Hypertension blood sample protective agent, vacuum blood collection tube for hypertension blood sample detection and application

Abstract

The invention provides a hypertension blood sample protective agent, a vacuum blood collection tube for hypertension blood sample detection and application, and belongs to the technical field of medical instruments, the hypertension blood sample protective agent is characterized by being prepared from the following raw materials in parts by weight: enapremarate, an anticoagulant and a complexing agent; the vacuum blood collection tube for hypertension blood sample detection contains the hypertension blood sample protective agent. According to the application, the vacuum blood collection tube for hypertension blood sample detection is adopted for directly storing blood. By adopting the vacuum blood collection tube for hypertension blood sample detection, the tedious steps of reagent preparation and on-site reagent addition can be reduced, so that the detection efficiency and the accuracy of a detection result are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a hypertensive blood sample protective agent and a vacuum blood collection tube for hypertensive blood sample detection and applications, in particular to a hypertensive blood sample protective agent for detecting angiotensin I and angiotensin II and a vacuum blood collection tube for hypertensive blood sample detection and applications. Background Art

[0002] With the continuous increase in the prevalence of hypertension and the continuous increase in the mortality rate of cardiovascular and cerebrovascular diseases, people pay more and more attention to the prevention, detection and treatment of hypertension. The commonly used indicators for hypertension detection are plasma renin, plasma adrenocorticotropic hormone, plasma angiotensin II, plasma aldosterone and plasma cortisol. The renin-angiotensin-aldosterone (RAAS) system is an important system for regulating water and salt metabolism and maintaining circulatory blood pressure. Renin is secreted by the juxtaglomerular cells of the juxtaglomerular arterioles of the kidney. Renin can catalyze the conversion of angiotensinogen secreted by the liver into angiotensin I. Angiotensin I can be degraded into angiotensin II by angiotensin converting enzyme from pulmonary epithelial cells in the pulmonary circulation.

[0003] In order to block the conversion of angiotensin I and angiotensin II and keep their concentrations relatively stable to achieve the purpose of accurate detection, anticoagulants, enzyme inhibitors and chelating agents are added to the blood collection tube after blood collection. Preventing the conversion of angiotensin I and angiotensin II is a common method for sample pretreatment for detecting angiotensin I and angiotensin II. Currently, most test kits on the market use sample pretreatment that involves adding inhibitors after collecting venous blood using anticoagulant tubes. This operation not only increases the detection time but also fails to standardize the blood collection operation, which can easily cause large errors in the test.

[0004] However, existing vacuum blood collection tubes cannot provide enzyme inhibitors for hypertensive blood collection, so they cannot be fully applicable to the detection of hypertensive blood. Summary of the invention

[0005] The purpose of the present invention is to solve the problem that the existing vacuum blood collection tubes are not fully applicable to hypertension blood testing, and to provide a hypertension blood sample protective agent and a vacuum blood collection tube for hypertension blood sample testing and its application.

[0006] To achieve the above purpose, the technical solution adopted by the present invention is:

[0007] A hypertensive blood sample protective agent comprises, by weight, 1 to 1.3 parts of enalapril maleate, 15.2 to 18.6 parts of an anticoagulant and 13.8 to 16.9 parts of a complexing agent.

[0008] Furthermore, the complexing agent is imidazolidinyl urea and 8-hydroxyquinoline sulfate.

[0009] Furthermore, the weight ratio of imidazolidinyl urea to 8-hydroxyquinoline sulfate is 7.5-9.2:6.3-7.7.

[0010] Furthermore, the anticoagulant is dipotassium ethylenediaminetetraacetate.

[0011] Furthermore, the preparation method of the hypertension blood sample protective agent is to take enalapril maleate, an anticoagulant and a complexing agent, add injection water to dissolve them, and prepare the protective agent.

[0012] Furthermore, the hypertensive blood sample protective agent contains 15.2-18.6 g / 100 mL of dipotassium ethylenediaminetetraacetate, 7.5-9.2 g / 100 mL of imidazolidinyl urea, 6.3-7.7 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.0-1.3 g / 100 mL of enalapril maleate.

[0013] A vacuum blood collection tube for hypertension blood sample detection contains the above-mentioned hypertension blood sample protective agent.

[0014] Furthermore, when the specification of the vacuum blood collection tube for hypertension blood sample testing is 3mL, 34.0-41.6μL of the hypertension blood sample protective agent is sprayed, and when the specification is 5mL, 56.7-69.3μL of the hypertension blood sample protective agent is sprayed; other specifications are sprayed with corresponding amounts of hypertension blood sample protective agent according to the proportion.

[0015] An application of a vacuum blood collection tube for hypertension blood sample detection, the application is to directly store blood using the vacuum blood collection tube for hypertension blood sample detection.

[0016] Furthermore, during the blood preservation process, the volume ratio of the hypertension blood sample protective agent to the blood is 1:50-100.

[0017] The beneficial effects of the hypertensive blood sample protective agent and the vacuum blood collection tube for hypertensive blood sample detection and the application of the present invention are:

[0018] The hypertension blood sample protector of the present invention uses enalapril maleate to replace conventional enzyme inhibitors, and is combined with an anticoagulant and a complexing agent, and can be directly used for blood sample collection of angiotensin I and angiotensin II.

[0019] The present invention uses enalapril maleate instead of conventional enzyme inhibitors as the enzyme inhibitor of the present invention, which can inhibit angiotensin converting enzyme, thereby blocking the process of angiotensin I converting to angiotensin II; at the same time, 8-hydroxyquinoline sulfate is used as a metal ion complexing agent to complex zinc ions and inhibit the activity of angiotensin converting enzyme, thereby improving the detection efficiency of hypertension blood samples and the accuracy of the detection results;

[0020] The use of the vacuum blood collection tube for hypertension blood sample detection of the present invention can reduce the cumbersome steps of reagent preparation and on-site reagent addition, thereby improving detection efficiency and the accuracy of detection results; and there is no need to add conventional enzyme inhibitors during the entire detection process, which can reduce the detection cost of the vacuum blood collection tube for hypertension blood sample detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 1 is a simplified structural diagram of a vacuum blood collection tube for hypertension blood sample detection in Example 1 of the present invention. DETAILED DESCRIPTION

[0022] The technical solutions in the embodiments of the present invention are described clearly and completely below. In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention can also be implemented in other ways different from those described herein, and those skilled in the art can make similar generalizations without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0023] Example 1 A blood sample protective agent for hypertension and a vacuum blood collection tube for detecting blood samples for hypertension I. Preparation of blood sample protective agent for hypertension

[0024] 1) Formulation

[0025] A hypertensive blood sample protectant contains 16.9 g / 100 mL of dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL of imidazolidinyl urea, 6.9 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.2 g / 100 mL of enalapril maleate, and the solvent is sterile water for injection.

[0026] 2) Preparation method

[0027] According to the above formula, calculate the amount of reagents required for 100mL of hypertension blood sample protective agent, weigh dipotassium ethylenediaminetetraacetate, imidazolidinyl urea, 8-hydroxyquinoline sulfate and enalapril maleate according to the weighing requirements and add them to a beaker, measure an appropriate amount of sterile water for injection to completely dissolve the reagents, pour into a 100mL volumetric flask, and use sterile water for injection to make up to the mark to obtain the hypertension blood sample protective agent.

[0028] 2. Vacuum blood collection tubes for hypertension blood sample testing

[0029] 1) Structure of vacuum blood collection tube for hypertension blood sample testing

[0030] like Figure 1As shown, a vacuum blood collection tube for hypertension blood sample detection includes a rubber plug, a cap, a label, a test tube and the above-mentioned hypertension blood sample protective agent. The hypertension blood sample protective agent is located in the test tube, the rubber plug is tightly plugged on the tube mouth of the test tube, there is a cap outside the rubber plug, the rubber plug is fixedly connected to the cap, and the label is attached to the outside of the test tube. Among them, the test tube is a plastic tube made of PET. The rubber plug is made of halogenated butyl rubber material, and the cap is made of PE or HDPE plastic.

[0031] 2) Preparation method of vacuum blood collection tube for hypertension blood sample detection

[0032] The hypertensive blood sample protective agent is sprayed into the test tube, and a vacuum blood collection tube containing the hypertensive blood sample protective agent is prepared according to the traditional vacuum blood collection tube production process. Among them, the 3mL vacuum blood collection tube for hypertensive blood sample detection is sprayed with 37.8μL of the hypertensive blood sample protective agent, the 5mL vacuum blood collection tube for hypertensive blood sample detection is sprayed with 63μL of the hypertensive blood sample protective agent, and the vacuum blood collection tubes for hypertensive blood sample detection of other specifications can be sprayed with the corresponding amount of the hypertensive blood sample protective agent according to the proportion requirements.

[0033] 3. Application of Vacuum Blood Collection Tubes for Hypertension Blood Sample Testing

[0034] During the use of the vacuum blood collection tube for hypertension blood sample detection, the volume ratio of the hypertension blood sample protectant to the blood sample is 1:50-100, preferably, the volume ratio of the hypertension blood sample protectant to the blood sample is 1:80. When the blood sample directly enters the vacuum blood collection tube for hypertension blood sample detection, it is inverted and mixed. The vacuum blood collection tube for hypertension blood sample detection is pre-filled with a hypertension blood sample protectant, which can reduce the cumbersome steps of reagent preparation and on-site reagent addition, thereby improving the detection efficiency and the accuracy of the test results. The test tube is covered with a rubber stopper, evacuated, and labeled.

[0035] Example 2 Application of a vacuum blood collection tube for hypertension blood sample detection

[0036] 1. Blood collection

[0037] Vacuum blood collection tubes for hypertension blood sample testing and ordinary blood collection tubes are used for blood sample storage and testing, as follows:

[0038] For 30 volunteers, 5 mL of blood was collected from the elbow vein by conventional blood sampling method. Three tubes were collected from each volunteer, one for the experimental group, one for the control group, and one for the negative control group; wherein the experimental group collected the collected blood directly into the vacuum blood collection tube for hypertension blood sample detection in Example 1, turned upside down several times, and immediately placed in an ice water bath or a 4°C refrigerator for 1 to 2 hours as the blood collection tube for the experimental group. After the control group completed the blood collection and pulled out the needle, it was added to the anticoagulant tube (i.e., the vacuum blood collection tube containing the anticoagulant) containing the anticoagulant (EDTA-K2 or EDTA-Na2), the tube cover was opened, and 25 μL of 0.32M dimercaprol solution and 50 μL of 0.34M 8-hydroxyquinoline sulfate were added according to the proportion required by the kit, the tube mouth was sealed and turned upside down several times, and after mixing, it was immediately placed in an ice water bath or a 4°C refrigerator for 1 to 2 hours as the blood collection tube for the control group. After the blood collection of the negative control group is completed and the needle is pulled out, the blood is added to the anticoagulant tube (i.e., the vacuum blood collection tube containing the anticoagulant) containing the anticoagulant (EDTA-K2 or EDTA-Na2), the tube cover is opened, and 50 μL of 0.34M 8-hydroxyquinoline sulfate is added according to the proportion required by the kit. After the tube mouth is sealed, it is turned upside down several times. After mixing, it is immediately placed in an ice water bath or a 4°C refrigerator for 1 to 2 hours as the negative control group blood collection tube.

[0039] Among them, the kit used for the anticoagulant tube includes:

[0040] The kit for determining angiotensin I (chemiluminescence method) includes: magnetic microspheres, luminescent markers, low-point calibrators, high-point calibrators, quality control products; auxiliary reagents: anticoagulants, enzyme inhibitors, pH regulators, and 0.32M dithiocaprol solution.

[0041] The kit for determining angiotensin II (chemiluminescence method) includes: kit: magnetic microspheres, luminescent markers, low-point calibrators, high-point calibrators, quality control products; auxiliary reagents: anticoagulants, enzyme inhibitors, 0.32M dithiocaprol solution.

[0042] The above test kits were all provided by Shenzhen New Industry Biomedical Engineering Co., Ltd.

[0043] Prepare the anticoagulant tube as follows:

[0044] According to the blood collection volume of 5 mL, add 50 μL of 0.3M potassium EDTA (anticoagulant), 25 μL of 0.32M dimercaprol solution, and 50 μL of 0.34M 8-hydroxyquinoline sulfate to each blood collection tube. After preparation, seal and store at 2-8°C for one week. Anticoagulant tubes can also use blood collection tubes containing anticoagulants. When preparing, only 0.32M dimercaprol solution and 8-hydroxyquinoline sulfate need to be added in proportion. No 0.3M potassium EDTA (anticoagulant) is needed. After preparation, seal and store at 2-8°C for one week.

[0045] If anticoagulant tubes are not prepared, blood can be collected using blood collection tubes without any additives. After removing the needle, open the tube cap and add 0.3M potassium EDTA (anticoagulant) (if anticoagulant tubes containing EDTA are used, the anticoagulant provided by the kit does not need to be added), 0.32M dithiocaprol solution and 0.34M 8-hydroxyquinoline sulfate in proportion.

[0046] After preparing the above samples, perform the test preparation according to the test method of the kit, and after preparation, perform pipetting and incubation, calibration, quality control, analytical procedures, calculations and results.

[0047] 2. Plasma Processing

[0048] 1) Take the blood collection tubes of the experimental group, control group and negative control group out of the ice water bath or 4°C refrigerator, centrifuge at 1700g for 10 min, separate the plasma, and obtain the corresponding plasma samples.

[0049] 2) The angiotensin I content in plasma samples of the experimental group, control group and negative control group of the same patients was measured as follows:

[0050] The determination of angiotensin I content is actually to determine the production rate of angiotensin I in plasma, which is a test for plasma renin activity (PRA). That is, two copies of the same plasma sample are taken, one of which is directly reacted with antibodies at 2-8°C to measure the concentration of angiotensin I, which is called the control tube; the other is incubated at 37°C for a period of time, then reacted with antibodies, and the concentration of angiotensin I is measured, which is called the assay tube. The angiotensin I concentration in the assay tube minus the angiotensin I concentration in the control tube divided by the incubation time is the production rate of angiotensin I per unit time, which is called renin activity (PRA).

[0051] The plasma sample was taken out of the blood collection tube and divided into two parts, which were placed in a 12*75mm PET test tube. A pH adjuster was added to each part according to the ratio specified in the kit used for the anticoagulant tube and mixed. One plasma sample was placed in an ice bath, and the other sample was incubated at 37°C for 1 hour and then immediately placed in an ice bath. The on-machine detection procedures and steps were carried out in accordance with the instructions of the kit used for the anticoagulant tube. No enzyme inhibitors were added to the experimental group and the negative control group, and enzyme inhibitors were added normally to the control group. The test results are shown in Table 1.

[0052] Table 1 Analysis results of angiotensin I-responsive plasma renin activity (PRA)

[0053]

[0054]

[0055] The measured values ​​of the three groups of samples were subjected to a T test. The P value between the experimental group and the control group was 0.7252, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9884. The P value between the negative control group and the control group was 0.0001, which was less than 0.05, with a significant difference, and the measured value correlation coefficient was 0.6995. It can be considered that the vacuum blood collection tube for hypertension blood sample detection provided by the present invention is suitable for the determination of angiotensin I by the chemiluminescence method, but the negative control without adding enzyme inhibitors is not suitable for the determination of angiotensin I by the chemiluminescence method.

[0056] 3) The plasma samples of the experimental group, control group and negative control group from the same patients were used to measure the angiotensin II content according to the method in the instruction manual of the kit used for the anticoagulation tube. Among them, no enzyme inhibitors were added to the experimental group and the negative control group, while enzyme inhibitors were added normally to the control group. The measurement results are shown in Table 2.

[0057] Table 2 Angiotensin II analysis results

[0058]

[0059]

[0060] The measured values ​​of the three groups of samples were subjected to a T test. The P value between the experimental group and the control group was 0.9638, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9806; the P value between the negative control group and the control group was 0, which was less than 0.05, with a significant difference, and the measured value correlation coefficient was 0.4137. It can be considered that the vacuum blood collection tube for hypertension blood sample detection provided by the present invention is suitable for the determination of angiotensin II by the chemiluminescence method, but the negative control without adding enzyme inhibitors is not suitable for the determination of angiotensin II by the chemiluminescence method.

[0061] Example 3 Application of a vacuum blood collection tube for hypertension blood sample detection

[0062] 1. Blood collection

[0063] Since this group of experiments is about the influence of the storage time after blood collection, according to the requirements of the test kit for the use of blood collection tubes for sample collection, in order to prevent the use of vacuum blood collection tubes without additives, anticoagulant tubes are still used for blood collection in the control group and the positive control group of this experiment.

[0064] Vacuum blood collection tubes for hypertension blood sample testing and ordinary blood collection tubes are used for blood sample storage and testing, as follows:

[0065] For 30 volunteers, 5 mL of blood was collected from the elbow vein using a conventional blood sampling method. Three tubes were collected from each volunteer, one for the experimental group, one for the control group, and one for the positive control group; the experimental group collected the collected blood directly into the vacuum blood collection tube for hypertension blood sample detection in Example 1, turned it upside down several times, and immediately put it in an ice water bath or a 4°C refrigerator for 2h as the blood collection tube for the experimental group. After the control group completed the blood collection and pulled out the needle, it was added to the anticoagulant tube containing the anticoagulant (EDTA-K2 or EDTA-Na2), and the tube cover was immediately opened. 25 μL of 0.32M dimercaprol solution and 50 μL of 0.34M 8-hydroxyquinoline sulfate were added according to the proportion required by the kit. After the tube mouth was sealed, it was turned upside down several times, and after mixing, it was immediately placed in an ice water bath or a 4°C refrigerator for 2h, as the blood collection tube for the control group.

[0066] After the positive control group blood collection is completed and the needle is pulled out, the blood is added to the anticoagulant tube containing anticoagulant (EDTA-K2 or EDTA-Na2), and immediately placed in an ice water bath or a 4°C refrigerator for 1 hour. Then the tube cover is opened, and 25 μL of 0.32M dithiopropanol solution and 50 μL of 0.34M 8-hydroxyquinoline sulfate are added according to the proportion required by the kit. After the tube mouth is sealed, it is turned upside down several times. After mixing, it is immediately placed in an ice water bath or a 4°C refrigerator for 1 hour. This is used as the blood collection tube for the positive control group.

[0067] The anticoagulation tubes and the kit used in this embodiment are the same as those in Example 2.

[0068] 2. Blood Sample Processing

[0069] The blood collection tubes of the experimental group, the control group and the positive control group were used to detect the content of angiotensin I and angiotensin II in the plasma samples of the same patients in the following manners, as follows:

[0070] 1) Take out the blood collection tubes from the experimental group, control group and positive control group that have been stored for a certain period of time, centrifuge at 1700g for 10 minutes, separate the plasma, and obtain the corresponding plasma samples.

[0071] 2) The angiotensin I content in the plasma samples of the experimental group, control group and positive control group of the same patients was measured as follows:

[0072] The plasma sample was taken out of the blood collection tube and divided into two portions. Each portion was mixed with the regulator according to the ratio of 8:1 (800 μL plasma plus 100 μL pH regulator). One plasma sample was placed in an ice bath, and the other plasma sample was placed in an ice bath immediately after incubation at 37°C for 1 hour. The on-machine detection procedures and steps were carried out according to the instructions of the kit used for the anticoagulant tube. The experimental group did not add enzyme inhibitors, and the control group and the positive control group added enzyme inhibitors normally. The results are shown in Table 3.

[0073] Table 3 Analysis results of angiotensin I-responsive plasma renin activity (PRA)

[0074]

[0075]

[0076] The measured values ​​of the three groups of samples were subjected to T test, and the experimental group and the positive control group were compared with the control group. The P value between the experimental group and the control group was 0.6773, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9969; the P value between the positive control group and the control group was 0.0469, which was less than 0.05, but the measured value correlation coefficient was 0.9238. The experimental group and the positive control group were placed for the same time, and the experimental group could meet the chemiluminescence angiotensin I determination, while the positive control group could only add the corresponding reagent in the kit immediately after blood collection, and the reagent was added after a period of placement, which had a greater impact on the test results.

[0077] 3) The plasma samples of the experimental group, control group and positive control group from the same patients were used to measure the angiotensin II content according to the method in the instruction manual of the kit used for the anticoagulation tube. The experimental group did not add enzyme inhibitors, while the control group and the positive control group both added enzyme inhibitors normally. The measurement results are shown in Table 4.

[0078] Table 4 Angiotensin II analysis results

[0079]

[0080]

[0081] The measured values ​​of the three groups of samples were subjected to T test, and the experimental group and the positive control group were compared with the control group. The P value between the experimental group and the control group was 0.9035, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9724; the P value between the positive control group and the control group was 0.00001, which was less than 0.05, and the measured value correlation coefficient was 0.9022. The experimental group and the positive control group were placed for the same time, and the experimental group could meet the chemiluminescence angiotensin II determination, while the positive control group could only add the corresponding reagent in the kit immediately after blood collection, and the reagent was added after a period of placement, which had a greater impact on the test results.

[0082] Example 4 Application of a vacuum blood collection tube for hypertension blood sample detection

[0083] 1. Blood collection

[0084] According to the formula of 16.9 g / 100 mL of dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL of imidazolidinyl urea, 6.9 g / 100 mL of 8-hydroxyquinoline sulfate, and 0.5 g / 100 mL of enalapril maleate, with the solvent being sterile water for injection, the method for preparing a hypertension blood sample protective agent in Example 1 was used to prepare a control hypertension blood sample protective agent 1, and the control hypertension blood sample protective agent 1 was used to make a control vacuum blood collection tube 1.

[0085] According to the formula of 16.9 g / 100 mL of dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL of imidazolidinyl urea, 6.9 g / 100 mL of 8-hydroxyquinoline sulfate, and 2.0 g / 100 mL of enalapril maleate, with the solvent being sterile water for injection, the method for preparing a hypertension blood sample protective agent in Example 1 was used to prepare a control hypertension blood sample protective agent 2, and the control hypertension blood sample protective agent 1 was used to make a control vacuum blood collection tube 2.

[0086] Vacuum blood collection tubes for hypertension blood sample testing and ordinary blood collection tubes are used for blood sample storage and testing, as follows:

[0087] For 30 volunteers, 5 mL of blood was collected from the elbow vein by conventional blood collection methods. Four tubes were collected from each volunteer, one for the experimental group, one for the control group, one for the control group one, and one for the control group two; wherein the experimental group, the control group one, and the control group two directly collected the collected blood samples into the vacuum blood collection tubes for blood sample detection of hypertension in Example 1, the control vacuum blood collection tube one, and the control vacuum blood collection tube two, turned upside down several times, and immediately placed in an ice water bath or a 4°C refrigerator for 2h, as the blood collection tubes for the experimental group. After the control group blood collection was completed and the needle was pulled out, it was added to the anticoagulant tube containing the anticoagulant (EDTA-K2 or EDTA-Na2), the tube cover was immediately opened, and 25 μL of a 0.32M dimercaprol solution and 50 μL of a 0.34M 8-hydroxyquinoline sulfate were added according to the proportion required by the kit, the tube mouth was sealed, turned upside down several times, and immediately placed in an ice water bath or a 4°C refrigerator for 2h after mixing, as the blood collection tubes for the control group.

[0088] The anticoagulation tubes and the kit used in this embodiment are the same as those in Example 2.

[0089] 2. Blood Sample Processing

[0090] The blood collection tubes of the experimental group, the control group and the positive control group were used to detect the content of angiotensin I and angiotensin II in the plasma samples of the same patients in the following manners, as follows:

[0091] 1) Take out the blood collection tubes of the experimental group, control group, control group 1 and control group 2 that have reached the storage time, centrifuge at 1700g for 10 minutes, separate the plasma, and obtain the corresponding plasma samples.

[0092] 2) The angiotensin I content in plasma samples of the experimental group, control group, control group 1 and control group 2 of the same patient was measured as follows:

[0093] The plasma sample was taken out of the blood collection tube and divided into two portions. Each portion was mixed with the regulator according to the ratio of 8:1 (800 μL plasma plus 100 μL pH regulator). One plasma sample was placed in an ice bath, and the other plasma sample was placed in an ice bath immediately after incubation at 37°C for 1 hour. The on-machine detection procedures and steps were carried out according to the instructions of the kit used for the anticoagulation tube. No enzyme inhibitors were added to the experimental group, control group one and control group two, and enzyme inhibitors were added normally to the control group. The results are shown in Table 5.

[0094] Table 5 Analysis results of angiotensin I-responsive plasma renin activity (PRA)

[0095]

[0096]

[0097] T test was performed on the measured values ​​of the four groups of samples, and the experimental group was compared with the control group 1 and the control group 2. The P value between the experimental group and the control group was 0.9857, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9973; the P value between the control group 1 and the control group was 0.0407, which was less than 0.05, and the measured value correlation coefficient was 0.9488; the P value between the control group 2 and the control group was 0.0458, which was less than 0.05, and the measured value correlation coefficient was 0.9544. The experimental group can meet the determination of angiotensin I content, while the control group 1 and the control group 2 have poor results in determining angiotensin I content and cannot meet the use requirements.

[0098] 3) The plasma samples of the experimental group, control group, control group 1 and control group 2 from the same patients were used to measure the angiotensin II content according to the method in the instruction manual of the kit used for the anticoagulation tube. Among them, the experimental group, control group 1 and control group 2 did not add enzyme inhibitors, and the control group added enzyme inhibitors normally. The measurement results are shown in Table 6.

[0099] Table 6 Angiotensin II analysis results

[0100]

[0101]

[0102] T test was performed on the measured values ​​of the four groups of samples, and the experimental group was compared with the control group 1 and the control group 2. The P value between the experimental group and the control group was 0.8658, which was greater than 0.05, with no significant difference, and the measured value correlation coefficient was 0.9983; the P value between the control group 1 and the control group was 0.000012, which was less than 0.05, and the measured value correlation coefficient was 0.9467; the P value between the control group 2 and the control group was 0.0001, which was less than 0.05, and the measured value correlation coefficient was 0.9562. The experimental group can meet the determination of angiotensin II content, while the control group 1 and the control group 2 have poor results in determining angiotensin II content and cannot meet the use requirements.

[0103] Examples 5 to 8 Hypertension blood sample protective agent and vacuum blood collection tube for hypertension blood sample detection

[0104] Examples 5 to 8 are respectively a hypertensive blood sample protective agent and a vacuum blood collection tube for hypertensive blood sample detection, which include a preparation method of a hypertensive blood sample protective agent and a vacuum blood collection tube for hypertensive blood sample detection prepared using the same. The overall process is basically the same as that in Example 1, and the only difference is the difference in the amount of some raw materials and the process parameters. See Table 7 for details:

[0105] Table 7 List of process parameters in Examples 5 to 8

[0106]

[0107] The contents of other parts of Examples 5 to 8 are the same as those of Example 1.

[0108] Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

Claims

1. A hypertensive blood sample protective agent, characterized in that: The raw materials of the hypertension blood sample protective agent include, by weight: 1-1.3 parts of enalapril maleate, 15.2-18.6 parts of anticoagulant and 13.8-16.9 parts of complexing agent.

2. The hypertensive blood sample protective agent according to claim 1, characterized in that The complexing agents are imidazolidinyl urea and 8-hydroxyquinoline sulfate.

3. The hypertensive blood sample protective agent according to claim 2, characterized in that: The weight ratio of imidazolidinyl urea to 8-hydroxyquinoline sulfate is 7.5-9.2:6.3-7.

7.

4. The hypertensive blood sample protective agent according to any one of claims 1 to 3, characterized in that: The anticoagulant is dipotassium ethylenediaminetetraacetate.

5. The hypertensive blood sample protective agent according to any one of claims 1 to 3, characterized in that: The preparation method of the hypertension blood sample protective agent is to take enalapril maleate, an anticoagulant and a complexing agent, add injection water to dissolve them, and prepare the agent.

6. The hypertensive blood sample protective agent according to any one of claims 1 to 3, characterized in that: The hypertension blood sample protective agent contains 15.2-18.6 g / 100 mL of dipotassium ethylenediaminetetraacetate, 7.5-9.2 g / 100 mL of imidazolidinyl urea, 6.3-7.7 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.0-1.3 g / 100 mL of enalapril maleate.

7. A vacuum blood collection tube for hypertension blood sample detection, characterized in that: The vacuum blood collection tube for hypertension blood sample detection contains the hypertension blood sample protective agent according to any one of claims 1 to 6.

8. The vacuum blood collection tube for hypertension blood sample detection according to claim 7, characterized in that: When the specification of the vacuum blood collection tube for hypertension blood sample detection is 3mL, 34.0~41.6μL of the hypertension blood sample protective agent is sprayed, and when the specification is 5mL, 56.7~69.3μL of the hypertension blood sample protective agent is sprayed; other specifications are sprayed with corresponding amounts of hypertension blood sample protective agent according to the proportion.

9. An application of a vacuum blood collection tube for hypertension blood sample detection, characterized in that: The application is to directly store blood using the vacuum blood collection tube for hypertension blood sample detection as described in claim 7 or 8.

10. The use of the vacuum blood collection tube for hypertension blood sample detection according to claim 9, characterized in that: During the blood preservation process, the volume ratio of the hypertension blood sample protectant to the blood is 1:50-100.

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