CN113304234A

CN113304234A - Traditional Chinese medicine composition for treating chronic renal failure

Info

Publication number: CN113304234A
Application number: CN202110766447.XA
Authority: CN
Inventors: 肖振卫; 董美辰; 朱羽硕; 李文圃; 侯亚威; 王会浩; 冯修承; 郭凯琴
Original assignee: Shandong University of Traditional Chinese Medicine
Current assignee: Shandong University of Traditional Chinese Medicine
Priority date: 2021-07-07
Filing date: 2021-07-07
Publication date: 2021-08-27
Anticipated expiration: 2041-07-07
Also published as: CN113304234B

Abstract

The invention relates to the field of kidney disease medicines, and particularly provides a traditional Chinese medicine composition for treating chronic renal failure, which is prepared from Suye coptis decoction, bran-fried immature bitter orange, curcuma zedoary, codonopsis pilosula, astragalus mongholicus, radix rehmanniae, cistanche, eucommia ulmoides, fructus cannabis, platycladi seed, angelica sinensis, liquorice and the like.

Description

Traditional Chinese medicine composition for treating chronic renal failure

Technical Field

The invention relates to the field of kidney disease medicines, and in particular relates to a traditional Chinese medicine composition for treating chronic renal failure.

Background

Chronic renal failure is a clinical syndrome in which the glomerular filtration rate is reduced due to progressive deterioration of renal parenchyma damage, and water, electrolyte and acid-base balance disorder and systemic multisystem damage related to the decline of glomerular filtration rate are caused, and the increase of blood creatinine is typically shown. The prevalence rate of chronic renal failure is as high as 2.59%, and once end-stage renal disease progresses, renal replacement therapy is necessary, so that the life quality of patients is seriously affected, and heavy burden is brought to families and socioeconomic of patients. Therefore, delaying the progression of patients to end-stage renal disease is a major goal and focus of chronic renal failure prevention and treatment efforts.

At present, the western medicine does not have ideal treatment for the patients with non-dialysis chronic renal failure. The measures for improving the chronic kidney disease assessment issued by the global kidney disease prognosis organization (KDIGO) and managing the chronic kidney disease prevention and treatment recommended by the clinical practice guidelines in 2012 are mainly the integrated treatment of the chronic kidney disease, including measures for changing life style, controlling blood pressure and blood sugar, preventing infection, managing anemia, correcting chronic kidney disease-mineral-bone metabolic abnormality and the like. For the treatment of reducing the blood creatinine, the western medicine is commonly treated by the medicinal charcoal tablets, but has the following adverse reactions: 1. nausea can occur, and 2. constipation and other discomfort easily aggravate after long-term administration.

In the aspect of Chinese patent medicines, the Chinese patent medicines strongly recommended by clinical application guidelines (2020 edition) for treating chronic kidney diseases in 3-5 stages (non-dialysis) at present are uremia clearing granules, but the problem of unstable curative effect exists in the clinical use process. Therefore, how to fill the gap of the existing traditional Chinese medicine for treating chronic renal failure becomes a difficult problem of Chinese medical workers in China and is the research direction.

Disclosure of Invention

Aiming at the blank of the prior art, the inventor of the invention combines the traditional Chinese medicine theory, from the physiological functions of the spleen and the stomach to the basic pathogenesis of chronic renal failure, and combines the clinical practice process to find that when the traditional Chinese medicine formula which takes the principles of strengthening the spleen and replenishing qi, and regulating the middle warmer and descending the turbid is used for treating the patients which accord with the pathogenesis characteristics of spleen deficiency and damp turbidity in the traditional Chinese medicine, the traditional Chinese medicine formula has obvious effect of improving symptoms such as nausea, hypodynamia and the like and has obvious effect of reducing blood creatinine. The composition is prepared from perilla leaf and coptis decoction, bran-fried immature bitter orange, curcuma zedoary, codonopsis pilosula, astragalus membranaceus, radix rehmanniae, cistanche, eucommia ulmoides, fructus cannabis, platycladi seed, angelica sinensis, liquorice and the like, is mainly used for tonifying spleen and qi, regulating middle warmer and descending turbidity, is used in a lifting and descending manner and is applied in a combined manner of purgation and tonification, and has obvious curative effects on aspects of reducing blood creatinine, improving symptoms of chronic renal failure, improving life quality of patients and the like.

The traditional Chinese medicine considers that the basic pathogenesis of the chronic renal failure is the deficiency of vital qi, excess of pathogenic factors and interior accumulation of turbid toxin. Clinical manifestations show that chronic renal failure is mostly manifested by nausea, vomiting, anorexia, hypodynamia, constipation, intolerance of cold, proteinuria and hematuria in urine, high level of toxins (blood creatinine is an observation index) and the like, and the clinical manifestations suggest that the disorder of spleen and stomach is actually a main mechanism of chronic renal failure.

Physiologically, the spleen and stomach are connected by membrane, located in the abdomen and exterior-interior to each other. The spleen and stomach are barn officers and the body is meat, opening into the mouth. The stomach is the sea of food, mainly decomposing and receiving food; the spleen governs transportation and transformation, distributes food essence, which is the source of generation and transformation, and depends on the five zang-organs, six fu-organs, four limbs and bones. The spleen also has the important physiological functions of tonifying qi, promoting blood circulation, and controlling muscles and limbs. Therefore, ancient people called the spleen and stomach as the "acquired root".

The spleen functions mainly to transport and transform, the stomach functions mainly to accept and accept, and the relationship between them is "spleen is stomach to transport body fluids". The spleen governs ascending clear and the stomach governs descending turbid, which are opposite to each other. When spleen qi rises, food essence can be distributed; when stomach qi descends, food and dregs will descend. The spleen and stomach are also the pivotal points of qi movement of the human body. The spleen and stomach are physiologically related to each other, and thus pathologically interact with each other. For example, failure of spleen to transport and transform can affect the accepting, regulating and descending of the stomach, or vice versa.

The chronic renal failure patients belong to the category of consumptive disease in the traditional Chinese medicine, and decline is the main cause of the chronic renal failure patients in successive days. The failure of the spleen to transport and the failure of the spleen to ascend and the failure of the stomach to descend lead to nausea and vomiting. The invasion of the vital essence and the micro-substance is manifested as proteinuria and hematuria, and the toxin is retained in the body, which means that the spleen does not control the blood and the blood components flow outwards, and that the clear qi does not rise and the turbid qi does not fall.

The spleen governs transportation and transformation of food and water dampness, and the spleen is closely related to damp pathogen. Spleen deficiency produces damp turbidity, and damp pathogen stagnates the spleen. The deficiency and excess syndromes of spleen disease are opposite. Spleen deficiency failing to transport and water retention is mostly due to deficiency with excess, either deficiency or excess, and both of the syndromes of deficiency and excess cold and heat can manifest damp syndrome, so when treating diseases, it should be combined with dampness-drying, dampness-draining, water-expelling and dampness-resolving herbs, and when removing dampness, the spleen transport can be recovered.

From the theory of essence, qi, blood and body fluids, the spleen mainly functions in transportation and transformation, and is in mobility, requiring qi, which is a material of many states, so that it is clinically common to be spleen qi deficiency and spleen yang deficiency. Patients with chronic renal failure are mostly cold-intolerant and hypodynamia, and the deficiency of spleen yang is common.

The spleen is the acquired origin, and the kidney is the innate origin. The spleen's function of promoting the generation of essence and blood depends on the warming of kidney yang, so it is said that the spleen yang is in the kidney yang. Essence qi in kidney depends on the cultivation and nourishment of food essence, so it can be filled and matured continuously. Therefore, the spleen and kidney are physiologically acquired and innate relationships that contribute and promote each other. They also affect each other pathologically, and are causal. The spleen disease affects less blood, and chronic renal failure is a chronic disease, and the qi and blood of the viscera affect each other, so that a pathological mechanism of blood stasis appears.

In conclusion, the inventor finally finds that the treatment of chronic renal failure is a main link and a main contradiction, and based on the thought of the inventor, the regulation of the abnormal ascending and descending of the spleen and stomach is key. In clinic, more patients with spleen deficiency and damp turbidity syndrome are treated, so the spleen should be treated with importance on the basis of syndrome differentiation treatment, spleen qi is sufficient and healthy, the functions of ascending the clear and descending the turbid are achieved, qi and blood are sufficient, qi movement is smooth, the spleen is favorable for removing damp turbidity, blood stasis and turbid toxin, and blood creatinine can be descended, the treatment mechanism provided by the inventor is applied to the specific treatment process:

on the basis of the treatment mechanism, the inventor provides the following specific technical scheme by combining the action mechanism of related medicaments:

a traditional Chinese medicine composition for treating chronic renal failure comprises the following main components in parts by weight:

3-9 parts of perilla leaf, 6-12 parts of coptis chinensis, 9-15 parts of bran-fried immature bitter orange, 9-18 parts of curcuma zedoary, 15-30 parts of codonopsis pilosula, 25-35 parts of astragalus membranaceus, 15-20 parts of radix rehmanniae recen, 10-15 parts of cistanche, 10-15 parts of eucommia ulmoides, 10-20 parts of fructus cannabis, 10-15 parts of platycladi seed, 9-12 parts of angelica sinensis and 3-6 parts of liquorice;

the best treatment effect can be obtained within the dosage range, and the primary and secondary pathogenesis surrounded by the formula can be changed when the dosage of the medicine is too large or too small.

In the pharmaceutical composition, the specific mechanism of the administration is as follows:

the technical scheme is that the decoction is prepared from original prescription of Suye coptis decoction, namely, according to the following steps of Wazuda professor, adding flavor, and dissolving, the original prescription comprises perilla leaves, coptis, immature bitter orange stir-fried with bran, curcuma zedoary and rhubarb, wherein the perilla leaves are light and clear, have upward sexual floating, help spleen qi to float upward, the coptis is bitter and dry, thicken intestines and stomach, and lower stomach qi. Stir-baked with bran to lower the qi of intestines and stomach, Da Huang purges and purges, helps Huang Lian to lower stomach qi, and E Zhu to activate blood and resolve stasis.

The inventor considers that the rhubarb in the prior prescription is named as 'general', accumulated in the intestine is washed away, the force for breaking qi is strong, the qi is damaged immediately after breaking the qi, the spleen and stomach qi must be seriously damaged after long-term use, the side effect of the black bowel disease can also be seen clinically, and in order to remove the side effect, the inventor finally improves the basic prescription, removes the rhubarb and adds the heat to the fructus cannabis and the semen boitae.

The basic formula has less drugs for reducing the weight of the stomach and increasing the spleen, while the spleen deficiency is the main one, and the stomach is self-descending when the spleen increases. Therefore, the inventor decides to use the codonopsis pilosula and the astragalus root to tonify middle-jiao and qi, nourish acquired root, strengthen spleen qi, and strengthen spleen to rise again; the cistanche and the eucommia bark are selected to tonify kidney yang, help the ginseng and the astragalus to tonify spleen yang, and are matched with the fresh and nourishing dried land to obtain the effect of seeking yang from yin; in addition, fructus cannabis and semen boitae are selected to relax bowel, provide channels for turbid toxin and strengthen the function of descending the turbid; the final technical scheme is finally obtained by comprehensively utilizing the curcuma zedoary for activating blood and dissolving stasis, the angelica sinensis for nourishing and activating blood and regulating liver to strengthen spleen and the liquorice for regulating the effects of other drugs in the recipe.

The more specific pharmaceutical mechanism of the traditional Chinese medicine and the western medicine for each medicine is as follows:

perilla leaf: pungent and warm. It enters lung and spleen meridians. Relieve exterior syndrome, dispel cold, move qi and harmonize stomach. The book of Shen nong Ben Cao Jing (Shen nong's herbal) has a main expression: the smell is pungent, mild, warm and nontoxic, and the main effect is to expel qi … … and avoid bad qi. The main components of the perilla leaf are volatile oil, such as purple perilla aldehyde, perillarin, luteolin, etc. Modern pharmacological research finds that the perilla has various pharmacological effects, including antibiosis, antivirus, anti-inflammation, antianaphylaxis, inhibition of mesangial cell proliferation and the like;

coptis chinensis: bitter and cold. It enters heart, spleen, stomach, liver, gallbladder and large intestine meridians. Has effects of clearing heat, eliminating dampness, purging pathogenic fire, and removing toxic substance. The cloud recorded in the endowment of the pearl sac with drug property is used for purging heart fire and also for treating heart fire; remove dampness-heat from the middle energizer … … to stop blood in the middle, six also. Berberine, coptisine and the like are main effective components of coptis chinensis. Modern researches have shown that rhizoma Coptidis has antibacterial, antiinflammatory, and immunity regulating effects. Animal experiments show that coptisine can realize the effect of protecting the kidney by reducing the expression of TGF-beta 1 and PAI-1 in CRF rat serum and kidney tissues to be down-regulated. The coptis chinensis decoction can improve glomerular basement membrane lesion of rats with metabolic syndrome and reduce the level of swelling and necrosis of renal tubular epithelial cells; the combination of the perilla leaf and the coptis root has the effects of warming and cooling, diffusing and reducing, pungent opening and bitter reducing, regulating cold and heat, diffusing and regulating, ensuring constant ascending and descending and self-harmonizing stomach qi;

stir-frying immature bitter orange with bran: bitter, pungent and sour, slightly cold. It enters spleen and stomach meridians. It is collected as a middle-grade product in Shen nong Ben Cao Jing (Shen nong's herbal Jing), and has the effects of breaking qi, removing food retention, resolving phlegm and dispersing masses. Stir-baked with bran can alleviate the drastic nature and enhance the action of dispersing food stagnation and relieving stuffiness. The main effective components of the immature bitter orange comprise alkaloids, flavonoids, volatile oil and the like. Modern pharmacological research shows that the immature bitter orange extract can resist oxidation, resist bacteria and relieve pain, can excite gastrointestinal smooth muscle and increase renal blood flow;

zedoary turmeric: pungent, bitter and warm. It enters liver and spleen meridians. Move qi and break blood, resolve food stagnation and alleviate pain. In the book of Yi Xue Zhong Can xi Lu, Ze Zhu Wei Ku … … is the essential herb for removing blood stasis. The chemical components of the curcuma zedoaria mainly contain polysaccharides, sterols, alkaloids and the like, and the modern pharmacological research shows that the curcuma zedoaria has various pharmacological effects, such as kidney tissue fibrosis resistance, blood sugar reduction, oxidation resistance and the like. Zedoary turmeric oil can reduce TGF-beta expression, prevent Connective Tissue Growth Factor (CTGF) secretion, relieve damage of renal interstitial fibrosis, and resist renal fibrosis;

codonopsis pilosula: sweet in flavor and neutral in nature. It enters spleen and lung meridians. To invigorate the spleen, benefit the lung, nourish blood and promote the production of body fluid. The herbal medicine is loaded from the New: "Bu Zhong Yi Qi, harmonize spleen and stomach, remove polydipsia … … and even to be safe. Modern pharmacological research shows that the codonopsis pilosula polysaccharide can regulate immune reaction, strengthen the immune function of organisms and improve the activity of antioxidant enzyme. The radix Codonopsis water extract can protect kidney tissue;

astragalus root: sweet in flavor and slightly warm in nature. Entering spleen and lung meridians, has the effects of invigorating qi and yang, consolidating superficial resistance and arresting sweating, inducing diuresis to alleviate edema, promoting fluid production and nourishing blood. The book Ben Cao Hui Yan is called: herbs that tonify lung and spleen, strengthen wei-defensive aspect to arrest sweating, dispel wind and remove toxicity are also named. "the book of Western medicine in the medical profession" is called cloud: … … Biyao is the best for tonifying qi. Polysaccharides, saponins, flavonoids and the like are main chemical components of astragalus, and the active components of astragalus polysaccharides, astragaloside and the like can protect podocytes and delay the development process of nephropathy. Astragaloside IV can relieve renal fibrosis by inhibiting inflammatory reaction;

dried rehmannia root: sweet and cold in nature. It enters heart, liver and kidney meridians. Has effects in clearing away heat, cooling blood, nourishing yin, and promoting salivation. The radix rehmanniae comprises catalpol, various amino acids, mannitol, campesterol, etc. Modern pharmacological research shows that the radix rehmanniae iridoid glycoside has an inhibiting effect on AGEs and high sugar stimulation proliferation of mesangial cells, and glycosides, volatile oils and other substances of the radix rehmanniae iridoid glycoside can improve the immunity of the organism and protect the kidney. The effective component of the rehmannia root, namely the alcohol glycoside and the derivative thereof have weak diuretic effect;

cistanche deserticola: sweet, salty and warm. It enters kidney and large intestine meridians. It excels at tonifying kidney yang, nourishing essence and blood, moistening intestines and relaxing bowels. The book Ben Cao Jing Shu Yun: cistanche deserticola, the essential drug for nourishing and tonifying essence and blood … … also has the effects of tonifying kidney, liver and essence and blood. The Li Shizhen Yue: the active ingredients of the cistanche deserticola comprise polysaccharides, glycosides and the like, and experimental observation of billows and the like shows that the cistanche deserticola polysaccharide can regulate the immunologic function by increasing the release of cell factors and improving the phagocytosis of human monocyte leukocyte (THP-1);

eucommia ulmoides: sweet and warm. It enters liver and kidney meridians. Has effects in nourishing liver and kidney, and strengthening tendons and bones. Shen nong Ben Cao Jing: the eucommia bark has pungent and mild taste, is mainly used for treating the pain of waist and knees, strengthens bones and muscles … … for long-term use, and is light and durable. The water extract and ethanol extract of eucommia bark can improve the immunologic function of human body; it has been reported that eucommia ulmoides leaf extract accelerates the regeneration of capillary vessels, improving and promoting local microcirculation. The aucubin serving as an active ingredient can promote diuresis, and accelerate removal of uric acid by stimulating parasympathetic nerve center;

fructus cannabis: sweet in flavor and neutral in nature. It enters spleen, stomach and large intestine meridians. Good at moistening dryness and smoothing intestine. In the materia Medica, Ma Zi ren, a herb not blood but blood-activating herb, is used to promote qi circulation without tonifying qi. Recent pharmacological research shows that the fructus cannabis has an anti-inflammatory effect;

arborvitae seed: sweet and neutral. It enters heart, kidney and large intestine meridians. Has the effects of nourishing heart, tranquilizing mind, loosening bowel, relieving constipation, etc. Shen nong Ben Cao Jing: cupressus seed, sweet and neutral in flavor, palpitations and palpitation, and … … for calming five internal organs and improving hearing and eyesight. "compendium of materia Medica": "nourish heart qi, moisten kidney dryness … … benefit intelligence and tranquilize mind. The semen boitae chemical components comprise amino acids, terpenoids, polysaccharides and the like and have the function of intestinal propulsion;

chinese angelica: sweet and pungent with warm property. It enters liver, heart and spleen meridians. Tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines to relieve constipation. The book Ben Cao Hui Yan (treatise on materia Medica): the use is preferably used for patients with various diseases at night and patients with blood diseases due to deficiency cold. Radix Angelicae sinensis contains polysaccharide, flavonoid, etc. as effective components. The Angelica polysaccharide acts on hemopoietic system, and has effects of enhancing immunity and replenishing blood. The effective chemical components of the angelica can reduce the urine albumin content, thereby maintaining the structural integrity of the podocyte mitotic membrane and having the function of protecting rat kidney podocytes;

licorice root: sweet and neutral. It enters heart, lung, stomach and spleen meridians. Invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs. Modern researches have shown that radix Glycyrrhizae contains multiple chemical components, such as glycyrrhizic acid, glycyrrhetinic acid, glycyrrhizic acid polysaccharide, etc., and has antiinflammatory, antiallergic, and immunity enhancing effects.

Furthermore, the inventor reasonably optimizes the medicinal components to finally obtain the following technical scheme: the medicine comprises the following main components in parts by weight:

6 parts of perilla leaf, 9 parts of coptis chinensis, 12 parts of bran-fried immature bitter orange, 15 parts of curcuma zedoary, 18 parts of codonopsis pilosula, 25 parts of astragalus membranaceus, 18 parts of radix rehmanniae recen, 12 parts of cistanche, 12 parts of eucommia ulmoides, 15 parts of fructus cannabis, 15 parts of platycladi seed, 12 parts of angelica sinensis and 6 parts of liquorice.

On the basis of the above-mentioned medicinal composition, the inventors further provide the following preparation method:

weighing the traditional Chinese medicines according to the proportion of the raw materials, adding water until the traditional Chinese medicines are submerged for 2-3 fingers above the medicine surface, soaking for one hour, boiling with strong fire, decocting with slow fire for 40 minutes, filtering out medicine juice for later use, adding water into medicine residues again until the medicine residues are submerged for 1-2 fingers above the medicine residue surface, boiling with strong fire, decocting with slow fire for 20 minutes, filtering out medicine juice, and mixing with the medicine juice of the last time to obtain the traditional Chinese medicine composition.

The medicine obtained by the formula and the preparation method is applied to clinic, the curative effect is very obvious, and a large number of experiments prove that compared with the Chinese patent medicine uremia clearing granules strongly recommended by the current Chinese patent medicine clinical application guidelines (2020 edition) for treating 3-5 stages (non-dialysis) of chronic kidney diseases, the medicine composition has the obvious curative effect, has more obvious effects of reducing serum creatinine and urea nitrogen, and has obvious advantages in the aspects of reducing uric acid, improving anemia and improving the life quality of patients. Therefore, the technical scheme of the invention has obvious advantages from theory to clinical effect.

In conclusion, the traditional Chinese medicine composition special for treating chronic renal failure is obtained by taking the Suyehuanglian decoction as a basis, combining the traditional Chinese medicine theory and the disease and condition combination theory, mainly strengthens spleen and replenishes qi, regulates middle-jiao and lowers turbid pathogen, is used in combination with ascending and descending, purgation and tonification, is combined with various medicines, and has obvious curative effects on aspects of reducing blood creatinine, improving symptoms of chronic renal failure, improving life quality of patients and the like.

Detailed description of the preferred embodiments

The present invention is not limited to the following examples, which are described in the following examples and description only to illustrate the principle of the present invention, and various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention, which fall within the scope of the present invention as claimed.

Example 1

A traditional Chinese medicine composition for treating chronic renal failure is prepared from the following medicines:

6g of perilla leaf, 9g of coptis root, 12g of bran-fried immature bitter orange, 15g of curcuma zedoary, 18g of codonopsis pilosula, 25g of astragalus membranaceus, 18g of radix rehmanniae recen, 12g of cistanche, 12g of eucommia ulmoides, 15g of fructus cannabis, 15g of platycladi seed, 12g of angelica sinensis and 6g of liquorice.

The preparation method comprises the following steps:

(1) firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 1200ml of cold water, and soaking for 1 hour;

(2) boiling the mixed raw materials with strong fire, decocting with slow fire for 40 min, and filtering with gauze to obtain filtrate and residue;

(3) mixing the decoction dregs obtained in the step (2) with 550ml of hot water, decocting, wherein the hot water is purified water with the temperature of 80 ℃, boiling with strong fire, decocting with slow fire for 20 minutes, and filtering with gauze again to obtain filtrate and decoction dregs;

(4) and (3) mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3) to obtain the traditional Chinese medicine decoction for treating chronic renal failure.

Example 2

3g of perilla leaf, 6g of coptis root, 9g of bran-fried immature bitter orange, 9g of curcuma zedoary, 15g of codonopsis pilosula, 25g of astragalus membranaceus, 15g of radix rehmanniae recen, 10g of cistanche, 10g of eucommia ulmoides, 10g of fructus cannabis, 10g of platycladi seed, 9g of angelica sinensis and 3g of liquorice.

The preparation method comprises the following steps:

(1) firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 900ml of cold water, and soaking for 1 hour;

(3) mixing the decoction dregs obtained in the step (2) with 400ml of hot water, decocting, wherein the hot water is purified water with the temperature of 80 ℃, boiling with strong fire, decocting with slow fire for 20 minutes, and filtering with gauze again to obtain filtrate and decoction dregs;

Example 3

9g of perilla leaf, 12g of coptis root, 15g of bran-fried immature bitter orange, 18g of curcuma zedoary, 30g of codonopsis pilosula, 35g of astragalus membranaceus, 20g of radix rehmanniae recen, 15g of cistanche, 15g of eucommia ulmoides, 20g of fructus cannabis, 15g of platycladi seed, 12g of angelica sinensis and 6g of liquorice.

The preparation method comprises the following steps:

(1) firstly, weighing the traditional Chinese medicines according to the proportion of the raw materials, uniformly mixing, adding 1500ml of cold water, and soaking for 1 hour;

(3) mixing the decoction dregs obtained in the step (2) with 600ml of hot water, decocting, wherein the hot water is purified water with the temperature of 80 ℃, boiling with strong fire, decocting with slow fire for 20 minutes, and filtering with gauze again to obtain filtrate and decoction dregs;

Examples of the experiments

1. Clinical data

1.1 study source and sample size:

study selection subjects: outpatient and inpatient patients of department of nephrology of traditional Chinese medicine of Shandong province in 9-2020 in 2018. And (3) estimating the sample size: according to the formula N-2 [ (alpha + beta) × sigma/delta]²The minimum sample size required was estimated to be 60 cases, and a total of 60 patients were included in this experimental example.

1.2 diagnostic criteria:

1.2.1 Western diagnostic criteria:

reference to KDIGO chronic kidney disease 2012Evaluation and management of Western diagnostic criteria for Chronic Kidney Disease (CKD) in the clinical practice guidelines. (1) The occurrence of a kidney injury marker is greater than 3 months; (2) or eGFR < 60ml/(min 1.73 m)²) More than 3 months. Definition of chronic renal failure in the guidelines for the integration of traditional and western medicine for chronic renal failure (2015 edition): CRF represents only a subset of CKD patients with decreased GFR with abnormal manifestations. The CRF referred to in this guideline includes stage 3 of CKD [ GFR 30-59mL/(min 1.73 m)²)]And stage 4 [ GFR 15-29mL/(min 1.73 m)²)]And stage 5 [ GFR < 15mL/(min 1.73 m)²)]A non-dialysis patient.

According to the clinical staging standard of chronic kidney diseases in KDIGO 'Chronic kidney disease assessment and management clinical practice guideline' of 2012 (see Table 1), non-dialysis patients of stage CKD3-5 are selected in the experimental example.

With CKD-EPI_2009ScrThe formula estimates glomerular filtration rate, eGFR.

Female: scr ≤ 62, eGFR × (Scr/62)^-0.329×(0.993)^age；Scr＞62，eGFR＝144×(Scr/62)^-1.209×(0.993)^age；

Male: scr ≤ 80, eGFR × (Scr/80)^-0.411×(0.993)^age；Scr＞80，eGFR＝141×(Scr/80)^-1.209×(0.993)^age；

TABLE 1 staging criteria for chronic renal disease

1.2.2 Chinese medicine syndrome diagnosis standard:

the diagnosis criteria of the syndrome are combined with each score according to the diagnosis scale of chronic renal failure (spleen deficiency and damp turbidity) (see appendix 1).

Appendix 1 diagnosis scale for chronic renal failure and spleen deficiency and turbid dampness syndrome

Name: sex: age: the course of the disease is as follows:

honored sick friends:

your good! To get a more detailed understanding of your condition, please fill in the subjective feelings of your patients since the last two weeks. And draw a "√" before the option you think is appropriate. Thank you for their coordination and wish you to recover early!

1. Do you have a recent sensation of nausea?

One is not available at all, lighter, more serious

2. Do you have a feeling of a reduced diet and not wanting to eat?

One is not available at all, lighter, more serious

3. Do you have a feeling of fullness and discomfort in the upper abdomen or abdomen?

One is not available at all, lighter, more serious

4. Do you have the feeling of mental drowsiness and lassitude in limbs?

One is not available at all, lighter, more serious

5. Do you have a sensation of heavy limbs and difficulty moving?

One is not available at all, lighter, more serious

The following is filled in by the doctor: (please draw "√ shaped")

6. Sallow complexion

7. Swollen tongue with teeth marks (no teeth marks)

8. The tongue color is light

9. Greasy tongue coating (first none)

10. A soft pulse without

11. The slow pulse is firstly

And (3) differentiation of syndromes:

spleen deficiency with turbid dampness syndrome: □ yes at □ no

The surveyor signs:

investigation date:

according to the previous clinical comprehensive research of the inventor, the comprehensive weight coefficient of each symptom related to chronic renal failure is determined by combining statistical methods such as a Delphi method, a factor analysis method and the like as follows: (see Table 2)

TABLE 2 comprehensive weight coefficient of each symptom

The inventor determines the diagnosis threshold value of the spleen deficiency and damp turbidity syndrome in the traditional Chinese medicine of chronic renal failure according to the optimal boundary point theory through a working characteristic curve of a subject obtained in early clinical comprehensive investigation: 194.5.

(1) spleen deficiency with turbid dampness syndrome: and Y represents the syndrome integral of chronic renal failure and spleen deficiency and damp turbidity syndrome:

y is 3 food deficiency and anorexia +15 listlessness and debilitation +8 abdominal fullness +7 nausea +11 body weight loss +7 sallow complexion +14 swollen tongue with teeth mark +11 pale tongue +12 greasy coating +7 soft pulse +4 slow pulse (syndrome integral diagnosis threshold Y is 194.5)

(quantification of symptom items in 1-5 respectively represents that 1 is counted as 'none' and 2 is counted as 'light' and 3 is counted as 'general' and 4 is counted as 'serious' and 5 is counted as 'serious'. The quantification of tongue vein items adopts binarization treatment and 3 is counted as 'present' and 1 is counted as 'none')

(spleen deficiency manifested as anorexia, listlessness, asthenia, abdominal distention, turbid dampness manifested as nausea and heaviness of body, and tongue pulse manifested as sallow complexion, swollen tongue with teeth marks, pale tongue, greasy coating, soft-superficial pulse, and slow pulse)

The syndrome is determined: has at least one index of spleen deficiency (anorexia, listlessness, debilitation, abdominal distention) and damp turbidity (nausea, body sleepiness), and the sum of the index points is more than or equal to 194.5, thus can be identified as spleen deficiency and damp turbidity.

(2) The mild, moderate and severe grading diagnosis standards of chronic renal failure and spleen deficiency damp turbidity syndrome are as follows: the syndrome score [234, 256) is mild, the syndrome score [256, 274.5) is moderate, and the syndrome score [274.5, + ∞) is severe.

1.3 case selection criteria

1.3.1 inclusion criteria:

(1) meets the Western medicine diagnosis standard of 3-5 stages of chronic kidney diseases. (2) The age is 18-80 years old, and the nature is not limited. (3) The traditional Chinese medicine differentiation is diagnosed by a chronic renal failure (spleen deficiency and damp turbidity) diagnosis scale to be in accordance with the spleen deficiency and damp turbidity. (4) The compliance is good, and the questionnaire can be filled in truly and objectively. (5) The outpatients and hospitalized patients who participated in the experimental example were known and agreed to, and voluntarily signed an informed consent.

1.3.2 exclusion criteria:

(1) patients who have undergone hemodialysis, peritoneal dialysis. (2) Patients with mental illness, or mental disorder, cannot understand and coordinate completion investigators. (3) Pregnant or lactating women. (4) Those with severe pathological changes of other organs. (5) Glucocorticoid and immunosuppressant therapy is currently used. (6) Patients undergoing other clinical trial studies are undergoing or have undergone within a few months.

1.3.3 rejection and shedding criteria:

(1) patients lost visits. (2) The patient withdraws himself. (3) The patient did not comply with the study protocol requirements. (4) Adverse events occurred during the course of the study.

2. The research method comprises the following steps:

2.1 study design:

60 patients with spleen deficiency and damp turbidity syndrome from chronic kidney disease patients in 3-5 stages who are not dialyzed and meet the Western diagnosis standard are selected and randomized into a test group and a control group by a random digital table method, wherein the two groups comprise 30 patients. Clinical efficacy observations were made by comparing the pharmaceutical composition treatment of example 1 (200 ml of liquid medicine obtained by decocting using the process and amount of example 1, and taking 100ml of liquid medicine twice a day in the morning and at night) with uremia clearance granules. The treatment course is 4 weeks, and the quantitative score change of the traditional Chinese medicine syndrome, the index change of the experimental value and the score change of the quality of life scale (SF-36) of the diagnosis scale of chronic renal failure (spleen deficiency and damp turbidity) of the patients before and after two groups of treatment are observed. After the treatment period, all data were subjected to statistical analysis processing using statistical software SPSS 23.0, and differences between the test group and the control group before and after treatment and between the two groups were compared.

2.2 methods of treatment:

conventional treatment: all selected patients adopt high-quality low-protein, low-phosphorus and low-fat diet; controlling the progression factors of chronic kidney disease: controlling proteinuria, controlling blood pressure, blood sugar, blood lipid, etc., correcting anemia, hypoproteinemia, and controlling infection; treatment of complications: correcting water, electrolyte and acid-base balance disorder, and preventing and treating renal anemia, mineral and bone abnormality, etc.; avoid overwork and forbid the use of nephrotoxic drugs.

Grouping treatment:

(1) test groups:

200ml of liquid medicine is obtained by applying the process and the dosage of the embodiment 1 and is warm taken twice in the morning and at night, and each time is 100 ml.

(2) Control group: uremia cleared granule, a minister drug industry (inner Mongolia) Limited liability company, approved document No.: chinese medicine standard Z20073256, 5 g/bag, taking with boiled water, 4 times/d (1 bag for each of morning, noon and evening, 2 bags for each before sleep.)

The observation time of the test group and the control group is 4 weeks, and then the follow-up visit is carried out regularly, the improvement condition of subjective symptoms before and after the treatment of the patient, the improvement condition of laboratory examination and the adverse reaction of the patient are known.

2.3 observation indexes:

(1) chronic renal failure (spleen deficiency and damp turbidity syndrome) was scored.

(2) Clinical efficacy observation index (1 record for each of 4 weeks before and after treatment)

Renal function: blood creatinine (Scr), urea nitrogen (BUN), Uric Acid (UA);

second, nutrition status index: hemoglobin (Hb), albumin (Alb);

(iii) others: serum potassium (K), serum calcium (Ca), serum phosphorus (P), 24h urine protein quantification (24 UPQ).

(3) Quality of life scale (SF-36) score profile. (see appendix 2)

(4) The safety index is as follows: vital signs, liver function, blood routine, electrolytes, stool routine, electrocardiogram and the like; adverse drug reactions were recorded during treatment.

The above symptoms and indexes are recorded once before and after treatment.

Appendix 2 SF-36 health survey Profile

Name: sex: age: the course of the disease is as follows:

1. in general, your health is:

good

2. The health condition of you more than you feel like before 1 year is:

the first year is more than 1 year, the second year is more than 1 year, the third year is almost more than 1 year, the fifth year is more than 1 year

(weights or scores are 1, 2, 3, 4 and 5 in order)

Health and daily activities

3. These problems are all related to daily activities. Asking if you think of a fancy, if your health conditions limit these activities? If there is a limitation, how much? (weights or scores are 1, 2, 3;)

(1) The gravity moves. Such as running to lift weight, participating in strenuous exercise, etc.:

the method includes the steps of firstly, great limitation, some limitation and no limitation

(2) Moderate activity. If move a desk, sweep the floor, make taijiquan, do simple gymnastics etc.:

(3) The daily necessities are carried by hands. Such as buying vegetables, shopping, etc.:

(4) Go up several layers of stairs:

(5) And (5) going up a layer of stairs:

(6) Bending down, bending knees and squatting:

(7) Walking over a distance of 1500 meters:

(8) Walk 1000 meters:

(9) Walk 100 meters:

(10) Bathing and dressing by oneself:

4. In the last 4 weeks, do your work and daily activities have the following problems due to physical health? (weight or score 1, 2 in order; the same applies below)

(1) Reducing work or other activity time:

is not

(2) What is intended to be done is only a partial one:

is not

(3) The kind of work or activities that are desired to be dried is limited:

is not

(4) Difficulty in completing work or other activities increases (such as additional effort required):

is not

5. In the last 4 weeks, do your work and daily activities suffer from the following problems due to emotional causes (e.g., depression or anxiety)? (weight or score 1, 2 in order; the same applies below)

(1) The work or activity time is reduced:

is not

(2) What is intended to be done is only a partial one:

is not

(3) The dry matters are not as careful as usual:

is not

6. How well your health or mood affects your normal social interaction with family, friends, neighbors or groups during the past 4 weeks? (weight or score 5, 4, 3, 2, 1 in order)

(ii) completely have no influence (one influence at all), (moderate influence), (great influence), (7), and (4 weeks in the past), do you have physical pain?

No pain, little pain, moderate pain, severe pain

(weight or score in order 6, 5.4, 4.2, 3.1, 2.2, 1)

8. Did your physical pain affect your work and family during the last 4 weeks?

No influence, medium influence, great influence

(if 7 is not 8, the weight or score is 6, 4.75, 3.5, 2.25, 1.0 in sequence; if 7 is 8, 5, 4, 3, 2, 1)

Your feeling

9. The following questions are about your own feelings in the past 1 month, what do your situation is what for what each question says?

(1) You feel full life:

all the time, most time, much time and part of time

For a small part of time (zero)

(weight or score in order 6, 5, 4, 3, 2, 1)

(2) You are a sensitive person:

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5, 6 in order)

(3) Your mood is very bad and nothing can make you happy:

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5, 6 in order)

(4) Your mind is calm:

all the time, most time, much time and part of time

For a small part of time (zero)

(weight or score in order 6, 5, 4, 3, 2, 1)

(5) You are energetic to do things:

all the time, most time, much time and part of time

For a small part of time (zero)

(weight or score in order 6, 5, 4, 3, 2, 1)

(6) Your mood falls:

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5, 6 in order)

(7) You feel exhausted:

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5, 6 in order)

(8) You are a happy person:

all the time, most time, much time and part of time

For a small part of time (zero)

(weight or score in order 6, 5, 4, 3, 2, 1)

(9) You feel bored:

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5, 6 in order)

10. Unhealthy affects your social activities (e.g. visiting friends):

all the time, most time, much time and part of time

For a small part of time (zero)

(weights or scores are 1, 2, 3, 4, 5 in order)

General health condition

11. Please see each question below, which answer best fits your situation?

(1) I seem to be more sick than others:

absolute correct, mostly correct, not sure, mostly wrong, absolute wrong

(weights or scores are 1, 2, 3, 4, 5 in order)

(2) I are as healthy as the surrounding:

absolute correct, mostly correct, not sure, mostly wrong, absolute wrong

(weight or score 5, 4, 3, 2, 1 in order)

(3) I believe my health is deteriorating:

absolute correct, mostly correct, not sure, mostly wrong, absolute wrong

(weights or scores are 1, 2, 3, 4, 5 in order)

(4) My health condition is very good:

absolute correct, mostly correct, not sure, mostly wrong, absolute wrong

(weight or score 5, 4, 3, 2, 1 in order)

2.4 criteria for clinical efficacy

(1) Evaluating the traditional Chinese medicine syndrome curative effect: the diagnosis scale of chronic kidney disease (spleen deficiency and damp turbidity) is the quantitative score change of traditional Chinese medicine symptoms.

The evaluation standard of the traditional Chinese medicine syndrome curative effect is as follows:

and (3) healing: the symptoms of the patient basically disappear, and the traditional Chinese medicine syndrome integral is reduced by more than or equal to 90 percent;

the effect is shown: the symptom of the patient is obviously relieved, and the integral of the traditional Chinese medicine syndrome is reduced by more than or equal to 60 percent and less than 90 percent;

the method has the following advantages: the symptoms of the patient are reduced to some extent, and the integral of the traditional Chinese medicine symptoms is reduced by less than 60 percent and is more than or equal to 30 percent;

and (4) invalidation: the symptoms of the patients are not reduced or even aggravated, and the traditional Chinese medicine syndrome integral is reduced by less than 30 percent.

Note: the therapeutic index is [ (total fraction of symptoms before treatment-total fraction of symptoms after treatment for four weeks)/total fraction of symptoms before treatment ] × 100%

(2) Comprehensive treatment effect evaluation standard:

the effect is shown: firstly, the symptom is relieved or disappeared, and the symptom integral is reduced by more than or equal to 60 percent; increasing the endogenous creatinine clearance rate (Ccr) by more than or equal to 20 percent; ③ the reduction of serum creatinine (Scr) is more than or equal to 20 percent.

The method has the following advantages: firstly, the symptom is relieved, and the symptom integral is reduced by more than or equal to 30 percent but less than 60 percent; increasing Ccr by more than or equal to 10 percent; and the reduction of Scr is more than or equal to 10 percent.

And (3) stabilizing: firstly, the clinical symptoms are improved, and the symptom integral is reduced by less than 30 percent; ccr is not reduced or increased by less than 10%; ③ no increase of Scr, or an increase of less than 10 percent.

And (4) invalidation: the clinical symptoms are not improved or aggravated; ccr is reduced; increasing Scr.

The judgment standards are necessary, and item III has item 1, namely judgment can be carried out.

2.5 evaluation criteria for safety:

level 1: safe and has no adverse reaction.

And 2, stage: is safe, has slight adverse reaction, and can be continuously used without treatment.

And 3, level: has safety problem, but the adverse reaction is not serious, and the medicine can be continuously taken after treatment.

4, level: has serious safety problem, and can not be used continuously after being treated.

2.6 data statistics processing:

all data in this experimental example were statistically analyzed using statistical software SPSS 23.0. The numerical data are all mean + -standard deviation

The form of the method is shown in the specification, if the measured data obey normal distribution, t test is adopted, the comparison before treatment and after treatment among groups respectively adopts independent sample t test, and the comparison before treatment and after treatment in the groups adopts paired sample t test; comparing by adopting rank sum test which is not in accordance with normal distribution; using X as classified data²And (4) checking, wherein the grade data adopts rank sum check. The data tested were considered statistically different when P <0.01 < P <0.05, and were considered very significant when P < 0.01.

3. Results and analysis

3.1 general data

All patients were obtained from outpatients and inpatients of department of nephrology department of traditional Chinese medicine in Shandong province, 9 months in 2018 to 12 months in 2020, 60 patients were treated, 30 patients were treated in the test group and the control group, and no disease cases fell off in the treatment process in both groups. Wherein, the test group comprises 14 males and 16 females, the age is between 36 and 80 years, and the average age (66.40 + -9.91) is year; control group 10 men and 20 women aged between 40-79 years, mean age (60.60 + -11.94) years; the patients in both groups had no statistical difference in pre-treatment sex (P ═ 0.292), age (P ═ 0.169) and course (P ═ 0.378) (P > 0.05), and were comparable. (see tables 3, 4, 5)

TABLE 3 gender comparison of two groups of patients

TABLE 4 age comparison of two groups of patients

TABLE 5 comparison of the course of disease between two groups of patients

3.2 laboratory index comparison

3.2.1 comparison of renal function before and after treatment (Scr, BUN, UA)

Before treatment, the comparison of Scr, BUN and UA of two groups of patients has no statistical significance (P is more than 0.05). Compared with the two groups of patients before and after treatment, the Scr and BUN are reduced (P is less than 0.05), UA in a test group is reduced (P is less than 0.05), and UA in a control group has no obvious difference (P is more than 0.05); compared with the control group, the Scr, BUN and UA of the test group are all lower than those of the control group after treatment, and the statistical difference is generated (P is less than 0.05). See tables 6 and 7.

TABLE 6 comparison of renal function in the groups before treatment (Scr, BUN, UA)

Note: the P values compared among the Scr, BUN and UA groups before treatment were 0.628, 0.680 and 0.875, respectively.

TABLE 7 comparison of renal function in the post-treatment groups (Scr, BUN, UA)

3.2.2 comparison of Hb and Alb in the two groups before and after treatment

The Hb and Alb of the patients in the two groups are not obviously different (P is more than 0.05) compared before treatment. Compared with the control group, the Hb and the Alb of the test group are higher than those of the control group, Hb is statistically different (P is less than 0.05), and Alb is statistically different (P is less than 0.01). See tables 8 and 9 for details.

TABLE 8 Pre-treatment groups Hb, Alb

Note: the comparison P values between Hb and Alb groups before treatment were 0.622 and 0.344, respectively.

TABLE 9 Hb, Alb in the post-treatment groups

3.2.3 comparison of K, Ca, P in two groups before and after treatment

Before treatment, the K, Ca and P of two groups of patients have no obvious difference and are comparable (P is more than 0.05); compared with the two groups of patients before and after treatment, Ca is increased, P is reduced (P is less than 0.05), K in the test group is reduced (P is less than 0.05), K in the control group is not obviously different (P is more than 0.05), and the test group is statistically different (P is less than 0.05) compared with the control group after treatment. See tables 10 and 11.

TABLE 10 treatment of the first two groups K, Ca, P

Note: the comparison P values among K, Ca and P groups in the former group are 0.071, 0.900 and 0.322 respectively.

TABLE 11 post-treatment groups of K, Ca, P

3.2.4 comparison of two groups of 24UPQ before and after treatment

Before treatment, the 24UPQ of two groups of patients has no obvious difference and is comparable (P is more than 0.05); in comparison between the two groups of patients before and after treatment, the test group has 24UPQ reduction (P is less than 0.05), the control group has no statistical difference (P is more than 0.05), and the test group has statistical difference (P is less than 0.05) compared with the control group after treatment. See tables 12 and 13.

TABLE 12 Pre-treatment two groups 24UPQ

TABLE 13 post-treatment groups of 24UPQ

3.3 comparison of the scores of the Chinese medical symptoms before and after treatment of the two groups

TABLE 14 comparison of pre-and post-treatment chief complaint scores in two groups

Note: compared with the delta P before treatment is less than 0.05 and the delta P is less than 0.01, compared with the P <0.05 and the P <0.01 after the treatment of the contrast group.

3.4 the curative effects of the two groups of syndrome before and after treatment

TABLE 15 comparison of the overall therapeutic effects of the two pre-and post-treatment traditional Chinese medicine syndromes

Note: Δ P <0.05 and Δ P <0.01, compared to the control group.

Through statistical analysis, the effective rate of the traditional Chinese medicine syndrome of the patients in the test group reaches 86.67 percent, the effective rate of the traditional Chinese medicine syndrome of the patients in the control group reaches 46.67 percent, and the difference of the traditional Chinese medicine syndrome of the patients in the test group is more obvious than that of the patients in the control group (P is less than 0.01) (see table 15).

3.5 short-form score of SF-36 quality of Life survey before and after treatment of two groups

TABLE 16 two groups of SF-36 quality of Life Scale before and after treatment with scores for each dimension

Before treatment, the quality of life scales of two groups of patients have no obvious difference in each dimension and are comparable (P is more than 0.05); after treatment, the test groups showed significant effects (P <0.01) in seven dimensions of Physiological Function (PF), physiological function (RP), somatic pain (BP), General Health (GH), Social Function (SF), emotional function (RE), Mental Health (MH), and energy (VT) dimension (P < 0.05) compared to before treatment, and significant statistical differences (P <0.01) between before and after treatment in the two groups of patients, as shown in table 16.

3.6 Total effective rate before and after two groups of treatment

TABLE 17 comparison of the Total effective rates before and after treatment

Note: Δ P <0.05 and Δ P <0.01, compared to the control group.

Through statistical analysis, the total effective rate of the patients in the test group is 83.33%, the total effective rate of the patients in the control group is 56.67%, the test group is obviously superior to the control group, and the difference is obvious (P is less than 0.01) when the two groups are compared before and after treatment (see table 17).

3.7 evaluation of safety

In the treatment process, no discomfort symptoms related to the medicines occur in two groups of patients, and no adverse reaction event occurs, so that the two medicines have better safety, and the safety evaluation is grade 1.

Specific cases

1. Li Jie, male, 25 years old, Shandong chatty, 1 month in 2020, the disease is seen at the time of clinic diagnosis in our hospital because of "lack of strength for more than 7 years": weakness, heaviness of the body, nausea, abdominal fullness and distention, no vomiting, soreness of the waist, regular sleep, 1 movement in the stool day, sticky texture, difficulty in defecation, pale red tongue with teeth marks, white coating and soft-superficial pulse. 161.0 mu mol/L of serum creatinine, 8.40mmol/L of urea nitrogen and 538.0 mu mol/L of uric acid. The medicine obtained in example 1 is administered 1 dose of 200ml per day, and is taken warm twice in the morning and evening, 100ml each time; after 4 weeks of administration, 107.2. mu. mol/L of serum creatinine, 6.80mmol/L of urea nitrogen and 433.0. mu. mol/L of uric acid were examined. The traditional Chinese medicine symptom score before treatment is 233 scores, the quality of life score is 108 scores, the traditional Chinese medicine symptom score after 4 weeks of treatment is 172 scores, and the quality of life score is 119 scores.

2. Liu Yi, female, 44 years old, Shandong chat people, 1 month in 2021, the patients with the symptoms of the disease are seen in the outpatient service of our hospital because "the body is checked and the serum creatinine is increased by 3 months": general weakness, soreness and aversion to cold of waist, obvious sitting time, no nausea, poor sleep, dreaminess, 1 row of stool in a day, pale red tongue with teeth marks, white and greasy coating and deep and slow pulse. Serum creatinine 253.4. mu. mol/L, urea nitrogen 12.29mmol/L, and carbon dioxide 17.9 mmol/L. The medicine obtained in example 1 is administered 1 dose of 200ml per day, and is taken warm twice in the morning and evening, 100ml each time; after taking for 2 weeks, rechecking the blood creatinine of 180.9 mu mol/L, the urea nitrogen of 9.93mmol/L and the carbon dioxide of 18.3 mmol/L; after 4 weeks of administration, the serum creatinine was examined at 159.0. mu. mol/L, the urea nitrogen at 9.93mmol/L, and the carbon dioxide at 18.1 mmol/L. The traditional Chinese medicine symptom score before treatment is 265 scores and the quality of life score is 103.8 scores, the traditional Chinese medicine symptom score after 4 weeks of treatment is 182 scores and the quality of life score is 123 scores.

Therefore, the traditional Chinese medicine composition specially used for treating chronic renal failure, which is obtained by the invention, mainly strengthens the spleen and supplements qi, regulates the middle-jiao and lowers the turbid, is used in combination with ascending and descending, tonification and purgation, is used in combination with various medicines, and has obvious curative effects on aspects of reducing blood creatinine, improving chronic renal failure symptoms, improving life quality of patients and the like.

Claims

1. A traditional Chinese medicine composition for treating chronic renal failure is characterized in that: the main components are as follows by weight:

3-9 parts of perilla leaf, 6-12 parts of coptis chinensis, 9-15 parts of bran-fried immature bitter orange, 9-18 parts of curcuma zedoary, 15-30 parts of codonopsis pilosula, 25-35 parts of astragalus membranaceus, 15-20 parts of radix rehmanniae recen, 10-15 parts of cistanche, 10-15 parts of eucommia ulmoides, 10-20 parts of fructus cannabis, 10-15 parts of platycladi seed, 9-12 parts of angelica sinensis and 3-6 parts of liquorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: the main components are as follows by weight:

3. The method for preparing a Chinese medicinal composition for treating chronic renal failure according to claim 1, wherein the method comprises the following steps: the method comprises the following specific steps: