A traditional Chinese medicine composition for treating uremia and a preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition for treating uremia and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition for treating uremia is prepared from raw materials and is characterized by kidney-tonifying, spleen-strengthening, qi-benefiting, turbidity-removing, dampness-removing and blood-stasis-removing, and is an effective medicine for treating chronic renal failure and is worth popularization and application.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine composition for treating uremia and its preparation method. Background Technology

[0002] Chronic renal failure (CRF) is a syndrome caused by severe damage to nephrons due to various reasons, leading to the retention of metabolic products, electrolyte and acid-base imbalances, and endocrine dysfunction. Currently, Western medicine lacks a specific treatment for CRF, while Traditional Chinese Medicine (TCM) has significant potential and advantages in its prevention and treatment, and is increasingly attracting attention from the medical community both domestically and internationally. The characteristic of TCM treatment for CRF lies in syndrome differentiation and treatment based on syndrome differentiation, which is crucial for a comprehensive understanding of the disease's nature and improving prevention and treatment outcomes.

[0003] The distribution pattern of symptoms in CRF:

[0004] The initial stage of this disease is often due to physical weakness, exposure to external pathogens, or imbalances in diet and emotions, leading to a deficiency of spleen and kidney yang or liver and kidney yin and blood. This deficiency results in impaired fluid metabolism, causing the accumulation of phlegm, dampness, and other pathogenic factors, leading to qi stagnation, obstruction of the collaterals, heat and blood stasis, or even wind-related disturbances. The process is one of deficiency leading to excess, followed by further damage from the excess, presenting a mixed pattern of deficiency and excess. Phlegm, dampness, and damp-heat, the most common of the six pathogenic factors, are precisely products of fluid metabolism disorders following spleen and kidney deficiency.

[0005] Diagnostic classification of CRF:

[0006] There is an intrinsic connection between syndrome differentiation and treatment. The inventors have summarized many effective prescriptions for treating CRF in clinical practice, achieving good results. However, the syndrome differentiation classifications differ among different physicians. CRF is divided into four types. Clinical observation shows a close relationship between the TCM types of CRF and the Western medicine stages of renal function. The Qi and Yin deficiency type and the Liver and Kidney Yin deficiency type belong to the compensatory and azotemia stages of CRF; the Spleen and Kidney Yang deficiency type belongs to the azotemia stage of CRF; and the Yin and Yang deficiency type mostly belongs to the uremia stage of CRF.

[0007] Microscopic study of CRF symptoms:

[0008] Modern research shows that CRF patients have a close relationship with the levels of lipid metabolites in their blood, such as total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL). In CRF patients with dyslipidemia, post-treatment testing significantly reduces lipid metabolism levels and increases hemoglobin (Hb) levels in patients with anemia.

[0009] Modern research shows that most patients with chronic renal failure (CRF) exhibit abnormal changes in blood rheology, suggesting a close relationship between CRF and blood stasis syndrome. CRF patients often have abnormal blood rheology. Among these, whole blood viscosity, whole blood reduced viscosity, plasma viscosity, hematocrit, and fibrinogen are significantly elevated in CRF, and these elevations become more pronounced with increasing severity of renal impairment. For CRF patients with spleen and kidney qi deficiency and dampness-turbidity syndrome, treatment with traditional Chinese medicine (TCM) that strengthens the body's resistance, eliminates turbidity, and promotes blood circulation can improve renal hemodynamics and further improve renal function. Observation of changes in renal hemodynamics after TCM treatment using color Doppler ultrasound provides clinical evidence for the prevention and treatment of this disease using TCM.

[0010] Modern research also shows that most CRF patients have elevated blood urea nitrogen (BUN) and serum creatinine (Scr) levels, while their endogenous creatinine clearance rate (Ccr) is significantly reduced. Treatment of CRF patients can significantly reduce blood urea nitrogen (BUN) and serum creatinine (Scr) levels and increase endogenous creatinine clearance rate (Ccr). However, most current Chinese medicine combinations have limited efficacy. Summary of the Invention

[0011] To overcome the aforementioned deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating uremia and its preparation method.

[0012] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0013] On one hand, the present invention provides a traditional Chinese medicine composition for treating uremia, which is prepared from raw materials comprising the following parts by weight: 5.5-10 parts of charred cattail pollen, 7.5-20 parts of talc, 6-10 parts of charred human hair, 6-12 parts of kelp, 15-25 parts of calcined oyster shell, 15-30 parts of charred astragalus, and 15-30 parts of charred purple garlic.

[0014] Optionally, the preparation method of the cattail pollen charcoal includes: drying cattail pollen to obtain the cattail pollen charcoal.

[0015] Optionally, the baking temperature is 100–150°C;

[0016] The baking time is 5 to 6 minutes.

[0017] Preferably, the preparation method of the cattail pollen charcoal includes: spreading cattail pollen evenly in an enamel dish with a thickness of 5.5 cm, placing it in an oven, and baking it at 120°C for 5.5 min.

[0018] Optionally, the method for preparing talc includes: removing impurities, washing, crushing into small pieces, placing in a stainless steel container, adding water, grinding into a paste, adding water and stirring until the coarse powder settles, immediately pouring out the suspension, grinding the settled coarse particles again, repeating this process until fine, finally discarding the impurities that cannot be suspended, combining the suspensions poured out before and after and letting it stand, after sedimentation, pouring off the clear water on top, taking the precipitate, drying it, and then grinding it into an extremely fine powder.

[0019] Optionally, the preparation method of the blood charcoal includes: taking hair from a healthy person, removing impurities, washing away oil and dirt with dilute alkaline water, rinsing clean, drying, placing it in a pot, covering it with a smaller-diameter pot, sealing the joint between the two pots with salt mud, pressing down with a heavy object, attaching a strip of white paper or placing a few grains of rice on the bottom of the pot lid, heating it over high heat, and calcining it until the white paper or rice turns yellowish-brown. Remove it from the heat, let it cool, take it out, and chop it into small pieces.

[0020] Optionally, the method for preparing kelp includes: adding 8 times the amount of water to kelp, soaking it in water at a temperature of 10-20°C for 48 hours, washing it, drying it until it is semi-dry, and then shredding and drying it.

[0021] Optionally, the method for preparing the calcined oyster includes: calcining the oyster to obtain the calcined oyster.

[0022] Optionally, the calcination temperature is 45–55°C;

[0023] The calcination time is 60–90 minutes.

[0024] Preferably, the method for preparing the calcined oyster shell includes: crushing the cleaned oyster shells into particles with a size of 4.5 cm. 3 Small pieces were placed in a crucible, spread to a thickness of 4.5 cm, and calcined at 50°C for 75 minutes.

[0025] Optionally, the preparation method of the charred astragalus includes: taking astragalus slices, frying them according to the charring method until thick smoke rises, the surface is charred black, and the inside is brownish-brown, then spraying water lightly to extinguish the sparks, taking them out, and drying them.

[0026] Optionally, the preparation method of the purple-skinned garlic charcoal includes: digging a square opening at the stem of a watermelon to obtain a square lid for later use; removing the pulp and keeping the shell; placing purple-skinned garlic inside the shell; covering the opening of the shell with the square lid; evenly coating the outside of the shell with a layer of hemp seed mud; then firing over high heat for 30-60 minutes; continuing to fire over low heat; simmering and calcining to preserve its properties; and after cooling, breaking the mud shell to obtain the purple-skinned garlic charcoal.

[0027] Optionally, the hemp mud is made from a mixture of clay, hemp fibers, and water;

[0028] The mass ratio of the clay, hemp fibers, and water is 2-4:1:1-3;

[0029] The temperature of the fire-smelting process is 75–95°C.

[0030] The temperature for the smelting process is 55–70°C.

[0031] The simmering time is 40 to 70 minutes.

[0032] Preferably, the preparation method of the purple-skinned garlic charcoal includes: selecting a 600g dark green thick-skinned watermelon, washing it, cutting a 15cm×15cm square opening at the stem end to obtain a square lid for later use, removing the pulp and leaving the shell, stuffing the washed purple-skinned garlic into the shell, placing the square lid on the opening of the shell, and evenly and tightly pasting a layer of hemp mud (mud:hemp fibers:water = 3:1:2, mass ratio) with a thickness of 1.5-2cm on the outside of the shell, then placing it in a furnace and firing it over a high fire for 25-30 minutes, continuing to fire it over a low fire, simmering and calcining it to preserve its properties, cooling it, breaking the mud shell, taking out the garlic charcoal, crushing it and sieving it to obtain the purple-skinned garlic charcoal.

[0033] Secondly, this application provides a method for preparing the aforementioned traditional Chinese medicine composition for treating uremia, comprising the following steps:

[0034] (1) Mix kelp with water and boil it. Concentrate the decoction to 1 / 2 to 1 / 4 of the original volume to obtain a concentrated liquid.

[0035] (2) The concentrated liquid is mixed with cattail pollen charcoal, talc, human hair charcoal, calcined oyster shell, astragalus charcoal, and purple garlic charcoal to obtain the traditional Chinese medicine composition for treating uremia.

[0036] Optionally, in step (1), the volume ratio of kelp to water is 0.5 to 1:1.

[0037] Optionally, in step (1), the temperature of decocting is 95-100°C;

[0038] The decoction is prepared 1 to 3 times.

[0039] Each simmering time is 25 to 35 minutes.

[0040] In this invention, the effects of each traditional Chinese medicine component are as follows:

[0041] Cattail pollen charcoal: Sweet and neutral in nature. It promotes urination, stops bleeding, and dissipates blood stasis. Cattail pollen charcoal is a processed product obtained by stir-frying the dried pollen of *Typha angustifolia* L., a plant in the Typhaceae family. Modern medical research has proven that the main components of cattail pollen charcoal are typhasterol, isorhamnetin, fatty oil, and yellow pigment, etc., and it has the effects of stopping bleeding, dissipating blood stasis, and promoting urination. Cattail pollen charcoal has an inhibitory effect on in vitro tumor cells; a water extract or 5% ethanol extract of cattail pollen charcoal can significantly shorten the clotting time of rabbits.

[0042] Talc: It is sweet, bland, and cold in nature, and enters the stomach and bladder meridians. It promotes urination and relieves strangury, clears heat and relieves summer heat, and astringes dampness and heals sores. It can clear damp heat in the bladder and promote urination. It is a commonly used drug for treating strangury, and is often used clinically to treat heat strangury, urinary stones, and painful and burning urination.

[0043] Carbonized human hair: It is neutral in nature, bitter in taste, and enters the liver and stomach meridians. It has the effects of astringing and stopping bleeding, removing blood stasis and promoting diuresis.

[0044] Kelp: Cold in nature, non-toxic, and enters the liver, stomach, and kidney meridians. Kelp has the effects of softening and dispersing nodules, resolving phlegm, and promoting diuresis. Kelp mainly contains alginic acid, amino acids, polysaccharides, and iodine-containing compounds. Modern research shows that kelp and seaweed contain salt, are highly susceptible to moisture absorption and weight gain, and contain impurities. If not processed, their salt content easily absorbs moisture, causing mold and spoilage, affecting quality. Usually, it is cleaned by washing with water, using iodine content as a test indicator. This indicates that washing is the best water treatment method for kelp, and the longer the rinsing time, the greater the loss of iodine content.

[0045] Calcined oyster shell: It is salty and cold in nature, and has the effects of astringing and consolidating, neutralizing acid and relieving pain, calming the mind and soothing the nerves, and softening and dispersing nodules. Due to its astringent and consolidating properties, it can treat various types of collapse syndromes.

[0046] Astragalus charcoal: slightly warm in taste and sweet in nature; enters the lung and spleen meridians. It has the effects of strengthening the spleen and replenishing qi, promoting diuresis and reducing swelling, strengthening the body's defensive qi and promoting tissue regeneration.

[0047] Purple-skinned garlic charcoal: It has anti-inflammatory, diuretic, and de-edema-reducing effects.

[0048] Compared with the prior art, the beneficial effects of the present invention include:

[0049] (1) The traditional Chinese medicine composition provided in this application consists of seven herbs: charred cattail pollen, talc, charred human hair, kelp, calcined oyster shell, charred astragalus, and charred purple garlic. Among them, charred cattail pollen has diuretic and blood-stasis-removing effects; talc has diuretic and strangury-clearing effects; charred human hair has blood-stasis-removing and diuretic effects; kelp has the effects of softening and dispersing nodules, resolving phlegm, and promoting diuresis; calcined oyster shell has astringent and consolidating effects; charred astragalus has diuretic and swelling-reducing effects, and strengthens the body's defenses; and charred purple garlic has anti-inflammatory, diuretic, and anti-edema and proteinuria-reducing effects. The combined use of these herbs has a holistic effect of tonifying the kidney, strengthening the spleen, replenishing qi, clearing turbidity, removing dampness, and removing blood stasis, which can significantly improve the clinical symptoms of patients with chronic renal failure; improve the patients' renal function; and improve various indicators to varying degrees.

[0050] (2) Each Chinese herbal medicine is extracted, concentrated at low temperature, purified, dried at low temperature, and mixed evenly in a certain proportion to make granules, powders, tablets or capsules.

[0051] (3) The traditional Chinese medicine composition (Puhua Capsules) provided in this application can significantly improve the clinical symptoms and renal function of patients with chronic renal failure, with varying degrees of improvement in all indicators. The total effective rate was 93.88%, which was significantly better than that of the control group, and the statistical analysis showed that P < 0.05. Laboratory results showed that Puhua Capsules can significantly reduce the blood urea nitrogen (BUN) and serum creatinine (Scr) levels in patients with chronic renal failure and increase the endogenous creatinine clearance rate (Ccr); in patients with CRF accompanied by dyslipidemia, the post-treatment test showed that it can significantly reduce the levels of triglycerides, cholesterol, and low-density lipoprotein in patients, with varying degrees of improvement in various blood lipid indicators; it can increase the hemoglobin (Hb) content in patients with anemia and improve their anemia status; and it can improve various blood rheological indicators, improve the hypercoagulable state and blood circulation in patients.

[0052] (4) This application is a formulation developed based on the characteristics of the pathogenesis of chronic renal failure in traditional Chinese medicine. Pharmacodynamic studies and clinical observations have further confirmed the effectiveness and mechanism of action of the composition. It has the overall effects of tonifying the kidney, strengthening the spleen and replenishing qi, removing turbidity and dampness and removing blood stasis. It is an effective drug for the treatment of chronic renal failure and is worth promoting and applying. Detailed Implementation

[0053] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0054] Example 1

[0055] A method for preparing a traditional Chinese medicine composition for treating uremia, comprising the following steps:

[0056] (1) Take 5.5g of charred cattail pollen, 20g of talc, 6g of charred human hair, 12g of kelp, 15g of calcined oyster shell, 30g of charred astragalus, and 15g of charred purple garlic.

[0057] (2) Take the above-mentioned medicinal materials and prepare them according to the following preparation method:

[0058] Cattail pollen charcoal: Spread cattail pollen evenly on an enamel plate to a thickness of 5.5cm, place it in an oven, and bake at 150℃ for 5.5min.

[0059] Talc: Remove impurities, wash, crush into small pieces, place in a stainless steel container, add water, grind into a paste, add more water and stir until the coarse powder settles. Immediately pour off the suspension, and grind the settled coarse particles again. Repeat this process until fine. Finally, discard any unsustainable impurities, combine the suspensions from both ends, let stand, and after sedimentation, pour off the clear water on top. Take the precipitate, dry it, and grind it into powder.

[0060] Human hair charcoal: Take hair from a healthy person, remove impurities, wash away oil and grime with diluted alkaline water, rinse clean, dry, and place in a pot. Cover with a smaller pot, seal the joint between the two pots with salt mud, and weigh it down. Attach a strip of white paper or a few grains of rice to the bottom of the lid, heat over high heat, and char until the paper or rice turns a golden-brown color. Remove from heat, let cool, and then chop into small pieces.

[0061] Kelp: Soak kelp in 8 times the amount of water at 15℃ for 48 hours, wash it, let it dry until semi-dry, and then cut it into strips and dry it.

[0062] Calcined oysters: Crush the cleaned oysters into particles with a size of 4.5cm. 3 Small pieces were placed in a crucible, spread to a thickness of 4.5 cm, and calcined at 50°C for 75 minutes.

[0063] Astragalus charcoal: Take astragalus slices and stir-fry them according to the charcoal-frying method until thick smoke rises, the surface is charred black, and the inside is brownish-brown. Spray a little water to extinguish the sparks, take them out, and let them dry.

[0064] Purple-skinned garlic charcoal: Select a 600g dark green thick-skinned watermelon, wash it, and cut a 15cm×15cm square opening at the stem end to obtain a square lid. Keep the lid for later use. Remove the pulp, leaving the shell. Put the washed purple-skinned garlic into the shell, and place the square lid on the opening of the shell. Evenly and tightly paste a 2cm thick layer of hemp mud (mud:hemp:water = 3:1:2, mass ratio) on the outside of the shell. Then put it in a furnace and fire it at 95℃ for 30 minutes, and continue to fire it at 70℃ for 40 minutes. After calcining, remove the mud shell, take out the garlic charcoal, crush it and sieve it to obtain the purple-skinned garlic charcoal.

[0065] (3) Boil the kelp twice with twice the amount of water, 30 minutes each time. Combine the two decoctions and concentrate to 15 ml to obtain a concentrated solution for later use.

[0066] (4) The concentrated liquid is mixed with cattail pollen charcoal, talc, human hair charcoal, calcined oyster shell, astragalus charcoal, and purple garlic charcoal, granulated, and encapsulated to obtain the traditional Chinese medicine composition for treating uremia.

[0067] Example 2

[0068] A method for preparing a traditional Chinese medicine composition for treating uremia, comprising the following steps:

[0069] (1) Take 10g of charred cattail pollen, 7.5g of talc, 10g of charred human hair, 6g of kelp, 25g of calcined oyster shell, 15g of charred astragalus, and 30g of charred purple garlic.

[0070] (2) Take the above-mentioned medicinal materials and prepare them according to the following preparation method:

[0071] Cattail pollen charcoal: Spread cattail pollen evenly on an enamel plate to a thickness of 5.5cm, place it in an oven, and bake at 150℃ for 5.5min.

[0072] Talc: Remove impurities, wash, crush into small pieces, place in a stainless steel container, add water, grind into a paste, add more water and stir until the coarse powder settles. Immediately pour off the suspension, and grind the settled coarse particles again. Repeat this process until fine. Finally, discard any unsustainable impurities, combine the suspensions from both ends, let stand, and after sedimentation, pour off the clear water on top. Take the precipitate, dry it, and grind it into powder.

[0073] Human hair charcoal: Take hair from a healthy person, remove impurities, wash away oil and grime with diluted alkaline water, rinse clean, dry, and place in a pot. Cover with a smaller pot, seal the joint between the two pots with salt mud, and weigh it down. Attach a strip of white paper or a few grains of rice to the bottom of the lid, heat over high heat, and char until the paper or rice turns a golden-brown color. Remove from heat, let cool, and then chop into small pieces.

[0074] Kelp: Soak kelp in 8 times the amount of water at 15℃ for 48 hours, wash it, let it dry until semi-dry, and then cut it into strips and dry it.

[0075] Calcined oysters: Crush the cleaned oysters into particles with a size of 4.5cm. 3 Small pieces were placed in a crucible, spread to a thickness of 4.5 cm, and calcined at 50°C for 75 minutes.

[0076] Astragalus charcoal: Take astragalus slices and stir-fry them according to the charcoal-frying method until thick smoke rises, the surface is charred black, and the inside is brownish-brown. Spray a little water to extinguish the sparks, take them out, and let them dry.

[0077] Purple-skinned garlic charcoal: Select a 600g dark green thick-skinned watermelon, wash it, and cut a 15cm×15cm square opening at the stem end to obtain a square lid. Keep the lid for later use. Remove the pulp, leaving the shell. Put the washed purple-skinned garlic into the shell, and place the square lid on the opening of the shell. Evenly and tightly paste a 2cm thick layer of hemp mud (mud:hemp:water = 3:1:2, mass ratio) on the outside of the shell. Then put it in a furnace and fire it at 95℃ for 30 minutes, and continue to fire it at 70℃ for 40 minutes. After calcining, remove the mud shell, take out the garlic charcoal, crush it and sieve it to obtain the purple-skinned garlic charcoal.

[0078] (3) Boil the kelp twice with twice the amount of water, 30 minutes each time. Combine the two decoctions and concentrate to 15 ml to obtain a concentrated solution for later use.

[0079] (4) The concentrated liquid is mixed with cattail pollen charcoal, talc, human hair charcoal, calcined oyster shell, astragalus charcoal, and purple garlic charcoal, granulated, and encapsulated to obtain the traditional Chinese medicine composition for treating uremia.

[0080] Experimental Example 1

[0081] Taking the traditional Chinese medicine composition prepared in Example 1 as an example (hereinafter referred to as Puhua Capsules), the clinical observation results are as follows:

[0082] I. Basic Information

[0083] 1. Case source and grouping

[0084] Sixty-three patients meeting the diagnostic criteria for chronic renal failure (Ccr < 80 ml / min, Scr > 133 μmol / L) were selected. Among them, 32 had primary glomerulonephritis, 11 had diabetic nephropathy, 8 had hypertensive nephropathy, 5 had pyelonephritis, and 7 had other underlying conditions. All enrolled cases were randomly divided into a treatment group (n=32) and a control group (n=31). There were no significant differences in gender, age, or degree of renal impairment between the two groups.

[0085] 2. Treatment Plan

[0086] General treatment: Both groups of patients were given a high-quality, low-protein, low-phosphorus diet to ensure energy supply. At the same time, they were given symptomatic treatments such as lowering blood pressure, correcting acidosis, correcting electrolyte imbalance, and anti-infection. Patients with severe anemia were given erythropoietin (EPO) treatment to eliminate aggravating factors.

[0087] Treatment group: In addition to general treatment, patients were given Puhua capsules (prepared in Example 1), 3 times a day, 10 capsules each time. The dosage can be adjusted appropriately according to the patient's condition, aiming for two soft bowel movements per day. One course of treatment lasted 60 days.

[0088] Control group: In addition to general treatment, patients were given Uremic Clearing Granules [product of Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd.], 5g four times a day, 10g before bedtime, for 60 days as one course of treatment.

[0089] Observation indicators: Observe the patient's clinical symptoms and signs before and after treatment, detect the changes in laboratory indicators such as blood urea nitrogen (BUN), serum creatinine (Scr), and creatinine clearance rate (Ccr) before and after treatment, and observe the changes in TCM syndrome.

[0090] Efficacy evaluation: The efficacy evaluation criteria refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the "Efficacy Judgment Criteria for New Traditional Chinese Medicines in the Treatment of Chronic Renal Failure" and the "Efficacy Judgment Criteria for Traditional Chinese Medicine Syndromes".

[0091] 3. Criteria for judging the efficacy of treatment for diseases

[0092] Significant effect: (1) Clinical symptom score decreased by ≥60%; (2) Endogenous creatinine clearance increased by ≥20%; (3) Serum creatinine decreased by ≥20%.

[0093] Effective: (1) Clinical symptom score decreased by ≥30%; (2) Endogenous creatinine clearance increased by ≥10%; (3) Serum creatinine decreased by ≥10%.

[0094] Stable: (1) Clinical symptoms have improved and the score has decreased by <30%; (2) Endogenous creatinine clearance has not decreased or has increased by <10%; (3) Serum creatinine has not increased or has decreased by <10%.

[0095] Ineffective: (1) No improvement or worsening of clinical symptoms; (2) Decreased endogenous creatinine clearance; (3) Increased serum creatinine.

[0096] If all of the above items (1) are required, and at least one item (2) or (3) is required, the determination can be made.

[0097] The criteria for judging the efficacy of treatment for symptoms are as follows:

[0098] Clinical cure: The clinical symptoms and signs in traditional Chinese medicine have disappeared or basically disappeared, and the symptom score has decreased by ≥95%.

[0099] Significant effect: Clinical symptoms and signs in TCM are significantly improved, and the symptom score is reduced by ≥70%.

[0100] Effective: Clinical symptoms and signs in Traditional Chinese Medicine improved, and the symptom score decreased by ≥30%.

[0101] Ineffective: No significant improvement or even worsening of clinical symptoms and signs in Traditional Chinese Medicine, with a symptom score reduction of less than 30%.

[0102] The symptom score was evaluated according to the Chronic Renal Failure Symptom Grading Quantification Table in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine".

[0103] 4. Data Processing. t-tests were used for continuous data, and chi-square tests were used for categorical data. 2 Test, Ridit analysis.

[0104] II. Clinical Observation Results

[0105] (I) Comparison of therapeutic effects

[0106] 1. Sixty-three patients were selected and divided into a treatment group (n=32) and a control group (n=31). The efficacy of treatment (Puhua Capsules) and treatment (Ureapon Clearing Granules) in the treatment group and the control group (Ureapon Clearing Granules) was compared between the two groups. The results are shown in Table 1.

[0107] Table 1 Comparison of treatment efficacy between the two groups of cases

[0108]

[0109] As shown in Table 1, after statistical processing and Ridit analysis, the total effective rate of the treatment group (93.88%) was significantly better than that of the control group (78.98%). The treatment group had 32 cases and the control group had 31 cases.

[0110] 2. Effects on gastrointestinal symptoms

[0111] Sixty-three patients with obvious gastrointestinal symptoms were selected, including 32 patients in the treatment group and 31 patients in the control group. The changes in symptom grading scores before and after treatment were used to assess the impact on gastrointestinal symptoms. The results are shown in Tables 2 and 3.

[0112] Table 2. CRF Gastrointestinal Symptom Grading

[0113]

[0114] Symptom score: 0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms.

[0115] Table 3 Comparison of syndrome efficacy between the two groups of cases after treatment

[0116]

[0117] Comparison of symptom-related efficacy between the two groups: The treatment group consisted of 32 cases, and the control group consisted of 31 cases. Statistical analysis using Ridit showed that the total effective rate in the treatment group (50.00%) was significantly higher than that in the control group (16.13%). This indicates that the treatment group had a significant advantage in improving clinical symptoms.

[0118] (II) The present invention observed some patients with mild anemia (without epo) and performed hemoglobin testing. The results are shown in Table 4.

[0119] Table 4 Comparison of Hb changes before and after treatment in the two groups

[0120]

[0121] This invention observed hemoglobin testing in some patients with mild anemia (who did not use EPO). There were 32 patients in the treatment group and 31 patients in the control group. After treatment, the hemoglobin (Hb) of both groups increased to varying degrees. There was a significant difference between the treatment group and the control group.

[0122] (III) The results of the comparison of blood urea nitrogen changes before and after treatment in the two groups of cases are shown in Table 5.

[0123] Table 5 Comparison of blood urea nitrogen changes before and after treatment in the two groups (ml / min)

[0124]

[0125] Note: △This indicates that there was a significant difference between the two groups after treatment and before treatment (p < 0.05). * This indicates that there was a significant difference between the treatment group and the control group after treatment (P < 0.05).

[0126] (iv) Comparison of blood lipid changes before and after treatment in the two groups of cases. The results are shown in Table 6.

[0127] Table 6 Comparison of blood lipid changes before and after treatment in the two groups of cases

[0128]

[0129] Note: △ This indicates a significant difference in the treatment group before and after treatment (p < 0.05). * This indicates that there was a significant difference between the treatment group and the control group after treatment (P < 0.05).

[0130] III. Animal Experimental Efficacy Studies

[0131] Experimental methods:

[0132] Fifty-four male rats weighing 160–180 g were randomly divided into three groups: a normal control group (n=10), a model group (n=14), and groups receiving either high- or low-dose Puhua capsules (1 g / kg, 2 g / kg (5% and 10% suspension, 2 ml / 100 g) or uremic toxin-clearing granules [Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd. product] (9 g / kg (30% suspension, 2 ml / 100 g)). Except for the normal control group, all rats were fed a mixed diet containing 0.75% adenine for 5 consecutive weeks, with administration starting from the second week. Administration was done via gavage for 4 consecutive weeks. The model group received 2 ml / 100 g of water, the 2 g / kg group received twice daily, and the other groups received once daily. Rats were fasted for 12 hours. Two hours after the last administration, the rats were weighed, lightly anesthetized with ether, and blood was collected from the jugular vein. The rats were then dissected, and both kidneys were weighed. The kidney index (K = (kidney weight / body weight) × 100) was calculated, and various tests were performed. The experimental data were statistically compared using t-tests and u-tests, respectively.

[0133] Experimental results:

[0134] 1. Effects on Hb in rats with chronic renal failure

[0135] Take 20 μl of jugular vein blood from rats, add it to 5 ml of Venzie's solution, shake well, let stand for 30 min, and then measure the OD value of each sample at 540 nm. The Hb level of each rat is obtained by dividing the sample OD value by the standard OD value and multiplying by 150 g / L. The results are shown in Table 7.

[0136] Table 7. Effects of Puhua capsules on Hb in rats with renal failure.

[0137] normal control group 10 <![CDATA[147.81±16.57 *** ]]> Model group 14 131.45±10.94 Puhua Capsules 2g / kg 10 <![CDATA[144.29±8.11 ** ]]> Puhua Capsules 1g / kg 10 <![CDATA[138.55±7.22 ** ]]> Uremic Clearing Granules 10 <![CDATA[134.52±7.25 * ]]>

[0138] Note: Compared with the model group, ***P<0.001, **P<0.01, *P>0.05.

[0139] Experimental results suggest that Puhua capsules, at a dose of 40 ml / kg, can significantly increase the serum Hb content in rats with renal failure.

[0140] 2. The effects on the kidney index of rats with experimental renal failure are shown in Table 8.

[0141] Table 8. Effects of Puhua capsules on renal index in rats with chronic renal failure.

[0142] normal control group 10 <![CDATA[0.85±0.12 *** ]]> Model group 14 2.49±0.41 Puhua Capsules 2g / kg 10 <![CDATA[1.88±0.33 ** ]]> Puhua Capsules 1g / kg 10 <![CDATA[1.90±0.24 ** ]]> Uremic Clearing Granules 10 <![CDATA[2.17±0.25 * ]]>

[0143] Note: Compared with the model group, ***P<0.001, **P<0.01, *P<0.05.

[0144] After administration of Puhua capsules, the degree of turbid swelling of the kidneys in rats with chronic renal failure was significantly reduced, and the renal index was significantly lower than that of the model, indicating that it has a significant protective effect on the kidney lesions themselves. The renal index of the 2g / kg Puhua capsule group was significantly lower than that of the Uremic Clearing Granules group (P<0.05).

[0145] 3. Effects on serum creatinine (Scr) and blood urea nitrogen (BUN) levels in rats with renal failure

[0146] Blood was collected from the jugular vein of rats, centrifuged at 3000 r / min for 10 minutes, and serum was separated. The levels of Scr and BUN in the serum were measured. The results are shown in Table 9.

[0147] Table 9. Effects of Puhua capsules on serum Scr and BUN in rats with renal failure.

[0148]

[0149]

[0150] Note: Compared with the model group, *P < 0.05, **P < 0.01, ***P < 0.001

[0151] Puhua capsules significantly reduced serum creatinine (Scr) and blood urea nitrogen (BUN) levels in rats with renal failure. The Scr level in the 2g / kg Puhua capsule group was significantly lower than that in the Uremic Clearing Granules group.

[0152] 4. Serum triglycerides (TG), total cholesterol (TC), and high-density lipoprotein cholesterol (HDL-C) in each group of rats were determined by enzyme reaction endpoint method. The results are shown in Table 10.

[0153] Table 10 Effects of Puhua capsules on serum TG, TC, and HDL-C in rats ( mmol / l)

[0154] normal control group 10 <![CDATA[0.86±0.23 *** ]]> <![CDATA[1.85±0.30 *** ]]> <![CDATA[36.01±7.23 ** ]]> Model group 14 1.53±0.36 2.70±0.55 26.92±6.71 Puhua Capsules 2g / kg 10 1.22±0.26 2.26±0.56 33.03±7.60 Puhua Capsules 1g / kg 10 <![CDATA[1.06±0.31 * ]]> <![CDATA[2.01±0.41 * ]]> <![CDATA[37.13±7.01 ** ]]> Uremic Clearing Granules 10 1.35±0.28 <![CDATA[2.11±0.46 * ]]> <![CDATA[34.90±6.93 * ]]>

[0155] Note: Compared with the model group: *P<0.05, **P<0.01, ***P<0.001.

[0156] In summary, the Puhua capsules prepared in this invention can significantly improve the clinical symptoms and renal function of patients with chronic renal failure, with varying degrees of improvement in all indicators. The total effective rate was 93.88%, significantly better than the control group (P < 0.05). Laboratory results showed that Puhua capsules can significantly reduce blood urea nitrogen (BUN) and serum creatinine (Scr) levels in patients with chronic renal failure, and increase endogenous creatinine clearance (Ccr). In CRF patients with dyslipidemia, post-treatment testing showed a significant reduction in blood triglyceride, cholesterol, and low-density lipoprotein levels, with varying degrees of improvement in all lipid indicators. It can also increase hemoglobin (Hb) levels in patients with anemia, improving their anemia status. Furthermore, it can improve various hemorheological parameters, and improve hypercoagulable state and blood circulation in patients.

[0157] This application is a formulation developed based on the characteristics of the pathogenesis of chronic renal failure in traditional Chinese medicine. Pharmacodynamic studies and clinical observations have further confirmed the effectiveness and mechanism of action of the traditional Chinese medicine composition of this invention. It has the overall effects of tonifying the kidney and spleen, replenishing qi, promoting the elimination of turbidity and dampness and removing blood stasis. It is an effective drug for the treatment of chronic renal failure and is worthy of promotion and application.

[0158] Experimental Example 2

[0159] Taking the traditional Chinese medicine compositions prepared in Examples 1 and 2 as examples (hereinafter referred to as Puhua Capsules), the relevant clinical trial cases are as follows:

[0160] Case 1

[0161] (1) Patient: Zhao Moumou, male, 37 years old. Date of initial visit: September 23, 2018.

[0162] Chief complaint: Lower back pain and weakness for 3-4 years, which has worsened in the past 3 months and is accompanied by headache and edema.

[0163] Three months prior to the initial consultation, the patient presented to a Western medicine internal medicine department with symptoms of fatigue, stomach discomfort, and headache. At that time, blood pressure was 189 / 150 mmHg, creatinine was 244.9 mmol / L, and the patient experienced chest tightness, shortness of breath, and increased nocturia. The patient was hospitalized in the nephrology department and diagnosed with chronic nephritis, renal insufficiency, and secondary hypertension. After antihypertensive treatment, blood pressure was slightly controlled, and the patient was discharged two weeks later. Follow-up visits to the nephrology outpatient clinic were conducted. However, due to worsening of lower back pain, fatigue, and headache, along with facial and lower extremity edema, foamy urine, and 5-6 nocturia, the patient was transferred to the traditional Chinese medicine department. Medical history: For the past 3-4 years, the patient had experienced lower back pain and fatigue, occasional morning facial edema, and increased nocturia for the past 2 years. Chief complaints at the time of consultation: lower back pain, fatigue, foamy urine, bitter and slightly sticky taste in the mouth, and loose stools. Urinalysis revealed: protein 3+ / HP, red blood cells 2+ / HP, white blood cells 2-4 / HP, quantified urine protein 1.5g / 24h, creatinine 253.7mol / L, blood urea nitrogen 13.3mmol / L, C-reactive protein 0.4mg / L. Renal 3D ultrasound showed: right renal artery resistance index 0.65, left renal artery resistance index 0.67. Blood pressure: 140 / 105mmHg. Tongue coating was white, greasy, and slightly yellow; tongue body was pale red; pulse was thready and weak.

[0164] The diagnosis was spleen and kidney qi deficiency with liver yang hyperactivity and damp-heat stagnation. The patient was a male who had experienced lower back pain and fatigue for the past 3-4 years, with foamy urine and increased nocturia for the past 2 years. Three months prior to consultation, he experienced worsening lower back pain, fatigue, and frequent nocturia, accompanied by headache, bitter and slightly sticky taste in the mouth, facial and lower limb edema, and loose stools. His blood pressure was 140 / 105 mmHg. His tongue coating was white, greasy, and slightly yellow; the tongue body was pale red; and his pulse was thready and weak. His urine protein levels were 3+ / HP, red blood cells 2+ / HP, white blood cells 2-4 / HP, creatinine 244.9 mol / L, and blood urea nitrogen 13.3 mmol / L. He was diagnosed with chronic nephritis, renal insufficiency, and secondary hypertension. Lower back pain, fatigue, frequent urination at night, edema, and foamy urine are signs of spleen and kidney qi deficiency; high blood pressure and headache are signs of liver yang hyperactivity; bitter and slightly sticky taste in the mouth, loose stools, and a white, greasy, and slightly yellow tongue coating are signs of damp heat; a reddish tongue body is a sign of blood stasis in the collaterals; and a thin and weak pulse is a sign of spleen qi deficiency.

[0165] (2) Treatment plan

[0166] General treatment: Provide the patient with a high-quality, low-protein, low-phosphorus diet, along with symptomatic treatments such as antihypertensive and anti-infective therapies.

[0167] Treatment with Puhua capsules: In addition to general treatment, take Puhua capsules (prepared in Example 1), 3 times / day, 10 capsules / time. One course of treatment is 60 days. A total of 3 courses of treatment were administered, resulting in a cure.

[0168] Follow-up visit on September 30: Lower back pain, fatigue, and headache have improved; lower limb edema has gradually subsided. Repeat urinalysis showed: protein 1+ / HP, red blood cells + / HP, white blood cells 0 / HP; blood pressure: 135 / 90 mmHg; tongue coating: thin and slightly greasy; tongue body: pale red; pulse: thready and weak.

[0169] Third consultation on October 7th: Slight lower back pain and weakness, thin white tongue coating, pale red tongue body, and thready pulse. Continue taking the medication.

[0170] On October 15th, the patient reported no lower back pain or fatigue, normal nocturia, and relieved headache. The tongue coating was thin, white, and slightly greasy, the tongue body was pale red, and the pulse was soft. After two months of continued treatment, a follow-up examination showed creatinine at 169.2, 24-hour protein quantification at 0.60g / 24h, urine protein + / HP, and a 3D renal ultrasound: right renal artery resistance index 0.47, left renal artery resistance index 0.60, and C-reactive protein 0.3mg / L.

[0171] One year later, at the follow-up, creatinine was 118 μmol / L, 24-hour protein quantification was 0.5 g / 24h, and urine protein was negative / HP. Creatinine levels remained between 110 and 129 μmol / L for 5 years.

[0172] Case 2

[0173] (1) Patient: Ms. Xiang, 37 years old. Date of initial visit: March 17, 2019.

[0174] Chief complaint: Headache accompanied by edema in both lower limbs for 5 years, which has worsened in the past 2 months.

[0175] The patient reported experiencing headaches for 5 years, which were relieved by rest and were not taken seriously. Three years ago, they also experienced blurred vision, eyelid edema, and a slightly sticky, bitter taste in their mouth. These symptoms did not improve with rest, prompting them to seek medical attention. High blood pressure was discovered, reaching a maximum of 230 / 130 mmHg. They received antihypertensive treatment at another hospital, but blood pressure control was unsatisfactory. In the afternoon, they experienced bilateral lower extremity edema and foamy urine. Two weeks prior to this visit, after coughing, they experienced abnormal heaviness and weakness in their lower extremities. Urinalysis revealed: protein 2+ / HP, red blood cells 3+ / HP, white blood cells 2-3 / HP, creatinine 133 μmol / L, blood urea nitrogen 9.5 mmol / L, and hemoglobin (Hb) 8.13. Upon examination, the patient presented with a sallow complexion, facial puffiness, lower extremity swelling with minimal pitting edema, a thin, greasy, slightly yellow tongue coating, a pale red tongue body, and a slippery pulse. Blood pressure: 180 / 110 mmHg. The patient presented with abnormal heaviness and soreness in the lower limbs, significant fatigue, sallow complexion, and foamy urine, indicating spleen and kidney qi deficiency. Spleen and kidney qi deficiency leads to impaired kidney function, resulting in foamy urine. Internal accumulation of toxins and elevated creatinine levels, along with impaired qi transformation, cause facial and lower limb edema. Internal damp-heat manifests as a bitter and slightly sticky taste in the mouth and dry stools. Insufficient liver blood results in blurred vision. A pale red tongue indicates qi deficiency and blood stasis in the meridians. A thin and slippery pulse indicates spleen qi deficiency and internal retention of dampness.

[0176] (2) Treatment plan

[0177] General treatment: Provide the patient with a high-quality, low-protein, low-phosphorus diet and ensure energy supply. At the same time, administer symptomatic treatments such as antihypertensive drugs and erythropoietin (EPO) and eliminate aggravating factors.

[0178] Treatment with Puhua capsules: In addition to general treatment, Puhua capsules (prepared in Example 2) were administered, 3 times / day, 10 capsules / time. One course of treatment lasted 60 days. A total of 4 courses of treatment were administered, resulting in a cure.

[0179] The dosage can be adjusted appropriately according to the patient's condition, aiming for two soft bowel movements per day, with 60 days constituting one course of treatment.

[0180] Follow-up visit on March 24: Headache, lower limb edema, and fatigue improved; urine foam decreased. 24-hour urine protein quantification report: 2.28g / 24h. Repeat urinalysis: urine protein 2+ / HP, red blood cells + / HP, white blood cells 0-2 / HP, blood pressure: 145 / 90 mmHg, thin tongue coating.

[0181] Third consultation on April 8th: Lower back pain and weakness have largely disappeared; no foamy urine; one soft bowel movement per day; repeat urinalysis showed proteinuria +; 24-hour urine protein quantification was 0.89g / 24h. Tongue coating was thin and white; tongue body was pale red; pulse was thready. Continue with the previous treatment plan.

[0182] On April 19, routine urinalysis showed negative results for proteinuria. Renal function tests showed creatinine at 117 μmol / L and blood urea nitrogen at 6.5 mmol / L. Three months later, creatinine was 103 μmol / L. During a four-year follow-up, creatinine levels remained between 128 and 213 μmol / L.

[0183] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating uremia, characterized in that, It is prepared from the following raw materials in parts by weight: 5.5-10 parts of cattail pollen charcoal, 7.5-20 parts of talc, 6-10 parts of human hair charcoal, 6-12 parts of kelp, 15-25 parts of calcined oyster shell, 15-30 parts of astragalus charcoal, and 15-30 parts of purple-skinned garlic charcoal. The method for preparing the purple-skinned garlic charcoal is as follows: dig a square opening at the stem of a watermelon to obtain a square lid for later use. Remove the pulp and keep the shell. Place the purple-skinned garlic inside the shell and cover the opening of the shell with the square lid. Evenly coat the outside of the shell with a layer of hemp seed mud. Then, heat it over high heat for 30-60 minutes, continue to heat it over low heat, simmer and calcine to retain its properties, and after cooling, break the mud shell to obtain the purple-skinned garlic charcoal.

2. The traditional Chinese medicine composition for treating uremia according to claim 1, characterized in that, The preparation method of the cattail pollen charcoal includes: drying cattail pollen to obtain the cattail pollen charcoal.

3. The traditional Chinese medicine composition for treating uremia according to claim 2, characterized in that, The baking temperature is 100~150℃; The baking time is 5-6 minutes.

4. The traditional Chinese medicine composition for treating uremia according to claim 1, characterized in that, The method for preparing calcined oysters includes: calcining oysters to obtain calcined oysters.

5. The traditional Chinese medicine composition for treating uremia according to claim 4, characterized in that, The calcination temperature is 45~55℃; The calcination time is 60-90 minutes.

6. The traditional Chinese medicine composition for treating uremia according to claim 1, characterized in that, The hemp mud is made of a mixture of clay, hemp fibers, and water. The mass ratio of the clay, hemp fibers, and water is 2~4:1:1~3; The temperature of the fire-smelting process is 75~95℃; The temperature for the smelting process is 55~70℃; The simmering time is 40-70 minutes.

7. A method for preparing a traditional Chinese medicine composition for treating uremia according to any one of claims 1 to 6, characterized in that, The steps include the following: (1) Mix kelp with water and boil it. Concentrate the decoction to 1 / 2 to 1 / 4 of the original volume to obtain a concentrated liquid; (2) The concentrated liquid is mixed with cattail pollen charcoal, talc, human hair charcoal, calcined oyster shell, astragalus charcoal, and purple garlic charcoal to obtain the traditional Chinese medicine composition for treating uremia.

8. The preparation method according to claim 7, characterized in that, In step (1), the volume ratio of kelp to water is 0.5 to 1:

1.

9. The preparation method according to claim 7, characterized in that, In step (1), the decocting temperature is 95~100℃; The decoction is prepared 1 to 3 times. Each simmering time is 25-35 minutes.

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