Traditional Chinese medicine composition for tonifying spleen and eliminating dampness as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for tonifying spleen and eliminating dampness as well as preparation and application thereof. The traditional Chinese medicine composition comprises astragalus membranaceus, radix angelicae pubescentis, codonopsis pilosula, rhizoma atractylodis macrocephalae, poria cocos, Chinese yam, pericarpium citri reticulatae, fructus amomi, platycodon grandiflorum, fructus aurantii and honey-fried licorice root. Different from the traditional viewpoint of emphasizing treatment from liver and kidney, a large number of experimental studies find that spleen deficiency is the important pathogenesis of early KOA, and the traditional Chinese medicine compound with the effects of tonifying spleen, eliminating dampness, dispelling wind, dredging collaterals and relieving pain is developed and used for solving the problem of clinical treatment of early KOA, and has a wide application prospect. The prepared astragalus mongholicus granules have the advantages of being affordable in price, remarkable and stable in curative effect, small in adverse reaction, simple and convenient to prepare and the like, and clinical symptoms of early KOA patients can be relieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a spleen-strengthening and dampness-eliminating traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Knee osteoarthritis (KOA) is a common and intractable bone and joint disease in my country and one of the main causes of limb deformity and disability. The most important pathological change of KOA is cartilage degeneration, which is inevitable once it occurs. So far, there is no drug that can reverse cartilage degeneration. Therefore, intervention in the early stage of the disease when cartilage degeneration is not obvious is an important strategy for the treatment of KOA. At present, early-stage KOA is mainly treated with conservative symptomatic treatment, but the pros and cons of various treatment methods still need to be weighed: exercise is the most economical treatment method, but it has disadvantages such as poor patient compliance and inability to persist for a long time; non-steroidal anti-inflammatory drugs (NSAIDs) are the first-line drugs for relieving KOA pain, but their long-term use is associated with a high incidence of gastrointestinal and cardiovascular adverse events; intra-articular injection of glucocorticoids can quickly relieve inflammation, but it can also cause rapid degradation of the cartilage matrix and should not be used more than twice a year; the clinical efficacy of sodium hyaluronate and medical chitosan is still controversial; intra-articular injection of platelet-rich plasma (PRP) helps inhibit inflammation and repair cartilage and delay disease progression, but its cost is high and it is not suitable for widespread use.

[0003] In the TCM syndrome differentiation and treatment system of KOA, according to the existing guidelines, KOA is divided into five syndrome types: damp-heat arthralgia syndrome, cold-damp arthralgia syndrome, qi stagnation and blood stasis syndrome, liver and kidney deficiency syndrome, and qi and blood deficiency syndrome. For damp-heat arthralgia syndrome, the principle of treatment is to clear away dampness and heat, and Si Miao San is recommended as the basic prescription. For cold-damp arthralgia syndrome, the principle of treatment is to warm the meridians and dispel cold, remove dampness and remove arthralgia, and Qu Bi Tang is recommended as the basic prescription. For qi stagnation and blood stasis syndrome, the principle of treatment is to activate blood circulation and remove blood stasis, unblock the meridians and relieve pain, and Xuefu Zhuyu Tang is recommended as the basic prescription. For liver and kidney deficiency syndrome, the principle of treatment is to nourish the liver and kidney, unblock the meridians and relieve pain, and Zuogui Pills (biased towards yin deficiency) or Yougui Pills (biased towards yang deficiency) are recommended as the basic prescriptions. For qi and blood deficiency syndrome, the principle of treatment is to tonify qi and nourish blood, and Bazhen Tang is recommended as the basic prescription. In clinical practice, the method of nourishing the liver and kidneys is the most widely used. The common ones are: tonifying the kidney and activating blood circulation, tonifying the kidney and strengthening bones, tonifying the kidney and strengthening tendons, tonifying the kidney and unblocking meridians, etc.

[0004] Traditional Chinese medicine has obvious advantages in treating early KOA, which can significantly relieve pain, improve function, and improve the quality of life of patients. The premise for traditional Chinese medicine to exert its efficacy is accurate syndrome differentiation. In this regard, the current mainstream view is to treat KOA from the perspective of liver and kidney, believing that liver and kidney deficiency is the main syndrome of the disease. Prescriptions and medications are mostly based on the principle of tonifying the liver and kidney. While obtaining better clinical outcome indicators, there is also a bottleneck in efficacy, which suggests that the onset of KOA cannot be understood only from the perspective of liver and kidney deficiency.

[0005] The syndrome differentiation and treatment system currently widely used in clinical practice overemphasizes the tonification of liver and kidney, while liver and kidney deficiency is more common in the late stage of the disease, so the treatment method of tonifying liver and kidney may not be suitable for early KOA. In addition, with the change of times, regions and local customs, the distribution of syndromes of this disease will inevitably change accordingly, and the efficacy of blindly following the tonification of liver and kidney is ultimately limited.

[0006] In the early stage, the research team took the lead in formulating and issuing relevant Guangdong provincial local standards and clinical guidelines around KOA, pointing out that the overall incidence of the disease is 8.1%. With the intensification of the aging process of Chinese society, the incidence of KOA will further increase. The related clinical symptoms (joint swelling, pain, joint deformity in severe cases, etc.) and medical expenses seriously threaten the physical and mental health and quality of life of patients. Therefore, solving the prevention and treatment of KOA has important social significance. Summary of the invention

[0007] The purpose of the present invention is to overcome the shortcomings of the prior art and provide a Chinese medicine composition for strengthening the spleen and removing dampness, which is used to solve the clinical treatment problem of early KOA.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is:

[0009] In the first aspect, the present invention provides a Chinese medicine composition for strengthening the spleen and removing dampness, comprising the following components in parts by weight: 10-35 parts of Astragalus, 5-15 parts of Angelica dahurica, 10-25 parts of Codonopsis pilosula, 10-35 parts of Atractylodes macrocephala, 10-25 parts of Poria, 5-15 parts of Dioscorea opposita, 5-15 parts of Tangerine peel, 5-15 parts of Amomum villosum, 5-15 parts of Platycodon grandiflorum, 5-15 parts of Citrus aurantium, and 5-15 parts of Radix Glycyrrhizae Preparata.

[0010] In the early stage of the present invention, according to the physiological characteristics, functions, meridian distribution, etc. of the spleen, combined with the main clinical manifestations of early KOA such as pain location (spleen and stomach meridians), flexion and extension weakness (muscle atrophy), joint swelling and friction sound (abnormal fluid distribution), etc., it was found that spleen deficiency is an important pathogenesis of early KOA, and a Chinese medicine composition for strengthening the spleen and removing dampness is proposed, which is composed of astragalus, angelica dahurica, codonopsis pilosula, atractylodes macrocephala, Poria cocos (Yunling), yam, tangerine peel, amomum villosum, platycodon grandiflorum, fructus aurantii, and licorice. This prescription is based on the modified Shenling Baizhu powder in Taiping Huimin Hejijufang. In the formula, Astragalus membranaceus is used to replenish Qi, relieve stagnation and relieve numbness, while Angelica dahurica dispels wind and dampness, unblocks the meridians and relieves pain. The two are the main medicines; Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Chinese yam, Tangerine peel, Amomum villosum are used to strengthen the spleen and have the function of removing dampness, and are the assistant medicines; Platycodon grandiflorum and Citrus aurantium are used to regulate Qi; finally, roasted Licorice root is used to harmonize the various medicines. The combination of various medicines complements each other and has the effects of strengthening the spleen and removing dampness, dispelling wind and unblocking the meridians and relieving pain.

[0011] Among the Chinese medicinal raw materials used in the present invention, astragalus is the dried root of Mongolian astragalus or membrane capsule astragalus of leguminous plants. It is sweet in nature and slightly warm; it enters the spleen and lung meridians; it has the effects of replenishing qi and raising yang, benefiting the body and strengthening the exterior, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, promoting stagnation and relieving arthralgia, supporting toxins and expelling pus, and astringing sores and promoting muscle regeneration. It can treat qi deficiency and fatigue, poor appetite and loose stools, edema and oliguria, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia; weak lung qi, cough and shortness of breath; spontaneous sweating due to deficiency of the exterior; internal heat and thirst; blood deficiency and sallow complexion, qi and blood deficiency; qi deficiency and blood stagnation, hemiplegia, arthralgia and numbness; qi and blood deficiency, carbuncle is difficult to ulcerate, and ulcers are not healed for a long time. Modern pharmacology shows that it mainly contains triterpenoid saponins: astragaloside I, II, III, IV (astragaloside A), capsule astragaloside I, II, etc.; flavonoid components: formononetin, calycosin glucoside, etc.; it also contains polysaccharides, amino acids, etc. Astragalus polysaccharides can promote RNA and protein synthesis, make cells grow vigorously, prolong life, and resist fatigue, low temperature and influenza virus. Astragalus decoction, polysaccharides and saponins have protective and promoting effects on hematopoietic function. Astragalus total saponins have positive inotropic effects, and astragalus total flavonoids and total saponins can protect ischemic and hypoxic myocardium. Astragalus decoction has the effects of protecting kidneys, eliminating urine protein and diuresis, and has a bidirectional regulating effect on blood pressure. In addition, astragalus has anti-aging, anti-radiation, anti-inflammatory, lipid-lowering, blood sugar-lowering, immune-enhancing, anti-tumor and liver-protecting effects.

[0012] Duhuo is the dried root of the Umbelliferae plant Angelica sinensis. It is pungent, bitter and slightly warm in nature. It enters the kidney and bladder meridians. It has the effects of dispelling wind and dampness, relieving numbness and pain, and relieving the symptoms of the symptoms. It can treat wind-cold-dampness arthralgia, pain in the waist and knees, headache caused by wind-cold and dampness, and headache caused by the hidden wind of Shaoyin. Modern pharmacology shows that it mainly contains osthole, bergamotol, prickly ash toxin, dihydro-eugenol angelic acid ester and other ingredients. Duhuo has anti-inflammatory, analgesic and sedative effects; it has an inhibitory effect on platelet aggregation; and it has a hypotensive effect, but it is not persistent; the bergamotol and prickly ash toxin contained in it have photosensitizing and anti-tumor effects.

[0013] Codonopsis is the dried root of Codonopsis pilosula, Codonopsis pilosula or Codonopsis pilosula of the Campanulaceae family; it is sweet and flat in nature. It enters the spleen and lung meridians; it has the effects of tonifying the spleen and lungs, nourishing blood and promoting body fluid. It can treat spleen and lung qi deficiency, lack of appetite and fatigue, cough and asthma; insufficient qi and blood, sallow complexion, dizziness and fatigue, palpitations and shortness of breath; damage to both qi and body fluid, shortness of breath and thirst, internal heat and thirst. Modern pharmacology shows that it mainly contains Codonopsis pilosula polysaccharides, codonoside, phytosterols, codonopsis lactone, flavonoids, phenolic acids, alkaloids, coumarins, inorganic elements, amino acids, trace elements, etc. Codonopsis pilosula water decoction alcohol precipitation can regulate gastrointestinal motility and resist ulcers. Codonopsis pilosula water decoction can stimulate the release of gastrin. Codonopsis pilosula polysaccharides can promote the growth of bifidobacteria and regulate the imbalance of intestinal flora; it can increase peripheral blood hemoglobin and promote spleen compensatory hematopoietic function; it can also enhance immune function. Codonopsis pilosula saponins can excite the respiratory center. Codonopsis water, alcohol extract and codonopsis polysaccharide can improve learning and memory ability, and have the effect of improving intelligence and resisting dementia. In addition, codonopsis has the effects of delaying aging, resisting hypoxia, resisting radiation, lowering blood sugar, regulating blood lipids and resisting myocardial ischemia.

[0014] Atractylodes macrocephala is the dried rhizome of Atractylodes macrocephala, a plant of the Asteraceae family. It is sweet, bitter and warm in nature. It enters the spleen and stomach meridians. It has the effects of invigorating qi and strengthening the spleen, drying dampness and promoting diuresis, stopping sweating and calming the fetus. It can treat spleen deficiency, fatigue due to poor appetite, abdominal distension and diarrhea, phlegm and fluid palpitations, edema, leucorrhea, spontaneous sweating due to qi deficiency, and restless fetus due to spleen deficiency. It mainly contains volatile oils such as atractylodesone, atractylodes alcohol, atractylodes ether, juniper brain, atractylodes lactone, lactone compounds such as atractylodes lactone I to IV, and double atractylodes lactone, and contains fructose, inulin, atractylodes polysaccharides, various amino acids, atractylodes triols and vitamin A. Atractylodes decoction can promote gastric emptying and small intestinal propulsion function in mice, and can prevent and treat experimental gastric ulcers. Atractylodes lactone I has the effects of enhancing salivary amylase activity, promoting nutrient absorption, and regulating gastrointestinal function. Atractylodes decoction and fluid extract have obvious and lasting diuretic effects. Atractylodes polysaccharides and volatile oils of Atractylodes macrocephala can enhance cellular immune function. Atractylodes macrocephala decoction has anti-aging effects. Atractylodes macrocephala ethanol extract and petroleum ether extract can inhibit the contraction of uterine smooth muscle in experimental animals. In addition, Atractylodes macrocephala has liver protection, gallbladder-promoting, blood sugar-lowering, antibacterial, anti-tumor, sedative, antitussive, and expectorant effects.

[0015] Poria cocos is the dried sclerotium of the fungus Poria cocos of the Polyporaceae family; it is sweet, light and flat in nature; it enters the heart, lung, spleen and kidney meridians; it has the effects of diuresis, invigorating the spleen, and calming the mind. It can treat edema and oliguria; phlegm and fluid, palpitations; spleen deficiency, poor appetite, loose stools and diarrhea; restlessness, palpitations and insomnia. It mainly contains polysaccharides, with the highest content of β-poria polysaccharide; triterpenoid components: pachymic acid, pyrolysic acid, stomatolysic acid, etc.; sterol components: ergosterol, etc. It also contains protein, fat, lecithin, adenine, etc. Poria decoction, syrup, alcohol extract, and ether extract have the effects of diuresis, sedation, anti-tumor, and increasing myocardial contractility, respectively. Poria polysaccharide has the effect of enhancing immune function, as well as protecting the liver, lowering blood sugar, delaying aging, and resisting gastric ulcers.

[0016] Tangerine peel is the dried mature peel of the citrus plant and its cultivated varieties of the Rutaceae family. It is bitter, pungent and warm in nature. It enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It can treat abdominal distension, poor appetite, vomiting and diarrhea caused by spleen and stomach qi stagnation and dampness obstruction; vomiting, hiccups; damp phlegm, cold phlegm, cough and sputum; chest pain. Modern pharmacology shows that it mainly contains volatile oils, flavonoids or flavonoid components, organic amines and trace elements. Tangerine peel decoction has a significant promoting effect on salivary amylase activity, can inhibit the spontaneous activity of rabbit isolated duodenum, reduce contraction and tension; and has a direct inhibitory effect on isolated and in vivo stomach and intestinal motility. Volatile oil can relax isolated bronchial smooth muscle of guinea pigs. Both water extract and volatile oil can block the contraction and spasm of bronchial smooth muscle caused by chloroacetylcholine and histamine phosphate, and have the effects of relieving asthma and antitussive. Volatile oil has a stimulating expectorant effect, and the main active ingredient is limonene. This product also has the effects of raising blood pressure, anti-platelet aggregation, anti-oxidation, anti-aging, cardiotonic, anti-shock, anti-allergic, anti-tumor, antibacterial, contraceptive, anti-ultraviolet radiation, and insecticidal.

[0017] Chinese yam is a dried tuber of the Dioscoreaceae family and is a common medicinal and edible material. Chinese yam is sweet in taste and neutral in nature. It enters the spleen, lung and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting fluid and benefiting the lungs, tonifying the kidneys and astringing essence. It can treat spleen deficiency, poor appetite, chronic diarrhea, excessive leucorrhea, asthma and cough due to lung deficiency, spermatorrhea, leucorrhea and frequent urination due to kidney deficiency, and thirst due to deficiency heat. Modern pharmacology shows that it mainly contains glycosides, mucins, glycoproteins, mannans, allantoin, yam, choline, dopamine, crude fiber, pectin, amylase and trace elements. Chinese yam decoction has preventive and therapeutic effects on animal models of spleen deficiency, inhibits gastric emptying and intestinal propulsion, antagonizes the tonic contraction of isolated ileum, enhances small intestinal absorption, helps digestion, and protects gastric mucosal damage. Chinese yam polysaccharides and Chinese yam decoction can lower blood sugar. Chinese yam polysaccharides can improve nonspecific immune function, specific cellular immunity and humoral immunity. Yam polysaccharides, total flavonoids and yam alcohol extracts have antioxidant and anti-aging effects. The allantoin in yam has anti-irritation, anesthetic analgesic, anti-inflammatory and antibacterial effects. In addition, yam has lipid-lowering and anti-tumor effects.

[0018] Amomum villosum is the dried mature fruit of Amomum villosum, Amomum villosum or Amomum villosum of the ginger family. Amomum villosum is pungent and warm, and it enters the spleen, stomach and kidney meridians. It has the effects of removing dampness and appetizing, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It can treat warm turbidity in the middle, abdominal distension without hunger; spleen and stomach deficiency and cold, vomiting and diarrhea; nausea and vomiting during pregnancy, and restless fetus. Modern pharmacology shows that it mainly contains volatile oils, the main components of which are preferably camphor, borneol, borneol acetate, limonene, nerolidol, etc., and contains saponins. This product can enhance the function of the stomach, promote the secretion of digestive juices, enhance intestinal motility, and discharge the accumulated gas in the digestive tract. It can help digestion and eliminate the symptoms of intestinal flatulence. Amomum villosum can significantly inhibit the aggregation of rabbit platelets caused by ADP, has a significant protective effect on the acute death of mice induced by arachidonic acid, and has a significant effect against the acute death of mice induced by collagen and adrenaline.

[0019] Platycodon grandiflorum is the dried root of Platycodon grandiflorum, a plant of the Campanulaceae family. Platycodon grandiflorum tastes bitter, pungent, and flat. It belongs to the lung meridian and has the effects of clearing the lungs, removing phlegm, relieving sore throat, and draining pus. It can treat cough with a lot of sputum, uncomfortable sputum, chest tightness, sore throat and hoarseness, and lung abscess with spitting pus. Modern pharmacology shows that this product mainly contains triterpenoid saponins: platycodon saponins A, D, polygala saponins, etc.; it also contains platycodon polysaccharides composed of fructose. Platycodon grandiflorum and the saponins it contains can enhance the release of respiratory mucins, showing a strong expectorant effect. Both the decoction and the water extract have a good antitussive effect. There is no obvious antiasthmatic effect when used alone, but the effect is obvious when used in combination as a compound. This product has antibacterial, anti-inflammatory, and immune-enhancing effects, can inhibit gastric juice secretion and anti-ulcer, and has the effects of lowering blood pressure and cholesterol, sedation, analgesia, antipyretic, and anti-allergic. The water extract has a significant liver-protecting effect, both water and alcohol extracts have a blood sugar-lowering effect, and the petroleum ether extract has anti-cancer and antioxidant effects.

[0020] Citrus aurantium is the dried immature fruit of the plant Citrus aurantium and its cultivated varieties of the Rutaceae family. It tastes bitter, pungent, sour, slightly cold, and enters the spleen and stomach meridians. It has the effects of regulating qi, relieving fullness, and relieving stagnation and swelling. It can treat internal stagnation, fullness and pain, heaviness after diarrhea, constipation, phlegm blocking qi stagnation, chest pain, chest congestion, and organ ptosis. This product mainly contains flavonoids: hesperidin, hesperidin, naringin, naringenin, neohesperidin, naringenin, etc.; alkaloids: synephrine, N-methyltyramine, etc.; volatile oils: a-aquafenicol, a-pinene, limonene, linalool, etc. This product also contains protein, carbohydrates, carotene, riboflavin, γ-aminobutyric acid, etc. Citrus aurantium regulates gastrointestinal motility. A small amount of Citrus aurantium decoction can significantly reduce the activity of intestinal smooth muscle, and a small amount has an inhibitory effect on intestinal smooth muscle; it can relieve small intestinal spasm caused by acetylcholine or barium chloride; it has an excitatory effect on gastrointestinal smooth muscle, which can significantly increase the tension of gastric fundus smooth muscle, promote gastric motility, and accelerate gastric emptying. Among them, flavonoid glycosides inhibit the contraction of rat intestinal smooth muscle in vitro, while volatile oils first excite and then inhibit. This product also has anti-ulcer and choleretic effects. In addition, this product also has the effects of regulating uterine function, increasing blood pressure, strengthening the heart, anti-oxidation, antibacterial, analgesic, liver protection, lowering blood sugar, lowering blood lipids, anti-thrombotic, anti-shock, diuretic, and anti-allergic.

[0021] Licorice is the dried root and rhizome of the leguminous plants licorice, licorice inflated fruit or licorice glabra. It tastes sweet and flat, and enters the heart, lung, spleen and stomach meridians. It has the functions of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain and harmonizing various medicines. It can treat spleen and stomach weakness, fatigue and fatigue; insufficient heart qi, palpitations and shortness of breath, pulse knot; carbuncle, sore throat, cough and sputum; abdominal and limb spasm and pain; relieve drug toxicity and potency. This product mainly contains triterpenes such as glycyrrhizin, glycyrrhizic acid, and glycyrrhetinic acid, and flavonoids such as glycyrrhizin, isoliquiritiflavone, herbicide, and isoliquiritigenin; it also contains alkaloids, polysaccharides, coumarins, amino acids and a small amount of volatile components. Glycyrrhetinic acid and flavonoids have anti-arrhythmic effects. Glycyrrhizic acid and flavonoids are the two main active ingredients of licorice in anti-ulcer. Licorice water extract, glycyrrhizic acid, and flavonoids of licorice have anti-Helicobacter pylori effects. Licorice decoction, licorice extract, licorice, isoliquiritigenin, and total flavonoids of licorice can reduce intestinal tension, reduce contraction amplitude, and have an antispasmodic effect. Glycyrrhizic acid, glycyrrhizic acid, and flavonoids of licorice have antitussive, expectorant, and antiasthmatic effects. In addition, licorice has anti-diuretic, lipid-lowering, liver-protecting, and adrenocortical hormone-like effects.

[0022] Preferably, the Chinese medicine composition for strengthening the spleen and removing dampness comprises the following components in parts by weight: 30 parts of Astragalus, 10 parts of Angelica dahurica, 20 parts of Codonopsis pilosula, 30 parts of Atractylodes macrocephala, 20 parts of Poria, 10 parts of Dioscorea opposita, 10 parts of Tangerine peel, 10 parts of Amomum villosum, 10 parts of Platycodon grandiflorum, 10 parts of Citrus aurantium, and 10 parts of Radix Glycyrrhizae.

[0023] Through a large number of experimental studies, the present invention has found that the weight ratio of the Chinese medicinal raw materials in the Chinese medicinal composition for strengthening the spleen and removing dampness is within the above-mentioned range, has significant effects of strengthening the spleen and removing dampness, dispelling wind and unblocking meridians and relieving pain, is mainly used to treat spleen deficiency and dampness obstruction syndrome of knee osteoarthritis, has significant and stable therapeutic effects, and has few adverse reactions. It has unique advantages in improving symptoms such as fatigue, joint swelling, etc. in early KOA patients.

[0024] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition for strengthening the spleen and removing dampness, comprising the following steps: weighing the Chinese medicine raw material components according to weight, extracting with water, concentrating, and drying to obtain the Chinese medicine composition for strengthening the spleen and removing dampness.

[0025] Preferably, the amount of water added is 10 times the weight of the raw material.

[0026] Preferably, the extraction is performed twice.

[0027] Preferably, the extraction time is 1 h.

[0028] Preferably, the extraction temperature is 100°C.

[0029] In a third aspect, the present invention provides use of the above-mentioned spleen-strengthening and dampness-eliminating Chinese medicine composition in the preparation of a medicament for treating knee osteoarthritis.

[0030] Preferably, the knee osteoarthritis is early-stage knee osteoarthritis.

[0031] In a fourth aspect, the present invention provides a medicine for treating early-stage knee osteoarthritis, comprising the above-mentioned spleen-strengthening and dampness-removing Chinese medicine composition.

[0032] Preferably, the drug further comprises pharmaceutically acceptable excipients.

[0033] Preferably, the dosage form of the drug is granules, tablets, pills or capsules.

[0034] More preferably, the drug is in the form of granules, which are taken with boiled water twice a day, with 6 weeks of treatment as one course of treatment.

[0035] The beneficial effects of the present invention are:

[0036] Different from the traditional view that emphasizes "treating from the perspective of liver and kidney", this Chinese medicine compound focuses on the application of spleen-strengthening method, focusing on the early stages of KOA. It does not blindly follow the traditional shackles of nourishing the liver and kidney, and develops a Chinese medicine compound with the effects of strengthening the spleen and removing dampness, removing wind and dredging meridians and relieving pain. It is used to solve the clinical treatment problems of early KOA. It has significant and stable efficacy and few adverse reactions. It has unique advantages, especially in improving symptoms such as fatigue and swollen joints in early KOA patients. DETAILED DESCRIPTION

[0037] In order to better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments.

[0038] Embodiment 1:

[0039] An embodiment of the Chinese medicine composition for strengthening the spleen and removing dampness of the present invention comprises the following components in parts by weight: 30 parts of astragalus, 10 parts of angelica dahurica, 20 parts of codonopsis pilosula, 30 parts of atractylodes macrocephala, 20 parts of poria, 10 parts of yam, 10 parts of tangerine peel, 10 parts of amomum, 10 parts of platycodon, 10 parts of fructus aurantii, and 10 parts of roasted liquorice.

[0040] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness comprises the following steps:

[0041] The Chinese medicine raw material components are weighed according to weight, 10 times the amount of water is added to the medicinal materials and extracted twice at 100° C., each time for 1 hour, the two extracts are combined, concentrated, and dried to obtain the Chinese medicine composition for strengthening the spleen and removing dampness.

[0042] Embodiment 2:

[0043] An embodiment of the Chinese medicine composition for strengthening the spleen and removing dampness of the present invention comprises the following components in parts by weight: 10 parts of Astragalus, 15 parts of Angelica dahurica, 25 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 10 parts of Poria cocos, 15 parts of Dioscorea opposita, 5 parts of Tangerine peel, 5 parts of Amomum villosum, 15 parts of Platycodon grandiflorum, 5 parts of Citrus aurantium, and 5 parts of Radix Glycyrrhizae.

[0044] The preparation method of the spleen-strengthening and dampness-removing Chinese medicine composition is the same as that of Example 1.

[0045] Embodiment 3:

[0046] An embodiment of the Chinese medicine composition for strengthening the spleen and removing dampness of the present invention comprises the following components in parts by weight: 35 parts of Astragalus, 5 parts of Angelica dahurica, 10 parts of Codonopsis pilosula, 35 parts of Atractylodes macrocephala, 25 parts of Poria, 5 parts of Dioscorea opposita, 15 parts of Tangerine peel, 15 parts of Amomum villosum, 5 parts of Platycodon grandiflorum, 15 parts of Citrus aurantium, and 15 parts of Radix Glycyrrhizae.

[0047] The preparation method of the spleen-strengthening and dampness-removing Chinese medicine composition is the same as that of Example 1.

[0048] Comparative Example 1:

[0049] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the Chinese herbal composition for strengthening the spleen and removing dampness of this comparative example is different from Example 1 only in that: this comparative example does not add astragalus, and the other components and weight ratios are the same as Example 1.

[0050] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0051] Comparative Example 2:

[0052] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the Chinese herbal composition for strengthening the spleen and removing dampness of this comparative example is different from Example 1 only in that: this comparative example does not add Angelica dahurica, and the other components and weight ratios are the same as Example 1.

[0053] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0054] Comparative Example 3:

[0055] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the Chinese herbal composition for strengthening the spleen and removing dampness of the comparative example is different from Example 1 only in that: Codonopsis pilosula is not added in this comparative example, and the other components and weight ratios are the same as Example 1.

[0056] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0057] Comparative Example 4:

[0058] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the Chinese herbal composition for strengthening the spleen and removing dampness of this comparative example is different from Example 1 only in that: this comparative example does not add Atractylodes macrocephala, and the other components and weight ratios are the same as Example 1.

[0059] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0060] Comparative Example 5:

[0061] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the Chinese herbal composition for strengthening the spleen and removing dampness of this comparative example is different from Example 1 only in that: this comparative example does not add Poria cocos, and the other components and weight ratios are the same as Example 1.

[0062] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0063] Comparative Example 6:

[0064] A comparative example of the Chinese herbal composition for strengthening the spleen and removing dampness of the present invention, the difference between the Chinese herbal composition for strengthening the spleen and removing dampness in this comparative example and Example 1 is only that: Chinese yam is not added in this comparative example, and the other components and weight ratios are the same as those in Example 1.

[0065] The preparation method of the Chinese medicine composition for strengthening the spleen and removing dampness is the same as that of Example 1 (the missing components are replaced with water in equal parts by weight).

[0066] Experimental Example 1: Clinical trial effect test

[0067] 1. Case source and group treatment

[0068] Early spleen deficiency and dampness obstruction type KOA patients who were receiving conservative treatment were recruited from the orthopedic outpatient clinic of Guangdong Second Traditional Chinese Medicine Hospital and divided into a treatment group and a control group, with 36 cases in each group. The control group was given quadriceps functional exercise, and the treatment group was given the spleen-strengthening and dampness-removing Chinese medicine composition (Qi Du Granules) prepared in Example 1 on the basis of the control group, and the treatment was carried out for 6 weeks, after which the index analysis and testing were performed.

[0069] The specific grouping process is as follows:

[0070] (1) The control group was given quadriceps muscle exercise, including:

[0071] ①Isometric contraction exercise. The patient lies on his back, straightens both lower limbs, dorsiflexes the ankle joints, tightens the quadriceps muscles, slowly lifts the affected limb as high as possible, holds for 10-20 seconds, and then slowly lowers the affected limb. Practice in 3 groups per day, 50 times per group.

[0072] ②Isotonic exercise. The patient sits on the bed with his legs hanging down. Tie a sandbag to the calf. The maximum weight of the sandbag should not exceed 40% of the patient's body weight. Perform knee flexion and extension exercises. Do 3 sets of exercises a day, 15 times per set.

[0073] ③ Vastus medialis muscle exercise. The patient lies on his back with the knee flexed 10-15 degrees, the heel placed on the bed, a 10cm sponge pad or pillow placed on the inside of the knee joint, and both knee joints are forced to move inward for resistance exercise. This is divided into 3 groups per day, 20 times per group. Continue the exercise for 6 weeks.

[0074] (2) In addition to the control group, the treatment group was given Qidu Granules orally. The granules were added to 400 mL of water and taken orally, twice a day, one dose each time, for 6 consecutive weeks.

[0075] 2. Observation indicators

[0076] (1) Analysis of general data of the two groups of patients

[0077] The general data of the patients in the treatment group and the control group are shown in Tables 1 and 2. 2 The results of the t-test and independent sample T-test showed that there were no significant differences in gender, affected side, age, height, weight, and BMI between the two groups (P>0.05), indicating that the two groups were comparable.

[0078] Table 1 Gender and affected side distribution (n=36)

[0079]

[0080] Note: Compared with the control group, P>0.05.

[0081] Table 2 Comparison of age, height, weight and BMI (X±S)

[0082] Group Age (years) Height (cm) Weight(kg) <![CDATA[BMI(kg / m 2 )]]> Treatment Group 58.83±3.08 160.11±4.40 60.20±4.36 23.46±1.26 Control group 59.08±2.89 158.92±5.01 58.91±4.00 23.31±0.83

[0083] Note: Compared with the control group, P>0.05.

[0084] (2) Comparison of extensor peak torque and extensor peak torque / body weight ratio between the two groups before and after treatment

[0085] Peak torque is the peak torque value generated when joint muscles actively contract. Its ratio to body weight is the extensor peak torque / body weight ratio. Both are important reference indicators reflecting muscle strength and motor function. They are tested using the isokinetic muscle strength testing and training system (Bio-dex System4Pro).

[0086] The results of comparison of extensor peak torque are shown in Table 3. There was no significant difference in the extensor peak torque between the two groups of patients before treatment (P>0.05). After 6 weeks of treatment, the peak torque of the treatment group was significantly higher than that of the control group (P<0.01).

[0087] Table 3 Comparison of peak extensor torque between the two groups before and after treatment (X±S)

[0088]

[0089] Note: Compared with before treatment, ##P<0.01; compared with the control group, **P<0.01.

[0090] The results of the comparison of the extensor peak torque / body weight ratio are shown in Table 4. There was no significant difference in the extensor peak torque / body weight ratio between the two groups before treatment (P>0.05), which was comparable. After treatment, the extensor peak torque / body weight ratio of the treatment group was significantly higher than that of the control group (P<0.01).

[0091] Table 4 Comparison of extensor peak torque / body weight ratio between the two groups before and after treatment (X±S)

[0092]

[0093] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0094] (3) Comparison of Womac Index of Knee Joint

[0095] The Womac index of the knee joint is 96 points in total. The lower the total score, the better the knee joint function.

[0096] The results are shown in Table 5. There was no significant difference in WOMAC scores between the two groups before treatment (P>0.05), which was comparable. After treatment, the WOMAC score of the treatment group was significantly lower than that of the control group (P<0.01).

[0097] Table 5 Comparison of WOMAC scores between the two groups before and after treatment (X±S)

[0098]

[0099]

[0100] Note: Compared with before treatment, ##P<0.01; compared with the control group, **P<0.01.

[0101] (4) Comparison of VAS scores between the two groups

[0102] The VAS score range is 0-10 points, 0 points means no pain, 10 points means severe pain that is unbearable, and the higher the score, the higher the pain. Mild: <3 points, slight pain; moderate: 4-6 points, obvious pain but tolerable; severe: 7-10 points, unbearable pain.

[0103] The results are shown in Table 6. There was no significant difference in the VAS scores of the two groups before treatment (P>0.05). After 6 weeks, the VAS scores of the two groups were significantly reduced compared with those before treatment (P<0.05), and the VAS scores of the treatment group were lower than those of the control group (P<0.05).

[0104] Table 6 Comparison of VAS scores between the two groups of patients before and after treatment (X±S)

[0105] VAS score Before treatment Treatment for 6 weeks Treatment Group 5.36±0.23 <![CDATA[2.20±0.12 *# ]]> Control group 5.50±0.26 <![CDATA[2.50±0.14 * ]]>

[0106] Note: * indicates P < 0.05 compared with before treatment, # indicates P < 0.05 compared with the control group.

[0107] (5) Comparison of swelling degree between the two groups

[0108] Swelling degree of knee joint: Use a tape measure to measure the circumference of 10 cm above the upper edge of the patella of the affected limb. Taking into account the differences between individual patients, the difference between the affected knee and the healthy side of each patient, that is, the circumference difference, is calculated to more accurately observe the swelling degree of the affected knee joint.

[0109] The results are shown in Table 7. Before treatment, there was no significant difference in the degree of swelling between the two groups (P>0.05). After 6 weeks of treatment, the degree of swelling in both groups was significantly reduced compared with that before treatment (P<0.05); at the same time, the degree of swelling in the treatment group was more significantly relieved than that in the control group (P<0.05).

[0110] Table 7 Comparison of swelling degree between the two groups of patients before and after treatment (X±S)

[0111]

[0112] Note: * indicates P < 0.05 compared with before treatment, # indicates P < 0.05 compared with the control group.

[0113] Experimental Example 2: Comparison of efficacy among different groups

[0114] The same method as above was used to compare the efficacy of different groups, that is, the Chinese medicine composition for strengthening the spleen and removing dampness prepared in comparative examples 1-6 was compared with that in Example 1. The experimental steps were the same as in Experimental Example 1, and the knee joint Womac score, VAS pain score and knee joint swelling degree were evaluated.

[0115] The results are shown in Tables 8-10. Before treatment, there was no significant difference in the Womac score, VAS pain score, and swelling degree among the groups (P>0.05). After 6 weeks of treatment, the Womac score, VAS pain score, and swelling degree of Example 1 were significantly different from those of Comparative Examples 1-6, and the effect of the formula of Example 1 was significantly improved compared with that before treatment (P<0.05).

[0116] Table 8 Comparison of Womac scores before and after treatment (X±S)

[0117]

[0118] Note: * indicates that compared with before treatment, P < 0.05, # indicates that compared with Example 1, P < 0.05.

[0119] Table 9 Comparison of VAS scores before and after treatment (X±S)

[0120]

[0121] Note: * indicates that compared with before treatment, P < 0.05, # indicates that compared with Example 1, P < 0.05.

[0122] Table 10 Comparison of swelling degree before and after treatment (X±S)

[0123]

[0124]

[0125] Note: * indicates that compared with before treatment, P < 0.05, # indicates that compared with Example 1, P < 0.05.

[0126] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for strengthening the spleen and removing dampness, characterized in that: The invention comprises the following components in parts by weight: 10-35 parts of astragalus, 5-15 parts of angelica dahurica, 10-25 parts of codonopsis pilosula, 10-35 parts of atractylodes macrocephala, 10-25 parts of tuckahoe, 5-15 parts of yam, 5-15 parts of tangerine peel, 5-15 parts of amomum villosum, 5-15 parts of platycodon grandiflorum, 5-15 parts of aurantium and 5-15 parts of roasted liquorice.

2. The Chinese medicine composition for strengthening the spleen and removing dampness as claimed in claim 1, characterized in that: The invention comprises the following components in parts by weight: 30 parts of astragalus, 10 parts of angelica dahurica, 20 parts of codonopsis pilosula, 30 parts of atractylodes macrocephala, 20 parts of tuckahoe, 10 parts of yam, 10 parts of tangerine peel, 10 parts of amomum villosum, 10 parts of platycodon grandiflorum, 10 parts of aurantium and 10 parts of roasted liquorice.

3. A method for preparing the spleen-strengthening and dampness-removing Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The following steps are involved: The Chinese medicine raw material components are weighed according to weight, extracted with water, concentrated and dried to obtain the Chinese medicine composition for strengthening the spleen and removing dampness.

4. Use of the spleen-strengthening and dampness-eliminating Chinese medicinal composition according to any one of claims 1 to 2 in the preparation of a medicament for treating knee osteoarthritis.

5. The use according to claim 4, characterized in that The knee osteoarthritis is early-stage knee osteoarthritis.

6. A drug for treating early-stage knee osteoarthritis, characterized in that: A Chinese medicinal composition for strengthening the spleen and removing dampness comprising any one of claims 1-2.

7. The drug for treating early knee osteoarthritis according to claim 6, characterized in that: Also included are pharmaceutically acceptable excipients.

8. The drug for treating early knee osteoarthritis according to claim 6, characterized in that: The dosage form of the medicine is granules, tablets, pills or capsules.

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