External traditional Chinese medicine mixture for repairing genital skin mucous membrane ulceration wound and preparation method of external traditional Chinese medicine mixture

Abstract

The invention discloses an external traditional Chinese medicine mixture aiming at genital skin mucosa ulceration wound repair and a preparation method thereof, relates to the field of traditional Chinese medicines, and aims to provide a genital skin mucosa ulceration wound repair medicine which has the effects of promoting wound repair and relieving itching, and is simple in component, small in allergy probability, light and thin in dosage form and good in skin feeling. The traditional Chinese medicine mixture is prepared from chicken butter, honeysuckle stem, felwort, cortex dictamni, fructus kochiae, radix scutellariae, cortex phellodendri, angelica sinensis, radix rehmanniae, radix arnebiae seu lithospermi, sanguisorba officinalis and bletilla striata. The traditional Chinese medicine mixture disclosed by the invention realizes simultaneous treatment of pruritus vulvae and ulceration, fills the treatment blank, relieves symptoms as soon as possible, shortens the treatment cycle and saves expenditure. The curative effect is prominent, and current clinical requirements are met. Cost and loss are reduced. Preparation is convenient, high-end machines are not needed, and preparation can be carried out at home.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds and a preparation method thereof. Background Art

[0002] In the treatment of gynecological diseases with traditional Chinese medicine, it is found that whether it is vulvovaginitis or vulvar malnutrition, vulvar itching is mostly accompanied by ulceration during the acute attack period, and atrophy is often accompanied by ulceration. Itching and ulceration are often the most typical and painful symptoms for patients. Among them, there are many patients with itching and ulceration caused by vulvar malnutrition. The reason is that on the one hand, the disease itself causes the female vulvar skin, mucous membrane and skin around the anus to become thinner and lose elasticity, which is very easy to cause chapped skin and ulcers. On the other hand, the female vulva is rich in nerves and is the opening of the urethra, vagina and anus. It is difficult to keep clean and is easily infected and stimulated. In addition, patients scratch unconsciously because of severe itching, forming a vicious cycle of "scratching-ulceration-scratching".

[0003] Vulvar dystrophy, also known as vulvar non-neoplastic intraepithelial lesions and vulvar white lesions, refers to a group of chronic diseases in which the pigmentation of the female vulvar skin and mucosal tissues changes and degeneration occurs. In severe cases, the disease may be accompanied by unbearable itching, chapped skin, ulcers, burning pain, vulvar atrophy, adhesions, difficulty urinating, and difficulty in sexual intercourse. There is currently no ideal treatment, and some patients are at risk of cancer.

[0004] At present, Western medicine treatment is mostly topical corticosteroid hormones, calcineurin inhibitors, or testosterone, estrogen, progesterone ointments and other creams may have certain effects, topical skin moisturizers such as cod liver oil ointment, vitamin E, vaseline, etc. can be used as long-term management and treatment for patients, and anti-inflammatory drugs such as erythromycin ointment are mainly applied to the ulcer caused by it. In addition to the adverse reactions and dependence of long-term hormone application, simple anti-inflammatory drugs have no effect on itching and repair. Patients repeatedly scratch and ulcerate repeatedly, the vulva is repeatedly stimulated, the disease continues to progress, and the clinical effect is limited. Physical therapy includes focused ultrasound, laser therapy, freezing, and photodynamic therapy, which can relieve symptoms, but the effect is not ideal. Severe ulcers are generally treated with surgical operations, but surgical treatment can easily lead to vaginal stenosis and scar formation, and the recurrence rate is extremely high.

[0005] In traditional Chinese medicine, this disease is classified as "genital itching", "genital sores" and "genital erosion". Modern doctors believe that this disease is a mixture of deficiency and excess, with dysfunction of the liver, spleen and kidney, resulting in endogenous evil damaging the Chong, Ren, Du and Dai meridians as the root cause, and "dampness, heat and worms" invading the genitals as the symptoms. There is currently no unified syndrome differentiation and treatment method for this disease. The treatment is mainly based on the clinical experience of various schools, with the goal of regulating the internal organs and treating both the symptoms and the root cause. Our department's Chinese herbal decoction combined with white spot cream and Chinese herbal sitz bath treatment has outstanding efficacy in treating this disease. The prescription is excellent and the medicinal properties are mild. It can significantly reduce the patient's subjective symptoms, correct signs such as atrophy and whitening, and significantly improve the patient's quality of life. It has a definite effect and is very popular among clinical patients.

[0006] However, in many years of clinical work, the author found that when patients seek medical treatment, they are often in the onset of the disease, and severe vulvar itching is often accompanied by ulceration. On the one hand, the ulcerated wound will affect the efficacy of Chinese medicine sitz baths and Chinese medicine ointments. For example, there is a risk of pain and infection when the wound comes into contact with water during the sitz bath and ointment cleaning process, which may cause the fragile vulvar skin to be damaged again. For patients with severe dampness and heat, the ointment is slightly thick, and the fragile skin is sensitive and intolerant. Therefore, some patients with itching and ulceration can only apply Chinese medicine sitz baths and external application of Chinese medicine ointments after the ulcers have healed. On the other hand, the patient's own skin degeneration and itching are severely aggravated at night, making the patient anxious and the condition worse. The patient's unconscious scratching often causes repeated attacks and aggravations of skin ulcers, which are difficult to heal and delay subsequent treatment.

[0007] To address this problem, a drug that not only promotes wound repair but also relieves itching is needed, with simple ingredients, low allergy risk, and a light and thin dosage form with good skin feel, as a supplement to ointments and sitz baths. Currently, most clinical studies focus on the degree of vulvar itching and pain, the range of lesions, the area of ​​pigment loss, and skin elasticity. There are no clinical studies on Chinese medicine for vulvar genital skin and mucosal ulceration in patients. There is also no research on Chinese medicine that takes into account the treatment of vulvar itching and ulceration. Summary of the invention

[0008] In view of the above problems, the present invention provides an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds and a preparation method thereof.

[0009] The invention discloses an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds. The Chinese medicine mixture is composed of 200-400 parts of egg yolk oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Chinese angelica, 10-30 parts of Radix Rehmanniae, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis and 10-30 parts of Bletilla striata.

[0010] Furthermore, the Chinese medicine mixture is composed of 300-400 parts of egg yellow oil, 90-100 parts of honeysuckle vine, 60-70 parts of gentian, 40-50 parts of Dictamni cortex, 40-50 parts of Kochia scoparia, 30-40 parts of Scutellaria baicalensis, 30-40 parts of Phellodendron amurense, 20-30 parts of Angelica sinensis, 20-30 parts of Rehmannia glutinosa, 20-30 parts of Lithospermum officinale, 20-30 parts of Sanguisorba officinalis and 20-30 parts of Bletilla striata.

[0011] Furthermore, the Chinese medicine mixture is composed of 200-300 parts of egg yellow oil, 85-95 parts of honeysuckle vine, 55-65 parts of gentian, 35-45 parts of Dictamni cortex, 35-45 parts of Kochia scoparia, 25-35 parts of Scutellaria baicalensis, 35-45 parts of Phellodendron amurense, 15-25 parts of Angelica sinensis, 15-25 parts of Rehmannia glutinosa, 15-25 parts of Lithospermum officinale, 15-25 parts of Sanguisorba officinalis and 15-25 parts of Bletilla striata.

[0012] The method for preparing the external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds of the present invention is carried out in the following manner:

[0013] 1) preparing drug powder: weighing 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Angelica sinensis, 10-30 parts of Radix Rehmanniae, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis and 10-30 parts of Bletilla striata according to weight; crushing the weighed drugs, and adding 2000-3000 parts of sesame oil for soaking;

[0014] 2) frying 200-400 parts by weight of egg yolk until oil comes out;

[0015] 3) adding the powder soaked in step 1) to the chicken oil in step 2), heating and stirring continuously until the surface of the powder turns dark brown, removing the powder from the oil and filtering to remove the residue, collecting the oil phase, and adding borneol to complete the preparation of the external Chinese medicine mixture for repairing genital skin and mucosal ulcers.

[0016] Furthermore, the amount of sesame oil added is 2500 parts by weight.

[0017] Furthermore, the sesame oil is soaked for more than 10 days, and is shaken every 1 to 2 days.

[0018] Furthermore, the added amount of borneol is 10 parts by weight.

[0019] Furthermore, after adding borneol in step 3), the mixture is bottled and refrigerated for 6 to 8 days before use.

[0020] The invention discloses an application of an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds. The external Chinese medicine mixture is used as a medicine for treating vulvar pruritus, ulceration, penile erosion and ulceration, vulvar leukoplakia atrophy and dryness, and burning, dryness and stinging pain of senile vaginitis.

[0021] Furthermore, when the external Chinese medicine mixture is used as a medicament for treating atrophy and dryness of vulvar leukoplakia, the Chinese medicine mixture is composed of 200-400 parts of egg yellow oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron chinense, 10-30 parts of Angelica sinensis, 10-30 parts of Rehmannia glutinosa, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis, 10-30 parts of Bletilla striata, 40-60 parts of cinnamon, 100-200 parts of safflower and 50-100 parts of Psoralea corylifolia.

[0022] Furthermore, when the external Chinese medicine mixture is used to treat the burning, dryness and stinging of senile vaginitis, the Chinese medicine mixture is composed of 200-400 parts of egg yellow oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron chinense, 10-30 parts of Angelica sinensis, 10-30 parts of Rehmannia glutinosa, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis, 10-30 parts of Bletilla striata, 40-60 parts of honeysuckle, 50-150 parts of Agrimoniae, 10-50 parts of wild chrysanthemum, 10-30 parts of Tongcao, 100-150 parts of Sophora flavescens and 50-100 parts of Taraxacum officinale.

[0023] The present invention has focused on the TCM treatment of gynecological diseases for many years, and believes that vulvar itching and ulceration is a disease of "root deficiency and superficial excess", which contains two meanings. One is that the "root deficiency" of internal organs leads to the production of "superficial excess" of human pathological products (dampness, heat, stasis, dryness, wind, etc.); the other is the influence of the "root deficiency" of internal organ dysfunction on the "superficial excess" of external skin itching, pain, and ulceration. As the "Yellow Emperor's Internal Classic" records, "If there are various forms inside, they must be manifested outside." Therefore, this disease requires Chinese medicine to be taken orally to regulate the internal organs to treat its root, and to treat the skin externally to solve its symptoms. "Treatment of the root" focuses on the liver, spleen and kidney, and "treatment of symptoms" is responsible for the heart and lungs.

[0024] "Huangdi Neijing·Suwen·Zhizhen Yaodalun Pian" records that "all pains, itches and sores belong to the heart", and "Suwen·Five Zang Organs Formation" records: "all blood belongs to the heart", itching occurs when the heart blood is not nourished; blood deficiency generates heat, and wind qi is also stirred, and itching also occurs when wind and fire fan each other; itching is perceived by the mind, and insufficient heart blood nourishes the mind, causing the mind to be uneasy, secretly consuming yin blood, and blood dryness generates wind, which affects each other, causing the heart fire to burn downward, itching and pain to be severe, and sores to occur when the heat is strong. As Liu Wansu of the Jin Dynasty recorded in "Suwen Xuanji Yuanbingshi", "people who are close to fire qi will itch if they are slightly hot, and pain if they are very hot. If they are close to the elbow, they will burn and become sores, all of which are caused by fire", it can be seen that "heart fire" is the direct cause of skin itching, pain and even ulceration.

[0025] "Suwen Jue Lun" states: "The front genitals are where the ancestral tendons gather." The meridian of the liver meridian of foot Jueyin "enters the hair, passes the genitals, and reaches the lower abdomen"; the main meridian of the gallbladder meridian of foot Shaoyang "enters the hairline, and harmonizes with Jueyin"; the tendons of the liver meridian of foot Jueyin and the kidney meridian of foot Shaoyin "knot at the genitals"; the tendons of the spleen meridian of foot Taiyin and the stomach meridian of foot Yangming "gather at the genitals"; the Ren meridian comes out of the perineum, passes the genitals, "and goes up the hairline"; the Du meridian "enters the court hole in women," and "its collaterals run along the genitals"; the Chong meridian "joins the stomach meridian of Yangming at the ancestral tendons." It can be seen that the internal organs are connected to the front genitals through the meridians, achieving the inevitable result of "what is inside must be reflected outside."

[0026] In this link, the "lung" plays a vital role. "Suwen·Jingmai Bielun" says: "Food qi enters the stomach, turbid qi returns to the heart, and the essence is in the veins. The qi of the meridians flows through, and the qi of the meridians returns to the lungs. The lungs face all the meridians and deliver essence to the skin and hair. The hair and veins combine the essence and circulate the qi in the organs. The spirit of the organs is bright and stays in the four organs..." Therefore, if there is a problem with the function of the internal organs of the human body, it will affect the meridians, and whether the meridians are unobstructed will also affect the function of the internal organs. The internal organs are connected inside and outside, and the power of the meridians to be unobstructed comes from the lungs. On the one hand, when the internal organs are diseased, the qi sent by the internal organs will also be unclear, so the turbid qi will fumigate the lungs. When the lungs are damaged, the function of descending and descending will be lost, and the turbid qi will be emitted to the skin, resulting in itchy and ulceration of the skin. On the other hand, "all meridians are responsible for qi, and collaterals are responsible for blood. Long-term illness will cause blood stasis", "At first, the qi is stagnant in the meridians, and after a long time, the blood will be injured and enter the collaterals", "Long-term illness will cause more stasis", "Long-term illness will cause more phlegm", phlegm and blood stasis are mutually bound, condensed and enter the collaterals, the meridians are blocked, and the righteous qi is difficult to recover, which is the root cause of the difficulty in treating this disease and the long-term treatment.

[0027] Therefore, the present invention uses egg yolk oil and honeysuckle vine as the main medicine. Egg yolk is sweet in taste and flat in nature. It is in the heart, kidney and spleen meridians. Sun Simiao's "Prescriptions for Emergency Qianjin" records: "It is slightly cold and mainly removes heat, fire burns, rotten sores and fever." Egg yolk oil, also known as "Phoenix Oil", was first seen in the prescription for treating fire sores in the Northern Zhou Dynasty's "Collected Proven Prescriptions". "Xian Fang Collection" also has its records of treating "Yin sores and ulcers, due to not avoiding menstruation and sexual intercourse, and ulcers in the penis". It has the effects of removing heat from the heart, nourishing yin and blood, moistening dryness and extinguishing wind. Because it has the quality of nourishment, it is a product with blood and flesh, which is conducive to improving the local nutritional conditions of the lesion, so it can grow muscle and skin, reduce swelling and relieve pain, heal sores and protect the wound surface. Honeysuckle vine is used heavily because it is sweet and spicy, cold in nature, and enters the lung, heart, and stomach meridians. It can clear away heat and detoxify, dispel wind and dredge collaterals, and is good at clearing wind and heat in the meridians. "Compendium of Materia Medica" records that it "treats all kinds of rheumatism and swelling, carbuncle, scabies, bayberry sores, and dissipates heat and detoxifies." "Yao Xing Qie Yong" evaluates it as "a good medicine for clearing meridians and activating collaterals, and is suitable for arthritis with heat." It has the effects of clearing internal heat, dispersing external evil, removing blood stasis and relieving pain, and relaxing muscles and activating collaterals. The combination of the two medicines can relieve itching and pain when wind and heat are removed, and the meridians are unblocked, and the positive energy is restored, providing a prerequisite for the recovery of this disease.

[0028] Liver depression and spleen deficiency will inevitably produce damp heat, while liver and kidney yin deficiency will cause blood dryness and wind. Therefore, I use Gentiana scabra, Dictamni cortex, Kochia scoparia, Scutellaria baicalensis, Phellodendron chinense and other herbs to clear damp heat in the lower part of the body and strengthen the effect of dispelling wind and relieving itching. As the saying goes, "When yin is weak and yang is strong, the fire of the phase will be strong..." Therefore, the assistant Rehmannia glutinosa is used to nourish the blood to nourish yin and retreat yang. Angelica sinensis is a blood-qi medicine, which has the effect of nourishing and attacking toxins, promoting tissue regeneration and healing sores. Combined with Radix Sanguisorbae, Lithospermum officinale, Bletilla striata and other herbs that cool blood and detoxify, heal sores and promote tissue regeneration, it strengthens the effect of healing sores and promoting the healing of ulcers. Borneol is the messenger, and the pungent and fragrant herb is a great unblocker. It mainly disperses depressed fire, opens and closes to search for evil, and also has the effects of clearing heat and reducing swelling, promoting tissue regeneration and healing sores. All the herbs work together to achieve the effects of clearing heat and drying dampness, dispersing wind and unblocking meridians, and heal sores and promoting tissue regeneration.

[0029] The components of an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds (hereinafter referred to as Phoenix Oil Mixture) of the present invention are analyzed as follows:

[0030] Analysis of drug selection for Phoenix Oil Mixture:

[0031] Egg yolk oil: sweet in taste, neutral in nature, enters the heart, kidney, and spleen meridians, has the effects of removing heat from the heart, nourishing yin and blood, moistening dryness and extinguishing wind. Because of its nourishing nature, it is a product of blood and flesh, which is beneficial to improving the local nutritional conditions of vulvar lesions, can regenerate muscles and skin, reduce swelling and relieve pain, heal sores and wounds, and protect the wound surface. It has the effects of regenerating muscles and skin, reducing swelling and relieving pain, heal sores and wounds, and protecting the wound surface. Modern research shows that egg yolk oil has anti-inflammatory and antioxidant effects, and regulates the Nrf2 / NF-κB pathway to exert anti-inflammatory effects; it reduces the expression of interleukin-12, interleukin-6, interleukin-10, gamma interferon and tumor necrosis factor-α without interfering with infection defense, thereby reducing inflammatory responses. At the same time, it promotes the recovery of epidermal cells after sunburn by reducing inflammatory mediators, improves lymphedema, and promotes wound healing. In the mouse writhing test, the administration of 300mg / kg of egg yolk oil to mice had a similar analgesic effect as 5mg / kg of morphine. The analgesic effect of 300mg / kg of egg yolk oil injected into mice was comparable to that of morphine (10mg / kg). It induced the expression of endothelin, epidermal growth factor and vascular endothelial growth factor in the blood vessels and wounds of diabetic rats to promote epithelial cell proliferation and angiogenesis on the wound surface of rats, and stimulated collagen deposition on the wound surface to promote wound healing, reduce scar formation, effectively accelerate skin burn healing, have strong repair ability, and shorten wound healing time. Egg yolk oil carbon dots extracted from egg yolk oil can significantly reduce the activated partial thromboplastin time, increase fibrinogen and platelets, significantly shorten the bleeding time of mice, and have hemostatic function.

[0032] Honeysuckle vine: sweet and pungent in taste, cold in nature, enters the lung, heart and stomach meridians, can clear away heat and detoxify, soothe wind and dredge the meridians, and is good at clearing wind-heat in the meridians. It has the effects of clearing internal heat, dispersing external evil, removing blood stasis and relieving pain, and relaxing muscles and activating collaterals. When wind-heat is removed, itching and pain in the vulva will stop, and when the meridians are unblocked, the positive energy will be restored, which helps to repair the lesions of the vulva. Modern research believes that it has anti-inflammatory, antioxidant, antiviral, lipid-lowering, and blood sugar-lowering effects. It has good antioxidant activity with a DPPH clearance rate of 39.51%. The luteolin, quercetin and kaempferol contained in it have a strong inhibitory effect on Bacillus cereus ATCC14579. The extracted liquid has antibacterial effects on Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa; it can also play an antiviral effect by regulating nonspecific immunity and inhibiting or blocking viral replication or synthesis.

[0033] Gentiana scabra: bitter in taste, cold in nature. It enters the liver and gallbladder meridians, has the effects of clearing away heat and dampness, and purging liver and gallbladder fire. The "Pharmaceutical Chemistry" records that it can treat "male erectile swelling, or shiny pus, or itching and pain in the penis, female vaginal urinary pain, or itching and sores." The "Compendium of Materia Medica" records that it "dredges the dampness and heat in the lower part of the body, and is sufficient to do its best", so it can relieve vulvar itching and ulceration and promote wound healing. Modern pharmacological studies have shown that it has biological activities such as anti-inflammatory and analgesic, liver protection, anti-tumor, regulating gastrointestinal function and the nervous system, and anti-oxidation. Studies have shown that Gentiana can regulate the level of inflammatory factors by regulating NF-κB and its related signaling pathways. It can inhibit the transcriptional activity of NF-κB and the nuclear translocation of NF-κB subunits (p65 and p50) by intervening in lipopolysaccharide-induced RAW264.7 cells, improve the inflammatory response of mouse ear edema and paw edema, and exert anti-inflammatory and detumescent effects. Gentiana picroside can alleviate the symptoms of Freund's complete adjuvant-induced persistent pain mice by downregulating the protein expression of NR2B receptors, and exert an analgesic effect. It can exert anti-tumor effects by inhibiting tumor cell proliferation, invasion and migration, inducing tumor cell apoptosis, and reducing the levels of reactive oxygen and malondialdehyde in PC12 cells, thereby protecting against nerve damage. The GSP-IIb, GSP-IIa (proteoglycans) and iridoid compounds contained in it can scavenge DPPH free radicals and have stable antioxidant activity. Gentiana picroside can be used to improve skin diseases with damaged epidermal barrier.

[0034] Dictamni: bitter and salty, cold in nature, enters the spleen and stomach meridians, has the effects of clearing heat and dampness, dispelling wind and relieving itching, and detoxification. "Compendium of Materia Medica" records that it "has a cold nature... a medicine for removing dampness and heat" and "Compendium of Materia Medica" records that it "can clear and disperse stagnant heat in the blood". Current research has confirmed that more than 200 chemical components have been isolated and identified from Dictamni, mainly including alkaloids, limonoids, flavonoids, sesquiterpenes and their glycosides, steroids, etc. Studies have shown that it has antibacterial, anti-inflammatory, anti-allergic, insecticidal, anti-tumor, liver protection, improvement of cardiovascular system function, and neuroprotection.

[0035] Kochia scoparia: Spicy and bitter in taste, cold in nature, enters the kidney and bladder meridians, has the effects of clearing away heat and dampness, dispelling wind and relieving itching. "Bielu" records that it "removes heat from the skin, moisturizes the body, disperses malignant sores and hernias, and strengthens the yin." "Yunnan Materia Medica" records that it "relieves bladder urination and heat accumulation, washes away wind from the skin, and treats heat in women's meridians... It is good for women with damp heat. Modern research has confirmed that it has anti-inflammatory, anti-allergic, hypoglycemic, anti-cancer, anti-fungal, antipruritic and analgesic effects and is widely used in clinical practice.

[0036] Scutellaria baicalensis: bitter and cold in taste, enters the heart, lung, gallbladder and large intestine meridians, has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding and stabilizing pregnancy. "Shennong's Herbal Classic" records that it can treat "malignant sores, ulcers and fire ulcers; "Bencao Zheng" records that it "especially removes heat from the skin surface, so it treats macules, fistulas, sores and red eyes"; modern research has confirmed that Scutellaria baicalensis has multiple pharmacological effects such as antibacterial, antiviral, anti-inflammatory, antioxidant and anti-tumor. Its main active ingredient, baicalin, can effectively reduce the proliferation activity and migration ability of tumor cells.

[0037] Phellodendron: bitter, cold in nature, enters the kidney, bladder, and large intestine meridians, has the effects of clearing away heat and dampness, purging fire and removing steam, detoxifying and curing sores. "Shennong's Herbal Classic" records that it can treat "women's red and white discharge, genital ulcers", and "Ben Cao Jing Shu" records that it can treat "skin heat and redness". Modern research has confirmed that the chemical components of Phellodendron mainly include alkaloids, limonoids, phenolic acids, phenylpropanoids, and some volatile components, sterol components, and trace elements. It has anti-atherosclerosis, anti-ulcer, anti-gout, anti-tumor, hypoglycemic, neuroprotective, antidiarrheal, antibacterial and other pharmacological effects. It can significantly promote wound healing of ulcer skin in diabetic rats, promote extracellular matrix production, inhibit high sugar-induced oxidative damage of HaCaT cells, significantly increase the level of epidermal growth factor in ulcers, accelerate ulcer healing, and promote mucosal healing and reduce inflammatory response.

[0038] Angelica: It tastes sweet, spicy and warm. It enters the liver, heart and spleen meridians. It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. Modern pharmacological research has confirmed that it has pharmacological activities such as enhancing immunity, regulating hematopoiesis, lowering blood pressure and blood lipids, analgesic and anti-inflammatory, anti-tumor, and protecting the liver and kidneys.

[0039] Shengdi: sweet, cold. It enters the heart, liver and kidney meridians, and has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid. The Ben Jing Feng Yuan records that it "cools blood and nourishes yin internally, and moisturizes the skin externally". Modern pharmacological research has confirmed that it has pharmacological effects such as hemostasis, promoting hematopoiesis, anti-depression, protecting nerves, inhibiting neuralgia, regulating immunity, protecting the respiratory system, anti-oxidation, anti-tumor, regulating blood sugar and blood lipids, protecting the kidneys, lowering blood pressure and inhibiting bacteria.

[0040] Lithospermum officinale: sweet, salty, cold, and enters the heart and liver meridians. It has the effects of cooling blood, activating blood circulation, detoxifying and clearing rashes. The "Compendium of Materia Medica" records that: "All patients with external ulcers and blood heat can use it." The chemical components in Lithospermum officinale mainly include naphthoquinones, polysaccharides, monoterpenoid phenols, benzoquinones and esters. Modern pharmacological and clinical studies have confirmed that Lithospermum officinale has anti-inflammatory, anti-tumor, antibacterial, liver protection and immunomodulatory effects. Shikonin inhibits the HMGB1 / TLR4 / NF-κB signaling pathway and reduces the expression of IL-1β, IL-6 and TNF-α proinflammatory cytokines, thereby inhibiting edema of damaged parts, reducing inflammatory reactions and promoting tissue repair.

[0041] Sanguisorba officinalis: slight odor, slightly bitter taste, enters the liver and large intestine meridians, has the effects of cooling blood and stopping bleeding, detoxifying and healing sores. "Shennong's Herbal Classic" records that it "treats breast pain, seven injuries, leucorrhea, relieves pain, removes bad flesh, stops sweating, and treats wounds." "Compendium of Materia Medica" records that "add Sanguisorba officinalis to treat sores and carbuncles, and add Huangling to treat itching." Modern research has confirmed that it has the effects of stopping bleeding and coagulation, anti-oxidation, anti-allergy, anti-inflammatory, antibacterial, anti-tumor, kidney protection, and increasing white blood cells.

[0042] Bletilla striata: It is bitter, sweet, astringent, slightly cold, and enters the lung, liver, and stomach meridians. It has the effects of astringent hemostasis, swelling reduction, and tissue regeneration. "Shennong's Herbal Classic" records that it "mainly treats carbuncle, malignant ulcer, gangrene, injury to the yin and dead muscle". Modern research has confirmed that it has antibacterial and anti-tumor effects, healing mucosal ulcers, internal and external bleeding, and silicosis. The bibenzyl compounds and phenanthrene components contained in Bletilla striata may be the main active ingredients of Bletilla striata in antibacterial, and have a significant inhibitory effect on the activity of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Bacillus subtilis; Bletilla striata polysaccharide can reduce the expression of NF-κBp65 and TLR-4 genes and proteins, improve the abnormal secretion of pro-inflammatory factors interleukin 23 and interleukin 17, thereby reducing inflammation and playing a role in protecting and repairing the mucosa.

[0043] Phoenix Oil Mixture Compatibility Analysis:

[0044] 1. Clear away heat, detoxify, dry dampness and relieve itching

[0045] Honeysuckle, Gentiana, Scutellaria, and Phellodendron all have the effect of clearing away heat and detoxifying, and can effectively remove heat and toxins from the body. Gentiana specifically enters the liver and gallbladder meridians, and the front vulva is located on the route of these two meridians, which can relieve the liver and gallbladder fire while also relieving the vulva fire; Scutellaria and Phellodendron focus more on clearing damp heat in the middle and lower jiao. The combination of various medicines targets symptoms such as vulvar itching, pain, and ulceration caused by damp heat in the lower jiao and intense heat and toxins. Among them, Honeysuckle is powerful and can dispel wind and dredge the meridians. When the meridians are unblocked, the positive energy will be restored and the disease will be cured, thus providing a prerequisite for the repair and healing of the vulvar skin.

[0046] Both Dictamni and Kochia seeds have the effects of clearing away heat, drying dampness, dispelling wind and relieving itching, and have significant therapeutic effects on vulvar skin itching, eczema, urticaria, etc. caused by damp heat. When used in combination with the above-mentioned heat-clearing and detoxifying drugs, the heat-clearing, dampness-drying and itching-relieving effects of the entire prescription can be enhanced.

[0047] 2. Cooling blood, activating blood circulation and nourishing blood

[0048] Both Radix Rehmanniae and Radix Lithospermi can cool blood. Radix Rehmanniae has the effects of clearing away heat and cooling blood, nourishing yin and promoting body fluid, while Radix Lithospermi can cool blood, activate blood circulation, detoxify and cure rashes. The combination of the two can not only cool blood to eliminate blood heat, but also detoxify to heal sores and carbuncles, activate blood circulation to disperse blood stasis, and nourish blood to stop wind itching.

[0049] Angelica is a holy blood-tonifying medicine that can nourish blood, invigorate blood circulation, regulate menstruation and relieve pain. This prescription combines Angelica with Radix Rehmanniae, Radix Lithospermi and other blood-cooling and blood-activating medicines, which can not only enhance the blood-tonifying effect, but also prevent the blood-cooling medicines from being too cold and damaging the body.

[0050] 3. Astringent, hemostatic and repairing tissue

[0051] Both Sanguisorba officinalis and Bletilla striata can stop bleeding and heal sores. Sanguisorba officinalis has the effects of cooling blood and stopping bleeding, detoxifying and heal sores, while Bletilla striata can astringe and stop bleeding, reduce swelling and promote tissue regeneration. Both are important hemostatic drugs, but Sanguisorba officinalis focuses more on cooling blood and stopping bleeding, and is suitable for bleeding sores caused by blood heat; Bletilla striata focuses more on astringing and stopping bleeding and promoting tissue regeneration, and is suitable for ulcers that do not heal for a long time and sores that do not heal for a long time. In this prescription, they are combined with heat-clearing and detoxifying, dampness-drying and itching-relieving drugs to prevent the further development of symptoms such as skin damage and bleeding caused by damp heat or heat toxins, and promote skin repair and healing.

[0052] Chicken seed oil is a kind of blood and flesh, which can remove latent heat, nourish yin and blood, moisten dryness and extinguish wind, and protect wound surface. This recipe uses chicken seed oil in combination with Radix Sanguisorbae, Radix Bletillae, etc. The moisturizing and repairing effect of chicken seed oil and the hemostatic and detumescent, heat-clearing and detoxifying effects of Radix Sanguisorbae and Radix Bletillae complement each other, and jointly strengthen the therapeutic effect on skin damage. Radix Sanguisorbae and Radix Bletillae are good hemostatic medicines, and some components in chicken seed oil also have the effect of promoting blood coagulation. After the two are combined, the hemostatic effect is more significant. The combination in this recipe not only promotes wound healing, but also reduces inflammatory reactions and helps prevent the occurrence of infection. The combination of chicken seed oil and Radix Sanguisorbae and Radix Bletillae also reflects the "holistic concept" in traditional Chinese medicine. For example, the heat-clearing and detoxifying effect of Radix Sanguisorbae helps to remove the heat and toxic evil spirits in the body, while the nourishing effect of chicken seed oil can replenish the qi, blood and body fluids consumed by diseases. By regulating the balance of yin and yang and the harmony of qi and blood in the body, they jointly promote the recovery and health of the body.

[0053] 4. Harmonize the medicinal properties and enhance the efficacy

[0054] In addition to its effect of nourishing blood and activating blood circulation, angelica can also harmonize the properties of other drugs. In this prescription, angelica can ease the conflict between the properties of various drugs, making the whole prescription more peaceful and easier to be absorbed and utilized by the human body.

[0055] Chicken egg oil: Although chicken egg oil is not often used as the main drug in traditional Chinese medicine, it has the effects of nourishing yin and moistening dryness, nourishing blood and protecting wound surface. Adding chicken egg oil to this prescription can enhance the nourishing and repairing effect of the entire prescription, and help improve the patient's vulvar skin quality and nutritional status.

[0056] In summary, the significance of these drug combinations lies in achieving the therapeutic purpose through the synergistic effects of clearing away heat and detoxification, drying dampness and relieving itching, dispersing wind and unblocking collaterals, cooling blood and activating blood circulation, nourishing blood and replenishing blood, astringing and stopping bleeding, repairing and regenerating muscles, etc. At the same time, through the harmonizing effect of drugs such as angelica and the nourishing and repairing effect of egg yolk, the entire prescription is more peaceful and easy to be absorbed and utilized by the human body, meeting the needs of treating itching and ulcers at the same time, and helping to improve the treatment effect and the patient's recovery speed.

[0057] The present invention has the following beneficial effects:

[0058] 1. Chicken egg oil is prepared together with Chinese medicinal oil, which reduces the loss of chicken egg oil. The finished product contains chicken egg oil ingredients, which increases the output of chicken egg oil and enables it to be successfully applied in clinical practice, thus avoiding the disadvantages of difficult production of chicken egg oil, low output, and inability to meet clinical needs.

[0059] 2. It achieves the simultaneous treatment of vulvar itching and ulceration, fills the treatment gap, relieves symptoms as soon as possible, shortens the treatment cycle, and saves money.

[0060] 3. The preparation method is flexible and can be improved to target different problems. Currently, it has developed into three types, targeting No. 1 vulvar itching and ulceration (also effective for penile erosion and ulceration), No. 2 vulvar leukoplakia, atrophy and dryness (add 150g of safflower, 80g of psoralea corylifolia, 50g of cinnamon, etc.), and No. 3 burning, dryness and stinging of senile vaginitis (add 120g of Sophora flavescens, 100g of Agrimoniae, 90g of Taraxacum, 50g of Honeysuckle, 30g of Chrysanthemum, 20g of Tongcao, etc.).

[0061] 4. Outstanding therapeutic effect, meeting current clinical needs.

[0062] 5. Reduce costs and losses.

[0063] 6. Easy to prepare, no high-end machines are required, and simple production is possible. DETAILED DESCRIPTION

[0064] In order to make the objectives, technical solutions and advantages of the embodiments of the present invention more clearly understood, the spirit of the contents disclosed by the present invention will be described in detail below. After understanding the embodiments of the contents of the present invention, any technician in the relevant technical field can change and modify them according to the techniques taught by the contents of the present invention without departing from the spirit and scope of the contents of the present invention.

[0065] The exemplary embodiments of the present invention and the description thereof are used to explain the present invention but are not intended to limit the present invention.

[0066] Example 1

[0067] 1. Clinical Research

[0068] 1. Case sources and grouping

[0069] This study is a real-world retrospective study. The case data of patients diagnosed with vulvar itch and ulceration in all gynecological outpatient clinics of Heilongjiang Provincial Hospital of Traditional Chinese Medicine from June 2021 to June 2024 were collected and statistically analyzed, and their clinical characteristics, treatment and treatment outcomes were reviewed. In the past three years, 376 patients were diagnosed with vulvar itch and ulceration, of which 37 cases were excluded due to incomplete data, 5 cases with malignant tumor diseases were excluded, and 12 cases with vulvovaginal candidiasis and Trichomonas vaginitis were excluded. According to whether Phoenix Oil Mixture was used in the early stage, they were divided into an observation group and a control group. 163 cases were actually included in the observation group and 159 cases in the control group. The experiment in this embodiment is filed with the relevant management department of the hospital, and the basic information of the patients and the condition information are complete and accurate.

[0070] 2. Diagnostic criteria

[0071] 2.1 Western medicine diagnostic standards: Refer to the contents of Practical Obstetrics and Gynecology (Fourth Edition) and Obstetrics and Gynecology regarding vulvar itching and ulceration, which are consistent with the diagnosis of vulvitis and vulvar dystrophy. Pathological diagnosis can show manifestations of vulvar squamous cell hyperplasia, lichen sclerosus, and mixed types.

[0072] 2.2 TCM diagnostic criteria: With reference to the literature such as Practical TCM Gynecology (Second Edition) and TCM Gynecology edited by Ma Baozhang, the diagnostic criteria for vulvar itch are formulated, including liver-kidney yin deficiency type, spleen-kidney yang deficiency type, heart-spleen deficiency type, liver depression and qi stagnation type, and liver meridian damp-heat type.

[0073] 3. Inclusion criteria: patients aged 16 to 75 years old with vulvar pruritus accompanied by ulceration who meet the diagnostic criteria of Western medicine and TCM syndrome differentiation criteria; complete clinical data, and patients have given informed consent for the use of medical records in this study.

[0074] 4. Exclusion criteria: ① Those who do not meet the diagnostic criteria of this study. ② Those whose clinical data are incomplete and data analysis cannot be performed. ③ Those with combined vulvovaginal candidiasis and Trichomonas vaginitis, and those with other serious diseases and receiving treatment.

[0075] 5. Disease scoring standards: The following standards were formulated with reference to the 1993 edition of the "Guidelines for Clinical Research of New Chinese Medicines" and other relevant documents.

[0076] 5.1 Physical sign scoring criteria

[0077] 5.1.1 Scoring of zoning of vulvar skin lesions: The entire affected skin area is divided into 12 zones, namely, the mons pubis area, the anterior connection and area of ​​the labia minora, the clitoral area, one zone on each side of the labia minora, one zone on each side of the interlabial groove, one zone on each side of the labia majora, the perineum area, the anus area, and the vaginal opening area. Each zone is scored with 1 point.

[0078] 5.1.2 Scoring of the degree of vulvar skin lesions: 3 points: The lesion area is slightly white or grayish, infiltrated into patches, hyperkeratotic, and infiltrated and thickened, which may shrink over time, resulting in atrophy and adhesion of the vulva, making it difficult to distinguish the labia majora and minora, and affecting sexual intercourse and urination; 2 points: The lesion area is white or grayish, multiple, over-keratotic, and infiltrated and thickened; 1 point: The lesion area is flushed or slightly white or grayish, single or a few, with mild keratosis; 0 points: The vulva is normal and unchanged.

[0079] 5.1.3 Comprehensive score of the degree of vulvar lesions: Comprehensive score of the degree of vulvar lesions = the degree of vulvar skin lesions* and the range of the lesion area. The most serious case is 12×3=36 points.

[0080] 5.1.4 Scoring of the degree of vulvar skin ulceration: 3 points: lichenification, cracking, and erosion; 2 points: cracking, ulceration, and a little exudation; 1 point: slight cracking; 0 point: no ulceration.

[0081] 5.1.5 Comprehensive score of vulvar ulcer degree: Comprehensive score of vulvar skin ulcer = score of vulvar skin ulcer degree × range of vulvar ulcer area. The most serious case is 12 × 3 = 36 points.

[0082] 5.2 Scoring criteria for vulvar itch and pain symptoms

[0083] 5.2.1 Vaginal itch severity score: 6 points: continuous severe itching, unbearable, seriously affecting sleep and work; 4 points: vulvar itch is sometimes mild and sometimes severe, affecting sleep, work, study and life; 2 points: vulvar itch comes and goes, not affecting work and life; 0 points: no vulvar itch.

[0084] 5.2.2 Vaginal pain severity score: 6 points: continuous pain, obvious tenderness, serious impact on sleep and work; 4 points: mild pain, impact on sleep, work, study and life; 2 points: intermittent pain, no impact on work and life; 0 points: no vulvar pain.

[0085] 5.3 Comprehensive vulvar disease score: Comprehensive vulvar disease score = physical sign score (comprehensive score of lesion degree + comprehensive score of ulcer degree) + symptom score (vulvar itch degree score + vulvar pain degree score)

[0086] 6. Treatment Methods

[0087] According to the diagnosis and treatment plan, both groups were given lifestyle and dietary guidance.

[0088] 6.1 Observation group: Apply the Phoenix Oil mixture of the present invention (ingredients: honeysuckle vine, gentian, Dictamni, Kochia scoparia, Scutellaria, Phellodendron, Angelica, Radix Rehmanniae, Lithospermum officinale, Radix Sanguisorbae, Bletilla striata) to the lesions and ulcers of the vulva for 30 minutes each time, twice a day. Record the follow-up visits on the 3rd, 5th and 7th days of treatment, and record the days required for the disappearance of vulvar itching symptoms and the healing of ulcers.

[0089] 6.2 Control group: Apply Chuanbai Antipruritic Lotion (Approval number of Beijing Zhenyu Minsheng Pharmaceutical Co., Ltd.: National Medicine Standard B20020271 Ingredients: Sophora flavescens, Willow of Xihe, Cnidium monnieri, Portulaca oleracea, Nepeta tenuifolia, Dictamni, Stemona officinalis, Beehive, Peach twig, Willow twig, Sophora japonica twig, Ligusticum chuanxiong, etc.) to the vulvar lesions, and apply erythromycin eye ointment + metronidazole to the ulcer for 30 minutes each time, twice a day. Record follow-up visits on the 3rd, 5th, and 7th days of treatment, and record the number of days required for the disappearance of vulvar itching symptoms and the healing of ulcers.

[0090] 7. Observation indicators and efficacy evaluation criteria

[0091] 7.1 Observation indicators: (1) Changes in vulvar skin lesions and ulcers; (2) Changes in vulvar itch and pain symptoms; (3) Number of treatment days for symptom disappearance and ulcer healing in both groups.

[0092] 7.2 Criteria for judging the efficacy: Cured: The vulvar skin returns to normal, and the itching and pain symptoms disappear, or basically disappear. The symptom and sign integral value decreases by ≥90%. Significantly effective: The symptom of vulvar itching and pain is significantly relieved compared with before, and the area of ​​skin ulceration is significantly reduced compared with before. The symptom and sign integral value decreases by ≥70%, <90%. Effective: The symptom of vulvar itching and pain is relieved compared with before, and the area of ​​skin ulceration is reduced compared with before. The symptom and sign integral value decreases by ≥30%, <70%. Ineffective: The symptom of vulvar itching and pain is not relieved compared with before, and the area of ​​skin ulceration is not reduced compared with before. The symptom and sign integral value decreases by <30%. Note: Symptom and sign integral value = (pre-treatment integral value - post-treatment integral value) ÷ pre-treatment integral value × 100%.

[0093] 8. Statistical methods: SPSS 29.0 was used to analyze the data, and all tests were performed using two-sided tests. If P < 0.05, it means there is a difference; if P > 0.05, it means there is no difference. Count data are expressed as percentage (%), and the chi-square test is used. 2 Test. The test level was α = 0.05, and P < 0.05 was considered statistically significant. The measurement data were expressed as "mean ± standard deviation" (Mean ± SD) when they were in accordance with the normal distribution. The independent sample t test was used for inter-group comparison, and the paired sample t test was used for intra-group comparison. The median, interquartile range (M, IQR) was used to express the data that were not in accordance with the normal distribution. The independent sample rank sum test was used for inter-group comparison, and the rank sum test of two related samples was used for intra-group comparison.

[0094] 2. Research Results

[0095] 1. General information and comparison of efficacy indicators before treatment

[0096] After testing, there was no significant difference in the age, disease course, menopausal status, first diagnosis, TCM syndrome type, underlying disease status, and efficacy indicators before treatment between the two groups of patients (P>0.05), indicating that the two groups were balanced and had comparable baselines.

[0097] 2 Comparison of efficacy

[0098] 2.1 Comparison of the severity of vulvar skin lesions

[0099] Table 1 Comparison of the vulvar skin lesion area between the two groups at 0d, 3d, 5d and 7d after treatment

[0100]

[0101] It means that P<0.05 before and after treatment in each group. There were statistically significant differences in each stage between the two groups after treatment compared with those before treatment (P<0.05). At 3d, 5d, and 7d after treatment, there were statistically significant differences between the two groups (P<0.05).

[0102] Table 2 Comparison of the comprehensive scores of vulvar skin lesions between the two groups at 0d, 3d, 5d and 7d after treatment

[0103]

[0104] The difference between the two groups at 3, 5, and 7 days after treatment was statistically significant (P<0.05).

[0105] Table 1-2 shows that the observation group was better than the control group in reducing the severity and area of ​​vulvar skin lesions.

[0106] 2.2 Comparison of the degree of vulvar skin ulceration

[0107] Table 3 Comparison of vulvar skin ulceration area between the two groups at 0d, 3d, 5d and 7d after treatment

[0108]

[0109]

[0110] The difference between the two groups before and after treatment was statistically significant (P<0.05). The difference between the two groups at 3d, 5d, and 7d after treatment was statistically significant (P<0.05).

[0111] Table 4 Comparison of the scores of vulvar skin ulceration between the two groups at 0d, 3d, 5d and 7d after treatment

[0112]

[0113] The difference between the two groups at 3, 5, and 7 days after treatment was statistically significant (P<0.05).

[0114] Table 3-4 shows that the observation group was better than the control group in promoting the healing of vulvar ulcers, reducing the area of ​​vulvar ulcers, and alleviating the severity of ulcers.

[0115] 2.3 Comparison of vulvar skin itching

[0116] Table 5 Comparison of vulvar skin itch scores between the two groups at 0d, 3d, 5d, and 7d after treatment

[0117]

[0118] The difference between the two groups before and after treatment was statistically significant (P<0.05). The difference between the two groups at 3d, 5d, and 7d after treatment was statistically significant (P<0.05). This indicates that the observation group is better than the control group in reducing the degree of vulvar itching.

[0119] 2.4 Comparison of vulvar pain severity

[0120] Table 6 Comparison of vaginal pain scores between the two groups at 0d, 3d, 5d and 7d after treatment

[0121]

[0122]

[0123] The difference between the two groups before and after treatment was statistically significant (P<0.05). The difference between the two groups at 3d, 5d, and 7d after treatment was statistically significant (P<0.05). This indicates that the effect of reducing the degree of vulvar pain in the observation group is better than that in the control group.

[0124] 2.5 Comparison of comprehensive vulvar disease scores

[0125] Table 7 Comparison of comprehensive vulvar disease scores between the two groups at 0d, 3d, 5d and 7d after treatment

[0126]

[0127] The difference between the two groups before and after treatment was statistically significant (P<0.05). The difference between the two groups at 3, 5, and 7 days after treatment was statistically significant (P<0.05). This shows that the observation group is better than the control group in reducing the severity of vulvar syndrome.

[0128] 2.6 Comparison of comprehensive efficacy of vulvar treatment after 7 days

[0129] Table 8 Comparison of comprehensive efficacy of vulva in two groups after 7-day treatment

[0130]

[0131] After testing, the comprehensive efficacy of vulva treatment between the two groups was compared after 7 days of treatment, P < 0.05, and the difference was statistically significant. This indicates that the cure rate and total effective rate of the observation group in alleviating itching symptoms and healing ulcers were significantly higher than those of the control group.

[0132] 2.7 Comparison of the number of days for itching relief and ulcer healing between the two groups

[0133] Table 9 Comparison of the number of days for itching relief and ulcer healing between the two groups

[0134]

[0135]

[0136] After testing, the comparison of the number of days for pruritus relief and ulceration healing between the two groups was P<0.05, and the difference was statistically significant. This shows that the number of days for pruritus relief and ulceration healing in the observation group was less than that in the control group, which can shorten the treatment time of patients.

[0137] Conclusion

[0138] 1. The chicken seed oil (phoenix oil) mixture of the present invention has good clinical efficacy. This example once again verifies the effectiveness of the chicken seed oil (phoenix oil) mixture in treating vulvar itching and ulceration.

[0139] 2. Compared with the control group, Phoenix Oil Mixture can better improve patients' vulvar itching and pain, heal vulvar ulcers, reduce the area of ​​vulvar lesions, improve the cure rate and significant efficacy of patients' comprehensive therapeutic effects, and the therapeutic effect is more satisfactory.

[0140] 3. The observation group that used the Phoenix Oil mixture of the present invention at an early stage had significantly shorter disappearance time of vulvar pruritus and healing time of vulvar ulceration than the control group. Compared with the control group, the Phoenix Oil mixture treatment took effect faster and could shorten the treatment time of patients to a certain extent.

[0141] 4. Phoenix Oil Mixture is safe and effective in treatment, and can provide a set of effective treatment plans for clinical practice, achieving the simultaneous treatment of vulvar itching and ulceration, filling the treatment gap, relieving symptoms as soon as possible, shortening the treatment time, breaking the vicious cycle of "scratching-ulceration-scratching", allowing patients to enter the next treatment stage as soon as possible, avoiding recurrence of the disease, and saving money.

[0142] IV. Conclusion

[0143] Vulvar itching treatment requires Chinese medicine to regulate the internal organs to treat the root cause, and external treatment of the skin to relieve the symptoms. Phoenix Oil Mixture, as a symptomatic medicine, can effectively and quickly relieve the symptoms of vulvar itching and heal the ulcers, filling the gap that itching and ulcers cannot be treated with "one prescription" and "one medicine" at the same time, breaking the vicious cycle of "scratching-ulcer-scratching", allowing patients to enter the next stage of treatment as soon as possible, relieve pain, avoid recurrence of the disease, and save money.

[0144] Example 2

[0145] 1. Clinical data

[0146] 1.1 Case sources and groups

[0147] The case data of patients diagnosed with atrophic vaginitis who visited the gynecology outpatient clinic of Heilongjiang Provincial Hospital of Traditional Chinese Medicine from August 2023 to August 2024 were collected and statistically analyzed. According to the review of their clinical characteristics, treatment and prognosis, a total of 126 patients were diagnosed with atrophic vaginitis in the past year, of which 9 cases with a history of hormone, antibiotic and other drug use before the visit were excluded, 2 cases with other serious diseases were excluded, 64 cases were excluded due to incomplete data, and 51 cases were finally included. According to whether the Phoenix Oil mixture was used, the patients were divided into 28 observation groups and 23 control groups. This study was filed with the relevant management department of the hospital, and the basic information of the patients and the condition information were complete and accurate.

[0148] 1.2 Diagnostic criteria

[0149] 1.2.1 Western medicine diagnostic criteria: According to the "Expert Consensus on Clinical Diagnosis and Treatment of Menopausal Genitourinary Syndrome", "Practical Obstetrics and Gynecology (4th Edition)" and "Guidelines for Menopausal Management and Menopausal Hormone Therapy in China (2018)" related to the diagnosis of atrophic vaginitis

[0150] 1.2.2 TCM diagnostic criteria: refer to the description of kidney yin deficiency and dampness type of leucorrhea in Practical TCM Gynecology (Second Edition) and TCM Gynecology.

[0151] 1.3 Case selection criteria

[0152] 1.3.1 Inclusion criteria: ① Women aged 40 to 70 years with a history of sexual life, amenorrhea for ≥ 12 months, and patients who meet the diagnostic criteria of Western medicine and TCM disease differentiation and syndrome differentiation; ② No history of hormone drug use within 3 months before treatment, no history of antibiotics, vulvar and vaginal local drugs use within 1 month before treatment, and no related treatment for this disease within 1 month before treatment; ③ Patients in good health, without serious medical diseases, gynecological tumors, known or suspected estrogen-dependent diseases, and no history of vulvar and vaginal surgery in the past 3 months; ④ Complete clinical data, and patients informed consent to use the medical records for this study.

[0153] 1.3.2 Exclusion criteria: ① Women with no sexual history ② Patients with vulvovaginal candidiasis, Trichomonas vaginitis, confirmed or suspected cervical lesions, vaginal and uterine malignant lesions, and vulvar hypopigmentation diseases ③ Patients with relatively serious medical diseases, blood system diseases, and mental disorders ④ Those without informed consent.

[0154] 1.3.3 Exclusion criteria: ① Patients who actively requested to withdraw and were lost to follow-up; ① Patients whose efficacy could not be determined due to the lack of relevant research records;

[0155] 2. Research Methods

[0156] 2.1 Dosage

[0157] Observation group: Phoenix oil mixture (ingredients: honeysuckle vine, gentian, white fresh bark, Kochia scoparia, scutellaria, phellodendron, angelica, raw rehmannia, lithospermum officinale, dandelion, white elm, bletilla striata, sophora flavescens, agrimony, dandelion, honeysuckle, wild chrysanthemum, tongcao) vaginal administration. Medication method: wipe the vagina with a cotton ball soaked in medicated oil, then insert a cotton strip soaked in medicated oil into the vagina, remove it after 4 hours, start from the second day after the first visit, once a day, 7 days as a course of treatment, a total of 2 courses of medication

[0158] Control group: Baofukang suppository (Specification: 1.74g / tablet. Produced by Hainan Bikai Pharmaceutical Co., Ltd. Approval number 20090414.) Under the doctor's guidance, clean hands and vulva with clean water every night before going to bed. The patient or family member wears disposable medical gloves, takes out 1 suppository, and inserts it deep into the vagina, 1 suppository / day, 7 days as a course of treatment, and 2 courses of medicine are used in total.

[0159] The two groups of patients were advised to pay attention to diet and drink healthy water during treatment, and to avoid spicy seafood and alcohol. They were also prohibited from having sex, swimming, or taking a bath during treatment.

[0160] The two groups of patients were observed until the end of the treatment course, and the medication was stopped for 3 days before re-examination. The efficacy of the treatment group and the control group was observed respectively; the recurrence rate of the disease was calculated one month after stopping the medication.

[0161] 2.2 Observation indicators: ① Improvement of clinical manifestations and TCM syndromes of patients after treatment. ② Gynecological examination to compare the amount of vaginal secretions, changes in vaginal mucosa, and changes in vaginal elasticity and moisture. ③ Vaginal secretion detection

[0162] 2.3 Disease scoring criteria

[0163] With reference to the Guiding Principles for Clinical Research of New Chinese Medicines, Expert Consensus on Clinical Diagnosis and Treatment of Menopausal Genitourinary Syndrome, Practical Obstetrics and Gynecology (4th Edition), TCM Gynecology, Practical TCM Gynecology (2nd Edition), Vaginal Health Index Score (VHIS) and related literature, the clinical efficacy indicators were formulated in combination with clinical manifestations, including: ① Vaginal Health Index Scoring Standard: Vaginal mucosa: 4 points: ecchymosis before contact; 3 points: bleeding spots when lightly touched; 2 points: bleeding after scraping; 1 point: not brittle, thin mucosa; 0 points: not brittle, normal mucosa; Vaginal moisture: 4 points: none, mucosa inflammation; 3 points: none, no inflammation on the surface; 2 points: little; 1 point: slightly less; 0 points: normal; Vaginal mucosal elasticity: 4 points: no elasticity; 3 points: poor; 2 points: moderate; 1 point: good; 0 points: very good; Vaginal secretion: 4 points: no secretion; 3 points: sparse, yellow-green or yellow; 2 points: little, light yellow or white; 1 point: moderate, light white; 0 points: normal; ② Vaginal secretion detection grading standards: including vaginal pH (≤4.6; ≥4.8), cleanliness (grade I; grade II; grade III; grade IV), lactobacilli (large, medium, small, little or no), leukocyte esterase, hydrogen peroxide (negative, weakly positive, positive). ③ TCM syndrome evaluation standards: vaginal discharge amount, vaginal discharge color, vaginal discharge texture, vaginal discharge odor, vaginal discomfort, urination frequency, urination pain, lower abdominal discomfort, vaginal pain, five-heart heat, insomnia, dry throat, dizziness, tinnitus, waist and knee weakness, respectively, according to no (0 points), mild (1 point), moderate (2 points), severe (3 points), the higher the score, the higher the severity of the patient's TCM syndrome.

[0164] 2.4 Criteria for judging efficacy

[0165] References: "Guidelines for Clinical Research of New Chinese Medicines", "Expert Consensus on Clinical Diagnosis and Treatment of Menopausal Genitourinary Syndrome", "Practical Obstetrics and Gynecology (4th Edition)", "Chinese Medicine Gynecology", "Practical Chinese Medicine Gynecology (2nd Edition)", "Vaginal Health Index Score Sheet" The efficacy evaluation criteria were formulated based on the contents of the "VHIS" and related literature: ① TCM syndrome efficacy judgment criteria: cured: TCM syndrome basically disappeared, and the syndrome score decreased by ≥90%; markedly effective: TCM syndrome was significantly improved, and the syndrome score decreased by <90%, ≥70%; effective: TCM syndrome was improved, and the syndrome score decreased by <70%, ≥30%; ineffective: TCM syndrome was not improved or aggravated, and the syndrome score decreased by <30%; syndrome score reduction rate = (total score before treatment - total score after treatment) / total score before treatment × 100; TCM syndrome total effective rate = (cured + markedly effective + effective) cases / total number of cases × 100% ② Clinical comprehensive efficacy judgment criteria: cured: vaginal secretion detection: pH ≤ 4.6, cleanliness level I-II, large or medium-small lactobacilli, negative or weakly positive hydrogen peroxide, negative or weakly positive leukocyte esterase =Effective: TCM score reduction ≥ 90%; total score reduction ≥ 50%; markedly effective: vaginal secretion test: pH ≤ 4.6, cleanliness Ⅰ-Ⅱ, large or medium-small amount of lactobacilli, negative or weakly positive hydrogen peroxide, negative or weakly positive leukocyte esterase; TCM score reduction < 90%, ≥ 70%; total score reduction ≥ 30%; effective: vaginal secretion test: pH ≤ 4.6, cleanliness Ⅱ-Ⅲ, small or no lactobacilli, positive or weakly positive hydrogen peroxide, positive or weakly positive leukocyte esterase; TCM score reduction < 70%, ≥ 30%; total score reduction < 30%; ineffective: vaginal secretion test: pH ≥ 4.8, cleanliness Ⅲ-Ⅳ, few or no lactobacilli, positive hydrogen peroxide, positive leukocyte esterase; TCM score reduction < 30%; total score reduction < 30%; total score = symptom score + TCM syndrome score

[0166] 3. Statistical methods

[0167] SPSS29.0 was used to analyze the data, and all tests were bilateral. If P < 0.05, it means there is a difference; if P > 0.05, it means there is no difference. The count data were expressed as percentage (%), and the chi-square test was used. The test level was α = 0.05, and P < 0.05 was considered statistically significant. The measurement data were expressed as "mean ± standard deviation" (Mean ± SD) when they were in accordance with the normal distribution. The independent sample t test was used for inter-group comparison, and the paired sample t test was used for intra-group comparison; the median, interquartile range (M, IQR) was used when they were not in accordance with the normal distribution. The independent sample rank sum test was used for inter-group comparison, and the rank sum test of two related samples was used for intra-group comparison.

[0168] 2. Research Results

[0169] 1. General information and comparison of efficacy indicators before treatment

[0170] After testing, there was no statistically significant difference in the age, disease course, menopausal status, underlying diseases before treatment, and efficacy indicators before treatment between the two groups of patients (P>0.05), indicating that the two groups were balanced and the baselines were comparable.

[0171] 2 Comparison of efficacy

[0172] 2.1 Comparison of vaginal health index scores

[0173] Table 1 Comparison of vaginal health index scores between the two groups before and after treatment

[0174]

[0175] It means that P<0.05 before and after treatment in each group, and there were statistically significant differences between the two groups before and after treatment (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05), indicating that the observation group was better than the control group in improving vaginal mucosal atrophy, relieving vaginal dryness, improving vaginal elasticity, and regulating the nature of secretions.

[0176] 2.2 Comparison of vaginal discharge detection grades

[0177] After testing, there was no statistically significant difference in the vaginal secretion tests between the two groups of patients before and after treatment (P>0.05), indicating that the observation group and the control group both had a positive regulatory effect on the vaginal pH value, cleanliness, lactobacillus, leukocyte esterase, and hydrogen peroxide in women.

[0178] 2.3 Comparison of TCM syndrome scores

[0179] Table 2 Comparison of TCM main symptom scores between the two groups before and after treatment

[0180]

[0181] It means that P<0.05 before and after treatment in each group. There were statistically significant differences between the two groups before and after treatment (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05).

[0182] Table 3 Comparison of TCM sub-symptom scores between the two groups before and after treatment

[0183]

[0184] It means that P<0.05 before and after treatment in each group. There were statistically significant differences between the two groups before and after treatment (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05).

[0185] Table 4 Comparison of total TCM syndrome scores between the two groups before and after treatment

[0186]

[0187] It means that P<0.05 before and after treatment in each group. There were statistically significant differences between the two groups before and after treatment (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05).

[0188] Table 2-4 shows that the improvement of TCM syndrome in the observation group was better than that in the control group.

[0189] 2.4 Comparison of comprehensive clinical efficacy

[0190] Table 5 Comparison of the total score of clinical comprehensive efficacy between the two groups before and after treatment

[0191]

[0192]

[0193] It means that P<0.05 before and after treatment in each group, there were statistical differences in the two groups before and after treatment (P<0.05), and after treatment, the difference between the two groups was statistically significant (P<0.05), indicating that the comprehensive clinical efficacy of the observation group was significantly higher than that of the control group.

[0194] Table 6 Comparison of comprehensive clinical efficacy between the two groups before and after treatment

[0195]

[0196] After testing, the comparison of clinical comprehensive efficacy between the two groups before and after treatment was P < 0.05, and the difference was statistically significant, indicating that the total effective rate of the observation group in improving the clinical comprehensive efficacy was significantly higher than that of the control group.

[0197] Conclusion

[0198] 1. Chicken seed oil (Phoenix oil) mixture has good clinical efficacy. This example once again verifies the effectiveness of chicken seed oil (Phoenix oil) mixture in treating atrophic vaginitis.

[0199] 2. Compared with the control group, Phoenix Oil Mixture can better improve the degree of vaginal mucosal atrophy, relieve vaginal dryness, improve vaginal elasticity, regulate the nature of secretions, improve TCM symptoms, and improve the cure rate and significant efficacy of the patient's comprehensive therapeutic effect, with more satisfactory therapeutic effects.

[0200] Example 3

[0201] 1. Clinical data

[0202] 1.1 Case sources and groups

[0203] The case data of all patients diagnosed with vulvar dystrophy in the gynecological outpatient clinic of Heilongjiang Provincial Hospital of Traditional Chinese Medicine from June 2022 to June 2024 were collected and counted. Patients with atrophy and dryness of vulvar skin and mucosa as the main manifestation were included in the study, and their clinical characteristics, treatment and treatment outcomes were reviewed. In the past two years, a total of 84 patients met the inclusion criteria, 27 cases were excluded due to incomplete data and other reasons, and 57 cases were actually included. According to whether Phoenix Oil Mixture was used, they were divided into an observation group of 31 cases and a control group of 26 cases. The experiment in this embodiment was filed with the relevant management department of the hospital, and the basic information of the patients and the condition information were complete and accurate.

[0204] 1.2 Diagnostic criteria

[0205] 1.2.1 Western medicine diagnostic standards: Refer to the contents of "Practical Obstetrics and Gynecology (Fourth Edition)" and "Obstetrics and Gynecology" to meet the diagnostic standards for vulvar dystrophy. Pathological diagnoses include vulvar squamous cell hyperplasia, lichen sclerosus, mixed types, etc.

[0206] 1.2.2 TCM diagnostic criteria: With reference to the literature such as Practical TCM Gynecology (Second Edition) and TCM Gynecology edited by Ma Baozhang, the diagnostic criteria for vulvar malnutrition were formulated, including liver-kidney deficiency type, spleen-kidney yang deficiency type, heart-spleen deficiency type, liver depression and qi stagnation type, and damp-heat type.

[0207] 1.3 Case selection criteria

[0208] 3.1 Inclusion criteria: Women aged 16 to 75 years old, who meet the diagnostic criteria of Western medicine and TCM, and whose main manifestations are atrophy and dryness of vulvar skin and mucosa, have complete clinical data, and the patients have given informed consent for the use of their medical records in this study.

[0209] 1.3.2 Exclusion criteria: ① Those who do not meet the diagnostic criteria of this study. ② Those whose clinical data are incomplete and data analysis is not possible. ③ Patients with vulvar cancer, vulvar vitiligo, and albinism are excluded. ④ Those who have been confirmed to have related symptoms caused by other diseases such as psoriasis, vulvitis, diabetes, etc., and those who have other serious diseases and are receiving treatment are excluded.

[0210] 1.3.3 Exclusion criteria: ① Patients who actively requested to withdraw and were lost to follow-up; ② Patients whose efficacy could not be determined due to the lack of relevant research records;

[0211] 2. Research Methods

[0212] 2.1 Dosage

[0213] According to the diagnosis and treatment plan, both groups were given lifestyle and dietary guidance.

[0214] Observation group: Apply the Phoenix Oil mixture of the present invention (ingredients: honeysuckle vine, gentian, Dictamni, Kochia scoparia, Scutellaria, Phellodendron, Angelica, Radix Rehmanniae, Lithospermum officinale, Radix Sanguisorbae, Bletilla striata, Carthamus tinctorius, Psoralea corylifolia, Cinnamomum cassia) to the vulva lesions for 30 minutes each time, twice a day. One course of treatment is 2 weeks, and three courses are used in succession.

[0215] Control group: Apply flufenamic acid butyl ester ointment (Shanghai Tonglian Pharmaceutical Co., Ltd. National Medicine Standard H20163106) on the vulvar lesions twice a day. One course of treatment is 2 weeks, and three courses of treatment are used in succession.

[0216] Record the changes of vulvar skin and mucosa in the two groups before and after treatment

[0217] 3. Disease scoring criteria:

[0218] 3.1 Physical sign scoring criteria: ① Scoring of the range of vulvar skin lesions: The entire lesion skin area is divided into 12 areas, namely, the pubic area, the anterior labia and area, the clitoral area, 1 area on each side of the labia minora, 1 area on each side of the interlabial groove, 1 area on each side of the labia majora, the perineum area, the anus area, and the vaginal opening area. Each area is scored 1 point. ② Scoring of vulvar lesion morphology: 3 points: thin, severe atrophy, obvious adhesion, difficult to distinguish the labia majora and minora, affecting sexual intercourse and urination; 2 points: moderate thinning and atrophy, adhesion; 1 point: mild thinning and atrophy; 0 points: normal vulva without changes. ③ Comprehensive score of vulvar lesion morphology: Comprehensive score of vulvar lesion morphology = lesion morphology score × lesion range score, the most severe case is 12 × 3 = 36 points; ④ Score of vulvar lesion color: 3 points: lesion area is gray or pale, soaked into pieces; 2 points: lesion area is white or gray, multiple; 1 point: lesion area is flushed or slightly white or gray, single or a few; 0 points: vulva is normal without change. ⑤ Comprehensive score of vulvar lesion color: Comprehensive score of vulvar lesion color = vulvar lesion color score × lesion range score, the most severe case is 12 × 3 = 36 points. ⑥ Clinical sign score: Clinical sign score = comprehensive score of vulvar lesion morphology + comprehensive score of vulvar lesion color, the most severe case is 36 + 36 = 72 points.

[0219] 3.2 Clinical symptom scoring criteria: ① Vulvar pruritus: 6 points: continuous severe itching, accompanied by obvious tenderness, erosion, unbearable, seriously affecting sleep and work; 4 points: itching is sometimes light and sometimes heavy, accompanied by mild pain, ulceration, a little exudation, affecting sleep, work, study and life; 2 points: itching is intermittent, sometimes dull and sometimes painful, not affecting work and life; 0 points: no vulvar pruritus and pain, no ulceration. ② Vulvar dryness: 6 points: severe vulvar dryness, washing more than 4 times a day; accompanied by continuous pain or burning pain, cracking, obvious tenderness, seriously affecting sleep, work, study and life; 4 points: obvious vulvar dryness, sometimes need to be washed (washed less than 3 times a day); accompanied by mild pain or burning pain, cracking, affecting sleep, work, study and life; 2 points: the vulva is slightly dry, sometimes dull and sometimes painful, or there is a burning sensation, slight cracking, not affecting work and life 0 points: no vulvar dryness and pain, no cracking. ③Clinical symptom score: Clinical symptom score = vulvar pruritus score + vulvar dryness score, the most severe case is 6+6=12 points.

[0220] 3.3 Vulvar comprehensive disease score: Vulvar comprehensive disease score = vulvar lesion sign score (vulvar lesion morphology score + vulvar lesion color score) + clinical symptom score (vulvar pruritus degree score + vulvar dryness degree score)

[0221] 4. Observation indicators and efficacy evaluation criteria

[0222] 4.1 Observation indicators: ① Changes in the color and atrophy of vulvar skin lesions ② Changes in vulvar itching and dryness symptoms;

[0223] 4.2 Criteria for judging the efficacy: Cured: The vulvar skin returns to normal, and the symptoms of dryness, itching and pain disappear, or basically disappear. The integral value of symptoms and signs decreases by ≥90%. Significantly effective: The symptoms of dryness, itching and pain in the vulva are significantly relieved compared with before, and the area of ​​skin lesions is significantly reduced compared with before. The integral value of symptoms and signs decreases by ≥70%, <90%. Effective: The symptoms of dryness, itching and pain in the vulva are relieved compared with before, and the area of ​​skin lesions is reduced compared with before. The integral value of symptoms and signs decreases by ≥30%, <70%. Ineffective: The symptoms of dryness, itching and pain in the vulva are not relieved compared with before, and the area of ​​skin lesions is not reduced compared with before. The integral value of symptoms and signs decreases by <30%. Note: The integral value of symptoms and signs = (the score before treatment - the score after treatment) ÷ the score before treatment × 100%.

[0224] 5. Statistical methods: SPSS29.0 was used to analyze the data, and all tests were bilateral. If P < 0.05, it means there is a difference; if P > 0.05, it means there is no difference. The count data are expressed as percentages (%) and the chi-square test was used. The test level α = 0.05, P < 0.05 is considered statistically significant. The measurement data conformed to the normal distribution and were expressed as "mean ± standard deviation" (Mean ± SD). The independent sample t test was used for inter-group comparison, and the paired sample t test was used for intra-group comparison; the median, interquartile range (M, IQR) was used for non-normal distribution. The independent sample rank sum test was used for inter-group comparison, and the rank sum test of two related samples was used for intra-group comparison.

[0225] 2. Research Results

[0226] 1. Comparison of general data: After testing, there was no significant difference in age, menopausal status, disease course, underlying diseases, and TCM syndrome types before treatment between the two groups of patients (P>0.05), indicating that the two groups were balanced and had comparable baselines.

[0227] 2. Comparison of efficacy indicators before treatment: After testing, the two groups of patients were compared in terms of vulvar lesion range, lesion morphology, lesion color, clinical sign score, vulvar pruritus, vulvar dryness, and clinical symptom score before treatment. The results showed that there was no statistically significant difference between the two groups (P>0.05), indicating that the two groups were balanced and the baselines were comparable.

[0228] 3. Comparison of efficacy

[0229] 3.1 Comparison of clinical signs before and after treatment

[0230] Table 1 Comparison of vulvar lesion range scores between the two groups before and after treatment

[0231]

[0232] It means that P<0.05 before and after treatment in each group, and there were statistical differences between the two groups before and after treatment (P<0.05). After treatment, there was no statistically significant difference between the two groups (P>0.05). This shows that both groups can reduce the scope of patient lesions to a certain extent.

[0233] Table 2 Comparison of comprehensive scores of vulvar lesion morphology between the two groups before and after treatment

[0234]

[0235] The difference between the two groups before and after treatment was statistically significant (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05). This shows that the observation group is better than the control group in improving the lesion morphology and relieving vulvar atrophy and adhesion.

[0236] Table 3 Comparison of comprehensive scores of vulvar lesion color before and after treatment between the two groups

[0237]

[0238]

[0239] The difference between the two groups before and after treatment was statistically significant (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05). This shows that the observation group is better than the control group in improving the local depigmentation of the lesions and relieving the hypopigmentation of the vulva.

[0240] Table 4 Comparison of clinical sign scores between the two groups before and after treatment

[0241]

[0242] The difference between the two groups before and after treatment was statistically significant (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05). This shows that the observation group is better than the control group in improving the clinical signs of the vulva.

[0243] 3.2 Comparison of clinical symptoms before and after treatment

[0244] Table 5 Comparison of vulvar pruritus scores before and after treatment between the two groups

[0245]

[0246] It means that P<0.05 before and after treatment in each group, and there were statistical differences between the two groups before and after treatment (P<0.05). After treatment, there was no statistically significant difference between the two groups (P>0.05). This shows that both the observation group and the treatment group can improve the symptoms of vulvar itching in patients.

[0247] Table 6 Comparison of vulvar dryness scores between the two groups before and after treatment

[0248]

[0249]

[0250] The difference between the two groups before and after treatment was statistically significant (P<0.05). After treatment, the difference between the two groups was statistically significant (P<0.05). This shows that the observation group is better than the control group in improving the dryness of the vulva.

[0251] Table 7 Comparison of clinical symptom scores between the two groups before and after treatment

[0252]

[0253] It means that P<0.05 before and after treatment in each group, there were statistical differences between the two groups before and after treatment (P<0.05), and after treatment, there was a statistically significant difference between the two groups (P<0.05). This shows that the effect of the observation group on improving the clinical symptoms of patients is better than that of the control group.

[0254] Table 8 Comparison of comprehensive vulvar disease scores between the two groups before and after treatment

[0255]

[0256] It means that P<0.05 before and after treatment in each group, there were statistical differences between the two groups before and after treatment (P<0.05), and after treatment, there was a statistically significant difference between the two groups (P<0.05). This shows that the effect of the observation group on improving the comprehensive condition of patients is better than that of the control group.

[0257] Table 9 Comparison of comprehensive clinical efficacy between the two groups before and after treatment

[0258]

[0259]

[0260] After testing, the clinical comprehensive efficacy of the two groups after treatment was P<0.05, and the difference was statistically significant. The effective rate of the observation group was significantly higher than that of the control group, indicating that the overall effect of the observation group in improving vulvar atrophy and whitening and relieving vulvar itching and dryness was better than that of the control group.

[0261] Conclusion

[0262] 1. Chicken seed oil (Phoenix oil) mixture has good clinical efficacy. This example once again verifies the effectiveness of chicken seed oil (Phoenix oil) mixture in treating vulvar dystrophy.

[0263] 2. Compared with the control group, Phoenix Oil Mixture can better improve the morphology and pigmentation loss of patients' vulvar lesions, relieve vulvar dryness and atrophy, and improve the cure rate and significant efficacy of patients' comprehensive therapeutic effects, with more satisfactory therapeutic effects.

Claims

1. A Chinese medicine mixture for external use for repairing genital skin and mucosal ulcer wounds, characterized in that The Chinese medicine mixture is composed of 200-400 parts of egg yolk oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Angelica sinensis, 10-30 parts of Radix Rehmanniae, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis and 10-30 parts of Bletilla striata.

2. The external Chinese medicine composition for repairing genital skin and mucosal ulcer wounds according to claim 1, characterized in that The Chinese medicine mixture is composed of 300-400 parts of egg yolk oil, 90-100 parts of honeysuckle vine, 60-70 parts of gentian, 40-50 parts of Dictamni cortex, 40-50 parts of Kochia scoparia, 30-40 parts of Scutellaria baicalensis, 30-40 parts of Phellodendron amurense, 20-30 parts of Chinese angelica, 20-30 parts of Radix Rehmanniae, 20-30 parts of Lithospermum officinale, 20-30 parts of Sanguisorba officinalis and 20-30 parts of Bletilla striata.

3. The external Chinese medicine composition for repairing genital skin and mucosal ulcer wounds according to claim 1, characterized in that The Chinese medicine mixture is composed of 200-300 parts of egg yolk oil, 85-95 parts of honeysuckle vine, 55-65 parts of gentian, 35-45 parts of Dictamni cortex, 35-45 parts of Kochia scoparia, 25-35 parts of Scutellaria baicalensis, 35-45 parts of Phellodendron amurense, 15-25 parts of Angelica sinensis, 15-25 parts of Radix Rehmanniae, 15-25 parts of Lithospermum officinale, 15-25 parts of Sanguisorba officinalis and 15-25 parts of Bletilla striata according to weight.

4. A method for preparing a Chinese medicine mixture for external use for repairing genital skin and mucosal ulcer wounds according to claim 1, characterized in that The preparation method is carried out as follows: 1) preparing drug powder: weighing 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Angelica sinensis, 10-30 parts of Radix Rehmanniae, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis and 10-30 parts of Bletilla striata according to weight; crushing the weighed drugs, and adding 2000-3000 parts of sesame oil for soaking; 2) frying 200-400 parts by weight of egg yolk until oil comes out; 3) adding the powder soaked in step 1) to the chicken oil in step 2), heating and stirring continuously until the surface of the powder turns dark brown, removing the powder from the oil and filtering to remove the residue, collecting the oil phase, and adding borneol to complete the preparation of the external Chinese medicine mixture for repairing genital skin and mucosal ulcers.

5. A method for preparing an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds according to claim 4, characterized in that The amount of sesame oil added is 2500 parts by weight, the sesame oil soaking time is more than 10 days, and the sesame oil is shaken every 1 to 2 days.

6. A method for preparing an external Chinese medicine mixture for repairing genital skin and mucosal ulcer wounds according to claim 4, characterized in that The added amount of borneol is 10 parts by weight.

7. The method for preparing a Chinese medicine mixture for external use for repairing genital skin and mucosal ulcer wounds according to claim 4, characterized in that Step 3) After adding borneol, fill the mixture and refrigerate for 6 to 8 days before use.

8. The use of a Chinese medicine mixture for external use for repairing genital skin and mucosal ulcer wounds as claimed in claim 1, characterized in that The external Chinese medicine mixture is used as a medicine for treating vulvar pruritus, ulceration, penile erosion and ulceration, vulvar leukoplakia atrophy and dryness, and burning, dryness and stinging pain of senile vaginitis.

9. The use according to claim 8, characterized in that When the external Chinese medicine mixture is used as a medicine for treating atrophy and dryness of vulvar leukoplakia, the Chinese medicine mixture is composed of 200-400 parts of egg yolk oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Angelica sinensis, 10-30 parts of Rehmannia glutinosa, 10-30 parts of Lithospermum officinale, 10-30 parts of Sanguisorba officinalis, 10-30 parts of Bletilla striata, 40-60 parts of cinnamon bark, 100-200 parts of safflower and 50-100 parts of psoralea corylifolia.

10. The use according to claim 8, characterized in that When the external Chinese medicine mixture is used to treat the burning, dryness and stinging of senile vaginitis, the Chinese medicine mixture is composed of 200-400 parts of egg yolk oil, 80-100 parts of honeysuckle vine, 50-70 parts of gentian, 30-50 parts of Dictamni cortex, 30-50 parts of Kochia scoparia, 20-40 parts of Scutellaria baicalensis, 20-40 parts of Phellodendron amurense, 10-30 parts of Angelica sinensis, 10-30 parts of Radix Rehmanniae, 10-30 parts of Lithospermum officinale, 10-30 parts of Radix Sanguisorbae, 10-30 parts of Bletilla striata, 40-60 parts of honeysuckle, 50-150 parts of Agrimoniae, 10-50 parts of wild chrysanthemum, 10-30 parts of Thunbergia nigra, 100-150 parts of Sophora flavescens and 50-100 parts of Taraxacum officinale.

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