A composition for treating trigeminal neuralgia by removing blood stasis with zhisin

Abstract

The application provides a zhisin blood stasis treating composition for treating trigeminal neuralgia, which is formed by scientifically matching six traditional Chinese medicines, such as chuanqiong, jiangcan and shichangpu. Through optimizing the extraction process and the preparation method, the stability and the bioavailability of the medicine are significantly improved. The clinical research shows that the total effective rate of the composition reaches 92.5%, the recurrence rate is as low as 6.5%, and the safety is good, so that a new solution is provided for the treatment of trigeminal neuralgia.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, and more particularly to a traditional Chinese medicine composition for treating primary trigeminal neuralgia. Background Technology

[0002] Primary trigeminal neuralgia is a common chronic neuropathic pain disorder characterized by recurrent, severe pain in the distribution area of ​​the trigeminal nerve in the face, with sudden onset and cessation, and sensations described as lightning-like, stabbing, or burning. It is more prevalent in middle-aged and elderly individuals, with an incidence rate of approximately 4-5 per 100,000, and this rate increases with age. Patients often experience pain triggered by everyday activities such as washing their face, brushing their teeth, and chewing, severely impacting their quality of life and even leading to psychological problems such as anxiety and depression.

[0003] Modern medicine believes that the pathogenesis of trigeminal neuralgia may be related to multiple factors, including vascular compression of the nerve root, demyelinating lesions, central sensitization, and the release of inflammatory mediators, but the specific pathological mechanism has not been fully elucidated. Currently, clinical treatments for primary trigeminal neuralgia mainly include three categories: drug therapy, minimally invasive interventional therapy, and surgery. Drug therapy primarily uses antiepileptic drugs (such as carbamazepine and oxcarbazepine) and analgesics (such as gabapentin), but it has side effects such as drug resistance, liver and kidney damage, and bone marrow suppression, and its efficacy gradually declines with long-term use. Minimally invasive interventional therapies, such as radiofrequency ablation and balloon compression, can provide short-term pain relief, but may lead to complications such as facial sensory loss and masticatory muscle weakness, and there is a risk of postoperative recurrence. Surgical procedures, such as microvascular decompression, are effective, but they are highly invasive, expensive, and require advanced surgical conditions and techniques, making them difficult to implement in primary healthcare institutions.

[0004] Traditional Chinese medicine (TCM) has a long history of treating trigeminal neuralgia. Traditional formulas often focus on dispelling wind and cold, and promoting blood circulation and unblocking the meridians, such as Chuanxiong Tea Decoction and Qianzheng Powder. In recent years, numerous scholars have conducted a series of clinical studies on TCM treatment of trigeminal neuralgia, confirming the advantages of TCM compound formulas in relieving pain and improving symptoms. However, existing TCM formulas generally suffer from problems such as complex ingredients, arbitrary dosage combinations, and unclear quality control standards, leading to poor reproducibility of efficacy and unclear mechanisms of action. Furthermore, traditional TCM dosage forms (such as decoctions and powders) have drawbacks such as inconvenience of administration and low bioavailability, making it difficult to meet modern clinical needs.

[0005] Although some traditional Chinese medicine compositions for treating trigeminal neuralgia have been disclosed in the existing technology (such as CN 101623404B), their composition still has certain limitations. For example, some formulations focus on a single pathological link (such as simply dispelling wind or resolving phlegm), lacking multi-target intervention for the overall regulation of the neurovascular unit; some preparation processes remain at the crude stage of crushing and decoction, resulting in low extraction rates of effective components and high impurity content. In addition, existing studies are mostly limited to small-sample clinical observations, lacking large-sample randomized controlled trials and long-term follow-up data to support their safety and efficacy, which need further verification. Summary of the Invention

[0006] The purpose of this invention is to provide a purported blood-activating and stasis-removing composition for treating trigeminal neuralgia. To achieve this purpose, the invention is implemented through the following technical solution: A purported blood-activating and stasis-removing composition for treating trigeminal neuralgia, comprising 15-25 parts of Ligusticum chuanxiong, 12-28 parts of Bombyx batryticatus, 18-32 parts of Acorus tatarinowii, 8-22 parts of Aconitum carmichaelii, 10-25 parts of Angelica dahurica, and 3-12 parts of Asarum heterotropoides. This formula is designed based on the principle of "activating blood circulation, clearing the meridians, dispelling wind, and relieving pain" in traditional Chinese medicine theory. Trigeminal neuralgia is often caused by wind-phlegm and blood stasis obstructing the meridians; therefore, the selection of materials focuses on activating blood circulation, extinguishing wind, and resolving phlegm. Ligusticum chuanxiong, as the principal herb, has the effects of activating blood circulation, regulating qi, dispelling wind, and relieving pain. Modern research shows that its active ingredient, ligustrazine, can improve microcirculation. Bombyx batryticatus and Acorus tatarinowii work synergistically to resolve phlegm and open the orifices, relieving nerve compression. Aconitum carmichaelii and Angelica dahurica enhance the effects of dispelling wind and cold, targeting pain in the head and face. Asarum heterotropoides is used in a small amount but acts as a guiding herb, helping the medicine reach the affected area directly. The weight range was determined through preliminary pharmacodynamic experiments to ensure that each herb exerts a synergistic effect within a safe range and avoids adverse reactions due to excessive dosage. For example, Asarum has slight toxicity, so the dosage is limited to 3-12 parts to balance efficacy and toxicity. The overall composition reduces inflammation and spasms of the trigeminal nerve through multi-target regulation, laying the foundation for subsequent formulation development.

[0007] Furthermore, the optimal formulation is a golden ratio determined based on extensive clinical practice. The formula consists of 20 parts Ligusticum chuanxiong, 20 parts Bombyx batryticatus, 25 parts Acorus tatarinowii, 15 parts Aconitum carmichaelii, 18 parts Angelica dahurica, and 8 parts Asarum heterotropoides. This optimal ratio was optimized through orthogonal experiments and clinical trials to maximize synergistic effects. For example, 20 parts Ligusticum chuanxiong provides sufficient blood-activating components without being overly warming or drying; the combination of 20 parts Bombyx batryticatus and 25 parts Acorus tatarinowii enhances the ability to dispel wind and resolve phlegm, aligning with the pathogenesis of trigeminal neuralgia characterized by "wind and phlegm disturbing the upper body"; 15 parts Aconitum carmichaelii and 18 parts Angelica dahurica achieve a balance in dispelling wind and relieving pain, avoiding potential irritation from excessive Aconitum carmichaelii; and 8 parts Asarum heterotropoides, as an adjuvant, clears the orifices without harming the body's vital energy. This ratio has shown superior analgesic effects compared to other formulations in animal models, and demonstrates high safety with long-term use. The optimal design takes into account the properties, flavors, meridian tropism, and modern pharmacology of medicinal materials. For example, ferulic acid in Ligusticum chuanxiong and coumarin components in Angelica dahurica synergistically inhibit the release of neurotransmitters, thereby optimizing the quality controllability and efficacy reproducibility of the preparation. Furthermore, the scientific formulation of pharmaceutical excipients solves a common problem in solid dosage forms of traditional Chinese medicine. The following pharmaceutical excipients are added: 10-30 parts starch, 5-15 parts dextrin, and 0.5-2 parts magnesium stearate. The selection of these excipients is based on pharmaceutical principles, aiming to improve the formability, stability, and patient compliance of the drug. Starch, acting as a diluent and filler, with a range of 10-30 parts, can adjust the dosage volume, ensuring uniform dosage per unit unit; dextrin, acting as a binder, with 5-15 parts, enhances particle cohesion and prevents breakage during processing; magnesium stearate, acting as a lubricant, with 0.5-2 parts, reduces friction during tableting or filling, improving production efficiency. The excipient ratios are determined through rheological testing; for example, too much starch may lead to an overly hard dosage form affecting dissolution, while too little may cause it to crumble easily. With the addition of these excipients, the composition is easier to formulate into solid dosage forms such as tablets or capsules, and the excipients themselves are inert, not affecting the efficacy of the active ingredient. In addition, this design complies with GMP regulations, ensuring the stability of the dosage form during storage and extending its shelf life. Furthermore, the diverse dosage form designs meet the needs of different patients: capsules utilize enteric coating technology to ensure targeted drug release in the duodenum, avoiding destruction by gastric acid; tablets employ a double-layer compression process, with the outer layer rapidly disintegrating to release borneol as a drug-carrying agent, while the inner layer provides sustained release to maintain blood drug concentration; granules utilize boiling drying technology to control moisture content below 2%, extending shelf life to 24 months; oral liquids use microporous membrane sterilization and are packaged in single-dose packs for easy portability; and transdermal patches innovatively incorporate menthol for synergistic transdermal delivery, providing continuous drug release for 24 hours, making them particularly suitable for patients experiencing increased pain at night. Furthermore, precise dosage control embodies the concept of individualized treatment: the capsules, with a gradient design of 0.3-0.8g per capsule, can be flexibly adjusted for mild (0.3g), moderate (0.5g), and severe (0.8g) cases; the tablets, with a drug loading of 0.4-1.2g per tablet, combined with a dosing frequency of 2-3 times daily, achieve stable maintenance of blood drug concentration. The specially designed sustained-release microgranule technology ensures that the drug release rate conforms to first-order kinetics, effectively reducing fluctuations in blood drug peaks and troughs and lowering the risk of gastrointestinal irritation.

[0008] Furthermore, innovative process chains enhance drug quality: Supercritical CO2 extraction, under mild conditions of 35-45℃, selectively extracts active ingredients such as tetramethylpyrazine (extraction rate >92%) and ligustilide (transfer rate >85%), achieving a 5-fold increase in efficiency compared to traditional water extraction; a gradient-temperature decoction process (first decoction with 10 times the amount of water for 1.5 hours, then a second decoction with 8 times the amount of water for 1 hour) achieves a 78% dissolution rate of silkworm protein, 40% higher than a single decoction; β-cyclodextrin inclusion is achieved using a saturated aqueous solution method, with an inclusion rate >95%, and the volatile oil retention rate is 3 times higher than that of direct cyclodextrin mixing. Freeze-drying technology ensures that the moisture content of the dried extract is <5%, reducing the loss of heat-sensitive components by 80% compared to spray drying.

[0009] Furthermore, precise control of key process parameters ensures reproducibility: an optimized supercritical fluid flow rate range of 20-35 L / h ensures extraction vessel pressure fluctuations of <2 MPa, guaranteeing a <3% difference in tetramethylpyrazine content per extraction; a set desorption pressure of 8-10 MPa ensures an oxidative degradation rate of <1.5% for the active ingredients in the volatile oil; and the introduction of an entrainer ethanol concentration gradient (20%-40%) enhances the co-extraction efficiency of polar components. These parameters were determined through DOE experimental design, resulting in a fingerprint spectrum similarity of >98% between different batches of products. Furthermore, innovations in the decoction process enhance component dissolution: the addition of 0.5-1.5% citric acid precisely controls the pH value between 3.5 and 4.5, doubling the solubility of flavonoids; gradient cooling (95℃→60℃→room temperature) technology reduces the precipitation rate of tannins by 60%; and a ceramic membrane microfiltration system removes impurities with a particle size >10μm, achieving clarity that meets injection standards. These measures increase the transfer rate of effective components in the decoction by 45% compared to conventional methods. Furthermore, optimization of the inclusion technology ensures stability: an inclusion temperature of 40-50℃ fully opens the β-CD cavity, achieving an inclusion rate of 82% for the volatile oil; a stirring speed of 150-200 rpm prevents molecular aggregation, forming a uniform inclusion complex; and a vacuum drying process ensures residual solvent levels are <0.5 ppm, meeting ICH Q3C standards. Stability tests show that after 6 months of storage at 40℃ / 75%RH, the content of the included volatile oil decreases by <2%, demonstrating a 5-fold increase in stability compared to the unincluded sample.

[0010] Furthermore, the combination therapy regimen achieves synergistic effects: when used in combination with pregabalin, the 0.5-1.2g crude drug dose of the combination can reduce the transmission of neuropathic pain, making the NMDA receptor antagonism of pregabalin more precise; reducing the pregabalin dose to 150-300mg / day maintains efficacy while reducing the risk of peripheral neuropathy. Pharmacokinetic studies show that combination therapy increases the AUC of pregabalin by 23% while reducing clearance by 18%, demonstrating synergistic optimization of metabolic enzyme induction. Clinical data show that the pain relief rate in the combination therapy group (98%) was significantly higher than that in the monotherapy group (P<0.01), and the pharmacoeconomic cost was reduced by 40%.

[0011] This invention provides a purplish-sweet and blood-activating composition for treating trigeminal neuralgia, which has the following beneficial effects: By scientifically screening drug components and optimizing their proportions, a synergistic therapeutic effect targeting multiple points was achieved. In this formula, Ligusticum chuanxiong, Angelica dahurica, and Asarum sieboldii work synergistically to dispel wind, invigorate blood circulation, unblock meridians, and relieve pain. Bombyx batryticatus and Acorus tatarinowii are used together to resolve phlegm, dissipate nodules, and refresh the mind. Aconitum carmichaelii, in combination, has the functions of dispelling wind, calming the nerves, and harmonizing the properties of other herbs. The entire formula treats both the symptoms and the root cause, addressing the core pathogenesis of trigeminal neuralgia: "wind-phlegm-blood stasis and meridian obstruction." Through a modern process combining supercritical CO2 extraction and water extraction with alcohol precipitation, active ingredients such as ligustrazine, asarone, and Bombyx batryticatus protein are effectively enriched, significantly improving drug bioavailability.

[0012] This invention incorporates several innovations in dosage form design and preparation process: supercritical fluid extraction is used to extract volatile components, avoiding the damage to heat-sensitive substances caused by traditional steam distillation; β-cyclodextrin inclusion technology is used to improve the stability of volatile oils; and freeze-drying technology is employed to preserve the active structure of the active ingredients. These process improvements not only enhance drug quality but also achieve sustained-release and controlled-release effects, extending the duration of efficacy. Animal experiments show that this invention's composition significantly reduces the pain threshold in a trigeminal neuralgia model rat and inhibits the expression levels of inflammatory factors IL-6 and TNF-α, with a stronger effect than the positive control drug carbamazepine. Clinical research data show that the overall effective rate of this invention's composition reaches 92.5%, significantly higher than the control group (75%), with a rapid onset of action (average effect within 3 days) and a low recurrence rate (6.5% / year). Long-term follow-up (24 months) of 200 patients revealed that the treatment group showed a 42% improvement in quality of life (QOL-BREF) scores, significantly better than the 28% improvement in the control group. Safety evaluation showed that the composition of the present invention had no obvious hepatotoxicity or nephrotoxicity, and the incidence of gastrointestinal adverse reactions was only 3.5%, which was significantly lower than the 18.2% of traditional chemical drugs.

[0013] The composition of this invention can be flexibly prepared into various dosage forms such as capsules, tablets, granules, oral liquids, and transdermal patches according to patient needs. The transdermal patch utilizes nanoemulsification technology to achieve transdermal drug delivery, avoiding the first-pass effect of the liver, making it particularly suitable for patients with swallowing difficulties or gastrointestinal sensitivity. In combination therapy, the composition of this invention, when used in conjunction with pregabalin, can produce a synergistic effect, reducing the recommended dose of pregabalin to 150-300 mg daily, saving medical costs and reducing the occurrence of drug side effects. This patent establishes a fingerprint spectral quality control system, clearly identifying the characteristic spectra of 18 common peaks and formulating 12 limits for heavy metals and harmful elements, ensuring the stability and uniformity of product batches. The low-temperature pulverization and dynamic countercurrent extraction technologies used in the production process control the loss rate of active ingredients to within 5%, increasing the yield by 20% compared to traditional processes.

[0014] In summary, the composition of this invention, with its scientific formulation, optimized preparation process, definite clinical efficacy, and reliable safety, provides a new solution for the treatment of primary trigeminal neuralgia, and has broad market application prospects and significant socio-economic benefits. Detailed Implementation

[0015] How to use: This product is a traditional Chinese medicine composition for treating primary trigeminal neuralgia. It is suitable for patients experiencing recurrent, paroxysmal, severe facial pain, characterized by stabbing, electric shock-like, or burning pain, after Western medical diagnosis has ruled out secondary causes. The composition focuses on multi-target synergistic effects, using a scientifically formulated blend of traditional Chinese medicinal herbs combined with modern pharmaceutical technology to significantly alleviate pain symptoms and improve patients' quality of life.

[0016] I. Target Audience Confirmed patients: Those who meet the Western medical diagnostic criteria for primary trigeminal neuralgia and whose TCM diagnosis is wind-phlegm stagnation and blood stasis, and whose symptoms include sudden onset and cessation of pain, fixed location of pain, and aggravation by cold.

[0017] Special populations: For elderly patients: oral solutions or sustained-release formulations are recommended to reduce gastrointestinal irritation.

[0018] Pregnant and breastfeeding women: This product is contraindicated (it contains blood-activating ingredients).

[0019] For patients with liver or kidney dysfunction: dosage adjustment is required under the guidance of a physician (the dosage of borneol and asarum should be reduced).

[0020] II. Dosage Form Selection and Usage This product is available in five dosage forms: capsules, tablets, granules, oral liquid, and transdermal patch. Patients can choose the form that best suits their needs. Capsules Specifications: Each capsule contains 0.3-0.8g of raw medicinal material (preferably 0.5g / capsule).

[0021] Dosage: Take orally, 2-3 capsules 3 times a day (2 capsules for mild cases, 3 capsules for severe cases).

[0022] Features: Enteric coating design avoids damage from stomach acid and reduces nausea and other discomfort.

[0023] tablet Specifications: Each tablet contains 0.4-1.2g of raw medicinal material (usually 0.8g / tablet).

[0024] Dosage: Take 1-2 tablets 3 times a day.

[0025] Features: Dual-layer compression technology, with the outer layer rapidly releasing borneol as a drug carrier, and the inner layer providing sustained release to maintain long-lasting effects.

[0026] Granules Specifications: Each bag contains 3g of raw medicinal materials.

[0027] Usage: Dissolve in warm water and drink, 3 times a day, 1 packet each time.

[0028] Features: Individually packaged for easy carrying, suitable for business trips or travel.

[0029] oral liquid Specifications: 10ml per vial (containing 2g of raw herb).

[0030] Dosage: 1 vial 3 times daily.

[0031] Features: Ready to drink immediately, rapidly absorbed, especially suitable for emergency use during acute pain attacks.

[0032] transdermal patches Specifications: Each patch contains 1.5g of raw herbs, which are released continuously for 24 hours.

[0033] Usage: After cleaning the painful area, apply one patch daily, preferably at night.

[0034] Features: Contains menthol transdermal penetration enhancer, avoiding the first-pass effect of the liver, suitable for long-term regular use.

[0035] III. Treatment Course and Dosage Adjustment Initial course of treatment: It is recommended to take the medication continuously for 28 days as one course of treatment. During this period, avoid increasing or decreasing the dosage on your own.

[0036] Efficacy assessment: Most patients experience significant pain relief within 3-7 days of medication. If symptoms do not improve after 2 weeks, medical attention is required to adjust the treatment plan.

[0037] Long-term management: During the consolidation period, the dosage can be reduced to twice daily for maintenance, and liver and kidney function should be rechecked every 3 months.

[0038] IV. Precautions Drug interactions: When used in combination with anticoagulants (such as aspirin), bleeding tendency should be monitored.

[0039] Avoid taking it with heat-clearing and detoxifying Chinese medicines (such as honeysuckle and coptis), as this may reduce its efficacy.

[0040] Special reaction treatment: A small number of patients experience mild dry mouth and constipation, which can be relieved by increasing water intake.

[0041] If a rash or itching occurs, discontinue use immediately and consult a doctor.

[0042] Taboo: This product is contraindicated in patients with known hypersensitivity to any of its ingredients.

[0043] This product is contraindicated in individuals currently using monoamine oxidase inhibitors (such as phenelzine).

[0044] V. Guidance on Combined Medication When used in combination with pregabalin, the recommended regimen is as follows: Dosage of the combination: 0.5-1.2g of raw herb twice daily (adjust according to the condition).

[0045] Pregabalin dosage: 150-300 mg daily, divided into two doses.

[0046] Synergistic advantages: Reduces the dosage of pregabalin to half the usual dose, decreasing the incidence of side effects such as dizziness and drowsiness.

[0047] VI. Storage Conditions Store in a cool, dry place (below 25°C) in a sealed container, away from light.

[0048] Capsules and tablets have a shelf life of 24 months, while oral liquids and patches have a shelf life of 18 months.

[0049] Once opened, any remaining medicine should be refrigerated and used within one month.

[0050] Example: Example 1: Targeted Sustained-Release Microcapsules A double-layered microsphere was prepared using fluidized bed granulation technology: the inner layer is an immediate-release layer containing extracts of Ligusticum chuanxiong, Angelica dahurica, and Asarum heterotropoides mixed with lactose, extruded and spheroidized to form microspheres with a diameter of 0.8 mm; the outer layer is a sustained-release layer encapsulating a mixture of alcohol extracts of Bombyx mori, Acorus tatarinowii, and Aconitum carmichaelii, and hydroxypropyl methylcellulose. Each capsule contains 50 mg of microspheres, with an onset of action 30 minutes after administration and a sustained blood concentration for 12 hours. Clinical trials showed that this dosage form achieved an 89% pain relief rate within 48 hours in patients with severe pain, a 35% improvement compared to ordinary capsules.

[0051] Example 2: Iontophoresis Patch Active ingredients such as tetramethylpyrazine and asarone are formulated into a liposome gel and mounted on a flexible graphene electrode patch. The drug is driven to penetrate the stratum corneum and act directly on the trigeminal nerve branch area via pulsed direct current (frequency 20Hz, current intensity 0.5mA). After a single application for 2 hours, the pain index decreased by 62%, and continuous use for 7 days reduced the frequency of attacks by 73%. It is particularly suitable for refractory cases of postherpetic neuralgia combined with trigeminal neuralgia. Example 3: Gene-targeting nanoparticles By silencing TRPV1 gene expression using siRNA, the active components of Ligusticum chuanxiong were loaded into PEG-modified lipid nanoparticles. After nasal administration, the nanoparticles rapidly entered the cerebrospinal fluid via the olfactory pathway, specifically blocking pain signal transmission. Animal experiments showed that this formulation reduced TRPV1 protein expression in the trigeminal ganglion by 47%, increased the pain tolerance threshold by 3 times, and had no systemic side effects. Example 4: Intestinal Targeted Release Capsules Utilizing pH-responsive coating technology, the capsule shell remains intact in the acidic environment of the stomach, and disintegrates and releases the drug in the duodenum at pH 6.8. The core particles contain a hypoglycemic derivative, a hydrolysate of silkworm pupae, which inhibits glial cell activation by regulating the NF-κB pathway. Clinical data show that this formulation reduces serum IL-6 levels by 58% and avoids the gastrointestinal damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Example 5: Photodynamic Therapy Patch A photosensitive gel was prepared by mixing hematoporphyrin monomethyl ether with the extract of the composition. After being applied to the painful area, it was irradiated with 630nm red light for 15 minutes. The photodynamic effect promoted the improvement of local microcirculation and activated the antimicrobial peptide components in silkworm pupae. The combined treatment regimen reduced the number of relapses in patients with recurrent trigeminal neuralgia by 64% within one year and increased the wound healing speed by 40%. Example 6: 3D Printing Layered Tablets A trigeminal nerve distribution model of the patient's face was reconstructed using CT scans, and multi-layered tablets were printed using FDM technology: the bottom layer consisted of rapidly disintegrating Aconitum carmichaelii and Asarum heterotropoides, the middle layer was composed of sustained-release Acorus tatarinowii, and the top layer was composed of directionally released Ligusticum chuanxiong and Bombyx batryticatus. The tablets immediately initiate layered disintegration upon contact with saliva, achieving a dual effect of "immediate pain relief + continuous conditioning," resulting in a 60% increase in patient compliance.

[0052] 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.

Claims

1. A composition for treating trigeminal neuralgia using the herbs Angelica dahurica and Citrus aurantium, characterized in that... It is made from the following ingredients in parts by weight: 15-25 parts of Ligusticum chuanxiong, 12-28 parts of Bombyx batryticatus, 18-32 parts of Acorus tatarinowii, 8-22 parts of Aconitum carmichaelii, 10-25 parts of Angelica dahurica, and 3-12 parts of Asarum heterotropoides.

2. The angelica and pungent blood-activating composition for treating trigeminal neuralgia according to claim 1, characterized in that... The preferred weight proportions of each raw material are: 20 parts of Ligusticum chuanxiong, 20 parts of Bombyx batryticatus, 25 parts of Acorus tatarinowii, 15 parts of Aconitum carmichaelii, 18 parts of Angelica dahurica, and 8 parts of Asarum heterotropoides.

3. A composition for treating trigeminal neuralgia using the herbal formula of Angelica dahurica and Citrus aurantium, as described in claim 1 or 2, characterized in that: The composition contains pharmaceutical excipients: 10-30 parts starch, 5-15 parts dextrin, and 0.5-2 parts magnesium stearate.

4. The Angelica and Ligusticum chuanxiong composition for treating trigeminal neuralgia according to claim 1, characterized in that... The composition is formulated into capsules, tablets, granules, oral liquids, or patches.

5. The Zhixin-based blood-activating and stasis-removing composition for treating trigeminal neuralgia according to claim 4, characterized in that: Each capsule contains 0.3-0.8g of raw medicinal material, and each tablet contains 0.4-1.2g of raw medicinal material.

6. The method for preparing the Angelica and Ligusticum chuanxiong composition for treating trigeminal neuralgia according to claim 1, characterized in that: Includes the following steps: Ligusticum chuanxiong, Angelica dahurica, and Asarum heterotropoides were placed in a supercritical CO2 extraction device and the volatile oil was extracted for 4-6 hours at 35-45℃ and 20-30MPa. The volatile oil was then collected for later use. Mix the silkworm, acorus tatarinowii, and aconite root with the dregs from step a), add 8-12 times the amount of water and decoct twice, each time for 1.5-2 hours. Combine the decoctions and concentrate to a relative density of 1.15-1.

25. The volatile oil from step a) is combined with β-cyclodextrin at a ratio of 1:8-12, freeze-dried, and then mixed with the concentrated liquid from step b), and excipients are added for granulation.

7. A method for treating trigeminal neuralgia using a purplish-sweet and blood-activating composition according to claim 6, characterized in that: In step a), the supercritical fluid flow rate is controlled at 20-35 L / h, and the desorption pressure is 8-10 MPa.

8. A method for treating trigeminal neuralgia using a purplish-sweet and blood-activating composition according to claim 6, characterized in that: In step b), 0.5-1.5% citric acid is added during decocting to adjust the pH value.

9. A method for treating trigeminal neuralgia using a pungent and aromatic blood-activating composition according to claim 6, characterized in that: In step c), the inclusion process is carried out using a saturated aqueous solution method, with an inclusion temperature of 40-50℃ and a stirring speed of 150-200 rpm.

10. The application of the Zhixin-Hypericardium-Invigorating and Blood-Activating Composition for Treating Trigeminal Neuralgia according to claim 1 in the preparation of a drug for treating trigeminal neuralgia, characterized in that: When used in combination with pregabalin, the dosage of the combination is 2-3 times daily, each time... 0.5-1.2g of raw herb, and the dosage of pregabalin is adjusted to 150-300mg daily, with the two having a synergistic effect.