rapid coagulation time and excellent coagulation quality.

[0077] Test 3: Clinical analyte concentration

[0078] Test method: Blood was collected from 24 healthy volunteers using the vacuum blood collection tubes provided in Example 1 and Comparative Examples 1-2. Immediately after blood collection, the tubes were gently inverted 6-8 times to mix the blood. After mixing, the tubes were left to stand upright until the blood completely coagulated. Once the blood had completely coagulated, the tubes were centrifuged at 1800g for 10 minutes to obtain serum. The concentrations of common clinical analytes were then determined using an automated biochemical analyzer and a chemiluminescence immunoassay analyzer. The types of analytes and acceptance criteria are shown in Table 1.

[0079] Table 1. Clinical Analyte Types and Bias Acceptance Criteria

[0080]

[0081] Note: Allowable deviations are subject to Westgard rules. For detailed information, please refer to the official website: https: / / www.westgard.com / biodatabase1.htm.

[0082] Test results: As shown in Table 2, the deviations of Example 1 and Comparative Examples 1-2 in the 44 clinical indicators detected are within the allowable deviation range of Westgard, indicating that the blood samples stored using the vacuum blood collection tubes provided in this application can accurately detect clinical indicators, and that the vacuum blood collection tubes provided in this application will not interfere with the detection results of clinical serum indicators.

[0083] Table 2. Analysis of Clinical Analyte Concentration Determination

[0084]

[0085] The above are merely preferred embodiments of this application and are not intended to limit the present invention. Although this application has been described in detail with reference to examples, those skilled in the art can still modify the technical solutions described in the foregoing examples or make equivalent substitutions for some of the technical features. However, any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A rapid coagulation additive, characterized in that, Using a buffer solution with a concentration of 1× to 10× as the solvent, the following components are included in the specified mass concentrations: The coagulation-promoting active ingredient is 1~100 IU / mL; Alkalinity regulator: 0.001~0.1 mol / L; Amino acid stabilizer 1~10 mg / mL; Protein protectant 1~5 mg / mL; Carbohydrate protectant 10~100 mg / mL; Osmotic pressure regulator 0.5~5% (w / v); Serum protein stabilizer 5~50 mg / mL; Polymer content: 0.5-10% (w / v); Antioxidant 1~20 mg / mL.

2. The rapid coagulation additive according to claim 1, characterized in that, Using a 1× buffer solution as the solvent, the following components are included at their respective mass concentrations: Procoagulant active ingredient 2~50 IU / mL; Alkalinity regulator: 0.005~0.05 mol / L; Amino acid stabilizer 2~5 mg / mL; Protein protectant 1~3 mg / mL; Carbohydrate protectant 30-60 mg / mL; Osmotic pressure regulator 1~3% (w / v); Serum protein stabilizer 10-30 mg / mL; 1-5% (w / v) of high molecular weight polymers; Antioxidant 2~10 mg / mL.

3. The rapid coagulation additive according to claim 1, characterized in that: The procoagulant active ingredient is selected from at least one of thrombin, snake venom thrombin, and fibrinogen activator. And / or, the alkalinity regulator is selected from at least one of sodium hydroxide, potassium hydroxide, and sodium bicarbonate; And / or, the amino acid stabilizer is selected from at least one of glycine, alanine, and lysine; And / or, the protein protectant is selected from at least one of gelatin, collagen, and casein; And / or, the sugar protectant is selected from at least one of trehalose, sucrose, and glucose; And / or, the osmotic pressure regulator is selected from at least one of mannitol, sorbitol, and sodium chloride; And / or, the serum protein stabilizer is selected from at least one of bovine serum albumin, human serum albumin, and recombinant albumin; And / or, the polymer is selected from at least one of PEG-8000, PEG-6000, and PVP K30; And / or, the antioxidant is selected from at least one of reduced glutathione, cysteine, and lipoic acid; And / or, the buffer solution is selected from at least one of PBS, Tris-HCl, and HEPES.

4. A method for preparing the rapid coagulation additive according to any one of claims 1 to 3, characterized in that, Includes the following steps: The rapid coagulation additive is obtained by mixing and filtering a mixture of coagulant active ingredients, alkaline regulators, amino acid stabilizers, protein protectants, carbohydrate protectants, osmotic pressure regulators, serum protein stabilizers, polymers, antioxidants, and buffer solutions.

5. The application of a rapid coagulation additive according to any one of claims 1 to 3 or a rapid coagulation additive prepared by the preparation method according to claim 4, characterized in that, Used for coagulation treatment of isolated blood samples; or, used to prepare products with rapid coagulation effects.

6. A vacuum blood collection tube, characterized in that, The vacuum blood collection tube contains the rapid coagulation additive as described in any one of claims 1 to 3 or the rapid coagulation additive prepared by the preparation method described in claim 4.

7. The vacuum blood collection tube according to claim 6, characterized in that, The volume ratio of the rapid coagulation additive to the volume of the vacuum blood collection tube is 1:(1000~2000).

8. The vacuum blood collection tube according to claim 6, characterized in that, It also includes a separating gel containing an acrylate polymer.

9. A method for preparing a vacuum blood collection tube according to any one of claims 7-8, characterized in that, The process includes the following steps: adding a rapid coagulation additive to the blood collection tube, and then vacuuming and sterilizing the blood collection tube to obtain a vacuum blood collection tube. When the vacuum blood collection tube also includes a separating gel, the separating gel is first added into the blood collection tube. After the separating gel is deposited at the bottom of the blood collection tube, a rapid coagulation additive is added.

10. The application of a vacuum blood collection tube according to any one of claims 7-8 or a vacuum blood collection tube prepared by the method of claim 9, characterized in that, Used for coagulation treatment of isolated blood samples.

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