A traditional Chinese medicine composition for treating trigeminal neuralgia

Abstract

This invention provides a traditional Chinese medicine composition for trigeminal neuralgia, belonging to the field of traditional Chinese medicine technology. The composition comprises eleven medicinal materials: gypsum, buffalo horn, vitex fruit, tribulus terrestris, purple oyster shell, pyrrolizum grass, zephyranthes root, photinia serratifolia, geranium, seven-leaf lotus, and loofah sponge. Animal experiments show that this traditional Chinese medicine composition significantly increases the head withdrawal threshold in rats with trigeminal neuralgia, reduces the levels of pro-inflammatory factors TNF-α, IL-1β, and IL-6 in serum, increases the activity of antioxidant enzymes SOD and GSH-Px, and reduces MDA content, exhibiting significant anti-inflammatory, antioxidant, and neuroprotective effects. Clinical studies show that the total effective rate of this traditional Chinese medicine composition combined with carbamazepine in treating trigeminal neuralgia is as high as 96.67%, significantly reducing patients' VAS pain scores, improving sleep quality and quality of life, and exhibiting good safety and tolerability, providing a safe and effective new treatment option for trigeminal neuralgia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for trigeminal neuralgia. Background Technology

[0002] Trigeminal neuralgia (TN) is a neuropathic pain characterized by recurrent, electric shock-like pain on one side of the face. According to the International Classification of Headaches (3rd Edition), it can be classified into classic, secondary, and idiopathic types. Studies show that TN is not only a peripheral nerve compression disease but also a comprehensive neurological disorder involving the reorganization of central brain networks. The clinical characteristics of this disease include lightning-like, stabbing, or burning pain that appears suddenly and stops abruptly, lasting from a few seconds to several minutes. It is often localized to the distribution area of ​​one or more branches of the trigeminal nerve, severely impacting patients' quality of life, sleep, and mental health.

[0003] Currently, the clinical treatment of trigeminal neuralgia mainly includes drug therapy and surgical treatment. Drug therapy is primarily based on antiepileptic drugs such as carbamazepine and oxcarbazepine. Although they can temporarily relieve pain, long-term use can easily lead to adverse reactions such as dizziness, drowsiness, ataxia, liver damage, and skin rashes, and can also lead to drug resistance. Some patients do not respond well to the drugs or cannot tolerate them. Surgical treatment includes microvascular decompression, radiofrequency ablation, and Gamma Knife treatment. Although these have certain effects, they are invasive, expensive, have many postoperative complications, and a high recurrence rate. Some patients may also experience sequelae such as facial numbness and decreased sensation.

[0004] Based on its clinical manifestations, trigeminal neuralgia can be categorized under "headache," "facial pain," and "facial wind" in Traditional Chinese Medicine (TCM), with its core pathogenesis often involving wind-heat and blood stasis. While some TCM formulas are currently used clinically, these formulas tend to focus on single treatment methods, such as simply clearing heat or promoting blood circulation, failing to comprehensively address the complex pathogenesis of trigeminal neuralgia involving wind-heat and blood stasis. Therefore, developing a scientifically formulated, effective, and low-side-effect TCM composition for the treatment of trigeminal neuralgia is of significant clinical importance. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for trigeminal neuralgia.

[0007] (II) Technical Solution

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

[0009] This invention provides a traditional Chinese medicine composition for trigeminal neuralgia, the composition comprising the following medicinal materials in parts by weight: 20-40 parts gypsum, 5-25 parts buffalo horn, 3-20 parts Vitex trifolia, 3-20 parts Tribulus terrestris, 15-25 parts Cibotium barometz, 3-20 parts Pyrola rotundifolia, 2-12 parts Zanthoxylum nitidum, 3-20 parts Photinia serratifolia, 3-20 parts Geranium wilfordii, 3-20 parts Acer palmatum, and 5-24 parts Luffa cylindrica.

[0010] Preferably, the traditional Chinese medicine composition comprises the following medicinal materials in parts by weight: 25-35 parts gypsum, 10-20 parts buffalo horn, 5-15 parts Vitex trifolia, 5-15 parts Tribulus terrestris, 10-20 parts Cibotium barometz, 5-15 parts Pyrola rotundifolia, 3-9 parts Zanthoxylum nitidum, 5-15 parts Photinia serratifolia, 5-15 parts Geranium wilfordii, 5-15 parts Achyranthes bidentata, and 8-16 parts Luffa cylindrica.

[0011] Preferably, the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 30 parts gypsum, 15 parts buffalo horn, 10 parts Vitex trifolia, 10 parts Tribulus terrestris, 15 parts Cibotium barometz, 10 parts Pyrola rotundifolia, 6 parts Zanthoxylum nitidum, 10 parts Photinia serratifolia, 10 parts Geranium wilfordii, 10 parts Acer palmatum, and 12 parts Luffa cylindrica.

[0012] This invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating trigeminal neuralgia.

[0013] The pharmacological effects of each herb in the herbal composition of this invention are as follows:

[0014] Raw gypsum: a sulfate mineral belonging to the gypsum group, mainly containing hydrated calcium sulfate (CaSO4·2H2O). It has a sweet and pungent taste and is extremely cold in nature. It enters the lung and stomach meridians. It has the effects of clearing heat and purging fire, relieving irritability and quenching thirst. It is used for exogenous febrile diseases, high fever and thirst, lung heat and cough, excessive stomach fire, headache, and toothache.

[0015] Buffalo horn: The horn of the buffalo, *Bubalus bubalis* Linnaeus. It has a bitter taste and is cold in nature. It enters the heart and liver meridians. It has the effects of clearing heat and cooling blood, detoxifying, and calming the nerves. It is used for febrile diseases with high fever, delirium, rashes, hematemesis, epistaxis, infantile convulsions, and mania.

[0016] Vitex trifolia fruit: The dried, mature fruit of Vitex trifolia L. var. simplicifolia Cham. or Vitex trifolia L., both belonging to the Verbenaceae family. It has a pungent and bitter taste, and is slightly cold in nature. It enters the bladder, liver, and stomach meridians. It has the effects of dispersing wind-heat and clearing the head and eyes. It is used for headaches due to wind-heat, swollen and painful gums, red and watery eyes, blurred vision, and dizziness.

[0017] White Tribulus: The dried, mature fruit of *Tribulus terrestris* L., a plant in the Zygophyllaceae family. It has a pungent and bitter taste, and is slightly warm in nature. It enters the Liver meridian. It has the effects of calming the liver and relieving depression, promoting blood circulation and dispelling wind, improving eyesight, and relieving itching. It is used for headaches and dizziness, chest and rib pain, mastitis, red and pterygium eyes, and itchy rashes.

[0018] Purple Clam Shell: The shell of the Arabian bream (Mauritia arabica), a member of the family Mauritiaceae. It has a salty taste and neutral properties. It enters the liver and heart meridians. It has the effects of calming the liver and suppressing yang, soothing the mind and relieving convulsions. It is used for infantile high fever and convulsions, dizziness, palpitations, irritability, insomnia, dreaminess, red and swollen eyes, and eye diseases caused by heat toxins.

[0019] Pyrola calliantha H. Andres (also known as Pyrola decorata H. Andres) is the dried whole herb of the plant in the Pyrolaaceae family. It has a sweet and bitter taste and is warm in nature. It enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, strengthening tendons and bones, stopping bleeding, and relieving cough. It is used for rheumatic pain, kidney deficiency causing lower back pain, weakness of the lower back and knees, menorrhagia, and chronic cough.

[0020] Zanthoxylum nitidum (Roxb.) DC., a plant in the Rutaceae family, is a dried root. It has a bitter and pungent taste and is neutral in nature. It enters the liver and stomach meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain, dispelling wind and unblocking meridians, and detoxifying and reducing swelling. It is used for injuries from falls and blows, stomachache, toothache, rheumatic pain, and snake bites; externally, it is used to treat burns and scalds.

[0021] Photinia serratifolia: The dried branches and leaves of Piper puberulum, a plant in the Piperaceae family. It has a pungent taste and warm properties. It enters the liver and spleen meridians. It has the effects of dispelling wind and dampness, relaxing muscles and tendons, strengthening the waist and knees, and relieving pain. It is used for wind-cold-dampness arthralgia, muscle and bone pain, weakness of the waist and knees, cough and asthma, kidney deficiency cough, and impotence.

[0022] Geranium: The dried aerial parts of *Erodium stephanianum* Willd., *Geranium wilfordii* Maxim., or *Geranium carolinianum* L., belonging to the Geraniaceae family. It has a pungent and bitter taste, and is neutral in nature. It enters the liver, kidney, and spleen meridians. It has the effects of dispelling wind and dampness, clearing the meridians, and stopping diarrhea and dysentery. It is used for rheumatic pain, numbness and contractures, muscle and bone pain, diarrhea, and dysentery.

[0023] Seven-leaf schefflera: The stems and leaves of *Scheffleva arboricola* Hayata and *Scheffleva venulosa* (Wight et Arn.) Harms, both belonging to the Araliaceae family. It has a bitter and sweet taste and is warm in nature. It possesses analgesic, blood-stasis-dispersing, and swelling-reducing properties. It is used for rheumatic pain, headache, toothache, abdominal pain, dysmenorrhea, postpartum abdominal pain, traumatic swelling and pain, fractures, and sores.

[0024] Luffa sponge: The vascular bundles of the dried, mature fruit of *Luffa cylindrica* (L.) Roem., a plant in the Cucurbitaceae family. It has a sweet taste and neutral properties. It enters the lung, stomach, and liver meridians. It has the effects of dispelling wind, clearing the meridians, promoting blood circulation, and promoting lactation. It is used for arthralgia, chest and rib pain, insufficient lactation, and mastitis.

[0025] (III) Beneficial Effects

[0026] This invention provides a traditional Chinese medicine composition for trigeminal neuralgia, comprising the following eleven medicinal materials: gypsum, buffalo horn, vitex fruit, tribulus terrestris, purple cowrie shell, pyrrolizum herb, tsundere, photinia serratifolia, geranium, seven-leaf lotus, and loofah sponge. This composition closely addresses the core pathogenesis of trigeminal neuralgia, namely "wind and fire stirring, and blood stasis obstructing the meridians," working together to clear wind and fire, calm the liver and subdue yang, and unblock the meridians and relieve pain. Gypsum and buffalo horn are the principal herbs in the formula. Gypsum clears heat and purges fire, relieves irritability and quenches thirst, and is particularly effective in clearing excess heat in the yangming qi level. Its pungent and dispersing properties also have the effect of expelling pathogenic factors, allowing the internally stagnant heat to be released from the outside. Buffalo horn clears heat and cools the blood, detoxifies and calms the nerves, effectively clearing liver fire, calming internal liver wind, and entering the blood level to cool the blood and disperse blood stasis, resolving symptoms of heat scorching blood stasis. Gypsum clears Yangming stomach fire, while buffalo horn drains Jueyin liver fire. The two work synergistically to clear both Qi and blood, treat both the liver and stomach, and extinguish wind and fire. Vitex trifolia, Tribulus terrestris, and Cinnamomum cassia are used as assistant herbs. Vitex trifolia disperses wind-heat and clears the head and eyes, effectively treating headaches caused by wind-heat attacking upwards; Tribulus terrestris calms the liver, relieves stagnation, invigorates blood, and dispels wind, alleviating headaches, facial pain, and red, swollen eyes caused by liver Yang hyperactivity; Cinnamomum cassia, being salty and neutral, enters the liver and heart meridians, calming the liver, suppressing Yang, and relieving palpitations and anxiety, thus alleviating palpitations and irritability during trigeminal neuralgia attacks and enhancing the liver-calming and Yang-suppressing effects of the principal herbs. Vitex trifolia is light and clears wind, Tribulus terrestris soothes the liver and extinguishes wind, and Cinnamomum cassia is heavy and calms the liver. The three work together to assist the principal herbs in clearing wind and fire, and to calm internal liver wind, resulting in a clear and peaceful head and face, and a balance of wind and fire. The formula uses *Pyrola rotundifolia*, *Zanthoxylum nitidum*, *Photinia serratifolia*, *Geranium wilfordii*, and *Schefflera heptaphylla* as adjuvant herbs. *Pyrola rotundifolia* dispels wind and dampness, strengthens tendons and bones; its warm and moist nature helps to counteract the coldness of other herbs in the formula, preventing damage to the spleen and stomach, and also nourishes the liver and kidneys, preventing prolonged pain from harming the body's vital energy. *Zanthoxylum nitidum* invigorates blood circulation, removes blood stasis, promotes qi circulation, and relieves pain; its ability to remove blood stasis and unblock meridians is potent, penetrating deep into small veins to resolve stagnation. *Photinia serratifolia* dispels wind and dampness, relaxes tendons and meridians, effectively treating pain caused by blocked meridians in the head and face, clearing small meridians, and promoting smooth flow of qi and blood. *Geranium wilfordii* dispels wind and dampness, unblocks meridians, and also addresses the pain caused by prolonged illness affecting the meridians. *Schefflera heptaphylla* relieves pain, disperses blood stasis, and reduces swelling, alleviating the severe pain during trigeminal neuralgia attacks. Each of the five auxiliary herbs performs its specific function: *Zanthoxylum nitidum* and *Schefflera heptaphylla* invigorate blood circulation, remove blood stasis, and relieve pain; *Geranium wilfordii* and *Photinia serratifolia* dispel wind, eliminate dampness, and unblock the meridians; *Pyrola rotundifolia* tonifies the liver and kidneys and regulates cold and heat. The five herbs work together to unblock the meridians of the head and face, resolve blood stasis, and address the key issue of "pain due to obstruction," thus doubling the analgesic power of the entire formula. *Luffa cylindrica* is used as the guiding herb. *Luffa cylindrica* dispels wind, unblocks the meridians, invigorates blood, and resolves phlegm. Its light and airy nature allows it to unblock the meridians of the three jiaos, guiding the other herbs directly to the affected area of ​​the head and face, penetrating deep into the tiny collaterals; simultaneously, it resolves stagnant phlegm and dampness in the collaterals, ensuring smooth meridian flow and normal blood circulation.

[0027] Animal experiments showed that the herbal composition of this invention significantly increased the head withdrawal threshold in rats with trigeminal neuralgia, reduced the levels of pro-inflammatory factors TNF-α, IL-1β, and IL-6 in serum, increased the activity of antioxidant enzymes SOD and GSH-Px, and reduced MDA levels, exhibiting significant anti-inflammatory, antioxidant, and neuroprotective effects. Clinical studies showed that the total effective rate of the herbal composition of this invention combined with carbamazepine in treating trigeminal neuralgia was as high as 96.67%, significantly reducing patients' VAS pain scores, improving sleep quality and quality of life, and demonstrating good safety and tolerability, providing a safe and effective new treatment option for trigeminal neuralgia. Attached Figure Description

[0028] Figure 1 This invention relates to the effect of the traditional Chinese medicine composition on the head retraction threshold in a rat model of trigeminal neuralgia; Note: Compared with the model group. * P<0.05, ** P<0.01; compared with prescription group 1, & P<0.05, && P<0.01.

[0029] Figure 2 This invention relates to the effects of the traditional Chinese medicine composition on serum indicators in model rats; Note: Compared with the sham-operated group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01; compared with prescription group 1, & P<0.05, && P<0.01. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Example 1

[0032] A traditional Chinese medicine composition for trigeminal neuralgia, the composition comprising the following medicinal materials in parts by weight: 30 parts gypsum, 15 parts buffalo horn, 10 parts Vitex trifolia, 10 parts Tribulus terrestris, 15 parts Cibotium barometz, 10 parts Pyrola rotundifolia, 6 parts Zanthoxylum nitidum, 10 parts Photinia serratifolia, 10 parts Geranium wilfordii, 10 parts Acer palmatum, and 12 parts Luffa cylindrica.

[0033] Example 2

[0034] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 20 parts gypsum, 5 parts buffalo horn, 3 parts Vitex trifolia, 3 parts Tribulus terrestris, 15 parts Cibotium barometz, 3 parts Pyrola rotundifolia, 2 parts Zanthoxylum nitidum, 3 parts Photinia serratifolia, 3 parts Geranium wilfordii, 3 parts Acer palmatum, and 5 parts Luffa cylindrica.

[0035] Example 3

[0036] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 40 parts gypsum, 25 parts buffalo horn, 20 parts Vitex trifolia, 20 parts Tribulus terrestris, 25 parts Cibotium barometz, 20 parts Pyrola rotundifolia, 12 parts Zanthoxylum nitidum, 20 parts Photinia serratifolia, 20 parts Geranium wilfordii, 20 parts Acer palmatum, and 24 parts Luffa cylindrica.

[0037] Example 4

[0038] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 25 parts gypsum, 10 parts buffalo horn, 5 parts Vitex trifolia, 5 parts Tribulus terrestris, 10 parts Cibotium barometz, 5 parts Pyrola rotundifolia, 3 parts Zanthoxylum nitidum, 5 parts Photinia serratifolia, 5 parts Geranium wilfordii, 5 parts Acer palmatum, and 8 parts Luffa cylindrica.

[0039] Example 5

[0040] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 35 parts gypsum, 20 parts buffalo horn, 15 parts Vitex trifolia, 15 parts Tribulus terrestris, 20 parts Cibotium barometz, 15 parts Pyrola rotundifolia, 9 parts Zanthoxylum nitidum, 15 parts Photinia serratifolia, 15 parts Geranium wilfordii, 15 parts Acer palmatum, and 16 parts Luffa cylindrica.

[0041] Example 6

[0042] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 22 parts gypsum, 8 parts buffalo horn, 4 parts Vitex trifolia, 4 parts Tribulus terrestris, 12 parts Cibotium barometz, 4 parts Pyrola rotundifolia, 3 parts Zanthoxylum nitidum, 3 parts Photinia serratifolia, 4 parts Geranium wilfordii, 4 parts Acer palmatum, and 7 parts Luffa cylindrica.

[0043] Example 7

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 38 parts gypsum, 22 parts buffalo horn, 18 parts Vitex trifolia, 18 parts Tribulus terrestris, 22 parts Cinnamomum camphora, 18 parts Pyrola rotundifolia, 11 parts Zanthoxylum nitidum, 16 parts Photinia serratifolia, 18 parts Geranium wilfordii, 18 parts Acer palmatum, and 21 parts Luffa cylindrica.

[0045] Experimental Example 1

[0046] 1. Materials and Methods

[0047] 1.1 Laboratory Animals

[0048] Fifty-six SPF-grade SD rats, weighing 180-220g, half male and half female, were provided by Henan Skebest Biotechnology Co., Ltd. The rats were housed in an environment with a temperature of 22-25℃ and a relative humidity of 50%-60%, with 12h / 12h light-dark cycles, and free access to food and water. Experiments were conducted after one week of acclimatization.

[0049] 1.2 Establishment of an animal model of trigeminal neuralgia

[0050] A chronic compressive trigeminal neuralgia (CCI-ION) model was established in rats by surgically compressing the infraorbital nerve. The specific procedures were as follows: After anesthetizing the rats with sodium pentobarbital (50 mg / kg) via intraperitoneal injection, they were fixed in a supine position on a 37°C constant-temperature mat. Under aseptic conditions, skin preparation was performed, and a 5 mm long facial incision parallel to the midline was made from the lower edge of the orbit to the corner of the mouth. The superficial fascia was then directly dissected to expose the distal end of the infraorbital nerve within the orbit. After the dissected infraorbital nerve was released, it was ligated twice with 4-0 chromic catgut, with a ligation interval of 2 mm. The ligation force was controlled to slightly reduce the diameter of the infraorbital nerve to delay nerve conduction, but without obstructing the blood circulation of the superficial epineurium. After the operation, the muscles and skin were sutured layer by layer, and the rats were placed in a suitable temperature environment for resuscitation.

[0051] 1.3 Animal grouping and administration

[0052] On day 7 after modeling, the successfully modeled rats were randomly divided into a model group and prescription groups 1-5, with 8 rats in each group. Another 8 rats were used as the sham surgery group, with only the nerves exposed and no ligation performed.

[0053] Dosing regimen: The sham surgery group and the model group were given an equal volume of physiological saline by gavage; Prescription 1-5 groups were given the corresponding drug (the specific prescription composition is shown in Table 1) decoction by gavage, the dosage was calculated based on the amount of raw drug as 10g / kg, and the administration volume was 10mL / kg, once a day for 14 consecutive days.

[0054] Table 1. Composition of drug prescriptions in each group

[0055]

[0056] 1.4 Behavioral Testing

[0057] The head-withdrawal threshold (HWT) was used to determine the response threshold of rats to mechanical stimulation. Pressure was applied to the whisker pads on the operated side of the rats using a von Frey electronic analgesic device before modeling (day 0), before drug administration (day 7), and on days 7 and 14 after drug administration (days 14 and 21) until the rats exhibited a head-withdrawal response. The corresponding pressure values ​​were recorded as the thresholds. Each rat was tested 5 times, with each test 5 minutes apart, and the average value was taken as the final result.

[0058] 1.5 Serum Biochemical Indicators

[0059] One hour after the last administration, rats were anesthetized by intraperitoneal injection of sodium pentobarbital (50 mg / kg). Blood was collected from the abdominal aorta, allowed to stand at room temperature for 30 minutes, and then centrifuged at 3000 rpm for 15 minutes. Serum was separated and stored at -80℃ for later use. The levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in serum were detected by ELISA, strictly following the kit instructions. The activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) and the level of malondialdehyde (MDA) in serum were detected by colorimetric methods, strictly following the kit instructions.

[0060] 1.6 Statistical Methods

[0061] Data analysis was performed using GraphPad Prism 8.0 statistical software. Quantitative data were expressed as mean ± standard deviation. One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were used for pairwise comparisons between groups. P < 0.05 was considered statistically significant.

[0062] 2. Results

[0063] 2.1 Effect on head withdrawal threshold in rats with trigeminal neuralgia

[0064] Depend on Figure 1 Before modeling, there was no significant difference in HWT among the groups of rats (P>0.05). On day 7 after modeling, compared with the sham-operated group, the HWT of rats in each modeling group was significantly reduced, indicating that the trigeminal neuralgia model was successfully established. On days 7 and 14 after modeling, compared with the model group, the HWT of rats in each treatment group was significantly increased. Among them, the HWT of prescription group 1 showed the greatest increase. The above results indicate that the traditional Chinese medicine composition of this invention can effectively relieve the pain symptoms caused by trigeminal neuralgia.

[0065] 2.2 Effects on serum markers in rats with trigeminal neuralgia

[0066] Depend on Figure 2It was found that, compared with the sham-operated group, the serum levels of TNF-α, IL-1β, and IL-6 in the model group rats were significantly increased, while the activities of SOD and GSH-Px were significantly decreased, and the MDA content was significantly increased (P<0.01). Compared with the model group, the serum levels of the above-mentioned inflammatory factors in rats of each treatment group were significantly decreased, the activities of antioxidant enzymes were significantly increased, and the MDA content was significantly decreased. Among them, prescription group 1 showed the most significant improvement. The above results indicate that the traditional Chinese medicine composition of the present invention can significantly reduce neuroinflammatory response and improve oxidative stress.

[0067] 3. Conclusion

[0068] The above experimental results show that the herbal composition of this invention can significantly increase the head withdrawal threshold in rats with trigeminal neuralgia and alleviate neuropathic pain; it can significantly reduce the levels of pro-inflammatory factors TNF-α, IL-1β, and IL-6 in serum and inhibit inflammatory responses; it can significantly increase the activity of antioxidant enzymes SOD and GSH-Px, reduce MDA content, and alleviate oxidative stress damage. Further analysis revealed that prescription group 1 showed the most significant improvement effect on the above indicators, exhibiting the best comprehensive analgesic, anti-inflammatory, and antioxidant efficacy, indicating that the proportions of the medicinal materials in the herbal composition of this invention have a synergistic effect, and can synergistically exert the therapeutic effect on trigeminal neuralgia through anti-inflammatory, antioxidant, and neuroprotective effects.

[0069] Experimental Example 2

[0070] 1. Materials and Methods

[0071] 1.1 General Information

[0072] One hundred and twenty patients with trigeminal neuralgia admitted between January 2024 and November 2025 were selected and randomly divided into a control group and an observation group, with 60 patients in each group. In the control group, there were 32 males and 28 females; their ages ranged from 18 to 69 years, with a mean age of (43.25±13.53) years; their disease duration ranged from 5 months to 10 years, with a mean duration of (4.93±3.12) years. In the observation group, there were 24 males and 36 females; their ages ranged from 18 to 67 years, with a mean age of (45.38±14.79) years; their disease duration ranged from 3 months to 11 years, with a mean duration of (5.42±3.00) years. There were no statistically significant differences between the two groups in terms of gender, age, and disease duration (P>0.05), making them comparable. All patients voluntarily participated in this study and signed informed consent forms.

[0073] 1.2 Diagnostic criteria

[0074] 1.2.1 Western Medicine Diagnostic Criteria

[0075] The diagnostic criteria for trigeminal neuralgia are formulated based on the "Diagnostic Criteria for Internal Medicine Diseases" in the "Modern Clinical Medical Diagnostic Criteria Series": The pain is paroxysmal, lasting from a few seconds to 2 minutes before subsiding; the pain is located in one or more branches of the trigeminal nerve distribution area, and is sudden, superficial, stabbing, severe, burning, or electric shock-like, with sudden onset and cessation, and normal intervals; there are no neurological defects; the pain can be triggered by daily activities such as chewing, washing the face, and speaking.

[0076] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0077] Based on the diagnostic criteria for migraine with qi stagnation and blood stasis syndrome in "Internal Medicine of Traditional Chinese Medicine", the following symptoms are proposed: recurrent facial pain, fixed location of pain, heaviness and dizziness in the head, or accompanied by facial muscle numbness; tongue and pulse: dark purple tongue or with ecchymosis, greasy coating, wiry or hesitant pulse.

[0078] 1.3 Inclusion Criteria

[0079] Meets the above diagnostic criteria in both traditional Chinese and Western medicine; aged 18-70 years; pain episodes lasting ≥4 days / week, with an attack frequency ≥3 times / day, and a visual analog scale (VAS) score ≥5; is conscious and able to cooperate in completing various examinations and assessments; and voluntarily participates in this study and signs an informed consent form.

[0080] 1.4 Exclusion Criteria

[0081] Patients who have undergone surgical treatments such as Gamma Knife therapy resulting in loss of neurological function; patients with other head and facial pain; patients whose trials were not conducted as required or whose clinical data is incomplete, making it impossible to determine the reliability of the treatment efficacy; patients currently participating in other medical trials; patients with mental illness and behavioral disorders who are unable to cooperate with treatment; women with allergies, who are pregnant or breastfeeding; patients with cerebral vascular malformations, tumors, or intracranial space-occupying lesions; and patients with severe dysfunction of organs such as the heart, liver, and kidneys.

[0082] 1.5 Treatment Methods

[0083] 1.5.1 Control Group

[0084] Carbamazepine tablets (Beijing Novartis Pharmaceutical Co., Ltd., 200mg / tablet, National Drug Approval Number H11022279) were administered orally, starting at 100mg twice daily. The dose was increased by 100mg every other day thereafter until pain relief was achieved, with a maximum dose not exceeding 400mg per dose. The treatment course was 4 weeks.

[0085] 1.5.2 Observation Group

[0086] In addition to the treatment given to the control group, the herbal composition of this invention was administered. The prescription consists of: 30g gypsum, 15g buffalo horn, 10g Vitex trifolia fruit, 10g Tribulus terrestris, 15g Cypripedium erythrorhizon, 10g Pyrola rotundifolia, 6g Zanthoxylum nitidum, 10g Photinia serratifolia vine, 10g Geranium wilfordii, 10g Achyranthes bidentata, and 12g Luffa cylindrica. One dose is taken daily, decocted in water to obtain 400mL of liquid, and taken warm twice daily, morning and evening. The course of treatment is 4 weeks.

[0087] 1.6 Observation Indicators

[0088] 1.6.1 Pain level

[0089] The visual analog scale (VAS) was used to assess the pain levels of both groups of patients before and after treatment. The VAS score ranged from 0 to 10, with higher scores indicating more severe pain.

[0090] 1.6.2 Sleep Quality

[0091] The Richards-Campbell Sleep Quality Scale (RCSQ) was used to assess the sleep quality of both groups of patients before and after treatment. The scale covers five aspects: sleep depth, sleep latency, number of nighttime awakenings, ability to fall back asleep, and overall sleep quality, with a total score of 100 points. A higher score indicates better sleep quality.

[0092] 1.6.3 Quality of life

[0093] The Short Form Quality of Life Scale (SF-12) was used to assess the quality of life of both groups of patients before and after treatment. The scale includes two dimensions: physical health and mental health. Each dimension has a total score of 100 points, with higher scores indicating better quality of life.

[0094] 1.6.4 Adverse Reactions

[0095] The adverse reactions that occurred in the two groups of patients during treatment were statistically analyzed, including neurological adverse reactions such as dizziness, drowsiness, ataxia, and blurred vision; digestive adverse reactions such as nausea, vomiting, dry mouth, and constipation; and skin allergic reactions such as rash and itching.

[0096] 1.7 Criteria for Evaluating Therapeutic Effect

[0097] The following criteria for evaluating the efficacy of traditional Chinese medicine in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" were adopted:

[0098] Clinical cure: pain completely disappeared, VAS score dropped to 0, and there was no recurrence during a 3-month follow-up after discontinuation of medication;

[0099] Significant effect: Pain is significantly reduced, VAS score decreases by >70%, and the frequency of attacks is significantly reduced;

[0100] Effective: Pain is reduced, VAS score decreases by 30%-70%, and frequency of attacks is reduced;

[0101] Ineffective: Pain is not significantly relieved or worsened, and the VAS score decreases by <30%.

[0102] Overall effective rate = (Number of clinically cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100%

[0103] 1.8 Statistical Methods

[0104] Data analysis was performed using GraphPad Prism 8.0 statistical software. Quantitative data were expressed as mean ± standard deviation; paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. Categorical data were expressed as percentages (%); between-group comparisons were performed using... Test. P < 0.05 indicates that the difference is statistically significant.

[0105] 2. Results

[0106] 2.1 Impact on the patient's pain level

[0107] As shown in Table 2, there was no significant difference in VAS scores between the two groups before treatment (P>0.05). After 4 weeks of treatment, the VAS scores of both groups were significantly lower than before treatment, and the VAS score of the observation group was lower than that of the control group (P<0.05), indicating that the traditional Chinese medicine composition of the present invention can effectively relieve the pain of patients with trigeminal neuralgia.

[0108] 2.2 Impact on patients' sleep quality

[0109] As shown in Table 2, there was no significant difference in RCSQ scores between the two groups before treatment (P>0.05). After 4 weeks of treatment, the RCSQ scores of both groups were significantly higher than before treatment, and the RCSQ score of the observation group was higher than that of the control group (P<0.05), indicating that the traditional Chinese medicine composition of the present invention can effectively improve the sleep quality of patients with trigeminal neuralgia.

[0110] Table 2. Comparison of VAS and RCSQ scores before and after treatment in the two groups of patients (points)

[0111]

[0112] Note: Compared with pre-treatment levels within the group. * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01.

[0113] 2.3 Impact on patients' quality of life

[0114] As shown in Table 3, there were no significant differences in any of the SF-12 scores between the two groups before treatment (P>0.05). After 4 weeks of treatment, the total scores of mental health and physical health in both groups were significantly higher than before treatment, and the total scores of mental health and physical health in the observation group were higher than those in the control group (P<0.05), indicating that the traditional Chinese medicine composition of the present invention can effectively improve the quality of life of patients.

[0115] Table 3 Comparison of total SF-12 scores before and after treatment in the two groups (points)

[0116]

[0117] Note: Compared with pre-treatment levels within the group. * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01.

[0118] 2.4 Adverse Reactions

[0119] Table 4 shows that during the treatment period, the control group experienced 8 adverse reactions, including 3 neurological adverse reactions (2 cases of dizziness and 1 case of blurred vision), 2 gastrointestinal adverse reactions (1 case of nausea and 1 case of dry mouth), and 3 skin allergic reactions (3 cases of rash), with a total incidence of 13.33%. The observation group experienced 1 adverse reaction, a gastrointestinal adverse reaction (1 case of nausea), with a total incidence of 1.67%. The incidence of adverse reactions in the observation group was significantly lower than that in the control group, and the difference was statistically significant (P<0.05). All adverse reactions were mild and resolved spontaneously without special treatment, and did not affect continued treatment.

[0120] Table 4 Comparison of adverse reaction rates between the two groups (cases, %)

[0121]

[0122] 2.5 Clinical efficacy

[0123] As shown in Table 5, after 4 weeks of treatment, the total clinical effective rate in the observation group was 96.67%, which was significantly higher than that in the control group (83.33%), and the difference was statistically significant (P<0.05).

[0124] Table 5. Comparison of clinical efficacy between the two groups of patients (cases, %)

[0125]

[0126] 3. Conclusion

[0127] The above experimental results show that the traditional Chinese medicine composition of the present invention can significantly improve the clinical efficacy of trigeminal neuralgia, alleviate the pain level of patients, improve patients' sleep quality and quality of life, and has a low incidence of adverse reactions and high safety, providing a safe and effective new solution for the clinical treatment of trigeminal neuralgia.

[0128] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for trigeminal neuralgia, characterized in that, The traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 20-40 parts gypsum, 5-25 parts buffalo horn, 3-20 parts Vitex trifolia, 3-20 parts Tribulus terrestris, 15-25 parts Cibotium barometz, 3-20 parts Pyrola rotundifolia, 2-12 parts Zanthoxylum nitidum, 3-20 parts Photinia serratifolia, 3-20 parts Geranium wilfordii, 3-20 parts Achyranthes bidentata, and 5-24 parts Luffa cylindrica.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 25-35 parts gypsum, 10-20 parts buffalo horn, 5-15 parts Vitex trifolia, 5-15 parts Tribulus terrestris, 10-20 parts Cibotium barometz, 5-15 parts Pyrola rotundifolia, 3-9 parts Zanthoxylum nitidum, 5-15 parts Photinia serratifolia, 5-15 parts Geranium wilfordii, 5-15 parts Achyranthes bidentata, and 8-16 parts Luffa cylindrica.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 30 parts gypsum, 15 parts buffalo horn, 10 parts Vitex trifolia, 10 parts Tribulus terrestris, 15 parts Cibotium barometz, 10 parts Pyrola rotundifolia, 6 parts Zanthoxylum nitidum, 10 parts Photinia serratifolia, 10 parts Geranium wilfordii, 10 parts Acer palmatum, and 12 parts Luffa cylindrica.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating trigeminal neuralgia.

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