Traditional Chinese medicine composition for treating chronic kidney diseases and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic kidney diseases and application thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: astragalus membranaceus, rheum officinale, cassia twig, poria cocos, radix paeoniae rubra, peach kernels and moutan bark. The traditional Chinese medicine components in the traditional Chinese medicine composition are scientific in compatibility, and the traditional Chinese medicine composition has a very remarkable effect on treating the chronic kidney diseases. Researches show that the traditional Chinese medicine composition can effectively treat the chronic kidney disease, improve the kidney function of a kidney disease patient, reduce the serum creatinine level and the urea nitrogen level, increase the expression level of peroxisome related functional enzymes and relieve kidney pathological injuries.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a traditional Chinese medicine composition for treating chronic kidney disease and application thereof. Background Art

[0002] Chronic kidney disease (CKD) refers to abnormal kidney structure and / or function caused by various reasons, which lasts for at least 3 months. Currently, renin-angiotensin system (RAS) inhibitors are the cornerstone of CKD treatment. However, the renal protective effects of RAS inhibitors vary in different subgroups, and their application is controversial as renal function declines. Therefore, the development of more effective drugs for the treatment of CKD is a problem that needs to be solved urgently.

[0003] Chronic kidney disease can be classified into the categories of "deficiency and fatigue", "lumbar pain", "edema", "blockage", "urinary retention" and other diseases in traditional Chinese medicine. Traditional Chinese medicine believes that CKD is mainly located in the spleen and kidney, and is closely related to the dysfunction of the lungs, liver, and triple energizer. Its main characteristics are deficiency of the body and excess of pathogens. The deficiency of the body is mainly spleen and kidney deficiency, and the excess of pathogens is mostly wind, dampness, heat, poison, and blood stasis.

[0004] Peroxisomes are organelles present in most eukaryotic cells, with the highest density in the liver and kidney. Peroxisomes have more than 50 enzymes and are involved in apoptosis, innate immunity and inflammation, aging, and age-related diseases. In recent years, there has been a lot of evidence that peroxisomes are involved in the pathogenesis of renal injury. Studies have found that downregulated proteins in damaged kidneys are involved in energy production, including many peroxisomal matrix proteins that play a role in fatty acid oxidation, such as acyl-CoA oxidase (ACOX), enoyl-CoA hydratase and 3-hydroxyacyl-CoA dehydrogenase (EHHADH) and catalase (CAT), acyl-CoA thioesterase 4 (ACOT4), etc. Therefore, restoring peroxisomal function is helpful for the treatment of CKD. Summary of the invention

[0005] In view of the deficiencies in the prior art, the object of the present invention is to provide a Chinese medicine composition for treating chronic kidney disease and its application.

[0006] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic kidney disease, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: astragalus, rhubarb, cinnamon twig, tuckahoe, red peony root, peach kernel and peony bark.

[0008] The Chinese medicine composition involved in the present invention is based on the treatment principle that chronic kidney disease should be accurately treated with deficiency and excess, clear the turbidity channel, remove dampness, dissipate blood stasis and expel turbidity and toxins, and is in line with the method of strengthening the body and eliminating evil, and attacking and tonifying at the same time. In the prescription, astragalus and Poria tonify the spleen and replenish qi, promote diuresis and reduce swelling; astragalus and cinnamon twig replenish qi and promote blood circulation, dredge the meridians and raise yang, transform qi and promote diuresis; red peony root and peach kernel promote blood circulation and blood circulation, remove blood stasis and promote new blood circulation; rhubarb and peony bark purge heat and remove blood stasis. All the medicines are used together, attacking and tonifying at the same time, and play the role of strengthening the spleen and kidney, promoting blood circulation and removing turbidity.

[0009] The Chinese medicine composition of the present invention is scientifically compatible with each other and has a significant effect in treating chronic kidney disease. Studies have shown that the Chinese medicine composition can effectively treat chronic kidney disease, improve the renal function of patients with kidney disease, reduce blood creatinine levels and urea nitrogen levels, increase the expression level of peroxisome-related functional enzymes, and reduce kidney pathological damage.

[0010] The Chinese medicines involved in the present invention can be purchased from general Chinese medicine stores, and their specifications meet the standards of the Chinese Pharmacopoeia.

[0011] Preferably, the Chinese medicine composition is prepared from the following Chinese medicine raw materials by mass: 15-60 parts of astragalus, 5-20 parts of rhubarb, 5-20 parts of cinnamon twig, 5-20 parts of poria, 5-20 parts of red peony root, 5-20 parts of peach kernel and 5-20 parts of peony bark.

[0012] When the components of the traditional Chinese medicine composition of the present invention are combined in the above-mentioned specific mass ratio, it has more significant effects in improving the renal function of patients with kidney disease, reducing blood creatinine levels and urea nitrogen levels, increasing the expression levels of peroxisome-related functional enzymes, and alleviating kidney pathological damage.

[0013] The “15-60 copies” can be selected from 15, 18, 20, 25, 30, 35, 40, 45, 50, 55, 60, etc.; the “5-20 copies” can be selected from 5, 8, 10, 12, 14, 16, 17, 18, 19, 20, etc.

[0014] Preferably, the Chinese medicine composition is prepared from the following Chinese medicine raw materials by mass: 28-32 parts of astragalus, 8-12 parts of rhubarb, 8-12 parts of cinnamon twig, 8-12 parts of poria, 8-12 parts of red peony root, 8-12 parts of peach kernel and 8-12 parts of peony bark.

[0015] The “28-32 portions” may be selected from 28 portions, 29 portions, 30 portions, 31 portions, 32 portions, etc.; the “8-12 portions” may be selected from 8 portions, 9 portions, 10 portions, 11 portions, 12 portions, etc.

[0016] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0017] The Chinese medicine composition involved in the present invention includes granules compounded from various Chinese medicine formula granules, solutions compounded from various Chinese medicine formula granules and dissolved in water, decoctions formed by decocting various Chinese medicine pieces, or Chinese medicine extracts formed by further concentrating the decoctions.

[0018] Preferably, the Chinese medicine composition is prepared by a preparation method comprising the following steps:

[0019] (1) mixing and soaking Poria cocos, red peony root, peach kernel, and peony bark with water to obtain a first soaking liquid; mixing and soaking Astragalus membranaceus with water to obtain a second soaking liquid; mixing and soaking Rhubarb with water to obtain a third soaking liquid; mixing and soaking cinnamon twig with water to obtain a fourth soaking liquid;

[0020] (2) heating the first soaking liquid, heating it to boiling over high heat, then decocting it slowly over low heat; then mixing it with the fourth soaking liquid and heating it, heating it to boiling over high heat, then decocting it slowly over low heat, filtering the decoction to obtain a decoction liquid and a decoction residue;

[0021] The first decoction residue is mixed with water and heated, and after being heated to boiling over high heat, it is slowly decocted over low heat; then mixed with the third soaking liquid and heated, and after being heated to boiling over high heat, it is slowly decocted over low heat, and the decoction liquid is filtered to obtain the second decoction liquid;

[0022] (3) heating the second soaking liquid, heating it to boiling over high heat, then slowly decocting it over low heat, filtering the decoction to obtain an astragalus decoction;

[0023] (4) mixing the astragalus decoction with the first decoction and the second decoction to obtain the Chinese medicine composition;

[0024] There is no distinction between the order of steps (2) and (3).

[0025] Compared with other decoction methods of Chinese medicine compositions, the above-mentioned specific preparation process can enable the final Chinese medicine composition to exert the medicinal properties of each Chinese medicine to a greater extent, and has more significant effects in improving the renal function of patients with kidney disease, reducing blood creatinine levels and urea nitrogen levels, increasing the expression levels of peroxisome-related functional enzymes, and reducing renal pathological damage.

[0026] Preferably, the material-liquid ratio in step (1) is independently 5-15 g / mL, for example 5 g / mL, 7 g / mL, 8 g / mL, 9 g / mL, 10 g / mL, 11 g / mL, 13 g / mL, 14 g / mL, 15 g / mL, etc.

[0027] Preferably, the soaking time in step (1) is independently 20-40 min, for example, 20 min, 25 min, 30 min, 35 min, 40 min, etc.

[0028] Preferably, in step (2), the first soaking liquid is heated, heated to boiling over high heat, and then simmered over low heat for 10-20 min (for example, 10 min, 12 min, 15 min, 18 min, 20 min, etc.); then, the first soaking liquid is mixed and heated, heated to boiling over high heat, and then simmered over low heat for 10-20 min (for example, 10 min, 12 min, 15 min, 18 min, 20 min, etc.), and the decoction is filtered to obtain a decoction liquid and a decoction residue.

[0029] Preferably, in step (2), the first decoction residue is mixed and heated with water at a material-liquid ratio of 5-15 g / mL (for example, 5 g / mL, 7 g / mL, 8 g / mL, 9 g / mL, 10 g / mL, 11 g / mL, 13 g / mL, 14 g / mL, 15 g / mL, etc.), and after heating to boiling over high heat, decocted slowly for 5-15 min (for example, 5 min, 8 min, 10 min, 12 min, 15 min, etc.) over low heat; then mixed and heated with the third soaking liquid, and after heating to boiling over high heat, decocted slowly for 5-15 min (for example, 5 min, 8 min, 10 min, 12 min, 15 min, etc.) over low heat, and the decoction liquid is filtered to obtain the second decoction liquid.

[0030] Preferably, the decoction liquid is filtered independently using a 300-400 mesh (eg, 300 mesh, 320 mesh, 350 mesh, 380 mesh, 400 mesh, etc.) sieve.

[0031] Preferably, in step (3), the second soaking liquid is decocted 1-3 times, for example, 1 time, 2 times or 3 times; each time lasts 40-70 minutes, for example, 40 minutes, 50 minutes, 60 minutes, 70 minutes, etc.

[0032] Preferably, the filtration in step (3) is performed using a 300-400 mesh (e.g., 300 mesh, 320 mesh, 350 mesh, 380 mesh, 400 mesh, etc.) sieve.

[0033] Preferably, in step (4), the astragalus decoction is mixed with the first decoction and the second decoction and then concentrated.

[0034] Preferably, the concentration process is followed by a drying process.

[0035] In a second aspect, the present invention provides use of the Chinese medicine composition according to the first aspect in the preparation of a medicament for preventing, improving or treating chronic kidney disease.

[0036] Preferably, the medicament is used to alleviate weight loss in patients with chronic kidney disease.

[0037] The drug is used to alleviate kidney pathological damage.

[0038] The drug is used to lower blood creatinine levels and urea nitrogen levels.

[0039] The drug is used to maintain the expression amount of peroxisome-related enzymes at a normal level.

[0040] Preferably, the dosage form of the drug includes solution, powder, tablet, capsule, and pill.

[0041] Preferably, the medicine further contains pharmaceutically acceptable excipients.

[0042] Preferably, the auxiliary material comprises any one of a diluent, a flavoring agent, a binder, a filler, a thickener, a disintegrant, a solubilizing agent, a suspending agent, a lubricant or a buffer, or a combination of at least two thereof.

[0043] Compared with the prior art, the present invention has the following beneficial effects:

[0044] The Chinese medicine composition involved in the present invention is based on the treatment principle that the treatment of chronic kidney disease should accurately grasp the underlying deficiency and superficial excess, open up the turbidity passage, remove dampness, dissipate blood stasis and remove turbidity and toxins. In terms of treatment, it complies with the method of strengthening the body and eliminating evil, and combining attack and supplement. The Chinese medicine components are scientifically matched to make it very effective in treating chronic kidney disease. Studies have shown that the Chinese medicine composition can effectively treat chronic kidney disease, improve the renal function of patients with kidney disease, reduce blood creatinine levels and urea nitrogen levels, increase the expression level of peroxisome-related functional enzymes, and reduce kidney pathological damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is the PAS staining image of the kidney tissue of mice in the normal control group;

[0046] Figure 2 is the PAS staining image of kidney tissue of mice in the model group;

[0047] Figure 3 is the PAS staining image of the kidney tissue of mice in the Example 1 group;

[0048] Figure 4 is the Masson staining image of kidney tissue of mice in the normal control group;

[0049] Figure 5 is the Masson staining image of kidney tissue of mice in the model group;

[0050] Figure 6 This is a Masson staining image of the kidney tissue of mice in the Example 1 group. DETAILED DESCRIPTION

[0051] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0052] The Chinese medicine raw materials involved in the following contents are all Chinese medicine decoction pieces.

[0053] Example 1

[0054] The present embodiment provides a traditional Chinese medicine composition, the preparation raw materials of which include: 30 parts of astragalus, 10 parts of rhubarb, 10 parts of cinnamon twig, 10 parts of poria, 10 parts of red peony root, 10 parts of peach kernel and 10 parts of peony bark.

[0055] Its preparation method is:

[0056] (1) Poria cocos, red peony root, peach kernel, peony bark and water were mixed at a solid-liquid ratio of 1:10 g / mL, and the mixture was soaked at 25°C for 30 minutes to obtain a first soaking liquid; Astragalus membranaceus was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a second soaking liquid; Rhubarb was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a third soaking liquid; Cinnamon twig was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a fourth soaking liquid;

[0057] (2) heating the first soaking liquid, heating it to boiling over high heat, and then decocting it for 15 minutes over low heat; then mixing it with the fourth soaking liquid and continuing to heat it, heating it to boiling over high heat, and then decocting it for 15 minutes over low heat, filtering the decoction using a 350-mesh sieve to obtain a decoction liquid and a decoction residue;

[0058] The first decoction residue was mixed with water at a material-liquid ratio of 8 g / mL and heated, and after being heated to boiling over high heat, it was decocted for 10 minutes over low heat; then it was mixed with the third soaking liquid and continued to be heated, and after being heated to boiling over high heat, it was decocted for 10 minutes over low heat, and the decoction was filtered through a 350-mesh sieve to obtain a second decoction liquid;

[0059] (3) heating the second soaking liquid, heating it to boiling over high heat, then decocting it over low heat for 60 minutes, filtering the decoction using a 350-mesh sieve, adding water to the residue and repeating the above operation once, combining the two filtrates to obtain an astragalus decoction;

[0060] (4) The Astragalus membranaceus decoction is mixed with the first decoction and the second decoction, and concentrated to 2 g crude drug / mL to obtain the traditional Chinese medicine composition.

[0061] Example 2

[0062] The present embodiment provides a traditional Chinese medicine composition, the preparation raw materials of which include: 32 parts of astragalus, 8 parts of rhubarb, 12 parts of cinnamon twig, 8 parts of poria, 12 parts of red peony root, 8 parts of peach kernel and 12 parts of peony bark.

[0063] Its preparation method is:

[0064] (1) Poria cocos, red peony root, peach kernel, peony bark and water were mixed at a solid-liquid ratio of 1:12 g / mL, and the mixture was soaked at 25°C for 40 minutes to obtain a first soaking liquid; Astragalus membranaceus was mixed at a solid-liquid ratio of 1:12 g / mL and the mixture was soaked at 25°C for 40 minutes to obtain a second soaking liquid; Rhubarb was mixed at a solid-liquid ratio of 1:12 g / mL and the mixture was soaked at 25°C for 40 minutes to obtain a third soaking liquid; Cinnamon twig was mixed at a solid-liquid ratio of 1:12 g / mL and the mixture was soaked at 25°C for 40 minutes to obtain a fourth soaking liquid;

[0065] (2) heating the first soaking liquid, heating it to boiling over high heat, and then decocting it for 12 minutes over low heat; then mixing it with the fourth soaking liquid and continuing to heat it, heating it to boiling over high heat, and then decocting it for 12 minutes over low heat, filtering the decoction using a 300-mesh sieve to obtain a decoction liquid and a decoction residue;

[0066] The first decoction residue was mixed with water at a material-liquid ratio of 10 g / mL and heated, and after being heated to boiling over high heat, it was changed to slow decocting for 8 minutes; then it was mixed with the third soaking liquid and continued to be heated, and after being heated to boiling over high heat, it was changed to slow decocting for 8 minutes, and the decoction was filtered through a 300-mesh sieve to obtain a second decoction liquid;

[0067] (3) heating the second soaking liquid, heating it to boiling over high heat, then decocting it over low heat for 70 minutes, filtering the decoction using a 300-mesh sieve, adding water to the residue and repeating the above operation once, combining the two filtrates to obtain an astragalus decoction;

[0068] (4) The Astragalus membranaceus decoction is mixed with the first decoction and the second decoction, and concentrated to 2 g crude drug / mL to obtain the traditional Chinese medicine composition.

[0069] Example 3

[0070] The present embodiment provides a traditional Chinese medicine composition, the preparation raw materials of which include: 28 parts of astragalus, 12 parts of rhubarb, 8 parts of cinnamon twig, 12 parts of poria, 8 parts of red peony root, 12 parts of peach kernel and 8 parts of peony bark.

[0071] Its preparation method is:

[0072] (1) Poria cocos, red peony root, peach kernel, peony bark and water were mixed at a solid-liquid ratio of 1:7 g / mL, and the mixture was soaked at 25°C for 20 minutes to obtain a first soaking liquid; Astragalus membranaceus was mixed at a solid-liquid ratio of 1:7 g / mL and the mixture was soaked at 25°C for 20 minutes to obtain a second soaking liquid; Rhubarb was mixed at a solid-liquid ratio of 1:7 g / mL and the mixture was soaked at 25°C for 20 minutes to obtain a third soaking liquid; Cinnamon twig was mixed at a solid-liquid ratio of 1:7 g / mL and the mixture was soaked at 25°C for 20 minutes to obtain a fourth soaking liquid;

[0073] (2) heating the first soaking liquid, heating it to boiling over high heat, and then decocting it for 20 minutes over low heat; then mixing it with the fourth soaking liquid and continuing to heat it, heating it to boiling over high heat, and then decocting it for 20 minutes over low heat, filtering the decoction using a 400-mesh sieve to obtain a decoction liquid and a decoction residue;

[0074] The first decoction residue was mixed with water at a material-liquid ratio of 5 g / mL and heated, and after heating to boiling over high heat, it was changed to slow decocting for 15 minutes; then it was mixed with the third soaking liquid and continued to heat, and after heating to boiling over high heat, it was changed to slow decocting for 15 minutes, and the decoction was filtered through a 400-mesh sieve to obtain a second decoction liquid;

[0075] (3) heating the second soaking liquid, heating it to boiling over high heat, then decocting it over low heat for 50 min, filtering the decoction using a 400-mesh sieve, adding water to the residue and repeating the above operation once, combining the two filtrates to obtain an astragalus decoction;

[0076] (4) The Astragalus membranaceus decoction is mixed with the first decoction and the second decoction, and concentrated to 2 g crude drug / mL to obtain the traditional Chinese medicine composition.

[0077] Example 4

[0078] This embodiment provides a Chinese medicine composition, the raw materials for its preparation are the same as those in Example 1, but the preparation method is different, as follows:

[0079] (1) Poria cocos, red peony root, peach kernel, peony bark, astragalus, rhubarb, cinnamon twig and water were mixed at a solid-liquid ratio of 1:10 g / mL and soaked at 25° C. for 30 min to obtain an soaking solution;

[0080] (2) The soaking liquid is heated, heated to boiling over high heat, and then slowly decocted for 60 minutes over low heat; the decoction is filtered through a 350-mesh sieve to obtain a medicinal liquid and a medicinal residue; the medicinal residue is mixed with water at a solid-liquid ratio of 8 g / mL and heated, heated to boiling over high heat, and then slowly decocted for 60 minutes over low heat; the decoction is filtered through a 350-mesh sieve to obtain a medicinal liquid and a medicinal residue.

[0081] (3) The two medicinal solutions were combined and concentrated to 2 g crude drug / mL to obtain the traditional Chinese medicine composition.

[0082] Example 5

[0083] This embodiment provides a Chinese medicine composition, the raw materials for its preparation are the same as those in Example 1, but the preparation method is different, as follows:

[0084] (1) Poria cocos, red peony root, peach kernel, peony bark and water were mixed at a solid-liquid ratio of 1:10 g / mL, and the mixture was soaked at 25°C for 30 minutes to obtain a first soaking liquid; Astragalus membranaceus was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a second soaking liquid; Rhubarb was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a third soaking liquid; Cinnamon twig was mixed at a solid-liquid ratio of 1:10 g / mL and the mixture was soaked at 25°C for 30 minutes to obtain a fourth soaking liquid;

[0085] (2) heating the first soaking liquid, heating it to boiling over high heat, then decocting it for 30 minutes over low heat, filtering the decoction with a 350-mesh sieve to obtain a medicinal solution and a medicinal residue; mixing the medicinal residue with water at a solid-liquid ratio of 8 g / mL, heating it, heating it to boiling over high heat, then decocting it for 20 minutes over low heat, filtering the decoction with a 350-mesh sieve to obtain a medicinal solution; combining the two medicinal solutions to obtain a first water decoction;

[0086] (3) heating the second soaking liquid, heating it to boiling over high heat, then decocting it for 60 minutes over low heat, filtering the decoction with a 350-mesh sieve to obtain a medicinal solution and a medicinal residue; mixing the medicinal residue with water at a solid-liquid ratio of 8 g / mL, heating it, heating it to boiling over high heat, then decocting it for 60 minutes over low heat, filtering the decoction with a 350-mesh sieve to obtain a medicinal solution; combining the two medicinal solutions to obtain a water decoction of Astragalus membranaceus;

[0087] (4) heating the third soaking liquid, heating it to boiling over high heat, then decocting it over low heat for 10 min, filtering the decoction with a 350-mesh sieve to obtain a rhubarb decoction;

[0088] (5) heating the fourth soaking liquid, heating it to boiling over high heat, then decocting it over low heat for 15 min, filtering the decoction using a 350-mesh sieve to obtain a cinnamon twig decoction;

[0089] (6) The first water decoction, the astragalus water decoction, the rhubarb water decoction, and the cinnamon twig water decoction are mixed and concentrated to 2 g crude drug / mL to obtain the traditional Chinese medicine composition.

[0090] Comparative Example 1

[0091] This comparative example provides a Chinese medicine composition, the raw materials for its preparation differ from those in Example 1 only in that Poria cocos is missing, and its mass fraction is proportionally distributed to the mass fractions of red peony root, peach kernel, and peony bark. The preparation method thereof is referred to Example 1.

[0092] Comparative Example 2

[0093] This comparative example provides a Chinese medicine composition, the raw materials for its preparation differ from those in Example 1 only in that red peony root is missing, and its mass fraction is proportionally distributed to the mass fractions of Poria cocos, peach kernel, and peony bark. The preparation method thereof is referred to Example 1.

[0094] Comparative Example 3

[0095] This comparative example provides a Chinese medicine composition, the raw materials for its preparation differ from those in Example 1 only in that peach kernel is missing, and its mass fraction is proportionally distributed to the mass fractions of Poria cocos, red peony root, and peony bark. The preparation method thereof is referred to Example 1.

[0096] Comparative Example 4

[0097] This comparative example provides a Chinese medicine composition, the raw materials for its preparation differ from those in Example 1 only in that the peony bark is missing, and its mass fraction is proportionally distributed to the mass fractions of Poria cocos, red peony root, and peach kernel. The preparation method thereof is referred to Example 1.

[0098] Test Case

[0099] Evaluation of the therapeutic effect of Chinese medicine combination on chronic kidney disease model mice:

[0100] (1) Experimental animals: C57BL / 6 male mice, age: 6 weeks, all animals had free access to food and sterile tap water, the housing temperature was 20-24°C; the relative humidity was 50%-60%; the photoperiod was 12 / 12 h light / dark.

[0101] (2) Experimental groups and intervention methods:

[0102] There were 11 groups in total, with 6 mice in each group, namely:

[0103] (2.1) Normal control group: mice were fed with normal feed for 4 weeks without other special treatments;

[0104] (2.2) CKD model group: mice were fed with a diet containing 0.2% adenine by mass for 4 weeks to obtain CKD model mice;

[0105] (2.3) Example 1 group: The mice were fed with a feed containing 0.2% adenine by mass for 4 weeks, and the Chinese medicine composition of Example 1 was gavaged at a dose of 27.2 g / kg / d based on the amount of raw materials for 4 weeks;

[0106] (2.4) Example 2 group: The mice were fed with a feed containing 0.2% adenine by mass for 4 weeks, and the Chinese medicine composition of Example 2 was gavaged at a dose of 27.2 g / kg / d based on the amount of raw materials for 4 weeks;

[0107] (2.5) Example 3 group: The mice were fed with a feed containing 0.2% adenine by mass for 4 weeks, and the Chinese medicine composition of Example 3 was gavaged at a dose of 27.2 g / kg / d based on the amount of raw materials for 4 weeks;

[0108] (2.6) Example 4-5, Comparative Example 1-4 group: The mice were fed with a feed containing 0.2% by mass of adenine for 4 weeks, and the Chinese medicine compositions of Example 4-5 and Comparative Example 1-4 were gavaged at a dose of 27.2 g / kg / d based on the amount of raw materials, respectively, for 4 weeks.

[0109] (3) Testing indicators:

[0110] (3.1) Effect on body weight of CKD mice:

[0111] After the feeding was completed, the body weight of mice in each group was measured. The test results are shown in Table 1 (compared with the normal control group, *** indicates P < 0.001; compared with the CKD model group, ### indicates P < 0.001, ## indicates P < 0.01, and # indicates P < 0.05; compared with the group in Example 1, && indicates P < 0.01, and &&& indicates P < 0.001).

[0112] Table 1

[0113]

[0114]

[0115] It can be seen from the data results in Table 1 that, compared with the comparative example product, the Chinese medicine composition involved in the present invention can alleviate the phenomenon of body weight loss caused by chronic kidney disease, and the preparation process of the Chinese medicine composition also has a certain influence on the above effect.

[0116] (3.2) Effects on serum creatinine and urine nitrogen in CKD mice:

[0117] After the feeding was completed, the creatinine content in the serum samples of each group of mice was detected by ELISA kit, and the urea nitrogen content in the serum samples of each group of mice was detected by ELISA kit. The test results are shown in Table 2 (compared with the normal control group, *** indicates P < 0.001; compared with the CKD model group, ### indicates P < 0.001, ## indicates P < 0.01, # indicates P < 0.05; compared with the group in Example 1, &&& indicates P < 0.001).

[0118] Table 2

[0119]

[0120]

[0121] It can be seen from the data results in Table 2 that, compared with the comparative example product, the Chinese medicine composition involved in the present invention can reduce the blood creatinine and urine nitrogen levels of CKD mice, that is, it can improve the renal function of CKD mice, and the preparation process of the Chinese medicine composition also has a certain influence on the above effect.

[0122] (3.3) Effects on peroxisome expression levels in CKD mice:

[0123] After the feeding was completed, the Western Blot method was used to detect the expression levels of peroxisome-related functional enzymes in the kidney tissue homogenate samples of each group of mice. The test results are shown in Table 3 (compared with the normal control group, ** indicates P < 0.01, *** indicates P < 0.001; compared with the CKD model group, ### indicates P < 0.001, ## indicates P < 0.01, # indicates P < 0.05; compared with the group in Example 1, & indicates P < 0.05, && indicates P < 0.01, &&& indicates P < 0.001, ns indicates no significant difference).

[0124] Table 3

[0125]

[0126]

[0127] It can be seen from the data results in Table 3 that, compared with the comparative example product, the Chinese medicine composition involved in the present invention can reverse the phenomenon of decreased expression levels of peroxisome-related functional enzymes in the kidney tissue of CKD mice, and the preparation process of the Chinese medicine composition also has a certain influence on the above effect.

[0128] (3.4) Observation of pathological damage of kidney tissue in CKD mice:

[0129] After the feeding was completed, PAS staining and Masson staining were performed on the kidney tissues of the mice in the normal control group, the model group and the Example 1 group, and the corresponding staining images were obtained by microscopic examination and photography.

[0130] Among them, the PAS staining steps are as follows:

[0131] ① Bake kidney tissue slices at 60℃ for 1h;

[0132] ② Dewaxing to water: xylene 5min×2 times; 95% alcohol 3min×1 time; 80% alcohol 1min×1 time; 80% alcohol 1min×1 time; double distilled water 1min×1 time;

[0133] ③ Oxidation with 1% periodic acid for 5 minutes; washing with running water for 5 minutes; immersion in distilled water twice;

[0134] ④Stain with Schiff's solution in the dark for 30 minutes; soak in 0.5% sodium metabisulfite for 2 minutes × 2 times; rinse with running water for 5 minutes; rinse with distilled water;

[0135] ⑤ Harris hematoxylin staining for 5 minutes; tap water washing for 1 minute; 1% hydrochloric acid alcohol differentiation for 30 seconds;

[0136] ⑥ Rinse thoroughly with tap water; warm water (or 1% ammonia water) to turn blue; rinse with running water;

[0137] ⑦95% alcohol 1 min × 2 times; 100% alcohol 1 min; 100% alcohol 2 min; xylene 1 min × 3 times; neutral gum sealing.

[0138] The Masson staining steps are as follows:

[0139] ① Bake kidney tissue slices at 60℃ for 1h;

[0140] ② Dewaxing to water: xylene 5min×2 times; 95% alcohol 3min×1 time; 80% alcohol 1min×1 time; 80% alcohol 1min×1 time; double distilled water 1min×1 time;

[0141] ③ Place the slices in Bouin's solution for a second fixation at room temperature overnight; rinse with running water until the yellow color disappears, and then wash with distilled water;

[0142] ④Weiger's iron hematoxylin staining solution for 10 minutes; rinse with running water; differentiate with 1% hydrochloric acid alcohol for 30 seconds;

[0143] ⑤ Add Ponceau red dye solution and dye for 10 minutes; rinse with distilled water;

[0144] ⑥ Treat with 0.1% phosphomolybdic acid aqueous solution for 5 minutes until the collagen fibers turn light red;

[0145] ⑦ Aniline blue for 5 minutes; 1% glacial acetic acid for 1 minute;

[0146] ⑧95% alcohol 1 min × 2 times; 100% alcohol 1 min; 100% alcohol 2 min; xylene 1 min × 3 times; neutral gum sealing.

[0147] The PAS staining images of the renal tissues of mice in the normal control group, model group and Example 1 group are shown in Figure 2. Figure 1-Figure 3 The Masson staining images of the kidney tissues of the normal control group, model group and Example 1 group are shown in Figure 4-Figure 6As shown in the figure, compared with the normal control group, the renal tubular epithelial cells of the mice in the model group atrophied and fell off, the renal tubules dilated, and the renal interstitial collagen was deposited. The renal tubular epithelial cell damage of the mice in the Example 1 group was significantly alleviated, and the renal interstitial collagen deposition was reduced, indicating that the Chinese medicine composition involved in the present invention can alleviate the renal pathological damage of CKD mice after treatment.

[0148] In summary, the Chinese medicine composition of the present invention can reduce the blood creatinine level and urea nitrogen level of the body suffering from chronic kidney disease, improve the renal function of animals suffering from kidney disease, reduce renal pathological damage, and can also maintain the expression of peroxisome-related functional enzymes at a normal level, alleviate the phenomenon of body weight loss caused by chronic kidney disease, and can be used to treat chronic kidney disease.

[0149] The applicant declares that the present invention illustrates the technical solution of the present invention through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of various raw materials of the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0150] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0151] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

Claims

1. A Chinese medicine composition for treating chronic kidney disease, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: astragalus, rhubarb, cinnamon twig, tuckahoe, red peony root, peach kernel and peony bark.

2. The Chinese medicine composition for treating chronic kidney disease according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicine raw materials by weight: 15-60 parts of astragalus, 5-20 parts of rhubarb, 5-20 parts of cinnamon twig, 5-20 parts of tuckahoe, 5-20 parts of red peony root, 5-20 parts of peach kernel and 5-20 parts of peony bark.

3. The Chinese medicine composition for treating chronic kidney disease according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicine raw materials by weight: 28-32 parts of astragalus, 8-12 parts of rhubarb, 8-12 parts of cinnamon twig, 8-12 parts of poria, 8-12 parts of red peony root, 8-12 parts of peach kernel and 8-12 parts of peony bark.

4. The Chinese medicine composition for treating chronic kidney disease according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition is prepared by a preparation method comprising the following steps: (1) mixing and soaking Poria cocos, red peony root, peach kernel, and peony bark with water to obtain a first soaking liquid; mixing and soaking Astragalus membranaceus with water to obtain a second soaking liquid; mixing and soaking Rhubarb with water to obtain a third soaking liquid; mixing and soaking cinnamon twig with water to obtain a fourth soaking liquid; (2) heating the first soaking liquid, heating it to boiling over high heat, then decocting it slowly over low heat; then mixing it with the fourth soaking liquid and heating it, heating it to boiling over high heat, then decocting it slowly over low heat, filtering the decoction to obtain a decoction liquid and a decoction residue; The first decoction residue is mixed with water and heated, and after being heated to boiling over high heat, it is slowly decocted over low heat; then mixed with the third soaking liquid and heated, and after being heated to boiling over high heat, it is slowly decocted over low heat, and the decoction liquid is filtered to obtain the second decoction liquid; (3) heating the second soaking liquid, heating it to boiling over high heat, then decocting it over low heat, filtering the decoction, and obtaining an astragalus decoction; (4) mixing the astragalus decoction with the first decoction and the second decoction to obtain the Chinese medicine composition; There is no distinction between the order of steps (2) and (3).

5. The Chinese medicine composition for treating chronic kidney disease according to claim 4, characterized in that: In step (1), the material-liquid ratio is independently 5-15 g / mL; Preferably, the soaking time in step (1) is independently 20-40 minutes.

6. The Chinese medicine composition for treating chronic kidney disease according to claim 4, characterized in that: In step (2), the first soaking liquid is heated, and after being heated to boiling over high heat, it is simmered for 10-20 minutes over low heat; then, it is mixed with the fourth soaking liquid and heated, and after being heated to boiling over high heat, it is simmered for 10-20 minutes over low heat, and the decoction is filtered to obtain a decoction liquid and a decoction residue; Preferably, in step (2), the first decoction residue is mixed and heated with water at a material-liquid ratio of 5-15 g / mL, and after being heated to boiling over high heat, it is decocted slowly for 5-15 min over low heat; then, it is mixed and heated with the third soaking liquid, and after being heated to boiling over high heat, it is decocted slowly for 5-15 min over low heat, and the decoction liquid is filtered to obtain the second decoction liquid; Preferably, the decoctions are filtered independently using a 300-400 mesh sieve.

7. The Chinese medicine composition for treating chronic kidney disease according to claim 4, characterized in that: In step (3), the second soaking liquid is decocted 1 to 3 times, each time for 40 to 70 minutes; Preferably, the filtration in step (3) is performed using a 300-400 mesh screen; Preferably, in step (4), the astragalus decoction is mixed with the first decoction and the second decoction and then concentrated; Preferably, the concentration process is followed by a drying process.

8. Use of the Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a medicament for preventing, improving or treating chronic kidney disease.

9. The use according to claim 8, characterized in that: The drug is used to alleviate the weight loss of patients with chronic kidney disease; The drug is used to alleviate pathological damage to the kidney; The drug is used to reduce blood creatinine levels and urea nitrogen levels; The drug is used to maintain the expression amount of peroxisome-related enzymes at a normal level.

10. The use according to claim 8, characterized in that: The dosage forms of the drug include solution, powder, tablet, capsule, and pill; Preferably, the drug further contains pharmaceutically acceptable excipients; Preferably, the auxiliary material comprises any one of a diluent, a flavoring agent, a binder, a filler, a thickener, a disintegrant, a solubilizing agent, a suspending agent, a lubricant or a buffer, or a combination of at least two thereof.

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