A traditional Chinese medicine composition for anti-inflammation, swelling and pain relief, joint lubrication, and a preparation method thereof and application thereof in preparing a medicine for treating arthralgia syndrome

Abstract

This invention belongs to the field of traditional Chinese medicine preparation technology, and provides a traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, its preparation method, and its application in the preparation of drugs for treating arthralgia. The method includes the following steps: Smilax glabra, Corydalis yanhusuo (processed with vinegar), and Stephania tetrandra are pulverized, mixed, decocted with water, filtered, the filtrate is concentrated, ethanol is added to precipitate, the supernatant is collected, the ethanol is recovered and concentrated to obtain a water-extracted alcohol-immersed extract, which is then mixed with maltodextrin, wet-granulated, and dried to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition obtained by this invention is based on the principles of promoting joint mobility, reducing swelling and relieving pain. It can significantly inhibit ankle joint swelling in rats with gouty arthritis, improve local inflammatory cell infiltration, and reduce synovial tissue hyperplasia in rats with gouty arthritis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, its preparation method, and its application in the preparation of drugs for treating arthralgia. Background Technology

[0002] Bi syndrome is a common category of diseases in Traditional Chinese Medicine (TCM), encompassing various conditions such as rheumatoid arthritis, gouty arthritis, and others. Gout, in particular, is a crystal-related arthropathy and a common complication of hyperuricemia; its essence remains a metabolic disorder. With my country's rapid economic development and rising living standards, gout has become the second leading metabolic disease in my country, second only to diabetes. Age is a significant factor in gout development. Middle-aged and elderly individuals are the most susceptible to primary gout, with an average age of 44. This is likely due to older age, decreased kidney function, and reduced uric acid excretion. However, in recent years, with improved living standards and changes in dietary structure, the age of onset has shown a trend towards younger onset. Epidemiological studies in my country have found that the incidence of gout and hyperuricemia is higher in coastal areas than in inland areas, possibly due to significantly higher seafood consumption in these regions. Gout exhibits a strong familial aggregation; studies show that relatives with hyperuricemia have a 44 times higher risk of developing gout compared to those without the condition. Alcohol consumption and obesity are key concerns for modern people regarding gout. Long-term consumption of meat and seafood significantly increases the probability of developing gout. Beer, containing high levels of guanine, has the strongest correlation with gout, followed by spirits, while small amounts of red wine do not increase the risk of gout. This indicates that with the rapid development of my country's economy and society, changes in people's living standards and dietary habits, and the increasing aging population, the incidence and prevalence of hyperuricemia and gout are rising year by year, and the age of onset is decreasing. Therefore, how to effectively prevent and treat hyperuricemia and gout, restore patients' limb motor function, and alleviate pain in affected limbs has become a problem that needs to be taken seriously and actively addressed. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition that is simple in formulation, has a definite curative effect, and can effectively prevent and treat hyperuricemia and gout, restore the patient's limb motor function, and relieve pain in the affected limb.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a method for preparing a traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, comprising the following steps: (1) After crushing Smilax glabra, Corydalis yanhusuo (processed with vinegar) and Stephania tetrandra, mix them together, add water and decoct, filter and collect the filtrate; (2) Concentrate the filtrate, add ethanol to precipitate, take the supernatant, recover the ethanol and concentrate it to obtain water-extracted alcohol immersion paste; (3) The water-extracted alcohol immersion paste obtained in step (2) is mixed with maltodextrin to obtain a soft material, which is then wet-granulated and dried to obtain the Chinese medicine composition.

[0005] Preferably, the traditional Chinese medicine composition consists of the following traditional Chinese medicine raw materials in parts by weight: 350-370 parts of vinegar-processed Corydalis Rhizome, 350-370 parts of Smilax Rhizome, and 280-300 parts of Stephania Tetrandra Root.

[0006] Preferably, in step (1), the mesh size of the sieve after the raw material is pulverized is 80-100 mesh, and the amount of water added is 8-10 times the volume of the raw material.

[0007] Preferably, the filtrate from step (2) is concentrated to a relative density of 1.12 to 1.15, and 90 to 95% ethanol is added to bring the alcohol content to 65 to 75%.

[0008] Preferably, the mass ratio of water-extracted alcohol immersion paste to maltodextrin in step (3) is 1000g: 325~375g.

[0009] Preferably, in step (3), the material temperature is controlled at 45~55℃ and stirred at 400~600rpm for 10~30min.

[0010] Preferably, in step (3), a swing granulator is used for granulation, and the screen mesh number is 10~20 mesh.

[0011] Preferably, in step (3), the drying temperature is 55~65℃, the drying time is 15~25 minutes, and the inlet air velocity is 0.8~1.2 m. 3 / s.

[0012] This invention provides a traditional Chinese medicine composition that has anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties.

[0013] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating arthralgia.

[0014] The aforementioned arthritis includes rheumatoid arthritis, gouty arthritis, and osteoarthritis.

[0015] In this invention, Smilax glabra is the dried rhizome of *Smilax glabra*, a plant in the Liliaceae family. It has detoxifying, dampness-removing, and joint-relieving effects. Smilax glabra contains a variety of functional substances, with four main categories: organic acids, polysaccharides, phytosterols, and flavonoids. Flavonoids, such as astilbin, have poor water solubility but are readily soluble in organic solvents such as methanol, ethanol, or ethyl acetate. Experimental studies have shown that the flavonoid components of Smilax glabra can effectively promote uric acid excretion and improve the inflammatory response in rats with kidney disease.

[0016] Corydalis, also known as Yuanhu, possesses pharmacological effects including sedation, anti-anxiety, hypnosis, analgesia, antiarrhythmia, anti-ulcer, anti-myocardial ischemia, and anti-tumor properties. Alkaloids are the main chemical components of Corydalis, including isoquinoline alkaloids, apophene alkaloids, and protoberberine alkaloids. It also contains non-alkaloid components such as steroids and polysaccharides. It is slightly soluble in water but readily soluble in organic solutions such as hydrochloric acid and acetate buffer. Studies by Zhang Xu et al. have found that Corydalis extract has a protective effect against hyperuricemia, and that it inhibits inflammatory factors and oxidative damage.

[0017] Fangji is the dried root of *Stephania tetrandra*, a plant in the Menispermaceae family. It has diuretic, anti-edema, wind-dispelling, and analgesic effects. Plants in the Menispermaceae family are rich in a wide variety of alkaloids, such as tetrandrine and fangchinorline, and also contain flavonoids, sterols, and other compounds. Tetrandrine is almost insoluble in water; fangchinorline is readily soluble in water, methanol, and ethanol; and sparingly soluble in benzene, ether, and other nonpolar solvents. It possesses pharmacological effects such as antiarrhythmic, anti-inflammatory, analgesic, antibacterial, insecticidal, and antitumor properties.

[0018] This product is mainly used to treat rheumatic arthralgia. According to the etiology and pathogenesis of traditional Chinese medicine, the main pathogenesis of this syndrome is insufficient vital energy, invasion of external pathogens, obstruction of meridians, and pain due to obstruction. The etiology is mainly related to congenital deficiency, and invasion of the body's meridians by pathogens such as wind, cold, dampness and heat. It is often affected by factors such as cold and fatigue, improper diet, excessive drinking and rich food.

[0019] This formula has anti-inflammatory, swelling-reducing, analgesic, and joint-promoting effects. It can be used to treat arthralgia and gouty arthritis, playing a positive role in relieving joint swelling, heaviness, and pain, and inhibiting inflammatory responses. It can significantly improve the clinical manifestations of gout patients, such as severe pain in the limbs and joints, difficulty in flexion and extension, and limited mobility. It is expected to become an ideal drug for treating gout and gouty arthritis, fully utilizing the effects of traditional Chinese medicine in promoting blood circulation, relieving pain, reducing swelling, and promoting joint mobility.

[0020] This product is formulated based on the principle of promoting joint movement and relieving swelling and pain. In the formula, Smilax glabra is used as the monarch drug, which has the effects of detoxifying and removing dampness, and promoting joint movement. Modern pharmacological research shows that Smilax glabra has good anti-inflammatory, analgesic, and antibacterial effects. It is sweet, light, and flat in nature, and belongs to the liver and stomach meridians. "Brief Recipes of Materia Medica" states that "Smilax glabra decoction can treat carbuncles, scrofula, and malignant sores; it is beneficial for joints and strengthens tendons and bones." Li Shizhen summarized in "Compendium of Materia Medica" that Smilax glabra is sweet, flat, and non-toxic, and mainly treats joint swelling and pain caused by wind-dampness. Clinical application has found that high-dose Smilax glabra can effectively control the redness, swelling, heat, and pain of joints in the acute stage of gout; in this formula, it is used to detoxify and remove dampness, strengthen tendons and bones to treat the root cause, and promote joint movement to reduce swelling to treat the symptoms, so it is the monarch drug. In many ancient and modern formulas for promoting joint movement and strengthening tendons and bones, this product is often used. Since the main symptoms of this syndrome are poor blood circulation and joint swelling and pain, to enhance the power of the monarch drug, Corydalis yanhusuo and Stephania tetrandra are used as ministerial drugs in the formula. Corydalis yanhusuo is pungent and warm in nature, and can promote qi circulation, activate blood circulation, and relieve pain.历代医家均是其为止痛的要药。Corydalis yanhusuo and its active ingredient tetrahydropalmatine both have good analgesic effects. Stephania tetrandra is bitter and cold, and can dispel wind and relieve pain, promote diuresis and reduce swelling. When Stephania tetrandra is combined with Smilax glabra, Stephania tetrandra mainly focuses on promoting qi and reducing swelling and pain, while Smilax glabra mainly focuses on promoting joint movement. The combination of the two drugs enhances the effect of promoting joint movement and relieving pain, and detoxifying and removing dampness helps more with joint movement. In addition, the combination of Corydalis yanhusuo and Stephania tetrandra balances cold and warmth, and promotes qi and resolves stagnation with pungency and bitterness, making the medicinal properties mild. Corydalis yanhusuo promotes blood circulation and relieves pain, Stephania tetrandra reduces swelling, dispels wind, and relieves pain; together, they achieve the effects of removing blood stasis and relieving pain, reducing swelling and relieving pain. The combination of all drugs achieves the effects of anti-inflammatory, reducing swelling and pain, dispelling wind and removing dampness, and promoting joint movement, making all symptoms improve.

[0021] The present invention adopts the water extraction and alcohol precipitation process, which can effectively enrich the effective components such as flavonoids and alkaloids in the medicinal materials, and at the same time remove a large amount of impurities such as starch and polysaccharides. Compared with traditional water decoctions or using crude powders as medicine, the composition prepared by this method has a smaller dosage for patients to take, and better patient compliance. Detailed implementation methods

[0022] The traditional Chinese medicine raw materials used in the present invention: Smilax glabra: The Smilax glabra Roxb dried rhizome of Smilax glabra Roxb. of the Liliaceae family. Processing technology: Remove the fibrous roots, wash, and dry; or cut into thin slices while still fresh and dry. Based on the first part of the "Pharmacopoeia of the People's Republic of China" in 2015 as the identification basis, it is identified and inspected as qualified. Non-toxic.

[0023] Stephania tetrandra: The dried root of Stephania tetrandra S. Moore of the Menispermaceae family Stephania tetrandra S.Moore Processing technology: Wash, remove the rough bark, sun-dry until semi-dry, cut into sections, and for larger pieces, cut longitudinally and then dry. Based on the first part of the "Pharmacopoeia of the People's Republic of China" in 2015 as the identification basis, it is identified and inspected as qualified. Non-toxic.

[0024] Corydalis yanhusuo: The dried tuber of Corydalis yanhusuo W. T. Wang et Hsiao of the Papaveraceae family Corydalix yanhuosuo W.T. The dried root. Processing method: Remove the fibrous roots, wash, boil or steam in boiling water until just past the white core disappears, then remove and sun-dry. Based on the 2015 edition of the Pharmacopoeia of the People's Republic of China, Part I, the identification and testing were qualified. Non-toxic.

[0025] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0026] Example 1

[0027] A traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, prepared by: (1) Pulverize 360 ​​parts of Smilax glabra, 360 parts of vinegar-processed Corydalis yanhusuo and 290 parts of Stephania tetrandra and pass them through an 80-mesh sieve. Mix them together, add 10 times the total volume of the medicine to water and decoct for 1.5 hours. Filter and collect the filtrate. Then add 8 times the volume of the wet residue and decoct for 2 hours. Filter and collect the filtrate. Combine the two filtrates. (2) Concentrate the filtrate to a relative density of 1.15, add 95% ethanol to a 70% alcohol content, let it stand to precipitate overnight, take the supernatant, recover the ethanol, and obtain the water-extracted alcohol immersion paste. (3) The water-extracted alcohol immersion paste obtained in step (2) is mixed with maltodextrin at a mass ratio of 1000g:350g, and stirred at 500rpm for 20min at 50℃ to obtain a soft material. Granulation is carried out using a swing granulator with a sieve mesh of 20 mesh. Drying is performed at 60℃ for 20 minutes with an inlet air velocity of 1 m. 3 / s, and the traditional Chinese medicine composition is obtained.

[0028] Example 2

[0029] A traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, prepared by: (1) Pulverize 350 parts of Smilax glabra, 350 parts of vinegar-processed Corydalis yanhusuo and 300 parts of Stephania tetrandra and pass them through an 80-mesh sieve. Mix them together, add 10 times the total volume of the medicine to water and decoct for 2 hours. Filter and collect the filtrate. Then add 8 times the volume of the wet residue to water and decoct for 1.5 hours. Filter and collect the filtrate. Combine the two filtrates. (2) Concentrate the filtrate to a relative density of 1.20, add 95% ethanol to a 70% alcohol content, let it stand to precipitate overnight, take the supernatant, recover the ethanol, and obtain the water-extracted alcohol immersion paste. (3) The water-extracted alcohol immersion paste obtained in step (2) is mixed with maltodextrin at a mass ratio of 1000g:300g, and stirred at 500rpm for 20min at 50℃ to obtain a soft material. Granulation is carried out using a swing granulator with a sieve mesh of 20 mesh, and then dried (drying temperature is 60℃, drying time is 20min, and air inlet velocity is 1m). 3 / s, and the traditional Chinese medicine composition is obtained.

[0030] Comparative Example 1

[0031] A method for preparing a traditional Chinese medicine combination is as follows: 360 parts of Smilax glabra, 360 parts of Corydalis yanhusuo (processed with vinegar), and 290 parts of Stephania tetrandra are dried at 70℃ for 5 hours, pulverized and passed through an 80-mesh sieve, mixed, and then 15% corn starch slurry is added at a mass-volume ratio of 100g:90mL. After mixing, the mixture is made into pills, dried for 12 hours, and then dried with hot air at 80℃ for 5 hours. The pills are then placed in a water chestnut-type coating machine for polishing to obtain the traditional Chinese medicine combination.

[0032] Comparative Example 2

[0033] Unlike Example 1, in step (3), maltodextrin is replaced with an equal amount of corn starch.

[0034] Comparison of Particle Physical Properties in Experimental Example 1

[0035] The angle of repose was determined using the fixed funnel method to evaluate particle flowability, the critical relative humidity (CRH) of the particles was determined to evaluate their hygroscopic resistance, and the glass transition temperature was determined using differential scanning calorimetry.

[0036] Table 1 Comparison of Particle Physical Properties

[0037] Table 1 shows that the angle of repose of Examples 1 and 2 is less than 35°, indicating good particle flowability; the flowability of Comparative Example 1 is at an acceptable level. The critical relative humidity of Examples 1 is all above 70%, indicating excellent moisture resistance. The glass transition temperature is all above 50°C, which can effectively prevent the particles from softening and clumping due to temperature rise during storage. Among them, Examples 1 has the best storage stability.

[0038] Effects of Experiment 2 on a mouse model of hyperuricemia

[0039] 1. Sixty healthy male ICR mice were randomly divided into six groups: blank group, model group, drug group (BPC group), Example 1 group, comparative example 1 group, and comparative example 2 dosage group, with 10 mice in each group.

[0040] Administration: Mice were administered the drug by gavage for 28 consecutive days. The dosage for Comparative Example 2, Comparative Example 1, and Example 1 was 18 g / kg. The Western medicine group was given allopurinol (100 mg), which was crushed into powder and mixed with distilled water (50 ml) to prepare a solution of 2 mg / ml, and the dosage was 40 mg / kg.

[0041] Model preparation: Within 1 hour after the last gavage administration, mice were intraperitoneally injected with xanthine (preparation method: 3g of hypoxanthine dissolved in 60mL of physiological saline to prepare a 0.05g / ml concentration solution) at a dose of 1g / kg to induce a hyperuricemia model.

[0042] 2. Sample collection and processing: 1 hour after the model was replicated, blood was collected from mice by removing the eyeballs. The blood was placed in a vacuum blood collection tube and left to stand for 2 hours. The blood was then centrifuged at 3500 rpm for 10 minutes to separate the serum, which was then stored at -20°C for later use.

[0043] Enzyme-linked immunosorbent assay (ELISA) to determine the expression levels of enzymes related to purine metabolism.

[0044] (1) Dilution and addition of standard: Add the standard to the standard wells in sequence according to the kit instructions, and control the sample volume of each well to 50µL.

[0045] (2) Adding samples: Do not add enzyme labeling reagents and samples to the blank wells. Other operations are the same as those for the sample wells. Then, add 10µL of mouse serum to the sample wells and shake gently to mix.

[0046] (3) Add enzyme-labeled antibody: Add 50µL of enzyme-labeled antibody to each well except the blank well.

[0047] (4) Incubation: After sealing with a sealing film, place it at 37°C and incubate in the dark for 30 minutes.

[0048] (5) Preparation and washing: Dilute the washing solution with distilled water (30 times) and set aside. Then remove the sealing film and discard the liquid. Then add a certain amount of washing solution to each well, let it stand for 30 seconds and then discard it. Pat the microplate dry. Repeat this process 5 times.

[0049] (6) Color development: Add 50µL of color developer A and color developer B to each well in sequence, mix gently, and then incubate at 37°C in the dark for 10 min.

[0050] (7) Termination: Add 50µL of termination solution to each well to terminate the reaction. At this time, the solution will turn yellow.

[0051] (8) Measurement: After the reaction is terminated, the sample should be transferred to an ELISA reader within 15 minutes to measure the OD value (λ=450nm).

[0052] (9) Using relevant computer software, the OD value of the standard is defined as the vertical axis, and the concentration of the standard is the horizontal axis. This gives us the standard curve. Then, the concentration of the mouse serum sample can be determined from the OD value measured on the microplate reader.

[0053] Table 2. Determination of XOD, ADA, and GDA levels in hyperuricemia model mice ( ±s)

[0054] Note: Compared with the control group, ΔP < 0.05, ΔΔP < 0.01; compared with the model group... P < 0.05 P < 0.01.

[0055] Table 3. Determination of UA, Scr, and BUN levels in hyperuricemia model mice ( ±s)

[0056] Note: Compared with the blank group ΔP<0.05,ΔΔP<0.01 Comparison with model group P＜0.05， P＜0.01 .

[0057] As shown in Table 2, the present invention can reduce the content of ADA, XOD and GDA, which helps to reduce the production of uric acid. As shown in Table 3, the present invention can significantly reduce the content of UA, Scr and BUN, accelerate kidney metabolism, and has a certain degree of protective effect on kidney function.

[0058] Effects of Experiment 3 on Rats with Gouty Arthritis

[0059] Sixty clean-grade male SD rats were selected, weighed and recorded. After one week of feeding, they were randomly divided into six groups: blank control group, model control group, western medicine control group, Example 1 group, comparative example 1 group and comparative example 2 group, with 10 rats in each group.

[0060] Administration: Rats were administered the drug by gavage for 21 days. The dosage for Comparative Example 2, Comparative Example 1, and Example 1 (H) was 12 g / kg. The control group received 0.01 mg / ml colchicine (preparation method: 1 mg of colchicine tablets was ground into powder and dissolved in 0.9% sodium chloride solution to prepare 111 ml of solution). The model control group received the same dose of 0.9% sodium chloride solution.

[0061] Model replication: After 18 days of prophylactic administration, the puncture point was selected on the posterolateral side of the right ankle joint of each group of rats. After local disinfection, the bevel of the needle was inserted into the ankle joint cavity at a 45-degree angle with the tibia. Except for the blank control group, the other groups of rats were injected into the joint cavity with sodium urate solution (0.2 ml) using a No. 4 needle (preparation method: weigh 500 mg of sodium urate crystals, add 18 ml of physiological saline, and then add 2 ml of Tween 80 to make 20 ml of solution) to induce the gout model. The standard for injection is to make the contralateral joint capsule bulge. After successful model replication, the drug was administered by gavage until the day of sample collection.

[0062] Sample collection and processing: Four days after modeling, animals were anesthetized (0.4 ml of 3% chloral hydrate was injected intraperitoneally per 100 g body weight of rats), with 14 rats in each group. Blood was collected from the abdominal aorta, and after standing at room temperature for 2 h, the serum was separated by centrifugation at 3000 r / min for 10 min and stored at -20℃. After blood collection, the animals were sacrificed, and the tested joint tissues were removed and fixed in 4% formaldehyde for later use.

[0063] The ankle joint circumference before and after modeling was measured using the suture method: The test site of the right ankle joint of each group of rats was marked with a marker to ensure that the measurement site was consistent each time. The original circumference of the right ankle joint of each group of rats was measured using the suture method at 1, 24, 48, and 72 h after ankle joint modeling.

[0064] ELISA method for measuring changes in serum levels of IL-1β, IL-6, TNF-α, etc.

[0065] All experimental data in this study were initially processed and then statistically analyzed using SPSS 18.0. Categorical data were expressed as follows: ±s, the data obtained during the experiment should satisfy the normal distribution, and a one-way ANOVA should be performed on the basis of homogeneity of variance. P<0.05 indicates that it is statistically significant.

[0066] By comparing the ankle circumference of rats before and after modeling, the success of replicating the rat model of acute gouty arthritis can be determined. Comparing the rate of swelling is one of the important indicators for evaluating the effectiveness and degree of effectiveness of the herbal composition of this invention (see Table 4 for details).

[0067] Before modeling, there was no difference in ankle joint circumference among the groups of rats. 24 hours after modeling, there were significant differences between the western medicine control group, Example 1, Comparative Example 1, and Comparative Example 2 and the model control group (P<0.01). Example 1 showed the best effect. This indicates that the present invention can significantly inhibit ankle joint swelling in rats with gouty arthritis.

[0068] Table 4 Ankle circumference of rats in each group ( ±s,n=7)

[0069] Note: Compared with the blank group P＜0.05， P＜0.01 Comparison with model group ΔP<0.05,ΔΔP<0.01 .

[0070] Serum IL-1β, IL-6 and TNF-α levels in each group of rats

[0071] The IL-1β content in rat serum showed that the difference between the model control group and the blank control group was significant (P<0.01); compared with the model control group, the IL-1β content in the serum of rats in the Western medicine control group and the groups of Example 1, Comparative Example 1 and Comparative Example 2 was significantly reduced.

[0072] Serum IL-6 levels in rats showed that the serum IL-6 levels in the model control group were significantly higher than those in the blank control group (P<0.01); there was a significant difference between the western medicine control group and the model control group (P<0.01); and the IL-6 levels in the Example 1 group were significantly lower than those in the model control group (P<0.01).

[0073] Serum TNF-α levels in rats showed a significant increase compared to the blank control group (P<0.01). The levels in the western medicine control group were significantly different from those in the model control group (P<0.01). In comparison with the model group, the TNF-α levels in Example 1, Comparative Examples 1 and 2 were significantly decreased (P<0.01). See Table 5 for details.

[0074] Table 5. IL-1β, IL-6 and TNF-α levels in rats of each group

[0075] Note: Compared with the blank group P < 0.05 P < 0.01; compared with the model group, ΔP < 0.05, ΔΔP < 0.01.

[0076] Changes in NO, SOD, and MDA levels in the serum of rats in each group

[0077] The NO content in rat serum showed that the model control group was significantly different from the blank control group (P<0.01). Compared with the model control group, the NO content in the serum of rats in the Western medicine control group and the groups of Example 1, Comparative Example 1 and Comparative Example 2 was significantly reduced. The Western medicine control group and Example 1 were more effective than Comparative Example 1 and 2.

[0078] The SOD content in rat serum showed that the SOD content in the model control group was significantly higher than that in the blank control group (P<0.01); the SOD content in the western medicine control group was significantly different from that in the model control group (P<0.01); and the SOD content in all other groups was significantly higher than that in the model control group (P<0.01). The effect of Example 1 was better than that of Comparative Examples 1 and 2.

[0079] Serum MDA levels in rats showed a significant increase compared to the blank control group (P<0.01). All other groups showed significant differences compared to the model control group (P<0.01), indicating that Example 1 was more effective than Comparative Examples 1 and 2.

[0080] Table 6. Contents of NO, SOD, and MDA in each group ( ±s, n=7)

[0081] Note: Compared with the blank group P < 0.05 P < 0.01; compared with the model group, ΔP < 0.05, ΔΔP < 0.01.

[0082] This invention can inhibit the levels of TNF-α, IL-1β, and IL-6 in the serum of rats with gouty arthritis, improve local inflammatory cell infiltration, and reduce synovial tissue hyperplasia in the rats with gouty arthritis. This suggests that the drug has a strong anti-inflammatory and anti-swelling effect.

[0083] In summary, the herbal composition of this invention can significantly reduce serum uric acid levels in mice, accelerate purine metabolism, and effectively inhibit joint swelling in rats caused by chemical factors. This indicates that the pharmacodynamic studies of the herbal composition of this invention are consistent with its clinical pharmacological effects, providing a basis for clinical use.

[0084] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for preparing a traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties, characterized in that, Includes the following steps: (1) After crushing Smilax glabra, Corydalis yanhusuo (processed with vinegar) and Stephania tetrandra, mix them together, add water and decoct, filter and collect the filtrate; (2) Concentrate the filtrate, add ethanol to precipitate, take the supernatant, recover the ethanol, and obtain the water-extracted alcohol immersion paste; (3) The water-extracted alcohol immersion paste obtained in step (2) is mixed with maltodextrin to obtain a soft material, which is then wet-granulated and dried to obtain the Chinese medicine composition.

2. The preparation method according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight of traditional Chinese medicine raw materials: 350-370 parts of vinegar-processed Corydalis Rhizome, 350-370 parts of Smilax Rhizome, and 280-300 parts of Stephania Tetrandra Root.

3. The preparation method according to claim 1, characterized in that, In step (1), the sieve mesh size of the raw drug after pulverization is 80-100 mesh, and the amount of water added is 8-10 times the volume of the raw drug.

4. The preparation method according to claim 1, characterized in that, The filtrate from step (2) is concentrated to a relative density of 1.12 to 1.15, and 90 to 95% ethanol is added to bring the alcohol content to 65 to 75%.

5. The preparation method according to claim 1, characterized in that, The mass ratio of the water-extracted alcohol immersion paste to maltodextrin in step (3) is 1000g: 300~350g.

6. The preparation method according to claim 1, characterized in that, In step (3), the material temperature is controlled at 45~55℃ and stirred at 400~600rpm for 10~30min.

7. The preparation method according to claim 1, characterized in that, In step (3), a swing granulator is used for granulation, and the screen mesh number is 10~20 mesh.

8. The preparation method according to claim 1, characterized in that, In step (3), the drying temperature is 55~65℃, the drying time is 15~25 minutes, and the inlet air velocity is 0.8~1.2 m. 3 / s.

9. A traditional Chinese medicine composition with anti-inflammatory, swelling-reducing, analgesic, and joint-relieving properties is prepared by the preparation method according to any one of claims 1 to 8.

10. The use of the traditional Chinese medicine composition according to claim 9 in the preparation of a medicament for treating arthralgia.

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