A Chinese medicine composition for treating IgA nephropathy and preparation method thereof

Abstract

The present invention provides a Chinese medicine composition for treating IgA nephropathy and a preparation method thereof, and belongs to the technical field of Chinese medicine compositions. The Chinese medicine composition of the present invention comprises raw rehmannia, astragalus, caesalpinia, codonopsis, radix rehmanniae, ophiopogon, plantago, tuckahoe, scutellaria, umbellate, motherwort, bupleurum, oldenlandia diffusa, scutellaria barbata, caulis scabra, radix scutellariae, radix scutellariae, radix licorice. The present invention also provides a preparation method of the Chinese medicine composition, comprising: weighing the raw materials according to the raw material ratio, decocting with water, and filtering to obtain a medicinal liquid. The composition provided by the present invention has a mild medicinal property, clears the heart fire, replenishes qi and yin, has no toxic side effects, can effectively reduce hematuria, proteinuria and adverse drug reactions, and is used for the treatment of chronic glomerulonephritis (IgA nephropathy).

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to a traditional Chinese medicine composition for treating IgA nephropathy and a preparation method thereof. Background Art

[0002] IgA nephropathy, also known as mesangial proliferative IgA nephropathy, is a common primary glomerular disease characterized by the extensive deposition of immunoglobulin IgA in the mesangial region of the glomerulus. Some patients may also have deposition of IgG and IgM. The clinical manifestations of IgA nephropathy are diverse and can occur in different populations, manifested as macroscopic hematuria, microscopic hematuria and proteinuria, nephrotic syndrome, acute renal failure, chronic renal failure, and hypertension.

[0003] Modern medicine mostly treats IgA nephropathy with ACEI / ARB, hormones, immunosuppressive drugs, anti-infection, diuretics, etc., but the efficacy is poor. For rapidly progressive IgA nephropathy, hormones and immunosuppressants are often used as the main treatment, but hormones and immunosuppressants have toxic side effects and do not improve the patient's prognosis; for patients with 24h urine protein>0.5g, ACEI / ARB drugs are often used as the main treatment; for patients with simple hematuria, only symptomatic treatment is used as the main treatment, lacking effective means. Traditional Chinese medicine believes that the above drugs can consume qi and damage yin, and easily cause liver and kidney damage and other toxic side effects. In particular, long-term use of glucocorticoids and immunosuppressants will cause feedback inhibition of the "hypothalamus-pituitary-adrenal cortex" axis, resulting in various side effects and complications such as reduced immunity, infection, and Cushing's syndrome. Clinically, it is often manifested as frequent sweating, fatigue, dry mouth, and five-heart heat.

[0004] IgA nephropathy is often classified into the categories of "edema", "hematuria", "low back pain", "kidney wind" and so on in the field of traditional Chinese medicine. The basic pathogenesis is deficiency of the root and excess of the symptoms. Clinically, this disease is often manifested as deficiency of the internal organs, especially spleen and kidney deficiency. Water dampness, damp heat, wind evil, blood stasis and other symptoms are the symptoms of the lesions, which is a mixed syndrome of deficiency and excess. Through multi-center epidemiological surveys, as the pathological damage worsens, the syndrome of traditional Chinese medicine changes from spleen and lung qi deficiency syndrome and qi and yin deficiency syndrome to liver and kidney yin deficiency syndrome and spleen and kidney yang deficiency syndrome. Qi and yin deficiency syndrome is the most common syndrome and is also the key turning point for the development of IgA nephropathy from low risk to high risk.

[0005] Therefore, how to find an effective Chinese medicine prescription for the treatment of Qi and Yin deficiency syndrome in IgA nephropathy from the perspective of traditional Chinese medicine has become a technical problem that needs to be solved in this field. Summary of the invention

[0006] In view of this, the object of the present invention is to provide a Chinese medicine composition for treating Qi and Yin deficiency syndrome of IgA nephropathy and a preparation method thereof, which has a significant therapeutic effect on IgA nephropathy and its related complications.

[0007] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0008] The invention provides a traditional Chinese medicine composition for treating IgA nephropathy. The traditional Chinese medicine composition comprises, by weight, 15-25 parts of raw rehmannia root, 25-35 parts of astragalus, 15-25 parts of caesalpinia seeds, 25-35 parts of codonopsis pilosula, 10-20 parts of lycium bark, 15-25 parts of ophiopogon, 15-25 parts of plantain seeds, 10-20 parts of tuckahoe, 10-15 parts of scutellaria baicalensis, 15-25 parts of umbellatus, 25-35 parts of motherwort, 5-15 parts of bupleurum, 25-35 parts of oldenlandia diffusa, 10-20 parts of scutellaria barbata, 10-20 parts of caulis scutellariae, 10-20 parts of euphorbia pulex and 3-10 parts of roasted liquorice.

[0009] Preferably, the Chinese medicine composition comprises, by mass: 18-22 parts of raw rehmannia, 28-32 parts of astragalus, 18-23 parts of caesalpinia, 27-32 parts of codonopsis, 13-18 parts of lycium bark, 18-22 parts of ophiopogon, 18-23 parts of plantain seeds, 13-17 parts of poria, 11-13 parts of scutellaria, 18-23 parts of umbellatus, 28-32 parts of motherwort, 8-12 parts of bupleurum, 28-31 parts of oldenlandia diffusa, 12-16 parts of scutellaria barbata, 12-17 parts of clematis, 13-17 parts of licorice, and 4-7 parts of roasted liquorice.

[0010] Preferably, the Chinese medicine composition comprises, by mass: 20 parts of raw rehmannia, 30 parts of astragalus, 20 parts of caesalpinia, 30 parts of codonopsis, 15 parts of rehmannia root, 20 parts of ophiopogon, 20 parts of plantain seeds, 15 parts of poria, 12 parts of scutellaria, 20 parts of umbellatus, 30 parts of motherwort, 10 parts of bupleurum, 30 parts of oldenlandia diffusa, 15 parts of scutellaria barbata, 15 parts of clematis, 15 parts of glycyrrhiza uralensis, and 5 parts of roasted liquorice.

[0011] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps: weighing raw medicines according to the raw material ratio, adding water for decoction, and filtering to obtain a medicinal solution.

[0012] Preferably, the amount of water added is 6 to 10 times the mass of the raw material drug.

[0013] Preferably, water is added and boiled for 2 to 3 times, each time boiling for 1 to 2 hours.

[0014] Preferably, the medicinal liquid is concentrated to a clear paste with a relative density of 1.20 to 1.25, and auxiliary materials are added to prepare a corresponding Chinese medicine compound dosage form.

[0015] Preferably, the Chinese medicine compound dosage form includes granules, pills, pastes, and tablets.

[0016] The present invention also provides application of the Chinese medicine composition in the pharmaceutical preparation of IgA nephropathy and its related complications.

[0017] The present invention also provides application of the Chinese medicine composition in the preparation of medicine for the deficiency of both qi and yin in IgA nephropathy.

[0018] Beneficial effects of the present invention:

[0019] The present invention is guided by the theory of traditional Chinese medicine, based on solid clinical practice, using modern scientific research methods as a means, and taking invigorating qi and nourishing yin, unblocking meridians and removing dampness as a treatment principle, and is used for the treatment of IgA nephropathy.

[0020] The Chinese medicine composition provided by the present invention can nourish the kidney and astringe the essence, invigorate the qi and yin, eliminate dampness and turbidity, dispel wind and dredge the meridians, and can effectively reduce hematuria, proteinuria and adverse drug reactions. The Chinese medicine composition provided by the present invention has a mild nature, is neither cold nor hot, and can be taken regularly to clear the heart and nourish the spirit, retain essence and replenish deficiency, nourish the stomach and intestines, and regulate blood, and can be used for the treatment of IgA nephropathy. Compared with similar drugs, the prescription of the present invention has sufficient theoretical basis of traditional Chinese medicine, mild nature, rigorous compatibility, clear pharmacodynamic substances, significant clinical efficacy, and can achieve good therapeutic effects within three months. DETAILED DESCRIPTION

[0021] The invention provides a traditional Chinese medicine composition for treating IgA nephropathy. The traditional Chinese medicine composition comprises, by weight, 15-25 parts of raw rehmannia root, 25-35 parts of astragalus, 15-25 parts of caesalpinia seeds, 25-35 parts of codonopsis pilosula, 10-20 parts of lycium bark, 15-25 parts of ophiopogon, 15-25 parts of plantain seeds, 10-20 parts of tuckahoe, 10-15 parts of scutellaria baicalensis, 15-25 parts of umbellatus, 25-35 parts of motherwort, 5-15 parts of bupleurum, 25-35 parts of oldenlandia diffusa, 10-20 parts of scutellaria barbata, 10-20 parts of caulis scutellariae, 10-20 parts of euphorbia pulex and 3-10 parts of roasted liquorice.

[0022] Preferably, the Chinese medicine composition comprises, by mass: 18-22 parts of raw rehmannia, 28-32 parts of astragalus, 18-23 parts of caesalpinia, 27-32 parts of codonopsis, 13-18 parts of lycium bark, 18-22 parts of ophiopogon, 18-23 parts of plantain seeds, 13-17 parts of poria, 11-13 parts of scutellaria, 18-23 parts of umbellatus, 28-32 parts of motherwort, 8-12 parts of bupleurum, 28-31 parts of oldenlandia diffusa, 12-16 parts of scutellaria barbata, 12-17 parts of clematis, 13-17 parts of licorice, and 4-7 parts of roasted liquorice.

[0023] More preferably, the Chinese medicine composition comprises, by mass: 20 parts of raw rehmannia, 30 parts of astragalus, 20 parts of caesalpinia, 30 parts of codonopsis, 15 parts of lycium bark, 20 parts of ophiopogon, 20 parts of plantain seeds, 15 parts of poria, 12 parts of scutellaria, 20 parts of umbellatus, 30 parts of motherwort, 10 parts of bupleurum, 30 parts of oldenlandia diffusa, 15 parts of scutellaria barbata, 15 parts of clematis, 15 parts of glycyrrhiza uralensis, and 5 parts of roasted liquorice.

[0024] The main drugs in the Chinese medicine formula provided by the present invention are introduced as follows:

[0025] Shengdihuang is the fresh or dried root of Rehmannia glutinosa, a plant of the genus Rehmannia in the family Scrophulariaceae. It has the effects of clearing away heat and cooling blood, nourishing yin and promoting body fluid. It is mainly used to treat heat entering the blood, red tongue and thirst, macules and vomiting and bleeding, yin deficiency and internal heat, bone steaming and fatigue fever, thirst due to loss of body fluid, internal heat and thirst, and constipation due to dry intestines.

[0026] Astragalus is the root of Astragalus mongolica or Astragalus membranaceus, a plant of the genus Astragalus in the Leguminosae family. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, benefiting the body's defense and strengthening the exterior, promoting urination, and removing toxins and promoting tissue regeneration. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal after a long time, etc.

[0027] Echeveria seeds are the mature fruits of the lotus plant of the Nymphaeaceae family. They have the effects of clearing dampness and heat, stimulating appetite, clearing the heart and calming the mind, and stopping semen and diarrhea. They are often used for dysentery, vomiting and loss of appetite, restlessness and insomnia, spermatorrhea, turbid urine, and leucorrhea.

[0028] Codonopsis pilosula is the root of Codonopsis pilosula, Codonopsis pilosula or Codonopsis pilosula of the Campanulaceae family. It has the effects of tonifying the spleen and lungs, promoting the production of body fluids and nourishing blood. It is mainly used to treat spleen and stomach weakness, asthma and cough due to lung deficiency, thirst due to loss of body fluids, and weakness due to blood deficiency.

[0029] Lycium bark is the dried root bark of Lycium barbarum or Lycium ningxiaense, a plant of the Solanaceae family. It has the effects of cooling blood and removing steam, clearing the lungs and reducing fire. It is mainly used to treat fever due to yin deficiency, night sweats and bone steaming, cough due to lung heat, and bleeding due to blood heat.

[0030] Ophiopogon japonicus is a perennial evergreen herb of the genus Ophiopogonis in the Liliaceae family. It has the effects of promoting body fluid and quenching thirst, moistening the lungs and relieving cough. It is mainly used to treat dry cough due to lung dryness, tuberculosis due to yin deficiency, sore throat due to throat numbness, thirst due to loss of body fluid, internal heat and thirst, restlessness and insomnia, dry intestines and constipation, etc.

[0031] Plantago seed is the dried mature seeds of the plant Plantago or Plantago asiatica of the Plantaginaceae family. It has the effects of clearing away heat and promoting diuresis, dispelling dampness and stopping diarrhea, improving eyesight and removing phlegm. It is mainly used to treat urinary problems, stranguria and leucorrhea, edema, summer-heat diarrhea, red eyes and cataracts, and cough and asthma due to phlegm and heat.

[0032] Poria cocos is the dried sclerotium of the fungus Poria cocos of the genus Poria of the family Polyporaceae. It has the effects of promoting diuresis and reducing swelling, dispelling dampness, strengthening the spleen, and calming the mind. It is mainly used to treat edema, phlegm and fluid retention, spleen deficiency diarrhea, palpitations, and insomnia.

[0033] Scutellaria baicalensis is the dried root of Scutellaria baicalensis, a plant of the genus Scutellaria in the Lamiaceae family. It has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is mainly used to treat damp-heat, summer-heat dampness, chest tightness and nausea, damp-heat fullness, jaundice and diarrhea, lung heat cough, high fever and thirst, blood heat vomiting and epistaxis, and fetal movement disorder.

[0034] Polyporus is the dried sclerotium of the fungus Polyporus of the Polyporaceae family. It has the effects of promoting diuresis, reducing swelling, and removing dampness. It is mainly used to treat edema, dysuria, beriberi, diarrhea, stranguria, leucorrhea, etc.

[0035] Motherwort is the fresh or dried aerial part of the plant Leonurus of the Lamiaceae family. It has the effects of promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, clearing away heat and detoxifying. It is mainly used to treat irregular menstruation, dysmenorrhea, amenorrhea, lochia retention, edema, oliguria, sores and swelling.

[0036] Bupleurum is the dried root of Bupleurum or Bupleurum angustifolia, a plant of the genus Bupleurum in the family Apiaceae. It has the effects of relieving fever, soothing the liver and relieving depression, and raising Yang Qi. It is mainly used to treat fever due to superficial symptoms, Shaoyang syndrome, liver depression and qi stagnation, qi deficiency and sinking, organ prolapse, and antipyretic and antimalarial.

[0037] Hedyotis diffusa is the whole herb of Hedyotis diffusa of the Rubiaceae family. It has the effects of clearing away heat and detoxifying, promoting dampness and relieving stranguria. It is mainly used to treat carbuncle, sore throat, snake bites, and hot stranguria.

[0038] Scutellaria barbata is the whole herb of Scutellaria barbata, a plant of the Lamiaceae family. It has the effects of clearing away heat and detoxifying, dispersing blood stasis and stopping bleeding, and diuresis and swelling. It is mainly used to treat heat-toxic carbuncle, sore throat, lung carbuncle, intestinal carbuncle, scrofula, snake bites, traumatic injuries, hematemesis, epistaxis, hematuria, edema, ascites and cancer.

[0039] Caulis Sinensis is the dried vine stem of Caulis Sinensis and Caulis Sinensis of the Menispermaceae family. It has the effects of removing rheumatism, unblocking meridians, and promoting urination. It is used for rheumatic pain, joint swelling, paralysis and itching.

[0040] The winged branches or winged appendages of Euonymus japonicus, a plant of the Celastraceae family, have the effects of breaking blood and promoting menstruation, detoxifying and reducing swelling, and killing insects. It is used for lumps and masses, heart and abdominal pain, amenorrhea, dysmenorrhea, metrorrhagia, postpartum abdominal pain due to stasis, retained lochia, hernia, pain in the joints, sores, bruises, abdominal pain due to worm accumulation, burns, and snake bites.

[0041] Roasted licorice is a processed product of licorice, which is made by frying licorice with refined honey. It also has the effects of tonifying, purging, soothing and harmonizing, but the application of roasted licorice is mostly for its characteristics of tonifying, soothing and harmonizing, and its effect of invigorating qi is stronger than licorice.

[0042] In the prescription of the present invention, the medication rule of monarch, minister, assistant and envoy is followed. In this prescription, astragalus and raw rehmannia are used as monarch drugs to nourish qi and yin; Codonopsis pilosula replenishes qi and raises yang, lotus seeds nourish spleen yin and clear heart fire, and Rehmannia root bark and Ophiopogon japonicus nourish yin, and these four drugs are collectively ministerial drugs; Bupleurum and Scutellaria baicalensis can both disperse the stagnant heat of the liver and gallbladder and clear the heat of the heart and lungs in the upper part of the body, and the lung heat can be cleared and descended; Hedyotis diffusa and Scutellaria barbata clear away heat and detoxify; Caulis Sinomenii, Euphorbia obtusifolia and Leonurus japonicus dispel wind and dredge the meridians, and are collectively adjuvant drugs; Poria, Polyporus umbellata and Plantago seed can clear away dampness and heat, so that the heat evil can be eliminated through urination, and Radix Glycyrrhizae uralensis can relieve the symptoms and are collectively used as envoy drugs.

[0043] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps: weighing the raw materials according to the raw material ratio, adding water for decoction, and filtering to obtain the medicinal liquid.

[0044] The present invention weighs the raw materials according to the above raw material ratio, adds 6 to 10 times the mass of water, and completely immerses the raw materials in the water. Preferably, the amount of water added in the present invention is 7 to 9 times the raw materials, and more preferably 8 times. Preferably, the water in the present invention is boiled water or purified water.

[0045] The present invention directly decocts the raw material medicine and water. The decoction conditions of the present invention are: add water and decoct for 2 to 3 times, and decoct for 1 to 2 hours each time. As an optional embodiment, the present invention decocts for 1.5 hours under natural pressure, and filters to obtain a medicinal liquid, and the medicinal residue is repeatedly decocted 1 to 2 times using the above decoction steps, and the decoction is filtered, and the filtrate is combined to obtain the obtained medicinal liquid.

[0046] The present invention concentrates the obtained medicinal liquid into a clear paste with a relative density of 1.20 to 1.25 (60° C.), and adds auxiliary materials to prepare a corresponding Chinese medicine compound dosage form. The present invention does not limit the specific Chinese medicine dosage form, and the dosage form includes but is not limited to granules, pills, pastes, and tablets.

[0047] As an optional embodiment, the present invention prepares granules from the above-mentioned Chinese medicine composition: adding appropriate amount of auxiliary materials to the obtained clear paste to make a soft material, passing through a 14-mesh sieve to make wet granules, drying, and granulating to make a granule product.

[0048] The traditional Chinese medicine compound prepared by the invention has the effects of invigorating qi and nourishing yin, unblocking meridians and removing dampness.

[0049] The indications of the present invention are: used for fatigue, shortness of breath, laziness to speak, soreness of waist and knees, dizziness, palpitations, poor appetite, dry mouth and tongue, fever in the five parts of the body, spontaneous sweating, night sweats, pale or light red tongue, fat and large with teeth marks on the edges, little and dry coating, deep and thin pulse or fine and weak pulse, etc. caused by deficiency of both qi and yin; patients with chronic nephritis, nephrotic syndrome, urinary tract infection, and proteinuria with the above symptoms.

[0050] The dosage of the Chinese medicine composition of the present invention is: oral administration, 15 g per time, twice a day, 30 days as a course of treatment (specific dosage can be changed according to clinical conditions).

[0051] The present invention also provides the use of the above-mentioned Chinese medicine composition in the preparation of medicines for IgA nephropathy and its related complications. The present invention also provides the use of the above-mentioned Chinese medicine composition in the preparation of medicines for the Qi and Yin deficiency syndrome of IgA nephropathy. After many years of clinical observation and treatment, the effective rate of IgA nephropathy patients with different etiologies and symptoms can reach more than 95%, with significant therapeutic effect.

[0052] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0053] Example 1

[0054] A traditional Chinese medicine composition for treating IgA nephropathy, comprising, by weight, 20g of raw rehmannia root, 30g of astragalus, 20g of caesalpinia, 30g of codonopsis pilosula, 15g of lycium bark, 20g of ophiopogon, 20g of plantain seed, 15g of tuckahoe, 12g of scutellaria, 20g of umbellate, 30g of motherwort, 10g of bupleurum, 30g of oldenlandia diffusa, 15g of scutellaria barbata, 15g of caulis scutellariae, 15g of euphorbia pulex, and 5g of roasted liquorice.

[0055] According to the above raw material ratio, weigh the raw materials respectively, add 8 times the amount of water, and boil for 3 times under natural pressure, each time for 1.5 hours. Filter the decoction, combine the filtrate, and concentrate it to a clear paste with a relative density of 1.20-1.25 (60°C). Add appropriate amount of starch: dextrin (1:1) as an auxiliary material to make a soft material, pass through a 14-mesh sieve to make wet granules, dry, and granulate to make a granule product.

[0056] Example 2

[0057] A traditional Chinese medicine composition for treating IgA nephropathy, comprising, by weight, 18g of raw rehmannia root, 28g of astragalus, 19g of caesalpinia, 29g of codonopsis pilosula, 16g of lycium bark, 19g of ophiopogon, 18g of plantain seed, 19g of tuckahoe, 13g of scutellaria baicalensis, 17g of umbellate, 28g of motherwort, 11g of bupleurum, 31g of oldenlandia diffusa, 14g of scutellaria barbata, 13g of caulis scutellariae, 16g of euphorbia pulex, and 4g of roasted liquorice.

[0058] According to the above raw material ratio, weigh the raw materials respectively, add 9 times the amount of water, and boil twice under natural pressure, each time for 2 hours. Filter the decoction, combine the filtrate, and concentrate it to a clear paste with a relative density of 1.20-1.25 (60°C). Add appropriate amount of starch: dextrin (1:1) as an auxiliary material to make a soft material, pass through a 14-mesh sieve to make wet granules, dry, and granulate to make a granule product.

[0059] Example 3

[0060] A traditional Chinese medicine composition for treating IgA nephropathy, comprising, by weight, 22g of raw rehmannia root, 25g of astragalus, 20g of caesalpinia seeds, 31g of codonopsis pilosula, 14g of lycium bark, 20g of ophiopogon, 21g of plantain seeds, 15g of tuckahoe, 13g of scutellaria baicalensis, 20g of umbellate, 31g of motherwort, 9g of bupleurum, 30g of oldenlandia diffusa, 16g of scutellaria barbata, 15g of caulis scutellariae, 15g of euphorbia pulex, and 3g of roasted liquorice.

[0061] According to the above raw material ratio, weigh the raw materials respectively, add 7 times the amount of water, and boil for 3 times under natural pressure, each time for 2 hours. Filter the decoction, combine the filtrate, and concentrate it to a clear paste with a relative density of 1.20-1.25 (60°C). Add appropriate amount of starch: dextrin (1:1) as an auxiliary material to make a soft material, pass through a 14-mesh sieve to make wet granules, dry, and granulate to make a granule product.

[0062] Example 4

[0063] A traditional Chinese medicine composition for treating IgA nephropathy, comprising, by weight, 21g of raw rehmannia root, 30g of astragalus, 20g of caesalpinia, 30g of codonopsis pilosula, 16g of lycium bark, 21g of ophiopogon, 20g of plantain seed, 14g of tuckahoe, 12g of scutellaria, 21g of umbellate, 29g of motherwort, 10g of bupleurum, 31g of oldenlandia diffusa, 18g of scutellaria barbata, 16g of caulis scutellariae, 16g of euphorbia pulex, and 8g of roasted liquorice.

[0064] The preparation method is the same as Example 1.

[0065] Example 5

[0066] A traditional Chinese medicine composition for treating IgA nephropathy, comprising, by weight, 20g of raw rehmannia root, 30g of astragalus, 16g of caesalpinia, 25g of codonopsis pilosula, 10g of lycium bark, 16g of ophiopogon, 21g of plantain seed, 14g of tuckahoe, 15g of scutellaria, 15g of umbellatus, 26g of motherwort, 10g of bupleurum, 30g of oldenlandia diffusa, 10g of scutellaria barbata, 10g of caulis scabra, 11g of euphorbia pulex, and 7g of roasted liquorice.

[0067] The preparation method is the same as Example 1.

[0068] Example 6

[0069] In this example, the granules prepared in Example 1 were used for clinical trials.

[0070] 1. Disease diagnosis

[0071] Refer to "Nephrology": Renal pathological immunofluorescence clearly shows diffuse deposition of IgA or IgA-based immune complexes in the glomerular mesangial area; clinical manifestations are hematuria mainly composed of malformed red blood cells, which may or may not be accompanied by varying degrees of proteinuria, hypertension, and renal function impairment; secondary factors are excluded.

[0072] 2. Diagnostic criteria for TCM syndromes: (Refer to the Guiding Principles for Clinical Research of New Chinese Medicines). Practical Guidelines for Western Medicine Diagnosis and TCM Syndrome Differentiation of IgA Nephropathy

[0073] Main symptoms: shortness of breath, fatigue, night sweats, spontaneous sweating, soreness of waist and knees, and hot hands and feet.

[0074] Secondary symptoms: dry mouth, fatigue.

[0075] Tongue and pulse: The tongue is pale or light red, thick and has teeth marks on the edges, with little and dry coating, and the pulse is deep and thin or fine and weak.

[0076] 3. Inclusion criteria

[0077] (1) IgA nephropathy was confirmed by renal puncture biopsy without crescent formation, 24-hour urine protein was less than 3.5 g, and eGFR (glomerular filtration rate) was ≥ 30 ml / min / 1.73 m 2 ;

[0078] (2) The TCM syndrome information was collected in a standardized manner and met the criteria for Qi and Yin deficiency syndrome;

[0079] (3) Volunteer to participate in this study and sign the informed consent.

[0080] 4. Exclusion criteria

[0081] (1) Patients who have progressed to end-stage renal disease when starting treatment;

[0082] (2) Patients with systemic diseases such as diabetes, rheumatoid arthritis, Sjögren's syndrome, chronic viral hepatitis, vasculitis renal damage, and lupus nephritis;

[0083] (3) Patients who are known to be allergic to the ingredients of the study drugs or have allergic constitutions;

[0084] (4) Patients with severe primary diseases of the respiratory, digestive, and blood systems, as well as current concurrent infections and mental illnesses, or patients with congestive heart failure grades I-IV; or patients with malignant tumors, or those who are pregnant or breastfeeding; or patients with a history of critical illnesses such as malignant hypertension, myocardial infarction, cerebrovascular accident, and diabetic ketoacidosis within 6 months;

[0085] (5) When the clinical researcher believes that the subjects participating in the clinical research cannot cooperate with the observation.

[0086] 5. Research Methods

[0087] Patients were enrolled according to the inclusion and exclusion criteria and divided into a Chinese medicine group and a control group according to a random number table. Both groups were given basic treatment. Basic treatment includes a low-salt, low-fat, high-quality protein diet with a high-quality protein intake of about 0.8 g / kg / d. Adequate ACEI treatment was applied for more than 6 months. Combined with other conditions: Patients with difficult-to-correct hypertension were treated with CCB drugs on the basis of ACEI. In addition to basic treatment, the Chinese medicine group was given the preparation of Example 1 of the present invention, orally, 15 g once, twice a day. Evaluate the efficacy evaluation indicators, including the Chinese medicine syndrome integral scale, and check renal function, 24-hour urine protein quantification, urine routine, estimate the glomerular filtration rate, and perform statistical analysis; evaluate safety evaluation indicators, including blood routine, liver function, kidney function, etc., and perform statistical analysis.

[0088] 6. Efficacy standards

[0089] 6.1. TCM syndrome efficacy standard: refer to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" formulated and promulgated by the Ministry of Health of the People's Republic of China in 2002. The calculation formula adopts the nimodipine method.

[0090] Calculation formula: [〔score before treatment - score after treatment〕÷score before treatment]×100%;

[0091] (1) Clinical recovery: symptoms and signs disappear or almost disappear, and syndrome score decreases by ≥95%;

[0092] (2) Significantly effective: symptoms and signs were significantly improved, and the syndrome score was reduced by ≥70%;

[0093] (3) Effective: symptoms and signs improved, and the syndrome score decreased by ≥30%;

[0094] (4) Ineffective: There is no significant improvement in symptoms and signs, or they may even worsen, and the symptom score decreases by less than 30%.

[0095] 6.2. Comprehensive efficacy evaluation criteria for the disease: (Refer to the standard efficacy evaluation criteria formulated in the "Diagnosis, Syndrome Differentiation and Efficacy Evaluation of IgA Nephropathy (Trial Program)" formulated in 2007)

[0096] (1) Complete remission: TCM symptom score decreased by ≥95%, red blood cell count in urine sediment microscopy <8,000 / ml or ≤3 / high-power field, 24-hour urine protein ≤0.3g, and normal renal function;

[0097] (2) Significantly effective: The TCM symptom score is reduced by ≥70% and <95%, the number of red blood cells in urine sediment is reduced by ≥50%, the 24-hour urine protein is reduced by ≥50%, and renal function is normal;

[0098] (3) Effective: TCM symptom score decreased by ≥30% and <70%, the number of red blood cells in urine sediment decreased by ≥5% and <50%, the 24-hour urine protein decreased by ≥25% and <50%, and renal function was normal;

[0099] (4) Ineffective: The TCM symptom score decreased by <30% and the above laboratory indicators showed no significant improvement or even worsened.

[0100] 6.3. Observation indicators:

[0101] (1) TCM syndrome scoring method: The scoring criteria are shown in Table 1. Observation and recording were performed before and after treatment.

[0102] Table 1 Symptom scoring criteria

[0103]

[0104]

[0105]

[0106] The tongue and pulse in the table are used to assist in determining the syndrome type and concurrent syndromes and do not participate in the scoring.

[0107] (2) Other observation indicators:

[0108] Demographic information: gender, age, long-term living area, diet, personal history, history of IgA nephropathy, etc.

[0109] Physical examination information: height, weight, blood pressure and other indicators.

[0110] Safety indicators: observe blood routine, liver function, electrocardiogram, etc. before and after treatment.

[0111] The therapeutic effects of the Chinese medicine group and the control group after 90 days of treatment were statistically analyzed and are shown in Tables 2 to 6.

[0112] Table 2 Comparison of efficacy and total effective rate between the two groups of IgA nephropathy patients

[0113]

[0114] Note: Compared with the control group, # P<0.01

[0115] As shown in Table 2, compared with the control group, the total effective rate of the Chinese medicine group was significantly higher, with statistical significance (P<0.01).

[0116] Table 3 Comparison of symptom quantitative scores between the two groups of IgA nephropathy patients

[0117]

[0118] Note: Compared with the control group, # P<0.01

[0119] As shown in Table 3, the scores of main symptoms and minor symptoms of both groups of patients decreased after treatment. After treatment, compared with the control group, the quantitative scores of main symptoms and minor symptoms in the Chinese medicine group decreased significantly, which was statistically significant (P<0.05).

[0120] Table 4 Comparison of 24-hour urine protein and urine red blood cell count between the two groups of IgA nephropathy patients

[0121]

[0122] Note: Compared with before treatment, # P<0.05; compared with the control group, ▲ P<0.05

[0123] As shown in Table 4, compared with before treatment, the 24-hour urine protein and urine red blood cell count of the two groups of patients decreased after treatment, which was statistically significant (P<0.05). After treatment, compared with the control group, the 24-hour urine protein and urine red blood cell count of the Chinese medicine group decreased significantly, which was statistically significant (P<0.05).

[0124] Table 5 Comparison of renal function between the two groups of IgA nephropathy patients

[0125]

[0126] Note: Compared with before treatment, # P<0.05

[0127] Table 6 Comparison of glomerular filtration rate between two groups of IgA nephropathy patients

[0128]

[0129] Note: Compared with before treatment, # P<0.05

[0130] As shown in Table 5 and Table 6, compared with before treatment, the renal function of the control group and the Chinese medicine group was significantly improved after treatment, and the glomerular filtration rate increased, which was statistically significant (P<0.05). After treatment, compared with the control group, there was no significant difference in renal function and glomerular filtration rate in the Chinese medicine group.

[0131] Example 7

[0132] This example provides a typical case to further illustrate the therapeutic effect of the present invention.

[0133] Zhou, male, 58 years old, first diagnosed on February 20, 2021. Chief complaint: intermittent eyelid edema for 7 years, aggravated by bilateral lower limb edema for 1 month. Current medical history: The patient had eyelid edema without obvious cause 7 years ago, which occurred after fatigue and relieved by itself after rest, so no systematic diagnosis and treatment was given. More than a month ago, without obvious cause, the edema of both eyelids worsened, accompanied by edema of both lower limbs, and the degree of edema was asymmetric. He then went to Baicheng Central Hospital for treatment. Urinalysis showed: protein +3, occult blood +3, red blood cell count 179 / u1, white blood cell count 73 / u1, liver function showed: total protein 53g / L, albumin 23g / L, kidney function showed: 125umo1 / L, and he was diagnosed with "nephrotic syndrome". He was treated with oral Chinese medicine and intravenous injection of circulation-improving, diuretic and detumescent drugs (specific details unknown). Re-examination of relevant physical and chemical tests 12 days later showed: Urinalysis: protein +2, occult blood +3, red blood cell count 316 / ul, white blood cell count 40 / ul, liver function showed: albumin 27g / L, kidney function showed: 169umol / L. In order to seek systematic diagnosis and treatment of traditional Chinese medicine, he came to our hospital for treatment.

[0134] Current symptoms: edema of both eyes, face and lower limbs, back pain, occasional fatigue, hot palms and soles, frequent urination, 2-3 times of nocturia, constipation, 1 time every 3-5 days, normal appetite and sleep, occasional numbness of right lower limb. Past history: history of hypertension for more than 1 month, with the highest blood pressure reaching 170 / 90mmHg; history of hypothyroidism for more than 1 month; physical examination: pale tongue, white and greasy coating, slippery pulse, blood pressure 173 / 90mmHg. Auxiliary examination: Urinalysis: urine protein +4, occult blood +3, urine red blood cell count 474.6 / ul, urine red blood cell 85.4 / HPF; hematuria localization: non-uniform red blood cells 70%; urine microalbumin 9653mg / L; 24-hour urine protein 15.65g, 24-hour urine volume 3.7L; liver function: albumin 25.4g / L; blood lipids: total cholesterol 7.1mmol / L, triglycerides 2.7mmol / L; renal function: urea nitrogen 11.5mmol / L, blood creatinine 141umol / L. Renal biopsy pathology: proliferative sclerosis IgA nephropathy (Lee grade V).

[0135] Traditional Chinese medicine diagnosis: edema, qi and yin deficiency syndrome; Western medicine diagnosis: IgA nephropathy.

[0136] Treatment principle: tonify Qi and nourish Yin, clear away heat and transform dampness.

[0137] Prescription: The granules prepared in Example 1 are taken orally, 15 g at a time, twice a day.

[0138] After taking it for 60 days, the second diagnosis showed: edema of both lower limbs improved, but still weak, heat in the palms and soles improved, physical examination: pale red tongue, white and greasy fur, deep pulse. Auxiliary examination: urine routine: urine protein +3, occult blood +3, red blood cell count 106 / ul, red blood cell (high power field) 19.1 / HPF; urine microalbumin 3034.97mg / L; renal function: urea nitrogen 9.9mmol / L, blood creatinine 104umol / L.

[0139] After taking it for 90 days, the third diagnosis showed that the patient had no edema of the eyelids and lower limbs, and no fatigue. Physical examination: pale red tongue, thin white fur, deep pulse. Auxiliary examination: Urinalysis: urine protein +3, occult blood +3, red blood cell count 192.9 / ul, red blood cell (high power field) 34.7 / HPF; urine microalbumin 2477.89mg / L; renal function: urea nitrogen 10.4mmol / L, blood creatinine 103umol / L.

[0140] After taking the medicine for half a year, the urine routine examination showed: protein +2, occult blood +1, red blood cells 6.7 / HPF; urine microalbumin 1318.79mg / L; biochemistry: albumin 35.1g / L, blood creatinine 111umol / L.

[0141] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating IgA nephropathy, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 15-25 parts of raw rehmannia root, 25-35 parts of astragalus, 15-25 parts of caesalpinia, 25-35 parts of codonopsis, 10-20 parts of lycium bark, 15-25 parts of ophiopogon, 15-25 parts of plantain, 10-20 parts of tuckahoe, 10-15 parts of scutellaria, 15-25 parts of umbellatus, 25-35 parts of motherwort, 5-15 parts of bupleurum, 25-35 parts of oldenlandia diffusa, 10-20 parts of scutellaria barbata, 10-20 parts of scutellaria baicalensis, 10-20 parts of euphorbia pulex, and 3-10 parts of roasted liquorice; The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the raw material medicine according to the raw material ratio, decocting with water, and filtering to obtain the medicinal liquid; the amount of water added is 6 to 10 times the mass of the raw material medicine; decocting with water 2 to 3 times, decocting for 1 to 2 hours each time; concentrating the medicinal liquid to a clear paste with a relative density of 1.20 to 1.25, and adding auxiliary materials to prepare the corresponding traditional Chinese medicine composition.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 18-22 parts of raw rehmannia root, 28-32 parts of astragalus, 18-23 parts of caesalpinia, 27-32 parts of codonopsis pilosula, 13-18 parts of lycium bark, 18-22 parts of ophiopogon, 18-23 parts of plantain seeds, 13-17 parts of tuckahoe, 11-13 parts of scutellaria, 18-23 parts of umbellatus, 28-32 parts of motherwort, 8-12 parts of bupleurum, 28-31 parts of oldenlandia diffusa, 12-16 parts of scutellaria barbata, 12-17 parts of caulis scutellariae, 13-17 parts of euphorbia pulex, and 4-7 parts of roasted liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials by weight: 20 parts of raw rehmannia, 30 parts of astragalus, 20 parts of caesalpinia, 30 parts of codonopsis, 15 parts of lycium bark, 20 parts of ophiopogon, 20 parts of plantain, 15 parts of tuckahoe, 12 parts of scutellaria, 20 parts of umbellatus, 30 parts of motherwort, 10 parts of bupleurum, 30 parts of oldenlandia diffusa, 15 parts of scutellaria barbata, 15 parts of clematis, 15 parts of glycyrrhiza uralensis, and 5 parts of roasted liquorice.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is in the form of granules, pills, paste or tablets.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of medicines for IgA nephropathy and its related complications.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of medicines for treating IgA nephropathy with deficiency of both qi and yin.

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