Kidney-tonifying and dampness-removing traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a kidney-tonifying and dampness-removing traditional Chinese medicine composition and a preparation method and application thereof. The traditional Chinese medicine composition capable of tonifying kidney and promoting diuresis is prepared from the following raw materials in parts by weight: 60 to 120 parts of radix astragali seu hedysari, 60 to 120 parts of fructus ligustri lucidi, 120 to 240 parts of herba taraxaci, 120 to 240 parts of rhizoma imperatae, 40 to 80 parts of semen persicae, 60 to 120 parts of radix paeoniae rubra, 120 to 240 parts of herba leonuri, 120 to 240 parts of folium pyrrosiae, 20 to 40 parts of flos carthami and 80 to 160 parts of radix ilicis pubescentis. The traditional Chinese medicine composition for tonifying kidney and promoting diuresis provided by the invention regulates immune inflammatory response through multiple mechanisms and multiple targets, improves kidney pathology, and potentially intervenes the action mechanism of intestinal-renal axis disorder.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a kidney-tonifying and dampness-eliminating Chinese herbal composition, its preparation method, and its application. Background Technology

[0002] Chronic glomerulonephritis (CGN) is a group of primary glomerular diseases characterized by proteinuria, hematuria, hypertension, and edema. The disease is protracted and progresses slowly, eventually leading to end-stage renal disease. IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide, accounting for approximately 29.9%-37.2% of all primary glomerular diseases. Its pathological mechanism is complex, and the internationally recognized "four-hit" theory elucidates its core components: abnormal mucosal immunity leading to galactose-deficient IgA1 (Gd-IgA1) production → autoantibody production → formation of immune complexes → deposition in the kidneys and activation of complement, triggering inflammation and fibrosis.

[0003] In the field of Traditional Chinese Medicine (TCM), although there are numerous reports on the treatment of chronic nephritis, most prescriptions, while showing some efficacy, focus primarily on improving single aspects of the condition. They fail to systematically combine "strengthening the body's resistance" with "eliminating pathogens and unblocking the meridians," and fail to elucidate the advantages of multi-target and holistic regulatory effects from a modern medical perspective. Furthermore, some drugs, while effective, have side effects such as liver damage and reproductive toxicity. Therefore, there is a need to research a safe, effective, and scientifically elucidated TCM composition to fill the gaps in existing technologies in these areas. Summary of the Invention

[0004] The purpose of this invention is to provide a kidney-tonifying and dampness-eliminating traditional Chinese medicine composition, its preparation method, and its application, in order to solve the above-mentioned problems. The kidney-tonifying and dampness-eliminating traditional Chinese medicine composition provided by this invention improves patients' clinical symptoms and indicators such as hematuria and proteinuria, and improves renal microscopic changes through multi-target and multi-mechanism regulation of immune inflammatory responses.

[0005] According to a first aspect of the present invention, a kidney-tonifying and dampness-eliminating traditional Chinese medicine composition is provided, comprising the following raw materials in parts by weight: Astragalus membranaceus 60-120 parts, Ligustrum lucidum 60-120 parts, Taraxacum mongolicum 120-240 parts, Imperata cylindrica 120-240 parts, Prunus persica 40-80 parts, Paeonia lactiflora 60-120 parts, Leonurus japonicus 120-240 parts, Pyrrosia lingua 120-240 parts, Carthamus tinctorius 20-40 parts, and Ilex pubescens 80-160 parts.

[0006] Traditional Chinese medicine (TCM) classifies chronic glomerulonephritis (including IgA nephropathy) under the categories of "asthenia," "kidney wind," "turbid urine," "hematuria," and "edema." Its fundamental pathogenesis lies in the deficiency of the root and the excess of the branch. The "root deficiency" primarily involves deficiency of lung, spleen, and kidney qi. Lung qi deficiency weakens the body's defensive qi, making it susceptible to external pathogens, which obstruct water flow and cause recurrent edema. Spleen deficiency impairs the transformation and transportation of fluids and the control of essence, leading to internal retention of dampness and leakage of protein and essence. Kidney deficiency results in impaired storage and control, leading to proteinuria and hematuria. The "branch excess" primarily involves damp-heat and blood stasis. Damp-heat can be caused by external pathogens or by internal dampness and heat generated due to abnormal fluid metabolism caused by lung, spleen, and kidney deficiency. This dampness accumulates in the lower abdomen, scorching the kidney vessels and forcing blood to flow erratically, resulting in hematuria. The persistent damp-heat is difficult to cure, leading to a prolonged illness. Prolonged illness penetrates the collaterals, leading to qi deficiency and insufficient blood circulation. Furthermore, damp-heat obstructs qi flow and damages yin fluids, further impairing the blood vessels. All of these factors contribute to the internal generation of blood stasis, which obstructs the collaterals and further damages the kidneys, becoming a crucial link in disease progression. Therefore, qi and yin deficiency, damp-heat, and blood stasis are intertwined and mutually causal, collectively constituting the core pathogenesis of this disease.

[0007] Based on the aforementioned core pathogenesis, this invention presents a self-formulated kidney-tonifying and dampness-eliminating traditional Chinese medicine composition. Adhering to the principles of traditional Chinese medicine—"treating the root cause" and "strengthening the body's resistance and eliminating pathogenic factors"—it targets the core pathogenesis of "deficiency of both qi and yin with damp-heat stagnation," establishing a treatment method of "tonifying qi and nourishing the kidneys, clearing heat and eliminating dampness, and promoting blood circulation and removing blood stasis." The formula includes: The principal herbs are Astragalus membranaceus and Ligustrum lucidum. Astragalus membranaceus is sweet and warm in nature, greatly tonifying the Qi of the spleen and lungs, strengthening the exterior, promoting diuresis and reducing swelling, and also controlling bleeding, thus addressing the root cause of Qi deficiency. Ligustrum lucidum is sweet and bitter in nature, nourishing the Yin of the liver and kidneys, cooling the blood and stopping bleeding. The two herbs combined tonify both Qi and Yin, protecting both innate and acquired constitutions, and together they serve as the principal herbs.

[0008] Assistant herbs: Dandelion, Imperata cylindrica root, and Pyrrosia lingua. Dandelion clears heat and detoxifies, promotes urination and relieves strangury; Imperata cylindrica root cools the blood and stops bleeding, clears heat and promotes urination; Pyrrosia lingua promotes urination and relieves strangury, cools the blood and stops bleeding. The three herbs combined powerfully clear damp-heat in the lower burner, detoxify and cool the blood, targeting the symptoms of damp-heat, and are therefore assistant herbs.

[0009] Adjuvant herbs: Red peony root, peach kernel, safflower, motherwort, and holly. Red peony root clears heat and cools the blood, disperses blood stasis and relieves pain; peach kernel and safflower invigorate blood, remove blood stasis, moisten the intestines and promote bowel movements; motherwort invigorates blood, regulates menstruation, promotes diuresis and reduces swelling; holly clears heat and detoxifies, invigorates blood and unblocks the meridians. The five herbs work together to invigorate blood, remove blood stasis, unblock the meridians and relieve pain, break up blood stasis in the kidney meridians, and improve microcirculation, thus serving as adjuvant herbs.

[0010] Licorice in the formula harmonizes the various herbs and also serves as an excipient in preparations to improve flavor.

[0011] The combination of these herbs emphasizes both strengthening the body's resistance and eliminating pathogens, and combines clearing heat with promoting blood circulation. They nourish without causing stagnation, clear away toxins without harming the body's vital energy, and promote blood circulation without causing bleeding. Together, they achieve the effects of invigorating qi and promoting blood circulation, clearing heat and promoting diuresis.

[0012] The drugs provided by this invention all comply with the relevant provisions of the Pharmacopoeia of the People's Republic of China (2020 edition), and their dosages are strictly controlled within the safe range specified in the Pharmacopoeia. The raw materials are all produced in accordance with the Chinese Pharmacopoeia and the National Processing Standards, specifically sourced from: Astragalus: Astragalus mongholicus, a plant in the legume family. Astragalus membraneceus (Fisch.) Bge. var. mongholicus (Bge.)Hsiao Or Astragalus membranaceus Astragalus membraneceus (Fisch.) Bge. The dried root.

[0013] Privet fruit: Ligustrum lucidum, a plant in the Oleaceae family. Ligustrum lucidum Ait. The dried, ripe fruit.

[0014] Dandelion: Dandelion, a plant in the Asteraceae family. Taraxacum mongolicum Hand.-Mazz. Alkali-grown dandelion Taraxacum sinicum Kitag. Or the dried whole herb of several plants in the same genus.

[0015] Imperata cylindrica root: Imperata cylindrica, a plant of the Poaceae family. Imperata cylindrica Beauv. var. major (Nees)C. E. Hubb. The dried rhizome.

[0016] Peach kernel: a plant of the Rosaceae family called peach. Prunus persica (L.) Batsch or mountain peach Prunus davidiana (Carr.)Franch. The dried, mature seeds.

[0017] Red peony: Paeonia lactiflora, a plant in the Ranunculaceae family. Paeonia lactiflora Pall. Or Sichuan red peony Paeonia veitchii Lynch The dried root.

[0018] Motherwort: Leonurus japonicus, a plant in the Lamiaceae family. Leonurus japonicus Houtt. Fresh or dried above-ground parts.

[0019] Pyrrosia lingua: A plant belonging to the Polypodiaceae family, Pyrrosia lingua. Pyrrosia sheareri (Bak.)Ching Pyrrosia Pyrrhosia language (Thunb.)Farwell Or a petiole Pyrrosia petiolosa (Christ)Ching The dried leaves.

[0020] Safflower: Safflower (Carthamus tinctorius), a plant in the Asteraceae family. Carthamus tinctorius L. Dried flowers.

[0021] Ilex pubescens: Ilex pubescens, a plant belonging to the genus Ilex in the Ilex pubescens Hook. et Arn. The roots and leaves are used in medicine.

[0022] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition comprises the following raw materials in parts by weight: Astragalus membranaceus 60-100 parts, Ligustrum lucidum 60-100 parts, Taraxacum mongolicum 120-200 parts, Imperata cylindrica 120-200 parts, Prunus persica 40-60 parts, Paeonia lactiflora 60-100 parts, Leonurus japonicus 120-200 parts, Pyrrosia lingua 120-200 parts, Carthamus tinctorius 20-30 parts, and Ilex pubescens 80-120 parts.

[0023] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition comprises the following raw materials in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, and Ilex pubescens 80 parts. This formulation is based on the preparation of 1000 sachets of granules, with each sachet equivalent to 6.8g of raw herbs.

[0024] In some embodiments, privet fruit is salt-processed privet fruit, and its processing method is as follows: Take clean privet fruit and dry it by salt water roasting method. Use 2 kg of salt for every 100 kg of privet fruit. Salt processing guides the medicine downward, enhances its effects of nourishing the liver and kidneys, nourishing yin and reducing fire, and focuses more on treating diseases of the lower jiao (kidneys).

[0025] In some embodiments, the peach kernels are prepared by blanching, and the preparation method is as follows: Take clean peach kernels and remove the skin according to the blanching method. Blanching can reduce their slight toxicity and moderate their purgative effect, making their blood-activating and stasis-removing effects more prominent.

[0026] In some embodiments, motherwort is processed using a four-step method, as follows: Dried motherwort is mixed thoroughly with a mixture of salt, vinegar, ginger, and rice wine, then steamed for 2 hours and sun-dried. For example, 500g of dried motherwort is prepared with 30g of salt, 30ml of vinegar, 30g of sliced ​​ginger, and 50ml of rice wine. This four-step processing method aims to synergistically enhance its effects: the rice wine processing strengthens its blood-activating and menstrual-regulating properties; the vinegar processing guides it to the liver meridian, enhancing its blood-activating and pain-relieving effects; the salt processing guides the medicine downwards to the kidneys; and the ginger processing moderates its cold nature and enhances its warming and blood-activating properties. This four-step process integrates the effects of multiple excipients, allowing motherwort to more specifically target the pathogenesis of kidney meridian obstruction, in addition to its blood-activating and diuretic properties.

[0027] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 30-50 parts of Poria cocos, 20-30 parts of Alisma plantago-aquatica, and 15-20 parts of Plantago asiatica. These additional ingredients are added to address severe edema in patients, enhancing the diuretic and dampness-eliminating effects. Poria cocos is a fungus belonging to the Polyporaceae family. Poria cocos (Schw.) Wolf The dried sclerotium of Alisma plantago-aquatica, belonging to the Alismataceae family. Alisma orientalis (Sam.)Juzep. The dried tubers of Plantago asiatica, also known as plantain seeds, are the dried tubers of the Plantago asiatica plant (Plantago asiatica). Plantago asiatica L. Or flatcar Plantago depressa Willd. The dried, mature seeds. Preferably, the mixture consists of 30 parts Poria cocos, 20 parts Alisma plantago-aquatica, and 15 parts Plantago asiatica.

[0028] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 15-30 parts of Cirsium japonicum, 10-20 parts of Sanguisorba officinalis charcoal, and 30-50 parts of Capsella bursa-pastoris. These are added to address the patient's prominent hematuria, enhancing its blood-cooling and hemostatic effects. Cirsium japonicum is a plant of the Asteraceae family. Cirsium setosum(Willd.)MB.The dried aerial parts of *Sanguisorba officinalis*, charred *Sanguisorba officinalis* is a processed product of *Sanguisorba officinalis* processed by the charring method (General Rule 0213) until the surface is charred black and the interior is brownish-brown. *Sanguisorba officinalis* is a plant of the Rosaceae family. Sanguisorba officinalis L. Or long-leaved burnet Sanguisorba officinalis L.var.longifolia(Bert.) YuietLi The dried root of shepherd's purse; shepherd's purse is a plant of the Brassicaceae family. Capsella bursa-pastoris (Linnaeus) Medikus The dried whole herb. Preferably, it contains 15 parts of small thistle, 10 parts of charred burnet root, and 30 parts of shepherd's purse.

[0029] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 20-40 parts of Codonopsis pilosula and 15-30 parts of stir-fried Atractylodes macrocephala. The dosage of Astragalus membranaceus can be increased to 85-100 parts. This additional ingredient is added to address patients with significant qi deficiency symptoms (such as extreme fatigue, poor appetite, and loose stools) to enhance the spleen-tonifying and qi-boosting effects. Codonopsis pilosula is a plant of the Campanulaceae family. Codonopsis pilosula (Franch.) Nannf. Codonopsis pilosula (Western Codonopsis) Codonopsis pilosula Nannf. var. modest (Nannf.) LT Shen or Sichuan Codonopsis Codonopsis tangshen Oliv. The dried root of Atractylodes macrocephala; stir-fried Atractylodes macrocephala is a processed product of Atractylodes macrocephala, and the processing method is as follows: sprinkle honey-fried wheat bran into a hot pan, and when it smokes, add Atractylodes macrocephala slices, stir-fry until yellowish-brown and release a caramel aroma, remove, and sift out the honey-fried wheat bran. Use 10 kg of honey-fried wheat bran for every 100 kg of Atractylodes macrocephala slices. Atractylodes macrocephala is a plant of the Asteraceae family. Atractylodes macrocephala Koidz. The dried rhizomes. Preferably, 20 parts of Codonopsis pilosula and 15 parts of stir-fried Atractylodes macrocephala.

[0030] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 10-15 parts of Phellodendron bark, 10-15 parts of Gardenia fruit, and 20-30 parts of Smilax glabra. This addition is specifically for patients with severe damp-heat accumulation (such as a thick, greasy yellow tongue coating, bitter taste, and dry mouth), to enhance heat-clearing, dampness-drying, and detoxifying effects. Phellodendron bark is a plant of the Rutaceae family, specifically the yellow-skinned tree (Phellodendron amurense). Phellodendron chinense Schneid. The dried bark of the tree; Gardenia is the plant *Gardenia jasminoides* of the Rubiaceae family. Gardenia jasminoides Ellis The dried, ripe fruit of Smilax glabra, a plant belonging to the Liliaceae family. Smilax glabra Roxb. The dried rhizome. Preferably, it contains 10 parts of Phellodendron bark, 10 parts of Gardenia fruit, and 20 parts of Smilax glabra.

[0031] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 20-30 parts of Salvia miltiorrhiza, 10-30 parts of Ligusticum chuanxiong, and 3-5 parts of Hirudo medicinalis. This addition is made to address patients with significant blood stasis symptoms (such as a dark complexion, a purplish-dark tongue with ecchymosis, and fixed, stabbing pain) to enhance blood circulation and unblock the meridians. Salvia miltiorrhiza is a plant of the Lamiaceae family. Salvia miltiorrhiza Bge. The dried roots and rhizomes of Ligusticum chuanxiong, a plant belonging to the Apiaceae family. Ligusticum chuanxiong Hort. The dried rhizome of the leech, which is a type of leech belonging to the Hirudinaceae family. Whitmania pigra Whitman ,leech Hirudo nipponica Whitman Or willow leaf leeches Whitmania acranulata Whitman The dried whole body. Preferably, 20 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, and 3 parts of Hirudo medicinalis.

[0032] In some embodiments, the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition also includes 15-30 parts of Rehmannia glutinosa and 15-30 parts of Eclipta prostrata. This is added when the patient also presents with yin deficiency (such as hot palms and soles, dry mouth and throat) to assist in nourishing yin. Rehmannia glutinosa is a plant of the Scrophulariaceae family. Rehmannia glutinosa Libosch. The dried tuberous root of Eclipta prostrata, also known as Eclipta prostrata, is a plant belonging to the genus Eclipta in the family Asteraceae. Eclipta prostrata (L.) L. The whole herb. Preferably, 15 parts Rehmannia glutinosa and 15 parts Eclipta prostrata.

[0033] According to another aspect of the present invention, a traditional Chinese medicine preparation obtained from the above-mentioned kidney-tonifying and dampness-eliminating traditional Chinese medicine composition is provided. This preparation can be formulated into common existing dosage forms such as granules, decoctions, pastes, pills, powders, and capsules. The granules are prepared in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules".

[0034] In some embodiments, when traditional Chinese medicine preparations are formulated into common dosage forms, pharmaceutically acceptable excipients may be added. These excipients may include at least one of the following: sustained-release agents, excipients, fillers, binders, humectants, disintegrants, absorption promoters, adsorbents, surfactants, and lubricants. For example, excipients may include at least one of the following: starch, microcrystalline cellulose, lactose, dextrin, talc, magnesium stearate, steviol glycosides, honey, and white sugar.

[0035] According to another aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine preparation is provided, wherein when preparing it into a decoction, the method includes the following steps: Weigh the raw materials according to the weight ratio, add water and decoct two or three times: the first time add water to cover the herbs by 2-3 cm, and simmer over low heat for 0.8-1.5 hours after boiling; the second and / or third time add water to cover the herbs by 1-2 cm, and simmer over low heat for 0.5-1 hours after boiling; filter after each decoction, combine the filtrates to obtain the decoction.

[0036] In some implementations, the water is boiled for the first time and then simmered for 1 hour, and boiled for 0.75 hours each time after the water boils for the second and third times.

[0037] When taking this medicine, one dose of the decoction is taken daily, divided into two administrations, each dose being 200ml to 300ml.

[0038] The process of making it into granules includes the following steps: (1) Weigh the raw materials according to the weight ratio, add water and decoct three times: the first time add water to cover the herbs by 2-3cm, and simmer for 0.8-1.5 hours after boiling; the second and third times add water to cover the herbs by 1-2cm, and simmer for 0.5-1 hours after boiling; filter after each decoction and combine the three filtrates. (2) The filtrate obtained in step (1) is combined and concentrated under reduced pressure at 50°C to a relative density of 1.08~1.15 (approximately 1.3~1.5 times the total amount of raw medicinal materials) to obtain a concentrated solution; (3) After cooling the concentrated solution obtained in step (2) at room temperature, slowly add 95% (v / v) ethanol while stirring to make the alcohol content of the solution reach 55% (v / v). After stirring evenly, let it stand at low temperature (2-8℃) for 24 hours to allow the impurities to fully precipitate, and then filter to take the supernatant. (4) Take the supernatant obtained in step (3), filter it, and recover ethanol from the filtrate under reduced pressure at 60-70℃ until the ethanol residue is ≤0.5% (v / v). Then continue to concentrate it to a thick extract with a relative density of not less than 1.296~1.350 (60℃). (5) Take the thick extract obtained in step (4) and the excipients, put them in a mixer and mix them thoroughly. Stir to make a soft material, and granulate the soft material through a 14-mesh sieve to obtain wet granules. (6) Dry the wet granules obtained in step (5) in a 70℃ hot air circulating oven until the moisture content is ≤5.0%. After drying, granulate the granules through a 10-mesh sieve to remove fine powder and oversized particles. Pack the granulated granules into pharmaceutical composite film bags in 6g portions and seal. Take one bag three times a day.

[0039] In some embodiments, the excipients are soluble starch and powdered sugar, and the amounts used are: 100 parts of thick extract, 155-160 parts of soluble starch and 88-90 parts of powdered sugar.

[0040] The preparation method provided by this invention includes key parameters such as the timing of the three decoctions, the alcohol precipitation process with a 55% alcohol content, and the key parameters of concentration to a relative density of 1.296~1.350, which are core technologies to ensure the stability of the granule preparation quality and maximize the extraction and retention of effective components.

[0041] According to another aspect of the present invention, the above-mentioned kidney-tonifying and dampness-eliminating traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine preparation is provided for the use in the preparation of drugs for treating chronic glomerulonephritis (especially IgA nephropathy), particularly for the use in the preparation of drugs for treating IgA nephropathy. It is suitable for patients with qi and yin deficiency and damp-heat stagnation syndrome diagnosed by traditional Chinese medicine, and improves the clinical symptoms of patients with chronic glomerulonephritis with qi and yin deficiency and damp-heat stagnation syndrome, such as fatigue, weakness, susceptibility to colds, dry mouth, edema, hematuria, proteinuria, etc., so as to protect renal function and achieve the purpose of delaying the progression of renal failure. Attached Figure Description

[0042] Figure 1 This is a frequency distribution chart of keywords for TCM syndrome types.

[0043] Figure 2 This is a graph showing the trend of the mean values ​​of each indicator over time.

[0044] Figure 3 This is a graph showing the changes in urine red blood cell count. The bars represent the median, the error bars represent the range, and the red dots represent the mean.

[0045] Figure 4 The graph shows the change in the urine protein-to-creatinine ratio. The bars represent the mean, and the error bars represent the mean ± standard deviation.

[0046] Figure 5 This graph shows the changes in creatinine levels. The bars represent the mean, and the error bars represent the mean ± standard deviation.

[0047] Figure 6 The graph shows the changes in eGFR. The bars represent the mean, and the error bars represent the mean ± standard deviation.

[0048] Figure 7 The horizontal axis represents the percentage change of each indicator from the baseline to the third month.

[0049] Figure 8 This is a graph showing the trend of the urine protein-to-creatinine ratio over time.

[0050] Figure 9 This is a graph showing the trend of urine red blood cell count over time.

[0051] Figure 10 This is a graph showing the trend of eGFR over time.

[0052] Figure 11 This is a graph showing how different indicators change over time. Detailed Implementation

[0053] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. The process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available. Among them, when simmering over low heat, the water is in a state of slight boiling. "Slight boiling" means that the water has just reached the boiling point and a few bubbles are emerging. At this time, the water temperature is between 93-100℃ (standard atmospheric pressure).

[0054] Example 1 This kidney-tonifying and dampness-eliminating traditional Chinese medicine composition comprises the following raw materials in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, and Ilex pubescens 80 parts. Here, 1 part represents 1g.

[0055] The above-mentioned kidney-tonifying and dampness-eliminating Chinese herbal medicine composition is prepared into a decoction as follows: Weigh the raw materials according to the weight ratio, add water and decoct three times: the first time add water so that it covers the surface of the herbs by 2-3 cm, and simmer for 1 hour after the water boils; the second and third times add water so that it covers the surface of the herbs by 1-2 cm, and simmer for 45 minutes each after the water boils; filter after each decoction, combine the three filtrates to obtain the decoction.

[0056] Example 2 This kidney-tonifying and dampness-eliminating traditional Chinese medicine composition comprises the following raw materials in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, and Ilex pubescens 80 parts. Here, 1 part represents 1g.

[0057] The above-mentioned kidney-tonifying and dampness-eliminating traditional Chinese medicine composition is prepared into granules as follows: (1) Weigh the raw materials according to the weight ratio, add water and decoct three times: the first time add water to cover the herbs by 2-3cm, and simmer for 0.8-1.5 hours after boiling; the second and third times add water to cover the herbs by 1-2cm, and simmer for 0.5-1 hours after boiling; filter after each decoction and combine the three filtrates. (2) The filtrate obtained in step (1) is combined and concentrated under reduced pressure at 50°C to a relative density of 1.08~1.15 (approximately 1.3~1.5 times the total amount of raw medicinal materials) to obtain a concentrated solution; (3) After cooling the concentrated solution obtained in step (2) at room temperature, slowly add 95% (v / v) ethanol while stirring to make the alcohol content of the solution reach 55% (v / v). After stirring evenly, let it stand at low temperature (2-8℃) for 24 hours to allow the impurities to fully precipitate, and then filter to take the supernatant. (4) Take the supernatant obtained in step (3), filter it, and recover ethanol from the filtrate under reduced pressure at 60-70℃ until the ethanol residue is ≤0.5% (v / v). Then continue to concentrate it to a thick extract with a relative density of not less than 1.296~1.350 (60℃). (5) Take 100 parts of the thick extract obtained in step (4), 155 parts of soluble starch and 88 parts of white sugar powder, put them in a mixer and mix them thoroughly. Stir to make a soft material, and granulate the soft material through a 14-mesh sieve to obtain wet granules. (6) Dry the wet granules obtained in step (5) in a hot air circulating oven at 70°C until the moisture content is ≤5.0%. After drying, the granules are granulated by passing them through a 10-mesh sieve to remove fine powder and excessively large particles.

[0058] Example 3 The kidney-tonifying and dampness-eliminating Chinese herbal composition consists of the following raw materials in parts by weight: Astragalus membranaceus 120 parts, Ligustrum lucidum 120 parts, Taraxacum mongolicum 200 parts, Imperata cylindrica 200 parts, Prunus persica 80 parts, Paeonia lactiflora 120 parts, Leonurus japonicus 220 parts, Pyrrosia lingua 240 parts, Carthamus tinctorius 40 parts, and Ilex pubescens 160 parts.

[0059] Example 4 The kidney-tonifying and dampness-eliminating traditional Chinese medicine composition consists of the following ingredients in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Poria cocos 30 parts, Alisma plantago-aquatica 20 parts, and Plantago asiatica 15 parts. This is for patients who still have severe edema.

[0060] Example 5 The kidney-tonifying and dampness-eliminating traditional Chinese medicine composition consists of the following raw materials in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Cirsium japonicum 15 parts, Sanguisorba officinalis charcoal 10 parts, and Capsella bursa-pastoris 30 parts. This is for patients who still have prominent hematuria.

[0061] Example 6 This kidney-tonifying and dampness-eliminating traditional Chinese medicine composition consists of the following ingredients in parts by weight: Astragalus membranaceus 90 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Codonopsis pilosula 20 parts, and Atractylodes macrocephala (fried) 15 parts. This is for patients who still have obvious symptoms of Qi deficiency, such as extreme fatigue, poor appetite, and loose stools.

[0062] Example 7 This kidney-tonifying and dampness-eliminating Chinese herbal composition consists of the following ingredients in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Phellodendron chinense 10 parts, Gardenia jasminoides 10 parts, and Smilax glabra 20 parts. This is for patients who still have severe damp-heat accumulation, such as a thick, greasy yellow tongue coating, bitter taste in the mouth, and dry mouth.

[0063] Example 8 The kidney-tonifying and dampness-eliminating Chinese herbal composition consists of the following raw materials in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Salvia miltiorrhiza 20 parts, Ligusticum chuanxiong 10 parts, and Hirudo medicinalis 3 parts. This is for patients who still have significant blood stasis symptoms, such as a dark complexion, a purplish-dark tongue with ecchymosis, and fixed stabbing pain.

[0064] Example 9 This kidney-tonifying and dampness-eliminating traditional Chinese medicine composition consists of the following ingredients in parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, Ilex pubescens 80 parts, Rehmannia glutinosa 15 parts, and Eclipta prostrata 15 parts. This is for patients who also have yin deficiency, such as hot palms and soles, dry mouth and throat.

[0065] The following retrospective study uses the Yishen Lishi Granules obtained in Example 2 as the research object to conduct a clinical efficacy and safety study on the treatment of IgA nephropathy (Qi deficiency, damp-heat stagnation syndrome).

[0066] 1. Experimental subjects and methods Study subjects: Fifty patients with IgA nephropathy who visited the Nephrology Department of Guangdong Provincial Hospital of Traditional Chinese Medicine between January 2022 and January 2025 and took Yishen Lishi Granules for ≥3 months were selected.

[0067] Diagnostic criteria: The Western medicine diagnosis meets the criteria for IgA nephropathy in Internal Medicine and is confirmed by renal biopsy; the TCM syndrome differentiation meets the syndrome of Qi and Yin deficiency with damp-heat stagnation (main symptoms: fatigue, weakness, soreness and weakness of the waist and knees; secondary symptoms: edema, dark yellow urine, dry mouth and bitter taste, dark red tongue or with petechiae, yellow and greasy tongue coating, slippery or hesitant pulse).

[0068] Treatment method: All patients received basic treatment (such as angiotensin-converting enzyme inhibitors / angiotensin II receptor antagonists, blood pressure control, and immunosuppressant use), plus Yishen Lishi Granules, one sachet (6g) each time, three times a day, dissolved in warm water. The patients were observed after continuous medication for 3 months.

[0069] Observation indicators: Primary efficacy indicator: urine protein-to-creatinine ratio (UPCR), urine red blood cell count (RBC). Secondary efficacy indicators: serum creatinine (Scr), estimated glomerular filtration rate (eGFR). Measurements were taken before treatment (baseline) and at the end of months 1, 2, and 3 after treatment.

[0070] Safety indicators: complete blood count, liver and kidney function, electrolytes, and adverse event records.

[0071] 2. Experimental Results: (1) Basic patient information: A total of 50 patients were included, of which 22 were male (44%) and 28 were female (56%); the average age was 37.5 years (range 19-61 years); the average treatment duration was 9.3 months; the main TCM syndrome was spleen and kidney qi deficiency (26 cases, 52%), such as Figure 1As shown, the key terms for the syndrome types, from top to bottom, are: spleen and kidney qi deficiency, damp-heat stagnation, qi and yin deficiency, spleen and kidney deficiency, blood stasis, dampness and stagnation, kidney deficiency with damp-heat, qi and blood deficiency, water retention, and internal damp-heat.

[0072] Table 1 Patient Information Table

[0073] (2) Therapeutic results The therapeutic results are shown in Tables 2 to 5 and Figures 2 to 7 As shown.

[0074] The urine protein-to-creatinine ratio decreased significantly after treatment. The baseline value was 0.73±0.67 g / g, which decreased to 0.59±0.55 g / g at the end of the third month, and the difference was statistically significant (p<0.001). This indicates that the formula has the effect of reducing protein leakage.

[0075] Urine red blood cell count: Significantly decreased after treatment. The baseline value was 47.48±121.99 cells / μL, which decreased to 17.71±21.04 cells / μL at the end of the 3rd month, with a highly statistically significant difference (p<0.001). The data indicate that this formula has a significant effect on improving hematuria.

[0076] Renal function indicators: The baseline serum creatinine level was 95.48±33.35 μmol / L, and the level at the end of the 3rd month was 94.36±36.98 μmol / L, with no statistically significant change (p>0.05). The baseline eGFR level was 81.54±23.76 mL / min / 1.73m², and the level at the end of the 3rd month was 85.79±27.15 mL / min / 1.73m², remaining stable. This indicates that while effectively relieving symptoms, this formula did not burden renal function and showed a trend of stabilizing or even improving renal function.

[0077] Table 2. Urine red blood cell count (cells / µl)

[0078] Table 3. Urinary protein to creatinine ratio (g / g)

[0079] Table 4 Creatinine (μmol / L)

[0080] Table 5 eGFR (ml / min / 1.73m²)

[0081] (3) Subgroup analysis: Subgroup analysis of Yishen Lishi Granules in the treatment of IgA nephropathy—based on whether or not Zhengqing Fengtongning / immunosuppressants were used in combination. The results of the urine protein-to-creatinine ratio are shown in Table 6 and Figure 8 As shown, within-group comparisons (compared to baseline), the UPCR in the non-medication group decreased significantly in month 3 (p = 0.032), the UPCR in the combined medication group decreased significantly in month 3 (p = 0.009), and the trend of change was not significant in the combined medication group and the combined immunosuppressant group (p>0.05).

[0082] Intergroup comparison (at month 3) showed significant overall differences among the four groups (p = 0.015, ANOVA). The group without combined treatment was significantly different from the group that only took immunosuppressants (p<0.05, Tukey HSD), indicating that the efficacy of Yishen Lishi Granules alone may be superior to that of combined use with immunosuppressants.

[0083] There was no significant difference between the group taking the three medications in combination and the group not taking them in combination (p>0.05), but the mean value was lower, showing the advantage trend of combination therapy.

[0084] The results showed that Yishen Lishi Granules could independently and significantly reduce proteinuria. Its efficacy was comparable to that of combined use of Zhengqing Fengtongning and immunosuppressants.

[0085] Table 6 Urine protein-to-creatinine ratio

[0086] The results of urine red blood cell count are shown in Table 7 and Figure 9 As shown, within-group comparisons (compared to baseline), the group taking all three medications showed a significant decrease in urinary red blood cell count in the third month (p = 0.041), while the other groups showed a decreasing trend, but this did not reach statistical significance (p>0.05), which may be related to the large fluctuations in the data.

[0087] Intergroup comparison (at month 3), there were no significant differences among the four groups (p = 0.465, Kruskal-Wallis H test).

[0088] The results showed that all treatment regimens exhibited a positive trend in controlling hematuria. Among them, the regimen of Yishen Lishi Granules combined with Zhengqing Fengtongning and immunosuppressants showed the most significant and consistent effect in suppressing renal inflammatory activity.

[0089] Table 7 Urine Red Blood Cell Count

[0090] Note: The number of patients may vary from month to month due to cases where patients were not examined. The glomerular filtration rate results are shown in Table 8 and Figure 10As shown, within-group comparisons (compared to baseline), the changes in eGFR in each group within 3 months did not reach statistical significance (p>0.05), indicating that all treatment regimens could stabilize renal function and did not lead to acute deterioration of renal function.

[0091] Intergroup comparison (at month 3) showed no significant difference among the four groups (p = 0.812, ANOVA), indicating that the renal function stabilization effect was similar under different medication backgrounds.

[0092] The results showed that Yishen Lishi Granules (whether or not in combination with other drugs) demonstrated good renal safety during the 3-month treatment period and could effectively stabilize renal function.

[0093] Table 8. Glomerular filtration rate (eGFR, ml / min / 1.73m²)

[0094] (4) Safety results No drug-related adverse events were reported in any of the 50 patients during the entire observation period. Post-treatment safety indicators such as complete blood counts and liver function tests (ALT, AST) remained within the normal range, as shown in Tables 9 to 12. Figure 11 As shown, no abnormal fluctuations were observed. This demonstrates that Yishen Lishi Granules have good safety in clinical application.

[0095] Table 9. Serum potassium (mmol / L)

[0096] Table 10 ALT (U / L)

[0097] Table 11 AST (U / L)

[0098] Table 12 White blood cell count (10 9 / L)

[0099] 3. Experimental Conclusions This clinical observation confirms that Yishen Lishi Granules can significantly reduce the levels of urinary red blood cells and urinary protein in patients with IgA nephropathy of the Qi deficiency and damp-heat stagnation type, and help stabilize renal function. Moreover, it is safe for clinical application and has no adverse reactions, making it an effective traditional Chinese medicine compound for the treatment of this disease.

[0100] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A kidney-nourishing and dampness-dispelling traditional Chinese medicine composition, characterized in that, It comprises the following raw materials in parts by weight: Astragalus membranaceus 60-120 parts, Ligustrum lucidum 60-120 parts, Taraxacum mongolicum 120-240 parts, Imperata cylindrica 120-240 parts, Prunus persica 40-80 parts, Paeonia lactiflora 60-120 parts, Leonurus japonicus 120-240 parts, Pyrrosia lingua 120-240 parts, Carthamus tinctorius 20-40 parts, and Ilex pubescens 80-160 parts.

2. The kidney-nourishing and dampness-dispelling traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients are made from the following parts by weight: Astragalus membranaceus 60 parts, Ligustrum lucidum 60 parts, Taraxacum mongolicum 120 parts, Imperata cylindrica 120 parts, Prunus persica 40 parts, Paeonia lactiflora 60 parts, Leonurus japonicus 120 parts, Pyrrosia lingua 120 parts, Carthamus tinctorius 20 parts, and Ilex pubescens 80 parts. 3.The kidney-nourishing and dampness-dispelling traditional Chinese medicine composition of claim 1 or 2, characterized in that, Also includes: Poria cocos 30-50 parts, Alisma plantago-aquatica 20-30 parts, Plantago asiatica 15-20 parts; or 15-30 parts of small thistle, 10-20 parts of charred burnet root, and 30-50 parts of shepherd's purse; or 20-40 parts of Codonopsis pilosula and 15-30 parts of stir-fried Atractylodes macrocephala; or 10-15 parts of Phellodendron bark, 10-15 parts of Gardenia fruit, and 20-30 parts of Smilax glabra; or Salvia miltiorrhiza 20-30 parts, Ligusticum chuanxiong 10-30 parts, Hirudo medicinalis 3-5 parts; or 15-30 parts of Rehmannia glutinosa and 15-30 parts of Eclipta prostrata.

4. A traditional Chinese medicine preparation prepared from the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition according to claim 1 or 2, wherein the dosage form of the traditional Chinese medicine preparation includes granules, decoctions, pastes, pills, powders or capsules.

5. The preparation method of claim 4, characterized in that, When the traditional Chinese medicine preparation is in granule form, the following steps are included: (1) Weigh the raw materials and decoct them three times with water: the first time, add water to cover the herbs by 2-3 cm, and simmer for 0.8-1.5 hours after boiling; the second and third times, add water to cover the herbs by 1-2 cm, and simmer for 0.5-1 hours after boiling; filter after each decoction and combine the three filtrates. (2) Combine the filtrates obtained in step (1) and concentrate them under reduced pressure at 50°C to a relative density of 1.08~1.15 to obtain a concentrated solution; (3) After cooling the concentrated solution obtained in step (2) at room temperature, slowly add ethanol while stirring, let it stand at 2-8℃, and then filter to take the supernatant. (4) Take the supernatant obtained in step (3), filter it, and recover the ethanol from the filtrate under reduced pressure at 60-70℃. Then, continue to concentrate it to a thick extract with a relative density of not less than 1.296~1.350 (60℃). (5) Take the thick extract obtained in step (4) and mix it with the excipients, stir it to make a soft material, and granulate the soft material through a 14-mesh sieve to obtain wet granules. (6) Dry the wet granules obtained in step (5) until the moisture content is ≤5.0%. After drying, the granules are granulated by passing them through a 10-mesh sieve.

6. The preparation method of claim 4, characterized in that, When the traditional Chinese medicine preparation is a decoction, it includes the following steps: weigh the raw materials according to the weight ratio, add water and decoct two or three times: the first time, the amount of water added should be 2-3 cm above the surface of the medicine, and after the water boils, simmer for 0.8-1 hour; the second or third time, the amount of water added should be 1-2 cm above the surface of the medicine, and after the water boils, simmer for 0.5-1 hour each time; filter after each decoction, combine the filtrates to obtain the decoction, and take it orally in two doses.

7. The use of the kidney-tonifying and dampness-eliminating traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating chronic glomerulonephritis.

8. Use according to claim 7, characterized in that, The TCM syndrome of chronic glomerulonephritis is characterized by deficiency of both Qi and Yin, with damp-heat stagnation.

9. The use of the traditional Chinese medicine preparation according to claim 4 in the preparation of a drug for treating chronic glomerulonephritis.

10. Use according to claim 9, characterized in that, The TCM syndrome of chronic glomerulonephritis is characterized by deficiency of both Qi and Yin, with damp-heat stagnation.

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