Condom added with matrine hyaluronic acid lubricating liquid and preparation method of condom

Abstract

The invention discloses a condom added with sophocarpidine hyaluronic acid lubricating liquid and a preparation method of the condom, and belongs to the technical field of condom production. The core of the method is that after matrine is dissolved, the matrine is added into hyaluronic acid lubricating liquid for the condoms, the hyaluronic acid lubricating liquid containing the matrine is prepared through stirring and mixing, the concentration of the matrine in the hyaluronic acid lubricating liquid is 7.7-25.0 mg / g, when the condoms are subjected to inner packaging, the matrine-containing lubricating agent is added into the condoms, and when the condoms are subjected to inner packaging, the matrine-containing lubricating agent is added into the condoms. And preparing the condom added with the sophocarpidine-containing hyaluronic acid lubricating liquid. According to the condom, inflammation generated after vaginal epithelial cells are stimulated by bacterial structural components is improved through matrine, and the common pathogenic bacteria such as staphylococcus aureus, escherichia coli, enterococcus faecalis and streptococcus agalactiae of vaginitis are inhibited in the using process; and the up-regulation level of NF-kB phosphorylation generated after lipopolysaccharide and peptidoglycan stimulate vaginal epithelial cells is relieved.

Description

Technical Field

[0001] This invention relates to a condom and its preparation method, belonging to the field of condom manufacturing technology, specifically to a condom with added matrine and hyaluronic acid lubricant and its preparation method. Background Technology

[0002] Lower genital tract infections in women are among the most common diseases seen in gynecological clinics. Under physiological conditions, estrogen levels in women of reproductive age increase glycogen in vaginal epithelial cells, which facilitates lactobacillus colonization. Lactobacillus produces lactic acid, which lowers the vaginal pH, creating an acidic environment that inhibits pathogen growth and maintains vaginal homeostasis. Pathologically, however, the number of lactobacilli decreases while pathogenic bacteria increase. Vaginal infections include bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomonal vaginitis (TV).

[0003] The 2018 European League for STD Control / World Health Organization Guidelines on the Management of Vaginal Discharge (Vaginal Inflammation) recommend clindamycin vaginal ointment as a treatment option. For severe cases, steroids can be used in combination to relieve inflammation. Based on clindamycin's antibacterial spectrum, it is effective against infections caused by Gram-positive cocci. However, among common vaginitis pathogens, *Escherichia coli* and *Enterococcus faecalis* are not on its antibacterial spectrum. Other studies have used oral antibiotics, but oral medications may cause drug resistance or even intestinal flora imbalance. Even if they provide good short-term results, they are not conducive to long-term treatment.

[0004] Sophora flavescens, a treasure of traditional Chinese medicine, has matrine as its main component. Matrine has been pharmacologically proven to have anti-inflammatory, anti-allergic, antiviral, and anti-fibrotic effects. Invention CN113171418A discloses a contraceptive antibacterial gel and applicator. This gel includes nonoxynol ether, aloe vera extract, matrine, motherwort extract, Cnidium monnieri extract, rose essential oil, hyaluronic acid, and silver peptides, as well as cationic antibacterial agents. Matrine and silver peptides can effectively inhibit or kill bacteria such as Candida albicans, Staphylococcus aureus, Escherichia coli, and Candida albicans, reducing the occurrence of reproductive tract infections and inflammation. Aloe vera extract and Cnidium monnieri extract effectively achieve antibacterial and antitrichomonal effects, repair and enhance antiviral and antibacterial infection capabilities, thereby inhibiting inflammation and antagonizing the inflammatory stimulation of endotoxins, enhancing vaginal mucosal immunity, and providing long-lasting deep nourishment to the vulva, thus reducing the occurrence of various gynecological diseases. No related technologies regarding the use of matrine in condoms have been disclosed. Summary of the Invention

[0005] The purpose of this invention is to provide a condom with added matrine and hyaluronic acid lubricant and its preparation method, thereby enhancing the functionality of traditional condoms. The lubricant in this condom contains matrine. Studies have shown that when matrine is used at concentrations between 7.7 mg / g and 25 mg / g, it increases the inhibitory effect on Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, and Streptococcus agalactiae in the vagina, providing a good adjunctive therapeutic effect on vaginal inflammation caused by these pathogens.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A method for preparing a condom with added matrine and hyaluronic acid lubricant, comprising the following steps: (1) Dissolving: Place matrine in a clean container, add cold water at 10-15℃ at a ratio of 1:5, and use an ultrasonic cleaner to dissolve it by ultrasonic vibration until a clear liquid is obtained. The solution is then ready for use. (2) Mixing: Put the condom lubricant into the liquid mixing tank, and then put the matrine solution that has been dissolved in step (1) into the liquid mixing tank. Start the mixer of the mixing tank and mix to obtain the hyaluronic acid lubricant for condoms containing matrine. The mixing time is 20-30 minutes and the stirring speed is 50-60 revolutions / minute. (3) Metering addition: The lubricant obtained in step (2) is added to the condom through a metering pump within 48 hours. The amount added is between 200-1200mg. The condom is packaged with composite aluminum film. The resulting condom is a condom with added matrine lubricant.

[0007] The ultrasonic cleaner mentioned in step (1) has a power of 500W.

[0008] The condom lubricant mentioned in step (2) is a water-based lubricant.

[0009] The concentration of matrine in the condom lubricant described in step (2) is 7.7 mg / g-25.0 mg / g.

[0010] The amount of matrine lubricant added in step (3) is 200-1200 mg / piece.

[0011] The concentration of matrine used above is 7.7 mg / g-25.0 mg / g.

[0012] The above-mentioned water-based lubricant is mainly composed of betaine, sodium hyaluronate, glycerin, and purified water.

[0013] A condom with added matrine and hyaluronic acid lubricant was obtained using the above preparation method.

[0014] Analysis of the mechanism of action of matrine on vaginal inflammation: 1. It achieves its antibacterial effect by disrupting the cell membrane of pathogenic bacteria. By inhibiting bacterial cell membrane synthesis, interfering with bacterial protein synthesis, and damaging bacterial cell walls, bacteria's cell membrane function is affected, causing them to lose their normal physiological functions, thus exerting an antibacterial effect.

[0015] 2. Interferes with the bio-oxidation process of pathogenic bacteria By affecting the respiratory chain or energy metabolism of bacteria, microorganisms are made to have insufficient energy supply, thereby inhibiting their activity.

[0016] Anti-inflammatory effect The alkaloids in matrine can inhibit the chemotaxis and phagocytosis of leukocytes, thereby reducing the inflammatory response and making it extremely effective in treating mucosal inflammation caused by vaginitis.

[0017] Immunomodulatory effects Matrine can regulate the body's immune response, enhance immunity, and help the body better resist infection and promote the healing process.

[0018] Analgesic effect For mild pain caused by vaginitis, matrine, an alkaloid, has a central analgesic effect and can help relieve discomfort.

[0019] The beneficial effects of this invention are as follows: The condoms produced by this method not only play a physical barrier role in preventing pregnancy and sexually transmitted diseases, but also help fight inflammation, inhibit pathogens, and relieve symptoms, thereby effectively assisting in the treatment of vaginal inflammation caused by pathogens.

[0020] By adding matrine and other ingredients to condom lubricants, contraception and prevention of sexually transmitted diseases are achieved while simultaneously regulating and inhibiting the growth of pathogenic bacteria, which helps prevent and treat gynecological diseases. This patented invention adds matrine to the lubricant, allowing it to be evenly distributed within the vagina during sexual intercourse, directly targeting the lesion. This enables the matrine to exert its effect more concentratedly, improving efficacy and making it more convenient and quick to use. At concentrations of 7.7 mg / g-25.0 mg / g, matrine significantly inhibits Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, and Streptococcus agalactiae, while also alleviating the upregulation of NF-κB phosphorylation after stimulation by lipopolysaccharide and peptidoglycan. When used in combination with other antibacterial drugs, it can reverse drug resistance and prevent or reduce drug toxicity.

[0021] Matrine regulates the vaginal microecology by inhibiting bacterial growth, reducing inflammation, relieving itching, and promoting vaginal health. The specific mechanisms are as follows: 1. Inhibiting bacterial growth: The active ingredients in matrine can inhibit or kill pathogenic bacteria, reducing the number of bacteria in the vagina and preventing microecological imbalance caused by excessive bacterial growth; 2. Anti-inflammatory effect: Matrine has a certain anti-inflammatory effect, reducing mucosal damage by inhibiting the NF-κB pathway and the release of inflammatory factors, relieving local redness, swelling, itching, and other symptoms, and maintaining the normal physiological state of the vagina; 3. Antipruritic effect: Matrine can relieve itching symptoms caused by infection or allergies, reducing patient discomfort; 4. Promoting vaginal health: Matrine can regulate the proportion of beneficial bacteria in the vagina, restore the normal microecological environment, and improve local immunity, thereby maintaining vaginal health. Detailed Implementation

[0022] The present invention will be further described in detail below through examples. These embodiments are only used to illustrate the present invention and do not limit the scope of the present invention. Example 1

[0023] A condom with added matrine lubricant and its preparation method (1) Dissolving: Place 1.63 kg of matrine (purity: 98%, produced by Xi'an Aosai Biotechnology Co., Ltd.) in a clean container, add 8.15 kg of cold water at a temperature of 10-15℃ at a material-to-liquid ratio of 1:5, and use an ultrasonic cleaner (model: BILON22-500A, produced by Shanghai Bilang Instrument Manufacturing Co., Ltd.) to dissolve it by ultrasonic vibration until a clear liquid is obtained. The dissolving is complete and ready for use. (2) Mixing: Put 90Kg of hyaluronic acid condom lubricant (commercially available, Huaxi Biotechnology Co., Ltd.) into a regular liquid mixing tank (liquid mixing tank, volume 1 cubic meter, model: MH-4, produced by Guangdong Menghui Machinery Technology Co., Ltd.), and then put the matrine solution dissolved in step (1) into the liquid mixing tank. Start the mixer of the mixing tank and mix for 20-30 minutes at a speed of 50-60 rpm. The matrine concentration in the hyaluronic acid condom lubricant containing matrine prepared by the above method is approximately 16.0 mg / g.

[0024] (3) Metering addition: The mixed lubricant is added to the condom through a metering pump when packaging the condom. The amount added is between 200-1200mg. The condom is packaged with composite aluminum film to obtain the lubricant with added matrine and hyaluronic acid.

[0025] Ordinary condoms without added matrine lubricant were used as a control group, and antibacterial tests were conducted in the laboratory to evaluate the antibacterial effect of condoms with added matrine hyaluronic acid lubricant.

[0026] Experimental steps: 1. Bacterial resuscitation and preparation of bacterial suspension: 1.1. Take an inoculation loop from the slant of the 2nd to 4th generation bacterial culture and inoculate the frozen culture onto Mueller Hinton (MH) medium using the streak plate method. Incubate overnight at 37°C with 5% CO2 in a bacterial incubator. Pick 3-5 colonies of the same morphology and inoculate them into MH broth medium. Incubate at 37°C with a shaker for 6 hours to obtain a bacterial suspension. Measure the turbidity using a bacterial turbidimeter and adjust the bacterial suspension concentration to 1×10⁻⁶ using MH broth medium. 6 cfu / ml.

[0027] 1.2 Antibacterial test Following the guidelines for clinical microbiology testing in the United States, samples were loaded into 96-well plates. The first column served as a negative control, with only 200 μL of MH broth culture medium added. The second column served as a control group, with 100 μL of bacterial suspension added to each well, along with 100 μL of lubricant without matrine. The third column served as the experimental group, with 100 μL of bacterial suspension added to each well, along with 100 μL of lubricant containing 32 mg / g matrine and hyaluronic acid, resulting in a bacterial concentration of 5 × 10⁻⁶ per well. 5 The concentration of matrine was 16 mg / g, and the above experimental groups were incubated overnight at 37°C with 5% carbon dioxide.

[0028] 1.3 Result Determination If the fluid inside the well is clear and not turbid when observed with normal vision, it can be determined that there is no sterile growth.

[0029] The results are as follows:

[0030] The above comparative experiments show that adding matrine to condom lubricant can effectively improve the inflammation caused by bacterial structural components stimulating vaginal epithelial cells and inhibit common pathogens causing vaginitis.

[0031] The above-disclosed embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of the invention. Those skilled in the art will understand that implementing all or part of the processes of the above embodiments and making equivalent changes in accordance with the claims of the present invention are still within the scope of the invention.

Claims

1. A method for preparing a condom with added matrine and hyaluronic acid lubricant, characterized in that, Includes the following steps: (1) Dissolving: Place matrine in a clean container, add cold water, and dissolve it by ultrasonic vibration using an ultrasonic cleaner; set aside for later use. (2) Mixing: Put the condom lubricant into a liquid mixing tank, and then put the matrine solution prepared in step (1) into the liquid mixing tank and stir to obtain a condom lubricant containing matrine. (3) Metering addition: The lubricant obtained in step (2) is added to the condom through a metering pump within 48 hours. The condom is packaged with composite aluminum film. The resulting condom is a condom with added matrine lubricant.

2. The preparation method according to claim 1, characterized in that, The amount of cold water added in step (1) is: matrine: cold water = 1:

5.

3. The preparation method according to claim 1 or 2, characterized in that, The temperature of the cold water is 10-15℃.

4. The preparation method according to claim 1, characterized in that, The ultrasonic cleaner mentioned in step (1) has a power of 500W.

5. The preparation method according to claim 1, characterized in that, The condom lubricant mentioned in step (2) is a water-based lubricant.

6. The preparation method according to claim 5, characterized in that, The water-based lubricant is mainly composed of betaine, sodium hyaluronate, glycerin, and purified water.

7. The preparation method according to claim 1, characterized in that, The mixing time in step (2) is 20-30 minutes, and the stirring speed is 50-60 rpm.

8. The preparation method according to claim 1, characterized in that, The matrine content in the condom lubricant containing matrine described in step (2) is 7.7 mg / g to 25.0 mg / g by weight.

9. The preparation method according to claim 1, characterized in that, The amount of lubricant added in step (3) is 200-1200 mg / piece.

10. A condom with added matrine lubricant, characterized in that, It is obtained by the preparation method described in any one of claims 1-9.

Images