Traditional Chinese medicine preparation for dispelling wind and eliminating dampness and application

Abstract

The invention provides a traditional Chinese medicine preparation for dispelling wind and eliminating dampness and application, and relates to the technical field of traditional Chinese medicine pharmacy, the traditional Chinese medicine preparation is composed of honeysuckle stem, spatholobus stem, silkworm excrement, gentian, safflower, peach kernel, ash bark, arisaema cum bile, medicated leaven and honeycomb; the traditional Chinese medicine preparation can remarkably reduce the ankle joint swelling degree of an acute gouty arthritis model rat, reduce the expression level of inflammatory factors such as TNF-alpha, IL-1beta and IL-6 in serum and reduce the content of uric acid, creatinine and XOD in the serum, so that the effects of resisting inflammation, easing pain and reducing blood uric acid are achieved; clinical test results show that the traditional Chinese medicine preparation can relieve the pain degree of a patient, reduce the levels of inflammation-related factors TNF-alpha and IL-1beta in knee joint synovial fluid of the patient, reduce inflammation indexes WBC, ESR and CRP in serum, relieve the inflammatory reaction of the body of the patient, reduce the occurrence rate of adverse reactions, and improve the curative effect of the patient. A novel traditional Chinese medicine preparation with high safety and good curative effect is provided for treatment of acute gout.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a traditional Chinese medicine preparation for dispelling wind and dampness and an application thereof. Background Art

[0002] Gout is an acute or chronic inflammation and tissue damage caused by the deposition of monosodium urate (MSU) in the bones, joints, kidneys or subcutaneous tissues. It is closely related to hyperuricemia caused by purine metabolism disorders and / or reduced uric acid excretion. It is a common metabolic rheumatic disease in clinical practice. In recent years, the incidence of gout in my country has increased year by year, and it is showing a trend of younger patients. When gout attacks acutely, it can cause severe joint pain and limited activity in patients, causing great pain to patients. On the other hand, gout can be complicated by kidney disease. In severe cases, joint destruction and renal function damage may occur. It is often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease, which are extremely harmful to the patient's life and health. Modern medicine mainly treats gout in the acute stage with anti-inflammatory and analgesic drugs. Commonly used drugs in clinical practice include colchicine, nonsteroidal anti-inflammatory drugs, glucocorticoids, etc. Although these drugs can relieve pain, they cause adverse reactions in the digestive tract to varying degrees, induce or aggravate acute and chronic renal failure, increase the incidence of tophi, and other adverse reactions, which seriously affect the quality of life of patients.

[0003] TCM believes that gout belongs to the category of "severe joint disease" and "heat arthralgia", which is caused by damp heat turbidity toxins flowing into the joints, or exogenous wind and cold, invading the meridians, blocking the flow of qi and blood, gathering dampness into phlegm, and blocking the meridians; or insufficient endowment, spleen failure, kidney failure to transform qi, endogenous water and dampness, which accumulate for a long time and turn into heat, stagnate in the blood, flow into the joints, and injure the tendons and bones. TCM 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. However, the treatment cycle of Chinese patent medicines for the treatment of acute gout attacks on the market is long and the effect is not significant. Therefore, it is urgent to develop a drug for the treatment of gout with good efficacy and high safety. Summary of the invention

[0004] 1. Technical issues to be resolved

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

[0006] (II) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] The invention provides a traditional Chinese medicine preparation for dispelling wind and dampness. The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 10-30 parts of honeysuckle vine, 5-25 parts of millettia reticulata, 10-30 parts of silkworm excrement, 5-25 parts of gentian, 1-10 parts of safflower, 1-20 parts of peach kernel, 1-20 parts of qinpi, 1-20 parts of arisaema ciliata, 1-20 parts of Shenqu and 1-20 parts of honeycomb.

[0009] Furthermore, the Chinese medicine preparation is composed of the following raw materials in parts by weight: 15-25 parts of honeysuckle vine, 10-18 parts of Millettia reticulata, 15-25 parts of silkworm excrement, 10-20 parts of gentian, 1-5 parts of safflower, 5-15 parts of peach kernel, 5-15 parts of qinpi, 5-15 parts of arisaema, 5-15 parts of Shenqu, and 5-15 parts of beehive.

[0010] Furthermore, the Chinese medicine preparation is composed of the following raw materials in parts by weight: 18 parts of honeysuckle vine, 12 parts of Millettia reticulata, 20 parts of silkworm excrement, 15 parts of gentian, 3 parts of safflower, 9 parts of peach kernel, 9 parts of Qinpi, 10 parts of Arisaema ciliata, 7 parts of Shenqu, and 9 parts of beehive.

[0011] The invention provides a method for preparing a traditional Chinese medicine preparation for dispelling wind and dampness, characterized in that the medicine is prepared into any oral dosage form acceptable to the human body by conventional traditional Chinese medicine pharmaceutical methods and with medically acceptable auxiliary materials.

[0012] Furthermore, the dosage forms include but are not limited to pills, powders, decoctions, tablets, granules, oral liquids, etc.

[0013] Furthermore, a Chinese herbal decoction for dispelling wind and dampness is prepared according to the following steps:

[0014] (1) Weigh the raw materials according to the above weight proportions, add water until the water surface is 2-3 cm above the medicinal materials, and soak for 20-30 minutes;

[0015] (2) Transfer the above medicinal materials and soaking liquid to a casserole and boil, then continue to simmer for 20-30 minutes. Filter the decoction while it is still hot, repeat twice, and combine the decoctions.

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

[0017] The pharmacological effects of each Chinese medicine component in the Chinese medicine preparation of the present invention are as follows:

[0018] Honeysuckle: sweet in taste, cold in nature, enters the lung and stomach meridians; has the effects of clearing away heat and detoxifying, dispersing wind and unblocking collaterals; used for fever caused by febrile diseases, dysentery caused by heat toxins, carbuncle, sore, rheumatic pain, and red, swollen, hot and painful joints; Honeysuckle contains chemical components such as organic acids, flavonoids, cyclopentane, etc., which have pharmacological activities such as antipyretic, analgesic, anti-inflammatory and antibacterial.

[0019] Millettia reticulata: bitter and sweet in taste, warm in nature, enters the liver and kidney meridians; has the effects of promoting blood circulation, tonifying blood, regulating menstruation and relieving pain, relaxing muscles and tendons; used for irregular menstruation, dysmenorrhea, amenorrhea, rheumatic pain, numbness and paralysis, and anemia; Millettia reticulata contains chemical components such as flavonoids, phenylpropanoids, phenolic acids, etc., which have pharmacological activities such as regulating the blood system, anti-oxidation, anti-inflammatory, anti-tumor, anti-viral, and neuroprotection.

[0020] Silkworm sand: sweet and spicy in taste, warm in nature, enters the liver, spleen and stomach meridians; has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain; used for rheumatism, itching of rashes, headache, numbness of the skin, joint paralysis, acute vomiting and diarrhea, cramps, cold pain in the waist and feet, and ulcers; silkworm sand contains chemical components such as alkaloids, flavonoids, lignin, terpenes, phytol, chlorophyll salts, amino acids, etc., with anti-inflammatory, liver-protecting, antioxidant, antiviral, antibacterial, and blood sugar-lowering pharmacological activities.

[0021] Gentiana: bitter in taste, cold in nature, enters the liver and gallbladder meridians; has the effects of clearing away heat and dampness, and purging liver and gallbladder fire; used for damp-heat jaundice, vaginal swelling and itching, leucorrhea, strong spleen, eczema itching, red eyes, deafness, flank pain, bitter mouth, convulsions; Gentiana contains chemical components such as cyclopentane, flavonoids, triterpenes, etc., which have pharmacological activities such as liver protection, anti-inflammatory, anti-tumor, stomachic, and diuretic.

[0022] Safflower: spicy, warm in nature, enters the heart and liver meridians; has the effects of promoting blood circulation and relieving dysmenorrhea, dispersing blood stasis and relieving pain; used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to blood stasis, stabbing pain in the chest and flanks, injuries from falls, and sores and swelling; safflower contains chemical components such as flavonoids, quinone chalcone, spermidine, alkaloids, polyacetylene, organic acids, etc., and is widely used in diseases of the vascular system, nervous system, immune system, as well as anti-oxidation, anti-inflammatory, and anti-tumor.

[0023] Peach kernel: bitter and sweet in taste, neutral in nature, enters the heart, liver, and large intestine meridians; has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and promoting bowel movements, relieving cough and relieving asthma; used for amenorrhea, dysmenorrhea, lumps and masses, lung abscesses and intestinal abscesses, injuries from falls, dry intestines and constipation, cough and asthma; peach kernels mainly contain flavonoids and their glycosides, steroids, terpenes, phenolic acids, carotenoids, sugars and other chemical components, which have anti-inflammatory, hypoglycemic, anticoagulant, neuroprotective, and delayed renal interstitial fibrosis and other pharmacological effects.

[0024] Qinpi: bitter and astringent in taste, cold in nature, enters the liver, gallbladder, and large intestine meridians; has the effects of clearing away heat and dampness, astringing and stopping dysentery, stopping leukorrhea, and improving eyesight; used for damp-heat diarrhea, red and swollen eyes, and eye opacities; Qinpi contains chemical components such as coumarins, cyclopentane ether terpenes, lignin, phenolic acids, triterpenes, etc., which have pharmacological effects such as anti-inflammatory, antibacterial, antitussive and expectorant, anti-tumor, and lowering blood uric acid.

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

[0026] Shenqu: sweet and spicy in taste, warm in nature, enters the spleen and stomach meridians; has the effects of strengthening the spleen and stomach, digesting food and regulating the middle; used for food stagnation, chest fullness and abdominal distension, vomiting and diarrhea, postpartum blood stasis and abdominal pain, and large and hard abdomen in children; Shenqu contains chemical components such as yeast, enzymes, vitamins, ergosterol, volatile oils, glycosides, etc., which have anti-inflammatory, anti-ulcer, antioxidant, smooth muscle contraction, digestive, and antibacterial pharmacological effects.

[0027] Beehive: sweet in taste, neutral in nature, and enters the stomach meridian; it has the effects of attacking toxins and killing insects, dispelling wind and relieving pain; it is used for sores, swelling, mastitis, scrofula, stubborn skin tinea, tinea pedis, toothache, rheumatism and pain; beehive contains chemical components such as amino acids, polypeptides, organic acids, phenolic acids, volatile oils, coumarins, tannins, triterpenes, phytosterols, cardiac glycosides, etc., which have anti-inflammatory, antibacterial, antiviral, anti-tumor, antioxidant, promote wound healing, protect the cardiovascular system and other pharmacological effects.

[0028] (III) Beneficial effects

[0029] The invention provides a Chinese medicine preparation for dispelling wind and dampness and its application. The Chinese medicine preparation is composed of ten Chinese medicines, namely honeysuckle vine, millet vine, silkworm excrement, gentian, safflower, peach kernel, qinpi, arisaema cinerea, Shenqu and beehive. The Chinese medicine preparation uses honeysuckle vine and millet vine as monarch medicines. Honeysuckle vine has the effects of clearing away heat and detoxicating, dispersing wind and unblocking collaterals. Millet vine can invigorate blood circulation and replenish blood, regulate menstruation and relieve pain, and relax muscles and activate collaterals. The combination of the two medicines is helpful to remove heat and toxins in the body, promote blood circulation around joints, relieve joint pain and swelling, and improve the overall state of the body and enhance resistance. Silkworm excrement, gentian, safflower and peach kernel are used as assistant medicines, and the monarch medicine is coordinated in terms of removing wind and rheumatism, clearing heat and drying dampness, promoting blood circulation and removing blood stasis, and enhancing drug efficacy. Silkworm excrement has the effects of removing wind and rheumatism, harmonizing the stomach and removing dampness, and is helpful to dispel wind evil and damp evil in joints and adjust spleen and stomach functions. Gentian has the effects of clearing heat and drying dampness, purging liver and gallbladder fire, and can remove damp heat in the body and relieve joints. The safflower and peach kernel both have the effect of promoting blood circulation and removing blood stasis. The combination of the two can promote blood circulation, dissipate blood stasis, and relieve the symptoms of joint pain and poor mobility. With Qinpi and Dan Nanxing as adjuvants, Qinpi has the effects of clearing heat and dampness, astringing and stopping dysentery, stopping leukorrhea, and improving eyesight, and Dan Nanxing has the effects of clearing heat and resolving phlegm, calming wind and calming convulsions. The combination of the two can further assist the monarch and minister in clearing dampness and heat, resolving phlegm turbidity, and relieving symptoms such as limb cramps and poor mobility caused by joint pain; Shenqu and beehive are used as guiding drugs to harmonize the spleen and stomach and guide all the drugs to the diseased area. Shenqu has the effect of digesting food and harmonizing the stomach, which can promote the transportation and transformation function of the spleen and stomach, reduce the adverse effects of drugs on the spleen and stomach, and harmonize all the drugs; beehive has the effects of attacking toxins and killing insects, dispelling wind and relieving pain, which helps to relieve joint pain, eliminate the insect poison caused by damp-heat evil in the body, and can also guide all the drugs to the diseased area, playing the role of guiding the meridians and reporting the messengers. The Chinese medicine preparation of the present invention is based on the theory of traditional Chinese medicine, follows the reasonable compatibility of monarch, minister, assistant and guiding ingredients, comprehensively considers the etiology and pathogenesis of gout, and comprehensively treats gout from multiple aspects and multiple targets.

[0030] The Chinese medicine preparation of the present invention can significantly reduce the swelling degree of the ankle joint of rats with acute gouty arthritis model, reduce the expression level of serum TNF-α, IL-1β, IL-6 inflammatory factors, and reduce the content of serum uric acid, creatinine, and XOD, thereby achieving the effects of anti-inflammatory analgesia and reducing blood uric acid. Clinical trial results show that the Chinese medicine preparation of the present invention can reduce the VAS score of patients with acute gouty arthritis, increase the HSS score, reduce the levels of inflammatory related factors TNF-α and IL-1β in the synovial fluid of the knee joint of patients, reduce the inflammatory indicators WBC, ESR, and CRP in the serum, reduce the degree of pain in patients, alleviate the inflammatory response of the patient's body, and reduce the incidence of adverse reactions, providing a safe and effective idea for the treatment of acute gout attacks. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Example 1

[0033] A traditional Chinese medicine preparation for dispelling wind and dampness, the traditional Chinese medicine preparation is composed of the following raw materials in weight fractions: 18 parts of honeysuckle vine, 12 parts of Millettia reticulata, 20 parts of silkworm excrement, 15 parts of gentian, 3 parts of safflower, 9 parts of peach kernel, 9 parts of qinpi, 10 parts of arisaema ciliata, 7 parts of Shenqu, and 9 parts of honeycomb.

[0034] Example 2

[0035] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 12 parts of honeysuckle vine, 7 parts of Millettia reticulata, 13 parts of silkworm excrement, 10 parts of gentian, 4 parts of safflower, 6 parts of peach kernel, 6 parts of Qinpi, 7 parts of Arisaema ciliata, 5 parts of Shenqu, and 6 parts of honeycomb.

[0036] Example 3

[0037] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 26 parts of honeysuckle vine, 24 parts of Millettia reticulata, 28 parts of silkworm excrement, 23 parts of gentian, 9 parts of safflower, 18 parts of peach kernel, 18 parts of Qinpi, 20 parts of Arisaema ciliata, 16 parts of Shenqu, and 18 parts of honeycomb.

[0038] Example 4

[0039] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 14 parts of honeysuckle vine, 8 parts of Millettia reticulata, 16 parts of silkworm excrement, 12 parts of gentian, 2 parts of safflower, 8 parts of peach kernel, 8 parts of Qinpi, 10 parts of Arisaema ciliata, 6 parts of Shenqu, and 8 parts of honeycomb.

[0040] Example 5

[0041] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 10 parts of honeysuckle vine, 5 parts of Millettia reticulata, 10 parts of silkworm excrement, 5 parts of gentian, 1 part of safflower, 1 part of peach kernel, 1 part of Qinpi, 1 part of Arisaema ciliata, 1 part of Shenqu, and 1 part of honeycomb.

[0042] Example 6

[0043] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 22 parts of honeysuckle vine, 20 parts of Millettia reticulata, 24 parts of silkworm excrement, 20 parts of gentian, 7 parts of safflower, 16 parts of peach kernel, 16 parts of Qinpi, 18 parts of Arisaema ciliata, 15 parts of Shenqu, and 16 parts of honeycomb.

[0044] Example 7

[0045] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is composed of the following raw materials in parts by weight: 20 parts of honeysuckle vine, 18 parts of Millettia reticulata, 22 parts of silkworm excrement, 17 parts of gentian, 6 parts of safflower, 13 parts of peach kernel, 13 parts of Qinpi, 15 parts of Arisaema ciliata, 10 parts of Shenqu, and 13 parts of honeycomb.

[0046] Test Example 1

[0047] 1 Materials and methods

[0048] 1.1 Experimental animals

[0049] 70 SPF SD rats, male, weighing 180-200 g, were purchased from Beijing Weitonglihua Experimental Animal Co., Ltd.

[0050] 1.2 Trial Drugs

[0051] 18 parts of honeysuckle vine, 12 parts of millettia reticulata, 20 parts of silkworm excrement, 15 parts of gentian, 3 parts of safflower, 9 parts of peach kernel, 9 parts of qinpi, 10 parts of arisaema cinerea, 7 parts of Shenqu, and 9 parts of honeycomb.

[0052] Weigh each raw material according to the above weight proportions, wash and chop, soak in water for 20-30 minutes, transfer to a casserole and boil for 20-30 minutes, filter while hot, repeat twice, combine the two filtrates, and concentrate to a crude drug content of 1 g / mL to obtain the traditional Chinese medicine stock solution.

[0053] Western medicine control drug: benzbromarone;

[0054] Chinese medicine control drug: Tongfengshu tablets.

[0055] 1.3 Animal grouping, modeling and drug administration

[0056] 70 SD rats were randomly divided into blank control group, model control group, western medicine control group, Chinese medicine control group, Chinese medicine low-dose group, Chinese medicine medium-dose group, and Chinese medicine high-dose group, with 10 rats in each group. The rats in the model group and each drug-treated group were intraperitoneally injected with 3% potassium oxonate (prepared with 0.9% saline) and gavaged with 1% adenine (prepared with 0.3% sodium carboxymethylcellulose) at a dose of 10mL / kg. The blank group was intraperitoneally injected with an equal amount of saline and gavaged with sodium carboxymethylcellulose solution, once a day, for continuous modeling for 14 days; on the 13th day, except for the blank group, the animals were anesthetized, the posterior side of the right ankle joint was selected as the puncture point, and the posterior side of the right ankle joint of the rat was inserted into the joint cavity at a 45° direction along the medial side of the Achilles tendon. After feeling a sense of emptiness, 0.1mL of 25mg / mL sodium urate solution was injected into the joint cavity. Compared with the blank group, the model group rats showed bulging on the contralateral side of the joint capsule and a significant increase in serum uric acid levels, indicating successful modeling.

[0057] During the modeling period, drugs were administered synchronously: the blank control group and the model control group were administered with distilled water; the western medicine control group was administered with 10 mg / kg of benzbromarone; the traditional Chinese medicine control group was administered with 400 mg / kg of Tongfengshu tablets; the low-dose group of traditional Chinese medicine preparations was administered with 125 mg / kg of the traditional Chinese medicine preparations of the present invention; the medium-dose group of traditional Chinese medicine preparations was administered with 250 mg / kg of the traditional Chinese medicine preparations of the present invention; and the high-dose group of traditional Chinese medicine preparations was administered with 500 mg / kg of the traditional Chinese medicine preparations of the present invention, and the drugs were administered continuously for 14 days.

[0058] 1.4 Determination of ankle swelling

[0059] The swelling degree of the ankle joints of the rats was measured before modeling and at 6, 12, 24 and 48 h after modeling. The drainage volume of the ankle joints of the right hind limbs of the rats was measured using a toe volume meter to evaluate the swelling degree of the joints of the rats.

[0060] Joint swelling degree = (joint drainage volume at the 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 animals were fasted for 12 hours and anesthetized. Blood was collected through the abdominal aorta and centrifuged at 3000 rpm for 10 minutes. The supernatant was stored in a 4°C refrigerator for later use. Serum uric acid, creatinine and XOD levels were determined according to the instructions of each kit.

[0063] 1.6 Determination of serum inflammation-related factors

[0064] Take the spare serum and determine the levels of inflammatory related factors TNF-α, IL-1β, and IL-6 in the serum according to the instructions of the ELISA detection kit.

[0065] 1.7 Statistical methods

[0066] The data were analyzed using Graphpad Prism 8.0 statistical software. One-way analysis of variance was used for comparison among different groups. The rank sum test was used when the variances were unequal. Differences were considered statistically significant when P < 0.05.

[0067] 2 Results

[0068] 2.1 Effects of various drugs on ankle swelling in rats

[0069] The effects of various drugs on ankle swelling in rats with acute gouty arthritis model are shown in Table 1. Compared with the blank control group, the ankle swelling of rats in the model control group at the same time point was significantly increased (P<0.01), and reached a peak 24 hours after modeling; compared with the model control group, the ankle swelling of rats in each drug-treated group at the same time point was reduced to varying degrees, indicating that the Chinese medicine preparation of the present invention can reduce the ankle swelling of rats with acute gouty arthritis model and reduce the inflammatory response of the ankle joint of rats. Among them, the high-dose group had the best effect, which was better than the Chinese medicine control group.

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

[0071] Grouping 6h 12h 24h 48h Blank control group 12.44±2.85 13.92±1.82 13.67±1.58 12.63±2.50 Model control group <![CDATA[56.27±3.03 ## ]]> <![CDATA[74.84±2.44 ## ]]> <![CDATA[75.22±1.82 ## ]]> <![CDATA[70.78±2.50 ## ]]> Western medicine control group <![CDATA[36.87±2.32 ** ]]> <![CDATA[46.03±2.29 ** ]]> <![CDATA[41.88±2.14 ** ]]> <![CDATA[34.83±2.24 ** ]]> Chinese medicine control group <![CDATA[44.16±3.17 ** ]]> <![CDATA[52.11±1.74 ** ]]> <![CDATA[47.93±1.66 ** ]]> <![CDATA[41.31±1.80 ** ]]> Low-dose Chinese medicine preparation group 50.77±1.56 <![CDATA[62.68±2.16 ** ]]> <![CDATA[56.26±2.04 ** ]]> <![CDATA[50.48±2.43 ** ]]> Chinese medicine preparation medium dose group <![CDATA[46.16±2.09 ** ]]> <![CDATA[56.58±2.58 ** ]]> <![CDATA[49.85±1.48 ** ]]> <![CDATA[45.59±3.14 ** ]]> High-dose Chinese medicine preparation group <![CDATA[40.78±2.32 ** ]]> <![CDATA[48.39±3.14 ** ]]> <![CDATA[46.94±2.00 ** ]]> <![CDATA[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 various drugs on serum uric acid, creatinine and XOD in rats

[0074] Table 2 shows the effects of various drugs on serum uric acid, creatinine and XOD in rats with acute gouty arthritis model. Compared with the blank control group, the serum uric acid, creatinine and XOD levels of rats in the model control group were significantly increased (P<0.01). 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 Chinese medicine preparation of the present invention can significantly inhibit the formation of uric acid and improve the excretion capacity of the kidney, among which the high-dose group had the best effect.

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

[0076] Grouping Uric acid (μmol / L) Creatinine (μmol / L) XOD(U / L) Blank control group 91.76±6.30 22.19±2.53 20.86±2.31 Model control group <![CDATA[258.49±6.13 ## ]]> <![CDATA[66.66±2.27 ## ]]> <![CDATA[39.80±2.16 ## ]]> Western medicine control group <![CDATA[139.16±4.29 ** ]]> <![CDATA[28.80±2.76 * ]]> <![CDATA[25.04±2.03 ** ]]> Chinese medicine control group <![CDATA[163.56±4.35 ** ]]> <![CDATA[34.05±1.80 ** ]]> <![CDATA[26.79±2.58 ** ]]> Low-dose Chinese medicine preparation group <![CDATA[207.08±7.68 ** ]]> <![CDATA[51.64±2.16 ** ]]> 34.45±2.18 Chinese medicine preparation medium dose group <![CDATA[187.68±4.99 ** ]]> <![CDATA[41.64±3.03 ** ]]> <![CDATA[31.89±3.07 ** ]]> High-dose Chinese medicine preparation group <![CDATA[157.60±5.95 ** ]]> <![CDATA[31.69±3.26 ** ]]> <![CDATA[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 Effects of each drug on inflammatory factors in rat serum

[0079] Table 3 shows the effects of each drug group on serum inflammation-related factors in rats with acute gouty arthritis model. Compared with the blank control group, the serum TNF-α, IL-1β, and IL-6 levels of rats in the model group were significantly increased (P<0.01). Compared with the model control group, the serum TNF-α, IL-1β, and IL-6 levels of rats in each drug group were significantly decreased (P<0.01), indicating that the Chinese medicine preparation of the present invention can reduce the inflammatory response by inhibiting the secretion of inflammation-related factors, among which the high-dose group has the most obvious effect.

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

[0081] Grouping TNF-α IL-1β IL-6 Blank control group 215.54±12.07 95.58±9.69 112.76±11.98 Model control group <![CDATA[434.31±19.51 ## ]]> <![CDATA[361.46±18.07 ## ]]> <![CDATA[280.55±21.33 ## ]]> Western medicine control group <![CDATA[275.95±11.70 ** ]]> <![CDATA[162.62±25.63 ** ]]> <![CDATA[145.41±8.65 ** ]]> Chinese medicine control group <![CDATA[291.67±5.72 ** ]]> <![CDATA[184.42±9.47 ** ]]> <![CDATA[175.67±11.01 ** ]]> Low-dose Chinese medicine preparation group <![CDATA[373.49±20.71 ** ]]> <![CDATA[272.38±14.71 ** ]]> <![CDATA[223.66±7.89 ** ]]> Chinese medicine preparation medium dose group <![CDATA[345.02±19.26 ** ]]> <![CDATA[219.54±15.39 ** ]]> <![CDATA[190.72±13.39 ** ]]> High-dose Chinese medicine preparation group <![CDATA[284.58±20.60 ** ]]> <![CDATA[168.42±17.08 ** ]]> <![CDATA[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 Chinese medicine preparation of the present invention can significantly reduce the swelling of the ankle joints of rats with acute gouty arthritis model, reduce inflammatory cell infiltration; reduce the expression levels of inflammatory factors TNF-α, IL-1β, and IL-6 in rat serum, thereby achieving anti-inflammatory and analgesic effects; and can significantly reduce the content of serum uric acid, creatinine, and XOD in rats, and achieve the purpose of reducing blood uric acid by inhibiting uric acid production and promoting uric acid excretion. Among the various dosages, the high-dose group has the best therapeutic effect on acute gouty arthritis.

[0085] Test Example 2

[0086] 1 Materials and methods

[0087] 1.1 General Information

[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 randomly divided into a control group and an observation group according to the random number method, with 39 cases in each group. There were 28 males and 11 females in the control group, aged 32-69 years old, with an average age of (51.13±13.03) years old; there were 29 males and 10 females in the observation group, aged 36-64 years old, with an average age of (50.07±11.57) years old. There was no significant difference in gender, age, etc. between the two groups (P<0.05).

[0089] 1.2 Diagnostic criteria

[0090] 1.2.1 Western medicine diagnostic criteria

[0091] The patient meets the diagnostic criteria for acute gout attack in the "2016 Chinese Gout Diagnosis and Treatment Guidelines" and is confirmed by ultrasound examination.

[0092] 1.2.2 TCM diagnostic criteria

[0093] It meets the relevant standards of bone arthritis in the "Guidelines for Clinical Research of New Chinese Medicines", with symptoms including: joint pain and swelling, which are sometimes mild and sometimes severe, difficulty in bending and stretching, or cold and painful joints, fear of cold and preference for warmth, cold limbs, frequent urination, pale and fat tongue, white or greasy tongue coating, and deep and thin or deep and stringy pulse.

[0094] 1.3 Inclusion and Exclusion Criteria

[0095] 1.3.1 Inclusion criteria

[0096] (1) Patients diagnosed with gout; (2) Acute attack <72h; (3) The condition was confirmed by blood routine, blood uric acid measurement and laboratory tests; (4) Patients agreed and signed the informed consent form.

[0097] 1.3.2 Exclusion criteria

[0098] (1) Patients with combined joint deformity, joint infection, rheumatism, and rheumatoid arthritis; (2) Patients with combined pigmented villonodular synovitis; (3) Patients with serious organic diseases such as heart, liver, and kidney; (4) Patients with severe arthritis and deformity requiring surgical treatment; (5) Patients who have taken nonsteroidal anti-inflammatory drugs, colchicine, and other drugs within the past month; (6) Patients with autoimmune or infectious diseases; (7) Patients with severe mental illness.

[0099] 1.4 Methods

[0100] 1.4.1 Control group

[0101] Oral etoricoxib tablets 60 mg / time, once / day; colchicine 0.5 mg / time, twice / day, after 3 days of taking, change to 0.5 mg / time, once / day; sodium bicarbonate 1 g / time, 3 times / day, continue treatment for 2 weeks.

[0102] 1.4.2 Observation Group

[0103] On the basis of the treatment of the control group, the Chinese medicine preparation of the present invention is applied, the prescription is: 18 parts of honeysuckle vine, 12 parts of Millettia reticulata, 20 parts of silkworm excrement, 15 parts of gentian, 3 parts of safflower, 9 parts of peach kernel, 9 parts of Qinpi, 10 parts of Arisaema ciliata, 7 parts of Shenqu, 9 parts of beehive; 1 dose / day, decocted in water, taken in the morning and evening, and the treatment is continued for 2 weeks.

[0104] 1.5 Observation indicators and evaluation criteria

[0105] 1.5.1 VAS scoring

[0106] The patient's pain level is assessed using the VAS score, which is determined by the doctor through physical examination. The score ranges from 0 to 10, and the more severe the pain, the higher the score.

[0107] 1.5.2 HSS Scale

[0108] The HSS scale was used to evaluate the knee function of the patients in terms of pain, gait, stability, mobility, dysfunction and range of motion before and after treatment.

[0109] 1.5.3 Inflammatory factors in knee synovial fluid

[0110] The patient was placed in a supine position, and the knee joint was punctured under sterile conditions. 1 mL of light yellow synovial fluid was collected and stored at -80°C.

[0111] The levels of IL-1β and TNF-α in the knee synovial fluid of patients before and after treatment were detected according to the ELISA kit instructions.

[0112] 1.5.4WBC, CRP, ESR

[0113] 4 mL of fasting venous blood was collected from the patients in the morning before and after treatment to detect WBC, CRP, and ESR levels.

[0114] 1.5.6 Incidence of adverse reactions

[0115] The adverse reactions of the two groups of patients were observed and recorded, including gastrointestinal symptoms (such as acid reflux, abdominal distension and 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), etc.

[0116] 1.6 Statistical methods

[0117] SPSS 23.0 statistical software was used to process the data. The count data were expressed as rate (%) and the two groups were compared using χ 2Test; measurement data were expressed as mean ± standard deviation (ˉx±s), independent sample t test was used for inter-group comparison, paired t test was used for intra-group comparison; Mann-Whitney test was used for non-normal distribution. P<0.05 was considered statistically significant.

[0118] 2 Results

[0119] 2.1 Effects of each drug on VAS and HSS scores before and after treatment

[0120] The effects of each drug on the VAS scores of the two groups of patients before and after treatment are shown in Table 1. There was no significant difference in the VAS scores of the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the VAS scores of the control group and the observation group were significantly lower than those before treatment (P<0.01), and the VAS score of the observation group was significantly lower than that of the control group (P<0.01), indicating that the Chinese medicine preparation of the present invention can significantly reduce the pain level of patients and alleviate the degree of joint inflammation in patients.

[0121] 2.2 Effects of each drug on VAS and HSS scores before and after treatment

[0122] The effects of each drug group on the HSS scores of the two groups of patients before and after treatment are shown in Table 1. There was no significant difference in the HSS scores of the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the HSS scores of the control group and the observation group were significantly lower than those before treatment (P<0.05, P<0.01), and the HSS score of the observation group was significantly higher than that of the control group (P<0.01), indicating that the Chinese medicine preparation of the present invention can significantly reduce the pain degree of the patient's knee joint.

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

[0124]

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

[0126] 2.3 Effects of each drug on inflammatory factors in the synovial fluid of the knee joint of patients before and after treatment

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

[0128] Table 2 Comparison of inflammation-related factors in the synovial fluid of the knee joint of patients before and after treatment

[0129]

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

[0131] 2.4 Effects of each drug on serum parameters of patients before and after treatment

[0132] Table 3 shows the effects of each drug on the inflammatory indicators WBC, CRP and ESR in the serum of the two groups of patients before and after treatment. There was no significant difference in the serum indicators between the control group and the observation group before treatment (P>0.05). After 2 weeks of treatment, the serum WBC, ESR and CRP of the control group and the observation group were significantly reduced (P<0.05, P<0.01), and the serum WBC, ESR and CRP of the observation group were significantly lower than those of the control group (P<0.05), indicating that the Chinese medicine preparation of the present invention can significantly alleviate the inflammatory response of patients with acute gouty arthritis.

[0133] Table 3 Comparison of WBC, CRP and ESR in patients' serum before and after treatment

[0134]

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

[0136] 2.5 Occurrence of adverse reactions

[0137] As shown in Table 4, there were 3 cases of gastrointestinal abnormalities, 3 cases of nervous system abnormalities, 2 cases of abnormal blood routine, 2 cases of abnormal liver and kidney function in the control group, and the adverse reaction rate was 25.64%; there was 1 case of gastrointestinal abnormalities, 1 case of nervous system abnormalities, 1 case of abnormal liver and kidney function in the observation group, and the adverse reaction rate was 7.69%, which was significantly lower than that of the control group (P<0.05).

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

[0139]

[0140] 3 Conclusion

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

[0142] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine preparation for dispelling wind and dampness, characterized in that: The invention is composed of the following raw materials in parts by weight: 10-30 parts of honeysuckle vine, 5-25 parts of Millettia reticulata, 10-30 parts of silkworm excrement, 5-25 parts of gentian, 1-10 parts of safflower, 1-20 parts of peach kernel, 1-20 parts of qinpi, 1-20 parts of arisaema cinerea, 1-20 parts of Shenqu and 1-20 parts of beehive.

2. A Chinese medicine preparation for dispelling wind and dampness according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 15-25 parts of honeysuckle vine, 10-18 parts of Millettia reticulata, 15-25 parts of silkworm excrement, 10-20 parts of gentian, 1-5 parts of safflower, 5-15 parts of peach kernel, 5-15 parts of qinpi, 5-15 parts of arisaema cinerea, 5-15 parts of Shenqu and 5-15 parts of beehive.

3. A Chinese medicine preparation for dispelling wind and dampness according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 18 parts of honeysuckle vine, 12 parts of Millettia reticulata, 20 parts of silkworm excrement, 15 parts of gentian, 3 parts of safflower, 9 parts of peach kernel, 9 parts of qinpi, 10 parts of arisaema cinerea, 7 parts of Shenqu and 9 parts of honeycomb.

4. A method for preparing a Chinese medicine preparation for dispelling wind and dampness according to any one of claims 1 to 3, characterized in that: The drug is prepared into any oral dosage form acceptable to the human body, including pills, powders, granules, oral liquids, decoctions and tablets, according to conventional Chinese medicine pharmaceutical methods and with medically acceptable excipients.

5. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a drug for preventing and / or treating acute gout attacks.

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