A traditional Chinese medicine composition for treating chronic kidney disease stages 3-5, and its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicines and relates to a traditional Chinese medicine composition for treating chronic kidney disease stage 3-5 and a preparation method thereof. The traditional Chinese medicine composition comprises astragalus, rhubarb, salvia miltiorrhiza, millettia reticulata, achyranthes bidentata, codonopsis pilosula, euryale ferox, coptis chinensis, perilla leaf, pyrrosia solani, leech and liquorice. The traditional Chinese medicine composition comprises spleen and kidney tonifying drugs, blood circulation promoting drugs and heat-clearing and detoxifying drugs, which replenish spleen and kidney qi, promote blood circulation, and remove damp-heat and turbidity. The traditional Chinese medicine composition is used together with the tonic and dispersing drugs in moderation, and has the effects of tonifying the kidney and strengthening the spleen, promoting blood circulation and removing blood stasis, clearing heat and purging turbidity. The traditional Chinese medicine composition has a significant therapeutic effect on improving the clinical symptoms of patients with chronic kidney disease stage 3-5, protecting renal function, significantly improving complications such as calcium and phosphorus metabolism disorders, successfully intervening in the development of chronic kidney disease, and improving and enhancing the survival and quality of life of patients.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly 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 (CKD) is a syndrome characterized by persistent changes in kidney structure, function, or both, which impact individual health. CKD has a complex pathogenesis and is a persistent condition. Its primary pathological feature is renal fibrosis, which progresses to end-stage renal disease (ESRD), severely impacting patients' survival and quality of life. The medical costs of renal replacement therapy also place a heavy economic burden on the nation, society, and patients' families. Therefore, increasing awareness of CKD and identifying effective prevention and treatment strategies are crucial for delaying its progression and reducing the incidence of ESRD.

[0003] Currently, there is no cure for chronic kidney disease, especially for patients in stages 3-5. Western medicine treats chronic kidney disease primarily through lifestyle modification, renin-angiotensin system blockers, and symptomatic treatment of various comorbidities and complications to slow its progression. However, many patients inevitably require renal replacement therapy. Western medicine lacks clear noninvasive diagnostic markers or specific treatments for renal fibrosis. While renin-angiotensin system blockers have some efficacy, the results are not ideal.

[0004] Numerous clinical practices have demonstrated the significant advantages of traditional Chinese medicine in the treatment of chronic kidney disease and renal fibrosis. The combined use of traditional Chinese and Western medicine in the treatment of chronic kidney disease and renal fibrosis has demonstrated efficacy, effectively delaying the progression of chronic kidney disease to end-stage renal disease, improving patients' clinical symptoms, significantly reducing outpatient and inpatient costs, and improving survival and quality of life. Therefore, the search for effective traditional Chinese medicine compositions for the prevention and treatment of chronic kidney disease has become a challenging task for many practitioners of traditional Chinese medicine, and has been a key research direction and trend 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 traditional Chinese medicine theory and the basic pathogenesis of chronic kidney disease, combined with clinical practice experience, found that prescriptions based on the principles 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 and 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, cypress, codonopsis, euryale ferox, coptis chinensis, perilla leaf, pyrrosia, leech and liquorice. The traditional Chinese medicine composition comprises spleen and kidney tonifying drugs, blood circulation promoting drugs and heat-clearing and detoxifying drugs, so that the spleen and kidney qi are replenished and the blood vessels flow smoothly, and damp-heat turbidity and toxins are removed naturally. The traditional Chinese medicine composition is used in combination with both attacking and tonifying drugs and dispersing drugs in moderation, and has the effects of tonifying the kidney and strengthening the spleen, activating blood circulation and removing blood stasis, clearing heat and removing turbidity. The traditional Chinese medicine composition has a significant therapeutic effect 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 and phosphorus metabolism disorders, and improving the survival and quality of life of patients.

[0006] Based on the clinical manifestations of chronic kidney disease, it can be categorized as "edema," "kidney wind," "urinary retention," "low back pain," "blocked bowel movements," "kidney fatigue," "drowning poisoning," "micro-masses in the kidney meridians," and "yin meridian disease - kidney meridian." The basic pathogenesis is generally characterized by underlying deficiency and superficial excess, with spleen and kidney deficiency as the underlying deficiency, and blood stasis, damp-heat, and turbid toxins as the primary excess pathogens. Clinically, patients with chronic kidney disease stages 3-5 often experience fatigue, soreness of the waist and knees, dull complexion, numbness of the limbs, nausea and vomiting, heaviness of the limbs, a pale tongue with teeth marks, a dark purple tongue, or a greasy yellow tongue, and a sluggish or deep pulse. These clinical manifestations suggest that spleen and kidney deficiency and blood stasis and dampness are the primary mechanisms of chronic kidney disease.

[0007] Spleen and kidney deficiency is a crucial underlying factor in the development of chronic kidney disease and renal fibrosis. Traditional Chinese Medicine emphasizes that "kidney disease is often caused by deficiency" and that "chronic illness affects the kidneys." The kidneys are the root of vital energy and the foundation of the innate constitution, containing both primordial yin and primordial yang. Kidney essence transforms into yang, which becomes the body's yang, while kidney essence transforms into yin, which becomes the body's yin. The essence and qi stored in the kidneys are the original driving force and material foundation for human life. The spleen and kidneys share a common origin, transforming the essence of water and grain while also transforming it into qi and blood, the foundation of acquired constitution. The Suwen (Suwen) states that the spleen "is the central earth, irrigating the surrounding areas." This interdependent relationship with the kidneys, the innate foundation that stores vital energy, is mutually nourishing. Furthermore, the kidneys govern the opening and closing of water, while the spleen governs the transportation and transformation of water and moisture, synergistically regulating fluid metabolism. If the spleen and kidneys are deficient, the distribution and transformation of qi, blood, and body fluids become unbalanced, leading to the endogenous generation of pathological products such as damp-heat, blood stasis, and turbid toxins. These pathological products stagnate in the body, depleting vital energy. This can lead to excess symptoms, or vice versa, ultimately resulting in a mixture of deficiency and excess. Clinically, symptoms primarily related to spleen and kidney deficiency include soreness and weakness in the lower back and knees, fatigue, cold limbs and aversion to cold, frequent and clear urination, tinnitus, and dizziness. Modern medicine considers pathological changes such as a decrease in the number of healthy nephrons, thinning of the renal cortex, and renal fibrosis as signs of spleen and kidney deficiency, particularly kidney and essence deficiency, in patients with chronic kidney disease. Studies on the syndromes of chronic kidney disease have also shown that spleen and kidney deficiency is the most common underlying deficiency syndrome in chronic kidney disease and is a consistent feature of the disease.

[0008] Blood stasis is a common problem throughout chronic kidney disease and renal fibrosis. Traditional Chinese medicine states that "long-term illness leads to more blood stasis" and "blood stasis blocks the meridians, and when blood and qi are out of balance, a myriad of illnesses arise." The persistent and prolonged course of chronic kidney disease can be attributed to a variety of factors, including spleen and kidney deficiency, damp-heat, and turbid toxins, all of which can contribute to blood stasis. Qi deficiency in the spleen and kidneys, with qi as the primary regulator of blood, is insufficient, and qi deficiency prevents blood circulation. This inability to promote blood circulation leads to blood stasis, as described in the book "Medical Errors Correction": "When vital energy is deficient, it cannot reach the blood vessels. Without qi in the blood vessels, blood flow stagnates and stagnates. This is qi deficiency and blood stasis." Damp-heat, turbid toxins, and other toxic pathogens enter the meridians and clash with the blood, causing obstruction of qi flow. This stagnation leads to blood stasis, coinciding with the sayings "heat scorches blood into lumps" and "warm toxins refine the blood internally, and when the blood is refined, it coagulates." The interplay of damp-heat, turbid toxins, and blood stasis often manifests clinically as abdominal distension and tightness, heaviness in the limbs, lower back and knee pain, and a dark complexion. These symptoms are often accompanied by a dark red or dark tongue, a greasy or yellow tongue coating, a thready or smooth pulse, and loose or sticky stools, all of which indicate internal accumulation of damp-heat, turbid toxins, and blood stasis blocking the collaterals. The pathological manifestations of renal fibrosis, including glomerulosclerosis, interstitial fibrosis, and vascular sclerosis, all fall under the category of "blood stasis" in Traditional Chinese Medicine. Blood stasis is both a primary pathological product and a key pathogenic factor in the disease process, permeating the entire process of chronic kidney disease and renal fibrosis and influencing the progression and outcome of the disease.

[0009] Damp-heat and turbidity are key components of chronic kidney disease and renal fibrosis. The kidney governs water and regulates opening and closing, while the spleen governs transportation and transformation. The kidney's transpiration and transpiration dominate the body's water metabolism. A deficiency of kidney essence and qi leads to impaired transpiration and erratic opening and closing. Combined with spleen weakness, this inability to transport and transform water and dampness hinders water distribution and metabolism, leading to stagnation of water and dampness. Xue Shengbai stated, "When dampness and fluid accumulate in the Taiyin meridian, foreign pathogens enter the body, drawing the internal and external forces together, resulting in damp-heat symptoms." Danxi's Heart Method further states, "Turbidity governs damp-heat." Therefore, dampness, affected by external factors, internal injuries, and various other pathogens, such as drugs and food, can accumulate over time, transforming into heat and turbidity, resulting in damp-heat and turbidity. Yifang Kao states, "Diseases in the lower jiao are often attributed to damp-heat." Xu Dachun added, "While dampness may not always be associated with heat, it is often associated with 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, damp-heat and turbid 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 renal 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, and damp-heat, turbidity, and toxins are mutually causal, forming a complex causal relationship. Spleen and kidney deficiency impairs the transport and transformation of qi, which easily leads to the accumulation of damp-heat, turbidity, and toxins. Dampness and turbidity become heavy and sticky, obstructing the flow of qi. Heat, on the other hand, damages the yin meridians, forcing blood to overflow and obstructing blood circulation. Furthermore, the interaction of damp-heat, turbidity, and toxins promotes and exacerbates blood stasis. Once dampness and stasis form, it depletes the body's vital energy, easily hindering the transport and distribution of essence, qi, blood, and body fluids. This deprives the spleen and kidneys of nourishment, further exacerbating spleen and kidney deficiency. These three pathological mechanisms, spleen and kidney deficiency, damp-heat, turbidity, and toxins, interact to accelerate renal fibrosis.

[0011] In summary, the inventors of the present invention ultimately discovered 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 strengthening the spleen, promoting blood circulation and removing blood stasis, and clearing away heat and turbidity are the key. In clinical practice, there are many patients with spleen and kidney deficiency and blood stasis and dampness. Therefore, it is necessary to pay attention to tonifying the qi of the spleen and kidney, promoting blood circulation and clearing away heat on the basis of syndrome differentiation and treatment. When qi is strong, blood circulates, and qi is full and 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 has been applied to the specific treatment process.

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

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

[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 Hirudo, 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 stages 3-5 is characterized in that: the Chinese medicine composition is prepared from the following 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 Pyrilaria officinalis, 30 parts of Euryale ferox, 3 parts of Hirudo, 10 parts of Codonopsis pilosula, 10 parts of Coptidis rhizome, and 6 parts of Liquorice.

[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 stages 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 traditional Chinese medicine composition for treating chronic kidney disease stages 3-5 is characterized by: first, weighing out each traditional 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 medicinal juice for later use, adding water to the medicinal residue again until the surface of the medicinal residue is covered by 1-2 fingers, boiling over high heat, then simmering over low heat for 20 minutes, filtering out the medicinal juice and combining it with the previous medicinal juice to obtain the product.

[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 herbal medicine in the Chinese herbal 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 swelling, promotes fluid production 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, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness, and carbuncles that are difficult to heal and that do not heal for a long time.

[0028] Rhubarb: bitter in taste, cold in nature, enters the spleen, stomach, large intestine, liver, and pericardium meridians, clears heat and unclogs the intestines, cools blood and detoxifies, removes blood stasis and dredges the menstruation; used for constipation due to excess heat, abdominal pain due to stagnation, diarrhea, jaundice due to damp heat, vomiting and epistaxis 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, external treatment of burns due to 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 irregular menstruation, blood stasis and amenorrhea, postpartum abdominal pain due to 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 and 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 blood deficiency 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 dampness; used for blood stasis, amenorrhea, dysmenorrhea, traumatic injuries, 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, spleen deficiency diarrhea, spleen deficiency leukorrhea, leukorrhea and other symptoms.

[0035] Leech: salty and bitter in taste, neutral in nature, enters the liver meridian, breaks blood, removes blood stasis, and promotes 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 fluids; used for spleen and lung qi deficiency, poor appetite and fatigue, cough and shortness of breath, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluids, 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 fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, vomiting and epistaxis due to blood heat, red eyes, toothache, diabetes, carbuncle, furuncle; external treatment of 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, eliminates phlegm and relieves cough, relieves urgency and stops pain, and harmonizes various medicines; it is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, cramps and pain in the abdomen and limbs, carbuncles, swellings, and sores, and to relieve 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 achieved within the above dosage range. Excessive or insufficient drug dosage will lead to changes in the primary and secondary pathogenesis of the prescription.

[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 tonifies 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 together with qi and blood, and not only regulates qi, attacks accumulation and purges, but also cools blood, removes blood stasis, activates blood circulation, clears heat, eliminates turbidity and detoxifies. Astragalus, salvia miltiorrhiza, and rhubarb are all the main drugs, and together they play the role of "tonifying the spleen and kidney, removing blood stasis, and eliminating dampness and turbidity." Codonopsis, Achyranthes, Coptis chinensis, Perilla frutescens, and Selaginella dahurica are the assistant drugs. Codonopsis pilosula strengthens the spleen and promotes fluid production, Achyranthes knee nourishes the kidney and promotes blood circulation, Coptis chinensis combined with Perilla frutescens clears heat and soothes the stomach, and Selaginella dahurica promotes diuresis and relieves stranguria. The five invigorating and dispersing prescriptions are the assistant drugs, and they also have the effects of tonifying the kidney, promoting blood circulation, and purging. Euryale ferox is used to strengthen the kidney and astringe the essence, Millettia reticulata promotes blood circulation and relaxes muscles, Hirudo removes blood stasis and eliminates symptoms, and Licorice is used to harmonize the other 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 phosphorus and 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, with significant clinical effects and superior to similar clinical drugs, providing a better product for clinical relief and cure of patients with late-stage chronic kidney disease.

[0045] The traditional Chinese medicine composition of the present invention has definite clinical efficacy and high safety, a simple preparation method, low cost, and readily available raw materials, and has a prospect for 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 the 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 blood 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, 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 in stages 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 cyperus rotundus, 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 500mL of purified water, soak for 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the medicinal juice for later use, add 500mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the medicinal 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 in stages 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 cyperus rotundus, 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 the raw materials, add 600mL of purified water, soak for 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the medicinal juice for later use, add 400mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the medicinal 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 in stages 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 odorata, 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 the raw materials, add 600mL of purified water, soak for 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the medicinal juice for later use, add 500mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the medicinal 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 in stages 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 cyperus rotundus, 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 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the medicinal juice for later use, add 600mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the medicinal 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 in stages 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 cyperus rotundus, 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 1 hour, boil over high heat, then simmer over low heat for 30 minutes, filter out the medicinal juice for later use, add 600mL of purified water to the residue again, boil over high heat, then simmer over low heat for 20 minutes, filter out the medicinal 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 in stages 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 leaf, 15g of Pyrilaria officinalis, 30g of Euryale ferox, 3g of Hirudo, 10g of Codonopsis pilosula, 10g of Coptis chinensis, and 6g of Licorice root.

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

[0074] Comparative Example 2

[0075] A traditional Chinese medicine composition for treating chronic kidney disease in stages 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 peach kernel, 12g of perilla leaf, 15g of pyrrosia, 30g of euryale ferox, 3g of leech, 10g of atractylodes macrocephala, 10g of scutellaria baicalensis, and 6g of liquorice.

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

[0077] Comparative Example 3

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

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

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

[0081] 1. Experimental Methods

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

[0083] All rats except the normal control group were gavaged with 200 mg / kg of 2.5% adenine suspension once a day from week 1 to week 3 and once every other day from week 4 to week 6. 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 normal saline.

[0085] 2. Sample collection and indicator testing

[0086] Twelve weeks after administration, blood was collected, centrifuged, and the supernatant was kept and stored at -80°C. Serum creatinine (Scr), urea nitrogen (BUN), blood phosphorus, and blood calcium were tested.

[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. The comparison among multiple groups was performed by one-way analysis of variance, and the comparison between groups was performed by SNK-q. 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 the Example 1 group and the Example 2 group was significantly reduced; the urea nitrogen of the Example 1 group and the Example 2 group was significantly reduced. The effect of the Example 1 group on improving blood creatinine and urea nitrogen was the best, and it had a significant protective effect on the renal function of the rats. 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 decreased; the blood calcium of Example 1 group was significantly increased. The effect of Example 1 group in improving blood phosphorus and blood calcium was the best, and it was able to significantly improve the complications of phosphorus and calcium metabolism disorder caused by chronic kidney disease. The 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 phosphate and calcium metabolism disorders, consistent with the characteristics of late-stage chronic kidney disease. After treatment with the Chinese medicine composition Example 1, renal function and complications of phosphate and calcium metabolism disorders were significantly improved, successfully intervening in the progression of chronic kidney disease, and providing 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] Sixty patients with chronic kidney disease (CKD) who met the K / DOQI criteria for stage III and IV CKD were enrolled in our hospital. They were randomly divided into a control group and a treatment group, with 30 patients in each group. The control group consisted of 17 males and 13 females, including 12 with hypertensive nephropathy, 11 with diabetic nephropathy, 5 with glomerulonephritis, and 2 with gouty nephropathy, with a mean age of (59.1±8.7) years. The treatment group consisted of 19 males and 11 females, including 14 with hypertensive nephropathy, 9 with diabetic nephropathy, 6 with glomerulonephritis, and 1 with gouty nephropathy, with a mean age of (58.6±7.5) years.

[0098] There was no statistical difference in the general information of patients in each group (P>0.05), and the groups 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 three months after treatment, fasting venous blood was collected from participants in the morning for serum creatinine measurement and calculation of glomerular filtration rate, which was used to assess chronic kidney disease staging and treatment efficacy. Clinical efficacy was determined based on the criteria outlined in the "Guiding Principles for Clinical Research of New Traditional 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 for men = (140-age)*weight (kg) / [0.818*serum creatinine (umol / L)]; creatinine clearance for women = 0.85*(140-age)*weight (kg) / [0.818*serum 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 tested for normal distribution and homogeneity of variance, and the inter-group comparisons were performed using one-way analysis of variance, with P < 0.05 considered 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, with significant clinical effects and superior to similar clinical drugs, providing a better product for clinical relief and cure of patients with late-stage chronic kidney disease.

[0113] The above embodiments are merely examples for clarity of explanation and are not intended to limit the embodiments. Those skilled in the art will appreciate that other variations or modifications may be made based on the above description, and any such variations or modifications are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating chronic kidney disease stages 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 Hirudo, 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 stages 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 Pyrilaria officinalis, 30 parts of Euryale ferox, 3 parts of Hirudo, 10 parts of Codonopsis pilosula, 10 parts of Coptidis rhizome, and 6 parts of Liquorice.

3. The Chinese medicine composition for treating chronic kidney disease stages 3-5 according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared by using the raw material medicine or the water or ethanol extract of the raw material medicine as the active ingredient, and adding the 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 traditional Chinese medicine composition is prepared into an oral preparation.

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

6. A method for preparing the Chinese medicine composition for treating chronic kidney disease stages 3-5 according to claim 5, characterized in that: The preparation method comprises the following steps: (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 auxiliary materials or auxiliary ingredients commonly used in pharmacy to prepare the drug.

7. The method for preparing the Chinese medicine composition for treating chronic kidney disease stages 3-5 according to claim 6, characterized in that: The preparation method comprises the following steps: firstly, each Chinese medicine is weighed out according to the ratio of the raw materials, then water is added until the surface of the medicine is covered by 2-3 fingers, soaked for 1 hour, boiled over high heat, then simmered over low heat for 30 minutes, the medicinal juice is filtered out for later use, water is added again to the medicinal residue until the surface of the medicinal residue is covered by 1-2 fingers, boiled over high heat, then simmered over low heat for 20 minutes, the medicinal juice is filtered out and combined with the previous medicinal juice to obtain the product.

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

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