A traditional Chinese medicine transdermal external preparation for treating vulvar hypopigmentation disease

Abstract

The present application belongs to the technical field of traditional Chinese medicine composition, and relates to a traditional Chinese medicine transdermal external preparation for treating vulvar hypopigmentation disease. The preparation is a paste prepared by mixing traditional Chinese medicine powder and horse oil. The traditional Chinese medicine powder is composed of the following raw materials by weight: Xuchangqing 10-12, Pugongying 10-15, Difusiduo 12-15, Tuzifuding 12-15, Baiji 10-15, Huzhang 9-12, Quansie 6-10, Diyu 10-12, Xuezhi 10-12, Danggui 6-10, Rushang 6-10, Miedu 6-10, Bingpian 1-3. The traditional Chinese medicine transdermal external preparation has definite and significant effects on vulvar hypopigmentation disease, especially in relieving intractable pruritus, promoting pigment recovery and improving skin sclerosis / atrophy. The traditional Chinese medicine transdermal external preparation has high safety, few adverse reactions and low recurrence rate.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and more specifically, relates to a transdermal topical preparation of traditional Chinese medicine for treating vulvar hypopigmentation. Background Technology

[0002] Vulvar hypopigmentation is a common chronic condition, often manifested by vulvar itching, hypopigmentation / loss of pigmentation, and skin and mucous membrane lesions. Vulvar hypopigmentation is characterized by a prolonged course and frequent recurrence. Due to the sensitive location of the lesion, patients often experience significant discomfort and psychological distress, severely impacting their daily lives.

[0003] Current treatments primarily involve topical medications and related procedures, but these methods still have limitations in terms of efficacy stability and recurrence control. For example, modern medicine currently treats these diseases mainly with topical hormones and immunosuppressants, as well as local treatments such as cryotherapy, laser therapy, focused ultrasound, and surgery. Although there are many treatment options available, some only provide temporary relief from symptoms and may have side effects. Clinically, there is still a need for safer, more compliant, and more stable treatment plans.

[0004] To improve efficacy and safety, existing technologies have also proposed the use of external application of traditional Chinese medicine. For example, Chinese patent CN111346189A (application number 202010224020.2) discloses a traditional Chinese medicine composition and its preparation for treating vulvar leukoplakia. This composition contains multiple traditional Chinese medicines, including honeysuckle, dictamnus root bark, epimedium, cnidium fruit, schizonepeta, saposhnikovia root, phellodendron bark, purslane, Sichuan pepper, sophora root, smilax rhizome, lithospermum root, tribulus fruit, artemisia leaf, and safflower, and is prepared as an aqueous external wash. Chinese patent CN102526572B discloses a traditional Chinese medicine wash for treating vulvar leukoplakia in girls, made from the following raw materials in parts by weight: 5-20 parts sophora root, 5-20 parts stemona root, 5-20 parts dictamnus root bark, 5-20 parts cnidium fruit, 5-20 parts coptis root, 5-20 parts phellodendron bark, and 5-20 parts patrinia root. The preparation of the aforementioned existing technologies typically involves decocting Chinese herbal raw materials with water to obtain a Chinese herbal preparation. The decoction time is, for example, 30-50 minutes, and may include steps such as filtration and cooling after decoction. The preferred method of use is sitz bath. Although this type of external wash / sitz bath type Chinese herbal external treatment can relieve symptoms such as itching, burning, dryness and roughness to a certain extent, it still has the following shortcomings: First, the administration of external wash / sitz bath is mainly based on "rinsing / soaking", and the effective retention of the drug at the lesion site and the continuous effect through the skin and mucous membrane are easily affected by time, dilution and loss; Second, the decoction-filtration-cooling-sitz bath process is relatively cumbersome, and the convenience and repeatability of preparation and use need to be improved; Third, the combination of multiple medicinal materials increases the batch differences of raw materials and the complexity of quality control, which is not conducive to the formation of a technical path that is easier to standardize and promote.

[0005] On the other hand, for the treatment of vulvar hypopigmentation, in addition to topical medication, synergistic intervention combining meridian and acupoint stimulation is considered to have potential significance: acupoint stimulation such as acupuncture can regulate the endocrine axis and help improve local microcirculation, promote tissue repair and functional recovery; at the same time, local acupoints of the vulva (such as Qugu, Huiyin, Yinlian, etc.) are located along the relevant meridians or at the site of the lesion, and stimulation through acupressure, kneading, etc., can also dredge the meridians and regulate the local condition. However, existing technologies (such as the above-mentioned external washing / sitz bath programs) mostly focus on "topical application of washes" and usually lack standardized combination procedures that combine with meridian and acupoint stimulation, especially lacking more easily implemented and promoted technical solutions for the synergistic mechanism of "continuous action of local drug administration" and "overall regulation of the meridians".

[0006] Therefore, there is an urgent need to provide a new technical solution: while improving the persistence and standardization of local drug effects, a comprehensive intervention pathway of "local-meridian-systemic" synergistic regulation should be formed to further improve the stability of therapeutic efficacy and reduce the risk of recurrence. Summary of the Invention

[0007] In view of the shortcomings of the prior art, the purpose of this invention is to provide a transdermal preparation of traditional Chinese medicine for treating vulvar hypopigmentation. This transdermal preparation of traditional Chinese medicine has a definite and significant effect on vulvar hypopigmentation, especially in relieving intractable itching, promoting pigmentation recovery, and improving skin hardening / atrophy. It is also safe, has few adverse reactions, and a low recurrence rate.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A transdermal preparation of traditional Chinese medicine for treating vulvar hypopigmentation, wherein the preparation is made by mixing traditional Chinese medicine powder with horse oil to form a paste, wherein the mass ratio of horse oil to traditional Chinese medicine powder is 1:(0.5-0.8); horse oil, as a matrix, has good permeability, moisturizing and repairing properties, which can make the medicine powder (traditional Chinese medicine powder) uniformly form a paste and help transdermal absorption and skin barrier repair; the traditional Chinese medicine powder is composed of the following ingredients by weight: Cynanchum paniculatum 10-12, Taraxacum mongolicum 10-15, Kochia scoparia 12-15, Smilax glabra 12-15, Bletilla striata 10-15, Polygonum cuspidatum 9-12, Buthus martensii 6-10, Sanguisorba officinalis 10-12, Daemonorops draco 10-12, Angelica sinensis 6-10, Boswellia carterii 6-10, Commiphora myrrha 6-10, Borneol 1-3.

[0010] As a preferred embodiment of the present invention, the herbal powder is composed of the following ingredients by weight: 12g of Cynanchum paniculatum, 15g of Taraxacum mongolicum, 12g of Kochia scoparia, 12g of Smilax glabra, 15g of Bletilla striata, 10g of Polygonum cuspidatum, 9g of Buthus martensii, 10g of Sanguisorba officinalis, 10g of Daemonorops draco, 9g of Angelica sinensis, 9g of Boswellia carterii, 9g of Commiphora myrrha, and 2g of Borneol.

[0011] The transdermal topical preparation of traditional Chinese medicine provided by this invention has outstanding advantages in relieving intractable itching, promoting pigmentation recovery, and improving skin hardening / atrophy. Therefore, it can be used in the preparation of topical preparations for treating vulvar hypopigmentation.

[0012] This invention also provides a method for preparing a transdermal topical Chinese medicine preparation for treating vulvar hypopigmentation. The preparation method is as follows: Cynanchum paniculatum, Taraxacum mongolicum, Kochia scoparia, Smilax glabra, Bletilla striata, Polygonum cuspidatum, Buthus martensii, Sanguisorba officinalis, Daemonorops draco, Angelica sinensis, Boswellia carterii, Commiphora myrrha, and Borneol are mixed in a weight ratio, pulverized, and passed through an 80-100 mesh sieve. Then, they are mixed with horse oil to obtain the transdermal topical Chinese medicine preparation required for treatment.

[0013] When the transdermal topical Chinese medicine preparation provided by this invention is used in conjunction with acupoint stimulation, the therapeutic effect is even better. During treatment, after cleaning and wiping the vulva, the prepared paste is applied to the affected area of ​​the vulva, and acupoints such as the pulse point, uterus, and perineum are treated with acupressure, pressing, and kneading techniques, and a pushing technique is performed along the path of the liver meridian of the vulva. Each treatment lasts for 20 minutes. At the same time, based on local transdermal drug delivery and combined with acupoint stimulation of the vulva, acupuncture is further introduced at Baihui, Xuanli, Xuanlu, and Qubin acupoints, with needles retained for 30 minutes. During this period, a balanced tonifying and reducing technique is performed once. The combined intervention of acupoint stimulation and head acupuncture can further improve the therapeutic effect, aiming to achieve synergistic effects from both local symptom improvement and overall regulation, overcoming the shortcomings of existing technologies in terms of continuous drug delivery, standardized operation, and overall regulation.

[0014] The drug composition, compatibility, and acupoint effects in this invention are as follows:

[0015] Xu Changqing: It has a pungent and bitter taste, and is warm in nature. It enters the liver and stomach meridians. It is good at dispelling wind and dampness, promoting blood circulation and relieving pain, relieving itching and detoxifying. It is especially suitable for skin itching caused by rheumatic fever or wind-evil attacking the surface. Its volatile oil components are an important material basis. Studies suggest that it has analgesic, anti-inflammatory, anti-allergic and certain antispasmodic effects. It can relieve pain and itching by inhibiting inflammatory mediators and reducing peripheral nerve sensitization. In clinical application, it is mostly taken as a decoction. Due to its aromatic and penetrating nature, it is traditionally added later or decocted for a short time to retain the volatile components. However, it is warm and dispersing. It should be used with caution in cases of yin deficiency and fire excess, blood heat and wind stirring, or heat-induced skin lesions.

[0016] Dandelion: It tastes bitter and sweet, is cold in nature, and enters the liver and stomach meridians. It is good at clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis and relieving strangury. It is effective for symptoms such as painful and astringent urination and yellow and foul-smelling leukorrhea caused by damp-heat accumulation. It can clear heat and detoxify and promote diuresis to allow the pathogenic factors to be expelled. Its flavonoids, phenolic acids (such as chlorogenic acid), triterpenes and polysaccharides have been shown in studies to have anti-inflammatory, antioxidant, immunomodulatory and certain antibacterial activities. Therefore, it is often used as an important medicine in the syndrome of "heat toxicity with dampness" or "damp-heat accumulation".

[0017] Kochia scoparia: It has a bitter and pungent taste, is cold in nature, and enters the kidney and bladder meridians. It is good at clearing heat and dampness, dispelling wind and relieving itching. It is mainly used for vulvar itching, eczema and rubella caused by damp-heat accumulation and wind-damp-heat accumulation on the skin surface. Its antipruritic effect is mainly due to clearing damp-heat and dispelling wind and evil to "remove the cause". It contains saponins, flavonoids and volatile oils, and studies suggest that it has anti-inflammatory, anti-allergic, antibacterial and diuretic effects. Clinically, it can be taken internally as a decoction or used externally as a decoction for bathing to achieve local clearing and relieving itching. However, it is cold in nature. Itching caused by spleen deficiency and loose stools or blood deficiency and wind, or yin deficiency and internal heat should be treated with syndrome differentiation and should not be used as soon as itching occurs.

[0018] Smilax glabra: It has a sweet and bland taste, and is neutral in nature. It enters the liver and stomach meridians. It is good at detoxifying and removing dampness, and promoting joint mobility. It is good at treating skin eczema, itching, sores, and joint obstruction caused by dampness and heat. Its characteristics are that it "detoxifies without being drastic and removes dampness without harming the body's vital energy". It is suitable for long-term treatment based on syndrome differentiation. It contains flavonoids, phenolic acids, steroidal saponins and polysaccharides. Studies suggest that it has anti-inflammatory, antioxidant and immunomodulatory activities. It can provide a certain material basis for improving damp-heat inflammatory state and skin and mucous membrane reactions. It is often decocted or made into a concentrated water extract for easy consumption. However, since it is more inclined to remove dampness and promote diuresis, those with dry mouth and insufficient yin and blood should be combined with yin-nourishing and fluid-generating products to prevent damage to body fluids.

[0019] Bletilla striata: It tastes bitter, sweet, and astringent, and is slightly cold in nature. It enters the lung, stomach, and liver meridians. Its main functions are to astringe and stop bleeding, reduce swelling, and promote tissue regeneration. It can be used for internal bleeding such as hemoptysis, hematemesis, and epistaxis, as well as traumatic bleeding and ulcers and sores that are slow to heal. Its "astringent and hemostatic" and "tissue regeneration and wound healing" work together to stop bleeding and promote repair. Bletilla striata is rich in Bletilla striata polysaccharides and contains bibenzyl compounds. The adhesion and film-forming properties of polysaccharides are believed to be related to hemostasis and wound protection. Studies also suggest that it may promote granulation tissue growth and wound healing by regulating inflammatory response and improving local microenvironment. Clinically, it can be decocted, ground into powder for internal use, or applied externally to take advantage of its film-forming and wound-healing effects.

[0020] Polygonum cuspidatum: Slightly bitter in taste, slightly cold in nature, and enters the liver, gallbladder, and lung meridians. It clears dampness, heat, and toxins, disperses blood stasis, and relieves pain. It is used for damp-heat jaundice, urinary tract infections, rheumatic pain, carbuncles, boils, and traumatic injuries. Polygonum cuspidatum contains anthraquinone compounds such as polydextrin, resveratrol, and emodin, as well as stilbene compounds. Polydextrin and resveratrol have significant antioxidant, anti-inflammatory, microcirculation-improving, and antiviral (such as influenza virus and herpes virus) effects. Anthraquinone derivatives such as emodin have antibacterial effects.

[0021] Whole scorpion: pungent in taste, neutral in nature, toxic, and enters the liver meridian. It calms wind and relieves spasms, unblocks meridians and relieves pain, and attacks toxins and dissipates nodules. It is used for sores and carbuncles. The main active ingredient of whole scorpion is scorpion venom, a mixture composed of various neurotoxins and polypeptides. Scorpion venom has powerful analgesic and antithrombotic effects. Its analgesic mechanism differs from opioids, and it has low addictive potential. Furthermore, whole scorpion extract has inhibitory effects on various tumor cells.

[0022] Sanguisorba officinalis: Bitter, sour, and astringent in taste; slightly cold in nature; enters the liver and large intestine meridians. It cools the blood and stops bleeding, detoxifies and astringes sores. Used for burns, boils, and carbuncles. Sanguisorba officinalis is rich in tannins (including gallic acid tannins and inverse gallic acid tannins) and sanguisorbin. Its tannin components have significant astringent, hemostatic, and antibacterial effects, can constrict blood vessels, and promote platelet aggregation. Sanguisorbin and tannins have good protective, astringent, and healing-promoting effects on burns and scalds.

[0023] Dragon's Blood (Salmon's Blood): Sweet and salty in taste, neutral in nature, and enters the heart and liver meridians. It invigorates blood circulation, relieves pain, removes blood stasis, stops bleeding, promotes tissue regeneration, and heals sores. It is an essential medicine in traumatology and surgery, used for injuries from falls and blows, stabbing pain in the heart and abdomen, external bleeding, and slow-healing sores. The main components of dragon's blood are flavonoid derivatives such as daphne and daphne erythrin, as well as resin esters. Pharmacological studies have shown that dragon's blood can significantly improve microcirculation, promote blood flow, and prevent thrombosis; it has anti-inflammatory and analgesic effects; and it can promote fibroblast growth and granulation tissue proliferation, accelerating wound healing.

[0024] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It nourishes and invigorates blood. It is a highly effective blood-nourishing medicine and an essential medicine in gynecology. Angelica sinensis contains volatile oil (mainly ligustilide), ferulic acid, angelica polysaccharides, and various amino acids. Ferulic acid and angelica polysaccharides can promote the proliferation and differentiation of hematopoietic stem cells, thus having a blood-nourishing effect. Angelica sinensis as a whole possesses multiple pharmacological activities, including antiplatelet aggregation, antithrombosis, regulation of uterine smooth muscle, enhanced immunity, and liver protection.

[0025] Frankincense: Pungent and bitter in taste, warm in nature, and enters the heart, liver, and spleen meridians. It invigorates blood circulation, relieves pain, reduces swelling, and promotes tissue regeneration. It is used for rheumatic pain, traumatic injuries, and sores and swellings. Frankincense mainly contains volatile oils (α-pinene, octyl acetate, etc.) and resin acids (boswellic acid compounds). Modern research shows that boswellic acid has a strong anti-inflammatory effect, its mechanism being related to the inhibition of 5-lipoxygenase and leukotriene synthesis, showing significant efficacy in treating chronic inflammation such as arthritis. In addition, it also has analgesic, wound-healing-promoting, and certain anti-tumor activities.

[0026] Myrrh: It has a pungent and bitter taste, and is neutral in nature. It enters the heart, liver, and spleen meridians. It disperses blood stasis, relieves pain, reduces swelling, and promotes tissue regeneration. Its effects are similar to frankincense, and they are often used together to treat traumatic injuries, pain due to blood stasis, and slow-healing sores. Myrrh mainly contains volatile oils (furanocynes, myrrhene, etc.) and resins (myrrhic acid, myrrhnic acid, etc.). Myrrh resin has strong anti-inflammatory and analgesic effects and can inhibit the synthesis of prostaglandins and leukotrienes.

[0027] Borneol: Pungent and bitter in taste, slightly cold in nature, and enters the heart, spleen, and lung meridians. It opens the orifices and awakens the mind, clears heat and relieves pain. It is used for febrile delirium, convulsions, as well as red and swollen eyes, sore throat, mouth ulcers, carbuncles, and burns. Borneol mainly contains dextrorotatory borneol. Its pharmacological properties are prominently characterized by its "adjuvant effect," meaning it has a very strong permeation-enhancing effect, significantly increasing the absorption rate and amount of other drugs across the blood-brain barrier, skin, and mucous membranes. Furthermore, borneol itself has antibacterial, anti-inflammatory, analgesic, and sedative effects, and possesses a bidirectional regulatory function on the central nervous system, exhibiting both excitatory and inhibitory effects.

[0028] This formula uses Cynanchum paniculatum and Kochia scoparia as the principal herbs, focusing on the main symptoms of vulvar hypopigmentation, such as local itching, burning pain, and recurrent irritation. It exerts its core effects of dispelling wind, relieving itching, detoxifying, and relieving pain. The two herbs work synergistically: firstly, they dispel wind and relieve itching to alleviate persistent itching and discomfort; secondly, they simultaneously address pain and regulate local inflammatory responses, laying the foundation for subsequent clearing of dampness and toxins and promoting repair. This constitutes the main direction of the preparation and the primary source of its efficacy.

[0029] Dandelion, Smilax glabra, and Polygonum cuspidatum serve as assistant herbs, working synergistically with the principal herb to enhance intervention in local damp-heat with toxicity, lingering heat, and chronic inflammation from the perspective of "clearing heat and detoxifying, promoting diuresis and unblocking collaterals." Dandelion focuses on clearing heat and detoxifying, reducing swelling and dissipating nodules; Smilax glabra emphasizes detoxification and dampness removal; Polygonum cuspidatum combines the functions of clearing heat and dampness with promoting blood circulation and removing blood stasis. It not only helps to clear local toxic heat and dampness, but also provides auxiliary support for improving local microcirculation and optimizing the tissue repair environment, thereby enhancing the overall anti-irritant effect and improving the local microenvironment.

[0030] The combination of adjuvant herbs takes into account both "promoting blood circulation and removing blood stasis, promoting tissue regeneration and relieving pain" and "astringing sores, stopping bleeding, and promoting repair." Among them, blood draught, frankincense, myrrh, and angelica are combined with angelica to promote blood circulation, remove blood stasis, reduce swelling and relieve pain, and promote tissue regeneration. This is suitable for symptoms such as prolonged disease course, local blood stasis, dryness and cracking, and tenderness. Bletilla striata and Sanguisorba officinalis focus on astringing and stopping bleeding, promoting tissue regeneration, and clearing heat and detoxifying to improve local erosion, fissures, exudation, or repeated damage. Scorpion is used as an adjuvant to dispel wind, clear the meridians, detoxify and disperse nodules. It is designed to address the difficult-to-treat characteristics of long-term disease affecting the meridians, stubborn itching, or local stagnation and discomfort, enhance the penetration and improvement of stubborn diseases, and form a synergistic effect with the blood-activating and tissue-regenerating herbs.

[0031] Borneol is used as an adjuvant, taking advantage of its aromatic and penetrating properties, heat-clearing and pain-relieving effects, and its ability to guide other medications. This promotes the effective penetration of the powder and directs it to the affected area, enhancing the local onset speed and overall efficacy. It also coordinates the effects of other medications and alleviates local discomfort and fullness. Horse oil is used as the external base and carrier. The powder and horse oil are mixed in a ratio of 0.5–0.8:1 to form an ointment-like composition, which ensures uniform dispersion of the drug components and improves spreadability and adhesion. This prolongs the contact and retention time at the affected area, while also moisturizing and protecting the skin, reducing friction and irritation, improving dryness and cracking, and enhancing patient tolerance. This, combined with borneol's ability to "guide and penetrate the drug," achieves the formulation characteristics of guiding the drug into the collaterals, providing sustained action, and promoting repair.

[0032] Jimai (LR12): It belongs to the Liver Meridian of Foot-Jueyin. It is located below the outer lower part of the pubic tubercle, at the pulsation point of the femoral artery in the groin. Deep inside is the external genitalia and pelvic region. As the saying goes, "where the meridian passes, the treatment reaches." The Liver Meridian circulates "around the genitals and reaches the lower abdomen." Jimai is one of the acupoints on the Liver Meridian that is most directly and closely related to the genitals. Stimulating Jimai can directly reach the affected area and most effectively dredge the stasis of the Liver Meridian in the genital area, and infuse liver blood to nourish the external genital skin. Jimai can also soothe the liver and regulate qi, promote blood circulation and remove blood stasis. The liver is in charge of dredging and regulating qi, and smooth qi movement. Qi is the commander of blood, and qi stagnation leads to blood stasis. Vulvar leukoplakia is often accompanied by local skin roughness, thickening, and atrophy, which belongs to the category of "blood stasis" in traditional Chinese medicine. Acupuncture or moxibustion of Jimai can strongly soothe liver depression, promote local blood circulation, generate new blood while removing stasis, improve local nutritional status, and help restore skin color and elasticity. Regulate qi movement in the lower jiao. Jimai is located at the crucial point where qi and blood converge and circulate in the lower jiao. Stimulating it can effectively regulate the qi and blood circulation in the pelvic cavity and external genitalia, dispel possible pathogenic factors such as cold, dampness, and heat, and create a good environment for local tissue repair.

[0033] Huiyin (CV1): It is the meeting point of the Conception Vessel, Governor Vessel, and Penetrating Vessel, the source of "one origin with three branches." It is located in the perineum, at the midpoint between the anterior and posterior yin. It is exactly at the center or adjacent area of the vulvar hypopigmentation lesion area. Huiyin regulates the yin and yang of the whole body. The Conception Vessel is the "sea of yin meridians," the Governor Vessel is the "sea of yang meridians," and the Penetrating Vessel is the "sea of the twelve meridians." One acupoint, Huiyin, connects three vessels, and it is the key hub for the transformation of yin and yang qi and blood in the human body. Stimulating Huiyin can regulate the balance of yin and yang and the prosperity and decline of qi and blood in the whole body at the highest level. Vulvar leukoplakia shows local "deficiency of yin blood" and "failure of yang qi to reach." Physical stimulation of Huiyin directly acting on the lesion (such as specific manual massage, mild moxibustion) can directly act on the diseased tissue, promote local microcirculation, and stimulate the meridian qi, which is the manifestation of "where the acupoint is located, the treatment reaches." Huiyin tonifies the kidney and regulates menstruation. The kidney opens into the two yin. Huiyin is the starting point of the Conception and Governor Vessels and is connected to the kidney qi. Regulating Huiyin can strengthen the kidney and cultivate the original qi. Sufficient kidney qi can nourish the external genitalia. When paired with Baihui, it communicates between the upper and lower parts, guiding qi back to the origin. Huiyin is the hub of qi movement. Stimulating it can make the clear yang rise and the turbid yin descend, and enable the qi and blood in the upper jiao to smoothly reach the lower part to nourish the genital area.

[0034] Zigung (Uterus) acupoint: This is an extra acupoint located in the lower abdomen, 4 cun below the umbilicus (Zhongji acupoint) and 3 cun lateral to it. Situated in the lower abdomen, adjacent to the uterus and adnexa, it is the surface projection area of ​​the female reproductive system (uterus and adnexa). The vulva and uterus are closely connected through meridians and blood vessels (both belonging to the category of "vagina"). Stimulating Zigung directly radiates and affects the entire pelvic cavity and vulvar reproductive area, making it an effective acupoint for treating gynecological and vulvar diseases. Zigung has the effects of promoting blood circulation, removing blood stasis, resolving masses, regulating the qi and blood of the uterus, dispersing local stagnation, promoting metabolism, and simultaneously regulating the Chong and Ren meridians. Combined with the synergistic effect of moxibustion, the warmth of moxibustion can warm and unblock the meridians, dispel cold and dampness, and invigorate yang qi. It is particularly effective for vulvar leukoplakia accompanied by local coldness and pale skin, indicating a deficiency-cold syndrome. The heat energy reaches deep into the body, improving local blood circulation and nutrient supply.

[0035] Baihui (GV20): Belonging to the Governing Vessel, it is the meeting point of multiple meridians, including the Foot Jueyin Liver Meridian and the Foot Shaoyang Gallbladder Meridian. It can connect all Yang meridians and link the Liver Meridian. It has the function of raising Yang and lifting prolapse. For deficiency syndromes such as vulvar distension and prolapse (e.g., uterine prolapse) and chronic eczema that are slow to heal due to Qi deficiency and insufficient Yang Qi, moxibustion at Baihui can play a key role in lifting and consolidating the prolapse, exemplifying the principle of "treating the lower body by treating the upper body." It also calms the mind and soothes the nerves, calming the liver and suppressing Yang. Liver stagnation transforming into fire or liver Yang hyperactivity can disturb the genitals, causing vulvar burning pain, itching, and irritability. Stimulating Baihui can calm the mind and soothe the will, reducing liver fire and relieving symptoms from the source. Furthermore, it regulates the Yang Qi of the whole body, as the Governing Vessel governs all Yang Qi. By regulating Baihui, it can indirectly affect the distribution of Yang Qi throughout the body, improving pathological conditions such as cold, dampness, and blood stasis in the vulva.

[0036] Xuanlu, Xuanli, and Qubin are all acupoints on the Gallbladder Meridian of Foot-Shaoyang. All three are located on the side of the head along the Gallbladder Meridian and have similar effects, often used synergistically. They have the function of clearing away Shaoyang wind-heat. For conditions such as vulvar redness, swelling, itching, pain, and sores (e.g., acute vulvitis, herpes zoster) caused by stagnant heat in the Gallbladder Meridian or damp-heat in the Liver and Gallbladder, acupuncture or bloodletting at these three points directly clears the excess heat along the meridian, achieving a "root cause" effect. They also have the effect of unblocking the meridians and relieving pain and itching, as stagnation of Qi and blood in the Gallbladder Meridian affects the Liver Meridian, which is its counterpart. These three acupoints are located at a "pivotal" position on the head and are adept at unblocking the Qi and blood of this meridian. They have a good effect of unblocking the meridians, relieving pain and itching for vulvar pain (such as neuropathic pain) and itching that are located along the Liver and Gallbladder Meridians.

[0037] Advantages and beneficial effects of the present invention:

[0038] (1) Local high concentration and continuous drug delivery to the lesion: This invention mixes Chinese herbal powder (Xu Changqing 10-12, Dandelion 10-15, Kochia scoparia 12-15, Smilax glabra 12-15, Bletilla striata 10-15, Polygonum cuspidatum 9-12, Scorpion 6-10, Sanguisorba officinalis 10-12, Dragon's Blood 10-12, Angelica sinensis 6-10, Boswellia carterii 6-10, Commiphora myrrha 6-10, Borneol 1-3) with horse oil to form a paste and directly applies it to the vulvar lesion area. This allows the drug to form an adhesive action environment at the lesion site, reducing the dilution and loss of external washing / sitz bath drugs, thereby helping to improve the local effective ingredient residence time and transdermal penetration efficiency. This formula has a definite and significant effect on vulvar hypopigmentation diseases, especially in relieving intractable itching, promoting pigment recovery, and improving skin hardening / atrophy. It is also safe, has few adverse reactions, and has a low recurrence rate.

[0039] (2) The formula combines clearing heat and detoxifying, removing dampness and dispelling wind, relieving itching and promoting tissue regeneration to quickly improve the main symptoms: Xu Changqing in the formula is more inclined to dispel wind and relieve itching, and unblock the meridians and relieve pain. For the stubborn itching, burning pain, stinging pain and tightness that are common in vulvar hypopigmentation diseases, transdermal application can make its effect more concentrated on the local lesion; Kochia scoparia is good at clearing heat and removing dampness, dispelling wind and relieving itching. When combined with Xu Changqing, it can enhance the antipruritic effect and reduce the damage and secondary stimulation caused by scratching; Dandelion is good at clearing heat and detoxifying, reducing swelling and dissipating nodules, which helps to reduce the local "heat toxin / inflammatory stimulation" reaction; Smilax glabra focuses on detoxifying and removing dampness, and unblocking the meridians. When combined with Dandelion, Polygonum cuspidatum and other herbs, it can improve the pathological basis of damp-heat and toxin, and prolonged recurrence; Bletilla striata has the advantages of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration. For the skin and mucous membrane barrier damage such as scratching, cracking, erosion and exudation, when used with Sanguisorba officinalis, Daemonorops draco and other herbs, it can promote wound healing, hemostasis and tissue regeneration. The combination of the above-mentioned drugs forms a structured formula of "clearing heat, detoxifying, and removing dampness (dandelion, Smilax glabra) - dispelling wind, relieving itching and pain (Cynanchum paniculatum, Kochia scoparia) - astringing sores, stopping bleeding, and promoting tissue regeneration (Bletilla striata)". It works synergistically with the blood-activating, meridian-clearing, tissue-regenerating, and pain-relieving drugs in the formula. Combined with borneol to enhance penetration and transdermal drug delivery, it can more effectively concentrate its action on the vulvar lesions, help to quickly relieve itching and burning pain, improve skin lesions, promote tissue repair and pigmentation recovery, and improve the stability of the therapeutic effect.

[0040] (3) Cooling blood and stopping bleeding, astringing and healing sores, promoting wound and mucosal repair: The ingredients of the formula, such as Sanguisorba officinalis and Daemonorops draco, have the functions of cooling blood and stopping bleeding, astringing and healing sores. Combined with transdermal patch administration, it can help improve local erosion, exudation, cracking and other skin lesions, and promote tissue repair and skin barrier recovery in the lesion site.

[0041] (4) Promote blood circulation, remove blood stasis, unblock collaterals and relieve pain, improve hypertrophic sclerosis and pain discomfort: Angelica sinensis, frankincense, myrrh and other ingredients in the formula promote blood circulation, remove blood stasis, regulate qi and relieve pain. When combined with Polygonum cuspidatum and other ingredients, and with local continuous penetration, it can help improve local microcirculation and tissue nutrition status, relieve pain, tightness and hypertrophic sclerosis related discomfort, and promote tissue reconstruction in the process of pigment recovery.

[0042] (5) Synergistic effect of “penetration aid carrier + drug delivery” to improve transdermal absorption and medication experience: Horse oil as a matrix has moisturizing, penetration aid and skin repair friendly properties. Combined with 1 to 3 parts of borneol, which has aromatic penetration and drug delivery effects, it can further improve the transdermal absorption efficiency and local comfort, reduce dryness and friction, and improve the external experience and the feasibility of continuous treatment.

[0043] (6) Acupoint manipulation and meridian pushing promote the "medicinal power entering the meridian" and enhance the synergistic effect of local and meridian: After cleaning the vulva and applying the paste, apply acupoints such as the pulse, uterus, and perineum to the affected area by pressing, kneading, and pushing along the path of the liver meridian of the vulva. Each operation lasts for 20 minutes. This can help to dredge the meridian, regulate qi and blood, and improve local microcirculation, thereby promoting drug absorption and tissue repair, and making the "medicinal power + meridian qi" synergistic effect.

[0044] (7) Adding head acupuncture to enhance overall regulation helps stabilize efficacy and control recurrence: Simultaneously acupuncture Baihui, Xuanli, Xuanlu and Qubin acupoints, retaining needles for 30 minutes, and performing a balanced tonifying and reducing technique once during the period, can help achieve overall functional regulation through acupoint stimulation, forming a "local-overall" synergy with local transdermal drug delivery and local acupoint manipulation, thereby improving efficacy stability and significantly reducing the risk of recurrence.

[0045] (8) Clear process and treatment parameters facilitate standardized implementation and clinical replication: This invention combines external application, acupoint manipulation (20 minutes) and acupuncture (30 minutes of needle retention) into a fixed process, and adopts a management path of 18 days / treatment course, 3 consecutive treatment courses, and post-treatment follow-up, which can improve the operability and replicability of the technical solution, facilitate standardized promotion and application, and help to objectively evaluate the stability of efficacy and recurrence.

[0046] (9) The mechanism of action of the transdermal topical Chinese medicine preparation provided by this invention may be the result of the synergistic effect of multiple targets, such as transdermal absorption of the effective components of Chinese medicine, regulation of qi and blood, improvement of microcirculation, anti-inflammatory and immune regulation, through acupoint stimulation. This approach can significantly improve the quality of life of patients and provides a safe and effective new non-hormonal treatment strategy for clinical practice, which has important clinical application value and promotion prospects. Detailed Implementation

[0047] This invention discloses a transdermal topical preparation of traditional Chinese medicine for treating vulvar hypopigmentation. Those skilled in the art can refer to this document and, without departing from the spirit of this invention, make appropriate adjustments to the weight range of the traditional Chinese medicine components, the type of matrix, the preparation process parameters, and the acupoint operation parameters to achieve the desired effect. It is particularly important to note that all equivalent substitutions and obvious modifications made based on the concept of this invention should be considered to fall within the protection scope of this invention.

[0048] Example 1:

[0049] This embodiment provides a transdermal preparation of traditional Chinese medicine for treating vulvar hypopigmentation. The transdermal preparation is a paste made by mixing traditional Chinese medicine powder with horse oil. Horse oil, as a matrix, has good permeability, moisturizing and repair properties, which can make the medicine powder (traditional Chinese medicine powder) uniformly form a paste and help with transdermal absorption and skin barrier repair. The traditional Chinese medicine powder is composed of the following ingredients by weight: 12g of Cynanchum paniculatum, 15g of Taraxacum mongolicum, 12g of Kochia scoparia, 12g of Smilax glabra, 15g of Bletilla striata, 10g of Polygonum cuspidatum, 9g of Buthus martensii, 10g of Sanguisorba officinalis, 10g of Daemonorops draco, 9g of Angelica sinensis, 9g of Boswellia carterii, 9g of Commiphora myrrha, and 2g of Borneol.

[0050] This embodiment also provides a method for preparing a transdermal traditional Chinese medicine preparation for treating vulvar hypopigmentation. The method for preparing the transdermal traditional Chinese medicine preparation is as follows: The above-mentioned traditional Chinese medicinal materials are pulverized separately (e.g., pulverized to 80-120 mesh), sieved, and then mixed evenly to obtain traditional Chinese medicine powder; an appropriate amount of horse oil is taken as a base and fully mixed with the traditional Chinese medicine powder in a ratio that can form a uniform paste to obtain a transdermal traditional Chinese medicine paste. The paste should have good spreadability and adhesion to facilitate the formation of a stable drug film in the vulvar lesion area and promote transdermal absorption. In this embodiment, the mass ratio of horse oil to traditional Chinese medicine powder is 1:(0.5-0.8); specifically, the mass ratio of horse oil to traditional Chinese medicine powder is 1:0.6.

[0051] In this embodiment, the transdermal topical Chinese medicine preparation is used in conjunction with acupoint manipulation and acupuncture at scalp acupoints. The specific operation method is as follows:

[0052] (1) Local treatment: Clean and dry the affected area of ​​the vulva.

[0053] (2) Transdermal application: Apply the paste obtained in Example 1 evenly to the vulvar lesion area so that the drug covers the lesion and forms a continuous drug layer.

[0054] (3) Acupoint manipulation and pushing: Pointing, pressing and kneading techniques are used on the acupoints of Jimai, Zigong, and Huiyin, and pushing is performed along the path of the liver meridian of the vulva. The total duration of a single treatment is 20 minutes.

[0055] (4) Head acupuncture: Simultaneously acupuncture Baihui, Xuanli, Xuanlu and Qubin acupoints. After routine disinfection, insert the needles and retain them for 30 minutes. During the retention period, perform a balanced tonifying and reducing technique once.

[0056] (5) Treatment course setting: 18 days is one course of treatment, and three courses of treatment are performed consecutively; follow-up is conducted after the course of treatment to observe the stability of the efficacy and recurrence.

[0057] In this embodiment, to improve clinical operability, the consistency of the paste can be adjusted according to the ambient temperature and the patient's skin tolerance; the intensity of the point, pressing, and kneading techniques can be appropriately increased or decreased according to the patient's pain tolerance; the pushing technique should be performed evenly and continuously along the liver meridian; the even tonifying and reducing technique during the retention of needles in the head can be performed once in the middle. All the above adjustments do not change the core technical solution of this invention.

[0058] The transdermal topical preparation of traditional Chinese medicine provided by this invention, combined with acupressure on acupoints such as Jimai, Zigong, and Huiyin, and pushing along the liver meridian (20 minutes each time), along with acupuncture at Baihui, Xuanli, Xuanlu, and Qubin acupoints with needle retention for 30 minutes, and one even tonifying and reducing treatment during this period, facilitates the formation of a synergistic treatment system of "local transdermal drug delivery - meridian and acupoint stimulation - overall regulation". This method can effectively improve vulvar itching, burning pain, dryness and cracking, and skin lesions, and promote pigmentation recovery. It can be used in the preparation of topical preparations for treating vulvar hypopigmentation. The following clinical data illustrates the application effect of the technical solution of this invention.

[0059] One hundred and eighty patients with vulvar hypopigmentation who visited the Obstetrics and Gynecology Treatment Center of Changchun University of Traditional Chinese Medicine were selected. They were randomly divided into treatment group 1, treatment group 2, treatment group 3 and control group, with 45 patients in each group. The mean age of treatment group 1 was (44.27±5.17) years, the mean duration of disease was (2.71±1.67) years, and the mean lesion area was (45.13±4.58)%. The mean age of treatment group 2 was (44.77±4.37) years, the mean duration of disease was (2.58±1.89) years, and the mean lesion area was (46.03±2.58)%. The mean age of treatment group 3 was (45.41±3.17) years, the mean duration of disease was (2.31±2.08) years, and the mean lesion area was (46.01±3.18). The mean age of the control group was (44.11±3.9) years, the mean duration of disease was (3.13±1.85) years, and the mean lesion area was (45.67±5.02)%. There were no statistically significant differences in age and duration of disease among the four groups (P>0.05), indicating comparability.

[0060] 1. Diagnostic criteria

[0061] 1.1 The Western medicine diagnostic criteria refer to the standards established in "Obstetrics and Gynecology".

[0062] Main symptoms:

[0063] (1) Itching, burning pain in the vulva or perianal skin;

[0064] (2) Decreased skin elasticity in the affected area, atrophy and narrowing of the vaginal opening, dryness and discomfort, leading to difficulty in urination or pain during intercourse;

[0065] (3) Repeated cracking and ulceration of the skin at the affected area, or accompanied by abnormal vaginal discharge.

[0066] At least one of the above symptoms must be present.

[0067] Physical signs:

[0068] (1) Decreased pigmentation of the skin of the vulva or perianal region;

[0069] (2) The skin at the affected area becomes thin, the labia majora and minora and the clitoris atrophy and adhere, and even the vaginal opening becomes narrow;

[0070] (3) The affected skin is cracked, wrinkled and peeling, or the skin and mucous membranes are thickened, resembling leather or eczema.

[0071] At least one of the above physical signs must be present.

[0072] Auxiliary examinations: Pathological classifications include: ① Squamous hyperplasia type: hyperkeratosis or parakeratosis of vulvar squamous epithelial cells, irregular proliferation of spinous cells, and varying amounts of inflammatory cell infiltration in the superficial dermis. ② Lichen sclerosus type: epidermal atrophy and thinning, hyperkeratosis, accompanied by a decrease in melanocytes, and blunting or disappearance of epithelial pegs; early superficial dermal edema, later collagen fibrosis leading to structural loss and the formation of homogenized bands, accompanied by band-like infiltration of lymphocytes. ③ Mixed type: microscopic examination shows the coexistence of both hyperplasia and sclerosing types. Diagnosis can be made based on the above main symptoms, essential signs, combined with medical history and auxiliary examinations. Pathological diagnosis is mandatory; if it has been performed within 6 months prior to the consultation, it is not mandatory.

[0073] 1.2 Traditional Chinese Medicine Diagnostic Criteria

[0074] The diagnostic criteria for vulvar pruritus were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" and "Traditional Chinese Medicine Gynecology".

[0075] Symptoms: Vulvar itching or even pain, worsening at night; thinning, atrophy, or thickening of the skin in the affected area of ​​the vulva and / or anus; cracking, fissures, and ulcers may also occur. In the later stages of the disease, the labia minora may fuse, the labia majora may flatten, and the vagina may become narrow or even atrophy and close. It may be accompanied by shortness of breath, fatigue, lower back pain, tinnitus, hot flashes, and sweating.

[0076] 2. Inclusion criteria

[0077] (1) Meets the diagnostic criteria;

[0078] (2) Patients diagnosed with vulvar hypopigmentation by pathological biopsy;

[0079] (3) Those who gave informed consent to this experiment.

[0080] 3. Exclusion Criteria

[0081] (1) Individuals allergic to the test drug;

[0082] (2) Vulvar cancer or precancerous lesions;

[0083] (3) Those with severe mental or neurological disorders and cognitive impairment.

[0084] 4. Criteria for Removing Shedged Items

[0085] (1) Individuals allergic to the test drug;

[0086] (2) Vulvar cancer or precancerous lesions;

[0087] (3) Those with severe mental or neurological disorders and cognitive impairment.

[0088] Management of dropout cases: Contact subjects through various means to obtain and record the reasons for dropout, the last treatment time, and completed observation data. Different solutions should be adopted for different reasons. If adverse reactions or allergies occur, or the treatment regimen is ineffective, treatment and intervention measures should be implemented to minimize the impact and harm of such events. Clinical trial data on dropout cases should be preserved.

[0089] 5. Termination Criteria

[0090] (1) Adverse events such as severe allergic reactions or worsening of the condition that are difficult to control during treatment;

[0091] (2) Other serious illnesses were diagnosed during the trial;

[0092] (3) The patient is unwilling to continue during the clinical trial and applies to the attending physician to withdraw.

[0093] 6. Disease Score Criteria

[0094] Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition), we formulated scoring standards for the extent of vulvar skin lesions, vulvar hypopigmentation, and vulvar pruritus.

[0095] 6.1 Scoring criteria for the extent of skin lesions

[0096] Vulvar lesion extent grading (total 12 points): Grade I (1~3 points), Grade II (4~7 points), Grade III (8~10 points), Grade IV (11~12 points).

[0097] Calculation method: 1 point each for the left and right labia majora and minora, 1 point each for the left and right labial grooves and vaginal walls, and 1 point each for the perineum, clitoris, urethral opening and anus. The cumulative score based on the extent of vulvar lesions can be divided into grades I-IV, where grades I and II are mild lesions, and grades III and IV are moderate to severe lesions.

[0098] 6.2 Scoring criteria for vulvar hypopigmentation

[0099] Based on the degree of vulvar hypopigmentation, it can be divided into 4 colors: white (3 points), pink (2 points), red (1 point), and light brown (0 points).

[0100] 6.3 Scoring criteria for vulvar pruritus

[0101] Vulvar itching can be classified according to its severity as follows: Mild (1 point): Vulvar itching occurs occasionally; Moderate (2 points): Itching occurs frequently, but does not affect daily life and can be controlled with medication; Severe (3 points): Vulvar itching occurs frequently, affects daily life, and cannot be controlled with ordinary medications.

[0102] 7. Treatment methods

[0103] 7.1 Treatment Group 1: Transdermal Chinese medicine combined with acupoint manipulation and scalp acupuncture

[0104] After cleaning the vulva, the paste from Example 1 was applied to the affected area. Then, acupressure, pressing, and kneading techniques were used on the acupoints of Jimai, Huiyin, and Zigung. Pushing techniques were applied along the liver meridian pathway of the vulva. Each treatment lasted 20 minutes. The use of heat-clearing, blood-stasis-removing, and itch-relieving Chinese herbal medicine facilitated the application of these techniques, which in turn allowed the medicine to penetrate deeper into the affected area, relieving unbearable vulvar itching and pain, improving skin and mucous membrane lesions, and restoring skin color and elasticity. Simultaneously, acupuncture was performed on Baihui, Xuanli, Xuanlu, and Qubin acupoints, with needles retained for 30 minutes, during which a balanced tonifying and reducing technique was applied once.

[0105] Treatment Group 2: Transdermal Chinese medicine combined with acupoint manipulation (excluding acupuncture at head acupoints).

[0106] Treatment Group 3: Topical application of traditional Chinese medicine preparations (without acupuncture at the affected acupoints or acupuncture at the head acupoints).

[0107] 7.2 Control group: Bamboo red mycotoxin was applied topically to the affected area.

[0108] The control group received topical application of bamboo red mycotoxin ointment (Yunnan Baiyao Group Dali Pharmaceutical Co., Ltd., National Drug Approval Number Z5302282) once a day.

[0109] For all four treatment groups, a standard chemotherapy regimen was established, with each cycle lasting 18 days. For premenopausal patients, treatment should begin immediately after menstruation ends, lasting 18 consecutive days. After completing one cycle, a comprehensive analysis and evaluation of the treatment effect will be conducted. The entire treatment process consists of three cycles. Six months after the completion of treatment, patients will be followed up for one month to further understand the treatment effect and changes in their condition.

[0110] 8. Observation Items and Methods

[0111] Efficacy indicators were evaluated before treatment and after each course of treatment, and recurrence was observed 6 months after treatment.

[0112] 8.1 Therapeutic Indicators

[0113] (There are no definitive laboratory indicators for this disease as reliable standards for observation. Currently, observation is mostly based on the degree of improvement in the patient's symptoms and changes in physical signs.)

[0114] (1) Improvement in clinical symptoms and signs;

[0115] (2) Colposcopy;

[0116] 8.2 Comprehensive Efficacy Evaluation Criteria

[0117] Based on the 2002 "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the following formula is proposed: Efficacy Index (n) = [(Pre-treatment condition score - Post-treatment condition score) / Pre-treatment condition score] × 100%

[0118] (1) Cured: symptoms such as vulvar itching and pain are eliminated, skin elasticity is restored, skin color in the lesion area turns brown, n≥90%, and there has been no recurrence for 6 months after stopping the medication.

[0119] (2) Significant effect: Vulvar itching and pain are significantly reduced, and the skin turns pink, 70%≤n<90%.

[0120] (3) Effective: Vulvar itching and pain are relieved to a certain extent, and the skin at the lesion site is pink or mottled, 30%≤n<70%.

[0121] (4) Ineffective: Symptoms and signs did not improve significantly, n<30%.

[0122] 9. Follow-up criteria

[0123] All cases were followed up for 6 months after the end of treatment.

[0124] (1) Stable or basically stable: After a month of follow-up observation, the patient’s vulvar itching symptoms did not reappear, or only occasional mild itching occurred, and the overall condition remained stable or basically stable.

[0125] (2) Recurrence: Patients who have responded to treatment will experience vulvar itching again, and the area of ​​vulvar depigmentation will increase, and the color and texture of the skin will deteriorate significantly.

[0126] 10. Adverse Event Records

[0127] Record adverse events truthfully, including the time of occurrence, severity, measures taken, and outcome.

[0128] 11. Statistical Methods

[0129] Data were analyzed using SPSS 20.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s) and analyzed using t-tests; categorical data were expressed as percentages (%) and analyzed using chi-square tests. A p-value < 0.05 was considered statistically significant.

[0130] 12. Results

[0131] 12.1 The therapeutic effect was significant, with substantial improvement in core symptoms and signs.

[0132] Overall therapeutic efficacy was outstanding: the total effective rate of the treatment group (transdermal Chinese medicine + acupoint manipulation + scalp acupuncture) reached 95.56%, which was significantly higher than that of the control group (P<0.05). The combined therapy was effective in improving vulvar itching, promoting pigmentation recovery, and improving skin elasticity.

[0133] Table 1. Comparison of clinical efficacy among the groups (n=45)

[0134] Group get well Effective efficient invalid Overall effectiveness % Treatment group 1 21 12 10 2 95.56 Treatment group 2 16 12 14 3 93.33 Treatment group 3 17 13 11 4 91.11 control group 14 10 8 13 71.11

[0135] Table 2 Comparison of the percentage of vulvar depigmentation area in groups 2 (n=45)

[0136] Group First course of treatment Second course of treatment Third course of treatment Treatment group 1 24.09±3.20 <![CDATA[18.94±2.32 ## ]]> <![CDATA[7.23±1.03 ## ]]> Treatment group 2 25.27±2.31 19.58±2.02 <![CDATA[8.34±1.32 ## <!-- 10 -->]]> Treatment group 3 24.86±3.19 19.49±3.13 <![CDATA[8.71±1.52 # ]]> control group 25.48±2.16 20.29±1.92 9.54±1.67

[0137] Note: Compared with the control group, # P＜0.05， ## P＜0.01。

[0138] Table 3 Comparison of recurrence rates at 6-month follow-up after treatment

[0139] Group Number of cases without recurrence Number of relapses Recurrence rate % Treatment group 1 40 3 6.98 Treatment group 2 38 4 9.52 Treatment group 3 36 5 12.20 control group 23 9 28.13

[0140] As shown in Tables 1 to 3, the efficacy of each group showed a gradient difference: Treatment group 1 had the best overall effect: the highest total effective rate, the most significant improvement in the area of ​​pigment loss, and the lowest recurrence rate during follow-up; Treatment group 2 was second best: the total effective rate and the improvement in the area of ​​pigment loss were both better than the control group, suggesting that "transdermal + acupoint manipulation" has a stable synergistic effect; Treatment group 3 was still better than the control: transdermal application alone can achieve certain efficacy, but overall it is not as good as group 1 and group 2.

[0141] Typical case examples:

[0142] (1) Ms. Ma, 43 years old, presented in June 2023 with a history of vulvar itching for over a year, which had worsened over the past two months. Two months prior, her vulvar symptoms had worsened without any obvious cause, affecting her daily life. A gynecological examination revealed vulvar hypopigmentation. She experienced vulvar itching, restlessness, worsening symptoms at night, irritability, occasional chest tightness, and foot fright. Her appetite was good, but her sleep was poor. Her urination was normal, but her bowel movements were incomplete. Her tongue was red with a thin yellow coating, and her pulse was wiry. Traditional Chinese medicine diagnosed her with vulvar sores and heat toxicity syndrome, while Western medicine diagnosed her with vulvar leukoplakia. She was treated with the transdermal preparation of traditional Chinese medicine from Example 1 of this invention, combined with acupoint manipulation and head acupoint acupuncture, once daily for one course of treatment. The itching was reduced, and the clinical symptoms disappeared after three courses of treatment. She was followed up until March 2024 without recurrence.

[0143] (2) Ms. Liu, female, 50 years old, presented in November 2023 with a 3-year history of vulvar itching and worsening local swelling and pain over the past 3 days. She reported experiencing vulvar itching 3 years prior without any obvious cause. Pathological examination revealed vulvar leukoplakia. Over the past 3 days, she felt the above symptoms had worsened, with the discovery of boils and pain on the vulva. The vulvar itching was accompanied by local boil pain, which worsened at night. She also experienced irritability, chest tightness, normal appetite, poor sleep, yellow urine, occasional involuntary urinary incontinence, and loose stools. Her tongue was pale red with a thin white coating, and her pulse was deep. Traditional Chinese medicine diagnosed her with vulvar cold-dampness syndrome, while Western medicine diagnosed her with vulvar hypopigmentation. She was treated with the transdermal Chinese medicine preparation described in Example 1 of this invention, combined with acupoint manipulation and head acupoint acupuncture, once daily for one course of treatment. The itching lessened, and after three courses of treatment, the clinical symptoms disappeared. Follow-up until August 2024 showed no recurrence.

[0144] (3) Ms. Lü, 51 years old, came to the clinic in November 2023 due to vulvar itching for more than one year, which had worsened for three days. She had vulvar itching accompanied by pain, which was relieved at night. She also had lower abdominal heaviness, back pain, irritability, chest tightness, good appetite and sleep, yellow urine, and normal bowel movements. Her tongue was pale red with a thin white coating and her pulse was deep. Traditional Chinese medicine diagnosed her with vulvar cold-dampness syndrome, while Western medicine diagnosed her with vulvar hypopigmentation. She was treated with the transdermal preparation of traditional Chinese medicine in Example 1 of this invention, combined with acupoint manipulation and head acupoint acupuncture, once a day for one course of treatment. The itching was relieved, and the clinical symptoms disappeared after three courses of treatment. She was followed up until July 2024 and there was no recurrence.

[0145] (4) Ms. Pan, female, 50 years old, had vulvar itching for 10 years without systematic treatment. Half a month ago, the vulvar itching worsened without any obvious cause. She visited the clinic in May 2023. Currently, she has vulvar itching accompanied by pain. Her appetite is fair but her sleep is poor. Her bowel movements are normal. Her tongue is red with a thick white coating and her pulse is deep and thready. The TCM diagnosis is vulvar sores with heat toxin syndrome, and the Western medicine diagnosis is vulvar hypopigmentation disease. She was treated with the transdermal preparation of Chinese medicine in Example 1 of this invention, combined with acupoint manipulation and acupuncture manipulation of head acupoints, once a day for 1 course of treatment. The itching was relieved. After 4 courses of treatment, the clinical symptoms disappeared. She was followed up until December 2023 and there was no recurrence.

[0146] It should be noted that the transdermal topical Chinese medicine preparation combined with acupoint manipulation and acupuncture treatment provided by this invention is a comprehensive external treatment plan of traditional Chinese medicine formed on the basis of long-term clinical practice. The Chinese medicine formula and its transdermal delivery method, acupoint manipulation (pointing, pressing, and kneading relevant acupoints of the affected area such as the pulse point, uterus, and perineum, and pushing along the liver meridian of the vulva), and head acupuncture (Baihui, Xuanli, Xuanlu, and Qubin, with needles retained for 30 minutes and one even tonifying and reducing treatment) are all derived from years of clinical application and summarization, and have been used in the treatment of patients with vulvar leukoplakia (vulvar hypopigmentation disease) in relevant clinical institutions / clinics. The above content is only a description of part of the clinical application data of the treatment plan of this invention and does not constitute a limitation on the application scenario of this invention.

[0147] The above description represents a preferred embodiment of the present invention and is not intended to limit the invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention, such as the weight range of the raw materials, the paste matrix, the preparation process parameters, the selection of acupoints and the operation time, the needle retention time, and the manipulation techniques, should be included within the scope of protection of the present invention.

Claims

1. A transdermal topical preparation of traditional Chinese medicine for treating vulvar hypopigmentation, characterized in that, The transdermal preparation of traditional Chinese medicine is made by mixing traditional Chinese medicine powder with horse oil to form a paste, with the mass ratio of horse oil to traditional Chinese medicine powder being 1:(0.5-0.8). The traditional Chinese medicine powder is composed of the following raw materials by weight: Cynanchum paniculatum 10-12, Taraxacum mongolicum 10-15, Kochia scoparia 12-15, Smilax glabra 12-15, Bletilla striata 10-15, Polygonum cuspidatum 9-12, Buthus martensii 6-10, Sanguisorba officinalis 10-12, Daemonorops draco 10-12, Angelica sinensis 6-10, Boswellia carterii 6-10, Commiphora myrrha 6-10, Borneol 1-3.

2. The transdermal topical preparation of traditional Chinese medicine for treating vulvar hypopigmentation according to claim 1, characterized in that, The Chinese herbal powder is composed of the following ingredients by weight: 12g of Cynanchum paniculatum, 15g of Taraxacum mongolicum, 12g of Kochia scoparia, 12g of Smilax glabra, 15g of Bletilla striata, 10g of Polygonum cuspidatum, 9g of Buthus martensii, 10g of Sanguisorba officinalis, 10g of Daemonorops draco, 9g of Angelica sinensis, 9g of Boswellia carterii, 9g of Commiphora myrrha, and 2g of Borneol.

3. The use of the transdermal topical preparation of traditional Chinese medicine for treating vulvar hypopigmentation as described in claim 1 or 2 in the preparation of topical preparations for treating vulvar hypopigmentation.

4. A method for preparing a transdermal topical traditional Chinese medicine preparation for treating vulvar hypopigmentation as described in claim 1 or 2, characterized in that, The preparation method is as follows: Xu Changqing, dandelion, Kochia scoparia, Smilax glabra, Bletilla striata, Polygonum cuspidatum, scorpion, Sanguisorba officinalis, dragon's blood, Angelica sinensis, frankincense, myrrh, and borneol are mixed in a weight ratio, pulverized, and passed through an 80-100 mesh sieve. Then, they are mixed with horse oil to obtain the desired transdermal preparation of traditional Chinese medicine.