A Chinese medicine composition for treating candidal balanoposthitis and its preparation method and application

Abstract

The invention discloses a Chinese medicine composition for treating candidal balanoposthitis, a preparation method and an application thereof. The Chinese medicine composition comprises 3-7 parts of rhubarb, 8-12 parts of sophora flavescens, 3-9 parts of scutellaria baicalensis, 3-9 parts of phellodendron amurense, 7-13 parts of kochia scoparia, and 7-13 parts of toosendan. The invention has significant clinical efficacy on candidal balanoposthitis, high safety, and is worthy of clinical promotion.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating candidal balanoposthitis and a preparation method and application thereof. Background Art

[0002] Balanopopthitis (BP) is a common male genital inflammation, which is prone to occur in the glans penis and the inner plate of the foreskin of adult men. The initial symptoms are erythema, edema, itching and smegma secretion of the glans penis and foreskin, followed by erosion, or develop into symptoms such as ulcers. Modern medicine divides it into two categories: fungal infection and bacterial infection, among which fungi are mostly Candida infections. At present, the disease is mainly treated with oral antifungal drugs and topical fungal preparations, and the short-term efficacy is relatively satisfactory. However, it is prone to recurrence of the disease, especially in cases of excessive foreskin or vaginal Candida infection of sexual partners. The protracted disease will cause a certain economic burden and great physical and psychological discomfort to the patient, seriously affecting the patient's quality of life. Summary of the invention

[0003] The main purpose of the present invention is to provide a Chinese medicine composition for treating candidal balanoposthitis.

[0004] The technical solution adopted by the present invention to solve its technical problem is:

[0005] A Chinese medicine composition for treating candidal balanoposthitis, comprising, by mass:

[0006] 3-7 parts of rhubarb, 8-12 parts of sophora flavescens, 3-9 parts of scutellaria baicalensis, 3-9 parts of phellodendron amurense, 7-13 parts of kochia scoparia, and 7-13 parts of toosendan.

[0007] The present invention also provides a method for preparing the Chinese medicine composition for treating candidal balanoposthitis, comprising the following steps: adding 10-20 times the volume of water to the Chinese medicine composition, decocting to 3-5 volumes, and obtaining the desired medicinal solution.

[0008] The invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating balanoposthitis.

[0009] Furthermore, the medicine is a decoction for external use.

[0010] Furthermore, the balanoposthitis is candidal balanoposthitis.

[0011] According to traditional Chinese medicine, all genital sores are collectively called "scurvy" and "shame sores", and balanoposthitis belongs to them. It was called "cuff sores" in ancient times, and was first seen in "Essentials of the Surgical Methods of the Golden Mirror of the Medical Ancestor": "Its name is different and its shape is different... The sores on the penis, which are swollen and wrapped in the outer skin, are called cuff sores." Traditional Chinese medicine believes that candidal balanitis is mostly caused by excessive foreskin, sitting or lying in wet places, and unclean intercourse, which leads to the invasion of damp heat and toxic evils, and damp heat and fire toxicity move down along the meridians and attack the penis. Or it may be caused by the budding of the rest of the year, without venting, and the turbid blood of the sperm is lost, and the stagnation of the ancestral tendons. The skin of the foreskin and penis is thin and tender, and the damp heat and toxic evils infiltrate the local skin and cause redness, swelling, itching, and ulceration. Therefore, the external treatment method should use "clearing heat and detoxification, removing dampness and relieving itching" products to be effective.

[0012] The pharmaceutical composition of the present invention (named as Sanhuangfulian Lotion) is adapted from Sanhuang Lotion in "Surgery" and has significant heat-clearing and damp-drying, astringent and antipruritic effects. It is suitable for skin diseases caused by damp-heat pathogens. At the same time, considering that the skin of the glans penis is thin and tender, the nerves and blood vessels are rich, and the inflammatory stimulation is relatively sensitive, the patient often suffers from two major symptoms of itching and pain, so the Kochia scoparia is added to strengthen the power of dispelling wind and relieving itching, and the Toosendan fruit is used to relieve liver heat, promote qi and relieve pain. In the prescription, rhubarb is bitter and cold in nature, belongs to the large intestine, spleen, stomach, and liver meridians, has the functions of purging fire and detoxifying, clearing heat and cooling blood; Phellodendron chinense and Scutellaria baicalensis clear heat and dry dampness, purge fire and detoxify, and can be used externally to detoxify and treat sores, and they belong to the bladder and kidney meridians, and are good at clearing damp heat in the lower jiao; the three are used together as monarch drugs, clearing damp heat and fire poison in the lower jiao. Sophora flavescens clears heat and dries dampness, kills insects and promotes diuresis. It is good at treating eczema, wet sores, itchy skin, swelling and itching of the genitals, etc. It can be taken orally or washed externally. Kochia scoparia can clear heat and promote dampness, dispel wind and relieve itching. When used together with Sophora flavescens, it can treat eczema, rubella, scabies and other diseases caused by damp heat; the two are used together as ministerial drugs, and assist the monarch drugs to strengthen the effects of clearing heat and promoting dampness, relieving itching and relieving pain. Damp-heat toxic evil infiltrates the skin, which can cause local qi and blood stasis, depression and heat, and obvious pain and itching. Therefore, Chuanlianzi is added as an adjuvant drug to achieve the effect of soothing the liver and relieving heat, promoting qi and stopping unblocking, and treating both the symptoms and the root causes. At the same time, "Lingshu·Jingmai" says that "the liver foot Jueyin meridian... runs along the thigh yin, enters the hair, and passes the genitals." Chuanlianzi tastes bitter and cold, enters the foot Jueyin liver meridian, purges fire and eliminates restlessness, promotes diuresis and relieves pain, and can be used as a meridian-leading drug to lead all the drugs downward to the diseased area. The above medicines combined together have the effects of clearing away heat, detoxifying, promoting dampness and relieving itching.

[0013] Modern pharmacology believes that the main components of rhubarb are rhubarb, rhein and rhein phenol, which have different degrees of inhibitory effects on various pathogens such as Staphylococcus, hemolytic Streptococcus, Smegma bacteria, and gonorrhea. In antifungal research, Janeczko et al. showed that rhubarb has a significant inhibitory effect on Candida albicans, and its mechanism is related to its activity on CK2 protein kinase. At lower concentrations, it has a good inhibitory effect on mycelial growth. The main components of Phellodendron chinense and Scutellaria baicalensis are berberine, which has a strong antibacterial effect on Staphylococcus, Streptococcus, etc., and has a significant inhibitory effect on Chlamydia trachomatis, Trichomonas and various skin disease fungi. Matrine is an important active ingredient of Sophora flavescens, which can significantly reduce the activity of CYP51 enzyme in Candida albicans cells, thereby affecting the biosynthesis of ergosterol in Candida albicans, showing a significant antifungal effect. Pharmacological studies on Kochia scoparia have confirmed that it has anti-inflammatory, anti-allergic, anti-itching, and anti-pathogenic microbial effects, and can be used to treat various chronic skin diseases, such as skin itching, eczema, etc. Toosendan has significant anti-inflammatory activity, which inhibits inflammatory responses by regulating downstream target proteins such as MAPK1, PIK3CA, and RELA.

[0014] Compared with the background technology, this technical solution has the following advantages:

[0015] The pharmaceutical composition of the present invention is used for the treatment of balanoposthitis. After treatment, the total symptom score of the patient is significantly reduced (P<0.01), the erythema, erosion, pain symptoms and the amount of secretions of the Chinese medicine group are significantly relieved compared with before treatment (P<0.05, P<0.01), and the erythema, pain and erosion symptoms of the Chinese medicine group are more significantly reduced than those of the western medicine group (P<0.05, P<0.01). The three yellow skin neem lotion has a significant clinical effect on candidal balanoposthitis and is highly safe, and is worthy of clinical promotion. DETAILED DESCRIPTION

[0016] Example 1

[0017] Rhubarb 5g, Sophora flavescens 10g, Scutellaria baicalensis 6g, Phellodendron chinense 6g, Kochia scoparia 10g, Toosendan fruit 10g.

[0018] Add 500 ml of water to the Chinese medicinal composition and boil it down to 200 ml to obtain a medicinal solution.

[0019] Example 2

[0020] Rhubarb 3g, Sophora flavescens 12g, Scutellaria baicalensis 3g, Phellodendron amurense 9g, Kochia scoparia 7g, Toosendan fruit 13g.

[0021] Add 800 ml of water to the Chinese medicinal composition and boil it down to 200 ml to obtain a medicinal solution.

[0022] Example 3

[0023] Rhubarb 7g, Sophora flavescens 8g, Scutellaria baicalensis 9g, Phellodendron amurense 3g, Kochia scoparia 13g, Toosendan fruit 7g.

[0024] Add 500 ml of water to the Chinese medicinal composition and boil it down to 200 ml to obtain a medicinal solution.

[0025] A total of 60 patients who visited the outpatient clinic of the Men's Department of Xiamen Traditional Chinese Medicine Hospital from January 2024 to June 2024 and were diagnosed with candidal balanoposthitis were selected. The patients were divided into a Chinese medicine group and a Western medicine group according to a random number table. There were 30 cases in the Chinese medicine group, aged 20 to 53 years old, with an average age of (32.87±8.45) years old; the course of disease was 3d to 51d, with an average course of disease of (11.20±8.85) days. There were 30 cases in the Western medicine group, aged 23 to 54 years old, with an average age of (34.63±8.87) years old; the course of disease was 3d to 31d, with an average course of disease of (12.17±5.71) months. There was no significant difference in age and course of disease between the two groups (P>0.05).

[0026] Inclusion and Exclusion Criteria

[0027] Inclusion criteria: (1) Patients had redness, swelling, discomfort, itching and odor at the glans of the foreskin, white cheese-like secretions at the coronal sulcus, and local erosion of the glans of the foreskin in severe cases; (2) All patients were informed and voluntarily participated in this study. (3) No other drugs related to the treatment of balanoposthitis were used before the visit.

[0028] Exclusion criteria: (1) Patients with concurrent gonococcal, chlamydia, mycoplasma or other common bacterial infections were excluded; (2) Patients with a history of antifungal treatment within 1 month before enrollment were excluded; (3) Patients who were allergic to neem lotion and pyrazine; (4) Patients with multiple underlying diseases, including severe dysfunction of the circulatory, respiratory, nervous, digestive and other systems.

[0029] Elimination criteria

[0030] ① Patients who change their treatment plan or add other drugs on their own during treatment; ② Patients who stop taking medication on their own during treatment.

[0031] Treatment

[0032] Control group: Patients were treated with topical application of pevisone (triamcinolone acetonide econazole cream, Xi'an Janssen Pharmaceutical Co., Ltd., national medicine standard H20000454), once a day in the morning and evening, for one course of treatment. Other antifungal drugs should be suspended within half a month before treatment and during treatment, and the patient's condition should be recorded in detail.

[0033] Observation group: patients were treated with Chinese medicine Sanhuangfulian lotion, Sanhuangfulian lotion formula: prepared in Example 1. After heating the liquid medicine to 38°C-40°C, pour it into a 300-500mL container, wash the foreskin and glans with warm water, and then wash the foreskin and glans with the liquid medicine for 5-10 minutes, once a day, 7 days as a course of treatment.

[0034] Both groups of patients received life guidance during the treatment process: 1. Eat a balanced diet, avoid alcohol, fatty, spicy, and greasy foods. 2. Maintain a regular work and rest schedule, avoid holding urine, sitting or riding for too long, and exercise appropriately. 3. Avoid sexual intercourse during treatment. 4. Regulate emotions and maintain an optimistic mood.

[0035] Observation indicators

[0036] General indicators: record the patient's general information such as name, age, disease course, etc.

[0037] TCM Syndrome Scoring

[0038] The TCM syndrome scores of the two groups before and after treatment were calculated with reference to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)". The severity of erythema, itching, amount of secretions, papules, erosions and pain symptoms were evaluated. The scoring criteria were: 0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms.

[0039] 1.6 Criteria for determining efficacy

[0040] Efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. Ineffective: efficacy index ≤ 30%; Effective: symptoms are alleviated after treatment (30%-60%); Significantly effective: efficacy index ≥ 60%; Cured: the efficacy index after treatment reaches 100%, and clinical symptoms completely disappear.

[0041] Statistical methods

[0042] SPSS27.0 software was used for statistical analysis. Normally distributed quantitative data were presented in the form of mean ± standard deviation and analyzed by t-test. Non-normal distribution was described by median and interquartile range and analyzed by rank sum test. For count data, chi-square correction and Fisher correction were used to obtain results. Rank sum test was used for rank data. P<0.05 indicated that the difference was statistically significant.

[0043] result

[0044] TCM Syndrome Scoring

[0045] Before treatment, there was no statistical difference in the symptom scores between the two groups (P>0.05). After treatment, compared with before treatment, the scores of all symptoms and the total symptom score of the Chinese medicine group were significantly reduced (P<0.05, P<0.01). In the Western medicine group, only the scores of secretion quantity, itching, and pain symptoms were significantly reduced (P<0.05, P<0.01), while the changes in erosion and pain symptoms were not statistically significant (P>0.05). The erythema, erosion, and total symptom scores of the Chinese medicine group were significantly reduced compared with those of the Western medicine group (P<0.01), as shown in Table 1.

[0046] Table 1: Comparison of TCM syndrome scores between the two groups before and after treatment (x±s, points)

[0047]

[0048] Compared with the pre-treatment group, the results showed: 1) P < 0.05, 2) P < 0.01. Compared with the western medicine group after treatment, 3) P < 0.05

[0049] 4) P < 0.01

[0050] Efficacy evaluation

[0051] The total effective rate of the treatment group was 93%, and the total effective rate of the control group was 80%. The clinical efficacy of the Chinese medicine group was significantly better than that of the Western medicine group (P<0.01). See Table 2 for details.

[0052] Table 2: Comparison of the efficacy between the two groups of patients [cases (%)]

[0053]

[0054] The total effective rate of the study = (improvement + effectiveness + recovery) / total number of cases × 100%. The clinical efficacy is evaluated based on the efficacy index.

[0055] Adverse Reactions

[0056] In this study, no adverse reactions were observed in all patients after using the drug.

[0057] Combined with the results of the present invention, the three yellow neem lotion can treat candidal balanoposthitis and has a significant improvement effect on erythema, pain, itching and secretion symptoms. Compared with the western medicine group treated with pevisone cream, the treatment efficiency of the Chinese medicine group was significantly higher than that of the western medicine treatment group, and the degree of improvement in the total symptom score was better than that of the western medicine group (P<0.05). And it has a lower incidence of adverse reactions and disease recurrence rate. The above research results confirm that the three yellow neem lotion is safe and effective in the clinical diagnosis and treatment of candidal balanoposthitis, with stable efficacy, and is worthy of clinical promotion.

[0058] The above description is only a preferred embodiment of the present invention, and therefore cannot be used to limit the scope of the present invention. That is, equivalent changes and modifications made according to the patent scope of the present invention and the contents of the specification should still fall within the scope of the present invention.

Claims

1. A Chinese medicine composition for treating candidal balanoposthitis, comprising, by mass: 3-7 parts of rhubarb, 8-12 parts of sophora flavescens, 3-9 parts of scutellaria baicalensis, 3-9 parts of phellodendron amurense, 7-13 parts of kochia scoparia, and 7-13 parts of toosendan.

2. A Chinese medicine composition for treating candidal balanoposthitis according to claim 1, characterized in that: include: Rhubarb 5g, Sophora flavescens 10g, Scutellaria baicalensis 6g, Phellodendron chinense 6g, Kochia scoparia 10g, Toosendan fruit 10g.

3. A method for preparing a Chinese medicine composition for treating candidal balanoposthitis according to claim 1 or 2, comprising the following steps: adding 10-20 times the volume of water to the Chinese medicine composition and decocting it to 3-5 volumes to obtain the desired medicinal solution.

4. Use of the Chinese medicine composition according to claim 1 or 2 in preparing a medicine for treating balanoposthitis.

5. The use according to claim 4, characterized in that: The medicine is a decoction for external use.

6. The use according to claim 4, characterized in that: The balanoposthitis is candidal balanoposthitis.

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