Traditional Chinese medicine liniment for treating lumbocrural pain and hyperostosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine liniment for treating lumbocrural pain and hyperostosis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine liniment is prepared from notopterygium root, radix angelicae pubescentis, angelica sinensis, fructus lycii, flos carthami, clove and radix saposhnikoviae according to a specific weight part ratio through soaking in wine and extracting, and auxiliary materials such as glycerol can also be added according to requirements. The traditional Chinese medicine composition is scientific in formula, integrates functions of promoting blood circulation to remove blood stasis, dispelling wind and eliminating dampness and tonifying liver and kidney, and is high in permeability, quick in effect, good in stability and small in side effect. The preparation method adopts a percolation method for extraction, so that effective components can be reserved to the greatest extent, and stable quality of liquid medicine is ensured. The traditional Chinese medicine can be used for effectively treating arthralgia such as lumbocrural pain, hyperostosis, lumbar disc herniation, rheumatic arthritis and the like, and has good clinical application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia, and its preparation method. Background Technology

[0002] Lower back and leg pain, bone hyperplasia, and other similar conditions are very common in clinical practice, often caused by chronic strain, invasion of wind-cold-dampness pathogens, blood stasis, and liver and kidney deficiency. Patients frequently experience joint pain and limited mobility, severely impacting their quality of life. Currently, topical medications are a common treatment for these conditions, primarily plasters and patches, but these methods have several limitations.

[0003] Inconvenient to use: The plaster is applied to the skin surface, and some people may experience adverse reactions such as skin allergies and itching after use. In addition, the fixed coverage area of ​​the plaster affects the normal breathing of the skin and also affects the appearance, restricting the patient's daily activities. In cases of excessive sweating, the plaster is also prone to falling off, leading to interruption of treatment.

[0004] Limited penetration: The dosage form of traditional plasters and patches determines that their active ingredients are absorbed slowly through the skin and penetrate to insufficient depth, making it difficult to reach deep lesions, thus affecting the treatment effect and prolonging the treatment cycle for patients.

[0005] Limited dosage form: For cases requiring frequent massage or where the affected area is a large, uneven joint flexion and extension area, plasters and patches cannot be flexibly adapted and cannot meet diverse treatment needs.

[0006] Traditional Chinese medicine liniments (liquids), as a topical dosage form, have gradually gained attention due to their advantages such as ease of use, easy application and massage, ability to promote drug absorption, and no impact on patients' normal activities. However, currently available traditional Chinese medicine liquid products often suffer from limited efficacy, targeting only a single cause or symptom; some products are also highly irritating, easily causing skin irritation and discomfort after use.

[0007] Therefore, this invention proposes a traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia that is scientifically formulated, fast-acting, highly penetrable, stable, and has few side effects. Summary of the Invention

[0008] The primary objective of this invention is to provide a traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia. The liniment has a scientific and rational formulation that can achieve the synergistic effects of promoting blood circulation, removing blood stasis, dispelling wind and dampness, and tonifying the liver and kidneys. It is fast-acting, highly penetrating, and can effectively reach deep lesions. It is also stable, does not easily precipitate or deteriorate during storage, has low skin irritation, few side effects, and provides a good user experience.

[0009] Another objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine liniment. This method is simple to operate, highly controllable, and uses percolation extraction, which can retain the effective components in the raw materials to the greatest extent, reduce the content of impurities, ensure the stability of the quality of the liquid, and is conducive to industrial production.

[0010] Another objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine liniment in the preparation of drugs for treating muscle and bone pain, expand its clinical application scope, and provide new and effective drug options for the treatment of arthralgia such as lower back and leg pain, bone hyperplasia, lumbar disc herniation, and rheumatoid arthritis.

[0011] To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0012] A traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia, comprising the following raw materials in parts by weight:

[0013] 400-600 parts of Notopterygium root, 400-600 parts of Angelica pubescens root, 400-600 parts of Angelica sinensis root, 400-600 parts of wolfberry fruit, 400-600 parts of safflower, 800-1200 parts of clove, 400-600 parts of Saposhnikovia divaricata root, and white wine for soaking;

[0014] Furthermore, the raw materials are in the following weight proportions: 500 parts of Notopterygium incisum, 500 parts of Angelica pubescens, 500 parts of Angelica sinensis, 500 parts of Lycium barbarum, 500 parts of Carthamus tinctorius, 1000 parts of Syzygium aromaticum, and 500 parts of Saposhnikovia divaricata.

[0015] Furthermore, the liquor in question is 58% edible liquor.

[0016] A method for preparing a traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia includes the following steps:

[0017] S1. Raw material pretreatment: Select notopterygium root, angelica root, angelica sinensis root, wolfberry fruit, safflower, clove, and saposhnikovia root that meet the medicinal standards, remove impurities, clean them, and then pulverize each raw material into coarse powder with a particle size of 20-40 mesh.

[0018] S2. Percolation extraction: Weigh the pretreated raw materials according to the weight parts, mix them evenly, put them into the percolation tube, add 58% alcohol, the amount of alcohol added is 8-12 times the total weight of the raw materials, soak for 24-48 hours, then percolate, control the percolation speed at 1-3 ml / min, and collect the percolate.

[0019] S3. Refining: Filter the collected permeate using a 0.45μm microporous membrane to remove impurities and insoluble particles; if glycerin needs to be added, add the calculated amount of glycerin after filtration, stir well, and obtain the traditional Chinese medicine liniment;

[0020] S4. Packaging: The refined Chinese herbal liniment is packed into clean, sterilized medicinal containers, sealed, and packaged to obtain the finished product.

[0021] Furthermore, in step S2, the amount of alcohol added is 10 times the total weight of the raw materials, the soaking time is 36 hours, and the percolation rate is 2 ml / min.

[0022] Furthermore, in step S3, the amount of glycerol added is 10% of the total weight of the drug solution.

[0023] The application of a traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia in the preparation of a medicine for treating muscle and bone pain, wherein the muscle and bone pain includes lower back and leg pain, bone hyperplasia, lumbar disc herniation, and pain caused by rheumatoid arthritis.

[0024] In the above formulation, each active pharmaceutical ingredient has a specific pharmacological effect and they work synergistically together:

[0025] Notopterygium root: It has a pungent and bitter taste, and is warm in nature. It enters the bladder and kidney meridians. It has the effects of relieving exterior syndromes, dispelling cold, eliminating wind and dampness, and relieving pain. It is often used for symptoms such as wind-cold-dampness arthralgia and shoulder and back pain. It can effectively dispel wind-cold-dampness in the upper body and relieve pain.

[0026] Angelica pubescens: It has a pungent and bitter taste, and is slightly warm in nature. It enters the kidney and bladder meridians. It has the effects of dispelling wind and dampness, relieving pain, and relieving exterior symptoms. It is especially suitable for symptoms such as wind-cold-dampness arthralgia in the lower body and pain in the waist and knees. When combined with Notopterygium incisum, it can achieve both upper and lower body treatment and enhance the effects of dispelling wind and dampness and relieving pain.

[0027] Angelica sinensis: It is sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It can improve local blood circulation, promote the flow of qi and blood, and relieve pain caused by blood stasis. It is an essential medicine for promoting blood circulation and nourishing blood in the formula.

[0028] Goji berries: sweet in taste, neutral in nature, and enter the liver and kidney meridians. They have the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight. They can replenish the deficiency of the liver and kidneys, strengthen muscles and bones, and fundamentally improve the weak muscles and bones caused by the deficiency of the liver and kidneys, thus playing a role in treating the root cause.

[0029] Safflower: It has a pungent taste and warm properties. It enters the heart and liver meridians and has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. Its ability to promote blood circulation and remove blood stasis is strong, which can accelerate local blood flow, promote the dissipation of blood stasis, and relieve pain symptoms.

[0030] Clove: It has a pungent taste and warm nature. It enters the spleen, stomach, lung and kidney meridians. It has the effects of warming the middle and relieving nausea, tonifying the kidney and assisting yang. At the same time, clove has a certain penetration-promoting effect, which can reduce skin barrier resistance, promote the transdermal absorption of the active ingredients of other drugs, and enhance the overall efficacy. Moreover, its dosage is relatively large, and it plays an important role in synergistic penetration promotion and adjuvant treatment in the prescription.

[0031] Fangfeng (Saposhnikovia divaricata): It has a pungent and sweet taste, and is slightly warm in nature. It enters the bladder, liver, and spleen meridians. It has the effects of dispelling wind and relieving exterior symptoms, eliminating dampness and relieving pain, and stopping spasms. It can dispel wind and dampness, relieve spasms and pain, and assist other drugs in enhancing the effects of dispelling pathogens and relieving pain.

[0032] The beneficial effects of this invention are as follows:

[0033] 1. Comprehensive Formula, Addressing Both Symptoms and Root Cause: In this invention's formula, Notopterygium root, Angelica pubescens root, and Saposhnikovia root work synergistically to dispel wind and dampness, and relieve pain, targeting arthralgia caused by the invasion of wind, cold, and dampness. Angelica sinensis root and Carthamus tinctorius root invigorate blood circulation and remove blood stasis, improving local blood stasis and alleviating pain symptoms. Lycium barbarum fruit nourishes the liver and kidneys, strengthens tendons and bones, fundamentally improving weak tendons and bones caused by liver and kidney deficiency. The scientific combination of these three groups of herbs achieves a synergistic effect of "invigorating blood circulation and removing blood stasis, dispelling wind and dampness, and nourishing the liver and kidneys," treating both the symptoms and pain, as well as the root cause of arthralgia and strengthening tendons. It can effectively treat arthralgia such as lower back and leg pain and bone hyperplasia, with long-lasting efficacy and a low recurrence rate.

[0034] 2. Extremely strong permeability and rapid onset of action: This invention innovatively adds sufficient cloves to the formula. Cloves not only have certain therapeutic effects, but more importantly, they have a significant permeation-promoting effect, which can reduce skin barrier resistance and promote the transdermal absorption of the effective components of drugs such as angelica, safflower, and notopterygium.

[0035] 3. Significant advantages of dosage form: This invention uses a liquid formulation, which has the following advantages compared to traditional plasters and patches: First, it is easy to apply, and the application range can be flexibly adjusted according to the size and shape of the lesion, especially suitable for uneven areas such as joints, waist, etc.; Second, it can be used in conjunction with massage after application to further promote local blood circulation and drug absorption, thereby enhancing the therapeutic effect; Third, it does not affect skin respiration or the patient's daily activities, and there is no obvious discomfort after use, resulting in high patient compliance.

[0036] 4. Good stability: The preparation method of this invention adopts percolation extraction, which can retain the effective components of the drug to the greatest extent and reduce the content of impurities; at the same time, glycerol can be added as a stabilizer and humectant. Glycerol can improve the stability of the drug solution and prevent the effective components from precipitating out.

[0037] 5. High safety: The raw materials used in this invention are all commonly used Chinese medicinal materials, which are highly safe; the preparation process is controllable, and impurities are removed through purification, filtration and other steps to reduce irritation. Attached Figure Description

[0038] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope.

[0039] Figure 1 This is a flowchart illustrating the preparation process of the traditional Chinese medicine liniment of the present invention. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0041] A traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia includes 400-600 parts of Notopterygium incisum, 400-600 parts of Angelica pubescens, 400-600 parts of Angelica sinensis, 400-600 parts of Lycium barbarum, 400-600 parts of Carthamus tinctorius, 800-1200 parts of Syzygium aromaticum, and 400-600 parts of Saposhnikovia divaricata.

[0042] To further improve the stability and skin compatibility of the medicinal solution, glycerin can be added to the herbal liniment of this invention. The amount of glycerin added is 5%-15% of the total weight of the medicinal solution. Glycerin has a good moisturizing effect, which can reduce the evaporation rate of the medicinal solution on the skin surface, prolong the drug's action time, and help improve the stability of the medicinal solution, preventing the active ingredients from precipitating due to water loss.

[0043] The preparation method of the herbal liniment of this invention adopts percolation extraction, and specifically includes the following steps:

[0044] (1) Raw material pretreatment: Select Qianghuo, Duhuo, Danggui, Gouqizi, Honghua, Dingxiang and Fangfeng that meet the medicinal standards of the Chinese Pharmacopoeia. First, remove impurities, then quickly wash them with purified water and dry them. After drying, use a universal pulverizer to pulverize each raw material into coarse powder. The particle size of the coarse powder is controlled at 20-40 mesh.

[0045] (2) Percolation Extraction: Weigh the pretreated raw materials according to the above-mentioned weight range, mix them thoroughly, and then load them into a clean percolation cylinder. When loading, use a layered loading method, gently compacting the material to avoid gaps or excessive compaction in the raw material layer, which would affect the percolation effect. Next, add 58% alcohol to the percolation cylinder. The preferred alcohol is 58-degree edible white liquor. The amount of alcohol added should be 8-12 times the total weight of the raw materials. After adding the alcohol, ensure the alcohol completely submerges the raw materials. Cover the percolation cylinder and soak for 24-48 hours to allow the raw materials to fully absorb water and swell, facilitating the dissolution of the active ingredients. After soaking, open the valve at the bottom of the percolation cylinder to begin percolation. Control the percolation rate at 1-3 ml / min, and collect the percolate simultaneously until the percolate becomes lighter in color and has no obvious medicinal odor. Generally, the amount of percolate collected is 6-10 times the total weight of the raw materials. Percolation extraction utilizes the gravity of the solvent to slowly penetrate the raw material layer and make full contact with the raw material, thereby maximizing the extraction of the effective components in the raw material. Moreover, the extraction process is gentle and can reduce the damage to heat-sensitive effective components.

[0046] (3) Refining: The collected permeate is transferred to a filtration device and filtered using a 0.45μm microporous membrane. Appropriate pressure can be applied during filtration to increase the filtration speed. The filtration removes impurities, fine particles, and some macromolecular substances from the permeate, making the liquid clear and transparent. If glycerin needs to be added to the formula, after filtration, glycerin is slowly added to the filtered permeate to ensure that the glycerin and permeate are thoroughly mixed to obtain the traditional Chinese medicine liniment.

[0047] (4) Packaging: After the refined Chinese medicine liniment is tested for content and quality to ensure that it meets the quality standards, it is packaged into clean, sterilized pharmaceutical plastic bottles or glass bottles to obtain the finished product.

[0048] Example 1

[0049] The raw materials for the Chinese herbal liniment are as follows (by weight): 500g of Notopterygium incisum, 500g of Angelica pubescens, 500g of Angelica sinensis, 500g of Lycium barbarum, 500g of Carthamus tinctorius, 1000g of Syzygium aromaticum, and 500g of Saposhnikovia divaricata; no glycerin is added.

[0050] Preparation method:

[0051] (1) Raw material pretreatment: Select the above-mentioned raw materials that meet the pharmaceutical standards, remove impurities, wash them with purified water, dry them at 65°C, and pulverize them into 30-mesh coarse powder.

[0052] (2) Percolation extraction: Weigh the above-mentioned pulverized raw materials, mix them evenly, put them into a percolation tube, add 58-degree edible liquor, the amount of liquor is 10 times the total weight of the raw materials (the total weight of the raw materials is 500×6+1000=4000g, the amount of liquor is 4000×10=40000ml), soak for 36 hours, percolate at a percolation speed of 2ml / min, and collect 35000ml of percolate.

[0053] (3) Refining: The percolate is filtered through a 0.45μm microporous membrane to obtain a clear medicinal liquid, which is the Chinese medicine liniment.

[0054] (4) Packaging: Pour the clarified liquid into a 50ml / bottle pharmaceutical glass bottle, seal it, affix a label, and obtain the finished product.

[0055] Example 2

[0056] The raw materials for the Chinese herbal liniment are as follows (by weight): 400g of Notopterygium incisum, 400g of Angelica pubescens, 400g of Angelica sinensis, 400g of Lycium barbarum, 400g of Carthamus tinctorius, 800g of Syzygium aromaticum, and 400g of Saposhnikovia divaricata; glycerin is added at 5% of the total weight of the liquid.

[0057] Preparation method:

[0058] (1) Raw material pretreatment: Select the above-mentioned raw materials that meet the pharmaceutical standards, remove impurities, wash them with purified water, dry them at 60°C, and pulverize them into 20-mesh coarse powder.

[0059] (2) Percolation extraction: Weigh the above-mentioned pulverized raw materials, mix them evenly, put them into a percolation cylinder, add 58-degree edible liquor, the amount of liquor is 8 times the total weight of the raw materials (the total weight of the raw materials is 400×6+800=3200g, the amount of liquor is 3200×8=25600ml), soak for 24 hours, percolate at a percolation speed of 1ml / min, and collect 20000ml of percolate.

[0060] (3) Refining: Filter the percolate through a 0.45μm microporous membrane. Based on the total weight of the medicine solution of 20000ml (assuming the density of the medicine solution is 1g / ml and the total weight of the medicine solution is 20000g), calculate the amount of glycerin to be used as 20000×5%=1000g. Add 1000g of glycerin to the filtered percolate and stir at a speed of 300r / min for 15 minutes to mix evenly and obtain the Chinese medicine liniment.

[0061] (4) Packaging: Pack the Chinese herbal liniment into a 20ml / bottle medicinal plastic bottle, seal it, affix a label, and you will get the finished product.

[0062] Example 3

[0063] The raw materials for the Chinese herbal liniment are as follows (by weight): 600g of Notopterygium incisum, 600g of Angelica pubescens, 600g of Angelica sinensis, 600g of Lycium barbarum, 600g of Carthamus tinctorius, 1200g of Syzygium aromaticum, and 600g of Saposhnikovia divaricata; glycerin is added at 15% of the total weight of the liquid.

[0064] Preparation method:

[0065] (1) Raw material pretreatment: Select the above-mentioned raw materials that meet the pharmaceutical standards, remove impurities, wash them with purified water, dry them at 70°C, and pulverize them into 40-mesh coarse powder.

[0066] (2) Percolation extraction: Weigh the above-mentioned pulverized raw materials, mix them evenly, put them into a percolation cylinder, add 58-degree edible liquor, the amount of liquor is 12 times the total weight of the raw materials (the total weight of the raw materials is 600×6+1200=4800g, the amount of liquor is 4800×12=57600ml), soak for 48 hours, percolate at a percolation rate of 3ml / min, and collect 45000ml of percolate.

[0067] (3) Refining: Filter the percolate through a 0.45μm microporous membrane. Based on the total weight of the medicine solution of 45000ml (assuming the density of the medicine solution is 1g / ml and the total weight of the medicine solution is 45000g), calculate the amount of glycerin to be used as 45000×15%=6750g. Add 6750g of glycerin to the filtered percolate and stir at a speed of 500r / min for 20 minutes to mix evenly and obtain the Chinese medicine liniment.

[0068] (4) Packaging: Pack the Chinese herbal liniment into a 10ml / bottle medicinal glass bottle, seal it, affix a label, and you will get the finished product.

[0069] To verify the safety, efficacy, and stability of the herbal liniment of this invention, the following experimental studies were conducted. The herbal liniments prepared in Examples 1-3 were used as experimental samples, while a commercially available herbal liquid for treating lower back and leg pain was used as a control group (the control group sample did not contain clove-derived penetration enhancers and was prepared using the traditional soaking method).

[0070] 1. Safety Experiment

[0071] Skin irritation test

[0072] Eight healthy rabbits, weighing 2.0-2.5 kg, were randomly divided into four groups of two rabbits each: groups 1-3 (Examples 1-3) and a control group. Hair was removed from both sides of the spine on the rabbits' backs, with each area measuring 3 cm × 3 cm. The left side was the treatment area, and the right side was the blank control area (applied with an equal volume of physiological saline). 0.5 ml of the corresponding sample was applied to each group's treatment area once daily for seven consecutive days, and skin reactions were observed.

[0073] Experimental Results: In Examples 1-3, no irritating reactions such as redness, swelling, itching, rash, or blisters were observed in the treatment areas of the rabbits, consistent with the skin condition of the blank control area. In the control group, one group of rabbits showed mild redness and swelling in the treatment area, which subsided two days after drug withdrawal. The experiment demonstrates that the herbal liniment of this invention has low skin irritation and high safety.

[0074] Skin allergy test

[0075] Sixteen healthy guinea pigs, weighing 250-300g, were randomly divided into four groups of four each: groups 1-3 (Examples 1-3) and a control group. The Buehler method was used for sensitization. On days 0 and 7, 0.2ml of the corresponding sample was applied to the left side of the bald area (2cm x 2cm) on the guinea pig's back to induce sensitization. On day 14, 0.2ml of the corresponding sample was applied to the right side of the bald area (2cm x 2cm) on the guinea pig's back to induce stimulation. Skin allergic reactions were observed at 24h, 48h, and 72h after stimulation.

[0076] Experimental Results: In Examples 1-3, no allergic reactions such as erythema or edema were observed in the skin of guinea pigs after stimulation, with an allergy rate of 0%. In the control group, two guinea pigs showed mild erythema after stimulation, with an allergy rate of 16.7%. The experiment demonstrates that the herbal liniment of this invention is non-allergenic and safe to use.

[0077] 2. Validity Experiment

[0078] Clinical efficacy trial

[0079] Two hundred patients clinically diagnosed with low back and leg pain, bone hyperplasia, lumbar disc herniation, and rheumatoid arthritis were selected, including 100 males and 100 females, aged 35-70 years, with a disease duration of 6 months to 10 years. The patients were randomly divided into four groups of 50 each: groups 1-3 (Examples 1-3) and a control group. There were no significant differences among the groups in terms of gender, age, disease duration, and disease severity (P>0.05), making them comparable.

[0080] Administration method: Patients in each group applied the corresponding sample to the lesion site 3 times a day. After application, gently massage for 5-10 minutes to promote drug absorption. One course of treatment is 4 weeks, and two consecutive courses of treatment are required.

[0081] Criteria for evaluating therapeutic efficacy:

[0082] Recovery: Symptoms such as pain, soreness, and limited mobility completely disappear, joint function returns to normal, and the person can work and live normally.

[0083] Significant effect: Symptoms such as pain and soreness are significantly reduced, and the limitation of movement is significantly improved, enabling people to basically work and live normally;

[0084] Effective: Symptoms such as pain and soreness are reduced, and limitations in mobility are improved, although it has some impact on work and life;

[0085] Ineffective: Symptoms such as pain, soreness, and limited mobility do not improve or worsen.

[0086] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0087] The results of the clinical efficacy trial are shown in the table below:

[0088] Table 1

[0089] Group Recovery (example) Significant effect (example) Valid (example) Invalid (example) Overall effectiveness (%) Example 1 Group 22 18 8 2 96.0 Example 2 group 20 17 10 3 94.0 Example 3 Group 23 19 7 1 98.0 control group 10 15 12 13 74.0

[0090] As shown in the table above, the total effective rate of all three groups in Examples 1-3 was above 94%, with the highest total effective rate in Example 3 reaching 98%, while the total effective rate of the control group was only 74%. The total effective rate of each example group was significantly different from that of the control group (P<0.05), indicating that the herbal liniment of this invention is significantly more effective than commercially available control group products in treating lumbago, leg pain, bone hyperplasia, and other arthralgia conditions.

[0091] Typical Cases

[0092] Case 1: Lumbar disc herniation (acute phase)

[0093] Patient basic information: Zhang, male, 45 years old, construction worker, disease course 3 years, acute onset 1 week ago.

[0094] Chief complaint: One week ago, the patient experienced severe lower back pain after lifting heavy objects, accompanied by radiating numbness and pain in the left lower limb. The pain VAS (Visual Analogue Scale) score was 8 out of 10. The patient was unable to stand upright and the pain worsened when sitting for a long time or bending over.

[0095] Treatment plan: Apply the herbal liniment prepared in Example 3 of this invention to the painful area of ​​the lower back, left buttock, and back of the thigh three times a day. After application, massage clockwise with the palm for 8 minutes to promote drug absorption. Use continuously for 4 weeks (1 course of treatment).

[0096] Treatment effect:

[0097] After 4 weeks of medication: lower back pain completely disappeared, VAS score was 0, and light work could be resumed. Lumbar spine mobility returned to normal (90° forward flexion, 30° backward extension, and 30° lateral flexion to the left and right).

[0098] Case 2: Knee osteoarthritis (degenerative osteoarthritis)

[0099] Patient basic information: Ms. Li, female, 62 years old, retired teacher, with a disease course of 5 years.

[0100] Chief complaint: Pain and swelling in both knees, accompanied by a "clicking" sound during movement, with significant pain when going up and down stairs or squatting, VAS score of 6; X-ray of the knee joints showed narrowing of the joint space in both knees and osteophyte formation at the edge of the tibial plateau.

[0101] Treatment plan: Apply the herbal liniment prepared in Example 1 of this invention to the inner and outer sides of both knee joints and around the patella three times a day. After application, gently massage the muscles around the knee joint with your fingertips for 5 minutes. Use continuously for 8 weeks (2 courses of treatment).

[0102] Treatment effect:

[0103] After 8 weeks of medication: knee pain and swelling completely disappeared, VAS score was 0, popping sound during activity disappeared, and the patient could normally climb up and down 3 flights of stairs and dance in the square. The range of motion of the knee joint returned to normal (flexion 120°, extension 0°).

[0104] Case 3: Rheumatoid arthritis (multi-joint involvement)

[0105] Patient basic information: Wang, male, 38 years old, programmer, with a disease course of 2 years and symptoms worsening in the past 2 months.

[0106] Chief complaint: Symmetrical pain and swelling in the metacarpophalangeal joints, wrist joints, and ankle joints of both hands; joint stiffness upon waking (morning stiffness lasts for about 1.5 hours); VAS score: 7.

[0107] Treatment plan: Apply the herbal liniment prepared in Example 5 of this invention to the swollen and painful areas of the palmar and finger joints, wrist joints, and ankle joints of both hands three times a day. Massage each joint for 5 minutes after application. Continue to use for 8 weeks.

[0108] Treatment effect:

[0109] After 8 weeks of medication: morning stiffness symptoms completely disappeared, pain and swelling in all affected joints disappeared, VAS score was 0, and joint range of motion returned to normal.

[0110] In summary, this invention has good effects on diseases such as lower back and leg pain, bone hyperplasia, lumbar disc herniation, and pain caused by rheumatoid arthritis, and has high clinical value in the treatment of lower back and leg pain and bone hyperplasia-related diseases.

[0111] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine liniment for treating lumbocrural pain and hyperosteogeny, characterized in that, The raw medicinal materials are as follows in terms of weight parts: ​ Notopterygium 400-600 parts, Angelica pubescens 400-600 parts, Angelica sinensis 400-600 parts, Fructus Lycii 400-600 parts, Carthamus tinctorius 400-600 parts, Syzygium aromaticum 800-1200 parts, Saposhnikovia divaricata 400-600 parts, and white liquor for soaking.

2. The traditional Chinese medicine liniment for treating lower back and leg pain and bone hyperplasia according to claim 1, characterized in that: The raw medicinal materials are as follows in terms of weight parts: Notopterygium 500 parts, Angelica pubescens 500 parts, Angelica sinensis 500 parts, Fructus Lycii 500 parts, Carthamus tinctorius 500 parts, Syzygium aromaticum 1000 parts, Saposhnikovia divaricata 500 parts.

3. The Chinese medicine liniment for treating lumbocrural pain and hyperosteogeny according to claim 1, characterized in that: The white liquor is 58% edible white liquor. ​ 4. A preparation method of the Chinese medicine liniment for treating lumbocrural pain and hyperosteogeny according to any one of claims 1-3, characterized in that, The method comprises the following steps: S1. Raw material pretreatment: select Notopterygium, Angelica pubescens, Angelica sinensis, Fructus Lycii, Carthamus tinctorius, Syzygium aromaticum, and Saposhnikovia divaricata that meet the medicinal standards, remove impurities, clean, and then crush each raw medicinal material into coarse powder with a particle size of 20-40 mesh; S2. Percolation extraction: weigh the pretreated raw medicinal materials according to the weight parts, mix them evenly, load them into a percolation cylinder, add 58% liquor, the liquor addition amount is 8-12 times the total weight of the raw medicinal materials, soak for 24-48 hours, then perform percolation, control the percolation speed at 1-3 ml / min, and collect the percolation liquid; S3. Refining: filter the collected percolation liquid, use a 0.45 μm microporous filter membrane for filtration to remove impurities and insoluble particles; If glycerol needs to be added, add the calculated amount of glycerol after filtration, stir evenly, and obtain the traditional Chinese medicine liniment; S4. Dispensing: load the refined traditional Chinese medicine liniment into clean and sterilized medicinal containers, seal and package, and obtain the finished product.

5. The preparation method according to claim 4, characterized in that, In step S2, the liquor addition amount is 10 times the total weight of the raw medicinal materials, the soaking time is 36 hours, and the percolation speed is 2 ml / min.

6. The preparation method according to claim 4, characterized in that, In step S3, the addition amount of glycerol is 10% of the total weight of the medicinal liquid.

7. The use of the Chinese medicine liniment for treating lumbocrural pain and hyperosteogeny according to any one of claims 1-3 in the preparation of a medicine for treating arthralgia and numbness of limbs. The muscle and bone pain includes pain caused by lumbar and leg pain, hyperosteogeny, lumbar disc herniation, and rheumatic arthritis. The muscle and bone pain includes pain caused by lumbar and leg pain, hyperosteogeny, lumbar disc herniation, and rheumatic arthritis.

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