Traditional Chinese medicine composition for treating IgA nephropathy proteinuria, pharmaceutical preparation and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating IgA nephropathy proteinuria, a pharmaceutical preparation and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 35 to 45 parts of radix astragali seu hedysari, 35 to 45 parts of rhizoma dioscoreae, 25 to 35 parts of tortoise plastron, 25 to 35 parts of corn stigma, 25 to 35 parts of semen coicis, 10 to 20 parts of fructus ligustri lucidi and 10 to 20 parts of herba ecliptae. According to the present invention, the astragalus membranaceus is adopted as the monarch drug, and is matched with the Chinese yam, the tortoise plastron, the corn stigma, the coix seed, the glossy privet fruit and the eclipta according to the specific ratio, such that the kidney reinforcing and turbidity removing effects are provided, and the kidney function can be improved, the kidney can be protected, and the kidney damage can be prevented while the IgA nephropathy proteinuria can be treated.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating proteinuria in IgA nephropathy, a pharmaceutical preparation and a preparation method thereof. Background Art

[0002] IgA nephropathy (IgAN) is a glomerular disease, accounting for about 52.66% of primary glomerular diseases, with the highest incidence in Asia. The early clinical manifestations of IgA nephropathy are hidden, accompanied by varying degrees of proteinuria. If not effectively controlled in a timely manner, about 30-40% of patients will develop end-stage renal disease within 20-30 years after diagnosis. According to the pathological mechanism of IgA nephropathy, it can be classified into the categories of "turbid urine", "deficiency", and "kidney wind" in traditional Chinese medicine, while proteinuria is equivalent to "essence" and "essence" in traditional Chinese medicine. Although the etiology and pathogenesis of IgA nephropathy are complex, they can be generally summarized as: congenital kidney deficiency, acquired evil qi invasion, and aggravated lifestyle disorders. IgA nephropathy patients are born with deficiency or malnutrition, and most of them suffer from spleen and kidney deficiency of both Qi and Yin. Insufficient vital energy cannot resist external pathogens, or they cannot expel pathogens after being infected, or endogenous pathological products form pathogenic substances, which can lead to a pathological state in which the kidney is deficient and unable to retain water, and cannot control water, resulting in proteinuria and / or edema.

[0003] Traditional Chinese medicine treatment of IgA nephropathy takes a holistic approach, takes syndrome differentiation and treatment as the principle, and adopts the treatment method of "dispelling evil and strengthening the kidney". While reducing proteinuria, it can also protect the kidney, achieving the purpose of treating both the symptoms and the root cause, and has fewer adverse reactions. Therefore, how to provide an effective traditional Chinese medicine formula has become an urgent problem to be solved. Summary of the invention

[0004] In order to solve the above technical problems, the present disclosure provides a traditional Chinese medicine composition, a pharmaceutical preparation and a preparation method thereof for treating proteinuria in IgA nephropathy. The traditional Chinese medicine composition can protect the kidneys while reducing proteinuria, thereby achieving the purpose of treating both the symptoms and the root cause.

[0005] In a first aspect, the present disclosure provides a traditional Chinese medicine composition for treating IgA nephropathy proteinuria, wherein the traditional Chinese medicine composition comprises, by weight:

[0006] 35-45 parts of astragalus, 35-45 parts of yam, 25-35 parts of tortoise shell, 25-35 parts of corn silk, 25-35 parts of coix seeds, 10-20 parts of Ligustrum lucidum and 10-20 parts of Eclipta prostrata.

[0007] Astragalus: sweet in taste, slightly warm in nature, it has the effects of tonifying Qi and raising Yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood.

[0008] Yam: sweet in taste, neutral in nature, has the effects of nourishing the spleen and stomach, promoting fluid production and benefiting the lungs, nourishing the kidneys and astringing semen.

[0009] Turtle shell: sweet and salty in taste, slightly cold in nature, has the effects of nourishing yin and suppressing yang, benefiting the kidneys and strengthening bones, nourishing blood and replenishing the heart, consolidating menstruation and stopping metrorrhagia.

[0010] Corn silk: sweet, light in taste, neutral in nature, has the effects of diuresis, swelling reduction, liver clearing and bile promoting.

[0011] Job's tears: sweet, light in taste, cool in nature, has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea, removing arthralgia, discharging pus, detoxifying and dispersing nodules.

[0012] Fructus Ligustri Lucidi: sweet and bitter in taste, cool in nature, has the effects of nourishing the liver and kidneys, improving eyesight and darkening hair.

[0013] Eclipta prostrata: sweet and sour in taste, cold in nature, has the effects of nourishing the liver and kidneys, cooling blood and stopping bleeding.

[0014] The invention discloses a medicine using astragalus as the main drug, and combining it with yam, tortoise shell, corn silk, coix seed, Ligustrum lucidum and Eclipta prostrata, and preparing them in a specific proportion, which has the effects of strengthening the kidney and removing turbidity. While treating proteinuria of IgA nephropathy, it can also improve renal function, protect the kidney and prevent renal damage.

[0015] In the present disclosure, whether it is the main drug or other compatible drugs, adding too much or too little will affect the efficacy of the drug and cannot achieve the purpose of treating IgA nephropathy proteinuria and improving renal function.

[0016] Specifically, the weight proportion of Astragalus can be selected as 35, 36, 37, 38, 39, 40, 41, 42, 43, 44 or 45 parts, but is not limited to the listed values, and other unlisted values ​​within the range are also applicable.

[0017] The weight proportions of yam can be 35, 36, 37, 38, 39, 40, 41, 42, 43, 44 or 45 parts, but are not limited to the listed values, and other unlisted values ​​within the range are equally applicable.

[0018] The weight proportion of tortoise shell can be 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts, but is not limited to the listed values, and other unlisted values ​​within the range are also applicable.

[0019] The weight proportion of corn silk can be 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts, but is not limited to the listed values, and other unlisted values ​​within the range are equally applicable.

[0020] The weight proportion of coix seeds can be 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts, but is not limited to the listed values, and other unlisted values ​​within the range are also applicable.

[0021] The weight proportions of Ligustrum lucidum can be selected as 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 20 parts, but are not limited to the listed values, and other unlisted values ​​within the range are also applicable.

[0022] The weight proportions of Eclipta prostrata can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, but are not limited to the listed values, and other unlisted values ​​within the range are equally applicable.

[0023] The following are preferred technical solutions of the present disclosure, but are not intended to be limitations of the technical solutions provided by the present disclosure. Through the following technical solutions, the technical objectives and beneficial effects of the present disclosure can be better achieved and realized.

[0024] As a preferred technical solution of the present disclosure, the Chinese medicine composition comprises, by weight:

[0025] 38-42 parts of astragalus, 38-42 parts of yam, 28-32 parts of tortoise shell, 28-32 parts of corn silk, 28-32 parts of coix seeds, 13-18 parts of Ligustrum lucidum and 13-18 parts of Eclipta prostrata.

[0026] As a preferred technical solution of the present disclosure, the Chinese medicine composition comprises, by weight:

[0027] 40 parts of astragalus, 40 parts of yam, 30 parts of tortoise shell, 30 parts of corn silk, 30 parts of coix seeds, 15 parts of Ligustrum lucidum and 15 parts of Eclipta prostrata.

[0028] In a second aspect, the present disclosure provides a pharmaceutical preparation for treating proteinuria in IgA nephropathy, wherein the pharmaceutical preparation contains the effective ingredients of the traditional Chinese medicine composition as described in the first aspect;

[0029] The dosage form of the pharmaceutical preparation is any one of granules, powders, capsules, tablets, mixtures or oral liquids.

[0030] The active ingredients in the present disclosure refer to astragalus, yam, tortoise shell, corn silk, coix seed, glossy privet fruit and eclipta. As long as the medicament prepared by using the above active ingredients can achieve the purpose of treating IgA nephropathy proteinuria and improving renal function, it is not limited to a specific drug dosage form.

[0031] As a preferred technical solution of the present disclosure, the pharmaceutical preparation further includes one or more excipients.

[0032] As a preferred technical solution of the present disclosure, the pharmaceutical preparation is a granule, and the auxiliary materials include excipients and / or flavoring agents.

[0033] Preferably, the excipient comprises dextrin.

[0034] Preferably, the flavoring agent comprises sucrose.

[0035] Preferably, the mass ratio of the excipient to the flavoring agent is 1:(3-5), such as 1:3, 1:4 or 1:5, etc., but is not limited to the listed values, and other unlisted values ​​within the range are also applicable.

[0036] In a third aspect, the present disclosure provides a method for preparing a pharmaceutical preparation for treating IgA nephropathy proteinuria as described in the second aspect, wherein the pharmaceutical preparation is a granule, and the preparation method comprises the following steps:

[0037] (1) first decocting the tortoise shell with water, then adding astragalus, yam, corn silk, coix seed, Ligustrum lucidum and Eclipta prostrata for the first decoction, and performing solid-liquid separation to obtain a first water extract and a mixed solid;

[0038] (2) adding water to the obtained mixed solid for a second decoction, and performing solid-liquid separation to obtain a second aqueous extract;

[0039] (3) mixing the first water extract and the second water extract, and then concentrating to obtain an extract;

[0040] (4) Mix the extract with auxiliary materials to prepare granules.

[0041] As a preferred technical solution of the present invention, the weight of water added in step (1) is 10-15 times the total weight of the effective ingredients of the traditional Chinese medicine composition, for example, 10 times, 11 times, 12 times, 13 times, 14 times or 15 times, etc., but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0042] Preferably, the pre-frying time in step (1) is 20-30 min, for example, 20 min, 22 min, 24 min, 26 min, 28 min or 30 min, but is not limited to the listed values, and other values ​​not listed within the range are also applicable.

[0043] Preferably, the first decoction time in step (1) is 1-1.5 h, such as 1 h, 1.1 h, 1.2 h, 1.3 h, 1.4 h or 1.5 h, but is not limited to the listed values, and other values ​​not listed within the range are also applicable.

[0044] As a preferred technical solution of the present invention, the weight of water added in step (2) is 6-10 times the total weight of the effective ingredients of the traditional Chinese medicine composition, for example, 6 times, 7 times, 8 times, 9 times or 10 times, etc., but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0045] Preferably, the second decoction time in step (2) is 1-1.5 h, such as 1 h, 1.1 h, 1.2 h, 1.3 h, 1.4 h or 1.5 h, but is not limited to the listed values, and other values ​​not listed within the range are also applicable.

[0046] Preferably, the added weight of the auxiliary material in step (4) is 3-5 times the weight of the extract, for example 3 times, 4 times or 5 times, etc., but is not limited to the listed values, and other unlisted values ​​within this range are also applicable.

[0047] Compared with the prior art, the technical solution provided by the embodiments of the present disclosure has the following advantages:

[0048] (1) The present invention can start from the TCM pathogenesis of IgA nephropathy, adopt the treatment method of "dispelling evil and strengthening the kidney", use Astragalus as the main medicine, and match it with Chinese yam, tortoise shell, corn silk, coix seed, Ligustrum lucidum and Eclipta prostrata, and prepare them according to a specific ratio, which makes up for the limited therapeutic effect of a single drug, while reducing proteinuria, improving renal function, protecting the kidney and preventing renal damage.

[0049] (2) The Chinese medicine composition prepared in the present disclosure is based on the holistic view of traditional Chinese medicine and can regulate the organs of the whole body in an all-round way, enhance the functions of organs such as the kidney and liver, and achieve the purpose of strengthening the kidney and removing turbidity. DETAILED DESCRIPTION

[0050] In order to more clearly understand the above-mentioned objectives, features and advantages of the present disclosure, the scheme of the present disclosure will be further described below. It should be noted that the embodiments of the present disclosure and the features in the embodiments can be combined with each other without conflict.

[0051] In the following description, many specific details are set forth to facilitate a full understanding of the present disclosure, but the present disclosure may also be implemented in other ways different from those described herein; it is obvious that the embodiments in the specification are only part of the embodiments of the present disclosure, rather than all of the embodiments.

[0052] Example 1

[0053] This embodiment provides a Chinese medicine composition for treating IgA nephropathy proteinuria and a method for preparing the granules thereof. The Chinese medicine composition comprises, by weight:

[0054] 40 parts of astragalus, 40 parts of yam, 30 parts of tortoise shell, 30 parts of corn silk, 30 parts of coix seeds, 15 parts of Ligustrum lucidum and 15 parts of Eclipta prostrata.

[0055] The preparation method of the granules comprises the following steps:

[0056] (1) First, add water to the tortoise shell and decoct for 30 minutes, then add astragalus, yam, corn silk, coix seed, Ligustrum lucidum and Eclipta prostrata, decoct for 1 hour, and then separate the solid and liquid to obtain the first water extract and the mixed solid;

[0057] Among them, the weight of water added is 10 times the total weight of the active ingredients;

[0058] (2) the obtained mixed solid was boiled in water again for 1 hour, and then solid-liquid separation was performed to obtain a second aqueous extract;

[0059] Among them, the weight of water added is 6 times the total weight of the active ingredients;

[0060] (3) mixing the first water extract and the second water extract, and then concentrating to obtain an extract;

[0061] (4) mixing the extract with the auxiliary materials, stirring them thoroughly and uniformly, and then using a traditional Chinese medicine granulator to make granules;

[0062] Wherein, the auxiliary materials include dextrin and sucrose in a mass ratio of 1:4, and the added weight of the auxiliary materials is 4 times the weight of the extract.

[0063] Example 2

[0064] This embodiment provides a Chinese medicine composition for treating IgA nephropathy proteinuria and a method for preparing the granules thereof. The Chinese medicine composition comprises, by weight:

[0065] 35 parts of astragalus, 40 parts of yam, 25 parts of tortoise shell, 35 parts of corn silk, 25 parts of coix seeds, 16 parts of Ligustrum lucidum and 20 parts of Eclipta prostrata.

[0066] The preparation method of the granules is similar to that of Example 1.

[0067] Example 3

[0068] This embodiment provides a Chinese medicine composition for treating IgA nephropathy proteinuria and a method for preparing the granules thereof. The Chinese medicine composition comprises, by weight:

[0069] 45 parts of astragalus, 35 parts of yam, 25 parts of tortoise shell, 25 parts of corn silk, 28 parts of coix seeds, 10 parts of Ligustrum lucidum and 10 parts of Eclipta prostrata.

[0070] The preparation method of the granules is similar to that of Example 1.

[0071] Example 4

[0072] This embodiment provides a Chinese medicine composition for treating IgA nephropathy proteinuria and a method for preparing the granules thereof. The Chinese medicine composition comprises, by weight:

[0073] 45 parts of astragalus, 35 parts of yam, 35 parts of tortoise shell, 35 parts of corn silk, 35 parts of coix seeds, 20 parts of Ligustrum lucidum and 20 parts of Eclipta prostrata.

[0074] The preparation method of the granules is similar to that of Example 1.

[0075] Animal experiment: Taking the granular Chinese medicine composition obtained in Example 1 as an example

[0076] 1. Materials

[0077] Experimental animals: 8-week-old healthy SPF-grade SD male rats were provided by Beijing Huafukang Biotechnology Co., Ltd., license number: SCXK (Shanghai) 2018-0016. They were raised by the Experimental Animal Center of Fujian University of Traditional Chinese Medicine (Animal Use License Number: SYXK (Min) 2019-0007), with 5 rats per cage. During the breeding process, the room was kept at a constant temperature and humidity (temperature 20-25°C, humidity 40%-60%), with a day and night cycle of 12h / 12h, and free access to water and food.

[0078] 2. Methods

[0079] 2.1 Experimental Animal Grouping and Dosing

[0080] Ten rats were randomly selected as the normal control group, and the rest of the rats were gavaged with 600 mg / kg bovine serum albumin every other day for 12 weeks; at the same time, castor oil 0.3 mL + CCl4 0.1 mL was subcutaneously injected once a week for 12 weeks; and 0.05 mg lipopolysaccharide (LPS) was injected into the tail vein of the rats at the 8th and 10th weeks to prepare the IgA nephropathy rat model. The significant increase in the 24-hour urine protein level of the rats compared with the normal control group was regarded as the successful modeling standard of IgA nephropathy (i.e., the urine protein of the modeling rats was compared with that of the normal rats, p < 0.05).

[0081] The IgA nephropathy model rats were divided into groups using a random number table, with 10 rats in each group:

[0082] Model group: 1g of purified water was given orally per 100g of rats;

[0083] High-dose group: 0.88 g of granules were administered to rats weighing 100 g by gavage in the form of aqueous solution;

[0084] Medium-dose group: 0.44 g of granules were administered to rats weighing 100 g by gavage in the form of aqueous solution;

[0085] Low-dose group: 0.22 g of granules were administered to rats weighing 100 g by gavage in the form of aqueous solution;

[0086] Prednisone group (positive drug group): 0.5 mg of prednisone was administered orally per 100 g of rats in the form of aqueous solution.

[0087] In addition, the normal control group: 1g of purified water was given by gavage to every 100g of rats.

[0088] All groups were given the drug continuously for 14 days. In order to maintain a stable proteinuria state, rats in all groups except the normal control group were gavaged with 600 mg / kg bovine serum albumin every other day during the drug administration period.

[0089] 2.2 Biochemical index detection

[0090] 1) After the administration, all rats in the groups were placed in corresponding metabolic cages and fasted but not watered. The 24-hour urine of the rats was collected and the 24-hour urine protein level (24h-UTP) was detected using a kit. The number of red blood cells in the urine of the rats was detected using an automatic cell counter.

[0091] 2) After the administration was completed and urine of each group of rats was collected, the rats in each group were fasted but not watered for 12 hours, and then weighed and anesthetized with intraperitoneal injection of aflototin. Blood was collected from the abdominal aorta, centrifuged at 4000 rpm for 15 minutes, and the supernatant was stored at -80°C. The bilateral kidneys and liver were then dissected and removed. After the surrounding tissues were removed, the weights were recorded using an electronic balance, and the organ coefficient was calculated using the following formula: organ coefficient = organ mass (mg) / body mass (g).

[0092] The prepared serum was taken out, dissolved at room temperature, and the absorbance was measured using an ELISA reader according to the instructions of the kit. The serum creatinine (SCr) level, urea nitrogen (BUN) level, alanine aminotransferase (ALT) activity, and aspartate aminotransferase (AST) activity were calculated according to the calculation formula.

[0093] The kits used in the above detection process are specifically shown in Table 1.

[0094] Table 1

[0095]

[0096] Statistical analysis

[0097] The collected data were analyzed by SPSS26.0 statistical software. The mean values ​​of multiple groups were compared by one-way ANOVA, and further pairwise comparisons were performed by LSD (assuming equal variance) or Dunnett's T3 (not assuming equal variance). p < 0.05 was considered statistically significant.

[0098] 3. Results

[0099] 3.1 Effect of Chinese herbal medicine combination on 24-hour urine protein level and urine red blood cell count in rats with IgA nephropathy

[0100] Experimental data results of 24h-UTP and urine red blood cell count in rats of each group ( n=6), as shown in Table 2. Wherein, n represents the number of rats in each group used for the final statistical data.

[0101] Table 2

[0102]

[0103] Note: Compared with the normal control group, ## p<0.01;

[0104] Compared with the model group, **p<0.01.

[0105] As shown in Table 2, compared with the normal control group, the 24h-UTP and urine red blood cell count of the model group rats were significantly increased, indicating that the IgA nephropathy rat model was successfully established. Compared with the model group, the 24h-UTP and urine red blood cell count of the high-dose administration group, the medium-dose administration group, the low-dose administration group and the prednisone group were significantly reduced, indicating that the composition can reduce proteinuria in IgA nephropathy rats and alleviate hematuria.

[0106] 3.2 Effect of Chinese herbal medicine combination on renal coefficient, SCr level and BUN level in rats with IgA nephropathy

[0107] Experimental data results of kidney coefficient, SCr level and BUN level of rats in each group ( n=6), as shown in Table 3.

[0108] Table 3

[0109]

[0110]

[0111] Note: Compared with the normal control group, ## p<0.01;

[0112] Compared with the model group, **p<0.01.

[0113] As shown in Table 3, compared with the normal control group, there was no significant difference in the kidney coefficient of the rats in the model group, indicating that short-term modeling did not cause serious kidney damage to the rats. After administration, there was no significant difference in the kidney coefficient of the rats in each group compared with the normal control group, indicating that the composition would not cause nephrotoxicity to rats.

[0114] Compared with the normal control group, the serum SCr level and BUN level of the rats in the model group were significantly increased, indicating that the modeling drug caused renal damage to the rats while increasing proteinuria. Compared with the model group, the serum SCr level and BUN level of the rats in the high-dose administration group, the medium-dose administration group, the low-dose administration group and the prednisone group were significantly decreased, indicating that the composition can alleviate renal damage.

[0115] 3.3 Effect of Chinese herbal medicine combination on liver coefficient, ALT activity and AST activity in rats with IgA nephropathy

[0116] Experimental data results of liver coefficient, ALT and AST activity of rats in each group ( n=6), as shown in Table 4.

[0117] Table 4

[0118]

[0119] As shown in Table 4, there were no significant differences in the liver coefficient, ALT activity and AST activity of rats in the model group, high-dose administration group, medium-dose administration group, low-dose administration group and prednisone group, indicating that the Chinese medicine composition has good safety and no adverse reactions.

[0120] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0121] The above description is only a specific embodiment of the present disclosure, so that those skilled in the art can understand or implement the present disclosure. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure will not be limited to the embodiments described herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine composition for treating IgA nephropathy proteinuria, characterized in that: In parts by weight, the Chinese medicine composition comprises: 35-45 parts of astragalus, 35-45 parts of yam, 25-35 parts of tortoise shell, 25-35 parts of corn silk, 25-35 parts of coix seeds, 10-20 parts of Ligustrum lucidum and 10-20 parts of Eclipta prostrata.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the Chinese medicine composition comprises: 38-42 parts of astragalus, 38-42 parts of yam, 28-32 parts of tortoise shell, 28-32 parts of corn silk, 28-32 parts of coix seeds, 13-18 parts of Ligustrum lucidum and 13-18 parts of Eclipta prostrata.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: In parts by weight, the Chinese medicine composition comprises: 40 parts of astragalus, 40 parts of yam, 30 parts of tortoise shell, 30 parts of corn silk, 30 parts of coix seeds, 15 parts of Ligustrum lucidum and 15 parts of Eclipta prostrata.

4. A pharmaceutical preparation for treating IgA nephropathy proteinuria, characterized in that: The pharmaceutical preparation contains the active ingredient of the Chinese medicine composition according to any one of claims 1 to 3; The dosage form of the pharmaceutical preparation is any one of granules, powders, capsules, tablets, mixtures or oral liquids.

5. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutical preparation may further comprise one or more excipients.

6. The pharmaceutical preparation according to claim 5, characterized in that The pharmaceutical preparation is a granule, and the auxiliary materials include excipients and / or flavoring agents; Preferably, the excipient comprises dextrin; Preferably, the flavoring agent comprises sucrose; Preferably, the mass ratio of the excipient to the flavoring agent is 1:(3-5).

7. A method for preparing a pharmaceutical preparation for treating IgA nephropathy proteinuria according to any one of claims 4 to 6, characterized in that: The pharmaceutical preparation is a granule, and the preparation method comprises the following steps: (1) first decocting the tortoise shell with water, then adding astragalus, yam, corn silk, coix seed, Ligustrum lucidum and Eclipta prostrata for the first decoction, and performing solid-liquid separation to obtain a first water extract and a mixed solid; (2) adding water to the obtained mixed solid for a second decoction, and performing solid-liquid separation to obtain a second aqueous extract; (3) mixing the first water extract and the second water extract, and then concentrating to obtain an extract; (4) Mix the extract with auxiliary materials to prepare granules.

8. The preparation method according to claim 7, characterized in that: The weight of water added in step (1) is 10-15 times the total weight of the effective ingredients of the Chinese medicine composition; Preferably, the pre-frying time in step (1) is 20-30 minutes; Preferably, the first decoction time in step (1) is 1-1.5 hours.

9. The preparation method according to claim 7 or 8, characterized in that: The weight of water added in step (2) is 6-10 times the total weight of the effective ingredients of the Chinese medicine composition; Preferably, the second decoction time in step (2) is 1-1.5h; Preferably, the weight of the auxiliary material added in step (4) is 3-5 times the weight of the extract.

Images