A traditional Chinese medicine preparation for treating neuropathic pain and its preparation method

Abstract

The present invention belongs to the technical field of Chinese medicine preparations, and in particular to a Chinese medicine preparation for treating neuropathic pain and a preparation method thereof. The Chinese medicine preparation for treating neuropathic pain comprises the following raw materials in parts by weight: 18-25 parts of cassia twig, 13-17 parts of red thick shell, 12-15 parts of luffa, 8-12 parts of elm leaves, 10-14 parts of Chuanjianzi, 5-9 parts of eucommia, 3-8 parts of angelica, 1-5 parts of dendrobium, 1-3 parts of ginger, and 1-3 parts of liquorice. The Chinese medicine preparation provided by the present invention is used in combination with various medicines, taking into account both the main and secondary symptoms, and playing the effects of promoting blood circulation, promoting blood circulation and removing blood stasis, and relieving pain, and can effectively treat neuropathic pain caused by chronic constriction injury of the sciatic nerve.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating neuropathic pain and a preparation method thereof. Background Art

[0002] Neuropathic pain (NP) is a complex chronic pain syndrome caused by damage or disease of the somatosensory nervous system. Among them, neuropathic pain caused by chronic sciatic nerve compression is a common and complex condition. This pain typically stems from long-term or repeated compression of the sciatic nerve, leading to nerve dysfunction and abnormal pain sensations, causing significant pain and inconvenience to patients. Currently, common therapeutic drugs such as gabapentin, pregabalin, and tricyclic antidepressants have some efficacy, but long-term use can lead to drug dependence and side effects such as cognitive impairment, making them contraindicated. There are also some analgesics such as compound aspirin and analgesics, but they are limited to the treatment of mild pain. Therefore, the development of safer and more effective therapeutic drugs is particularly important.

[0003] In recent years, with the growing international influence of Traditional Chinese Medicine (TCM), research on TCM treatments for neuropathic pain has also garnered widespread attention. Traditional Chinese Medicine believes that "the meridians are constantly flowing, circulating endlessly. Cold qi enters the meridians, causing delays and delays, and the qi, which remains trapped within the meridians, becomes blocked, leading to sudden pain." Neuropathic pain, therefore, falls under the rubric of "arthralgia" and "blood stasis," with the core underlying cause being obstructed qi and blood flow and blocked meridians. Treatment emphasizes the principle of "unblocked, pain relieved; unblocked, pain relieved."

[0004] Therefore, how to combine the advantages of traditional Chinese medicine treatment to develop a traditional Chinese medicine preparation with analgesic effect and high safety is of great significance to meet the treatment needs of patients with neuropathic pain. Summary of the Invention

[0005] The first object of the present invention is to provide a traditional Chinese medicine preparation for treating neuropathic pain. The traditional Chinese medicine preparation of the present invention combines various herbs to take both the symptoms and the root cause into consideration, thereby achieving the effects of promoting blood circulation, removing blood stasis, and relieving pain, thereby effectively treating neuropathic pain.

[0006] A second object of the present invention is to provide a method for preparing a traditional Chinese medicine preparation for treating neuropathic pain. The traditional Chinese medicine preparation of the present invention adheres to the principle of monarch, minister, assistant and envoy, is mutually compatible, and is consistent with traditional Chinese medicine theory. Furthermore, the prescription is highly safe and can provide new technical support for the treatment of neuropathic pain.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is:

[0008] A traditional Chinese medicine preparation for treating neuropathic pain comprises the following raw materials in parts by weight: 18-25 parts of cassia twig, 13-17 parts of red thick shell, 12-15 parts of luffa, 8-12 parts of elm leaves, 10-14 parts of Chuanjian fruit, 5-9 parts of eucommia, 3-8 parts of angelica, 1-5 parts of dendrobium, 1-3 parts of ginger, and 1-3 parts of liquorice.

[0009] Furthermore, the invention comprises the following raw materials in parts by weight: 21 parts of cassia twig, 15 parts of red thick shell, 13 parts of luffa, 10 parts of elm leaves, 12 parts of Chuanjian fruit, 7 parts of Eucommia ulmoides, 5 parts of angelica, 3 parts of dendrobium, 2 parts of ginger and 2 parts of licorice.

[0010] The preparation method of the above-mentioned traditional Chinese medicine preparation for treating neuropathic pain comprises the following steps:

[0011] (1) After sieving the crushed raw materials, mix them evenly according to their weight proportions, soak them in water, and then boil the soaked mixture, filter it, and collect the filtrate A;

[0012] (2) adding water to the filter residue after filtering in step (1), repeating the aforementioned soaking, boiling, and filtering operations, and collecting the filtrate B;

[0013] (3) Filtrate A and filtrate B are combined and then concentrated. The concentrate is collected and pharmaceutically acceptable excipients are added to prepare a corresponding dosage form.

[0014] Furthermore, the amount of water added in step (1) is 6-10 times the total mass of each raw material.

[0015] Furthermore, the particle size of each raw material drug after pulverization in step (1) is 50-80 mesh.

[0016] Furthermore, the soaking time in step (1) is 30-90 minutes, and the decocting temperature is 90-100° C. and the decocting time is 2-3 hours.

[0017] Furthermore, for every gram of the raw material drug, the corresponding volume of the concentrate is 1-2 mL.

[0018] Furthermore, the neuropathic pain is neuropathic pain caused by chronic compression injury of the sciatic nerve.

[0019] Furthermore, the dosage form is an oral preparation.

[0020] Furthermore, the oral preparation is one of oral liquid, tablets, granules, capsules, and powders.

[0021] The pharmacological properties of the raw materials used in the present invention are analyzed as follows:

[0022] Cinnamon twig: Pungent, sweet, and warm. It enters the Heart, Lung, and Bladder meridians. It has the effects of inducing sweating, warming and unblocking the meridians, warming and supporting Yang Qi, and balancing and descending Qi. It is commonly used for colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid retention, edema, and palpitations. The Newly Revised Compendium of Materia Medica states: "Cinnamon is sweet and pungent, very hot, and toxic. It benefits the liver and lungs, and relieves cold and heat in the heart and abdomen."

[0023] Red Thick Shell: Slightly bitter and astringent; neutral. It enters the Liver and Lung meridians. It has the effects of removing blood stasis and relieving pain, and is primarily used to treat rheumatic pain, traumatic injuries, dysmenorrhea, and bleeding from trauma. The Zheng Lei Materia Medica states: "This herb has a slightly bitter taste and a neutral nature, and has the effects of removing blood stasis and relieving pain."

[0024] Luffa: Sweet, neutral. It enters the Lung, Stomach, and Liver meridians. It has the effects of activating meridians, clearing heat and resolving phlegm, dispelling wind, unblocking meridians, promoting blood circulation, and promoting lactation. It is commonly used to treat pain and cramps, chest and flank pain, lung heat and cough due to phlegm, amenorrhea, milk stagnation, and painful mastitis. "Compendium of Materia Medica" states: "It dredges the meridians, harmonizes blood vessels, resolves phlegm, and soothes qi."

[0025] Elm leaves, also known as elm leaves, are sweet and neutral in nature. Their primary functions include clearing heat and promoting urination, calming the nerves, and relieving coughs and expectoration. They are commonly used to treat edema, dysuria, stranguria with stones, turbid urine, insomnia, heatstroke, cough due to excessive phlegm, and alcoholic rhinitis. The Compendium of Materia Medica states that elm leaves, dried and ground into powder, can be mixed with light salt water, roasted, or sun-dried, and eaten with vegetables. It also has a pungent, diuretic, and water-relieving effect.

[0026] Chuanjianzi: Bitter, cold, and slightly toxic. It enters the liver, small intestine, and bladder meridians. It soothes the liver and relieves heat, promotes qi and relieves pain, kills insects, regulates qi and activates blood circulation, and soothes the stomach and relieves pain. The "Compendium of Materia Medica" records that it treats gonorrhea, penis pain that extends to the ribs, spermatorrhea, accumulation of blood, various reflux symptoms, hematuria, headaches, bleeding from the teeth, and kills insects.

[0027] Eucommia ulmoides: Sweet in flavor and warm in nature, it enters the Liver and Kidney meridians. It nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes pregnancy. It is primarily used to treat symptoms such as soreness of the waist and knees, weakness in the tendons and bones, dizziness, and restless fetuses caused by liver and kidney deficiency. Eucommia ulmoides also has antihypertensive properties and is effective for patients with hypertension. The Ben Jing states: "It treats low back pain, replenishes the middle and strengthens the essence and qi, strengthens the tendons and bones, strengthens the will, and relieves itching and dampness in the genitals and residual urine."

[0028] Angelica sinensis: Sweet, pungent, and bitter in flavor, warm in nature, enters the Liver, Heart, and Spleen meridians. It nourishes and invigorates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is commonly used for sallow complexion caused by blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, injuries from falls, carbuncles, ulcers, and constipation caused by dryness of the intestines. According to the "Bielu" (Beilu), it warms the middle and relieves pain, eliminates internal blood stasis, treats spasms and loss of sweating caused by stroke, treats dampness and arthritis, treats pathogenic qi in the body, and treats deficiency and cold. It also tonifies the five internal organs and promotes muscle growth.

[0029] Dendrobium: Sweet in flavor, slightly cold in nature, it enters the stomach and kidney meridians. It benefits the stomach and produces fluid, nourishes yin and clears heat, treats fluid loss caused by febrile illness, improves eyesight, and strengthens bones and muscles. It is used to treat fluid loss caused by febrile illness, thirst, stomachache due to yin deficiency, post-illness fever, and blurred vision caused by yin damage.

[0030] Ginger: Spicy and slightly warm in nature, it enters the lung, spleen, and stomach meridians. It has the effects of dispelling cold, warming the middle and stopping vomiting, warming the lungs and relieving coughs, and detoxifying. It is primarily used for colds, spleen and stomach coldness, vomiting due to stomach cold, coughs caused by lung cold, and detoxifying fish and crab poisoning.

[0031] Licorice: Sweet and neutral, it enters the spleen, stomach, heart, and lung meridians. Its primary functions are to soothe the stomach and relieve urgency, moisten the lungs and detoxify, and harmonize various other herbs. The Shennong Herbal Classic states that it treats cold and heat in the five internal organs, strengthens tendons and bones, increases muscle mass, increases strength, treats wounds and swellings, and detoxifies.

[0032] Compared with the prior art, the beneficial effects of the present invention are mainly:

[0033] 1. The present invention provides a traditional Chinese medicine preparation for treating neuropathic pain. The prescription comprises cinnamon twig and red scutellaria as monarch herbs, promoting qi and blood circulation, removing blood stasis and relieving pain; loofah, elm leaf, and Chuanxiong fruit as assistant herbs, promoting blood circulation and collaterals, calming the mind and clearing away heat, soothing the liver and relieving pain; eucommia bark, angelica, and dendrobium are used as adjuvant herbs to tonify the liver and kidneys, strengthen the tendons and bones, replenish blood and regulate menstruation, and benefit the stomach and promote the production of body fluid; and ginger and liquorice are used as guiding herbs to dispel cold and harmonize the medicinal properties. The present invention combines cinnamon twig, red scutellaria, loofah, elm leaf, Chuanxiong fruit, eucommia bark, angelica, dendrobium, ginger, and liquorice in a reasonable proportion. The herbs are used together to take into account both the symptoms and the root cause, thereby promoting blood circulation and blood stasis, removing blood stasis and relieving pain, and effectively improving the effect of treating sciatica.

[0034] 2. The Chinese medicine preparation of the present invention follows the principle of monarch, minister, assistant and envoy, and is compatible with each other, which is in line with the theory of traditional Chinese medicine. In addition, the prescription is relatively safe and has a good analgesic effect, which can provide new technical support for the treatment of neuropathic pain. DETAILED DESCRIPTION

[0035] The technical solution of the present invention will be further described below in conjunction with specific embodiments. However, it should be understood by those skilled in the art that the following examples are only intended to illustrate the present invention and should not be construed as limiting the present invention. Specific conditions not specified in the examples are to be followed according to conventional conditions or the conditions recommended by the manufacturer. All reagents or instruments used, unless otherwise specified, are conventional products obtained from commercial channels.

[0036] Example 1

[0037] A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 21 parts of cassia twig, 15 parts of red thick shell, 13 parts of luffa, 10 parts of elm leaves, 12 parts of Chuanjian fruit, 7 parts of eucommia, 5 parts of angelica, 3 parts of dendrobium, 2 parts of ginger, and 2 parts of liquorice.

[0038] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating neuropathic pain, comprising the following steps:

[0039] (1) The crushed cinnamon twig, red thick shell, loofah, elm leaf, Chuanjianzi, Eucommia bark, Chinese angelica, dendrobium, ginger, and licorice were sieved through a 60-mesh sieve and mixed evenly according to weight parts. The mixture was soaked in 8 times the amount of water for 60 minutes. The soaked raw material mixture was then decocted at 95°C for 2.5 hours, filtered with gauze, and the filtrate A was collected.

[0040] (2) adding water to the filter residue after filtration in step (1), repeating the above soaking, boiling, and filtering operations, and collecting the filtrate B;

[0041] (3) Combine filtrate A and filtrate B, and then concentrate them to make the volume of concentrate corresponding to each gram of raw material drug be 1.5 mL. Collect the concentrate, and then add 1% of the mass of the concentrate of white sugar, and prepare oral solution according to the conventional method.

[0042] Example 2

[0043] A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 18 parts of cassia twig, 13 parts of red thick shell, 12 parts of luffa, 8 parts of elm leaves, 10 parts of Chuanjian fruit, 5 parts of Eucommia, 3 parts of angelica, 1 part of dendrobium, 1 part of ginger, and 1 part of liquorice.

[0044] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating neuropathic pain, comprising the following steps:

[0045] (1) The crushed cinnamon twig, red thick shell, loofah, elm leaf, Chuanjianzi, Eucommia bark, Chinese angelica, dendrobium, ginger, and licorice were sieved through a 50-mesh sieve and mixed evenly according to weight parts. The mixture was soaked in 6 times the amount of water for 30 minutes. The soaked raw material mixture was then decocted at 90°C for 3 hours, filtered with gauze, and the filtrate A was collected.

[0046] (2) adding water to the filter residue after filtering in step (1), repeating the aforementioned soaking, boiling, and filtering operations once, and collecting the filtrate B;

[0047] (3) Combine filtrates A and B, then concentrate them. Collect the concentrate and control the volume of the concentrate to 1 mL per gram of the API. Add starch and dextrin to the concentrate and prepare granules according to conventional methods.

[0048] Example 3

[0049] A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 25 parts of cassia twig, 17 parts of red thick shell, 15 parts of luffa, 12 parts of elm leaves, 14 parts of Chuanjian fruit, 9 parts of eucommia, 8 parts of angelica, 5 parts of dendrobium, 3 parts of ginger, and 3 parts of liquorice.

[0050] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating neuropathic pain, comprising the following steps:

[0051] (1) The crushed cinnamon twig, red thick shell, loofah, elm leaf, Chuanjianzi, Eucommia bark, Chinese angelica, dendrobium, ginger, and licorice were sieved through an 80-mesh sieve and mixed evenly according to weight parts. The mixture was soaked in 10 times the amount of water for 90 minutes. The soaked raw material mixture was then decocted at 100°C for 2 hours, filtered with gauze, and the filtrate A was collected.

[0052] (2) adding water to the filter residue after filtering in step (1), repeating the aforementioned soaking, boiling, and filtering operations once, and collecting the filtrate B;

[0053] (3) Combine filtrates A and B, then concentrate them and collect the concentrate. Control the volume of the concentrate per gram of the API to be 2 mL. Add dextrin to the concentrate, wet granulate it, dry it, and put it into capsules to make capsules.

[0054] Comparative Example 1

[0055] The difference between this comparative example 1 and embodiment 1 is that the red thick shell is omitted, and the other parts are consistent with embodiment 1.

[0056] Comparative Example 2

[0057] The difference between Comparative Example 2 and Example 1 is that the elm leaves are omitted, and the rest are consistent with Example 1.

[0058] Comparative Example 3

[0059] The difference between this comparative example 3 and Example 1 is that: Chuanjianzi is omitted, and the rest are consistent with Example 1.

[0060] Comparative Example 4

[0061] The difference between this comparative example 4 and Example 1 is that: the leaves of elm and the chuanxiong fruit are omitted, and the amount of loofah is increased to 35 parts; the other parts are consistent with Example 1.

[0062] Experimental example

[0063] 1.1 Selection and grouping of animals: SPF-grade SD rats, half male and half female, weighing 180-220 g, were selected and fed using a standardized process. They were kept in a clean laboratory at a temperature of 24° C. and a relative humidity of 55%. The rats were replaced with bedding every day. Light was maintained from 7:00 a.m. to 7:00 p.m. every day according to the rat's circadian rhythm. The rats were adaptively raised for 7 days, during which they were fed with ordinary feed and had free access to water. The rats were randomly divided into a model group, a high-dose group in Example 1, a medium-dose group in Example 1, a low-dose group in Example 1, an Example 2 group, an Example 3 group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, and a sham operation group, with 10 rats in each group.

[0064] 1.2 Model construction and drug administration regimen:

[0065] Rats were anesthetized with an intraperitoneal injection of Zota (50 mg / kg), placed in the prone position, and their limbs immobilized. After hair removal and disinfection, a 2-3 cm incision was made parallel to the femur. Muscle tissue was bluntly dissected with forceps to expose the sciatic nerve. Surrounding mucosa and tissue were carefully dissected with a glass needle, and approximately 1 cm of the smooth sciatic nerve trunk was freed. Four 4-0 chromic catgut ligatures were placed around the sciatic nerve, with one knot every 1 mm for a total of four. This was done until slight depression of the nerve sheath and slight tremor of the left hind limb were observed, creating a segmented chronic compression. Finally, the muscle and skin tissues were sutured layer by layer. The successful establishment of a chronic sciatic nerve constriction injury (CCI) model was confirmed by behavioral signs such as lameness and paw licking. In the sham-operated group, only the sciatic nerve was exposed, leaving it intact, without ligation. Oral administration began on day one after model establishment.

[0066] Example 1 High-dose group: oral administration of 2 g crude drug / kg, once a day for 15 days;

[0067] The medium-dose group in Example 1: the oral dose was 1 g crude drug / kg, once a day for 15 days;

[0068] Example 1 Low-dose group: oral administration of 0.5 g crude drug / kg, once a day for 15 days;

[0069] Example 2 group: oral administration dose of 2 g crude drug / kg once a day for 15 days;

[0070] Group 3: Oral administration of 2 g crude drug / kg, once a day for 15 days;

[0071] Comparative Example 1: Oral administration of 2 g crude drug / kg, once a day for 15 days;

[0072] Comparative Example 2: Oral administration of 2 g crude drug / kg, once a day for 15 days;

[0073] Comparative Example 3: Oral administration of 2 g crude drug / kg, once a day for 15 days;

[0074] Comparative Example 4: Oral administration of 2 g crude drug / kg, once a day for 15 days;

[0075] The model group and the sham operation group were gavaged with an equal volume of normal saline once a day for 15 days.

[0076] 1.3 Behavioral Scoring

[0077] Spontaneous pain behavioral scores were measured 1 day before model establishment and on days 3, 7, 12, and 15 after model establishment. Rats were placed in a 0.45 m × 1.2 m × 1.2 m grid, serving as the testing area, and allowed to acclimate to the surrounding environment for 30 minutes. The rats were then allowed to move freely, and their hind limb use and lameness were observed over a 15-minute period. Behavioral scores were then calculated, ranging from 0 to 5, with scores recorded every 5 minutes. The specific scoring criteria are as follows:

[0078] A score of 0 means that the rat's hind feet can be placed flat on the ground completely normally without other abnormal behaviors.

[0079] 1 point means: the rat's hind paw lightly touches the ground, with the toes tightly together and facing downward;

[0080] A score of 2 means that the rat's hind paw only touches the ground with the inner edge;

[0081] A score of 3 means that only the heel of the rat's hind foot is on the ground, and the toes are arched;

[0082] 4 points means that the rat's entire hind legs are completely off the ground and in a lifted state;

[0083] A score of 5 means that the rat licks the hind paw on the operated side with its tongue.

[0084] The results of each group were averaged and the measured experimental results were recorded in Table 1.

[0085] Table 1

[0086]

[0087] From the experimental results of Table 1, it is known that before the model was established, the score of each group of rats was 0, and the score of the sham-operated group was always 0, which was significantly different from that of each experimental group. Compared with the model group, the scores of Example 1-3 groups were significantly reduced and lower than those of Comparative Examples 1-4 groups. Comparative Example 1 omitted the red thick shell, Comparative Example 2 omitted the leaves of Ulm, Comparative Example 3 omitted the Fructus Chuanxiong, Comparative Example 4 omitted the leaves of Ulm and the Fructus Chuanxiong, and the amount of loofah was increased to 35 parts, and Comparative Example 4 had the worst effect. This shows that in the Chinese medicine preparation of the present invention, there is a synergistic effect between loofah and the leaves of Ulm and the Fructus Chuanxiong, which relieves the pain in rats.

[0088] 1.4 Mechanical withdrawal threshold (MWT)

[0089] Mechanical withdrawal threshold tests were performed one day before model establishment and on days 3, 7, 12, and 15 after model establishment. Rats were individually placed in a 22 cm × 12 cm × 12 cm plexiglass box for 30 minutes to allow them to acclimate to the environment. The base of the plexiglass box consisted of a 0.4 cm × 0.6 cm metal grid. Von-Frey fibers were applied vertically through the metal grid at varying forces, ranging from light to heavy, at 2 g, 4 g, 6 g, 8 g, 10 g, 15 g, and 26 g. Stimulation was maintained vertically for 3 seconds per stimulation, with a 30-second interval between stimulations. The rats were observed for paw withdrawal. A sudden paw withdrawal or lift was considered a positive response; otherwise, a negative response was considered. After the first positive response, stimulation was repeated with the next lower force fiber. If a negative response was observed, stimulation was repeated with the next higher force fiber. After six measurements, the MWT of each group of mice was recorded and calculated to assess mechanical allodynia. The results are shown in Table 2.

[0090] Table 2

[0091]

[0092] The basal value was measured one day before surgery, and the results showed that there was no significant difference between the groups. Compared with the sham operation group, the MWT value of the model group rats decreased significantly after surgery. Compared with the model group, the MWT values ​​of Example 1-3 groups after the experiment increased significantly. Comparative Example 1 omitted the red thick shell, Comparative Example 2 omitted the elm leaves, Comparative Example 3 omitted the Chuanjianzi, Comparative Example 4 omitted the elm leaves and Chuanjianzi, and increased the amount of loofah to 35 parts. Among them, Comparative Example 1 had the worst effect, Comparative Examples 2 and 3 were second, and Comparative Example 4 was slightly lower than Example 1. The above experimental results show that red thick shell, as the main drug, can significantly reduce the MWT value of rats, and plays a role in promoting blood circulation and relieving pain in traditional Chinese medicine preparations. Elm leaves, Chuanjianzi and loofah have a synergistic effect and can reduce the MWT value.

[0093] 1.5 Thermal withdrawal latency (TWL)

[0094] Thermal withdrawal latency was measured using a thermal radiation analgesia instrument 1 day before model establishment and on days 3, 7, 12, and 15 after model establishment. Before testing, rats were placed on a behavioral testing platform, covered with a plexiglass dome, and allowed to acclimate for 30 minutes before measurement began. Using a thermal stimulation device, the rat's paw was positioned within a 5 mm diameter aperture. The time from the start of irradiation until the rat's painful withdrawal reflex was recorded. The irradiation duration was set to no more than 20 seconds to avoid burns. The test was repeated six times, with a 5-minute interval between each test. The average value was used as the thermal withdrawal latency. The results are shown in Table 3.

[0095] Table 3

[0096]

[0097] The experimental results in Table 3 show that before model establishment, there were no significant differences in TWL values ​​among the rat groups. After drug administration, the TWL values ​​of the model group rats were significantly lower than those of the sham-operated group. Compared with the model group, the TWL values ​​of Examples 1-3 increased after 7 days of drug administration. By 15 days, the TWL values ​​of Examples 1-3 groups had increased to levels close to those of the sham-operated group. Compared with Example 1, the TWL values ​​of Comparative Example 1 group decreased most significantly, and Comparative Examples 2-4 also showed varying degrees of decrease.

[0098] In summary, in the traditional Chinese medicine preparation of the present invention, cinnamon twig and red thick shell are both the main drugs, which have the effects of promoting qi and blood circulation, removing blood stasis and relieving pain; loofah, elm leaves and Chuanxiong fruit have a synergistic effect and are both the auxiliary drugs; the components in the prescription are compatible with each other to achieve the effects of promoting blood circulation, removing blood stasis, removing blood stasis and relieving pain, and can effectively treat neuropathic pain.

[0099] Finally, it should be noted that the above embodiments are intended only to illustrate the technical solutions of the present invention and are not intended to limit the same. The basic principles and main features of the present invention have been described above using specific implementation schemes. Modifications or substitutions may be made based on the present invention, but such modifications or substitutions do not detract from the essence of the corresponding technical solutions from the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine preparation for treating neuropathic pain, characterized in that: The invention is composed of the following raw materials in parts by weight: 18-25 parts of cassia twig, 13-17 parts of red thick shell, 12-15 parts of loofah, 8-12 parts of elm leaves, 10-14 parts of Chuanjian fruit, 5-9 parts of eucommia, 3-8 parts of angelica, 1-5 parts of dendrobium, 1-3 parts of ginger and 1-3 parts of liquorice.

2. A Chinese medicine preparation for treating neuropathic pain according to claim 1, characterized in that The invention is composed of the following raw materials in parts by weight: 21 parts of cassia twig, 15 parts of red thick shell, 13 parts of loofah, 10 parts of elm leaves, 12 parts of Chuanjian fruit, 7 parts of eucommia, 5 parts of angelica, 3 parts of dendrobium, 2 parts of ginger and 2 parts of liquorice.

3. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 1, wherein: The steps include: (1) After sieving the crushed raw materials, mix them evenly according to their weight proportions, soak them in water, and then boil the soaked mixture, filter it, and collect the filtrate A; (2) adding water to the filter residue after filtering in step (1), repeating the aforementioned soaking, boiling, and filtering operations, and collecting the filtrate B; (3) Filtrate A and filtrate B are combined and then concentrated. The concentrate is collected and pharmaceutically acceptable excipients are added to prepare a corresponding dosage form.

4. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein: The amount of water added in step (1) is 6-10 times the total mass of each raw material.

5. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein: The particle size of each raw material drug after pulverization in step (1) is 50-80 mesh.

6. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein: The soaking time in step (1) is 30-90 minutes; the decocting temperature is 90-100° C. and the decocting time is 2-3 hours.

7. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein: For every gram of API, the corresponding volume of concentrate is 1-2 mL.

8. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 1, wherein: The neuropathic pain is neuropathic pain caused by chronic compression injury of the sciatic nerve.

9. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein: The dosage form is an oral preparation.

10. The method for preparing a traditional Chinese medicine preparation for treating neuropathic pain according to claim 9, wherein: The oral preparation is one of oral liquid, tablet, granule, capsule and powder.

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