Traditional Chinese medicine preparation for treating neuropathic pain and preparation method thereof

Abstract

The 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. The 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 loofah sponge, 8-12 parts of elm leaf, 10-14 parts of melia toosendan, 5-9 parts of eucommia ulmoides, 3-8 parts of angelica sinensis, 1-5 parts of dendrobe, 1-3 parts of fresh ginger and 1-3 parts of liquorice. According to the traditional Chinese medicine preparation provided by the invention, all the medicines are combined, both symptoms and root causes are taken into consideration, the effects of clearing and activating the channels and collaterals, promoting blood circulation to remove blood stasis and removing blood stasis to relieve pain are achieved, and neuropathic pain caused by sciatic nerve chronic compression injury can be effectively treated.

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 diseases of the somatic sensory nervous system. Among them, neuropathic pain caused by chronic compressive injury of the sciatic nerve is a common and complex disease. This pain usually results from long-term or repeated compression of the sciatic nerve, leading to nerve dysfunction and the generation of abnormal pain sensations, bringing great pain and inconvenience to patients. Currently, common treatment drugs such as gabapentin, pregabalin, and tricyclic antidepressants have certain curative effects, but there are side effects such as easy drug dependence and cognitive impairment after long-term use, and they cannot be taken for a long time. Currently, there are also some analgesics such as compound aspirin and painkillers, but they are limited to the treatment of mild pain. Therefore, it is particularly important to develop safer and more effective treatment drugs.

[0003] In recent years, with the gradually increasing influence of traditional Chinese medicine in the international arena, the research on the treatment of neuropathic pain with traditional Chinese medicine has also attracted wide attention. Traditional Chinese medicine believes that "the meridians flow continuously without stopping, circulating around. When cold qi enters the meridians and stagnates, it cannot flow smoothly. When it lodges in the vessels, qi cannot circulate, so sudden pain occurs." That is, neuropathic pain belongs to the categories of "bi syndrome" and "blood stasis", and the core lies in the obstruction of qi and blood circulation and the blockage of the meridians. When treating, it emphasizes "unblocking leads to no pain".

[0004] Therefore, how to combine the advantages of traditional Chinese medicine treatment and develop a traditional Chinese medicine preparation with analgesic effect and high safety is of great significance for meeting the treatment needs of neuropathic pain patients. 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, taking into account both the symptoms and the root causes, and jointly achieving the effects of dredging meridians and collaterals, promoting blood circulation to remove blood stasis, and dispelling stasis to relieve pain, and can effectively treat neuropathic pain.

[0006] The second object of the present invention is to provide a preparation method of a traditional Chinese medicine preparation for treating neuropathic pain. The traditional Chinese medicine preparation of the present invention follows the principle of monarch, minister, assistant, and envoy, and is mutually compatible, conforming to traditional Chinese medicine theory, and the safety of this prescription is relatively high, which can provide new technical support for the treatment of neuropathic pain.

[0007] In order to achieve the above objects, the technical solution adopted by the present invention is: A traditional Chinese medicine preparation for treating neuropathic pain, comprising the following raw materials in parts by weight: 18-25 parts of cinnamon twig, 13-17 parts of Calophyllum inophyllum L., 12-15 parts of luffa cylindrica (L.) Roem., 8-12 parts of elm leaves, 10-14 parts of Szechwan Chinaberry Fruit, 5-9 parts of Eucommia ulmoides Oliv., 3-8 parts of Angelica sinensis (Oliv.) Diels, 1-5 parts of Dendrobium nobile Lindl., 1-3 parts of ginger, and 1-3 parts of liquorice.

[0008] Further, it comprises the following raw materials in parts by weight: 21 parts of cinnamon twig, 15 parts of Calophyllum inophyllum L., 13 parts of luffa cylindrica (L.) Roem., 10 parts of elm leaves, 12 parts of Szechwan Chinaberry Fruit, 7 parts of Eucommia ulmoides Oliv., 5 parts of Angelica sinensis (Oliv.) Diels, 3 parts of Dendrobium nobile Lindl., 2 parts of ginger, and 2 parts of liquorice.

[0009] The preparation method of the above traditional Chinese medicine preparation for treating neuropathic pain comprises the following steps: (1) After sieving the crushed raw materials of each medicine, mix them evenly according to the parts by weight, soak them in water, then decoct the soaked mixture, filter, and collect filtrate A; (2) Add water to the filter residue after filtering in step (1), repeat the above soaking, decocting, and filtering operations, and collect filtrate B; (3) Combine filtrate A and filtrate B, then concentrate, collect the concentrated solution, add pharmaceutically acceptable excipients, and make into the corresponding dosage form to obtain the product.

[0010] Further, the addition amount of water in step (1) is 6-10 times the total mass of the raw materials of each medicine.

[0011] Further, the particle size of the crushed raw materials of each medicine in step (1) is 50-80 mesh.

[0012] Further, the soaking time in step (1) is 30-90 min, the decocting temperature is 90-100 °C, and the time is 2-3 h.

[0013] Further, for each gram of raw material medicine, the volume of the corresponding concentrated solution is 1-2 mL.

[0014] Further, the neuropathic pain is neuropathic pain caused by chronic compressive injury of the sciatic nerve.

[0015] Further, the dosage form is an oral preparation.

[0016] Further, the oral preparation is one of oral liquid, tablets, granules, capsules, and powders.

[0017] The pharmacological properties analysis of the raw materials used in the present invention is as follows: Cinnamomum cassia Presl: pungent, sweet, warm. It acts on the heart, lung, and bladder meridians. It has the effects of inducing sweating to relieve exterior syndrome, warming and dredging the meridians, warming and boosting yang qi, and calming the adverse qi. It is commonly used for wind-cold colds, cold pain in the epigastrium and abdomen, blood-cold amenorrhea, arthralgia, phlegm retention, edema, palpitations, etc. "Newly Revised Materia Medica" records: Cinnamon, sweet, pungent, very hot, toxic. It benefits the liver and lung qi, and the cold and heat in the heart and abdomen.

[0018] Calophyllum inophyllum L.: slightly bitter and astringent; flat. It acts on the liver and lung meridians. It has the effect of dispelling stasis and relieving pain, and is mainly used to treat rheumatic pain, traumatic injury, dysmenorrhea, and external injury bleeding. "Illustrated Classic of Materia Medica" records: This herb is slightly bitter in taste, flat in nature, and has the function of dispelling stasis and relieving pain.

[0019] Luffa cylindrica (L.) Roem.: sweet, flat. It acts on the lung meridian, stomach meridian, and liver meridian. It has the effects of dredging the meridians and collaterals, clearing heat and resolving phlegm, expelling wind, dredging the collaterals, promoting blood circulation, and inducing lactation. It is commonly used to treat arthralgia with muscle spasm, distending pain in the chest and hypochondrium, cough with lung heat and phlegm, amenorrhea in women, milk obstruction, and breast abscess with swelling and pain. "New Compilation of Materia Medica" records: Dredge the meridians and collaterals, harmonize the blood vessels, resolve phlegm and regulate qi.

[0020] Ulmus pumila L. leaves: also known as elm leaves, sweet in taste, neutral in nature; its functions and indications are clearing heat and promoting diuresis; calming the mind; resolving phlegm and relieving cough. It is commonly used to treat edema; dysuria; stranguria; urinary turbidity; insomnia; summer heat and stuffiness; excessive phlegm and cough; rosacea. "Compendium of Materia Medica" records that elm leaves are dried in the sun and made into powder, mixed with light salt water, or roasted or dried in the sun, and then mixed with vegetables for consumption, which is also pungent, smooth, and promotes the excretion of water qi.

[0021] Toona sinensis (A. Juss.) Roem.: bitter in taste, cold, slightly toxic. It acts on the liver, small intestine, and bladder meridians. It has the effects of soothing the liver and clearing heat, promoting qi movement and relieving pain, killing parasites, regulating qi and activating blood circulation, and harmonizing the stomach and relieving pain. "Searching for the Origin of Materia Medica" records: Treat gonorrhea with pain in the penis radiating to the hypochondrium, spermatorrhea, accumulation, all kinds of adverse qi rushing upward, hematuria during urination, headache, bleeding from gingival recession, and killing parasites.

[0022] Eucommia ulmoides Oliv.: sweet in taste, warm in nature; it acts on the liver and kidney meridians. It has the effects of tonifying the liver and kidney, strengthening the bones and muscles, and preventing miscarriage, and is mainly used to treat symptoms such as soreness and weakness of the waist and knees, weakness of the bones and muscles, dizziness and vertigo, and threatened abortion caused by deficiency of the liver and kidney. In addition, Eucommia ulmoides Oliv. also has a blood pressure-lowering effect and has a certain therapeutic effect on patients with hypertension. "Shennong's Classic of Materia Medica" records: It mainly treats pain in the lumbar spine and spine, supplements the middle and benefits qi and essence, strengthens the bones and muscles, strengthens the will, eliminates itching and dampness under the genitals, and residual dripping of urine.

[0023] Angelica sinensis (Oliv.) Diels: sweet; pungent; bitter; warm in nature; it acts on the liver meridian; heart meridian; spleen meridian. It has the effects of tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting defecation. It is commonly used for sallow complexion due to blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, cold pain in deficiency syndrome, rheumatic arthralgia, traumatic injury, carbuncle and ulcer, and constipation due to intestinal dryness. "Supplementary Records of Materia Medica" records: Warming the middle and relieving pain, removing internal obstruction by stasis of guest blood, stroke with spasm and no sweating, damp arthralgia, sudden syncope due to pathogenic factors, deficiency and cold, tonifying the five zang-organs, and promoting the growth of muscles.

[0024] Dendrobium officinale: Sweet in taste, slightly cold in nature, attributing to the stomach and kidney meridians. It has the effects of promoting the production of body fluid to moisten the stomach, nourishing yin and clearing heat, relieving polydipsia caused by febrile diseases, improving eyesight, and strengthening tendons and bones. Its functions and indications include polydipsia caused by febrile diseases, vexation and thirst, stomachache due to yin deficiency, residual heat after illness, and dim eyesight due to yin injury, etc.

[0025] Ginger: Pungent in taste, slightly warm in nature. Attributing to the lung, spleen and stomach meridians. It has the effects of inducing sweating to dispel cold, warming the middle-jiao to arrest vomiting, warming the lungs to arrest cough, and detoxifying, and is mainly used for wind-cold cold, cold syndrome of the spleen and stomach, vomiting due to stomach cold, cough due to lung cold, and detoxifying fish and crab poison.

[0026] Licorice: Sweet, neutral, attributing to the spleen, stomach, heart and lung meridians. Its main functions are to regulate the middle-jiao and relieve spasm, moisten the lungs and detoxify, and harmonize various medicinal herbs. "Shennong Ben Cao Jing" records: It mainly treats cold and heat pathogens in the five zang-organs and six fu-organs, strengthens tendons and bones, grows muscles, increases strength, treats traumatic injury swelling, and detoxifies.

[0027] Compared with the prior art, the beneficial effects of the present invention mainly lie in: 1. The present invention provides a traditional Chinese medicine preparation for treating neuropathic pain. In the formula, Cinnamomum cassia and Calophyllum inophyllum are used as the monarch drugs, promoting qi and activating blood circulation, removing stasis and relieving pain; Luffa cylindrica, Ulmus pumila leaves and Melia toosendan are used as the minister drugs, dredging the channels and collaterals, calming the mind and clearing heat, soothing the liver and relieving pain; Eucommia ulmoides, Angelica sinensis and Dendrobium officinale are used as the assistant drugs, tonifying the liver and kidney, strengthening tendons and bones, tonifying blood and regulating menstruation, promoting the production of body fluid to moisten the stomach; Ginger and Licorice are used as the envoy drugs, inducing sweating to dispel cold and regulating the properties of medicinal herbs. The present invention rationally proportions Cinnamomum cassia, Calophyllum inophyllum, Luffa cylindrica, Ulmus pumila leaves, Melia toosendan, Eucommia ulmoides, Angelica sinensis, Dendrobium officinale, Ginger, Licorice, etc. When these medicinal herbs are used in combination, they take into account both the symptoms and the root causes, and jointly achieve the effects of dredging the channels and collaterals, promoting blood circulation to remove stasis, and removing stasis and relieving pain, effectively improving the treatment effect of sciatic neuralgia.

[0028] 2. The traditional Chinese medicine preparation of the present invention follows the principle of monarch, minister, assistant and envoy, and is mutually compatible, conforming to traditional Chinese medicine theory. Moreover, the prescription has high safety and good analgesic effect, and can provide new technical support for the treatment of neuropathic pain. Detailed implementation mode

[0029] The following further describes the technical solutions of the present invention in combination with specific implementation modes. However, those skilled in the art should understand that the following examples are only used to illustrate the present invention and should not be regarded as limiting the present invention. The specific conditions not specified in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used, unless otherwise specified, are all conventional products obtained through commercial channels.

[0030] Example 1 A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 21 parts of Cinnamomum cassia, 15 parts of Calophyllum inophyllum, 13 parts of Luffa cylindrica, 10 parts of Ulmus pumila leaves, 12 parts of Melia toosendan, 7 parts of Eucommia ulmoides, 5 parts of Angelica sinensis, 3 parts of Dendrobium officinale, 2 parts of Ginger, and 2 parts of Licorice.

[0031] This embodiment also provides a preparation method of the above traditional Chinese medicine preparation for treating neuropathic pain, including the following steps: (1) After sieving the crushed cinnamon twig, Calophyllum inophyllum L., luffa cylindrica, elm leaves, Szechwan chinaberry fruit, eucommia bark, Chinese angelica, dendrobium, ginger, and licorice through a 60-mesh sieve, mix them evenly according to the weight parts, add 8 times the amount of water and soak for 60 min, then decoct the soaked raw material mixture at 95 °C for 2.5 h, filter with gauze, and collect filtrate A; (2) Add water to the filter residue after filtration in step (1), repeat the above soaking, decocting, and filtering operations, and collect filtrate B; (3) Combine filtrate A and filtrate B, then concentrate to make the volume of the concentrated liquid corresponding to each gram of raw material 1.5 mL, collect the concentrated liquid, then add 1% of granulated sugar based on the mass of the concentrated liquid, and prepare into oral liquid according to the conventional method.

[0032] Example 2 A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 18 parts of cinnamon twig, 13 parts of Calophyllum inophyllum L., 12 parts of luffa cylindrica, 8 parts of elm leaves, 10 parts of Szechwan chinaberry fruit, 5 parts of eucommia bark, 3 parts of Chinese angelica, 1 part of dendrobium, 1 part of ginger, and 1 part of licorice.

[0033] This embodiment also provides a preparation method of the above traditional Chinese medicine preparation for treating neuropathic pain, including the following steps: (1) After sieving the crushed cinnamon twig, Calophyllum inophyllum L., luffa cylindrica, elm leaves, Szechwan chinaberry fruit, eucommia bark, Chinese angelica, dendrobium, ginger, and licorice through a 50-mesh sieve, mix them evenly according to the weight parts, add 6 times the amount of water and soak for 30 min, then decoct the soaked raw material mixture at 90 °C for 3 h, filter with gauze, and collect filtrate A; (2) Add water to the filter residue after filtration in step (1), repeat the above soaking, decocting, and filtering operations once, and collect filtrate B; (3) Combine filtrate A and B, then concentrate, collect the concentrated liquid, control the volume of the concentrated liquid corresponding to each gram of raw material to be 1 mL, add starch and dextrin to the concentrated liquid, and prepare into granules according to the conventional method.

[0034] Example 3 A traditional Chinese medicine preparation for treating neuropathic pain is composed of the following raw materials in parts by weight: 25 parts of cinnamon twig, 17 parts of Calophyllum inophyllum L., 15 parts of luffa cylindrica, 12 parts of elm leaves, 14 parts of Szechwan chinaberry fruit, 9 parts of eucommia bark, 8 parts of Chinese angelica, 5 parts of dendrobium, 3 parts of ginger, and 3 parts of licorice.

[0035] This embodiment also provides a preparation method of the above traditional Chinese medicine preparation for treating neuropathic pain, including the following steps: (1) After screening the crushed Ramulus Cinnamomi, Calophyllum inophyllum L., Luffa cylindrica (L.) Roem., Ulmus pumila L. leaves, Fructus Toosendan, Eucommia ulmoides Oliv., Angelica sinensis (Oliv.) Diels, Dendrobium nobile Lindl., ginger, and licorice through an 80-mesh sieve, mix them evenly according to the weight parts, add 10 times the amount of water and soak for 90 min. Then, decoct the soaked raw material mixture at 100 °C for 2 h, filter it with gauze, and collect filtrate A. (2) Add water to the filter residue obtained in step (1), repeat the above soaking, decocting, and filtering operations once, and collect filtrate B. (3) Combine filtrate A and B, then concentrate, collect the concentrated solution, control the volume of the concentrated solution corresponding to each gram of the raw material medicine to be 2 mL, add dextrin to the concentrated solution, granulate by wet method, dry, and fill into capsules to prepare capsule preparations.

[0036] Comparative Example 1 The difference between this Comparative Example 1 and Example 1 is that Calophyllum inophyllum L. is omitted, and the others are the same as in Example 1.

[0037] Comparative Example 2 The difference between this Comparative Example 2 and Example 1 is that Ulmus pumila L. leaves are omitted, and the others are the same as in Example 1.

[0038] Comparative Example 3 The difference between this Comparative Example 3 and Example 1 is that Fructus Toosendan is omitted, and the others are the same as in Example 1.

[0039] Comparative Example 4 The difference between this Comparative Example 4 and Example 1 is that Ulmus pumila L. leaves and Fructus Toosendan are omitted, and the dosage of Luffa cylindrica (L.) Roem. is increased to 35 parts; the others are the same as in Example 1.

[0040] Experimental Example 1.1 Selection and grouping of animals: Select SPF-grade SD rats, with half males and half females, weighing 180 - 220 g. Feed them using a standardized process, raise them in a clean-grade laboratory at a temperature of 24 °C and a relative humidity of 55%. Change the bedding for the rats every day, maintain illumination from 7:00 am to 7:00 pm according to the circadian rhythm of the rats, and adaptively raise them for 7 days. During this period, feed them with ordinary feed and provide free drinking water. Randomly divide the above rats into a model group, a high-dose group of Example 1, a medium-dose group of Example 1, a low-dose group of 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.

[0041] 1.2 Model construction and dosing regimen: Rats were anesthetized by intraperitoneal injection of Zoletil (50 mg / kg). The rats were placed in the prone position, and their four limbs were fixed. After depilation and disinfection of the left hindlimb thigh area of the rats, a 2-3 cm incision was made along the direction parallel to the femur. The muscle tissue was bluntly separated using tissue forceps to expose the sciatic nerve. The surrounding mucosa and tissues were carefully separated with a glass microprobe, and about 1 cm of smooth sciatic nerve trunk was freed. The sciatic nerve was ligated with 4-0 chromic catgut at intervals of 1 mm, with a total of 4 ligatures, until the perineurium was slightly sunken and the left hindlimb twitched slightly, forming a segmental chronic compression. Finally, the muscle and skin tissues were sutured layer by layer. The establishment of the chronic constriction injury (CCI) model of the rat sciatic nerve was considered successful when the rats showed behavioral manifestations such as limping and licking the foot. In the sham operation group, only the sciatic nerve was exposed, and the integrity of the sciatic nerve was retained without ligation. Gastric gavage administration was started on the 1st day after the model was established.

[0042] Example 1 high-dose group: The gavage dose was 2 g crude drug / kg once a day for 15 days. Example 1 medium-dose group: The gavage dose was 1 g crude drug / kg once a day for 15 days. Example 1 low-dose group: The gavage dose was 0.5 g crude drug / kg once a day for 15 days. Example 2 group: The gavage dose was 2 g crude drug / kg once a day for 15 days. Example 3 group: The gavage dose was 2 g crude drug / kg once a day for 15 days. Control group 1: The gavage dose was 2 g crude drug / kg once a day for 15 days. Control group 2: The gavage dose was 2 g crude drug / kg once a day for 15 days. Control group 3: The gavage dose was 2 g crude drug / kg once a day for 15 days. Control group 4: The gavage dose was 2 g crude drug / kg once a day for 15 days. The model group and the sham operation group were gavaged with an equal amount of normal saline once a day for 15 days.

[0043] 1.3 Behavioral scoring The determination of the spontaneous pain behavioral score was carried out 1 day before the model establishment and on the 3rd, 7th, 12th, and 15th days after the model establishment. The rats were placed in a grid with dimensions of 0.45 m × 1.2 m × 1.2 m as the test area and allowed to adapt to the surrounding environment for 30 min. Then the rats were allowed to move freely, and the use of the hindlimbs and the degree of limping of the rats were observed within 15 min, and the behavioral score was carried out. The scoring range was from 0 to 5 levels, and the score was recorded every 5 min. The specific scoring criteria were as follows: A score of 0 means that the rat's hind feet can be placed flat on the ground completely normally without other abnormal behaviors.

[0044] 1 point means that the rat's hind feet lightly touch the ground, with the toes tightly together and facing downward; A score of 2 means that the rat's hind paw only touches the ground with the inner edge; A score of 3 means that only the heel of the rat's hind foot is on the ground, and the toes are arched; 4 points means that the entire hind leg of the rat is completely off the ground and in a lifted state; A score of 5 means that the rat licks the hind paw on the operated side with its tongue.

[0045] The results of each group were averaged and the measured experimental results were recorded in Table 1.

[0046] Table 1 It is known from the experimental results of Table 1 that before the model was established, the scores of the rats in each group were all 0, and the scores of the sham operation group were all always 0, which was significantly different from the experimental groups. Compared with the model group, the scores of the Example 1-3 groups were significantly reduced, and were lower than the Comparative Example 1-4 groups. 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 the amount of loofah was increased to 35 parts, and the effect of Comparative Example 4 was the worst. This shows that the Chinese medicine preparation of the present invention has a synergistic effect with the elm leaves and Chuanjianzi to relieve the pain of rats.

[0047] 1.4 Mechanical withdrawal threshold (MWT) Mechanical withdrawal reflex threshold tests were performed 1 day before model establishment and on the 3rd, 7th, 12th, and 15th days after model establishment. Rats were placed alone in a 22 cm×12 cm×12 cm plexiglass box for 30 min to adapt to the environment. The base of the plexiglass box was a 0.4 cm×0.6 cm metal grid. The folding force was 2 g, 4 g, 6 g, 8 g, 10 g, 15 g, and 26 g. Von-Frey fibers were used to vertically stimulate the middle of the left hind limb of the rat through the metal grid from light to heavy. The rats were kept vertical. Each stimulation lasted for 3 s, and there was a 30 s interval between two stimulations. The rats were observed to see if they withdrew their feet. If the rat suddenly withdrew or lifted its foot, it was considered a positive reaction, otherwise it was a negative reaction. After the first positive result was obtained, the adjacent lower-level force fiber was used for stimulation again; if a negative reaction occurred, the adjacent higher-level force was used for stimulation again. After 6 measurements, the MWT of each group of mice was recorded and calculated to evaluate the mechanical pain sensitivity of the mice. The experimental results are shown in Table 2.

[0048] Table 2 The baseline values were measured 1 day before the surgery, and the results showed no significant differences among the groups. Compared with the sham operation group, the MWT value of the model group rats decreased significantly after the surgery. Compared with the model group, the MWT values of the groups of Examples 1-3 increased significantly after the experiment. In Comparative Example 1, Calophyllum inophyllum was omitted; in Comparative Example 2, Ulmus pumila leaves were omitted; in Comparative Example 3, Toona sinensis fruits were omitted; in Comparative Example 4, Ulmus pumila leaves and Toona sinensis fruits were omitted, and the dosage of Luffa cylindrica was increased to 35 parts. Among them, Comparative Example 1 had the worst effect, followed by Comparative Examples 2 and 3, and Comparative Example 4 was slightly lower than Example 1. The above experimental results indicate that Calophyllum inophyllum, as the monarch 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. Ulmus pumila leaves, Toona sinensis fruits and Luffa cylindrica have a synergistic effect and can reduce the MWT value.

[0049] 1.5 Thermal withdrawal latency (TWL) Before the model establishment on day 1 and on the 3rd, 7th, 12th, and 15th days after the model establishment, the thermal withdrawal latency was measured using a thermal radiation pain tester. Before the test, the rats were placed on the behavioral test bench, covered with an acrylic glass cover, and waited for 30 min to adapt to the environment before starting the measurement. Using a thermal stimulation instrument, the plantar surface of the rat was placed within the irradiation aperture with a diameter of 5 mm, and the time from the start of irradiation to the appearance of the foot withdrawal escape reflex due to the rat feeling pain was recorded. The irradiation duration was set not to exceed 20 s to avoid burns. The test was repeated 6 times with an interval of 5 min each time. The average value was taken as the thermal withdrawal latency value. The experimental results are shown in Table 3.

[0050] Table 3 From the experimental results in Table 3, it can be seen that before the model establishment, there were no significant differences in the TWL values of the rats in each group. After administration, the TWL value of the model group rats was significantly lower than that of the sham operation group. Compared with the model group, the TWL values of Examples 1-3 increased after 7 days of administration, and until 15 days, the groups of Examples 1-3 all increased to be close to that of the sham operation group. Compared with Example 1, the decrease in the Comparative Example 1 group was the most obvious, and different degrees of decrease also occurred in Comparative Examples 2-4.

[0051] In summary, in the traditional Chinese medicine preparation of the present invention, Cinnamomum cassia and Calophyllum inophyllum are used as the monarch drugs, which have the effects of promoting qi circulation and activating blood circulation, removing stasis and relieving pain; Luffa cylindrica, Ulmus pumila leaves and Toona sinensis fruits have a synergistic effect and are used as the ministerial drugs; the components in the formula are mutually compatible, and together they have the effects of dredging the channels and collaterals, promoting blood circulation to remove stasis, and removing stasis and relieving pain, and can effectively treat neuropathic pain.

[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. The basic principles and main features of the present invention have been described in the above with specific implementation schemes. On the basis of the present invention, some modifications or replacements can be made, but these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the present invention claimed.

Claims

1. A traditional Chinese medicine preparation for treating neuropathic pain, characterized in that, It comprises the following raw materials in parts by weight: 18 - 25 parts of Cinnamomum cassia, 13 - 17 parts of Calophyllum inophyllum, 12 - 15 parts of Luffa cylindrica, 8 - 12 parts of Ulmus pumila leaves, 10 - 14 parts of Toona sinensis, 5 - 9 parts of Eucommia ulmoides, 3 - 8 parts of Angelica sinensis, 1 - 5 parts of Dendrobium nobile, 1 - 3 parts of ginger, and 1 - 3 parts of liquorice.

2. The traditional Chinese medicine preparation for treating neuropathic pain according to claim 1, characterized in that, It comprises the following raw materials in parts by weight: 21 parts of Cinnamomum cassia, 15 parts of Calophyllum inophyllum, 13 parts of Luffa cylindrica, 10 parts of Ulmus pumila leaves, 12 parts of Toona sinensis, 7 parts of Eucommia ulmoides, 5 parts of Angelica sinensis, 3 parts of Dendrobium nobile, 2 parts of ginger, and 2 parts of liquorice.

3. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain as described in claim 1, characterized in that, It comprises the following steps: (1) After sieving the pulverized raw medicinal materials, they are mixed evenly according to the parts by weight, soaked in water, and then the soaked mixture is decocted, filtered, and filtrate A is collected; (2) Water is added to the residue filtered in step (1), and the aforementioned soaking, decocting, and filtering operations are repeated, and filtrate B is collected; (3) Filtrate A and filtrate B are combined, then concentrated, the concentrated solution is collected, pharmaceutically acceptable excipients are added, and the corresponding dosage form is prepared to obtain the product.

4. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, characterized in that, In step (1), the addition amount of water is 6 - 10 times the total mass of the raw medicinal materials.

5. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein, In step (1), the particle size of the pulverized raw medicinal materials is 50 - 80 mesh.

6. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, characterized in that, In step (1), the soaking time is 30 - 90 min; the decocting temperature is 90 - 100 °C, and the time is 2 - 3 h.

7. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain according to claim 3, wherein, For each gram of raw medicinal material, the volume of the corresponding concentrated solution is 1 - 2 mL.

8. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain as described in claim 1, characterized in that, The neuropathic pain is neuropathic pain caused by chronic constriction injury of the sciatic nerve.

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

10. The preparation method of a traditional Chinese medicine preparation for treating neuropathic pain according to claim 9, characterized in that, The oral preparation is one of oral liquid, tablets, granules, capsules, and powders.

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