A traditional Chinese medicine preparation for dispelling wind and dampness and application thereof

Abstract

The application provides a traditional Chinese medicine preparation for dispelling wind and removing dampness and application, and relates to the technical field of traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is composed of ten traditional Chinese medicines including Lonicera japonica, Spatholobus suberectus Dunn, silkworm sand, gentiana, safflower, persica, cortex fraxini, ardisia japonica, medicated leaven and honeycomb; the traditional Chinese medicine preparation can significantly reduce the swelling degree of ankle joint of an acute gouty arthritis model rat, reduce the expression level of serum TNF-alpha, IL-1beta and IL-6 inflammatory factors, and reduce the content of serum uric acid, creatinine and XOD, so as to achieve the effects of anti-inflammation and analgesia, reduction of blood uric acid, and the like; the clinical test results show that the traditional Chinese medicine preparation can reduce the pain degree of a patient, reduce the levels of inflammation related factors TNF-alpha and IL-1beta in synovial fluid of a knee joint of the patient, reduce the inflammation indexes WBC, ESR and CRP in serum, reduce the inflammation reaction of the patient's body, reduce the incidence of adverse reactions, and provide a new traditional Chinese medicine preparation with high safety and good curative effect for the treatment of acute attack of gout.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine preparation for dispelling wind and dampness and application thereof. BACKGROUND

[0002] Gout is acute and chronic inflammation and tissue damage caused by monosodium urate (MSU) deposition in bone joints, kidneys or subcutaneous parts, and is closely related to hyperuricemia caused by purine metabolism disorder and / or decreased uric acid excretion, and is a common metabolic rheumatic disease. In recent years, the incidence of gout in China has been increasing year by year, and is showing a trend of younger. When gout attacks acutely, it can cause severe joint pain in patients, limited activity, and brings great pain to patients; on the other hand, gout can be complicated with kidney disease, and severe cases can cause joint destruction, kidney damage, often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease, etc., which is extremely harmful to the life and health of patients. The treatment of acute gout in modern medicine mainly focuses on anti-inflammatory and analgesic, and the commonly used drugs in clinic are colchicine, non-steroidal anti-inflammatory drugs, glucocorticoids, etc. These drugs can relieve pain, but cause adverse reactions such as gastrointestinal reactions, induce or aggravate acute and chronic renal insufficiency, and increase the incidence of gout stones, etc., which seriously affect the quality of life of patients.

[0003] Traditional Chinese medicine believes that gout belongs to the category of "Lijie disease" and "Re Bi", which is caused by dampness and heat flowing into the joints, or by external wind and cold invading the meridians, blocking the movement of blood and causing dampness to accumulate as phlegm, or by deficiency of innate constitution, spleen dysfunction, kidney dysfunction, internal water and dampness, heat accumulation, retention in blood, and flow into bone joints, damaging tendons and eroding bones. Traditional Chinese medicine treatment of gout has unique advantages in controlling symptoms and improving the quality of life of patients, especially in relieving acute symptoms and preventing recurrence, but the existing traditional Chinese medicine for treating acute gout has a long treatment cycle and unsatisfactory effect, so it is urgent to develop a drug for treating gout with good efficacy and high safety. SUMMARY

[0004] (I) Technical problems to be solved

[0005] In view of the deficiencies in the prior art, the present application provides a traditional Chinese medicine preparation for dispelling wind and dampness and application thereof.

[0006] (II) Technical solutions

[0007] To achieve the above object, the present application is realized by the following technical solutions:

[0008] The application provides a traditional Chinese medicine preparation for dispelling wind and dampness, which is prepared from the following raw materials in parts by weight: Lonicera japonica 10-30 parts, Spatholobus suberectus 5-25 parts, silkworm excrement 10-30 parts, gentiana 5-25 parts, safflower 1-10 parts, persicae semen 1-20 parts, cortex fraxini 1-20 parts, arisaema 1-20 parts, divaricate milkvetch 1-20 parts, honeycomb 1-20 parts.

[0009] Further, the traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: Lonicera japonica 15-25 parts, Spatholobus suberectus 10-18 parts, silkworm excrement 15-25 parts, gentiana 10-20 parts, safflower 1-5 parts, persicae semen 5-15 parts, cortex fraxini 5-15 parts, arisaema 5-15 parts, divaricate milkvetch 5-15 parts, honeycomb 5-15 parts.

[0010] Further, the traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: Lonicera japonica 15-25 parts, Spatholobus suberectus 10-18 parts, silkworm excrement 15-25 parts, gentiana 10-20 parts, safflower 1-5 parts, persicae semen 5-15 parts, cortex fraxini 5-15 parts, arisaema 5-15 parts, divaricate milkvetch 5-15 parts, honeycomb 5-15 parts.

[0011] The application provides a preparation method of the traditional Chinese medicine preparation for dispelling wind and dampness.

[0012] Further, the dosage form includes, but is not limited to, pills, powders, water decoctions, tablets, granules, oral liquids and the like.

[0013] Further, the traditional Chinese medicine water decoction for dispelling wind and dampness is prepared according to the following steps:

[0014] (1) the raw materials are weighed according to the above weight parts, water is added to 2-3 cm above the medicinal materials, and then soaked for 20-30 min;

[0015] (2) the medicinal materials and the soaking liquid are transferred into a sand pot and boiled, the fire is changed to a low fire and the decoction is continued for 20-30 min, the decoction is filtered while hot, and the operation is repeated twice, and then the decoction is combined to obtain the traditional Chinese medicine water decoction.

[0016] The application provides application of the traditional Chinese medicine preparation in preparation of a medicine for preventing and / or treating acute gout.

[0017] The pharmacological effects of the traditional Chinese medicine components in the traditional Chinese medicine preparation are as follows:

[0018] Lonicera japonica: sweet in taste, cold in nature, and belonging to lung and stomach channels; having the effects of clearing heat and resolving toxins, dispelling wind and dredging collaterals; used for treating warm disease fever, dysentery with blood, carbuncle and sore, rheumatism and arthralgia; Lonicera japonica contains organic acids, flavonoids, iridoid terpenes and other chemical components, and has the pharmacological activities of relieving fever and pain, anti-inflammatory and antibacterial.

[0019] Caulis Spatholobi: bitter and sweet in taste, warm in nature, it returns to the liver and kidney channels. It has the functions of activating blood and tonifying blood, regulating menstruation and relieving pain, relaxing sinews and activating collaterals. It is used for irregular menstruation, dysmenorrhea, amenorrhea, rheumatic arthralgia, numbness and paralysis, and emaciation due to blood deficiency. Caulis Spatholobi contains flavonoids, phenylpropanoids, phenolic acids and other chemical components, and has the pharmacological activities of regulating the blood system, antioxidant, anti-inflammatory, antitumor, antiviral, and neuroprotective effects.

[0020] Silkworm chrysalis: sweet and pungent in taste, warm in nature, it returns to the liver, spleen and stomach channels. It has the functions of dispelling wind and dampness, promoting blood circulation and relieving pain. It is used for rheumatic arthralgia, pruritus, headache, numbness, joint dysfunction, acute diarrhea, cold pain in the waist and legs, and ulcerative keratitis. Silkworm chrysalis contains alkaloids, flavonoids, lignin, terpenes, phytol, chlorophyll salts, amino acids and other chemical components, and has the pharmacological activities of anti-inflammatory, liver protection, antioxidant, antiviral, antibacterial, and hypoglycemic effects.

[0021] Gentian: bitter in taste, cold in nature, it returns to the liver and gallbladder channels. It has the functions of clearing heat and drying dampness, and purging liver and gallbladder fire. It is used for damp-heat jaundice, vaginal itching, leukorrhagia, strong, pruritus, red and swollen eyes, deafness, hypochondriac pain, bitter taste, and convulsions. Gentian contains iridoid glycosides, flavonoids, triterpenes and other chemical components, and has the pharmacological activities of liver protection, anti-inflammatory, antitumor, stomachic, and diuretic effects.

[0022] Safflower: pungent in taste, warm in nature, it returns to the heart and liver channels. It has the functions of activating blood and relieving pain, and removing blood stasis and relieving pain. It is used for amenorrhea, dysmenorrhea, lochia, mass and lumps, chest pain, abdominal pain due to blood stasis, chest and hypochondriac pain, sprains and contusions, and ulcer pain. Safflower contains flavonoids, quinonoid chalcone, spermidine, alkaloids, polyacetylene, organic acids and other chemical components, and is widely used in diseases of the vascular system, nervous system and immune system, as well as antioxidant, anti-inflammatory and antitumor effects.

[0023] Peach kernel: bitter and sweet in taste, neutral in nature, it returns to the heart, liver and large intestine channels. It has the functions of activating blood and removing blood stasis, moistening the intestines and relieving constipation, relieving cough and asthma. It is used for amenorrhea and dysmenorrhea, abdominal mass and lumps, lung and intestinal abscesses, sprains and contusions, dry constipation, cough and asthma. Peach kernel mainly contains flavonoids and their glycosides, steroids, terpenes, phenolic acids, carotenoids, sugars and other chemical components, and has the pharmacological effects of anti-inflammatory, hypoglycemic, anticoagulant, neuroprotective, and delaying renal interstitial fibrosis.

[0024] Cortex Fraxini: bitter and astringent in taste, cold in nature, it returns to the liver, gallbladder and large intestine channels. It has the functions of clearing heat and drying dampness, astringing and relieving diarrhea, stopping leukorrhagia, and clearing the eyes. It is used for damp-heat diarrhea, leukorrhagia, red and swollen eyes, and eye nebula. Cortex Fraxini contains coumarin, iridoid glycosides, lignin, phenolic acids, triterpenes and other chemical components, and has the pharmacological effects of anti-inflammatory, antibacterial, relieving cough and expectoration, antitumor, and reducing blood uric acid.

[0025] Arisaema cum Bile: It tastes bitter and slightly pungent, and is cool in nature. It enters the lung, liver, and spleen meridians. It has the effects of clearing heat and resolving phlegm, calming wind and relieving convulsions. It is used for cough with phlegm and heat, thick yellow phlegm, stroke with phlegm coma, and epilepsy. Arisaema cum Bile mainly contains bile acids, flavonoids, nucleosides, phenolic acids, sugars and other chemical components, and has pharmacological effects such as antipyretic, anti-inflammatory and analgesic, and anticonvulsant.

[0026] Shenqu (medicated leaven): It has a sweet and pungent taste, is warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and stomach, promoting digestion and regulating the middle jiao. It is used for food stagnation, chest tightness and abdominal distension, vomiting and diarrhea, postpartum blood stasis and abdominal pain, and abdominal distension and hard masses in children. Shenqu contains chemical components such as yeast, enzymes, vitamins, ergosterol, volatile oils, and glycosides. It has pharmacological effects such as anti-inflammatory, anti-ulcer, antioxidant, smooth muscle contraction, digestion promotion, and antibacterial effects.

[0027] Beehive: Sweet in taste, neutral in nature, and enters the stomach meridian; it has the effects of attacking toxins and killing parasites, dispelling wind and relieving pain; it is used for sores and carbuncles, mastitis, scrofula, stubborn skin tinea, tinea pedis, toothache, and rheumatic pain; beehive contains chemical components such as amino acids, polypeptides, organic acids, phenolic acids, volatile oils, coumarins, tannins, triterpenes, phytosterols, and cardiac glycosides, and has pharmacological effects such as anti-inflammatory, antibacterial, antiviral, antitumor, antioxidant, wound healing promotion, and cardiovascular protection.

[0028] (III) Beneficial Effects

[0029] The application provides a traditional Chinese medicine preparation for dispelling wind and removing dampness and an application. The traditional Chinese medicine preparation is composed of ten traditional Chinese medicines, including Lonicera japonica, Spatholobus suberectus, silkworm excrement, Gentiana scabra, Carthamus tinctorius, Persicae Semen, Cortex Fraxini, Aralia chinensis, Massa Medicata Fermentata and honeycomb. Lonicera japonica and Spatholobus suberectus are used as monarch drugs. Lonicera japonica has the effects of clearing heat and resolving toxins and dispelling wind and freeing the network vessels. Spatholobus suberectus has the effects of activating blood and tonifying blood, regulating menstruation and relieving pain, and relaxing sinews and freeing the network vessels. The combination of the two can help to remove heat and toxins in the body, promote blood circulation around joints, reduce joint pain and swelling, improve the overall state of the body and enhance the resistance. Silkworm excrement, Gentiana scabra, Carthamus tinctorius and Persicae Semen are used as minister drugs. The four can cooperate with the monarch drug in aspects of dispelling wind and dampness, clearing heat and drying dampness, activating blood and resolving stasis, and enhance the efficacy. Silkworm excrement has the effects of dispelling wind and dampness and harmonizing the stomach and dampness. It can help to dispel wind and dampness in the joint and adjust the function of the spleen and stomach. Gentiana scabra has the effects of clearing heat and drying dampness and purging the liver and gallbladder fire. It can remove internal damp heat, reduce inflammation of arthritis and reduce redness, swelling, heat and pain of joints. Carthamus tinctorius and Persicae Semen both have the effect of activating blood and resolving stasis. The combination of the two can promote blood circulation, dissipate blood stasis, reduce joint pain and difficulty in movement. Cortex Fraxini and Aralia chinensis are used as assistant drugs. Cortex Fraxini has the effects of clearing heat and drying dampness, astringing and stopping diarrhea, stopping leucorrhea and improving eyesight. Aralia chinensis has the effects of clearing heat and resolving phlegm and calming wind and relieving convulsions. The combination of the two can further assist the monarch and minister in clearing damp heat and resolving phlegm, and relieve symptoms such as limb convulsions and difficulty in movement caused by joint pain. Massa Medicata Fermentata and honeycomb are used as messenger drugs. Massa Medicata Fermentata has the effect of digesting and harmonizing the stomach. It can promote the function of the spleen and stomach, reduce the adverse effects of drugs on the stomach and harmonize the drugs. Honeycomb has the effects of attacking toxins and killing insects, dispelling wind and relieving pain. It can relieve joint pain, eliminate toxins caused by damp heat and toxins, guide the drugs to the diseased part and play the role of a messenger. The traditional Chinese medicine preparation is prepared according to the theory of traditional Chinese medicine. The monarch, minister, assistant and messenger are reasonably matched. The etiology and pathogenesis of gout are comprehensively considered, and the gout is treated from multiple aspects and multiple targets.

[0030] The traditional Chinese medicine preparation can significantly reduce the swelling degree of the ankle joint of an acute gouty arthritis model rat, reduce the expression levels of serum TNF-α, IL-1β and IL-6 inflammatory factors, and reduce the contents of serum uric acid, creatinine and XOD, so as to achieve the effects of anti-inflammatory analgesia and reducing blood uric acid. The clinical test results show that the traditional Chinese medicine preparation can reduce the VAS score of an acute gouty arthritis patient, increase the HSS score, reduce the levels of inflammation-related factors TNF-α and IL-1β in the synovial fluid of the knee joint of the patient, reduce the inflammation indexes WBC, ESR and CRP in the serum of the patient, reduce the pain degree of the patient, reduce the inflammation reaction of the body of the patient and reduce the incidence of adverse reactions, thereby providing a safe and effective idea for the treatment of acute gout. DETAILED DESCRIPTION

[0031] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0032] Embodiment 1

[0033] A traditional Chinese medicine preparation for dispelling wind and removing dampness, which is composed of the following raw materials in parts by weight: Lonicera japonica 18 parts, Spatholobus suberectus 12 parts, silkworm sand 20 parts, gentiana 15 parts, safflower 3 parts, peach kernel 9 parts, cortex fraxini 9 parts, aconitum 10 parts, divinum 7 parts, honeycomb 9 parts.

[0034] Embodiment 2

[0035] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 12 parts, Spatholobus suberectus 7 parts, silkworm sand 13 parts, gentiana 10 parts, safflower 4 parts, peach kernel 6 parts, cortex fraxini 6 parts, aconitum 7 parts, divinum 5 parts, honeycomb 6 parts.

[0036] Embodiment 3

[0037] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 26 parts, Spatholobus suberectus 24 parts, silkworm sand 28 parts, gentiana 23 parts, safflower 9 parts, peach kernel 18 parts, cortex fraxini 18 parts, aconitum 20 parts, divinum 16 parts, honeycomb 18 parts.

[0038] Embodiment 4

[0039] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 14 parts, Spatholobus suberectus 8 parts, silkworm sand 16 parts, gentiana 12 parts, safflower 2 parts, peach kernel 8 parts, cortex fraxini 8 parts, aconitum 10 parts, divinum 6 parts, honeycomb 8 parts.

[0040] Embodiment 5

[0041] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 10 parts, Spatholobus suberectus 5 parts, silkworm sand 10 parts, gentiana 5 parts, safflower 1 part, peach kernel 1 part, cortex fraxini 1 part, aconitum 1 part, divinum 1 part, honeycomb 1 part.

[0042] Embodiment 6

[0043] The embodiment is different from example 1 in that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 22 parts, Spatholobus suberectus 20 parts, silkworm ash 24 parts, gentiana 20 parts, safflower 7 parts, peach kernel 16 parts, cortex fraxini 16 parts, Aconitum 18 parts, divine powder 15 parts, honeycomb 16 parts.

[0044] Example 7

[0045] The embodiment is different from example 1 in that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: Lonicera japonica 22 parts, Spatholobus suberectus 20 parts, silkworm ash 24 parts, gentiana 20 parts, safflower 7 parts, peach kernel 16 parts, cortex fraxini 16 parts, Aconitum 18 parts, divine powder 15 parts, honeycomb 16 parts.

[0046] Test example 1

[0047] 1 Materials and methods

[0048] 1.1 Test animals

[0049] 70 SPF level SD rats, male, body weight 180-200 g, purchased from Beijing Vito Li Hua Experimental Animal Co., Ltd.

[0050] 1.2 Test drugs

[0051] Lonicera japonica 18 parts, Spatholobus suberectus 12 parts, silkworm ash 20 parts, gentiana 15 parts, safflower 3 parts, peach kernel 9 parts, cortex fraxini 9 parts, Aconitum 10 parts, divine powder 7 parts, honeycomb 9 parts.

[0052] According to the above weight parts, each raw material is weighed, washed and cut, soaked in water for 20-30 min, then transferred to a sand pot for decoction for 20-30 min, filtered while hot, repeated twice, and the two filtrates were combined and concentrated to a crude drug content of 1 g / mL to obtain the traditional Chinese medicine stock solution.

[0053] Western medicine control drug: benzbromarone;

[0054] Traditional Chinese medicine control drug: Goutishu tablet.

[0055] 1.3 Animal grouping, modeling and administration

[0056] 70 SD rats were randomly divided into blank control group, model control group, western medicine control group, traditional Chinese medicine control group, traditional Chinese medicine preparation low-dose group, traditional Chinese medicine preparation middle-dose group, and traditional Chinese medicine preparation high-dose group, 10 rats in each group. The model group and each administration group were intraperitoneally injected with 3% oxonate potassium (0.9% physiological saline) and were intragastrically administered with 1% adenine (0.3% carboxymethyl cellulose sodium) at a dose of 10 mL / kg, once a day, for 14 days of continuous modeling. On the 13th day, except for the blank group, the animals were anesthetized, the right ankle joint was selected as the puncture point, and 25 mg / mL sodium urate solution 0.1 mL was injected into the joint cavity along the medial side of the Achilles tendon at an angle of 45°. Compared with the blank group, the model group rats showed joint capsule contralateral swelling and a significant increase in serum uric acid level, indicating successful modeling.

[0057] Synchronous administration during modeling, the blank control group and the model control group were given distilled water, the western medicine control group was given benzbromarone 10 mg / kg, the traditional Chinese medicine control group was given Goutishu tablets 400 mg / kg, the traditional Chinese medicine preparation low-dose group was given the traditional Chinese medicine preparation of the application 125 mg / kg, the traditional Chinese medicine preparation middle-dose group was given the traditional Chinese medicine preparation of the application 250 mg / kg, and the traditional Chinese medicine preparation high-dose group was given the traditional Chinese medicine preparation of the application 500 mg / kg, for 14 days of continuous administration.

[0058] 1.4 Swelling degree of ankle joint

[0059] The swelling degree of the ankle joint of the rats was measured before modeling and at 6, 12, 24 and 48 h after modeling, the drainage volume of the right hind ankle joint of the rats was measured by using a toe volume measuring instrument, and the joint swelling degree of the rats was evaluated.

[0060] Joint swelling degree = (joint drainage volume at test time point - initial joint drainage volume) / joint drainage volume before modeling × 100%

[0061] 1.5 Biochemical index detection

[0062] After the last administration, the rats were fasted for 12 h, anesthetized, and blood was taken from the abdominal aorta, centrifuged at 3000 rpm for 10 min, and the supernatant was stored in a 4°C refrigerator for standby, and the contents of serum uric acid, creatinine and XOD were determined according to the instructions of the reagent kit.

[0063] 1.6 Serum inflammation-related factor determination

[0064] The standby serum was taken, and the contents of inflammation-related factors TNF-α, IL-1β and IL-6 in the serum were determined according to the instructions of the ELISA detection kit.

[0065] 1.7 Statistical method

[0066] Data were analyzed using Graphpad Prism 8.0 statistical software, and comparisons between different groups were made using one-way ANOVA, and rank sum test was used when the variance was not uniform, and P<0.05 was considered to have statistical significance.

[0067] 2Results

[0068] 2.1 Effects of each drug on the swelling degree of the ankle joint of rats

[0069] The effects of each drug on the swelling degree of the ankle joint of acute gouty arthritis model rats are shown in Table 1. Compared with the blank control group, the ankle joint swelling degree of the model control group rats at the same time node was significantly increased (P<0.01), and reached a peak after 24 h of modeling; compared with the model control group, the ankle joint swelling degree of each drug group rats at the same time node was reduced to different degrees, indicating that the traditional Chinese medicine preparation of the application can reduce the swelling degree of the ankle joint of acute gouty arthritis model rats and reduce the inflammatory reaction of the ankle joint of rats, and the effect of the high-dose group is the best, which is better than that of the traditional Chinese medicine control group.

[0070] Table 1 Comparison of ankle joint swelling degree of rats in each group

[0071] Group 6h 12h 24h 48h Control group 12.44±2.85 13.92±1.82 13.67±1.58 12.63±2.50 Model group 56.27 ± 3.03 ## ]] 74.84 ± 2.44 ## ]] 75.22 ± 1.82 ## ]] 70.78 ± 2.50 ## ]] Western medicine control group 36.87 ± 2.32 ** ]] 46.03 ± 2.29 ** ]] 41.88 ± 2.14 ** ]] 34.83 ± 2.24 ** ]] Traditional Chinese medicine control group 44.16 ± 3.17 ** ]] 52.11 ± 1.74 ** ]] 47.93 ± 1.66 ** ]] 41.31 ± 1.80 ** ]] Traditional Chinese medicine preparation low-dose group 50.77±1.56 62.68 ± 2.16 ** ]] 56.26 ± 2.04 ** ]] 50.48 ± 2.43 ** ]]> Traditional Chinese medicine preparation middle-dose group 46.16 ± 2.09 ** ]] 56.58 ± 2.58 ** ]] 49.85 ± 1.48 ** ]] 45.59 ± 3.14 ** ]] Traditional Chinese medicine preparation high-dose group 40.78 ± 2.32 ** ]] 48.39 ± 3.14 ** ]] 46.94 ± 2.00 ** ]] 38.48 ± 2.18 ** ]]

[0072] Note: compared with the blank control group, # P<0.01, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0073] 2.2 Effects of each drug on serum uric acid, creatinine and XOD of rats

[0074] Table 2 shows the effects of each drug on serum uric acid, creatinine and XOD of acute gouty arthritis model rats. Compared with the blank control group, the serum uric acid, creatinine and XOD levels of the model control group rats were significantly increased (P<0.01), and compared with the model control group, each drug group could significantly reduce the serum uric acid, creatinine and XOD levels of rats (P<0.05, P<0.01), indicating that the traditional Chinese medicine preparation of the application can significantly inhibit the generation of uric acid and improve the excretion ability of the kidney, and the effect of the high-dose group is the best.

[0075] Table 2 Comparison of serum uric acid, creatinine and XOD levels of rats in each group

[0076] Group Uric acid (μmol / L) Creatinine (μmol / L) XOD (U / L) Control group 91.76±6.30 22.19±2.53 20.86±2.31 Model group 258.49 ± 6.13 ## ]] 66.66 ± 2.27 ## ]] 39.80 ± 2.16 ## ]] Western medicine control group 139.16 ± 4.29 ** ]] 28.80 ± 2.76 * ]] 25.04 ± 2.03 ** ]] Traditional Chinese medicine control group 163.56 ± 4.35 ** ]] 34.05 ± 1.80 ** ]] 26.79 ± 2.58 ** ]]> Traditional Chinese medicine preparation low-dose group 207.08 ± 7.68 ** ]] 51.64 ± 2.16 ** ]] 34.45±2.18 Traditional Chinese medicine preparation middle-dose group 187.68 ± 4.99 ** ]] 41.64 ± 3.03 ** ]] 31.89 ± 3.07 ** ]] Traditional Chinese medicine preparation high-dose group 157.60 ± 5.95 ** ]] 31.69 ± 3.26 ** ]] 26.18 ± 1.86 ** ]]

[0077] Note: compared with the blank control group, # P<0.01, ## P<0.01; compared with the model control group,* P<0.05, ** P<0.01.

[0078] 2.3 The influence of each drug on serum inflammation-related factors of rats

[0079] Table 3 is the influence of each drug group on serum inflammation-related factors of acute gouty arthritis model rats. Compared with the blank control group, the serum TNF-α, IL-1β and IL-6 contents of the model group rats are significantly increased (P<0.01). Compared with the model control group, the serum TNF-α, IL-1β and IL-6 of each drug group rats are significantly reduced (P<0.01), which indicates that the traditional Chinese medicine preparation of the application can reduce the inflammatory response by inhibiting the secretion of inflammation-related factors, and the effect of the high-dose group is the most obvious.

[0080] Table 3 Comparison of serum inflammation-related factors of rats (pg / mL)

[0081] Group TNF-α IL-1β IL-6 Control group 215.54±12.07 95.58±9.69 112.76±11.98 Model group 434.31 ± 19.51 ## ]] 361.46 ± 18.07 ## ]] 280.55 ± 21.33 ## ]] Western medicine control group 275.95 ± 11.70 ** ]] 162.62 ± 25.63 ** ]] 145.41 ± 8.65 ** ]] Traditional Chinese medicine control group 291.67 ± 5.72 ** ]] 184.42 ± 9.47 ** ]] 175.67 ± 11.01 ** ]] Traditional Chinese medicine preparation low-dose group 373.49 ± 20.71 ** ]] 272.38 ± 14.71 ** ]] 223.66 ± 7.89 ** ]] Traditional Chinese medicine preparation middle-dose group 345.02 ± 19.26 ** ]] 219.54 ± 15.39 ** ]] 190.72 ± 13.39 ** ]] Traditional Chinese medicine preparation high-dose group 284.58 ± 20.60 ** ]] 168.42 ± 17.08 ** ]] 154.02 ± 10.53 ** ]]

[0082] Note: compared with the blank control group, # P<0.01, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0083] 3 Conclusion

[0084] The above test results show that the traditional Chinese medicine preparation of the application can significantly reduce the swelling degree of the ankle joint of the acute gouty arthritis model rats, reduce the inflammatory cell infiltration; reduce the expression level of serum TNF-α, IL-1β and IL-6 inflammatory factors of rats, so as to achieve the effect of anti-inflammatory analgesia; and can obviously reduce the contents of serum uric acid, creatinine and XOD of rats, inhibit the generation of uric acid and promote the excretion of uric acid to reduce the blood uric acid. Among each drug dose, the high-dose group has the best treatment effect on acute gouty arthritis.

[0085] Test Example 2

[0086] 1 Data and methods

[0087] 1.1 General data

[0088] The clinical data of 78 patients with acute gouty arthritis admitted to a hospital in Zhengzhou from September 2022 to March 2024 were selected, and they were randomly divided into control and observation groups according to random number method, 39 cases in each group. In the control group, 28 males and 11 females, aged 32-69 years, with an average of (51.13±13.03) years; in the observation group, 29 males and 10 females, aged 36-64 years, with an average of (50.07±11.57) years. There was no significant difference between the two groups in terms of gender, age and other aspects (P<0.05).

[0089] 1.2 Diagnostic criteria

[0090] 1.2.1 Western medicine diagnostic criteria

[0091] In accordance with the relevant diagnostic criteria of acute gout in the 2016 China Gout Diagnosis and Treatment Guidelines, and confirmed by ultrasonic examination.

[0092] 1.2.2 TCM diagnostic criteria

[0093] In accordance with the relevant standards of Gouty Arthritis in the Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine, the symptoms are: joint pain, swelling, sometimes heavy, flexion and extension, or cold pain, cold and warm, cold limbs, frequent urination, pale tongue, white or white and greasy, and pulse is thin or sunken.

[0094] 1.3 Inclusion and exclusion criteria

[0095] 1.3.1 Inclusion criteria

[0096] (1) Patients with gout; (2) acute onset <72h; (3) confirmed by blood routine, blood uric acid determination and laboratory examination; (4) with the consent of the patient, and signed the informed consent form.

[0097] 1.3.2 Exclusion criteria

[0098] (1) Combined with joint deformity, joint infection, rheumatism, rheumatoid arthritis; (2) Combined with pigmented villous nodular synovitis; (3) Combined with serious organic lesions of heart, liver, kidney and other organs; (4) Arthritis severe deformity need surgical treatment; (5) Within 1 month, taking non-steroidal anti-inflammatory drugs, colchicine and other drugs; (6) Autoimmune or infectious diseases; (7) Severe mental illness.

[0099] 1.4 Methods

[0100] 1.4.1 Control group

[0101] Oral etoricoxib tablets 60mg / time, 1 / time / day; colchicine 0.5mg / time, 2 / time / day, after 3 days, 0.5mg / time, 1 / time / day; sodium bicarbonate 1g / time, 3 / time / day, for 2 weeks.

[0102] 1.4.2 Observation group

[0103] On the basis of the control group treatment, the traditional Chinese medicine preparation in the application is applied, the prescription is: Lonicera japonica 18 parts, Millettia nitida 12 parts, silkworm ash 20 parts, gentiana 15 parts, safflower 3 parts, peach kernel 9 parts, Cortex Fraxini 9 parts, Aconitum 10 parts, Shenqu 7 parts, honeycomb 9 parts; 1 dose / day, decoction with water, morning and evening, continuous treatment for 2 weeks.

[0104] 1.5 Observation index and evaluation standard

[0105] 1.5.1 VAS score

[0106] The degree of pain of the patient is taken as the standard of VAS score, which is evaluated by VAS score, and the pain score is determined by the doctor through physical examination, the score is 0-10, and the higher the score, the more serious the pain.

[0107] 1.5.2 HSS scale

[0108] The HSS scale is used to evaluate the knee joint function of the patient before and after treatment from the aspects of pain, gait, stability, activity ability, dysfunction and activity degree.

[0109] 1.5.3 Inflammatory related factors in synovial fluid of knee joint

[0110] The patient takes a supine position, and the knee joint is punctured under sterile conditions to take 1mL of light yellow synovial fluid, which is stored at-80℃.

[0111] According to the instruction of ELISA kit, the levels of IL-1β and TNF-α in the synovial fluid of knee joint of the patient before and after treatment are detected.

[0112] 1.5.4 WBC, CRP, ESR

[0113] 4mL of venous blood of the patient is collected before and after treatment, and the levels of WBC, CRP and ESR are detected.

[0114] 1.5.6 Incidence of adverse reactions

[0115] The adverse reactions of the patients in the two groups are observed and recorded, including gastrointestinal symptoms (such as acid reflux, abdominal distension and abdominal pain, vomiting, etc.), nervous system reactions (such as dizziness, headache, etc.), blood routine (abnormal white blood cell count), liver and kidney function (abnormal liver and kidney function) and other conditions.

[0116] 1.6 Statistical method

[0117] The data is processed by SPSS23.0 statistical software, the count data is represented by rate (%), and χ 2Test; measurement data with mean ± standard deviation (x ± s) is expressed, the comparison between groups is independent sample t test, the comparison within the group uses paired t test; non-normal distribution uses Mann-Whitney test. P<0.05 is statistically significant difference.

[0118] 2Results

[0119] 2.1 The influence of each drug on VAS score and HSS score of patients before and after treatment

[0120] The influence of each drug on VAS score of patients in two groups before and after treatment is shown in Table 1, and there is no significant difference in VAS score of patients in control group and observation group before treatment (P>0.05), and the VAS score of control group and observation group is significantly lower than that before treatment (P<0.01), and the VAS score of observation group is significantly lower than that of control group (P<0.01), which shows that the traditional Chinese medicine preparation can obviously reduce the pain degree of patients and reduce the degree of arthritis of patients.

[0121] 2.2 The influence of each drug on VAS score and HSS score of patients before and after treatment

[0122] The influence of each drug group on HSS score of patients in two groups before and after treatment is shown in Table 1, and there is no significant difference in HSS score of patients in control group and observation group before treatment (P>0.05), and the HSS score of control group and observation group is significantly lower than that before treatment (P<0.05, P<0.01), and the HSS score of observation group is significantly higher than that of control group (P<0.01), which shows that the traditional Chinese medicine preparation can obviously reduce the pain degree of patients' knee joint.

[0123] Table 1 Comparison of VAS score and HSS score of patients before and after treatment

[0124]

[0125] Note: compared with the treatment group, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.01, ## P<0.01.

[0126] 2.3 The influence of each drug on inflammatory related factors in synovial fluid of patients' knee joint before and after treatment

[0127] Table 2 is the influence of each drug on the inflammatory related factors TNF-α, IL-1β in the knee synovial fluid of the two groups of patients before and after treatment. There is no significant difference in the TNF-α, IL-1β levels of the patients in the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the TNF-α, IL-1β levels of the control group and the observation group are significantly reduced (P<0.01), and the TNF-α, IL-1β levels of the observation group are significantly lower than those of the control group, indicating that the traditional Chinese medicine preparation can significantly reduce the inflammation degree of the patients with acute gouty arthritis.

[0128] Table 2 is the influence of each drug on the inflammatory related factors TNF-α, IL-1β in the knee synovial fluid of the two groups of patients before and after treatment. There is no significant difference in the TNF-α, IL-1β levels of the patients in the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the TNF-α, IL-1β levels of the control group and the observation group are significantly reduced (P<0.01), and the TNF-α, IL-1β levels of the observation group are significantly lower than those of the control group, indicating that the traditional Chinese medicine preparation can significantly reduce the inflammation degree of the patients with acute gouty arthritis.

[0129]

[0130] Note: comparison with the treatment group, * P<0.05, ** P<0.01; comparison with the control group after treatment, # P<0.01, ## P<0.01.

[0131] 2.4 Influence of each drug on serum indexes of patients before and after treatment

[0132] Table 3 is the influence of each drug on the inflammatory indexes WBC, CRP, ESR in the serum of the two groups of patients before and after treatment. There is no significant difference in the serum indexes of the patients in the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the WBC, ESR, CRP of the serum of the control group and the observation group are significantly reduced (P<0.05, P<0.01), and the WBC, ESR, CRP of the serum of the observation group are significantly lower than those of the control group (P<0.05), indicating that the traditional Chinese medicine preparation can significantly alleviate the inflammatory reaction of the patients with acute gouty arthritis.

[0133] Table 3 is the influence of each drug on the inflammatory related factors TNF-α, IL-1β in the knee synovial fluid of the two groups of patients before and after treatment. There is no significant difference in the TNF-α, IL-1β levels of the patients in the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the TNF-α, IL-1β levels of the control group and the observation group are significantly reduced (P<0.01), and the TNF-α, IL-1β levels of the observation group are significantly lower than those of the control group, indicating that the traditional Chinese medicine preparation can significantly reduce the inflammation degree of the patients with acute gouty arthritis.

[0134]

[0135] Note: comparison with the treatment group, * P<0.05, ** P<0.01; comparison with the control group after treatment, # P<0.01, ## P<0.01.

[0136] 2.5 Adverse reaction occurrence

[0137] From table 4, 3 cases of gastrointestinal abnormalities, 3 cases of nervous system abnormalities, 2 cases of blood routine abnormalities, 2 cases of liver and kidney function abnormalities, the incidence of adverse reactions was 25.64%; 1 case of gastrointestinal abnormalities, 1 case of nervous system abnormalities, 1 case of liver and kidney function abnormalities, the incidence of adverse reactions was 7.69%, significantly lower than that of the control group (P<0.05).

[0138] Table 4: Comparison of the incidence of adverse reactions of two groups (cases, %)

[0139]

[0140] 3 Conclusion

[0141] The above experimental data show that the traditional Chinese medicine preparation can significantly reduce the pain degree of patients with acute gouty arthritis, reduce the VAS score, and increase the HSS score; can significantly reduce the levels of inflammatory related factors TNF-α and IL-1β in the synovial fluid of the knee joint of the patients, reduce the inflammatory indexes WBC, ESR and CRP in the serum, thereby reducing the inflammatory reaction of the patient's body and the incidence of adverse reactions, and providing a safe and effective idea for the treatment of acute gout.

[0142] The above examples are only used to illustrate the technical solutions of the present application, but not limit them; although the present application has been described in detail with reference to the foregoing examples, it should be understood by those skilled in the art that the technical solutions recorded in the foregoing examples can be modified, or some technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A traditional Chinese medicine preparation for dispelling wind and removing dampness, characterized in that, It is composed of the following raw materials in parts by weight: Lonicera japonica 15-25 parts, caesalpinia 10-18 parts, silkworm chaff 15-25 parts, gentiana 10-20 parts, safflower 1-5 parts, persica 5-15 parts, cortex fraxini 5-15 parts, aconitum 5-15 parts, Renshen 5-15 parts, honeycomb 5-15 parts.

2. The wind-dampness-removing traditional Chinese medicine preparation according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: Lonicera japonica 15-25 parts, caesalpinia 10-18 parts, silkworm chaff 15-25 parts, gentiana 10-20 parts, safflower 1-5 parts, persica 5-15 parts, cortex fraxini 5-15 parts, aconitum 5-15 parts, Renshen 5-15 parts, honeycomb 5-15 parts.

3. The preparation method of the wind-dampness-removing traditional Chinese medicine preparation according to any one of claims 1-2, characterized in that, The medicine is prepared into any human body acceptable oral dosage form, including pills, powders, granules, oral liquid, decoction, tablets, according to the conventional Chinese medicine pharmaceutical method, with the medical acceptable adjuvant.

4. The use of the traditional Chinese medicine preparation according to any one of claims 1 to 2 in the preparation of a medicine for preventing and / or treating acute gout.

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