Application of Penthorum chinense Pursh in preparing medicine for treating elevated serum creatinine or health care product for preventing and treating elevated serum creatinine

Abstract

The present invention discloses the application of Penthorum chinense Pursh in the preparation of a medicament for treating elevated blood creatinine or a health product for preventing and treating elevated blood creatinine. The present invention discovers for the first time that the water extract of Penthorum chinense Pursh has good curative effects on the elevation of blood creatinine, blood uric acid, and blood urea nitrogen caused by primary chronic kidney diseases and abnormal glomerular filtration, especially specifically reduces the serum creatinine level, and can significantly improve the clinical symptoms of patients with renal hypercreatinemia; Penthorum chinense Pursh has the effects of clearing heat and detoxifying, dredging collaterals and resolving masses, and promoting diuresis and detumescence, has no obvious damage to liver function, and has a protective effect. Therefore, it has high safety and can be eaten as a health product in daily life for preventing and treating the elevation of blood creatinine.

Description

Technical Field

[0001] The present invention relates to the application of a traditional Chinese medicine, and particularly to the application of Penthorum chinense Pursh in the preparation of a drug for treating elevated serum creatinine or a health product for preventing and treating elevated serum creatinine. Background Art

[0002] Penthorum chinense Pursh, also known as Pterocaulon virgatum, Lindernia procumbens, Ammannia baccifera, is mainly produced in East China, North China, Central South and other places in China, and the authentic medicinal materials are from Gulin County at the junction of Sichuan, Yunnan and Guizhou provinces. Penthorum chinense Pursh is bitter, pungent, slightly cold in nature, and belongs to the liver, kidney and bladder meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and reducing jaundice, and promoting blood circulation to remove blood stasis. It was first recorded in "Herbal for Relief of Famine", and is the main prescription for the Miao people to treat liver diseases. Modern pharmacological studies have shown that the main active ingredients of Penthorum chinense Pursh are flavonoids, organic acids, terpenoids, esters, steroids and trace elements and other effective components. It also contains gallic acid, quercetin, pinocembrin, apigenin, luteolin, kaempferol, lupenol, ursolic acid, betulinic acid, syringaresinol, etc. It has been clearly shown by research that Penthorum chinense Pursh and its extracts have many pharmacological functions such as protecting liver cells, improving microcirculation, reversing the formation of liver fibrosis, and anti-cancer. Clinically, it is also widely used in the treatment of liver insufficiency, liver fibrosis, the treatment of osteomyelitis, and protecting the liver from alcohol.

[0003] With the change of the lifestyle of the social population and the acceleration of the aging process, the incidence of Chronic Kidney Disease (CKD) has been increasing year by year and showing a trend of getting younger. It not only seriously reduces the quality of life of patients, but also brings a serious economic burden to society and families. Hypercreatinemia is the most common clinical feature of kidney diseases and plays a crucial role in the diagnosis and grading of chronic kidney diseases, the evaluation and prognosis of renal function. The mechanism of further damage to the kidneys caused by elevated serum creatinine is reflected in acid-base imbalance and water-sodium retention, and in severe cases, it can lead to heart failure. Research shows that serum creatinine is more sensitive and has more advantages in the evaluation of early renal damage, which buys precious time for the diagnosis and treatment of chronic kidney diseases. For chronic kidney diseases caused by different etiologies, the classic Western medicine treatment methods mostly adopt symptomatic treatment and diet regulation, but lack specific drugs for reducing creatinine, and may also increase the risk of elevated creatinine while treating symptoms. Chronic kidney disease belongs to the category of "edema" and "consumptive disease" in traditional Chinese medicine. Penthorum chinense Pursh belongs to the liver and kidney meridians. Ancient books record that Penthorum chinense Pursh can: "reduce swelling, promote diuresis, remove blood stasis, and promote qi movement". At present, there are already relevant studies on the prevention and treatment of proteinuria with Penthorum chinense Pursh, but the efficacy of Penthorum chinense Pursh in reducing serum creatinine is not yet clear. How to reduce serum creatinine while reducing proteinuria and ensure the safety of the drug, and broaden the application scope of traditional Chinese medicine is still an important research goal. Summary of the Invention

[0004] The object of the present invention is to overcome the disadvantages and deficiencies of the prior art, and to provide the application of Patrinia villosa Juss. in the preparation of drugs for treating elevated serum creatinine or health products for preventing and treating elevated serum creatinine.

[0005] The object of the present invention is achieved by the following technical solutions:

[0006] The application of Patrinia villosa Juss. in the preparation of drugs for treating elevated serum creatinine or health products for preventing and treating elevated serum creatinine. This research result is obtained from further studies on the efficacy of Patrinia villosa Juss., and it is found that Patrinia villosa Juss. can be used as the sole active ingredient to reduce elevated serum creatinine.

[0007] The said application preferably includes the following steps: extracting Patrinia villosa Juss. to obtain the extract of Patrinia villosa Juss., which is used for the preparation of drugs for treating serum creatinine or health products for preventing and treating elevated serum creatinine.

[0008] The extract of Patrinia villosa Juss. is preferably the water extract of Patrinia villosa Juss.

[0009] The preparation method of the extract of Patrinia villosa Juss. includes the following steps:

[0010] (1) Decocting Patrinia villosa Juss. with water, separating the solid and liquid to obtain the medicinal liquid and the medicinal residues;

[0011] (2) Repeatedly decocting the medicinal residues for more than 0 times. The repeated decoction is to better extract its active ingredients;

[0012] (3) Combining the medicinal liquids obtained in step (1) and step (2) to obtain the water extract of Patrinia villosa Juss.; when the number of repeated decoctions is 0, the medicinal liquid obtained in step (1) is the water extract of Patrinia villosa Juss.

[0013] In step (1), the dosage of water is preferably calculated according to the ratio of Patrinia villosa Juss.: water = solid-liquid ratio of 1:1 - 5 (g / mL); more preferably calculated according to the ratio of Patrinia villosa Juss.: water = solid-liquid ratio of 1:3 - 4 (g / mL).

[0014] In step (1), the Patrinia villosa Juss. is preferably soaked first and then decocted.

[0015] The soaking time is preferably 20 - 40 min; more preferably 30 min.

[0016] In step (1), the decocting time is preferably 30 - 60 min; more preferably 30 - 40 min.

[0017] In step (2), the dosage of water for repeated decoction is preferably calculated according to the ratio of Patrinia villosa Juss.: water = solid-liquid ratio of 1:1 - 5 (g / mL); more preferably calculated according to the ratio of Patrinia villosa Juss.: water = solid-liquid ratio of 1:2 - 3 (g / mL).

[0018] In step (2), the time for repeated decoction is preferably 20 - 40 min; more preferably 30 min.

[0019] The number of times of repeated decoction described in step (2) is preferably 0 to 2 times; more preferably 1 to 2 times.

[0020] The dosage form of the drug is decoction, pill, powder, plaster, pellet, granule, oral liquid, capsule, tablet or injection.

[0021] The drug is an ordinary preparation, sustained-release preparation, controlled-release preparation, targeted preparation or particulate drug delivery system.

[0022] The increase in serum creatinine is caused by kidney disease.

[0023] The kidney disease is preferably a chronic kidney disease, more preferably one of diabetic nephropathy, immunoglobulin A nephropathy, idiopathic membranous nephropathy and chronic renal failure.

[0024] The present invention has the following advantages and effects compared with the prior art:

[0025] (1) The inventors of the present invention first discovered that the water extract of Penthorum chinense Pursh has good curative effects on the increase in serum creatinine, blood uric acid, blood urea nitrogen and abnormal glomerular filtration caused by primary chronic kidney disease, especially specifically reduces the serum creatinine level, and can significantly improve the clinical symptoms of patients with renal hypercreatininemia.

[0026] (2) The Penthorum chinense Pursh provided by the present invention has the effects of clearing heat and detoxifying, dredging collaterals and dissipating stasis, promoting diuresis and detumescence, has no obvious damage to liver function, and has a protective effect, so the safety is relatively high. It can be eaten as a health product in daily life for preventing and treating the increase in serum creatinine.

[0027] (3) Compared with the treatment with the western medicine oral kidney-protecting and detoxifying symptomatic treatment drugs (such as antihypertensive and kidney-protecting drugs, oral hypoglycemic drugs, immunosuppressants) alone before and after the combination of the water extract of Penthorum chinense Pursh provided by the present invention, the treatment has better effects on reducing the increase in serum creatinine, blood uric acid, blood urea nitrogen, abnormal glomerular filtration, improving the glomerular filtration rate, and treating hypercreatininemia, and the recovery is faster. And compared with the existing Huangkui Capsule in the prior art, it has broad application prospects in reducing the increase in renal serum creatinine and protecting renal function. Description of the Drawings

[0028] Figure 1 It is a diagram of the detection results of serum creatinine levels in patients with diabetic kidney disease (DKD) before and after drug treatment; among them, group A is Penthorum chinense Pursh, and group B is Huangkui Capsule.

[0029] Figure 2 It is a diagram of the detection results of serum creatinine levels in patients with IgA nephropathy before and after drug treatment; among them, group A is Penthorum chinense Pursh, and group B is Huangkui Capsule.

[0030] Figure 3It is a graph showing the results of detecting serum creatinine levels in patients with idiopathic membranous nephropathy before and after drug treatment; among them, Group A is Phyllanthus niruri, and Group B is Huangkui Capsule.

[0031] Figure 4 It is a graph showing the results of detecting serum creatinine levels in patients with chronic renal failure before and after drug treatment; among them, Group A is Phyllanthus niruri, and Group B is Huangkui Capsule.

[0032] Figure 5 It is a graph showing the effect of Phyllanthus niruri on the body weight of UUO mice; among them, A is 1 week, B is 2 weeks, and C is 3 weeks.

[0033] Figure 6 It is a graph showing the effect of Phyllanthus niruri on the body weight of UUO mice at different times.

[0034] Figure 7 It is a graph showing the effect of Phyllanthus niruri on the kidney weight of UUO mice; among them, A is 1 week, B is 2 weeks, and C is 3 weeks.

[0035] Figure 8 It is a graph showing the effect of Phyllanthus niruri on the kidney weight of UUO mice at different times.

[0036] Figure 9 It is a graph showing the effect of Phyllanthus niruri on the serum creatinine of UUO mice; among them, A is 1 week, B is 2 weeks, and C is 3 weeks.

[0037] Figure 10 It is a graph showing the effect of Phyllanthus niruri on the serum creatinine of UUO mice at different times.

[0038] Figure 11 It is a graph showing the effect of Phyllanthus niruri on the blood uric acid of UUO mice; among them, A is 1 week, B is 2 weeks, and C is 3 weeks.

[0039] Figure 12 It is a graph showing the effect of Phyllanthus niruri on the blood uric acid of UUO mice at different times.

[0040] Figure 13 It is a graph showing the effect of Phyllanthus niruri on the blood lipid and total cholesterol of UUO mice; among them, A is blood lipid and B is total cholesterol.

[0041] Figure 14 It is a graph showing the effect of Phyllanthus niruri on the liver function of UUO mice; among them, A is alanine aminotransferase and B is aspartate aminotransferase.

[0042] Figure 15 It is a graph showing the effect of Phyllanthus niruri on the body weight of DN rats.

[0043] Figure 16 It is a graph showing the effect of Phyllanthus niruri on the renal function of DN rats; among them, A is serum creatinine, B is blood urea nitrogen, and C is 24-hour urinary protein.

[0044] Figure 17 These are the pathological test result diagrams of the kidneys of each group of DN rats. Specific implementation manners

[0045] The present invention will be further described in detail below in conjunction with embodiments and the accompanying drawings, but the implementation manners of the present invention are not limited thereto.

[0046] Example 1 Clinical study on the treatment of hypercreatininemia with Penthorum chinense Pursh

[0047] (1) Subjects: Retrospective analysis was performed on 289 patients who were diagnosed with diabetic kidney disease (DKD), immunoglobulin A nephropathy (IgA) nephropathy, membranous nephropathy, and chronic renal failure and who visited Dongzhimen Hospital of Beijing University of Chinese Medicine from December 2021 to December 2022. The clinical manifestation was elevated serum creatinine. Among them, there were 45 DKD patients, 33 idiopathic membranous nephropathy patients, 119 IgA nephropathy patients, and 92 chronic renal failure patients. There were no significant differences in the gender and age of the patients. According to the test report data and case materials, the general information of the selected patients and the relevant laboratory test data before and after taking the medicine (including serum creatinine, blood urea nitrogen, blood uric acid, eGFR, 24-hour urinary protein quantification) and the safety indexes related to liver function were collected.

[0048] (2) Diagnostic and inclusion criteria:

[0049] For diabetic kidney disease patients:

[0050] Diagnostic criteria: According to the diagnostic criteria for DKD in the "Expert Consensus on the Prevention and Treatment of Diabetic Kidney Disease (2014 Edition)", for ① patients with a clear history of diabetes, and the course of the disease is usually more than 6 - 10 years; ② abnormal urinary albumin (rechecked within 3 - 6 months, 2 times or more out of 3 results) > 20 μg / min (or > 30 mg / 24 h), or even overt proteinuria (> 500 mg / 24 h), or having the clinical characteristics of nephrotic syndrome; often accompanied by hypertension, and microaneurysms can be found in the fundus. The following situations need to exclude other kidney diseases, and renal puncture biopsy is necessary to clarify the diagnosis when necessary: ① patients with type 1 diabetes for less than 10 years and presenting proteinuria; ② patients with rapid deterioration of renal function without obvious inducement; ③ patients without diabetic retinopathy; ④ patients with obvious hematuria.

[0051] Inclusion criteria: ① Aged 30 - 80 years old, regardless of gender; ② Having received renal puncture biopsy within 6 months, and the pathological result is considered DKD; or not having undergone renal puncture biopsy, but the clinical manifestation conforms to DKD; ③ Hypercreatininemia: > 106 μmol / L for males; > 97 μmol / L for females.

[0052] For IgA nephropathy patients:

[0053] Diagnostic criteria: According to the diagnostic criteria in the textbook "Nephrology", the pathological diagnosis of IgA nephropathy was confirmed by renal biopsy.

[0054] Inclusion criteria: ① No restrictions on gender and age; ② Patients with a definite diagnosis of IgA nephropathy by renal biopsy; ③ Hypercreatininemia: > 106 μmol / L in males; > 97 μmol / L in females. Patients with isolated microscopic hematuria and 24-hour urinary protein quantification ≤ 0.15 g, and those with severe lesions in other organs such as the heart and brain are not included in the inclusion criteria.

[0055] Patients with idiopathic membranous nephropathy:

[0056] Diagnostic criteria: The pathological diagnostic criteria for idiopathic membranous nephropathy refer to the national renal biopsy pathological diagnostic criteria in 2001. The diagnosis is mainly based on the light microscopy, fluorescence, and electron microscopy findings of renal pathology, and combined with clinical PLA2R antibody detection to distinguish idiopathic membranous nephropathy from secondary membranous nephropathy.

[0057] Inclusion criteria: The renal tissue pathological examination diagnoses membranous nephropathy, with no restrictions on gender and age; with or without hypercreatininemia. Clinically exclude secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B virus, tumors, and drugs; secondary membranous syndrome patients with rheumatic diseases, renal amyloidosis, tumor-related renal damage, etc. Those with a history of tumors, severe underlying diseases such as respiratory, hematological, and cardiovascular system diseases, and those with a history of mental diseases are not included in the inclusion criteria.

[0058] Patients with chronic renal failure:

[0059] Diagnostic criteria: Adopt the "Definition and Staging of Chronic Kidney Disease" in the KDOQI (2002) Clinical Practice Guidelines for Chronic Kidney Disease issued by the United States as the diagnostic criteria, and refer to the staging criteria in the "Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Chronic Renal Failure" (2015 edition) proposed by the Professional Committee of Kidney Diseases of the Chinese Association of Integrated Traditional Chinese and Western Medicine. The early stage of chronic renal failure corresponds to CKD stage 3, the middle stage corresponds to CKD stage 4, and the late stage corresponds to CKD stage 5.

[0060] Inclusion criteria: Meet the diagnostic and staging criteria for chronic renal failure; the patient's age is between 18 and 80 years old, with no gender restrictions; with or without hypercreatininemia. Patients with severe heart, lung, liver, and hematopoietic system diseases; pregnant or lactating women; psychiatric patients; patients with allergic constitution or multiple drug allergies are not included in the inclusion criteria.

[0061] (3) Methods and Treatments: A self - controlled before - and - after study was conducted, divided into Group A (50 g of Penthorum chinense Pursh) and Group B (Huangkui Capsules). In Group A, before the treatment with Penthorum chinense Pursh, Western medicine basic treatment was adopted. The Western medicine basic treatment mainly included symptomatic treatment plans for diabetic nephropathy, IgA nephropathy, membranous nephropathy, and chronic renal failure. The treatment with Penthorum chinense Pursh was Western medicine basic treatment plus 50 g of Penthorum chinense Pursh per dose. Penthorum chinense Pursh was decocted in water (sufficient pieces of the herbal medicine were soaked in water for 30 minutes and then decocted twice, 30 minutes each time, filtered, and the filtrates were combined to obtain the decoction), 3 doses per day, taken separately after breakfast, lunch, and dinner. 28 days was one course of treatment, and 6 courses were taken continuously. In Group B, before the treatment with Huangkui Capsules, Western medicine basic treatment was adopted. The Western medicine basic treatment mainly included symptomatic treatment plans for diabetic nephropathy, IgA nephropathy, membranous nephropathy, and chronic renal failure. The treatment with Huangkui Capsules was Western medicine basic treatment plus Huangkui Capsules, taken according to the drug instruction manual.

[0062] (4) Main Observation Indicators

[0063] Efficacy indicators: Record serum creatinine (Scr), glomerular filtration rate, blood urea nitrogen (BUN), blood uric acid (UA), and 24 - hour urinary protein quantification (24h - UTP) in the clinical biochemical test (automatic biochemical analyzer) indicators; Glomerular filtration formula: eGFR = 170×(Scr)^(-1.234)×(age)^(-0.179)×(0.79 for female / 1 for male).

[0064] Safety indicators: Liver function (alanine aminotransferase, aspartate aminotransferase).

[0065] (5) Statistical Methods

[0066] Statistical analysis was performed using SPSS 20.0. Paired - sample t - test or non - parametric test was used before and after clinical treatment. P < 0.05 indicates statistical significance.

[0067] (6) Results

[0068] 1) Comparison of Efficacy Indicators

[0069] A. Comparison of the efficacy of diabetic nephropathy patients before and after treatment

[0070] ① Changes in serum creatinine levels of diabetic nephropathy patients before and after treatment

[0071] The self - controlled before - and - after treatment of diabetic nephropathy patients with Penthorum chinense Pursh is shown in Table 1 and Figure 1As shown, at 12 weeks of medication, the difference in Scr was statistically significant (p < 0.01). After 24 weeks of medication, compared with week 0, the Scr level in group A decreased significantly (p < 0.01). After medication in group B, the serum creatinine level of the patients showed a downward trend, but it was not statistically significant (p > 0.05). It can be seen that Qianhuangcao can effectively reduce the serum creatinine level of diabetic nephropathy patients, and the therapeutic effect is better than Huangkui Capsule.

[0072] Table 1 Effects of Qianhuangcao on Serum Creatinine in DKD Patients

[0073]

[0074] Note: * indicates p < 0.05 compared with before medication (week 0) in each group; ** indicates p < 0.01 compared with before medication (week 0) in each group.

[0075] ② Changes in renal function of diabetic nephropathy patients before and after treatment

[0076] By comparing the renal function levels of the patients before and after detection, the results are shown in Table 2: After 24 weeks of taking Qianhuangcao in group A, compared with week 0, uric acid (p < 0.05) and 24-hour urinary protein (p < 0.01) decreased significantly, glomerular filtration increased (p < 0.01), and blood urea nitrogen showed no obvious change (p > 0.05), indicating improved renal function. After medication in group B, the 24-hour urinary protein of the patients decreased significantly (p < 0.01), and the renal function-related indicators (uric acid, blood urea nitrogen, and glomerular filtration) showed an improving trend, but it was not statistically significant (p > 0.05). It can be seen that Qianhuangcao can effectively improve the renal function of diabetic nephropathy patients and is superior to Huangkui Capsule in reducing uric acid and improving glomerular filtration.

[0077] Table 2 Effects of Qianhuangcao on Renal Function in DKD Patients

[0078]

[0079] Note: *: p < 0.05 compared with before medication (week 0) in each group; **: p < 0.01 compared with before medication (week 0) in each group.

[0080] ③ Blood glucose levels of diabetic nephropathy patients before and after treatment

[0081] Glycated hemoglobin (HbA1c) is the product of the combination of hemoglobin in red blood cells and sugars in serum, reflecting the blood glucose level in the recent 2-3 months. It is the "gold standard" for evaluating long-term blood glucose control. As shown in Table 3: In group A, compared with 0 weeks of medication, after taking Phyllanthus sutchuenensis for 24 weeks, the glycated hemoglobin and fasting blood glucose levels can be effectively improved, and the differences are statistically significant (p < 0.01; p < 0.01); in group B, after 24 weeks of medication, there were no significant differences in HbA1c and FGB levels compared with 0 weeks. The results indicate that Phyllanthus sutchuenensis can significantly improve the blood glucose control level, and its effect is better than that of Huangkui Capsule.

[0082] Table 3 Effects of Phyllanthus sutchuenensis on glycated hemoglobin in diabetic patients

[0083]

[0084] Note: HbA1c (%) is glycated hemoglobin, and FGB is fasting blood glucose. *: Compared with before medication (0 weeks) in each group, p < 0.05; **: Compared with before medication (0 weeks) in each group, p < 0.01.

[0085] ④ Safety of diabetic nephropathy patients before and after treatment

[0086] The levels of liver function (alanine aminotransferase and aspartate aminotransferase) of the patients were detected and compared before and after. As shown in Table 4: In group A, compared with 0 weeks, after taking Phyllanthus sutchuenensis for 24 weeks, alanine aminotransferase and transaminase decreased significantly (p < 0.05; p < 0.01), and the differences were statistically significant. In group B, compared with 0 weeks, after 24 weeks of medication, there was no obvious change in the liver function of the patients (p > 0.05), indicating that Phyllanthus sutchuenensis has certain safety in the treatment of diabetic nephropathy.

[0087] Table 4 Effects of Phyllanthus sutchuenensis on liver function in DKD patients

[0088]

[0089] Note: ALT is alanine aminotransferase, and AST represents aspartate aminotransferase. *: Compared with before medication (0 weeks) in each group, p < 0.05; **: Compared with before medication (0 weeks) in each group, p < 0.01.

[0090] B. Comparison of curative effects of IgA nephropathy patients before and after treatment

[0091] ① Changes in serum creatinine of IgA patients before and after treatment

[0092] The self-control before and after treatment of IgA patients with Phyllanthus sutchuenensis is shown in Table 5 and Figure 2As shown: In Group A, compared with week 0, after 12 weeks of using Penthorum chinense Pursh, there was a statistically significant difference in Scr (p < 0.01), and after 24 weeks of medication, the Scr level decreased significantly (p < 0.01); in Group B, compared with week 0, after medication, there was no significant decrease in the serum creatinine level of IgA nephropathy patients (p > 0.05). It can be seen that Penthorum chinense Pursh can effectively reduce the serum creatinine level of IgA patients, and the treatment effect is better than that of Huangkui Capsule.

[0093] Table 5 Effects of Penthorum chinense Pursh on Serum Creatinine in IgA Patients

[0094]

[0095] Note: *: Compared with before medication (week 0) in each group, p < 0.05; **: Compared with before medication (week 0) in each group, p < 0.01.

[0096] ② Changes in Renal Function of IgA Patients before and after Treatment

[0097] The results of comparing the renal function levels of patients before and after detection are shown in Table 6: In Group A, after 24 weeks of using Penthorum chinense Pursh, compared with week 0, uric acid (p < 0.01) and 24-hour urinary protein (p < 0.01) decreased significantly, glomerular filtration increased (p < 0.01), and blood urea nitrogen had no obvious change (p > 0.05), and renal function improved; in Group B, after medication, 24-hour urinary protein of patients decreased significantly (p < 0.01), and there was a tendency for improvement in uric acid and glomerular filtration, but there was no statistical significance (p > 0.05). It can be seen that Penthorum chinense Pursh can effectively reduce uric acid and 24-hour urinary protein in IgA patients and improve the glomerular filtration rate, and has a better effect on protecting renal function.

[0098] Table 6 Effects of Penthorum chinense Pursh on Renal Function of IgA Patients

[0099]

[0100] Note: *: Compared with before medication (week 0) in each group, p < 0.05; **: Compared with before medication (week 0) in each group, p < 0.01.

[0101] ③ Safety of IgA Patients before and after Treatment

[0102] The results of comparing the liver function levels of patients before and after detection are shown in Table 7: In Group A, compared with week 0, after 24 weeks of using Penthorum chinense Pursh, alanine aminotransferase and transaminase decreased significantly (p < 0.05; p < 0.01), and the difference was statistically significant; after 24 weeks of medication in Group B, compared with week 0, there was no obvious change in the liver function of patients (p > 0.05), indicating that treating IgA patients with Penthorum chinense Pursh can improve the liver function of patients and has a certain safety.

[0103] Table 7 Effects of Phyllanthus confertus on liver function in IgA patients

[0104]

[0105]

[0106] Note: ALT is alanine aminotransferase, and AST is aspartate aminotransferase. *: Compared with before treatment (0 week) in each group, p < 0.05; **: Compared with before treatment (0 week) in each group, p < 0.01.

[0107] C. Comparison of curative effects before and after treatment in patients with idiopathic membranous nephropathy

[0108] ① Changes in serum creatinine in patients with idiopathic membranous nephropathy before and after treatment

[0109] In the self - control before and after treatment of IgA patients with Phyllanthus confertus, the results are shown in Table 8 and Figure 3 as follows: In group A, compared with 0 week, at 12 weeks of medication, the difference in Scr was statistically significant (p < 0.01), and after 24 weeks of medication, the Scr level continued to decrease (p < 0.05); in group B, compared with 0 week, there was no significant improvement in the serum creatinine level of patients after medication (p > 0.05). It can be seen that Phyllanthus confertus can effectively reduce the serum creatinine level in IgA patients, with a lasting therapeutic effect, which is superior to Huangkui Capsule.

[0110] Table 8 Effects of Phyllanthus confertus on serum creatinine in patients with idiopathic membranous nephropathy

[0111]

[0112] Note: *: Compared with before treatment (0 week) in each group, p < 0.05; **: Compared with before treatment (0 week) in each group, p < 0.01.

[0113] ② Changes in renal function in patients with idiopathic membranous nephropathy before and after treatment

[0114] The results of the pre - and post - treatment comparison of the renal function level of patients are shown in Table 9: In group A, after 24 weeks of taking Phyllanthus confertus, the levels of blood urea nitrogen (p < 0.01), uric acid (p < 0.05), and 24 - hour urinary protein (p < 0.01) decreased, and the glomerular filtration rate increased (p < 0.01), indicating an improvement in renal function; in group B, compared with 0 week, after medication, the 24 - hour urinary protein of patients decreased effectively (p < 0.01), and there was a tendency of renal function improvement, but it was not statistically significant (p > 0.05). It can be seen that Phyllanthus confertus can effectively improve the renal function of patients with idiopathic membranous nephropathy.

[0115] Table 9 Effects of Phyllanthus confertus on renal function in patients with idiopathic membranous nephropathy

[0116]

[0117] Note: *: Compared with before treatment (0 week) in each group, p < 0.05; **: Compared with before treatment (0 week) in each group, p < 0.01.

[0118] ③ Safety of patients with idiopathic membranous nephropathy before and after treatment

[0119] The liver function levels of patients with idiopathic membranous nephropathy were measured before and after treatment, and the results are shown in Table 10: In group A, after 24 weeks of using Phyllanthus niruri, the levels of alanine aminotransferase and aspartate aminotransferase decreased, but the difference was not statistically significant (p > 0.05); in group B, compared with week 0, there was no significant change in the liver function of patients after 24 weeks of medication (p > 0.05). The results indicate that Phyllanthus niruri has no liver function damage in the treatment of patients with idiopathic membranous nephropathy and has a certain degree of safety.

[0120] Table 10 Effects of Phyllanthus niruri on liver function in patients with idiopathic membranous nephropathy

[0121]

[0122] Note: ALT is alanine aminotransferase, and AST represents aspartate aminotransferase.

[0123] D. Comparison of curative effects of patients with chronic renal failure before and after treatment

[0124] ① Changes in serum creatinine of patients with chronic renal failure before and after treatment

[0125] The self - control before and after treatment of patients with chronic renal failure by Phyllanthus niruri showed that the results are shown in Table 11 and Figure 4 as follows: In group A, compared with week 0, at 12 weeks of using Phyllanthus niruri, the difference in Scr was statistically significant (p < 0.01), and the Scr level continued to decrease after 24 weeks of medication (p < 0.05); in group B, compared with week 0, at 12 weeks after medication in group B, the Scr level decreased significantly, and the difference was statistically significant (p < 0.05), and at 24 weeks, the serum creatinine level of the patients decreased but there was no significant difference (p > 0.05). It can be seen that Phyllanthus niruri can effectively reduce the serum creatinine level of patients with chronic renal failure, and the treatment effect is persistent, which is better than Huangkui Capsule.

[0126] Table 11 Effects of Phyllanthus niruri on serum creatinine in patients with chronic renal failure

[0127]

[0128] Note: *: Compared with before treatment (0 week) in each group, p < 0.05; **: Compared with before treatment (0 week) in each group, p < 0.01.

[0129] ② Changes in renal function of patients with chronic renal failure before and after treatment

[0130] The renal function levels of the patients were measured before and after treatment, and the results are shown in Table 12: In group A, compared with week 0, after 24 weeks of using Penthorum chinense Pursh, uric acid (p < 0.05) and 24-hour urinary protein (p < 0.05) were significantly decreased, glomerular filtration was increased (p < 0.01), and blood urea nitrogen showed no significant change (p > 0.05), indicating improved renal function; after treatment in group B, there was a tendency for the renal function of the patients to improve, but it was not statistically significant (p > 0.05). It can be seen that Penthorum chinense Pursh can effectively improve the renal function of patients with chronic renal failure.

[0131] Table 12 Effects of Penthorum chinense Pursh on renal function of patients with chronic renal failure

[0132]

[0133] Note: *: Compared with before treatment (week 0) in each group, p < 0.05; **: Compared with before treatment (week 0) in each group, p < 0.01.

[0134] ③ Safety of patients with chronic renal failure before and after treatment

[0135] The liver function levels of patients with chronic renal failure were measured before and after treatment, and the results are shown in Table 13: In group A, after 24 weeks of using Penthorum chinense Pursh, the levels of alanine aminotransferase and aspartate aminotransferase decreased compared with week 0, but there was no significant difference; in group B, after 24 weeks of treatment, there was no significant change in the liver function of the patients compared with week 0 (p > 0.05). The results indicate that both Penthorum chinense Pursh and Huangkui Capsule have certain safety in the treatment of chronic renal failure.

[0136] Table 13 Effects of Penthorum chinense Pursh on liver function of patients with chronic renal failure

[0137]

[0138] Note: ALT is alanine aminotransferase, and AST represents aspartate aminotransferase.

[0139] Example 2 Pharmacodynamic experiment of water extract of Penthorum chinense Pursh in treating hypercreatinine in mice with chronic renal failure

[0140] Unilateral ureteral obstruction (UUO) surgery is a classic model of chronic kidney disease, which is easy to form a membrane and has stable lesions. Its principle is that after ureteral obstruction, urine retention compresses the renal tubules, leading to progressive necrosis of renal tubular epithelial cells, infiltration of inflammatory cells, and gradual replacement by scar tissue, ultimately resulting in renal interstitial fibrosis. The main symptoms are progressive decline in renal function and gradual decrease in glomerular filtration. Therefore, in this example, the UUO method was used to induce an experimental model of chronic renal failure to investigate the therapeutic effect of the water extract of Penthorum chinense Pursh in delaying chronic kidney disease and study its mechanism of action.

[0141] 1. Experimental materials

[0142] (1) Experimental animals

[0143] 72 male C57BL / 6N mice at 4 weeks of age with a body weight of 20 ± 2 g were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. (license number: SCXK (Beijing) 2016-0006). They were raised in the barrier environment experimental animal center of Dongzhimen Hospital, Beijing University of Chinese Medicine, and the experimental operation procedures were carried out according to the guidelines formulated by the barrier environment experimental animal center of Dongzhimen Hospital, Beijing University of Chinese Medicine.

[0144] (2) Drugs and reagents

[0145] The cut pieces of Penthorum chinense Pursh were provided by the Pharmacy Department of Dongzhimen Hospital, Beijing University of Chinese Medicine.

[0146] 2. Experimental methods

[0147] (1) Preparation of traditional Chinese medicine formula

[0148] 1) 50 g of cut pieces of Penthorum chinense Pursh were chopped, added with water according to the ratio of material to liquid of 1:3 (g / mL), soaked for 30 min, and decocted for 30 - 40 min to obtain the medicinal liquid and the medicinal residues.

[0149] 2) The medicinal residues were decocted twice according to the steps of adding water and decocting in step 1). The medicinal liquids obtained from step 1) and the aforementioned repeated decoction steps were combined to obtain the experimental medicinal liquid.

[0150] (2) Establishment of animal model:

[0151] C57BL / 6N mice were selected. After 1 week of adaptive feeding, they were fasted overnight for 6 hours with free access to water during this process. On the next day, the mice were anesthetized by intraperitoneal injection of 5% chloral hydrate, their four limbs were fixed with tape, their skin was prepared, and routine disinfection was carried out. The abdominal wall was incised at about 0.5 cm to the left of the midline between the pubic symphysis and the upper abdomen. The tissues were gradually separated to expose the left ureter of the mice. The ureter was ligated doubly with 3.0 silk thread at about 0.3 cm from the bladder entrance of the ureter, and it was cut short. The muscle layer and the abdominal wall were sutured layer by layer, and the suture site was cleaned with 75% alcohol. In the sham operation group, the abdomen was opened without ligation, and the rest was the same as the model group. One week after the model preparation was completed, when the mice were in stable condition, drugs were administered according to different groups. During the experiment, the mice had free access to water and were fasted.

[0152] (3) Experimental grouping and drug administration

[0153] Eight mice from the sham operation group were selected as the control group (mice with normal creatinine in routine feeding), and the successfully modeled mice were randomly divided into a model group and a Phyllanthus niruri group, with 8 mice in each group. The sham operation group was not intervened, and the model group and the sham operation group were given equal amounts of normal saline by gavage. The Phyllanthus niruri group was given 6.42 mL of water extract of Phyllanthus niruri -1 ·kg -1 ·d -1 , equivalent to 6.42 g of crude drug -1 ·kg -1 ·d -1 , and the drug administration was continued for 1 - 3 weeks after the model was established; once a day, samples were taken in batches every week.

[0154] (4) Detection methods

[0155] 1) General condition observation

[0156] The general state of the mice, including the mental state, food intake, water intake, urine output, feces output, body weight, body hair, and activity of the mice. General symptoms were continuously observed after drug administration to check whether the animals showed abnormal symptoms.

[0157] 2) Index monitoring

[0158] After the model was successfully established, the mice were fasted overnight without water restriction 3 weeks after drug administration. Blood was taken from the eyeballs, and urine was collected in a metabolic cage. ELISA method was used to detect serum creatinine, blood urea nitrogen, alanine aminotransferase, and aspartate aminotransferase in mice of each group.

[0159] (5) Statistical methods

[0160] Two independent sample t-tests were used for animal experiments. P < 0.05 indicated statistical significance, and P < 0.01 indicated significant differences.

[0161] 3. Results

[0162] (1) General condition observation

[0163] During the experiment, the mice in the control group were active, with normal diet and water intake, bright eyes, shiny fur, rosy and bright tails, gradually increasing body weight, normal urine and feces output, no symptoms of emaciation or abdominal distension, and good mental state. The food intake of the mice in the model group did not change significantly. They began to show fluffy, erected, messy and dull fur, listless spirits, preferred to lie down and were averse to moving, and were accompanied by biting and hair loss to varying degrees. Due to ureteral obstruction and kidney injury, their body weight decreased. In the third week, the body weight increased slightly but was still lower than that of the control group, probably because the model had developed from the acute phase to the chronic phase. After continuous observation after administration, it was found that the body weight of the mice increased, the fur was slightly messy, and the spirit gradually improved. The changes in body weight, kidney weight, and kidney weight index before and after the administration of Penthorum chinense were shown in Tables 14 - 15, Figures 5 - 8 as shown below.

[0164] Table 14 Effects of Penthorum chinense on the body weight (g) of UUO mice

[0165]

[0166] Note: ## : Compared with the control group, p < 0.01; *: Compared with the model group, p < 0.05.

[0167] Table 15 Effects of Penthorum chinense on the kidney weight ratio (healthy side / body weight) of UUO mice

[0168]

[0169] Note: ## : Compared with the control group, p < 0.01; *: Compared with the model group, p < 0.05.

[0170] (2) Renal function level of mice

[0171] Serum creatinine level is the gold standard for diagnosing chronic renal failure and has important value for evaluating the degree of tubulointerstitial damage; while the metabolism of uric acid in the kidney is mainly related to glomerular filtration and tubular reabsorption. As shown in Table 16, Figures 9 - 10 the serum creatinine (Scr) level of the mice in the UUO model group increased significantly compared with the control group (P < 0.01), and the renal function decreased significantly. After treatment with Penthorum chinense, the serum creatinine level decreased significantly, and the elevated serum uric acid level, a renal function-related index in the model group (Table 17, Figures 11 - 12 ) also decreased after treatment with Penthorum chinense (P < 0.01), indicating that Penthorum chinense can improve the renal function of UUO mice.

[0172] Table 16 Effects of Penthorum chinense on the serum creatinine of UUO mice

[0173]

[0174]

[0175] Note: # : Compared with the control group, p < 0.05; ## : Compared with the control group, p < 0.01; * : Compared with the model group, p < 0.05, ** : Compared with the model group, p < 0.01.

[0176] Table 17 Effects of Phyllanthus niruri on serum uric acid in UUO mice

[0177]

[0178] Note: # : Compared with the control group, p < 0.05; * : Compared with the model group, p < 0.05, ** : Compared with the model group, p < 0.01.

[0179] (3) Safety of Phyllanthus niruri in treating hypercreatininemia in chronic renal failure mice

[0180] The blood lipid, cholesterol levels and liver function (alanine aminotransferase, aspartate aminotransferase) levels of mice in each group were detected respectively to evaluate the safety of Phyllanthus niruri in treating chronic renal failure mice. As shown in Table 18, Figure 13 after UUO modeling and after Phyllanthus niruri intervention, there were no significant changes in the blood lipid and total cholesterol of mice (P > 0.05); compared with the control group (Table 19, Figure 14 ), the levels of alanine aminotransferase and aspartate aminotransferase in the model group were significantly increased (P < 0.01; P < 0.01); compared with the model group mice, the liver function was improved after Phyllanthus niruri intervention (P < 0.01; P < 0.05), indicating that Phyllanthus niruri in treating chronic renal failure can protect liver function and has a certain safety.

[0181] Table 18 Effects of Phyllanthus niruri on blood lipid and total cholesterol in UUO mice

[0182]

[0183] Note: TC is serum total cholesterol, and TG represents serum triglyceride.

[0184] Table 19 Effects of Phyllanthus niruri on liver function in UUO mice

[0185]

[0186]

[0187] Note: ALT is alanine aminotransferase, and AST is aspartate aminotransferase. ## : Compared with the control group, p < 0.01; *: Compared with the model group, p < 0.05, **: Compared with the model group, p < 0.01.

[0188] Pharmacodynamic experiment of the water extract of Penthorum chinense Pursh in treating high creatinine in diabetic nephropathy rats in Example 3

[0189] 1. Experimental materials

[0190] (1) Experimental animals

[0191] Male SD rats, 6 - 7 weeks old, weighing 200 ± 20 g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. (License number: SCXK (Beijing) 2016 - 0006). They were housed in the barrier environment experimental animal center of the Key Laboratory of Dongzhimen Hospital, Beijing University of Chinese Medicine. The experimental operation procedures were carried out in accordance with the guidelines formulated by the barrier environment experimental animal center of Dongzhimen Hospital, Beijing University of Chinese Medicine, and were approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine, with the ethics number: 18 - 19.

[0192] (2) Drugs and reagents

[0193] Same as Example 1.

[0194] 2. Experimental methods

[0195] (1) Preparation of traditional Chinese medicine formula

[0196] Same as Example 1.

[0197] (2) Establishment of animal model:

[0198] After the rats were adaptively fed with ordinary feed for 1 week, healthy rats with good condition, normal blood glucose, and negative urine protein quantification experiment were selected and divided into a normal control group of 8 rats and several model - making groups according to the random grouping method.

[0199] After the model group had eaten overnight, they were anesthetized and the back skin was prepared. After routine disinfection with iodophor, a longitudinal incision was made once through the skin and muscle layers 2 cm below the lower rib margin and 1 cm from the midline of the back to fully expose the unilateral kidney. The renal pedicle was ligated, the abdominal cavity was closed, and the incision was sutured layer by layer. After suturing the muscle layer, the suture site was rinsed with penicillin solution and then the cortex was sutured. After the cortex was sutured, it was wiped with an iodophor cotton ball, and then aureomycin ointment was applied. The rats were then placed back in the cage and waited to wake up. Two weeks later, the model group was injected intraperitoneally once in the left lower abdomen with a 1% streptozotocin (STZ) solution (prepared on ice with a 0.1 mol / L citric acid buffer solution at pH 4.4) at a dose of 55 mg / kg, and the control group was injected with an equal amount of citric acid buffer solution. Blood was collected from the tip of the tail 72 hours later, and rats with a random blood glucose concentration ≥ 16.7 mmol / L and a blood glucose level maintained for one week determined by a blood glucose meter were identified as diabetic nephropathy (DN) rat models.

[0200] (3) Experimental grouping and drug administration

[0201] Eight rats in the control group (rats with normal routine feeding and normal serum creatinine) were used, and the successfully modeled mice were randomly divided into a model group, a 30 g perfoliata group, and a 50 g perfoliata group, with 8 rats in each group. The control group was not intervened, and the model group was given an equal amount of normal saline by gavage. The perfoliata groups were given a water extract of perfoliata at a dose of 6.42 mL -1 ·kg -1 ·d -1 , equivalent to 6.42 g of crude drug -1 ·kg -1 ·d -1 , and the drug was administered for 12 weeks after the model was established; once a day.

[0202] (4) Detection methods

[0203] 1) General condition observation

[0204] The general state of the mice, including the mental state, food intake, water intake, urine output, feces output, body weight, body hair, and activity. General symptoms were continuously observed after drug administration to check if the animals showed any abnormal symptoms.

[0205] 2) Index monitoring

[0206] After the model was successfully established, the mice were fasted overnight without water restriction 3 weeks after drug administration. Blood was collected by eye puncture, and urine was collected in a metabolic cage. The serum creatinine, blood urea nitrogen, and total urine protein levels of each group of mice were detected by ELISA method, and the creatinine clearance rate was calculated. Alanine aminotransferase and aspartate aminotransferase were detected as safety evaluation indicators. Intact kidney tissues were collected, dehydrated, embedded, sectioned, and immunohistochemically stained to investigate kidney fibrosis changes.

[0207] (5) Statistical methods

[0208] Animal experiments used the two-independent-sample t-test. A P value < 0.05 indicated statistical significance, and a P value < 0.01 indicated a significant difference.

[0209] 3. Results

[0210] (1) General observation

[0211] During the experiment, the rats in the control group were active, with normal diet and water intake, bright eyes, shiny fur, rosy and bright tails, gradually increasing body weight, normal urine and feces output, no emaciation or abdominal distension symptoms, and good mental state. The food intake of the rats in the model group did not change significantly, and they preferred to lie down and were averse to movement, accompanied by varying degrees of weight loss. After continuous observation after administration, it was found that the body weight of the rats increased and their spirits gradually improved. The changes in body weight before and after the administration of Penthorum chinense Pursh are shown in Table 20, Figure 15 as shown.

[0212] Table 20 Effects of Penthorum chinense Pursh on the body weight (g) of DN rats

[0213]

[0214] Note: ## : p < 0.01 compared with the control group; **: p < 0.01 compared with the model group.

[0215] (2) Renal function level of DN rats

[0216] The serum creatinine level, as well as the levels of blood urea nitrogen and total albumin, were measured in rats of each group to evaluate the renal function of DN. The metabolism in the kidneys is mainly related to glomerular filtration and tubular reabsorption. As shown in Table 21 and Figure 16 as shown, after unilateral nephrectomy combined with STZ injection, the serum creatinine (Scr) level of the rats in the model group increased significantly compared with the control group (P < 0.01), and the renal function decreased significantly. Compared with the model group, after the treatment with Penthorum chinense Pursh, the serum creatinine level decreased significantly (P < 0.01), and the decrease in the serum creatinine level in the 50 g Penthorum chinense Pursh treatment group was more significant. Moreover, the elevated serum urea nitrogen level (P < 0.01) and 24 h urinary protein, which are renal function-related indicators in the model group, also decreased after the treatment with Penthorum chinense Pursh (P < 0.01), indicating that Penthorum chinense Pursh can improve the renal function of DN rats.

[0217] Table 21 Effects of Penthorum chinense Pursh on the renal function of DN rats

[0218]

[0219] Note: ## : p < 0.01 compared with the control group; *: p < 0.05 compared with the model group, **: p < 0.01 compared with the model group.

[0220] (3) Phyllanthus niruri Improves Renal Fibrosis in DN Rats

[0221] The renal pathology of DN rats in each group was detected (see Figure 17 ). The H&E results showed that there were no obvious changes in the renal tissue structure of each group; Masson staining found that compared with the control group, the collagen fibers in the renal tissue of the model group rats were blue-stained, indicating the aggravation of renal fibrosis. After intervention with Phyllanthus niruri, the blue-stained tissue decreased and the renal tissue fibrosis alleviated; further immunohistochemical staining was used to investigate the deposition of collagen fibers in the renal tissue. As Figure 17 shown, compared with the control group, the expressions of fibronectin (FN) and type IV collagen (Col-IV) in the model group were significantly increased. After intervention with Phyllanthus niruri, the deposition of collagen-related proteins decreased. All of the above indicated that Phyllanthus niruri could improve the renal pathological structure of DN rats and relieve renal tissue fibrosis.

[0222] (4) Safety of Phyllanthus niruri in the Treatment of DN Rats

[0223] The levels of alanine aminotransferase and aspartate aminotransferase in rats of each group were detected. As shown in Table 22, among the liver function indexes, the levels of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the model group rats were higher than those in the control group (P < 0.01; P < 0.01), while those were lower than those in the model group after treatment with Phyllanthus niruri. There was no significant difference between the Phyllanthus niruri 30g group and the Phyllanthus niruri 50g group in treatment. It can be seen that Phyllanthus niruri has a certain safety in the treatment of DN rats.

[0224] Table 22 Effects of Phyllanthus niruri on Liver Function in DN Rats

[0225]

[0226] Note: ALT is alanine aminotransferase, and AST represents aspartate aminotransferase. ## : Compared with the control group, p < 0.01; *: Compared with the model group, p < 0.05, **: Compared with the model group, p < 0.01.

[0227] 4. Conclusion

[0228] It can be seen from the experimental results that Penthorum chinense Pursh can reduce the serum creatinine levels in patients with diabetic nephropathy, IgA nephropathy, membranous nephropathy, and chronic renal failure, maintain the therapeutic effect after 24 weeks of treatment with Penthorum chinense Pursh, reduce the serum uric acid and urea nitrogen levels in patients with kidney diseases, and improve the glomerular filtration function, which is superior to Huangkui Capsule, a proprietary Chinese medicine related to the therapeutic principle of clearing heat and promoting diuresis. In different kidney disease model mice, there were obvious increases in blood creatinine levels and decreases in renal function, and the quality of life of the mice decreased significantly. Intervention treatment with Penthorum chinense Pursh can significantly reduce the blood creatinine levels in model mice / rats, protect renal function. The efficacy of Penthorum chinense Pursh at a dose of 30 g or 50 g is comparable, and the curative effect is more significant when the dose of Penthorum chinense Pursh is 50 g. The results show that the water extract of Penthorum chinense Pursh can reduce the blood creatinine levels in kidney diseases, regulate the levels of blood uric acid and urea nitrogen, and has a certain effect of improving glomerular filtration, which provides a basic basis for Penthorum chinense Pursh to treat elevated blood creatinine caused by kidney diseases. Penthorum chinense Pursh is expected to be developed into a new generation of drugs for treating elevated blood creatinine.

[0229] The above embodiments are the preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications made without departing from the spirit and principle of the present invention shall be equivalent replacement methods and are all included in the protection scope of the present invention.

Claims

1. Use of the water extract of Penthorum chinense Pursh as the only active ingredient in the preparation of a medicament for treating hypercreatinemia, characterized in that: The preparation method of the water extract of Penthorum chinense Pursh is as follows: (1) Decoct Penthorum chinense Pursh with water, separate the solid and liquid to obtain the medicinal liquid and the medicinal residues; wherein the amount of water used is calculated according to the ratio of Penthorum chinense Pursh to water, and the solid-liquid ratio is 1:1 - 5 in g / mL; Penthorum chinense Pursh is soaked first and then decocted; the decocting time is 30 - 60 min; (2) Decoct the medicinal residues 0 - 2 times repeatedly, wherein the amount of water used in the repeated decoction is calculated according to the ratio of Penthorum chinense Pursh to water, and the solid-liquid ratio is 1:1 - 5 in g / mL; the time for repeated decoction is 20 - 40 min; (3) Combine the medicinal liquids obtained in step (1) and step (2) to obtain the water extract of Penthorum chinense Pursh.

2. The use according to claim 1, characterized in that: In step (1), the amount of water used is calculated according to the ratio of Penthorum chinense Pursh to water, and the solid-liquid ratio is 1:3 - 4 in g / mL; the soaking time is 20 - 40 min; the decocting time is 30 - 40 min; In step (2), the amount of water used in the repeated decoction is calculated according to the ratio of Penthorum chinense Pursh to water, and the solid-liquid ratio is 1:2 - 3 in g / mL; the time for repeated decoction is 30 min; the number of repeated decoctions is 1 - 2 times.

3. The use according to any one of claims 1 - 2, characterized in that: The dosage form of the medicament is decoction, pill, powder, plaster, pellet, granule, oral liquid, capsule or tablet.

4. The use according to any one of claims 1 - 2, characterized in that: The medicament is an ordinary preparation, sustained-release preparation, controlled-release preparation or targeted preparation.

5. The application according to any one of claims 1 to 2, characterized in that: The hypercreatinemia is the increase of serum creatinine caused by kidney disease.

6. The application according to claim 5, characterized in that: The kidney disease is one of diabetic nephropathy, immunoglobulin A nephropathy, idiopathic membranous nephropathy and chronic renal failure.

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