Traditional Chinese medicine composition for treating vaginitis and urethritis

Abstract

The invention relates to a traditional Chinese medicine composition for treating vaginitis and urethritis. The traditional Chinese medicine composition is prepared from 10-50 parts by weight of dianthus superbus, 10-50 parts by weight of radix rehmanniae recen, 1-30 parts by weight of thunberg fritillary bulb, 1-30 parts by weight of radix sophorae flavescentis, 1-30 parts by weight of radix cyathulae, 1-25 parts by weight of angelica sinensis, 1-20 parts by weight of cooked rhubarb and 1-20 parts by weight of fried liquorice. The traditional Chinese medicine composition for treating recurrent senile vaginitis and urethritis is remarkable in curative effect, safe, reliable, few in adverse reaction, simple in preparation process operation and suitable for industrial production.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating vaginitis and urethritis. Background Art

[0002] Currently, the global population aged 60 and over has exceeded 500 million, accounting for approximately 9% of the total population. It is projected that by 2025, the number of people aged 65 and over will reach 800 million, representing 10% of the total population, with China's elderly population exceeding 300 million. With the development of society and the deepening trend of population aging, the health issues facing postmenopausal women are becoming increasingly prominent. Among them, urogenital problems caused by postmenopausal low estrogen levels seriously impact the quality of life of older women. Recurrent senile vaginitis and urethritis are highly prevalent in postmenopausal women, causing significant discomfort and reducing their quality of life.

[0003] After menopause, estrogen levels drop in women, leading to thinning and dryness of the urogenital tract mucosa, decreased local immunity, and increased risk of developing senile vaginitis and urethritis. Senile vaginitis is primarily characterized by increased vaginal discharge, vulvar itching, and burning sensation, while urethritis presents with symptoms such as frequent urination, urgency, and pain. These conditions can significantly exacerbate patients' physical and mental discomfort, severely impacting their daily lives.

[0004] The pathogenesis of urogenital problems in postmenopausal women is complex, primarily driven by changes in the urogenital epithelium and the urogenital microbiome, resulting from decreased estrogen levels. Decreased estrogen levels cause thinning and atrophy of the urogenital epithelium, weakening its barrier function and making it more susceptible to pathogen invasion. For example, thinning of the vaginal epithelium may lead to symptoms such as vaginal dryness and itching, while also increasing the risk of bacterial infection. Decreased estrogen levels, in turn, cause changes in the urogenital microbiome. For example, decreased estrogen and progesterone levels in postmenopausal women can lead to pathophysiological changes such as vulvar and vaginal atrophy, a decreased proportion of Lactobacilli, dysbiosis in the vaginal flora, and a compromised vaginal immune barrier. Furthermore, the distribution and composition of the urinary tract microbiome in the bladder of postmenopausal women differ, playing a significant role in the pathophysiology of recurrent urinary tract infections.

[0005] Currently, the primary treatment for recurrent senile vaginitis and urethritis is conventional pharmacological intervention. Among these, hormone replacement therapy, single hormone replacement therapy, topical or oral estrogen, or combined antibiotic therapy have demonstrated some clinical efficacy. Hormone replacement therapy can replenish estrogen deficiency in postmenopausal women, improve the condition of the urogenital mucosa, and enhance local resistance, thereby alleviating the symptoms of senile vaginitis and urethritis. Single hormone replacement therapy primarily uses estrogen. Topical or oral estrogen acts directly on the urogenital mucosa, relieving symptoms such as dryness and itching. Combined antibiotic therapy can target bacterial infections and enhance therapeutic efficacy. However, these treatments also have side effects and contraindications. For example, hormone replacement therapy may increase the risk of breast cancer and endometrial cancer; single hormone replacement therapy may cause adverse reactions such as vaginal bleeding and breast tenderness; topical or oral estrogen may cause nausea, vomiting, and headaches; and combined antibiotic therapy may lead to allergic reactions and drug resistance. These side effects and contraindications will have a certain adverse effect on patients' medication compliance, causing patients to fail to take medication on time or stop treatment, thus affecting the treatment effect.

[0006] According to Traditional Chinese Medicine, postmenopausal vaginitis and urethritis occur in the lower Jiao (lower Jiao). The primary etiology and pathogenesis are the depletion of yin essence in postmenopausal women, which gradually weakens kidney qi and leads to kidney yin deficiency. Kidney yin deficiency fails to nourish the internal organs, leading to dryness and astringency in the vaginal and urethral mucosa. Yin deficiency fails to control yang, generating internal fire that disturbs the lower Jiao, causing symptoms such as vaginal burning, frequent urination, urgency, and pain. The liver and kidney share a common origin, and deficiency of essence and blood leads to malnutrition of the vulva. Dry blood generates wind, causing vaginal itching. Furthermore, external damp-heat, dietary indiscriminate induction of damp-heat, or liver depression transforming into fire combined with spleen dampness, can cause damp-heat to descend to the lower Jiao, damaging the Ren and Dai meridians and the bladder. This leads to profuse, thick, yellowish vaginal discharge with an unpleasant odor, as well as frequent urination, urgency, and pain. The underlying pathogenesis is yin deficiency, with damp-heat as the secondary symptom.

[0007] Currently, there are few reports on effective traditional Chinese medicines for the treatment of vaginitis and urethritis. Therefore, there is still an urgent need to develop a traditional Chinese medicine that can effectively relieve uncomfortable symptoms such as frequent urination, urgency, pain when urinating, and incomplete urination, and has significant clinical efficacy in patients with recurrent senile vaginitis and urethritis. Summary of the Invention

[0008] To solve the above technical problems, the present invention includes the following aspects:

[0009] A first aspect of the present invention provides a traditional Chinese medicine composition for treating vaginitis and urethritis, wherein the traditional Chinese medicine composition is prepared from Dianthus bistortae, Rehmannia root, Fritillaria thunbergii, Sophora flavescens, Cyathula root, Angelica sinensis, Rhubarb and stir-fried Licorice root.

[0010] Preferably, the traditional Chinese medicine composition is prepared from 10-50 parts by weight of Dianthus bistortae, 10-50 parts by weight of Rehmannia root, 1-30 parts by weight of Fritillaria thunbergii, 1-30 parts by weight of Sophora flavescens, 1-30 parts by weight of Cyathula capitata, 1-25 parts by weight of Angelica sinensis, 1-20 parts by weight of Rhubarb and 1-20 parts by weight of stir-fried Licorice root.

[0011] More preferably, the traditional Chinese medicine composition is prepared from 20-40 parts by weight of Dianthus dianthus, 20-40 parts by weight of Rehmannia glutinosa, 5-25 parts by weight of Fritillaria thunbergii, 5-25 parts by weight of Sophora flavescens, 5-25 parts by weight of Cyathula capitata, 1-20 parts by weight of Angelica sinensis, 1-15 parts by weight of Rhubarb and 1-15 parts by weight of stir-fried Licorice root.

[0012] Further preferably, the traditional Chinese medicine composition is prepared from 25-35 weight parts of Dianthus bistortae, 25-35 weight parts of Rehmannia root, 10-20 weight parts of Fritillaria thunbergii, 10-20 weight parts of Sophora flavescens, 10-20 weight parts of Cyathula obtusifolia, 5-15 weight parts of Angelica sinensis, 1-10 weight parts of Rhubarb and 1-10 weight parts of stir-fried Licorice root.

[0013] Most preferably, the traditional Chinese medicine composition is prepared from 30 parts by weight of Dianthus bistortae, 30 parts by weight of Rehmannia root, 15 parts by weight of Fritillaria thunbergii, 15 parts by weight of Sophora flavescens, 15 parts by weight of Cyathula capitata, 10 parts by weight of Angelica sinensis, 5 parts by weight of Rhubarb and 5 parts by weight of stir-fried Licorice root.

[0014] Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0015] Preferably, the Chinese medicine composition is an oral preparation.

[0016] Preferably, the dosage form of the Chinese medicine composition is tablets, capsules, granules, tincture or decoction.

[0017] More preferably, the dosage form of the Chinese medicine composition is a decoction.

[0018] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the prescribed amount of Dianthus bistortae, Rehmannia root, Fritillaria thunbergii, Sophora flavescens, Cyathula root, Angelica sinensis, Rhubarb and stir-fried licorice, mixing and crushing, adding 6-10 times the total weight of the medicinal materials in purified water, boiling and then decocting on low heat for 30-60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1-2 times the total weight of the traditional Chinese medicine initially added, to obtain the composition.

[0019] Preferably, in the preparation method, purified water in an amount 10 times the total weight of the medicinal materials is added.

[0020] Preferably, in the preparation method, the mixture is boiled and then simmered on low heat for 45 minutes.

[0021] Preferably, in the preparation method, the traditional Chinese medicine filtrate is concentrated to twice the total weight of the initially added traditional Chinese medicine.

[0022] Preferably, the vaginitis and urethritis are recurrent senile vaginitis and urethritis.

[0023] Preferably, the vaginitis is bacterial vaginosis or fungal vaginitis. More preferably, the bacterial vaginosis is caused by Staphylococcus aureus and / or Escherichia coli.

[0024] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: weighing a prescribed amount of Dianthus bistortae, Rehmannia root, Fritillaria thunbergii, Sophora flavescens, Cyathula root, Angelica sinensis, Rhubarb and stir-fried licorice, mixing and crushing, adding 6-10 times the total weight of the medicinal materials in purified water, boiling and then decocting on low heat for 30-60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1-2 times the total weight of the traditional Chinese medicine initially added, to obtain the composition.

[0025] Preferably, in the preparation method, purified water in an amount 10 times the total weight of the medicinal materials is added.

[0026] Preferably, in the preparation method, the mixture is boiled and then simmered on low heat for 45 minutes.

[0027] Preferably, in the preparation method, the traditional Chinese medicine filtrate is concentrated to twice the total weight of the initially added traditional Chinese medicine.

[0028] The third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating vaginitis and urethritis.

[0029] Preferably, the vaginitis and urethritis are recurrent senile vaginitis and urethritis.

[0030] Preferably, the vaginitis is bacterial vaginosis or fungal vaginitis. More preferably, the bacterial vaginosis is caused by Staphylococcus aureus and / or Escherichia coli.

[0031] A fourth aspect of the present invention provides use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating recurrent urinary tract infection.

[0032] A fifth aspect of the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating frequent urination and / or urgency of urination.

[0033] A sixth aspect of the present invention provides use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for reducing the levels of IL-1β, IL-6 and / or TNF-α in serum.

[0034] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0035] Dianthus: Bitter in flavor, cold in nature, enters the Heart and Small Intestine meridians. Dianthus diuretic, relieving stranguria, promoting blood circulation and menstruation, is used for stranguria syndromes such as stranguria caused by heat, hematuria, and stranguria caused by stones, as well as urinary obstruction, painful and dribbling urine, amenorrhea caused by blood stasis, and irregular menstruation. It also has anti-tumor, antioxidant, antiviral, anti-inflammatory, antibacterial, and uterine stimulating effects.

[0036] Raw Rehmannia root: Sweet in flavor, cold in nature, enters the Heart, Liver, and Kidney meridians. It clears heat, cools blood, nourishes yin, and promotes fluid production. It is used for symptoms of heat invading the blood and nutrients, fever caused by febrile toxicity, bleeding from blood heat, yin damage caused by febrile illness, thirst caused by fluid loss, internal heat-induced thirst, yin deficiency and internal heat, bone steaming and fatigue fever, late-stage febrile illnesses, and constipation caused by fluid loss. It has hypoglycemic, antioxidant, anti-inflammatory, anti-tumor, immunomodulatory, neuroprotective, and antidepressant effects.

[0037] Fritillaria thunbergii: Bitter in flavor, cold in nature, enters the Lung and Heart meridians. It clears heat, resolves phlegm, relieves coughs, detoxifies, disperses stagnation, and eliminates carbuncles. It is used for wind-heat coughs, phlegm-heat coughs, scrofula, goiters, sores, lung abscesses, and mastitis. It has antitussive and expectorant effects, asthma relief, anti-inflammatory, antibacterial, analgesic, antioxidant, anticancer, and anti-tumor effects.

[0038] Sophora flavescens: Bitter in flavor, cold in nature, it enters the Heart, Liver, Stomach, Large Intestine, and Bladder meridians. It clears heat and dampness, kills insects and relieves itching, acts as a diuretic, and calms the heart and relieves palpitations. It is used to treat damp-heat dysentery, jaundice, vaginal discharge, vaginal swelling and itching, blood in the stool, itchy skin, eczema, scabies, leprosy, trichomonas vaginitis, stranguria, dysuria, urinary retention, palpitations, and has antibacterial, anti-inflammatory, and antiviral effects.

[0039] Sichuan Cyathula: Bitter, sour, and sweet in flavor, neutral in nature, enters the Liver and Kidney meridians. It removes blood stasis, dredges menstruation, nourishes the liver and kidneys, strengthens tendons and bones, promotes urination and relieves stranguria, and guides blood downward. It is used to treat menstrual and postpartum disorders such as amenorrhea, dysmenorrhea, postpartum abdominal pain, retained placenta, pain from falls, soreness of the waist and knees, weakness of tendons and bones, lower limb atrophy, stranguria, edema, dysuria, vomiting blood and epistaxis due to qi and fire reflux, toothache and mouth sores, and headache and dizziness due to yin deficiency and yang hyperactivity. It is used as a descending meridian-guiding herb, improving microcirculation, providing anti-inflammatory and anti-aging benefits, promoting protein synthesis, inhibiting platelet aggregation, and providing immune regulation.

[0040] Angelica sinensis: Sweet and pungent in flavor, warm in nature, it enters the liver, heart, and spleen meridians. It nourishes and invigorates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is used for blood deficiency symptoms, including irregular menstruation, amenorrhea, and dysmenorrhea caused by blood deficiency and blood stasis, asthenic abdominal pain due to cold, rheumatic pain, injuries from falls, carbuncles, and ulcers, as well as constipation caused by blood deficiency and dry intestines. It has anti-arrhythmic, vasodilatory, anti-platelet aggregation, hematopoietic cell production, immunity enhancement, anti-aging, antioxidant, free radical scavenging, anti-tumor, anti-depressant, analgesic, and anti-inflammatory effects.

[0041] Cooked rhubarb: Bitter in flavor and cold in nature, it enters the spleen, stomach, large intestine, liver, and pericardium meridians. Rhubarb has a laxative effect, clears away heat and purges fire, cools the blood and detoxifies, removes blood stasis and promotes menstruation, and promotes dampness and jaundice. Cooked rhubarb has a slower laxative effect. It is used for constipation caused by excess heat, vomiting and bleeding due to blood heat, red eyes and swollen throat, swollen and painful gums, carbuncles and boils, abdominal pain caused by intestinal carbuncles, and blood stasis symptoms such as amenorrhea, postpartum stasis, traumatic injuries, damp-heat dysentery, burns, and "phlegm-breaking" due to phlegm congestion, asthma, inability to sleep, and constipation. It has antiplatelet aggregation, antibacterial, anti-inflammatory, and antipyretic effects.

[0042] Stir-fried licorice root: Sweet in flavor, neutral in nature, it enters the Heart, Lung, Spleen, and Stomach meridians. Licorice root nourishes the spleen and replenishes Qi, clears heat and detoxifies, eliminates phlegm and relieves coughs, relieves pain, and harmonizes various medicinal herbs. It is used to treat spleen deficiency, fatigue, palpitations and irregular pulses caused by insufficient heart Qi, toxic heat sores, sore throats, coughs with excessive phlegm, and cramps in the abdomen and limbs. It also relieves drug toxicity and potency, and has immunomodulatory, antioxidant, antiviral, anti-inflammatory, and bactericidal properties.

[0043] In the Chinese medicine composition of the present invention, raw Rehmannia root is the main drug, nourishing yin and clearing heat, targeting the main pathogenesis of yin deficiency and internal heat, greatly replenishing the yin fluid in the body, and simultaneously clearing heat and cooling blood to eliminate heat pathogens. Fritillaria thunbergii, Sophora flavescens, Dianthus chinensis, and Rhubarb are the ministerial drugs, assisting raw Rehmannia root in clearing heat, promoting dampness removal and detoxification, and removing the damp-heat and turbid toxin pathogens in the lower jiao. Among them, Sophora flavescens not only helps the main drug clear heat and dry dampness, but also has the function of killing parasites and promoting diuresis, making it a key drug for the clinical treatment of vaginitis and urethritis. Rhubarb, Fritillaria thunbergii, and Dianthus chinensis can clear heat, purge fire, and promote diuresis, while the effects of removing blood stasis, promoting menstruation, and dispersing stagnation contribute to improving local blood circulation. The four drugs are combined and serve as ministerial drugs. Angelica sinensis and Cyathula cnidium assist the main drug and ministerial drugs in playing their roles, further strengthening the effects of promoting blood circulation and promoting menstruation, and promoting the recovery of diseased tissues, serving as adjuvant drugs. Sautéed Licorice root is the guiding drug, one of which is detoxifying, and the other two are harmonizing the other drugs. The whole prescription gives equal emphasis to clearing away heat and nourishing yin, promoting dampness removal and detoxification, and regulating qi and blood, so that dampness and heat in the body can be eliminated, yin deficiency can be replenished, and qi and blood can circulate smoothly, thereby achieving the purpose of treating senile vaginitis and urethritis due to yin deficiency and damp-heat syndrome.

[0044] The technical effects produced by the present invention are:

[0045] Based on extensive screening experiments and optimized traditional Chinese medicine components and proportions, the present invention has developed an oral traditional Chinese medicine preparation with significant efficacy in treating recurrent senile vaginitis and urethritis. This preparation not only rapidly alleviates symptoms of urinary tract infections, such as frequent urination, urgency, and pain, as well as atrophic vaginitis caused by various causes, but also improves the patient's immunity, preventing recurrence of the disease. The traditional Chinese medicine composition of the present invention is effective, safe, reliable, has few adverse reactions, and is simple to prepare, making it suitable for industrial production. DETAILED DESCRIPTION

[0046] Example 1

[0047] Weigh 30 g of Dianthus bistortae, 30 g of Rehmannia root, 15 g of Fritillaria thunbergii, 15 g of Sophora flavescens, 15 g of Cyathula capitata, 10 g of Angelica sinensis, 5 g of Rhubarb and 5 g of stir-fried Licorice root, mix and crush, add 1000 mL of purified water, boil and then simmer for 45 minutes, filter and concentrate the Chinese medicine filtrate to 200 mL to obtain the Chinese medicine decoction 1 of the present invention.

[0048] Example 2

[0049] Weigh 15 g of Dianthus bistortae, 30 g of Rehmannia root, 30 g of Fritillaria thunbergii, 15 g of Sophora flavescens, 15 g of Cyathula capitata, 10 g of Angelica sinensis, 5 g of Rhubarb and 5 g of stir-fried Licorice, mix and crush, add 1000 mL of purified water, boil and then simmer for 45 minutes, filter and concentrate the Chinese medicine filtrate to 200 mL to obtain the Chinese medicine decoction 2 of the present invention.

[0050] Example 3

[0051] Weigh 15 g of Dianthus bistortae, 30 g of Rehmannia root, 15 g of Fritillaria thunbergii, 30 g of Sophora flavescens, 15 g of Cyathula capitata, 10 g of Angelica sinensis, 5 g of Rhubarb and 5 g of stir-fried Licorice, mix and crush, add 1000 mL of purified water, boil and then simmer for 45 minutes, filter and concentrate the Chinese medicine filtrate to 200 mL to obtain the Chinese medicine decoction 3 of the present invention.

[0052] Example 4

[0053] Weigh 15 g of Dianthus bistortae, 30 g of Rehmannia root, 15 g of Fritillaria thunbergii, 15 g of Sophora flavescens, 15 g of Cyathula capitata, 25 g of Angelica sinensis, 5 g of Rhubarb and 5 g of stir-fried Licorice, mix and crush, add 1000 mL of purified water, boil and then simmer for 45 minutes, filter and concentrate the Chinese medicine filtrate to 200 mL to obtain the Chinese medicine decoction 4 of the present invention.

[0054] Comparative Example 1 (Cyclohexidine diffusa replaced by Alisma orientalis)

[0055] Weigh 30 g of Dianthus bistortae, 30 g of Rehmannia root, 15 g of Fritillaria thunbergii, 15 g of Sophora flavescens, 15 g of Rhizoma Alismatis, 10 g of Angelica sinensis, 5 g of Rhubarb and 5 g of stir-fried Licorice, mix and crush, add 1000 mL of purified water, boil and then simmer for 45 minutes, filter and concentrate the traditional Chinese medicine filtrate to 200 mL, and obtain the traditional Chinese medicine decoction comparative example 1.

[0056] Comparative Example 2 (Shengdihuang is replaced by Cornus officinalis)

[0057] Weigh 30 g of Dianthus bistortae, 30 g of Cornus officinalis, 15 g of Fritillaria thunbergii, 15 g of Sophora flavescens, 15 g of Cyathula capitata, 10 g of Angelica sinensis, 5 g of cooked rhubarb, and 5 g of stir-fried liquorice, mix and crush, add 1000 mL of purified water, boil, then simmer for 45 minutes, filter, and concentrate the traditional Chinese medicine filtrate to 200 mL to obtain a traditional Chinese medicine decoction comparative example 2.

[0058] Experimental Example 1: Therapeutic effect of the Chinese medicine composition of the present invention on bacterial vaginosis mouse model

[0059] 1. Test method

[0060] Female mice were subcutaneously injected with 0.05 mL of 2 mg / mL estradiol benzoate injection once every two days for three times. On the sixth day, 20 μL of the modeling solution (made from 10 9 cfu / mL Staphylococcus aureus and 10 9 CFU / mL Escherichia coli is mixed in equal volumes and injected into a sponge. The sponge into which the strain has been injected is plugged in the vagina of the mouse. On the 4th day after inoculation, vaginal secretion smears are taken with a sterile cotton swab. Grams staining and microscopy are performed to observe the growth of mycelia and blastospores to determine that the infection is successful. 140 mice are selected from the successful vaginitis model mice of modeling and are randomly divided into 7 groups, namely, a model group, an embodiment of the present invention 1-4 group, and a comparative example 1-2 group, 20 mice per group, and 20 mice not modeled are separately taken as a blank group. The embodiment of the present invention 1-4 group and the comparative example 1-2 group are respectively gavaged with the decoction prepared by the embodiment of the present invention 1-4 and the comparative example 1-2 according to the dosage of 10mL / kg body weight every day. The blank group and the model group are gavaged with the same dose of normal saline every day for 14 consecutive days, once a day. The degree of cure of the vaginal mucosal inflammation of each test group animal is observed 24h after the last administration. The pathological changes of the vaginal mucosa of mice were graded from 0 to III according to the mouse vaginal mucosal histopathological grading. Grade 0 indicated smooth mucosal epithelium without necrosis and shedding, no congestion, edema, hemorrhage, or inflammatory cell infiltration under the mucosa, and no inflammatory exudate in the vagina. Grade I indicated no necrosis and shedding of the mucosal epithelium, submucosal congestion and edema, and no inflammatory exudate in the vagina. Grade II indicated focal necrosis and shedding of the mucosal epithelium, submucosal congestion, edema, punctate hemorrhage, a small amount of inflammatory cell infiltration, and a small amount of inflammatory exudate in the vagina. Grade III indicated necrosis and shedding of the mucosal epithelium, submucosal congestion, edema, patchy hemorrhage, inflammatory cell infiltration, and a large amount of inflammatory exudate in the vagina.

[0061] 2. Test results

[0062] The vaginal mucosal pathological grading results of mice in each experimental group after administration of different Chinese medicine compositions are shown in Table 1 below.

[0063] Table 1 Vaginal mucosal pathological grades of mice in each experimental group

[0064] Group Level 0 Level I Level II Level III Blank group 19 1 0 0 Model Group 0 2 6 12 Example 1 group 10 6 4 0 Example 2 group 6 10 2 2 Example 3 group 5 12 2 1 Example 4 Group 6 9 4 1 Comparative Example 1 1 9 5 5 Comparative Example 2 2 8 4 6

[0065] As shown in Table 1 above, compared with the model group and the comparative example groups 1-2, the number of mice with vaginal mucosal pathology grades II and III in the groups 1-4 of the present invention was significantly reduced, and the number of grade 0 mice was significantly increased. The above test results confirm that the traditional Chinese medicine composition of the present invention can significantly improve bacterial vaginosis in mice, and it is expected that the traditional Chinese medicine composition of the present invention has significant clinical efficacy in treating recurrent vaginitis.

[0066] Experimental Example 2: Efficacy of the Chinese medicine composition of the present invention on a mouse model of recurrent urinary tract infection (rUTI)

[0067] 1. Test method

[0068] 100 C57BL / 6 female mice were fed adaptively for 1 week and 10 8 CFU of UTI89 strain was instilled into the mouse bladder twice through the urethra, 24 hours apart. Urine culture was performed on days 1, 3, 7, 10, 14, 21, and 28 after the second infection, and mice with persistent urine bacteria positive were retained. On day 28, 54 mg / ml trimethoprim and 270 mg / ml sulfamethoxazole were added to the drinking water of the mice for 10 consecutive days. Urine culture was performed after 10 days, and urine bacteria positive mice were eliminated. Four weeks after the start of antibiotic treatment, 10 8 The rUTI mouse model was constructed using the UTI89 strain with CFU, and a positive urine bacterial culture indicated that the model was successful.

[0069] 70 mice successfully modeled were randomly divided into a model group, an embodiment of the present invention 1-4 group, and a comparative example 1-2 group, with 10 mice in each group. Ten unmodeled mice were separately taken as a blank group. The blank group and the model group were gavaged with normal saline at a dose of 10 mL / kg body weight, and the embodiment of the present invention 1-4 group and the comparative example 1-2 group were gavaged with the decoction prepared in the embodiment of the present invention 1-4 and the comparative example 1-2, respectively, at a dose of 10 mL / kg body weight. Each test group was gavaged once a day for 14 consecutive days.

[0070] 2 hours after the last administration, place a filter paper without fluorescent agent on the bottom of the cage and provide food as usual, without providing drinking water. After 4 hours, remove the filter paper and let it dry. Illuminate with a fluorescent light and take pictures. Image J software was used to count the total number of urine spots (area larger than 1.7 mm 2 The urine spots are the number of urine spots in the center of the filter paper, which reflects the frequency of urination) and the number of central urine spots (the number of urine spots in the center 50% of the filter paper, which reflects the abnormal urination behavior of overactive bladder).

[0071] After the urine spot experiment, the eyeballs of mice in each experimental group were removed and blood was collected. The blood was centrifuged at 3000 r / min for 10 min to separate the serum. 10 μl of mouse serum was taken from each group and the ELISA kit was used according to the instructions to detect the levels of IL-1β, IL-6 and TNF-α in the serum of mice in each experimental group.

[0072] 2. Test results

[0073] 2.1 Comparison of mouse urine spot test results

[0074] The urine stain results of mice in each test group after administration of different Chinese medicine compositions are shown in Table 2 below.

[0075] Table 2 Comparison of the total number and central urine spots of mice in each experimental group

[0076] Group Total number of urine spots Number of central urine spots Blank group 6.70±0.92 1.70±0.52 Model Group 18.20±2.34 5.20±1.67 Example 1 group 7.50±1.08 1.90±0.61 Example 2 group 8.60±1.17 2.50±0.73 Example 3 group 9.20±1.25 2.70±0.79 Example 4 Group 9.30±1.31 2.80±0.81 Comparative Example 1 11.40±1.47 3.50±0.94 Comparative Example 2 11.80±1.38 3.70±0.97

[0077] The total number of urine spots and the number of central urine spots reflect the frequency of urination and abnormal urination in mice. As can be seen from Table 2 above, compared with the blank group, the total number of urine spots and the number of central urine spots in the model group mice were significantly increased (with statistical significance). Compared with the model group and the comparative example 1-2 group, the total number of urine spots and the number of central urine spots in the mice in the Example 1-4 group of the present invention were significantly reduced (both with statistical significance). The above test results confirm that the Chinese medicine composition of the present invention can significantly improve the symptoms such as frequent urination caused by recurrent urinary tract infection, and it is expected that the Chinese medicine composition of the present invention has significant clinical efficacy in treating recurrent urinary tract infection and urethritis. Surprisingly, under the same total weight of Chinese medicinal materials, the effect of improving the symptoms of frequent urination in mice given the Chinese medicine of Example 1 was significantly better than that of the other example groups, producing an excellent therapeutic effect that was difficult to expect.

[0078] 2.2 Comparison of IL-1β, IL-6, and TNF-α levels in mouse serum

[0079] The comparison results of the inflammatory factor levels in the serum of mice in each experimental group after administration of different Chinese medicine compositions are shown in Table 3 below.

[0080] Table 3 IL-1β, IL-6 and TNF-α levels in serum of mice in each experimental group

[0081]

[0082]

[0083] The increase in inflammatory factors in mouse serum can predict chronic infection and subsequent susceptibility to rUTI. As shown in Table 3 above, compared with the blank group, the IL-1β, IL-6 and TNF-α levels in the serum of the model group mice were significantly increased (with statistical significance). Compared with the model group and the comparative example 1-2 group, the IL-1β, IL-6 and TNF-α levels in the serum of the mice in the Example 1-4 group of the present invention were significantly reduced (all with statistical significance). The above test results show that the Chinese medicine composition of the present invention may reduce the recurrence rate of urinary tract infection and urethritis by reducing the levels of IL-1β, IL-6 and TNF-α in the serum of mice. Surprisingly, when the total weight of Chinese medicinal materials is the same, the anti-inflammatory effect of the mice given the Chinese medicine of Example 1 is significantly better than that of the other example groups, resulting in an excellent therapeutic effect that is difficult to expect.

[0084] Test Example 3: Clinical trial of the Chinese medicine composition of the present invention in treating recurrent senile vaginitis and urethritis

[0085] 1. Test method

[0086] 1.1. Subject inclusion and exclusion criteria

[0087] Inclusion criteria: ① Patients complained of vulvar itching, dyspareunia, burning pain during intercourse, frequent urination, dysuria, and urgency. Gynecological examination revealed disappearance and flattening of the vaginal wall, as well as thinning, congestion, and scattered small petechiae. ② Vaginal discharge was profuse and thin, turbid, or yellow and sticky. ③ Microscopic examination of vaginal discharge revealed cleanliness (I–IV), WBC count (0–++++), and occasional RBC count; urinalysis revealed RBC count (+–++) and WBC count (+–++). ④ Breast and pelvic examinations were normal. ⑤ Postmenopausal for 1–20 years. ⑥ Participants were informed of the study.

[0088] Exclusion criteria: ① those who are allergic to the study drugs; ② those with other acute or chronic inflammatory diseases; ③ those who stop taking the drugs midway; ④ those with comprehension disorders, cognitive disorders or mental illnesses.

[0089] 1.2 Disease Diagnostic Criteria

[0090] Refer to the 2021 textbook "Chinese Medicine Internal Medicine" edited by Wu Mianhua et al. (China Traditional Chinese Medicine Press) and the "Chinese Medicine Disease Diagnosis and Efficacy Standards" revised in 2017, the standards for Yin deficiency damp-heat type leucorrhea and gonorrhea:

[0091] Primary symptoms: Common in perimenopausal and postmenopausal women, often characterized by heavy, yellow or white vaginal discharge, vulvar itching, dyspareunia, vaginal burning, frequent urination, burning urgency, and painful urination, often occurring with exertion. Secondary symptoms: abdominal distension, difficulty urinating, lower back pain, and fatigue. Tongue: Red with scanty or yellow coating. Pulse: Wire-wire or deep-thready. Traditional Chinese Medicine (TCM) syndrome differentiation criteria: Based on combined tongue and pulse differentiation, a diagnosis is considered complete when two or more of the primary and secondary symptoms are present, along with one or more of the secondary symptoms.

[0092] 1.3 Trial Grouping and Dosage Regimen

[0093] This trial adopted a random grouping method. The 72 patients were numbered 001-072, and random data were generated through Excel tables. They were divided into treatment and control groups using a random number table method, with 36 cases in each group. The patients in the treatment group took the Chinese medicine decoction of the present invention (according to the drug ratio in Example 1, weighed 30g of Dianthus 30g, 30g of Rehmannia glutinosa, 15g of Fritillaria thunbergii, 15g of Sophora flavescens, 15g of Cyathula capitata, 10g of Angelica sinensis, 5g of Rhubarb and 5g of stir-fried Licorice, added into 600ml of water and soaked for 30min, decocted with high heat until boiling, changed to slow fire, boiled for 60min, poured out the juice, added 400ml of water to the residue, boiled with slow fire for 30min, poured out the juice, mixed the two juices into a daily dose, and took them twice a day), took the medicine for 20 consecutive days, and simultaneously co-administered promestriene vaginal capsules (Zhejiang Anbao Pharmaceutical Co., Ltd., national medicine standard H20045762, specification: 10mg / grain), and the moistened capsules were inserted into the deep vagina before going to bed every night for 20 days. Patients in the control group received the aforementioned promestriene vaginal capsules, inserting the moistened capsules deep into the vagina every night before bed for 20 days. Both groups completed case report forms before and after treatment, including Traditional Chinese Medicine (TCM) symptom scores, leucorrhea and urine routine tests, and efficacy evaluation.

[0094] 1.4. Traditional Chinese Medicine Clinical Symptom Scoring

[0095] The quantitative standards were formulated with reference to the 2002 "Guiding Principles for Clinical Research of New Chinese Medicines" (Trial), with higher scores representing more severe symptoms.

[0096] Vaginal dryness symptom score: no vaginal dryness symptom 0 points, tolerable 2 points, tolerable only for a moment 4 points, intolerable 6 points.

[0097] Vulvovaginal burning symptom score: no vulvovaginal burning symptom is 0 points, tolerable is 2 points, tolerable only for a moment is 4 points, and intolerable is 6 points.

[0098] Vulvovaginal pruritus symptom score: no vulvovaginal pruritus symptom is 0 points, tolerable is 2 points, tolerable only for a moment is 4 points, and unbearable is 6 points.

[0099] Symptom score for sexual intercourse pain: no sexual intercourse pain is 0 points, tolerable is 2 points, tolerable only for a moment is 4 points, and unbearable is 6 points.

[0100] Frequent urination symptom score: 0 points for normal urination frequency, 2 points for less than 1 times increase, 4 points for 1-2 times increase, and 6 points for more than 2 times increase.

[0101] Symptom score for dysuria: no symptoms: 0 points; dull urethral pain that does not affect urination: 2 points; severe pain and discomfort during urination: 4 points; unbearable pain: 6 points;

[0102] Urethral irritation symptom score: no symptoms counted as 0 points, dull urethral pain without burning sensation, occasional frequent urination counted as 2 points, obvious astringent pain, discomfort, accompanied by urethral burning sensation counted as 4 points, and continuous unbearable burning pain, frequent and urgent urination counted as 6 points.

[0103] 1.5. Routine evaluation of leucorrhea and urine

[0104] Routine leucorrhea indicators include leucorrhea leukocytes, which are measured using the conventional esterase method in the art. Routine urine indicators include urine leukocytes and urine red blood cell indicators, which are measured using the conventional esterase method and hemoglobin heme peroxidase method in the art, respectively.

[0105] 1.6 Clinical Efficacy Evaluation

[0106] The treatment was evaluated based on the improvement of the patient's symptoms and signs. A vaginal discharge cleanliness rating of I-II, with the disappearance of adverse symptoms and signs and vaginal mucosal congestion, was considered cured; a vaginal discharge cleanliness rating of I-II, with improvement of symptoms and signs and vaginal mucosal congestion, was considered markedly effective; a vaginal discharge cleanliness rating of II, with improvement of symptoms and signs, was considered effective; and a lack of improvement in symptoms and signs or vaginal discharge cleanliness, was considered ineffective. The specific evaluation criteria for vaginal discharge cleanliness ratings I-IV are shown in the table below. The total effective rate = cure rate + markedly effective rate + effective rate.

[0107] Leucorrhea cleanliness Bacillus epithelial cells White blood cells (cells / HP) Miscellaneous bacteria Clinical significance I ++++ ++++ 0-5 - normal II ++ ++ 5-15 - normal III - - 15-30 ++ Indicating inflammation IV - - >30 ++++ Severe vaginitis

[0108] 2. Test results

[0109] 2.1 Analysis of baseline data of enrolled patients

[0110] All patients in this trial were patients with Yin deficiency and damp-heat syndrome who visited the outpatient clinic of the Department of Gynecology of Traditional Chinese Medicine, Ningbo Hospital of Traditional Chinese Medicine from August 2023 to December 2024. A total of 72 subjects were included in this trial, and there were no dropout cases. The oldest patient in the two groups was 75 years old and the youngest was 53 years old. The average age of the observation group was (57.26±8.01) years old, and the average age of the control group was (58.79±6.67) years old. The shortest course of disease was 3 months and the longest was 5 years. After comparison of two independent sample t-tests and Mann-Whitney U tests, there was no statistically significant difference in age, course of disease, and number of previous miscarriages between the two groups of patients (P>0.05), indicating that the baseline data of the two groups of patients were at the same level before treatment and the trials were comparable.

[0111] 2.2 Comparison of TCM clinical symptom scores before and after treatment

[0112] The Wilcoxon signed-rank test and Mann-Whitney U test revealed no statistically significant difference in clinical symptom scores between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, the clinical symptom scores of all symptoms, except for vulvovaginal pruritus (P=0.05), decreased in both groups (P<0.05). Furthermore, the clinical symptom scores in the treatment group were lower than those in the control group (P<0.05), indicating that the treatment group had a better therapeutic effect than the control group. Specific statistical results are shown in Table 4.

[0113] Table 4 Comparison of TCM clinical symptom scores between the two experimental groups

[0114]

[0115] 2.3 Comparison of blood and urine routine before and after treatment

[0116] The Wilcoxon signed-rank test and Mann-Whitney U test revealed no statistically significant differences in leucorrhea white blood cell counts, urine white blood cell counts, and urine red blood cell counts between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, clinical symptom scores decreased in both groups (P<0.05), with the exception of urine red blood cell counts (P>0.05). These scores were significantly lower in the treatment group than in the control group (P<0.05), indicating that the treatment group had superior efficacy. Specific test results are shown in Table 5.

[0117] Table 5 Comparison of leucorrhea and urine routine before and after treatment in the two experimental groups

[0118]

[0119] 2.4 Comparison of clinical efficacy before and after treatment

[0120] The total effective rate of the treatment group was 88.9%, while that of the control group was 75.0%. The Mann-Whitney U test showed that p<0.05, indicating that the treatment group had a more significant effect (see Table 6).

[0121] Table 6 Comparison of clinical efficacy before and after treatment

[0122]

[0123] In summary, the above test results confirm that the Chinese medicine composition of Example 1 of the present invention is clinically effective in treating recurrent senile vaginitis and urethritis.

[0124] Although specific embodiments of the present invention have been described, it will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the scope or spirit of the present invention. Therefore, the present invention is intended to cover all such changes and modifications that fall within the scope of the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating vaginitis and urethritis, characterized in that: The traditional Chinese medicine composition is prepared from dianthus fragrans, raw rehmannia root, thunbergia thunbergii, sophora flavescens, cyathula root, angelica sinensis, cooked rhubarb and fried liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from 10-50 parts by weight of Dianthus bistortae, 10-50 parts by weight of Rehmannia root, 1-30 parts by weight of Fritillaria thunbergii, 1-30 parts by weight of Sophora flavescens, 1-30 parts by weight of Cyathula capitata, 1-25 parts by weight of Angelica sinensis, 1-20 parts by weight of Rhubarb and 1-20 parts by weight of stir-fried Licorice root.

3. The Chinese medicine composition according to claim 2, characterized in that The traditional Chinese medicine composition is prepared from 20-40 parts by weight of Dianthus bistortae, 20-40 parts by weight of Rehmannia root, 5-25 parts by weight of Fritillaria thunbergii, 5-25 parts by weight of Sophora flavescens, 5-25 parts by weight of Cyathula capitata, 1-20 parts by weight of Angelica sinensis, 1-15 parts by weight of Rhubarb and 1-15 parts by weight of stir-fried Licorice root.

4. The Chinese medicine composition according to claim 3, characterized in that The traditional Chinese medicine composition is prepared from 25-35 parts by weight of Dianthus bistortae, 25-35 parts by weight of Rehmannia root, 10-20 parts by weight of Fritillaria thunbergii, 10-20 parts by weight of Sophora flavescens, 10-20 parts by weight of Cyathula capitata, 5-15 parts by weight of Angelica sinensis, 1-10 parts by weight of Rhubarb and 1-10 parts by weight of stir-fried Licorice root.

5. The Chinese medicine composition according to claim 4, characterized in that The traditional Chinese medicine composition is prepared from 30 parts by weight of Dianthus bistortae, 30 parts by weight of Rehmannia root, 15 parts by weight of Fritillaria thunbergii, 15 parts by weight of Sophora flavescens, 15 parts by weight of Cyathula capitata, 10 parts by weight of Angelica sinensis, 5 parts by weight of Rhubarb and 5 parts by weight of stir-fried Licorice root.

6. The Chinese medicine composition according to any one of claims 1 to 5, characterized in that The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

7. The Chinese medicine composition according to claim 6, characterized in that The Chinese medicine composition is an oral preparation.

8. The Chinese medicine composition according to claim 7, characterized in that The dosage form of the Chinese medicine composition is tablets, capsules, granules, tinctures or decoctions.

9. The method for preparing the Chinese medicine composition according to any one of claims 1 to 8, characterized in that: The method comprises the following steps: weighing prescribed amounts of Dianthus bistortae, Radix Rehmanniae, Fritillaria thunbergii, Sophora flavescens, Cyathula capitata, Angelica sinensis, Rhubarb and stir-fried Licorice, mixing and then crushing, adding purified water 6-10 times the total weight of the medicinal materials, boiling and then decocting on low heat for 30-60 minutes, filtering and concentrating the Chinese medicinal filtrate to 1-2 times the total weight of the Chinese medicinal materials initially added, to obtain the product.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 8 in the preparation of medicines for treating vaginitis and urethritis.

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