A Chinese medicine composition for tonifying kidney and detoxifying, preparation method of concentrated pills thereof and use thereof

Abstract

The invention discloses a Chinese medicine composition for tonifying kidney and detoxifying, a preparation method and use of concentrated pills thereof, and relates to the technical field of Chinese medicines. The invention aims to solve the problems of insignificant efficacy, large toxic and side effects, and unstable quality control of the Chinese medicine composition in the prior art. The raw materials of the Chinese medicine composition of the present invention are composed of 50-70 parts of raw astragalus, 50-70 parts of codonopsis, 30-50 parts of raw rehmannia, 30-50 parts of stir-fried yam, 30-50 parts of cornus, 30-50 parts of Yunfuling, 30-50 parts of salt alisma, 50-70 parts of salvia, 30-50 parts of forsythia, 30-50 parts of peach kernel, 20-40 parts of safflower, 30-50 parts of angelica, 20-40 parts of fructus aurantii, 50-70 parts of kudzu root, 30-50 parts of red peony root, 30-50 parts of bupleurum, 50-70 parts of magnolia bark, 50-70 parts of charred cyperus, 20-40 parts of raw rhubarb, 20-40 parts of liquorice and 50-70 parts of tsaoko kernel by weight. The Chinese medicine composition of the present invention is used to prepare a medicine for treating kidney injury.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for tonifying the kidney and detoxifying, and a preparation method and use of concentrated pills thereof. Background Art

[0002] Chronic kidney disease (CKD) is a disease characterized by the gradual decline of kidney function, and its severity is divided into five stages. It has become one of the major public health issues in the world. Kidney diseases in traditional Chinese medicine mainly include edema, turbid urine, constipation, and urinary retention, which belong to the category of modern medical nephrology. In clinical practice, kidney diseases include glomerulonephritis, pyelonephritis, nephrotic syndrome, chronic renal insufficiency, renal failure, or uremia. The clinical manifestations of chronic kidney disease include but are not limited to proteinuria, hematuria, hypoproteinemia, hyperlipidemia, edema, etc. There is no accurate name in traditional Chinese medicine. According to the clinical manifestations, it belongs to the categories of "edema", "urinary retention", "stranguria", "hematuria", "deficiency", "constipation", "low back pain" and so on in traditional Chinese medicine.

[0003] Chronic kidney disease is always characterized by deficiency of the root and excess of the symptoms. Deficiency of the body's health is the root, while excess of pathogenic factors is the symptom. Deficiency of the root refers to deficiency of the lung, spleen, and kidney, while excess of the symptoms refers to pathological products such as water dampness, damp-heat, phlegm, and blood stasis. Dysfunction of the lung, spleen, and kidney is the internal cause of the disease. Inappropriate diet, excessive fatigue, emotional disorder, and the six exogenous pathogens are the external causes of the disease, which lead to dysfunction of the internal organs and affect water metabolism, resulting in water dampness stagnation. The long-term accumulation of water dampness turns into heat. The long-term accumulation of damp heat causes phlegm turbidity to form in the body, and tangible and substantial pathogens accumulate in the body, blocking the circulation of qi and blood and turning into blood stasis. Treatment emphasizes strengthening the body's health and eliminating pathogens, and treating both the symptoms and the root causes. At different stages of chronic kidney disease, the focus of the pathogenesis is different. It is necessary to carefully distinguish the difference in the proportion of deficiency of the body's health and excess of pathogens, and handle the relationship between strengthening the body's health and eliminating pathogens well, without clinging to the evil and hurting the body. Professor Ma Hua 0 He believed that the root cause of chronic kidney disease is insufficient qi and blood, yin and yang, and deficiency of spleen and kidney. Internal accumulation of dampness and turbidity, and stasis and toxicity are the real evils that affect the different stages of the disease. He emphasized that treatment should be differentiated by stage and added or subtracted according to symptoms. In the early stage of the disease, it is important to invigorate qi and activate blood circulation. When the disease is more than halfway through, it is important to warm and nourish the yang of the spleen and kidney. For a long time, it is important to detoxify and reduce turbidity, and eliminate evil without forgetting to strengthen the body. Professor Dai Xiwen [2] Emphasize that during clinical treatment, we must pay attention to the treatment of solid evil and give it a way out. For water and dampness evil, we should use infiltration and facilitation; for dampness stagnation in the middle jiao, we should use transportation and transformation; for dampness and heat in the lower jiao, we should use clearing and facilitation; for turbid evil, we should use descending and drainage; for blood stasis, we should use activation and dispersion. Most patients with severe edema in chronic kidney disease are treated with the method of invigorating qi, activating blood circulation and promoting water excretion. Professor Ruan Shiwei [3]It is believed that the pathogenesis of chronic kidney disease lies in the deficiency of the body's vitality and the prevalence of pathogenic factors, as well as multiple focal and multiple organ lesions. The main method of treatment is to strengthen the body's vitality and eliminate pathogenic factors, and to eliminate them through the body. Therefore, in clinical treatment, it is important to protect the acquired and acquired constitutions. When the condition is stable, the main focus is on strengthening the foundation and eliminating pathogenic factors. When the condition flares up, both strengthening the body's vitality and eliminating pathogenic factors can be considered. At the same time, wind-clearing drugs are often used, and attention is paid to protecting body fluids and cutting off the spread of pathogenic factors, with significant results. Professor Zhang Binghou [4] It is believed that blood stasis exists in the process of chronic kidney disease. In the early stage, there is damage to the kidney network. Kidney deficiency is the root of blood stasis in CKD. Professor Zhang treats chronic kidney disease mainly by tonifying deficiency and removing blood stasis. He emphasizes the use of blood-activating drugs and treats them according to the severity of the disease. In the early stage, blood is harmonized and blood is activated, in the middle stage, blood is broken and blood is removed, and in the late stage, blood is nourished and blood is activated. Professor Wu Jinyu [5] It is believed that the pathogenesis of chronic kidney disease is characterized by deficiency of the root and excess of the symptoms, with spleen and kidney deficiency as the root and dampness, turbidity and blood stasis as the symptoms. Therefore, in clinical treatment, emphasis is placed on protecting the spleen and stomach, while replenishing qi and yin. Among the excess evils, "blood stasis" is the most important, and the method of promoting blood circulation and removing blood stasis is often used in clinical practice.

[0004] In summary, kidney diseases are mostly treated from the perspectives of "deficiency" and "excess", and the treatment methods mostly adopt methods such as tonifying the spleen and lungs, consolidating the kidneys and calming the liver, replenishing qi and nourishing yin, removing phlegm and promoting diuresis, promoting dampness and purging turbidity, and promoting blood circulation and removing blood stasis. Currently, there are many kinds of Chinese patent medicines for treating kidney diseases on the market, covering many traditional and modern prescriptions. However, these Chinese medicine compositions also have various problems in practical applications, including insignificant efficacy, large toxic and side effects, and unstable quality control. Summary of the invention

[0005] The technical problems to be solved by the present invention are:

[0006] The traditional Chinese medicine compositions in the prior art have problems such as insignificant therapeutic effects, significant toxic and side effects, and unstable quality control.

[0007] The present invention adopts the following technical solutions to solve the above technical problems:

[0008] The invention provides a traditional Chinese medicine composition for tonifying the kidney and detoxifying. The raw materials of the traditional Chinese medicine composition are composed of 50-70 parts of raw astragalus, 50-70 parts of codonopsis, 30-50 parts of raw rehmannia, 30-50 parts of stir-fried yam, 30-50 parts of cornus, 30-50 parts of yun fuling, 30-50 parts of salt alisma, 50-70 parts of salvia, 30-50 parts of forsythia, 30-50 parts of peach kernel, 20-40 parts of safflower, 30-50 parts of angelica, 20-40 parts of fructus aurantii, 50-70 parts of kudzu root, 30-50 parts of red peony root, 30-50 parts of bupleurum, 50-70 parts of magnolia bark, 50-70 parts of scorched areca, 20-40 parts of raw rhubarb, 20-40 parts of liquorice and 50-70 parts of tsaoko kernel.

[0009] Furthermore, the raw materials are composed by mass of 60 parts of raw astragalus, 60 parts of codonopsis, 40 parts of raw rehmannia, 40 parts of stir-fried yam, 40 parts of cornus, 40 parts of Yun Fuling, 40 parts of salt alisma, 60 parts of salvia miltiorrhiza, 40 parts of forsythia, 40 parts of peach kernel, 30 parts of safflower, 40 parts of angelica, 30 parts of fructus aurantii, 60 parts of kudzu root, 40 parts of red peony root, 40 parts of bupleurum, 60 parts of magnolia bark, 60 parts of charred areca, 30 parts of raw rhubarb, 30 parts of licorice and 60 parts of amomum villosum kernel.

[0010] Furthermore, the Chinese medicine composition is prepared into a Chinese medicine preparation for tonifying the kidney and detoxifying according to the dosage form of mixture, powder, pill, oral liquid, capsule, drop pill, granule or tablet.

[0011] A method for preparing concentrated pills of a Chinese medicine composition for tonifying the kidney and detoxifying is completed by the following steps:

[0012] 1. Weighing: Weigh the medicinal materials according to the mass fraction of the Chinese medicine composition for tonifying the kidney and detoxifying according to any one of the above technical solutions;

[0013] 2. Supercritical CO2 extraction: crush the grass fruit kernels weighed in step 1, and perform supercritical CO2 extraction to obtain grass fruit kernel volatile oil;

[0014] 3. Water extraction: The raw astragalus, codonopsis, raw rehmannia, stir-fried yam, cornus officinalis, Yunfuling, salt oriental water plantain, salvia miltiorrhiza, forsythia suspensa, peach kernel, safflower, angelica, fructus aurantii, kudzu root, red peony root, bupleurum, magnolia bark, charred cyperus, raw rhubarb and licorice weighed in step 1 are respectively subjected to water decoction extraction method to obtain astragalus paste, codonopsis paste, raw rehmannia paste, stir-fried yam paste, cornus officinalis paste, Yunfuling paste, salt oriental water plantain paste, salvia miltiorrhiza paste, forsythia paste, peach kernel paste, safflower paste, angelica paste, fructus aurantii paste, kudzu root paste, red peony root paste, bupleurum paste, magnolia bark paste, charred cyperus paste, raw rhubarb paste and licorice paste;

[0015] 4. Pill making: ①, the tsaoko kernel volatile oil obtained in step 2 is included by β-cyclodextrin, the mass ratio of the tsaoko kernel volatile oil to β-cyclodextrin is 1:60-120, and the cyclodextrin-included tsaoko kernel volatile oil is obtained; ②, the cyclodextrin-included tsaoko kernel volatile oil and the huangqi clear paste, codonopsis clear paste, raw rehmannia clear paste, stir-fried yam clear paste, cornus clear paste, Yunfuling clear paste, salt oriental clear paste, salvia clear paste, forsythia clear paste, peach kernel clear paste, safflower clear paste, angelica clear paste, fructus aurantii clear paste, kudzu root clear paste, red peony root clear paste, bupleurum clear paste, magnolia bark clear paste, scorched cyperus clear paste, raw rhubarb clear paste and liquorice clear paste obtained in step 3 are fully mixed and uniformly mixed, auxiliary materials are added, pill making is carried out, sieved, and dried at a temperature not exceeding 60°C to obtain kidney-tonifying and detoxifying concentrated pills.

[0016] Furthermore, the supercritical CO2 extraction process in step 2 is specifically as follows: the cardamom kernels weighed in step 1 are crushed, and supercritical CO2 extraction is performed at an extraction pressure of 15 MPa and an extraction temperature of 30° C. to obtain cardamom kernel volatile oil.

[0017] Furthermore, the water decoction extraction method in step 3 comprises the following steps:

[0018] ①. Add 8 times the amount of water to the weighed raw material, heat and reflux to extract for 1h to 3h, filter to obtain residue I and filtrate I;

[0019] ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 1h to 3h, filter to obtain residue II and filtrate II;

[0020] ③. Add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III;

[0021] ④. Combine filtrate I, filtrate II and filtrate III to obtain a decoction, and concentrate the decoction at 80°C to a relative density of 1.20-1.25.

[0022] Furthermore, in step 4①, the temperature for stirring and encapsulating the tsaoko kernel volatile oil with β-cyclodextrin is 10-30° C. and the stirring speed is 50 rpm-100 rpm.

[0023] Furthermore, the auxiliary material in step 4② is soluble starch.

[0024] Further, the mass ratio of the soluble starch to the total mass of Astragalus paste, Codonopsis paste, Rehmannia root paste, stir-fried yam paste, Cornus officinalis paste, Poria cocos paste, Salt Alisma orientalis paste, Salvia miltiorrhiza paste, Forsythia suspensa paste, Peach kernel paste, Safflower paste, Angelica sinensis paste, Citrus aurantium paste, Pueraria root paste, Red peony root paste, Bupleurum paste, Magnolia bark paste, Areca oleracea paste, Raw rhubarb paste and Licorice paste is 0.3-0.4:1.

[0025] The use of the Chinese medicine composition for tonifying the kidney and detoxifying as described in any of the above technical solutions is used in the preparation of drugs for treating kidney damage.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1. The present invention studies the therapeutic effect and mechanism of Chinese medicine composition on renal injury by establishing a nephritis rat model, and finds that raw astragalus, codonopsis, raw rehmannia, stir-fried yam, cornus officinalis, Yunfuling, salt amaranth, salvia miltiorrhiza, forsythia suspensa, peach kernel, safflower, angelica, fructus aurantii, kudzu root, red peony root, bupleurum, magnolia bark, charred cyperus, raw rhubarb, licorice and tsaoko kernel in a specific ratio have excellent effects on the treatment of renal injury, among which raw astragalus, codonopsis, raw rehmannia and cornus officinalis are monarch drugs, raw astragalus nourishes the middle and replenishes qi to help the source of qi and blood biochemical transformation; codonopsis strengthens the spleen and replenishes qi, and the two are the monarch drugs for strengthening the spleen. Raw rehmannia and cornus officinalis are used to nourish the kidney and nourish yin, replenish essence and blood, and the two are the monarch drugs for nourishing the kidney; salvia miltiorrhiza, angelica, yam and tuckahoe are used as minister drugs in the prescription; salvia miltiorrhiza and angelica are used to promote blood circulation and replenish blood, so as to increase the kidney-tonifying and blood-activating effects of raw rehmannia and cornus officinalis. Poria and Chinese yam are used to invigorate the spleen and replenish qi, transport and transform water and dampness, so as to increase the effect of astragalus and codonopsis. Forsythia and Pueraria root clear away heat and detoxify, peach kernel, safflower, red peony root promote blood circulation and dissipate blood stasis, and Citrus aurantium and Bupleurum regulate qi to increase the effect of promoting blood circulation; Alisma orientalis, rhubarb, Magnolia officinalis, Amomum villosum and Areca nut are used to detoxify and eliminate turbidity, eliminate filth, and disperse internal pathogens, and are adjuvants; Licorice is harmonized with various medicines, has the effects of invigorating qi and invigorating the spleen, relieving urgency and relieving pain, and is a guiding medicine. Experiments have shown that the Chinese medicine composition of the present invention has the effects of reducing low creatinine in rats with chronic kidney disease, reducing proteinuria, inhibiting inflammatory response, and alleviating kidney damage. Through the treatment investigation and follow-up of outpatients with different kidney diseases, it is shown that the Chinese medicine composition of the present invention has the effect of significantly reducing creatinine, urea nitrogen, and glomerular filtration rate in patients with chronic renal failure, and has the effect of significantly reducing creatinine and urea nitrogen in patients with diabetic nephropathy and hypertensive nephropathy. The results show that the concentrated kidney-tonifying and detoxifying pills of the present invention have a restoring effect on the renal function of patients with various kidney diseases, can significantly improve the state of kidney damage, and restore kidney function, especially for patients with chronic renal failure.

[0028] The present invention selects drugs with low toxicity and high safety, ensures the safety of long-term use, and effectively reduces adverse reactions. Standardized extraction and production processes are adopted to improve the stability and efficacy of the drugs. By optimizing the compatibility ratio and extraction process, the Chinese medicine composition of the present invention not only has a significant therapeutic effect. DETAILED DESCRIPTION

[0029] In order to enable those skilled in the art to better understand the scheme of the present invention, exemplary implementations or embodiments of the present invention are described below. Obviously, the described implementations or embodiments are only implementations or embodiments of a part of the present invention, not all. Based on the implementations or embodiments of the present invention, all other implementations or embodiments obtained by ordinary technicians in the field without creative work should fall within the scope of protection of the present invention.

[0030] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, specific embodiments of the present invention are described in detail below.

[0031] Specific implementation scheme one: The present invention provides a traditional Chinese medicine composition for tonifying the kidney and detoxifying, wherein the raw materials are composed of 50-70 parts of raw astragalus, 50-70 parts of codonopsis, 30-50 parts of raw rehmannia, 30-50 parts of stir-fried yam, 30-50 parts of cornus, 30-50 parts of Yun Fuling, 30-50 parts of salt alisma, 50-70 parts of salvia, 30-50 parts of forsythia, 30-50 parts of peach kernel, 20-40 parts of safflower, 30-50 parts of angelica, 20-40 parts of fructus aurantii, 50-70 parts of kudzu root, 30-50 parts of red peony root, 30-50 parts of bupleurum, 50-70 parts of magnolia bark, 50-70 parts of charred cyperus, 20-40 parts of raw rhubarb, 20-40 parts of licorice and 50-70 parts of amomum villosum.

[0032] Astragalus and Codonopsis in the Chinese medicine composition of this embodiment have the effect of invigorating qi and tonifying yang. Cornus officinalis and Chinese yam can invigorate qi and strengthen the spleen, nourish the kidney and strengthen the foundation. Poria cocos and Alisma orientalis are good at relieving the deficiency fire of the kidney meridian, especially treating damp heat in the lower part of the body. The two medicines are used together to transport dampness to the spleen and regulate the water channels, so that they are "tonifying but not harsh, beneficial but not fierce". "At the beginning of the disease, qi is blocked in the meridians, and after a long time, it enters the blood and enters the collaterals." Chronic kidney disease has a course of many years and is difficult to cure. The disease will inevitably damage the yin blood if it is long-term. Therefore, salvia miltiorrhiza, peach kernel, safflower, and red peony root are used to promote blood circulation, remove blood stasis and promote qi. At the same time, raw rehmannia root is used to clear heat and cool blood, nourish yin and promote body fluid. Chinese angelica can nourish blood and promote blood circulation. It is an important medicine for blood and can nourish yin and blood. Astragalus is an important medicine for qi. Astragalus and Chinese angelica are used together to achieve the effect of treating qi and blood at the same time, and together they can promote blood circulation, remove blood stasis and remove toxins. Bupleurum and Citrus aurantium can raise and lower the upper The Qi of Jiao is wide and the chest is widened to promote Qi, and Qi promotes blood flow; the main clinical manifestation of chronic kidney disease in the late stage is the sign of filthiness. Areca nut removes miasma, Magnolia officinalis breaks the evil, and Amomum villosum removes the hidden evil. "The three flavors work together to reach its nest, so that the evil Qi is defeated and quickly leaves the membrane." The three medicines are used together to reduce turbidity and Qi, break depression and eliminate fullness, regulate Qi, and Qi promotes blood flow; Forsythia suspensa is mainly clearing, clearing the middle and penetrating, and Rhubarb is good at clearing gastrointestinal accumulation and heat, mainly removing blood stasis, clearing the stomach and intestines, and breaking up the accumulation of tumors. Licorice is harmonized with other medicines, and it also has the effects of invigorating Qi and strengthening the spleen, relieving urgency and relieving pain. The whole prescription has the effects of invigorating the kidney and replenishing deficiency, strengthening the foundation and consolidating the original, promoting blood circulation and removing blood stasis, and removing turbidity and detoxification.

[0033] Specific implementation scheme 2: Its raw medicine is composed of 60 parts of raw astragalus, 60 parts of codonopsis, 40 parts of raw rehmannia, 40 parts of stir-fried yam, 40 parts of cornus, 40 parts of Yunfuling, 40 parts of salt alisma, 60 parts of salvia, 40 parts of forsythia, 40 parts of peach kernel, 30 parts of safflower, 40 parts of angelica, 30 parts of fructus aurantii, 60 parts of kudzu root, 40 parts of red peony root, 40 parts of bupleurum, 60 parts of magnolia bark, 60 parts of charred cyperus, 30 parts of raw rhubarb, 30 parts of liquorice and 60 parts of tsaoko kernel by mass. The rest of this implementation scheme is the same as the specific implementation scheme 1.

[0034] Specific implementation scheme three: the Chinese medicine composition is made into a Chinese medicine preparation for tonifying kidney and detoxifying in the form of mixture, powder, pill, oral liquid, capsule, dripping pill, granule or tablet. The rest of this implementation scheme is the same as specific implementation scheme one or specific implementation scheme two.

[0035] Specific implementation scheme 4: A method for preparing a concentrated pill of a Chinese medicine composition for tonifying the kidney and detoxifying is completed according to the following steps:

[0036] 1. Weigh: weigh 50-70 parts of raw astragalus, 50-70 parts of codonopsis, 30-50 parts of raw rehmannia, 30-50 parts of stir-fried yam, 30-50 parts of cornus, 30-50 parts of yun fuling, 30-50 parts of salt alisma, 50-70 parts of salvia, 30-50 parts of forsythia, 30-50 parts of peach kernel, 20-40 parts of safflower, 30-50 parts of angelica, 20-40 parts of fructus aurantii, 50-70 parts of kudzu root, 30-50 parts of red peony root, 30-50 parts of bupleurum, 50-70 parts of magnolia bark, 50-70 parts of charred cyperus, 20-40 parts of raw rhubarb, 20-40 parts of liquorice and 50-70 parts of tsaoko kernel according to the mass proportion;

[0037] 2. Supercritical CO2 extraction: crush the grass fruit kernels weighed in step 1, and perform supercritical CO2 extraction to obtain grass fruit kernel volatile oil;

[0038] 3. Water extraction: The raw astragalus, codonopsis, raw rehmannia, stir-fried yam, cornus officinalis, Yunfuling, salt oriental water plantain, salvia miltiorrhiza, forsythia suspensa, peach kernel, safflower, angelica, fructus aurantii, kudzu root, red peony root, bupleurum, magnolia bark, charred cyperus, raw rhubarb and licorice weighed in step 1 are respectively subjected to water decoction extraction method to obtain astragalus paste, codonopsis paste, raw rehmannia paste, stir-fried yam paste, cornus officinalis paste, Yunfuling paste, salt oriental water plantain paste, salvia miltiorrhiza paste, forsythia paste, peach kernel paste, safflower paste, angelica paste, fructus aurantii paste, kudzu root paste, red peony root paste, bupleurum paste, magnolia bark paste, charred cyperus paste, raw rhubarb paste and licorice paste;

[0039] 4. Pill making: ①, the tsaoko kernel volatile oil obtained in step 2 is included by β-cyclodextrin, the mass ratio of the tsaoko kernel volatile oil to β-cyclodextrin is 1:60-120, and the cyclodextrin-included tsaoko kernel volatile oil is obtained; ②, the cyclodextrin-included tsaoko kernel volatile oil and the huangqi clear paste, codonopsis clear paste, raw rehmannia clear paste, stir-fried yam clear paste, cornus clear paste, Yunfuling clear paste, salt oriental clear paste, salvia clear paste, forsythia clear paste, peach kernel clear paste, safflower clear paste, angelica clear paste, fructus aurantii clear paste, kudzu root clear paste, red peony root clear paste, bupleurum clear paste, magnolia bark clear paste, scorched cyperus clear paste, raw rhubarb clear paste and liquorice clear paste obtained in step 3 are fully mixed and uniformly mixed, auxiliary materials are added, pill making is carried out, sieve through 40 mesh, and dried at no more than 60°C to obtain kidney-tonifying and detoxifying concentrated pills.

[0040] The Bushenjiedu concentrated pills obtained in this embodiment are packaged independently, with 10 pills per bag; Usage and dosage: Oral. 2 bags at a time, 3 times a day, special groups (children, the elderly or patients taking other medicines at the same time) need to follow the doctor's advice; Precautions: Pregnant women should use with caution; Specification: 10 pills are equivalent to 5g of crude drug; Storage: Sealed.

[0041] The present invention adopts supercritical extraction technology to carry out supercritical CO2 extraction on grass kernel, and compared with the grass kernel volatile oil extracted by the existing steam distillation method, the volatile oil obtained by the steam distillation method has a eucalyptol content of 4.42 mg / g, and the volatile oil obtained by the supercritical CO2 extraction method has a eucalyptol content of 6.12 mg / g, so the supercritical CO2 extraction method can more efficiently extract the effective ingredients in the grass kernel. The present invention adopts β-cyclodextrin inclusion technology, utilizes β-cyclodextrin to include grass kernel volatile oil, takes the utilization rate of grass kernel volatile oil, the inclusion compound yield rate and the inclusion compound oil content as the investigation index, determines the inclusion process, improves the utilization rate of grass kernel volatile oil in the final product, the kidney-tonifying and detoxifying concentrated pills, and avoids the loss of grass kernel volatile oil in the pill making process, resulting in a reduction in product efficacy. Existing syrups have the disadvantages of high sucrose content, inconvenience in carrying and storage, etc., while the sucrose content in the kidney-tonifying and detoxifying concentrated pills prepared by the present invention is greatly reduced, so that the product can be used for type II diabetic patients and is convenient to carry and store.

[0042] The Bushenjiedu concentrated pills obtained in this embodiment can invigorate the kidney, invigorate blood circulation, detoxify and expel turbidity, and are used for treating kidney damage.

[0043] Specific implementation scheme five: in step one, 60 parts of raw astragalus, 60 parts of codonopsis, 40 parts of raw rehmannia, 40 parts of stir-fried yam, 40 parts of cornus, 40 parts of Yunfuling, 40 parts of salt alisma, 60 parts of salvia, 40 parts of forsythia, 40 parts of peach kernel, 30 parts of safflower, 40 parts of angelica, 30 parts of fructus aurantii, 60 parts of kudzu root, 40 parts of red peony root, 40 parts of bupleurum, 60 parts of magnolia bark, 60 parts of charred cyperus, 30 parts of raw rhubarb, 30 parts of liquorice and 60 parts of tsaoko kernel are weighed according to the mass fraction. The rest of this implementation scheme is the same as the specific implementation scheme four.

[0044] Specific implementation scheme 6: The supercritical CO2 extraction process in step 2 is as follows: crush the grass kernels weighed in step 1 to a particle size of 80 mesh, and perform supercritical CO2 extraction at an extraction pressure of 15 MPa and an extraction temperature of 30° C. to obtain grass kernel volatile oil. The rest of this implementation scheme is the same as that of specific implementation scheme 4.

[0045] Specific implementation scheme seven: The water decoction extraction method in step three comprises the following steps:

[0046] ①. Add 8 times the amount of water to the weighed raw material, heat and reflux to extract for 1h to 3h, filter to obtain residue I and filtrate I;

[0047] ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 1h to 3h, filter to obtain residue II and filtrate II;

[0048] ③. Add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III;

[0049] ④. Combine filtrate I, filtrate II and filtrate III to obtain a decoction, and concentrate the decoction at 80° C. to a relative density of 1.20 to 1.25. The rest of this embodiment is the same as the specific embodiment 4.

[0050] Specific implementation scheme eight: In step four ①, the temperature for stirring and encapsulating the volatile oil of the grass kernel with β-cyclodextrin is 10-30° C. and the stirring speed is 50 rpm-100 rpm. The rest of this implementation scheme is the same as that of the specific implementation scheme four.

[0051] Specific implementation scheme 9: In step 4①, the temperature for stirring and encapsulating the volatile oil of the grass kernel with β-cyclodextrin is 15° C. and the stirring speed is 65 rpm. The rest of this implementation scheme is the same as that of the specific implementation scheme 8.

[0052] Specific implementation scheme 10: The auxiliary material in step 4② is soluble starch. The rest of this implementation scheme is the same as that of the specific implementation scheme 4.

[0053] Specific implementation scheme eleven: the mass ratio of the soluble starch to the total mass of Astragalus paste, Codonopsis paste, Rehmannia root paste, stir-fried yam paste, Cornus officinalis paste, Yunfuling paste, Salt Alisma paste, Salvia miltiorrhiza paste, Forsythia paste, Peach kernel paste, Safflower paste, Angelica paste, Citrus aurantium paste, Pueraria root paste, Red peony root paste, Bupleurum paste, Magnolia bark paste, Jiaolantang paste, Raw rhubarb paste and Licorice paste is 0.3-0.4:1. The rest of this implementation scheme is the same as the specific implementation scheme ten.

[0054] Example 1

[0055] A method for preparing a kidney-tonifying and detoxifying concentrated pill is completed by the following steps:

[0056] 1. Weigh: weigh 60g raw astragalus, 60g codonopsis, 40g raw rehmannia, 40g stir-fried yam, 40g cornus, 40g tuckahoe, 40g salt alisma, 60g salvia, 40g forsythia, 40g peach kernel, 30g safflower, 40g angelica, 30g fructus aurantii, 60g kudzu root, 40g red peony root, 40g bupleurum, 60g magnolia bark, 60g scorched cyperus, 30g raw rhubarb, 30g liquorice and 60g tsaoko kernel;

[0057] 2. Supercritical CO2 extraction: 60 g of the grass kernels weighed in step 1 were crushed to a particle size of 80 mesh, and supercritical CO2 extraction was performed at an extraction pressure of 15 MPa and an extraction temperature of 30°C to obtain grass kernel volatile oil;

[0058] 3. Water extraction: 60g raw astragalus, 60g codonopsis, 40g raw rehmannia, 40g fried yam, 40g cornus, 40g yun fuling, 40g salt alisma, 60g salvia, 40g forsythia, 40g peach kernel, 30g safflower, 40g angelica, 30g aurantium, 60g kudzu root, 40g red peony root, 40g bupleurum, 60g magnolia bark, 60g scorched cypress, 30g safflower, 40g angelica, 30g fructus aurantii ...pueraria, 40g red peony root, 40g bupleurum, 60g magnolia bark, 60g scorched cypress, 30g safflower, 40g safflower, 40g magnolia bark, 60g scorched cypress, 30g safflower, 40g safflower, 40g magnolia bark, 60g scorched cypress, 30g safflower, 40g 0g of raw rhubarb and 30g of licorice were extracted by decoction, respectively, to obtain astragalus paste, codonopsis paste, raw rehmannia paste, stir-fried yam paste, cornus fruit paste, Yunfuling paste, salt oriental paste, salvia paste, forsythia paste, peach kernel paste, safflower paste, angelica paste, fructus aurantii paste, kudzu root paste, red peony root paste, bupleurum paste, magnolia bark paste, scorched cyperus paste, raw rhubarb paste, and licorice paste;

[0059] The specific preparation process of the Huangqi Qing Gao is as follows: ①, add 8 times the amount of water to 60g of Huangqi, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.24, and obtain Huangqi Qing Gao;

[0060] The specific preparation process of the Codonopsis pilosula paste is as follows: ①, add 8 times the amount of water to 60g of Codonopsis pilosula, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain Codonopsis pilosula paste;

[0061] The specific preparation process of the raw rehmannia paste is as follows: ①, adding 8 times the amount of water to 40g of raw rehmannia, heating and refluxing extraction for 2h, filtering, and obtaining a residue I and a filtrate I; ②, adding 8 times the amount of water to the residue I, heating and refluxing extraction for 2h, filtering, and obtaining a residue II and a filtrate II; ③, adding 6 times the amount of water to the residue II, heating and refluxing extraction for 1h to 3h, filtering, and obtaining a residue III and a filtrate III; ④, combining the filtrate I, the filtrate II and the filtrate III to obtain a decoction, and concentrating the decoction at 80°C to a relative density of 1.22 to obtain the raw rehmannia paste;

[0062] The specific preparation process of the stir-fried yam paste is as follows: ①, add 8 times the amount of water to 40g of stir-fried yam, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain stir-fried yam paste;

[0063] The specific preparation process of the cornus fruit paste is as follows: ①, adding 8 times the amount of water to 40g of cornus fruit, heating and refluxing extraction for 2h, filtering, and obtaining a residue I and a filtrate I; ②, adding 8 times the amount of water to the residue I, heating and refluxing extraction for 2h, filtering, and obtaining a residue II and a filtrate II; ③, adding 6 times the amount of water to the residue II, heating and refluxing extraction for 1h to 3h, filtering, and obtaining a residue III and a filtrate III; ④, combining the filtrate I, the filtrate II and the filtrate III to obtain a decoction, and concentrating the decoction at 80°C to a relative density of 1.23 to obtain the cornus fruit paste;

[0064] The specific preparation process of the Yun Fuling clear paste is as follows: ①, add 8 times the amount of water to 40g of Yun Fuling, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.23, and obtain Yun Fuling clear paste;

[0065] The specific preparation process of the salt oriental rhizome clear paste is as follows: ①, add 8 times the amount of water to 40g of salt oriental rhizome, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.23, and obtain the salt oriental rhizome clear paste;

[0066] The specific preparation process of the Danshen clear paste is as follows: ①, add 8 times the amount of water to 60g of Danshen, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.24, and obtain Danshen clear paste;

[0067] The specific preparation process of the forsythia paste is as follows: ①, add 8 times the amount of water to 40g of forsythia, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain the forsythia paste;

[0068] The specific preparation process of the peach kernel paste is as follows: ①, add 8 times the amount of water to 40g of peach kernel, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.24, and obtain peach kernel paste;

[0069] The specific preparation process of the safflower paste is as follows: ①, add 8 times the amount of water to 30g of safflower, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain safflower paste;

[0070] The specific preparation process of the Angelica sinensis paste is as follows: ①, add 8 times the amount of water to 40g of Angelica sinensis, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain Angelica sinensis paste;

[0071] The specific preparation process of the Citrus aurantium paste is as follows: ①, add 8 times the amount of water to 30g of Citrus aurantium, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain Citrus aurantium paste;

[0072] The specific preparation process of the kudzu root paste is as follows: ①, add 8 times the amount of water to 60g of kudzu root, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.21, and obtain kudzu root paste;

[0073] The specific preparation process of the red peony root paste is as follows: ①, add 8 times the amount of water to 40g of red peony root, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain the red peony root paste;

[0074] The specific preparation process of the Bupleurum Clear Paste is as follows: ①, add 8 times the amount of water to 40g of Bupleurum, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, and concentrate the decoction at 80°C to a relative density of 1.23 to obtain Bupleurum Clear Paste;

[0075] The specific preparation process of the Magnolia officinalis paste is as follows: ①, add 8 times the amount of water to 60g of Magnolia officinalis, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.21, and obtain Magnolia officinalis paste;

[0076] The specific preparation process of the scorched tangerine peel paste is as follows: ①, adding 8 times the amount of water to 60g of scorched tangerine peel, heating and refluxing extraction for 2h, filtering, and obtaining a residue I and a filtrate I; ②, adding 8 times the amount of water to the residue I, heating and refluxing extraction for 2h, filtering, and obtaining a residue II and a filtrate II; ③, adding 6 times the amount of water to the residue II, heating and refluxing extraction for 1h to 3h, filtering, and obtaining a residue III and a filtrate III; ④, combining the filtrate I, the filtrate II and the filtrate III to obtain a decoction, and concentrating the decoction at 80°C to a relative density of 1.22 to obtain the scorched tangerine peel paste;

[0077] The specific preparation process of the raw rhubarb paste is as follows: ①, add 8 times the amount of water to 30g of raw rhubarb, heat and reflux to extract for 2h, filter to obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux to extract for 2h, filter to obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux to extract for 1h to 3h, filter to obtain filter residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain a decoction, concentrate the decoction at 80°C to a relative density of 1.22, and obtain the raw rhubarb paste;

[0078] The specific preparation process of the licorice paste is as follows: ①, add 8 times the amount of water to 30g of licorice, heat and reflux to extract for 2h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 2h, filter to obtain residue II and filtrate II; ③, add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④, combine filtrate I, filtrate II and filtrate III to obtain decoction, concentrate the decoction at 80°C to a relative density of 1.21, and obtain licorice paste;

[0079] 4. Pill making: ①, at a temperature of 15°C, the tsaoko kernel volatile oil obtained in step 2 is stirred and included with β-cyclodextrin at a stirring speed of 65rpm, the mass ratio of the tsaoko kernel volatile oil to β-cyclodextrin is 1:100, and the cyclodextrin-included tsaoko kernel volatile oil is obtained; ②, the cyclodextrin-included tsaoko kernel volatile oil is mixed with the huangqi clear paste, dangshen clear paste, shengdihuang clear paste, stir-fried yam clear paste, cornus fruit clear paste, yunfuling clear paste, salt zephyranthes clear paste, danshen clear paste, forsythia clear paste, peach kernel clear paste, safflower clear paste, angelica clear paste, fructus aurantii clear paste, kudzu root clear paste, red peony root clear paste, chayote clear paste, The Huqing paste, Houpo paste, Jiaokanlang paste, Shengdahuang paste and Gancao paste are fully and evenly mixed, soluble starch is added, pills are made, passed through a 40-mesh sieve, and dried at 50°C to obtain kidney-tonifying and detoxifying concentrated pills; the ratio of the mass of the soluble starch to the total mass of Huangqi paste, Codonopsis paste, Shengdihuang paste, stir-fried yam paste, Cornus fruit paste, Yunfuling paste, Salt Alisma paste, Salvia miltiorrhiza paste, Forsythia paste, Peach kernel paste, Safflower paste, Angelica paste, Citrus aurantium paste, Pueraria root paste, Red peony root paste, Bupleurum paste, Houpo paste, Jiaokanlang paste, Shengdahuang paste and Gancao paste is 0.3:1.

[0080] Example 2: This example is different from Example 1 in that the mass ratio of the volatile oil of the grass kernel to β-cyclodextrin in step 4① is 1:80. The rest is the same as Example 1.

[0081] Example 3: This example is different from Example 1 in that the mass ratio of the volatile oil of the grass kernel to β-cyclodextrin in step 4① is 1:60. The rest is the same as Example 1.

[0082] Stability test study:

[0083] The Bushen Jiedu Concentrated Pills prepared in Examples 1 to 3 were weighed in equal amounts of 1 g each as experimental objects, and were successively divided into Experimental Group I (Bushen Jiedu Concentrated Pills prepared in Example 1), Experimental Group II (Bushen Jiedu Concentrated Pills prepared in Example 2) and Experimental Group III (Bushen Jiedu Concentrated Pills prepared in Example 3); the room temperature stability test data was used as the standard. Experimental Group I, Experimental Group II and Experimental Group III were stored at a temperature of 37-40°C and a relative humidity of 75%, and were examined once a month for three consecutive months except for the inspection once in the current month. The results are shown in Tables 1, 2 and 3.

[0084] Table 1

[0085]

[0086]

[0087] Table 2

[0088]

[0089] Table 3

[0090]

[0091]

[0092] It can be seen from Table 1, Table 2 and Table 3 that the Bushenjiedu concentrated pills prepared by the present invention have stable performance and can be stored for a long time.

[0093] Pharmacodynamic studies:

[0094] (1) Effect on creatinine in rats with chronic kidney disease

[0095] 40 clean-grade healthy SD rats were selected, 5 weeks old, with a body weight of 188-209g. A passive Heymann nephritis rat model was established by a single tail vein injection of anti-FX1A serum. After one week of adaptive feeding, the experimental animals were placed in a metal metabolism cage to collect 24h urine, and the 24h urine protein was determined using the Coomassie brilliant blue colorimetric method. The model was considered to be successfully established when the 24h urine protein was quantitatively ≥10mg. The 40 rats with successful modeling were randomly divided into 4 groups, namely, an experimental group, a decoction group, a positive control group, and a blank control group. The experimental group took the kidney-tonifying and detoxifying concentrated pills prepared in Example 1, and the concentrated pills were dissolved in water to make a solution. The rat dosage was set according to 10 times the total daily medication amount of adults, the raw drug dosage was 5g / (kg·d), and the drug was administered by gavage once a day, with the gavage volume of 2mL / 100g body weight; the decoction group used the same raw materials as the Bushen Jiedu Concentrated Pills to decoct the Chinese medicine decoction, including 30g of raw astragalus, 30g of Codonopsis, 20g of raw Rehmannia, 20g of stir-fried yam, 20g of Cornus officinalis, 15g of Yun Fuling, 15g of salt Alisma, 30g of Salvia miltiorrhiza, 20g of Forsythia suspensa, and 20g of peach kernel , 15g of safflower, 15g of angelica, 15g of fructus aurantii, 30g of kudzu root, 20g of red peony root, 20g of bupleurum, 30g of magnolia bark, 30g of scorched cypress, 15g of raw rhubarb, 15g of licorice and 30g of tsaoko kernel; soak each raw drug for 40 minutes, first boil the drug with high fire, and then keep it slightly boiling with low fire; the first decoction of the drug was 25 minutes, the second decoction was 20 minutes, and the two liquids were combined to about 190ml; the dosage of the raw drug of the decoction was 47.02g / (kg·d), and the gavage volume was 2ml / 100g. The positive drug control group was gavaged with irbesartan solution, the dosage of irbesartan was 13.5mg / (kg·d), and the gavage volume was also 2ml / 100g. The blank control group took distilled water of the same volume as the decoction, and the drug was continuously administered for 21 days. After the last administration, the rats were placed in a metabolic cage and blood was taken from the aorta to detect creatinine in each group. The results are shown in Table 4.

[0096] Table 4

[0097]

[0098] Note: Compared with the blank control group, a P<0.05; compared with the positive control group, b P<0.05; compared with the decoction group, c P < 0.05;

[0099] As shown in Table 5, after modeling, the Scr of each group increased. Compared with the blank control group, the Scr of the other groups decreased, and the difference was statistically significant (P < 0.05); compared with the positive control group, the decoction group and the experimental group could reduce the Scr, and the difference was statistically significant (P < 0.05); compared with the decoction group, the Scr of the experimental group was significantly reduced, and the difference was statistically significant (P < 0.05); this shows that Bushen Jiedu Concentrated Pills has the effect of reducing creatinine in rats with chronic kidney disease, and the effect is significantly better than irbesartan, and the effect is better than the decoction prepared with the same raw material.

[0100] (2) Effect on Quantification of Urine Protein in Rats

[0101] Forty clean-grade healthy SD rats, 5 weeks old, weighing 188-209 g, were selected. A passive Heymann nephritis rat model was established by a single tail vein injection of anti-FX1A serum. After one week of adaptive feeding, the experimental animals were placed in a metal metabolic cage to collect 24-hour urine. The 24-hour urine protein was determined using the Coomassie brilliant blue colorimetric method. The model was considered to be successfully established when the 24-hour urine protein was ≥10 mg. The 40 rats with successful modeling were randomly divided into 4 groups, namely, an experimental group, a decoction group, a positive control group, and a blank control group. The experimental group took the Bushen Jiedu Concentrated Pills prepared in Example 1, and the crude drug dosage was 5 g / (kg·d). The decoction group took the Chinese herbal decoction in Example 1, and the crude drug dosage was 47.02 g / (kg·d). The positive drug control group was given oral administration of irbesartan solution, and the dosage of irbesartan was 13.5 mg / (kg·d). The blank control group took distilled water with an equal volume of the decoction for 21 consecutive days. After the last dose, the rats were placed in metabolic cages to collect urine for 24 hours, and the urine protein content of each group was detected. The results are shown in Table 5.

[0102] Table 5

[0103]

[0104] Note: Compared with the blank control group, a P<0.05; compared with the positive control group, b P<0.05; compared with the decoction group, c P<0.05.

[0105] As shown in Table 5, the urine protein in each group increased after modeling. Compared with the blank control group, the urine protein in the other groups decreased, and the difference was statistically significant (P < 0.05); compared with the positive control group, the urine protein in the decoction group and the experimental group was significantly lower than that in the blank control group (P < 0.05), and the difference was statistically significant; compared with the decoction group, the urine protein in the experimental group was significantly reduced (P < 0.05), and the difference was statistically significant; Therefore, Bushen Jiedu Concentrated Pills has the effect of reducing proteinuria in rats, and the effect is significantly better than irbesartan, and the effect is better than the decoction prepared with the same raw material.

[0106] (3) Effects of serum inflammatory factors

[0107] Forty clean-grade healthy SD rats, 5 weeks old, weighing 188-209 g, were selected. A passive Heymann nephritis rat model was established by a single tail vein injection of anti-FX1A serum. After one week of adaptive feeding, the experimental animals were placed in a metal metabolic cage to collect 24-hour urine. The 24-hour urine protein was determined using the Coomassie brilliant blue colorimetric method. The model was considered to be successfully established when the 24-hour urine protein was ≥10 mg. The 40 rats with successful modeling were randomly divided into 4 groups, namely, an experimental group, a decoction group, a positive control group, and a blank control group. The experimental group took the Bushen Jiedu Concentrated Pills prepared in Example 1, and the crude drug dosage was 5 g / (kg·d). The decoction group took the Chinese herbal decoction in Example 1, and the crude drug dosage was 47.02 g / (kg·d). The positive drug control group was given irbesartan solution by gavage, and the irbesartan dosage was 13.5 mg / (kg·d). The blank control group took distilled water with an equal volume of the decoction for continuous administration for 21 days. After the last administration, the rats in each group were placed in a metabolic cage to collect aortic blood, and the IL-6 and TNF-α contents were detected. The results are shown in Table 6.

[0108] IL-6 detection method: The IL-6 enzyme-linked immunosorbent assay (ELISA) kit was used to determine the IL-6 level in rat serum. The microplate was coated with purified IL-6 antibodies to prepare solid-phase antibodies. IL-6 was added to the microwells coated with monoclonal antibodies in sequence, and then combined with HRP-labeled goat anti-mouse antibodies to form an antibody-antigen-enzyme-labeled antibody complex. After thorough washing, the substrate TMB was added for color development. TMB was converted into blue under the catalysis of HRP enzyme, and converted into the final yellow under the action of acid. The depth of color is positively correlated with the IL-6 in the sample. The absorbance (OD value) was measured at a wavelength of 450nm using an enzyme reader, and the rat IL-6 concentration in the sample was calculated using the standard curve.

[0109] TNF-α detection method: TNF-α enzyme-linked immunosorbent assay (ELISA) kit was used to determine the level of TNF-α in rat serum. The microplate was coated with purified rat TNF-α antibody to prepare a solid-phase antibody. TNF-α was added to the microwells coated with monoclonal antibodies in turn and then combined with HRP-labeled goat anti-mouse antibody to form an antibody-antigen-enzyme-labeled antibody complex. After thorough washing, the substrate TMB was added for color development. TMB was converted into blue under the catalysis of HRP enzyme and converted into the final yellow under the action of acid. The depth of color is positively correlated with the TNF-α in the sample. The absorbance (OD value) was measured at a wavelength of 450nm using an enzyme reader, and the rat TNF-α concentration in the sample was calculated using the standard curve.

[0110] Table 6

[0111]

[0112] Note: Compared with the blank control group, a P<0.05; compared with the positive control group, b P<0.05; compared with the decoction group, c P<0.05.

[0113] As shown in Table 6, after modeling, the IL-6 concentration and TNF-α concentration of each group increased. Compared with the blank control group, the IL-6 concentration and TNF-α concentration of the other groups decreased, and the difference was statistically significant (P < 0.05). Compared with the positive control group, the decoction group and the experimental group could reduce the IL-6 and TNF-α concentration levels of rats, and the difference was statistically significant (P < 0.05). This shows that Bushen Jiedu Concentrated Pills can inhibit inflammatory response and reduce kidney damage in rats with Heymann nephritis, and the effect is significantly better than irbesartan, and the effect is better than the decoction prepared with the same raw material.

[0114] (4) Effects on creatinine in patients with different kidney diseases

[0115] A total of 131 CKD patients admitted to the Nephrology Department and Outpatient Clinic of Heilongjiang Provincial Hospital of Traditional Chinese Medicine from 2018 to 2023 were selected and divided into diabetic nephropathy group (n=32), hypertensive nephropathy group (n=25), and chronic renal failure group (n=74) according to their diagnosis. SCr, BUN, and eGFR were tested in each group. The results are shown in Table 7.

[0116] Table 7

[0117]

[0118] Note: * indicates that P < 0.05 compared with before treatment

[0119] As shown in Table 7, after drug treatment, the creatinine, urea nitrogen and glomerular filtration rate of the chronic renal failure group were significantly decreased compared with those before treatment, and the difference was statistically significant (P < 0.05). The creatinine and urea nitrogen of diabetic nephropathy and hypertensive nephropathy were significantly decreased compared with those before treatment, and the difference was statistically significant (P < 0.05). This shows that Bushen Jiedu Concentrated Pills has a restorative effect on the renal function of patients with various kidney diseases, can significantly improve the state of renal damage, and restore renal function, especially for patients with chronic renal failure, the effects are better in all aspects.

[0120] Although the present invention is disclosed as above, the protection scope of the present invention is not limited thereto. Those skilled in the art may make various changes and modifications without departing from the spirit and scope of the present invention, and these changes and modifications will fall within the protection scope of the present invention.

[0121] The documents cited in this invention include:

[0122] [1] Wu Liping, Ma Hua, Ma Tiancheng, et al. Clinical experience of Professor Ma Hua in treating chronic kidney disease [J / OL]. Liaoning Journal of Traditional Chinese Medicine, 1-9 [2024-03-08]. http: / / kns.cnki.net / kcms / detail / 21.1128.R.20230814.1804.020.html.

[0123] [2] Guo Yang, Rao Xiangrong, Yin Dehai, et al. Professor Dai Xiwen's academic thoughts and clinical experience in treating kidney diseases [J / OL]. Chinese Journal of Integrated Traditional and Western Medicine, 1-4 [2024-03-08]. http: / / kns.cnki.net / kcms / detail / 11.2787.R.20230908.1511.008.html.

[0124] [3] Wu Meiqin, Gao Jiawei, Ruan Shiwei. Ruan Shiwei's diagnosis and treatment of chronic kidney disease based on the theory of hidden evil[J]. Henan Traditional Chinese Medicine, 2023, 43(10): 1502-1506. DOI: 10.16367 / j.issn.1003-5028.2023.10.0292.

[0125] [4] Wang Yulin, Liu Mengchao, Zheng Bingjie, et al. Experience of famous Chinese medicine doctor Zhang Binghou in treating chronic kidney disease based on blood stasis[J]. Shaanxi Traditional Chinese Medicine, 2023, 44(11): 1602-1605.

[0126] [5] Zhou Ke, Wu Jinyu. Professor Wu Jinyu's clinical experience in treating chronic kidney disease[J]. Journal of Zhejiang Chinese Medical University, 2023, 47(12): 1472-1475. DOI: 10.16466 / j.issn1005-5509.2023.12.016.

Claims

1. A Chinese medicine composition for tonifying the kidney and detoxifying, characterized in that: The raw materials are composed of 50-70 parts of raw astragalus, 50-70 parts of codonopsis, 30-50 parts of raw rehmannia, 30-50 parts of stir-fried yam, 30-50 parts of cornus, 30-50 parts of yun fuling, 30-50 parts of salt alisma, 50-70 parts of salvia, 30-50 parts of forsythia, 30-50 parts of peach kernel, 20-40 parts of safflower, 30-50 parts of angelica, 20-40 parts of fructus aurantii, 50-70 parts of kudzu root, 30-50 parts of red peony root, 30-50 parts of bupleurum, 50-70 parts of magnolia bark, 50-70 parts of charred areca, 20-40 parts of raw rhubarb, 20-40 parts of liquorice and 50-70 parts of amomum villosum kernel.

2. The Chinese medicine composition for tonifying the kidney and detoxifying according to claim 1, characterized in that: The raw materials are composed by mass of 60 parts of raw astragalus, 60 parts of codonopsis, 40 parts of raw rehmannia, 40 parts of stir-fried yam, 40 parts of cornus, 40 parts of poria, 40 parts of salt alisma, 60 parts of salvia miltiorrhiza, 40 parts of forsythia, 40 parts of peach kernel, 30 parts of safflower, 40 parts of angelica, 30 parts of fructus aurantii, 60 parts of kudzu root, 40 parts of red peony root, 40 parts of bupleurum, 60 parts of magnolia bark, 60 parts of charred areca, 30 parts of raw rhubarb, 30 parts of liquorice and 60 parts of amomum villosum kernel.

3. The Chinese medicine composition for tonifying the kidney and detoxifying according to any one of claims 1 or 2, characterized in that: The Chinese medicine composition is prepared into a Chinese medicine preparation for tonifying the kidney and detoxifying according to the dosage form of mixture, powder, pill, oral liquid, capsule, dripping pill, granule or tablet.

4. A method for preparing concentrated pills of a Chinese medicine composition for tonifying the kidney and detoxifying, characterized in that: This is done by following these steps:

1. Weighing: weigh the medicinal materials according to the mass fraction of the Chinese medicine composition for tonifying the kidney and detoxifying according to any one of claims 1 to 2; 2. Supercritical CO2 extraction: crush the grass fruit kernels weighed in step 1, and perform supercritical CO2 extraction to obtain grass fruit kernel volatile oil; 3. Water extraction: The raw astragalus, codonopsis, raw rehmannia, stir-fried yam, cornus officinalis, Yunfuling, salt oriental water plantain, salvia miltiorrhiza, forsythia suspensa, peach kernel, safflower, angelica, fructus aurantii, kudzu root, red peony root, bupleurum, magnolia bark, charred cyperus, raw rhubarb and licorice weighed in step 1 are respectively subjected to water decoction extraction method to obtain astragalus paste, codonopsis paste, raw rehmannia paste, stir-fried yam paste, cornus officinalis paste, Yunfuling paste, salt oriental water plantain paste, salvia miltiorrhiza paste, forsythia paste, peach kernel paste, safflower paste, angelica paste, fructus aurantii paste, kudzu root paste, red peony root paste, bupleurum paste, magnolia bark paste, charred cyperus paste, raw rhubarb paste and licorice paste; 4. Pill making: ①, the tsaoko kernel volatile oil obtained in step 2 is included by β-cyclodextrin, the mass ratio of the tsaoko kernel volatile oil to β-cyclodextrin is 1:60-120, and the cyclodextrin-included tsaoko kernel volatile oil is obtained; ②, the cyclodextrin-included tsaoko kernel volatile oil and the huangqi clear paste, codonopsis clear paste, raw rehmannia clear paste, stir-fried yam clear paste, cornus clear paste, Yunfuling clear paste, salt oriental clear paste, salvia clear paste, forsythia clear paste, peach kernel clear paste, safflower clear paste, angelica clear paste, fructus aurantii clear paste, kudzu root clear paste, red peony root clear paste, bupleurum clear paste, magnolia bark clear paste, scorched cyperus clear paste, raw rhubarb clear paste and liquorice clear paste obtained in step 3 are fully mixed and uniformly mixed, auxiliary materials are added, pill making is carried out, sieved, and dried at a temperature not exceeding 60°C to obtain kidney-tonifying and detoxifying concentrated pills.

5. The method for preparing the concentrated pills of the Chinese medicine composition for tonifying the kidney and detoxifying according to claim 4, characterized in that: The supercritical CO2 extraction process in step 2 is specifically as follows: the grass fruit kernels weighed in step 1 are crushed, and supercritical CO2 extraction is performed at an extraction pressure of 15 MPa and an extraction temperature of 30° C. to obtain grass fruit kernel volatile oil.

6. The method for preparing the concentrated pills of the Chinese medicine composition for tonifying the kidney and detoxifying according to claim 4, characterized in that: The water decoction extraction method described in step 3 comprises the following steps: ①. Add 8 times the amount of water to the weighed raw material, heat and reflux to extract for 1h to 3h, filter to obtain residue I and filtrate I; ②, add 8 times the amount of water to the residue I, heat and reflux to extract for 1h to 3h, filter to obtain residue II and filtrate II; ③. Add 6 times the amount of water to the residue II, heat and reflux to extract for 1h to 3h, filter to obtain residue III and filtrate III; ④. Combine filtrate I, filtrate II and filtrate III to obtain a decoction, and concentrate the decoction at 80°C to a relative density of 1.20-1.

25.

7. The method for preparing the concentrated pills of Chinese medicine composition for tonifying kidney and detoxifying according to claim 4, characterized in that: In step 4①, the temperature of stirring and encapsulating the tsaoko kernel volatile oil with β-cyclodextrin is 10-30° C. and the stirring speed is 50 rpm-100 rpm.

8. The method for preparing the concentrated pills of the Chinese medicine composition for tonifying the kidney and detoxifying according to claim 4, characterized in that: The auxiliary material in step 4② is soluble starch.

9. The method for preparing the concentrated pills of the Chinese medicine composition for tonifying the kidney and detoxifying according to claim 8, characterized in that: The mass ratio of the soluble starch to the total mass of Astragalus paste, Codonopsis paste, Rehmannia root paste, stir-fried yam paste, Cornus officinalis paste, Poria cocos paste, Salt Alisma orientalis paste, Salvia miltiorrhiza paste, Forsythia suspensa paste, Peach kernel paste, Safflower paste, Angelica sinensis paste, Citrus aurantium paste, Pueraria root paste, Red peony root paste, Bupleurum paste, Magnolia bark paste, Areca oleracea paste, Raw rhubarb paste and Licorice paste is 0.3-0.4:

1.

10. The use of the Chinese medicine composition for tonifying the kidney and detoxifying according to any one of claims 1 to 2, characterized in that: Use in preparing medicine for treating kidney damage.

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