Traditional Chinese medicine composition for treating chronic nephritis as well as preparation method and application thereof

Abstract

The invention relates to the field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine composition for treating chronic nephritis and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following substances in parts by weight: 11-19 parts of garden balsam stem, 6-14 parts of cowherb seed, 11-19 parts of pubescent holly root, 6-14 parts of artemisia anomala, 11-19 parts of sambucus williamsii, 11-19 parts of mistletoe and 5-10 parts of cortex periplocae. The traditional Chinese medicine composition has the following effects that the curative effect on chronic nephritis is remarkable, the effects of reducing urine protein and traditional Chinese medicine syndrome integration and the like are achieved, and the safety is high.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing, and in particular to a traditional Chinese medicine composition for treating chronic nephritis, its preparation method, and its uses. Background Technology

[0002] Chronic nephritis can be categorized under the traditional Chinese medicine terms "chronic kidney wind," "edema," "turbid urine," and "urinary tract infection." Its symptoms were first described in the *Suwen* (Plain Questions) chapter on "Water and Heat Acupoints," which states: "The kidney is the gate of the stomach; if the gate is not functioning properly, water accumulates and follows its kind, overflowing to the skin, causing elbow swelling. Elbow swelling is a disease caused by the accumulation of water." "All water-related diseases are caused by kidney disease; when the kidney is deficient, water flows and disperses through the meridians" (*Zhu Bing Yuan Hou Lun*, Volume 21, "Edema"). "All types of urinary tract infections are due to kidney deficiency and bladder heat. Kidney wind is a disease characterized by generalized edema caused by exposure to wind-evil. Its cause is 'kidney sweating encountering wind,' a disease caused by external wind-evil. Therefore, the initial symptoms include swelling of the eyelids and face, often accompanied by fever, body aches, aversion to wind, and excessive sweating—all symptoms of external wind invasion."

[0003] The pathogenesis of chronic nephropathy is described as "its root lies in the kidneys, its manifestation in the lungs," highlighting the roles of both organs, with the kidneys being the root. This is because the kidneys are the most yin organ, governing water metabolism; any disturbance in water metabolism leading to edema is often rooted in kidney dysfunction. Secondly, the lungs are the upper source of water, regulating the water passages; if the lungs fail to properly disperse and descend fluids, water transport becomes abnormal, also causing edema. The normal functioning of the kidneys and spleen / stomach is crucial. For example, kidney qi deficiency impairs the transformation and transportation of water, leading to bladder dysfunction, fluid retention, and edema. Similarly, spleen qi deficiency impairs transportation and transformation, causing water retention and overflow into the skin, also resulting in edema. Furthermore, the kidneys and spleen / stomach pathologically influence each other. For instance, spleen deficiency prevents water control, leading to excessive dampness, which damages yang, eventually causing kidney yang deficiency. Likewise, kidney yang deficiency fails to nourish the spleen, resulting in weakness of both the spleen and kidneys, thus worsening edema.

[0004] Traditional Chinese medicine (TCM) believes that edema is caused by the invasion of wind-heat or wind-cold pathogens, leading to disharmony between the lung and defensive qi, impaired lung function, and disordered water metabolism. This results in the inability to properly regulate water metabolism to transport fluids to the bladder, causing water retention and various symptoms. Kidney wind is rooted in internal deficiency, with external invasion of damp-heat and other pathogenic factors as the manifestation. Treatment should focus on tonifying the kidney and replenishing essence, clearing heat and resolving dampness, and promoting blood circulation and removing blood stasis. The kidney and spleen / stomach also pathologically influence each other. For example, spleen deficiency prevents the control of water, leading to excessive dampness, which inevitably damages the spleen's yang energy, eventually resulting in kidney yang deficiency as well. Similarly, kidney yang deficiency fails to nourish the spleen, leading to weakness in both the spleen and kidneys, thus worsening edema.

[0005] Traditional Chinese medicine (TCM) treatment is based on the syndrome differentiation and treatment of chronic nephritis, which is rooted in internal deficiency and manifested by external invasion of pathogenic factors such as dampness and heat. Treatment generally focuses on tonifying the kidneys and replenishing essence, clearing heat and resolving dampness, and promoting blood circulation and removing blood stasis. Currently, TCM treatment for chronic nephritis has shown unique advantages. Single herbs and their purified extracts, as well as compound TCM formulas and their active ingredients, have achieved good results in treating chronic nephritis without serious toxic side effects. Research has found that TCM intervention starts from holistic regulation, utilizing the multi-pathway, multi-level, and multi-target effects of TCM, and has specific advantages in controlling the immune inflammatory response of the kidneys, anti-fibrosis, and reducing kidney damage. Therefore, TCM therapy may play a role in delaying the progression of kidney disease through multiple pathways.

[0006] Chinese patent document CN202311156181.2 discloses "A traditional Chinese medicine compound composition for tonifying the kidney and dispelling wind, its preparation method and application." The preparation comprises the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 10 parts Cornus officinalis (processed with wine), 4 parts Buthus martensii, 10 parts stir-fried Bombyx mori, 15 parts Codonopsis pilosula, 10 parts stir-fried Atractylodes macrocephala, 10 parts Pyrrosia lingua, 10 parts Carthamus tinctorius, 10 parts Ligusticum chuanxiong, 15 parts Hedyotis diffusa, 30 parts Poria cocos peel, and 15 parts Plantago asiatica. This invention's traditional Chinese medicine compound composition is more targeted in treating various diseases, showing significant efficacy for multiple pathological types of nephritis and mild to severe proteinuria, with a clear overall effective rate and low adverse reactions, enabling wider application and treatment. Chinese patent document CN202310699118.7 discloses "a traditional Chinese medicine composition for treating chronic nephritis and its preparation method," which is mainly composed of the following raw materials: 9-40 parts by weight of raw Astragalus membranaceus, 6-12 parts by weight of Paeonia lactiflora, 5-10 parts by weight of Saposhnikovia divaricata, 9-15g of Dioscorea nipponica, 9-15 parts by weight of stir-fried Euryale ferox, 6-12 parts by weight of Rosa laevigata, 15-30 parts by weight of Hedyotis diffusa, 9-15 parts by weight of Morus alba twigs, and 9-27 parts by weight of Acanthopanax senticosus. This composition has a rigorous formulation, scientific compatibility, significant efficacy, and can maximize the therapeutic effect of the drugs. It is also easy to prepare, has good patient compliance, and has no toxic side effects in treating chronic nephritis with qi deficiency and blood stasis syndrome.

[0007] There are many traditional Chinese medicine compositions for treating facial, lower limb, and generalized edema, lower back pain and weakness, oliguria, hematuria, and proteinuria caused by chronic nephritis. However, they all have more or less drawbacks, such as too many ingredients, difficulty in sourcing materials, high prices, and unclear efficacy and poor treatment results. Therefore, there is an urgent need for a drug that is effective in treating chronic nephritis, has fewer ingredients, and is easy to prepare. Summary of the Invention

[0008] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a traditional Chinese medicine composition for treating chronic nephritis, its preparation method and uses, in order to solve the problems in the prior art.

[0009] To achieve the above and other related objectives, the present invention first provides a traditional Chinese medicine composition for treating chronic nephritis, comprising the following components by weight:

[0010]

[0011] The present invention also provides a traditional Chinese medicine extract for treating chronic nephritis, wherein the traditional Chinese medicine extract is obtained by extraction from the above-mentioned traditional Chinese medicine composition.

[0012] The present invention also provides a method for preparing a traditional Chinese medicine extract for treating chronic nephritis, the method comprising: extracting the above-mentioned traditional Chinese medicine composition, the obtained extract being the traditional Chinese medicine extract.

[0013] The present invention also provides a traditional Chinese medicine preparation, which includes the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine extract.

[0014] The present invention also provides a method for preparing a traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is a granule, comprising the following steps: concentrating the above-mentioned traditional Chinese medicine extract to obtain an extract, mixing the extract with excipients, and then drying, granulating, and sizing to obtain the granules.

[0015] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition, the above-mentioned traditional Chinese medicine extract or the above-mentioned traditional Chinese medicine preparation in the preparation of a drug for treating chronic nephritis.

[0016] As described above, the traditional Chinese medicine composition for treating chronic nephritis, its preparation method, and its uses according to the present invention have the following beneficial effects:

[0017] 1) This formula uses Wang Bu Liu Xing (Semen Vaccariae) to invigorate blood and promote diuresis, and Tou Gu Cao (Herba Clematis) to dispel wind and unblock the meridians as the chief herbs; Mao Dong Qing (Herba Ilex) to dispel wind, invigorate blood, unblock the meridians, and promote diuresis as the assistant herbs; Liu Ji Nu (Herba Artemisiae) and Jie Gu Mu (Herba Sambu) to dispel wind and unblock the meridians as the adjuvant herbs; and Hu Ji Sheng (Herba Mistletoe) and Xiang Jia Pi (Herba Pericarpium) to tonify the liver and kidneys and promote diuresis as the guiding herbs. The combined effects of these herbs are to invigorate blood, promote diuresis, dispel wind, and unblock the meridians.

[0018] 2) The traditional Chinese medicine composition of the present invention has been clinically proven over a long period of time to reduce proteinuria and TCM syndrome scores, with significant therapeutic effects. It has the effects of promoting blood circulation and diuresis, dispelling wind and unblocking collaterals, and is suitable for chronic nephritis.

[0019] 3) It has a significant effect on treating chronic nephritis, requires few ingredients, is easy to prepare, has few toxic side effects, is convenient to take, is cheaper than similar drugs on the market, has good patient compliance, has high clinical promotion value, has development prospects, and is innovative. Detailed Implementation

[0020] This invention first provides a traditional Chinese medicine composition for treating chronic nephritis, comprising the following components by weight:

[0021]

[0022] In certain embodiments of the present invention, the Speranskia tuberculata in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 11-13份, 13-15份, 15-17份, 17-19份.

[0023] In certain embodiments of the present invention, the Vaccaria segetalis in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 6-8份, 8-10份, 10-12份, 12-14份.

[0024] In certain embodiments of the present invention, the Ilex pubescens in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 11-13份, 13-15份, 15-17份, 17-19份.

[0025] In certain embodiments of the present invention, the Artemisia anomala in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 6-8份, 8-10份, 10-12份, 12-14份.

[0026] In certain embodiments of the present invention, the Sambucus williamsii in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 11-13份, 13-15份, 15-17份, 17-19份.

[0027] In certain embodiments of the present invention, the Viscum coloratum in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 11-13份, 13-15份, 15-17份, 17-19份.

[0028] In certain embodiments of the present invention, the Cortex Periplocae in the traditional Chinese medicine composition is selected from any one of the following ranges by weight份: 5-6份, 6-份, 7-8份, 8-9份, 9-10份.

[0029] In a preferred embodiment of the present invention, the traditional Chinese medicine composition includes the following components by weight份:

[0030]

[0031] In a more preferred embodiment of the present invention, the traditional Chinese medicine composition includes the following components by weight份:

[0032]

[0033] It should be noted that the unit "份" in the original text is not a standard metric unit. It may need to be further determined according to the specific context or relevant regulations to accurately convert it. Here, it is directly translated as "份" for the sake of maintaining the original text.In the said traditional Chinese medicine composition, Speranskia tuberculata has a sweet, pungent and warm nature and belongs to the lung and liver meridians, with the efficacy of expelling toxins and relieving pain, and is mainly used to treat rheumatic arthralgia, contracture of muscles and bones, cold-damp beriberi, lumbar sprain, paralysis, amenorrhea, scrotal eczema, furuncles and carbuncles. "Compendium of Materia Medica" states: Speranskia tuberculata "treats all rheumatic pains and contractures of muscles and bones." If limb pain, numbness and limited flexion and extension are caused by the invasion of wind, cold and damp pathogens into the limb meridians, this herb can be selected to dispel wind, disperse cold and eliminate dampness. Once the pathogenic factors are removed, all symptoms will be cured automatically. "Lingmi Dan Yao Jian" states: "It treats heat toxins." "Yangcheng's Experience Prescription" selects this herb to treat the initial stage of carbuncles and sores. "Selected Chinese Herbal Medicines from Shaanxi, Gansu, Ningxia and Qinghai" uses this herb to treat scrotal eczema and sores and ulcers. Therefore, it can be considered that Speranskia tuberculata is used to treat skin ulcers, sores and carbuncles, and scrotal eczema. Generally, it is decocted in water for external washing. Because external washing with this medicine also has the characteristics of guiding the medicine to penetrate into the meridians and blood vessels, and dispelling wind, promoting blood circulation and relieving pain.

[0034] Vaccaria segetalis has a bitter and flat nature and belongs to the liver and stomach meridians, with the efficacy of promoting blood circulation to dredge the meridians, promoting lactation and reducing swelling, and promoting diuresis and relieving stranguria, and is used for amenorrhea, dysmenorrhea, insufficient lactation, breast abscess, stranguria with pain. "Compendium of Materia Medica": Promotes diuresis and removes bamboo and wood thorns. "Shennong Ben Cao Jing": Stops bleeding from traumatic injuries, expels pain and removes thorns, and dispels wind-bi syndrome and internal cold. Long-term use can make the body light and prolong life. "Bie Lu": Stops restlessness and nosebleeds, carbuncles and ulcers, and difficult labor in women.

[0035] Ilex pubescens has a slightly bitter, sweet and cold nature and belongs to the heart and lung meridians, with the efficacy of clearing heat and detoxifying, promoting blood circulation and dredging collaterals, and is mainly used to treat wind-heat cold, cough due to lung heat, sore throat, tonsillitis, dysentery, gingival swelling and pain, chest pain due to heart obstruction, hemiplegia due to stroke, thromboangiitis obliterans, erysipelas, burns and scalds, carbuncles and ulcers, central retinitis.

[0036] Artemisia anomala has a bitter and cold nature and belongs to the spleen, stomach, liver and gallbladder meridians, with the functions of promoting blood circulation to remove blood stasis, dredging the meridians to relieve pain, cooling blood to stop bleeding, clearing heat and promoting diuresis, and is used for traumatic injury, external bleeding, blood stasis amenorrhea, irregular menstruation, postpartum stasis pain, mass accumulation, bloody dysentery, bloody stranguria, damp-heat jaundice, edema and abdominal distension, excessive leucorrhea. "Newly Revised Materia Medica": "Mainly breaks blood and relieves distension." "Japanese Pharmacopoeia": "Treats heart pain, reduces qi and relieves water distension, qi and blood, dredges the meridians and collaterals of women, and stops cholera and diarrhea." "Kaibao Materia Medica": "The 'Supplementary Annotation of the Other Edition' states that it is an important medicine for treating traumatic injuries and stopping bleeding; it is extremely effective in treating postpartum residual diseases, reducing blood and relieving pain." "Materia Medica Mengquan": "Eliminates carbuncles and sores, and relieves the pain of burns." "Compendium of Materia Medica": "For children with hematuria, the fresh one is ground into powder for oral administration." "New Compilation of Materia Medica": "Treats leukorrhea turbidity."

[0037] Sambucus williamsii has a sweet, bitter and flat nature and belongs to the lung meridian, with the efficacy of expelling wind and removing dampness, promoting blood circulation and stopping bleeding, and is mainly used to treat rheumatic arthralgia, gout, Kashin-Beck disease, acute and chronic nephritis, rubella, traumatic injury, fracture swelling and pain, external bleeding. "Tang Materia Medica": Mainly treats fractures, reconnects muscles and bones, eliminates wind itching and dental caries, and can be used for bathing soup. "Thousand Golden Prescriptions for Supplementary Formulas": For bruises and bleeding, and lochia of parturients, all cases of stagnant or unstopped blood, decoct the juice and take it. Wang Lianshi's "Collection of Herbal Medicines": Promotes blood circulation and eliminates toxins, and washes all kinds of sores and skin diseases caused by wind. "Mirror of Hundred Herbs": Treats traumatic swelling and carbuncles.

[0038] Viscum coloratum is bitter in taste and neutral in nature, and pertains to the Liver and Kidney meridians. It has the functions of dispelling wind-dampness, tonifying the Liver and Kidney, strengthening tendons and bones, and preventing miscarriage. It is used for wind-dampness arthralgia, soreness and weakness of the waist and knees, flaccidity of tendons and bones, menorrhagia, metrorrhagia during pregnancy, threatened abortion, dizziness and vertigo. "Shennong Ben Cao Jing": It is mainly used for low back pain, stiffness of the back of children, carbuncles and sores, preventing miscarriage, enriching the muscles and skin, strengthening hair, teeth, and growing beard and eyebrows. "Rihuazi Bencao": It helps the tendons and bones and benefits the blood vessels. "Shengcaoyao Xingbei Yao": It clears heat, nourishes and tonifies, chases wind. It nourishes blood and disperses heat, makes tea, and soothes the tendons and activates collaterals.

[0039] Periploca sepium is pungent, bitter, and warm in nature, and pertains to the Liver, Kidney, and Heart meridians. It has the functions of promoting diuresis to alleviate edema, dispelling wind-dampness, and strengthening tendons and bones. It is used for lower limb edema, palpitations and shortness of breath, wind-cold-dampness arthralgia, soreness and weakness of the waist and knees. "Ben Jing": It mainly treats abdominal hernia, abdominal pain, benefits qi and treats cramps, children's inability to walk, carbuncles and sores with yin erosion. "Bencao Jingshu": For Periploca sepium, observing the syndromes mainly treated in "Ben Jing", they are all due to the invasion of wind-cold-dampness pathogens into the (Kidney Meridian of Foot少阴 and Liver Meridian of Foot厥阴) two meridians, and dampness is particularly the most. The "Classic" says that those injured by dampness are first affected in the lower part. It also says that the dampness of the earth, when sensed, harms the skin, muscles, tendons and vessels of people. The Liver and Kidney are located in the lower part and govern the tendons and bones. Therefore, the wind-cold-dampness pathogens mostly invade these two meridians first. This medicine is pungent and can disperse wind, warm and can dispel cold, bitter and can dry dampness. When the two zang-organs obtain its qi, all syndromes will be cured. Moreover, when dampness invades and soaks, the tendons and vessels of the five zang-organs will become flaccid and loose; when dampness stays in the middle, there will be weakness and lack of qi due to deficiency and emaciation. Once the damp pathogen is removed, the middle jiao will be regulated and the tendons and bones will become firm by themselves, and qi will increase day by day and the middle will be tonified by itself. Its main function of tonifying essence and strengthening will is because the kidney stores essence and will. "Bie Lu": It treats impotence in men, dampness under the scrotum, residual dripping of urine, itching of the vulva in women, pain in the waist and spine, pain and flaccidity of the two feet due to wind, weakness of the five types of flaccidity, deficiency and emaciation, tonifies the middle and benefits essence, strengthens tendons and bones, and strengthens will.

[0040] In this formula, Speranskia tuberculata is used to dispel wind and dredge collaterals, and Vaccaria segetalis is used to promote blood circulation and dredge channels as the monarch drugs; Ilex pubescens is used to dispel wind, promote blood circulation, dredge collaterals and promote diuresis as the minister drug; Artemisia anomala and Sambucus williamsii are used to dispel wind and dredge collaterals as the assistant drugs; Viscum coloratum and Periploca sepium are used to tonify the Liver and Kidney and promote diuresis as the envoy drugs. When all the drugs are used together, they jointly achieve the effects of promoting blood circulation and diuresis, and dispelling wind and dredging collaterals.

[0041] The diagnostic criteria for the said chronic nephritis are as follows:

[0042] 1) Western medicine diagnostic criteria: The criteria refer to the "Clinical Practice Guidelines - Nephrology Sub-volume" published by the Nephrology Branch of the Chinese Association of Chinese Medicine in 2011: ① There may be a history of edema, hypertension, proteinuria, hematuria and cylindruria alone or in combination, with a prolonged course. Whether there is renal function impairment or not, this disease should be considered. ② The diagnosis does not solely depend on the length of the disease history. The onset patterns are various, and it can present as insidious onset, chronic onset or acute onset. ③ Exclude secondary glomerulonephritis and hereditary glomerulonephritis. ④ Renal biopsy pathological examination can confirm the diagnosis.

[0043] 2) Traditional Chinese Medicine Diagnostic Criteria: Meets the diagnostic criteria for Wind-Subdued Kidney Collateral Syndrome in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" (formulated by the Ministry of Health of China): Wind-Subdued Kidney Collateral Syndrome: Main symptoms: Edema of the face or limbs, which is triggered by wind, recurs when exposed to wind, or is aggravated by wind or is prolonged and does not heal; discomfort in the joints of the limbs; increased foam in the urine; Secondary symptoms: dull complexion, soreness and weakness of the waist and knees, fatigue and weakness, pale tongue, and thin yellow or white coating.

[0044] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: thoroughly mixing the components.

[0045] This invention also provides a traditional Chinese medicine extract for treating chronic nephritis, wherein the extract is obtained by extraction from the aforementioned traditional Chinese medicine composition. The extract can be any suitable formulation in the art. In one specific embodiment of this invention, the extract is obtained by water extraction, i.e., it can be an aqueous extract.

[0046] The present invention also provides a method for preparing a traditional Chinese medicine extract for treating chronic nephritis, the method comprising: extracting the above-mentioned traditional Chinese medicine composition, the obtained extract being the traditional Chinese medicine extract.

[0047] In some embodiments of the present invention, the extraction method is a decoction method or an immersion method.

[0048] In some embodiments of this invention, the traditional Chinese medicine composition is pretreated before soaking.

[0049] Furthermore, the pretreatment involves soaking the herbal composition in a solvent used for extraction, or increasing the extraction time of some components. These pretreatment operations promote the full dissolution of the active ingredients.

[0050] In some embodiments of the present invention, the solvent for extraction is water.

[0051] In some embodiments of the present invention, the volume ratio of the pharmaceutical composition to the extraction solvent is 1:(5-9). The volume ratio of the pharmaceutical composition to the extraction solvent is selected from any of the following ranges: 1:(5-6), 1:(6-7), 1:(7-8), 1:(8-9).

[0052] In some embodiments of the present invention, the extraction time is 1.5 to 2.5 hours.

[0053] In some embodiments of the invention, extraction is carried out at temperatures ranging from 20°C to the solvent's boiling point. Preferably, extraction is carried out under heating conditions. For example, boiling the solvent for extraction can improve the extraction efficiency.

[0054] In some embodiments of the present invention, the extraction is performed once or multiple times. Increasing the number of extractions ensures that the active ingredients are fully extracted.

[0055] In some embodiments of the present invention, if the extraction is performed multiple times, the extraction liquids are also combined.

[0056] In some embodiments of the present invention, post-treatment of the extract is also included.

[0057] Furthermore, the post-processing involves allowing the extract to stand and then concentrating the supernatant to obtain an extract. Concentration removes some or all of the solvent from the extract, facilitating the preservation or transport of the formulation or composition.

[0058] In a preferred embodiment of the present invention, the settling time is 12 to 24 hours. The settling time is selected from any of the following ranges: 12 to 14 hours, 14 to 16 hours, 16 to 18 hours, 18 to 20 hours, 20 to 22 hours, and 22 to 24 hours.

[0059] In a preferred embodiment of the present invention, the concentration method is vacuum concentration.

[0060] In a preferred embodiment of the present invention, the concentration temperature is 70–90°C. The concentration temperature is selected from any of the following ranges: 70–75°C, 75–80°C, 80–85°C, and 85–90°C.

[0061] In a preferred embodiment of the present invention, the density of the extract is 1.0 to 1.2. The density of the extract is selected from any of the following ranges: 1.0 to 1.05, 1.05 to 1.10, 1.10 to 1.15, and 1.15 to 1.2.

[0062] In a more preferred embodiment of the present invention, the density of the extract is 1.14 to 1.15.

[0063] The present invention also provides a traditional Chinese medicine preparation, which includes the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine extract.

[0064] In some embodiments of the present invention, the traditional Chinese medicine preparation further includes pharmaceutical excipients. These excipients include one or more combinations of fillers, disintegrants, lubricants, suspending agents, excipients, binders, sweeteners, flavoring agents, and preservatives.

[0065] In some embodiments of the present invention, the traditional Chinese medicine preparation may be various suitable dosage forms in the art, and the preparation methods of these dosage forms should be known to those skilled in the art.

[0066] Furthermore, the dosage form of the traditional Chinese medicine preparation includes one of the following: capsules, tablets, granules, powders, oral liquids, soft capsules, pills, mixtures, syrups, gels, poultices, suppositories, or sustained-release preparations.

[0067] The present invention also provides a method for preparing a traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is a granule, comprising the following steps: concentrating the above-mentioned traditional Chinese medicine extract to obtain an extract, mixing the extract with excipients, and then drying, granulating, and sizing to obtain the granules.

[0068] In some embodiments of the present invention, the excipient is dextrin.

[0069] In one specific embodiment, the mass ratio of the extract to dextrin is 1:30-40.

[0070] In some embodiments of the present invention, the drying is spray drying.

[0071] In some embodiments of the present invention, the drying equipment is a spray dryer.

[0072] Specifically, the spray dryer has an inlet air temperature of 135–165℃, an outlet air temperature of 90–110℃, an internal tower pressure of -0.6–-0.1 kPa, a wall temperature of 10–45℃, an atomizer frequency of 100–350 Hz, and a peristaltic pump frequency of 10–20 Hz.

[0073] The inlet air temperature is selected from any of the following ranges: 135~145℃, 145~155℃, 155~165℃; the outlet air temperature is selected from any of the following ranges: 90~95℃, 95~100℃, 100~105℃, 105~110℃; the tower internal pressure is selected from any of the following ranges: -0.6~-0.5Kpa, -0.5~-0.4Kpa, -0.4~-0.3Kpa. -0.3~-0.2Kpa, -0.2~-0.1Kpa; the wall temperature is selected from any of the following ranges: 10~20℃, 20~30℃, 30~40℃, 40~45℃; the atomizer frequency is selected from any of the following ranges: 100~200hz, 200~300hz, 300~350hz; the peristaltic pump frequency is selected from any of the following ranges: 10~15hz, 15~20hz.

[0074] In some embodiments of the present invention, the granulation equipment is a granulator.

[0075] Specifically, the extrusion pressure of the pellet mill is 10–60 kg; the side sealing pressure is 10–30 kg; the extrusion speed is 20–35 rad / min; the feeding speed is 40–64 rad / min; the pelleting speed is 55–110 rad / min; and the cooling temperature is 10–16 °C.

[0076] The extrusion pressure of the pellet mill is selected from any of the following ranges: 10-20 kg, 20-30 kg, 30-40 kg, 40-50 kg, 50-60 kg; the side sealing pressure is selected from any of the following ranges: 10-15 kg, 15-20 kg, 20-25 kg, 25-30 kg; the extrusion speed is selected from any of the following ranges: 20-25 rad / min, 25-30 rad / min, 30-35 rad / min; the feeding speed is selected from any of the following ranges: 40-45 rad / min, 45-50 rad / min, 50-55 rad / min, 55-60 rad / min, 60-64 rad / min; the pelleting speed is selected from any of the following ranges: 55-75 rad / min, 75-95 rad / min, 95-110 rad / min.

[0077] In some embodiments of the present invention, granulation is accomplished by a vibrating screen.

[0078] Specifically, the upper layer of the vibrating screen is 10-20 mesh, and the lower layer is 55-65 mesh.

[0079] In some embodiments of the present invention, the method for preparing the granules further includes packaging the granulated granules.

[0080] In one specific embodiment, packaging is completed by an automatic packaging machine.

[0081] The longitudinal sealing temperature of the automatic packaging machine is 155℃~195℃, 165±10℃ when the bag / minute is 80~90 bags, and 185±10℃ when the bag / minute is 90~100 bags.

[0082] The horizontal sealing temperature of the automatic packaging machine is 175℃~205℃, 185±10℃ when the bag / minute is 80~90 bags, and 195±10℃ when the bag / minute is 90~100 bags.

[0083] The automatic packaging machine has a dispensing speed of 80-100 packages per minute.

[0084] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition, the above-mentioned traditional Chinese medicine extract or the above-mentioned traditional Chinese medicine preparation in the preparation of a drug for treating chronic nephritis.

[0085] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0086] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention; in the specification and claims of the present invention, unless otherwise expressly stated in the text, the singular forms "a", "an" and "this" include the plural forms.

[0087] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. In addition to the specific methods, apparatus, and materials used in the embodiments, based on the knowledge of the prior art possessed by one of ordinary skill in the art and the description of this invention, any prior art methods, apparatus, and materials similar to or equivalent to those described, apparatus, and materials in the embodiments of this invention may be used to implement the present invention.

[0088] Example 1: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part 1)

[0089] 15 parts of Clematis armandii, 10 parts of Vaccaria segetalis, 15 parts of Ilex pubescens, 10 parts of Artemisia capillaris, 15 parts of Sambucus chinensis, 15 parts of Mistletoe, and 7.5 parts of Periploca sepium.

[0090] Example 2: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part Two)

[0091] 19 parts of Clematis armandii, 6 parts of Vaccaria segetalis, 12 parts of Ilex pubescens, 14 parts of Artemisia capillaris, 12 parts of Sambucus chinensis, 11 parts of Mistletoe, and 6 parts of Periploca sepium.

[0092] Example 3: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part 3)

[0093] 11 parts of Clematis armandii, 10 parts of Vaccaria segetalis, 11 parts of Ilex pubescens, 6 parts of Artemisia capillaris, 14 parts of Sambucus chinensis, 12 parts of Viscum album, and 6 parts of Periploca sepium.

[0094] Example 4: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part Four)

[0095] 16 parts of Clematis armandii, 8 parts of Vaccaria segetalis, 12 parts of Ilex pubescens, 8 parts of Artemisia capillaris, 14 parts of Sambucus chinensis, 12 parts of Mistletoe, and 8 parts of Periploca sepium.

[0096] Example 5: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part 5)

[0097] 14 parts of Clematis armandii, 12 parts of Vaccaria segetalis, 12 parts of Ilex pubescens, 9 parts of Artemisia capillaris, 13 parts of Sambucus chinensis, 16 parts of Mistletoe, and 9 parts of Periploca sepium.

[0098] Example 6: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (VI)

[0099] 15 parts of Clematis armandii, 14 parts of Vaccaria segetalis, 14 parts of Ilex pubescens, 8 parts of Artemisia capillaris, 16 parts of Sambucus chinensis, 12 parts of Mistletoe, and 6 parts of Periploca sepium.

[0100] Example 7: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (VII)

[0101] 15 parts of Clematis armandii, 6 parts of Vaccaria segetalis, 18 parts of Ilex pubescens, 12 parts of Artemisia capillaris, 19 parts of Sambucus chinensis, 14 parts of Mistletoe, and 7 parts of Periploca sepium.

[0102] Example 8: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (Part 8)

[0103] 12 parts of Clematis armandii, 7 parts of Vaccaria segetalis, 18 parts of Ilex pubescens, 6 parts of Artemisia capillaris, 16 parts of Sambucus chinensis, 12 parts of Mistletoe, and 10 parts of Periploca sepium.

[0104] Example 9: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (IX)

[0105] 14 parts of Clematis armandii, 8 parts of Vaccaria segetalis, 15 parts of Ilex pubescens, 11 parts of Artemisia capillaris, 11 parts of Sambucus chinensis, 15 parts of Viscum album, and 8.5 parts of Periploca sepium.

[0106] Example 10: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (X)

[0107] 14 parts of Clematis armandii, 10 parts of Vaccaria segetalis, 12 parts of Ilex pubescens, 8 parts of Artemisia capillaris, 15 parts of Sambucus chinensis, 13 parts of Viscum album, and 6 parts of Periploca sepium.

[0108] Example 11: Preparation of a Traditional Chinese Medicine Composition for Treating Chronic Nephritis (XI)

[0109] 15 parts of Clematis armandii, 6 parts of Vaccaria segetalis, 11 parts of Ilex pubescens, 6 parts of Artemisia capillaris, 15 parts of Sambucus chinensis, 14 parts of Viscum album, and 7.5 parts of Periploca sepium.

[0110] Example 12: Preparation of tablets / capsules for treating chronic nephritis

[0111] Take any one of the traditional Chinese medicine compositions described in Examples 1-11, add 7 times the amount of water, decoct for 1.5-2.5 hours, and filter out the decoction. Then add 6 times the amount of water, decoct for 1 hour, filter out the decoction, combine the two decoctions, and let the decoction settle for 16 hours. Take the supernatant, concentrate it to an extract with a density of 1.25; add pharmaceutical excipients, vacuum dry, pulverize and granulate, and compress into tablets or capsules.

[0112] Example 13: Preparation of granules for treating chronic nephritis

[0113] Extraction: Take any one of the traditional Chinese medicine compositions described in Examples 1-11 and put it into a decoction machine. Add 7 times the amount of water and boil for 2 hours. During the decoction process, control the steam pressure ≤0.08MPa and the temperature 90-100℃. After 2 hours, filter out the decoction and pass it through an 80-mesh sieve. Pour the filtrate into a medicine storage tank. Add another 6 times the amount of water and decoct for 1 hour. During the decoction process, control the steam pressure ≤0.08MPa and the temperature 100℃. After 1 hour, filter out the decoction and pass it through an 80-mesh sieve. Collect the filtrate and combine the two filtrates. Allow the filtrate to settle for 18 hours.

[0114] Concentration: Take the supernatant and concentrate it under vacuum at a temperature of 70°C until it becomes an extract with a density of 1.15. Pass the extract through a 100-mesh sieve for later use.

[0115] Drying: Transfer the prepared extract to a mixing tank, turn on the steam valve, heat to 30°C, dilute the dextrin with 3 times the amount of purified water and pass it through a 100-mesh sieve, mix it with the extract, and spray after mixing for 5 minutes.

[0116] (1) Set the inlet air temperature to 135℃, the outlet air temperature to 100℃, the tower pressure to -0.4KPa, and the wall temperature to 35℃.

[0117] (2) Blower and exhaust fan, steam heating valve (steam pressure is 0.45MPa), electric heating valve 2 in sequence. If the temperature is insufficient, electric heating valve 1 can be turned on to heat up quickly. After the temperature is reached, turn off electric heating valve 1 and turn on tower wall fan.

[0118] (3) Turn on the cooling water of the atomizer and start the atomizer. The frequency of the atomizer is 350 Hz. Turn on the peristaltic pump. The frequency of the peristaltic pump is 20 Hz. Turn on the vibration and spray dry to obtain dry paste powder.

[0119] Granulation: Install the equipment correctly and install a 12-mesh sieve. Set the equipment operating parameters according to the material density and viscosity, and adjust the operating parameters in a timely manner during operation to ensure that the particle size and color of the produced granules meet the requirements.

[0120] Setting parameter range: extrusion pressure is 40 kg (approximately 4 MPa), side sealing pressure is 30 kg (approximately 3 MPa), extrusion speed is 35 rad / min, feeding speed is 64 rad / min, granulation speed is 80 rad / min, and cooling temperature is controlled at 16℃.

[0121] During the production process, pay close attention to the equipment operation and granulation process, and adjust the parameters promptly if any problems are found.

[0122] During granulation, the fine powder sieved out is promptly returned to the tableting and granulation process. When the amount of fine powder is less than the minimum granulation requirement (approximately 0.3 kg), it is no longer returned, and the remaining fine powder is disposed of as waste.

[0123] The granulated particles are placed in a vibrating screen (10 mesh upper screen, 60 mesh lower screen) for sizing. The sized particles are then placed into a material bag and sealed for later use.

[0124] Inner packaging: Check the intermediate product name, batch number, specifications, and quantity based on the "Batch Packaging Instruction Sheet".

[0125] 1. Wipe and disinfect the automatic packaging machine and measuring cups with 75% ethanol.

[0126] 2. Confirm the production date, product batch number, and expiration date to ensure accuracy, and install the measuring cup, steel lettering, and composite film for pharmaceutical packaging.

[0127] 3. Set the longitudinal sealing temperature of the automatic granule packaging machine to 165℃ and the transverse sealing temperature to 185℃. Preheat to the set temperature and start the machine.

[0128] 4. Set the dispensing speed to 90 packs / minute, add the granules to the hopper, start the machine for trial operation, adjust the filling amount to a filling amount difference of 2.5g±6%, check the inner packaged products every 30 minutes, after the products are qualified, put them into plastic turnover boxes, seal them and transfer them to the intermediate station for temporary storage, and transfer them to the next process operation after this batch is completed.

[0129] Example 14: Preparation of a compound / oral solution / syrup for treating chronic nephritis

[0130] Take any one of the traditional Chinese medicine compositions described in Examples 1-11, add 9 times the amount of water, decoct for 2 hours, and filter out the decoction. Add another 5 times the amount of water, decoct for 1.5 hours, filter out the decoction, combine the two decoctions, and allow the decoction to settle for 24 hours. Take the supernatant and concentrate it to an extract with a density of 1.4; add appropriate pharmaceutical excipients to prepare a compound, oral liquid, or syrup.

[0131] Example 15 Clinical Trial

[0132] The clinical efficacy of the traditional Chinese medicine composition and compound preparation of the present invention in the treatment of chronic nephritis was observed and evaluated through clinical trials.

[0133] Medical records: One hundred patients with chronic nephritis admitted to our hospital from June 2021 to June 2023 were selected as the study subjects. The clinical diagnosis was consistent with the diagnostic criteria for chronic nephritis.

[0134] Diagnostic criteria:

[0135] 1) Western Medicine Diagnostic Criteria: The criteria refer to the "Clinical Practice Guidelines - Nephrology Volume" published by the Nephrology Branch of the China Association of Traditional Chinese Medicine in 2011: ① Edema, hypertension, proteinuria, hematuria, and a history of urinary casts may be present alone or in combination. The disease course is prolonged, and this disease should be considered regardless of whether there is renal function impairment. ② Diagnosis does not entirely depend on the length of the medical history; the onset can vary, including insidious, chronic, or acute onset. ③ Secondary glomerulonephritis and hereditary glomerulonephritis must be excluded. ④ Renal biopsy pathological examination can confirm the diagnosis.

[0136] 2) Traditional Chinese Medicine Diagnostic Criteria: Meets the diagnostic criteria for Wind-Subdued Kidney Collateral Syndrome in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" (formulated by the Ministry of Health of China): Wind-Subdued Kidney Collateral Syndrome: Main symptoms: Edema of the face or limbs, which is triggered by wind, recurs when exposed to wind, or is aggravated by wind or is prolonged and does not heal; discomfort in the joints of the limbs; increased foam in the urine; Secondary symptoms: dull complexion, soreness and weakness of the waist and knees, fatigue and weakness, pale tongue, and thin yellow or white coating.

[0137] Inclusion and exclusion criteria:

[0138] Inclusion criteria: ① No restrictions on age, gender, region, ethnicity, occupation, or other social and natural factors; must have independent behavioral capacity; ② Meet the Western medicine diagnostic criteria for chronic glomerulonephritis; ③ Meet the TCM syndrome differentiation criteria for wind-heat syndrome; ④ Hypertension and infection are effectively controlled; ⑤ 24-hour urine protein quantification ≤3.5g; ⑥ Fresh urine centrifuged sediment >3 red blood cells per high-power field, and the deformity rate of red blood cells in urine ≥70% under phase-contrast microscopy; ⑦ Renal function test glomerular filtration rate (eGFR) ≥60ml / (min·1.73m2) or GFR <60ml / (min·1.73m2) <3 months.

[0139] Exclusion criteria: ① Not meeting the diagnostic criteria for chronic glomerulonephritis in either Traditional Chinese Medicine or Western Medicine; ② Glomerular filtration rate (eGFR) < 60 ml / (min·1.73 m2) for ≥ 3 months, with or without kidney damage criteria; ③ Patients with serious underlying diseases, such as heart, brain, liver, or hematopoietic system diseases, making it impossible to correctly assess the treatment effect; ④ Having factors that cause a transient and reversible decline in renal function, such as abnormal blood pressure, serious infection, excessive protein intake, or inappropriate use of nephrotoxic drugs; ⑤ Pregnant or lactating women; those who may be allergic to the test drug; those with poor compliance and those with mental illness; ⑥ 24-hour urinary protein quantification ≥ 3.5 g / d.

[0140] Treatment methods: Patients diagnosed with chronic nephritis were randomly divided into a control group and an experimental group, with 50 patients in each group.

[0141] Control group: Nephritis Recovery Tablets (composed of Rehmannia glutinosa, Dioscorea opposita, Eucommia ulmoides, Salvia miltiorrhiza, Hedyotis diffusa, etc., product of Tianjin Tongrentang Pharmaceutical Co., Ltd., batch number CP17141), 8 tablets each time, 3 times a day, orally, for 8 weeks.

[0142] Experimental group: The traditional Chinese medicine composition in this application consists of: 15g of Clematis armandii, 10g of Vaccaria segetalis, 15g of Ilex pubescens, 10g of Artemisia capillaris, 15g of Sambucus chinensis, 15g of Viscum album, and 7.5g of Periploca sepium. One dose is taken daily, decocted in 400ml of water, twice a day, orally, for a course of 8 weeks.

[0143] Observation indicators: ① Observe the number of red blood cells in urine sediment, 24-hour urine protein quantification, and TCM symptom scores before and after treatment. ② Safety indicators: Observe the patient's blood routine, electrocardiogram, liver function, and kidney function.

[0144] Syndrome Grading: Referring to the relevant TCM symptom grading standards in the "Guiding Principles for Clinical Research on New Chinese Medicine Drugs for the Treatment of Chronic Glomerulonephritis", symptoms are divided into three levels: mild, moderate and severe. The main symptom of Wind-Lying Kidney Collateral Syndrome is scored as follows: mild 2 points, moderate 4 points, and severe 6 points; secondary symptoms are scored as follows: mild 1 point, moderate 2 points, and severe 3 points. Tongue appearance and pulse appearance are each scored as 1 point.

[0145] Efficacy criteria: Based on the standards established in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine in the Treatment of Chronic Glomerulonephritis". Clinical control: Urinalysis shows negative for proteinuria, or 24-hour urine protein quantification is normal; urinalysis shows normal red blood cell count, or urine sediment shows normal red blood cell count. Significant effect: Urinalysis shows a reduction of 2 "+" in protein, or a reduction of ≥40% in 24-hour urine protein; urinalysis shows a reduction of ≥3 red blood cells / HP (HP: high-power field) or a reduction of 2 "+"; or urine sediment count shows a reduction of ≥40% in red blood cells. Effective: Urinalysis shows a reduction of 1 "+" in protein, or a reduction of <40% in 24-hour urine protein quantification; urinalysis shows a reduction of <3 red blood cells / HP, or urine sediment count shows a reduction of <40% in red blood cells. Ineffective: No improvement or worsening of the above indicators.

[0146] Statistical methods: Data were integrated and analyzed using SPSS 26.0 statistical software. Quantitative data following a normal distribution were expressed as (mean ± standard deviation) and analyzed using t-tests. Categorical data (n(%)) were analyzed using chi-square tests. Ordinal data were analyzed using Ridit analysis. All tests were interpreted with P > 0.05 as no statistical difference, P < 0.05 as statistically significant, and P < 0.01 as statistically significant.

[0147] result:

[0148] (1) Comparison of clinical efficacy between the two groups: see Table 1. Ridit analysis showed that the efficacy of the experimental group was better than that of the control group.

[0149] Table 1. Clinical efficacy of the two groups (cases (%))

[0150]

[0151] (2) Comparison of the efficacy of proteinuria treatment between the two groups: see Table 2. Ridit analysis showed that the treatment group had better efficacy than the control group.

[0152] Table 2. Treatment efficacy for proteinuria in the two groups (cases (%))

[0153]

[0154] (3) Comparison of efficacy of urinary red blood cell treatment between the two groups: see Table 3. Ridit analysis showed that there was no significant difference in efficacy between the treatment group and the control group in terms of urinary red blood cell treatment.

[0155] Table 3. Efficacy of treatment for urinary red blood cell counts in the two groups (cases (%))

[0156]

[0157] (4) Changes in TCM syndrome scores before and after treatment in both groups: see Table 4. The TCM syndrome scores of both the treatment group and the control group decreased significantly after treatment (P<0.01), and the score of the treatment group was lower than that of the control group after treatment (P<0.05), with a statistically significant difference.

[0158] Table 4. TCM syndrome scores for the two groups (scores, mean ± standard deviation)

[0159]

[0160] Compared with the control group, *P<0.05; compared with pre-treatment levels, ##P<0.01

[0161] (5) During the medication treatment, the detection of safety indicators such as blood routine, electrocardiogram, liver function and kidney function before and after treatment showed that no patients had abnormal safety indicators.

[0162] Conclusion: The above clinical research results show that the traditional Chinese medicine composition of the present invention has significant therapeutic effects on chronic nephritis, can significantly reduce 24-hour urinary protein quantification, and reduce TCM syndrome scores.

[0163] The above embodiments are for illustrating the implementation schemes disclosed in this invention and should not be construed as limiting the invention. Furthermore, various modifications and variations of the methods listed herein will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been specifically described in conjunction with various specific preferred embodiments, it should be understood that the invention should not be limited to these specific embodiments. In fact, various modifications as described above that are obvious to those skilled in the art to obtain the invention should be included within the scope of this invention.

Claims

1. A traditional Chinese medicine composition for treating chronic nephritis, characterized in that, By weight, it includes the following components:

2. A traditional Chinese medicine extract for treating chronic nephritis, characterized in that, It is obtained by extraction from the traditional Chinese medicine composition described in claim 1.

3. The preparation method of claim 2, characterized in that, The preparation method includes: extracting the traditional Chinese medicine composition according to claim 1, and the resulting extract is the traditional Chinese medicine extract.

4. The preparation method of claim 3, characterized in that, Includes one or more of the following conditions: 1) The extraction methods are boiling or soaking; 2) The volume ratio of the traditional Chinese medicine composition to the extraction solvent is 1:5-9; 3) The extraction time is 1.5 to 2.5 hours; 4) Extraction is carried out at a temperature of 20°C to the solvent's boiling point; 5) The extraction may be performed once or multiple times; 6) The Chinese herbal medicine composition is pretreated before soaking; preferably, the pretreatment is soaking in a solvent used for extraction.

5. The preparation method of claim 3, characterized in that, It also includes post-treatment of the extract; Preferably, the post-treatment involves allowing the supernatant to stand and then concentrating it into an extract; more preferably, the standing time is 12 to 24 hours. More preferably, the concentration temperature is 70–90°C; even more preferably, the density of the extract is 1.0–1.

2.

6. A traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation comprises the traditional Chinese medicine composition of claim 1 or the traditional Chinese medicine extract of claim 2.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage form of the traditional Chinese medicine preparation is one of the following: capsules, tablets, granules, powders, oral liquids, soft capsules, pills, mixtures, syrups, gels, poultices, suppositories, or sustained-release preparations.

8. The preparation method of claim 7, wherein the granules are characterized in that, The process includes the following steps: concentrating the traditional Chinese medicine extract according to claim 2 to obtain an extract, mixing the extract with excipients, and then drying, granulating, and sizing to obtain the granules.

9. The method of claim 8, wherein the granules are prepared by a process comprising: Includes one or more of the following conditions: 1) The density of the extract is 1.0 to 1.2; 2) The excipient is dextrin; preferably, the mass ratio of the extract to dextrin is 1:30-40; 3) The drying process is spray drying.

10. The use of the traditional Chinese medicine composition according to claim 1, the traditional Chinese medicine extract according to claim 2, or the traditional Chinese medicine preparation according to any one of claims 6 to 9 in the preparation of a drug for treating chronic nephritis.

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