CN115192657B

CN115192657B - Traditional Chinese medicine preparation for treating type 2 diabetes kidney disease and application thereof

Info

Publication number: CN115192657B
Application number: CN202211126125.XA
Authority: CN
Inventors: 赵家军; 韩文霞
Original assignee: Shandong Provincial Hospital Affiliated to Shandong First Medical University
Current assignee: Shandong Provincial Hospital Affiliated to Shandong First Medical University
Priority date: 2022-09-16
Filing date: 2022-09-16
Publication date: 2023-02-17
Anticipated expiration: 2042-09-16
Also published as: CN115192657A

Abstract

The invention provides a traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney disease and application thereof, belonging to the technical field of medicines. The active pharmaceutical ingredients of the traditional Chinese medicine preparation comprise the following raw material medicines in parts by weight: 6-14 parts of radix pseudostellariae, 5-14 parts of raw astragalus membranaceus, 6-12 parts of wolfberry fruit, 6-9 parts of dogwood, 7-12 parts of poria cocos, 6-9 parts of dried orange peel, 6-10 parts of salvia miltiorrhiza, 3-6 parts of ligusticum wallichii, 6-10 parts of lotus seed pulp and 3-6 parts of cassia twig. The medicinal preparation takes natural plants including radix pseudostellariae and raw radix astragali as core components, is matched with various traditional Chinese medicine components for tonifying qi, nourishing yin, promoting blood circulation and removing blood stasis, has the effects of protecting the kidney of the type 2 diabetes mellitus kidney disease, reducing the excretion of urine protein and improving clinical symptoms, and has good safety and effectiveness proved by clinical research, so the medicinal preparation has good value of practical application.

Description

Traditional Chinese medicine preparation for treating type 2 diabetes kidney disease and application thereof

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine preparation for treating type 2 diabetes kidney disease and application thereof.

Background

The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.

Type 2 diabetes mellitus (DKD), a chronic microvascular complication of type 2 diabetes mellitus, is one of the common serious complications of type 2 diabetes mellitus. The development of type 2 diabetes mellitus nephropathy may involve many mechanisms, wherein hyperglycemia is a necessary condition for causing kidney damage, and the development of type 2 diabetes mellitus nephropathy can be delayed after intensive control of blood glucose levels. In addition, the generation of mitochondrial reactive oxygen species, the accumulation of advanced glycosylation endproducts, the activation of intracellular signaling molecules, and the hemodynamics are the pathways that contribute to their pathogenesis, and these factors work together to cause renal disease in type 2 diabetic patients. The important sign of the diabetic kidney disease is proteinuria, urinary microalbumin is an important index for judging the early diabetic kidney disease, the occurrence of the urinary microalbumin indicates the initiation of the disease, but the non-diabetic kidney injury is not eliminated after the kidney injury occurs to part of type 2 diabetic patients, so the diagnosis is confirmed by renal biopsy.

At present, the prevention and treatment of type 2 diabetes mellitus kidney diseases are mainly the control of blood sugar and blood pressure, and ideal blood sugar and blood pressure levels are the main treatment basis of type 2 diabetes mellitus kidney diseases. It is worth noting that the choice of western medicines is still quite confusing, and although many types of medicines can improve the blood sugar level of type 2 diabetes patients, the special advantages in preventing and treating type 2 diabetes kidney disease still remain to be defined; in the aspect of blood pressure control, angiotensin converting enzyme inhibitors can improve endothelial functions, control hypertension, protect the kidney, and calcium antagonists can lower mean arterial pressure and improve proteinuria, and have important roles in the treatment of diabetic nephropathy with hypertension.

In recent years, the research on type 2 diabetic nephropathy in traditional Chinese medicine is also deepened. The traditional Chinese medicine considers that the causes of the type 2 diabetes kidney disease include food tiredness, congenital endowment deficiency, six excesses injury and the like, which cause five internal organs deficiency, body fluid deficiency and fluid consumption, and cause various pathogens, and carries out treatment according to syndrome differentiation, clinical manifestations and the like, provides more traditional Chinese medicine formulas, has the characteristics of treating both principal and secondary aspects of diseases, flexibly adding and subtracting the medicines, safety, reliability and the like, and plays a role in multiple layers and multiple target points. The traditional Chinese medicine distinguishes diabetic kidney diseases into three stages of early stage, middle stage and late stage according to renal functions of chronic kidney diseases in Western medicine, wherein the early stage and the middle stage can be divided into qi-yin deficiency blood stasis syndrome, yang deficiency blood stasis syndrome and yin-yang deficiency blood stasis syndrome according to syndrome types, and the late stage can be divided into yin deficiency blood stasis damp turbidity syndrome, yang deficiency blood stasis damp turbidity syndrome and qi-blood yin-yang deficiency blood stasis damp turbidity syndrome. According to the characteristics of clinical type 2 diabetic kidney patients, the number of patients who are in line with the deficiency of both qi and yin and blood stasis is the greatest.

The traditional Chinese medicine for treating type 2 diabetes mellitus kidney disease can improve indexes and relevant clinical symptoms and delay disease progress, and has the advantages of good curative effect, low cost, less adverse reaction, various forms and the like. However, traditional Chinese medicine treatment also has many disadvantages: (1) The standardized assessment basis exists for the type of the kidney disease of type 2 diabetes, but the understanding of each doctor in clinic is still struggled for hundreds of doctors, and the theoretical system is difficult to unify; (2) The differentiation and administration of the kidney diseases of type 2 diabetes by each doctor are mainly based on experience and lack of evidence of syndrome-following medicine; (3) The large-scale, multi-center and normalized clinical research is lacked, and the research heterogeneity is high. Therefore, the research of the problems is further deepened, the traditional Chinese medicine treatment system for the kidney disease of the type 2 diabetes is perfected, the standardization of clinical research is emphasized, various treatment methods of the traditional Chinese medicine are comprehensively applied, and a standardized traditional Chinese medicine treatment mode is formed, so that the advantages of the traditional Chinese medicine in treating the kidney disease are better exerted.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney diseases and application thereof. Clinical research results prove that the traditional Chinese medicine preparation has the effects of protecting the kidney, obviously reducing urine protein excretion and the like, and has good practical application value.

In order to achieve the purpose, the invention adopts the following technical scheme:

in the first aspect of the invention, a core formula with good curative effect is obtained by aiming at the treatment of the kidney disease of the diabetes with the syndrome of deficiency of both qi and yin and blood stasis based on the concept of the traditional Chinese medicine and by integrating the clinical experiences of the inventor for many years, so that the pharmaceutical active ingredients of the traditional Chinese medicine preparation for treating the kidney disease of the type 2 diabetes comprise the following raw material medicines in parts by weight:

6-14 parts of radix pseudostellariae, 5-14 parts of raw astragalus membranaceus, 6-12 parts of wolfberry fruit, 6-9 parts of dogwood, 7-12 parts of poria cocos, 6-9 parts of dried orange peel, 6-10 parts of salvia miltiorrhiza, 3-6 parts of ligusticum wallichii, 6-10 parts of lotus seed pulp and 3-6 parts of cassia twig.

Specifically, the traditional Chinese medicine preparation can also comprise pharmaceutically acceptable auxiliary materials besides the active pharmaceutical ingredients.

In a second aspect of the invention, the application of the traditional Chinese medicine preparation in preparing a product for treating type 2 diabetes and kidney diseases is provided.

Compared with the prior art, the technical scheme of the invention has the following beneficial effects:

the traditional Chinese medicine preparation disclosed by the invention takes natural plants including radix pseudostellariae and raw radix astragali as core components, is matched with various traditional Chinese medicine components for tonifying qi, nourishing yin, promoting blood circulation and removing blood stasis, has the effects of protecting the kidney function of type 2 diabetes kidney diseases, reducing the excretion of urine protein and improving clinical symptoms, and has good practical application value as clinical researches prove that the traditional Chinese medicine preparation is safe and effective.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.

FIG. 1 shows BMI (body height-weight index) in clinical trial 1 of the present invention before and after treatment with the control group and the Chinese medicinal composition.

FIG. 2 shows the hip circumference before and after treatment of the control group and the Chinese herbal medicine in clinical trial 1 of the present invention.

Detailed Description

It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of the stated features, steps, operations, and/or combinations thereof, unless the context clearly indicates otherwise.

As introduced in the background art, the drugs for treating diabetic nephropathy in the prior art have certain defects, and in order to solve the technical problems, a core formula with good curative effect is obtained by integrating years of clinical experience of the inventor based on the Chinese traditional medicine concept in the treatment of diabetic nephropathy with deficiency of both qi and yin and blood stasis.

In view of this, in a typical embodiment of the present invention, a traditional Chinese medicine preparation for treating type 2 diabetes kidney disease is provided, wherein the pharmaceutical active ingredients comprise the following raw material medicines in parts by weight:

In another embodiment of the present invention, the active ingredient comprises the following raw material drugs in parts by weight:

10 parts of radix pseudostellariae, 10 parts of raw astragalus membranaceus, 10 parts of wolfberry fruit, 6 parts of dogwood, 10 parts of poria cocos, 6 parts of dried orange peel, 10 parts of salvia miltiorrhiza, 6 parts of ligusticum wallichii, 10 parts of lotus seed pulp and 6 parts of cassia twig.

The raw materials can be traditional Chinese medicine decoction pieces; meanwhile, in order to facilitate the quality control of the medicine, the raw material medicines may be traditional Chinese medicine formula granules prepared by extracting and concentrating traditional Chinese medicine decoction pieces processed according to the traditional standard, and are not particularly limited herein.

The active ingredients have the following specific effects:

taizi Shen is sweet, slightly bitter and neutral. Is nontoxic. It enters spleen and lung meridians. It is mainly used for replenishing qi to invigorate the spleen, promoting the production of body fluid and moistening the lung. The efficacy of the herbs is mild, qi and yin tonify, and the clear and tonics are good. Research shows that the radix pseudostellariae improves insulin resistance, relieves oxidative stress and remarkably regulates blood sugar balance by regulating an insulin signal conduction mechanism.

Raw Huang Qi, sweet and slightly warm. Is nontoxic. It enters lung and spleen meridians. It is mainly used to tonify qi, raise yang, induce diuresis to alleviate edema, promote fluid production and nourish blood. Huang Qi, is also known as Chang. Huang Qi is yellow in color and is the good tonic herb. The spleen is the source of vital energy generation in Zhongzhou, is the acquired root, and the astragalus root has special potency and is used for tonifying qi and reinforcing deficiency; for the life of a herb, they also have the actions of inducing diuresis to alleviate edema, and they do not have the fear of lingering pathogen but support healthy qi. Modern pharmacological research proves that astragalus has the effects of reducing platelet activation and aggregation, improving the high blood coagulation state, relieving oxygen radical injury, improving insulin resistance, protecting kidney capillary and reducing urine protein discharge.

Wolfberry fruit, sweet and neutral. Is nontoxic. It enters liver and kidney meridians. It is effective in nourishing liver and kidney, replenishing vital essence and improving eyesight. It is a key herb for deficiency of liver and kidney-yin, with strong and pure taste, moistening and nourishing, and specially for tonifying kidney, promoting the production of body fluid and replenishing qi. Research shows that the lycium barbarum polysaccharide can increase insulin sensitivity, reduce islet cell damage, relieve diabetic retinopathy, enhance the oxidation resistance of kidneys and delay the progress of diabetic nephropathy.

Dogwood is sour, astringent and slightly warm. Is nontoxic. It enters liver and kidney meridians. It is mainly indicated for tonifying liver and kidney, inducing astringency and relieving depletion. The body temperature is mainly nourishing, the taste is sour and mainly astringing, the nourishing of liver and kidney is beneficial to essence and energy and the astringing of essence and energy is not discharged. Experimental research finds that the cornus officinalis active ingredient iridoid glycoside can obviously reduce microalbuminuria, lighten the pathological change of the kidney, has good structural function protection effect and is widely applied to the prevention and treatment of diabetes and complications thereof.

Poria cocos, sweet, bland and neutral. Is nontoxic. It enters heart, lung, spleen and kidney meridians. It mainly induces diuresis and excretes dampness, invigorates spleen and calms heart. Tuckahoe, poria, sweet in flavor, can tonify the middle energizer and promote the restoration of consciousness. The middle energizer is also treated by spleen-earth, but the middle energizer cannot moisten lung, the lower cannot nourish kidney, water-damp is endogenous, and Poria has the actions of invigorating spleen-qi, inducing resuscitation and excreting dampness. Pharmacological research shows that pachyman can eliminate free radical, protect lipid peroxidation damage and obviously reduce blood sugar level.

Chen Pi is bitter, pungent and warm. Is nontoxic. It enters lung and spleen meridians. Regulate qi to invigorate spleen, dry dampness and resolve phlegm. Qi moving causes blood to move, and qi stagnation causes blood stasis. It is pungent and fragrant, moving and fleeing, and has the actions of moving qi and activating blood. Research shows that the pericarpium citri reticulatae has wide pharmacological action, plays a positive role in cardiovascular and cerebrovascular diseases, and has great curative effect on treating cardiovascular and cerebrovascular complications of diabetes.

Dan Shen is bitter and slightly cold. Is nontoxic. It enters heart and liver meridians. Promoting blood circulation, removing blood stasis, regulating menstruation, relieving pain, clearing away heart-fire, relieving restlessness, cooling blood, and eliminating carbuncle. Research shows that the salvia miltiorrhiza bunge is used as a high-efficiency medicine for promoting blood circulation and removing blood stasis, has pharmacological activity of improving microcirculation and expanding blood vessels, and can obviously improve the circulation of tiny blood vessels of eyeground and kidney of a diabetic patient.

Chuan Xiong, pungent and warm. Is nontoxic. It enters liver, gallbladder and pericardium meridians. Promote blood circulation and move qi, dispel wind and alleviate pain. It is a blood-qi-tonifying herb, because it can activate blood, remove stasis, move qi and relieve stagnation, because it is pungent, fragrant and moving in nature. Modern pharmacology shows that ligustrazine, ferulic acid, ligustilide and other components in the ligusticum wallichii have pharmacological activity of improving microcirculation and expanding blood vessels, and can obviously improve the circulation of tiny blood vessels of eyeground and kidney of a diabetic patient.

Lotus seed meat is sweet, astringent and mild. Is nontoxic. It enters spleen, kidney and heart meridians. Tonify spleen to check diarrhea, stop leukorrhagia, tonify kidney to arrest seminal emission, nourish heart to induce tranquilization. Research shows that the lotus seed pulp is beneficial to treating proteinuria in early stage of diabetic nephropathy. The classic Ming prescription, lotus seed drink for clearing away the heart fire, is a preparation for tonifying qi and yin and clearing away dampness and heat, and the records in Taiping Huimin He Ji Ju Fang that the medicine has the effects of warming and smoothing the property of medicine, keeping the medicine from cold and not hot, clearing away the heart fire and tranquilizing the mind frequently, nourishing deficiency by secret essence, moistening intestines and stomach and regulating blood and qi.

Gui Zhi, pungent, sweet and warm. It is nontoxic and enters heart, lung and bladder meridians. Induce sweating and release muscles, warm and dredge meridians, strengthen yang and regulate qi, and smooth pulse and descend adverse qi. It is pungent and warm in property and can be used for treating blood stasis. Modern pharmacological studies prove that cinnamaldehyde can regulate blood sugar down by up-regulating the expression of mouse skeletal muscle GLUT4 gene level, and can also enhance the antioxidant defense of active oxygen generated under the hyperglycemic condition, thereby protecting pancreatic islet beta cells from being lost and generating the hypoglycemic effect.

The traditional Chinese medicine theory considers that the disease of diabetes is always 'yin deficiency and dryness heat'. The basic pathogenesis of the stage is that qi and yin deficiency is accompanied by stasis, the qi and yin deficiency is the basis, the stasis is the target, and qi deficiency fails to promote blood circulation and leads to stasis; yin deficiency leading to internal heat, burning fluid consumption and blood stasis; the diabetic nephropathy is formed by stagnation of the kidney collaterals and chronic invasion of turbid pathogen. The key to the disease is the kidney, lung, spleen and liver.

So the deficiency of the body can be caused by warming and qi-flowing; the deficiency of essence can supplement the flavor of the food. In the traditional Chinese medicine preparation, the spleen is the source of middle soil and qi; the lung is the main part of the treatment of joint diseases and qi, and the radix pseudostellariae is used together with raw astragalus root to play the role of replenishing qi and tonifying deficiency and also has the effect of nourishing yin and promoting diuresis; the medlar and the dogwood are combined, so that the efficacy is strong and the function is great, the effects of tonifying the liver and kidney, nourishing true yin and astringing vital essence are achieved; poria cocos and dried orange peel have the effects of replenishing qi to invigorate the spleen, and excreting dampness and drying, so as to accord with the property of drying and strengthening Taiyin, and also guide turbidity to promote the production of body fluid; the chronic disease enters collaterals and the chronic disease reaches collaterals, the diabetic nephropathy is closely related to the 'collateral blood stasis', and the 'blood stasis' is the key of the pathogenesis of the diabetic nephropathy. In the formula, the salvia miltiorrhiza and the ligusticum wallichii have the effects of activating blood and promoting qi, dissolving stasis and dredging stagnation, and removing stasis without damaging the body resistance. The lotus seed pulp has the effects of tonifying spleen and kidney, and arresting seminal emission; gui Zhi warms yang and transforms yin, it is pungent and sweet to transform yang and warm and unblock blood vessels, it is sour and sweet to transform yin, and yang goes to yin, unblock yang and induce diuresis. The medicines are played together to play the roles of strengthening the spleen and tonifying the kidney, tonifying qi, nourishing yin and activating blood circulation, and also has the functions of excreting dampness and guiding turbidity, inducing astringency and vital essence, inducing diuresis and relieving swelling, and the effects are all achieved together.

Therefore, the traditional Chinese medicine preparation can effectively relieve qi and yin deficiency and blood stasis of diabetic nephropathy and has safety and effectiveness.

Specifically, the Chinese medicinal preparation may further include pharmaceutically acceptable excipients in addition to the above pharmaceutically active ingredients, wherein the content of the excipients in the Chinese medicinal preparation may be 1% by weight to 98% by weight, including but not limited to 5% by weight, 10% by weight, 20% by weight, 30% by weight, 40% by weight, 50% by weight, 60% by weight, 70% by weight, 80% by weight, 90% by weight, 95% by weight, 98% by weight, and usually about 80% by weight.

The administration dosage form of the traditional Chinese medicine preparation can be liquid dosage form and solid dosage form. The liquid dosage form can be true solution (such as decoction), colloid, microparticle, emulsion, or suspension. The solid dosage form can be tablet, capsule, pill, powder, granule, lyophilized powder for injection, clathrate, and landfill.

The Chinese medicinal preparation of the invention can contain common auxiliary materials, wherein the auxiliary materials include but are not limited to: ion exchangers, aluminum oxide, aluminum stearate, lecithin, serum proteins, such as human serum albumin, buffer substances, such as phosphates, glycerol, sorbates, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts or electrolytes, such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salts, magnesium trisilicate, polyvinylpyrrolidone, etc.

Oral tablets and capsules may contain excipients such as syrup, acacia, sorbitol, tragacanth, or polyvinylpyrrolidone; fillers, such as dextrin, lactose, sucrose, corn starch, calcium phosphate, sorbitol, glycine; lubricants, such as magnesium stearate, talc, polyethylene glycol, silica; a disintegrant such as potato starch, or an acceptable humectant such as sodium lauryl sulfate. Oral tablets may be coated by methods well known in the art of pharmacy.

The oral liquid can be made into water and oil suspension, solution, emulsion, syrup, etc., or made into dry product, and supplemented with water or other suitable medium before use. Such liquid preparations may contain conventional additives such as suspending agents, sorbitol, cellulose methyl ether, glucose syrup, gelatin, hydroxyethyl cellulose, carboxymethyl cellulose, aluminum stearate gel, hydrogenated edible fats and oils, emulsifying agents, such as lecithin, sorbitan monooleate, gum arabic; or a non-aqueous carrier including almond oil, fats and oils such as glycerin, ethylene glycol, or ethanol; preservatives, including methyl, propyl, or sorbic acid.

The specific preparation method of the Chinese medicinal preparation is not particularly limited, and the preparation can be produced according to corresponding dosage forms by a person skilled in the art. In a specific embodiment of the invention, the active pharmaceutical ingredients of the Chinese medicinal preparation can be prepared by a conventional decoction method, for example, after the raw materials are mixed, 8-10 times of clear water is added, the mixture is soaked for 10-30 minutes, and then the decoction is poured out after the mixture is decocted for 10-30 minutes; adding 5-8 times of clear water into the residue, decocting for 8-15 min, and mixing the two decoctions to obtain decoction. The decoction can be administered to patients. In order to facilitate the industrialized production, the preparation method also comprises the steps of concentrating the decoction under reduced pressure to obtain clear paste, and further mixing the clear paste with the auxiliary materials to prepare the corresponding Chinese medicinal preparation in each dosage form.

In another specific embodiment of the invention, the application of the traditional Chinese medicine preparation in preparing a product for treating type 2 diabetes mellitus and kidney diseases is provided.

In order to make the technical solutions of the present invention more clearly understood by those skilled in the art, the technical solutions of the present invention will be described in detail below with reference to specific embodiments.

Example 1

A traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney diseases comprises the following pharmaceutical active components: 10g of radix pseudostellariae, 10g of raw astragalus membranaceus, 10g of wolfberry fruit, 6g of dogwood, 10g of poria cocos, 6g of dried orange peel, 10g of salvia miltiorrhiza, 6g of ligusticum wallichii, 10g of lotus seed pulp and 6g of cassia twig; mixing the raw materials, adding 8 times of clear water, soaking for 15 minutes, decocting for 15 minutes, and pouring out the liquid medicine; adding 6 times of clear water into the residue, decocting for 10 min, and mixing the two decoctions to obtain decoction.

Example 2

A traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney disease comprises the following pharmaceutical active ingredients: 8g of radix pseudostellariae, 12g of raw astragalus membranaceus, 8g of wolfberry fruit, 8g of dogwood, 12g of poria cocos, 8g of dried orange peel, 8g of salvia miltiorrhiza, 3g of ligusticum wallichii, 8g of lotus seed pulp and 5g of cassia twig; mixing the raw materials, adding 8 times of clear water, soaking for 15 minutes, decocting for 15 minutes, and pouring out the liquid medicine; adding 6 times of clear water into the residue, decocting for 10 min, mixing the two decoctions, concentrating, adding dextrin, spray drying, granulating, and sieving to obtain granule.

Example 3

A traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney disease comprises the following pharmaceutical active ingredients: 14g of radix pseudostellariae, 5g of raw astragalus membranaceus, 12g of wolfberry fruit, 9g of dogwood, 7g of poria cocos, 7g of dried orange peel, 6g of salvia miltiorrhiza, 5g of ligusticum wallichii, 6g of lotus seed pulp and 3g of cassia twig; mixing the raw materials, adding 8 times of clear water, soaking for 15 minutes, decocting for 15 minutes, and pouring out the liquid medicine; adding 6 times of clear water into the residue, decocting for 10 min, mixing the two decoctions, concentrating, adding sucrose, stirring, and packaging to obtain oral liquid.

Clinical trial 1: evaluation of Kidney function protective Effect

50 diabetic nephropathy patients who meet the stage III and stage IV deficiency of both qi and yin and blood stasis are taken as subjects, and are randomly divided into a control group and a traditional Chinese medicine group. The kidney function is evaluated by collecting blood and urine specimen inspection indexes.

1. The subject requires:

1.1 number of subjects: the effective number of the cases is more than 30.

1.2 Subjects claim

1.2.1 subject inclusion requirements: (1) all group casesAll meet the Western medicine diagnosis standard of DM; (2) the patient who accords with DN albuminuria is reexamined within 3-6 months, and the UACR is more than or equal to 30mg/g for more than or equal to 2 times in 3 times of results, and accords with the staging standard of Mongensen stage III and IV; (3) eGFR is more than or equal to 45ml/min/1.73m ² The eGFR is reduced by less than or equal to 25 percent within 2 weeks; (4) the composition is suitable for patients with diabetes, nephropathy, qi and yin deficiency and blood stasis; (5) unlimited sex, age 18-80, body Mass Index (BMI) less than or equal to 45 kg/m; (6) HbA1c is 6-11%, FPG is less than or equal to 15mmol/l; (7) patients with hypertension need to take hypotensive medicine to make systolic pressure/diastolic pressure (SBP/DBP) less than or equal to 180/120 mmHg (sitting position); (8) the case data are complete, and the doctor voluntarily participates in the clinical test and actively cooperates with the doctor to sign on an informed consent.

1.2.2 subject exclusion requirements: (1) acute complications of diabetes such as diabetic ketosis, hypoglycemia coma and lactic acidosis occur recently; (2) patients with heart failure and myocardial infarction are merged; combined infection, malignant tumor and immune disease; (3) combined liver disease (ALT, AST or ALP levels three times higher than the upper normal limit); (4) male Scr is more than or equal to 1.50 mg/dl (114.4 mol/l) or female Scr is more than or equal to 1.40 mg/dl (106.8 mol/l); (5) in the last 3 months, the symptoms of kidney disease syndrome or acute and chronic nephritis, or proteinuria caused by other causes, such as strenuous exercise, infection fever diseases, gout, heart failure, urinary system infection and the like appear; (6) those treated with nephrotoxic drugs and antioxidants in approximately 2 weeks or with systemic glucocorticoid therapy; patients in need of dialysis or kidney transplant treatment; (7) a history of bariatric surgery or other surgery that can affect gastrointestinal absorption within 2 years; (8) patients with medication contraindications: (9) women in special physiological periods such as pregnancy, lactation and perinatal period, allergic constitution, and people who are allergic to the prescription for supplementing qi, nourishing yin and promoting blood circulation; in the R, there is a history of epidemic disease; other non-cooperatives, such as psychotic patients, abusers with alcohol abuse or psychoactive substances;

halt the test for other reasons;

other interventional medicines are simultaneously taken in within about 1 monthIs a clinical researcher.

2. Subject intervention: the traditional Chinese medicine is used for combined basic treatment of a traditional Chinese medicine preparation (decoction in example 1, one dose is taken every day and is orally taken twice in the morning and at night), a control group is used for conventional basic treatment, the intervention period of a subject is 12 weeks, and the kidney function and urinary protein excretion amount after the intervention are compared to change from a baseline. Meanwhile, the statistical results in table 1 and table 2 are illustrated as follows:

the classification data are described as n (%); such as: gender, female, 6 (20); described as 6 women, in 30 subjects in the Chinese medicinal group, the proportion is 20%.

The normal distribution continuous variable is described as mean ± standard deviation; for example, age, 52.77 ± 11.40; described as mean age 53.

The non-normally distributed continuous variables are described as median (upper and lower interquartile range), such as 7.92 fasting glucose (6.25, 10.62), 7.92 median blood glucose level, and 6.25-10.62 interquartile range.

The data result meets the requirements of statistical conditions.

TABLE 1 Baseline characteristics of the subjects in each of the traditional Chinese medicine group and the control group (n = 50)

TABLE 2 improvement of renal function and urinary protein excretion (n = 50) in subjects of each of the Chinese herbal medicine and the control group

Note: comparison before and after useP<0.05。

As can be seen from the data in Table 2, the invention has obvious effects of improving the kidney function of diabetic nephropathy patients and reducing the urinary microalbumin excretion.

3. Comparison of height-body-weight index (BMI) and hip circumference of control group and Chinese medicinal patients before and after treatment

Numerous studies have shown that higher height-body-weight index and hip circumference are associated with increased risk of diabetic nephropathy, and therefore, decreasing height-body-weight index and hip circumference during the treatment phase indicates treatment and recovery from diabetic nephropathy. Therefore, the height and weight index and hip circumference of the control group and the traditional Chinese medicine patients before and after treatment are compared.

3.1 comparison of BMI status before and after treatment for control and herbal patients

As shown by K-S test between the two groups before treatment,P=0.161 > 0.05, according to a normal distribution, as can be seen by t-test, t =0.288,P=0.775 > 0.05. Indicating that the BMI of the two groups of patients is not statistically significant and is comparable.

K-S test is respectively carried out before and after the control group and the traditional Chinese medicine treatment, and the results are allP=0.200 > 0.05, according to a normal distribution, as shown in table 3 and fig. 1, and by t-test, t =2.284 for the control group,P=0.034 < 0.05; the traditional Chinese medicine t =2.912,P=0.007 < 0.05, BMI decreased after both groups of treatments, statistically significant. The BMI of the Chinese medicinal composition after treatment is 24.66 +/-3.09 kg/m ² Not only significantly reduced (p) compared with the pretreatment<0.005 And the BMI reduction is larger than that of the control group.

3.2 Comparison of hip circumference before and after treatment of control group and Chinese medicinal patients

As shown by K-S test between the two groups before treatment,P=0.200 > 0.05, according to a normal distribution, and t-test shows that t = -0.894,P=0.376 > 0.05. The results show that the two groups of patients have no statistical significance on the hip circumference and are comparable.

As shown in Table 4 and FIG. 2, after treatment, the hip circumference of the control group was 98.05. + -. 5.54 cm, which was increased from 97.79. + -. 6.37 cm before treatment, so that the control group had no significant effect (p > 0.005) in improving the hip circumference; the hip circumference of the traditional Chinese medicine group after treatment is 96.78 +/-6.99 cm, and is obviously reduced compared with 99.60 +/-7.43 cm before treatment, which shows that the traditional Chinese medicine can obviously improve the hip circumference (p is less than 0.005), and the traditional Chinese medicine has statistical significance (p is less than 0,005) compared with a control group.

Clinical trial 2: evaluation of safety of the inventive Chinese medicinal preparation

In the clinical test 1, the vital signs of all subjects before and after treatment are stable, no obvious abnormal change is found in the evaluation of safety indexes of liver function, blood routine and blood coagulation function, no allergy and serious adverse reaction appear in two groups of patients during medication, and the clinical medication is safe and reliable.

It should be noted that the above-mentioned embodiments are only preferred embodiments of the present invention, and the present invention is not limited thereto, and although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications and equivalents can be made in the technical solutions described in the foregoing embodiments, or equivalents thereof. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention. Although the present invention has been described with reference to the specific embodiments, it should be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.

Claims

1. The traditional Chinese medicine preparation for treating type 2 diabetes mellitus kidney disease is characterized in that the active pharmaceutical ingredients are the following raw material medicines in parts by weight: 6-14 parts of radix pseudostellariae, 5-14 parts of raw astragalus membranaceus, 6-12 parts of wolfberry fruit, 6-9 parts of dogwood, 7-12 parts of poria cocos, 6-9 parts of dried orange peel, 6-10 parts of salvia miltiorrhiza, 3-6 parts of ligusticum wallichii, 6-10 parts of lotus seed pulp and 3-6 parts of cassia twig; the traditional Chinese medicine preparation comprises pharmaceutically acceptable auxiliary materials.

2. The traditional Chinese medicine preparation of claim 1, wherein the active ingredients comprise the following raw material medicines in parts by weight: 10 parts of radix pseudostellariae, 10 parts of raw astragalus membranaceus, 10 parts of wolfberry fruit, 6 parts of dogwood, 10 parts of poria cocos, 6 parts of dried orange peel, 10 parts of salvia miltiorrhiza, 6 parts of ligusticum wallichii, 10 parts of lotus seed pulp and 6 parts of cassia twig.

3. The Chinese medicinal preparation of claim 1, wherein the content of the adjuvant in the Chinese medicinal preparation is 1% by weight to 98% by weight.

4. The Chinese medicinal preparation of claim 1, wherein the administration form of the Chinese medicinal preparation is a liquid form or a solid form.

5. The Chinese medicinal formulation of claim 4, wherein the liquid dosage forms comprise true solutions, particulate dosage forms, and suspension dosage forms.

6. The traditional Chinese medicine preparation of claim 4, wherein the liquid dosage forms include colloidal and emulsion dosage forms.

7. The Chinese medicinal preparation of claim 1, wherein the adjuvants comprise an ion exchanger and a buffer substance.

8. The traditional Chinese medicine preparation of claim 4, wherein the solid dosage forms comprise oral tablets and capsules.

9. The traditional Chinese medicine preparation of claim 8, wherein the oral tablets and capsules contain excipients.

10. The use of a Chinese medicinal preparation according to any one of claims 1 to 9 in the manufacture of a medicament for the treatment of type 2 diabetes mellitus renal disease.