Traditional Chinese medicine composition for treating spleen and kidney qi deficiency and blood stasis toxin blocking collateral type diabetic nephropathy

Abstract

The invention relates to a traditional Chinese medicine composition for treating spleen-kidney qi deficiency and stasis toxin obstruction type diabetic nephropathy, which can effectively solve the medication problem for treating spleen-kidney qi deficiency and stasis toxin obstruction type diabetic nephropathy. The traditional Chinese medicine composition is prepared from, by weight, 37-33 g of astragalus membranaceus, 27-33 g of centella asiatica, 18-22 g of ligusticum wallichii, 18-22 g of winged euonymus twig, 18-22 g of salvia miltiorrhiza and 14-16 g of prepared rehmannia root. The traditional Chinese medicine composition is prepared by removing impurities from the raw materials, washing, airing, smashing and evenly mixing. The components are simple, scientific and reasonable, are compatible according to the main and secondary relationship of monarch, minister, assistant and guide, are mutually correlated and compatible in function to play a role, and are combined to play the roles of clearing heat and promoting diuresis, detoxifying and activating blood, reinforcing qi and nourishing yin, and tonifying kidney and replenishing essence, so that the traditional Chinese medicine is effectively used for preparing the medicine for treating spleen-kidney qi deficiency and blood stasis toxin blocking type diabetic nephropathy, and is good in curative effect and free of toxic and side effects. The traditional Chinese medicine composition is a great innovation of medicines for treating spleen and kidney qi deficiency and stasis toxin blocking collateral type diabetic nephropathy, and has remarkable social and economic benefits.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxicity obstruction type. Background Art

[0002] As a global public health problem, the incidence of diabetes continues to rise. The 2023 "Diabetes and Kidney Disease Report" released by the International Diabetes Federation (IDF) pointed out that up to 40% of diabetic patients will develop chronic kidney disease. Between 1990 and 2017, the number of new cases of chronic kidney disease caused by type 2 diabetes worldwide increased from 1.4 million to 2.04 million, an increase of about 74%. On January 11, 2025, a collaborative study by the Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine and the Chinese Center for Disease Control and Prevention showed that the burden of chronic kidney disease in adult diabetic patients in China is heavy, and about 1 / 3 of diabetic patients suffer from chronic kidney disease (CKD). Moreover, the mortality rate of all ages caused by diabetes-related CKD in China (per 100,000 people) has increased from 4.5 in 1990 to 6.0 in 2016, an increase of 33.3%, and the situation is not optimistic.

[0003] Diabetic nephropathy (DKD) is one of the most common and serious chronic complications of diabetes, and its clinical manifestations are diverse. Frequent urination may occur in the early stage, and the frequency of urination increases under normal drinking conditions; as the disease progresses, foamy urine will appear, because the urine contains a large amount of protein. When the patient urinates, a large amount of foam will appear in the urine and it is not easy to dissipate; edema is also a common symptom, mostly pitting edema, and when the swollen part is pressed by hand, it will not rebound naturally in a short time. It may appear in the lower limbs and eyelids at first, and in severe cases it may develop to the whole body. In addition, patients may also have symptoms such as nausea and vomiting, fatigue, loss of appetite, weight loss, insomnia, and skin itching. In the middle and late stages, blood creatinine may gradually increase until uremia, accompanied by related clinical manifestations of end-stage renal disease, such as anemia, gastrointestinal symptoms, bone pain, etc.

[0004] At present, Western medicine mainly relies on hypoglycemic, antihypertensive, lipid-lowering drugs and dialysis therapy in the treatment of diabetic nephropathy. However, these treatment methods have certain limitations. Long-term use of Western medicine to lower blood sugar and blood pressure may cause some patients to develop drug resistance, resulting in a gradual weakening of the drug effect and difficulty in maintaining stable blood sugar and blood pressure levels. Like some common hypoglycemic drugs, as the duration of medication increases, the hypoglycemic effect is much worse than before, forcing doctors to constantly adjust the dosage or change the drug. Although dialysis therapy can replace kidney function to a certain extent, it is only an alternative therapy and cannot fundamentally repair damaged kidney tissue. In addition, the dialysis process will also bring a series of complications, such as infection, cardiovascular disease, etc., which seriously affect the patient's quality of life and long-term survival rate.

[0005] In contrast, traditional Chinese medicine shows unique advantages in the treatment of diabetic nephropathy. From the perspective of drug ingredients, the effective ingredients of traditional Chinese medicine are rich and diverse, which can regulate the physiological functions of the human body. Some ingredients can stimulate the secretion of insulin, some ingredients can dilate blood vessels, relax smooth muscles, regulate muscle function and blood pressure, and some ingredients can promote cell metabolism, thereby improving the symptoms of diabetes and nephropathy. Moreover, traditional Chinese medicine has overall harmony, and multiple ingredients work together to complement each other during treatment, which can produce more significant therapeutic effects and reduce adverse reactions to the human body. Traditional Chinese medicine can also regulate the human immune system and enhance the body's own immunity, thereby preventing the recurrence of diabetic nephropathy and preventing various complications caused by diabetes. In the field of diabetic nephropathy treatment, traditional Chinese medicine is playing an increasingly important role with its unique mechanism of action and advantages. However, there are currently few traditional Chinese medicine preparations for diabetic nephropathy, especially for diabetic nephropathy with spleen and kidney qi deficiency, blood stasis and toxicity obstruction. Therefore, it is urgent to develop a traditional Chinese medicine for the treatment of diabetic nephropathy with spleen and kidney qi deficiency, blood stasis and toxicity obstruction, which is a technical problem that needs to be seriously solved. Summary of the invention

[0006] In view of the above situation, in order to overcome the shortcomings of the prior art, the purpose of the present invention is to provide a Chinese medicine composition for treating diabetic nephropathy of spleen and kidney qi deficiency and stasis and toxicity obstruction of the collaterals, which can effectively solve the problem of medication for diabetic nephropathy of spleen and kidney qi deficiency and stasis and toxicity obstruction of the collaterals.

[0007] The technical solution solved by the present invention is a traditional Chinese medicine composition for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxicity obstruction type, which is composed of the following raw materials by weight: 37-33g of Astragalus, 27-33g of Centella asiatica, 18-22g of Chuanxiong, 18-22g of Euphorbia obliquus, 18-22g of Salvia miltiorrhiza and 14-16g of Rehmannia glutinosa. Impurities are removed from the raw materials, washed, dried, crushed and mixed evenly to form the traditional Chinese medicine composition.

[0008] The Chinese medicine composition of the present invention can be prepared into pharmaceutically acceptable dosage forms such as powder, granule, tablet and decoction by conventional preparation methods of various dosage forms as required.

[0009] The components of the invention are simple, scientific and reasonable, and are matched according to the primary and secondary relationship of monarch, minister, assistant and envoy. The functions are interrelated and matched with each other to play a role. The medicines are used together to play the effects of clearing away heat and dampness, detoxifying and activating blood circulation, invigorating qi and nourishing yin, and tonifying the kidney and replenishing essence. The invention is effectively used for preparing a medicine for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxin obstruction type, has good efficacy, and is free of toxic and side effects. It is a major innovation in the medicine for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxin obstruction type, and has significant social and economic benefits. DETAILED DESCRIPTION

[0010] The specific implementation modes of the present invention are described in detail below in combination with embodiments and specific situations.

[0011] The present invention can be specifically implemented by the following embodiments:

[0012] Embodiment 1:

[0013] The invention discloses a traditional Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy. The composition is composed of the following raw materials by weight: 30g of astragalus, 30g of centella asiatica, 20g of chuanxiong, 20g of euphorbia obliquus, 20g of salvia miltiorrhiza and 15g of rehmannia root. Impurities are removed from the raw materials, washed, dried, crushed and mixed evenly to form the traditional Chinese medicine composition.

[0014] Embodiment 2:

[0015] The invention discloses a traditional Chinese medicine composition for treating diabetic nephropathy of spleen-kidney qi deficiency, blood stasis and toxicity obstruction type. The composition is composed of the following raw materials by weight: 33g of astragalus, 33g of centella asiatica, 22g of chuanxiong, 22g of euphorbia obliquus, 22g of salvia miltiorrhiza and 16g of rehmannia root. Impurities are removed from the raw materials, the raw materials are washed, dried, crushed and evenly mixed to form the traditional Chinese medicine composition.

[0016] Embodiment 3:

[0017] The invention discloses a traditional Chinese medicine composition for treating diabetic nephropathy of spleen-kidney qi deficiency, blood stasis and toxicity obstruction type. The composition is composed of the following raw materials by weight: 27g of astragalus, 27g of centella asiatica, 18g of chuanxiong, 18g of euphorbia obliquus, 18g of salvia miltiorrhiza and 14g of rehmannia root. Impurities are removed from the raw materials, washed, dried, crushed and mixed evenly to form the traditional Chinese medicine composition.

[0018] Embodiment 4:

[0019] The invention discloses a traditional Chinese medicine composition for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxicity obstruction type. The composition comprises the following raw materials by weight: 27g of astragalus, 33g of centella asiatica, 22g of chuanxiong, 18g of euphorbia obliquus, 22g of salvia miltiorrhiza and 14g of rehmannia root. Impurities are removed from the raw materials, the raw materials are washed, dried, crushed and evenly mixed to form the traditional Chinese medicine composition.

[0020] Example 5

[0021] The invention discloses a traditional Chinese medicine composition for treating diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxicity obstruction type. The composition comprises the following raw materials by weight: 33g of astragalus, 27g of centella asiatica, 18g of chuanxiong, 22g of euphorbia obliquus, 18g of salvia miltiorrhiza and 16g of rehmannia root. Impurities are removed from the raw materials, the raw materials are washed, dried, crushed and evenly mixed to form the traditional Chinese medicine composition.

[0022] It should be noted that when taking the Chinese medicine composition of the present invention, according to different stages of treatment, Euryale ferox or Rosa laevigata fruit can also be added to the Chinese medicine composition, with the added amount being 15g Euryale ferox or 10g Rosa laevigata fruit, to make a series of products to meet the treatment needs at different stages.

[0023] The compositions given in the above embodiments can be used to prepare any amount of Chinese medicine compositions as required, and can be prepared into pharmaceutically acceptable dosage forms such as powders, granules, tablets and decoctions using conventional preparation methods of various dosage forms as required.

[0024] Taking granules as an example, the Chinese medicine composition is made into an extract or powder paste according to a conventional method, and auxiliary materials such as corn starch and stevioside are added. The mixture is granulated by a granulator and sieved to form granules. For decoction, the Chinese medicine composition is immersed in water, soaked at room temperature for 0.5-1h, decocted over high heat, and simmered over low heat for 30-40min to obtain the first medicinal liquid. Water is added to the residue, decocted over high heat, and simmered over low heat for 20-30min to obtain the second medicinal liquid. The two medicinal liquids are combined and mixed to form a decoction, which is taken once in the morning and evening.

[0025] The given examples are only used to illustrate the specific implementation methods of the present invention, rather than to limit the protection scope of the present invention. The technical core protected by the present invention is the Chinese medicine composition.

[0026] In the above-mentioned drug combinations, wherein:

[0027] Astragalus: slightly warm in nature and sweet in flavor, it enters the spleen and lung meridians, replenishes Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, and removes toxins and promotes tissue regeneration.

[0028] Centella asiatica: cold in nature, bitter and pungent in taste, enters the liver, spleen and kidney meridians, clears away heat, detoxifies, promotes dampness and reduces swelling.

[0029] Chuanxiong: warm in nature and pungent in flavor, it enters the liver, gallbladder, and pericardium meridians, promotes blood circulation and qi, dispels wind and relieves pain.

[0030] Ghost Arrow Feathers: It is cold in nature and bitter in taste. It enters the Liver Channel, relieves blood stasis, unblocks meridians, detoxifies and reduces swelling.

[0031] Salvia miltiorrhiza: slightly cold in nature and bitter in taste, it enters the heart and liver meridians, promotes blood circulation and removes blood stasis, regulates menstruation and relieves pain, clears the heart and relieves restlessness, cools blood and eliminates carbuncles.

[0032] Rehmannia root: slightly warm in nature and sweet in taste, it enters the liver and kidney meridians, replenishes blood and yin, and strengthens essence and fills marrow.

[0033] Gorgon Fruit: It is mild in nature, sweet and astringent in taste, and belongs to the spleen and kidney meridians. It can nourish the kidney and consolidate the essence, tonify the spleen and stop diarrhea, and remove dampness and stop leukorrhea. It belongs to the category of astringent drugs, which can consolidate essence, reduce urine and stop leukorrhea.

[0034] Rosa Laevigata: It is neutral in nature, sour, sweet and astringent in taste, and enters the kidney meridian, bladder meridian and large intestine meridian. It can consolidate semen, reduce urine, astringe intestines and stop diarrhea. It belongs to the category of astringent drugs, which can consolidate semen, reduce urine and stop leukorrhea.

[0035] According to the principles of traditional Chinese medicine, the above components are interrelated in function and work in combination with each other according to the order of primary and secondary monarch, minister, assistant and envoy. Astragalus is the monarch in the prescription, which has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood. In diabetic nephropathy with spleen and kidney qi deficiency and blood stasis and toxicity blocking the collaterals, astragalus greatly replenishes the spleen, enhances the spleen's transportation and transformation function, promotes the generation and distribution of water and grain essence, and corrects the state of qi and blood deficiency; at the same time, its diuretic function can alleviate edema symptoms. It fundamentally improves the patient's state of qi deficiency and enhances the body's ability to resist pathogens.

[0036] Centella asiatica, Ligusticum chuanxiong and Psoralea corylifolia are used as ministerial drugs. The "Supplement to Compendium of Materia Medica" records that Centella asiatica "clears away summer heat, relieves latent heat, and can be taken with mashed juice and raw wine". It is bitter, pungent, and cold in nature, and enters the liver, spleen, and kidney meridians. Centella asiatica has the effects of clearing heat and dampness, detoxifying and reducing swelling. For diabetic nephropathy with spleen and kidney qi deficiency and blood stasis and toxin blocking the collaterals, Centella asiatica can remove dampness and toxins, and resolve the pathological state of blood stasis and toxins in the kidney collaterals by clearing heat and dampness, improving the local microenvironment of the kidney, reducing inflammatory damage, and delaying the process of renal fibrosis. Ligusticum chuanxiong promotes blood circulation and qi, improves kidney blood circulation, allows blood stasis to flow, unblocks the veins, and relieves blood stasis symptoms such as numbness and pain in the limbs. Together with Centella asiatica, it strengthens the effects of detoxification, blood circulation, and collaterals. Psoralea corylifolia promotes blood circulation, removes blood stasis, detoxifies and dredges the collaterals, further removes blood stasis and toxins in the kidney collaterals, improves kidney metabolic function, and reduces the accumulation of metabolites.

[0037] With Danshen as adjuvant, it assists the main and auxiliary drugs, enhances the effect of promoting blood circulation and removing blood stasis, improves kidney microcirculation, relieves kidney meridian stasis, and also has a certain effect on relieving the emotional symptoms such as irritability caused by long-term illness and spleen and kidney qi deficiency.

[0038] With Rehmannia glutinosa as the guiding drug, it guides all the drugs into the kidney meridian, so that the whole formula can better act on the kidney, play the role of nourishing the kidney and replenishing essence, and treating diabetic nephropathy;

[0039] The combination of the medicines has the effects of clearing away heat and dampness, detoxifying and activating blood circulation, replenishing qi and nourishing yin, and tonifying the kidney and replenishing essence. It is effectively used to treat diabetic nephropathy of spleen and kidney qi deficiency, blood stasis and toxicity blocking collaterals, with good efficacy, high efficiency, no toxic side effects, short cycle, no recurrence, and has achieved very good beneficial technical effects through experiments. The relevant test materials are as follows (taking the granules prepared in Example 1 as an example):

[0040] 1. Source of cases:

[0041] A total of 30 patients with spleen and kidney qi deficiency and blood stasis and toxicity obstruction type diabetic nephropathy (stage III-V) were treated in the outpatient and inpatient departments, including 23 males and 7 females, aged 18-75 years old, with an average age of 57.83±11.37 years old.

[0042] 2. Diagnostic criteria: Refer to the "Guidelines for Clinical Research of New Chinese Medicines (2002 Edition)" and the "Standards for Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Diabetic Nephropathy (Trial Scheme)" issued by the Nephrology Branch of the Chinese Association of Traditional Chinese Medicine in 2007.

[0043] Typical symptoms: symptoms caused by spleen and kidney qi deficiency and blood stasis and toxic obstruction of the collaterals include fatigue, turbid and foamy urine, dry or bitter mouth, poor appetite and abdominal distension, nausea and vomiting, difficult bowel movements or constipation, soreness of the waist and knees, difficulty urinating, skin and nail cracking or numbness of the limbs, etc. Patients with diabetic nephropathy have the above symptoms.

[0044] Main symptoms: fatigue, turbid and foamy urine, dry or bitter mouth, poor appetite and abdominal distension, nausea and vomiting, difficult bowel movements or constipation, pain in the waist and knees, difficulty urinating, skin and nail numbness or limb numbness.

[0045] Secondary symptoms: The tongue is enlarged or has teeth marks on the edges, the tongue is dark purple, the tongue coating is thick and greasy, and the pulse is deep and thready.

[0046] 3. Criteria for inclusion of cases:

[0047] Patients who meet the TCM diagnostic criteria for spleen and kidney qi deficiency, blood stasis and toxic obstruction of collaterals, and the exclusion criteria (including inconvenience or exclusion criteria) are under 18 years old or over 75 years old, pregnant or lactating women; those who are allergic to this drug; those with serious primary diseases such as cardiovascular, lung, liver, kidney and hematopoietic system, and mental patients; those who do not meet the inclusion criteria, do not use the drug as prescribed, cannot judge the efficacy or have incomplete data that affect the judgment of efficacy and safety.

[0048] IV. Treatment Plan

[0049] The confirmed patients were treated with the Chinese medicine granules prepared by the composition of the present invention, three times a day, 10 g each time, half an hour after meals, and the efficacy was statistically analyzed for 2-3 months.

[0050] V. Criteria for determining efficacy

[0051] The criteria for determining the efficacy of clinical diseases and the efficacy of clinical syndromes in traditional Chinese medicine were respectively formulated with reference to the 2007 Diabetes Nephropathy Diagnosis, Syndrome Differentiation and Efficacy Evaluation Criteria (Trial Program) and the "Xiaoke Disease (Diabetes) and Chronic Renal Failure" section of the 2002 "Guiding Principles for Clinical Research of New Chinese Medicines", and the standards were formulated in light of actual conditions.

[0052] Criteria for judging the efficacy of clinical syndromes in traditional Chinese medicine:

[0053] Recovery: TCM clinical symptoms and signs disappear or basically disappear, and syndrome score decreases by ≥95%;

[0054] Markedly effective: Clinical symptoms and signs of TCM were significantly improved, with the syndrome score reduced by 70%≤<95%;

[0055] Effective: TCM clinical symptoms and signs are improved, and the syndrome score is reduced by 30%≤<70%;

[0056] Ineffective: TCM clinical symptoms and signs have no significant improvement or even worsen, and the syndrome score decreases by less than 30%;

[0057] Clinical disease efficacy judgment criteria:

[0058] Markedly effective: ① clinical symptoms disappear; ② eGFR increases by ≥20%; ③ Scr decreases by ≥20%; ④ UACR decreases by ≥50%; ⑤ 24hUTP decreases by more than 1 / 2;

[0059] Effective: ① Clinical symptoms improved compared with before treatment; ② eGFR increased by <20%; ③ Scr decreased by <20%; ④ UACR decreased, but not enough to meet the significant effect standard; ⑤ 24hUTP decreased by less than 1 / 2 compared with before treatment;

[0060] Ineffective: ① Clinical symptoms did not improve or worsened; ② Laboratory indicators did not change; ③ Laboratory indicators worsened;

[0061] Note: For the above efficacy assessment, item ① must be met, and any one of items ②, ③, ④, and ⑤ only needs to be met.

[0062] VI. Efficacy Observation Indicators

[0063] 1) Main efficacy index: 24h urine protein quantification (24h-Upro);

[0064] 2) Secondary efficacy indicators: urine albumin / creatinine ratio (UACR), urea nitrogen (BUN), serum creatinine (Scr), and estimated glomerular filtration rate (eGFR*).

[0065] 3) Safety indicators: body temperature, pulse, respiration, blood pressure, liver function, electrolytes, and electrocardiogram.

[0066] 6. Results

[0067] Clinical efficacy after treatment: see Tables 1 and 2.

[0068] Table 1 Therapeutic effect of TCM syndromes

[0069]

[0070] Table 2 Total clinical efficacy

[0071]

[0072] Changes of clinical indicators before and after treatment: see Table 3.

[0073] Table 3 Changes of 24hUTP before and after treatment / M(P25,P75)

[0074]

[0075] Before and after comparison P<0.05.

[0076] Adverse reactions: After many years of clinical application, no obvious adverse reactions have been found.

[0077] While conducting experiments on Example 1, the same experiments were also conducted on other examples, and the same or similar results were obtained, which will not be listed here one by one.

[0078] VII. Conclusion

[0079] Diabetic nephropathy (DN) is one of the common microvascular complications of diabetes. Although there is no name for "diabetic nephropathy" in traditional Chinese medicine, it can be classified into the categories of "digestion", "edema" and "turbid urine" according to its clinical manifestations. There are records about diabetes in the "Huangdi Neijing", such as "those with weak five internal organs are prone to diseases such as thirst". Diabetes lasts for a long time and the condition is not cured. Long-term illness enters the collaterals, and the circulation of qi and blood is not smooth, and the kidney collaterals are blocked. In addition, the pathological characteristics of diabetes are yin deficiency and dryness, which consume qi and damage yin, and eventually lead to qi and yin deficiency, blood stasis, and then cause diabetic nephropathy. From the perspective of modern medicine, diabetic nephropathy is caused by long-term hyperglycemia, which causes changes in renal hemodynamics, metabolic disorders, local inflammatory reactions and oxidative stress in renal tissue, etc., leading to thickening of the glomerular basement membrane, proliferation of mesangial cells, accumulation of extracellular matrix, and eventually glomerular sclerosis and tubular interstitial fibrosis, thereby affecting the normal function of the kidneys.

[0080] In the treatment of diabetic nephropathy, relying solely on Western medicine has certain limitations. Western medicine mainly controls blood sugar and blood pressure, and uses drugs such as angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) to delay disease progression, but these treatments can often only target a single target or symptom, and it is difficult to comprehensively improve the patient's overall condition. In addition, long-term use of certain drugs may cause adverse reactions, such as ACEI drugs may cause dry cough, hypotension, etc. Traditional Chinese medicine treatment emphasizes holistic concepts and syndrome differentiation, focusing on fundamentally adjusting the balance of yin and yang in the human body and the circulation of qi and blood. Through multi-target and multi-pathway mechanisms of action, it improves patients' clinical symptoms and quality of life, and reduces the occurrence of complications. It has unique advantages in the treatment of diabetic nephropathy, and can play a synergistic role in combination with Western medicine to provide patients with a more comprehensive and effective treatment plan.

[0081] Among the many syndromes of diabetic nephropathy, spleen and kidney qi deficiency and blood stasis and toxin obstruction are more common and complicated. The spleen is the foundation of acquired constitution and the source of qi and blood biochemical transformation; the kidney is the foundation of congenital constitution and is responsible for storing essence and water. When the course of diabetes is prolonged, the spleen and kidney are damaged, and the spleen fails to function properly, the essence of water and grain cannot be properly transported, and the qi and blood biochemical transformation lacks the source, resulting in symptoms such as fatigue, limb fatigue, and loss of appetite; the kidney fails to seal and store, and the essence is leaked, which can cause proteinuria to worsen. At the same time, the kidney's function of controlling water is abnormal, water metabolism is impaired, dampness and turbidity are generated internally, and depression turns into heat and toxicity. In addition, long-term illness enters the collaterals, blood stasis is blocked, and a pathological state of blood stasis and toxins blocking the kidney collaterals is formed. In addition to the common edema and proteinuria of diabetic nephropathy, the external manifestations may also be accompanied by dark complexion, skin and nail discoloration, numbness and pain in the limbs, and other signs of blood stasis and toxins blocking the kidney collaterals.

[0082] Experiments show that the Chinese medicine composition of the present invention targets the basic pathogenesis of diabetic nephropathy with spleen and kidney qi deficiency and blood stasis and toxins blocking the collaterals, and accurately treats diabetic nephropathy from multiple aspects and multiple targets. It can not only improve the hemodynamics of the kidneys, reduce blood viscosity, and relieve blood stasis in the kidney collaterals, but also regulate the body's immune function, reduce inflammatory response and oxidative stress damage, reduce proteinuria, improve renal function, and delay the progression of diabetic nephropathy. It embodies the characteristics of overall conditioning and treating both the symptoms and the root causes of Chinese medicine compound prescriptions, and provides an effective technical approach and medicine for the treatment of diabetic nephropathy. Compared with other Western medicine treatments and other Chinese medicine prescriptions, it has the characteristics of safe medication, stable and reliable efficacy, no toxic side effects, good efficacy, and a clinical effective rate of more than 90%. It is a major innovation in the treatment of diabetic nephropathy with spleen and kidney qi deficiency, blood stasis and toxins blocking the collaterals, with significant social and economic benefits.

Claims

1. A Chinese medicine composition for treating spleen and kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy, comprising the following raw materials by weight: 37-33g of Astragalus, 27-33g of Centella asiatica, 18-22g of Ligusticum chuanxiong, 18-22g of Psoralea corylifolia, 18-22g of Salvia miltiorrhiza and 14-16g of Rehmannia glutinosa. Remove impurities from the raw materials, wash, dry, crush and mix evenly to form a traditional Chinese medicine composition.

2. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 30g of Astragalus, 30g of Centella asiatica, 20g of Chuanxiong, 20g of Psoralea corylifolia, 20g of Salvia miltiorrhiza and 15g of Rehmannia glutinosa. The raw materials are cleaned of impurities, dried, crushed and mixed evenly to form a Chinese medicine composition.

3. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 33g of Astragalus, 33g of Centella asiatica, 22g of Chuanxiong, 22g of Psoralea corylifolia, 22g of Salvia miltiorrhiza and 16g of Rehmannia glutinosa. The raw materials are cleaned of impurities, dried, crushed and mixed evenly to form a Chinese medicine composition.

4. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 27g of Astragalus, 27g of Centella asiatica, 18g of Chuanxiong, 18g of Psoralea corylifolia, 18g of Salvia miltiorrhiza and 14g of Rehmannia glutinosa. The raw materials are cleaned of impurities, dried, crushed and mixed evenly to form a Chinese medicine composition.

5. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 27g of Astragalus, 33g of Centella asiatica, 22g of Ligusticum chuanxiong, 18g of Psoralea corylifolia, 22g of Salvia miltiorrhiza and 14g of Rehmannia glutinosa. The raw materials are cleaned of impurities, dried, crushed and mixed evenly to form a Chinese medicine composition.

6. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 33g of Astragalus, 27g of Centella asiatica, 18g of Ligusticum chuanxiong, 22g of Psoralea corylifolia, 18g of Salvia miltiorrhiza and 16g of Rehmannia glutinosa. The raw materials are cleaned of impurities, dried, crushed and mixed evenly to form a Chinese medicine composition.

7. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 1, characterized in that: Gorgon fruit or Rosa laevigata fruit is also added, with the added amount being 14-16g of Gorgon fruit or 9-11g of Rosa laevigata fruit to prepare a series of products.

8. The Chinese medicine composition for treating diabetic nephropathy of spleen-kidney qi deficiency, blood stasis and toxicity obstruction type according to any one of claims 1 to 7 can be prepared into pharmaceutically acceptable dosage forms by conventional preparation methods of various dosage forms as needed.

9. The Chinese medicine composition for treating spleen-kidney qi deficiency, blood stasis and toxicity obstruction type diabetic nephropathy according to claim 8 can be prepared into pharmaceutically acceptable dosage forms by conventional preparation methods of various dosage forms as needed, characterized in that: The dosage forms are powder, granule, tablet and decoction.

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