CN117462611A - A traditional Chinese medicine composition for treating early diabetic nephropathy and its preparation method - Google Patents

Abstract

The invention belongs to the technical field of diabetic nephropathy medicines, and in particular relates to a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following main components in parts by weight: 20-40 parts of astragalus membranaceus, 10-20 parts of radix pseudostellariae, 20-40 parts of radix rehmanniae, 10-20 parts of dogwood, 10-20 parts of semen Abutili, 10-20 parts of semen euryales, 9-15 parts of cortex mori, 10-20 parts of herba lycopi, 3-6 parts of leech and 3-6 parts of scorpion.

Description

A traditional Chinese medicine composition for treating early diabetic nephropathy and its preparation method

Technical field

The invention belongs to the technical field of diabetic nephropathy drugs, and specifically relates to a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof.

Background technique

Diabetic kidney disease (DKD) is one of the common complications of diabetes (diabetes mellitus, DM). The incidence rate among DM patients is about 25% to 40%, and it has been increasing in recent years. With the continuous expansion of the DM population base in my country, DKD has become the leading cause of end-stage renal disease. The mechanism of DKD is not yet fully understood. Clinically, it is believed that it is mainly related to long-term high blood sugar levels that cause glucose metabolism disorders, peroxidative stress reactions, and changes in renal vasodynamics in the kidneys. In addition, it is also related to the body's immune mechanism and genetic factors. .

The pathological characteristics of DKD patients mainly include changes in renal microvessels and glomeruli. In the early stage, the basement membrane of glomerular capillaries first appears diffusely thickened, and the mesangial area matrix increases, which further leads to the formation of nodular glomerulosclerosis and the appearance of proteinuria. The filtration rate decreases, followed by symptoms such as microalbuminuria and lower limb edema. As the disease progresses and the renal function damage enters the clinical stage, the disease will develop progressively, the glomerular filtration rate will continue to decrease, and the patient’s The clinical symptoms are also getting worse day by day. Without timely treatment and intervention, it will cause renal failure, uremia symptoms, and even death of the patient. DKD is a fatal complication of diabetes and one of the main causes of death in patients with diabetes. It also has a high risk of disability. Since irreversible renal pathological damage has not yet occurred in patients with early-stage DKD, active treatment and intervention are of great significance to control the progression of the disease, improve patient prognosis, and reduce the rate of death and disability. End-stage DKD patients can only maintain their lives through continuous hemodialysis, peritoneal dialysis and other renal replacement therapies. The quality of life of patients is poor. Kidney transplantation technology is currently difficult to implement in our country and is expensive, which will also bring problems to patients. comes with a huge financial burden.

Currently, Western medicine has no specific treatment for early-stage DKD. It mainly focuses on three aspects: lowering blood sugar, lowering lipids, and lowering blood pressure. ACEI/ARB drugs are often used in order to control the progression of the disease. The emergence of new drugs such as sodium-glucose synergist protein 2 inhibitors provides new and good treatment options for the treatment of DKD patients. Studies have shown that canagliflozin can effectively reduce the risk of renal and cardiovascular events, has strong safety, and can control patients' blood pressure and blood sugar levels. These Western medicine treatment measures have a clear role in delaying the disease process of DKD, but the therapeutic effect has certain limitations and cannot fully meet the requirements for widespread clinical use.

The Chinese medical theory believes that DKD is derived from "diabetes disease". Contemporary doctors define it as "diabetes disease and kidney disease", which belongs to deficiency in origin and syndrome in which deficiency of viscera, qi and blood is the root cause, phlegm alone, dampness and heat, and The reality of blood stasis is the standard. Multiple studies have shown that the use of traditional Chinese medicine to treat early-stage DKD has significant effects in reducing blood sugar and serum creatinine levels, increasing insulin sensitivity, and improving kidney function. It can effectively reduce clinical symptoms, improve prognosis, and delay the progression of DKD. Traditional Chinese medicine treatment It has few adverse reactions, high safety in clinical use, low financial burden on patients, and high acceptance. However, there is currently no complete consensus on the syndrome differentiation and treatment of DKD using traditional Chinese medicine. Traditional Chinese medicine still lacks a unified and effective treatment plan for the prevention and treatment of early-stage DKD, and the effectiveness still needs to be improved. Currently, traditional Chinese medicine compounds have been used in the clinical treatment of this disease, but the efficacy is average. Although it has a certain effect on lowering blood sugar and blood creatinine, it cannot correct insulin secretion disorders, protect kidney function, comprehensively improve clinical symptoms, and delay disease progression. On the other hand, the effect is still unstable.

Contents of the invention

In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof. The traditional Chinese medicine composition combines a kidney-tonifying and spleen-tonifying medicine with a blood-activating and collateral-activating medicine, and is tonic without being greasy. Attacking evil without harming righteousness, it has the effect of strengthening the spleen and replenishing qi, tonifying the kidneys, activating blood and unblocking the collaterals. It has significant effects on lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving the quality of life of patients.

The inventor combined the traditional medical theory of the motherland, from the physiological functions of the spleen and kidneys to the basic pathogenesis of early diabetic nephropathy, and combined with the clinical practice process, discovered that the use of prescriptions based on the principles of strengthening the spleen and replenishing qi, tonifying the kidney, activating blood circulation and dredging the collaterals can be used to treat early diabetic nephropathy. When treating patients who meet the pathogenesis characteristics of spleen and kidney deficiency and blood stasis syndrome in traditional Chinese medicine, it can especially improve symptoms such as fatigue and fatigue, and has obvious effects on lowering blood sugar and blood creatinine. The invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy. The traditional Chinese medicine composition is a combination of a kidney-tonifying and spleen-tonifying medicine and a blood-activating and collateral-activating medicine, which can nourish the body without making it greasy, attack evil without damaging the body, and jointly strengthen the spleen. It has the effect of replenishing qi, nourishing kidneys, activating blood and unblocking collaterals, and has significant effects on lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving patients' quality of life.

Although there is no name for diabetic nephropathy in traditional Chinese medicine, the understanding of it has a long history. It belongs to the syndrome of diabetes mellitus. The syndrome of diabetes mellitus is combined with fullness, water disease, exhaustion, edema, and turbid urine mentioned in the works of doctors of the past dynasties. , Shenxiao, Guange, etc. are all related diseases and syndromes. Therefore, diabetic nephropathy is generally classified into "edema", "urinary turbidity", "Shenxiao", "gaolin" and "Guange" in traditional Chinese medicine. Because the location of diabetic nephropathy is always in the kidneys, and this kind of kidney disease is secondary to diabetes, some Chinese medicine scholars directly call it "diabetes nephropathy". The main symptoms of early diabetic nephropathy are dry mouth and desire to drink, fatigue, soreness in waist and knees, edema, pain and numbness in limbs, polyuria, long and clear urine or turbid urine, dark tongue or ecchymosis, and weak or heavy pulse. These clinical manifestations suggest to the inventor that in fact spleen and kidney deficiency and blood stasis and internal obstruction are the main pathogenesis of early diabetic nephropathy.

The spleen and stomach are acquired foundations and the source of Qi and blood biochemistry, but the biochemistry of the spleen relies on the encouragement of kidney yang, and the sealing of the kidneys relies on the spleen's biochemistry of yin and fluid for nourishment. The protein in urine belongs to the subtle substances of water and grain in the human body. Its metamorphosis, solidification and absorption are all controlled by the spleen, and its storage is done by the kidneys. It should be used as energy to nourish the body's limbs and bones without being lost. "Suwen: Different Treatise on Meridians": "Drink in the stomach, swim on the essence, go up to the spleen, circle and disperse the essence, return to the lungs, regulate water channels, and pass down to the bladder. The water essence is spread all over the five meridians." "Eating qi enters the stomach, disperses semen in the liver, and obscene qi circulates in the tendons. Intestinal qi enters the stomach, turbid qi returns to the heart, and obscene qi travels to the pulse; pulse qi flows through, and meridian qi returns to the lungs, which move toward the meridians, and infuse semen into the skin." The process of microtransformation and absorption of water and grains is explained. "Essentials of Syndrome and Treatment" "Three disappears for a long time and the urine does not smell bad, but becomes sweet and boils in the drowning bucket, the disease is serious. It is more like pig fat floating on the drowning surface, like candle tears splashing on the edge of the bucket, this essence is exhausted Yes, it is difficult to treat. Water in the world and the human body is both sweet and salty. Sweetness causes anger, and saltyness causes death. The urination of stagnant water is salty in nature but sweet in nature. It is the release of vitality, and the vitality of the spleen and stomach sinks." Chen Shi. Select from "Syndrome Differentiation Record": "The symptoms of thirst are all due to spleen and kidney failure. Spleen is bad and earth cannot resist water. Kidney failure means water cannot resist fire. The combination of the two causes the disease." The above explains spleen and kidney deficiency. It is the key cause and key link in the onset of early diabetes and nephropathy.

In summary, the inventor adheres to the perspective of treatment from the spleen and kidneys and believes that tonifying the spleen and kidneys is the key. In clinical practice, there are many patients with spleen and kidney deficiency and blood stasis. Therefore, we should pay attention to treating the spleen and kidneys on the basis of syndrome differentiation and treatment. The spleen is the foundation of acquired diseases, and the kidneys are the foundation of innateness. The nourishment of Qi and blood throughout the body depends on them. Only when the spleen is healthy and the kidney Qi is sufficient can Qi and blood be sufficient. , the Qi movement is smooth, and it is also conducive to the removal of blood stasis, thereby achieving the effect of improving the patient's blood sugar and blood creatinine levels and delaying the progression of diabetic nephropathy. The above is the treatment mechanism proposed by the inventor, and it is applied to the specific treatment process:

A traditional Chinese medicine composition for treating early diabetic nephropathy, the main components of which are calculated in parts by weight:

20-40 parts of Astragalus membranaceus, 10-20 parts of Radix Pseudostellariae, 20-40 parts of Rehmannia glutinosa, 10-20 parts of Dogwood, 10-20 parts of mallow seeds, 10-20 parts of Gorgon fruit, 9-15 parts of Morus alba, Zeelandia 10-20 servings, 3-6 servings of leeches, 3-6 servings of whole scorpions. The best therapeutic effect can be obtained within the above dosage range. If the dosage of the drug is too large or too small, the priority of the pathogenesis surrounding the prescription will change.

Preferably, the main components of the traditional Chinese medicine composition are calculated in parts by weight:

25-35 parts of Astragalus membranaceus, 12-18 parts of Radix Pseudostellariae, 25-35 parts of Rehmannia glutinosa, 12-18 parts of Dogwood, 10-15 parts of mallow seeds, 12-18 parts of Gorgon fruit, 10-15 parts of Morus alba bark, Zeelandia 10-15 parts, 3-4 parts of leeches, 3-4 parts of whole scorpion.

In the prescription of the present invention, Astragalus membranaceus and Rehmannia glutinosa are the dominant ones. Astragalus is sweet in taste and slightly warm in nature. Rehmannia glutinosa is sweet in taste and cold in nature. It is sweet and warm to nourish qi, and sweet and cold to nourish yin. Astragalus and rehmannia glutinosa are used together to strengthen the spleen and qi, nourish yin and promote body fluid. Qi and yin help each other. Both blood and blood are replenished, and Qi is sufficient to promote blood circulation. It targets the basic pathogenesis of early diabetic nephropathy due to spleen and kidney deficiency and blood stasis and internal obstruction.

Take Radix Pseudostellariae, Cornus officinalis and Gorgon as root. Radix Pseudostellariae is sweet, slightly bitter, flat, nourishes qi, strengthens the spleen, promotes fluid production and moisturizes the lungs; Dogwood is sour, astringent, slightly warm, has the effect of warming the liver and kidneys, astringing and fixing astringency; Gorgon Fruit , sweet, astringent, flat, can nourish the spleen and remove dampness, nourish the kidneys and strengthen essence. All the medicines are ministerial drugs, which are both yin and yang tonic, and help the monarch drug to strengthen the spleen and kidneys, and make it nourishing but not greasy, and astringent but not leaving dampness.

Take matsutake seeds, mulberry white bark and adenophora as auxiliary ingredients. Mallow seeds are sweet, cold, diuretic and relieve stranguria, smooth intestines and laxative; mulberry white bark, sweet, cold, purge the lungs and relieve asthma, diuretic and reduce swelling; adenophora. , bitter, pungent, slightly warm, activates blood circulation and regulates menstruation, removes blood stasis and eliminates carbuncle, diuresis and swelling. All the medicines are adjuvant medicines to achieve the effects of activating blood circulation, promoting menstruation, diuresis and reducing swelling.

Use leech and whole scorpion as ingredients. Leech is salty, bitter, and flat. It is good at breaking blood and removing blood stasis to stimulate menstruation. Whole scorpion is pungent and flat. It has the effects of calming wind and relieving spasm, attacking toxins and dissipating stagnation, unblocking collaterals and relieving pain. The two medicines reach the meridians of the limbs well and convey the power of the medicines to the whole body. The combination of various medicines can jointly strengthen the spleen and qi, nourish the kidneys, activate blood circulation and unblock meridians.

The more specific mechanisms of Chinese and Western medicines for each medicine are as follows:

Astragalus: First seen in "Fifty-Two Prescriptions for Diseases", it tastes sweet and slightly warm, returns to the spleen and lung meridian, is sweet and warm, and is sweet and light in expelling benefits. Yiweiguobiao. "Medicine Zhongshenxilu" says: "It has the best effect of replenishing qi...it is called Qiye". Astragalus controls the release of profibrotic factors, increases the secretion of inflammatory factors, and participates in the anti-inflammatory response, thereby adjusting the function of the autophagy mechanism and reducing oxidative stress and other functions, thereby improving the renal function of DKD patients and delaying the progression of DKD. the goal of.

Radix Pseudostellariae: sweet, slightly bitter, neutral, returns to the spleen and lung meridian, has the effects of replenishing qi and strengthening the spleen, producing body fluid and moistening the lungs. Studies have shown that Pseudostellariae heterogeneous glucan H-1-2 (172) can enhance insulin secretion, improve blood sugar and blood lipid levels, and improve glucose and insulin tolerance; Pseudostellariae cyclic peptides and Pseudostellariae polysaccharides can activate different The signaling pathway exerts anti-inflammatory effects; Pseudostellariae polysaccharides have cytoprotective effects.

Rehmannia glutinosa: first recorded in "Shen Nong's Materia Medica", it tastes sweet, bitter, and cold in nature. It mainly enters the heart, liver, and kidney meridians, clears away heat and cools blood, nourishes yin and promotes fluid production. "Famous Doctors": "Replenishes the five internal organs, relieves internal injuries, unblocks blood vessels, and replenishes qi and strength." Entering the kidney meridian can nourish kidney yin and reduce deficiency fire. Research has found that the active ingredients of raw rehmannia glutinosa (rehmannia glutinosa oligosaccharides, rehmannia glutinosa oligosaccharides, and rehmannia glutinosa glycosides) can lower blood sugar and improve insulin resistance. Among them, rehmannia glutinosa oligosaccharides rebuild the endocrine regulatory network and maintain blood sugar homeostasis. Rehmannia glutinosa has antioxidant and lipid peroxidation damage, improves blood rheology, reduces Hs-CRP, IL-6, and TNF-α levels and inhibits the expression of inflammatory pathways, thus having anti-inflammatory effects.

Dogwood: sour, astringent, slightly warm, returns to the liver and kidney meridians, warms and nourishes the liver and kidneys, and astringes and solidifies astringency. It not only nourishes kidney yang, but also nourishes kidney essence. It is a product that nourishes both yin and yang. "Lei Gong Pao Zhi Lun": "Zhuang Yuan Qi, Secret Essence." Modern chemical research shows that Cornus officinalis contains a variety of active ingredients, which reduce the inflammatory response by downregulating the phosphorylation expression of Akt, thereby protecting the kidneys. Among them, total glycosides of Cornifolia can reduce renal AGEs and increase SOD activity; monoside can reduce blood sugar, triglycerides and cholesterol, reduce urinary protein, reduce serum urea nitrogen, protect islet cells, and prevent endothelial cells, mesangial cells and podocytes. Hyperplasia and degeneration, and has a protective effect on podocyte apoptosis; loganin reduces renal oxidative stress by inhibiting the AGE-RAGE pathway, thereby alleviating the development of DKD. It can also improve endoplasmic reticulum stress of GMCs, alleviate inflammatory reactions and organelle damage. .

Mallow seeds: sweet in taste and cold in nature. It belongs to the large intestine, small intestine and bladder meridians. It can diuretic, relieve stranguria, smooth the intestines, relieve constipation, and release breast milk. Treat edema. Studies have found that mallow seeds, a plant in the Malvaceae family, have anti-inflammatory, antibacterial, and anti-cancer effects. Mallow seeds are rich in plant protein, anthocyanins, and polysaccharides, which can enhance one's own resistance and the ability to repair tissue damage; it contains a large amount of Linoleic acid has a strong inhibitory effect on inflammation.

Gorgon fruit: sweet, astringent, neutral in nature, returns to the spleen and kidney meridian, sweet, tonic, astringent and astringent, flat but not biased, with mild medicinal effect. It can nourish the spleen and remove dampness, nourish the kidneys and consolidate essence. It has the advantages of tonifying but not greasy, astringent but not retaining dampness. It is mainly used to treat chronic diarrhea due to spleen deficiency and kidney deficiency where the lower yuan is not consolidated. Replenishing the kidneys and strengthening essence, nourishing the spleen and stopping diarrhea, removing dampness and stopping bandages. "Materia Medica Qiuzhen" says: "It tastes sweet and nourishes the spleen, so it can diuresis, so that diarrhea and abdominal pain can be cured. It tastes astringent and strengthens the kidneys, so it can hold one's breath, so that incontinence and urination can be cured." Pharmacological research shows that Gorgon fruit The alcohol extract can reduce glomerulosclerosis in DKD rats, reduce 24h urinary protein and urinary microalbumin content, and has certain antioxidant effects. Clinical studies also show that when Gorgon is used to treat early-stage DKD, the urinary albumin excretion rate, urinary microalbumin, serum creatinine and other indicators in the treatment group are significantly lower than those in the control group.

Mulberry bark: sweet in taste, cold in nature, returns to the lung meridian, purges the lungs and relieves asthma, diuresis and reduces swelling. Podocytes, together with the glomerular basement membrane and vascular endothelial cells, constitute the filtration barrier of the kidney and play an important role in maintaining the normal structure and function of the glomerulus. Experimental results show that flavonoid extract of Morus alba may increase the regulation of miR- 223-3p expression reduces high glucose-induced podocyte damage.

Zelania: first recorded in "Shen Nong's Materia Medica", it tastes bitter, pungent, slightly warm, returns to the liver and spleen meridians, has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncle, diuresis and reducing swelling. "Rihuazi Materia Medica" discusses it: "It clears the nine orifices, sharpens the joints, nourishes blood and qi, breaks the blood, and eliminates the syndrome." Research has found that adenophora can inhibit the TGF-β1 signaling pathway of mesangial cells and podocytes, and down-regulate PKCα, PKCβⅠ can reduce mesangial hyperplasia, up-regulate nephrin expression in podocytes, alleviate podocyte damage, reduce proteinuria, and improve DKD; Zeelan-containing serum can up-regulate Syndecan-1, Glypican-1, CD31 protein and mRNA expression, and inhibit α-SMA and its mRNA expression, suggesting that Zeelandia alleviates high glucose-induced damage to GECs by protecting glycocalyx core protein.

Leech: salty, bitter, flat, slightly toxic, returns to the liver meridian, good at breaking blood, removing blood stasis, and stimulating menstruation. Zhang Xichun said: "All blood-breaking medicines mostly hurt the Qi, but the salty taste of leeches penetrates the blood without any damage to the Qi. And after taking it, you don't feel any pain in the abdomen, nor do you feel that it is broken, and the blood stasis disappears silently. Intangible, it is a truly good medicine." Hirudin can enhance the body's sensitivity to its own insulin and strengthen the tissue's ability to reuptake and utilize blood sugar, thereby achieving long-term and stable blood sugar control. Leeches and their extracts can reduce podocyte damage by inhibiting thrombin activity, thereby slowing down renal fibrosis and protecting the kidneys; leeches can also improve glomerular filtration function by maintaining the podocyte skeleton shape and density, reducing Proteinuria occurs. In addition, leeches and their active ingredients may alleviate and treat blood stasis syndrome by regulating lipid metabolism disorders.

Whole scorpion: pungent, flat, poisonous, returns to the liver meridian, has the functions of calming wind and relieving spasm, attacking toxins and dissipating stagnation, unblocking collaterals and relieving pain. Whole scorpion may reduce the pathological damage of kidneys in DKD rats by increasing the expression of renal BMP-7, reducing the accumulation of renal ECM and delaying the process of renal fibrosis.

Furthermore, the inventor reasonably optimized the above-mentioned pharmaceutical components and finally obtained the following technical solution: The main components of the pharmaceutical are calculated in parts by weight:

30 parts of Astragalus membranaceus, 15 parts of Radix Pseudostellariae, 30 parts of Rehmannia glutinosa, 15 parts of Dogwood, 12 parts of Mallow seeds, 15 parts of Gorgon fruit, 12 parts of Morus alba, 12 parts of Adenophora, 3 parts of leeches, and 3 parts of whole scorpion.

First, weigh out each traditional Chinese medicine according to the ratio of raw materials, then add water until the surface of the medicine is covered by 3-5 cm, soak for 1.5 hours, boil over high heat, then simmer over low heat for 40-50 minutes, filter out the medicine juice and put it into the medicine residue. Add water again until the surface of the medicinal residue is covered by 1-2 cm, bring to a boil over high heat, and then simmer over low heat for 20-30 minutes. Filter out the medicinal juice and combine it with the previous medicinal juice to obtain the traditional Chinese medicine decoction.

Instructions for taking: 1 dose per day, twice in the morning and evening, taken warmly 1-2 hours after meals.

The medicine obtained by utilizing the prescription and preparation method of the present invention can be used in clinical practice, and the curative effect is very significant. The inventor has proved through a large number of experiments that the pharmaceutical composition of the present invention can reduce blood sugar and blood creatinine, improve symptoms of diabetic nephropathy, and improve The effect is remarkable in terms of patients' quality of life and other aspects. Therefore, the technical solution of the present invention has obvious advantages from theory to clinical effect. In actual disease conditions, the prescription of the present invention can be selected to be used together with western medicine.

To sum up, the present invention combines the theory of traditional Chinese medicine and the theory of combination of disease and syndrome to obtain a traditional Chinese medicine composition specially used for the treatment of early diabetic nephropathy. It can strengthen the spleen and replenish qi, nourish the kidneys, activate blood circulation and unblock the meridians. It has significant effects on lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving the quality of life of patients.

Detailed ways

The present invention is not limited by the following examples. The following examples and descriptions only illustrate the principles of the present invention. There will be various changes and improvements in the present invention without departing from the spirit and scope of the present invention. These changes and modifications are within the scope of the claimed invention.

Example 1

A traditional Chinese medicine composition for treating early diabetic nephropathy, prepared from the following medicines:

30g of Astragalus membranaceus, 15g of Radix Pseudostellariae, 30g of Rehmannia glutinosa, 15g of Cornus officinale, 12g of mallow seeds, 15g of Gorgon fruit, 12g of Morus bark, 12g of Adenophora, 3g of leech, 3g of whole scorpion;

Its preparation method is as follows:

(1) First, weigh out each traditional Chinese medicine according to the ratio of raw materials, mix evenly, add 1200ml cold water, and soak for 1.5 hours;

(2) Boil the mixed raw medicine over high heat, simmer over low heat for 45 minutes, and filter with gauze to obtain the filtrate and medicine residue;

(3) Mix the medicinal residue obtained in step (2) with 550ml of hot water and boil it. The hot water is pure water with a temperature of 80°C. Boil it over high heat. Boil over low heat for 25 minutes and then filter it again with gauze to obtain the filtrate and medicine residue;

(4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3) to obtain a traditional Chinese medicine decoction for treating early diabetic nephropathy.

Example 2

A traditional Chinese medicine composition for treating early diabetic nephropathy, prepared from the following medicines:

20g of Astragalus membranaceus, 12g of Radix Pseudostellariae, 20g of Rehmannia glutinosa, 12g of Cornus officinale, 10g of mallow seeds, 12g of Gorgon fruit, 9g of Morus alba bark, 10g of Adenophora adenophora, 3g of leech, 3g of whole scorpion;

Its preparation method is as follows:

(1) First, weigh out each traditional Chinese medicine according to the ratio of raw materials, mix evenly, add 900ml cold water, and soak for 1.5 hours;

(2) Boil the mixed raw materials over high heat, simmer over low heat for 40 minutes, and filter with gauze to obtain the filtrate and medicinal residue;

(3) Mix the medicinal residue obtained in step (2) with 400 ml of hot water and decoct it. The hot water is pure water with a temperature of 80°C. Boil over high heat. After decoction over low heat for 20 minutes, filter again with gauze to obtain the filtrate and medicine residue;

(4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3) to obtain a traditional Chinese medicine decoction for early diabetic nephropathy.

Example 3

A traditional Chinese medicine composition for treating early diabetic nephropathy, prepared from the following medicines:

40g of Astragalus membranaceus, 18g of Radix Pseudostellariae, 40g of Rehmannia glutinosa, 18g of Cornus officinale, 18g of mallow seeds, 18g of Gorgon fruit, 15g of mulberry bark, 18g of Adenophora adenophora, 6g of leech, 6g of whole scorpion;

Its preparation method is as follows:

(1) First, weigh out each traditional Chinese medicine according to the ratio of raw materials, mix evenly, add 1500ml cold water, and soak for 1.5 hours;

(2) Boil the mixed raw materials over high heat, simmer over low heat for 50 minutes, and filter with gauze to obtain the filtrate and medicinal residue;

(3) Mix the medicinal residue obtained in step (2) with 600ml of hot water and decoct it. The hot water is pure water with a temperature of 80°C. Boil over high heat. After simmering for 30 minutes, filter again with gauze to obtain the filtrate and medicine residue;

(4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3) to obtain a traditional Chinese medicine decoction for early diabetic nephropathy.

Example 4

A traditional Chinese medicine composition for treating early diabetic nephropathy, prepared from the following medicines:

25g of astragalus, 12g of Radix Pseudostellariae, 25g of Rehmannia glutinosa, 12g of Dogwood, 10g of mallow seeds, 12g of Gorgon fruit, 10g of mulberry bark, 10g of Adenophora, 3g of leech, 3g of whole scorpion;

Its preparation method is as follows:

(1) First weigh out each traditional Chinese medicine according to the ratio of raw materials, mix evenly, add 1000ml cold water, and soak for 1.5 hours;

(2) Boil the mixed raw materials over high heat, simmer over low heat for 40 minutes, and filter with gauze to obtain the filtrate and medicinal residue;

(3) Mix the medicinal residue obtained in step (2) with 450 ml of hot water and decoct it. The hot water is pure water with a temperature of 80°C. Boil over high heat, simmer over low heat for 20 minutes and filter again with gauze. Obtain filtrate and medicinal residue;

(4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3) to obtain a traditional Chinese medicine decoction for early diabetic nephropathy.

Example 5

A traditional Chinese medicine composition for treating early diabetic nephropathy, prepared from the following medicines:

35g of Astragalus membranaceus, 18g of Radix Pseudostellariae, 35g of Rehmannia glutinosa, 18g of Cornus officinale, 15g of mallow seeds, 18g of Gorgon fruit, 15g of mulberry bark, 15g of Adenophora adenophora, 4g of leech, 4g of whole scorpion;

Its preparation method is as follows:

(1) First, weigh out each traditional Chinese medicine according to the ratio of raw materials, mix evenly, add 1400ml of cold water, and soak for 1.5 hours;

(2) Boil the mixed raw medicine over high heat, simmer over low heat for 45 minutes, and filter with gauze to obtain the filtrate and medicine residue;

(3) Mix the medicinal residue obtained in step (2) with 550 ml of hot water and decoct it. The hot water is purified water with a temperature of 80°C. Boil over high heat, simmer over low heat for 30 minutes and filter again with gauze. Obtain filtrate and medicinal residue;

(4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3) to obtain a traditional Chinese medicine decoction for early diabetic nephropathy.

Experimental example

1.Clinical data

1.1 Source of research objects and sample size

The case data come from outpatients and inpatients in the Department of Endocrinology of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2022 to January 2023. This case selected a total of 60 patients who had been diagnosed with early stage diabetic nephropathy according to traditional Chinese medicine syndrome of spleen and kidney deficiency and blood stasis and required drug intervention.

1.2 Diagnostic criteria

1.2.1 Western medicine diagnostic standards

Diabetes standards refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition), see Table 1. The DKD standard refers to the Chinese Clinical Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2019 Edition).

Table 1 Diagnostic criteria for diabetes

Diagnostic criteria for DKD: After it is clear that hyperglycemia is the cause of kidney damage and other causes of chronic kidney disease are excluded, those with at least one of the following can be diagnosed with diabetic nephropathy:

① Under the condition of excluding the influence of interfering factors, at least two random urine albumin to creatinine ratio (UACR) ≥ 30 mg/g in 3 examinations within 3 to 6 months; ② Estimated renal diameter The estimated glomerular filtration rate (eGFR) is <60ml/(min·1.73m2) and lasts for more than 3 months.

Diagnostic criteria for early DKD: UAER (Urinary albumin excretion rate, UAER) 20-200μg/min or 30-300mg/24h, persistent microalbuminuria; blood pressure slightly elevated, lowering blood pressure can partially reduce urinary microalbumin of discharge.

1.2.2 Traditional Chinese Medicine Diagnostic Standards

According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and with reference to the 2011 "Diagnosis and Treatment Standards of Traditional Chinese and Western Medicine for Diabetic Kidney Disease"

Main symptoms: ① Turbid urine ② Poor appetite and loose stools ③ Soreness and coldness of waist and knees.

Secondary symptoms: ① fatigue and fatigue; ② heat in the palms, soles and heart; ③ thirsty and fond of drinking; ④ edema of the limbs.

Tongue and pulse: ① Dark red tongue, thin white fur with ecchymosis, tooth marks on the edges, dark or light sublingual veins; ② Thready or astringent pulse.

Anyone who has two main symptoms plus one secondary symptom or one main symptom plus two secondary symptoms or more can be diagnosed by referring to the tongue and pulse.

1.3 Inclusion criteria

(1) Meet the criteria for diagnosis of type 2 diabetes;

(2) Meet the criteria for diagnosis of DKD and early DKD;

(3) Traditional Chinese medicine syndrome differentiation is spleen and kidney deficiency and blood stasis type;

(4) Age range is 30 to 75 years old, gender is not limited;

(5) The patient voluntarily signed the informed consent form.

1.4 Exclusion criteria

(1) The increase in urinary microalbumin and the decrease in renal function are caused by other kidney diseases;

(2) Those with serious abnormalities in the heart, liver, lungs and other organs as well as the blood system;

(3) Those who are currently undergoing surgery, trauma, tumor, or combined with systemic infection;

(4) Those who have allergies or are allergic to any traditional Chinese medicine ingredients in the Buqi Huoxue Tongluo prescription;

(5) Those who have taken angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists and other related drugs in the past month;

(6) Patients who are participating in the research of other drugs or taking other traditional Chinese medicine related to this disease;

(7) Women who are preparing to become pregnant, are pregnant or lactating;

(8) People with a history of depression, schizophrenia and other mental-related diseases.

1.5 Shedding Standard

(1) Patients who voluntarily withdraw from the trial;

(2) Patients who were lost to follow-up due to various reasons.

1.6 Termination criteria

Patients who are unable to undergo further observation due to the presence of serious adverse reactions.

1.7 Elimination criteria

(1) There is no relevant data recorder for this clinical observation;

(2) Those with poor compliance and failure to take medication as prescribed affects the judgment of efficacy.

1.8 Situations that may occur during research and response plans

(1) Treatment of dropout cases

If a case of dropout occurs, the last efficacy will be used for clinical evaluation and then included in the analysis, and the reasons for the dropout will be recorded in detail.

(2) Treatment of adverse reactions

During the clinical observation process, once the patient experiences any adverse reactions, he or she should contact the researcher as soon as possible and solve the problem through symptomatic treatment. In severe cases, the drug will be discontinued. Finally, it will be decided based on the patient's condition whether to continue the experimental study.

2. Research content

2.1 Research design

Select 60 patients with early-stage diabetic nephropathy who meet the diagnostic criteria of Western medicine and with syndrome of spleen and kidney deficiency and blood stasis diagnosed by traditional Chinese medicine. They are randomly divided into an experimental group and a control group using the random number table method, with 30 patients in each group and one group. The other group was treated with the pharmaceutical composition of Example 1, the other group was treated with basic Western medicine, and the clinical efficacy of the two groups was observed. The treatment course lasted for 8 weeks. The changes in the TCM syndrome quantitative score and experimental value index changes of the early diabetic nephropathy (spleen and kidney deficiency and blood stasis syndrome) diagnostic scale of the two groups of patients before and after treatment were observed. After the course of treatment, all data will be analyzed statistically using statistical software SPSS27.0, and the differences between the test group and the control group before and after treatment and between the two groups will be compared.

2.2 Treatment methods

(1) Control group: given standard DKD basic Western medicine treatment

①General treatment: DKD patients should reasonably control their protein intake. The protein intake should be about 0.8g/kg ^-l, d ^-1 . Salt intake should be limited (<6g/d). According to their own conditions, reasonable and Exercise regularly and quit smoking.

②Reasonable control of blood sugar: According to the patient's actual blood sugar situation, adjust the dosage of conventional hypoglycemic drugs (metformin) to control the patient's blood sugar. Control the patient's fasting blood sugar (FBG) at 5-8mmol/L, 2 hours after a meal Control blood sugar below 11.0mmol/L, control glycated hemoglobin below 9%, and avoid hypoglycemia.

③ Regulate blood pressure: The general target value is below 130/80mmHg. For DKD patients, ACEI/ARB is the first choice for antihypertensive drugs. For those who cannot maintain blood pressure below 130/80mmHg, other non-ACEI/ARB antihypertensive drugs are added.

④Correction of lipid metabolism disorders: Statins are the first choice. The target for blood lipid treatment in DKD patients is very high-risk patients with a history of ASCVD or eGFR <60ml·min ^-1 ·1.73m ^-2 and LDL-C levels less than 1.8mmol/L. Other patients Should be less than 2.6mmol/L.

(2) Treatment group: On the basis of the treatment of the control group, the pharmaceutical composition of Example 1 was used for treatment (200 ml of traditional Chinese medicine decoction was obtained by decoction using the process and dosage of Example 1, and was taken warmly twice in the morning and evening, 100 ml each time).

2.3 Observation indicators

2.3.1 General information

Gender, age, disease duration, body mass index (BMI).

2.3.2 Security indicators

(1) Four vital signs: body temperature, respiration, heart rate, and blood pressure;

(2) General examination items: electrocardiogram, blood, urine and stool routine, ion measurement, liver function.

2.3.3 Efficacy indicators

(1) TCM syndrome scores are formulated based on the standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": the manifestations of main symptoms and secondary symptoms are divided into four levels (points): no main symptoms (0), mild (2), moderate (4), severe (6), minor symptoms (0), mild (1), moderate (2), severe (3), calculate the total score, and evaluate once before and after the test; (2) Laboratory indicators:

①Urine protein indicators: 24-hour urinary protein quantity (24h-Upro), urinary albumin excretion rates (UAER), and urinary microalbumin (UMA).

② Sugar metabolism indicators: fasting blood-glucose (FBG), 2-hours postprandial glucose (2hPG), glycosylated hemoglobin (HbA1c). ③Lipid metabolism indicators: triglyceride (TG), total cholesterol (TC), low-density lipoprotein Cholesterol (LDL-C). ④ Renal function indicators: eGFR, serum creatinine (Scr), cystatin C (Cystatin C, CysC).

Check and record once before and after treatment.

2.4 Criteria for judging efficacy

1) Criteria for judging efficacy of TCM syndromes:

The efficacy is comprehensively determined based on the changes in the patient's TCM symptoms and signs (the former) and the degree of reduction in points (the latter).

Markedly effective: the main clinical symptoms and signs are significantly improved, and the syndrome points are reduced by ≥70%;

Effective: The main clinical symptoms and signs are improved, and the syndrome points are reduced by ≥30%;

Invalid: There is no significant improvement in the main clinical symptoms and signs, or even worsening, and the syndrome score is reduced by <30%;

Syndrome treatment efficiency (nimodipine method): [(points before treatment - points after treatment)/points before treatment]*100%

2)Clinical efficacy evaluation criteria

Refer to the "Standards for Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Diabetic Nephropathy" as follows:

(1) Markedly effective: clinical symptoms improved significantly; 24Upro and UACR decreased to normal or decreased by more than half, and renal function was within the normal range;

(2) Effective: clinical symptoms are better than before treatment; 24Upro and UACR are reduced, but do not reach the standard of significant effect; renal function is within the normal range;

(3) Invalid: clinical symptoms do not improve or even worsen; relevant physical and chemical indicators do not change or even increase.

2.5 Safety assessment standards

The safety assessment standards are as follows:

Determination based on the degree of adverse reactions occurring in subjects.

Level 1: No adverse reactions;

Level 2: mild, tolerable, does not affect treatment, and does not require special treatment;

Level 3: Moderate, unbearable, medication withdrawal or special treatment is required;

Level 4: Severe, life-threatening, immediate withdrawal of medication or emergency treatment.

2.6 Statistical processing

All data in this experimental example were analyzed and processed using statistical software SPSS27.0. Numerical data are expressed as mean ± standard deviation. In the form of State distributions were compared using the rank sum test; categorical data used the ^X2 test, and hierarchical data used the rank sum test. If 0.01＜P＜0.05, it is considered that the difference in the tested data is statistically different, and if P＜0.01, the difference is considered to be very significant.

3 Results and analysis

3.1 General information

1) Before treatment, the gender, age, and course of disease data of the two groups of patients were statistically analyzed by chi-square test and two independent samples t test respectively. The results showed that there was no significant difference (P>0.05), indicating that the baseline data of the two groups of patients were basically the same. Comparability, details are as follows. (See Table 2, Table 3, and Table 4)

Table 2 Comparison of gender distribution of patients between the two groups

Table 3 Comparison of age distribution of patients between the two groups

Table 4 Comparison of disease course distribution between the two groups of patients

3.2 Comparison of observation indicators

1) Urinary protein index

(1)24hUpro

Comparing the 24hUpro levels between the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the 24hUpro levels in both groups were significantly lower than those before treatment (P<0.05), and the decrease in the treatment group was higher than Control group (P<0.05). (see table 5)

Table 5 Comparison of 24hUpro levels between two groups of patients

(2)UACR

Comparing the UACR levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the UACR level of the treatment group was significantly lower than before treatment (P<0.05). (see table 6)

Table 6 Comparison of UACR levels between the two groups of patients

(3)UMA

Comparing the UMA levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the UMA levels of both groups were significantly improved compared with those before treatment (P<0.05), and the reduction effect of the treatment group was significantly better than that of Control group (P<0.05). (see table 7)

Table 7 Comparison of UMA levels between two groups of patients

2) Sugar metabolism indicators

(1)FBG

Comparing the FBG levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, FBG in both groups was significantly improved compared with before treatment (P<0.05), and the FBG reduction level in the treatment group was significantly better than that before treatment. Control group (P<0.05). (see table 8)

Table 8 Comparison of FBG levels between two groups of patients

(2)2hPG

Comparing the 2hPG levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the 2hPG levels of both groups were significantly improved compared with those before treatment (P<0.05), and the decrease in 2hPG in the treatment group was significantly higher. Compared with the control group (P<0.05). (see table 9)

Table 9 Comparison of 2hPG levels between two groups of patients

(3)HbA1c

Comparing the HbA1c levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the HbA1c levels of the two groups were significantly improved compared with those before treatment, and the improvement in HbA1c in the treatment group was better than that in the control group (P< 0.05). (see table 10)

Table 10 Comparison of HbA1c levels between the two groups of patients

3) Lipid metabolism indicators

(1)TG

Comparing the TG levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the TG levels of both groups were significantly lower than those before treatment (P<0.05), and the decrease in the treatment group was significantly better than that before treatment. Control group (P<0.05). (See Table 11)

Table 11 Comparison of TG levels between two groups of patients

(2)TC

Comparing the TC levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the TC level of the treatment group was significantly lower than before treatment (P<0.05). (See Table 12)

Table 12 Comparison of TC levels between two groups of patients

(3)LDL-C

Comparing the LDL-C levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the LDL-C levels of the two groups were significantly lower than those before treatment (P<0.05), but after treatment There was no significant difference in LDL-C levels between the two groups (P>0.05). (See Table 13)

Table 13 Comparison of LDL-C levels between two groups of patients

4) Kidney function indicators

(1)eGFR

Comparing the eGFR levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the eGFR level of the treatment group was significantly improved compared with that before treatment (P<0.05), and the eGFR level of the control group was significantly different from that before treatment. There was no statistical significance (P>0.05). Comparing the two groups after treatment, the improvement in eGFR level in the treatment group was significantly better than that in the control group (P<0.05). (See Table 14)

Table 14 Comparison units of eGFR levels between two groups of patients:

[ml/(min·1.73m ² )]

(2)Scr

Comparing the Scr levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the Scr level of the treatment group was significantly improved compared with that before treatment (P<0.05), and the Scr level of the control group was significantly different from that before treatment. There was no statistical significance (P>0.05), but there was no significant difference in Scr levels between the two groups after treatment (P>0.05). (See Table 15)

Table 15 Comparison of Scr levels between two groups of patients

(3)CysC

Before treatment, there was no statistically significant difference in CysC levels between the two groups (P>0.05), which was comparable; after treatment, there was no statistically significant difference in CysC levels between the two groups compared with before treatment (P>0.05). After treatment, the two groups There was no significant difference in CysC levels (P>0.05). (see table 16)

Table 16 Comparison of CysC levels between two groups of patients

5) Comparison of TCM syndrome scores

Comparing the TCM syndrome score levels of the two groups before treatment, the difference was not statistically significant (P>0.05) and was comparable; after treatment, the TCM syndrome score levels of the two groups were significantly lower than before treatment (P<0.05), and after treatment The decrease in TCM syndrome scores in the group was significantly better than that in the control group (P<0.05). (See Table 17)

Table 17 Comparison of TCM syndrome score levels between the two groups of patients

3.3 Comparison of efficacy

1) Comparison of efficacy of traditional Chinese medicine syndromes

According to the criteria for judging the effectiveness of traditional Chinese medicine, the changes in TCM syndrome scores of the two groups were counted, and the effective, effective, and ineffective were determined, and the effective rate was calculated. After comparison, the effective rate of the treatment group was significantly better than that of the control group, and the difference was statistically significant (P<0.05). . (See Table 18)

Table 18 Comparison of efficacy of traditional Chinese medicine syndromes

2) Comparison of clinical efficacy

According to the clinical efficacy judgment standards and combined with the changes in laboratory indicators, the effective, effective, and ineffective were determined, and the effective rate was calculated. After comparison, the effective rate of the treatment group was significantly better than that of the control group, and the difference was statistically significant (P<0.05).

(See Table 19)

Table 19 Comparison of clinical efficacy

3.4 Recurrence rate

Twelve weeks after the end of treatment, 2 people in the treatment group relapsed, with a recurrence rate of 6.67%, and 8 people in the control group relapsed, with a recurrence rate of 26.67%. Compared with the control group, the difference was statistically significant (P<0.05). (See Table 20) Table 20 Comparison of clinical recurrence rates

3.5 Security

No adverse drug reactions occurred in the two groups of patients during the treatment, and no abnormalities were found in safety index testing, indicating that the safety of the study was acceptable.

specific cases

Case 1

Wang, male, 50 years old, was first diagnosed on March 4, 2022. Chief complaint: Abnormal renal function was found for 5 months, accompanied by mild edema of both lower limbs for 6 days. The patient's renal function examination 5 months ago revealed that urea nitrogen (BUN) was 11.37mmol/L, creatinine (Scr) was 134μmol/L, uric acid (UA) was 589μmol/L, and estimated glomerular filtration rate (eGFR)

98ml/(min·1.73m ² ), urine routine: urine protein (+). Six days ago, the patient developed mild edema in both lower limbs, accompanied by soreness and weakness in the waist and knees, asthma after activity, poor energy, poor appetite, poor sleep, slightly loose stools, and foam during urination. There has been no significant change in body weight recently. The tongue is dull, the coating is thin and white, and the pulse is deep and weak. Past history: I have a history of diabetes for more than 10 years. Taking "Repaglinide and Dapagliflozin", my fasting blood sugar is controlled at about 7mmol/L, and my blood sugar 2 hours after a meal is controlled at 10-11mmol/L. He has a history of hypertension for 3 years, with the highest blood pressure reaching 180/100mmHg. He takes "valsartan and amlodipine" and reports that his blood pressure is under control. Auxiliary examination: 24hUpro178.49mg/24h, UACR89.93mg/g, UMA102.94mg/L, FBG7.36mmol/L, 2hPG10.13mmol/L, HbA1c7.24%, TG2.45mmol/L, TC5.37mmol/L, LDL-C3.64mmol/L, eGFR97.34ml/(min·1.73m2), Scr80.73μmol/L, CysC1.35mg/L. Western medicine diagnosis: diabetic nephropathy stage III, Chinese medicine diagnosis: Diabetes nephropathy (syndrome of spleen and kidney deficiency and blood stasis). Treatment method: Strengthen the spleen and replenish qi, nourish the kidney, activate blood circulation and unblock collaterals. Prescription: 30g of Astragalus membranaceus, 15g of Radix Pseudostellariae, 30g of Rehmannia glutinosa, 15g of Cornus officinale, 12g of mallow seeds, 15g of Gorgon fruit, 12g of Morus alba bark, 12g of Adenophora adenophora, 3g of leech, 3g of whole scorpion, decoction of traditional Chinese medicine obtained according to the preparation method of Example 1 Liquid, 1 dose of 200ml per day, taken warmly twice in the morning and evening, 100ml each time, 28 doses.

Follow-up visit on April 1, 2022: The patient's edema in both lower limbs improved slightly, his fatigue was relieved, and his stool was normal. Auxiliary examination: FBG 6.94mmol/L, 2hPG 9.82mmol/L, continuous administration from above, 28 pays.

Follow-up visit on April 29, 2022: The patient's edema in both lower limbs was significantly improved, urinary foam was reduced, symptoms of soreness and weakness in the waist and knees were alleviated, the patient was in good spirits, could sleep well, and had regular bowel movements. Auxiliary examination: 24hUpro136.72mg/24h, UACR69.43mg/g, UMA72.21mg/L, FBG6.35mmol/L, 2hPG7.20mmol/L, HbA1c6.91%, TG1.98mmol/L, TC4.88mmol/L, LDL-C3.02mmol/L, eGFR102.51ml/(min·1.73m2), Scr77.07μmol/L, CysC1.18mg/L. Continuing service from above, 7 payments.

Case 2

Liu, male, 47 years old, was first diagnosed on August 10, 2022. Chief complaint: Blood sugar has been elevated for more than 15 years. The patient's physical examination 15 years ago revealed that his fasting blood sugar was 8mmol/L and his blood pressure was 150/95mmHg. He is now taking "gliquidone, irbesartan and hydrochlorothiazide" and complained that his blood sugar control has been unstable recently. The patient has dry mouth, edema of both lower limbs, and pain in his hands and feet. Slightly cold, tired and weak, sometimes dizzy, sleeping well, foamy urine, loose stools, walking 2 to 3 times a day, pale tongue, thin white fur, tooth marks on the edges, and a heavy and thready pulse. Auxiliary examination: 24hUpro192.75mg/24h, UACR93.47mg/g, UMA108.52mg/L, FBG8.45mmol/L, 2hPG9.75mmol/L, HbA1c7.84%, TG2.24mmol/L, TC5.75mmol/L, LDL-C2.96mmol/L, eGFR92.82ml/(min·1.73m ² ), Scr76.38μmol/L, CysC1.50mg/L. Western medicine diagnosis: diabetic nephropathy stage III. TCM diagnosis: Diabetes nephropathy (syndrome of spleen and kidney deficiency and blood stasis). Treatment method: Strengthen the spleen and replenish qi, nourish the kidney, activate blood circulation and unblock collaterals. Prescription: 30g of Astragalus membranaceus, 15g of Radix Pseudostellariae, 30g of Rehmannia glutinosa, 15g of Cornus officinale, 12g of mallow seeds, 15g of Gorgon fruit, 12g of Morus alba bark, 12g of Adenophora adenophora, 3g of leech, 3g of whole scorpion, decoction of traditional Chinese medicine obtained according to the preparation method of Example 1 Liquid, 1 dose of 200ml per day, taken warmly twice in the morning and evening, 100ml each time, 28 doses.

Follow-up visit on September 7, 2022: The patient's left lower limb had mild edema, dry mouth was relieved, fatigue was relieved, dizziness was reduced, stool was still loose, and he walked twice a day. Auxiliary examination: FBG 7.36mmol/L, 2hPG 9.05mmol/L, upper dose, 28 pay.

Follow-up visit on October 5, 2022: The patient's edema was significantly reduced, symptoms such as dry mouth and fatigue were significantly relieved, urinary foam was reduced, and the stool was normal. Auxiliary examination: 24hUpro132.57mg/24h, UACR65.21mg/g, UMA74.53mg/L, FBG6.98mmol/L, 2hPG7.60mmol/L, HbA1c7.01%, TG1.83mmol/L, TC4.81mmol/L, LDL-C2.43mmol/L, eGFR100.32ml/(min·1.73m ² ), Scr68.25μmol/L, CysC1.24mg/L. Continuing service from above, 7 pays.

It can be seen that the traditional Chinese medicine composition obtained by the present invention is specially used to treat early diabetic nephropathy. It mainly strengthens the spleen and replenishes qi, nourishes the kidneys, activates blood circulation and unblocks the collaterals. It is nourishing but not greasy, attacks evils without damaging the good, and is effective in lowering blood sugar and serum creatinine. It has significant effects in improving symptoms of diabetic nephropathy and improving patients' quality of life.

Claims (4)

1. A traditional Chinese medicine composition for treating early diabetic nephropathy is characterized in that: the main components of the paint are as follows in parts by weight: 20-40 parts of astragalus membranaceus, 10-20 parts of radix pseudostellariae, 20-40 parts of radix rehmanniae, 10-20 parts of dogwood, 10-20 parts of semen Abutili, 10-20 parts of semen euryales, 9-15 parts of cortex mori, 10-20 parts of herba lycopi, 3-6 parts of leech and 3-6 parts of scorpion.

2. The traditional Chinese medicine composition for treating early diabetic nephropathy according to claim 1, wherein the traditional Chinese medicine composition is characterized in that: the main components of the paint are as follows in parts by weight: 25-35 parts of astragalus membranaceus, 12-18 parts of radix pseudostellariae, 25-35 parts of radix rehmanniae, 12-18 parts of dogwood, 10-15 parts of semen Abutili, 12-18 parts of semen euryales, 10-15 parts of cortex mori, 10-15 parts of herba lycopi, 3-4 parts of leech and 3-4 parts of scorpion.

3. The traditional Chinese medicine composition for treating early diabetic nephropathy according to claim 2, wherein the traditional Chinese medicine composition is characterized in that: the main components of the paint are as follows in parts by weight: 30 parts of astragalus membranaceus, 15 parts of radix pseudostellariae, 30 parts of radix rehmanniae, 15 parts of dogwood, 12 parts of semen Abutili, 15 parts of semen euryales, 12 parts of cortex mori radicis, 12 parts of herba lycopi, 3 parts of leech and 3 parts of scorpion.

4. A method for preparing a traditional Chinese medicine composition for treating early diabetic nephropathy according to any one of claims 1 to 3, which is characterized in that: the preparation method comprises the following specific steps: firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, adding water until the water is 3-5 cm above the medicine surface, soaking for 1.5-2 hours, boiling with strong fire, decocting with slow fire for 40-50 minutes, filtering the medicine juice for standby, adding water again into the medicine residue until the water is 1-2 cm above the medicine residue surface, boiling with strong fire, decocting with slow fire for 20-30 minutes, filtering the medicine juice, and combining the medicine juice with the medicine juice.