Medicine for treating postherpetic neuralgia and preparation method thereof
By leveraging the synergistic effect of a combination of traditional Chinese medicines such as Coptis chinensis, Scutellaria baicalensis, and Phellodendron chinense, the problem of significant side effects and superficial treatment of postherpetic neuralgia in existing methods has been solved, achieving both rapid relief and fundamental cure.
Patent Information
- Application Number
- CN202511189426.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-08-25
- Publication Date
- 2025-11-14
AI Technical Summary
Existing treatments for postherpetic neuralgia suffer from significant side effects, limited target sites, and failure to address the root cause. Traditional Chinese medicine external treatment formulas are not comprehensive enough, resulting in poor treatment outcomes and a negative patient experience.
This treatment uses a combination of traditional Chinese medicines such as Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, and Gardenia jasminoides, which integrates the methods of clearing heat, promoting blood circulation, dispelling wind, regulating qi, and strengthening the body's resistance. Through synergistic effects, it can quickly relieve various types of neuralgia and treat the root cause by eliminating inflammation and improving circulation.
It achieves rapid relief of various types of neuralgia, improves microcirculation, repairs nerves, treats both the symptoms and the root cause, reduces side effects, and improves patient compliance and treatment effectiveness.
Smart Images
Figure CN120939098A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of pharmaceutical technology for treating herpes zoster, and particularly relates to a drug for treating postherpetic neuralgia and its preparation method. Background Technology
[0002] Herpes zoster is an acute infectious skin disease caused by the reactivation of the varicella-zoster virus, characterized by clusters of small blisters distributed along a unilateral peripheral nerve and severe neuralgia. Clinically, although the skin lesions may heal within weeks, the inflammatory damage and destruction caused by the virus to sensory ganglia and nerve fibers can persist for a long time, leading to an extremely intractable and severe chronic pain syndrome, namely postherpetic neuralgia (PHN). PHN is defined as pain that persists for more than 1-3 months after the rash has healed. The nature of the pain is diverse, manifesting as persistent burning pain, deep aching pain, stabbing pain, or paroxysmal electric shock-like pain, and is often accompanied by hyperalgesia and paresthesia, causing patients enormous physical and psychological suffering and severely reducing their quality of life.
[0003] Currently, modern medicine employs a comprehensive strategy for treating PHN, including systemic drug administration and topical treatment. Systemic drugs include pregabalin, gabapentin, tricyclic antidepressants, 5% lidocaine patches, and opioid analgesics. However, these treatment options generally have limitations: First, systemic medications are often accompanied by significant central and peripheral side effects such as dizziness, drowsiness, dry mouth, and constipation, leading to poor patient tolerance and low compliance. Second, while existing topical preparations such as lidocaine patches or capsaicin ointments can avoid systemic side effects, they target only a single point of action, often only temporarily relieving superficial pain and having limited effects on repairing deep nerve inflammation and damage. Furthermore, some products (such as high-concentration capsaicin) can cause a strong burning sensation, resulting in a poor patient experience. Third, the bottleneck in treatment lies in the fact that current methods mostly treat the symptoms rather than the root cause.
[0004] In the field of Traditional Chinese Medicine (TCM), this disease falls under the category of "Bi syndrome" or "pain syndrome" resulting from "shingles" or "herpes zoster" (a type of herpes zoster) and "waist-encircling fire rash." Its core pathogenesis is considered to be the lingering effects of damp-heat toxins, which accumulate in the meridians, depleting Yin and blood, leading to Qi deficiency and blood stasis, and meridian obstruction, resulting in both "pain due to obstruction" and "pain due to lack of nourishment." Conventional external TCM treatments often focus on single effects such as clearing heat and detoxifying or promoting blood circulation and removing blood stasis, and the formulations are often not comprehensive enough to address the complex and intertwined pathogenesis of PHN (herpes zoster). Furthermore, the traditional preparation processes of ointments, pills, and powders are relatively crude, making it difficult to guarantee the extraction rate of effective ingredients and the stability of the preparations. This results in slow onset of action, the need for frequent application, inconvenient dosage forms, and poor patient experience, limiting their clinical application. Therefore, there is an urgent need in this field for a well-formulated TCM composition based on the holistic concept of TCM to compensate for the shortcomings of existing treatment options. Summary of the Invention
[0005] In view of the above situation and to overcome the shortcomings of the prior art, the drug formula disclosed in this invention integrates the methods of clearing heat, promoting blood circulation, dispelling wind, regulating qi, and strengthening the body's resistance. It can not only quickly relieve neuralgia of various types, but also fundamentally treat the condition by eliminating inflammation, improving circulation, and repairing nerves.
[0006] To achieve the above objectives, the following technical solution is adopted: This invention provides a drug for treating postherpetic neuralgia, comprising the following components in parts by weight: Coptis chinensis 5-12 parts, Scutellaria baicalensis 5-12 parts, Phellodendron chinense 5-12 parts, Gardenia jasminoides 5-12 parts, Magnolia officinalis 5-12 parts, Citrus aurantium 5-12 parts, Pheretima aspergillum 5-12 parts, Cervi cornu slices (decocted first) 8-20 parts, Buthus martensii 5-12 parts, Scolopendra subspinipes 5-12 parts (head and feet removed), Glycyrrhiza uralensis 15-40 parts, Gypsum fibrosum 80-150 parts, Paeonia lactiflora 5-12 parts, Salvia miltiorrhiza 5-12 parts, Paeonia suffruticosa 5-12 parts, Leonurus japonicus 5-12 parts, Astragalus membranaceus 8-20 parts, Ligustrum lucidum 8-20 parts, Schizonepeta tenuifolia 5-12 parts, Mentha haplocalyx 5-12 parts.
[0007] The above components have the following mechanisms and pharmacological effects:
[0008] Coptis chinensis: extremely bitter and cold, it has a strong ability to clear heat and dry dampness, and to purge fire and detoxify. It is especially good at clearing heart fire and damp heat in the middle jiao, and can relieve burning pain caused by heat toxins.
[0009] Scutellaria baicalensis: Clears heat and dries dampness, drains fire and detoxifies, especially effective in clearing lung fire and upper burner heat, and can also cool the blood. When combined with Coptis chinensis, it enhances the effect of clearing heat toxins from the body.
[0010] Phellodendron bark: Clears heat and dries dampness, drains fire and detoxifies. Its nature is downward, and it is especially good at clearing damp-heat in the lower burner. Coptis chinensis, Scutellaria baicalensis, and Phellodendron bark form a powerful foundation for clearing heat and draining fire.
[0011] Gardenia: Clears heat and relieves irritability, promotes diuresis and eliminates dampness, cools the blood and detoxifies. It can guide the fire evil of the triple burner out through urination, assisting the above three medicines in providing an outlet for the heat evil.
[0012] Gypsum: pungent, sweet, and extremely cold. It clears heat and drains fire, relieves irritability and quenches thirst. It is a key medicine for clearing excess heat in the Qi level (high fever, profuse sweating, and extreme thirst). In this formula, it is used in the largest dosage, intended to use its cooling properties to powerfully clear away the accumulated intense heat and toxins in the body, showing significant effects on the "burning pain" of PHN.
[0013] Red peony root: Clears heat and cools the blood, disperses blood stasis and relieves pain. It can clear stagnant heat in the blood, promote blood circulation and unblock the meridians, and relieve stabbing pain caused by blood stasis.
[0014] Danshen (Salvia miltiorrhiza): It invigorates blood circulation, removes blood stasis, regulates menstruation, relieves pain, clears the mind, and eliminates irritability. It is a key herb for "invigorating blood circulation and removing blood stasis," significantly improving microcirculation and promoting tissue repair.
[0015] Moutan bark: Clears heat and cools the blood, invigorates blood and removes blood stasis. It can help heat-clearing drugs to remove latent heat in the blood, and it can also help blood-invigorating drugs to dissipate blood stasis in the meridians.
[0016] Motherwort: It invigorates blood circulation, regulates menstruation, promotes diuresis, reduces swelling, and clears heat and detoxifies. It can assist in promoting blood circulation and removing blood stasis, as well as eliminating dampness and toxins, thus providing a way for pathogens to be expelled.
[0017] Scorpion: It calms wind and relieves spasms, attacks toxins and disperses nodules, unblocks meridians and relieves pain. Its penetrating power is extremely strong, and it can penetrate deep into the meridians to dispel wind and stop spasms. It is especially effective for stubborn nerve spasms and lightning-like pain.
[0018] Centipede: It calms wind and relieves spasms, attacks toxins and dissipates nodules, unblocks meridians and relieves pain. Its effects are similar to those of scorpion, and they are often used together. When combined, their effects of dispelling wind, unblocking meridians, breaking up blood stasis and relieving pain are greatly enhanced, making them a core herbal pair for treating stubborn arthralgia.
[0019] Earthworm: Clears heat and calms the nerves, unblocks meridians, relieves asthma, and promotes urination. It has a strong penetrating nature, can unblock meridians and activate collaterals, and also has the function of clearing heat, making it especially suitable for heat-related arthralgia. It can assist scorpion and centipede, and guide the medicine downwards.
[0020] Magnolia officinalis: It dries dampness and eliminates phlegm, lowers qi and relieves fullness. It can promote qi circulation and eliminate stagnation, thus relieving distension and discomfort caused by qi stagnation.
[0021] Fructus Aurantii Immaturus: It breaks up qi stagnation, eliminates stagnation, resolves phlegm, and disperses masses. When combined with Cortex Magnoliae Officinalis, it can enhance the qi-regulating and phlegm-resolving effects. When qi flows, blood flows, which helps blood-activating drugs and insect-based drugs to exert their effects.
[0022] Astragalus: It tonifies Qi and raises Yang, strengthens the defensive Qi and consolidates the exterior, promotes diuresis and reduces swelling, and promotes tissue regeneration and detoxification. As the "leader in tonifying Qi," it is used here to support the body's vital energy. Sufficient Qi can promote blood circulation, expel toxins, and promote the repair and regeneration of damaged nerve tissue.
[0023] Privet fruit: Nourishes the liver and kidneys, darkens hair and improves eyesight. In the later stages of PHN, heat toxicity easily depletes yin and blood. Privet fruit can nourish yin and blood, targeting the pathogenesis of "pain due to lack of nourishment," and nourishes damaged nerves.
[0024] Deer antler slices (decocted first): Warms kidney yang, nourishes essence and blood, strengthens tendons and bones, promotes blood circulation and reduces swelling. This product, being a substance rich in blood and flesh, has a strong effect in tonifying the kidney and assisting yang. It can warm and unblock the meridians, promoting the growth and repair of bones and tissues. In this formula, when combined with cold-natured herbs, it prevents the large amount of cold-natured herbs from causing blood stasis, while its warming properties help to unblock the meridians and promote deep repair. "Decocting first" is to extract its effective components more fully.
[0025] Schizonepeta: Relieves exterior symptoms and dispels wind, promotes rash eruption and eliminates sores. Its medicinal properties are light and upward, which can promote the flow of stagnant qi and blood, expel pathogens, and guide other medicines to the skin surface.
[0026] Peppermint: Disperses wind-heat, clears the head and eyes, soothes the throat and promotes rash eruption, and soothes the liver and regulates qi. It has a fragrant, pungent, and cooling effect, dispelling wind and heat, relieving local discomfort, and providing a mild cooling and analgesic effect. Adding it later prevents the loss of its volatile active ingredients during prolonged decoction.
[0027] Licorice: Tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, relieves spasms and pain, and harmonizes the effects of other herbs. This formula uses a relatively large dosage, not only to harmonize the properties of the herbs and prevent cold and insect-based herbs from harming the stomach, but also because its "relieving spasms and pain" effect has a direct effect on alleviating acute pain caused by neuromuscular spasms.
[0028] Preferably, the medicine comprises the following components in parts by weight: Coptis chinensis 4-10 parts, Scutellaria baicalensis 4-10 parts, Phellodendron chinense 4-10 parts, Gardenia jasminoides 4-10 parts, Magnolia officinalis 4-10 parts, Citrus aurantium 4-10 parts, Pheretima aspergillum 4-10 parts, Cervi cornu slices (decocted first) 6-18 parts, Buthus martensii 4-10 parts, Scolopendra subspinipes 4-10 parts (head and feet removed), Glycyrrhiza uralensis 12-35 parts, Gypsum fibrosum 70-130 parts, Paeonia lactiflora 4-10 parts, Salvia miltiorrhiza 4-10 parts, Paeonia suffruticosa 4-10 parts, Leonurus japonicus 4-10 parts, Astragalus membranaceus 6-18 parts, Ligustrum lucidum 6-18 parts, Schizonepeta tenuifolia 4-10 parts, Mentha haplocalyx 4-10 parts.
[0029] As the most preferred embodiment, the drug comprises the following components in parts by weight: Coptis chinensis 3-9 parts, Scutellaria baicalensis 3-9 parts, Phellodendron chinense 3-9 parts, Gardenia jasminoides 3-9 parts, Magnolia officinalis 3-9 parts, Citrus aurantium 3-9 parts, Pheretima aspergillum 3-9 parts, Cervi cornu slices (decocted first) 5-15 parts, Buthus martensii 3-9 parts, Scolopendra subspinipes 3-9 parts (head and feet removed), Glycyrrhiza uralensis 10-30 parts, Gypsum fibrosum 60-120 parts, Paeonia lactiflora 3-9 parts, Salvia miltiorrhiza 3-9 parts, Paeonia suffruticosa 3-9 parts, Leonurus japonicus 3-9 parts, Astragalus membranaceus 5-15 parts, Ligustrum lucidum 5-15 parts, Schizonepeta tenuifolia 3-9 parts, Mentha haplocalyx 3-9 parts.
[0030] Furthermore, the drug can be formulated into an oral Chinese medicine preparation, which is one of the following: decoction, pill, tablet, mixture, capsule, granule, powder, or ointment.
[0031] Furthermore, the drug also includes pharmaceutically acceptable excipients selected from one or more of preservatives, flavoring agents, and coloring agents.
[0032] The present invention also provides a method for preparing the aforementioned medicament for treating postherpetic neuralgia, comprising the following steps:
[0033] S1. Processing the medicinal materials: Cut Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Magnolia officinalis, Citrus aurantium, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, and Astragalus membranaceus into thin slices 2-4 mm thick; cut Glycyrrhiza uralensis, Leonurus japonicus, and Schizonepeta tenuifolia into segments 5-10 mm long; crush Ligustrum lucidum into particles 3-5 mm in diameter; cut Pheretima aspergillum into segments 3-5 mm long; crush Gypsum fibrosum and pass it through a 20-mesh sieve to remove fine powder; keep Scorpion and Centipede (remove head and feet) intact and clean; cut Mentha haplocalyx into segments 3-5 mm long.
[0034] S2. First, decoct the deer antler slices: Place the deer antler slices into a ceramic decoction container, add purified water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30-40 minutes until the deer antler slices soften. Reserve the decoction liquid for later use.
[0035] S3. Combined Decoction: First decoction of deer antler slices and dregs, then add gypsum, scorpion, centipede, earthworm, as well as Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Gardenia jasminoides, Magnolia officinalis, Citrus aurantium, Glycyrrhiza uralensis, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, Leonurus japonicus, Astragalus membranaceus, Ligustrum lucidum, and Schizonepeta tenuifolia to a ceramic decoction container. Add purified water and soak for 60 minutes. Heat over high heat to a boil, then reduce to low heat and simmer for 30 minutes. Filter through a 100-mesh sieve to collect the first decoction, keeping the dregs.
[0036] S4, Second decoction: Add purified water to the dregs left from step S3, heat over high heat until boiling, then immediately add mint, reduce heat to low and simmer for 15 minutes, filter through a 100-mesh sieve and collect the second decoction.
[0037] S5. Combine the decoctions: Mix the first decoction with the second decoction evenly and let stand for 30 minutes; filter with a 120-mesh sieve to remove the precipitate and obtain a clear decoction; place the clear decoction in a ceramic container, heat it in a water bath at 60-80℃, stir constantly, and concentrate it until each milliliter of decoction is equivalent to 1-1.5g of the original herb, thus obtaining the drug.
[0038] Furthermore, in step S2, the amount of purified water added is 8-10 times the mass of the antler slices.
[0039] Furthermore, in step S3, the total amount of purified water added is 6-8 times the total mass of all medicinal materials in this step.
[0040] Furthermore, in step S4, the amount of purified water added is 4-5 times the mass of the dregs.
[0041] The beneficial effects of this invention are as follows: For postherpetic neuralgia, this invention achieves both symptomatic and root-cause treatment through the synergistic effect of its components. The formula heavily utilizes gypsum, combined with Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, and Gardenia jasminoides to powerfully clear heat, purge fire, and detoxify, thoroughly eliminating residual damp-heat toxins and relieving burning pain from the source. Salvia miltiorrhiza, Paeonia lactiflora, Paeonia suffruticosa, and Leonurus japonicus work synergistically to invigorate blood circulation, remove blood stasis, and cool the blood, breaking up local blood stasis and improving microcirculation to relieve stinging pain. Insect-based medicines such as scorpion, centipede, and earthworm penetrate deep into the meridians to dispel wind and unblock collaterals, strongly... This formula effectively relieves spasms; Magnolia officinalis and Citrus aurantium promote qi circulation and resolve phlegm, thus aiding the flow of qi and facilitating the action of the medicine; Astragalus membranaceus, Ligustrum lucidum, and deer antler slices invigorate qi, nourish yin, warm and repair, and support the body's vital energy to promote the regeneration of nerve tissue; Schizonepeta tenuifolia and Mentha haplocalyx dispel wind and penetrate the exterior, guiding the medicine directly to the affected area; Glycyrrhiza uralensis harmonizes the various herbs and relieves pain. This formula integrates the methods of clearing heat, promoting blood circulation, dispelling wind, regulating qi, and supporting the body's vital energy. It can quickly relieve various types of neuralgia and fundamentally treat the condition by eliminating inflammation, improving circulation, and repairing nerves. Attached Figure Description
[0042] Figure 1 A bar chart showing the analgesic effect of the drug prepared in this invention;
[0043] Figure 2 This is a bar chart showing the detection results of inflammation and pain factors in the drug prepared according to the present invention.
[0044] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. Detailed Implementation
[0045] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.
[0046] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.
[0047] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, and the experimental materials used in the following examples are all purchased from commercial channels. The drugs in the following examples are all formulated as oral traditional Chinese medicine preparations, which are pills. The drugs also include pharmaceutically acceptable excipients, including preservatives, flavoring agents, and coloring agents.
[0048] Example 1: This example provides a drug for treating postherpetic neuralgia, which is composed of the following components in parts by weight: Coptis chinensis 8 parts, Scutellaria baicalensis 8 parts, Phellodendron chinense 8 parts, Gardenia jasminoides 8 parts, Magnolia officinalis 8 parts, Citrus aurantium 8 parts, Pheretima aspergillum 8 parts, Cervi cornu slices (decocted first) 12 parts, Buthus martensii 8 parts, Scolopendra subspinipes 8 parts (head and feet removed), Glycyrrhiza uralensis 25 parts, Gypsum fibrosum 100 parts, Paeonia lactiflora 8 parts, Salvia miltiorrhiza 8 parts, Paeonia suffruticosa 8 parts, Leonurus japonicus 8 parts, Astragalus membranaceus 12 parts, Ligustrum lucidum 12 parts, Schizonepeta tenuifolia 8 parts, Mentha haplocalyx 8 parts.
[0049] Example 2: This example provides a drug for treating postherpetic neuralgia, which is composed of the following components in parts by weight: 10 parts Coptis chinensis, 10 parts Scutellaria baicalensis, 10 parts Phellodendron chinense, 10 parts Gardenia jasminoides, 10 parts Magnolia officinalis, 10 parts Citrus aurantium, 10 parts Pheretima aspergillum, 15 parts deer antler slices (decocted first), 10 parts Buthus martensii, 10 parts Scolopendra subspinipes (head and feet removed), 30 parts Glycyrrhiza uralensis, 120 parts Gypsum fibrosum, 10 parts Paeonia lactiflora, 10 parts Salvia miltiorrhiza, 10 parts Paeonia suffruticosa, 10 parts Leonurus japonicus, 15 parts Astragalus membranaceus, 15 parts Ligustrum lucidum, 10 parts Schizonepeta tenuifolia, and 10 parts Mentha haplocalyx.
[0050] Example 3: This example provides a drug for treating postherpetic neuralgia, which is composed of the following components in parts by weight: 6 parts Coptis chinensis, 6 parts Scutellaria baicalensis, 6 parts Phellodendron chinense, 6 parts Gardenia jasminoides, 6 parts Magnolia officinalis, 6 parts Citrus aurantium, 6 parts Pheretima aspergillum, 10 parts deer antler slices (decocted first), 6 parts Buthus martensii, 6 parts Scolopendra subspinipes (head and feet removed), 20 parts Glycyrrhiza uralensis, 90 parts Gypsum fibrosum, 6 parts Paeonia lactiflora, 6 parts Salvia miltiorrhiza, 6 parts Paeonia suffruticosa, 6 parts Leonurus japonicus, 10 parts Astragalus membranaceus, 10 parts Ligustrum lucidum, 6 parts Schizonepeta tenuifolia, and 6 parts Mentha haplocalyx.
[0051] Example 4: This example provides a drug for treating postherpetic neuralgia, which is composed of the following components in parts by weight: Coptis chinensis 8 parts, Scutellaria baicalensis 8 parts, Phellodendron chinense 8 parts, Gardenia jasminoides 8 parts, Magnolia officinalis 8 parts, Citrus aurantium 8 parts, Pheretima aspergillum 8 parts, Cervi cornu slices (decocted first) 14 parts, Buthus martensii 8 parts, Scolopendra subspinipes 8 parts (head and feet removed), Glycyrrhiza uralensis 28 parts, Gypsum fibrosum 110 parts, Paeonia lactiflora 8 parts, Salvia miltiorrhiza 8 parts, Paeonia suffruticosa 8 parts, Leonurus japonicus 8 parts, Astragalus membranaceus 14 parts, Ligustrum lucidum 14 parts, Schizonepeta tenuifolia 8 parts, Mentha haplocalyx 8 parts.
[0052] Example 5: This example provides a drug for treating postherpetic neuralgia, which is composed of the following components in parts by weight: Coptis chinensis 5 parts, Scutellaria baicalensis 5 parts, Phellodendron chinense 5 parts, Gardenia jasminoides 5 parts, Magnolia officinalis 5 parts, Citrus aurantium 5 parts, Pheretima aspergillum 5 parts, Cervi cornu slices (decocted first) 8 parts, Buthus martensii 5 parts, Scolopendra subspinipes 5 parts (head and feet removed), Glycyrrhiza uralensis 15 parts, Gypsum fibrosum 80 parts, Paeonia lactiflora 5 parts, Salvia miltiorrhiza 5 parts, Paeonia suffruticosa 5 parts, Leonurus japonicus 5 parts, Astragalus membranaceus 8 parts, Ligustrum lucidum 8 parts, Schizonepeta tenuifolia 5 parts, Mentha haplocalyx 5 parts.
[0053] Example 6: A method for preparing the drug for treating postherpetic neuralgia, wherein the drugs of Examples 1-5 above are prepared according to the following steps:
[0054] S1. Processing the medicinal materials: Cut Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Magnolia officinalis, Citrus aurantium, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, and Astragalus membranaceus into thin slices with a thickness of 3mm; cut Glycyrrhiza uralensis, Leonurus japonicus, and Schizonepeta tenuifolia into segments with a length of 8mm; crush Ligustrum lucidum into particles with a diameter of 4mm; cut Pheretima aspergillum into segments with a length of 4mm; crush Gypsum fibrosum and pass it through a 20-mesh sieve to remove fine powder; keep the whole scorpion and centipede (with head and feet removed) intact; cut Mentha haplocalyx into segments with a length of 3mm.
[0055] S2. First, decoct the deer antler slices: Place the deer antler slices into a ceramic decoction container, add purified water at 8 times the weight of the deer antler slices, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 35 minutes until the deer antler slices soften. Reserve the decoction liquid for later use.
[0056] S3. Combined Decoction: First decoction of deer antler slices and dregs, then add gypsum, scorpion, centipede, earthworm, as well as Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Gardenia jasminoides, Magnolia officinalis, Citrus aurantium, Glycyrrhiza uralensis, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, Leonurus japonicus, Astragalus membranaceus, Ligustrum lucidum, and Schizonepeta tenuifolia to a ceramic decoction container. Add purified water at 7 times the total weight of all herbs, soak for 60 minutes, then heat over high heat to a boil, then reduce to low heat and simmer for 30 minutes. Filter through a 100-mesh sieve to collect the first decoction, and retain the dregs.
[0057] S4. Second decoction: Add purified water at 4 times the weight of the dregs to the dregs left in step S3, heat over high heat until boiling, then immediately add mint, reduce heat to low and simmer for 15 minutes, filter through a 100-mesh sieve and collect the second decoction.
[0058] S5. Combine the decoctions: Mix the first decoction with the second decoction evenly and let stand for 30 minutes; filter with a 120-mesh sieve to remove the precipitate and obtain a clear decoction; place the clear decoction in a ceramic container, heat it in a water bath at 70°C, stir constantly, and concentrate it until each milliliter of decoction is equivalent to 1.5g of the original drug, thus obtaining the drug.
[0059] Results Analysis
[0060] I. Laboratory Animals and Grouping:
[0061] Sixty SPF-grade male SD rats, weighing 200-250g, were selected and acclimatized for one week (temperature 22±2℃, 12h light-dark cycle, free access to food and water).
[0062] Grouping: Randomly divided into 6 groups, with 10 animals in each group:
[0063] Normal control group: subjected to sham surgery and gavage with normal saline;
[0064] Model control group: PHN model was used, and patients were given physiological saline by gavage;
[0065] Positive drug control group: PHN model was used, and pregabalin (a commonly used oral antineuralgia drug in clinical practice) was administered by gavage;
[0066] Low-dose group of traditional Chinese medicine composition: using the PHN model, low-dose drug solution was administered by gavage;
[0067] Medium-dose group of traditional Chinese medicine composition: using PHN model, medium-dose drug solution was administered by gavage (converted to clinical equivalent dose);
[0068] High-dose group of traditional Chinese medicine composition: using the PHN model, high-dose drug solution was administered by gavage.
[0069] II. Test Drug:
[0070] Traditional Chinese medicine composition: Prepared according to the method of Example 6, the concentrated solution (1.2g raw drug / mL) was diluted with physiological saline to three concentrations: low (0.3g / mL), medium (1.2g / mL), and high (2.4g / mL) before use. Physiological saline was used as the solvent for the control group.
[0071] Positive control drug: Pregabalin capsules (commercially available, 75mg / capsule), dissolved in physiological saline before use, and the dosage is calculated based on the rat's body weight (10mg / kg).
[0072] III. Methods for establishing PHN animal models:
[0073] After weighing, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (300 mg / kg), fixed on the operating table, and their right hind limbs were shaved and the skin disinfected with povidone-iodine. A longitudinal incision (approximately 1.5 cm long) was made along the posterolateral aspect of the right thigh, the biceps femoris muscle was separated, and the main trunk of the sciatic nerve (from the piriformis foramen to its branch) was exposed. Three loose ligations were made on the sciatic nerve trunk using 4-0 chromic catgut, spaced approximately 1 mm apart. The ligation strength should be sufficient to slightly obstruct nerve blood flow and slightly increase the nerve diameter (avoid complete severance). The muscles and skin were sutured layer by layer, disinfected with povidone-iodine, and the rats were housed individually. Three days post-surgery, penicillin (40,000 U / rat) was administered intramuscularly to prevent infection.
[0074] Sham surgery group: Only the sciatic nerve is exposed, without ligation, and the rest of the steps are the same as above.
[0075] IV. Dosing Regimen
[0076] Drug administration began on day 7 after modeling and continued for 21 days.
[0077] Administration method: Once daily (9:00 AM) by gavage, with a dosage volume calculated based on the rat's body weight (10 mL / kg).
[0078] The traditional Chinese medicine composition was administered via gavage at low, medium, and high doses of 0.3 g / mL, 1.2 g / mL, and 2.4 g / mL, respectively.
[0079] Positive control group: Pregabalin solution was administered by gavage at a dose of 10 mg / kg;
[0080] Normal control group and model control group: both were given an equal volume of physiological saline by gavage.
[0081] V. Testing Indicators and Time Points
[0082] Behavioral testing: To evaluate the analgesic effect, mechanical pain threshold (PWT) was measured 1 day before modeling, 7 days after modeling (before drug administration), and 7, 14, and 21 days after drug administration. The minimum pressure (g) required to induce paw withdrawal in rats was recorded by stimulating the sole of the affected paw with von Freyfilaments. Each group was tested three times, and the average value was taken. Results are shown below. Figure 1 .
[0083] Inflammation and pain factor detection: 24 hours after the last administration, DRG tissue was taken from the surgical side, homogenized, and the levels of inflammatory factors (TNF-α, IL-6) and pain mediators (CGRP) were detected. Results are shown below. Figure 2 .
[0084] from Figure 1 It can be seen that the mechanical pain threshold of the model group was significantly reduced after modeling, while the pain threshold was increased in all dose groups of the traditional Chinese medicine composition after administration, and the effect was more significant with increasing dose and prolonged administration time, indicating that it has a dose-dependent analgesic effect. Figure 2 It can be seen that the levels of pro-inflammatory factors and pain-related mediators in the DRG tissue of the model group were significantly increased. After administration, the Chinese medicine composition could significantly reduce the above indicators. The medium and high dose groups were more effective than the positive control drug, indicating that it exerts its therapeutic effect by inhibiting the release of neuroinflammatory and pain mediators.
[0085] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.
[0086] The present invention and its embodiments have been described above. This description is not restrictive, and the embodiments shown are only one of the embodiments of the present invention. The actual application is not limited to this. In conclusion, if those skilled in the art are inspired by this description and design similar methods and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.
Claims
1. A drug for treating postherpetic neuralgia, characterized in that: The ingredients include the following components in parts by weight: Coptis chinensis 5-12 parts, Scutellaria baicalensis 5-12 parts, Phellodendron chinense 5-12 parts, Gardenia jasminoides 5-12 parts, Magnolia officinalis 5-12 parts, Citrus aurantium 5-12 parts, Pheretima aspergillum 5-12 parts, Cervi cornu slices (decocted first) 8-20 parts, Buthus martensii 5-12 parts, Scolopendra subspinipes 5-12 parts (head and feet removed), Glycyrrhiza uralensis 15-40 parts, Gypsum fibrosum 80-150 parts, Paeonia lactiflora 5-12 parts, Salvia miltiorrhiza 5-12 parts, Paeonia suffruticosa 5-12 parts, Leonurus japonicus 5-12 parts, Astragalus membranaceus 8-20 parts, Ligustrum lucidum 8-20 parts, Schizonepeta tenuifolia 5-12 parts, Mentha haplocalyx 5-12 parts.
2. The medicament for treating postherpetic neuralgia according to claim 1, characterized in that: The ingredients include the following components in parts by weight: Coptis chinensis 4-10 parts, Scutellaria baicalensis 4-10 parts, Phellodendron chinense 4-10 parts, Gardenia jasminoides 4-10 parts, Magnolia officinalis 4-10 parts, Citrus aurantium 4-10 parts, Pheretima aspergillum 4-10 parts, Cervi cornu slices (decocted first) 6-18 parts, Buthus martensii 4-10 parts, Scolopendra subspinipes 4-10 parts (head and feet removed), Glycyrrhiza uralensis 12-35 parts, Gypsum fibrosum 70-130 parts, Paeonia lactiflora 4-10 parts, Salvia miltiorrhiza 4-10 parts, Paeonia suffruticosa 4-10 parts, Leonurus japonicus 4-10 parts, Astragalus membranaceus 6-18 parts, Ligustrum lucidum 6-18 parts, Schizonepeta tenuifolia 4-10 parts, Mentha haplocalyx 4-10 parts.
3. The medicament for treating postherpetic neuralgia according to claim 1, characterized in that: The ingredients include the following components in parts by weight: Coptis chinensis 3-9 parts, Scutellaria baicalensis 3-9 parts, Phellodendron chinense 3-9 parts, Gardenia jasminoides 3-9 parts, Magnolia officinalis 3-9 parts, Citrus aurantium 3-9 parts, Pheretima aspergillum 3-9 parts, Cervi cornu slices (decocted first) 5-15 parts, Buthus martensii 3-9 parts, Scolopendra subspinipes 3-9 parts (head and feet removed), Glycyrrhiza uralensis 10-30 parts, Gypsum fibrosum 60-120 parts, Paeonia lactiflora 3-9 parts, Salvia miltiorrhiza 3-9 parts, Paeonia suffruticosa 3-9 parts, Leonurus japonicus 3-9 parts, Astragalus membranaceus 5-15 parts, Ligustrum lucidum 5-15 parts, Schizonepeta tenuifolia 3-9 parts, Mentha haplocalyx 3-9 parts.
4. The medicament for treating postherpetic neuralgia according to claim 1, characterized in that: The drug can be formulated into oral Chinese medicine preparations, which are one of the following: decoction, pills, tablets, mixtures, capsules, granules, powders, or ointments.
5. The medicament for treating postherpetic neuralgia according to claim 1, characterized in that: The drug also includes pharmaceutically acceptable excipients, which are selected from one or more of preservatives, flavoring agents, and coloring agents.
6. A method for preparing a medicament for treating postherpetic neuralgia as described in any one of claims 1-5, characterized in that: Includes the following steps: S1. Processing the medicinal materials: Cut Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Magnolia officinalis, Citrus aurantium, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, and Astragalus membranaceus into thin slices 2-4 mm thick; cut Glycyrrhiza uralensis, Leonurus japonicus, and Schizonepeta tenuifolia into segments 5-10 mm long; crush Ligustrum lucidum into particles 3-5 mm in diameter; cut Pheretima aspergillum into segments 3-5 mm long; crush Gypsum fibrosum and pass it through a 20-mesh sieve to remove fine powder; keep Scorpion and Centipede (remove head and feet) intact and clean; cut Mentha haplocalyx into segments 3-5 mm long. S2. First, decoct the deer antler slices: Place the deer antler slices into a ceramic decoction container, add purified water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30-40 minutes until the deer antler slices soften. Reserve the decoction liquid for later use. S3. Combined Decoction: First decoction of deer antler slices and dregs, then add gypsum, scorpion, centipede, earthworm, as well as Coptis chinensis, Scutellaria baicalensis, Phellodendron chinense, Gardenia jasminoides, Magnolia officinalis, Citrus aurantium, Glycyrrhiza uralensis, Paeonia lactiflora, Salvia miltiorrhiza, Paeonia suffruticosa, Leonurus japonicus, Astragalus membranaceus, Ligustrum lucidum, and Schizonepeta tenuifolia to a ceramic decoction container. Add purified water and soak for 60 minutes. Heat over high heat to a boil, then reduce to low heat and simmer for 30 minutes. Filter through a 100-mesh sieve to collect the first decoction, keeping the dregs. S4, Second decoction: Add purified water to the dregs left from step S3, heat over high heat until boiling, then immediately add mint, reduce heat to low and simmer for 15 minutes, filter through a 100-mesh sieve and collect the second decoction. S5. Combine the decoctions: Mix the first decoction with the second decoction evenly and let stand for 30 minutes; filter with a 120-mesh sieve to remove the precipitate and obtain a clear decoction; place the clear decoction in a ceramic container, heat it in a water bath at 60-80℃, stir constantly, and concentrate it until each milliliter of decoction is equivalent to 1-1.5g of the original herb, thus obtaining the drug.
7. The method for preparing the medicament for treating postherpetic neuralgia according to claim 6, characterized in that: In step S2, the amount of purified water added is 8-10 times the mass of the antler slices.
8. The method for preparing the medicament for treating postherpetic neuralgia according to claim 6, characterized in that: In step S3, the total amount of purified water added is 6-8 times the total mass of all medicinal materials in this step.
9. The method for preparing the medicament for treating postherpetic neuralgia according to claim 6, characterized in that: In step S4, the amount of purified water added is 4-5 times the mass of the dregs.