Lotion for treating male balanitis and peridermatitis and preparation method thereof

Abstract

The invention provides a lotion for treating male balanitis and peridermatitis and a preparation method thereof. The lotion is prepared from the following components in percentage by mass: 5 to 10 percent of mangostia mangostana peel extract, 3 to 5 percent of kalocasia macrophylla leaf extract, 3 to 5 percent of polysiphonophyllum lanigerum extract, 1 to 3 percent of compound polysaccharide, 1 to 1.5 percent of beta-glucan, 2 to 4 percent of glycerol and the balance of water. The raw materials used in the lotion are purely natural, free of toxic and side effects, mild and safe, targeted extraction is conducted according to the characteristics of different raw materials, effective components can be effectively separated and collected, all the effective components are matched with one another, a better medicine effect is achieved, the lotion has a good treatment effect on male patients suffering from balanitis and peridermatitis, relapse is not likely to happen, and the lotion is suitable for clinical application. The application prospect is good. No adverse reaction occurs in the treatment process, and no irritation is caused to private skin.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a wash for treating male balanitis and posthitis, and its preparation method. Background Technology

[0002] Balanitis and posthitis are relatively common male genital diseases. Balanitis and posthitis refer to inflammation of the mucous membranes of the glans penis and foreskin caused by factors such as trauma, irritation, or infection. Male genital diseases can cause inconvenience to work and daily life, and can also lead to infection in female partners through sexual intercourse, causing inflammation of the vulva, vagina, and cervix.

[0003] Clinically, Western medicine treatments often have significant side effects, and improper treatment leads to recurrent relapses. Furthermore, due to the long course of balanitis and posthitis, the improper and excessive use of antibiotics easily leads to drug resistance. Traditional Chinese medicine decoctions and washes are also not very effective, with drawbacks such as inducing drug resistance, high recurrence rates, and inconvenience in administration. These methods fail to achieve the desired results with traditional treatments, and long-term chronic inflammation negatively impacts urogenital health, affecting daily life and work.

[0004] Therefore, there is a need for a preparation that can effectively treat balanitis and posthitis in men, with high efficacy, few side effects, and low recurrence rate, effectively relieving patients' suffering, which is of practical significance. Summary of the Invention

[0005] In view of this, the present invention proposes a wash for treating male balanitis and posthitis and its preparation method.

[0006] The technical solution of this invention is implemented as follows: A wash for treating balanitis and posthitis in men, comprising, by weight percentage: 5%-10% *Citrus aurantium* pericarp extract, 3%-5% *Citrus sagittatum* leaf extract, 3%-5% *Polygonum hydropiper* extract, 1%-3% complex polysaccharide, 1%-1.5% β-glucan, 2%-4% glycerin, and the balance being water.

[0007] Furthermore, the complex polysaccharide comprises, by mass percentage, 35%-40% *Panax japonicus* polysaccharide, 20%-30% *Sargassum fusiforme* polysaccharide, 20%-25% *Tulipa tuberosum* polysaccharide and 5%-25% *Pueraria lobata* polysaccharide.

[0008] Furthermore, the preparation method of the *Cephalotaxus fortunei* pericarp extract includes: crushing the *Cephalotaxus fortunei* pericarp, mixing it with ethanol, performing vacuum distillation, collecting the distillate, passing it through a macroporous adsorption resin chromatography column, concentrating the eluent to a solid content of 6-8 mg / mL, and obtaining the *Cephalotaxus fortunei* pericarp extract.

[0009] Furthermore, the concentration of the ethanol is 40-50% v / v, and the amount added is 6-8 times the weight of the pericarp of the 'Inula japonica'; the vacuum distillation is carried out at -0.07~-0.08 MPa and 50-70℃ for 40-60 min; the macroporous adsorption resin is a mixture of two resins, HZ-801 and AB-8, in a mass ratio of 1:1-3.

[0010] Furthermore, the preparation method of the arrow-leaf orange leaf extract includes: pulverizing arrow-leaf orange leaves, performing supercritical CO2 extraction, passing the extract through an ultrafiltration membrane with a strength of less than 3 kDa, and concentrating the retentate under reduced pressure to obtain the arrow-leaf orange leaf extract.

[0011] Furthermore, the supercritical CO2 extraction specifically involves static extraction at 30-40 MPa and 50-60 °C for 1-2 hours, followed by dynamic extraction at 2.0-3.5 L / min for 30-50 minutes.

[0012] A method for preparing a wash for treating balanitis and posthitis in men includes the following steps: heating water to 50-60℃, adding glycerin and β-glucan sequentially, homogenizing, cooling to 40-45℃, adding extracts of *Citrus aurantium* pericarp, *Citrus sagittatum* leaf, and *Polygonum hydropiper*, stirring at low speed, finally adding a complex polysaccharide, shearing at high speed, defoaming, and filling to obtain the wash.

[0013] Furthermore, the homogenization is performed at 1800-2000 rpm for 5-7 minutes; the low-speed stirring is performed at 100-200 rpm for 40-60 minutes; and the high-speed shearing is performed at 2200-2500 rpm for 8-10 minutes.

[0014] Compared with the prior art, the beneficial effects of the present invention are: The present invention reduces sensitivity and improves discomfort in the private parts. (1) The raw materials used in the wash of the present invention are all natural, non-toxic and have no side effects. It is mild and safe and will not cause any adverse reactions in the treatment of male patients with balanitis and posthitis. It is non-irritating to the skin of the private parts.

[0015] (2) This invention extracts the active ingredients in a targeted manner according to the characteristics of different raw materials, which can effectively separate and collect the active ingredients. The active ingredients work together to exert better efficacy. According to experimental examples, it has a good therapeutic effect on male balanitis and posthitis, relieves itching, inhibits bacteria and has anti-inflammatory effect, and is not easy to relapse. It has good application prospects. Detailed Implementation

[0016] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0017] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0018] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0019] The extract of Polytubularia velutipes of the present invention was purchased from Zhenghe (Guangzhou) Biotechnology Co., Ltd.

[0020] The preparation method of the extract of *Cephalotaxus fortunei* pericarp used in the embodiments and comparative examples of this invention includes the following steps: The pericarp of *Cephalotaxus fortunei* was crushed and mixed with 40% v / v ethanol, with the amount of ethanol added being 7 times the weight of the pericarp. The mixture was then subjected to vacuum distillation at -0.07 MPa and 60 °C for 50 min. The distillate was collected and passed through a macroporous adsorption resin chromatography column. The macroporous adsorption resin was a mixture of HZ-801 and AB-8 resins in a mass ratio of 1:1. The eluent was concentrated to a solid content of 7 mg / mL to obtain the pericarp extract of *Cephalotaxus fortunei*.

[0021] The preparation method of the orange leaf extract used in the embodiments and comparative examples of this invention includes the following steps: The leaves of the orange tree were crushed and subjected to supercritical CO2 extraction. First, static extraction was performed at 35 MPa and 55℃ for 1 h, followed by dynamic extraction at 3.5 L / min for 50 min. The extract was then passed through an ultrafiltration membrane with a pressure of less than 3 kDa, and the retentate was concentrated under reduced pressure to obtain the orange tree leaf extract.

[0022] The compound polysaccharides used in the embodiments and comparative examples of this invention, by mass percentage, include 35% *Panax japonicus* polysaccharide, 20% *Sargassum fusiforme* polysaccharide, 25% *Tulipa jasminoides* polysaccharide, and 20% *Pueraria lobata* polysaccharide.

[0023] Examples 1-3 The raw materials and contents of the washing solutions in Examples 1-3 of this invention are shown in Table 1.

[0024] Table 1

[0025] The preparation methods of the washing solutions in Examples 1-3 include the following steps: Heat water to 55°C, add glycerol and β-glucan in sequence, homogenize at 2000 rpm for 6 min, cool to 40°C, add the pericarp extract of *Citrus aurantium*, the leaf extract of *Citrus sagittatus*, and the extract of *Polygonum hydropiper*, stir at 150 rpm for 50 min, finally add the complex polysaccharide, shear at 2500 rpm for 8 min, defoam and fill to obtain the washing solution.

[0026] Comparative Example 1 This comparative example follows the same components and preparation method as in Example 1, except that it lacks the extract of *Citrus aurantium* pericarp. The missing amount of *Citrus aurantium* pericarp extract is allocated to the corresponding components according to the ratio of *Citrus aurantium* leaf extract, *Polygonum hydropiper* extract, and complex polysaccharide. The remaining steps are performed as in Example 1.

[0027] Comparative Example 2 This comparative example follows the same components and preparation method as in Example 1, except that it lacks *Citrus aurantium* leaf extract. The missing amount of *Citrus aurantium* leaf extract is allocated to the corresponding components according to the proportions of *Citrus reticulata* pericarp extract, *Polygonum hydropiper* extract, and complex polysaccharide. The remaining steps are performed as in Example 1.

[0028] Comparative Example 3 This comparative example follows the same components and preparation method as in Example 1, except that it lacks the *Polygonum velutipes* extract. The missing amount of *Polygonum velutipes* extract is allocated to the corresponding components according to the ratio of *Citrus aurantium* pericarp extract, *Citrus aurantium* leaf extract, and complex polysaccharide. The remaining steps are performed as in Example 1.

[0029] Comparative Example 4 This comparative example follows the same components and preparation method as in Example 1, except that the complex polysaccharide in this comparative example lacks *Panax japonicus* polysaccharide and *Tulipa chinensis* polysaccharide; the missing amounts of *Panax japonicus* polysaccharide and *Tulipa chinensis* polysaccharide are allocated to the corresponding components according to the ratio of *Sargassum fusiforme* polysaccharide and *Pueraria lobata* polysaccharide. The remaining steps are performed as in Example 1.

[0030] Comparative Example 5 This comparative example follows the same components and preparation method as in Example 1. The only difference from Example 1 is that the extraction methods for the *Citrus reticulata* pericarp extract and *Citrus aurantium* leaf extract in this comparative example are both water extraction. The remaining steps are performed as in Example 1.

[0031] Test Example 1 This experimental case investigated the therapeutic effects of the washes obtained in the examples and comparative examples on balanitis and posthitis.

[0032] Specific experimental methods: 120 patients with balanitis and posthitis, aged 25-45 years, were selected. Their main symptoms included erythema, swelling, burning, needle-like pain, itching, and odor at the glans and foreskin. They had no other serious diseases or allergies. The patients were randomly divided into 8 groups of 15 each. Each group used the wash solution (2 mL) from Examples 1-3 and Comparative Examples 1-5, respectively, once daily for one month.

[0033] Efficacy evaluation criteria: Marked effect: Significant relief of erythema, swelling, burning, needle-like pain, itching and odor at the foreskin and glans; Effective: Some relief of erythema, swelling, burning, needle-like pain, itching and odor at the foreskin and glans; Ineffective: No change in condition.

[0034] Overall effectiveness rate = (Number of cases with significant effects + Number of cases with positive results) / Total number of cases × 100% The results are shown in Table 2.

[0035] Table 2

[0036] As shown in Table 2, the wash solutions prepared in Examples 1-3 of this invention have good therapeutic effects on balanitis and posthitis, with a high overall effective rate and low recurrence rate. Furthermore, no adverse reactions were observed in patients treated with the wash solutions in the examples and comparative examples during the treatment of balanitis, and they showed no irritation to the genital skin.

[0037] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A wash for treating balanitis and posthitis in men, characterized in that, By weight percentage, it includes 5%-10% *Citrus aurantium* pericarp extract, 3%-5% *Citrus sagittatum* leaf extract, 3%-5% *Polygonum hydropiper* extract, 1%-3% complex polysaccharides, 1%-1.5% β-glucan, 2%-4% glycerol, and the balance being water.

2. The wash solution for treating balanitis and posthitis in men as described in claim 1, characterized in that, The complex polysaccharide comprises, by mass percentage, 35%-40% *Panax notoginseng* polysaccharide, 20%-30% *Sargassum fusiforme* polysaccharide, 20%-25% *Tulipa tuberosum* polysaccharide and 5%-25% *Pueraria lobata* polysaccharide.

3. The wash solution for treating balanitis and posthitis in men as described in claim 1, characterized in that, The preparation method of the *Cynanchum paniculatum* pericarp extract includes: crushing the pericarp of *Cynanchum paniculatum*, mixing it with ethanol, performing vacuum distillation, collecting the distillate, passing it through a macroporous adsorption resin chromatography column, concentrating the eluent to a solid content of 6-8 mg / mL, and obtaining the *Cynanchum paniculatum* pericarp extract.

4. A wash solution for treating balanitis and posthitis in men as described in claim 3, characterized in that, The concentration of ethanol is 40-50% v / v, and the amount added is 6-8 times the weight of the pericarp of the 'Inula japonica'; the vacuum distillation is carried out at -0.07~-0.08 MPa and 50-70℃ for 40-60 min; the macroporous adsorption resin is a mixture of two resins, HZ-801 and AB-8, in a mass ratio of 1:1-3.

5. A wash solution for treating balanitis and posthitis in men as described in claim 1, characterized in that, The preparation method of the arrow-leaf orange leaf extract includes: crushing arrow-leaf orange leaves, performing supercritical CO2 extraction, passing the extract through an ultrafiltration membrane with a strength of less than 3 kDa, and concentrating the retentate under reduced pressure to obtain the arrow-leaf orange leaf extract.

6. A wash solution for treating balanitis and posthitis in men as described in claim 5, characterized in that, The supercritical CO2 extraction specifically involves static extraction at 30-40 MPa and 50-60℃ for 1-2 hours, followed by dynamic extraction at 2.0-3.5 L / min for 30-50 minutes.

7. The method for preparing a wash solution for treating balanitis and posthitis in men as described in claim 1, characterized in that, The specific preparation steps include: Heat water to 50-60℃, add glycerin and β-glucan in sequence, homogenize, cool to 40-45℃, add the extracts of *Citrus aurantium* pericarp, *Citrus sagittatum* leaf, and *Polygonum hydropiper*, stir at low speed, and finally add the complex polysaccharide. Shear at high speed, defoam and fill to obtain the washing solution.

8. The method for preparing a wash solution for treating male balanitis and posthitis as described in claim 7, characterized in that, The homogenization is performed at 1800-2000 rpm for 5-7 minutes; the low-speed stirring is performed at 100-200 rpm for 40-60 minutes; and the high-speed shearing is performed at 2200-2500 rpm for 8-10 minutes.

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