Traditional Chinese medicine composition for treating diabetic nephropathy and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention is prepared from the following raw materials in parts by weight: 30 to 120 parts of raw radix astragali seu hedysari, 10 to 20 parts of radix pseudostellariae, 5 to 15 parts of herba dendrobii, 5 to 15 parts of radix trichosanthis, 10 to 20 parts of radix rehmanniae recen, 10 to 20 parts of raw radix puerariae, 25 to 35 parts of herba agrimoniae, 5 to 15 parts of rhizoma discoreae, 10 to 20 parts of fructus corni, 10 to 20 parts of ramuli euonymi, 10 to 20 parts of serissa serissoide, 25 to 35 parts of chinaroot greenbrier, 4 to 8 parts of fructus schisandrae chinensis, 10 to 20 parts of herba pyrolae and 10 to 20 parts of corn stigma. The traditional Chinese medicine composition disclosed by the invention can be used for improving the clinical curative effect, improving symptoms, repairing podocyte damage and relieving oxidative stress by virtue of unique traditional Chinese medicine composition and aiming at pathogenesis treatment of the DN with the syndrome of deficiency of both qi and yin, and a new thought and a new method are provided for traditional Chinese medicine treatment of the DN.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diabetic nephropathy and its application. Background Art

[0002] Diabetic Nephropathy (DN), as a major microvascular complication of diabetes, has an increasing incidence year by year as the number of global diabetic patients continues to grow. According to statistics, about 14% to 44% of diabetic patients will eventually develop into DN, making DN one of the important causes leading to end-stage renal failure. Oxidative stress plays a crucial role in the occurrence and development of DN. According to traditional Chinese medicine theory, there are various TCM syndromes of DN, including qi-yin deficiency syndrome, liver-kidney yin deficiency syndrome, spleen-kidney yang deficiency syndrome, yin-yang deficiency syndrome, etc., among which qi-yin deficiency syndrome is one of the most common syndromes. Patients with qi-yin deficiency syndrome often show symptoms such as fatigue, shortness of breath, dizziness, dreaminess, dry throat and mouth, feverish palms and soles, and restlessness of the heart. Its pathological mechanism is closely related to the pathological processes of oxidative stress, inflammatory response, and renal fibrosis in DN. Therefore, for the treatment of patients with qi-yin deficiency syndrome, traditional Chinese medicine emphasizes the treatment method of supplementing qi and nourishing yin, activating blood circulation and dredging collaterals, in order to achieve the purpose of improving clinical symptoms and delaying the deterioration of renal function.

[0003] This application provides a traditional Chinese medicine composition (Tangshen Formula) for treating DN. However, in-depth studies on the specific clinical efficacy, podocyte protection, and oxidative stress level of Tangshen Formula in patients with qi-yin deficiency syndrome of DN are still insufficient. Podocytes, as an important part of the glomerular filtration barrier, the integrity of their structure and function is crucial for maintaining the normal function of the kidney. DN patients are often accompanied by podocyte damage and detachment, resulting in damage to the glomerular filtration barrier and further causing clinical manifestations such as proteinuria. Therefore, exploring the protective effect of Tangshen Formula on podocytes in DN patients is of great significance for revealing its treatment mechanism. In addition, oxidative stress plays a key role in the occurrence and development of DN. The excessive production of reactive oxygen species can lead to a series of pathological changes such as mesangial cell hypertrophy, mesangial expansion, and extracellular matrix protein accumulation, thereby accelerating the progression of DN. Therefore, evaluating the effect of Tangshen Formula on the oxidative stress level in DN patients helps to further understand its potential mechanism for treating DN. This study aims to explore the clinical efficacy, podocyte protection, and oxidative stress level of Tangshen Formula in patients with qi-yin deficiency syndrome of DN through systematic clinical observations and experimental studies. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating diabetic nephropathy, which can protect podocytes, reduce the oxidative stress level, and effectively delay the progression of DN in DN patients with qi-yin deficiency syndrome.

[0005] To achieve the above-mentioned invention object, the present invention provides the following technical solutions:

[0006] The present invention provides a traditional Chinese medicine composition for treating diabetic nephropathy, comprising the following traditional Chinese medicine raw materials in parts by weight: 30-120 parts of Astragalus membranaceus, 10-20 parts of Pseudostellaria heterophylla, 5-15 parts of Dendrobium officinale, 5-15 parts of Trichosanthes kirilowii Maxim., 10-20 parts of Rehmannia glutinosa, 10-20 parts of Pueraria lobata, 25-35 parts of Agrimonia pilosa Ledeb., 5-15 parts of Dioscorea opposita Thunb., 10-20 parts of Cornus officinalis Sieb. et Zucc., 10-20 parts of Euonymus alatus, 10-20 parts of Serissa japonica, 25-35 parts of Smilax china, 4-8 parts of Schisandra chinensis, 10-20 parts of Pyrola calliantha and 10-20 parts of Stigma maydis.

[0007] Preferably, when there is concurrent syndrome of internal heat, the traditional Chinese medicine composition further comprises 10-20 parts of Prunella vulgaris and 5-15 parts of Arctium lappa.

[0008] Preferably, when there is concurrent syndrome of edema, the traditional Chinese medicine composition further comprises 15-25 parts of Polyporus umbellatus, 15-25 parts of Poria cocos and 10-20 parts of Plantago asiatica L.

[0009] Preferably, when there is concurrent syndrome of proteinuria, the traditional Chinese medicine composition further comprises 10-20 parts of Alisma orientale and 15-25 parts of Dioscorea nipponica Makino.

[0010] The present invention also provides an application of the traditional Chinese medicine composition in the preparation of a medicament for treating diabetic nephropathy.

[0011] Preferably, the medicament further comprises excipients commonly used in medicine.

[0012] Preferably, the diabetic nephropathy is of the type of qi and yin deficiency.

[0013] Preferably, the dosage form of the medicament is a granule, and the preparation method of the granule is as follows:

[0014] (1) Take the traditional Chinese medicine raw materials, mix them with water according to a weight ratio of 1:3-5, decoct them 2-3 times at 90-100 °C for 1-2 h each time, filter to remove the residue, and combine the filtrates;

[0015] (2) Concentrate the filtrate by evaporation to a concentrated solution with a relative density of 1.10-1.20;

[0016] (3) Mix the concentrated solution, dextrin and starch evenly, and use a granulator to make wet granules;

[0017] (4) Dry the wet granules at 60-80 °C until the water content is less than 5% to obtain dry granules;

[0018] (5) Package and seal the dry granules to obtain the granule.

[0019] The traditional Chinese medicine composition for treating diabetic nephropathy provided by the present invention. Astragalus membranaceus has the effects of replenishing qi and consolidating the exterior, enhancing immunity, and improving the disease resistance of the body, and has a significant effect on improving the overall condition of patients with diabetic nephropathy; Pseudostellaria heterophylla replenishes qi and strengthens the spleen, promotes the production of body fluid and moistens the lungs, and helps to improve the qi deficiency symptoms of patients with diabetic nephropathy. Dioscorea opposita nourishes the liver and kidney, replenishes qi and strengthens the spleen, and has an obvious improvement effect on the kidney deficiency symptoms of patients with diabetic nephropathy. Trichosanthes kirilowii has the effects of clearing heat and promoting the production of body fluid, dissipating swelling and discharging pus, and also has a certain hypoglycemic effect. Rehmannia glutinosa clears heat and cools blood, nourishes yin and promotes the production of body fluid, and helps to reduce blood sugar and improve the yin deficiency symptoms of diabetic patients. Pueraria lobata promotes the production of body fluid and quenches thirst, raises yang and stops diarrhea, and can reduce blood sugar and improve insulin resistance. Euonymus alatus has the effects of promoting blood circulation by breaking blood stasis, detoxifying and dissipating swelling, and can reduce urinary protein, reduce ACR and improve renal function. Corn silk promotes diuresis and reduces swelling, clears the liver and benefits the gallbladder, and helps to reduce the excretion of urinary protein and improve renal function. Polyporus umbellatus, Poria cocos, Plantago asiatica (add granules for edema), these diuretic and dampness-promoting herbs can increase urine volume, promote the excretion of excess water and waste in the body, and help to reduce edema and improve renal function. Dendrobium officinale has the effect of nourishing yin and clearing heat, and can reduce the symptoms of hyperactivity of fire due to yin deficiency in the diabetic state, thereby reducing the damage to podocytes. Cornus officinalis and Agrimonia pilosa have the effects of astringing and consolidating, strengthening the spleen and tonifying the kidney, and can enhance the repair and regeneration ability of kidney tissue and reduce the damage to the kidney caused by oxidative stress reaction. Serissa japonica dispels wind and clears heat, promotes diuresis and activates blood circulation. Smilax china expels wind and dampness, detoxifies and disperses stasis. Schisandra chinensis astringes and consolidates, replenishes qi and promotes the production of body fluid, tonifies the kidney and soothes the heart. Pyrola calliantha strengthens the kidney and bones, expels wind and dampness, relieves cough and stops bleeding. In the present invention, multiple drugs act synergistically and have a significant curative effect on diabetic nephropathy.

[0020] The Tangshen formula of the present invention uses Astragalus membranaceus and Pseudostellaria heterophylla as the monarch herbs to replenish qi and strengthen the spleen; Dendrobium officinale, Trichosanthes kirilowii, Rehmannia glutinosa, Pueraria lobata, Agrimonia pilosa, Dioscorea opposita, Cornus officinalis as the minister herbs to nourish yin and promote the production of body fluid, nourish the liver and kidney; Euonymus alatus, Serissa japonica, Smilax china, Schisandra chinensis, Pyrola calliantha, Corn silk as the assistant and guiding herbs to promote blood circulation by removing blood stasis, promote diuresis and dampness elimination, astringe and consolidate. The whole formula together exerts the effects of replenishing qi and nourishing yin, promoting blood circulation by removing blood stasis, promoting diuresis and dampness elimination, can improve the clinical curative effect, relieve symptoms, repair podocyte damage, reduce oxidative stress, and provides new ideas and methods for the traditional Chinese medicine treatment of DN. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is the paired parallel graph of GPX4, GSH, MDA, and serum iron in the study group and the control group in Experimental Example 1. DETAILED DESCRIPTION OF THE INVENTION

[0022] The technical solutions provided by the present invention will be described in detail below in conjunction with the embodiments, but they cannot be understood as limiting the protection scope of the present invention.

[0023] Example 1

[0024] Take 75 g of Astragalus membranaceus, 15 g of Pseudostellaria heterophylla, 10 g of Dendrobium officinale, 10 g of Trichosanthes kirilowii Maxim., 15 g of Rehmannia glutinosa Libosch., 15 g of Pueraria lobata (Willd.) Ohwi, 30 g of Agrimonia pilosa Ledeb., 10 g of Dioscorea opposita Thunb., 15 g of Corni officinalis Sieb. et Zucc., 15 g of Euonymus alatus (Thunb.) Sieb., 15 g of Serissa japonica (Thunb.) Thunb., 30 g of Smilax china L., 6 g of Schisandra chinensis (Turcz.) Baill., 15 g of Pyrola calliantha H. Andr., 15 g of Stigma maydis. Mix the above traditional Chinese medicine raw materials according to a weight ratio of 1:4, add water and mix, decoct 3 times at 100 °C, each time for 1.5 h, filter to remove the residue, and then combine the filtrates; evaporate and concentrate the filtrate to a concentrated solution with a relative density of 1.10; mix the concentrated solution with dextrin and starch and stir evenly, and use a granulator to make wet granules; dry the wet granules at 70 °C until the moisture content is less than 5% to obtain dry granules; package and seal the dry granules to prepare a granule of traditional Chinese medicine composition, namely Tangshen Recipe, with a specification of 4 g / bag.

[0025] When the patient has concurrent symptom of internal heat, the raw materials of Tangshen Recipe also include 15 g of Prunella vulgaris L. and 10 g of Arctium lappa L.

[0026] When the patient has concurrent symptom of edema, the raw materials of Tangshen Recipe also include 20 g of Polyporus umbellatus (Pers.) Fries, 20 g of Poria cocos (Schw.) Wolf, and 15 g of Plantago asiatica L.

[0027] When the patient has concurrent symptom of proteinuria, the raw materials of Tangshen Recipe also include 15 g of Alisma orientale (Sam.) Juzep. and 20 g of Dioscorea nipponica Makino.

[0028] Example 2

[0029] Take 30 g of Astragalus membranaceus, 10 g of Pseudostellaria heterophylla, 5 g of Dendrobium officinale, 5 g of Trichosanthes kirilowii Maxim., 10 g of Rehmannia glutinosa Libosch., 10 g of Pueraria lobata (Willd.) Ohwi, 25 g of Agrimonia pilosa Ledeb., 5 g of Dioscorea opposita Thunb., 10 g of Corni officinalis Sieb. et Zucc., 10 g of Euonymus alatus (Thunb.) Sieb., 10 g of Serissa japonica (Thunb.) Thunb., 25 g of Smilax china L., 4 g of Schisandra chinensis (Turcz.) Baill., 10 g of Pyrola calliantha H. Andr., 10 g of Stigma maydis. Mix the above traditional Chinese medicine raw materials according to a weight ratio of 1:3, add water and mix, decoct 2 times at 100 °C, each time for 1 h, filter to remove the residue, and then combine the filtrates; evaporate and concentrate the filtrate to a concentrated solution with a relative density of 1.10; mix the concentrated solution with dextrin and starch and stir evenly, and use a granulator to make wet granules; dry the wet granules at 60 °C until the moisture content is less than 5% to obtain dry granules; package and seal the dry granules to prepare a granule of traditional Chinese medicine composition, namely Tangshen Recipe, with a specification of 4 g / bag.

[0030] When the patient has concurrent symptom of internal heat, the raw materials of Tangshen Recipe also include 10 g of Prunella vulgaris L. and 5 g of Arctium lappa L.

[0031] When the patient has concurrent symptom of edema, the raw materials of Tangshen Recipe also include 15 g of Polyporus umbellatus (Pers.) Fries, 15 g of Poria cocos (Schw.) Wolf, and 10 g of Plantago asiatica L.

[0032] When the patient has concurrent symptom of proteinuria, the raw materials of Tangshen Recipe also include 10 g of Alisma orientale (Sam.) Juzep. and 15 g of Dioscorea nipponica Makino.

[0033] Example 3

[0034] Take 120 g of Astragalus membranaceus, 20 g of Pseudostellaria heterophylla, 15 g of Dendrobium officinale, 15 g of Trichosanthes kirilowii Maxim., 20 g of Rehmannia glutinosa Libosch., 20 g of Pueraria lobata (Willd.) Ohwi, 35 g of Agrimonia pilosa Ledeb., 15 g of Dioscorea opposita Thunb., 20 g of Macrocarpium officinale (Sieb. et Zucc.) Nakai, 20 g of Euonymus alatus (Thunb.) Sieb., 20 g of Serissa japonica (Thunb.) Thunb., 35 g of Smilax china L., 8 g of Schisandra chinensis (Turcz.) Baill., 20 g of Pyrola calliantha H. Andr., 20 g of Stigma maydis. Mix the above traditional Chinese medicine raw materials according to a weight ratio of 1:5 with water, decoct 3 times at 100 °C for 2 h each time, filter to remove the residue, and combine the filtrates; evaporate and concentrate the filtrates to a concentrated solution with a relative density of 1.10; mix the concentrated solution with dextrin and starch and stir evenly, and use a granulator to make wet granules; dry the wet granules at 80 °C until the water content is less than 5% to obtain dry granules; package and seal the dry granules to prepare a granule of the traditional Chinese medicine composition, which is the Tangshen formula, with a specification of 4 g / bag.

[0035] When the patient has concurrent symptoms of internal heat, the raw materials of the Tangshen formula also include 20 g of Prunella vulgaris L. and 15 g of Arctium lappa L.

[0036] When the patient has concurrent symptoms of edema, the raw materials of the Tangshen formula also include 25 g of Polyporus umbellatus (Pers.) Fries, 25 g of Poria cocos (Schw.) Wolf, and 20 g of Plantago asiatica L.

[0037] When the patient has concurrent symptoms of proteinuria, the raw materials of the Tangshen formula also include 20 g of Alisma orientale (Sam.) Juz. and 25 g of Dioscorea nipponica Makino.

[0038] Experimental Example 1

[0039] 1. Case data

[0040] A total of 100 patients with qi-yin deficiency syndrome of diabetic nephropathy were selected. Inclusion criteria: All patients met the relevant diagnostic criteria for diabetic nephropathy in the "Expert Consensus on Clinical Diagnosis of Diabetic Kidney Disease in Chinese Adults" in Western medicine; all patients met the TCM syndrome type of qi-yin deficiency syndrome in the "Guiding Principles for Clinical Research of New Chinese Medicines" in traditional Chinese medicine. Main syndromes: Fatigue, shortness of breath and reluctance to speak, dry throat and mouth, soreness and weakness of the waist and knees. These symptoms reflect the pathological state of coexistence of qi deficiency and yin deficiency in patients. Secondary syndromes: Spontaneous sweating or night sweating, five-palm heat, thirst and desire to drink, constipation or dry first and then loose stools, small tongue body, red or light red tongue, thin white or less coating on the tongue, thready and weak or thready and rapid pulse. These secondary syndromes further support the diagnosis of qi-yin deficiency. Age ≥ 60 years; all signed informed consent forms in the hospital. Exclusion criteria: Patients with kidney diseases caused by other diseases; patients with severe hematological diseases; patients with severe liver and kidney failure; patients with diseases of the heart, brain, etc.; patients allergic to the drugs in this study. The grouping method was the blocked randomization method (according to the admission time, the 1st to 4th subjects formed the first block, the 5th to 8th subjects formed the second block, and so on), and they were divided into a control group (conventional Western medicine treatment, 50 cases) and a study group (conventional Western medicine + Tangshen Formula treatment). There was no statistical significance in the comparison of the baseline data between the two groups (P > 0.05), as shown in Table 1. It was reviewed and approved by the Medical Ethics Committee (Ethical Approval Number: LXSQ2019-02).

[0041] Table 1 Comparison of baseline data between the two groups ( ; n, %)

[0042]

[0043]

[0044] 2. Treatment methods

[0045] Both the control group and the study group were given basic diet control and drug treatment.

[0046] Control group: Given conventional Western medicine treatment, hypoglycemic (repaglinide taken before meals, 3 times a day and dapagliflozin 10 mg taken before breakfast, once a day), antihypertensive (valsartan 80 mg, taken orally once a day), lipid-lowering (atorvastatin 20 mg, once a day).

[0047] Study group: Given the Tangshen Formula granule prepared in Example 1, 4 bags per day, 2 bags each after breakfast and dinner. During the trial, the routine treatment of diabetes and hypertension was maintained, and traditional Chinese medicines that affect blood glucose and anticoagulant drugs were avoided, and FBG ≤ 7.8 mmol / L and HbA1c < 7.5% were maintained; hypoglycemic Western medicines were adjusted when necessary. The blood pressure was controlled at < 140 / 90 mmHg, and antihypertensive drugs could be adjusted, but ACEI and ARB drugs were excluded.

[0048] 3. Observation indicators

[0049] 1) Efficacy criteria: Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines". Cure: Symptoms and signs completely disappear, and urine protein turns negative. Marked effect: The clinical symptom score is reduced by 60%, glycated hemoglobin is normal or decreased by ≥1%; or the 24-hour urine protein is reduced by more than 40% compared with that before treatment. Effective: The clinical symptom score is reduced by ≥30%, glycated hemoglobin is decreased by ≥0.5%; or the 24-hour urine protein is reduced by 10% - 39% compared with that before treatment. Ineffective: The clinical symptom score is not reduced or aggravated, and there is no obvious change in the levels of glycated hemoglobin and urine protein.

[0050] 2) TCM syndrome score: Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines". Symptoms and signs are divided into two categories: main and secondary. Both are divided into three levels: mild, moderate, and severe according to frequency, degree, and manifestation, and are assigned scores respectively (main symptoms such as fatigue, shortness of breath, dry throat and mouth: 2 / 4 / 6 points; secondary symptoms such as thirst, restlessness, and feverish palms and soles: 1 / 2 / 3 points). The sum of all scores is the TCM syndrome score, with a total score of 27 points. After a 3-month treatment course, the changes in the TCM syndrome scores before and after treatment in the two groups were compared.

[0051] 3) Blood glucose: Before treatment and 3 months after treatment, a blood glucose meter was used to detect the levels of FBG, 2hBG, and HbAlc in patients.

[0052] 4) Renal function: Before treatment and 3 months after treatment, fasting venous blood of patients was collected, serum was separated after centrifugation, and a fully automatic biochemical analyzer was used to detect serum GFR, UA, SCR, and BUN in patients.

[0053] 5) Podocyte injury: Before and 3 months after treatment, urine samples of patients were collected, and flow cytometry was used to evaluate the changes in Nephrin and Podocin in urine, and the level of α-SMA was measured by ELISA method (Santa Company, HZ-0189R).

[0054] 6) Oxidative stress: ELISA was used to detect the levels of serum GPX4, GSH, MDA, and serum iron.

[0055] 4. Statistical methods

[0056] All data were analyzed using SPSS 22.0. Count data were expressed as n(%) and χ 2 test was carried out, and rank sum test was carried out for rank data; measurement data were expressed as Independent sample t-test was carried out between the two groups, and paired t-test was carried out at different time points within the group. P < 0.05 indicated a statistical difference.

[0057] 5. Results

[0058] 5.1 The comparison results of clinical efficacy are shown in Table 2 below

[0059] Table 2 Comparison of clinical efficacy (n, %)

[0060]

[0061]

[0062] As can be seen from Table 2, the clinical efficacy was better than that of the control group (p<0.05), and the total clinical effective rate of the study group was 82.00%, significantly higher than 64.00% of the control group (P<0.05).

[0063] 5.2 The results of TCM syndrome scores are shown in Table 3 below

[0064] Table 3 Comparison of TCM syndrome scores

[0065]

[0066] Note: a Indicates comparison with before treatment, P<0.05.

[0067] As can be seen from Table 3, 3 months after treatment, the TCM syndrome scores of both groups decreased compared with before treatment (P<0.05), and the TCM syndrome scores of the study group were lower than those of the control group (P<0.05).

[0068] 5.3 The comparison results of blood glucose are shown in Table 4 below

[0069] Table 4 Comparison of blood glucose between the two groups

[0070]

[0071] Note: a Comparison with before treatment, P<0.05.

[0072] As can be seen from Table 4, 3 months after treatment, FBG, 2hBG, and HbAlc in both groups decreased compared with before treatment (P<0.05), and FBG, 2hBG, and HbAlc in the study group were lower than those of the control group (P<0.05).

[0073] 5.4 The results of renal function and ACR are shown in Table 5 below

[0074] Table 5 Comparison of renal function and ACR between the two groups

[0075]

[0076]

[0077] As shown in Table 5, three months after treatment, the GFR of both groups increased compared with that before treatment, while UA, SCR, BUN, and ACR in both groups decreased compared with those before treatment (P<0.05). The GFR of the study group was higher than that of the control group, and UA, SCR, BUN, and ACR were lower than those of the control group (P<0.05).

[0078] 5.5 Comparison results of podocyte protection are shown in Table 6 below

[0079] Table 6 Comparison of excretion levels of Podocin, Nephrin, and α-SMA in two groups

[0080]

[0081] Note: a Compared with before treatment, P<0.05.

[0082] It can be seen that three months after treatment, the excretion of urine Podocin, Nephrin, and α-SMA in both groups decreased compared with that before treatment (P<0.05), and the excretion of urine Podocin, Nephrin, and α-SMA in the study group was lower than that of the control group (P<0.05).

[0083] 5.6 Comparison results of oxidative stress levels are shown in Table 7 and Figure 1 as follows

[0084] Table 7 Comparison of GPX4, GSH, MDA, and serum iron in two groups

[0085]

[0086]

[0087] Note: a Compared with before treatment, P<0.05.

[0088] It can be seen that three months after treatment, GPX4 and GSH in both groups increased compared with those before treatment, while MDA and serum iron decreased compared with those before treatment (P<0.05). GPX4 and GSH in the study group were higher than those of the control group, and MDA and serum iron were lower than those of the control group (P<0.05).

[0089] 6. In summary, the results of this study showed that after treatment, FBG, 2hBG, and HbAlc in both groups were significantly decreased, and the decrease in the study group was greater. After 3 months of treatment, GFR in both groups increased, while UA, SCR, BUN, and ACR decreased. The study group was superior to the control group in terms of the increase in GFR and the decrease in UA, SCR, BUN, and ACR. It is suggested that the Tangshen Formula used in the treatment of patients with qi-yin deficiency syndrome of DN can reduce blood glucose and ACR, and also reduce the syndrome score and serum inflammatory factors, and improve renal function.

[0090] In this study, after 3 months of treatment, the excretion of urine Podocin, Nephrin, and α-SMA in both groups decreased compared with that before treatment, and the excretion of urine Podocin, Nephrin, and α-SMA in the study group was lower than that in the control group, suggesting that the Tangshen Formula used in the treatment of patients with qi-yin deficiency syndrome of DN can repair podocyte damage. Multiple traditional Chinese medicine components in the Tangshen Formula, such as Astragalus membranaceus and Dendrobium officinale, are rich in antioxidant substances, which can scavenge free radicals and reduce oxidative stress response, thereby protecting podocytes from damage. Inflammatory response plays an important role in the pathogenesis of DN. The traditional Chinese medicine components in the Tangshen Formula have anti-inflammatory effects, which can reduce the inflammatory response in kidney tissues and lower the level of inflammatory factors, thereby reducing the damage to podocytes. Under the diabetic state, the disorder of immune system function will also aggravate kidney damage. The Tangshen Formula can regulate the immune system function and enhance the disease resistance of the body, thereby reducing the immune damage to podocytes.

[0091] Oxidative stress is an important link in the pathogenesis of DN. A hyperglycemic environment can cause kidney cells to produce a large amount of ROS, trigger oxidative stress response, and then damage kidney tissues, including podocytes, mesangial cells, and endothelial cells. This damage will lead to the impairment of the glomerular filtration barrier and the production of proteinuria, and finally develop into DN. Oxidative stress response will exacerbate the progression of DN. Reactive molecules such as ROS will attack biological macromolecules such as lipids, proteins, and DNA in kidney tissues, resulting in abnormal cell structure and function and accelerating kidney damage. The Tangshen Formula of the present invention used in the treatment of patients with qi-yin deficiency syndrome of DN can reduce oxidative stress. This is because multiple traditional Chinese medicine components in the Tangshen Formula are rich in antioxidant substances, such as polysaccharides and flavonoid compounds. These antioxidant substances can scavenge free radicals in the body and reduce oxidative stress response, thereby protecting kidney tissues from damage.

[0092] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic nephropathy, characterized in that, It comprises the following Chinese herbal medicine raw materials in parts by weight: 30 - 120 parts of Astragalus membranaceus, 10 - 20 parts of Pseudostellaria heterophylla, 5 - 15 parts of Dendrobium officinale, 5 - 15 parts of Trichosanthes kirilowii Maxim., 10 - 20 parts of Rehmannia glutinosa, 10 - 20 parts of Pueraria lobata, 25 - 35 parts of Agrimonia pilosa Ledeb., 5 - 15 parts of Dioscorea opposita Thunb., 10 - 20 parts of Cornus officinalis Sieb. et Zucc., 10 - 20 parts of Euonymus alatus, 10 - 20 parts of Serissa japonica, 25 - 35 parts of Smilax china, 4 - 8 parts of Schisandra chinensis, 10 - 20 parts of Pyrola calliantha and 10 - 20 parts of Stigma maydis.

2. The traditional Chinese medicine composition according to claim 1, wherein When there is concurrent syndrome of internal heat, the Chinese medicine composition further comprises 10 - 20 parts of Prunella vulgaris and 5 - 15 parts of Arctium lappa.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, When there is concurrent syndrome of edema, the Chinese medicine composition further comprises 15 - 25 parts of Polyporus umbellatus, 15 - 25 parts of Poria cocos and 10 - 20 parts of Plantago asiatica.

4. The traditional Chinese medicine composition according to claim 1, characterized in that When there is concurrent syndrome of proteinuria, the Chinese medicine composition further comprises 10 - 20 parts of Alisma orientale and 15 - 25 parts of Dioscorea nipponica.

5. Use of the Chinese medicine composition according to any one of claims 1 - 4 in the preparation of a medicament for treating diabetic nephropathy.

6. The application according to claim 5, wherein The medicament further comprises excipients commonly used in medicine.

7. The application according to claim 5, wherein The diabetic nephropathy is of the type of qi - yin deficiency.

8. The application according to claim 5, wherein The dosage form of the medicament is a granule, and the preparation method of the granule is as follows: (1) Take the Chinese herbal medicine raw materials and mix them with water according to a weight ratio of 1:3 - 5, decoct for 2 - 3 times at 90 - 100 °C, 1 - 2 h each time, filter to remove the residue, and then combine the filtrates; (2) Evaporate and concentrate the filtrate to a concentrated solution with a relative density of 1.10 - 1.20; (3) Mix the concentrated solution with dextrin and starch and stir evenly, and use a granulator to make wet granules; (4) Dry the wet granules at 60 - 80 °C until the water content is less than 5% to obtain dry granules; (5) Package and seal the dry granules to obtain the granule.

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