Traditional Chinese medicine composition for treating renal proteinuria as well as preparation method and application of granules of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating renal proteinuria and a preparation method and application of granules of the traditional Chinese medicine composition, relates to the technical field of traditional Chinese medicines, and aims to solve the problem that a traditional Chinese medicine composition for tonifying qi, dredging collaterals, dispelling wind, eliminating dampness, treating renal proteinuria from wind evil, inhibiting kidney inflammation and relieving kidney injury is lacked in the prior art. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by mass: 10-30 parts of raw astragalus membranaceus, 9-18 parts of sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia apiacea, 15-30 parts of rhizoma smilacis glabrae, 10-15 parts of plantain herb, 5-10 parts of radices stellariae dichotomae, 5-10 parts of coptis chinensis, 9-18 parts of fructus nelumbinis, 10-24 parts of caulis sinomenii, 3-9 parts of mole cricket, 9-18 parts of hematoxylon, 10-20 parts of honey-fried licorice root slices, 3-9 parts of leech and 9-18 parts of raw bighead atractylodes rhizome. The traditional Chinese medicine composition is used for preparing medicines for treating renal proteinuria, and has the effects of reducing proteinuria, inhibiting inflammatory response and relieving 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 treating renal proteinuria, and a preparation method and use of the granules thereof. Background Art

[0002] Renal proteinuria is proteinuria caused by a series of kidney lesions. Due to the impaired filtration-reabsorption function of the kidney, the urine protein content in the urine is higher than the normal level, which is called renal proteinuria. Renal proteinuria is the main symptom of many kidney diseases and is also a risk factor for aggravating renal damage. When the 24h urine protein is >150mg or the urine protein qualitative test is positive, it can be called proteinuria. High glomerular filtration and (or) low reabsorption of renal tubules are the main causes of proteinuria. Modern medicine often uses angiotensin-converting enzyme inhibitors, angiotensin receptor Ⅱ blockers, hormones, immunosuppressants and other treatments for proteinuria. These drugs can effectively reduce urine protein, but due to unsatisfactory treatment effects or adverse reactions, clinical application is limited. Traditional Chinese medicine, whether single Chinese medicine or compound preparations, has been proven to be safe and effective in the treatment of proteinuria. The pathogenesis of renal proteinuria is based on deficiency of the root and excess of the superficial, with deficiency of both spleen and kidney as the root, and blood stasis and dampness. Therefore, in clinical practice, it is often used to tonify the spleen and kidney, and at the same time, drugs with blood stasis and detoxification are used for treatment. There are many Chinese patent medicines available on the market, which mainly focus on overall regulation and spleen and kidney tonification. However, there is still a lack of research on treating renal proteinuria from the perspective of wind evil, combining qi-invigorating and collateral-draining, wind-removing and dampness-removing. Summary of the invention

[0003] The technical problems to be solved by the present invention are:

[0004] The prior art lacks a Chinese medicine composition that can invigorate qi, dredge collaterals, dispel wind and dampness, treat renal proteinuria from the perspective of wind evil, inhibit kidney inflammation, and alleviate kidney damage.

[0005] The present invention adopts the following technical solutions to solve the above technical problems:

[0006] The invention provides a traditional Chinese medicine composition for treating renal proteinuria. The raw materials of the traditional Chinese medicine composition are composed of 10-30 parts of raw astragalus, 9-18 parts of raw sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia annua, 15-30 parts of rhizoma smilacis, 10-15 parts of plantain, 5-10 parts of bupleurum, 5-10 parts of coptis, 9-18 parts of caesalpinia, 10-24 parts of scutellaria baicalensis, 3-9 parts of mole cricket, 9-18 parts of sappan wood, 10-20 parts of roasted liquorice tablets, 3-9 parts of leech and 9-18 parts of raw atractylodes.

[0007] Furthermore, its raw materials are composed by mass of 15 parts of raw astragalus, 9 parts of raw sun-dried ginseng, 10 parts of rhizoma anemarrhenae, 7.5 parts of artemisia annua, 15 parts of smilax glabra, 7.5 parts of plantain, 10 parts of bupleurum, 5 parts of coptis, 9 parts of caesalpinia, 12 parts of vineyard green wind vine, 4.5 parts of mole cricket, 9 parts of sophora japonica, 10 parts of roasted liquorice tablets, 3 parts of leech and 9 parts of raw atractylodes.

[0008] Furthermore, the Chinese medicine composition is prepared into a Chinese medicine preparation for treating renal proteinuria in the form of mixture, powder, pill, oral liquid, capsule, drop pill, granule or tablet.

[0009] The present invention also provides a method for preparing a Chinese medicine composition granule for treating renal proteinuria, which is completed by the following steps:

[0010] 1. Weighing: Weigh the medicinal materials according to the mass fraction of the traditional Chinese medicine composition for treating renal proteinuria described in the above technical solution;

[0011] 2. Water extraction: The raw astragalus, raw sun-dried ginseng, anemarrhena, artemisia annua, smilax glabra, plantain, bupleurum, coptis, caesalpinia, scutellaria baicalensis, mole cricket, roasted licorice tablets, leech and raw atractylodes weighed in step 1 are respectively subjected to multiple decoctions and water extractions, and the extracts are combined and concentrated to obtain astragalus paste, raw sun-dried ginseng paste, anemarrhena paste, artemisia annua paste, smilax glabra paste, plantain paste, bupleurum paste, coptis paste, caesalpinia paste, scutellaria baicalensis paste, mole cricket paste, roasted licorice tablets paste, leech paste and raw atractylodes paste, spray-dry, sieve the auxiliary materials to obtain dry paste powders of each raw material medicine for standby use;

[0012] 3. Ethyl acetate extraction: crush the Sappan wood weighed in step 1, extract with 75% ethanol for multiple times, combine the extracts, evaporate to dryness and dry, add double distilled water to suspend, and then extract with ethyl acetate to obtain the Sappan wood ethyl acetate extract;

[0013] 4. Preparation of granules: ①. The ethyl acetate extract of Saccharum officinale obtained in step 3 is included in β-cyclodextrin, and the mass ratio of the ethyl acetate extract of Saccharum officinale to β-cyclodextrin is 1:60-120, so as to obtain cyclodextrin-included ethyl acetate extract of Saccharum officinale; ②. The cyclodextrin-included ethyl acetate extract of Saccharum officinale and the raw material dry paste powder obtained in step 2 are fully mixed to obtain a mixed powder, and auxiliary materials are added to perform dry granulation and pilling to obtain granules of the Chinese medicine composition for the treatment of renal proteinuria.

[0014] Furthermore, in step 4①, the temperature of stirring and encapsulating the ethyl acetate extract of Sappan wood with β-cyclodextrin is 10-30°C and the stirring speed is 50rpm-100rpm.

[0015] Furthermore, the auxiliary material in step 4② is one or more of β-cyclodextrin, soluble starch or lactose.

[0016] Furthermore, in step 4②, the mass ratio of the mixed powder to the auxiliary material is 80:20

[0017] The present invention also provides use of the traditional Chinese medicine composition for treating renal proteinuria in preparing a medicine for treating renal proteinuria.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] One, the present invention studies the therapeutic effect and mechanism of Chinese medicine composition on renal proteinuria by establishing a rat model of chronic nephritis, and finds that astragalus, raw sun-dried ginseng, rhizoma anemarrhenae, sweet wormwood, rhizoma smilacis, herba plantain, radix bupleuri, rhizoma coptidis, caesalpiniae, caulis chinensis, molly cricket, sappan wood, licorice tablets, leech, and raw atractylodes macrocephala are used in combination according to a specific ratio to have excellent effects on the treatment of renal proteinuria. Clinical practice proves that the Chinese medicine composition of the present invention has the effects of reducing proteinuria, inhibiting inflammatory response, and alleviating kidney damage in rats with chronic nephritis. By conducting follow-up treatment feedback on patients with renal proteinuria in outpatient clinics, it is shown that the Chinese medicine composition of the present invention has the effect of significantly reducing the quantitative urine protein of patients in 24 hours, and also has good effects on symptoms such as edema that occur in some patients. It shows that Suqing granules of the present invention can significantly improve the state of renal proteinuria and restore renal function.

[0020] The present invention innovatively adopts the treatment method of invigorating qi, unblocking collaterals, dispelling wind and dampness, and treats renal proteinuria from the perspective of wind evil, thereby achieving the effects of reducing proteinuria, inhibiting kidney inflammation, and alleviating kidney damage. Patients with kidney disease often suffer from spleen and kidney deficiency for a long time, and wind evil invasion can easily lead to meridian blockage, aggravating kidney damage, kidney collateral blockage, water metabolism disorder, and aggravating kidney burden. After kidney damage, toxin accumulation aggravates the condition. The Chinese medicine composition of the present invention can fundamentally regulate the metabolic function of the kidney through multiple mechanisms, and can also protect local inflammation and damage to the kidney. The comprehensive conditioning of multiple targets and multiple pathways of the present invention can more comprehensively intervene in the course of disease, reduce adverse reactions, and achieve a more lasting therapeutic effect.

[0021] 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

[0022] 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.

[0023] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, a detailed description is given below in conjunction with specific embodiments of the present invention.

[0024] Specific implementation scheme one: The present invention provides a traditional Chinese medicine composition for treating renal proteinuria, wherein the raw materials include 10-30 parts of raw astragalus, 9-18 parts of raw sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia annua, 15-30 parts of smilax glabra, 10-15 parts of plantain, 5-10 parts of bupleurum, 5-10 parts of coptis, 9-18 parts of caesalpinia, 10-24 parts of celastrus, 3-9 parts of mole cricket, 9-18 parts of sappan wood, 10-20 parts of roasted liquorice tablets, 3-9 parts of leech and 9-18 parts of raw atractylodes.

[0025] The raw astragalus in the Chinese medicine composition of this embodiment can invigorate qi and strengthen the spleen, and can eliminate qi deficiency edema; Caulis Sinomenii and Sappanwood can dispel external wind, promote urination, and improve the symptoms of foam in urine. Raw sun-dried ginseng can invigorate qi and strengthen the spleen, nourish blood and produce body fluid; Bupleurum chinense and Coptis chinensis are used together to regulate qi and reduce fire, dry dampness and detoxify; Smilax glabra and Plantago can penetrate dampness and promote diuresis and reduce swelling; Anemarrhena asphodeloides and Artemisia annua can clear heat, nourish yin and cool blood; Echinochloa chinensis can clear heart fire and stop leukorrhea; raw Atractylodes macrocephala can invigorate the spleen and dry dampness, and promote diuresis; Leeches and mole crickets can enter the blood, and can dispel wind and dredge collaterals, promote diuresis and remove blood stasis; roasted licorice can alleviate the toxicity of toxic drugs and harmonize various medicines. The whole prescription has the effects of invigorating qi and removing dampness, replenishing deficiency and strengthening the root, and dispelling wind and unblocking collaterals.

[0026] In the present invention, raw Astragalus has the effects of invigorating qi, raising yang and strengthening spleen, and enhancing positive qi, and can also regulate the immune system, reduce inflammatory response, improve interstitial edema, and protect renal function. As a rattan medicine, Caulis Sinomenii has the effects of dispelling rheumatism and promoting urination. Rattan-type collateral-draining medicine can enter collaterals, can well protect renal collaterals, and significantly improve proteinuria symptoms; Su Mu is cool and slightly pungent, disperses wind, enters the blood, and has the effects of promoting blood circulation and removing blood stasis, regulating qi and unblocking collaterals; It is found in clinical practice that it can effectively reduce proteinuria and protect renal function; The above three are all monarch medicines, and exert their effects of dispelling wind and unblocking collaterals, purging turbidity and detoxifying. Raw sun-dried ginseng tastes sweet, slightly bitter, is slightly warm in nature, and returns to the spleen, lung, heart, and kidney meridians, and has the effects of greatly replenishing vital energy, tonifying the spleen and lungs, and promoting body fluid and nourishing blood. It has the effects of promoting blood circulation and improving microcirculation. Silver Bupleurum is sweet and slightly cold in nature. It belongs to the kidney and stomach meridians. It has the effects of clearing away heat, detoxifying and cooling blood. It has a certain regulating effect on the kidneys, can nourish the kidneys, and promote the balance of water metabolism. Coptis chinensis is bitter and cold in nature. It has the effects of clearing away heat and dampness, purging fire and detoxifying. Smilax glabra is sweet in taste and has a flat qi. It enters the foot Shaoyin kidney meridian. It can promote diuresis and purge dampness, dry the earth and strengthen the middle. Plantago is sweet and cold in taste. It has the effects of penetrating dampness and promoting diuresis and reducing swelling. Compared with Plantago, it also has the function of clearing heat and detoxifying. The combination of multiple drugs can play the role of tonifying the spleen and replenishing qi, promoting diuresis and reducing swelling, clearing heat and drying dampness, and they are all minister drugs. Anemarrhena asphodeloides is bitter and cold in nature. It clears heat and purges fire, nourishes yin and moisturizes dryness. It enters the kidney meridian, removes evil qi, limb edema, and relieves water. It also has the function of replenishing kidney water deficiency and benefiting the yin of the five internal organs; Artemisia annua is bitter, cold, non-toxic, enters the liver, gallbladder, and kidney meridians, removes deficiency heat, and cools blood. The two together control the warm and dry nature of Astragalus, and can be used with Plantago to promote urination; Echeveria seed is bitter and cold, clears heart fire, and stops leukorrhea; Raw Atractylodes macrocephala belongs to the spleen and stomach meridians, tastes bitter, sweet, and is warm. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. Leeches are salty, bitter, flat, and poisonous, and have the effects of breaking blood and removing blood stasis, and promoting diuresis. Mole crickets are salty and treat edema. Both are products of blood and flesh, which can enter the blood and dispel wind and dredge the collaterals, treat blood stasis blocking the kidney collaterals, and the symptoms of long-term stagnation of qi and blood. They are adjuvants with other medicines to strengthen the spleen and dry dampness, promote diuresis and remove blood stasis. Roasted licorice harmonizes all medicines, harmonizes the middle and relieves urgency, and alleviates the toxicity of Caulis Sinomenii and leeches, and is a guiding medicine. The whole formula has the effects of invigorating Qi and removing dampness, tonifying deficiency and strengthening the foundation, and dispelling wind and unblocking meridians.

[0027] Specific implementation scheme 2: Its raw medicines include 15 parts of raw astragalus, 9 parts of raw sun-dried ginseng, 10 parts of rhizoma anemarrhenae, 7.5 parts of artemisia annua, 15 parts of smilax glabra, 7.5 parts of plantain, 10 parts of bupleurum, 5 parts of coptis root, 9 parts of caesalpinia, 12 parts of scutellaria baicalensis, 4.5 parts of mole cricket, 9 parts of sappan wood, 10 parts of licorice tablets, 3 parts of leech and 9 parts of raw atractylodes by weight. The rest of this implementation scheme is the same as the specific implementation scheme 1.

[0028] Specific implementation scheme three: the Chinese medicine composition is a Chinese medicine preparation for treating renal proteinuria 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.

[0029] Specific embodiment 4: A method for preparing a Chinese medicine composition granule for treating renal proteinuria is completed by the following steps:

[0030] 1. Weigh: weigh 10-30 parts of raw astragalus, 9-18 parts of raw sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia annua, 15-30 parts of smilax glabra, 10-15 parts of plantain, 5-10 parts of bupleurum, 5-10 parts of coptis root, 9-18 parts of caesalpinia, 10-24 parts of scutellaria baicalensis, 3-9 parts of mole cricket, 9-18 parts of sappan wood, 10-20 parts of roasted licorice tablets, 3-9 parts of leech, and 9-18 parts of raw atractylodes;

[0031] 2. Water extraction: crush the Caulis Sinomenii weighed in step 1 (40 mesh), extract with water for multiple times, soak for 30 minutes, extract 9 times, add water to soak the medicine surface for 2 cm, combine the filtrates from five times and concentrate under reduced pressure (80°C, vacuum degree of -0.08MPa), concentrate into Caulis Sinomenii clear paste with a relative density of 1.10 (80°C), spray dry, pass through an 80-mesh sieve, and obtain Caulis Sinomenii dry paste powder;

[0032] 10-20 parts of raw astragalus, 9-18 parts of raw sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia annua, 15-30 parts of rhizoma smilax, 10-15 parts of plantain, 5-10 parts of bupleurum, 5-10 parts of coptis, 9-18 parts of caesalpinia, 3-9 parts of mole cricket, 10-20 parts of roasted licorice tablets, 3-9 parts of leech, and 9-18 parts of raw atractylodes are weighed in step 1 and boiled in water to obtain an extract, and the extract is extracted 2-3 times, and the mixture is combined. The extract was concentrated under reduced pressure (80° C., vacuum degree of −0.08 MPa) to a paste with a relative density of 1.10 (80° C.), and finally astragalus paste, raw sun-dried ginseng paste, rhizoma anemarrhenae paste, artemisia annua paste, smilax glabra paste, plantain paste, bupleurum paste, coptis paste, caesalpinia paste, mole cricket paste, licorice tablet paste, leech paste, and raw atractylodes paste were obtained, and the extract was spray-dried, and the auxiliary materials were sieved through an 80-mesh sieve to obtain dry paste powders of the raw materials for standby use;

[0033] 3. Ethyl acetate extraction: crush the Sappan wood weighed in step 1 (40 meshes) and soak it in 75% ethanol. After 4 hours, heat it to 85°C and extract it by reflux for 2 hours. Filter it and repeat the extraction twice. Combine the filtrate, evaporate it in a rotary evaporator in a water bath, and then transfer it to a vacuum drying oven to dry it to constant weight to prepare ethanol extraction dry powder. Add the ethanol extraction dry powder to double distilled water for suspension, extract it with ethyl acetate, and obtain the Sappan wood ethyl acetate extract;

[0034] 4. Granule preparation: ①. The ethyl acetate extract of Saccharum officinale obtained in step 3 is included in β-cyclodextrin, and the mass ratio of the ethyl acetate extract of Saccharum officinale to β-cyclodextrin is 1:60-120, so as to obtain cyclodextrin-included ethyl acetate extract of Saccharum officinale; ②. The cyclodextrin-included ethyl acetate extract of Saccharum officinale and the raw material dry paste powder obtained in step 2 are fully mixed to obtain a mixed powder, and auxiliary materials are added. The first feeding speed is 15-25rpm, the second feeding speed is 10-20rpm, the pressing wheel speed is 2-3rpm, the rolling wheel pressure is 3.5-5.5Mpar, the granulation mesh is 14 mesh, and the granulation speed is 150rpm. Dry granulation and pilling are carried out to obtain a Chinese medicine composition granule for the treatment of renal proteinuria, which is named Suqing Granules.

[0035] The Suqing granules obtained in this embodiment are individually packaged; Usage and dosage: Oral, 1 bag 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: Use with caution in pregnant women; Specification: Each bag is equivalent to 6g of crude drug; Storage: Sealed.

[0036] The present invention adopts the β-cyclodextrin inclusion technology, utilizes the β-cyclodextrin to include the ethyl acetate extract of sappan wood, takes the utilization rate of the ethyl acetate extract of sappan wood, the yield rate of the inclusion compound and the oil content of the inclusion compound as the inspection index, determines the inclusion process, improves the utilization rate of the ethyl acetate extract of sappan wood in the final product Suqing granules, and avoids the loss of the ethyl acetate extract of sappan wood in the pill making process, resulting in the reduction of the drug efficacy of the product. The existing syrup has the disadvantages of high sucrose content, inconvenient to carry and store, etc., while the sucrose content in the Suqing granules prepared by the present invention is greatly reduced, so that the product can be used for type II diabetics and is convenient to carry and store.

[0037] Different extracts of Sappan wood showed good immunosuppressive effects. There are many extraction methods for Sappan wood, such as water extraction and alcohol extraction. Hou Jingbo et al. [1,2] It is confirmed that both the water extract and the ethanol extract of Sappan wood have strong immunosuppressive effects. In this embodiment, the ethanol extract of Sappan wood is further extracted to obtain an ethyl acetate extract, which has a strong immunosuppressive effect and no obvious toxic side effects. In this embodiment, the ethyl acetate extract of Sappan wood is introduced into a traditional Chinese medicine composition, providing a new idea and option for treating renal proteinuria.

[0038] The Suqing granules obtained in this embodiment can invigorate qi, dredge meridians, dispel wind, remove dampness and eliminate turbidity, and are used to treat renal proteinuria.

[0039] Specific implementation scheme five: in step one, 15 parts of raw astragalus, 9 parts of raw sun-dried ginseng, 10 parts of rhizoma anemarrhenae, 7.5 parts of artemisia annua, 15 parts of rhizoma smilax, 7.5 parts of plantain, 10 parts of bupleurum, 5 parts of coptis root, 9 parts of caesalpinia, 12 parts of scutellaria baicalensis, 4.5 parts of mole cricket, 9 parts of sappan wood, 10 parts of licorice tablets, 3 parts of leech and 9 parts of raw atractylodes are weighed by mass. The rest of this implementation scheme is the same as the specific implementation scheme four.

[0040] Specific implementation scheme 6: In step 4①, the temperature for stirring and encapsulating the ethyl acetate extract of Sappan wood with β-cyclodextrin is 10-30°C and the stirring speed is 50rpm-100rpm. The rest of this implementation scheme is the same as that of specific implementation scheme 5.

[0041] Specific implementation scheme 7: In step 4①, the temperature for stirring and encapsulating the ethyl acetate extract of Sappan wood 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 specific implementation scheme 5.

[0042] Specific implementation scheme eight: the auxiliary material in step four ② is one or more of β-cyclodextrin, soluble starch or lactose. The rest of this implementation scheme is the same as that of specific implementation scheme four.

[0043] Specific implementation scheme 9: In step 4②, the mass ratio of the mixed powder to the auxiliary material is 80:20. The rest of this implementation scheme is the same as that of specific implementation scheme 8.

[0044] Specific implementation scheme 10: In step 4②, the first feeding speed is 15-20rpm, the second feeding speed is 10-15rpm, the pressing wheel speed is 2-3rpm, the rolling wheel pressure is 3.5Mpa, the granulation mesh is 14 mesh, and the granulation speed is 150rpm. The rest of this implementation scheme is the same as the specific implementation scheme 9.

[0045] Specific implementation scheme 11: In step 4②, the first feeding speed is 20-25rpm, the second feeding speed is 15-20rpm, the pressing wheel speed is 2-3rpm, the rolling wheel pressure is 4.5Mpa, the fixed granulation mesh is 14 mesh, and the granulation speed is 150rpm. The rest of this implementation scheme is the same as the specific implementation scheme 10.

[0046] Example 1

[0047] A method for preparing Suqing granules is completed by the following steps:

[0048] 1. Weigh: weigh 15g raw Astragalus, 9g raw sun-dried ginseng, 10g Rhizoma Anemarrhenae, 7.5g Artemisia annua, 15g Smilax glabra, 7.5g Plantago, 10g Bupleurum chinense, 5g Coptis chinensis, 9g Echinochloa crus-galli, 12g Caulis scutellariae, 4.5g Mole Cricket, 9g Sappanwood, 10g Roasted Licorice Tablets, 3g Leech and 9g raw Atractylodes macrocephala;

[0049] 2. Water extraction: Crush the Caulis Sinomenii weighed in step 1 (40 mesh), extract with water for multiple times, soak for 30 minutes, extract 9 times, add water to each time until the medicine surface is soaked 2 cm, combine the filtrates from five times and concentrate under reduced pressure (80°C, vacuum degree is -0.08MPa) to form a Caulis Sinomenii clear paste with a relative density of 1.10 (80°C), spray dry, pass through an 80-mesh sieve, and obtain Caulis Sinomenii dry paste powder for later use.

[0050] The raw astragalus, raw sun-dried ginseng, rhizoma anemarrhenae, artemisia annua, smilax glabra, plantain, silver bupleurum, coptis chinensis, caesalpinia, mole cricket, roasted licorice tablets, leech, and raw atractylodes macrocephala weighed in step one are sequentially put into water and decocted to obtain an extract, and then extracted three times, the extracts are combined, and concentrated under reduced pressure (80°C, vacuum degree is -0.08MPa), and concentrated into a clear paste with a relative density of 1.10 (80°C), and finally Astragalus clear paste, raw sun-dried ginseng clear paste, rhizoma anemarrhena clear paste, artemisia annua clear paste, smilax glabra clear paste, plantain clear paste, silver bupleurum clear paste, coptis chinensis clear paste, caesalpinia clear paste, mole cricket clear paste, roasted licorice tablets clear paste, leech clear paste, and raw atractylodes clear paste are spray-dried, and the auxiliary materials are sieved through 80 meshes to obtain dry paste powders of each raw material for standby use;

[0051] 3. Ethyl acetate extraction: grind the Sappan wood weighed in step 1 (40 meshes) and soak it in 75% ethanol. After 4 hours, heat it to 85°C and extract it by reflux for 2 hours. Filter and repeat the extraction twice. Combine the filtrate, evaporate it in a water bath on a rotary evaporator and then transfer it to a vacuum drying oven to dry to constant weight to prepare ethanol extraction dry powder. Add the ethanol extraction dry powder into double distilled water for suspension, extract it with ethyl acetate, and obtain the Sappan wood ethyl acetate extract.

[0052] The specific preparation process of the Huangqi Qing Gao is as follows: ①, add 8 times the amount of water to 15g of raw 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 1.11, and obtain Huangqi Qing Gao;

[0053] The specific preparation process of the raw sun-dried ginseng paste is as follows: ①, add 8 times the amount of water to 9g of raw sun-dried ginseng, 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 1.12, and obtain the raw sun-dried ginseng paste;

[0054] The specific preparation process of the Zhimu Qing Gao is as follows: ①, add 8 times the amount of water to 10g of Zhimu, 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 1.10 to obtain the Zhimu Qing Gao;

[0055] The specific preparation process of the Qinghaoqing paste is as follows: ①, add 8 times the amount of water to 7.5g of Qinghao, 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 1.12, and obtain Qinghaoqing paste;

[0056] The specific preparation process of the Chinese smilax glabra paste is as follows: ①, add 8 times the amount of water to 15g of Chinese smilax glabra, 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 1.13, and obtain the Chinese smilax glabra paste;

[0057] The specific preparation process of the plantain paste is as follows: ①, add 8 times the amount of water to 7.5g of plantain, 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 1.13, and obtain plantain paste;

[0058] The specific preparation process of the silver bupleurum paste is as follows: ①, add 8 times the amount of water to 10g of silver bupleurum, heat and reflux extraction for 2h, filter, and obtain filter residue I and filtrate I; ②, add 8 times the amount of water to the filter residue I, heat and reflux extraction for 2h, filter, and obtain filter residue II and filtrate II; ③, add 6 times the amount of water to the filter residue II, heat and reflux extraction for 1h to 3h, filter, and 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 1.09 to obtain the silver bupleurum paste;

[0059] The specific preparation process of the Huanglian Qing Gao is as follows: ①, adding 8 times the amount of water to 5g of Huanglian, 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 1.14 to obtain the Huanglian Qing Gao;

[0060] The specific preparation process of the caesalpinia caulis seed paste is as follows: ①, adding 8 times the amount of water to 9g of caesalpinia caulis seeds, 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 1.12 to obtain the caesalpinia caulis seed paste;

[0061] The specific preparation process of the mole cricket clear paste is as follows: ①, add 8 times the amount of water to 4.5g of mole cricket, 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 1.14, and obtain the mole cricket clear paste;

[0062] The specific preparation process of the licorice paste is as follows: ①, add 8 times the amount of water to 10g of roasted 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 1.12, and obtain licorice paste;

[0063] The specific preparation process of the leech paste is as follows: ①, add 8 times the amount of water to 3g of leeches, 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 1.11, and obtain the leech paste;

[0064] The specific preparation process of the raw Atractylodes macrocephala paste is as follows: ①, adding 8 times the amount of water to 9g of raw Atractylodes macrocephala, heating and reflux 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 reflux 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 reflux 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 1.11 to obtain the raw Atractylodes macrocephala paste;

[0065] 4. Granule preparation: ①. The ethyl acetate extract of Saccharum officinale obtained in step 3 is included in β-cyclodextrin, and the mass ratio of the ethyl acetate extract of Saccharum officinale to β-cyclodextrin is 1:120, so as to obtain cyclodextrin-included ethyl acetate extract of Saccharum officinale; ②. The cyclodextrin-included ethyl acetate extract of Saccharum officinale and the dry paste powder of the raw material obtained in step 2 are fully and uniformly mixed, and β-cyclodextrin auxiliary material is added in a ratio of 80:20 of the mass ratio of the dry paste powder to β-cyclodextrin, the first feeding speed is 20rpm, the second feeding speed is 15rpm, the pressing wheel speed is 2rpm, the rolling wheel pressure is 5.5Mpar, the granulation mesh is 14 mesh, and the granulation speed is 150rpm. Dry granulation and pilling are carried out to obtain the Chinese medicine composition granules for the treatment of renal proteinuria, namely Suqing granules.

[0066] Example 2: This example is different from Example 1 in that the mass ratio of the ethyl acetate extract of Sappan wood to β-cyclodextrin in step 5① is 1:80. The rest is the same as Example 1.

[0067] Example 3: This example is different from Example 1 in that the mass ratio of the ethyl acetate extract of Sappan wood to β-cyclodextrin in step 5① is 1:60. The rest is the same as Example 1.

[0068] Stability test study:

[0069] The Suqing granules prepared in Examples 1 to 3 were placed in an appropriate open container in equal amounts and spread into a thin layer ≤5 mm thick as experimental objects, which were experimental group I (Suqing granules prepared in Example 1), experimental group II (Suqing granules prepared in Example 2) and experimental group III (Suqing granules prepared in Example 3); room temperature stability test was performed. 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 assessed once a month for three consecutive months except for one inspection in the current month. The results are shown in Tables 1, 2 and 3.

[0070] Table 1

[0071]

[0072] Table 2

[0073]

[0074]

[0075] Table 3

[0076]

[0077] It can be seen from Tables 1, 2 and 3 that the Suqing granules prepared by the present invention have stable performance and can be preserved for a long time.

[0078] Example 4: This example is different from Example 1 in that the auxiliary material in step 4① is soluble starch. The rest is the same as Example 1.

[0079] Example 5: This example is different from Example 1 in that the auxiliary material in step 5① is lactose. The rest is the same as Example 1.

[0080] Investigation and test research on auxiliary materials:

[0081] Equal amounts of the Suqing granules prepared in Examples 1, 4 to 5 were placed in a suitable open container and spread into a thin layer ≤5 mm thick as experimental objects, namely Experimental Group I (Suqing granules prepared in Example 1), Experimental Group II (Suqing granules prepared in Example 10) and Experimental Group III (Suqing granules prepared in Example 11); the granulation and molding of different auxiliary materials were observed, and the types of auxiliary materials were screened based on the one-time molding rate of the granules, dry granulation conditions, granule properties, etc. The results are shown in Table 4.

[0082] Table 4

[0083]

[0084]

[0085] Pharmacodynamic studies:

[0086] (1) Effect on quantification of rat urine protein

[0087] 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 Suqing granules prepared in Example 1, and the raw drug dosage was 3 g / (kg·d). The decoction group took the Chinese herbal decoction obtained by decocting the same raw materials as in Example 1, and the raw drug dosage was 12.91 g / (kg·d). The positive drug control group was gavaged with 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.

[0088] Table 5

[0089]

[0090] 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.

[0091] It can be seen from Table 5 that compared with the blank control group, the urine protein in the other groups was reduced to varying degrees, 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 positive 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, Suqing Granules 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.

[0092] The documents cited in this invention include:

[0093] [1] Hou Jingbo, Yu Bo, Lü Hang, et al. Experimental study on the effect of aqueous extract of Sophora japonica against acute rejection of cardiac transplantation[J]. Chinese Journal of Emergency Medicine, 2002, (03): 4-5.

[0094] [2] Hou Jingbo, Yu Junmin, E Mingyan, et al. Effect of sappan wood alcohol extract on the levels of some helper T lymphocyte factors in peripheral blood after heart transplantation [J]. Chinese Journal of Cardiovascular Diseases, 2003, (03): 55-58.

Claims

1. A Chinese medicine composition for treating renal proteinuria, characterized in that: The raw materials are composed by mass of 10-30 parts of raw astragalus, 9-18 parts of raw sun-dried ginseng, 10-20 parts of rhizoma anemarrhenae, 10-15 parts of artemisia annua, 15-30 parts of smilax glabra, 10-15 parts of plantain, 5-10 parts of bupleurum, 5-10 parts of coptis, 9-18 parts of caesalpinia, 10-24 parts of celastrus, 3-9 parts of mole cricket, 9-18 parts of sappan wood, 10-20 parts of roasted liquorice tablets, 3-9 parts of leech and 9-18 parts of raw atractylodes.

2. The Chinese medicine composition for treating renal proteinuria according to claim 1, characterized in that: The raw materials are composed by mass of 15 parts of raw astragalus, 9 parts of raw sun-dried ginseng, 10 parts of rhizoma anemarrhenae, 7.5 parts of artemisia annua, 15 parts of smilax glabra, 7.5 parts of plantain, 10 parts of bupleurum, 5 parts of coptis chinensis, 9 parts of caesalpinia, 12 parts of vineyard green wind vine, 4.5 parts of mole cricket, 9 parts of sophora japonica, 10 parts of roasted liquorice tablets, 3 parts of leech and 9 parts of raw atractylodes.

3. The Chinese medicine composition for treating renal proteinuria according to claim 1 or 2, characterized in that: The Chinese medicine composition is prepared into a Chinese medicine preparation for treating renal proteinuria in the form of mixture, powder, pill, oral liquid, capsule, dripping pill, granule or tablet.

4. A method for preparing a Chinese medicine composition granule for treating renal proteinuria, characterized in that This is done by:

1. Weighing: Weigh the medicinal materials according to the mass fraction of the traditional Chinese medicine composition for treating renal proteinuria according to claim 1 or 2; 2. Water extraction: The raw astragalus, raw sun-dried ginseng, anemarrhena, artemisia annua, smilax glabra, plantain, bupleurum, coptis, caesalpinia, scutellaria baicalensis, mole cricket, roasted licorice tablets, leech and raw atractylodes weighed in step 1 are respectively subjected to multiple decoctions and water extractions, and the extracts are combined and concentrated to obtain astragalus paste, raw sun-dried ginseng paste, anemarrhena paste, artemisia annua paste, smilax glabra paste, plantain paste, bupleurum paste, coptis paste, caesalpinia paste, scutellaria baicalensis paste, mole cricket paste, roasted licorice tablets paste, leech paste and raw atractylodes paste, spray-dry, sieve the auxiliary materials to obtain dry paste powders of each raw material medicine for standby use; 3. Ethyl acetate extraction: crush the Sappan wood weighed in step 1, extract with 75% ethanol for multiple times, combine the extracts, evaporate to dryness and dry, add double distilled water to suspend, and then extract with ethyl acetate to obtain the Sappan wood ethyl acetate extract; 4. Preparation of granules: ①. The ethyl acetate extract of Saccharum officinale obtained in step 3 is included in β-cyclodextrin, and the mass ratio of the ethyl acetate extract of Saccharum officinale to β-cyclodextrin is 1:60-120, so as to obtain cyclodextrin-included ethyl acetate extract of Saccharum officinale; ②. The cyclodextrin-included ethyl acetate extract of Saccharum officinale and the raw material dry paste powder obtained in step 2 are fully mixed to obtain a mixed powder, and auxiliary materials are added to perform dry granulation and pilling to obtain granules of the Chinese medicine composition for the treatment of renal proteinuria.

5. The method for preparing the Chinese medicine composition granules for treating renal proteinuria according to claim 4, characterized in that: In step 4①, the ethyl acetate extract of Sappan wood is stirred and included with β-cyclodextrin at a temperature of 10 to 30°C and a stirring speed of 50 rpm to 100 rpm.

6. The method for preparing the Chinese medicine composition granules for treating renal proteinuria according to claim 5, characterized in that: The auxiliary materials in step 4② are one or more of β-cyclodextrin, soluble starch or lactose.

7. The method for preparing the Chinese medicine composition granules for treating renal proteinuria according to claim 6, characterized in that: In step 4②, the mass ratio of the mixed powder to the auxiliary materials is 80:

20.

8. The use of the Chinese medicine composition for treating renal proteinuria according to claim 1 or 2, characterized in that: Use in preparing medicine for treating renal proteinuria.

Images