Traditional Chinese medicine composition for sterilizing and relieving itching

Abstract

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 5 to 25 parts of rhizoma coptidis, 5 to 25 parts of cortex phellodendri, 5 to 25 parts of radix sophorae flavescentis, 5 to 25 parts of fructus cnidii, 5 to 25 parts of cortex dictamni, 5 to 25 parts of oldenlandia diffusa, 5 to 25 parts of radix stemonae, 1 to 20 parts of fructus kochiae and 1 to 20 parts of cortex meliae. The traditional Chinese medicine external preparation is easy to operate, economical, applicable, safe, reliable, few in adverse reaction, remarkable in treatment effect on leukorrheal diseases and eczema, easy to accept by patients and wide in application range.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a bactericidal and itchy traditional Chinese medicine composition. Background Art

[0002] Leucorrhea is a gynecological condition with a high clinical incidence. Its primary symptoms include a significant increase in vaginal discharge volume, abnormalities in color, texture, and odor, and sometimes vulvar itching or even systemic symptoms. In Western medicine, cervicitis, vaginitis, pelvic inflammatory disease, early cervical cancer, and other conditions associated with abnormal vaginal discharge can all be treated according to the syndrome differentiation and treatment of leucorrhea.

[0003] Leucorrhea is a common clinical illness among women of all ages, characterized by lingering symptoms, recurring episodes, and disruptions to work and life. The etiology of leucorrhea was first described in the Suwen Xuanjiyuanbingshi (Suwen Xuanji Yuanbingshi): "When dampness and heat in the lower Ren meridian are severe, body fluids surge and overflow, resulting in leucorrhea." This suggests that leucorrhea is often attributed to the Ren meridian, with dampness and heat primarily affecting the genitals. Traditional Chinese Medicine (TCM) treatments primarily focus on clearing heat and dampness, incorporating various therapies such as soothing the liver, strengthening the spleen, and tonifying the kidneys. Taking into account the physiological characteristics of women, a comprehensive approach using internal and external therapies, combined internal and external therapies, and a combination of traditional Chinese and Western medicine, including acupuncture, is employed.

[0004] Eczema is an inflammatory skin disease of the epidermis and dermis. The main clinical manifestations of the disease are severe itching and dampness of the skin. Depending on the duration of the disease, skin lesions of varying degrees may appear, such as flaky erythema, papules, desquamation, lichenification, and chapped skin. Eczema is an immune response mediated by T lymphocytes. Relevant studies have shown that the Th1 / Th2 balance is a decisive factor in maintaining the body's cellular immunity, and the occurrence of eczema is closely related to an imbalance in cell populations. Eczema falls into the category of "immersion sores" and "blood-wind sores" in Traditional Chinese Medicine, and is characterized by a long course of disease and easy recurrence. Corticosteroids are often used in clinical practice to treat eczema, but long-term use can cause side effects such as capillary dilation and skin atrophy.

[0005] Traditional Chinese and Western medicine each have their own unique therapeutic approaches. Western medicine is slightly more effective than traditional Chinese medicine, but it also has a higher recurrence rate and is prone to developing drug resistance. Traditional Chinese medicine, through syndrome differentiation and treatment, offers stable efficacy, low recurrence rates, and few adverse reactions. However, its effectiveness can be slow to take effect and insignificant. Therefore, there is an urgent need to develop a traditional Chinese medicine combination that combines significant efficacy and minimal side effects in treating leucorrhea and eczema. Summary of the Invention

[0006] To solve the above technical problems, the present invention includes the following aspects:

[0007] The first aspect of the present invention provides a bactericidal and antipruritic traditional Chinese medicine composition, which is prepared from coptis root, phellodendron amurense, sophora flavescens, cnidium monnieri, radix diffusae, hedyotis diffusa, radix stemonae, kochia scoparia and chinaberry bark.

[0008] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 5-25 parts by weight of Coptis chinensis, 5-25 parts by weight of Phellodendron amurense, 5-25 parts by weight of Sophora flavescens, 5-25 parts by weight of Cnidium monnieri, 5-25 parts by weight of Dictamnus cortex, 5-25 parts by weight of Hedyotis diffusa, 5-25 parts by weight of Stemona japonica, 1-20 parts by weight of Kochia scoparia and 1-20 parts by weight of Melia azedarach bark.

[0009] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-20 parts by weight of Coptis chinensis, 10-20 parts by weight of Phellodendron chinense, 10-20 parts by weight of Sophora flavescens, 10-20 parts by weight of Cnidium monnieri, 10-20 parts by weight of Dictamnus diffusa, 10-20 parts by weight of Hedyotis diffusa, 10-20 parts by weight of Stemona japonica, 5-15 parts by weight of Kochia scoparia and 5-15 parts by weight of Melia azedarach bark.

[0010] Further preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 15 parts by weight of Coptis chinensis, 15 parts by weight of Phellodendron chinense, 15 parts by weight of Sophora flavescens, 15 parts by weight of Cnidium monnieri, 15 parts by weight of Dictamnus cortex, 15 parts by weight of Hedyotis diffusa, 15 parts by weight of Stemona japonica, 10 parts by weight of Kochia scoparia and 10 parts by weight of Melia azedarach bark.

[0011] Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0012] Preferably, the Chinese medicine composition is an external preparation or an oral preparation.

[0013] Preferably, the dosage form of the Chinese medicine composition is a tablet, granule, pill, powder, decoction, lotion, gel, patch or ointment. More preferably, the dosage form of the Chinese medicine composition is a tablet lotion, gel, patch or ointment. Further preferably, the dosage form of the Chinese medicine composition is a tablet lotion.

[0014] The second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, which comprises the following steps: taking a prescribed amount of coptis chinensis, phellodendron amurense, sophora flavescens, cnidium monnieri, dactylic acid root, hedyotis diffusa, radix stemonae, kochia scoparia and chinaberry bark, mixing and crushing them, adding 4-8 times the weight of the traditional Chinese medicine in water, boiling them, then decocting them on low heat for 30-60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1-2 times the total weight of the initially added traditional Chinese medicine, and optionally adding pharmaceutically acceptable excipients to obtain the composition.

[0015] Preferably, the boiling time after adding water is 30 minutes.

[0016] Preferably, in the preparation method, water 6 times the weight of the Chinese medicine is added and boiled for 1 hour.

[0017] Preferably, in the preparation method, the traditional Chinese medicine filtrate is concentrated to 1.5 times the total weight of the initially added traditional Chinese medicine.

[0018] The third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating leukorrhea.

[0019] 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 eczema.

[0020] The fifth aspect of the present invention provides use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating vaginitis.

[0021] Preferably, the vaginitis is bacterial vaginosis, Trichomonas vaginitis or fungal vaginitis.

[0022] Preferably, the bacterial vaginosis is vaginitis caused by Escherichia coli and / or Staphylococcus aureus, and the fungal vaginitis is vaginitis caused by Candida albicans.

[0023] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0024] Coptis chinensis: clears away heat and dampness, purges fire and detoxifies, and has a significant inhibitory effect on yellow-blue hair fungi, flocculent epidermophyton, Candida albicans, etc.

[0025] Huangbai: bitter, cold and settling, good at clearing dampness and heat in the lower part of the body. It contains alkaloids such as berberine, jatrorrhizine, and palmatine, which have a strong inhibitory effect on skin pathogenic fungi such as Candida albicans, Epidermophyton floccosum, and Microsporum floccosum.

[0026] Sophora flavescens: Its bitter and cold properties are strong, clearing heat and dampness while also acting as a diuretic, expelling dampness and heat. It is used to treat a variety of damp-heat syndromes, clearing heat and dampness while also killing parasites and relieving itching, making it a key remedy for skin diseases. The matrine and oxymatrine contained in Sophora flavescens have varying degrees of inhibitory activity against dermatophytes such as Trichophyton, Trichophyton, and Epidermophyton rubrum.

[0027] Cnidium monnieri: It is pungent, pungent, warm and dry, and has the functions of drying dampness and dispelling wind, killing insects and relieving itching. It can resist skin fungi and molds. Its fluid extract can kill vaginal Trichomonas in vitro, and it also has anti-inflammatory and anti-allergic effects.

[0028] Dictamni: clears heat and dampness, dispels wind and detoxifies, and is good at treating eczema and dampness. Its water extract has varying degrees of inhibitory effects on various pathogenic fungi such as Trichophyton, Trichophyton, Microsporum, Epidermophyton, Nocardia australis, etc., and has anti-inflammatory and antipyretic effects.

[0029] Houttuynia cordata: clears away heat and detoxifies, promotes dampness and relieves stranguria. It has anti-tumor, antibacterial and anti-inflammatory effects. It can enhance the phagocytic ability of white blood cells in the body, and can prevent and treat erythema, papules, vulvar itching, etc. caused by damp heat in the skin.

[0030] Stemona: Has insecticidal and pediculocidal properties. Its ethanol extract has varying degrees of inhibitory activity against various pathogens, including Candida albicans. It also has inhibitory effects on various skin fungi. Both its alcohol and water extracts have some killing effects against head lice, body lice, and pubic lice, with the strongest killing effect against head lice.

[0031] Kochia scoparia seeds: clear away heat and dampness, dispel wind and relieve itching. Its water extract has varying degrees of inhibitory effect on a variety of skin fungi. Its water extract can inhibit the phagocytic function of the mononuclear macrophage system and delayed-type hypersensitivity reaction.

[0032] Melia azedarach bark: clears heat and dampness, kills insects and relieves itching. Its decoction or alcohol extract has an inhibitory and even paralyzing effect on Ascaris suum. The toosendanin it contains can penetrate the epidermis of the worm and directly act on the muscles of the Ascaris suum, disrupting its energy metabolism and causing contractile fatigue and spasms.

[0033] The Chinese medicine composition of the present invention comprises Sophora flavescens, which clears heat and dampness, kills insects and relieves itching; Coptis chinensis and Phellodendron chinense, which clear heat and dampness, purge fire and detoxify, as the main herbs; Cnidium monnieri, which clears heat and dampness, dispels wind and kills insects and relieves itching; Dictamni cortex, which clears heat and dampness, dispels wind and detoxifies; Hedyotis diffusa, which clears heat and detoxifies, promotes dampness and relieves stranguria; and Stemona officinalis, which kills insects and kills lice, as the assistant herbs; Kochia scoparia, which clears heat and dampness, dispels wind and relieves itching; and Chinaberry bark, which kills insects and treats tinea, as the adjuvant herbs. In the composition, Coptis chinensis and Phellodendron chinense are both bitter and cold in nature and flavor, and can clear heat and dry dampness, purge fire and detoxify, and are commonly used to treat symptoms of internal damp-heat or intense heat toxicity, and each is necessary for its use; Kochia scoparia and Chinaberry bark, when combined, can treat skin itching; and Kochia scoparia, which is compatible with Sophora flavescens, can treat damp-heat in the lower jiao. Sophora flavescens, Cnidium monnieri, Stemona officinalis, and Chinaberry bark are all insecticidal. The combination of these herbs achieves the effects of clearing heat and dampness, killing insects and relieving itching.

[0034] Clinical use method: Use 400 mL of the Chinese medicine lotion of the present invention to clean the vulva or take a sitz bath for 15 minutes, and apply externally or soak the affected area of the skin.

[0035] The technical effects produced by the present invention are:

[0036] Based on a large number of screening tests, the present invention obtains an external Chinese medicine lotion with excellent bactericidal and antipruritic effects by optimizing the Chinese medicine components and proportions (for example, the Chinese medicine lotion of Example 1 is preferably obtained, and in vivo animal experiments confirm that its therapeutic effects in bacterial vaginosis mouse models and eczema mouse models are significantly better than those of other examples and comparative examples).

[0037] The external-use Chinese medicinal preparation of the present invention is simple to operate, economical and applicable, safe and reliable, has few adverse reactions, is effective in treating leucorrhea (symptoms such as genital pruritus and excessive leucorrhea caused by bacterial vaginosis, trichomoniasis or fungal vaginitis) and eczema caused by damp heat blocking the skin (common symptoms include itching, erythema, papules, etc.), is easily accepted by patients, and has a wide range of applications. DETAILED DESCRIPTION

[0038] Example 1

[0039] Take 15g of Coptis chinensis, 15g of Phellodendron chinense, 15g of Sophora flavescens, 15g of Cnidium monnieri, 15g of Dictamnus cortex, 15g of Hedyotis diffusa, 15g of Stemona radix, 10g of Kochia scoparia and 10g of Chinaberry bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Chinese medicine lotion 1 of the present invention.

[0040] Example 2

[0041] Take 5g of Coptidis Rhizoma, 5g of Phellodendron Amurense, 15g of Sophora Flavescentis, 15g of Cnidium monnieri, 15g of Dictamnus Cortex, 15g of Hedyotis diffusa, 15g of Stemona Radix, 20g of Kochia Fructus and 20g of Melia azedarach Bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Chinese medicine lotion 2 of the present invention.

[0042] Example 3

[0043] Take 15g of Coptis chinensis, 15g of Phellodendron chinense, 5g of Sophora flavescens, 5g of Cnidium monnieri, 15g of Dictamni cortex, 15g of Hedyotis diffusa, 15g of Stemona radix, 20g of Kochia scoparia and 20g of Melia azedarach bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Chinese medicine lotion 3 of the present invention.

[0044] Example 4

[0045] Take 15g of Coptis chinensis, 15g of Phellodendron chinense, 15g of Sophora flavescens, 15g of Cnidium monnieri, 5g of Dictamnus cortex, 5g of Hedyotis diffusa, 15g of Stemona radix, 20g of Kochia scoparia and 20g of Chinaberry bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Chinese medicine lotion 4 of the present invention.

[0046] Comparative Example 1 (Scutellaria baicalensis replaced with Coptis chinensis)

[0047] Take 15g of Scutellaria baicalensis, 15g of Phellodendron chinense, 15g of Sophora flavescens, 15g of Cnidium monnieri, 15g of Dictamnus cortex, 15g of Hedyotis diffusa, 15g of Stemona radix, 10g of Kochia scoparia and 10g of Melia azedarach bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Comparative Example Chinese Medicine Lotion 1.

[0048] Comparative Example 2 (replacing Kochia scoparia with Alisma orientalis)

[0049] Take 15g of Coptis chinensis, 15g of Phellodendron chinense, 15g of Sophora flavescens, 15g of Cnidium monnieri, 15g of Dictamnus cortex, 15g of Hedyotis diffusa, 15g of Stemona radix, 10g of Alismatis and 10g of Melia azedarach bark, mix and crush, add 750mL of water, boil, then simmer for 30 minutes, filter and concentrate the Chinese medicine filtrate to 200mL to obtain Comparative Example Chinese Medicine Lotion 2.

[0050] Test Example 1: Protective effect of the Chinese medicine composition of the present invention on bacterial vaginosis mouse model

[0051] 1. Test method

[0052] Healthy female Kunming mice were subcutaneously injected with 0.2 mL of estradiol benzoate injection (0.5 mg / mL) once every two days for a total of three times. Six days later, the vagina of the mice was irrigated three times with PBS solution, and Escherichia coli (1×10 9 cfu / mL) and Staphylococcus aureus (1×10 9 cfu / mL) mixed with the bacterial solution. Four days after inoculation, vaginal smears were collected for Gram staining and microscopic examination to examine Staphylococcus aureus and Escherichia coli infection. When the mouse vagina showed obvious congestion, redness, swelling, and abundant purulent secretions, a smear was taken, revealing the presence of numerous infected bacteria and necrotic cells under the microscope, indicating successful establishment of a mouse bacterial vaginosis (BV) model.

[0053] 70 mice were taken out from the successful modeling mice and randomly divided into a model group, a Chinese medicine composition 1-4 group of the present invention and a comparative example Chinese medicine composition 1-2 group, with 10 mice in each group, and 10 healthy mice were set as a control group. The Chinese medicine composition 1-4 group of the present invention and the comparative example Chinese medicine composition 1-2 group of mice were respectively given 0.2mL of the Chinese medicine lotion prepared by Example 1-4 and Comparative Example 1-2 by local vaginal administration. The control group and the model group mice were given an equal amount of normal saline topically in the vagina for 14 consecutive days, once a day. After 4 days of drug withdrawal, each mouse was fully irrigated with PBS solution. 200 μL of vaginal lavage fluid was taken from each mouse and collected in a sterile test tube. It was centrifuged and the supernatant was taken. The vaginal lavage fluid IL-1β, IL-6 and TNF-α levels were detected according to the kit operating instructions.

[0054] 2. Test results

[0055] The levels of inflammatory factors in vaginal secretions of BV mice in each experimental group after treatment with the Chinese medicine composition of the present invention are shown in Table 1.

[0056] Table 1 Effect of the Chinese medicine composition of the present invention on the levels of IL-1β, IL-6 and TNF-α in vaginal secretions of BV mice

[0057]

[0058] Bacterial infection can activate endothelial cells, macrophages, and neutrophils, releasing a large number of inflammatory factors that damage and destroy the body. The pro-inflammatory factors IL-1β, IL-6, and TNF-α secreted after infection promote inflammatory cell activation, adhesion molecule synthesis, oxidative stress, and other factors, furthering tissue and organ damage.

[0059] As shown in the test results of Table 1, compared with the model group and the comparative example Chinese medicine composition group 1-2, the Chinese medicine composition group 1-4 lotion of the present invention significantly reduced the levels of IL-1β, IL-6 and TNF-α in the vaginal secretions of BV mice (with statistical differences). Among them, the Chinese medicine composition group 1 lotion reduced the levels of IL-1β, IL-6 and TNF-α the most significantly, producing an unexpected technical effect. The above test results show that the Chinese medicine composition of the present invention can inhibit the synthesis of IL-1β, IL-6 and TNF-α in the vaginal secretions of mice, and then alleviate the vaginal inflammatory response after bacterial infection, and is expected to have a good effect in treating bacterial vaginosis in clinical practice.

[0060] Test Example 2: Clinical Case 1 of the Treatment of Female Leucorrhea and Eczema of Damp-Heat Type by the Traditional Chinese Medicine Composition of the Present Invention

[0061] A 38-year-old female patient, Ms. Li, presented to the doctor with a primary complaint of "excessive vaginal discharge and recurrent vulvar itching for a year, which had worsened over the past two weeks." She typically enjoyed spicy foods, but a year earlier, she began experiencing increased vaginal discharge, thick yellowish color, and a fishy odor. She also experienced intermittent vulvar itching, which had worsened over the past two weeks, accompanied by dull lower abdominal pain, short, dark urine, and a bitter taste in the mouth and dry throat. She had a history of chronic pelvic inflammatory disease, but no diabetes or other systemic diseases.

[0062] Tongue and pulse: Red tongue with a greasy yellow coating, slippery and rapid pulse. Gynecological examination: Vulvar flushing, profuse, yellowish, and viscous vaginal discharge, and cervical congestion. Laboratory examination: Routine vaginal discharge showed grade IV cleanliness, white blood cells (+++), clue cells (+), fungi (-), and trichomonas (-). Pelvic ultrasound showed a small amount of pelvic fluid.

[0063] Western medicine diagnosis: bacterial vaginosis (BV); Traditional Chinese Medicine diagnosis: leucorrhea (damp-heat invasion).

[0064] Treatment principles: clearing away heat and dampness, detoxifying and stopping leukorrhea.

[0065] Treatment plan: Use 400 ml of the Chinese medicine composition lotion prepared in Example 1 of the present invention for sitz bath every night for 7 consecutive days.

[0066] Efficacy observation:

[0067] Second visit (followed by 7 sitz baths): Symptom changes: Leucorrhea volume decreased, color turned light yellow, vaginal itching alleviated, short and dark urine improved, bitter taste in the mouth lessened. Tongue and pulse: Tongue redness reduced, thin yellow greasy coating, slippery pulse. Leucorrhea reexamination: Grade III cleanliness, white blood cell count (WBC) positive. Continue with the original prescription and method for 7 doses.

[0068] Third visit (followed by 14 sitz baths): Symptoms: Leucorrhea has essentially returned to normal, with only occasional light yellow discharge, no vaginal itching, and the dull pain in the lower abdomen has disappeared. Urine is clear and the mouth is not bitter. Tongue and pulse: Pale red tongue with a thin, slightly greasy white coating, slow pulse. Leucorrhea reexamination: Clearness II, white blood cell count (-).

[0069] During the follow-up 3 months later, the patient's diet was slightly controlled and no abnormal leucorrhea was observed.

[0070] Case 2

[0071] A 32-year-old female patient, surnamed Wang, presented with a primary complaint of excessive vaginal discharge and vulvar burning pain for a month. She was experiencing high work pressure and frequent late nights. For the past month, she had experienced an abnormally increased amount of vaginal discharge, yellow-green in color, and a rancid odor. She also experienced vulvar burning and stinging pain, burning urine, and sticky stools. She had a history of recurrent vaginitis, which had not been treated with standard treatment.

[0072] Tongue and pulse: Dark red tongue with thick, greasy yellow fur, and a rapid, slippery pulse. Gynecological examination: Vulvar redness and swelling, vaginal congestion, Grade I cervical erosion, and yellow-green, frothy vaginal discharge. Laboratory examination: Routine vaginal discharge showed Grade III cleanliness, with positive results for white blood cells (++), clue cells (-), fungi (-), and trichomonas (+).

[0073] Western medicine diagnosis: Trichomonas vaginitis; Traditional Chinese medicine diagnosis: Leukorrhea (damp-heat descending with liver meridian stagnation and heat)

[0074] Treatment principles: clearing away heat and dampness, soothing the liver and detoxifying, killing insects and relieving itching.

[0075] Treatment plan: Use 400 ml of the Chinese medicine composition lotion prepared in Example 1 of the present invention for sitz bath every night for 7 consecutive days.

[0076] Efficacy observation:

[0077] Second visit (followed by 7 sitz baths): Symptom changes: Leucorrhea volume decreased, color turned light yellow, vaginal itching alleviated, short and dark urine improved, bitter taste in the mouth lessened. Tongue and pulse: Tongue redness reduced, coating thin and greasy yellow, pulse slippery. Leucorrhea reexamination: Cleanliness grade II, white blood cell count (-), Trichomonas (-).

[0078] Follow-up after 3 months showed no abnormal leucorrhea.

[0079] Case 3

[0080] A 45-year-old female patient, Ms. Zhao, presented with her initial complaint of "recurrent abnormal vaginal discharge accompanied by externally induced itching for over a year, with a recurrence occurring three days later." She had experienced ≥4 episodes of VVC within a year. She was obese and preferred sweet and greasy foods. For the past six months, she had persistent vaginal discharge with a fishy odor, a damp and itchy vaginal area that worsened in the afternoon, and fatigue. She also had a history of well-controlled diabetes.

[0081] Tongue and pulse: The tongue is enlarged with teeth marks on the edges, the coating is greasy white with a slight yellowish coating, and the pulse is slippery. Gynecological examination: The vulva is moist, the vaginal wall is mildly edematous, and the vaginal discharge is yellow-green and has a bean curd-like consistency. Laboratory examination: Routine vaginal discharge showed cleanliness grade III, white blood cells (+), fungi (++), and a pH of 4.0.

[0082] Western medicine diagnosis: recurrent vulvovaginal candidiasis (RVVC); Traditional Chinese Medicine diagnosis: leucorrhea (damp-heat invasion combined with spleen deficiency and dampness).

[0083] Treatment principles: Strengthen the spleen and eliminate dampness, clear away heat and stop leukorrhea, and have anti-fungal effects.

[0084] Treatment plan: Use 400 ml of the Chinese medicine composition lotion prepared in Example 1 of the present invention for sitz bath every night for 14 consecutive days, and insert 0.5 g of clotrimazole vaginal tablets into the vagina.

[0085] Efficacy observation:

[0086] Second visit (followed by 14 doses of sitz baths): Symptom changes: Leucorrhea volume decreased, color turned light yellow, vaginal itching alleviated, short and dark urine improved, and bitter taste in the mouth lessened. Tongue and pulse: Tongue redness reduced, coating thin and greasy yellow, pulse slippery. Leucorrhea reexamination: Grade III cleanliness, Candida (-), white blood cells (+). Continue with the original prescription and method for 14 doses.

[0087] Third visit (followed by 28 sitz baths): Symptoms: Leucorrhea has essentially returned to normal, with only occasional light yellow discharge, no vaginal itching, and the dull pain in the lower abdomen has resolved. Urine is clear, and there is no bitter taste in the mouth. Tongue and pulse: Pale red tongue with a thin, slightly greasy white coating, slow pulse. Leucorrhea reexamination: Clearness II, white blood cells (negative), Candida (negative).

[0088] One year later, the patient's blood sugar was under control and VVC did not recur.

[0089] Case 4

[0090] The patient, a 46-year-old male, presented with recurrent erythematous papules with exudative pruritus all over the body for more than a month, which worsened for a week.

[0091] Tongue and pulse: Red tongue with yellow and greasy coating, slippery and rapid pulse. Other symptoms: Dry mouth, bitter taste in the mouth, short dark urine, sticky stool.

[0092] Physical examination: erythema, papules, and papulovesicles were seen on the trunk and limbs, some of which were fused into sheets, some of which were eroded with exudate and crusted, with obvious scratches and dry skin.

[0093] Western medicine diagnosis: eczema; Traditional Chinese Medicine diagnosis: wet sores (damp-heat accumulation in the skin).

[0094] Treatment principles: clear away heat and dampness, dispel wind and relieve itching.

[0095] Treatment plan: Take an appropriate amount of the Chinese medicine composition prepared in Example 1 of the present invention according to the area of eczema, apply it to the affected area for 5-10 minutes, and use it multiple times a day for 7 consecutive days.

[0096] Efficacy observation:

[0097] Second diagnosis: The patient's itching was relieved, the papules became flattened, and the erosion surface dried and scabbed.

[0098] Follow-up after 2 weeks: no recurrence.

[0099] Case 5

[0100] A 42-year-old male employee presented with erythema and papules on both lower extremities, accompanied by intense pruritus for 10 days, which worsened with exudate for three days. Self-application of topical steroid ointment provided some relief, but the symptoms relapsed and worsened after discontinuation of the medication, with localized erosion and exudate, and severe itching at night that made it difficult to sleep. He also experienced a bitter, sticky taste in the mouth, yellow urine, and sticky, unpleasant stools.

[0101] Physical examination: Symmetrical erythema and dense papules on both lower extremities, some of which coalesced into patches, with erosion and exudate on the surface and unclear borders. Tongue and pulse: Red tongue with thick, greasy yellow fur and a weak, rapid pulse.

[0102] Western medicine diagnosis: eczema; Traditional Chinese Medicine diagnosis: wet sores (damp-heat accumulation in the skin).

[0103] Treatment principles: clear away heat and dampness, dispel wind and relieve itching.

[0104] Treatment plan: Take an appropriate amount of the Chinese medicine composition prepared in Example 1 of the present invention according to the area of eczema, apply it to the affected area for 5-10 minutes, and use it multiple times a day for 7 consecutive days.

[0105] Efficacy observation:

[0106] Second visit: The patient's pruritus was slightly relieved, but there were still scattered papules, and some erosions had dried and crusted. The tongue was red, with a slightly greasy coating at the base, and the pulse was weak. The original prescription was continued for one week.

[0107] Third visit: The patient had no itching, smooth skin without new rashes, dry scabs on the eroded surface, which fell off naturally, red tongue with thin white fur, regular bowel movements, and good spirits.

[0108] Fourth examination: No new skin lesions were found during the follow-up examination half a month later.

[0109] 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 bactericidal and antipruritic Chinese medicine composition, characterized in that: The traditional Chinese medicine composition is prepared from coptis root, phellodendron chinense, sophora flavescens, cnidium monnieri, dactylic acid root, hedyotis diffusa, stemona radix, kochia scoparia and chinaberry bark.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 5-25 parts by weight of coptis chinensis, 5-25 parts by weight of phellodendron amurense, 5-25 parts by weight of sophora flavescens, 5-25 parts by weight of cnidium monnieri, 5-25 parts by weight of licorice root bark, 5-25 parts by weight of oldenlandia diffusa, 5-25 parts by weight of stemona root, 1-20 parts by weight of kochia scoparia fruit and 1-20 parts by weight of chinaberry bark.

3. The Chinese medicine composition according to claim 2, characterized in that The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-20 parts by weight of coptis chinensis, 10-20 parts by weight of phellodendron amurense, 10-20 parts by weight of sophora flavescens, 10-20 parts by weight of cnidium monnieri, 10-20 parts by weight of licorice root bark, 10-20 parts by weight of oldenlandia diffusa, 10-20 parts by weight of stemona root, 5-15 parts by weight of kochia scoparia fruit and 5-15 parts by weight of chinaberry bark.

4. The Chinese medicine composition according to claim 3, characterized in that The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 15 parts by weight of coptis chinensis, 15 parts by weight of phellodendron amurense, 15 parts by weight of sophora flavescens, 15 parts by weight of cnidium monnieri, 15 parts by weight of licorice root bark, 15 parts by weight of oldenlandia diffusa, 15 parts by weight of stemona root, 10 parts by weight of kochia scoparia and 10 parts by weight of chinaberry bark.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

6. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The Chinese medicine composition is an external preparation or an oral preparation.

7. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The dosage form of the Chinese medicine composition is tablets, granules, pills, powders, decoctions, lotions, gels, patches or ointments.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 7, characterized in that: The preparation method comprises the following steps: taking prescribed amounts of coptis root, phellodendron amurense, sophora flavescens, cnidium monnieri, dactylic acid root bark, hedyotis diffusa, stemona radix, kochia scoparia fruit and chinaberry bark, mixing and crushing the mixture, adding water 4-8 times the weight of the Chinese medicinal materials, boiling the mixture and then decocting over 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, and optionally adding pharmaceutically acceptable excipients to obtain the product.

9. Use of the Chinese medicine composition according to any one of claims 1 to 7 in the preparation of medicines for treating leukorrhea.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a medicament for treating eczema.

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