Traditional Chinese medicine composition for treating chronic pain and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic pain. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8 to 12 parts of garden balsam stem, 4 to 6 parts of radix aconiti preparata, 3.2 to 4.8 parts of prepared kusnezoff monkshood root, 12 to 18 parts of corydalis tuber, 3.2 to 4.8 parts of asarum, 8 to 12 parts of notopterygium root, 8 to 12 parts of radix clematidis, 8 to 12 parts of gentiana macrophylla, 9.6 to 14.4 parts of frankincense, 9.6 to 14.4 parts of myrrh, 4 to 6 parts of safflower, 8 to 12 parts of radix morindae officinalis, 9.6 to 14.4 parts of eucommia ulmoides, 8 to 12 parts of ligusticum wallichii and 7.2 to 10.8 parts of lycopodium clavatum. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The medicine is safe, and the medicine effect and clinical experiments prove that the medicine has an obvious and lasting effect on treating chronic pain and is free of addiction. The traditional Chinese medicine composition has a good effect on treating chronic migraine, neuralgia after herpes zoster, knee joint degenerative diseases of old people and the like, and a new choice of an external transdermal agent is provided for clinically treating chronic pain.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating chronic pain, belonging to the field of traditional Chinese medicine. Background Art

[0002] Chronic pain is not just a symptom, but a disease. Experts say that before the cerebral cortex senses the pain signal, the corresponding painful area has been actually or potentially "injured". This pain can last for more than three months, and it is a disease with many types and complex causes. Reports show that the proportion of chronic pain is higher among the elderly. Common chronic pain includes chronic migraine, trigeminal neuralgia, intercostal neuralgia, pain in elderly knee degenerative lesions, swelling, chronic widespread pain, chronic cancer pain, etc. However, the public's understanding of these pain diseases is very low. Surveys show that the public's awareness of pain diseases is less than 20%, and the patient's consultation rate is less than 60%.

[0003] Pain is a very common clinical disease, but it is also a relatively complex disease. Traditional medicine believes that pain is caused by obstruction and pain is caused by looseness.

[0004] 1. Pain due to blockage "Suwen. Jutonglun" says, "Cold enters the meridians and delays the flow of qi and blood, and the meridians are blocked and cannot flow. If it stays outside the meridians, the blood will be insufficient. If it dissolves in the meridians, the qi will not flow out, so there is sudden pain... Cold enters the intestines and stomach, and it flows upward, so there is pain and vomiting." This sentence refers to the pain caused by cold stagnation in the meridians, affecting the flow of qi and blood, and the blockage of meridian qi and blood. In this case, the "warming and unblocking method" should be used to eliminate the cold evil, warm the meridians, and restore the normal flow of qi and blood.

[0005] 2. Pain if not relaxed "Suwen. Jutonglun" says, "Cold invades the outside of the meridians, and the cold meridians shrink and curl up. When they shrink and curl up, the meridians become tight and urgent, which pulls the small collaterals outward, causing sudden pain. Cold invades between the intestines and stomach, under the membrane, and the blood cannot be dispersed, and the small collaterals are pulled urgently, causing pain." Therefore, the "warming and dispersing method" should be used to disperse the cold, dredge the meridians and relieve spasms. This is also called "relaxing to treat pain."

[0006] Modern medicine's understanding of pain: Pain is a physical or psychological discomfort, usually related to damage, disease or trauma to tissues or organs. Pain can be divided into two types: acute pain and chronic pain. Acute pain is usually short-lived and caused by injury, surgery, disease or inflammation.

[0007] Chronic pain refers to pain that lasts for more than 3 months. It is usually caused by chronic diseases or injuries, and may last for a long time, having a serious impact on the patient's daily life and psychology. The causes of chronic pain can be bone problems, nervous system disorders, arthritis, muscle spasms, neuritis, etc. The most painful are patients with chronic pain. The long-term and repeated pain makes the patients miserable. It is a torture for the patient's body and mind. The quality of life will also be seriously reduced. In particular, some elderly people have knee pain and chronic pain and swelling in their legs and feet, and their movements are extremely inconvenient. Some even stay in bed for a long time. It seriously affects the quality of life. There are also some chronic cancer patients who basically rely on morphine for pain relief. Morphine is addictive, has some side effects, such as nausea, vomiting, etc., and is expensive.

[0008] Conventional Western medicine treatment drugs are: 1. Non-steroidal anti-inflammatory drugs, to achieve the purpose of pain relief. However, they are somewhat irritating to the gastrointestinal tract. And they can only solve temporary pain. 2. Central analgesics: such as gabapentin, carbamazepine, tramadol hydrochloride, etc. Strong analgesic effect, but there is dependence and gastrointestinal discomfort. 3. Narcotic analgesics: such as morphine hydrochloride, nefopam hydrochloride, etc., strong analgesic effect, but there is dependence and gastrointestinal discomfort. Mainly used before surgery to relieve surgical pain and cancer pain, most of them are addictive and expensive. Summary of the invention

[0009] In order to enhance the recognition and treatment of chronic pain, the present invention provides a Chinese medicine composition for treating chronic pain, and also provides a preparation method and use of the Chinese medicine composition.

[0010] The present invention provides a traditional Chinese medicine composition for treating chronic pain, which is prepared from the following raw materials in weight proportion:

[0011] 8-12 parts of Herba Polygoni Multiflori, 4-6 parts of processed Radix Aconiti Kusnezoffii, 3.2-4.8 parts of processed Radix Aconiti Kusnezoffii, 12-18 parts of Rhizoma Corydalis, 3.2-4.8 parts of Radix Asarum, 8-12 parts of Radix Notopterygii, 8-12 parts of Radix Clematidis, 8-12 parts of Radix Gentianae, 9.6-14.4 parts of Olibanum, 9.6-14.4 parts of Myrrh, 4-6 parts of Carthamus Tinctorius, 8-12 parts of Morinda Officinalis, 9.6-14.4 parts of Eucommia, 8-12 parts of Rhizoma Chuanxiong, and 7.2-10.8 parts of Herba Lycopodii.

[0012] More preferably, it is prepared from the following bulk drugs in the following weight ratio:

[0013] 10 parts of Herba Polygoni Multiflori, 5 parts of processed Aconiti Kusnezoffii, 4 parts of processed Aconiti Kusnezoffii, 15 parts of Corydalis Root, 4 parts of Asarum, 10 parts of Notopterygium, 10 parts of Radix Clematidis, 10 parts of Gentiana Macrophylla, 12 parts of Olibanum, 12 parts of Myrrh, 5 parts of Carthamus Flos, 10 parts of Morinda Officinalis, 12 parts of Eucommia, 10 parts of Rhizoma Chuanxiong, and 9 parts of Herba Lycopodiellae.

[0014] The Chinese medicine composition of the present invention is prepared from the raw powder of the raw medicine, water or organic solvent extract as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to form a commonly used external preparation in medicine.

[0015] Wherein, the external preparation is liniment, ointment, patch, gel, cream, tincture, spray, film coating.

[0016] The present invention also provides a method for preparing the Chinese medicine composition for treating chronic pain, which comprises the following steps:

[0017] a. Weigh the APIs of various weight ratios;

[0018] b. Powdering, or adding water or organic solvent to extract, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used external preparation in medicine.

[0019] The present invention provides use of the traditional Chinese medicine composition in preparing an external medicine for treating chronic pain.

[0020] The medicine is used to treat chronic migraine, postherpetic neuralgia and degenerative lesions of the knee joint in the elderly.

[0021] The invention provides use of the traditional Chinese medicine composition in preparing an external medicine with the functions of dispelling wind and cold, promoting blood circulation and dredging collaterals, relieving pain, warming kidney yang and strengthening tendons and bones.

[0022] The drug prescription of the present invention uses Radix Angelicae Pubescentis, processed Radix Aconiti Kusnezoffii, processed Radix Aconiti Kusnezoffii and Rhizoma Corydalis as the main drugs. The first main drug of this prescription, Radix Aconiti Kusnezoffii, is the whole herb of Radix Dioscoreae, which is pungent, dispersing, warming and unblocking, and good at moving. It enters the blood of the liver meridian, so it can promote blood circulation and invigorate qi. With the addition of the hot processed Radix Aconiti Kusnezoffii and processed Radix Aconiti Kusnezoffii, the effects of dispelling wind and dampness, dredge meridians and relieve pain are enhanced. According to modern medical research, some alkaloid compounds contained in processed Radix Aconiti Kusnezoffii and processed Radix Aconiti Kusnezoffii have a strong analgesic effect. It can effectively relieve muscle soreness, joint swelling and other painful diseases caused by wind, cold and dampness, and with Rhizoma Corydalis, it is good at analgesia. For chronic migraine, trigeminal neuralgia, intercostal neuralgia, chronic cancer pain and degenerative lesions of knee joints in the elderly, the effect is better. Asarum, Notopterygium incisum, Radix Clematis, Radix Gentianae Macrophyllae, frankincense, myrrh and safflower are used as the ministerial drugs. Asarum has the effects of new fragrance, warming and dispersing, dispelling wind and relieving pain. Qianghuo, clematis, qinjiao, pungent in nature, slightly warm, promote blood circulation and relieve pain. Frankincense, myrrh, safflower are warm in nature, pungent in taste, promote blood circulation and relieve pain. The above monarch and ministerial drugs complement each other, and have obvious improvement on stiff neck and back, pain, numbness of limbs, flexion and extension difficulties caused by wind-cold blood stasis. Among them, processed Chuanwu, processed Caowu, and asarum have strong spasmolytic and analgesic effects, which can relax smooth muscles, relieve muscle tension and spasm. It has a good effect on gastrointestinal colic and severe pain in internal organs and body surface. (Except acute) It has obvious effects on chronic cancer pain, pain caused by surgery or trauma, post-herpetic neuralgia, gout, dysmenorrhea, especially on the extensive pain of the shoulders, neck, back, limbs, legs and feet of the middle-aged and elderly people, and can control the further development of the disease. Assisted with Morinda officinalis and Eucommia ulmoides. Morinda officinalis and Eucommia ulmoides are sweet and warm in nature, tonify kidney yang, and strengthen tendons and bones. Chuanxiong and spatholobi are used as the guiding drugs. Chuanxiong is a new warm and fragrant herb that can ascend and descend, going up to the top of the head and down to the sea of ​​blood. It is a blood qi medicine. Together with the herb Stretch Marks, it can lead the medicine to the diseased area.

[0023] The medicine of the present invention is a powerful external transdermal agent for dispelling wind, dispersing cold, unblocking meridians and relieving pain. Therefore, most of the medicines used are good at unblocking meridians and relieving pain. Specially, two medicines, Morinda officinalis and Eucommia ulmoides, are used to strengthen the tendons and bones and replenish kidney yang, and four main medicines, seven auxiliary medicines, and two assistant medicines are added, which are a total of 15 medicines. The prescription is reasonable, the formula is appropriate, and wine is used as a carrier, which has the power of four taels to move a thousand pounds. For lumbar diseases, sciatica, and radiating pain and numbness in the buttocks or legs caused by early and middle-stage piriformis syndrome, the curative effect is obvious, and the further development of the disease can be controlled.

[0024] The drug of the present invention has multiple analgesic properties similar to tramadol hydrochloride, is an external transdermal agent, has good penetration effect, obvious analgesia, does not hurt the gastrointestinal tract, and is non-addictive. For patients with severe chronic pain, the drug is applied 3-5 times a day for 3 to 5 consecutive days, and the pain is eliminated and will not recur in one or three months. For young patients with chronic pain, transdermal therapy can be cured after a period of time, and the price is low. In clinical observation, no toxic side effects were found.

[0025] The drug of the present invention is safe, has good efficacy and clinical experiments have proved that it can treat chronic pain, has obvious effect, lasting efficacy and is non-addictive. It is particularly effective for chronic migraine, post-herpetic neuralgia, degenerative lesions of the knee joint in the elderly, etc., and provides a new choice of topical transdermal agent for clinical treatment of chronic pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 Effects of Chuanhongtongluo analgesic gel on hot plate test in mice;

[0027] Figure 2 Effect of Chuanhongtongluo analgesic gel on the writhing test in mice. DETAILED DESCRIPTION

[0028] Example 1 Preparation of the drug of the present invention

[0029] Take the following raw materials in weight ratio: 10g of Herba Scutellariae Ophiopogonis, 5g of processed Chuanwu, 4g of processed Caowu, 15g of Corydalis, 4g of Asarum, 10g of Notopterygium, 10g of Clematidis, 10g of Gentiana Macrophylla, 12g of Olibanum, 12g of Myrrh, 5g of Carthamus Tinctorius, 10g of Morinda Officinalis, 12g of Eucommia, 10g of Ligusticum chuanxiong and 9g of Herba Lycopodii, grind the above medicinal materials into coarse powder, soak and swell with 70% ethanol solution, put the powder into a percolation device and percolate with 3 times the amount of 70% ethanol, collect and combine the percolation, add vitamin E polyethylene glycol succinate at a mass concentration of 0.05%, mix and package to obtain a gel.

[0030] Example 2 Preparation of the drug of the present invention

[0031] Take the raw materials in each weight ratio: 8g of Herba Scutellariae Torrguelae, 4g of processed Chuanwu, 3.2g of processed Caowu, 12g of Corydalis, 3.2g of Asarum, 8g of Notopterygium, 8g of Clematidis, 8g of Gentiana Macrophylla, 9.6g of Frankincense, 9.6g of Myrrh, 4g of Carthamus, 8g of Morinda Officinalis, 9.6g of Eucommia, 8g of Ligusticum chuanxiong, and 7.2g of Herba Lycopodii, and prepare a tincture according to the preparation method of Example 1.

[0032] Example 3 Preparation of the drug of the present invention

[0033] Take the raw materials in each weight ratio: 12g of Herba Polygoni Multiflori, 6g of processed Chuanwu, 4.8g of processed Caowu, 18g of Corydalis, 4.8g of Asarum, 12g of Notopterygium, 12g of Clematidis, 12g of Gentiana Macrophylla, 14.4g of Frankincense, 14.4g of Myrrh, 6g of Carthamus Tinctorius, 12g of Morinda Officinalis, 14.4g of Eucommia, 12g of Ligusticum chuanxiong, and 10.8g of Herba Lycopodii, and prepare according to the method of Example 1.

[0034] The beneficial effects of the present invention are demonstrated by specific pharmacodynamic tests as follows.

[0035] Experimental Example 1 Analgesic Experimental Study Report of the Chinese Medicine Composition of the Present Invention (hereinafter referred to as "Chuanhong Tongluo Analgesic Gel")

[0036] 1. Purpose of the experiment

[0037] To explore the effect of Chuanhongtongluo analgesic gel on analgesia.

[0038] 2. Experimental Materials

[0039] Yunnan Baiyao tincture (Yunnan Baiyao Group Co., Ltd., ZD2401); formula monarch drug (self-made, prepared from the monarch drug in the formula); formula high, medium and low doses (self-made, prepared from the whole formula).

[0040] KM mice were purchased from the Experimental Animal Center of Southwest Medical University, with the experimental animal production license number: SYXK(Chuan)2023-0017.

[0041] 3. Hot Plate Experiment

[0042] 3.1 Experimental methods

[0043] Take female KM mice weighing between 18 and 20g, adjust the temperature of the hot plate to (55±0.5)℃, then measure the time (pain threshold) of each mouse licking the hind foot, and finally select mice with a time of 10 to 25s as experimental animals for subsequent experiments. 72 qualified mice were randomly divided into 6 groups, namely, model group, high, medium and low dose groups of Sichuan Hong Tongluo analgesic gel (high dose: 1.84g crude drug / mL, medium dose: 0.92g crude drug / mL, low dose: 0.46g crude drug / mL, prepared by Example 1), Sichuan Hong Tongluo analgesic gel monarch drug group (0.92g crude drug / mL), Yunnan Baiyao group, 12 mice in each group, female. After the mouse abdomen is shaved, 0.2mL / mouse is applied, and the model group is applied with 75% alcohol. 30 minutes after applying the medicine, the pain threshold of each mouse was measured using a hot plate apparatus. If the pain threshold reached 60 seconds, the experiment was stopped and the mouse was taken out to avoid scalding the mouse's paw. The pain threshold of the mouse was calculated as 60 seconds.

[0044] 3.2 Experimental Results

[0045] Compared with the model group, the time of foot licking in the Yunnan Baiyao group and the formula Junyao group was significantly higher than that in the model group (P < 0.05), and the time of foot licking in the high, medium and low dose groups was significantly higher than that in the model group (P < 0.01). The results showed that Chuanhong Tongluo analgesic gel had an analgesic effect on mice in the hot plate experiment. Compared with the Yunnan Baiyao group, the time of foot licking in the medium dose group was significantly higher than that in the Yunnan Baiyao group (P < 0.05), and the time of foot licking in the high and low dose groups was higher than that in the Yunnan Baiyao group, but there was no statistical difference. The results showed that in this experiment, the analgesic effect of the medium dose group was better than that of the Yunnan Baiyao group. Compared with the formula Junyao group, the time of foot licking in the medium and high dose groups was higher than that in the formula Junyao group.

[0046] The experimental results are shown in Table 1. Figure 1 In the hot plate experiment, the Sichuan Hong Tong Luo analgesic gel formula had an analgesic effect, and its analgesic effect was better than that of Yunnan Baiyao tincture, among which the medium dose had the best effect.

[0047] Table 1 Effects of Chuanhong Tongluo analgesic gel on hot plate test in mice (n=12, )

[0048]

[0049] Note: Compared with the model group, * Indicates P < 0.05, ** Indicates P < 0.01. Compared with the Yunnan Baiyao group, # Indicates P < 0.05, ## Indicates P < 0.01.

[0050] 4. Twisting test

[0051] 4.1 Experimental methods

[0052] 72 female KM mice weighing between 18 and 20 g were randomly divided into 6 groups, namely the model group, the high, medium and low dose groups of the whole formula of Chuanhong Tongluo analgesic gel, the main drug group of Chuanhong Tongluo analgesic gel, and the Yunnan Baiyao group, with 12 female mice in each group. After the hair was shaved on the abdomen of the mice, 0.2 mL / mouse was applied, and 75% alcohol was applied to the model group. 30 minutes after applying the medicine, all mice were intraperitoneally injected with freshly prepared 0.6% acetic acid (0.1 ml / 10 g). The number of twists and the time index of the first twist within 15 minutes after the injection of acetic acid were recorded (the occurrence of twisting reaction: the mouse's abdomen is concave, the trunk and hind limbs are extended, and the buttocks are raised, which is recorded as one twist).

[0053] 4.2 Experimental Results

[0054] Compared with the model group, the time of writhing in the Yunnan Baiyao group, the middle and high dose groups of the formula was significantly longer than that in the model group (P<0.01), and the time of licking feet in the formula Junyao group and the low dose group was significantly longer than that in the model group (P<0.05); the number of writhing times in the Yunnan Baiyao group, the Junyao group, the middle and high dose groups of the formula was significantly lower than that in the model group (P<0.01), and the number of writhing times in the low dose group was significantly lower than that in the model group (P<0.01). Compared with the Yunnan Baiyao group, the time of first writhing and the number of writhing times in 15 minutes in the low dose group were comparable to those in the Yunnan Baiyao group. Compared with the Junyao group, the time of first writhing in the high dose group was increased and the number of writhing times in 15 minutes was reduced.

[0055] The experimental results are shown in Table 2. Figure 2 In the acetic acid-induced writhing experiment, the Sichuan Hong Tongluo analgesic gel formula had an analgesic effect, and its analgesic effect was equivalent to that of Yunnan Baiyao tincture.

[0056] Table 2 Effects of Chuanhong Tongluo analgesic gel on the writhing test in mice (n=12, )

[0057]

[0058] Test Example 2 Typical Cases of the Chinese Medicine Composition of the Present Invention

[0059] The following typical cases were collected from the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University.

[0060] 1. Case 1:

[0061] Liu XX, gender: female, age 51 years old; date of consultation: May 18, 2024

[0062] Current medical history: The patient experienced pain and discomfort in the left knee joint without obvious cause more than 1 year ago. After receiving multiple treatments outside the hospital, the condition did not improve significantly.

[0063] Past history: The patient reported no history of hypertension, diabetes, coronary heart disease, etc.

[0064] Symptoms: Main complaint: left knee pain for 1+ years;

[0065] The four diagnostic methods of traditional Chinese medicine: red tongue, thin coating, and stringy pulse.

[0066] Specialist physical examination: The left iliac joint was slightly swollen, the skin color was normal, and there was no obvious abnormality in skin temperature. There was mild tenderness in the medial joint space, no obvious tenderness in the lateral joint space, mild tenderness in the medial eye, no obvious tenderness in the lateral knee eye, mild tenderness in the posterior joint space, positive floating patella test, positive patellar grinding test, positive hyperextension test, positive hyperflexion test, negative varus stress test, negative valgus stress test, negative varus squeeze test, negative valgus squeeze test, positive McBurney's sign, negative anterior drawer test, negative posterior drawer test, negative Lachman test, knee joint range of motion was 120°-0°-0°, and there was no obvious abnormality in extremity blood circulation, sensation, and movement.

[0067] Auxiliary examination: MRI of the left knee joint showed: degenerative lesions of the left knee joint, fluid accumulation in the joint cavity and suprapatellar bursa.

[0068] Diagnostic results: TCM diagnosis: pain and arthralgia, blood stasis and qi stagnation; Western medicine diagnosis: 1. osteoarthritis of the left knee joint; 2. pain in the left knee; the patient was advised to reduce weight-bearing activities of the injured limb, and to apply the Chinese medicine composition prepared in Example 1 of the present invention (prepared in Example 1) topically, and to take diacerein capsules orally for anti-inflammatory treatment.

[0069] Follow-up date: May 28, 2024

[0070] The patient reported that the pain in his left knee joint was significantly relieved and the range of motion was improved.

[0071] The four diagnostic methods of traditional Chinese medicine: red tongue, thin coating, and stringy pulse.

[0072] Physical examination: The swelling of the left knee joint was reduced, the skin color was normal, the skin temperature was not obviously abnormal, the tenderness of the medial joint space was reduced, the tenderness of the lateral joint space was not obvious, the tenderness of the medial knee eye was reduced, the tenderness of the lateral knee eye was not obvious, the mild tenderness of the posterior joint space was reduced, the floating patella test was weakly positive, the patella grinding test was positive, the hyperextension test was positive, the hyperflexion test was positive, the varus stress test was negative, the valgus stress test was negative, the varus squeeze test was negative, the valgus squeeze test was negative, the McBurney sign was positive, the anterior drawer test was negative, the posterior drawer test was negative, the Lachman test was negative, the Teng joint range of motion was 120°-0°-0°, and there was no obvious abnormality in the blood circulation, sensation and movement of the extremities. The patient had a definite effect after treatment, and the treatment was effective. The injured limb was advised to avoid weight-bearing activities, and the local Chuanhong Tongluo analgesic gel was continued for external use.

[0073] 2. Typical case 2:

[0074] Wu XX, gender: male, age: 75 years old; date of consultation: December 18, 2023

[0075] Current medical history: The patient developed right knee pain, swelling and difficulty in movement without obvious cause 2+ years ago. He sought medical treatment on his own. In the past 1+ week, the knee pain worsened, he was unable to walk, and his sleep at night was affected. For further diagnosis and treatment, he came to the Orthopedics Department of the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University for diagnosis and treatment.

[0076] Past medical history: The patient had hypertension for 3+ years and took medication regularly. He denied any history of diabetes, coronary heart disease, etc.

[0077] Chief complaint: right knee joint pain and swelling with poor mobility for 2 years, aggravated for 1+ week:

[0078] The four diagnostic methods of traditional Chinese medicine: red tongue, thin coating, and stringy pulse.

[0079] Physical examination: right knee joint swelling, slightly red skin color, slightly high skin temperature, tenderness in the medial joint space, mild tenderness in the lateral joint space, tenderness in the medial knee eye, mild tenderness in the posterior joint space relieved, floating patella test weakly positive, patellar grinding test positive, hyperextension test positive, hyperflexion test positive, varus stress test negative, valgus stress test negative, varus squeeze test negative, valgus squeeze test negative, McBurney sign positive, anterior drawer test negative, posterior drawer test negative, Lachman test negative, knee joint range of motion 120°-0°-0", no obvious abnormalities in extremity blood circulation, sensation and movement.

[0080] TCM diagnosis: pain and arthralgia, blood stasis and qi stagnation;

[0081] Western medicine diagnosis: 1. Osteoarthritis of the right knee joint, 2. Pain in the right knee joint;

[0082] The patients were advised to reduce weight-bearing activities on the injured limb, and were given the Chuanhong Tongluo analgesic gel prepared in Example 1 for external use, and diacerein capsules for oral anti-inflammatory treatment.

[0083] Follow-up date: December 25, 2023

[0084] The patient reported that the pain in the right knee joint was relieved, the flexion and extension activities were better, and he could bear some weight with the help of crutches;

[0085] The four diagnostic methods of traditional Chinese medicine: red tongue, thin coating, and stringy pulse.

[0086] Physical examination: The swelling of the right knee joint was significantly reduced, the skin temperature was basically normal, the tenderness in the medial joint space was significantly reduced, the tenderness in the lateral joint space was mild, the tenderness in the medial knee eye was reduced, the mild tenderness in the posterior joint space was reduced, the floating patella test was weakly positive, the patellar grinding test was positive, the hyperextension test was positive, the hyperflexion test was positive, the varus stress test was negative, the valgus stress test was negative, the varus squeeze test was negative, the valgus squeeze test was negative, the McBurney sign was positive, the anterior drawer test was negative, the posterior drawer test was negative, the Lachman test was negative, the knee joint range of motion was 120°-0°-0°, and there was no obvious abnormality in the blood circulation, sensation and movement of the extremities.

[0087] The patient felt a definite improvement after treatment and the treatment was effective.

[0088] 3. Typical case 3:

[0089] Tan X, gender: female, age 76 years old; consultation time: October 15, 2024

[0090] Current medical history: The patient developed low back pain, radiating pain in the lower limbs, and movement disorders 1 month ago and came to the Orthopedics Department of the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University for diagnosis and treatment.

[0091] Past medical history: denied history of hypertension, diabetes, coronary heart disease, etc.

[0092] Chief complaint: Low back pain for 1+ month.

[0093] The four diagnostic methods of traditional Chinese medicine: pale tongue, thin fur, and wiry pulse.

[0094] Physical examination: The physiological curvature of the lumbar spine became straight, tenderness at 2 cm on both sides of the lumbar 4 and 5 intervertebral spaces accompanied by pain and numbness in the posterior thighs, lateral calves, and dorsum of the feet; bilateral straight leg raising test 50° (+), strengthening test (+); negative double 4-shaped test, negative double hip flexion test, negative bilateral piriformis tension test, no tenderness in the piriformis running area. No tenderness in the bilateral groin walking area, bilateral lower limb rolling test (-), normal superficial sensation in the perineum, normal anal reflex, decreased sensation in the bilateral buttocks, posterior thighs, lateral calves, and dorsum of the feet, bilateral iliopsoas muscle strength of 5, bilateral quadriceps muscle strength of 5, bilateral tibialis anterior muscle strength of 5, bilateral extensor hallucis longus muscle strength of 4, bilateral peroneus longus and brevis muscle strength of 5, bilateral ankle plantar flexor muscle strength of 5, normal knee tendon reflex, normal Achilles tendon reflex, and negative Babinski sign.

[0095] Auxiliary examination: CT: 1. Vacuum degeneration of L4-S1 intervertebral disc, L3-S1 intervertebral disc herniation and L5-S1 intervertebral disc protrusion (left intervertebral foramen type), bilateral narrowing of L4-S1 intervertebral foramen; lumbar degeneration.

[0096] TCM diagnosis: pain and arthralgia, blood stasis and qi stagnation;

[0097] Western medicine diagnosis: lumbar spinal stenosis;

[0098] The back of the waist was given the Chuanhong Tongluo analgesic gel prepared in Example 1 for external use, and Yaotong Pills were taken orally for symptomatic treatment.

[0099] Follow-up date: October 29, 2024

[0100] The patient reported that the pain in the lower back and back had significantly improved, the radiating pain in the lower limbs had basically disappeared, and the lower limb activities had improved;

[0101] The four diagnostic methods of traditional Chinese medicine: pale tongue, fur coating, and wiry pulse.

[0102] Physical examination: The physiological curvature of the lumbar spine straightened, the tenderness at 2cm on both sides of the lumbar 4 and 5 intervertebral spaces was reduced, and the pain and numbness of the bilateral posterior thighs, lateral calf, and dorsum of the foot were relieved; the bilateral straight leg raising test was weakly positive, the double 4-shaped test was negative, the double hip flexion test was negative, the bilateral piriformis tension test was negative, and there was no tenderness in the piriformis running area. There was no tenderness in the bilateral groin walking area, the bilateral lower limb rolling test was (-), the superficial sensation in the perineum was normal, the anal reflex was normal, the bilateral buttocks, the posterior thighs, lateral calf, and dorsum of the foot were reduced, the bilateral iliopsoas muscle strength was level 5, the bilateral quadriceps muscle strength was level 5, the bilateral tibialis anterior muscle strength was level 5, the bilateral extensor hallucis longus muscle strength was level 4, the bilateral peroneus longus and brevis muscle strength was level 5, the bilateral ankle plantar flexor muscle strength was level 5, the bilateral knee tendon reflex was normal, the bilateral Achilles tendon reflex was normal, and the Babinski sign was negative.

[0103] The patient's pain was significantly relieved and the treatment was effective. He was advised to avoid sitting or standing for long periods of time, and continued to be given local application of Chuanhong Tongluo Analgesic Gel.

[0104] Clinical experiments have shown that the drug of the present invention has obvious efficacy in treating elderly knee degenerative lesions (osteoarthritis of the knee, joint pain, pain and arthralgia, lumbar spinal stenosis caused by blood stasis and qi stagnation, etc.

Claims

1. A Chinese medicine composition for treating chronic pain, characterized in that: It is prepared from the following raw materials in the following weight ratio: 8-12 parts of Herba Polygoni Multiflori, 4-6 parts of processed Radix Aconiti Kusnezoffii, 3.2-4.8 parts of processed Radix Aconiti Kusnezoffii, 12-18 parts of Rhizoma Corydalis, 3.2-4.8 parts of Radix Asarum, 8-12 parts of Radix Notopterygii, 8-12 parts of Radix Clematidis, 8-12 parts of Radix Gentianae, 9.6-14.4 parts of Olibanum, 9.6-14.4 parts of Myrrh, 4-6 parts of Carthamus Tinctorius, 8-12 parts of Morinda Officinalis, 9.6-14.4 parts of Eucommia, 8-12 parts of Rhizoma Chuanxiong, and 7.2-10.8 parts of Herba Lycopodii.

2. The Chinese medicine composition for treating chronic pain according to claim 1, characterized in that: It is prepared from the following raw materials in the following weight ratio: 10 parts of Herba Polygoni Multiflori, 5 parts of processed Aconiti Kusnezoffii, 4 parts of processed Aconiti Kusnezoffii, 15 parts of Corydalis Root, 4 parts of Asarum, 10 parts of Notopterygium, 10 parts of Radix Clematidis, 10 parts of Gentiana Macrophylla, 12 parts of Olibanum, 12 parts of Myrrh, 5 parts of Carthamus Flos, 10 parts of Morinda Officinalis, 12 parts of Eucommia, 10 parts of Rhizoma Chuanxiong, and 9 parts of Herba Lycopodiellae.

3. The Chinese medicine composition for treating chronic pain according to claim 1 or 2, characterized in that: The invention is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients are added to prepare a commonly used external preparation in medicine.

4. The Chinese medicine composition for treating chronic pain according to claim 3, characterized in that: The external preparation is a liniment, an ointment, a patch, a gel, a cream, a tincture, a spray, or a film-coating.

5. A method for preparing the Chinese medicine composition for treating chronic pain according to any one of claims 1 to 4, characterized in that: It includes the following steps: a. Weigh the APIs of various weight ratios; b. Powdering, or adding water or organic solvent for extraction, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used external preparation in medicine.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of an external medicine for treating chronic pain.

7. The use according to claim 6, characterized in that: The medicine is a medicine for treating chronic migraine, post-herpetic neuralgia and degenerative lesions of the knee joint in the elderly.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of external medicines having the effects of dispelling wind and cold, promoting blood circulation and relieving pain, warming the kidney yang, and strengthening the tendons and bones.

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