Traditional Chinese medicine composition for treating chronic glomerulonephritis

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic glomerulonephritis. Specifically, the invention provides a traditional Chinese medicine composition consisting of periostracum cicada, stiff silkworm, silkworm excrement, silkworm cocoon shell, coix lacryma-jobi root and cordyceps cicadae. The traditional Chinese medicine composition is simple in formula and exact in clinical curative effect. Animal experiments prove that the composition can effectively protect kidney tissues of chronic glomerulonephritis model rats, improve renal functions and relieve inflammatory response, and has application prospects in the field of chronic glomerulonephritis treatment.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine treatment, and in particular, to a traditional Chinese medicine composition for treating chronic glomerulonephritis. Background Art

[0002] Chronic glomerulonephritis (CGN) is a group of diseases that originate in the glomeruli and are caused by various reasons and have different pathological manifestations. It has a long course of disease and is clinically characterized by proteinuria, hematuria, edema and hypertension, and is often accompanied by renal impairment. The disease progresses slowly and can enter the end-stage renal failure. In China, glomerulonephritis is the leading cause of chronic kidney disease and dialysis patients, and glomerulonephritis is also the main cause of uremia in Chinese people.

[0003] Currently, the commonly used drug for treating chronic glomerulonephritis is Huangkui Capsule. Huangkui Capsule is made of Hibiscus hibiscus flowers, which mainly have the functions of clearing dampness and heat, detoxifying and reducing swelling. In clinical practice, it is mainly used for damp-heat syndrome of chronic nephritis, with symptoms such as edema, low back pain, proteinuria, hematuria, yellow and greasy tongue coating, etc.

[0004] The main problem with Huangkui Capsules is that they have a single composition and are mainly suitable for patients with chronic nephritis with damp-heat syndrome. They often need to be used in combination with other drugs. Compared with other drugs, Huangkui Capsules are expensive and are financially unaffordable for patients with long-term kidney disease. This is because Huangkui Capsules are in capsule form. Although they are convenient to take, the production cost is high, resulting in a high price.

[0005] Therefore, there is a need in the art to develop a low-cost treatment method for chronic glomerulonephritis. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition for treating chronic glomerulonephritis.

[0007] In the first aspect of the present invention, a Chinese medicine composition is provided, which is composed of the following raw medicinal materials or extracts thereof:

[0008] 3-15 parts by weight of cicada shells;

[0009] Bombyx batryticatus 5-20 parts by weight;

[0010] 15-45 parts by weight of silkworm cocoon shells;

[0011] Silkworm excrement 3-15 parts by weight;

[0012] 3-15 parts by weight of coix root;

[0013] 3-12 parts by weight of Cordyceps sinensis.

[0014] In another preferred embodiment, the raw medicinal materials include fresh medicinal materials, partially dried medicinal materials, dried medicinal materials or a combination thereof.

[0015] In another preferred embodiment, when the composition comprises raw medicinal materials, the weight portion thereof is calculated based on the dry weight of the corresponding raw medicinal materials.

[0016] In another preferred embodiment, when the composition comprises extracts of raw medicinal materials, the composition of the extracts is calculated based on the dry weight of the corresponding raw medicinal materials.

[0017] In another preferred embodiment, the extract includes: water extract, alcohol extract, aqueous solvent extract, carbon dioxide supercritical extract or active ingredient, or a combination thereof, preferably water extract and alcohol extract.

[0018] In another preferred embodiment, the active ingredient includes a single ingredient or a mixed ingredient.

[0019] In another preferred embodiment, the Chinese medicine composition is composed of the following raw medicinal materials or extracts thereof:

[0020] 6-12 parts by weight, preferably 9 parts by weight, of cicada shell;

[0021] Bombyx batryticatus 9-15 parts by weight, preferably 12 parts by weight;

[0022] 20-40 parts by weight of silkworm cocoon shells, preferably 30 parts by weight;

[0023] Silkworm excrement 6-12 parts by weight, preferably 9 parts by weight;

[0024] 6-12 parts by weight, preferably 9 parts by weight, of coix root;

[0025] 6-9 parts by weight of Cordyceps sinensis, preferably 6 parts by weight.

[0026] In another preferred example, in the traditional Chinese medicine composition, the weight ratio of cicada molt, silkworm pupa, silkworm cocoon shell, silkworm feces, coix root and cicada flower is (0.7-1.2): (0.7-1.2): (1.5-3): (0.7-1.2): (0.7-1.2): (0.3-0.8), preferably (0.75-1): 1: (2-2.5): (0.75-1): (0.75-1): (0.5-0.75).

[0027] In another preferred example, the Chinese medicine composition consists of 9 grams of cicada molts, 12 grams of Bombyx batryticatus, 30 grams of silkworm cocoon shells, 9 grams of silkworm feces, 9 grams of Coix root, and 6 grams of Cordyceps sinensis.

[0028] In the second aspect of the present invention, a Chinese medicine composition extractant is provided. The extractant is prepared by extracting the Chinese medicine composition as described in the first aspect of the present invention, wherein the extraction solvent of the extractant is an aqueous solvent.

[0029] In another preferred embodiment, the extraction solvent is water or alcohol, preferably ethanol.

[0030] In another preferred embodiment, the extractant includes an extractant with unadjusted (or unchanged) concentration, a concentrated extractant, and a diluted extractant.

[0031] In another preferred embodiment, the extractant is a decoction or extract of the traditional Chinese medicine composition.

[0032] In another preferred embodiment, the extractant is a concentrated decoction or extract.

[0033] In another preferred embodiment, the extractant is extracted with water-saturated n-butanol.

[0034] In the third aspect of the present invention, there is provided a method for preparing the extractant of the Chinese medicine composition as described in the second aspect of the present invention, comprising the steps of:

[0035] 1) Providing raw medicinal materials: 3-15 parts by weight of cicada molts, 5-20 parts by weight of silkworm pupae, 15-45 parts by weight of silkworm cocoon shells, 3-15 parts by weight of silkworm feces, 3-15 parts by weight of coix root, and 3-12 parts by weight of cicada flower;

[0036] 2) extracting the raw medicinal material using an aqueous solvent to obtain the Chinese medicine composition extract.

[0037] In another preferred embodiment, step 2) comprises defatting the raw medicinal material, extracting it by immersion in ethanol, removing the alcohol, adding water and stirring evenly, and finally extracting it with water-saturated n-butanol.

[0038] In a fourth aspect of the present invention, a pharmaceutical preparation is provided, the preparation comprising:

[0039] i) the Chinese medicine composition according to the first aspect of the present invention or the extractant of the Chinese medicine composition according to the second aspect of the present invention;

[0040] ii) other pharmaceutically acceptable adjuvants, carriers or excipients.

[0041] In another preferred embodiment, the pharmaceutical preparation is a traditional Chinese medicine preparation.

[0042] In another preferred embodiment, the preparation is an oral preparation or a non-oral preparation.

[0043] In another preferred embodiment, the preparation includes a liquid preparation, a semisolid preparation, or a solid preparation.

[0044] In another preferred embodiment, the preparation includes: powder, granule, capsule, mixture, powder, injection, tincture, oral solution, tablet, lozenge, or pill.

[0045] In the fifth aspect of the present invention, there is provided the use of the Chinese medicine composition as described in the first aspect of the present invention, the Chinese medicine composition extract as described in the second aspect of the present invention, or the pharmaceutical preparation as described in the fourth aspect of the present invention for preparing a drug for preventing and / or treating chronic glomerulonephritis.

[0046] In another preferred example, the chronic glomerulonephritis is characterized by symptoms selected from the group consisting of hematuria, proteinuria, edema, hypertension, or a combination thereof.

[0047] In another preferred embodiment, the prevention and / or treatment of chronic glomerulonephritis includes improvement of one or more indicators selected from the following group:

[0048] a) Reduce urine protein;

[0049] b) decrease in serum creatinine, or urea nitrogen, or uric acid, or a combination thereof;

[0050] c) reducing renal tissue IL-6, or ICAM-1, or TGF-β1, or a combination thereof.

[0051] In the sixth aspect of the present invention, a method for treating chronic glomerulonephritis is provided, comprising the steps of administering to a subject in need thereof a medically effective amount of the Chinese medicine composition as described in the first aspect of the present invention, the Chinese medicine composition extract as described in the second aspect of the present invention, or the pharmaceutical preparation as described in the fourth aspect of the present invention.

[0052] In another preferred embodiment, the subject is a patient with chronic glomerulonephritis.

[0053] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here. DETAILED DESCRIPTION

[0054] After extensive and in-depth research, the inventor has developed a Chinese medicine composition for treating chronic glomerulonephritis for the first time. The present invention treats proteinuria from the perspective of rheumatism, using cicada shells and silkworm pustules to dispel wind and relieve sore throat, silkworm sand to dispel wind and overcome dampness, silkworm cocoon shells to promote diuresis and reduce swelling, coix root to clear heat and relieve stranguria, and golden cicada flower to extinguish wind and stop spasm. The prescription is concise and the clinical efficacy is definite; animal experiments verify that the prescription of the present invention can effectively protect the kidney tissue of rats with chronic glomerulonephritis model, improve renal function, and reduce inflammatory response. On this basis, the present invention was completed.

[0055] the term

[0056] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0057] As used herein, the terms "comprise", "include", and "contain" are used interchangeably and include not only closed definitions, but also semi-closed and open definitions. In other words, the terms include "consisting of", "consisting essentially of".

[0058] As used herein, the term "pharmaceutically acceptable excipient, carrier or vehicle" refers to a substance that is suitable for use in humans and / or animals without excessive adverse side effects (such as toxicity, irritation and allergic reaction), i.e., has a reasonable benefit / risk ratio.

[0059] As used herein, the term "effective amount" refers to an amount that produces a function or activity in humans and / or animals and is acceptable to humans and / or animals. It should be understood by those skilled in the art that the "effective amount" may vary depending on the form of the pharmaceutical composition, the severity of the disease, and the combination of other drugs.

[0060] The "prevention", "treatment" or "improvement" described in the present invention includes delaying and stopping the progression of the disease, or eliminating the disease, and does not require 100% inhibition, elimination and reversal. In some embodiments, the Chinese medicine composition or pharmaceutical preparation of the present invention can prevent the occurrence of chronic glomerulonephritis, or reduce, inhibit and / or reverse the existing chronic glomerulonephritis or the symptoms caused by it by, for example, at least about 10%, at least about 30%, at least about 50%, or at least about 80%, compared to the level observed in the absence of the Chinese medicine composition or pharmaceutical preparation of the present invention.

[0061] As used herein, the terms "parts by weight" and "parts by weight" are used interchangeably, and the parts by weight may be any fixed weight expressed in milligrams, grams or kilograms (such as 1 mg, 1 g, 2 g or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b may be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (parts by weight of the component / sum of the parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0062] As used herein, the term "raw medicinal material" refers to the Chinese medicinal material used as the active medicinal material in the composition of the present invention, and the medicinal material may include various forms, for example, the medicinal material includes (but is not limited to) dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, or a combination thereof. In addition, when the composition of the present invention contains a raw medicinal material extract, the term also includes the raw medicinal material corresponding to the raw medicinal material extract or the corresponding raw medicinal material used to prepare the extract.

[0063] The Chinese medicine composition of the present invention

[0064] The invention provides a traditional Chinese medicine composition which can be used for preventing, treating and / or improving chronic glomerulonephritis.

[0065] Research theoretical support: Traditional Chinese medicine believes that chronic glomerulonephritis is characterized by the pathogenesis of deficiency and excess, and a mixture of deficiency and excess. Traditional Chinese medicine believes that wind evil attacks the kidney, and wind is the leader of all diseases. It is easy to be mixed with other evils. Cold, dampness, heat, and poison often attach to wind evil to invade the human body, damage the kidney and cause disease. According to the academic thought of Ding's internal medicine of Menghe School, the inventors have summarized the dialectical treatment of chronic kidney disease based on spleen and kidney, liver, blood stasis, fire, and wind, and put forward the academic thought that the early stage (CKD1-3 stage) is mainly based on clearing heat and dampness, promoting blood circulation and removing wind, and the late stage of chronic kidney disease (CKD4-5) is mainly based on strengthening the foundation and nourishing the essence. Patients with chronic kidney disease are mainly proteinuria and hematuria in the early stage, and edema in the late stage. Patients with chronic kidney disease are mainly qi deficiency or qi and yin deficiency in the early stage, with excess syndrome. Therefore, for patients with chronic kidney disease who are combined with hematuria and proteinuria in the early stage, Guben Tongluo prescription can be used for treatment. Regarding the pathological manifestations and pathological factors of proteinuria in chronic kidney diseases such as chronic glomerulonephritis, we propose to "treat proteinuria from the perspective of rheumatism."

[0066] Explanation of the prescription: The representative prescription for treating wind, Wucan Xiaobaiyin, uses cicada slough, silkworm, silkworm cocoon shell, silkworm feces, coix root, and cicada flower. The cicada slough and silkworm cocoon dispel wind and relieve sore throat, silkworm feces dispel wind and dampness, silkworm cocoon shell promotes diuresis and reduces swelling, coix root clears heat and relieves stranguria, and cicada flower extinguishes wind and stops spasms. The whole prescription has the functions of dispelling wind and dampness, replenishing qi and warming yang, promoting diuresis and reducing swelling. This prescription is suitable for those with exogenous wind evil and spleen and kidney qi and yang deficiency. The six herbs have the functions of dispelling wind and dampness, replenishing qi and yang, promoting diuresis and reducing swelling.

[0067] Cicada molt comes from the molt of the black grasshopper of the Cicadidae family when it molts. Its Latin name is Periostracum CicadaeCryptotympana atrata Fabricius. It is cool in nature, sweet and salty in taste; it enters the lung and liver meridians. It has many functions such as dispersing wind-heat, relieving sore throat and opening voice, clearing rashes, improving eyesight and removing cataracts, calming wind and stopping spasms.

[0068] Bombyx batryticatus is the dried body of the 4th to 5th instar larvae of the silkworm, an insect of the family Bombycidae, which are infected (or artificially inoculated) with Beauveria bassiana and killed. The Latin name of Bombyx batryticatus is Bombyx batryticatus. Bombyx batryticatus tastes salty and pungent, and is neutral in nature. It enters the liver meridian, lung meridian, and stomach meridian. It has the effects of dispelling wind and calming the nerves, resolving phlegm and dispersing knots, and dispelling wind and relieving pain.

[0069] Silkworm cocoon shell is the cocoon shell of the silkworm moth, an insect of the family Bombycidae. Its Latin name is Bombyx mori L. Silkworm cocoon shell is sweet, warm, non-toxic and enters the spleen meridian. It has the effects of clearing heat and stopping bleeding, quenching thirst, detoxifying and curing sores.

[0070] Silkworm excrement is the excrement of the larvae of the silkworm moth, an animal of the genus Bombyx, family Bombycidae. The Latin name of silkworm excrement is Faeces Bombycis. Silkworm excrement tastes sweet and spicy, and is warm in nature. It enters the liver, spleen, and stomach meridians. It has the effects of dispelling wind and dampness, harmonizing the stomach and eliminating dampness, clearing away heat and detoxifying, promoting diuresis and relieving swelling, stopping bleeding and promoting tissue regeneration, and antibacterial and anti-inflammatory.

[0071] Job's tears root comes from the root of the grass plant Coix lacryma-jobi L. Job's tears root is the root part of the plant with the Latin name Coix lacryma-jobi L. Job's tears root tastes bitter and sweet, and is slightly cold in nature; it enters the lung meridian. It has the effects of clearing away heat, removing dampness, relieving stranguria, strengthening the spleen and killing insects.

[0072] Cicada Flower is an insect-fungus complex formed by the parasitism of Penicillium cicadae on the nymph of a certain Homoptera cicada family insect. The Latin name of Cicada Flower is Ophiacordyceps sobolifera. Cicada Flower is sweet and salty in nature and cold in nature. It enters the lung and liver meridians. It has the effects of extinguishing wind and stopping spasms, improving eyesight and removing cataracts, clearing away heat and detoxifying, reducing swelling and relieving pain, dispelling wind and dampness, and moistening the lungs and relieving cough.

[0073] Extractant of the present invention and preparation method thereof

[0074] The invention provides an extractant of a traditional Chinese medicine composition, wherein the extractant is prepared by extracting the traditional Chinese medicine composition of the invention.

[0075] As used herein, "the extractant of the present invention" refers to an extract in the form of a decoction or an extract obtained by purifying the traditional Chinese medicine composition of the present invention through solvent extraction and filtration.

[0076] The effective components of the Chinese medicine composition of the present invention are purified by solvent extraction and filtration, wherein the extraction method adopted can select suitable extraction solvent and extraction conditions according to the physicochemical properties of the effective components in the medicine; preferably, the extractant of the present invention is prepared by the following method: cicada slough, silkworm pupa, silkworm cocoon shell, silkworm feces, coix root, and golden cicada flower are crushed and sieved, defatted, extracted by ethanol immersion, after removing the alcohol, water is added and stirred evenly, then extracted with water-saturated n-butanol, and finally concentrated and air-dried.

[0077] Preparation and administration

[0078] The present invention provides a preparation, which contains one or more medicinal materials of cicada slough, silkworm pupa, silkworm cocoon shell, silkworm feces, coix root, and golden cicada flower or their extracts. In the preparation, the content of the raw medicinal materials or their extracts can be 0.1-99.9wt%, based on the weight of the preparation. The composition can also contain a pharmaceutically or health product acceptable carrier.

[0079] In the present invention, it should be understood that the extract includes not only the concentrated solution (such as extract) or active ingredient (such as powder) obtained by extracting the raw medicinal materials after mixing, but also the concentrated solution (such as extract) or active ingredient mixture (including the mixture between concentrated solution and concentrated solution, active ingredient and active ingredient, or between concentrated solution and active ingredient) obtained by extracting a single medicinal material from the raw medicinal materials. The active ingredient of the raw medicinal materials includes a single ingredient or a mixed ingredient.

[0080] There is no particular limitation on the dosage form of the preparation of the present invention, and any dosage form suitable for mammals can be used. Preferably, the dosage form may include tablets, capsules, granules, pills, mixtures, powders, oral liquids, buccal tablets, or aerosols. From the standpoint of ease of preparation, administration or taking, the preferred composition is a solid preparation. Oral administration is preferred.

[0081] Various conventional carriers and / or excipients required for preparing different dosage forms can be added to the preparation of the present invention. The excipients described in the present invention are pharmaceutical specifications, including dextrin, lactose, sodium bicarbonate, citric acid, sodium hydroxymethyl starch, micropowder silica gel, starch, soluble starch, polyethylene glycol or magnesium stearate. The conventional method of traditional Chinese medicine preparation can be used to prepare any commonly used dosage form, such as tablets, capsules, granules, capsules, pills, powders.

[0082] Some examples of pharmaceutically acceptable excipients include cellulose and its derivatives (such as methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, etc.), gelatin, talc, solid lubricants (such as stearic acid, magnesium stearate), calcium sulfate, vegetable oils (such as soybean oil, sesame oil, peanut oil, olive oil, etc.), polyols (such as propylene glycol, glycerol, mannitol, sorbitol, etc.), emulsifiers (such as Tween), wetting agents (such as sodium lauryl sulfate), buffers, chelating agents, thickeners, pH adjusters, transdermal enhancers, colorants, flavorings, stabilizers, antioxidants, preservatives, antibacterial agents, pyrogen-free water, etc.

[0083] The preparation of the present invention can avoid temporary boiling of Chinese herbal medicine decoction before taking, which is easy to mold and deteriorate after long-term storage and brings a lot of inconvenience to patients. According to the characteristics of clinical medication, the physical and chemical properties of the main medicinal flavors in the prescription are preserved, and modern preparation technology is combined to prepare solid preparations such as granules, tablets, capsules, powders, etc., which can conveniently and effectively meet the needs of patients.

[0084] The preparation of the present invention can be directly used to prepare a drug for preventing and / or treating chronic glomerulonephritis. The preparation of the present invention can also contain other optional medicinal materials or extracts thereof or other drugs effective for treating and / or preventing chronic glomerulonephritis. Preferably, the preparation of the present invention can alleviate symptoms such as proteinuria and renal insufficiency caused by chronic glomerulonephritis.

[0085] The preparation of the present invention is usually administered at a dose of 0.001-20 g / kg of animal body weight per day, preferably 1-4 divided doses per day, or in a sustained release form. For most mammals, the total daily dose is 0.05-600 g. Of course, the specific dosage will also vary with the mode of administration, dosage form and severity of the disease being treated, and the route of administration is within the skill of a skilled physician. Administration can be carried out by conventional routes, including (but not limited to): oral, intramuscular, dermal, or topical administration. Oral administration is preferred.

[0086] The present invention also provides a method for preventing and / or treating chronic glomerulonephritis, the method comprising the steps of administering the composition or preparation of the present invention to a desired subject, which may be a human or a non-human mammal (e.g., dog, pig, cat, monkey, sheep, horse, cow, etc.).

[0087] The main advantages of the present invention include:

[0088] 1) The Chinese medicine composition of the present invention has definite efficacy and high safety;

[0089] 2) The preparation method of the Chinese medicine composition of the present invention is simple, low-cost, and the raw materials are readily available;

[0090] 3) The Chinese medicine composition of the present invention can improve renal function, reduce proteinuria, and reduce serum creatinine, uric acid, urea nitrogen, etc.

[0091] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the scope of the present invention. The experimental methods in the following examples where specific conditions are not specified are usually performed under conventional conditions, such as those described in Sambrook et al., Molecular Cloning: A Laboratory Manual (New York: Cold Spring Harbor Laboratory Press, 1989), or under conditions recommended by the manufacturer. Unless otherwise indicated, percentages and parts are weight percentages and weight parts.

[0092] The quality of the Chinese medicinal materials involved in the present invention all complies with the relevant provisions under the corresponding medicinal materials item of Part I of the Chinese Pharmacopoeia 2010 edition.

[0093] Example 1 Clinical Study

[0094] 1. Prescription composition, decoction method and explanation

[0095] Wucan Xiaobaiyin: cicada molt 9g, silkworm 12g, silkworm cocoon shell 30g, silkworm feces 9g, coix root 9g, golden cicada flower 6g

[0096] Take one dose daily, decocted in water and taken twice. One course of treatment is 2 months.

[0097] The cicada shell and silkworm pupae in the prescription dispel wind and relieve sore throat, silkworm sand dispels wind and overcomes dampness, silkworm cocoon shells promote diuresis and reduce swelling, coix root clears heat and relieves stranguria, and golden cicada flower extinguishes wind and stops spasms. The whole prescription has the effects of dispelling wind and dampness, replenishing qi and warming yang, promoting diuresis and reducing swelling.

[0098] 2. Research Methods

[0099] The study included 75 patients with chronic glomerulonephritis in the treatment group and the control group. The treatment group was given oral Wucan Xiaobaiyin on the basis of basic western medicine treatment, combined with external treatment (1. Foot bath: add the above Chinese medicine residues to warm water and soak for 30 minutes, then boil for 10 minutes, wait for the liquid to cool to about 40℃ and soak the ankle joints more than 10cm, soak for 30 minutes before going to bed; 2. Umbilical therapy: grind all the above medicines into fine powder, pass through a 120-mesh sieve, dry and set aside, mix with vaseline to make pills and apply to Shenque acupoint, once every other day). Wucan Xiaobaiyin was taken once a day, 150ml / bag, 1 bag warm each morning and evening; the control group was given the above external treatment on the basis of basic western medicine treatment. The observation time was 2 months.

[0100] 2. Observation indicators

[0101] 2.1 Clinical efficacy evaluation

[0102] It was formulated with reference to the Diagnosis, Syndrome Differentiation and Therapeutic Effect Evaluation of Chronic Renal Failure (Trial Program).

[0103] Markedly effective: clinical symptom score decreased by ≥60%, endogenous creatinine clearance or glomerular filtration rate increased by ≥30%, and serum creatinine (Scr) level decreased by ≥30%;

[0104] Effective: clinical symptom score decreased by ≥30%, endogenous creatinine clearance or glomerular filtration rate increased by ≥15%, Scr level decreased by >15%;

[0105] Stable: clinical symptoms have improved, symptom score has decreased by <30%, endogenous creatinine clearance or glomerular filtration rate has not decreased, or increased by <15%, Scr level has not increased or decreased by <15%;

[0106] Ineffective: clinical symptoms did not improve or worsened, endogenous creatinine clearance or glomerular filtration rate decreased, and Scr level increased.

[0107] Total clinical effective rate (%) = (number of markedly effective cases + number of effective cases) / total number of cases in the group × 100%.

[0108] 2.2 TCM syndrome score evaluation

[0109] According to the integral changes of the main and secondary symptoms of TCM syndromes, a semi-quantitative graded scoring evaluation method was used to register the scores before and after treatment to observe the changes in the integrals before and after treatment.

[0110] 2.3 Determination of biochemical and micro-inflammatory indicators

[0111] The subjects were fasting in the morning and blood was collected. The biochemical indicators such as creatinine (Scr), urea nitrogen (BUN), uric acid (UA) were detected by automatic biochemical analyzer (Roche 7600), and the glomerular filtration rate (eGFR) was calculated using the MDRD formula. Enzyme-linked immunosorbent assay (ELISA) was used to detect C-reactive protein (CRP), interleukin-18 (IL-18), interleukin-1β (IL-1β), tumor necrosis factor (TNF-α), reactive oxygen species (ROS), and malondialdehyde (MDA). The blood collection method was the same as before (the reagents were purchased from Bender and determined by the laboratory department of the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine).

[0112] 3. Results

[0113] 3.1 Comparison of clinical efficacy The total effective rates of the treatment group and the control group were 72.0% and 34.7%, respectively. The efficacy of the treatment group was better than that of the control group, and the difference was statistically significant (P < 0.01). See Table 1 for details.

[0114] Table 1 Comparison of clinical efficacy between the two groups [n(%)]

[0115]

[0116] 3.2 Comparison of TCM Syndrome Scores After treatment, the TCM syndrome scores of both groups decreased compared with those before treatment, and the clinical symptoms improved; compared between the two groups, the TCM syndrome scores of the treatment group were significantly lower than those of the control group, and the treatment group was superior to the control group in improving the clinical symptoms of patients (P < 0.01). See Table 2 for details.

[0117] Table 2 Comparison of TCM syndrome scores before and after treatment between the two groups ( point)

[0118]

[0119] Note: Intra-group comparison. * P<0.05, ** P<0.01; comparison between groups, ▲ P<0.05, ▲▲ P<0.01.

[0120] 3.3 Comparison of renal function indicators There was no significant difference in renal function between the two groups before treatment (P>0.05); the differences in Scr, UA, BUN, and eGFR before and after treatment in the treatment group were statistically significant (P<0.01); the differences in Scr, BUN, and eGFR before and after treatment in the control group were statistically significant (P<0.05), while there was no significant difference in UA (P>0.05). Compared with the control group, the renal function of the patients in the treatment group recovered more significantly after treatment. See Table 3 for details.

[0121] Table 3 Comparison of renal function between the two groups before and after treatment

[0122]

[0123] Note: Intra-group comparison. * P<0.05, ** P<0.01; comparison between groups, ▲ P<0.05, ▲▲ P<0.01.

[0124] 3.4 Comparison of micro-inflammatory indexes There was no significant difference in micro-inflammatory indexes between the two groups before treatment (P>0.05); the micro-inflammatory indexes of both groups decreased after treatment, and the decrease in the treatment group was more obvious (P<0.01); interleukin-1β (IL-1β) and tumor necrosis factor (TNF-α) in the control group decreased before and after treatment (P<0.05), while there was no significant difference in C-reactive protein (CRP) and interleukin-18 (IL-18) (P>0.05). See Table 4 for details.

[0125] Table 4 Comparison of micro-inflammatory indicators in the two groups before and after treatment

[0126]

[0127] Note: Intra-group comparison. * P<0.05, ** P<0.01; comparison between groups, ▲ P<0.05, ▲▲ P<0.01.

[0128] 3.5 Comparison of oxidative stress indicators

[0129] There was no significant difference in serum ROS and MDA levels between the two groups before treatment (P>0.05); compared with before treatment, the ROS and MDA levels of the two groups decreased after treatment (P<0.05), and the decrease in the treatment group was more obvious (P<0.01). See Table 5 for details.

[0130] Table 5 Comparison of micro-inflammatory indicators in the two groups before and after treatment

[0131]

[0132]

[0133] Note: Intra-group comparison. * P<0.05, ** P<0.01; comparison between groups, ▲P<0.05, ▲▲ P<0.01.

[0134] Example 2 Animal Experimental Study

[0135] Preparation method of Wucan Xiaobaiyin extractant: 9 grams of cicada molt, 12 grams of silkworm pupa, 30 grams of silkworm cocoon shell, 9 grams of silkworm feces, 9 grams of coix root and 6 grams of cicada flower are crushed and sieved, defatted, and extracted by ethanol soaking. After removing the alcohol, water is added and stirred evenly, and then extracted with water-saturated n-butanol, and finally concentrated and air-dried, and the weight of the air-dried powder is measured.

[0136] Forty SD rats were randomly divided into blank control group, model group, Wucanxiaobaiyin low, medium and high dose groups, with 8 rats in each group. The chronic glomerulonephritis rat model was established by bovine serum albumin method. The blank control group and model group were given normal saline by gavage, and the Wucanxiaobaiyin low, medium and high dose groups were given 3.75g / kg, 7.5g / kg and 15g / kg of Wucanxiaobaiyin extract by gavage, respectively, for 8 weeks. The renal histopathological changes of rats in each group were observed, and the proportion of peripheral blood T lymphocyte subsets and serum creatinine (Scr), urea nitrogen (BUN) and renal tissue interleukin-6 (IL-6), intercellular adhesion molecule-1 (ICAM-1), transforming growth factor-β1 (TGF-β1) levels were detected. Results There were no obvious pathological changes in the glomeruli and mesangial matrix of the rats in the blank control group, glomerular sclerosis and mesangial matrix hyperplasia of the rats in the model group, and the renal pathological changes of rats in each dose group of Wucanxiaobaiyin were significantly alleviated compared with the model group. The peripheral blood CD3, CD4 and CD4 / CD8 of rats in the model group were significantly lower than those in the blank control group and the low, medium and high dose groups of Wucan Xiaobaiyin, and the differences were statistically significant. The serum Scr and BUN levels of rats in the model group were higher than those in the blank control group and the low, medium and high dose groups of Wucan Xiaobaiyin, and the differences were statistically significant. The renal tissue IL-6, ICAM-1 and TGF-β1 levels of rats in the model group were higher than those in the blank control group and the low, medium and high dose groups of Wucan Xiaobaiyin, and the differences were statistically significant. Conclusion Wucan Xiaobaiyin can protect the renal tissue of rats with chronic glomerulonephritis model, improve renal function and reduce inflammatory response, and the mechanism may be related to immune regulation.

[0137] result

[0138] 1. The levels of Scr and BUN in the serum of rats in each group after administration are shown in Table 1. Compared with the normal group, the levels of Scr and BUN in the serum of rats in the model group were significantly increased (P < 0.01). Compared with the model group, the levels of Scr and BUN in the serum of each concentration group of Chinese medicine decreased to varying degrees, among which Scr in each concentration group of Chinese medicine was significantly improved compared with the model group (low, medium and high concentration groups of Chinese medicine: P < 0.01), and BUN was significantly improved in the medium and high concentration groups of Chinese medicine except that the low concentration group of Chinese medicine did not improve significantly (medium and high concentration groups of Chinese medicine: P < 0.01).

[0139] Table 1 Effect of Wucanxiaobaiyin on serum Scr and BUN levels in rats with chronic glomerulonephritis

[0140] Group Sample size Scr BUN Normal group 8 64.42±7.42 4.66±0.50 Model Group 8 <![CDATA[96.43±5.64 ** ]]> <![CDATA[10.24±2.84 ** ]]> Low concentration of Chinese medicine group 8 <![CDATA[86.44±9.55 ** ]]> <![CDATA[9.23±1.21 ** ]]> Chinese medicine medium concentration group 8 <![CDATA[69.88±9.07 ## ]]> <![CDATA[5.79±1.11 ## ]]> High concentration of Chinese medicine group 8 <![CDATA[68.00±9.08 ## ]]> <![CDATA[6.02±1.86 ## ]]>

[0141] Note: Compared with the normal group, *: P < 0.05, **: P < 0.01; compared with the model group, #: P < 0.05, ##: P < 0.01.

[0142] Table 2 Effects of Wucanxiaobaiyin on IL-6, ICAM-1 and TGF-β1 levels in rats with chronic glomerulonephritis

[0143] Group Sample size IL-6 ICAM-1 TGF-β1 Normal group 8 0.19±0.02 0.39±0.43 128.65±31.28 Model Group 8 <![CDATA[0.26±0.01 ** ]]> <![CDATA[0.53±0.04 ** ]]> <![CDATA[209.87±29.88 ** ]]> Low concentration of Chinese medicine group 8 <![CDATA[0.23±0.01 * ]]> <![CDATA[0.49±0.07 * ]]> <![CDATA[177.56±39.6 * ]]> Chinese medicine medium concentration group 8 <![CDATA[0.22±0.01 ## ]]> <![CDATA[0.45±0.04 ## ]]> <![CDATA[151.03±28.95 ## ]]> High concentration of Chinese medicine group 8 <![CDATA[0.21±0.01 ## ]]> <![CDATA[0.43±0.04 ## ]]> <![CDATA[130.6±25.46 ## ]]>

[0144] Note: Compared with the normal group, *: P < 0.05, **: P < 0.01; compared with the model group, #: P < 0.05, ##: P < 0.01.

[0145] Table 3 Effect of Wucanxiaobaiyin on the proportion of T lymphocyte subsets in the serum of rats with chronic glomerulonephritis

[0146] Group Sample size CD3 CD4 CD4 / CD8 Normal group 8 75.92±3.95 47.56±5.6 1.65±0.69 Model Group 8 <![CDATA[59.75±4.74 * ]]> <![CDATA[34.24±4.3 ** ]]> <![CDATA[0.87±0.41 ** <!-- 9 -->]]> Low concentration of Chinese medicine group 8 <![CDATA[65.34±6.13 # ]]> <![CDATA[34.87±1.98 ** ]]> <![CDATA[0.96±0.60 * ]]> Chinese medicine medium concentration group 8 <![CDATA[67.32±9.91 ## ]]> <![CDATA[38.08±5.06 ## ]]> <![CDATA[1.10±0.65 ## ]]> High concentration of Chinese medicine group 8 <![CDATA[69.34±6.13 ## ]]> <![CDATA[42.64±2.8 ## ]]> <![CDATA[1.31±0.66 ## ]]>

[0147] All documents mentioned in the present invention are cited as references in this application, just as each document is cited as reference individually. In addition, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition is composed of the following raw medicinal materials or their extracts: 3-15 parts by weight of cicada shells; Bombyx batryticatus 5-20 parts by weight; 15-45 parts by weight of silkworm cocoon shells; Silkworm excrement 3-15 parts by weight; 3-15 parts by weight of coix root; 3-12 parts by weight of Cordyceps sinensis.

2. The Chinese medicine composition according to claim 1, characterized in that The extract includes: a water extract, an alcohol extract, an aqueous solvent extract, a carbon dioxide supercritical extract or an effective ingredient, or a combination thereof.

3. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw medicinal materials or their extracts: 6-12 parts by weight of cicada shells; Bombyx batryticatus 9-15 parts by weight; 20-40 parts by weight of silkworm cocoon shells; Silkworm excrement 6-12 parts by weight; 6-12 parts by weight of coix root; 6-9 parts by weight of Cordyceps sinensis.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of 9 parts by weight of cicada molts, 12 parts by weight of silkworm pupae, 30 parts by weight of silkworm cocoon shells, 9 parts by weight of silkworm feces, 9 parts by weight of coix root and 6 parts by weight of cicada flower.

5. An extractant for a Chinese medicine composition, which is prepared by extracting the Chinese medicine composition as claimed in claim 1, wherein the extraction solvent of the extractant is an aqueous solvent.

6. The Chinese medicine composition extractant according to claim 5, characterized in that: The extraction solvent is ethanol.

7. A method for preparing the extractant of the Chinese medicine composition as claimed in claim 5, comprising the steps of: 1) Providing raw medicinal materials: 3-15 parts by weight of cicada molts, 5-20 parts by weight of silkworm pupae, 15-45 parts by weight of silkworm cocoon shells, 3-15 parts by weight of silkworm feces, 3-15 parts by weight of coix root, and 3-12 parts by weight of cicada flower; 2) extracting the raw medicinal material using an aqueous solvent to obtain the Chinese medicine composition extract.

8. A pharmaceutical preparation, comprising: i) the Chinese medicine composition according to claim 1 or the extractant of the Chinese medicine composition according to claim 5; ii) other pharmaceutically acceptable adjuvants, carriers or excipients.

9. Use of the Chinese medicine composition according to claim 1 or the Chinese medicine composition extract according to claim 5 or the pharmaceutical preparation according to claim 8 for preparing a medicament for preventing and / or treating chronic glomerulonephritis.

10. The use according to claim 9, characterized in that The prevention and / or treatment of chronic glomerulonephritis includes improving one or more indicators selected from the following group: a) Reduce urine protein; b) decrease in serum creatinine, or urea nitrogen, or uric acid, or a combination thereof; c) reducing renal tissue IL-6, or ICAM-1, or TGF-β1, or a combination thereof.

Images