Preparation method and application of condom with ovulation detection function

Abstract

The invention relates to the technical field of condoms, in particular to a preparation method and application of a condom with an ovulation detection function, and the preparation method comprises the following steps: (1) preparing a luteinizing hormone antibody solution and an antibody carrier solution, and mixing the luteinizing hormone antibody solution and the antibody carrier solution to prepare an antibody coating solution; (2) coating the outer surface of the condom with the antibody coating solution, standing and drying to obtain an antibody coating; and (3) preparing a catalyst solution and an indicator solution, coating the antibody coating with the catalyst solution and the indicator solution, and standing and drying to obtain the condom with the ovulation detection function. According to the condom, contraception and ovulation period detection can be effectively combined, the antibody coating coated on the outer surface of the condom is combined with luteinizing hormone in female secretion, color change is generated, the ovulation period is reflected in real time, the detection sensitivity is high, and a user can make a fertility plan conveniently.

Description

Technical Field

[0001] The present invention relates to the technical field of condoms, and particularly to a preparation method and application of a condom with an ovulation detection function. Background Art

[0002] Traditional condoms mainly prevent pregnancy and the spread of sexually transmitted diseases through physical barrier effects. With the increasing demand of women for birth control, how to monitor the ovulation cycle during daily contraception has become a potential need. Currently, ovulation test strips are commonly used in the market to detect the luteinizing hormone level in women's bodies. These tools require independent operation and are difficult to be combined with contraceptive products.

[0003] Chinese Patent Publication No. CN107212959 A proposes a condom, which includes a condom body seat, a condom body, a glans seat and a glans; the condom body is installed on the condom body seat, and the condom body is connected to the glans through the glans seat; the condom body, the glans seat and the glans are put into an outer membrane sleeve. This condom achieves the contraceptive effect through physical isolation with a traditional design and cannot obtain ovulation information in real time while using the condom, so as to better plan childbearing.

[0004] Therefore, there is a large room for improvement in the existing technology. Summary of the Invention

[0005] The purpose of the present invention is to make up for the deficiencies of the existing technology and provide a preparation method of a condom with an ovulation detection function. By detecting the luteinizing hormone level in the cervical and vaginal secretions of women, it can reflect the ovulation period in real time and feedback to the user through color change, prompting the current physiological state of the woman, which is beneficial for the user to make a good childbearing plan.

[0006] In order to achieve the above purpose, the technical solution adopted by the present invention is as follows: A preparation method of a condom with an ovulation detection function includes the following steps: (1) Prepare a luteinizing hormone antibody solution and an antibody carrier solution, and mix the luteinizing hormone antibody solution with the antibody carrier solution to prepare an antibody coating solution; (2) Coat the antibody coating solution on the outer surface of the condom and let it stand for drying to obtain an antibody coating; (3) Prepare a catalyst solution and an indicator solution, coat the catalyst solution and the indicator solution on the antibody coating, and let it stand for drying to obtain a condom with an ovulation detection function.

[0007] According to the above scheme, in the step (1), the luteinizing hormone antibody is a luteinizing hormone monoclonal antibody.

[0008] According to the above solution, the preparation method of the luteinizing hormone monoclonal antibody solution is as follows: Take the luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody solution to 50 μg / mL using phosphate buffer solution.

[0009] According to the above solution, in step (1), the antibody carrier is one of polyethyleneimine solution or aminopropylsilane solution.

[0010] According to the above solution, in step (1), the diluted antibody solution and the antibody carrier solution are fully mixed evenly at a volume ratio of 1:10 - 3:8 to prepare an antibody coating solution.

[0011] According to the above solution, in step (2), the antibody coating is spray-coated on the outer surface of the condom, and the spraying thickness is controlled at 1 - 2 μm.

[0012] According to the above solution, after the antibody coating in step (2) is coated, the condom is placed in an environment at 4°C for drying, with a relative humidity of 40% - 50% and a drying time of 18 - 24 hours.

[0013] According to the above solution, in step (3), the catalyst is horseradish peroxidase solution, and the indicator is a combination of 3,3'-diaminobenzidine solution. The horseradish peroxidase solution is evenly dripped on the antibody coating, left standing at 4°C for 30 minutes, then gently rinsed with phosphate solution to remove the horseradish peroxidase that has not been adsorbed on the antibody coating. After standing and drying, 3,3'-diaminobenzidine solution is sprayed on the surface.

[0014] According to the above solution, the preparation method of the horseradish peroxidase is as follows: Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution.

[0015] According to the above solution, the application method of the condom with ovulation detection function is that during the use of the condom, when the cervical and vaginal secretions of a female come into contact with the antibody coating on the surface of the condom, the luteinizing hormone monoclonal antibody on the antibody coating binds to the luteinizing hormone in the cervical and vaginal secretions of the female. Under the combined action of the catalyst horseradish peroxidase and the indicator 3,3'-diaminobenzidine, the condom will change from transparent to bright red or reddish-brown or dark brown.

[0016] Working principle of the present invention: The condom of the present invention is coated with a luteinizing hormone antibody coating on the outer surface. When the luteinizing hormone in the cervical and vaginal secretions of women specifically binds to the luteinizing hormone antibody coating, an antigen-antibody complex is formed. The antigen-antibody complex activates horseradish peroxidase, and the activated horseradish peroxidase catalyzes the oxidation of 3,3'-diaminobenzidine in the cervical and vaginal environment to generate oxidized 3,3'-diaminobenzidine. The oxidized 3,3'-diaminobenzidine is red or reddish-brown or dark brown. Therefore, as the concentration of luteinizing hormone is higher, the more oxidized 3,3'-diaminobenzidine is generated, and the color of the condom gradually changes from transparent to red or reddish-brown or dark brown, which can reflect the level of luteinizing hormone in the cervical and vaginal secretions of women and indicate that the woman is in the ovulatory physiological period.

[0017] Compared with the prior art, the present invention has the following beneficial effects: When in use, the condom of the present invention can effectively combine contraception with ovulation period detection. By the antibody coating coated on the outer surface of the condom binding to the luteinizing hormone in the female secretions, color changes occur, which can reflect the ovulation period in real time, convenient and efficient, and effectively breaks through the single sexual function of the conventional condom.

[0018] The condom of the present invention has high detection sensitivity for luteinizing hormone, can sensitively identify low-concentration luteinizing hormone, and can prompt users in time when the ovulation period arrives, which is beneficial for users to better make fertility plans. Specific embodiments

[0019] The following further details the present invention in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0020] Embodiment 1 A preparation method of a condom with ovulation detection function, comprising the following steps: (1) Prepare a luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL using a phosphate buffer solution; Prepare a polyethyleneimine solution antibody carrier: Take 5 mg of polyethyleneimine and dissolve it in 100 mL of phosphate buffer solution to prepare a 5 mg / mL polyethyleneimine solution; Fully mix the diluted antibody solution and the antibody carrier solution evenly according to a volume ratio of 1:10 to obtain an antibody coating solution.

[0021] (2)Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, control the spraying thickness to be 1 μm. After spraying, place the condom in a low-temperature environment of 4°C for drying, with a relative humidity of 40%, and dry for 18 hours.

[0022] (3)Prepare horseradish peroxidase solution: Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution.

[0023] Prepare 3,3'-diaminobenzidine solution: Take 2 mg of 3,3'-diaminobenzidine and dissolve it in 100 mL of acetate buffer solution to prepare a 0.02 mg / mL 3,3'-diaminobenzidine solution.

[0024] Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating, let it stand at 4°C for 30 minutes, then gently rinse with phosphate solution to remove the horseradish peroxidase that has not adsorbed on the antibody coating. After standing and drying, spray 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating. After spraying, let it stand at room temperature for 5 min to obtain a condom with ovulation detection function.

[0025] Further, the pH of the above-mentioned phosphate solution is 7.4.

[0026] Example 2 A preparation method of a condom with ovulation detection function, comprising the following steps: (1)Prepare luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL using phosphate buffer solution; Prepare a polyethyleneimine solution antibody carrier: Take 5 mg of polyethyleneimine and dissolve it in 100 mL of phosphate buffer solution to prepare a 5 mg / mL polyethyleneimine solution; Fully mix the diluted antibody solution and the antibody carrier solution evenly according to a volume ratio of 2:9 to obtain an antibody coating solution.

[0027] (2)Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, control the spraying thickness to be 1 μm. After spraying, place the condom in a low-temperature environment of 4°C for drying, with a relative humidity of 45%, and dry for 21 hours.

[0028] (3) Preparation of horseradish peroxidase solution: Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution, and coat the indicator solution on the antibody coating.

[0029] Preparation of 3,3'-diaminobenzidine solution: Take 2 mg of 3,3'-diaminobenzidine and dissolve it in 100 mL of acetate buffer solution to prepare a 0.02 mg / mL 3,3'-diaminobenzidine solution.

[0030] Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating, let it stand at 4°C for 30 minutes, then gently rinse with phosphate solution to remove the horseradish peroxidase that has not been adsorbed on the antibody coating. After standing and drying, spray 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating. After spraying, let it stand at room temperature for 5 min to obtain a condom with ovulation detection function.

[0031] Further, the pH of the above-mentioned phosphate solution is 7.4.

[0032] Example 3 A preparation method of a condom with ovulation detection function, comprising the following steps: (1) Preparation of luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL using phosphate buffer solution; Preparation of polyethylenimine solution as antibody carrier: Take 5 mg of polyethylenimine and dissolve it in 100 mL of phosphate buffer solution to prepare a 5 mg / mL polyethylenimine solution; Mix the diluted antibody solution and the antibody carrier solution evenly in a volume ratio of 3:8 to obtain an antibody coating solution.

[0033] (2) Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, and control the spraying thickness to be 1 μm. After spraying, place the condom in a low-temperature environment at 4°C for drying, with a relative humidity of 50%, and dry for 24 hours.

[0034] (3) Preparation of horseradish peroxidase solution: Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution, and coat the indicator solution on the antibody coating.

[0035] Prepare a 3,3'-diaminobenzidine solution. Take 2 mg of 3,3'-diaminobenzidine and dissolve it in 100 mL of acetate buffer solution to prepare a 3,3'-diaminobenzidine solution with a concentration of 0.02 mg / mL.

[0036] Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating. Let it stand at 4°C for 30 minutes, then gently rinse with phosphate solution to remove the horseradish peroxidase that has not adsorbed on the antibody coating. After standing and drying, spray the 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating. After spraying, let it stand at room temperature for 5 min to obtain a condom with ovulation detection function.

[0037] Further, the pH of the above-mentioned phosphate solution is 7.4.

[0038] Example 4 A method for preparing a condom with ovulation detection function, comprising the following steps: (1) Prepare a luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL using phosphate buffer solution; Prepare an aminopropylsilane solution antibody carrier: Take 2 mg of aminopropylsilane solution and dissolve it in 100 mL of phosphate buffer solution to prepare an aminopropylsilane solution with a concentration of 2 mg / mL; Fully mix the diluted antibody solution and the antibody carrier solution evenly according to a volume ratio of 1:10 to obtain an antibody coating solution.

[0039] (2) Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, and control the spraying thickness to be 2 μm. After spraying, place the condom in a low-temperature environment at 4°C for drying, with a relative humidity of 40%, and dry for 18 hours.

[0040] (3) Prepare a horseradish peroxidase solution; Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a horseradish peroxidase solution with a concentration of 0.1 mg / mL; Prepare a 3,3'-diaminobenzidine solution: Take 2 mg of 3,3'-diaminobenzidine and dissolve it in 100 mL of acetate buffer solution to prepare a 3,3'-diaminobenzidine solution with a concentration of 0.02 mg / mL; Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating. Let it stand at 4 °C for 30 minutes, then gently rinse it with phosphate solution to remove the horseradish peroxidase that has not been adsorbed on the antibody coating. After standing and drying, spray 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating. After spraying, let it stand at room temperature for 5 min to obtain a condom with ovulation detection function.

[0041] Further, the pH of the above-mentioned phosphate solution is 7.4.

[0042] Example 5 A method for preparing a condom with ovulation detection function, comprising the following steps: (1) Prepare luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL using phosphate buffer solution; Prepare an antibody carrier of aminopropylsilane solution: Take 2 mg of aminopropylsilane solution and dissolve it in 100 mL of phosphate buffer solution to prepare a 2 mg / mL aminopropylsilane solution; Fully mix the diluted antibody solution and the antibody carrier solution evenly according to a volume ratio of 2:9 to obtain an antibody coating solution.

[0043] (2) Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, and control the spraying thickness to be 2 μm. After spraying, place the condom in a low-temperature environment of 4 °C for drying, with a relative humidity of 45%, and dry for 21 hours.

[0044] (3) Prepare horseradish peroxidase solution; Take 10 mg of horseradish peroxidase and dissolve it in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution; Prepare 3,3'-diaminobenzidine solution: Take 2 mg of 3,3'-diaminobenzidine and dissolve it in 100 mL of acetate buffer solution to prepare a 0.02 mg / mL 3,3'-diaminobenzidine solution; Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating. Let it stand at 4 °C for 30 minutes, then gently rinse it with phosphate solution to remove the horseradish peroxidase that has not been adsorbed on the antibody coating. After standing and drying, spray 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating. After spraying, let it stand at room temperature for 5 min to obtain a condom with ovulation detection function.

[0045] Further, the pH of the phosphate solution mentioned above is 7.4.

[0046] Example 6 A preparation method of a condom with ovulation detection function, comprising the following steps: (1) Prepare luteinizing hormone monoclonal antibody solution: Take a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and dilute the luteinizing hormone monoclonal antibody to 50 μg / mL with phosphate buffer solution; Prepare an antibody carrier of aminopropylsilane solution: Take 2 mg of aminopropylsilane solution, dissolve it in 100 mL of phosphate buffer solution, and prepare a 2 mg / mL aminopropylsilane solution; Fully mix the diluted antibody solution and the antibody carrier solution evenly according to a volume ratio of 3:8 to obtain an antibody coating solution.

[0047] (2) Select a nozzle device with a diameter of 0.1 mm, keep a distance of 20 cm between the nozzle and the outer surface of the condom, evenly spray the antibody coating on the outer surface of the condom, control the spraying time for each area to be 5S, control the spraying thickness to be 2 μm, after spraying, place the condom in a low-temperature environment of 4°C for drying, with a relative humidity of 50%, and dry for 24 hours.

[0048] (3) Prepare horseradish peroxidase solution; Take 10 mg of horseradish peroxidase, dissolve it in 100 mL of phosphate buffer solution, and prepare a 0.1 mg / mL horseradish peroxidase solution; Prepare 3,3'-diaminobenzidine solution: Take 2 mg of 3,3'-diaminobenzidine, dissolve it in 100 mL of acetate buffer solution, and prepare a 0.02 mg / mL 3,3'-diaminobenzidine solution; Take 0.5 ml of horseradish peroxidase solution and evenly drop it on the antibody coating, let it stand at 4°C for 30 minutes, then gently rinse with phosphate solution to remove the horseradish peroxidase that has not been adsorbed on the antibody coating, after standing and drying, then spray 3,3'-diaminobenzidine solution on the surface to form a 0.5 μm coating, and let it stand at room temperature for 5 min after spraying to obtain a condom with ovulation detection function.

[0049] Further, the pH of the phosphate solution mentioned above is 7.4.

[0050] Comparative Example 1 Select the same condom raw materials as in Examples 1-5 without any process treatment.

[0051] Test experiment Test method: Prepare luteinizing hormone standard solutions with concentrations of 0 ng / mL, 0.1 ng / mL, 0.5 ng / mL, 1 ng / mL, 1.5 ng / mL, and 2 ng / mL, and drop them onto the condoms of Examples 1-6 respectively, and record the color changes.

[0052] The results of the color changes of the condoms in Examples 1-6 and Comparative Example 1 are shown in Table 1 below: Table 1

[0053] The results in Table 1 show that compared with conventional condoms, the condom prepared by the preparation method of the present invention has an antibody coating that can sensitively recognize luteinizing hormone. As the concentration of luteinizing hormone increases, the color change of the condom becomes more significant. The color of the condom changes from transparent (no luteinizing hormone) to red (low concentration of luteinizing hormone) to reddish-brown (medium concentration of luteinizing hormone), and finally to dark brown (high concentration of luteinizing hormone), indicating the ovulation physiological period of women, which is convenient and efficient. When the volume ratio of the antibody to the antibody carrier is 1:10, the antibody coating of the condom can sensitively recognize luteinizing hormone with a concentration of 0.1 ng / mL, and has high sensitivity, which can ensure that users are timely reminded to make a fertility plan when ovulation arrives.

[0054] The above are only the preferred embodiments of the present invention. Therefore, all equivalent changes or modifications made according to the structure, characteristics, and principles described in the scope of the present invention patent application are included in the scope of the present invention patent application.

Claims

1. A method for preparing a condom with ovulation detection function, characterized in that: The steps include: (1) preparing a luteinizing hormone antibody solution and an antibody carrier solution, and mixing the luteinizing hormone antibody solution and the antibody carrier solution to prepare an antibody coating solution; (2) coating the antibody coating solution on the outer surface of the condom and allowing it to dry to obtain the antibody coating; (3) preparing a catalyst solution and an indicator solution, applying the catalyst solution and the indicator solution on the antibody coating, and allowing to stand and dry to obtain a condom with ovulation detection function; The antibody carrier solution in step (1) is one of a polyethyleneimine solution and an aminopropylsilane solution; The catalyst solution in step (3) is a horseradish peroxidase solution, and the indicator solution is a 3,3'-diaminobenzidine solution.

2. The method for preparing a condom with ovulation detection function according to claim 1, characterized in that: The luteinizing hormone antibody in step (1) is a luteinizing hormone monoclonal antibody.

3. The method for preparing a condom with ovulation detection function according to claim 2, characterized in that: The preparation method of the luteinizing hormone monoclonal antibody solution is as follows: taking a luteinizing hormone monoclonal antibody solution with a concentration of 1 mg / mL, and diluting the luteinizing hormone monoclonal antibody solution to 50 μg / mL using a phosphate buffer.

4. The method for preparing a condom with ovulation detection function according to claim 3, characterized in that: In the step (1), the diluted antibody solution and the antibody carrier solution are fully mixed in a volume ratio of 1:10-3:8 to obtain an antibody coating solution.

5. The method for preparing a condom with ovulation detection function according to claim 4, characterized in that: In step (2), the antibody coating solution is sprayed onto the outer surface of the condom using a spraying technique, and the spraying thickness is controlled to be 1-2 μm.

6. The method for preparing a condom with ovulation detection function according to claim 5, characterized in that: After the antibody coating in step (2) is applied, the condom is placed in an environment at 4°C to dry, with a relative humidity of 40%-50%, and the drying time is 18-24 hours.

7. The method for preparing a condom with ovulation detection function according to claim 6, characterized in that: In step (3), the horseradish peroxidase solution is evenly dripped onto the antibody coating, allowed to stand at 4°C for 30 minutes, and then gently rinsed with a phosphate solution to remove the horseradish peroxidase not adsorbed on the antibody coating. After standing to dry, the 3,3'-diaminobenzidine solution is sprayed on the surface.

8. The method for preparing a condom with ovulation detection function according to claim 7, characterized in that: The preparation method of the horseradish peroxidase is as follows: 10 mg of horseradish peroxidase is taken and dissolved in 100 mL of phosphate buffer solution to prepare a 0.1 mg / mL horseradish peroxidase solution.

9. A condom with ovulation detection function, characterized in that: A condom made according to the preparation method with ovulation detection function according to any one of claims 1-8.

10. The method for using the condom with ovulation detection function according to claim 9, characterized in that: During the use of condoms, when female vaginal secretions come into contact with the antibody coating on the surface of the condom, the luteinizing hormone monoclonal antibody on the antibody coating combines with the luteinizing hormone on the female vaginal secretions, and the condom will change from transparent to bright red, reddish brown or dark brown under the combined action of the catalyst horseradish peroxidase and the indicator 3,3'-diaminobenzidine.

Images