Traditional Chinese medicine composition for treating and / or adjunctively treating chronic kidney diseases

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating and / or adjunctively treating chronic kidney diseases. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-30 parts of semen cuscutae, 15-30 parts of dogwood, 15-30 parts of glossy privet fruit, 30-60 parts of honeysuckle stem, 15-30 parts of caulis spatholobi and 15-30 parts of kadsura pepper stem. The traditional Chinese medicine composition disclosed by the invention can be used for treating or assisting in treating chronic kidney diseases and has a good application prospect.

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating and / or assisting in the treatment of chronic kidney disease. Background Art

[0002] Chronic kidney disease (CKD) is characterized by renal proteinuria, high morbidity and mortality, and has become a global public health problem. Modern medicine mainly uses angiotensin converting enzyme inhibitors (ACEI), glucocorticoids, immunosuppressants and symptomatic treatment to reduce proteinuria. Among them, ACEI alone is difficult to achieve the ideal therapeutic effect, while hormones and immunosuppressants have a long course of treatment, large side effects and high costs. CKD is a disease with advantages in traditional Chinese medicine. Traditional Chinese medicine has the characteristics of definite efficacy, rich experience, few side effects and low price in the treatment of CKD, and has become a basic model for the treatment of CKD.

[0003] In the prior art, there have been some studies on Chinese medicine compositions for treating CKD. For example, "CN201910120916.3 A Chinese medicine composition, preparation, preparation method and use thereof for treating or assisting the treatment of chronic kidney disease" provides a Chinese medicine composition for assisting the treatment of CKD, which is composed of: by weight, 5-90 parts of Astragalus, 5-90 parts of Panax notoginseng, 5-90 parts of Angelica sinensis, 5-90 parts of Achyranthes bidentata, 5-90 parts of Kelp, 5-90 parts of Coix seeds, 5-90 parts of Chinese yam and 5-90 parts of Licorice. However, the current Chinese medicine still lacks relevant theories on chronic kidney disease, which is not conducive to the development of new CKD Chinese medicine compositions. In addition, due to individual differences among different patients, their reactions to drugs and possible side effects are different. Therefore, it is still necessary to develop more Chinese medicine compositions for the treatment of CKD in this field, so as to provide more options for clinical medication. Summary of the invention

[0004] In view of the problems in the prior art, the object of the present invention is to provide a Chinese medicine composition for treating and / or assisting in the treatment of chronic kidney disease.

[0005] A Chinese medicine composition for treating and / or assisting in the treatment of chronic kidney disease, which is prepared from the following raw materials in parts by weight:

[0006] 15-30 parts of Cuscuta seeds,

[0007] 15-30 portions of Cornus officinalis,

[0008] 15-30 portions of Ligustrum lucidum fruit,

[0009] 30-60 portions of honeysuckle vine,

[0010] 15-30 portions of Millettia reticulata,

[0011] 15 to 30 servings of Pieris ovata.

[0012] Preferably, it is prepared from the following raw materials in parts by weight:

[0013] 30 parts of Cuscuta seeds,

[0014] 15 portions of Cornus officinalis,

[0015] 15 portions of Ligustrum lucidum,

[0016] 30 servings of Honeysuckle vine,

[0017] 15 servings of Millettia reticulata,

[0018] 15 servings of sea breeze vine.

[0019] Preferably, it is a preparation prepared with native drugs, water or organic solvent extracts of Cuscuta australis, Cornus officinalis, Ligustrum lucidum, Lonicera japonica, Millettia spatholobi, and Caulis clitoriae as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients added.

[0020] Preferably, the preparation is a powder, granules, tablets, decoction, atomizer, pills or capsules.

[0021] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0022] Step 1, extracting the raw material drug with water, concentrating it and then precipitating it with alcohol, and concentrating the supernatant into an extract;

[0023] Step 2, adding the extract to auxiliary materials to make a soft material, drying, crushing, and sieving to obtain the product.

[0024] Preferably, in step 1, the extraction process includes: soaking with 8 to 10 times the amount of water for 20 to 30 minutes, decocting for 30 to 45 minutes, and filtering; adding 4 to 6 times the amount of water to the residue and decocting again for 25 to 35 minutes, filtering, combining the filtrate, and concentrating to 1 times the volume of the raw material.

[0025] Preferably, in step 1, the extraction process includes: soaking with 9.09 times the amount of water for 30 minutes, boiling for 30 minutes, and filtering; adding 2-3 times the amount of water to the residue and boiling again for 30 minutes, filtering and combining the filtrate, and concentrating to 1 times the volume of the raw material.

[0026] Preferably, in step 2, the auxiliary material added is selected from at least one of the following components: sucrose, dextrin or ethanol.

[0027] The present invention also provides use of the above-mentioned traditional Chinese medicine composition in preparing medicine for treating and / or assisting in treating chronic kidney disease.

[0028] Preferably, the syndrome differentiation of chronic kidney disease is wind leakage in Xuanfu and kidney collateral stasis syndrome.

[0029] In the present invention, "adjuvant therapy" refers to the use of other treatment methods to improve the efficacy of the disease based on the general treatment methods.

[0030] There is no term for proteinuria in traditional Chinese medicine, but according to the clinical manifestations of proteinuria, it can be classified into the categories of "fine and subtle leakage" and "turbid urine". Chinese medicine believes that protein is a tangible "fine and subtle substance" belonging to the human body. When the kidney network is damaged, its ability to restrain the fine and subtle is weakened, and the fine and subtle can be discharged from the gate of the kidney network. Therefore, proteinuria should be classified into the category of "fine and subtle leakage" in Chinese medicine. The modern Chinese medicine theory "Zangfu Rheumatism Theory" believes that the internal evil is the basic pathological feature throughout chronic nephritis, and wind evil is the first of all diseases. Wind disturbs the kidney network and causes the kidney Xuanfu to fail to close, which is the primary factor for its onset. Therefore, the hidden wind opens the Xuanfu, which is the basic pathological mechanism of proteinuria in Chinese medicine. This is similar to the pathological mechanism of modern medicine that the production of renal proteinuria is mostly related to the deposition of circulating immune complexes (CIC) in the glomeruli, activating related inflammatory factors and causing damage to the glomerular filtration barrier. As for what Chinese medicine calls long-term illness causing blood stasis and obstruction of kidney collaterals, this also coincides with the fact that the long-term influence of inflammatory mediators on the glomeruli will further produce pathological changes such as thrombosis in capillaries, proliferation of mesangial cells, and glomerular sclerosis. The present invention, through the integration of the three major theories of Chinese medicine, namely “theory of visceral rheumatism”, “theory of Xuanfu” and “theory of collateral disease”, has established the theory of “hidden wind-dialysis of Xuanfu-collateral stasis”. It is believed that the occurrence and development of renal proteinuria is inextricably linked to “hidden wind”, that wind-dialysis of Xuanfu is the pathological basis for the production of proteinuria, and that blood stasis of kidney collaterals is both a pathological product and a pathogenic factor that aggravates the disease. (See the schematic diagram of the “hidden wind-dialysis of Xuanfu-collateral stasis” theory for details. Figure 1 ). Under the guidance of the theory of "hidden wind-dispelling Xuan-luo stasis", the research team of the present invention has carried out a large number of clinical practices on patients with renal proteinuria based on the treatment principle of "dispelling wind, consolidating Xuan and unblocking the collaterals", all of which have shown good therapeutic effects. With the continuous deepening of modern research on traditional Chinese medicine and the in-depth summary of clinical practice, we believe that traditional Chinese medicine plays an irreplaceable role in treating CKD, controlling disease-related risk factors, delaying the protracted development of the disease, reducing the incidence of complications, and improving the quality of life of patients. It is of great significance to invent a safe and effective traditional Chinese medicine preparation.

[0031] Traditional Chinese medicine often says "all seeds descend", and it is believed that Chinese medicine of the seed type is good at going to the lower part of the body, and is good at treating diseases of the lower part of the body. Moreover, the seeds and fruits are the essence of the plant, and are better at replenishing essence and strengthening the kidney than other medicinal materials. "Compendium of Materia Medica" points out: "All vines can open the meridians and enter the collaterals, and this thing is good at treating wind diseases." Chinese medicine of the vine type, twisting and winding, like meridians, crisscrossing and everywhere, is a good product for treating collateral diseases, because it is good at opening the meridians and entering the collaterals, not only can it penetrate into the kidney collaterals and reach the diseased area directly, but also can search and remove the hidden wind in the kidney. In clinical practice, vine drugs are often used to treat renal proteinuria. Modern pharmacological studies have also found that vine drugs can play multiple roles such as anti-inflammatory and immunomodulatory on immune-mediated glomerular diseases.

[0032] The research team of this invention explored the TCM connotation of renal proteinuria, and for the first time proposed the "Fufeng-Xiexuan-Luoyu" theory to explain the formation mechanism of renal proteinuria, and used the "Qufeng Guxuan-Dongluo" method to diagnose and treat renal proteinuria, and combined the TCM characteristics of "sub-category drugs are good at filling essence and consolidating Xuan" and "vine-category drugs are good at dispelling wind and unblocking collaterals", and carefully selected three sub-category and three vines for formula: Cuscuta chinensis, Cornus officinalis (also known as "Tianmu seeds"), Ligustrum lucidum, Lonicera japonica, Millettia reticulata, and Caulis Piperis ternata. Through long-term clinical use, it has been confirmed that the compound and its series of therapies have definite clinical efficacy. The whole formula has the following characteristics (the schematic diagram of the whole formula theory, method, and prescription is as follows Figure 2 ):

[0033] ① The combination of bitterness and bitterness, opening and closing

[0034] Ye Tianshi said: "The collaterals are spiciness for opening", "Attack the fortress with spiciness and fragrance, this is the main purpose of collateral diseases", "The Inner Canon" said: "Sourness binds and collects." Therefore, spiciness medicines ascend, disperse, run and jump, run but not stay, and are best at removing blood stasis and unblocking the collaterals, while sourness medicines astringe and bind, stay but not run, and are best at consolidating the Xuanfu. "Ben Jing Shu Zheng" said: "When it should be opened, it is to close the door and chase away the thieves, and when it should be closed, it is feared that the body fluids will disappear." The Ziteng Gushen Recipe of the present invention combines the spiciness of Haifeng Caulis and Cuscuta Semen with the sourness of Fructus Corni, and the spiciness and sourness are combined, and the opening and closing complement each other. The running of rattan medicines is matched with the guarding of Zi medicines, and the running and guarding are appropriate. There is stillness in movement and movement in stillness, so that the collaterals are unblocked without hurting the yin, and the Xuanfu is not retained by the thieves.

[0035] ②Supplementing both yin and yang, and both tonifying and restraining

[0036] The present invention uses Cuscuta seeds and Cornus officinalis as the main and auxiliary ingredients. Both are important medicines for balancing yin and yang. However, although both are said to balance yin and yang, they are biased towards tonifying yang. Therefore, Ligustrum lucidum is used to supplement yin and replenish essence, remove deficiency heat in the kidney, and make the supplementation without dryness to balance the medicinal properties. In addition, while balancing yin and yang, Cuscuta seeds and Cornus officinalis also have the ability to consolidate the mysterious palace. The two have both tonifying and astringing properties, which is a method of increasing income and reducing expenditure.

[0037] ③ Strengthen the body and eliminate evil, use both cold and warm

[0038] Chronic kidney disease is a syndrome of deficiency of the root and excess of the superficial. The prescription of the present invention uses rattan drugs to dispel hidden wind and dredge the kidney meridians, and uses rattan seeds to balance yin and yang, replenish essence and consolidate the body. The rattan seeds are combined to strengthen the body and dispel evil, and go hand in hand to achieve both superficial and fundamental treatment. In addition, while using warm drugs such as Millettia reticulata and Caulis Piperis dulse to dredge the meridians, the whole prescription also uses cold and cool products such as honeysuckle vine and Ligustrum lucidum to clear away deficiency heat. The cold and warm drugs are used together, which is balanced and stable, and suitable for patients to take for a long time.

[0039] Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

[0040] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This is a schematic diagram of the "hidden wind-discharging the mysterious-collateral stasis" theory;

[0042] Figure 2 This is a schematic diagram of the whole prescription theory, method and medicine;

[0043] Figure 3 The changes of TCM syndrome scores before and after treatment in the treatment group and the control group in Experimental Example 1 (treatment group N = 30; control group N = 30) (*: p < 0.05);

[0044] Figure 4 The changes in urine test indicators of CKD patients in the treatment group and the control group before and after treatment in Experimental Example 1: a. Changes in 24h urine protein quantification before and after treatment in the treatment group and the control group; b. Changes in urine microalbumin / urine creatinine (ACR) before and after treatment in the treatment group and the control group; c. Changes in urine red blood cell count before and after treatment in the treatment group and the control group. (Treatment group N = 30; control group N = 30) (*: p < 0.05);

[0045] Figure 5 The changes of urine podocyte injury indexes of CKD patients in the treatment group and the control group before and after treatment in Experimental Example 1: a. Changes of 24-hour urine Nephrin in the treatment group and the control group before and after treatment; b. Changes of 24-hour urine Podocin in the treatment group and the control group before and after treatment. (Treatment group N = 30; control group N = 30) (*: p < 0.05);

[0046] Figure 6The changes of inflammatory indicators of CKD patients in the treatment group and the control group before and after treatment in Experimental Example 1: a. Changes of interleukin 6 (IL-6) in the treatment group and the control group before and after treatment; b. Changes of tumor necrosis factor (TNF-α) in the treatment group and the control group before and after treatment. (Treatment group N = 30; control group N = 30) (*: p < 0.05). DETAILED DESCRIPTION

[0047] The raw materials and equipment used in the present invention are all known products, which are obtained by purchasing commercially available products.

[0048] Example 1 Chinese medicine composition

[0049] This embodiment provides a Chinese medicine composition, which consists of:

[0050] 30g of Cuscuta australis, 15g of Cornus officinalis, 15g of Ligustrum lucidum, 30g of Honeysuckle, 15g of Millettia reticulata, and 15g of Piper mesenteriae.

[0051] The Chinese medicine composition of this embodiment can be made into various dosage forms, taking the decoction-free granules as an example, and its specific preparation method is as follows:

[0052] Step 1, extraction: weigh the raw materials (30g of Cuscuta, 15g of Cornus officinalis, 15g of Ligustrum lucidum, 30g of Honeysuckle vine, 15g of Millettia spatholobi, and 15g of Kadzuki vine), add 1000ml of purified water, soak for 30min, decoct for 30min, filter, and retain the filtrate. Add 600ml of water to the residue, decoct again for 30min, filter and combine the filtrate, concentrate to 1:1 (i.e., concentrate to 110ml), add 95% ethanol, stir while adding, make the alcohol content reach 70%, and let it stand to precipitate. Take the supernatant, heat and concentrate to 10ml of extract for standby use.

[0053] Step 2, preparing a soft material: adding 30g sucrose and 10g dextrin as auxiliary materials to the above extract, adding an appropriate amount of 95% ethanol after mixing, stirring while adding to prepare a soft material, and drying in an oven at 50°C for 15 minutes for later use.

[0054] Step 3, whole grains: crush the dried soft material, pass it through a 16-mesh sieve, and package it.

[0055] Example 2 Chinese medicine composition

[0056] This embodiment provides a Chinese medicine composition, which consists of:

[0057] 30g of Cuscuta seeds, 15g of Cornus officinalis, 15g of Ligustrum lucidum, 60g of Honeysuckle vine, 15g of Millettia reticulata, and 15g of Piper mesenteriae.

[0058] The method for preparing the Chinese medicine composition in this embodiment is the same as that in Example 1.

[0059] Example 3 Chinese medicine composition

[0060] This embodiment provides a Chinese medicine composition, which consists of:

[0061] 15g of Cuscuta australis, 30g of Cornus officinalis, 30g of Ligustrum lucidum, 30g of Honeysuckle vine, 30g of Millettia reticulata, and 30g of Piper mesenteriae.

[0062] The method for preparing the Chinese medicine composition in this embodiment is the same as that in Example 1.

[0063] The technical solution of the present invention is further illustrated by experiments below.

[0064] Experimental Example 1: Experimental study on the efficacy of Chinese medicine composition

[0065] 1. Experimental Methods

[0066] 1. Clinical data

[0067] 1.1 General treatment

[0068] Clinical data of inpatients and outpatients of the Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University and patients with chronic kidney disease who sought medical treatment online from January 1, 2021 to January 1, 2023: There were 30 cases in the control group, including 18 males and 12 females, aged 14 to 52 years, with an average age of (31.53±9.00) years; 24-hour urine protein quantification was 1.05-2.61 mg / 24h, and the average 24-hour urine protein quantification was (1.71±0.39) mg / 24h; there were 30 cases in the treatment group, including 17 males and 13 females; they were aged 16 to 43 years, with an average age of (29.17±6.14) years; 24-hour urine protein quantification was 1.04-3.21 mg / 24h, and the average 24-hour urine protein quantification was (1.76±0.47) mg / 24h; This study was approved by the Ethics Committee and informed consent was obtained from the patients and their families.

[0069] 1.2 Inclusion criteria

[0070] 1) Meet the diagnostic criteria of CKD stage 1-4 in Western medicine;

[0071] 2) The urine protein qualitative test shows a positive reaction three times in a row or the 24-hour urine protein quantitative test is in the range of 0.15g / d to 3.5g / d;

[0072] 3) Meet the diagnostic criteria of wind leakage in Xuanfu and blood stasis in kidney meridians in traditional Chinese medicine (Symptom elements of wind leakage in Xuanfu and blood stasis in kidney meridians: ① Main symptoms: easy to catch cold, easy to sweat, hematuria, foamy urine, stabbing pain in waist. ② Secondary symptoms: aversion to wind, lack of energy, soreness of waist and knees, increased nocturia, spermatorrhea or increased leucorrhea, skin and nail disorder, stabbing pain in fixed parts of limbs. ③ Tongue: dull tongue, thin white or yellow fur, tongue with ecchymosis and petechiae, thick purple collaterals under tongue. ④ Pulse: thin and wiry pulse. The diagnosis can be made if two of the main symptoms are met and the tongue and pulse are referred to);

[0073] 4) Aged ≥18 and ≤75 years old, regardless of gender or ethnicity;

[0074] 5) The primary disease is stable and no glucocorticoid or immunosuppressant treatment is required;

[0075] 6) The patient or guardian agrees and voluntarily signs the Informed Consent Form.

[0076] 7) Take medication as directed by your doctor and complete follow-up visits regularly;

[0077] 8) No other serious medical diseases and complications.

[0078] 1.3 Exclusion criteria

[0079] 1) Exclude proteinuria caused by genetics, drugs, radiation, infection, tumors, etc.;

[0080] 2) Patients with severe primary diseases such as heart, brain, liver and hematopoietic system were excluded;

[0081] 3) Patients under 18 years of age or over 75 years of age, pregnant, breastfeeding, and with mental illness were excluded;

[0082] 4) Patients who were unable to cooperate with treatment or who did not complete treatment for various reasons were excluded;

[0083] 5) Patients who could not tolerate the medication used in the study for any reason were excluded;

[0084] 2. Treatment methods

[0085] Both groups of patients received CKD health education and conventional comprehensive treatment for CKD, including blood pressure control, correction of water, electrolyte and acid-base imbalance, correction of heart failure and metabolic acidosis, infection control, etc.; low-salt (sodium chloride 5g / d), low-fat, high-quality protein (25-35g / d) diet; use of beta-blockers or calcium channel blockers for patients with hypertension to control blood pressure within 130 / 80mmHg; use of insulin to control blood sugar in diabetic patients and require it to meet the standard; removal of reversible factors that cause renal dysfunction.

[0086] The control group, on the basis of CKD health education + CKD conventional comprehensive therapy, used ARB to control blood pressure and reduce proteinuria: oral Olmesartan Medoxomil Tablets (trade name: Lansha. Specification: 20 mg × 7 tablets / box, Beijing Fuyuan Pharmaceutical, National Medicine Standard No.: H20061312.), 20 mg each time, once a day, take the medicine on an empty stomach in the morning;

[0087] The treatment group was given the Chinese medicine composition of Example 1 (prescription group: 30g of honeysuckle vine, 15g of millet vine, 15g of Kadzu vine, 30g of dodder seed, 15g of cornus officinalis, 15g of glossy privet fruit; preparation method: decoction-free granules) on the basis of CKD health education + conventional comprehensive therapy for CKD. The Chinese medicine composition was taken once a day, divided into 3 times. The course of treatment was 3 months. Other Chinese medicines and Chinese patent medicines were discontinued during the treatment of the two groups.

[0088] 3. Observation items

[0089] The patient data were collected once before and after treatment, as follows: TCM syndrome score (see Table 1 for the TCM syndrome score table), laboratory indicators [24-hour urine protein quantification, urine albumin / urine creatinine (ACR), urine red blood cell count, serum creatinine (SCr), urea nitrogen (BUN), glomerular filtration rate (eGFR), 24-hour urine nephrin, 24-hour urine podocin, tumor necrosis factor (TNF-α), interleukin 6 (IL-6)].

[0090] Table 1 TCM syndrome scoring table

[0091]

[0092]

[0093]

[0094]

[0095] 4. Efficacy evaluation

[0096] Refer to "Diagnosis, Syndrome Differentiation and Therapeutic Effect Evaluation of Chronic Glomerulonephritis (Trial Scheme)" and "Standards for Diagnosis and Therapeutic Effect of Traditional Chinese Medicine Diseases":

[0097] (1) Complete remission: Symptoms and positive signs completely disappear, urine protein and urine red blood cells continue to turn negative, urine protein quantity is <0.2 / 24h, and renal function recovers or remains normal, lasting for more than 3 months.

[0098] (2) Basic remission: Symptoms and positive signs basically disappear, urine protein and urine red blood cells decrease by more than 50% compared with before treatment, renal function recovers or remains normal, or SCr remains unchanged or decreases by more than 20% compared with the baseline value, which lasts for more than 3 months.

[0099] (3) Effective: Symptoms and positive signs are significantly improved, urine protein and / or red blood cells decrease by 25% to 50% compared with before treatment, renal function recovers or remains normal, or SCr decreases by 10% to 20% compared with the baseline value, which lasts for more than 3 months.

[0100] (4) Stable: Clinical symptoms and positive signs have improved, urine protein and / or red blood cells have decreased by less than 25% compared with before treatment, and SCr has decreased by less than 10% compared with the baseline value, which lasts for more than 3 months.

[0101] (5) Ineffectiveness: No significant changes or aggravation in clinical symptoms and signs, no significant changes or aggravation in renal function, or SCr increased by >10% compared with the baseline value.

[0102] Total effective rate (%) = (number of complete remission cases + number of basic remission cases + number of effective cases) / total number of cases * 100%

[0103] 5. Statistical methods

[0104] SPSS25.0 statistical software was used for analysis. The measurement data were expressed as (mean ± standard deviation). The t-test was used to compare the measurement data between two groups. Analysis of variance (ANOVA) or rank sum test (Kruskal-Wallis H) was used to compare multiple groups. The chi-square test or rank sum test was used to compare the rates and constituent ratios. Bivariate association analysis and linear regression analysis were used for two random variables, and P < 0.05 was considered statistically significant.

[0105] 2. Experimental Results

[0106] There was no loss to follow-up in both the treatment group and the control group, which met the statistical requirements of scientific research.

[0107] 1. General data comparison

[0108] The comparison of general data of all cases in the two groups before treatment is shown in Table 2. There was no significant difference in age, TCM syndrome score, and laboratory indicators [24-hour urine protein quantity, urine microalbumin / urine creatinine (ACR), urine red blood cell count, serum creatinine (SCr), urea nitrogen (BUN), eGFR, 24-hour urine nephrin, 24-hour urine podocin, tumor necrosis factor (TNF-α), interleukin 6 (IL-6)] between the two groups (P>0.05), so the two groups were comparable.

[0109] Table 2 Basic data and biochemical indicators of the two groups before treatment

[0110]

[0111] 2. Comparison of clinical efficacy between the two groups

[0112] The total effective rate of the treatment group was 86.7% (26 / 30), significantly higher than that of the control group (60.0% (18 / 30), and the difference was statistically significant (x 2 =4.79, p<0.05), see Table 3.

[0113] Table 3 Clinical efficacy evaluation of the two groups (x±s, n=30)

[0114]

[0115] Note: Compared with the control group, *p<0.05.

[0116] 3. TCM syndrome scores of CKD patients (Table 4, Figure 3 )

[0117] After 3 months of treatment, the TCM syndrome scores of the treatment group and the control group decreased significantly, and the difference was statistically significant compared with before treatment (P < 0.05); there was a significant statistical difference in the syndrome scores between the treatment group and the control group after treatment (P < 0.05).

[0118] Table 4 Changes in TCM syndrome scores in the two groups before and after treatment

[0119]

[0120] Note: Compared with the group before treatment, a P<0.05; compared with the control group after treatment, b P<0.05

[0121] 4. Urine test indicators (Table 5, Figure 4 )

[0122] After 3 months of treatment, the urine test indicators such as 24h urine protein, ACR, and urine red blood cell count in the treatment group and the control group decreased significantly, and the difference was statistically significant compared with before treatment (P < 0.05); the urine test indicators such as 24h urine protein, ACR, and urine red blood cell count in the treatment group and the control group after treatment showed significant statistical differences (P < 0.05). (Table 5, Figure 2 )

[0123] Table 5 Changes of urine test indicators (24h urine protein, ACR, urine red blood cell count) before and after treatment in the two groups

[0124]

[0125] Note: Compared with the group before treatment, a P<0.05; compared with the control group after treatment, b P<0.05

[0126] 5. Urinary podocyte injury indicators in CKD patients (Table 6, Figure 5 )

[0127] After 3 months of treatment, the 24-hour urine Nephrin, 24-hour urine Podocin and other urine podocyte injury indicators in the treatment group and the control group were significantly decreased, and the difference was statistically significant compared with before treatment (P < 0.05); the 24-hour urine Nephrin, 24-hour urine Podocin and other urine podocyte injury indicators in the treatment group and the control group after treatment showed significant statistical differences (P < 0.05). (Table 6, Figure 3 )

[0128] Table 6 Comparison of urinary podocyte injury indicators (24h urine Nephrin, 24h urine Podocin) between the two groups before and after treatment

[0129]

[0130] Note: Compared with the group before treatment, a P<0.05; compared with the control group after treatment, b P<0.05

[0131] 6. Inflammatory indicators related to CKD patients (Table 7, Figure 6 )

[0132] After 3 months of treatment, the serum inflammatory indicators such as IL-6 and TNF-α in both the treatment group and the control group decreased significantly, and the differences were statistically significant compared with those before treatment (P < 0.05); there were significant statistical differences in the serum inflammatory indicators such as IL-6 and TNF-α between the treatment group and the control group after treatment (P < 0.05).

[0133] (Table 7, Figure 4 )

[0134] Table 7 Changes of serum inflammatory indicators (IL-6, TNF-α) in the two groups before and after treatment

[0135]

[0136] Note: Compared with the group before treatment, a P<0.05; compared with the control group after treatment, b P<0.05

[0137] Through the above embodiments and experimental examples, it can be seen that the present invention, in combination with the Chinese medicine composition of the present invention on the basis of lifestyle intervention therapy, can further improve the clinical symptoms and proteinuria and hematuria of CKD patients (TCM syndrome score, 24h urine protein quantification, ACR, urine red blood cell count), and has obvious therapeutic effects in reducing urine podocyte injury markers (24h urine Nephrin, 24h urine Podocin) and reducing systemic inflammatory response (TNF-α, IL-6). Therefore, the Chinese medicine composition of the present invention can be used for the treatment or adjuvant treatment of CKD, and has a good application prospect.

Claims

1. A Chinese medicine composition for treating and / or assisting in the treatment of chronic kidney disease, characterized in that: It is prepared from the following raw materials in parts by weight: 15-30 parts of Cuscuta seeds, 15-30 portions of Cornus officinalis, 15-30 servings of Ligustrum lucidum fruit, 30-60 portions of honeysuckle vine, 15-30 portions of Millettia reticulata, 15 to 30 servings of Pieris ovata.

2. The Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following raw materials in parts by weight: 30 parts of Cuscuta seeds, 15 portions of Cornus officinalis, 15 portions of Ligustrum lucidum, 30 servings of Honeysuckle vine, 15 servings of Millettia reticulata, 15 servings of sea breeze vine.

3. The Chinese medicine composition according to claim 1, characterized in that: The preparation is prepared by taking the native medicines of honeysuckle vine, Millettia reticulata, Caulis Piperis davidiana, Cuscuta australis, Cornus officinalis and Ligustrum lucidum as active ingredients, and adding pharmaceutically acceptable excipients or auxiliary ingredients.

4. The Chinese medicine composition according to claim 3, characterized in that: The preparation is in the form of powder, granule, tablet, decoction, atomizer, pill or capsule.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: Step 1, extracting the raw material drug with water, concentrating it and then precipitating it with alcohol, and concentrating the supernatant into an extract; Step 2, adding the extract to auxiliary materials to make a soft material, drying, crushing, and sieving to obtain the product.

6. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: In step 1, the extraction process includes: soaking with 8 to 10 times the amount of water for 20 to 30 minutes, decocting for 30 to 45 minutes, and filtering; adding 4 to 6 times the amount of water to the residue and decocting again for 25 to 35 minutes, filtering and combining the filtrate, and concentrating to 1 times the volume of the raw material.

7. The method for preparing the Chinese medicine composition according to claim 6, characterized in that: In step 1, the extraction process includes: soaking with 9.09 times the amount of water for 30 minutes, boiling for 30 minutes, and filtering; adding 2-3 times the amount of water to the residue and boiling again for 30 minutes, filtering and combining the filtrate, and concentrating it into 1 times the volume of the raw material.

8. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: In step 2, the added auxiliary material is selected from at least one of the following components: sucrose, dextrin or ethanol.

9. Use of the Chinese medicine composition according to any one of claims 1 to 8 in the preparation of a medicament for treating and / or assisting in the treatment of chronic kidney disease.

10. The use according to claim 9, characterized in that The syndrome differentiation of chronic kidney disease is wind leakage in Xuanfu and blood stasis in kidney collaterals.

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