A pharmaceutical composition for treating chronic glomerulonephritis, and its preparation method and use

Abstract

The present invention provides a kind of pharmaceutical composition for treating chronic glomerulonephritis, it is the preparation prepared from the following bulk drug by weight ratio: 32-48 parts of Astragalus, 12-18 parts of Codonopsis, 12-18 parts of Rehmannia, 16-24 parts of Cornus, 16-24 parts of Poria, 12-18 parts of Euryale, 12-18 parts of Pyrilaria, 24-36 parts of Leonurus, 12-18 parts of Eucommia, 16-24 parts of Achyranthes, 24-36 parts of Houttuynia, 16-24 parts of Imperata Rhizome, 12-18 parts of Galla, 12-18 parts of Chinese Yam, 4.8-7.2 parts of Oryza Sativa. The present invention also provides the preparation method and purposes of the pharmaceutical composition. The medicine of the present invention belongs to Chinese medicine preparation, and no obvious toxic and side effects are found through clinical studies, and after significantly reducing the urine protein level of the patient, the urine protein level can be well stabilized, which is beneficial to treatment, greatly enhances the patient's treatment enthusiasm, and provides a new medication selection for clinical use.

Description

Technical Field

[0001] The invention relates to a medicinal composition for treating chronic glomerulonephritis, belonging to the field of traditional Chinese medicine. Background Art

[0002] Chronic glomerulonephritis, or chronic nephritis for short, is a group of diseases originating in the glomeruli. These diseases are chronic and often last for more than three months. Mesangial proliferative glomerulonephritis, represented by IgA nephropathy, is characterized by recurrent episodes and a poor prognosis. Defective immunoglobulin A (IgA) deposits in the mesangium of the glomeruli, inducing inflammation and causing localized renal damage. This leads to clinical symptoms such as persistent edema, proteinuria, gross or microscopic hematuria, decreased renal function, and pathological damage. The sixth National CCDRFS Survey in my country reported that there are 82 million adults with chronic kidney disease in my country, of whom 67 million have proteinuria >30 mg / g. According to the survey, 57.4% of patients with uremia and / or end-stage renal disease in my country suffer from glomerulonephritis. IgA nephropathy accounts for nearly 50% of the causes of glomerulonephritis, meaning that 80,000 to 150,000 patients with IgA nephropathy are diagnosed in China each year. Among patients diagnosed with IgA nephropathy, approximately 20%-40% will develop end-stage renal disease within 20 years, with a mortality rate 10-100 times higher than the general mortality rate.

[0003] Existing Western medical treatments include mucosal immunomodulators, such as oral targeted delayed-release budesonide capsules (Nefecon), and IgA1 protease. Immune response modulators include B cell immunomodulators, cyclophosphamide, mycophenolate mofetil, leflunomide, and other immunosuppressants. Additionally, there are renin-angiotensin inhibitors, glucocorticoids, and fish oil. However, IgA1 protease has side effects such as nonspecific cleavage and immunogenicity, and other medications can cause gastrointestinal symptoms and adverse reactions such as elevated liver enzymes, diarrhea, hair loss, and anemia. Surgical treatments include tonsillectomy and kidney transplantation, but these procedures increase patient pain, require a long postoperative recovery period, and impose a heavy financial burden on patients. In addition, common medications include hormonal drugs and immunosuppressants, such as dexamethasone and cyclophosphamide. However, these drugs all have certain toxic side effects. For example, hormonal drugs can induce or aggravate infections, and can also cause adverse reactions such as gastrointestinal bleeding and metabolic disorders. Immunosuppressants can cause blood system reactions, such as leukopenia, anemia, hepatotoxicity, and nephrotoxicity. Some immunosuppressants can cause gastrointestinal reactions, resulting in nausea, vomiting, and other discomfort symptoms. Moreover, when Western medicine is used to treat this disease, the control of urine protein levels is unstable, and the patient's urine protein content is prone to repeated increases, resulting in a weakening of the patient's medication compliance. In addition, the recurrence of the disease will also lead to an increase in the patient's medication dosage, increasing the burden on the patient's liver and kidneys and the economy, all of which are not conducive to the treatment of this disease.

[0004] In Traditional Chinese Medicine (TCM), ancient physicians believed that the cause of IgA nephropathy was related to "wind evil" and "dampness." Traditional Chinese medicine lacks a clear definition of proteinuria; based on clinical symptoms, it is often attributed to categories such as "turbid urine," "edema," and "consumption." The ancient Chinese medical text "Suwen: Discussion on Water and Heat Acupoints" states: "The kidney is the gate to the stomach. If this gate is not properly closed, water will accumulate and follow its path." "Suwen: Zhizhen Yao Da Lun" states: "All swellings due to dampness belong to the spleen." "Jingyue Quanshu" also states: "All symptoms of edema are related to the spleen, lungs, and kidneys." "Zhubingyuanhou Lun: Various Symptoms of Edema" states: "Water diseases are caused by deficiency of both the kidney and spleen." During the onset and progression of chronic kidney disease, the body often exhibits symptoms of deficiency of the body's vital energy, with pathological products such as dampness and turbidity stagnate in the triple energizer, causing dysfunction of the triple energizer's function. Over time, this leads to deficiency of the internal organs and insufficient vital energy. Wang Huiying, summarizing Professor Lü Renhe's experience, believes that protein is the essence of the human body, produced by the spleen and stored by the kidneys. It is transformed from the essence of food and water, originating from the spleen and stomach, the foundation of our acquired constitution. Spleen and kidney deficiency, resulting in dysfunctional storage, leads to the loss of essence, resulting in protein leakage in the urine. Visceral deficiency is primarily characterized by Qi deficiency in the spleen and kidneys. Guided by the theory of syndrome differentiation and treatment in Traditional Chinese Medicine, and adhering to the principle of "treating kidney disease through the triple energizer," the fundamental principle is to mediate the triple energizer and strengthen the kidneys and spleen, addressing both deficiency and excess, thereby tonifying the spleen and kidneys, replenishing Qi, and strengthening the spleen.

[0005] The classification of chronic glomerulonephritis in traditional Chinese medicine is mainly based on the patient's specific symptoms and constitution. Common traditional Chinese medicine syndrome differentiation types include the following: kidney yang deficiency, cold stasis, damp heat, stasis heat, qi deficiency, spleen and kidney qi deficiency, qi and yin deficiency, spleen and kidney yang deficiency, liver and kidney yin deficiency, water-dampness syndrome, damp-heat (toxic) syndrome, blood stasis syndrome, damp turbidity syndrome (TCM Diagnosis and Treatment Plan for Chronic Kidney Wind (Chronic Glomerulonephritis) (2021)). Different syndrome differentiation types require different treatment methods (Wang Yuejuan, et al., A Preliminary Study on the Distribution and Evolution of Traditional Chinese Medicine Syndrome Types in Patients with Chronic Glomerulonephritis, Chinese Journal of Integrated Traditional Chinese and Western Nephrology, Vol. 10, No. 5, May 2009). Zhu Shukuan, "Galnut is good for treating proteinuria," Journal of Traditional Chinese Medicine, Vol. 39, No. 1, January 1998 (hereinafter referred to as Zhu Shukuan's prescription), discloses the addition of gallnut to a prescription (30g of Astragalus, 30g of Chinese Yam, 15g each of Cornus officinalis, Poria, Pyrola, Radix Dioscoreae, Rosa Laevigatae, and Euryale ferox, and 30g each of Leonurus japonicus and Coix Seed) for the treatment of refractory proteinuria. Chronic nephritis often requires long-term medication due to its long course. Long-term use of Radix Dioscoreae can irritate the digestive tract, leading to spleen and stomach discomfort, causing nausea, vomiting, stomach pain, and diarrhea. Coix Seed can strengthen the spleen and relieve diarrhea, but its spleen-tonifying effect is relatively weak. The progression of chronic nephritis is often accompanied by the invasion of external pathogens; the use of Rosa Laevigata in the prescription, due to its overly sour and astringent properties, may cause the enemy to remain inside, thereby exacerbating the chronic nephritis. In addition, there are also reports that Rosa laevigata can cause adverse reactions in the skin and nervous system, such as itching, rashes, and irritability. (Chinese Journal of Traditional Chinese Medicine, June 2016). Cai Meng et al., Safety Analysis of Astringent Chinese Herbal Pieces and Considerations for Prescription Vigilance. Summary of the Invention

[0006] The technical solution of the present invention is to provide a new pharmaceutical composition for treating chronic glomerulonephritis, and its preparation method and use. The present invention also provides the preparation method and use of the pharmaceutical composition.

[0007] The present invention provides a pharmaceutical composition for treating chronic glomerulonephritis, which is a preparation prepared from the following raw materials in the following weight ratios:

[0008] 32-48 parts of Astragalus, 12-18 parts of Codonopsis, 12-18 parts of Rehmannia, 16-24 parts of Cornus, 16-24 parts of Poria, 12-18 parts of Euryale, 12-18 parts of Pyrrosia, 24-36 parts of Leonurus, 12-18 parts of Eucommia, 16-24 parts of Achyranthes, 24-36 parts of Houttuynia, 16-24 parts of Imperata rhizome, 12-18 parts of Gallnut, 12-18 parts of Chinese Yam, and 4.8-7.2 parts of Taibai Rice.

[0009] More preferably, it is a preparation prepared from the following raw materials in the following weight ratio:

[0010] 40 parts of Astragalus, 15 parts of Codonopsis, 15 parts of Rehmannia, 20 parts of Cornus, 20 parts of Poria, 15 parts of Euryale, 15 parts of Pyrola, 30 parts of Leonurus, 15 parts of Eucommia, 20 parts of Achyranthes, 30 parts of Houttuynia, 20 parts of Imperata Rhizome, 15 parts of Gallnut, 15 parts of Chinese Yam, and 6 parts of Taibai Rice.

[0011] The Rehmannia root is raw Rehmannia root; the Cornus officinalis is processed Cornus officinalis wine; the Euryale ferox is stir-fried Euryale ferox; the Eucommia ulmoides is salted Eucommia ulmoides; and the Chinese yam is stir-fried Chinese yam with bran.

[0012] The pharmaceutical composition of the present invention is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to form an oral preparation commonly used in pharmacy.

[0013] Wherein, the oral preparations are granules, capsules, pills, and oral liquids.

[0014] The present invention also provides a method for preparing the pharmaceutical composition for treating chronic glomerulonephritis, which comprises the following steps:

[0015] a. Weigh the APIs of various weight ratios;

[0016] b. Powdering, or extracting with water or organic solvent, and adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare oral preparations commonly used in pharmacy.

[0017] The present invention provides use of the pharmaceutical composition in preparing medicine for treating chronic glomerulonephritis.

[0018] Wherein, the medicine is a medicine for reducing urine protein content.

[0019] The present invention provides use of the pharmaceutical composition in preparing a medicine with the effects of strengthening the spleen and kidney, invigorating qi and strengthening astringency.

[0020] Wherein, the medicine is a medicine for treating edema and proteinuria caused by spleen and kidney deficiency.

[0021] The fundamental pathogenesis of proteinuria in chronic nephritis lies in spleen and kidney deficiency, which leads to dysfunctional storage and the downward leakage of essence. Urinary protein falls under the category of essence in Traditional Chinese Medicine. Traditional Chinese Medicine believes that the body's grain and water essences are produced by the spleen and stored by the kidneys. If both the spleen and kidney are deficient and the storage is dysfunctional, this can lead to the leakage of grain and water essence in the urine, a major cause of elevated proteinuria in kidney disease. The spleen, located in the middle burner, is the source of acquired qi and blood production and metabolism, responsible for transportation and transformation, regulating the ascending of the clear, and regulating blood circulation. Weak spleen qi and its inability to transport and transform can lead to dysfunctional water and moisture transportation and transformation, preventing fluid from being properly distributed to the kidneys and bladder, causing moisture to stagnate in the body and resulting in edema. A weak spleen qi can also lead to dysfunctional retention. Qi deficiency can prevent the proper retention of grain and water essences, leading to the downward leakage of grain and water essences.

[0022] The "Yellow Emperor's Internal Classic. Six Sections on Zang-Xiang" states: "The kidney governs hibernation and is the foundation of storage." The kidney is the innate foundation of the body, responsible for bone and marrow production, and has the function of sealing and consolidating. Insufficient kidney qi impairs these functions, leading to the leakage of essence and proteinuria. Insufficient kidney qi deprives the marrow of nourishment, resulting in symptoms such as soreness and weakness in the waist and knees. The "Suwen Shanggu Tianzhen Lun" states: "The kidney governs water, receiving and storing essence from the five internal organs. Therefore, when the five internal organs are prosperous, they can be released." Furthermore, the "Suwen Ni Tiao Lun" states: "The kidney is the water organ and governs semen." Traditional Chinese medicine believes that the kidney governs water, and the body's water metabolism is related to the evaporation and vaporization of essence and qi within the kidney. Insufficient kidney qi can lead to impaired water metabolism, resulting in symptoms such as edema and difficulty urinating. Traditional Chinese medicine also states that "long-term illness causes more blood stasis." Because prolonged illness depletes vital energy, leading to a loss of Qi and blood, Qi deficiency weakens the body's circulation, and blood circulation becomes blocked, causing blood stasis. Furthermore, as the disease progresses, the lesions progress from superficial to deep, from the yang meridians (the body's surface collaterals) into the yin meridians (the internal organs' collaterals), causing blood stasis. This further exacerbates the condition, creating a vicious cycle. Based on this, we propose a formula that strengthens the spleen and kidneys, replenishes Qi, and strengthens the body to treat proteinuria in chronic nephritis.

[0023] The medicinal formula of the present invention uses astragalus and gallnut as the main ingredients. Astragalus has the effects of strengthening the spleen and replenishing qi, promoting diuresis and reducing swelling, and can enhance the governing power by tonifying the spleen qi, and can promote diuresis to reduce edema. Gallnut has the acidic taste and has the effects of astringency, tonifying the kidney and astringing the essence, and can nourish the kidney to enhance the function of consolidating the essence.

[0024] In this formula, Codonopsis pilosula strengthens the spleen and replenishes Qi, invigorating the clear Yang; Poria cocos promotes diuresis and eliminates dampness, also tonifying the spleen; and stir-fried Chinese yam nourishes the spleen and kidneys, consolidating essence and stopping nocturnal emission. These three herbs, when used together, tonify the spleen to enhance the function of consolidating essence and transforming dampness, thereby alleviating symptoms such as edema and proteinuria. Taibai rice regulates Qi and harmonizes the stomach, aiming to regulate the spleen and stomach. When used together with tonic herbs like Codonopsis pilosula and Astragalus membranaceus, it has the effect of tonifying the middle and promoting circulation, nourishing without stagnation, and enhancing the transformation function of the present invention's formula. These herbs collectively serve as ministerial ingredients in this formula.

[0025] Wine-infused cornus root nourishes the liver and kidneys, providing astringency and firming. Eucommia bark, when prepared with salt, enhances its kidney-tonifying properties. Achyranthes bidentata (Achyranthes bidentata) nourishes the liver and kidneys, strengthens tendons and bones, and promotes blood circulation and removes blood stasis. Euryale ferox (Gorgon fruit) strengthens the kidneys and essence, and also has some spleen-tonifying effects. Raw rehmannia root cools the blood, nourishes yin, and benefits the kidneys, while also preventing the potential for yin damage from tonics. Together, these herbs tonify the kidneys, strengthen tendons and bones, and alleviate symptoms such as spermatorrhea and soreness of the waist and knees. These herbs also serve as adjuvants in the formula.

[0026] Pyrifera, Houttuynia cordata, and Imperata root all clear heat and dampness; Leonurus japonicus also clears heat and dampness, but also has the effect of promoting blood circulation and removing blood stasis. Besides clearing heat and dampness, promoting diuresis and reducing swelling, these herbs also prevent the invasion of external pathogens (the leakage of the body's water and grain essences can lead to insufficient vital energy). These herbs serve as guiding herbs in the formula.

[0027] The present invention aims to strengthen the spleen and kidney, replenish qi and consolidate the body, increase the dosage of the qi-invigorating drug astragalus, and exert a synergistic effect through the compatibility of various raw materials. The specific advantages are as follows:

[0028] 1. The treatment method is more comprehensive, reflecting the holistic treatment concept of Traditional Chinese Medicine. The composition of the present invention strengthens the spleen and replenishes qi, eliminates dampness and turbidity, and astringes the body. At the same time, it also uses kidney tonification (eucommia ulmoides, Achyranthes bidentata, Rehmannia glutinosa) and qi regulation and blood stasis removal (Taibai rice, Achyranthes bidentata, Leonurus japonicus) to treat the disease. The treatment method is more comprehensive, reflecting the concept of the holistic treatment concept of Traditional Chinese Medicine.

[0029] 2. The pathogenesis of Chinese and Western medicine is integrated to improve the state of blood stasis caused by long-term illness in patients with nephritis. According to traditional Chinese medicine theory, patients with chronic nephritis suffer from qi deficiency and poor blood circulation after long-term illness, which can lead to blood stasis and qi stagnation. Current medical research has confirmed that in the late stage of chronic nephritis, there is a possibility of microcirculation disorder in the kidneys. Therefore, methods such as increasing the effective blood perfusion of the kidneys and the whole body, improving local microcirculation disorders, increasing oxygen supply, and enhancing metabolism should be adopted for treatment. The composition of the present invention adds Taibai rice and Achyranthes bidentata, two drugs with the functions of regulating qi and removing blood stasis, to improve the state of blood stasis caused by long-term illness in patients with chronic nephritis, i.e., microcirculation disorder, thereby significantly improving the clinical efficacy.

[0030] 3. Strengthen the spleen while also tonifying the kidneys, enhancing the sealing and consolidating effects. According to Traditional Chinese Medicine theory, spleen and kidney deficiency and dysfunction of the sealing and consolidating functions are the main causes of chronic nephritis. Therefore, the present invention's drug for treating chronic nephritis not only strengthens the spleen and replenishes Qi, but also strengthens its kidney-tonifying effects, further enhancing the sealing and consolidating effects, thereby preventing the leakage of essence.

[0031] 4. It can both eliminate dampness and detoxify, and prevent invasion of exogenous pathogens. Chronic nephritis patients have a long-term illness with insufficient vital energy, which makes them susceptible to invasion of exogenous pathogens, thereby aggravating their condition or causing loss of early treatment effects. The drug of the present invention is designed to treat edema caused by chronic nephritis, while taking into account the problem of preventing invasion of exogenous pathogens. The two drugs, Imperata cylindrica and Houttuynia cordata, can both eliminate dampness and detoxify, and can also clear away heat and detoxify, preventing invasion of exogenous pathogens.

[0032] The drug of the present invention can significantly reduce the patient's urine protein content in a short period of time. Clinical use has confirmed that after taking this prescription for about two weeks, the urine protein content of most patients has dropped significantly by more than 50%. The drug of the present invention is a traditional Chinese medicine preparation. Clinical studies have found no significant toxic side effects. After significantly reducing the patient's urine protein level, it can effectively stabilize the urine protein level, allowing for subsequent gradual treatment, greatly enhancing patient enthusiasm for treatment and providing a new medication option for clinical use. DETAILED DESCRIPTION

[0033] Example 1 Preparation of the granules of the present invention (hereinafter referred to as "Shenqi Jiangzhuo Granules")

[0034] Weigh the raw materials: 200g of Astragalus, 75g of Codonopsis pilosula, 75g of Rehmannia root, 100g of Cornus officinalis, 100g of Poria, 75g of stir-fried Euryale ferox, 75g of Pyrola, 150g of Leonurus japonicus, 75g of Salt Eucommia ulmoides, 100g of Achyranthes bidentata, 150g of Houttuynia cordata, 100g of Imperata cylindrica, 75g of Gallnut, 75g of stir-fried Chinese yam with bran, and 30g of Taibai rice.

[0035] Preparation of Chinese herbal extract: The above 15 medicinal materials were decocted twice with water, the first time with 10 times the amount of water and decocted for 2 hours, the second time with 8 times the amount of water and decocted for 1.5 hours, the decoction was filtered, and the filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.25-1.35 (60°C-65°C), and microwave-dried to prepare a dry paste powder.

[0036] Granulation: Mix the Chinese herbal medicine dry extract, the pharmaceutical excipient dextrin and 0.3g of aspartame, and spray with 75% ethanol to granulate; obtain wet granules, mix well, and make granules.

[0037] Granulation: After granulation, dry at low temperature (≤60°C), granulate into 1000g.

[0038] Example 2 Preparation of the pharmaceutical granules of the present invention

[0039] Astragalus 32g, Codonopsis pilosula 12g, Rehmannia glutinosa 12g, Cornus officinalis 16g, Poria 16g, Euryale ferox 12g, Pyrola 12g, Leonurus japonicus 24g, Eucommia ulmoides 12g, Achyranthes bidentata 16g, Houttuynia cordata 24g, Imperata cylindrica 16g, Gallnut 12g, Chinese yam 12g, Taibai rice 3g

[0040] Prepared according to the method of Example 1.

[0041] Example 3 Preparation of the pharmaceutical granules of the present invention

[0042] Astragalus 48g, Codonopsis pilosula 18g, Rehmannia glutinosa 18g, Cornus officinalis 24g, Poria 24g, Euryale ferox 18g, Pyrola 18g, Leonurus japonicus 36g, Eucommia ulmoides 18g, Achyranthes bidentata 24g, Houttuynia cordata 36g, Imperata cylindrica 24g, Gallnut 18g, Chinese yam 18g, and Taibai rice 6g.

[0043] Prepared according to the method of Example 1.

[0044] The beneficial effects of the present invention are demonstrated by the following pharmacodynamic tests.

[0045] Test Example 1 Animal Experiment of the Drug of the Present Invention

[0046] 1. Research Methods

[0047] Grouping method: (1) blank group; (2) model group; (3) negative control group; (4) model + Chinese medicine composition group (referred to as Chinese medicine composition group); (5) model + Chinese medicine composition without Taibai rice group (referred to as without Taibai rice group); (6) model + Chinese medicine composition without Galla chinensis group (referred to as without Galla chinensis group).

[0048] 2. Experimental Methods

[0049] (1) Animal modeling: Bovine serum albumin (BSA) (400 mg / kg) was administered orally for 8 weeks, and castor oil (0.3 mL) + CCl4 (0.1 mL) was administered subcutaneously once a week for 10 weeks. 0.05 mg of lipopolysaccharide (LPS) was administered via tail vein injection at weeks 6 and 8. 24-hour urine protein levels were measured at week 10. Three rats in each of the control and model groups were used for model validation.

[0050] (2) Treatment methods

[0051] Animal modeling week 10:

[0052] Negative control group: gavage with negative control prescription decoction, the gavage concentration is 2.1g / mL, the gavage dose is calculated as 1mL / 100g, once a day.

[0053] Treatment groups: the Chinese medicine combination group, the group without Taibai rice, and the group without Gallnut were gavaged with 2.8g (based on the original drug amount) / mL of each Chinese medicine decoction, with the gavage dose calculated as 1mL / 100g, once a day.

[0054] Blank group and model group: Oral administration of normal saline, the oral dose is calculated as 1mL / 100g, once a day.

[0055] The treatment course for the treatment group, blank group and model control group was 6 weeks.

[0056] The efficacy observation indicators include body weight and renal function indicators.

[0057] Body weight observation: The body weight of rats was recorded before and after treatment.

[0058] Observation of liver and kidney function indicators: The changes in 24-hour urine protein (mg / 24h), serum creatinine (Scr), and blood urea nitrogen (BUN) of rats in each group were detected at each stage.

[0059] 3. The results are as follows:

[0060] 3.1 General Condition: With the exception of the normal control group, rats in all experimental groups exhibited varying degrees of decreased food intake, lethargy, restlessness, and matted fur after modeling. By the end of the experiment, the model group weighed significantly less than the other groups. See Table 1 for details.

[0061] Table 1 Comparison of body weight of rats in each group at the end of the experiment (-X ± SD)

[0062]

[0063] Comparison between blank group and model group: #P<0.05, ##P<0.01; comparison between treatment group and model group: *P<0.05, **P<0.01.

[0064] As can be seen from Table 2, compared with the body weight of rats in the negative control group, the body weight of rats in each medication group increased. This result shows that Shenqi Jiangzhuo Granule can improve the food intake of rats with chronic glomerulonephritis, thereby increasing their weight.

[0065] Table 2 Comparison of body weight of rats in each treatment group at the end of the experiment (-X ± SD)

[0066]

[0067] Comparison between the negative control group and the Chinese medicine combination group: #P<0.05, ##P<0.01; comparison between the Chinese medicine combination group and the group without Taibai rice: *P<0.05, **P<0.01; comparison between the Chinese medicine combination group and the group without Gallnut, ※P<0.05.

[0068] 3.2 Changes in 24-hour urine protein: At the end of the 10th week of the experiment, urine protein in all modeling groups increased significantly, showing significant differences compared with the normal group. Urinary protein in all drug treatment groups decreased significantly after drug intervention, showing significant differences compared with the model group (see Table 3).

[0069] Table 3 Changes in 24-hour urine protein (-X±SD)

[0070]

[0071] Comparison between blank group and model group: #P<0.05, ##P<0.01; comparison between treatment group and model group:

[0072] *P<0.05, **P<0.01.

[0073] As can be seen from Table 4, compared with the negative control group, after treatment with the Chinese medicine composition group, the changes in 24h urine protein in rats were significantly reduced (P<0.01). The results show that Shenqi Jiangzhuo Granules have a significant effect on reducing urine protein. In order to further confirm the effects of Taibai rice and Schisandra chinensis in the prescription, this patent uses a method of splitting the prescription to verify that when Taibai rice is not present, the protein content in the 24h urine of rats is significantly increased compared with the negative control group. This result indicates that the effect of the rat kidney in regulating proteinuria is significantly weakened. This result proves that Taibai rice has a significant effect on reducing urine protein (P<0.01) and its importance as a minister in the prescription. Similarly, this patent uses a method of splitting the prescription to verify that Gallnut can nourish the kidneys and astringe essence, and has a better effect on reducing the protein content in rat urine (P<0.05) compared with the negative control group.

[0074] Table 4 Changes in 24-hour urine protein in each treatment group (-X±SD)

[0075]

[0076] Comparison between the negative control group and the Chinese medicine combination group: #P<0.05, ##P<0.01; comparison between the Chinese medicine combination group and the group without Taibai rice: *P<0.05, **P<0.01; comparison between the Chinese medicine combination group and the group without Gallnut, ※P<0.05, ※※P<0.01.

[0077] 3.3. Serum creatinine (Scr), urea nitrogen (BUN): At the end of the 12th week, the renal function (Scr, BUN) of the experimental rats in each group showed no significant difference among the groups. The results are shown in Table 5.

[0078] Table 5 Comparison of Scr and BUN in rats of each group (-X±SD)

[0079]

[0080] in conclusion:

[0081] The Chinese medicine composition of the present invention is applied to an IgA nephropathy animal model, improves general conditions, reduces urine protein and (or) hematuria, and can be used to prepare medicine for treating chronic nephritis.

[0082] Test Example 2 Clinical Trial of the Drug of the Present Invention

[0083] Treatment options

[0084] The Shenqi Jiangzhuo Granules group took Shenqi Jiangzhuo Granules orally, one bag (15g / bag, equivalent to 21.375g of the herbal drug) three times a day, mixed with boiled water, for 14 consecutive days. The Huangkui Capsule group took Huangkui Capsules orally, five capsules (0.43g / capsule) three times a day, for 14 consecutive days. Both groups maintained their normal diets during the trial.

[0085] (1) Clinical efficacy evaluation criteria

[0086] ①Clinical control: Routine urine examination shows negative protein level, or the 24-hour urine protein level is normal.

[0087] ② Significantly effective: The protein content in urine routine examination decreased by 2 “+”, or the quantitative urine protein content in 24 hours decreased by ≥40%.

[0088] ③Effective: The protein in urine routine examination is reduced by 1 “+”, or the quantitative urine protein in 24 hours is reduced by <40%.

[0089] ④ Ineffective: clinical manifestations and the above laboratory tests have not improved or have worsened.

[0090] (2) Criteria for determining efficacy of TCM syndromes

[0091] ① Clinical recovery: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

[0092] ② Markedly effective: Clinical symptoms and signs of TCM were significantly improved, and the syndrome score was reduced by ≥70%.

[0093] ③Effective: TCM clinical symptoms and signs are improved, and the syndrome score is reduced by ≥30%.

[0094] ④ Ineffective: TCM clinical symptoms and signs are aggravated, and the syndrome score is reduced by <30%.

[0095] (3) Safety evaluation standards

[0096] Level 1: Safe, without any adverse reactions; no abnormalities in the necessary safety indicators.

[0097] Level 2: Relatively safe, with mild adverse reactions. No treatment is required and the drug can continue to be administered. No abnormalities are found in the safety index examination.

[0098] Level 3: There are safety issues, moderate adverse reactions, or mild abnormalities in safety index examinations. The drug can continue to be administered after treatment.

[0099] Level 4: The trial is terminated due to serious adverse reactions or safety index examinations are obviously abnormal.

[0100] (IV) Efficacy analysis

[0101] 1. Clinical efficacy: The comparison of clinical efficacy between the two groups was statistically significant (see Table 6).

[0102] Table 6 Comparison of clinical efficacy between the two groups (cases, 100%)

[0103]

[0104] 2. Efficacy of TCM syndromes: The comparison of the efficacy of TCM syndromes between the two groups was statistically significant (see Table 7).

[0105] Table 7 Comparison of TCM syndrome efficacy between the two groups (examples, 100%)

[0106]

[0107] 3. Comparison of the reduction in TCM symptom scores after the trial: The comparison of the reduction in TCM symptom scores between the two groups after treatment was statistically significant. Comparison of the TCM symptom scores between the two groups after treatment showed that each group had a significant reduction; the comparison between the groups was statistically significant (see Table 8).

[0108] Table 8 Comparison of TCM syndrome scores between the two groups of patients after treatment

[0109]

[0110] 4. After treatment, the qualitative urine protein test results of the two groups were statistically significant within the group; the qualitative urine protein test results of the two groups were not statistically significant (see Table 9).

[0111] Table 9 Comparison of the qualitative efficacy of urine protein in two groups of patients (cases)

[0112]

[0113] 5. Comparison of 24-hour urine protein quantitative reduction values: The comparison of 24-hour urine protein quantitative reduction values ​​between the two groups was statistically significant, indicating that the urine protein reduction in the experimental group was significantly better than that in the control group (see Table 10).

[0114] Table 10 Comparison of the quantitative reduction of urine protein in the two groups of patients after treatment for 24 hours

[0115]

Claims

1. A pharmaceutical composition for treating chronic glomerulonephritis, characterized in that: It is a preparation made from the following raw materials in the following weight ratio: 32-48 parts of Astragalus, 12-18 parts of Codonopsis, 12-18 parts of Rehmannia, 16-24 parts of Cornus, 16-24 parts of Poria, 12-18 parts of Euryale, 12-18 parts of Pyrrosia, 24-36 parts of Leonurus, 12-18 parts of Eucommia, 16-24 parts of Achyranthes, 24-36 parts of Houttuynia, 16-24 parts of Imperata rhizome, 12-18 parts of Gallnut, 12-18 parts of Chinese Yam, and 4.8-7.2 parts of Taibai Rice.

2. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 1, characterized in that: It is a preparation made from the following raw materials in the following weight ratio: 40 parts of Astragalus, 15 parts of Codonopsis, 15 parts of Rehmannia, 20 parts of Cornus, 20 parts of Poria, 15 parts of Euryale, 15 parts of Pyrola, 30 parts of Leonurus, 15 parts of Eucommia, 20 parts of Achyranthes, 30 parts of Houttuynia, 20 parts of Imperata Rhizome, 15 parts of Gallnut, 15 parts of Chinese Yam, and 6 parts of Taibai Rice.

3. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 1 or 2, characterized in that: The described Rehmannia root is raw Rehmannia root; the described Cornus officinalis is processed Cornus officinalis wine; the described Euryale ferox is stir-fried Euryale ferox; and the described Chinese yam is stir-fried Chinese yam with bran.

4. The pharmaceutical composition for treating chronic glomerulonephritis according to any one of claims 1 to 3, characterized in that: The oral preparation is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients.

5. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 4, characterized in that: The oral preparations are granules, capsules, pills and oral liquids.

6. A method for preparing the pharmaceutical composition for treating chronic glomerulonephritis according to any one of claims 1 to 5, characterized in that: It includes the following steps: a. Weigh the APIs of various weight ratios; b. Powdering, or extracting with water or organic solvent, and adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare oral preparations commonly used in pharmacy.

7. Use of the pharmaceutical composition according to any one of claims 1 to 5 in the preparation of a medicament for treating chronic glomerulonephritis.

8. The use according to claim 7, characterized in that: The medicine is a medicine for reducing urine protein content.

9. Use of the pharmaceutical composition according to any one of claims 1 to 5 in the preparation of a medicament having the effects of strengthening the spleen and kidney, replenishing qi and strengthening astringency.

10. The use according to claim 9, characterized in that: The medicine is a medicine for treating edema and proteinuria caused by spleen and kidney deficiency.

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