Traditional Chinese medicine composition for treating osteoarticular diseases

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and provides a traditional Chinese medicine composition for treating osteoarticular diseases. The traditional Chinese medicine composition for treating osteoarticular diseases is prepared from the following raw materials in parts by weight: 35 to 45 parts of short-pedicel aconite root, 25 to 35 parts of radix aconiti preparata, 90 to 100 parts of rhizoma zingiberis, 20 to 30 parts of herba epimedii, 3 to 6 parts of catechu, 9 to 14 parts of caulis spatholobi, 2 to 5 parts of rhizoma corydalis, 1 to 3 parts of liquorice root and 1 to 3 parts of borneol. Compared with ostalgia tincture, the traditional Chinese medicine composition not only can regulate bone metabolism, tonify kidney and strengthen bone and treat liver and kidney deficiency essence of hyperosteogeny, has the effects of reducing toxicity and enhancing efficacy, but also can reduce irritation to skin and greatly reduce use side effects.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating bone and joint diseases. Background Art

[0002] Bone and joint diseases mainly refer to diseases caused by various reasons that lead to pathological changes in bones, articular cartilage, ligaments, tendons, synovium and other tissues, which in turn cause a series of clinical manifestations such as joint pain, swelling, deformity, and limited mobility. Bone and joint diseases include degenerative arthritis, bursitis, synovitis, cervical spondylosis, lumbar spondylosis, frozen shoulder, bone hyperplasia, rheumatoid arthritis, rheumatoid arthritis, femoral head necrosis, etc.

[0003] As a common and frequent disease, bone and joint diseases seriously affect the quality of life of patients. Globally, with the acceleration of population aging and changes in modern lifestyles, the incidence of bone and joint diseases has been increasing year by year. Such diseases not only cause physical pain and inconvenience to patients, but also impose a heavy burden on social medical resources.

[0004] At present, there are various treatments for bone and joint diseases. In terms of Western medicine treatment, drug treatment is common. For example, although non-steroidal anti-inflammatory drugs can relieve pain symptoms to a certain extent, long-term use can easily cause adverse reactions such as gastrointestinal discomfort and liver and kidney damage; although glucocorticoids have significant anti-inflammatory effects, long-term use may lead to serious complications such as osteoporosis and decreased immunity. Surgical treatment, such as joint replacement, can improve the joint function of some patients, but the surgical risk is high, the postoperative recovery period is long, and the cost is expensive, which not all patients can afford.

[0005] In contrast, traditional Chinese medicine has unique advantages in treating bone and joint diseases. According to traditional Chinese medicine theory, bone and joint diseases are mostly caused by liver and kidney deficiency, insufficient qi and blood, and wind, cold and dampness taking advantage of the weakness to invade the human body, blocking the meridians and causing poor circulation of qi and blood. Traditional Chinese medicine treatment focuses on overall conditioning, and by adjusting the balance of yin and yang in the human body, it fundamentally improves the body's state to achieve the effect of treating both the symptoms and the root causes. External use of traditional Chinese medicine is particularly prominent in the treatment of bone and joint diseases. It acts directly on the lesion site, allowing the active ingredients of the drug to penetrate through the skin and reach the diseased site, which can quickly relieve symptoms such as pain and swelling. At the same time, it avoids the potential effects of oral drugs on the internal organs of the whole body after absorption through the gastrointestinal tract, greatly reducing the risk of adverse reactions. In addition, external use of traditional Chinese medicine can continuously act on the local joints, with long-lasting efficacy, which helps to improve blood circulation around the joints, promote inflammation absorption, and enhance joint function.

[0006] Among the many external Chinese medicines, Gutongling Tincture is a commonly used Chinese medicine preparation for the treatment of bone and joint diseases. It can act directly on the affected part. The active ingredients of the medicine penetrate through the skin and quickly reach the lesion, playing the role of promoting blood circulation, activating blood circulation and removing blood stasis, removing wind and dampness, and relieving pain. It is relatively effective in relieving joint pain and swelling symptoms.

[0007] However, Gutongling tincture also has some disadvantages. First of all, its ingredients contain Artemisia annua, which is highly toxic. Even if it is for external use, it will still have significant toxic side effects if used for a long time or accidentally enters the mouth or nose. Secondly, although Gutongling tincture takes effect quickly and the experience during use is good, once the drug is stopped, the symptoms are still prone to recurrence. In addition, in terms of adverse reactions, a large number of users have reported skin-related problems, and some patients will experience skin irritation symptoms, manifested as redness, itching, and burning sensation at the application site. In more serious cases, allergic contact dermatitis may occur, with blisters, edema, and even skin peeling.

[0008] Therefore, developing an external Chinese medicine composition that can reduce toxicity, increase efficacy, treat both the symptoms and the root cause, and has few adverse reactions is of extremely important practical significance for improving the level of treatment of bone and joint diseases. Summary of the invention

[0009] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating bone and joint diseases. Compared with Gutongling tincture, the traditional Chinese medicine composition can not only regulate bone metabolism, nourish the kidney and strengthen bones, but also treat the "liver and kidney deficiency" nature of bone hyperplasia, play a role in reducing toxicity and increasing efficacy, but also can reduce irritation to the skin and greatly reduce side effects of use.

[0010] In order to achieve the above object, the solution adopted by the present invention is:

[0011] A traditional Chinese medicine composition for treating bone and joint diseases comprises the following raw materials by weight: 35-45 parts of Artemisia annua, 25-35 parts of processed Chuanwu, 90-100 parts of dried ginger, 20-30 parts of epimedium, 3-6 parts of catechu, 9-14 parts of Millettia reticulata, 2-5 parts of Corydalis yanhusuo, 1-3 parts of liquorice and 1-3 parts of borneol.

[0012] Further, in a preferred embodiment of the present invention, 38-42 parts of Artemisia snowwort, 28-32 parts of processed Chuanwu, 95-98 parts of dried ginger, 25-28 parts of epimedium, 4-6 parts of catechu, 11-13 parts of Millettia reticulata, 2-4 parts of Corydalis yanhusuo, 1-2 parts of licorice and 1-2 parts of borneol.

[0013] Furthermore, in a preferred embodiment of the present invention, the preparation method of the Chinese medicine composition comprises: (1) mixing Artemisia annua, dried ginger, processed Chuanwu, epimedium, catechu, Millettia reticulata, Corydalis yanhusuo and licorice according to weight proportions, grinding into coarse powder, extracting by percolation with a first ethanol having a concentration of 50%, and collecting the percolation liquid; (2) dissolving borneol in a second ethanol having a concentration of 50%, combining with the percolation liquid, mixing, standing for 48 hours, filtering, and obtaining the composition; the volume ratio of the percolation liquid to the second ethanol is 18-20:1.

[0014] Furthermore, in a preferred embodiment of the present invention, the Chinese medicine composition is an external preparation.

[0015] The beneficial effects of a traditional Chinese medicine composition for treating bone and joint diseases provided by the present invention are:

[0016] Artemisia sibiricum and processed Chuanwu are the main drugs, and these two drugs focus on the core pathogenesis of "cold dampness and numbness". Artemisia sibiricum has a more significant effect in relieving pain, and processed Chuanwu is stronger in removing cold and dampness. Its pungent and hot nature can better warm the meridians and dispel cold. The combination of the two can enhance the effects of dispelling wind and cold, dredge the meridians and relieve pain, and warm the meridians and dispel cold.

[0017] Dried ginger in the prescription can enhance the effect of warming the meridians and dispersing cold, assist the main medicine in dispersing the cold and dampness in the joints and meridians, and relieve the pain, swelling and other symptoms caused by the stagnation of cold and dampness; the active characteristic ingredient of epimedium, icariin, can inhibit the proliferation of osteoclasts, regulate bone metabolism, and treat the root cause; the two medicines act as assistant medicines together, which can enhance the effect of warming the meridians and dispersing cold in this prescription, while tonifying the kidneys and strengthening the bones, targeting the "liver and kidney deficiency" nature of bone hyperplasia.

[0018] Millettia reticulata, vinegar-corydalis yanhusuo, and catechu are used as adjuvants in this prescription. All three have the effects of promoting blood circulation and relieving pain, which can enhance the blood circulation and analgesic effects of the main medicine and promote wound healing. The ingredients such as catechins and epicatechins contained in catechu give it good astringent and hemostatic abilities and the ability to promote tissue repair. Millettia reticulata has the function of promoting blood circulation while avoiding the risk of allergic reactions caused by resin ingredients such as frankincense or myrrh. Vinegar-corydalis yanhusuo has the function of promoting blood circulation, qi circulation, and relieving pain, which can enhance local analgesia in this prescription.

[0019] In this prescription, borneol and licorice are both adjuvant drugs. Borneol has transdermal absorption and heat-clearing and analgesic effects; licorice can reduce swelling and relieve pain, harmonize various drugs, and antagonize the toxicity of aconitine to reduce the toxicity of the main drug.

[0020] The Chinese medicine composition is formulated based on the theory of traditional Chinese medicine and the pathogenesis of bone and joint diseases. The various drugs in the prescription are combined to have significant effects of dispelling wind and cold, dredge meridians and relieve pain, warm the meridians and dispel cold, and can also regulate bone metabolism, target the essence of "liver and kidney deficiency" of bone hyperplasia, warm the kidney and assist yang, strengthen the body and consolidate the foundation, and achieve the effect of strengthening tendons and bones and treating bone and joint diseases. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0022] The following is a detailed description of a Chinese medicine composition for treating bone and joint diseases provided in an embodiment of the present invention.

[0023] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0024] Example 1

[0025] This embodiment provides a Chinese medicine composition for treating bone and joint diseases. The raw materials thereof are calculated by weight: 35g Artemisia sutchuenensis, 35g processed Chuanwu, 90g dried ginger, 30g Epimedium, 3g catechu, 14g Millettia reticulata, 2g Corydalis, 3g Licorice and 1g Borneol.

[0026] The present embodiment provides a method for preparing the above-mentioned Chinese medicine composition, comprising: (1) mixing Artemisia annua, dried ginger, processed Chuanwu, epimedium, catechu, Millettia reticulata, Corydalis yanhusuo and licorice in the above-mentioned proportions, grinding them into coarse powder, extracting by percolation with a first ethanol with a concentration of 50%, and collecting 950 ml of the percolation liquid; (2) dissolving borneol in 50 ml of a second ethanol with a concentration of 50%, combining the percolation liquid with the percolation liquid, mixing well, standing for 48 hours, and filtering to obtain the composition.

[0027] Example 2

[0028] This embodiment provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 45g of Artemisia sibiricum, 25g of processed Chuanwu, 100g of dried ginger, 20g of Epimedium, 6g of catechu, 9g of Millettia reticulata, 5g of Corydalis, 1g of Licorice and 3g of Borneol. This embodiment provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0029] Example 3

[0030] This embodiment provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 38g of Artemisia sutchuenensis, 32g of processed Chuanwu, 95g of dried ginger, 28g of Epimedium, 4g of catechu, 13g of Millettia reticulata, 2g of Corydalis, 2g of Licorice and 1g of Borneolum. This embodiment provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0031] Example 4

[0032] This embodiment provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 42g of Artemisia annua, 28g of processed Chuanwu, 98g of dried ginger, 25g of Epimedium, 6g of catechu, 11g of Millettia reticulata, 4g of Corydalis, 1g of Licorice and 2g of Borneol. This embodiment provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0033] Example 5

[0034] This embodiment provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sibiricum, 30g of processed Chuanwu, 96g of dried ginger, 27g of Epimedium, 5g of catechu, 12g of Millettia reticulata, 3g of Corydalis, 1.5g of Licorice and 1.5g of Borneolum. This embodiment provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0035] Comparative Example 1

[0036] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 70g of Artemisia annua, 96g of dried ginger, 27g of Epimedium, 5g of catechu, 12g of Millettia reticulata, 3g of Corydalis, 1.5g of Licorice and 1.5g of Borneol. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0037] Comparative Example 2

[0038] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sutchuenensis, 30g of processed Chuanwu, 123g of dried ginger, 5g of catechu, 12g of Millettia reticulata, 3g of Corydalis yanhusuo, 1.5g of liquorice and 1.5g of borneol. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0039] Comparative Example 3

[0040] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sibiricum, 30g of processed Chuanwu, 96g of dried ginger, 27g of Epimedium, 20g of Corydalis, 1.5g of Licorice and 1.5g of Borneolum. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0041] Comparative Example 4

[0042] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sutchuenensis, 30g of processed Chuanwu, 5g of catechu, 12g of Millettia reticulata, 3g of Corydalis yanhusuo, 1.5g of Licorice and 1.5g of Borneol. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0043] Comparative Example 5

[0044] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sibiricum, 30g of processed Chuanwu, 96g of dried ginger, 27g of Epimedium, 1.5g of Licorice and 1.5g of Borneolum. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0045] Comparative Example 6

[0046] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sutchuenensis, 30g of processed Chuanwu, 96g of dried ginger, 27g of Epimedium, 5g of catechu, 12g of Millettia reticulata, and 3g of Corydalis yanhusuo. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0047] Comparative Example 7

[0048] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sibiricum, 30g of processed Chuanwu, 96g of dried ginger, and 27g of Epimedium. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0049] Comparative Example 8

[0050] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sutchuenensis, 30g of processed Chuanwu, 5g of catechu, 12g of Millettia spatholobi, and 3g of Corydalis yanhusuo. This comparative example provides a preparation method of the above Chinese medicine composition, please refer to Example 1.

[0051] Comparative Example 9

[0052] This comparative example provides a Chinese medicine composition for treating bone and joint diseases. The raw materials include: 40g of Artemisia sibiricum, 30g of processed Chuanwu, 1.5g of Licorice and 1.5g of Borneol. This comparative example provides a preparation method of the above Chinese medicine composition. Please refer to Example 1.

[0053] Experimental Example 1

[0054] 1. Experimental animals: 150 healthy adult rabbits (2-2.5 kg). The test animals should have smooth skin, no damage, and no skin diseases.

[0055] Grouping: The Chinese medicine compositions provided in Examples 1-5 and Comparative Examples 1-9 were used as administration groups 1-14, and Gutongling Tincture (Yunnan Shengke Pharmaceutical Co., Ltd., 10 ml*2 bags / box, national medicine standard Z53021244) was used as the control group, with 10 rabbits / group.

[0056] 2. Experimental methods

[0057] (1) Preparation of test animal skin:

[0058] Preparation of intact skin: 24 hours before administration, the hair on both sides of the dorsal spine of the animals was removed. The hair removal range was approximately equivalent to 10% of the body surface area. After 24 hours of hair removal, the hair-removed skin was checked to be intact and uninjured.

[0059] Preparation of damaged skin: Disinfect the depilated skin as described above, and use a sterilized scalpel to cut the epidermis in a tic-tac-toe pattern until slight bleeding occurs on the skin.

[0060] (2) Administration: The drug solution provided by the drug administration groups 1-14 and the control group was applied to the depilated area on the back of the animals (5 animals) at a rate of 2 ml / kg. The damaged skin (5 animals) was scratched in the depilated area and then applied with the drug solution, and fixed with non-irritating gauze, adhesive tape or mesh nylon bandage. After 24 hours, the residual drug solution was removed and the animals were observed daily for 7 consecutive days.

[0061] Observation: Observe the systemic poisoning symptoms and death of animals, including changes in weight, skin, hair, eyes and mucous membranes, respiration, circulation, central nervous system, limb activities, etc.

[0062] 3. Experimental results

[0063] The results are shown in Table 1:

[0064] Table 1

[0065]

[0066]

[0067] The experimental results in Table 1 show that the Chinese medicine composition provided by Examples 1-5 has a significant toxicity-reducing effect compared to Gutongling Tincture, and no erythema and edema appeared on the skin of the test area, nor any other obvious abnormal reactions.

[0068] Experimental Example 2

[0069] 1. Experimental animals: 170 guinea pigs (250-300 g), half male and half female; grouping: the Chinese medicine compositions provided in Examples 1-5 and Comparative Examples 1-9 were used as administration groups 1-14, Gutongling tincture was used as administration group 15, positive control group (applied 2,4-dinitrochlorobenzene (DNCB) with acetone to a 1% sensitizing concentration and a 0.1% excitation concentration), blank group (applied 75% ethanol), 10 guinea pigs / group.

[0070] 2. Experimental methods

[0071] (1) Sensitization contact: Shave the skin of the test animals on both sides of the back to obtain an area of ​​5 cm × 2 cm, and leave it alone for 24 h. First, apply 0.2 ml of the drug solution to the shaved area on the left side of the guinea pig's back for the treatment groups 1-15, 0.2 ml of DNCB (using 0.1% acetone solution) to the positive control group, and 0.2 ml of 75% ethanol to the blank group. After 6 h of contact, wash off the test substance. On the 7th day after the initial sensitization test, apply the drug to the shaved area of ​​the test animals in the same way, and the washing method is the same; the test on the 14th day is the same as on the 7th day.

[0072] (2) Provocative contact: 14 days after the three sensitization tests, the right test area of ​​the test animals was coated with 0.2 ml of the coating of the drug group 1-15, the positive control group was coated with 0.2 ml of 0.1% DNCB solution, and the blank group was coated with 0.2 ml of 75% ethanol. After 6 hours of contact, the test substance was washed off with warm water and the provocation release test was started. At 0h, 24h, 48h, and 72h, the skin color, properties, and the presence of skin lesions were observed, and abnormal reactions such as allergic reactions were recorded. The presence of systemic allergic reactions such as shock and syncope was observed. The number of allergic cases in the two groups of test animals was counted, and the allergic reaction was evaluated. The allergic rate (%) of each group = [number of allergic reaction cases / total number of samples] × 100%.

[0073] 3. Experimental results

[0074] Within 72 hours after provocative exposure:

[0075] (1) The guinea pigs in drug-administered groups 1-14 had no skin abnormalities, no physiological abnormalities, no behavioral abnormalities, no allergic animals, and the sensitization rate was 0.

[0076] (2) After 2 hours, the guinea pigs in group 15 showed obvious edema and erythema on the skin test area, which began to subside around 18 hours. The sensitization rate was 100%.

[0077] (3) In the positive drug control group, obvious erythema appeared in the test area of ​​guinea pig skin at 1 hour, which was most obvious at 6 hours and gradually disappeared at 24 hours. The sensitization rate was 100%.

[0078] The Chinese medicine compositions provided in Examples 1-5 of the present invention were tested for skin allergy in guinea pigs, and no allergic reaction was observed. The compositions have good safety and are safer to use.

[0079] Experimental Example 3

[0080] 1. Experimental animals: SD rats, half male and half female, body weight 180-220 g, provided by Chengdu Dashuo Biotechnology Co., Ltd., production license number: SCXK (Sichuan) 2020-0030.

[0081] 2. Experimental methods

[0082] 2.1 Animal grouping, modeling and drug administration:

[0083] 170 SD rats were randomly divided into 17 groups, 10 rats in each group, and evenly divided into a normal group, a model group, a Gutongling tincture group (Yunnan Shengke Pharmaceutical Co., Ltd., 10 ml*2 bags / box, national medicine standard Z53021244) and a drug administration group 1-14 (corresponding to the Chinese medicine composition provided in Examples 1-5 and Comparative Examples 1-9).

[0084] The drugs were administered twice, 1 day before modeling and immediately after modeling. The right hind limb toes of rats in the normal group and the model group were soaked in 10 mL of normal saline, soaked once at intervals of 5 minutes, and soaked 6 times in total, each time for 5 minutes; the right hind limb toes of rats in the Gutongling tincture group were soaked in 10 mL of Gutongling tincture, soaked once at intervals of 5 minutes, and soaked 6 times in total; the right hind limb toes of rats in the administration groups 1-14 were respectively soaked in 10 mL of the Chinese medicine composition provided in Examples 1-5 and Comparative Examples 1-9, soaked once at intervals of 5 minutes, and soaked 6 times in total.

[0085] One day after administration, the normal group was injected with an equal volume of saline, and the other groups were injected with 1% λ-carrageenan saline suspension subcutaneously in the middle of the plantar of the right hind limb of the rats, with an injection volume of 0.1 mL per rat. Immediately after modeling, each group was administered once again according to the above method. 0.5, 1, and 2 hours after modeling, the toe volume of each group of rats was measured using a toe volume meter.

[0086] Toe swelling (mL) = toe volume after injection - basal volume;

[0087] Toe swelling inhibition rate (%) = (swelling degree of model group - swelling degree of drug group) / swelling degree of model group × 100%.

[0088] 2.2 Statistical methods:

[0089] The experimental data were analyzed using SPSS18.0 statistical software. The data results were expressed as mean ± standard deviation (x ± s). One-way analysis of variance was used for comparison of the means among multiple groups, and the SNK method was used for pairwise comparison of the means among multiple groups. P < 0.05 was considered statistically significant.

[0090] 3. Experimental results

[0091] The experimental results are shown in Table 2:

[0092] Table 2

[0093]

[0094] Note: Compared with the normal control group, # P<0.05; compared with the model group, *P<0.05.

[0095] From the data in Table 2, it can be seen that Gutongling tincture has a significant effect 1 hour after modeling administration, and the dosage groups 1-5 can significantly reduce the swelling of the rats' toes within 0.5 hours after modeling administration (p < 0.05), indicating that the Chinese medicine composition provided in Examples 1-5 has a faster onset of detumescence effect.

[0096] Experimental Example 4

[0097] 1. Experimental animals: KM mice, half male and half female, body weight 18-22 g, provided by Chengdu Dashuo Biotechnology Co., Ltd., production license number: SCXK (Sichuan) 2020-0030.

[0098] 2. Experimental methods

[0099] 2.1 Animal grouping, modeling and drug administration:

[0100] 160 mice were divided into a model group, a Gutongling tincture group and medication groups 1-14 (corresponding to Examples 1-5 and Comparative Examples 1-9), 10 mice in each group.

[0101] Pour the drug solution (1 ml) provided by each group except the model group onto the non-woven fabric 2 cm thick. 2 (1*2cm), the abdomen of mice was depilated with 8% sodium sulfide, and then covered with non-woven fabrics, covered with two layers of sulfuric acid paper, and sealed and fixed with non-irritating adhesive tape. Each group was given the drug once a day, each time for 5 hours. One hour after the last dose, each group of mice was intraperitoneally injected with 0.6% acetic acid (0.1ml / 10g) solution (0.2ml / mouse) for modeling.

[0102] The number of body twisting of the mice within 15 minutes was recorded (based on the standard of abdominal concavity, hind limb extension, and hip elevation). The results are shown in Table 3:

[0103] 2.2 Statistical methods:

[0104] The experimental data were analyzed using SPSS18.0 statistical software. The data results were expressed as mean ± standard deviation (x ± s). One-way analysis of variance was used for comparison of the means among multiple groups, and the SNK method was used for pairwise comparison of the means among multiple groups. P < 0.05 was considered statistically significant.

[0105] 3. Experimental results

[0106] The experimental results are shown in Table 3:

[0107] Table 3

[0108]

[0109]

[0110] Note: Compared with the model group, *P<0.05.

[0111] As shown in Table 3, compared with the model group, the drug administration groups 1-5 can significantly reduce the number of acetic acid-induced writhing of mice (p < 0.05), and compared with the Gutongling tincture group, they also have significant analgesic effects. This shows that the Chinese medicine composition provided by Examples 1-5 has a more significant analgesic effect.

[0112] Experimental Example 5

[0113] 1. Experimental animals: SD rats, half male and half female, body weight 180-220 g, provided by Chengdu Dashuo Biotechnology Co., Ltd., production license number: SCXK (Sichuan) 2020-0030.

[0114] 2. Experimental methods

[0115] 2.1 Animal grouping, modeling and drug administration:

[0116] 170 SD rats were randomly divided into 17 groups, 10 rats in each group, and divided into a blank control group, a model control group, a positive control group (Gutongling tincture, Yunnan Shengke Pharmaceutical Co., Ltd., 10 ml * 2 bags / box, national medicine standard Z53021244) and drug administration groups 1-14 (corresponding to Examples 1-5, the Chinese medicine composition provided in Comparative Examples 1-9).

[0117] Except for 10 animals in the blank control group, the other animals were fasted for 12 hours before surgery and anesthetized with 10% chloral hydrate intraperitoneal injection. A longitudinal incision was made in the middle of the back with the spinous process of the 55th lumbar vertebra (L5) as the center. The skin and subcutaneous tissue were cut in sequence and peeled along both sides of the spinous process to expose the L4 and L5 lamina on both sides. The L4 and L5 spinous processes and the right lamina, articular process and part of the pedicle were bitten off to expose the right dura mater and the right nerve roots of L4 and L5. The skin and subcutaneous tissue were longitudinally cut to the coccygeal surface at 1 cm near the root of the rat's tail, and the 4 intervertebral spaces were separated to both sides. The fiber ring was cut transversely to remove the nucleus pulposus tissue (about 10 mg) and transplanted to the dorsal side of the right L4 and L5 nerve roots. In the blank control group, only the right half cone plate was bitten off to expose the L4 and L5 nerve roots. The incision was closed layer by layer and sutured. After surgery, each animal was given gentamicin sulfate injection, 0.4 mL / animal, once a day for 3 consecutive days.

[0118] On the second day after surgery, except for the animals in the blank control group, the remaining 160 modeling animals were randomly divided into 16 groups. The blank control group was smeared with deionized water 5mL / kg, the model control group was smeared with deionized water 5mL / kg, and the positive control group was applied with Gutongling tincture 5mL / kg; the drug administration groups 1-14 were applied with the Chinese medicine composition provided in Examples 1-5 and Comparative Examples 1-9 5mL / kg. The hair removal area on the back of the rat was applied according to different dosages, once a day, and removed after 24h of application for 15 consecutive days. 15 days after administration, the L5 nerve root and ganglion were fixed with 4% neutral formaldehyde for pathological observation.

[0119] The nerve roots were selected from the longitudinal and transverse planes, and the tissue blocks were routinely dehydrated, paraffin-embedded, sliced ​​to a thickness of 5 μm, and stained with HE. The histopathological changes were observed using a Leica DM300 optical microscope, and the image acquisition software Leica applicationsuite was used for image acquisition. The number of inflammatory cells (neutrophils, macrophages, and lymphocytes) in the nerve roots in three fields of view under a 500x optical microscope was counted. The statistical results are shown in Table 4.

[0120] 2.2 Statistical methods:

[0121] The experimental data were analyzed using SPSS18.0 statistical software. The data results were expressed as mean ± standard deviation (x ± s). One-way analysis of variance was used for comparison of the means among multiple groups, and the SNK method was used for pairwise comparison of the means among multiple groups. P < 0.05 was considered statistically significant.

[0122] 3. Experimental results

[0123] The experimental results are shown in Table 4:

[0124] Table 4 Effect of Chinese medicine composition on nerve roots of rats with lumbar disc herniation model (n=10, number / HP)

[0125]

[0126]

[0127] Compared with the blank control group, *p<0.05; compared with the model control group, # p<0.05.

[0128] As shown in Table 4, compared with the blank control group, the total number of inflammatory cells in the nerve roots of the rats in the model control group was significantly increased (P<0.05); compared with the model control group, the drug administration groups 1-5 significantly reduced the infiltration of inflammatory cells in the nerve roots of the rats with lumbar disc herniation model to a certain extent. The above results show that the Chinese medicine composition provided in the examples of the present application has a certain therapeutic and alleviating effect on the edema and inflammation of the nerve roots caused by the waist and leg pain.

[0129] In summary, compared with Gutongling tincture, the Chinese medicine composition for treating bone and joint diseases provided by the present invention can not only regulate bone metabolism, nourish the kidney and strengthen bones, but also treat the "liver and kidney deficiency" nature of bone hyperplasia, play a role in reducing toxicity and increasing efficacy, but also can reduce irritation to the skin and greatly reduce side effects of use.

[0130] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating bone and joint diseases, characterized in that: The raw materials include, by weight: 35-45 parts of Artemisia annua, 25-35 parts of processed Chuanwu, 90-100 parts of dried ginger, 20-30 parts of epimedium, 3-6 parts of catechu, 9-14 parts of Millettia reticulata, 2-5 parts of Corydalis yanhusuo, 1-3 parts of liquorice and 1-3 parts of borneol.

2. The Chinese medicine composition for treating bone and joint diseases according to claim 1, characterized in that: The composition comprises 38-42 parts of Artemisia snowwort, 28-32 parts of processed Chuanwu, 95-98 parts of dried ginger, 25-28 parts of epimedium, 4-6 parts of catechu, 11-13 parts of Millettia reticulata, 2-4 parts of Corydalis yanhusuo, 1-2 parts of liquorice and 1-2 parts of borneol.

3. The Chinese medicine composition for treating bone and joint diseases according to claim 1 or 2, characterized in that: The preparation method of the Chinese medicine composition comprises: (1) mixing the Artemisia suspensa, the dried ginger, the processed Chuanwu, the epimedium, the catechu, the Millettia reticulata, the Corydalis yanhusuo and the liquorice according to the weight proportions, grinding the mixture into a coarse powder, extracting the mixture by percolation with a first ethanol having a concentration of 50%, and collecting the percolation liquid; (2) dissolving the borneol in a second ethanol with a concentration of 50%, combining the mixture with the percolate, mixing well, standing for 48 hours, and filtering to obtain the product; the volume ratio of the percolate to the second ethanol is 18-20:

1.

4. The Chinese medicine composition for treating bone and joint diseases according to claim 1, characterized in that: The Chinese medicine composition is an external preparation.

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