Oral traditional Chinese medicine composition for treating postherpetic neuralgia, external traditional Chinese medicine composition for treating postherpetic neuralgia, preparation method and combined medication method

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to an oral traditional Chinese medicine composition and an external traditional Chinese medicine composition for treating postherpetic neuralgia, a preparation method and a combined medication method. The oral traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-12 parts of scutellaria baicalensis, 3-9 parts of rheum officinale, 9-15 parts of rhizoma anemarrhenae, 12-18 parts of lalang grass rhizome, 9-15 parts of asparagus cochinchinensis, 9-15 parts of honeysuckle, 12-18 parts of rhizoma phragmitis, 9-15 parts of burdock, 6-12 parts of cicada slough, 6-12 parts of gastrodia elata, 6-12 parts of moutan bark, 12-18 parts of kudzu vine root, 12-18 parts of dried rehmannia root and 12-18 parts of tortoise shell. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-25 parts of gypsum, 10-20 parts of gypsum rubrum, 0.1-0.3 part of borneol, 4-8 parts of mint, 3-7 parts of radix sophorae flavescentis, 4-8 parts of cortex dictamni and 1-3 parts of indigo naturalis. The traditional Chinese medicine composition achieves the aims of quickly and thoroughly relieving pain and regulating and improving the whole body.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to oral and topical Chinese medicine compositions, preparation methods, and combined administration methods for treating postherpetic neuralgia. Background Technology

[0002] Shingles, also known as herpes zoster, is an infectious skin disease caused by the varicella-zoster virus. The virus enters the body through the respiratory mucosa and is neurotropic, causing blisters along peripheral nerve fibers. After infection, approximately 10% of patients experience pain lasting more than a month. If left untreated or improperly treated, the pain can persist even after the blisters have subsided, and in some cases, it can last for decades. Postherpetic neuralgia refers to persistent, intractable pain in the shingles area for more than one month, 3-6 months after the blisters have subsided and skin lesions have formed.

[0003] Sun Yat-sen University disclosed a topical traditional Chinese medicine composition for treating postherpetic neuralgia in its Chinese invention patent application with publication number CN 103055069 A. This composition consists of 25 traditional Chinese medicinal herbs, including Gleditsia sinensis thorns, Panax notoginseng, chrysanthemum, Perilla frutescens leaves, Lycium chinense root bark, bitter almond, Cimicifuga foetida, Paeonia lactiflora, toad, Gentiana scabra, Cicadae periostracum, calcined pearl powder, Lithospermum erythrorhizon, Arisaema heterophyllum, Angelica sinensis, Sophora flavescens, Asarum sieboldii, Corydalis yanhusuo, Lobelia chinensis, Mentha haplocalyx, Fraxinus chinensis bark, Phellodendron chinense bark, and borneol. The above raw materials are ground into a fine powder, then warm-soaked in vegetable oil, filtered, and the oil is extracted to prepare a topical oil. In a clinical observation of 120 patients, this patent showed a cure rate of 72%, a total effective rate of 92%, and an average analgesic onset time of 25 minutes.

[0004] However, this patent has the following shortcomings. First, the solution only uses a single external treatment approach. Although topical medications can directly act on local lesions, for a disease like postherpetic neuralgia with complex pathogenesis and a mixture of deficiency and excess, simple external treatment is insufficient to regulate the body's overall condition and cannot fully utilize the advantages of traditional Chinese medicine's syndrome differentiation and treatment. Second, the formula contains as many as 25 ingredients with complex compatibility. The preparation process requires oil extraction, which is relatively cumbersome, and the oil-based application is not pleasant, affecting patient compliance. Third, although the solution has achieved some efficacy, 28% of patients still did not recover completely. The analgesic onset time is 25 minutes, and given the unbearable pain during acute attacks, this onset speed still has room for improvement.

[0005] Currently, commonly used Western medicine treatments for postherpetic neuralgia include antiviral drugs acyclovir and valacyclovir, antiepileptic drugs carbamazepine and pregabalin, neurotrophic drugs mecobalamin and B vitamins, and analgesics celecoxib and ibuprofen. However, Western medicine treatment still has significant limitations, mainly in three aspects. First, the analgesic effect is imperfect; clinical data shows that approximately 80% of patients still report varying degrees of pain. Second, drug side effects are significant; patients often experience adverse reactions such as dizziness, drowsiness, blurred vision, ataxia, and nausea; some analgesics also have dependence and addiction potential. Third, patients' systemic symptoms such as constipation, anxiety, irritability, depression, and difficulty urinating are not improved, seriously affecting their quality of life.

[0006] Traditional Chinese medicine (TCM) classifies shingles as a type of herpes zoster, including shingles and herpes zoster. Its pathogenesis involves the invasion of external pathogens, the transformation of toxins into fire, the intense burning of the lungs and spleen by the pathogens, and the generation of wind from the intense heat, all manifesting on the skin. This leads to obstruction of the skin's meridians, resulting in red rashes, blisters, and paroxysmal spasmodic pain. The pathogenesis of postherpetic neuralgia is even more complex, involving deficiency of vital energy, retention of pathogenic toxins, stagnation of qi and blood, accumulation of damp-heat, and obstruction of the meridians. Furthermore, many patients are elderly and weak, suffering from prolonged illness, leading to qi and blood deficiency and insufficient nourishment of the meridians, creating a situation where the weakest point becomes a breeding ground for pathogens. Therefore, treatment requires a comprehensive approach that addresses both the root cause and the symptoms, including clearing heat and detoxifying, promoting rash eruption, purging fire and cooling the blood, as well as moistening the lungs and generating fluids, dispelling wind and stopping spasms, nourishing yin and strengthening the spleen, nourishing yin and suppressing yang, and guiding fire back to its source.

[0007] Based on the above understanding, the present invention aims to provide a traditional Chinese medicine composition for treating postherpetic neuralgia with better efficacy, faster onset of action, more convenient use, and stronger systemic regulatory effect, as well as its preparation method. Summary of the Invention

[0008] The purpose of this invention is to provide an oral Chinese medicine composition, an external Chinese medicine composition, and their preparation methods for treating postherpetic neuralgia, as well as a treatment scheme using a combination of oral and external medications, to overcome the shortcomings of the prior art and achieve the therapeutic goals of rapid and thorough pain relief, systemic regulation and improvement, and no toxic side effects.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows.

[0010] The oral Chinese medicine composition provided by this invention is made from the following raw materials in parts by weight: 6-12 parts Scutellaria baicalensis, 3-9 parts Rheum palmatum, 9-15 parts Anemarrhena asphodeloides, 12-18 parts Imperata cylindrica, 9-15 parts Asparagus cochinchinensis, 9-15 parts Lonicera japonica, 12-18 parts Phragmites communis, 9-15 parts Arctium lappa, 6-12 parts Cicadae periostracum, 6-12 parts Gastrodia elata, 6-12 parts Paeonia suffruticosa, 12-18 parts Pueraria lobata, 12-18 parts Rehmannia glutinosa, and 12-18 parts Testudinis carapax. Preferably, the weight ratio of the raw materials is: 9 parts Scutellaria baicalensis, 6 parts Rheum palmatum, 12 parts Anemarrhena asphodeloides, 15 parts Imperata cylindrica, 12 parts Asparagus cochinchinensis, 12 parts Lonicera japonica, 15 parts Phragmites communis, 12 parts Arctium lappa, 9 parts Cicadae periostracum, 9 parts Gastrodia elata, 9 parts Paeonia suffruticosa, 15 parts Pueraria lobata, 15 parts Rehmannia glutinosa, and 15 parts Testudinis carapax.

[0011] The external application traditional Chinese medicine composition provided by this invention is made from the following raw materials in parts by weight: 15-25 parts gypsum, 10-20 parts gypsum fibrosum, 0.1-0.3 parts borneol, 4-8 parts peppermint, 3-7 parts sophora flavescens, 4-8 parts dictamnus dasycarpus, and 1-3 parts indigo naturalis. Preferably, the weight ratio of the raw materials is 20 parts gypsum, 15 parts gypsum fibrosum, 0.2 parts borneol, 6 parts peppermint, 5 parts sophora flavescens, 6 parts dictamnus dasycarpus, and 2 parts indigo naturalis.

[0012] In one embodiment of the present invention, the dosage form of the external herbal composition is one of ointment, gel, cream, or plaster. Most preferably, it is an ointment with petrolatum as a base, which has good spreadability, durability, and skin compatibility.

[0013] The preparation method of the oral Chinese medicine composition provided by the present invention includes the following steps: weighing the raw materials according to the specified ratio and placing them in a container, adding 15-20 times the volume of water according to the total weight of the medicinal materials, soaking at room temperature for 20-40 minutes, then heating over high heat to boiling, and then simmering over low heat for 20-40 minutes, filtering to obtain the juice, the volume of the filtrate being 70-85% of the original added water volume, and cooling to 35-45℃ to obtain the oral Chinese medicine composition. Preferably, the amount of water used is 18 times the volume of the total weight of the medicinal materials, the soaking time is 30 minutes, the simmering time is 30 minutes, the volume of the filtrate is 80% of the original added water volume, and the cooling temperature is 40℃.

[0014] The preparation method of the external application traditional Chinese medicine composition provided by the present invention includes the following steps: weighing and mixing the raw materials according to the specified ratio, pulverizing them through an 80-120 mesh sieve to obtain fine powder, mixing the fine powder with a medicinal matrix at a mass ratio of 1:2 to 1:5, and stirring thoroughly to obtain the external application traditional Chinese medicine composition. Preferably, the medicinal matrix is ​​one or a mixture of petrolatum, lanolin, silicone, and carbomer gel, and the mass ratio of the fine powder to the medicinal matrix is ​​1:3 to 1:4.

[0015] The combined medication regimen provided by the present invention is characterized by the combined use of the oral Chinese medicine composition and the external Chinese medicine composition. The oral Chinese medicine composition is taken 1-3 times a day, with each dose being 100-250mL. The external Chinese medicine composition is applied to the affected area 2-6 times a day, with each application being 1-3mm thick. The treatment lasts for 7-30 days as one course of treatment.

[0016] The beneficial effects of this invention are as follows: First, this invention employs a dual treatment approach combining oral and topical medications. The oral medication works holistically, clearing heat and detoxifying, nourishing yin and reducing fire, calming wind and stopping spasms, and guiding fire back to its source, addressing both the root cause and symptoms of postherpetic neuralgia, a condition characterized by a complex interplay of deficiency and excess. The topical medication acts directly on the affected area, clearing heat and purging fire, cooling blood and relieving pain, and promoting rash eruption and dispelling wind, with rapid and direct effects. The combined approach of internal and external treatments forms a comprehensive treatment plan that integrates both local and external approaches, resulting in significantly better efficacy than topical treatment alone.

[0017] Secondly, the oral formula of this invention is precisely formulated, following the principles of monarch-minister-assistant-guide compatibility. Scutellaria baicalensis, rhubarb, and honeysuckle are the monarch herbs, clearing heat, detoxifying, and purging fire, directly counteracting the intense heat. Anemarrhena asphodeloides, Rehmannia glutinosa, Asparagus cochinchinensis, and Imperata cylindrica are the assistant herbs, nourishing yin, clearing heat, and generating fluids, addressing both the root cause and the symptoms. Arctium lappa, Cicadae periostracum, and Pueraria lobata promote rash eruption and dissipate heat; Gastrodia elata calms wind and stops spasms; and Paeonia suffruticosa cools the blood and invigorates blood, serving as the assistant herbs. Tortoise shell nourishes yin, subdues yang, and guides fire back to its source, serving as the guiding herb, preventing the excessive depletion of vital energy by the large group of cold and bitter herbs. The entire formula combines cold and heat, attack and tonify, and clear and penetrate, reflecting an accurate grasp of the complex pathogenesis of postherpetic neuralgia, characterized by a mixture of deficiency and excess, and a deficiency of vital energy with lingering pathogenic factors. The formula integrates the principles of Baihu Tang (White Tiger Decoction) for clearing heat from the qi level and Qingying Tang (Clearing the nutritive level and cooling the blood), while also adding herbs that calm wind and stop spasms, promote rash eruption and dissipate heat, and nourish yin and guide fire, making it highly targeted.

[0018] Third, the external application formula of this invention is rationally formulated, using a large dose of gypsum combined with calcite as the main ingredient, resulting in a powerful heat-clearing and fire-purging effect that directly targets localized heat and pain. Although the dosage of borneol is small, its efficacy is significant; its aromatic and penetrating properties guide the other herbs directly to the affected area, opening the orifices, refreshing the mind, and relieving pain. Peppermint and Dictamnus dasycarpus dispel wind, detoxify, and promote rash eruption; Sophora flavescens clears heat and dries dampness; Indigo naturalis clears heat and cools the blood. The combination of these herbs forms an external treatment plan that clears heat, detoxifies, cools the blood, relieves pain, promotes rash eruption, and dispels wind. Compared to the complex formula of 25 herbs in the comparative document, the external application formula of this invention achieves superior effects with only 7 herbs, making the formula more concise and rational.

[0019] Fourth, the preparation method of this invention is simple and practical. The internal medicine formula uses the traditional decoction method, first soaking the medicinal materials to soften them and facilitate the extraction of active ingredients. After bringing to a boil over high heat, it is simmered over low heat to ensure full extraction while avoiding the volatilization and destruction of active ingredients. The external medicine formula simply involves grinding the medicinal materials into powder and mixing them with the base. The operation is simple and more convenient than the oil extraction method described in the prior art. Furthermore, the external medicine formula of this invention can be formulated into various dosage forms such as ointments and gels, offering a superior user experience compared to oil-based formulations and improving patient compliance.

[0020] Fifth, the clinical efficacy of this invention is significant. In a clinical observation of 76 patients, the topical medication took effect in just 3.8 minutes, far faster than the 25 minutes reported in the comparative document, and also far faster than the 28.3 hours for oral Western medicine. The oral medication took effect in 27.1 hours, comparable to Western medicine. In terms of analgesia, the visual analog scale score of the traditional Chinese medicine group was 2.1 points, significantly better than the 3.7 points of the Western medicine group. More importantly, this invention, through the systemic regulatory effect of the oral formula, can improve patients' systemic symptoms such as constipation, anxiety, irritability, depression, and difficulty urinating, thereby improving their overall quality of life, which cannot be achieved by simple topical treatment or Western medicine treatment.

[0021] Sixth, this invention has good safety. All medicinal materials used are commonly used traditional Chinese medicines listed in the National Pharmacopoeia, with wide availability and controllable quality. The internal formula has a reasonable combination of medicinal properties, balancing cold and heat, and combining tonification and purgation without excessively depleting the body's vital energy. The external formula acts locally, with minimal systemic absorption and mild adverse reactions. In clinical observation, only a few patients experienced mild local erythema and burning sensation, which subsided spontaneously after reducing the frequency of application, requiring no special treatment. No serious adverse reactions commonly seen with Western medicines, such as dizziness, drowsiness, blurred vision, ataxia, or drug dependence, were observed.

[0022] Seventh, this invention is economical and practical. The medicinal materials used are inexpensive, the preparation method is simple, no special equipment is required, and the cost is far lower than that of Western medicine treatment. At the same time, it has a rapid onset of action and a short course of treatment, further reducing the overall treatment cost. It is suitable for promotion and application in primary healthcare institutions and has good social and economic benefits. Detailed Implementation

[0023] The present invention will be further described in detail below with reference to specific embodiments. It should be noted that the following embodiments are only used to illustrate the present invention and are not intended to limit the scope of protection of the present invention.

[0024] All raw materials used in this invention conform to the standards of the 2020 edition of the Pharmacopoeia of the People's Republic of China and can be purchased from Chinese medicinal material markets or Chinese medicinal herb processing enterprises in various regions. Specifically, Scutellaria baicalensis is selected from Scutellaria baicalensis grown in Chengde, Hebei Province, with the best quality being thick, long, firm, and yellow in cross-section. Rheum palmatum is selected from Rheum palmatum grown in Qinghai Province, with the best quality being robust rhizomes, yellow cross-section, fragrant aroma, and bitter and slightly astringent taste. Anemarrhena asphodeloides is selected from cultivated varieties grown in Anguo, Hebei Province, with the best quality being thick, firm, and yellowish-white in cross-section. Imperata cylindrica is selected from wild varieties grown in Jiangsu Province, with the best quality being long, white, and without fibrous roots. Asparagus cochinchinensis is selected from wild varieties grown in Guizhou Province, with the best quality being large, yellowish-white, and translucent tubers. Lonicera japonica is selected from Lonicera japonica buds grown in Shandong Province, with the best quality being large, yellowish-white, and fragrant. The following are the best selections for medicinal herbs: Reed rhizome (from Jiangsu Province): Fresh reeds from Jiangsu Province, preferably robust, white, and sweet. Burdock seeds (from Northeast China): Wild burdock seeds from Northeast China, preferably large, plump, and grayish-brown. Cicada molts (from Shandong Province): Wild cicada molts from Shandong Province, preferably intact, yellow, light, and free of mud and sand. Gastrodia elata (from Yunnan Province): Wild gastrodia elata from Yunnan Province, preferably large, firm, and with a bright cross-section. Peony bark (from Tongling, Anhui Province): Peony bark from Tongling, Anhui Province, preferably with thick skin, a powdery white cross-section, and a strong aroma. Kudzu root (from Hunan Province): Wild kudzu root from Hunan Province, preferably large, firm, white, and with a high starch content. Rehmannia glutinosa (from Jiaozuo, Henan Province): Rehmannia glutinosa from Jiaozuo, Henan Province, preferably with large tubers, thin outer skin, and a dark, oily cross-section. Tortoise shells (from the carapace and plastron): Shells with intact, hard plates and free of rotten flesh are preferred. The gypsum selected is fibrous gypsum from Yingcheng, Hubei Province, with white color, fibrous texture, and softness being preferred. The calcite is a natural sulfate mineral, with lumps, white color, and hard texture being preferred. The borneol is a processed resin or chemically synthesized product of the camphor tree (Dipterocarpus santalinus), with flakes, white color, and a fragrant aroma being preferred. The peppermint is a cultivated variety from Jiangsu Province, with abundant green leaves and a fragrant aroma being preferred. The sophora flavescens is a wild variety from Shanxi Province, with thick, long roots, firm texture, and a yellowish-white cross-section being preferred. The dictamnus dasycarpus is a wild variety from Liaoning Province, with thick skin, white color, and a muttony smell being preferred. The indigo is a powder processed from the leaves of plants such as woad and indigofera tinctoria, with fine powder, bluish color, and light weight being preferred.

[0025] Regarding the pharmaceutical matrix, medical-grade white petrolatum, conforming to the standards of the 2020 edition of the Pharmacopoeia of the People's Republic of China, is used and can be purchased from chemical reagent companies, such as the medical-grade white petrolatum produced by Shanghai Maclean Biochemical Technology Co., Ltd. Medical-grade anhydrous lanolin, conforming to pharmacopoeia standards, is used and can be purchased from chemical reagent companies. Medical-grade dimethicone is used as the silicone, which can be purchased from chemical reagent companies. The carbomer gel is a hydrogel prepared with carbomer 940, which can be purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0026] Example 1: Preparation of an oral Chinese medicine composition The oral Chinese medicine composition prepared in this embodiment adopts the minimum ratio, and the weight parts of each raw material are: 6 parts of Scutellaria baicalensis, 3 parts of Rheum palmatum, 9 parts of Anemarrhena asphodeloides, 12 parts of Imperata cylindrica, 9 parts of Asparagus cochinchinensis, 9 parts of Lonicera japonica, 12 parts of Phragmites communis, 9 parts of Arctium lappa, 6 parts of Cicadae periostracum, 6 parts of Gastrodia elata, 6 parts of Paeonia suffruticosa, 12 parts of Pueraria lobata, 12 parts of Rehmannia glutinosa, and 12 parts of Tortoise shell.

[0027] The preparation method includes the following steps. First, weigh out all the raw materials according to the above-mentioned weight proportions, with a total weight of 132g. Mix the weighed herbs and place them in a stainless steel decoction container. Add 1980mL of water, which is 15 times the total weight of the herbs. Soak at room temperature for 20 minutes to allow the herbs to fully absorb water and soften, facilitating the extraction of active ingredients. After soaking, place the container on an induction cooker and heat over high heat until boiling. Once the water surface is observed to be bubbling, immediately reduce the heat to low and maintain a gentle simmer for 20 minutes. Stir occasionally during the decoction process to prevent the herbs from sticking to the pot. After decoction, filter through four layers of gauze, discard the residue, and collect the filtrate. The volume of the filtrate is approximately 1386mL, which is 70% of the original water volume. Cool the filtrate to 35℃ before use.

[0028] The oral Chinese medicine composition prepared in this embodiment is dark brown in color, has the unique aroma of Chinese medicine, and tastes bitter and slightly astringent, consistent with the sensory characteristics of Chinese medicine decoctions. The dosage of each herb in this formula is the minimum, making it suitable for patients with mild symptoms and a weak constitution. The formula uses 6g of Scutellaria baicalensis to clear heat and purge fire without being overly bitter or cold; 3g of Rheum palmatum to purge fire and promote bowel movement with a mild effect; and 9g of Anemarrhena asphodeloides to nourish yin and clear heat. Together with other herbs, these herbs exert the effects of clearing heat and detoxifying, nourishing yin and reducing fire, and calming wind and stopping spasms.

[0029] Example 2 Preparation of Oral Traditional Chinese Medicine Composition The oral Chinese medicine composition prepared in this embodiment adopts the preferred ratio, and the weight parts of each raw material are: 9 parts of Scutellaria baicalensis, 6 parts of Rheum palmatum, 12 parts of Anemarrhena asphodeloides, 15 parts of Imperata cylindrica, 12 parts of Asparagus cochinchinensis, 12 parts of Lonicera japonica, 15 parts of Phragmites communis, 12 parts of Arctium lappa, 9 parts of Cicadae periostracum, 9 parts of Gastrodia elata, 9 parts of Paeonia suffruticosa, 15 parts of Pueraria lobata, 15 parts of Rehmannia glutinosa, and 15 parts of Tortoise shell.

[0030] The preparation method includes the following steps: Weigh out all the raw materials according to the above-mentioned weight proportions, with a total weight of 165g. Mix the weighed herbs and place them in a ceramic decoction container. Add 2970mL of water, which is 18 times the total weight of the herbs. Soak at room temperature for 30 minutes to fully saturate the herbs. After soaking, place the container on a gas stove and heat over high heat until boiling. Once the water surface is observed to be bubbling vigorously, immediately reduce the heat to low and maintain a gentle simmer for 30 minutes. Stir every 10 minutes during the decoction process to ensure even heating of the herbs. After decoction, filter twice through fine gauze and collect the filtrate. The volume of the filtrate is approximately 2376mL, which is 80% of the original water volume. Cool the filtrate to 40℃ before taking it in divided doses.

[0031] The oral Chinese medicine composition prepared in this embodiment is dark brown with a slight reddish tinge, has a rich and aromatic aroma, and a bittersweet taste, with a more mellow flavor than that of Example 1. This formulation is an optimal ratio and is suitable for most patients with postherpetic neuralgia. The dosage of Scutellaria baicalensis (9g) enhances its heat-clearing and fire-purging effects, the dosage of Rheum palmatum (6g) provides a moderate purgative and bowel-clearing effect, and the dosage of Anemarrhena asphodeloides (12g) further improves its yin-nourishing and heat-clearing effects. Combined with 15g of Imperata cylindrica root to clear lung and stomach heat and cool the blood; 12g of Asparagus cochinchinensis root to clear lung heat, generate fluids, nourish yin, and moisten dryness; 12g of Lonicera japonica flower to clear heat, detoxify, and disperse wind-heat; 15g of Phragmites communis root to clear heat, purge fire, generate fluids, and relieve irritability; 12g of Arctium lappa fruit to disperse wind-heat, detoxify, and promote rash eruption; 9g of Cicadae periostracum to disperse wind-heat, promote rash eruption, calm wind, and stop spasms; 9g of Gastrodia elata to calm wind, stop spasms, dispel wind, and unblock the meridians; 9g of Paeonia suffruticosa root bark to clear heat, cool the blood, invigorate blood, and remove blood stasis; 15g of Pueraria lobata root to reduce fever, promote rash eruption, generate fluids, and quench thirst; 15g of Rehmannia glutinosa root to clear heat, cool the blood, nourish yin, and generate fluids; and 15g of Tortoise shell to nourish yin, subdue yang, and guide fire back to its source. The combination of these herbs is appropriate, working together to clear heat and detoxify, nourish yin and reduce fire, calm wind and stop spasms, and guide fire back to its source.

[0032] Example 3 Preparation of Oral Traditional Chinese Medicine Composition The oral Chinese medicine composition prepared in this embodiment adopts the maximum proportion, and the weight parts of each raw material are as follows: Scutellaria baicalensis 12 parts, Rheum palmatum 9 parts, Anemarrhena asphodeloides 15 parts, Imperata cylindrica 18 parts, Asparagus cochinchinensis 15 parts, Lonicera japonica 15 parts, Phragmites communis 18 parts, Arctium lappa 15 parts, Cicadae periostracum 12 parts, Gastrodia elata 12 parts, Paeonia suffruticosa 12 parts, Pueraria lobata 18 parts, Rehmannia glutinosa 18 parts, and Testudinis carapax 18 parts.

[0033] The preparation method includes the following steps: Weigh out all the raw materials according to the above-mentioned weight proportions, with a total weight of 207g. Mix the weighed herbs and place them in a clay pot, then add 4140mL of water, which is 20 times the total weight of the herbs. Soak at room temperature for 40 minutes to allow the herbs to fully absorb water and swell. After soaking, place the clay pot on an electric ceramic stove and heat over high heat until boiling. When the water surface is bubbling and the bubbles are dense, immediately reduce the heat to low and simmer for 40 minutes. Stir every 15 minutes during the simmering process and add water as needed to prevent evaporation. After simmering, first filter out large pieces of dregs with coarse gauze, then filter again with fine gauze and collect the filtrate. The volume of the filtrate is approximately 3519mL, which is 85% of the original water volume. Cool the filtrate to 45℃ before taking it in divided doses.

[0034] The oral Chinese medicine composition prepared in this embodiment has a dark, deep blackish-brown color, a strong odor, and an extremely bitter taste with a slight spiciness, indicating a potent medicinal effect. The dosage of each herb in this formula is at its maximum, making it suitable for patients with severe symptoms, a robust constitution, and excessive internal heat. The 12g dosage of Scutellaria baicalensis in the formula has a strong heat-clearing and fire-purging effect; the 9g dosage of Rheum palmatum has a significant purgative and bowel-clearing effect; and the 15g dosage of Anemarrhena asphodeloides has a significant yin-nourishing, heat-clearing, and fire-reducing effect. Combined with large doses of heat-clearing, detoxifying, yin-nourishing, fire-reducing, wind-calming, and spasm-relieving herbs, it can quickly control the pathogenic heat, calm the internal wind-yang, and relieve severe pain. Simultaneously, the 18g dosage of tortoise shell in the formula enhances the yin-nourishing, yang-subduing, and fire-returning effects, preventing excessive depletion of yin fluids by the large doses of heat-clearing and fire-purging herbs.

[0035] Example 4 Preparation of External Application Traditional Chinese Medicine Composition The external Chinese medicine composition prepared in this embodiment adopts the minimum ratio, and the weight parts of each raw material are 15 parts of gypsum, 10 parts of calcite, 0.1 parts of borneol, 4 parts of peppermint, 3 parts of sophora flavescens, 4 parts of dictamnus dasycarpus, and 1 part of indigo naturalis.

[0036] The preparation method includes the following steps: Weigh the raw materials according to the above-mentioned weight proportions, with a total weight of 37.1g. Mix gypsum, calcite, peppermint, sophora flavescens, dictamnus dasycarpus, and indigo naturalis, and place them in a traditional Chinese medicine pulverizer. Pulverize the mixture through an 80-mesh sieve to obtain coarse powder. Pulverize the coarse powder again through a 100-mesh sieve to obtain fine powder. Grind borneol separately into a fine powder and mix it evenly with the above fine powder to obtain approximately 35g of mixed powder. Weigh 140g of medical-grade white petrolatum and place it in a mortar. Gradually add the mixed powder while grinding to ensure thorough mixing of the powder and the base. At this point, the mass ratio of fine powder to petrolatum is 1:4. Continue grinding until the ointment is fine and uniform, without any grainy texture, and is a uniform light gray paste. Store the prepared ointment in a clean, dry wide-mouthed bottle, seal it, and it is ready for use.

[0037] The external herbal composition prepared in this embodiment is a light gray paste with a fine and smooth texture, good spreadability, and a cool, aromatic odor reminiscent of borneol. The dosage of each herb in this formulation is the minimum, making it suitable for patients with sensitive skin or mild symptoms. The formula uses 15g of gypsum to clear heat, purge fire, relieve irritability, and quench thirst; 10g of gypsum to enhance the heat-clearing and fire-purging effects; and a very small amount of borneol (0.1g), but its aromatic and penetrating properties guide the medicine to its fullest extent, opening the orifices, refreshing the mind, and relieving pain. Combined with 4g of peppermint to disperse wind-heat, promote qi circulation, and promote rash eruption; 3g of sophora flavescens to clear heat and promote diuresis; 4g of dictamnus dasycarpus to clear heat, dry dampness, dispel wind, and detoxify; and 1g of indigo naturalis to clear heat, detoxify, cool the blood, and purge fire, the combination of these herbs forms a mild external formula for clearing heat and relieving pain.

[0038] Example 5 Preparation of External Application Traditional Chinese Medicine Composition The external Chinese medicine composition prepared in this embodiment adopts the preferred ratio, and the weight parts of each raw material are 20 parts of gypsum, 15 parts of calcite, 0.2 parts of borneol, 6 parts of peppermint, 5 parts of sophora flavescens, 6 parts of dictamnus dasycarpus, and 2 parts of indigo naturalis.

[0039] The preparation method includes the following steps: Weigh the raw materials according to the above-mentioned weight proportions, totaling 54.2g. Dry the gypsum and calcite separately in an oven at 60℃ for 2 hours to remove moisture and make them easier to pulverize. Mix the dried gypsum and calcite with peppermint, sophora flavescens, dictamnus dasycarpus root bark, and indigo naturalis, then place in a high-speed traditional Chinese medicine pulverizer and pulverize through a 100-mesh sieve to obtain fine powder. Pulverize the fine powder again through a 120-mesh sieve to obtain extremely fine powder. Grind borneol separately into a fine powder and mix it evenly with the above extremely fine powder to obtain approximately 50g of mixed powder. Weigh 150g of medical-grade white petrolatum and 30g of anhydrous lanolin, mix them, and heat in a water bath to 60℃ to fully mix them into a homogeneous matrix. After cooling the matrix to 40℃, gradually add the mixed powder while stirring with an electric stirrer to ensure thorough mixing of the powder and matrix. At this point, the mass ratio of fine powder to matrix is ​​approximately 1:3.6. Continue stirring until the paste is smooth, uniform, and free of granules, appearing as a uniform gray paste. Pour the prepared ointment into clean, dry ointment tubes, seal, and store for later use.

[0040] The topical Chinese medicine composition prepared in this embodiment is a gray ointment with a fine and smooth texture, excellent spreadability, and a cool, aromatic scent of borneol and a faint herbal aroma. This formulation is an optimal ratio and suitable for most patients with postherpetic neuralgia. The formula contains 20g of gypsum for its powerful heat-clearing and fire-purging effects, 15g of gypsum to enhance its heat-clearing power, 0.2g of borneol to guide the medicine to the orifices, relieve pain, 6g of peppermint to disperse wind-heat, promote qi circulation, and promote rash eruption, 5g of sophora flavescens for clearing heat and promoting diuresis, 6g of dictamnus dasycarpus for clearing heat, drying dampness, dispelling wind, and detoxifying, and 2g of indigo naturalis for clearing heat, detoxifying, cooling blood, and purging fire. The combination of these herbs is appropriate, resulting in significant heat-clearing and pain-relieving effects. Furthermore, the addition of a small amount of lanolin to the base enhances the ointment's skin-friendliness and permeability.

[0041] Example 6 Preparation of External Application Traditional Chinese Medicine Composition The external Chinese medicine composition prepared in this embodiment adopts the maximum ratio, and the weight parts of each raw material are 25 parts of gypsum, 20 parts of calcite, 0.3 parts of borneol, 8 parts of peppermint, 7 parts of sophora flavescens, 8 parts of dictamnus dasycarpus, and 3 parts of indigo naturalis.

[0042] The preparation method includes the following steps. Weigh the raw materials according to the above-mentioned weight proportions, totaling 71.3g. The medicinal materials are processed using ultrafine pulverization technology. First, gypsum and calcite are pulverized at low temperature under liquid nitrogen freezing conditions to avoid heat generation during pulverization affecting the medicinal properties. Peppermint, sophora flavescens, dictamnus dasycarpus, and indigo naturalis are pulverized using an air jet mill, and all medicinal materials are passed through a 120-mesh sieve to obtain ultrafine powder. Borneol is separately finely ground and then mixed evenly with the above ultrafine powder to obtain approximately 65g of mixed powder. Weigh 9402g of carbomer and place it in a beaker, add 300mL of deionized water, stir and swell for 2 hours, then adjust the pH to 7.0 with triethanolamine to prepare a carbomer hydrogel. Gradually add the mixed powder to the carbomer gel, dispersing it simultaneously with a high-speed disperser to ensure uniform distribution of the powder in the gel. At this point, the mass ratio of fine powder to gel matrix is ​​approximately 1:4.6. Continue dispersing until the gel is fine and uniform, without any granular texture, and presents as a uniform gray-green gel. The prepared gel can be stored in a clean, dry plastic bottle and sealed for later use.

[0043] The external herbal composition prepared in this embodiment is a grayish-green gel with a light and moist texture, excellent spreadability, and a refreshing, non-greasy feel. It possesses the strong cooling sensation of borneol and the aromatic scent of traditional Chinese medicine. The dosage of each herb in this formulation is at its maximum, making it suitable for patients with severe symptoms and intense heat. The formula contains 25g of gypsum for its strong heat-clearing and fire-purging effect; 20g of gypsum to significantly enhance its heat-clearing effect; 0.3g of borneol to guide the medicine through the body and effectively relieve pain; 8g of peppermint for its powerful wind-heat dispersing effect; 7g of sophora flavescens for its significant heat-clearing and dampness-removing effect; 8g of dictamnus dasycarpus for its enhanced heat-clearing, dampness-drying, wind-dispelling, and detoxifying effects; and 3g of indigo naturalis for its increased heat-clearing, detoxifying, blood-cooling, and fire-purging power. The combined effects of these herbs are potent, resulting in rapid heat-clearing and pain-relieving effects. Furthermore, the use of a hydrogel matrix makes it refreshing and breathable, making it more suitable for use during the acute phase.

[0044] Comparative Example 1: Oral Chinese Medicine Composition Lacking Tortoise Shell The oral Chinese medicine composition prepared in this comparative example has the same proportions as that in Example 2, but the tortoise shell has been removed. The weight parts of each raw material are: 9 parts of Scutellaria baicalensis, 6 parts of Rheum palmatum, 12 parts of Anemarrhena asphodeloides, 15 parts of Imperata cylindrica, 12 parts of Asparagus cochinchinensis, 12 parts of Lonicera japonica, 15 parts of Phragmites communis, 12 parts of Arctium lappa, 9 parts of Cicadae periostracum, 9 parts of Gastrodia elata, 9 parts of Paeonia suffruticosa, 15 parts of Pueraria lobata, and 15 parts of Rehmannia glutinosa.

[0045] The preparation method is the same as in Example 2. Weigh out each raw material according to the above-mentioned weight proportions, totaling 150g. Mix the weighed herbs and place them in a ceramic decoction container. Add 2700mL of water and soak at room temperature for 30 minutes. Heat over high heat until boiling, then reduce to low heat and simmer for 30 minutes. Filter twice through fine gauze, collecting approximately 2160mL of filtrate. Cool to 40°C before use.

[0046] This comparative study aims to verify the important role of tortoise shell in the formula. Tortoise shell has the effects of nourishing yin and suppressing yang, and guiding fire back to its source. In the formula, it plays a key role in protecting the foundation and preventing the excessive consumption of yin fluids by the large group of heat-clearing and fire-purging drugs. Without tortoise shell, although the heat-clearing and fire-purging drugs in the formula, such as Scutellaria baicalensis, rhubarb, and Anemarrhena asphodeloides, can clear away fire and heat toxins, the lack of yin-nourishing and yang-suppressing effects can easily lead to excessive bitterness and coldness that damages yang, which is not conducive to long-term use.

[0047] Comparative Example 2: Oral Chinese Medicine Composition Lacking Gastrodia elata and Cicadae Periostracum The oral Chinese medicine composition prepared in this comparative example has the same proportions as that in Example 2, but the ingredients of Gastrodia elata and Cicadae Periostracum have been removed. The weight parts of each raw material are as follows: Scutellaria baicalensis 9 parts, Rheum palmatum 6 parts, Anemarrhena asphodeloides 12 parts, Imperata cylindrica 15 parts, Asparagus cochinchinensis 12 parts, Lonicera japonica 12 parts, Phragmites communis 15 parts, Arctium lappa 12 parts, Paeonia suffruticosa 9 parts, Pueraria lobata 15 parts, Rehmannia glutinosa 15 parts, and Testudinis carapax 15 parts.

[0048] The preparation method is similar to that in Example 2. Weigh out the raw materials according to the above-mentioned weight proportions, totaling 147g. Mix the weighed herbs and place them in a ceramic decoction container. Add 2646mL of water and soak at room temperature for 30 minutes. Heat over high heat until boiling, then reduce to low heat and simmer for 30 minutes. Filter twice through fine gauze, collecting approximately 2117mL of filtrate. Cool to 40°C before use.

[0049] This comparative study aims to verify the important roles of Gastrodia elata and Cicadae Periostracum in relieving wind and stopping spasms in the formula. Postherpetic neuralgia often presents with paroxysmal spasmodic pain, which Traditional Chinese Medicine (TCM) attributes to internal wind-evil and muscle spasm. Both Gastrodia elata and Cicadae Periostracum have the effects of relieving wind and stopping spasms, dispelling wind and unblocking the meridians, effectively alleviating spasmodic pain. Without these two herbs, although the formula contains heat-clearing, detoxifying, yin-nourishing, and fire-reducing herbs, its ability to control spasmodic pain is significantly weakened.

[0050] Comparative Example 3: External Chinese Medicine Composition Lacking Borneol The external Chinese medicine composition prepared in this comparative example has the same proportions as that in Example 5, but borneol has been removed. The weight parts of each raw material are 20 parts gypsum, 15 parts calcite, 6 parts peppermint, 5 parts sophora flavescens, 6 parts dictamnus dasycarpus, and 2 parts indigo naturalis.

[0051] The preparation method is similar to that in Example 5. Weigh the raw materials according to the above-mentioned proportions, with a total weight of 54g. Dry the gypsum and calcite, then mix them with peppermint, sophora flavescens, dictamnus dasycarpus root bark, and indigo naturalis. Grind the mixture through a 120-mesh sieve to obtain approximately 50g of extremely fine powder. Weigh 150g of medical-grade white petrolatum and 30g of anhydrous lanolin, mix them, heat to 60℃, cool to 40℃, then add the powdered medicine and stir until the paste is smooth and uniform.

[0052] This comparative study aims to verify the crucial role of borneol in external application formulas. Although borneol is used in extremely small quantities, its aromatic and penetrating properties guide the other medicines directly to the affected area, clearing the mind and relieving pain, which is a key factor in the rapid onset of action of external application formulas. Without borneol, although external application formulas contain gypsum and calcite for clearing heat and purging fire, the medicines have difficulty quickly penetrating deep into the skin, and the onset of action is significantly slowed down.

[0053] Comparative Example 4: Oral medication used alone This comparative example only used the oral Chinese medicine composition prepared in Example 2, and did not use the external application formula. The patient took the oral Chinese medicine composition 200 mL 3 times a day for 15 consecutive days.

[0054] Comparative Example 5: Use of topical formula alone This comparative example uses only the topical Chinese medicine composition prepared in Example 5, without using any oral medication. Patients apply the topical Chinese medicine composition four times daily, with each application approximately 2 mm thick, for 15 consecutive days.

[0055] To comprehensively evaluate the clinical efficacy of this invention, we designed a 3-year clinical observation study. The study included 76 patients diagnosed with postherpetic neuralgia, who were randomly divided into a traditional Chinese medicine (TCM) group (n=41) and a Western medicine group (n=35) using a random number table. The TCM group received treatment with the oral TCM composition prepared in Example 2 combined with the topical TCM composition prepared in Example 5. The Western medicine group received conventional Western medicine treatment, including oral pregabalin capsules 75 mg twice daily, mecobalamin tablets 0.5 mg three times daily, and celecoxib capsules 200 mg once daily.

[0056] All enrolled patients met the diagnostic criteria for herpes zoster in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases," namely, a clinical history of herpes zoster and persistent local pain 4 weeks after the skin lesions had healed. Exclusion criteria included autoimmune diseases, malignant tumors, and severe infections. In the traditional Chinese medicine group (TCM), there were 41 patients: 26 males and 15 females, aged 46-83 years (mean 66.2 years), with a disease duration of 65 days to 62 months (mean 8.3 months). Lesions were located in the head and face in 12 cases, the upper limbs in 7 cases, and the lower back, chest, and abdomen in 22 cases. In the Western medicine group (Western medicine), there were 35 patients: 22 males and 13 females, aged 48-81 years (mean 65.8 years), with a disease duration of 70 days to 58 months (mean 8.1 months). Lesions were located in the head and face in 10 cases, the upper limbs in 6 cases, and the lower back, chest, and abdomen in 19 cases. There were no statistically significant differences between the two groups in terms of gender, age, disease duration, and lesion location, making them comparable.

[0057] The treatment regimen for the traditional Chinese medicine group consisted of oral administration of the herbal composition, 200 mL three times daily, taken warm after meals; and topical application of the herbal composition to the affected area four times daily, with each application approximately 2 mm thick. In cases of severe pain, the application could be increased to once every four hours. One course of treatment lasted 15 days, and efficacy was statistically analyzed after two consecutive courses of treatment.

[0058] The observation indicators included the onset time of topical medication, the onset time of oral medication, and pain intensity. The onset time of topical medication was defined as the time required for the patient to experience a significant reduction in pain after application, recorded by the patient and the average value calculated. The onset time of oral medication was defined as the time required for the pain score to decrease by more than 30% from baseline after starting medication. Pain intensity was assessed using the visual analog scale (VAS). Patients marked their pain level on a 0-10cm scale, where 0cm represented no pain and 10cm represented unbearable pain. The distance from the marked point to 0cm was the pain score.

[0059] The efficacy evaluation criteria were based on the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine," and were assessed according to indicators such as pain, sleep, and daily life status. Cure was defined as the near disappearance of pain, normal sleep, and normal daily life status; significant effect was defined as a marked reduction in pain and a significant improvement in sleep and daily life status; improvement was defined as a reduction in pain and a slight improvement in sleep and daily life status; and ineffectiveness was defined as no improvement in pain and poor sleep and daily life status. The effectiveness rate was calculated based on cure, significant effect, and improvement.

[0060] Changes in the patient's vital signs and any adverse clinical reactions were recorded during treatment. A follow-up visit and telephone interview were conducted one year after treatment to monitor the patient's prognosis.

[0061] In addition, we conducted in vitro pharmacodynamic studies on the samples from each embodiment and comparative example. Antioxidant activity was evaluated using a DPPH free radical scavenging assay, with vitamin C as a positive control. Antibacterial activity was evaluated using an in vitro antibacterial assay, measuring the diameter of the inhibition zone against Staphylococcus aureus, Escherichia coli, and Candida albicans. Analgesic effect was evaluated using the mouse hot plate test, measuring the percentage increase in pain threshold after administration.

[0062] Clinical observation results showed that in the traditional Chinese medicine (TCM) group (41 patients), the onset time of external application was 3.8±0.15 minutes, while the onset time of oral administration was 27.1±0.97 hours, and the post-treatment visual analog scale (VAS) score for pain was 2.1±0.18. In the Western medicine (West China) group (35 patients), the onset time was 28.3±0.76 hours, and the post-treatment VAS score for pain was 3.7±0.63. The onset time of external application in the TCM group was significantly faster than that of oral administration in the West China group, with a highly statistically significant difference. The analgesic effect of the TCM group was significantly better than that of the West China group, with a greater reduction in pain score, and the difference was statistically significant.

[0063] The efficacy evaluation results showed that in the traditional Chinese medicine (TCM) group, among the 41 patients, 30 were cured, 6 showed significant improvement, 3 showed improvement, and 2 were ineffective, with a cure rate of 73.2% and a total effective rate of 95.1%. In the Western medicine (WMT) group, among the 35 patients, 18 were cured, 7 showed significant improvement, 5 showed improvement, and 5 were ineffective, with a cure rate of 51.4% and a total effective rate of 85.7%. The cure rate and total effective rate of the TCM group were both higher than those of the WMT group, and the differences were statistically significant.

[0064] Regarding adverse reactions, in the traditional Chinese medicine group, one of the 41 patients experienced mild erythema and burning sensation at the topical application site, occurring on the third day of treatment. This subsided spontaneously after three days of reduced application frequency and did not recur with continued treatment. No other adverse reactions were reported. In the Western medicine group, 8 of the 35 patients experienced dizziness, 12 experienced drowsiness, 5 experienced blurred vision, 6 experienced nausea, and 9 experienced constipation, with an adverse reaction rate of 57.1%, significantly higher than that in the traditional Chinese medicine group.

[0065] One-year follow-up results after treatment showed that among the 30 patients who recovered in the traditional Chinese medicine group, 2 relapsed, with a relapse rate of 6.7%. However, the pain level was significantly reduced compared to before treatment, and continued medication could quickly alleviate the symptoms. Among the 18 patients who recovered in the Western medicine group, 5 relapsed, with a relapse rate of 27.8%, which was significantly higher than that in the traditional Chinese medicine group.

[0066] The comparative clinical observation results showed that, in Comparative Example 1, the oral formula lacking tortoise shell resulted in increased symptoms of Yin deficiency such as dry mouth, irritability, and insomnia after 15 days of treatment, with a pain score of 2.8±0.24, indicating that the efficacy was not as good as in Example 2. In Comparative Example 2, the oral formula lacking Gastrodia elata and Cicadae Periostracum resulted in poor control of spasmodic pain after 15 days of treatment, with a pain score of 3.2±0.31, significantly higher than in Example 2. In Comparative Example 3, the external formula lacking borneol had a prolonged onset time of 15.6±1.2 minutes, much slower than the 3.8 minutes in Example 5. In Comparative Example 4, patients using the oral formula alone had a pain score of 2.9±0.26, indicating a slow onset of action and that the efficacy was not as good as the combined use of oral and external formulas. In Comparative Example 5, patients using the external formula alone had a pain score of 3.4±0.29. Although the external formula had a rapid onset of action, it lacked the systemic regulatory effect of the oral formula, limiting the overall efficacy.

[0067] In vitro pharmacodynamic studies showed that the oral formulation of Example 2 had a DPPH free radical scavenging rate of 78.3%, significantly higher than that of Comparative Example 1 (65.2%) and Comparative Example 2 (68.7%), indicating that the complete formulation had stronger antioxidant activity. The topical formulation of Example 5 showed inhibition zone diameters of 18.6 mm, 15.2 mm, and 14.8 mm against Staphylococcus aureus, Escherichia coli, and Candida albicans, respectively, all significantly larger than those of Comparative Example 3 (12.3 mm, 9.7 mm, and 9.2 mm), indicating that borneol plays an important role in enhancing antibacterial activity. Hot plate tests in mice showed that the combined use of Example 2 and Example 5 increased the pain threshold by 85.7%, significantly higher than that of Comparative Example 4 (62.3%) and Comparative Example 5 (58.9%), demonstrating a synergistic analgesic effect when used both orally and topically.

[0068] The test results are summarized in the table below:

[0069] The test results show that the combined oral and topical medication regimen of this invention has achieved clinical efficacy that is significantly superior to single treatment and Western medicine treatment.

[0070] The remarkable efficacy of this invention stems from an accurate understanding of the pathogenesis of postherpetic neuralgia and the ingenious design of its formulation. From the perspective of Traditional Chinese Medicine (TCM) theory, the pathogenesis of postherpetic neuralgia involves the invasion of external pathogens, the transformation of toxins into fire, the intense burning of the lungs and spleen by these pathogens, and the generation of wind from the intense heat, which manifests on the skin, leading to obstruction of the skin's meridians. With prolonged illness, the body's vital energy becomes deficient, pathogens linger, qi and blood stagnate, damp-heat accumulates, and the meridians become blocked, forming a complex situation of mixed deficiency and excess, with both the body's vital energy and pathogens remaining. Treatment must involve clearing heat and detoxifying to expel pathogens, nourishing yin and reducing fire to support the body's vital energy, calming wind and stopping spasms to relieve pain, and guiding fire back to its source to strengthen the body's foundation, while simultaneously using external therapies to directly target the affected area.

[0071] The formulation of this internal medicine prescription reflects a profound understanding of traditional Chinese medicine theory. Scutellaria baicalensis, bitter and cold in nature, enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It excels at clearing heat, purging fire, and detoxifying, and is one of the principal herbs. The flavonoids in Scutellaria baicalensis, such as baicalin and baicalein, have significant anti-inflammatory, antioxidant, and analgesic effects, inhibiting the release of inflammatory factors and reducing neuroinflammatory responses. Rheum palmatum, bitter and cold in nature, enters the spleen, stomach, large intestine, liver, and heart meridians. It excels at cooling the blood, detoxifying, purging accumulations, and promoting blood circulation and removing blood stasis, and is also a principal herb. The anthraquinone components in rheum palmatum, such as emodin and chrysophanol, have antibacterial, antiviral, and microcirculation-improving effects, promoting toxin excretion and improving local blood circulation. Lonicera japonica, sweet and cold in nature, enters the lung, heart, and stomach meridians. It excels at clearing heat, detoxifying, and dispersing wind-heat, and is the third principal herb. The chlorogenic acid and flavonoids in Lonicera japonica have broad-spectrum antibacterial, antiviral, antipyretic, and analgesic effects. The three herbs, when used together, clear heat, detoxify, and purge fire, directly counteracting the intense heat, and are the main ingredients of the entire formula.

[0072] Anemarrhena asphodeloides is bitter, sweet, and cold in nature, and enters the lung, stomach, and kidney meridians. Its functions include clearing heat and purging fire, generating fluids and moistening dryness, and nourishing yin and reducing fire. Rehmannia glutinosa is sweet, bitter, and cold in nature, and enters the heart, liver, and kidney meridians. Its functions include clearing heat and cooling blood, nourishing yin and generating fluids. Asparagus cochinchinensis is sweet, bitter, and cold in nature, and enters the lung and kidney meridians. Its functions include nourishing yin and moistening dryness, clearing the lungs and generating fluids. Imperata cylindrica is sweet and cold in nature, and enters the lung, stomach, and bladder meridians. Its functions include clearing heat and purging fire, cooling blood and stopping bleeding, and promoting urination. These four herbs act as assistant herbs, nourishing yin, clearing heat, and generating fluids. They can clear excess heat while nourishing yin fluids, preventing excessive depletion of yin fluids by other heat-clearing herbs, reflecting a treatment philosophy that addresses both the root cause and the symptoms. The polysaccharides, saponins, and amino acids contained in these herbs have immunomodulatory, antioxidant, and neuroprotective effects, which can improve the patient's overall condition.

[0073] Burdock seed is bitter, pungent, and cold in nature, and enters the lung and stomach meridians. Its functions include dispersing wind-heat, promoting lung function and relieving rashes, detoxifying, and soothing the throat. Cicada slough is sweet and cold in nature, and enters the lung and liver meridians. Its functions include dispersing wind-heat, soothing the throat and opening the voice, promoting rashes, improving eyesight and clearing corneal opacity, and calming wind and stopping spasms. Kudzu root is sweet, pungent, and cool in nature, and enters the spleen and stomach meridians. Its functions include relieving muscle tension and reducing fever, promoting rashes, generating fluids and quenching thirst, and raising yang and stopping diarrhea. These three herbs work together as adjuvants to disperse wind-heat, promote rashes and expel pathogens, helping to expel toxins. Gastrodia elata is sweet and neutral in nature, and enters the liver meridian. Its functions include calming wind and stopping spasms, suppressing liver yang, and dispelling wind and unblocking the meridians. The gastrodin and other components contained in Gastrodia elata have sedative, analgesic, and anticonvulsant effects, and can regulate the nervous system function and relieve spasmodic pain. Moutan bark is bitter, pungent, and slightly cold in nature, and enters the heart, liver, and kidney meridians. Its functions include clearing heat and cooling the blood, and promoting blood circulation and removing blood stasis. The peony bark contains components such as paeonol, which have anti-inflammatory, analgesic, and microcirculation-improving effects, reducing local congestion and edema and promoting blood circulation. Reed rhizome is sweet and cold in nature, entering the lung and stomach meridians, and excels at clearing heat and purging fire, generating fluids and quenching thirst, relieving irritability, and stopping vomiting. Combined with other auxiliary herbs, it can not only clear heat from surrounding areas and relieve wind and spasms, but also invigorate blood circulation, remove blood stasis, and relieve pain.

[0074] Tortoise shell is salty, sweet, and slightly cold in nature, and enters the liver, kidney, and heart meridians. Its functions include nourishing yin and suppressing yang, tonifying the kidneys and strengthening bones, nourishing blood and replenishing the heart, and consolidating the meridians and stopping uterine bleeding. Tortoise shell plays a crucial role in the formula as an adjuvant. The collagen, amino acids, and trace elements contained in tortoise shell nourish the liver and kidneys, strengthen tendons and bones, and calm the mind. It can guide fire back to its source and prevent upward flaring of deficient fire. In the combination of a large group of heat-clearing and fire-purging drugs, tortoise shell plays a key role in protecting the root cause and preventing excessive bitterness and coldness from damaging yang, thus ensuring that the entire formula is both tonifying and purging, and balanced in terms of cold and heat, making it suitable for long-term use.

[0075] The combination of herbs employs both warming and cooling properties, combines tonifying and purging methods, and integrates clearing and detoxifying techniques to achieve the effects of clearing heat and detoxifying, nourishing yin and reducing fire, calming wind and stopping spasms, and guiding fire back to its source. The formula embodies the treatment principle of Baihu Tang (White Tiger Decoction) in clearing heat from the qi level and generating fluids to quench thirst, and incorporates the spirit of Qingying Tang (Clearing the Ying level and cooling the blood). It also adds Gastrodia elata and Cicadae Periostracum to calm wind and stop spasms, Arctium lappa and Pueraria lobata to promote rash eruption and dissipate heat, and Tortoise shell to nourish yin and guide fire. This innovative formula is designed to address the characteristics of postherpetic neuralgia.

[0076] The combination of ingredients in the external application formula is equally exquisite. Gypsum, pungent, sweet, and extremely cold, enters the lung and stomach meridians, excelling at clearing heat and purging fire, relieving irritability and thirst, and astringing and promoting tissue regeneration. The main component of gypsum is hydrated calcium sulfate, which, when used externally, has heat-clearing, anti-inflammatory, astringent, and analgesic effects. Calcite, pungent, salty, and extremely cold, enters the heart, stomach, and kidney meridians, excelling at clearing heat and purging fire. These two herbs, used together as the principal ingredient, have a powerful heat-clearing and fire-purging effect, directly targeting localized heat and pain. Borneol, bitter, pungent, and slightly cold, enters the heart, spleen, and lung meridians, excelling at opening the orifices, refreshing the mind, clearing heat, and relieving pain. The main component of borneol is camphor, possessing a strong aromatic odor and a cooling sensation. When used externally, it can be absorbed through the skin, guiding the other herbs directly to the affected area. It also has local anesthetic and analgesic effects, key to the rapid onset of action in the external application formula. Peppermint, pungent and cool, enters the lung and liver meridians, excelling at dispersing wind-heat, clearing the head and eyes, relieving sore throat and promoting rash eruption, and soothing the liver and regulating qi. The volatile oil components of peppermint, such as menthol and menthone, have cooling, analgesic, antipruritic, and local blood circulation-promoting effects. Dictamnus dasycarpus root bark is bitter and cold, and enters the spleen, stomach, bladder, and small intestine meridians; it excels at clearing heat and drying dampness, dispelling wind and detoxifying. Sophora flavescens root is bitter and cold, and enters the heart, liver, stomach, large intestine, and bladder meridians; it excels at clearing heat and drying dampness, killing parasites, and promoting diuresis. Indigo naturalis root is salty and cold, and enters the liver, lung, and stomach meridians; it excels at clearing heat and detoxifying, cooling blood and eliminating rashes, and calming the nerves. The combination of these herbs clears heat and drains fire, cools blood and relieves pain, promotes rash eruption and dispels wind, acting directly on the affected area with rapid onset of action.

[0077] From a modern pharmacological perspective, the mechanism of action of this invention involves multiple aspects. First, the flavonoids, anthraquinones, and polyphenols contained in the heat-clearing and detoxifying herbs such as Scutellaria baicalensis, Rheum palmatum, and Lonicera japonica in the oral formula have significant anti-inflammatory and antioxidant effects. They can inhibit the activity of inflammatory enzymes such as cyclooxygenase and lipoxygenase, and reduce the production of inflammatory mediators such as prostaglandins and leukotrienes, thereby alleviating neuroinflammatory responses and relieving pain. Second, the polysaccharides, saponins, and amino acids contained in the yin-nourishing herbs such as Anemarrhena asphodeloides, Rehmannia glutinosa, and Asparagus cochinchinensis have immunomodulatory and neuroprotective effects, which can improve the body's immune function and promote the repair of damaged nerves. Third, the effective components contained in the wind-dispelling and spasm-relieving herbs such as Gastrodia elata and Cicadae periostracum can regulate neurotransmitter metabolism, inhibit abnormal neuronal discharge, and relieve spasmodic pain. In addition, the blood-activating and stasis-removing herbs such as Paeonia suffruticosa can improve local microcirculation and promote the absorption and excretion of inflammatory products. The yin-nourishing and yang-subduing herbs such as tortoise shell can regulate the neuroendocrine system, stabilize emotions, improve sleep, and improve quality of life.

[0078] In external application, gypsum and calcite, among other heat-clearing and fire-purging herbs, have cooling, anti-inflammatory, and analgesic effects. Borneol's aromatic and penetrating properties promote the transdermal absorption of other drug components, and its local anesthetic effect provides rapid pain relief. The active ingredients of peppermint, dictamnus root bark, sophora flavescens, and indigo naturalis, when applied externally, have antibacterial, anti-inflammatory, antipruritic, and local blood circulation-promoting effects.

[0079] This invention employs a combined oral and topical medication approach, achieving a perfect integration of systemic and local treatment. The oral formula works holistically, clearing heat and detoxifying, nourishing yin and reducing fire, calming wind and stopping spasms, and guiding fire back to its source, thus improving the overall condition and addressing the root cause. The topical formula acts directly on the affected area, clearing heat and purging fire, cooling blood and relieving pain, and promoting rash eruption and dispelling wind, quickly alleviating local symptoms and addressing the symptoms. The two formulas work together, treating both the internal and external aspects and addressing both the root cause and symptoms, producing a synergistic effect.

[0080] The test results fully demonstrate the superiority of this invention. The topical application of the traditional Chinese medicine (TCM) took effect in just 3.8 minutes. This rapid onset of action is attributed to the penetrating effect of borneol and its local anesthetic effect. Compared to the 25 minutes in the comparative document and the 28.3 hours for Western medicine, the onset speed of the topical application of this invention represents a qualitative leap. The oral medication took effect in 27.1 hours, comparable to Western medicine, indicating that the absorption and onset speed of the oral TCM decoction are not inferior to those of Western medicine. More importantly, the analgesic effect of the TCM group was significantly better than that of the Western medicine group, with the pain score decreasing from a baseline of 7.8 to 2.1, a reduction of 73.1%, while the Western medicine group only decreased to 3.7, a reduction of 52.6%. This demonstrates that this invention not only has a rapid onset of action but also provides better analgesia.

[0081] The efficacy evaluation results showed that the cure rate of the traditional Chinese medicine group was 73.2% and the total effective rate was 95.1%, both significantly higher than those of the Western medicine group (51.4% and 85.7%), proving that the present invention has higher clinical efficacy. The recurrence rate one year after treatment was only 6.7%, significantly lower than that of the Western medicine group (27.8%), indicating that the present invention can not only quickly relieve symptoms but also fundamentally improve the condition and reduce recurrence.

[0082] Regarding adverse reactions, only one case of mild local reaction occurred in the traditional Chinese medicine group, with an incidence rate of only 2.4%, while the incidence rate of adverse reactions in the Western medicine group was as high as 57.1%, showing a significant difference. This fully demonstrates that the present invention has good safety and is suitable for long-term use.

[0083] The results of the comparative studies further verified the scientific validity of the formulation of this invention. In Comparative Study 1, the absence of tortoise shell exacerbated the patient's Yin deficiency symptoms and reduced the therapeutic effect, demonstrating that tortoise shell plays an irreplaceable role in strengthening the body's foundation and preventing excessive use of bitter and cold herbs to damage Yang. In Comparative Study 2, the absence of Gastrodia elata and Cicadae Periostracum resulted in poor control of spasmodic pain, proving that wind-dispelling and spasm-relieving drugs play an important role in alleviating the spasmodic pain characteristic of postherpetic neuralgia. In Comparative Study 3, the absence of borneol significantly prolonged the onset of action, demonstrating that borneol plays a crucial role in guiding the drug's penetration and rapidly relieving pain in the external application formula. The results of Comparative Studies 4 and 5 demonstrate that the combined use of oral and external applications has a significant synergistic effect, and the efficacy of single treatment is significantly inferior to that of combined treatment.

[0084] In summary, this invention, through its ingenious formulation and innovative combination of oral and topical medications, achieves the therapeutic goals of rapid and thorough pain relief, systemic regulation and improvement, and no toxic side effects. It provides a safe, economical, and convenient traditional Chinese medicine treatment plan for postherpetic neuralgia, a stubborn clinical condition, and has significant clinical application value and broad prospects for promotion.

[0085] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An oral traditional Chinese medicine composition for treating postherpetic neuralgia, characterized in that... The composition is made from the following raw materials in parts by weight: Scutellaria baicalensis 6-12 parts, Rheum palmatum 3-9 parts, Anemarrhena asphodeloides 9-15 parts, Imperata cylindrica 12-18 parts, Asparagus cochinchinensis 9-15 parts, Lonicera japonica 9-15 parts, Phragmites communis 12-18 parts, Arctium lappa 9-15 parts, Cicadae periostracum 6-12 parts, Gastrodia elata 6-12 parts, Paeonia suffruticosa 6-12 parts, Pueraria lobata 12-18 parts, Rehmannia glutinosa 12-18 parts, and Testudinis carapax 12-18 parts.

2. The oral traditional Chinese medicine composition according to claim 1, characterized in that... The weight ratio of the raw materials is as follows: 9 parts Scutellaria baicalensis, 6 parts Rheum palmatum, 12 parts Anemarrhena asphodeloides, 15 parts Imperata cylindrica, 12 parts Asparagus cochinchinensis, 12 parts Lonicera japonica, 15 parts Phragmites communis, 12 parts Arctium lappa, 9 parts Cicadae periostracum, 9 parts Gastrodia elata, 9 parts Paeonia suffruticosa, 15 parts Pueraria lobata, 15 parts Rehmannia glutinosa, and 15 parts Tortoise shell.

3. A topical traditional Chinese medicine composition for treating postherpetic neuralgia, characterized in that... The composition is made from the following raw materials in parts by weight: 15-25 parts gypsum, 10-20 parts calcite, 0.1-0.3 parts borneol, 4-8 parts peppermint, 3-7 parts sophora flavescens, 4-8 parts dictamnus dasycarpus, and 1-3 parts indigo naturalis.

4. The topical Chinese medicine composition according to claim 3, characterized in that... The weight ratio of the raw materials is as follows: 20 parts gypsum, 15 parts calcite, 0.2 parts borneol, 6 parts peppermint, 5 parts sophora flavescens, 6 parts dictamnus dasycarpus, and 2 parts indigo naturalis.

5. The topical Chinese medicine composition according to claim 3 or 4, characterized in that... The dosage form of the composition is one of ointment, gel, cream, or patch.

6. A method for preparing the oral Chinese medicine composition according to claim 1 or 2, comprising the following steps: weighing the raw materials according to the proportion and placing them in a container, adding 15-20 times the volume of water of the total weight of the medicinal materials, soaking at room temperature for 20-40 minutes, then heating over high heat to boiling and then simmering over low heat for 20-40 minutes, filtering to obtain the juice, the volume of the filtrate being 70-85% of the original added water volume, and cooling to 35-45℃ to obtain the oral Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that... The amount of water used is 18 times the total weight of the medicinal materials, the soaking time is 30 minutes, the decoction time is 30 minutes, the volume of the filtrate is 80% of the original water volume, and the cooling temperature is 40℃.

8. A method for preparing the topical Chinese medicine composition according to claim 3 or 4, comprising the following steps: weighing and mixing the raw materials according to the formula, pulverizing them through an 80-120 mesh sieve to obtain fine powder, taking the fine powder and mixing it with a medicinal matrix at a mass ratio of 1:2-1:5, and stirring thoroughly to obtain the topical Chinese medicine composition.

9. The preparation method according to claim 8, characterized in that... The pharmaceutical matrix is ​​one or a mixture of petrolatum, lanolin, silicone, and carbomer gel, and the mass ratio of the fine powder to the pharmaceutical matrix is ​​1:3-1:

4.

10. A combined medication method for treating postherpetic neuralgia, characterized in that... The oral Chinese medicine composition according to claim 1 or 2 and the external Chinese medicine composition according to claim 3 or 4 are used in combination. The oral Chinese medicine composition is taken 1-3 times a day, with each dose being 100-250 mL. The external Chinese medicine composition is applied to the affected area 2-6 times a day, with each application being 1-3 mm thick. The treatment lasts for 7-30 days as one course of treatment.

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