Traditional Chinese medicine composition for treating chronic kidney disease 3-5 as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating chronic kidney diseases in stages 3-5 and a preparation method thereof, the traditional Chinese medicine composition is composed of astragalus membranaceus, rheum officinale, salvia miltiorrhiza, caulis spatholobi, radix achyranthis bidentatae, codonopsis pilosula, gordon euryale seeds, coptis chinensis, perilla leaves, pyrrosia lingua, leeches and liquorice, spleen and kidney tonifying medicine, blood circulation promoting medicine and heat clearing and detoxifying medicine are used together, qi of the spleen and kidney is inflated, blood vessels are smooth, and toxic and side effects are avoided. The traditional Chinese medicines are combined to achieve the effects of tonifying kidney and spleen, promoting blood circulation to remove blood stasis and clearing away heat and turbidity, and the traditional Chinese medicine composition has the effects of improving clinical symptoms of patients suffering from chronic kidney diseases at the third-fifth stage, protecting kidney functions, remarkably improving complications such as calcium and phosphorus metabolism disorder and the like, successfully intervenes in the development process of chronic kidney diseases, and has a remarkable curative effect on treating chronic kidney diseases of the patients suffering from chronic kidney diseases at the third-fifth stage. And the survival and life quality of the patient are improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating chronic kidney disease stages 3-5, and a preparation method and application thereof. Background Art

[0002] Chronic kidney disease is a syndrome characterized by persistent changes in kidney structure, function, or both that affect individual health. The pathogenesis of chronic kidney disease is complex and the condition is lingering. The main pathological feature is renal fibrosis, which continues to progress and eventually leads to end-stage renal disease, seriously affecting the survival and quality of life of patients. The medical expenses required for renal replacement therapy also impose a heavy economic burden on the country, society, and patients' families. Therefore, raising awareness of chronic kidney disease and seeking effective prevention and treatment strategies are of great significance for delaying the progression of chronic kidney disease and reducing the incidence of end-stage renal disease.

[0003] There is currently no cure for chronic kidney disease, especially for patients with chronic kidney disease stages 3-5. Western medicine treats chronic kidney disease mainly by improving lifestyle, using renin-angiotensin system blockers, and symptomatic treatment of various comorbidities and complications to delay its progression, but many patients still inevitably enter the renal replacement therapy stage. Western medicine has neither clear non-invasive diagnostic markers nor specific treatments for renal fibrosis. Although renin-angiotensin system blockers have a certain effect, the effect is not ideal.

[0004] Numerous clinical practices have shown that Chinese medicine has great advantages in the treatment of chronic kidney disease and renal fibrosis. The combination of Chinese and Western medicine in the treatment of chronic kidney disease and renal fibrosis has a positive effect, which can effectively delay the progression of chronic kidney disease to end-stage renal disease, improve patients' clinical symptoms, significantly reduce patients' outpatient and hospitalization costs, and improve patients' survival and quality of life. Therefore, exploring effective Chinese medicine compositions to prevent and treat chronic kidney disease has become a difficult problem for many Chinese medicine practitioners, and it is also the direction and trend of research in recent years. Summary of the invention

[0005] In view of the current situation that there is still a lack of unified and effective treatment plans for the prevention and treatment of chronic kidney disease with traditional Chinese medicine, the inventors of the present invention, based on the traditional Chinese medicine theory, according to the basic pathogenesis of chronic kidney disease, combined with clinical practice experience, found that the prescriptions based on the principle of invigorating Qi, activating blood and clearing away heat can effectively improve the clinical symptoms of patients with chronic kidney disease stages 3-5 who meet the pathogenesis characteristics of spleen and kidney deficiency and blood stasis and dampness in traditional Chinese medicine, protect renal function, reduce urine protein, alleviate complications such as anemia and calcium-phosphorus metabolism disorders, reduce fibrosis, oxidative stress and micro-inflammatory state, and are safe and effective. The invention provides a traditional Chinese medicine composition for treating chronic kidney disease in stages 3-5. The traditional Chinese medicine composition is composed of astragalus, rhubarb, salvia miltiorrhiza, millettia reticulata, achyranthes bidentata, codonopsis pilosula, euryale ferox, coptis chinensis, perilla leaf, pyrrosia, leech and liquorice. The spleen and kidney tonifying drugs, blood circulation drugs and heat-clearing and detoxifying drugs are used together, the spleen and kidney qi are full, the blood vessels are smooth, and the damp-heat turbidity and toxins are removed by themselves. The attack and tonification are applied simultaneously, and the tonification and dispersing are moderate. The combination of the drugs has the effects of tonifying the kidney and strengthening the spleen, activating blood circulation and removing blood stasis, clearing away heat and removing turbidity. The traditional Chinese medicine composition has significant therapeutic effects on improving the clinical symptoms of patients with chronic kidney disease in stages 3-5, protecting renal function, reducing urine protein, alleviating complications such as anemia and calcium-phosphorus metabolism disorders, and improving the survival and quality of life of patients.

[0006] According to the clinical manifestations of chronic kidney disease, it is classified into the categories of "edema", "kidney wind", "urinary retention", "low back pain", "blockage", "kidney fatigue", "drowning poison", "kidney network micro-mass", "yin network disease-kidney network" and so on. The basic pathogenesis is always the root deficiency and superficial excess. Spleen and kidney deficiency is the root of deficiency, and blood stasis, damp heat, and turbid toxins are the main excess evils. From the clinical manifestations, patients with chronic kidney disease in stages 3-5 of chronic kidney disease often have symptoms such as fatigue, sore waist and knees, dull complexion, numbness of limbs, nausea and vomiting, heavy limbs, pale tongue with teeth marks or purple or yellow greasy tongue, and sluggish or deep pulse. These clinical manifestations suggest that spleen and kidney deficiency and blood stasis and dampness are actually the main mechanisms of chronic kidney disease.

[0007] Deficiency of spleen and kidney is an important internal basis for the occurrence and development of chronic kidney disease and renal fibrosis. Traditional Chinese medicine emphasizes that "kidney disease is mostly caused by deficiency" and "long-term illness affects the kidney". The kidney is the root of vital energy and the innate foundation, and contains the original yin and yang. The essence of the kidney is transformed into yang, which is the yang of the human body, and the essence of the kidney is transformed into yin, which is the yin of the human body. The essence stored in the kidney is the original power and material basis of human life activities. The spleen and kidney have the same origin. The spleen transports and transforms the essence of water and grain, and at the same time transforms it into qi and blood, which is the acquired foundation. "Suwen" says that "the central soil irrigates the four sides", and it nourishes each other with the innate foundation of the kidney that stores the essence. The kidney is responsible for opening and closing water, while the spleen is responsible for transporting and transforming water and moisture. The two work together to regulate water metabolism. If the spleen and kidney are deficient, the distribution and transportation of qi, blood, body fluids and body fluids will be unbalanced, and pathological products such as dampness, heat, blood stasis, and turbid toxins will be generated endogenously. Many pathological products will stagnate in the body, and then damage the vital energy, or the deficiency will lead to excess, or the excess will lead to deficiency, and finally lead to deficiency in the main and excess in the secondary, or a mixture of deficiency and excess. Clinically, symptoms mainly due to spleen and kidney deficiency are often seen, such as sore waist and weak knees, fatigue, cold limbs and fear of cold, frequent and clear urination, tinnitus and dizziness. Modern medicine believes that pathological changes such as the reduction in the number of healthy renal units, thinning of the renal cortex and renal fibrosis are also signs of spleen and kidney deficiency in patients with chronic kidney disease, especially kidney deficiency and essence deficiency. Studies on the syndrome of related chronic kidney disease also show that spleen and kidney deficiency is the most common in the deficiency syndrome of chronic kidney disease, and it always runs through the disease.

[0008] Blood stasis runs through chronic kidney disease and renal fibrosis. Traditional Chinese medicine has always said that "long-term illness leads to more blood stasis" and "blood stasis blocks the collaterals, blood and qi are not harmonious, and all kinds of diseases arise". Chronic kidney disease is difficult to cure and the course of the disease is prolonged. Various factors such as spleen and kidney deficiency, damp heat, turbidity and toxins can all cause blood stasis. Spleen and kidney qi deficiency, qi is the leader of blood. If the spleen and kidney qi is insufficient, qi deficiency cannot promote the circulation of blood, and blood circulation is weak and stasis occurs, which is what "Medical Error Correction" says: "If the original qi is weak, it will not reach the blood vessels. If the blood vessels have no qi, they will stop flowing and stagnate. This is qi deficiency and blood stasis"; damp heat, turbidity and toxins enter the collaterals and fight with the blood, causing the meridian qi to be blocked, and the blood becomes stagnant due to the stagnation of toxic evils, which is the so-called "blood is simmered into lumps when heated" and "warm poison burns the blood inside, and the blood is burned and condensed". Damp-heat turbidity and blood stasis are intertwined, and clinical symptoms include chest tightness, heaviness of limbs, back pain and knee pain, dark complexion, etc., often accompanied by dark red or dark tongue, greasy or yellow tongue coating, thin and stringy or smooth pulse, loose stools or sticky and uncomfortable stools, etc., which are symptoms of internal damp-heat turbidity and blood stasis blocking the collaterals. Among the pathological manifestations of renal fibrosis, pathological changes such as glomerular sclerosis, renal interstitial fibrosis and renal vascular sclerosis can all be classified as "blood stasis syndrome" in traditional Chinese medicine. Blood stasis is both the main pathological product in the disease process and an important pathogenic factor. It runs through the entire process of chronic kidney disease and renal fibrosis, affecting the progression and outcome of the disease.

[0009] Damp-heat turbidity is an important part of chronic kidney disease and renal fibrosis. The kidney governs water and controls opening and closing, while the spleen governs transportation and transformation. The transpiration and gasification of the kidney dominates the water metabolism in the body. When the kidney's essence and qi are deficient and damaged, the gasification and transpiration are abnormal, the opening and closing are out of control, and the spleen is weak, and the water and dampness cannot be transported and transformed, which causes water distribution and metabolism disorders, leading to water and dampness stagnation. Xue Shengbai said, "Taiyin internal affairs, dampness and drink stagnate, and foreign evil comes again, and the inside and outside attract each other, so the disease is damp-heat." "Danxi's Heart Method" also said: "Turbidity controls dampness and heat." Therefore, water and dampness are affected by external infection, internal injury, and medicine and food. After a long time, heat turns into turbidity and becomes damp-heat turbidity. "Yi Fang Kao" said, "Diseases in the lower part of the body are caused by dampness and heat." Xu Dachun also said, "If there is dampness, there is heat. Although it may not be true, dampness is often easy to turn into heat." Dampness is a yin evil, and the spleen and kidneys are located in the lower part of the body. They are all yin organs and share the same qi. Therefore, dampness, heat, turbidity and toxins are extremely common in chronic kidney disease and renal fibrosis. This is consistent with many studies in modern syndromeology and can be attributed to the categories of inflammatory cell infiltration, swelling of intrinsic cells such as tubular epithelial and endothelial cells, and proliferation of extracellular matrix in the active stage in renal pathology.

[0010] In the pathological state of renal fibrosis in patients with chronic kidney disease, spleen and kidney deficiency, blood stasis, damp heat turbidity and toxins are mutually causal and mutually entangled into the disease. Spleen and kidney deficiency is not conducive to transportation and transformation, which is easy to accumulate damp heat turbidity and toxins. Dampness and turbidity are heavy and sticky and block the qi mechanism. Heat damages the yin and damages the collaterals, and blood overflows and hinders blood circulation. In addition, damp heat turbidity and toxins are entangled, which promotes and aggravates blood stasis and blood stasis. Once stasis and dampness are formed, it will damage the body's positive energy, easily leading to obstacles in the transportation and distribution of essence, qi, blood, body fluids, and spleen and kidneys are not nourished, thereby aggravating spleen and kidney deficiency. The three major pathological mechanisms of spleen and kidney deficiency, damp heat turbidity and toxins, and blood stasis affect each other and accelerate renal fibrosis.

[0011] In summary, the inventors of the present invention finally found that the treatment of chronic kidney disease should focus on the main links and main contradictions. Based on this, the inventors believe that tonifying the kidney and spleen, promoting blood circulation and removing blood stasis, clearing away heat and purging turbidity are the key. In clinical practice, there are many patients with spleen and kidney deficiency, blood stasis and dampness, so on the basis of syndrome differentiation and treatment, attention should be paid to tonifying the qi of the spleen and kidney, promoting blood circulation and clearing away. When the qi is strong, the blood flows, and when the qi is full and the blood is smooth, it is conducive to the removal of dampness and turbidity. The above is the treatment mechanism proposed by the inventors, and it is applied to the specific treatment process.

[0012] On the basis of the above treatment mechanism and in combination with the action mechanism of related drugs, the inventors provide the following specific technical solutions:

[0013] A Chinese medicine composition for treating patients with chronic kidney disease stage 3-5, prepared from the following raw materials in weight ratio:

[0014] 20-45 parts of Astragalus, 6-12 parts of Rhubarb, 12-18 parts of Salvia miltiorrhiza, 9-12 parts of Millettia reticulata, 12-18 parts of Achyranthes bidentata, 9-15 parts of Perilla frutescens, 12-20 parts of Pyrola, 20-30 parts of Euryale ferox, 2-6 parts of Leech, 9-12 parts of Codonopsis pilosula, 9-15 parts of Coptis chinensis, and 6-9 parts of Licorice.

[0015] Furthermore, the Chinese medicine composition for treating chronic kidney disease stage 3-5 is characterized in that: the Chinese medicine composition is prepared from raw materials in the following weight ratio:

[0016] 30 parts of Astragalus, 9 parts of Rhubarb, 15 parts of Salvia miltiorrhiza, 12 parts of Millettia reticulata, 15 parts of Achyranthes bidentata, 12 parts of Perilla frutescens, 15 parts of Pyrrosia, 30 parts of Euryale ferox, 3 parts of Hirudo, 10 parts of Codonopsis pilosula, 10 parts of Coptis chinensis, and 6 parts of Licorice.

[0017] Furthermore, the Chinese medicine composition for treating chronic kidney disease stages 3-5 is prepared from the powder of the raw material drug, or the water or ethanol extract of the raw material drug as the active ingredient, and the excipients or auxiliary ingredients commonly used in pharmacy.

[0018] Furthermore, the preparation is an oral preparation.

[0019] Furthermore, the oral preparation is a capsule, granule, powder, pill, tablet, oral liquid or decoction.

[0020] The preparation method of the Chinese medicine composition for treating chronic kidney disease stage 3-5 of the present invention comprises the following steps:

[0021] (1) Weighing raw materials and auxiliary materials according to weight ratio; (2) Using the powder of the raw material drug, or the water or ethanol extract of the raw material drug as the active ingredient, and adding the auxiliary materials or auxiliary ingredients commonly used in pharmacy to prepare it.

[0022] Furthermore, the preparation method of the Chinese medicine composition for treating chronic kidney disease stage 3-5 is characterized by: firstly weighing out each Chinese medicine according to the ratio of the raw materials, then adding water until the surface of the medicine is covered by 2-3 fingers, soaking for 1 hour, boiling over high heat, then simmering over low heat for 30 minutes, filtering out the medicine juice for later use, adding water to the residue again, until the surface of the residue is covered by 1-2 fingers, boiling over high heat, then simmering over low heat for 20 minutes, filtering out the medicine juice and combining it with the previous medicine juice.

[0023] The present invention also provides use of the traditional Chinese medicine composition for treating chronic kidney disease stages 3-5 in preparing a drug for treating chronic kidney disease.

[0024] Furthermore, the chronic kidney disease is chronic kidney disease stage 3-5.

[0025] Furthermore, the Chinese medicine composition improves renal function in patients with chronic kidney disease.

[0026] The properties, taste, meridians and effects of each Chinese medicine in the Chinese medicine composition of the present invention are as follows:

[0027] Astragalus: sweet in nature and slightly warm in flavor, it enters the lung and spleen meridians, replenishes qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and reduces edema, promotes the production of body fluids and nourishes blood, relieves stagnation and arthritis, removes toxins and discharges pus, and heals sores and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, long-term diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency and edema, internal heat and thirst, blood deficiency and sallow complexion, hemiplegia, pain and numbness of arthritis, carbuncles that are difficult to heal, and long-term sores that do not heal.

[0028] Rhubarb: bitter in taste, cold in nature, enters the spleen, stomach, large intestine, liver, and pericardium meridians, clears heat and clears the intestines, cools blood and detoxifies, removes blood stasis and dredges the menstruation; used for constipation due to excess heat, abdominal pain due to accumulation of blood, uncomfortable diarrhea, jaundice due to damp heat, vomiting and bleeding due to blood heat, red eyes, swollen throat, abdominal pain due to intestinal abscesses, carbuncles and furuncles, amenorrhea due to blood stasis, injuries from falls, and external treatment of burns caused by water or fire; upper gastrointestinal bleeding.

[0029] Salvia miltiorrhiza: bitter in taste, slightly cold in nature, enters the heart and liver meridians, promotes blood circulation and removes blood stasis, cools blood and eliminates carbuncles, clears the heart and relieves restlessness; it is used for symptoms such as irregular menstruation, blood stasis and amenorrhea, abdominal pain due to postpartum blood stasis, heart and abdominal pain, accumulation of lumps and masses, and limb pain.

[0030] Millettia reticulata: bitter, slightly sweet, warm in nature, enters the liver and kidney meridians, promotes blood circulation, replenishes blood, regulates menstruation, relaxes muscles and activates collaterals; used for irregular menstruation, dysmenorrhea, amenorrhea, rheumatic pain, numbness of hands and feet, paralysis of limbs, and anemia and sallow complexion.

[0031] Achyranthes bidentata: sweet, slightly bitter in taste, neutral in nature, enters the liver and kidney meridians, promotes blood circulation, removes blood stasis, dispels wind and removes dampness; used for blood stasis, amenorrhea, dysmenorrhea, bruises, rheumatic pain in the waist and knees, joint discomfort, hematuria, and hematuria.

[0032] Perilla leaves: spicy in taste, warm in nature, enter the lung and spleen meridians, have the effects of dispelling cold, promoting qi and harmonizing the stomach, and are used for colds, coughs, nausea, vomiting during pregnancy, and fish and crab poisoning.

[0033] Selaginella: sweet and bitter in taste, slightly cold in nature, enters the lung and bladder meridians, promotes diuresis and relieves stranguria, clears the lungs and relieves heat; used for stranguria pain, hematuria, urinary tract stones, nephritis, metrorrhagia, dysentery, lung heat cough, chronic tracheitis, wounds, carbuncles and other symptoms.

[0034] Gorgon fruit: sweet, astringent, neutral in nature, enters the spleen and kidney meridians, nourishes the kidneys and consolidates essence, tonifies the spleen and stops diarrhea, removes dampness and stops leukorrhea; used for nocturnal emission, spermatorrhea, diarrhea due to spleen deficiency, leukorrhea due to spleen deficiency, and leukorrhea.

[0035] Leeches: salty and bitter in taste, neutral in nature, enter the liver meridian, break up blood, remove blood stasis, and regulate menstruation; used for abdominal masses, blood stasis, amenorrhea, and injuries from falls.

[0036] Codonopsis: sweet in taste, neutral in nature, enters the lung and spleen meridians, tonifies the middle and replenishes qi, quenches thirst, strengthens the spleen and benefits the lungs, nourishes blood and produces body fluid; used for spleen and lung qi deficiency, poor appetite and fatigue, cough and weak wheezing, insufficient qi and blood, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluid, and internal heat and thirst.

[0037] Coptis chinensis: cold in nature, bitter in taste, enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians, clears away heat and dampness, purges fire and detoxifies; used for damp-heat and fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, vomiting and bleeding due to blood heat, red eyes, toothache, thirst, carbuncles and furuncles; externally used for eczema, wet sores, and pus in the ear canal.

[0038] Licorice: sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians, tonifies the spleen and replenishes Qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines; it is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive sputum, cramps and pain in the abdomen and limbs, carbuncles and sores, and relieves the toxicity and potency of drugs.

[0039] The above components are scientifically matched and used together to nourish the kidney and spleen, promote blood circulation and remove blood stasis, clear away heat and relieve turbidity, and have a definite effect in the treatment of chronic kidney disease.

[0040] The best therapeutic effect can be obtained within the above dosage range. Too much or too little drug dosage will lead to changes in the priority of the pathogenesis around which the prescription is formulated.

[0041] Beneficial effects of the present invention:

[0042] In the prescription of the present invention, astragalus, salvia miltiorrhiza and rhubarb are the main drugs. Astragalus not only nourishes the qi of the spleen and kidney, but also promotes diuresis and reduces swelling. Salvia miltiorrhiza not only promotes blood circulation and removes blood stasis, but also cools blood and eliminates carbuncle. Rhubarb is used for qi and blood, and not only regulates qi, attacks accumulation and purges, but also cools blood, removes blood stasis and promotes blood circulation, clears heat, removes turbidity and detoxifies. Astragalus, salvia miltiorrhiza and rhubarb are the main drugs, and they play the role of "tonifying the spleen and kidney, removing blood stasis and removing dampness and turbidity". Codonopsis, Achyranthes bidentata, Coptis chinensis, Perilla frutescens and Pyrola serrata are the ministerial drugs. Codonopsis pilosula strengthens the spleen and produces body fluid, Achyranthes bidentata nourishes the kidney and promotes blood circulation, Coptis chinensis is combined with Perilla frutescens to clear heat and harmonize the stomach, and Pyrola serrata promotes diuresis and relieves stranguria. The five are used as ministerial drugs with the effect of nourishing the kidney, promoting blood circulation and removing urination. Euryale ferox is used to strengthen the kidney and astringe the essence, Millettia spatholobi promotes blood circulation and relaxes muscles, Hirudo removes blood stasis and eliminates symptoms, and Licorice is used to coordinate the various drugs. The whole formula has the effects of nourishing the kidney and spleen, promoting blood circulation and removing blood stasis, clearing away heat and relieving turbidity.

[0043] After treatment with the Chinese medicine composition of the present invention, renal function and complications of phosphate-calcium metabolism disorders are significantly improved, and the development process of chronic kidney disease can be successfully intervened.

[0044] The Chinese medicine composition of the present invention can significantly reduce the serum creatinine of patients with chronic kidney disease, thereby improving the glomerular filtration rate, significantly intervening in and reversing the progression of chronic kidney disease, having a significant clinical effect and being superior to similar clinical drugs, and providing a better product for clinically alleviating and curing patients with advanced chronic kidney disease.

[0045] The Chinese medicine composition of the present invention has definite clinical efficacy, high safety, simple preparation method, low cost, and readily available raw materials, and has a prospect of application in the field of chronic kidney disease treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 Comparison of serum creatinine in each group

[0047] Compared with the normal control group, # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Example 1 group, & P<0.05, && P<0.01.

[0048] Figure 2 Comparison of urea nitrogen in each group

[0049] Compared with the normal control group, # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, & P<0.05, && P<0.01.

[0050] Figure 3 Comparison of serum phosphorus in each group

[0051] Compared with the normal control group, # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, & P<0.05, && P<0.01.

[0052] Figure 4 Comparison of serum calcium in each group

[0053] Compared with the normal control group, # P<0.05, ## P<0.01; compared with the model control group, * P<0.05; compared with the Example 1 group, & P<0.05, && P<0.01.

[0054] Figure 5 To compare the clinical efficacy of each group. DETAILED DESCRIPTION

[0055] The technical solution of the present invention is further described in detail below in conjunction with the accompanying drawings of the specification, but the protection scope of the present invention is not limited to the following.

[0056] Example 1

[0057] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 30g of astragalus, 9g of rhubarb, 15g of salvia miltiorrhiza, 12g of millettia reticulata, 15g of achyranthes bidentata, 12g of perilla leaf, 15g of pyrrosia, 30g of euryale ferox, 3g of leech, 10g of codonopsis pilosula, 10g of coptis chinensis, and 6g of liquorice.

[0058] First, weigh out each Chinese medicine according to the ratio of raw materials, add 500 mL of purified water, soak for 1 hour, boil over high heat, then simmer for 30 minutes, filter out the juice for later use, add 500 mL of purified water to the residue again, boil over high heat, then simmer for 20 minutes, filter out the juice and combine it with the previous juice to obtain a Chinese herbal compound decoction for the prevention and treatment of chronic kidney disease.

[0059] Example 2

[0060] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 35g of astragalus, 6g of rhubarb, 18g of salvia miltiorrhiza, 12g of millettia reticulata, 12g of achyranthes bidentata, 9g of perilla leaf, 20g of pyrrosia, 20g of euryale ferox, 6g of leech, 9g of codonopsis pilosula, 15g of coptis chinensis, and 6 parts of liquorice.

[0061] First, weigh out each Chinese medicine according to the ratio of raw materials, add 600 mL of purified water, soak for 1 hour, boil over high heat, then simmer for 30 minutes, filter out the juice for later use, add 400 mL of purified water to the residue again, boil over high heat, then simmer for 20 minutes, filter out the juice and combine it with the previous juice to obtain a Chinese herbal compound decoction for the prevention and treatment of chronic kidney disease.

[0062] Example 3

[0063] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 25g of astragalus, 12g of rhubarb, 12g of salvia miltiorrhiza, 9g of Millettia reticulata, 18g of Achyranthes bidentata, 15g of Perilla frutescens, 12g of Pyrrosia sinensis, 30g of Euryale ferox, 2g of leech, 9g of Codonopsis pilosula, 9g of Coptis chinensis, and 9 parts of liquorice.

[0064] First, weigh out each Chinese medicine according to the ratio of raw materials, add 600 mL of purified water, soak for 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the juice for later use, add 500 mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the juice and combine it with the previous juice to obtain a Chinese herbal compound decoction for the prevention and treatment of chronic kidney disease.

[0065] Example 4

[0066] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 20g of astragalus, 12g of rhubarb, 15g of salvia miltiorrhiza, 10g of millettia reticulata, 15g of achyranthes bidentata, 10g of perilla leaf, 12g of pyrrosia, 20g of euryale ferox, 5g of leech, 12g of codonopsis pilosula, 10g of coptis chinensis, and 8 parts of liquorice.

[0067] First, weigh out each Chinese medicine according to the ratio of raw materials, add 500mL of purified water, soak for 1h, boil over high heat, then simmer for 30min, filter out the juice for later use, add 600mL of purified water to the residue again, boil over high heat, then simmer for 20min, filter out the juice and combine it with the previous juice to obtain a Chinese herbal compound decoction for the prevention and treatment of chronic kidney disease.

[0068] Example 5

[0069] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 45g of astragalus, 10g of rhubarb, 16g of salvia miltiorrhiza, 11g of millettia reticulata, 16g of achyranthes bidentata, 12g of perilla leaf, 18g of pyrrosia, 20g of euryale ferox, 4g of leech, 12g of codonopsis pilosula, 15g of coptis chinensis, and 6 parts of liquorice.

[0070] First, weigh out each Chinese medicine according to the ratio of raw materials, add 550mL of purified water, soak for 1h, boil over high heat, then simmer for 30min, filter out the juice for later use, add 600mL of purified water to the residue again, boil over high heat, then simmer for 20min, filter out the juice and combine it with the previous juice to obtain a Chinese herbal compound decoction for the prevention and treatment of chronic kidney disease.

[0071] Comparative Example 1

[0072] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 30g of ginseng, 9g of rhubarb, 15g of angelica, 12g of Millettia reticulata, 15g of Achyranthes bidentata, 12g of Perilla frutescens, 15g of Pyrrosia sinensis, 30g of Euryale ferox, 3g of leech, 10g of Codonopsis pilosula, 10g of Coptis chinensis, and 6g of Licorice.

[0073] The preparation method is the same as Example 1.

[0074] Comparative Example 2

[0075] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5, prepared from the following raw materials: 30g of astragalus, 9g of rhubarb, 15g of salvia miltiorrhiza, 12g of millettia reticulata, 15g of peach kernel, 12g of perilla leaf, 15g of pyrrosia, 30g of euryale ferox, 3g of leech, 10g of atractylodes, 10g of scutellaria, and 6g of liquorice.

[0076] The preparation method is the same as Example 1.

[0077] Comparative Example 3

[0078] A traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 is prepared from the following raw materials: 30g of astragalus, 9g of rhubarb, 15g of salvia miltiorrhiza, 12g of chuanxiong, 15g of achyranthes bidentata, 12g of perilla leaf, 15g of pyrrosia, 30g of lotus seed, 3g of earthworm, 10g of coptis chinensis, 10g of coptis chinensis, and 6g of liquorice.

[0079] The preparation method is the same as Example 1.

[0080] Efficacy Example Therapeutic effect of the Chinese medicine composition of the present invention on rats with chronic kidney disease

[0081] 1. Experimental Methods

[0082] Clean grade male Wistar rats, weighing 220±20g, were given free access to water and food, and the room temperature was maintained at 20-25°C. After passing the quarantine for 7 days, the rats were randomly divided into a normal control group, a model control group, an example 1 group, an example 2 group, a comparative example 1 group, a comparative example 2 group, and a comparative example 3 group, with 8 rats in each group.

[0083] Except for the normal control group, rats in each group were gavaged with 200 mg / kg 2.5% adenine suspension once a day in the first to third weeks and once every other day in the fourth to sixth weeks. The normal control group was gavaged with an equal volume of normal saline.

[0084] The rats in each treatment group were gavaged with the corresponding drug at a dose of 12.6 g / kg, once a day, for 12 consecutive weeks. The normal control group and the model control group were gavaged with an equal volume of physiological saline.

[0085] 2. Sample collection and indicator testing

[0086] Blood was collected 12 weeks after administration, centrifuged and the supernatant was kept and stored at -80°C for detection of serum creatinine (Scr), urea nitrogen (BUN), serum phosphorus and serum calcium.

[0087] 3. Statistical methods

[0088] Graphpad Prism 9.0 software was used for data processing, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and SNK-q was used for pairwise comparison among groups. The difference was considered statistically significant when P < 0.05.

[0089] 4. Experimental Results

[0090] 4.1 Effects on serum creatinine and urea nitrogen in rats

[0091] Compared with the normal control group, the blood creatinine and urea nitrogen of the rats in the model control group increased significantly, indicating that the renal function of the rats was significantly damaged after modeling. Compared with the model control group, the blood creatinine of Example 1 and Example 2 groups decreased significantly; the urea nitrogen of Example 1 and Example 2 groups decreased significantly. The effect of improving blood creatinine and urea nitrogen in Example 1 group was the best, and it had a significant protective effect on the renal function of rats. The results are shown in Figure 1 , Figure 2 .

[0092] 4.2 Effects on serum phosphorus and calcium in rats

[0093] Compared with the normal control group, the model control group had significantly increased blood phosphorus and significantly decreased blood calcium, indicating that the rats had disordered phosphorus and calcium metabolism after modeling, which was consistent with the characteristics of chronic kidney disease. Compared with the model control group, the blood phosphorus of Example 1 and Example 2 groups were significantly reduced; the blood calcium of Example 1 group was significantly increased. Example 1 group had the best effect in improving blood phosphorus and blood calcium, and could significantly improve the complications of phosphorus and calcium metabolism disorder caused by chronic kidney disease. Results are shown in Figure 3 , Figure 4 .

[0094] Compared with the normal control group, the rats in the model control group had significantly increased serum creatinine, urea nitrogen and blood phosphorus, and significantly decreased serum calcium, indicating that the rats had significant renal damage and complications of phosphorus-calcium metabolism disorders, which were consistent with the characteristics of the late stage of chronic kidney disease. After treatment with the Chinese medicine composition Example 1, renal function and complications of phosphorus-calcium metabolism disorders were significantly improved, which could successfully intervene in the development of chronic kidney disease, and provide an effective product for alleviating and curing chronic kidney disease.

[0095] Clinical example: Observation on the clinical efficacy of the Chinese medicine composition of the present invention on patients with chronic kidney disease

[0096] 1. General Information

[0097] A total of 60 patients with chronic kidney disease in our hospital were selected, who met the diagnostic criteria of K / DOQI chronic kidney disease stage III and IV. They were randomly divided into a control group and a treatment group, with 30 patients in each group. Among them, there were 17 males and 13 females in the control group, 12 cases of hypertensive nephropathy, 11 cases of diabetic nephropathy, 5 cases of glomerulonephritis, and 2 cases of gouty nephropathy, with an average age of (59.1±8.7) years old; there were 19 males and 11 females in the treatment group, 14 cases of hypertensive nephropathy, 9 cases of diabetic nephropathy, 6 cases of glomerulonephritis, and 1 case of gouty nephropathy, with an average age of (58.6±7.5) years old.

[0098] There was no statistical difference in the general information of patients in each group (P>0.05), and they were comparable.

[0099] 2. Treatment Methods

[0100] The patients in the treatment group took the decoction of Example 1 orally, once in the morning and once in the evening; the patients in the control group took the Urea Clearing Granules orally, 4 times a day, and fasting blood was drawn for detection after 2 months of treatment.

[0101] 3. Observation indicators

[0102] Before treatment and 3 months after treatment, fasting venous blood was collected from the subjects in the morning for serum creatinine detection and calculation of glomerular filtration rate, for the evaluation of chronic kidney disease staging and treatment effect. The clinical efficacy judgment standard refers to the relevant standards of the "Guidelines for Clinical Research of New Chinese Medicines".

[0103] Markedly effective: endogenous creatinine clearance increased by ≥20%, and blood creatinine decreased by ≥20%; effective: endogenous creatinine clearance increased by ≥10%, and blood creatinine decreased by ≥10%; ineffective: endogenous creatinine clearance increased by <10% or decreased and blood creatinine decreased by <10% or increased.

[0104] Creatinine clearance rate for males = (140-age)*body weight (kg) / [0.818*blood creatinine (umol / L)]; creatinine clearance rate for females = 0.85*(140-age)*body weight (kg) / [0.818*blood creatinine (umol / L)].

[0105] Total effective rate = (number of clinically cured + markedly effective + effective) cases / total number of cases × 100%.

[0106] 4. Statistical methods

[0107] SPSS 19.0 software was used for data processing. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as statistically significant.

[0108] 5. Comparison of clinical efficacy

[0109] Table 1 Comparison of clinical efficacy

[0110] Group Number of cases / case Total effective rate / % Control group 30 61.2 Treatment Group 30 87.0

[0111] Depend on Figure 5 As shown in Table 1, the total effective rate of the control group was 61.2%, and the total effective rate of the treatment group was 87.0%. The clinical efficacy of the treatment group in improving chronic kidney disease was significantly better than that of the control group.

[0112] The Chinese medicine composition of the present invention can significantly reduce the serum creatinine of patients with chronic kidney disease, thereby improving the glomerular filtration rate, significantly intervening in and reversing the progression of chronic kidney disease, having a significant clinical effect and being superior to similar clinical drugs, and providing a better product for clinically alleviating and curing patients with advanced chronic kidney disease.

[0113] The above embodiments are merely examples for clear explanation and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description, and the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating chronic kidney disease stage 3-5, characterized in that: The Chinese medicine composition is prepared from the following raw materials in the following weight ratio: 20-45 parts of Astragalus, 6-12 parts of Rhubarb, 12-18 parts of Salvia miltiorrhiza, 9-12 parts of Millettia reticulata, 12-18 parts of Achyranthes bidentata, 9-15 parts of Perilla frutescens, 12-20 parts of Pyrola, 20-30 parts of Euryale ferox, 2-6 parts of Leech, 9-12 parts of Codonopsis pilosula, 9-15 parts of Coptis chinensis, and 6-9 parts of Licorice.

2. The Chinese medicine composition for treating chronic kidney disease stage 3-5 according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in the following weight ratio: 30 parts of Astragalus, 9 parts of Rhubarb, 15 parts of Salvia miltiorrhiza, 12 parts of Millettia reticulata, 15 parts of Achyranthes bidentata, 12 parts of Perilla frutescens, 15 parts of Pyrrosia, 30 parts of Euryale ferox, 3 parts of Hirudo, 10 parts of Codonopsis pilosula, 10 parts of Coptis chinensis, and 6 parts of Licorice.

3. The Chinese medicine composition for treating chronic kidney disease stage 3-5 according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition is prepared by using raw materials or water or ethanol extracts of raw materials as active ingredients, and adding auxiliary materials or auxiliary ingredients commonly used in pharmacy.

4. The Chinese medicine composition for treating chronic kidney disease stages 3-5 according to any one of claims 1-3, characterized in that: The preparation is an oral preparation.

5. The Chinese medicine composition for treating chronic kidney disease stage 3-5 according to claim 4, characterized in that: The oral preparation is a capsule, granule, powder, pill, tablet, oral liquid or decoction.

6. The method for preparing the Chinese medicine composition for treating chronic kidney disease stage 3-5 according to any one of claims 1-5, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: (1) weighing raw materials and auxiliary materials according to weight ratio; (2) using the powder of the raw material medicine, or the water or ethanol extract of the raw material medicine as the active ingredient, and adding auxiliary materials or auxiliary ingredients commonly used in pharmacy to prepare the composition.

7. The method for preparing the Chinese medicine composition for treating chronic kidney disease stage 3-5 according to claim 6, characterized in that: First, weigh out each Chinese medicine according to the ratio of raw materials, then add water until it covers the surface of the medicine by 2-3 fingers, soak for 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the juice for later use, add water to the residue again, until it covers the surface of the residue by 1-2 fingers, boil over high heat, then simmer over low heat for 20 minutes, filter out the juice and combine it with the previous juice.

8. Use of the Chinese medicine composition for treating chronic kidney disease stages 3-5 according to any one of claims 1 or 2 in the preparation of drugs for treating chronic kidney disease.

9. The use according to claim 8, characterized in that: The chronic kidney disease is chronic kidney disease stage 3-5.

10. The use according to claim 8, characterized in that: The Chinese medicine composition improves the renal function of patients with chronic kidney disease.

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