Compound traditional chinese medicine composition for treating diabetic nephropathy and use thereof

Abstract

Disclosed are a compound traditional Chinese medicine composition for treating diabetic nephropathy, a method for preparing same, and use thereof. The compound traditional Chinese medicine composition is prepared from Astragali Radix, Atractylodis Macrocephalae Rhizoma, Corni Fructus, Cinnamomi Cortex, Psoraleae Fructus, Rehmanniae Radix, Eucommiae Cortex, Achyranthis Bidentatae Radix, and Schisandrae Chinensis Fructus. Marsdenia tenacissima Caulis may also be added to the substance of the compound traditional Chinese medicine composition.

Description

Compound Traditional Chinese Medicine Compositions for the Treatment of Diabetic Nephropathy and Their Applications Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to compound traditional Chinese medicine compositions for treating diabetic nephropathy, natural products and their applications. Background Technology

[0002] Diabetic kidney disease (DKD) refers to the coexistence of diabetes and chronic kidney disease in the absence of other clearly identifiable causes of kidney damage. It is the most common complication of diabetes, affecting approximately 20-40% of diabetic patients. In China, DKD has surpassed glomerulonephritis to become the leading cause of chronic kidney disease (CKD). Currently, there is no specific treatment for DKD. Internationally, treatment primarily focuses on lowering blood sugar, lowering blood pressure, regulating lipids, and controlling protein intake. The American Diabetes Association guidelines recommend combining angiotensin-converting enzyme inhibitors / angiotensin receptor blockers with glycemic control medications as a treatment option to slow CKD progression by controlling proteinuria in DKD patients. However, evidence-based medicine studies have shown that this approach does not significantly reduce the incidence of vascular events and mortality associated with DKD.

[0003] Diabetic nephropathy (DKD) is not explicitly recorded in ancient medical texts. Based on its clinical characteristics, pathogenesis, and prognosis, it can be categorized under Traditional Chinese Medicine (TCM) terms such as "Xiao Ke" (wasting and thirsting disease), "edema," "kidney wasting," "turbid urine," "kidney fatigue," and "urinary retention." Modern TCM considers DKD to belong to the TCM category of "Xiao Ke disease," and has formally named it "Xiao Ke disease nephropathy." The pathogenesis of TCM "Xiao Ke disease nephropathy" is attributed to congenital deficiency, acquired spleen and stomach dysfunction, and improper diet, leading to spleen qi deficiency and the development of Xiao Ke. If left untreated, the spleen qi descends and affects the kidneys, damaging yin and affecting yang, resulting in spleen and kidney yang deficiency. If left untreated or mistreated, the condition continues to progress, leading to the dissipation of yang qi, impaired yang transformation, and abnormal metabolism of qi, blood, and body fluids. The accumulation of pathogenic factors such as blood stasis, damp heat, and phlegm over time generates toxins that lurk in the kidney meridians, ultimately worsening the symptoms and even developing into urinary retention.

[0004] In recent years, numerous clinical trials have demonstrated that Traditional Chinese Medicine (TCM) exhibits unique advantages in improving clinical symptoms of Disturbances-Kidney Disease (DKD), reducing proteinuria, protecting renal function, and slowing the progression of DKD. It demonstrates significant efficacy in the prevention and treatment of DKD across multiple aspects and levels. With the increasing emphasis placed on TCM and chronic diseases by the state, the State Administration of Traditional Chinese Medicine and the Chinese Medical Association have issued several programs, guidelines, and expert consensus statements related to the prevention, treatment, and management of DKD, clarifying the etiology, pathogenesis, diagnosis, treatment, and biochemical indicators for improvement in DKD.

[0005] According to the "Guidelines for the Prevention and Treatment of Diabetic Nephropathy in China (2021 Edition)" and the "Technical Guidelines for Clinical Research of New Traditional Chinese Medicine Drugs for Diabetic Kidney Disease" issued by the National Medical Products Administration, recommended biological evaluation indicators related to the improvement of diabetic kidney disease include the uninary albumin / creatinine ratio (UACR), 24-hour urinary protein excretion rate, and eGFR. The guidelines indicate that clinically, the 24-hour urinary albumin excretion rate (UAER) and UACR have comparable diagnostic value for diabetic kidney disease (DKD). The "Guidelines for the Prevention and Treatment of Diabetic Nephropathy with Traditional Chinese Medicine" issued by the Chinese Association of Traditional Chinese Medicine in 2011 clearly states that serum creatinine, blood urea / blood urea nitrogen (Urea / BUN), and other blood biochemical indicators play an important role in the diagnosis and treatment of diabetic kidney disease, helping to assess renal function and monitor disease progression. Furthermore, Traditional Chinese Medicine (TCM) believes that diabetes mellitus and nephropathy lead to imbalances in the metabolism of Qi, blood, and body fluids, resulting in abnormal Qi and blood circulation, impaired body fluid metabolism, and abnormal metabolism and distribution of lipids. This leads to the accumulation of phlegm, Qi stagnation, and blood stasis, with phlegm and blood stasis congealing in the blood vessels, causing stagnation and obstruction, thus contributing to the disease. The abnormal metabolism of lipids is similar to the modern medical concept of dyslipidemia. Therefore, modern physicians consider dyslipidemia to fall under the TCM categories of "phlegm turbidity, impure blood, and blood stasis." Related studies have also confirmed a correlation between certain blood lipid indicators and the urinary protein excretion rate (UAER), suggesting a close relationship between diabetic nephropathy and dyslipidemia, with dyslipidemia potentially promoting the development of diabetic nephropathy and leading to proteinuria. Summary of the Invention

[0006] The first technical objective of this invention is to provide a traditional Chinese medicine composition 1 for treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis. This composition can significantly improve the main clinical symptoms of diabetic nephropathy, significantly reduce the metabolism of microalbumin in urine in diabetic nephropathy, protect renal function, effectively prevent or delay the progression of diabetic nephropathy, and has no obvious adverse reactions, showing good safety. It is an effective traditional Chinese medicine composition for treating diabetic nephropathy.

[0007] The technical objective of this invention is achieved through the following technical solution: a traditional Chinese medicine composition 1 for treating diabetic nephropathy, made from the following components in parts by weight:

[0008] Astragalus membranaceus 15-65 parts, Atractylodes macrocephala 15-45 parts, Cornus officinalis 15-45 parts, Cinnamomum cassia 10-30 parts, Psoralea corylifolia 10-35 parts, Rehmannia glutinosa 15-45 parts, Eucommia ulmoides 15-45 parts, Achyranthes bidentata 10-35 parts, Schisandra chinensis 10-35 parts.

[0009] Furthermore, the traditional Chinese medicine composition 1 is made from the following components in parts by weight: 30 parts of Astragalus membranaceus, 20 parts of Atractylodes macrocephala, 20 parts of Cornus officinalis, 10 parts of Cinnamomum cassia, 15 parts of Psoralea corylifolia, 20 parts of Rehmannia glutinosa, 20 parts of Eucommia ulmoides, 15 parts of Achyranthes bidentata, and 15 parts of Schisandra chinensis.

[0010] The preparation method of the traditional Chinese medicine composition 1: Take 9 kinds of medicinal materials including Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis according to the above parts by weight, and perform extraction by the water extraction method. Add water with a volume 8 - 12 times the weight of the medicinal materials, and soak them in advance for 30 - 60 minutes; after soaking, put the medicinal materials into a frying pan for decoction. The first decoction of the medicinal materials is 30 - 60 minutes, filter and extract the medicinal liquid, the second decoction is 30 - 60 minutes, add water with a volume 5 - 8 times the weight of the medicinal materials, filter and extract the medicinal liquid; mix the two filtered medicinal liquids and put them into a rotary evaporator for rotary evaporation; after concentration, it is obtained.

[0011] Furthermore, the specific preparation method of the traditional Chinese medicine composition 1 is: Take 9 kinds of medicinal materials including Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis according to the above weights, and perform extraction by the water extraction method. Add water with a volume 10 times the weight of the medicinal materials, and soak them in advance for 30 minutes; after soaking, put the medicinal materials into a frying pan for decoction. The first decoction of the medicinal materials is 40 minutes (add water with a volume 10 times the weight of the medicinal materials for the first decoction), filter and extract the medicinal liquid, the second decoction is 30 minutes, add water with a volume 5 times the weight of the medicinal materials, filter and extract the medicinal liquid; mix the two filtered medicinal liquids and put them into a rotary evaporator for rotary evaporation; after concentration, it is obtained.

[0012] The application of the traditional Chinese medicine composition 1 in the preparation of drugs for treating diabetic kidney disease.

[0013] The second technical object of the present invention is to provide a natural product, Tenacissoside H. Tenacissoside H is a natural product extracted from the traditional Chinese medicine Marsdenia tenacissima, and has the structure of formula Ι, CAS No.: 191729 - 45 - 0. The application of Tenacissoside H in the preparation of drugs for treating diabetic kidney disease.

[0014] Marsdenia tenacissima is a plant widely used in traditional Chinese medicine. Its dried vine stems are used to treat various diseases and are considered to have the effects of promoting blood circulation to remove stasis and dredging the channels and collaterals. In traditional Chinese medicine theory, blood stasis blocking the collaterals means that the blood flow in the body is not smooth, resulting in insufficient blood supply to local tissues or organs, thus causing symptoms such as pain and swelling. It can be used for the symptoms of kidney disease caused by blood stasis blocking the collaterals to improve blood circulation.

[0015] The third technical objective of this invention is to provide a traditional Chinese medicine composition 2 for treating diabetic nephropathy. This composition is prepared from Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis, and has the effects of tonifying the spleen and kidneys, invigorating qi and warming yang, clearing heat and promoting body fluid production, and promoting blood circulation and removing blood stasis. It can be used to treat diabetic nephropathy. The technical solution adopted by this invention is: a traditional Chinese medicine composition 2 for treating diabetic nephropathy, made from the following components in parts by weight:

[0016] The herbal composition 2 is made from the following components in parts by weight: Astragalus membranaceus 15-65 parts, Atractylodes macrocephala 15-45 parts, Cornus officinalis 15-45 parts, Cinnamomum cassia 10-30 parts, Psoralea corylifolia 10-35 parts, Rehmannia glutinosa 15-45 parts, Eucommia ulmoides 15-45 parts, Achyranthes bidentata 10-35 parts, Schisandra chinensis 10-35 parts, and Clematis chinensis 10-30 parts. The preparation method of the traditional Chinese medicine composition 2 is as follows: Take 10 medicinal materials according to the above-mentioned weight proportions: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis. Extract them using water extraction, adding 8-12 times the weight of the medicinal materials by volume, and soaking for 30-60 minutes beforehand. After soaking, put the medicinal materials into a decoction pot for decoction. The first decoction is 30-60 minutes, and the decoction is filtered and extracted. The second decoction is 30-60 minutes, adding 5-8 times the weight of the medicinal materials by volume, and filtering and extracting the decoction. Mix the two filtered decoctions and place them in a rotary evaporator for rotary evaporation. After concentration, the final product is obtained.

[0017] Furthermore, the preparation method of the traditional Chinese medicine composition 2 is as follows: Take 10 medicinal materials according to the above weights: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis. Extract them using water extraction, adding water at 10 times the weight of the medicinal materials and soaking for 30 minutes beforehand. After soaking, put the medicinal materials into a decoction pot for decoction. The first decoction is 40 minutes (adding water at 10 times the weight of the medicinal materials), and the decoction is filtered and extracted. The second decoction is 30 minutes, adding water at 5 times the weight of the medicinal materials, and the decoction is filtered and extracted. Mix the two filtered decoctions and place them in a rotary evaporator for rotary evaporation. After concentration, the final product is obtained.

[0018] The application of the traditional Chinese medicine composition 2 in the preparation of a drug for treating diabetic nephropathy.

[0019] In this formula, Astragalus and Atractylodes macrocephala work synergistically to tonify the spleen, replenish qi, promote diuresis, and reduce edema, serving as the principal herbs. Psoralea corylifolia and Cinnamomum cassia tonify kidney yang, assist spleen yang, and warm and transform dampness, serving as the assistant herbs. Eucommia ulmoides, Achyranthes bidentata, Cornus officinalis, and Schisandra chinensis tonify the kidney and replenish essence, ensuring the source of qi and blood production, thus assisting the principal and assistant herbs in tonifying the spleen and warming the kidney. Rehmannia glutinosa clears heat and generates fluids, while Tetrandria baicalensis clears heat and detoxifies, thus mitigating the warming and drying properties of the principal and assistant herbs. This formula primarily tonifies the spleen, promotes diuresis, and reduces edema, while also warming and tonifying kidney yang to assist spleen yang in transforming qi and promoting diuresis. The spleen is the foundation of acquired constitution, transporting and transforming dampness; the kidney is the foundation of innate constitution, storing essence and transforming qi. The innate and acquired constitutions complement each other; kidney yang warms spleen yang, and spleen qi assists in generating kidney essence and qi, working together to promote fluid circulation and alleviate renal edema caused by DKD. This formula is supplemented with kidney-tonifying and essence-replenishing herbs, seeking yang within yin, to assist the principal and assistant herbs in tonifying the spleen and warming the kidneys, preventing malnutrition or protein-energy depletion caused by diabetic kidney disease (DKD). Simultaneously, heat-clearing and fluid-generating herbs are added to mitigate the warming and drying properties of the tonifying herbs and to treat the underlying deficiency and excess pathogenesis of diabetes (Xiao Ke Bing). Based on traditional Chinese medicine theory, this formula combines disease differentiation and syndrome differentiation with modern pharmacological research, and can improve various clinical symptoms in patients with diabetic nephropathy (spleen and kidney yang deficiency syndrome).

[0020] The beneficial effects of the traditional Chinese medicine compositions 1 and 2 of the present invention are: the traditional Chinese medicine compositions of the present invention can significantly reduce urinary albumin, UACR and 24-hour urinary albumin quantification in diabetic nephropathy mice; the traditional Chinese medicine compositions of the present invention can significantly improve the renal pathological changes in diabetic nephropathy mice. Attached Figure Description

[0021] Figure 1 shows the fasting blood glucose levels of mice in the normal control group, the model group, and the treatment groups of traditional Chinese medicine composition 1, Tongguanteng glycoside H, and traditional Chinese medicine composition 2.

[0022] Figure 2 shows the 24-hour urine volume and urinary albumin levels of mice in the normal control group, the model group, and the treatment groups of traditional Chinese medicine composition 1, Tongguanteng glycoside H, and traditional Chinese medicine composition 2.

[0023] Figure 3 shows the UACR and 24-hour urinary albumin excretion rate (UAER) of mice in the normal control group, model group, and treatment groups of traditional Chinese medicine composition 1, Tongguanteng glycoside H, and traditional Chinese medicine composition 2.

[0024] Figure 4 shows the blood urea (UREA) and BUN / crea ratios of mice in the normal control group, model group, and treatment groups of traditional Chinese medicine composition 1, Tongguanteng glycoside H, and traditional Chinese medicine composition 2.

[0025] Figure 5 shows the HE and PAS staining results of kidney tissue sections from mice in different fields of view in the normal control group, model group, and treatment groups of traditional Chinese medicine composition 1, Tongguanteng glycoside H, and traditional Chinese medicine composition 2; the upper figure shows HE staining, and the lower figure shows PAS staining.

[0026] Figure 6 shows the results of the electron microscopic ultrastructure of the kidney tissues in the model group, the traditional Chinese medicine composition 1 treatment group, and the traditional Chinese medicine composition 2 treatment group.

[0027] Figure 7 shows the ALT values of mice in the normal control group, the model group, and the traditional Chinese medicine composition 1, tylophorine H, and traditional Chinese medicine composition 2 treatment groups.

[0028] Figure 8 shows the TG, TCHO, and LDL-C values of mice in the normal control group, the model group, and the traditional Chinese medicine composition 1, tylophorine H, and traditional Chinese medicine composition 2 treatment groups. Specific embodiments

[0029] The present invention will be further described in detail below in conjunction with specific embodiments. The provided examples are only for illustrating the present invention and not for limiting the scope of the present invention.

[0030] Unless otherwise specified, the experimental methods used in the following embodiments are all conventional methods. The materials, reagents, etc. used in the following embodiments can be obtained from commercial channels unless otherwise specified.

[0031] Example 1

[0032] Animal study on the treatment of diabetic kidney disease by traditional Chinese medicine composition 1, tylophorine H, and traditional Chinese medicine composition 2

[0033] 1. Research materials and methods

[0034] 1.1 Materials

[0035] 1.1.1 Animals

[0036] Twenty-eight 5-week-old male db / db mice (spontaneous type 2 diabetic mice with leptin receptor deficiency, developing diabetic kidney disease complications at 8 - 12 weeks) and seven male heterozygous db / m mice (controls) were purchased from Jiangsu Jicui Yakang Biotechnology Co., Ltd. The experimental animal production license number: SCXK (Su) 2023 - 00Q9. The experimental animals were housed in the Experimental Animal Center of Hefei University of Technology. The experimental animal ethics number: HFUT20240423001. The indoor temperature was about 25°C, the humidity was about 45%, and the 12h light / 12h dark circadian rhythm was maintained. They were fed with ordinary feed and had free access to water.

[0037] 1.1.2 Drugs and reagents

[0038] Tongguan ginsenoside H (MedChemExpress) (Catalog No.: HY-N0670); blood glucose (Zhijia blood glucose meter, Wenyue blood glucose test strips), serum creatinine (Scr) (Meikang Biotechnology Co., Ltd., Catalog No.: H105), blood urea (Crea) (Meikang Biotechnology Co., Ltd., Catalog No.: H106W), urine albumin (UA) (Meikang Biotechnology Co., Ltd., Catalog No.: H107), triglycerides (TG) (Meikang Biotechnology Co., Ltd., Catalog No.: H201), low-density lipoprotein cholesterol (LDLC) (Meikang Biotechnology Co., Ltd., Catalog No.: H207), renal pathology HE staining (purchased from Beijing Solarbio Technology Co., Ltd., Catalog No.: G1120), renal pathology PAS staining (purchased from Beijing Solarbio Technology Co., Ltd., Catalog No.: G1281), electron microscopy staining (Anhui Xinle Biotechnology Co., Ltd.); ordinary feed, Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd. (Catalog No.: 1010009).

[0039] 1.1.3 Preparation methods of traditional Chinese medicine compositions 1 and 2

[0040] Traditional Chinese medicine composition 1: Astragalus membranaceus 62.4g, Atractylodes macrocephala 41.6g, Cornus officinalis 41.6g, Cinnamomum cassia 20.8g, Psoralea corylifolia 31.2g, Rehmannia glutinosa 41.6g, Eucommia ulmoides 41.6g, Achyranthes bidentata 31.2g, Schisandra chinensis 31.2g;

[0041] Take the following nine medicinal materials according to the above weights: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis. Extract them using the water extraction method. Add water at 10 times the weight of the medicinal materials and soak for 30 minutes beforehand. After soaking, decoct the medicinal materials in a pot. The first decoction is 40 minutes (add water at 10 times the weight of the medicinal materials), filter and extract the liquid. The second decoction is about 30 minutes, adding water at 5 times the weight of the medicinal materials, filter and extract the liquid. Combine the two filtered liquids and place them in a rotary evaporator for rotary evaporation. Evaporate until the concentration of the concentrated medicinal materials is 1.43 g / mL.

[0042] Chinese herbal composition 2: Astragalus membranaceus 62.4g, Atractylodes macrocephala 41.6g, Cornus officinalis 41.6g, Cinnamomum cassia 20.8g, Psoralea corylifolia 31.2g, Rehmannia glutinosa 41.6g, Eucommia ulmoides 41.6g, Achyranthes bidentata 31.2g, Schisandra chinensis 31.2g, and Clematis chinensis 20.8g;

[0043] Take the following 10 medicinal herbs according to the above weights: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis. Extract them using the water extraction method. Add water at 10 times the weight of the herbs and soak for 30 minutes beforehand. After soaking, decoct the herbs in a pot. The first decoction is 40 minutes (add water at 10 times the weight of the herbs), and the decoction is filtered. The second decoction is about 30 minutes, adding water at 5 times the weight of the herbs, and the decoction is filtered again. Combine the two filtered decoctions and evaporate them in a rotary evaporator until the concentration of the concentrated herbs is 1.52 g / mL.

[0044] 1.2 Experimental grouping and drug administration

[0045] After 5 weeks of acclimatization with a standard diet, 10-week-old mice were randomly sampled for urinary albumin and protein levels. Compared to db / m mice, db / db mice showed significantly higher levels of urinary albumin and protein. Subsequently, db / db mice were randomly divided into four groups: a model group, a traditional Chinese medicine composition group 1, a Tongguanteng glycoside H group, and a traditional Chinese medicine composition group 2, with seven mice in each group. Seven db / m mice of the same age served as a normal control group. The drug concentrations were as follows: Traditional Chinese medicine composition group 1 (based on 1 / 3 of the adult standard dose of 58.3g, the dose calculated based on mouse body surface area was 7.15g / kg / d, concentrated to 1.43g / mL by decoction), Tongguanteng glycoside H (60mg / kg), and Traditional Chinese medicine composition group 2 (based on 1 / 3 of the adult standard dose, the dose calculated based on mouse body surface area was 7.58g / kg / d, concentrated to 1.52g / mL by decoction). The decoction of the traditional Chinese medicine composition was taken out of the refrigerator and allowed to reach room temperature before gavage. It was administered once daily for a total of 4 weeks. After the last intervention, mice were placed in metabolic cages to collect urine samples. The mice were then fasted for 6 hours but allowed free access to water. Blood was collected from the tail tip to measure fasting blood glucose. Finally, blood was collected from the eyeballs. The collected blood was allowed to stand at room temperature for 2 hours, then centrifuged at 2000g for 20 minutes. The supernatant was collected as serum. Mice were then sacrificed, and kidney tissue samples were collected. Tongguanteng glycoside H was injected intraperitoneally every other day for a total of 20 days. After the last intervention, mice were placed in metabolic cages to collect urine samples. The mice were then fasted for 6 hours but allowed free access to water. Blood was collected from the tail tip to measure fasting blood glucose. Finally, blood was collected from the eyeballs. The collected blood was allowed to stand at room temperature for 2 hours, then centrifuged at 2000g for 20 minutes. The supernatant was collected as serum. Mice were then sacrificed, and kidney tissue samples were collected.

[0046] 1.3 Indicator Observation and Measurement

[0047] The general mental state, diet, and activity of mice in each group were observed. At 4 weeks of drug administration (14 weeks of age), 24-hour urine was collected from mice in metabolic cages. 24-hour urine volume, 24-hour urinary albumin quantification, urinary albumin, and urinary creatinine were measured using an automated biochemical analyzer (Hitachi, 3100). After fasting but allowing free access to water, blood was collected from the tail tip of the mice, and fasting blood glucose was measured using the automated biochemical analyzer. Blood was also collected from the eyeballs of the mice. The collected blood was allowed to stand at room temperature for 2 hours, then centrifuged at 2000g for 20 minutes. After centrifugation, the supernatant was collected as serum. Serum was collected, and serum creatinine (Scr), urea (Urea), ALT, TG, TCHO, and LDL-H levels were measured (specific procedures are described in the kit instructions).

[0048] 1.4 Histological observation of the kidney

[0049] Kidney tissue was fixed in 4% paraformaldehyde solution and then prepared into 4μm thick paraffin sections. Hematoxylin-eosin (HE) staining and periodic acid staining (PAS) staining were performed. The sections were mounted with neutral resin and observed under a light microscope to observe the pathological morphology of mouse kidneys.

[0050] Kidney tissue fixed with 2.5% glutaraldehyde was placed in 1% uric acid fixative and fixed at 4°C for 2 hours. It was then dehydrated with graded ethanol and embedded in epoxy resin. Polymerization was performed at 80°C for 24 hours, followed by ultrathin sectioning, double staining with uranyl acetate and lead citrate, and observation of the ultrastructure of glomeruli and renal tubules under a transmission electron microscope.

[0051] 2. Research Results

[0052] 2.1 Effects of Traditional Chinese Medicine Composition 1, Tongguanteng Glucose H, and Traditional Chinese Medicine Composition 2 on Fasting Blood Glucose Figure / Table 1 shows the changes in fasting blood glucose (FBG) in mice after 4 weeks of treatment. The results showed that the FBG of the model group mice was significantly higher than that of the normal control group, reaching 20.57 mmol / L. The FBG level of the normal control group was 4.24 mmol / L. The FBG levels of the Traditional Chinese Medicine Composition 1 treatment group, the Tongguanteng Glucose H treatment group, and the Traditional Chinese Medicine Composition 2 treatment group were similar to those of the model group, with FBG levels of 24.21 mmol / L, 18.43 mmol / L, and 18.84 mmol / L, respectively. There were no statistically significant differences between the Traditional Chinese Medicine Composition 1 treatment group, the Tongguanteng Glucose H treatment group, and the Traditional Chinese Medicine Composition 2 treatment group and the model group.

[0053] Table 1: Fasting blood glucose levels in mice of each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences between groups, and a p-value < 0.05 was considered sufficient. "*" indicates a comparison with the normal control group; ***p < 0.001.

[0054] Figure / Table 2 shows the changes in 24-hour urine volume and urinary albumin in mice after 4 weeks of drug administration. The results showed that the urine volume in the model group was significantly higher than that in other groups, reaching 14.49 mL. The 24-hour urine volume in the normal control group was 0.74 mL. The 24-hour urine volumes in the treatment groups of herbal composition 1, tongguanteng glycoside H, and herbal composition 2 reached 4.95 mL, 6.95 mL, and 4.71 mL, respectively. These results indicate that the treatment groups of herbal composition 1, tongguanteng glycoside H, and herbal composition 2 all significantly reduced 24-hour urine volume.

[0055] Regarding urinary albumin, the urinary albumin level in the model group mice reached 3.77 g / L, significantly higher than the 1.27 g / L in the normal control group. The urinary albumin levels in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng glycoside H, and Traditional Chinese Medicine Composition 2 were 1.17 g / L, 1.16 g / L, and 0.99 g / L, respectively. All three treatment groups significantly reduced urinary albumin, with the latter showing significantly better results than the former and the latter two.

[0056] Table 2. 24-hour urine volume and urinary albumin level of mice in each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences, and a p-value < 0.05 was considered sufficient for comparison between groups. "*" indicates that compared with the normal control group, **P < 0.01, ***P < 0.001; & "Indicates comparison with the model group, && P<0.01, &&& P<0.001.

[0057] Figure / Table 3 shows the changes in UACR (urinary albumin / creatinine ratio) and 24-hour urinary albumin excretion rate (UAER) in mice after 4 weeks of drug administration. The results showed that the UACR in the model group was significantly higher than in other groups, reaching 55.91 ug / mg. The UACR in the normal control group was 6.65 ug / mg. The UACR in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng Glycoside H, and Traditional Chinese Medicine Composition 2 were 23.39 ug / mg, 19.10 ug / mg, and 17.92 ug / mg, respectively. The results indicate that the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng Glycoside H, and Traditional Chinese Medicine Composition 2 could significantly reduce UACR. The effect of the treatment group of Traditional Chinese Medicine Composition 2 was significantly better than that of the treatment groups of Traditional Chinese Medicine Composition 1 and Tongguanteng Glycoside H, and there was a significant difference between the treatment groups of Traditional Chinese Medicine Composition 2 and 1.

[0058] The 24-hour urinary albumin excretion rate (UAER) results showed that the 24-hour urinary albumin excretion rate in the model group mice reached 54.55 mg, significantly higher than the 0.97 mg in the normal control group. The 24-hour urinary albumin excretion rates in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguantenggan H, and Traditional Chinese Medicine Composition 2 decreased to 6.26 mg, 7.96 mg, and 4.43 mg, respectively. All three groups significantly reduced the 24-hour urinary albumin excretion rate, with the treatment group of Traditional Chinese Medicine Composition 2 showing significantly better results than those of the treatment groups of Traditional Chinese Medicine Composition 1 and Tongguantenggan H.

[0059] Table 3. UACR and 24-hour urinary albumin excretion rate of mice in each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences, and a p-value < 0.05 was considered sufficient for comparison between groups. "*" indicates a comparison with the normal control group; ***P < 0.001; **P < 0.01. & "Indicates comparison with the model group, &&& P<0.001; # "This indicates a comparison with the treatment group using traditional Chinese medicine composition 1," # P<0.05.

[0060] Figure / Table 4 shows the changes in serum urea (UREA) and BUN / Crea (blood urea nitrogen / serum creatinine ratio) in mice after 4 weeks of treatment. The results showed that the serum urea level in the model group mice reached 8.36 mmol / L, significantly higher than the 5.06 mmol / L in the normal control group. The serum urea levels in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng glycoside H, and Traditional Chinese Medicine Composition 2 reached 5.44 mmol / L, 5.17 mmol / L, and 4.76 mmol / L, respectively. All three treatment groups significantly reduced serum urea levels, with the effect of Traditional Chinese Medicine Composition 2 being significantly better than that of the treatment groups of Traditional Chinese Medicine Composition 1 and Tongguanteng glycoside H.

[0061] According to the BUN / Crea results, the BUN / Crea ratio in the model group mice (58.23) was significantly higher than that in the normal control group (32.44). The BUN / Crea ratios in the TCM composition 1 treatment group, the Tongguanteng glycoside H treatment group, and the TCM composition 2 treatment group reached 39.85, 37.24, and 34.11, respectively. All three TCM composition groups significantly reduced BUN / Crea, with the TCM composition 2 treatment group showing significantly better results than the TCM composition 1 and Tongguanteng glycoside H treatment groups. Furthermore, there was a significant difference between the TCM composition 2 treatment group and the TCM composition 1 treatment group.

[0062] Table 4. Serum urea and BUN / cream levels in mice of each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences, and a p-value < 0.05 was considered sufficient for comparison between groups. "*" indicates a p-value < 0.001 compared to the normal control group; *** & "Indicates comparison with the model group, &&& P<0.001; # "This indicates a comparison with the treatment group using traditional Chinese medicine composition 1," # P<0.05.

[0063] Figure 5 shows the HE and PAS staining results of kidney tissue sections from mice in different fields of view. HE staining results showed that in the normal control group, the glomerular structure was clear, the glomerular capillary boundaries were clear, the renal tubules were tightly arranged, the renal tubular epithelial cells were regularly arranged and morphologically normal, and no obvious abnormalities were observed. In the model group, the glomeruli were enlarged, with mesangial proliferation, thickening of the basement membrane, dilation of the renal tubular lumen, and numerous focal infiltrations of inflammatory cells in the tubulointerstitium and glomeruli. The kidney pathological changes in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng Glycoside H, and Traditional Chinese Medicine Composition 2 were significantly milder than those in the model group. The glomeruli were clearly structured, without enlargement, and morphologically normal. The renal tubules were tightly arranged, the renal tubular epithelial cells were regularly arranged and morphologically normal, and a small number of focal infiltrations of inflammatory cells were observed in the tubulointerstitium and glomeruli.

[0064] PAS staining results showed that in the normal control group, the red collagen fibers in the kidney tissue of mice were evenly distributed, and the basement membrane was not thickened. In contrast, the glomeruli in the model group were significantly enlarged, the basement membrane was significantly thickened, and more PAS-positive material was visible, with hyalinization appearing in the capillary lumen. After treatment, compared with the model group, the kidney volume in the traditional Chinese medicine composition 1 group, the Tongguanteng glycoside H group, and the traditional Chinese medicine composition 2 group did not increase, but the basement membrane was partially thickened, and a small amount of PAS-positive material was visible.

[0065] The results of transmission electron microscopy of the kidneys are shown in Figure 6. In the model group, fusion of foot processes on the glomerular basement membrane (asterisk) and mild thickening of the glomerular basement membrane (arrow) indicate damage to the glomerular filtration barrier structure. Vacuole-like degeneration of mitochondria in renal tubular epithelial cells, myelin-like structural degeneration, and loss of mitochondrial cristae (triangular shape) suggest renal tubular cell dysfunction. Treatment groups 1 and 2 of traditional Chinese medicine composition effectively alleviated the aforementioned fusion of foot processes on the glomerular basement membrane and pathological changes in the glomerular basement membrane. Furthermore, the renal tubular epithelial cells contained abundant mitochondria with normal morphology and structure. In conclusion, treatment groups 1 and 2 of traditional Chinese medicine composition have significant protective effects against renal dysfunction and kidney injury in diabetic mice, thereby helping to delay the progression of DKD.

[0066] Figure 7 and Table 5 show the changes in alanine aminotransferase (ALT) levels in mice in each group after 4 weeks of treatment. The results showed that the ALT level in the model group mice reached 133.67 mmol / L, significantly higher than the 30.56 mmol / L in the normal control group. The ALT levels in the treatment groups of herbal composition 1, tongguantengan glycoside H, and herbal composition 2 reached 88.11 mmol / L, 73.84 mmol / L, and 63.51 mmol / L, respectively. This indicates that herbal composition 1, tongguantengan glycoside H, and herbal composition 2 can all significantly reduce ALT levels, and the effect of herbal composition 2 is significantly better than that of herbal composition 1 and tongguantengan glycoside H.

[0067] Table 5. ALT levels in mice of each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences, and a p-value < 0.05 was considered sufficient for comparison between groups. "*" indicates that compared with the normal control group, **P < 0.01, ***P < 0.001; & "Indicates comparison with the model group, & P<0.05, && P<0.01, &&& P<0.001.

[0068] Figure 8 and Table 6 show the changes in triglycerides (TG), total cholesterol (TCHO), and low-density lipoprotein cholesterol (LDL-C) in mice in each group after 4 weeks of treatment. According to the triglyceride (TG) results, the TG level in the model group mice reached 2.41 mmol / L, significantly higher than the 0.96 mmol / L in the normal control group. The treatment groups of Traditional Chinese Medicine Composition 1, Tongguantenggan H, and Traditional Chinese Medicine Composition 2 all significantly reduced TG levels. The TG levels in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguantenggan H, and Traditional Chinese Medicine Composition 2 reached 1.26 mmol / L, 1.11 mmol / L, and 1.07 mmol / L, respectively.

[0069] Based on the total cholesterol (TCHO) results, the TCHO level in the model group mice reached 3.72 mmol / L, significantly higher than the 2.09 mmol / L in the normal control group. The treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng glycoside H, and Traditional Chinese Medicine Composition 2 all significantly reduced TCHO levels. The TCHO levels in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguanteng glycoside H, and Traditional Chinese Medicine Composition 2 reached 2.41 mmol / L, 2.86 mmol / L, and 2.40 mmol / L, respectively, with the treatment groups of Traditional Chinese Medicine Composition 1 and Traditional Chinese Medicine Composition 2 showing significantly better effects than the Tongguanteng glycoside H treatment group.

[0070] Based on the total cholesterol and low-density lipoprotein cholesterol (LDL-C) results, the LDL-C level in the model group mice reached 0.83 mmol / L, significantly higher than the 0.33 mmol / L in the normal control group. The treatment groups of Traditional Chinese Medicine Composition 1, Tongguantenggan H, and Traditional Chinese Medicine Composition 2 all significantly reduced LDL-C levels. The TCHO levels in the treatment groups of Traditional Chinese Medicine Composition 1, Tongguantenggan H, and Traditional Chinese Medicine Composition 2 reached 0.36 mmol / L, 0.43 mmol / L, and 0.36 mmol / L, respectively, with the treatment groups of Traditional Chinese Medicine Composition 1 and Traditional Chinese Medicine Composition 2 showing significantly better effects than the Tongguantenggan H treatment group.

[0071] Table 6. Levels of TG, TCHO, and LDL-C in mice of each group Note: Data from the normal control group, model group, TCM composition 1 treatment group, Tongguanteng glycoside H treatment group, and TCM composition 2 treatment group are expressed as mean ± standard deviation (Mean ± SD). Non-parametric tests were used to statistically analyze differences, and a p-value < 0.05 was considered sufficient for comparison between groups. "*" indicates a p-value < 0.001 compared to the normal control group; *** & "Indicates comparison with the model group, && P<0.01, &&& P<0.001.

[0072] In summary, the traditional Chinese medicine compositions 1 and 2 of the present invention, along with the natural product Tongguanteng glycoside H, can significantly reduce pathological indicators related to diabetic nephropathy, such as urinary albumin, 24-hour urine volume, UACR, urinary albumin excretion, blood urea, triglycerides, total cholesterol, and low-density lipoprotein cholesterol. Simultaneously, they can effectively protect the morphology and function of kidney tissue. Furthermore, the effect of traditional Chinese medicine composition 2 is significantly better than that of traditional Chinese medicine composition 1 and Tongguanteng glycoside H. In conclusion, the traditional Chinese medicine compositions and natural products of the present invention can effectively improve kidney damage in diabetic mice.

[0073] Example 2

[0074] Traditional Chinese medicine composition 1 is composed of the following raw materials by weight: Astragalus membranaceus 30g, Atractylodes macrocephala 20g, Cornus officinalis 20g, Cinnamomum cassia 10g, Psoralea corylifolia 15g, Rehmannia glutinosa 20g, Eucommia ulmoides 20g, Achyranthes bidentata 15g, and Schisandra chinensis 15g.

[0075] Traditional Chinese medicine composition 2 is composed of the following raw materials by weight: Astragalus membranaceus 30g, Atractylodes macrocephala 20g, Cornus officinalis 20g, Cinnamomum cassia 10g, Psoralea corylifolia 15g, Rehmannia glutinosa 20g, Eucommia ulmoides 20g, Achyranthes bidentata 15g, Schisandra chinensis 15g, and Clematis chinensis 10g.

[0076] Example 3

[0077] Traditional Chinese medicine composition 1 is composed of the following raw materials by weight: Astragalus membranaceus 15g, Atractylodes macrocephala 15g, Cornus officinalis 15g, Cinnamomum cassia 10g, Psoralea corylifolia 10g, Rehmannia glutinosa 15g, Eucommia ulmoides 15g, Achyranthes bidentata 10g, and Schisandra chinensis 10g.

[0078] Preparation method of traditional Chinese medicine composition 1: Take the following 9 medicinal materials according to the above weight parts: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis. Extract them by water extraction. Add water at 8 times the weight of the medicinal materials and soak them for 30 minutes in advance. After soaking, put the medicinal materials into a decoction pot and decoct them. The first decoction is 30 minutes. Filter and extract the decoction. The second decoction is about 30 minutes. Add water at 5 times the weight of the medicinal materials and filter and extract the decoction. Mix the two filtered decoctions and put them into a rotary evaporator for rotary evaporation. After concentration, the product is obtained.

[0079] Traditional Chinese medicine composition 2 is composed of the following raw materials by weight: Astragalus membranaceus 15g, Atractylodes macrocephala 15g, Cornus officinalis 15g, Cinnamomum cassia 10g, Psoralea corylifolia 10g, Rehmannia glutinosa 15g, Eucommia ulmoides 15g, Achyranthes bidentata 10g, Schisandra chinensis 10g, and Clematis chinensis 10g.

[0080] The preparation method of the traditional Chinese medicine composition 2 is as follows: Take 10 medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis, according to the above-mentioned weight parts. Extract them by water extraction, add water with 8 times the weight of the medicinal materials and soak for 30 minutes in advance. After soaking, put the medicinal materials into a decoction pot for decoction. The first decoction is 30 minutes, and the decoction is filtered and extracted. The second decoction is 30 minutes, and water with 5 times the weight of the medicinal materials is added and filtered and extracted. Mix the two filtered decoctions and put them into a rotary evaporator for rotary evaporation. After concentration, the medicine is obtained.

[0081] Example 4

[0082] Traditional Chinese medicine composition 1 is composed of the following raw materials by weight: Astragalus membranaceus 65g, Atractylodes macrocephala 45g, Cornus officinalis 45g, Cinnamomum cassia 30g, Psoralea corylifolia 35g, Rehmannia glutinosa 45g, Eucommia ulmoides 45g, Achyranthes bidentata 35g, and Schisandra chinensis 35g.

[0083] Preparation method of traditional Chinese medicine composition 1: Take the following 9 medicinal materials according to the above weight parts: Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis. Extract them by water extraction. Add water at 12 times the weight of the medicinal materials and soak for 60 minutes in advance. After soaking, put the medicinal materials into a decoction pot and decoct for 60 minutes. The first decoction is 60 minutes. Filter and extract the decoction. The second decoction is about 60 minutes. Add water at 8 times the weight of the medicinal materials and filter and extract the decoction. Mix the two filtered decoctions and put them into a rotary evaporator for rotary evaporation. After concentration, the product is obtained.

[0084] Traditional Chinese medicine composition 2 is composed of the following raw materials by weight: Astragalus membranaceus 65g, Atractylodes macrocephala 45g, Cornus officinalis 45g, Cinnamomum cassia 30g, Psoralea corylifolia 35g, Rehmannia glutinosa 45g, Eucommia ulmoides 45g, Achyranthes bidentata 35g, Schisandra chinensis 35g, and Clematis chinensis 30g.

[0085] The preparation method of the traditional Chinese medicine composition 2 is as follows: Take 10 medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis, according to the above-mentioned weight parts. Extract them by water extraction, add water with a weight of 12 times the volume of the medicinal materials, and soak for 60 minutes in advance. After soaking, put the medicinal materials into a decoction pot for decoction. The first decoction is 60 minutes, and the decoction is filtered and extracted. The second decoction is 60 minutes, and water with a weight of 8 times the volume of the medicinal materials is added. Filter and extract the decoction. Mix the two filtered decoctions and put them into a rotary evaporator for rotary evaporation. After concentration, the product is obtained.

Claims

1. A traditional Chinese medicine composition for treating diabetic nephropathy, said traditional Chinese medicine composition being prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: Astragalus membranaceus 15-65 parts, Atractylodes macrocephala 15-45 parts, Cornus officinalis 15-45 parts, Cinnamomum cassia 10-30 parts, Psoralea corylifolia 10-35 parts, Rehmannia glutinosa 15-45 parts, Eucommia ulmoides 15-45 parts, Achyranthes bidentata 10-35 parts, and Schisandra chinensis 10-35 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein the weight ratio of each traditional Chinese medicine raw material in the traditional Chinese medicine composition is as follows: Astragalus membranaceus 30 parts, Atractylodes macrocephala 20 parts, Cornus officinalis 20 parts, Cinnamomum cassia 10 parts, Psoralea corylifolia 15 parts, Rehmannia glutinosa 20 parts, Eucommia ulmoides 20 parts, Achyranthes bidentata 15 parts, Schisandra chinensis 15 parts.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 comprises the following steps: taking nine medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis, and extracting them by water extraction, adding water at 8-12 times the weight of the medicinal materials, and soaking them for 30-60 minutes in advance; after soaking, putting the medicinal materials into a decoction pot for decoction, the first decoction is 30-60 minutes, filtering and extracting the decoction, the second decoction is 30-60 minutes, adding water at 5-8 times the weight of the medicinal materials, filtering and extracting the decoction; mixing the two filtered decoctions and putting them into a rotary evaporator for rotary evaporation; concentrating to obtain the final product.

4. The preparation method according to claim 3 comprises the following steps: taking nine medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, and Schisandra chinensis, and extracting them by water extraction, adding water at 10 times the weight of the medicinal materials and soaking them for 30 minutes in advance; after soaking, putting the medicinal materials into a decoction pot for decoction, the first decoction is 40 minutes (adding water at 10 times the weight of the medicinal materials for the first decoction), filtering and extracting the decoction, the second decoction is 30 minutes, adding water at 5 times the weight of the medicinal materials, filtering and extracting the decoction; mixing the two filtered decoctions and putting them into a rotary evaporator for rotary evaporation; concentrating to obtain the final product.

5. A traditional Chinese medicine composition for treating diabetic nephropathy, said traditional Chinese medicine composition being prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: Astragalus membranaceus 15-65 parts, Atractylodes macrocephala 15-45 parts, Cornus officinalis 15-45 parts, Cinnamomum cassia 10-30 parts, Psoralea corylifolia 10-35 parts, Rehmannia glutinosa 15-45 parts, Eucommia ulmoides 15-45 parts, Achyranthes bidentata 10-35 parts, Schisandra chinensis 10-35 parts, and Clematis chinensis 10-30 parts.

6. The traditional Chinese medicine composition according to claim 5, wherein the weight ratio of each traditional Chinese medicine raw material in the traditional Chinese medicine composition is as follows: Astragalus membranaceus 30 parts, Atractylodes macrocephala 20 parts, Cornus officinalis 20 parts, Cinnamomum cassia 10 parts, Psoralea corylifolia 15 parts, Rehmannia glutinosa 20 parts, Eucommia ulmoides 20 parts, Achyranthes bidentata 15 parts, Schisandra chinensis 15 parts, and Clematis chinensis 10 parts.

7. The preparation method of the traditional Chinese medicine composition according to claim 5, comprising the following steps: taking 10 medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis, and extracting them by water extraction, adding water at 8-12 times the weight of the medicinal materials, and soaking them for 30-60 minutes in advance; after soaking, putting the medicinal materials into a decoction pot for decoction, the first decoction is 30-60 minutes, filtering to extract the medicinal liquid, the second decoction is 30-60 minutes, adding water at 5-8 times the weight of the medicinal materials, filtering to extract the medicinal liquid; mixing the two filtered medicinal liquids and putting them into a rotary evaporator for rotary evaporation; concentrating to obtain the final product.

8. The preparation method according to claim 7, comprising the following steps: taking 10 medicinal materials, namely Astragalus membranaceus, Atractylodes macrocephala, Cornus officinalis, Cinnamomum cassia, Psoralea corylifolia, Rehmannia glutinosa, Eucommia ulmoides, Achyranthes bidentata, Schisandra chinensis, and Clematis chinensis, and extracting them by water extraction, adding water at 10 times the weight of the medicinal materials and soaking them for 30 minutes in advance; after soaking, putting the medicinal materials into a decoction pot for decoction, the first decoction is 40 minutes (adding water at 10 times the weight of the medicinal materials for the first decoction), filtering and extracting the decoction, the second decoction is 30 minutes, adding water at 5 times the weight of the medicinal materials, filtering and extracting the decoction; mixing the two filtered decoctions and putting them into a rotary evaporator for rotary evaporation; concentrating to obtain the final product.

9. The use of the traditional Chinese medicine composition according to claim 1 or claim 5 in the preparation of a drug for treating diabetic nephropathy.

10. Use of tenacissoside H having the structure of Formula I in the manufacture of a medicament for treating diabetic nephropathy.

Images