CN116492415A - Traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy - Google Patents
Traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy, which is selected according to modern medicine and traditional Chinese medicine theory and clinical characteristics of diabetic nephropathy occurrence and years of clinical application experience of an inventor, and has the effects of tonifying qi and nourishing yin, strengthening spleen and reinforcing kidney, and detoxifying and dredging collaterals. The composition is applied to early treatment of diabetic nephropathy, compared with the known disclosed technology for treating early symptoms of diabetic nephropathy, the composition has the advantages of specifically solving the symptoms of lassitude, weakness, dry mouth, dry throat, short breath, no speaking, heavy body, abdominal distention, edema and frequent urination, and supplementing the symptoms of early onset of diabetic nephropathy for clinical relief and treatment. The traditional Chinese medicine composition has the advantages of less medicinal composition, no toxicity and no peculiar smell, and low-toxicity leeches are used in the safe dosage range specified in pharmacopoeia to remove stasis and block, clear and activate the channels and collaterals, and the large amount of leeches can cause side effects such as nausea, vomiting, abdominal pain, diarrhea, bleeding and the like.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy.
Background
Diabetic nephropathy is a serious microvascular complication common to diabetes mellitus, and is a primary cause of chronic kidney disease and end-stage renal disease in China. In early and mid stages of diabetic nephropathy, symptoms such as lassitude, dry mouth, dry throat, shortness of breath, no speaking, heavy body, abdominal distension, edema and frequent urination are associated, and great pressure and discomfort are brought to the life of the patient.
The diabetic nephropathy belongs to the category of diabetes and nephropathy in traditional Chinese medicine. In ancient documents, there is no clear description about diabetic nephropathy, and most of the doctors summarize the symptoms and pathogenesis, and classify and name the diabetic nephropathy according to clinical symptoms. The early stage is accompanied with 'three more and one less', which belongs to the categories of 'diabetes', 'fever', 'kidney digestion'; when proteinuria appears, the urine can be attributed to turbid urine; when emaciation and edema are accompanied, they are often referred to as "edema" and "lumbago". "Shengji general records" cloud: for long-term diabetes, kidney qi injury … … water solution gathers in the body to cause edema. Patients will often transition to the Guangxi state when they reach the advanced stage. The diabetes and nephrosis embryonic form is first found in the Ming dynasty and Zhang Zhongjing (jin Kui Yao Lloyd) and the special thirsty in the book is recorded as ' Men's diabetes with excessive urine, one for drinking, one for urine and one for kidney qi pill '. "thirst with desire to drink water, dry mouth and dry throat". "Fuyang pulse number, food retention and digestion promoting". The patient name of diabetes and nephrosis is recorded in a book of Chinese medical noun in 2010 at present, and the patient refers to a plurality of difficult and complicated symptoms which are characterized clinically by foam, dizziness, blurred vision and edema in urine, wherein the diabetes and nephrosis is caused by long-term entering collaterals, kidney collaterals injury, kidney body failure, great injury of kidney function, and damage to liver, spleen, heart and five viscera.
For example, chinese patent CN201811035022.6 describes a Chinese angelica astragalus root therapeutic agent for treating early diabetic nephropathy and a preparation method thereof, but the formula is complex and is mainly used for treating the rise of blood sugar, urine protein and creatinine in the early diabetic nephropathy process; chinese patent CN201611079359.8 discloses another traditional Chinese medicine for treating early diabetic nephropathy and a preparation method thereof, and apart from obvious differences from the invention, the main intervention effect on the diabetic nephropathy is manifested by soreness of waist and knees or pain of heel, tinnitus and deafness, tooth loss and shaking, urine with excessive dribbling, excessive foam in urine or turbid urine. The academic paper discusses a traditional Chinese medicine compound capable of regulating autophagy of diabetic kidney cells based on the action mechanism of detoxification, vein relaxing and kidney protecting prescription discussed in LKB1/AMPK/Sirt1 signal pathway, and the prescription is the same as the traditional Chinese medicine composition, but has a large difference in proportion and different efficacy from the traditional Chinese medicine composition.
Disclosure of Invention
The invention discloses a traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy, which is different from the prior art based on clinical treatment and fumbling, has few traditional Chinese medicine formulas and outstanding curative effect.
The invention relates to a traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy, which is mainly prepared from the following raw materials in parts by weight:
10-30 parts of astragalus membranaceus, 5-10 parts of sun-dried ginseng, 3-5 parts of rheum officinale, 8-10 parts of yam rhizome, 7-10 parts of pyrrosia lingua, 7-10 parts of pulp of dogwood fruit, 8-10 parts of semen euryales, 8-10 parts of radix salviae miltiorrhizae and 1-2 parts of leech.
The traditional Chinese medicine composition is characterized in that the raw materials are preferably proportioned:
390g of astragalus root, 117g of sun-dried ginseng, 78g of wine rheum officinale, 195g of yam rhizome, 156g of pyrrosia lingua, 156g of pulp of dogwood fruit, 195g of gorgon euryale seed, 195g of root of red-rooted salvia and 39g of leech.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
1) Mixing radix astragali, sun-dried ginseng, wine rheum officinale, pyrrosia lingua, rhizoma dioscoreae septemlobae, dogwood fruit, semen euryales, radix salviae miltiorrhizae and leech according to a proportion, crushing, adding 6-10 times of water, and extracting at 100 ℃ for 1-2 hours to obtain a first liquid medicine and first dregs;
2) Adding 4-6 times of water into the first medicine residues, and extracting for 1-2 hours at the temperature of 100 ℃ to obtain second medicine liquid and second medicine residues;
3) Adding 4-6 times of water into the second medicine residues, and extracting for 1-2 hours at the temperature of 100 ℃ to obtain third medicine liquid and third medicine residues;
4) Mixing the first, second and third liquid medicine, concentrating under reduced pressure at 60-80 deg.c and 0.05-0.1 MPa to density of 1.20-1.30.
The traditional Chinese medicine composition can be finally used for decoction pieces, oral liquid or capsules, granules and tablets after being dried.
Step 1) is preferably prepared by mixing radix astragali, radix Ginseng, radix et rhizoma Rhei with wine, folium Pyrrosiae, rhizoma Dioscoreae Septemlobae, corni fructus, semen euryales, saviae Miltiorrhizae radix and Hirudo at a certain proportion, pulverizing, and extracting with 6 times of water for 1 hr.
The preferred first residue of step 2) is added 4 times for 1 hour.
Step 3) the preferred second residue is added 4 times for 1 hour.
Step 4) preferably combines the first, second and third liquid medicine, and concentrating under reduced pressure at 80deg.C and 0.08 Mpa.
In addition, the invention provides application of the traditional Chinese medicine compound, in particular to preparation of an oral dosage form comprising traditional Chinese medicine decoction pieces, oral liquid, capsules, tablets, granules and the like by preparing the extract of the traditional Chinese medicine compound and a pharmaceutically acceptable carrier.
The usage amount is as follows: 300mL of decoction is decocted in water for each dose, 150mL of decoction is orally taken for 2 times a day, and each dose is taken for 1 day;
the main functions are as follows: qi-tonifying and yin-nourishing, spleen-strengthening and kidney-strengthening, detoxifying and vein relaxing; can relieve symptoms of listlessness, debilitation, dry mouth, dry throat, short breath, no speaking, heavy body, abdominal distention, edema and frequent urination in early stage of diabetic nephropathy.
The invention is as follows: the Chinese medicinal composition mainly comprises astragalus membranaceus, sun-dried ginseng, wine rheum officinale, pyrrosia lingua, rhizoma dioscoreae septemlobae, cornus officinalis, semen euryales, radix salviae miltiorrhizae and leech, wherein astragalus membranaceus has the effects of tonifying qi and yang, inducing diuresis and relieving swelling, ginseng has the effects of tonifying primordial qi, nourishing yin and promoting fluid production, and the astragalus membranaceus is used as a monarch drug for tonifying qi of a body, and qi, foot, body fluid, essence and blood are generated to play a role of strengthening body resistance and strengthen body resistance to eliminate pathogenic factors. The wine rheum officinale has the effects of removing blood stasis, detoxifying and discharging turbidity, the yam rhizome has the effects of promoting diuresis and discharging turbidity, and Dan Weitong has the effects of treating damp turbidity toxin pathogen, and is used as ministerial drug, mainly eliminating pathogen, guiding pathogen out from lower jiao, detoxifying and eliminating dampness pathogen, and strengthening body resistance. Fructus Corni has effects of invigorating kidney, arresting seminal emission, stopping nocturnal emission, strengthening spleen, and removing dampness, and can be used as adjuvant drug for assisting principal drug to strengthen body resistance and protect kidney; the red sage root has the effects of promoting blood circulation to remove meridian obstruction, and the leech has the effect of removing blood stasis to remove meridian obstruction, so that the pathogenic factors hidden in the kidney meridian can be removed, and the combination of the two medicines is an adjuvant medicine. Astragalus root, radix astragali and ginseng tonify kidney collaterals deficiency, cornus officinalis and Gordon euryale seed both secure essence and nourish kidney collaterals, so that there is no hidden place for pathogenic factors.
The main indications are: tonifying qi and yin, strengthening spleen and kidney, removing toxic substances and dredging collaterals. Can be used for treating diabetes and nephropathy (qi and yin deficiency with dampness stasis), which is equivalent to early and middle stage (microalbuminuria stage or clinical albuminuria stage) of diabetic nephropathy. Lassitude, debilitation, dry mouth and throat, shortness of breath, lazy speaking, body heaviness, abdominal distension, mild edema, frequent urination, mixed or turbid urine, dark red tongue, deep and thready pulse or deep and thready pulse. The invention has outstanding clinical curative effect and is obviously different from other inventions or disclosed technologies.
The invention has the positive effects that: according to the modern medicine and Chinese medicine theory and clinical characteristics of diabetic nephropathy occurrence and the clinical application experience of the inventor for many years, the medicine composition has the effects of tonifying qi and nourishing yin, strengthening spleen and reinforcing kidney, and detoxifying and dredging collaterals. The composition is applied to early treatment of diabetic nephropathy, compared with the known disclosed technology for treating early symptoms of diabetic nephropathy, the composition has the advantages of specifically solving the symptoms of lassitude, weakness, dry mouth, dry throat, short breath, no speaking, heavy body, abdominal distention, edema and frequent urination, and supplementing the symptoms of early onset of diabetic nephropathy for clinical relief and treatment. The traditional Chinese medicine composition has the advantages of less medicinal composition, no toxicity and no peculiar smell, and uses the low-toxicity leech to remove stasis and blockage and clear and activate the channels and collaterals within the safe use dosage range specified in pharmacopoeia, and the large amount of leech can cause side effects such as nausea, vomiting, abdominal pain, diarrhea, hemorrhage and the like. The invention has obvious curative effect on early and middle symptoms of diabetes, has the effects of tonifying qi and yin, strengthening spleen and kidney, detoxifying and dredging collaterals, and can relieve symptoms of lassitude and hypodynamia, dry mouth and throat, short breath and no speaking, body weight, abdominal distension and fullness, edema and frequent urination which occur in the early stage of diabetic nephropathy.
Description of the embodiments
The present invention will be described in detail with reference to examples, but they should not be construed as limiting the scope of the invention. The following description is of the preferred embodiments of the present invention, and it should be noted that it will be apparent to those skilled in the art that modifications and variations can be made without departing from the principle of the present invention, and these modifications and variations should also be regarded as the scope of the invention.
Example 1
Mixing 390g of astragalus root, 117g of sun-dried ginseng, 78g of wine-dried rhubarb, 195g of yam rhizome, 156g of pyrrosia lingua, 156g of dogwood fruit, 195g of gorgon euryale seed, 195g of red sage root and 39g of leech, crushing, adding 6 times of water, and extracting for 1 hour at 100 ℃ to obtain a first liquid medicine and first dregs;
adding 4 times of water into the first medicine residues, and extracting for 1 hour at 100 ℃ to obtain second medicine liquid and second medicine residues;
adding 4 times of water into the second medicine residues, and extracting at 100 ℃ for 1 hour to obtain a third medicine liquid and third medicine residues;
combining the first, second and third medicinal liquids, concentrating under reduced pressure at 80deg.C and 0.08Mpa to a density of 1.27 to obtain a Chinese medicinal composition for relieving early and middle stage symptoms of diabetic nephropathy.
Example 2
200g of astragalus root, 100g of sun-dried ginseng, 60g of wine rheum officinale, 160g of yam rhizome, 140g of pyrrosia lingua, 140g of pulp of dogwood fruit, 160g of semen euryales, 160g of radix salviae miltiorrhizae and 20g of leech are mixed, crushed, added with 6 times of water and extracted for 1 hour at 100 ℃ to obtain a first liquid medicine and first dregs;
adding 4 times of water into the first medicine residues, and extracting for 1 hour at 100 ℃ to obtain second medicine liquid and second medicine residues;
adding 4 times of water into the second medicine residues, and extracting at 100 ℃ for 1 hour to obtain a third medicine liquid and third medicine residues;
combining the first, second and third medicinal liquids, concentrating under reduced pressure at 60deg.C and 0.1Mpa to density of 1.27 to obtain a Chinese medicinal composition for relieving early and middle stage symptoms of diabetic nephropathy.
Example 3
Mixing 400g of astragalus membranaceus, 200g of sun-dried ginseng, 100g of wine rheum officinale, 200g of yam rhizome, 200g of pyrrosia lingua, 200g of pulp of dogwood fruit, 200g of semen euryales, 200g of radix salviae miltiorrhizae and 40g of leech, crushing, adding 10 times of water, and extracting for 2 hours at 100 ℃ to obtain a first liquid medicine and first residues;
adding 6 times of water into the first medicine residues, and extracting for 2 hours at 100 ℃ to obtain second medicine liquid and second medicine residues;
adding 6 times of water into the second medicine residues, and extracting for 2 hours at 100 ℃ to obtain a third medicine liquid and third medicine residues;
combining the first, second and third medicinal liquids, concentrating under reduced pressure at 80deg.C and 0.05Mpa to a density of 1.27 to obtain a Chinese medicinal composition for relieving early and middle stage symptoms of diabetic nephropathy.
The medical effect of the invention is further demonstrated by the following experiments:
experimental example 1
The embodiment is prepared into traditional Chinese medicine decoction pieces, and an activity test is carried out on patients with diabetic nephropathy in early and middle stages, and the diagnosis and evaluation method is specifically as follows:
1. diagnosis and treatment scheme
1.1 Disease pattern typing for treatment of disease: syndrome of qi and yin deficiency with dampness and blood stasis;
1.2 Diagnosis of traditional Chinese medicine: reference to Tong Xiaolin Cook's clinical practice of diabetes traditional Chinese medicine guide (2016 edition);
1.3 Western diagnosis: reference is made to the guidelines for prevention and treatment of type 2 diabetes in China (version 2017) and the clinical guidelines for prevention and treatment of kidney disease in diabetes in China (version 2019).
1.4 Reference standard for clinical cure or improvement
Related symptoms: lassitude, debilitation, dry mouth and throat, shortness of breath, lazy speaking, body heaviness, abdominal distension, slight edema, frequent urination, mixed or turbid urine, dark red tongue, deep and thready pulse or deep and thready pulse with soft feeling;
the main symptoms and the secondary symptoms are respectively assigned 0, 2, 4 and 6 according to the symptoms of no symptom, light symptom, medium symptom and heavy symptom; 0.1, 2 and 3 minutes. Referring to DKD curative effect judgment standard in 2002 edition of guidelines for clinical study of New traditional Chinese medicine [14], a calculation formula is as follows: integral (pre-treatment to post-treatment)/(integral (pre-treatment) ×100% = efficacy index (reference nimodipine method) traditional Chinese medicine syndrome efficacy decision criterion:
the effect is shown: the clinical symptoms of the traditional Chinese medicine disappear or obviously improve, and the integral of symptoms is reduced by not less than 70%;
the method is effective: the clinical symptoms and signs of the traditional Chinese medicine are all improved, and the integral of symptoms is reduced by more than or equal to 30 percent and less than 30 percent;
invalidation: the clinical symptoms and physical signs of the traditional Chinese medicine are not obviously improved or even aggravated, and the integral of symptoms is reduced by less than 30 percent;
5.5 Dosage regimen the drugs of examples 1-3 were decocted with 300ml of each dose of water and taken orally 2 times per 150ml of day for 1 day each dose;
2. statistical analysis of clinical cases
2.1 Patient distribution
| Man's body | Female | Totals to |
| 165 | 135 | 300 |
300. In the case of the case history, males account for 55% of the total population, females account for 45% of the total population, and the sex aspect cannot account for the disease variability.
2.2 evaluation of efficacy
Number of observations: 300 cases; 43 cases of obvious effects; 213 cases are valid; 44 cases were not valid. The total effective rate is 85.3%. No adverse reaction was observed.
| Symptoms of | Integration before treatment | Post-treatment integration | P value |
| Lassitude and debilitation | 5.53±2.18 | 2.71±1.02 | P<0.05 |
| Dry mouth and throat | 5.39±1.98 | 1.12±0.99 | P<0.05 |
| Short breath and lazy speaking | 5.42±1.21 | 2.03±1.10 | P<0.05 |
| Body weight loss | 2.61±1.37 | 1.03±0.67 | P<0.05 |
| Abdominal distention and fullness | 2.19±1.62 | 1.09±0.74 | P<0.05 |
| Edema and edema | 3.02±1.21 | 0.88±1.20 | P<0.05 |
| Frequency of urination | 2.92±1.21 | 1.59±0.41 | P<0.05 |
The results show that the traditional Chinese medicine composition can effectively improve symptoms of lassitude, dry mouth, dry throat, shortness of breath, no speaking, body weight, abdominal distension, edema and frequent urination of patients in the treatment of patients with early and middle diabetes.
Claims (5)
1. A traditional Chinese medicine composition for relieving early and middle symptoms of diabetic nephropathy is mainly prepared from the following raw materials in parts by weight:
10-30 parts of astragalus membranaceus, 5-10 parts of sun-dried ginseng, 3-5 parts of rheum officinale, 8-10 parts of yam rhizome, 7-10 parts of pyrrosia lingua, 7-10 parts of pulp of dogwood fruit, 8-10 parts of semen euryales, 8-10 parts of radix salviae miltiorrhizae and 1-2 parts of leech.
2. The traditional Chinese medicine composition according to claim 1, characterized in that the raw materials are preferably:
390g of astragalus root, 117g of sun-dried ginseng, 78g of wine rheum officinale, 195g of yam rhizome, 156g of pyrrosia lingua, 156g of pulp of dogwood fruit, 195g of gorgon euryale seed, 195g of root of red-rooted salvia and 39g of leech.
3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the composition can be prepared into decoction pieces, oral liquid or dried for capsules, granules and tablets.
4. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, comprising the following steps:
1) Mixing astragalus, sun-dried ginseng, wine rheum officinale, pyrrosia lingua and yam rhizome in proportion, crushing, adding 6-10 times of water, and extracting at 100 ℃ for 1-2 hours to obtain a first liquid medicine and first dregs;
2) Adding 4-6 times of water into the first medicine residues, and extracting at 100 ℃ for 1-2 hours to obtain second medicine liquid and second medicine residues;
3) Adding 4-6 times of water into the second medicine residues, and extracting at 100 ℃ for 1-2 hours to obtain a third medicine liquid and third medicine residues;
4) Mixing the first, second and third liquid medicine, concentrating under reduced pressure at 60-80 deg.c and 0.05-0.1 MPa to density of 1.20-1.30.
5. The method for preparing the Chinese medicinal composition according to claim 4, wherein the method comprises the following steps of:
step 1) mixing astragalus root, sun-dried ginseng, wine rheum officinale, pyrrosia lingua, yam rhizome, dogwood fruit, gorgon euryale seed, red sage root and leech according to a certain proportion, crushing, and adding 6 times of water for extraction for 1 hour;
step 2), adding 4 times of the first residues to extract for 1 hour;
step 3), adding 4 times of the second medicine residues for extraction for 1 hour;
and 4) combining the first, second and third liquid medicine, and concentrating under reduced pressure at 80 ℃ and 0.08 Mpa.
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| 刘畅: "解毒通络保肾方治疗糖尿病肾病微量蛋白尿期（气阴两虚挟湿瘀毒证）的临床研究", 中国优秀硕士学位论文全文数据库医药卫生科技辑, no. 11, 15 November 2020 (2020-11-15), pages 056 - 68 * |
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