A pharmaceutical composition for treating chronic glomerulonephritis, its preparation method and application

Abstract

The present invention relates to a pharmaceutical composition for treating chronic glomerulonephritis, its preparation method and application. The pharmaceutical composition is composed of Rhizoma Smilacis Glabrae Albae, Flos Abelmoschi Manihot, Herba Ephedrae Delavayi, Radix Saposhnikoviae Divaricatae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Corydalis Saxicolae, Radix Salviae Yunnanensis, and Radix Achyranthis Aspera. The preparation method is to first extract the above nine herbs with ethanol and then with water, and the mixed solution is concentrated to make a pharmaceutical preparation. The combined use of this pharmaceutical preparation and western medicine can improve the treatment effect of chronic glomerulonephritis, with a total effective rate reaching 84%. Moreover, it can significantly reduce the urinary protein and red blood cells in patients, showing a significant difference compared with the control group using western medicine alone. This indicates that it can effectively improve the clinical symptoms of patients, has no adverse reactions, has high safety, and has extremely high popularization value.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine, and particularly relates to a pharmaceutical composition for treating chronic glomerulonephritis, a preparation method thereof, and an application thereof. Background Art

[0002] Chronic glomerulonephritis is a common chronic kidney disease with a high incidence. Chronic glomerulonephritis is prevalent globally. Research investigations have found that in 2020, the number of global chronic glomerulonephritis cases was 697.5 million, with a prevalence rate of approximately 9.1%, and approximately 1.2 million people died from chronic glomerulonephritis. China is a high-incidence area for chronic glomerulonephritis, and nearly 132.3 million chronic glomerulonephritis patients in the world live in China. If chronic glomerulonephritis is not intervened in a timely manner, there is a risk of renal failure and necrosis, which seriously affects the quality of life of patients and even endangers their lives. Currently, angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors are commonly used therapeutic drugs for chronic glomerulonephritis. However, considering that angiotensin-converting enzyme inhibitors have the adverse reaction of irritating dry cough and will increase the risk of stroke in patients, traditional Chinese medicine has been widely used in clinical treatment in recent years and has achieved certain clinical efficacy.

[0003] To solve the above problems, the invention team combined a large number of cases and prescription analyses of chronic glomerulonephritis in our hospital, and on the basis of the basic theory of traditional Chinese medicine and combined with the etiology of chronic glomerulonephritis, it was clarified that chronic glomerulonephritis belongs to the category of "edema", with spleen-kidney deficiency as the root, and the treatment mostly focuses on tonifying the spleen and kidney to strengthen the healthy qi. Patients are bedridden for a long time, with spleen-kidney deficiency, qi movement disorder, qi deficiency unable to promote blood circulation to form stasis, and qi deficiency unable to transport and transform water dampness pathogens to form phlegm-dampness. Phlegm-dampness and stasis trap and overflow the skin to form edema. After a large number of practical studies, the inventor used white glabrous greenbrier to dispel dampness and promote diuresis, and areca peel fluff to promote diuresis and relieve edema, directly reaching the pathogenesis, and they are used as the monarch drugs together; Herba Ephedrae and Radix Saposhnikoviae can dispel wind and relieve the exterior, enabling the water in the exterior to be dispelled through sweating, and they are used as the ministerial drugs; assisted by elm twigs, cooperating with Dichondra repens Forst. and Coptis saxicola to clear away damp-heat and promote the flow of urine and defecation, enabling the interior heat and water pathogens to go away from the lower part; Salvia miltiorrhiza and Achyranthes bidentata to promote blood circulation and remove stasis, new blood is generated after the stasis is removed, and body fluid and blood have the same origin, promoting the distribution and excretion of body fluid. Dispersing wind and relieving the exterior helps to promote the flow of damp-heat, and promoting the flow of damp-heat helps to disperse wind and relieve the exterior. The whole prescription diffuses and discharges from top to bottom, inside and outside, enabling the damp-heat pathogens to be cleared and eliminated, and then the swelling and heat will naturally subside. All the drugs are used together to achieve the effects of dispelling wind and activating blood circulation, clearing heat and resolving dampness.

[0004] For the convenience of drug use, the invention team also studied the physicochemical properties of the chemical components in the basic and prescription medicinal materials according to the characteristics of the drug composition, and studied the preparation process and clinical efficacy of the drug composition. The comprehensive test results showed that the combined use of this drug preparation and western medicine could improve the treatment effect of chronic glomerulonephritis, with a total effective rate of 84.0%, and could significantly reduce the urine protein and red blood cells in patients. There was a significant difference compared with the control group using western medicine alone, indicating that this drug could effectively improve the clinical symptoms of patients. Summary of the Invention

[0005] The object of the present invention is to provide a drug composition for rheumatoid arthritis.

[0006] Another object of the present invention is to provide a preparation method of a drug composition for treating chronic glomerulonephritis.

[0007] Another object of the present invention is to provide the application of the drug composition in the preparation of drugs for treating chronic glomerulonephritis.

[0008] The drug composition of the present invention is composed of 15-20 parts of Rhizoma Smilacis Glabrae Albae, 10-15 parts of Pericarpium Arecae Flos, 8-12 parts of Herba Ephedrae Delavayi, 8-12 parts of Radix Saposhnikoviae Divaricatae, 7-10 parts of Ramulus Ulmi Pumilae, 7-10 parts of Herba Dichondrae Repentis, 7-10 parts of Rhizoma Corydalis Saxicolae, 5-10 parts of Radix Salviae Yunnanensis, and 7-10 parts of Radix Achyranthis Aspera.

[0009] Preferably,

[0010] The drug composition of the present invention is composed of 18-20 parts of Rhizoma Smilacis Glabrae Albae, 12-15 parts of Pericarpium Arecae Flos, 10-12 parts of Herba Ephedrae Delavayi, 10-12 parts of Radix Saposhnikoviae Divaricatae, 8-10 parts of Ramulus Ulmi Pumilae, 8-10 parts of Herba Dichondrae Repentis, 8-10 parts of Rhizoma Corydalis Saxicolae, 8-10 parts of Radix Salviae Yunnanensis, and 8-10 parts of Radix Achyranthis Aspera.

[0011] Further preferably,

[0012] The drug composition of the present invention is composed of 20 parts of Rhizoma Smilacis Glabrae Albae, 15 parts of Pericarpium Arecae Flos, 12 parts of Herba Ephedrae Delavayi, 12 parts of Radix Saposhnikoviae Divaricatae, 10 parts of Ramulus Ulmi Pumilae, 10 parts of Herba Dichondrae Repentis, 8 parts of Rhizoma Corydalis Saxicolae, 8 parts of Radix Salviae Yunnanensis, and 8 parts of Radix Achyranthis Aspera.

[0013] The preparation method of the drug composition of the present invention is as follows:

[0014] (1) Ethanol extraction: Weigh Rhizoma Smilacis Glabrae Albae, Pericarpium Arecae Flos, Herba Ephedrae Delavayi, Radix Saposhnikoviae Divaricatae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Corydalis Saxicolae, Radix Salviae Yunnanensis, and Radix Achyranthis Aspera according to the formula ratio, add 30%-90% ethanol which is 4-8 times the total amount of the medicinal materials, heat and extract 1-2 times, each extraction for 0.5-1.5 hours, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0015] (2) Water extraction: Add 6 - 10 times the amount of water to the medicinal residues after ethanol extraction, heat and extract 1 - 2 times, each extraction for 0.5 - 1.5 hours, filter to obtain the water extraction solution;

[0016] (3) Concentration: Combine the ethanol extraction solution and the water extraction solution, concentrate to a thick paste with a relative density of 1.25 - 1.35 at 60 °C, and set aside;

[0017] (4) Formulation: Add pharmaceutically acceptable excipients to the thick paste to prepare a pharmaceutically acceptable formulation.

[0018] Preferably,

[0019] The preparation method of the pharmaceutical composition of the present invention is as follows:

[0020] (1) Ethanol extraction: Weigh rhizoma smilacis glabrae, flos abelmoschi manihot, herba ephedrae, radix ledebouriellae, twig of elm, dichondra repens, herba berberidis, radix salviae yunnanensis, and radix achyranthis bidentatae according to the formula ratio, add 4 - 7 times the total amount of the medicinal materials of 50% - 80% ethanol, heat and extract 1 - 2 times, each extraction for 0.5 - 1 hour, filter, and obtain the ethanol extraction solution after recovering ethanol from the filtrate;

[0021] (2) Water extraction: Add 6 - 8 times the amount of water to the medicinal residues after ethanol extraction, heat and extract 1 - 2 times, each extraction for 0.5 - 1 hour, filter to obtain the water extraction solution;

[0022] (3) Concentration: Combine the ethanol extraction solution and the water extraction solution, concentrate to a thick paste with a relative density of 1.30 - 1.35 at 60 °C, and set aside;

[0023] (4) Formulation: Add pharmaceutically acceptable excipients to the thick paste to prepare a pharmaceutically acceptable formulation.

[0024] Further preferably,

[0025] The preparation method of the pharmaceutical composition of the present invention is as follows:

[0026] (1) Ethanol extraction: Weigh rhizoma smilacis glabrae, flos abelmoschi manihot, herba ephedrae, radix ledebouriellae, twig of elm, dichondra repens, herba berberidis, radix salviae yunnanensis, and radix achyranthis bidentatae according to the formula ratio, add 4 times the total amount of the medicinal materials of 70% ethanol, heat and extract 1 time, each extraction for 0.5 hour, filter, and obtain the ethanol extraction solution after recovering ethanol from the filtrate;

[0027] (2) Water extraction: Add 8 times the amount of water to the medicinal residues after ethanol extraction, heat and extract 1 time, each extraction for 0.5 hour, filter to obtain the water extraction solution;

[0028] (3) Concentration: Combine the ethanol extraction solution and the water extraction solution, concentrate to a thick paste with a relative density of 1.30 at 60 °C, and set aside;

[0029] (4) Preparation: pharmaceutically acceptable excipients are added to the thick extract to prepare a pharmaceutically acceptable preparation.

[0030] The preparation described in the present invention is a solid preparation or a liquid preparation.

[0031] Preferably,

[0032] The solid preparation described in the present invention is a granule, a capsule, a tablet, a pill, or a dripping pill; the liquid preparation is an oral liquid.

[0033] The excipients described in the present invention are one or several of microcrystalline cellulose, aspartame, soluble starch, talc, pregelatinized starch, sodium carboxymethyl starch, refined honey, simple syrup, sodium benzoate, and polyethylene glycol 6000.

[0034] Use of the pharmaceutical composition described in the present invention in the preparation of a medicament for treating chronic glomerulonephritis.

[0035] The "parts" described in the present invention can be conventional units in the art such as "g, kg", etc.

[0036] Beneficial effects

[0037] 1. In the pharmaceutical formula of the present invention, Polygonatum cirrhifolium var. prattii removes dampness and promotes diuresis, and Areca peel promotes diuresis and reduces swelling, directly reaching the pathogenesis, and they are both monarch drugs; Ephedra gerardiana and Saposhnikovia divaricata can dispel wind and relieve the exterior, enabling the water in the exterior to be dissipated through sweating, and they are ministerial drugs; assisted by elm twigs, cooperating with Dichondra repens and Picrorhiza scrophulariiflora to clear away damp-heat and promote urination and defecation, enabling the interior heat and water pathogen to go away from the lower part; Salvia yunnanensis and Achyranthes aspera promote blood circulation and remove blood stasis, and when the blood stasis is removed, new blood is generated. Since body fluid and blood have the same origin, it promotes the distribution and excretion of body fluid. Dispersing wind and relieving the exterior helps to promote the elimination of damp-heat, and promoting the elimination of damp-heat helps to disperse wind and relieve the exterior. The whole formula disperses and eliminates pathogenic factors from the upper, lower, interior, and exterior, enabling the damp-heat pathogen to be cleared, and then the swelling and heat will subside by themselves; all the drugs together play the effects of dispelling wind and activating blood circulation, clearing heat and resolving dampness; it can clear away heat and dampness, promote blood circulation and remove blood stasis, promote diuresis and reduce swelling, directly reaching the pathogenesis.

[0038] 2. The prescription of the present invention adopts the traditional water extraction method, that is, decocting with water. The extraction rate of the total flavonoids, the active ingredient in this prescription, is only 19.4%. After a large number of experiments by the R & D team, the drug is first extracted with alcohol, and then the residue is extracted with water, maximizing the retention of the active ingredients in both alcohol and water, that is, water-soluble ingredients and fat-soluble ingredients, so that the extraction rate of total flavonoids is greatly increased to 64.38%, enriching the active ingredients and achieving the improvement of product quality and efficiency.

[0039] 3. The clinical efficacy test results of the present invention show that the combined use of this drug and western medicine can improve the treatment effect of chronic glomerulonephritis, with the total effective rate reaching 84%, and can significantly reduce the urine protein and red blood cells in patients; there are significant differences compared with the control group using western medicine alone, indicating that it can effectively improve the clinical symptoms of patients, has no adverse reactions, has high safety, and has extremely high promotion value. Specific implementation manners

[0040] The present invention will be described in detail below with reference to specific embodiments. The following embodiments will help those skilled in the art to further understand the present invention, but do not limit the present invention in any form. For those of ordinary skill in the art in this technical field, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all fall within the protection scope of the present invention.

[0041] Example 1

[0042] Formulation: 200 g of Smilax glabra var. rotundata, 150 g of floss of Areca peel, 120 g of Ephedra gerardiana, 120 g of Ledebouriella seseloides, 100 g of elm twig, 100 g of Dichondra repens, 80 g of Corydalis saxicola, 80 g of Salvia yunnanensis, 80 g of Achyranthes aspera.

[0043] Example 2

[0044] Formulation: 150 g of Smilax glabra, 100 g of floss of Areca peel, 80 g of Ephedra gerardiana, 80 g of Ledebouriella seseloides, 70 g of elm twig, 70 g of Dichondra repens, 70 g of Corydalis saxicola, 50 g of Salvia yunnanensis, 70 g of Achyranthes aspera.

[0045] Example 3

[0046] Formulation: 200 g of Smilax glabra, 150 g of floss of Areca peel, 120 g of Ephedra gerardiana, 20 g of Ledebouriella seseloides, 100 g of elm twig, 100 g of Dichondra repens, 100 g of Corydalis saxicola, 100 g of Salvia yunnanensis, 100 g of Achyranthes aspera.

[0047] Example 4

[0048] Formulation: 160 g of Smilax glabra, 110 g of floss of Areca peel, 90 g of Ephedra gerardiana, 90 g of Ledebouriella seseloides, 80 g of elm twig, 80 g of Dichondra repens, 80 g of Corydalis saxicola, 60 g of Salvia yunnanensis, 80 g of Achyranthes aspera.

[0049] Example 5

[0050] Formulation: 170 g of Smilax glabra, 120 g of floss of Areca peel, 100 g of Ephedra gerardiana, 100 g of Ledebouriella seseloides, 90 g of elm twig, 90 g of Dichondra repens, 90 g of Corydalis saxicola, 70 g of Salvia yunnanensis, 90 g of Achyranthes aspera.

[0051] Example 6

[0052] Formulation: 180 g of Smilax glabra, 130 g of floss of Areca peel, 110 g of Ephedra gerardiana, 110 g of Ledebouriella seseloides, 100 g of elm twig, 100 g of Dichondra repens, 100 g of Corydalis saxicola, 80 g of Salvia yunnanensis, 80 g of Achyranthes aspera.

[0053] Example 7

[0054] Formulation: 190 g of Smilax glabra Roxb., 140 g of Pericarpium Arecae, 100 g of Ephedra gerardiana Wall., 100 g of Ledebouriella seseloides (Hoffm.) Wolff, 100 g of Ulmus pumila L. twig, 100 g of Dichondra repens Forst., 100 g of Corydalis saxicola Bunting, 100 g of Salvia yunnanensis C. H. Wright, 100 g of Achyranthes aspera L.

[0055] Example 8

[0056] Formulation: 200 g of Smilax glabra Roxb., 120 g of Pericarpium Arecae, 100 g of Ephedra gerardiana Wall., 100 g of Ledebouriella seseloides (Hoffm.) Wolff, 80 g of Ulmus pumila L. twig, 80 g of Dichondra repens Forst., 80 g of Corydalis saxicola Bunting, 60 g of Salvia yunnanensis C. H. Wright, 80 g of Achyranthes aspera L.

[0057] Example 9

[0058] Formulation: 200 g of Smilax glabra Roxb., 130 g of Pericarpium Arecae, 80 g of Ephedra gerardiana Wall., 100 g of Ledebouriella seseloides (Hoffm.) Wolff, 70 g of Ulmus pumila L. twig, 80 g of Dichondra repens Forst., 80 g of Corydalis saxicola Bunting, 60 g of Salvia yunnanensis C. H. Wright, 80 g of Achyranthes aspera L.

[0059] Example 10

[0060] Formulation: 160 g of Smilax glabra Roxb., 120 g of Pericarpium Arecae, 100 g of Ephedra gerardiana Wall., 120 g of Ledebouriella seseloides (Hoffm.) Wolff, 90 g of Ulmus pumila L. twig, 80 g of Dichondra repens Forst., 70 g of Corydalis saxicola Bunting, 60 g of Salvia yunnanensis C. H. Wright, 80 g of Achyranthes aspera L.

[0061] The formulations of Examples 1 - 10 are respectively prepared by any one of the preparation methods of Examples 11 - 18.

[0062] Example 11

[0063] (1) Ethanol extraction: Weigh Smilax glabra Roxb., Pericarpium Arecae, Ephedra gerardiana Wall., Ledebouriella seseloides (Hoffm.) Wolff, Ulmus pumila L. twig, Dichondra repens Forst., Corydalis saxicola Bunting, Salvia yunnanensis C. H. Wright, Achyranthes aspera L. according to the formulation ratio, add 4 times the total amount of the medicinal materials of 70% ethanol, heat and extract once, each extraction for 0.5 hours, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0064] (2) Water extraction: Take the medicinal residues after ethanol extraction, add 8 times water, heat and extract once, each extraction for 0.5 hours, filter, and obtain the water extract;

[0065] (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.30 at 60 °C, and set aside;

[0066] (4) Preparation of preparation: Add 200 g of microcrystalline cellulose, 10 g of aspartame, and an appropriate amount of soluble starch to the thick paste, mix evenly, granulate through a 18 - mesh sieve, dry at 70 °C, and screen the granules to make 1000 g of granules, thus obtaining.

[0067] Example 12

[0068] (1) Ethanol extraction: Weigh Rhizoma Smilacis Glabrae, Flos Malvae, Herba Ephedrae Delavayi, Radix Saposhnikoviae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Corydalis Saxicolae, Radix Salviae Yunnanensis, and Radix Achyranthis Bidentatae according to the formula ratio, add 60% ethanol which is 6 times the total amount of the medicinal materials, heat and extract twice, each extraction for 1 hour, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0069] (2) Water extraction: Take the medicinal residues after ethanol extraction, add 6 times water, heat and extract twice, each extraction for 1 hour, filter, and obtain the water extract;

[0070] (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.35 at 60 °C, and reserve for use;

[0071] (4) Preparation: Add 200 g of microcrystalline cellulose, 10 g of aspartame, and an appropriate amount of soluble starch to the thick paste, mix evenly, granulate through a 18-mesh sieve, dry at 70 °C, screen the granules, and make 1000 g of granules, thus obtaining the product.

[0072] Example 13

[0073] (1) Ethanol extraction: Weigh Rhizoma Smilacis Glabrae, Flos Malvae, Herba Ephedrae Delavayi, Radix Saposhnikoviae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Corydalis Saxicolae, Radix Salviae Yunnanensis, and Radix Achyranthis Bidentatae according to the formula ratio, add 90% ethanol which is 8 times the total amount of the medicinal materials, heat and extract once, each extraction for 0.5 hour, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0074] (2) Water extraction: Take the medicinal residues after ethanol extraction, add 10 times water, heat and extract once, each extraction for 0.5 hour, filter, and obtain the water extract;

[0075] (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.25 at 60 °C, and reserve for use;

[0076] (4) Preparation: Add 200 g of microcrystalline cellulose, 10 g of aspartame, and an appropriate amount of soluble starch to the thick paste, mix evenly, granulate through a 18-mesh sieve, dry at 70 °C, screen the granules, and make 1000 g of granules, thus obtaining the product.

[0077] Example 14

[0078] (1) Ethanol extraction: Weigh Rhizoma Smilacis Glabrae, Flos Malvae, Herba Ephedrae Delavayi, Radix Saposhnikoviae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Corydalis Saxicolae, Radix Salviae Yunnanensis, and Radix Achyranthis Bidentatae according to the formula ratio, add 70% ethanol which is 4 times the total amount of the medicinal materials, heat and extract once, each extraction for 0.5 hour, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0079] (2) Water extraction: Take the medicinal residues after ethanol extraction, add 8 times water, heat and extract once, each extraction for 0.5 hour, filter, and obtain the water extract;

[0080] (3) Concentration: Combine the ethanol extract and the water extract, and concentrate to a thick paste having a relative density of 1.30 at 60°C for later use;

[0081] (4) Preparation: Add 150 g of soluble starch to the thick paste, mix well, dry, crush, add 5 g of talcum powder, mix well, put into capsule shells, and obtain 1000 capsules.

[0082] Embodiment 15

[0083] (1) Ethanol extraction: weigh white tuckahoe, big belly cortex, mountain ephedra, cloud windproof, elm twig, horse hoof gold, rock coptis root, Yunnan salvia miltiorrhiza, and wild achyranthes bidentata according to the proportion of the formula, add 70% ethanol of 4 times the total amount of the medicinal materials, heat and extract once, each extraction time is 0.5 hour, filter, and recover ethanol from the filtrate to obtain an ethanol extract;

[0084] (2) Water extraction: Take the residue after ethanol extraction and add 8 times water, heat and extract once, each extraction time is 0.5 hours, filter, and obtain the water extract;

[0085] (3) Concentration: Combine the ethanol extract and the water extract, and concentrate to a thick paste having a relative density of 1.30 at 60°C for later use;

[0086] (4) Preparation: Add 200 g of pregelatinized starch to the thick paste, mix well, granulate with 5% starch slurry, dry, add 5 g of sodium carboxymethyl starch, mix well, and tablet to prepare 1000 tablets.

[0087] Example 16

[0088] (1) Ethanol extraction: weigh white tuckahoe, big belly cortex, mountain ephedra, cloud windproof, elm twig, horse hoof gold, rock coptis root, Yunnan salvia miltiorrhiza, and wild achyranthes bidentata according to the proportion of the formula, add 70% ethanol of 4 times the total amount of the medicinal materials, heat and extract once, each extraction time is 0.5 hour, filter, and recover ethanol from the filtrate to obtain an ethanol extract;

[0089] (2) Water extraction: Take the residue after ethanol extraction and add 8 times water, heat and extract once, each extraction time is 0.5 hours, filter, and obtain the water extract;

[0090] (3) Concentration: Combine the ethanol extract and the water extract, and concentrate to a thick paste having a relative density of 1.30 at 60°C for later use;

[0091] (4) Preparation: Add 300 g of soluble starch to the thick paste, dry it, grind it into fine powder, add 5 g of sodium carboxymethyl starch, and use 10 g of refined honey to make 1000 pills.

[0092] Embodiment 17

[0093] (1) Ethanol extraction: Weigh rhizoma smilacis glabrae, flos malvae, herba ephedrae, radix ledebouriellae, twig of elm, dichondra repens, corydalis saxicola, salvia yunnanensis, and achyranthes aspera according to the formula ratio, add 4 times the total amount of the medicinal materials of 70% ethanol, heat and extract once, extract for 0.5 hours each time, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0094] (2) Water extraction: Add 8 times water to the medicinal residues after ethanol extraction, heat and extract once, extract for 0.5 hours each time, filter, and obtain the water extract;

[0095] (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.30 at 60 °C, and set aside;

[0096] (4) Preparation: Add 200 ml of simple syrup and 3 g of sodium benzoate to the thick paste, dilute to 1000 ml with an appropriate amount of water, stir well, let stand, filter, seal, sterilize, and obtain the oral liquid.

[0097] Example 18

[0098] (1) Ethanol extraction: Weigh rhizoma smilacis glabrae, flos malvae, herba ephedrae, radix ledebouriellae, twig of elm, dichondra repens, corydalis saxicola, salvia yunnanensis, and achyranthes aspera according to the formula ratio, add 4 times the total amount of the medicinal materials of 70% ethanol, heat and extract once, extract for 0.5 hours each time, filter, and obtain the ethanol extract after recovering ethanol from the filtrate;

[0099] (2) Water extraction: Add 8 times water to the medicinal residues after ethanol extraction, heat and extract once, extract for 0.5 hours each time, filter, and obtain the water extract;

[0100] (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.30 at 60 °C, and set aside;

[0101] (4) Preparation: Take an appropriate amount of polyethylene glycol 6000, heat to melt it, mix it with the thick paste, and drop to form 1000 g of dripping pills to obtain.

[0102] In order to further verify the effectiveness of the present invention, a series of verification tests were carried out for the invention, which are specifically as follows:

[0103] I. Prescription composition and compatibility relationship

[0104] 1. Prescription composition

[0105] 20 parts of rhizoma smilacis glabrae, 15 parts of flos malvae, 12 parts of herba ephedrae, 12 parts of radix ledebouriellae, 10 parts of twig of elm, 10 parts of dichondra repens, 8 parts of corydalis saxicola, 8 parts of salvia yunnanensis, 8 parts of achyranthes aspera.

[0106] Rhizoma Heterosmilacis Yunnanensis is the dried tuber of Heterosmilas yunnanensis Gagnep. (Family Liliaceae). It is dug in autumn and winter, with fibrous roots removed, washed and dried. It is sweet and bland in taste, and neutral in property. It acts on the liver and kidney meridians. It has the effects of dispelling wind and dampness, clearing heat and detoxifying, promoting diuresis and relieving stranguria. It is used for rheumatic arthralgia, turbid urine, etc.

[0107] Flos Caryophylli Praeparatus is the processed product of the dried pericarp of Areca catehu L. (Family Palmae). It is pungent in taste and warm in property. It acts on the spleen, stomach and large intestine meridians. It has the effects of promoting qi circulation to relieve distension and promoting diuresis to reduce edema. It is used for dampness obstruction and qi stagnation, fullness and distension in the epigastrium and abdomen, unsmooth defecation, edema and distension, dysuria, etc.

[0108] Herba Ephedrae Likiangensis is the dried herbaceous stem of Ephedra likiangensis Florin (Family Ephedraceae). The green herbaceous stem is cut in autumn and dried. It is pungent and slightly bitter in taste, and warm in property. It acts on the lung and bladder meridians. It has the effects of inducing sweating to dispel cold, dispersing the lung qi to relieve asthma, and promoting diuresis to reduce edema. It is used for wind-cold common cold, wind-water edema, etc.

[0109] Radix et Rhizoma Seselidis Mairei is the dried root and rhizome of Seseli mairei Wolff (Family Umbelliferae). It is dug in spring and autumn, with fibrous roots and impurities removed and dried. It is pungent and sweet in taste, and warm in property. It acts on the lung, liver and spleen meridians. It has the effects of expelling wind and relieving exterior syndrome, and promoting diuresis. It is used for headache due to common cold, itching of rubella, etc.

[0110] Ramulus Ulmi Pumilae is the dried branch of Ulmus pumila L. (Family Ulmaceae). It is collected throughout the year, with leaves removed, cut into sections and dried in the sun. It is sweet in taste and neutral in property. It acts on the heart, kidney and bladder meridians. It has the effects of promoting diuresis and relieving stranguria, and reducing swelling. It is used for dysuria, edema, etc.

[0111] Herba Dichondrae Repentis is the dried whole herb of Dichondra repens Forst. (Family Convolvulaceae). It is bitter and pungent in taste, and cool in property. It acts on the liver meridian. It has the effects of clearing heat and detoxifying, promoting diuresis and activating blood circulation. It is used for jaundice, edema, stranguria syndrome, etc.

[0112] Herba Corydalis Saxicolae is the dried whole herb of Corydalis saxicola Bunting (Family Papaveraceae). It is dug in autumn, with sediment removed, cut into sections and dried. It is bitter in taste and cool in property. It has the effects of clearing heat and promoting diuresis, and stopping bleeding and relieving pain. It is used for nephritis, diarrhea, tumors, etc.

[0113] Radix et Rhizoma Salviae Yunnanensis is the dried root and rhizome of Salvia yunnanensis C.H.Wright. (Family Labiatae). It is dug in spring and autumn, with impurities removed and dried. It is slightly bitter and sweet in taste, and slightly cold in property. It acts on the heart and liver meridians. It has the effects of promoting blood circulation to remove blood stasis, cooling blood to stop bleeding, and detoxifying and reducing swelling. It is used for limb numbness, irregular menstruation, etc.

[0114] The dried roots and rhizomes of Achyranthes aspera L. (Amaranthaceae) are the medicinal materials of *Tuniu Xi*. They are collected after the stems and leaves wither in winter, the above-ground parts and fibrous roots are removed, washed, and dried. It is bitter and sour in taste, slightly cold in nature, and acts on the liver, lung and kidney meridians. It has the effects of promoting blood circulation to remove stasis, inducing diuresis for relieving dampness, and clearing heat and detoxifying. It is used for stranguria, hematuria, sore throat, rheumatoid arthritis, etc.

[0115] 2. Compatibility relationship

[0116] In the drug formula, Rhizoma Smilacis Glabrae and Pericarpium Arecae remove dampness and promote diuresis, and Pericarpium Arecae (floss) promotes diuresis and reduces swelling, directly reaching the pathogenesis, and they are the monarch drugs together; Herba Ephedrae and Radix Saposhnikoviae can dispel wind and relieve the exterior syndrome, enabling the water in the exterior to be dispelled through sweating, and they are the ministerial drugs; Ramulus Ulmi Pumilae is used as an adjuvant drug to cooperate with Herba Dichondrae Repentis and Rhizoma Coptidis Delavayi to clear away damp-heat and promote urination and defecation, enabling the interior heat and water pathogen to go away from the lower part; Radix Salviae Miltiorrhizae and *Tuniu Xi* promote blood circulation and remove stasis. After the stasis is removed, new blood is generated. Since body fluid and blood share the same origin, it promotes the distribution and excretion of body fluid. Dispersing wind and relieving the exterior syndrome helps to promote the elimination of damp-heat, and promoting the elimination of damp-heat also helps to disperse wind and relieve the exterior syndrome. The whole formula disperses and eliminates pathogenic factors from the upper, lower, exterior and interior parts together, so that the damp-heat pathogen is cleared, and the swelling and heat will disappear naturally. All the drugs are used together to achieve the effects of dispersing wind and promoting blood circulation, clearing heat and resolving dampness.

[0117] II. Research and experiment on the preparation process

[0118] The prescription of the present invention is composed of 9 herbs, including Rhizoma Smilacis Glabrae, Pericarpium Arecae (floss), Herba Ephedrae, Radix Saposhnikoviae, Ramulus Ulmi Pumilae, Herba Dichondrae Repentis, Rhizoma Coptidis Delavayi, Radix Salviae Miltiorrhizae, and *Tuniu Xi*. The traditional water decoction method was initially adopted in the preparation process, and it was found that the extraction rate of total flavonoids from the drugs was relatively low. After comprehensively analyzing the active ingredients of the herbs in the prescription by the inventor through consulting relevant information, it was found that flavonoids are an important material basis for the prescription of the present invention to exert its therapeutic effect. In order to seek the best extraction method, the research team of the present invention took the extraction rate of total flavonoids in the prescription as the investigation index, and compared 4 different extraction processes, namely water extraction method, ethanol extraction method, ethanol extraction first and then water extraction method, and water extraction first and then ethanol extraction method, and finally optimized the best extraction process.

[0119] 1. Preliminary selection of extraction methods

[0120] 1.1 Water extraction method

[0121] Weigh the medicinal materials according to the formula ratio, add 8 times the amount of water, heat and extract 2 times, each extraction for 0.5 hours, filter, concentrate the filtrate and make up the volume to an appropriate amount, and determine the extraction rate of total flavonoids.

[0122] 1.2 Ethanol extraction method

[0123] Weigh the medicinal materials according to the formula ratio, add 8 times the amount of 70% ethanol, heat and extract 2 times, each extraction for 0.5 hours, filter, recover the ethanol from the filtrate, then concentrate and make up the volume to an appropriate amount, and determine the extraction rate of total flavonoids.

[0124] 1.3 Ethanol extraction first and then water extraction method

[0125] Weigh the medicinal materials according to the formula ratio. First, add 8 times the amount of 70% ethanol, heat and extract for 0.5 hours, filter, and after recovering the ethanol from the filtrate, obtain the ethanol extract. Add 8 times the amount of water to the medicinal residues, heat and extract for 0.5 hours, filter, and after combining the filtrate with the above ethanol extract, concentrate and make up the volume to an appropriate amount, and measure the extraction rate of total flavonoids.

[0126] 1.4 Water extraction followed by ethanol extraction

[0127] Weigh the medicinal materials according to the formula ratio. First, add 8 times the amount of water, heat and extract for 0.5 hours, filter to obtain the water extract. Add 8 times the amount of 70% ethanol to the medicinal residues, heat and extract for 0.5 hours, filter, and after recovering the ethanol from the filtrate, combine it with the above water extract, concentrate and make up the volume to an appropriate amount, and measure the extraction rate of total flavonoids.

[0128] 1.5 The measurement results are shown in Table 1.

[0129] Table 1 Results of the extraction rate of total flavonoids by different extraction methods

[0130] Extraction method Water extraction method Alcohol extraction method Alcohol extraction first and then water extraction method Water extraction first and then alcohol extraction method Total flavonoid extraction rate 19.4％ 36.1％ 51.2％ 46.9％

[0131] It can be seen from the test results that the extraction rate of total flavonoids in the prescription is not high when using water extraction alone or ethanol extraction alone, while the extraction rate of total flavonoids in the prescription increases significantly when using ethanol extraction followed by water extraction. Therefore, the preparation process of the present invention determines to use the method of ethanol extraction followed by water extraction.

[0132] 2. Optimization of process parameters of the extraction method

[0133] 2.1 Process parameters of ethanol extraction

[0134] 2.1.1 Investigation of ethanol concentration

[0135] Take Smilax glabra Roxb., Pericarpium Arecae, Herba Ephedrae, Radix Saposhnikoviae, Ramulus Ulmi Pumilae, Dichondra repens Forst., Corydalis saxicola Bunting, Salvia yunnanensis C. H. Wright, Achyranthes aspera L., a total of 4 portions according to the prescription ratio, and heat and extract with 6 times the amount of 30%, 50%, 70% and 90% ethanol for 0.5 hours respectively. After filtering the extract, dilute it with ethanol of the corresponding concentration and make up the volume to 1000 ml. Measure the extraction rate of total flavonoids, and the results are shown in Table 2.

[0136] Table 2 Results of the investigation of ethanol concentration

[0137] Test number Ethanol concentration (%) Alcohol addition amount (times) Extraction time (hours) Total flavonoid extraction rate (%) 1 30 6 0.5 24.2 2 50 6 0.5 28.2 3 70 6 0.5 35.5 4 90 6 0.5 38.7

[0138] The test results show that when the ethanol concentration is greater than 70%, the extraction rate of total flavonoids in the prescription increases little. In order to save production costs and reduce the ethanol usage, 70% ethanol is selected as the extraction solvent.

[0139] 2.1.2 Optimization by orthogonal experiment

[0140] The amount of added alcohol (Factor A), extraction time (Factor B), and extraction times (Factor C) were selected as the investigation factors, and the orthogonal experiment was used to screen the optimal alcohol extraction process parameters. The factors and levels are shown in Table 3, the orthogonal design and experimental results are shown in Table 4, and the variance analysis results are shown in Table 5.

[0141] Table 3 Factors and Levels of Orthogonal Experiment for Alcohol Extraction Process

[0142] Level Factor A (times) Factor B (hours) Factor C (times) 1 4 0.5 1 2 6 1 2 3 8 2 3

[0143] Table 4 Orthogonal Experiment Design and Results of Alcohol Extraction Process

[0144] Number Factor A Factor B Factor C Error D Total flavonoid extraction rate (%) 1 1 1 1 1 31.41 2 1 2 2 2 32.12 3 1 3 3 3 35.31 4 2 1 2 3 34.43 5 2 2 3 1 33.22 6 2 3 1 2 36.11 7 3 1 3 2 36.86 8 3 2 1 3 34.24 9 3 3 2 1 35.07 K1 98.84 102.70 101.76 99.70 K2 103.76 99.58 101.62 105.09 K3 106.17 106.49 105.39 103.98 R 7.33 6.91 3.77 5.39

[0145] Table 5 Variance Analysis Results of Alcohol Extraction Process

[0146] Source of variance Sum of squared deviations Degree of freedom Mean square F value Significance A 9.30 2 4.65 1.72 Not significant B 7.98 2 3.99 1.48 Not significant C 3.05 2 1.52 0.56 Not significant D (error) 5.40 2 2.70

[0147] Note: F 0.05 (2, 2) = 19

[0148] From the orthogonal experiment results in Table 4, it can be seen that the influence of each factor on the alcohol extraction effect is A > B > C, and A3 > A2 > A1, B3 > B1 > B2, C3 > C1 > C2. The optimal alcohol extraction process parameters are A3B3C3. Combining with the variance analysis in Table 5, it can be seen that among the three factors A, B, and C, there is no significant influence. Since the levels of the three factors are close, considering from the perspective of cost saving, the optimal parameters of the alcohol extraction process can be adjusted to A1B1C1, that is, extract once with 4 times 70% ethanol for 0.5 hours.

[0149] 2.1.3 Verification of Optimal Parameters of Alcohol Extraction Process

[0150] Take smilax glabra, areca peel fluff, ephedra, divaricate saposhnikovia root, elm twig, dichondra repens, corydalis saxicola, yunnan salvia root, achyranthes bidentata, a total of 3 portions according to the prescription ratio, and extract them respectively according to the optimal alcohol extraction process parameters selected above. The extract is diluted with 70% ethanol and made up to 1000 ml. The extraction rate of total flavonoids was measured, and the results are shown in Table 6.

[0151] Table 6 Verification Results of Optimal Parameters of Alcohol Extraction Process

[0152]

[0153] The verification results show that when the optimal alcohol extraction process parameters obtained by orthogonal experiment are used to extract this pharmaceutical composition, the extraction rate of total flavonoids is 31.19%.

[0154] 2.2 Water Extraction Process Parameters after Alcohol Extraction

[0155] 2.2.1 Optimization by Orthogonal Experiment

[0156] The water addition amount (Factor A), extraction time (Factor B), and extraction times (Factor C) were selected as the investigated factors. First, the Chinese medicinal materials in the prescription were extracted with 4 times 70% ethanol, and then the residue was screened for the optimal water extraction process parameters by orthogonal experiment. The factors and levels are shown in Table 7, the orthogonal design and experimental results are shown in Table 8, and the variance analysis results are shown in Table 9.

[0157] Table 7 Factors and levels of orthogonal experiment for water extraction process after ethanol extraction

[0158] Level Factor A (times) Factor B (hours) Factor C (times) 1 6 0.5 1 2 8 1 2 3 10 1.5 3

[0159] Table 8 Orthogonal experiment design and result table for water extraction process after ethanol extraction

[0160] Number Factor A Factor B Factor C Error D Total flavonoid extraction rate (%) 1 1 1 1 1 52.43 2 1 2 2 2 59.70 3 1 3 3 3 57.64 4 2 1 2 3 62.33 5 2 2 3 1 68.45 6 2 3 1 2 65.96 7 3 1 3 2 62.11 8 3 2 1 3 64.34 9 3 3 2 1 66.07 K1 169.77 176.87 182.73 186.95 K2 196.74 192.49 188.10 187.77 K3 192.52 189.67 188.20 184.31 R 26.97 15.62 5.47 3.46

[0161] Table 9 Variance analysis results of water extraction process after ethanol extraction

[0162]

[0163]

[0164] Note: F 0.05 (2, 2) = 19

[0165] From the orthogonal experiment results in Table 8, it can be seen that the influence of each factor on the water extraction effect is A > B > C, and A2 > A3 > A1, B2 > B3 > B1, C3 > C2 > C1. The optimal water extraction process parameters are A2B2C3. Combining with the variance analysis in Table 9, it can be seen that among the three factors, A and B have significant differences, and factor C has no significant influence. Therefore, from the perspective of cost saving, the optimal parameters of the water extraction process can be adjusted to A2B2C1, that is, decoct with 8 times water for 1 time, and the decoction time is 0.5 hours.

[0166] 2.2.2 Verification of the optimal parameters of the water extraction process after ethanol extraction

[0167] According to the prescription ratio, take Smilax glabra, Areca peel fluff, Ephedra gerardiana, Ledebouriella seseloides, Ulmus pumila twig, Dichondra repens, Corydalis saxicola, Salvia yunnanensis, Achyranthes aspera, a total of 3 portions, and perform ethanol extraction first and then water extraction according to the optimal process parameters selected above. After the extraction solution is concentrated and fixed in volume, the total flavonoid extraction rate is measured, and the results are shown in Table 10.

[0168] Table 10 Verification results of the optimal water extraction process parameters after ethanol extraction

[0169]

[0170] The verification results show that the total flavonoid extraction rate in the prescription is 64.38% by extracting with the optimal process parameters selected by orthogonal experiment. This method has a high extraction efficiency, and the process is reasonable and feasible, and can be used as the optimal extraction process for this prescription.

[0171] III. Clinical Efficacy Verification

[0172] In order to verify the clinical efficacy of the drug group of the present invention and its preparation process preparations, the research team of the present invention further carried out a clinical efficacy verification experiment.

[0173] 1. Data and Methods

[0174] 1.1 Clinical Data

[0175] A total of 100 patients with chronic glomerulonephritis admitted to the outpatient department of our traditional Chinese medicine hospital from September 2020 to February 2022 were selected as the research objects. A random number table was generated by the SAS statistical software package, and 100 patients with chronic glomerulonephritis were randomly divided into a treatment group and a control group at a ratio of 1:1, with 50 patients in each group. There were no statistically significant differences in the general data such as age and disease course between the two groups of patients, and they were comparable.

[0176] 1.2 Diagnostic Criteria

[0177] The western medicine diagnostic criteria were formulated with reference to "Chronic Glomerulonephritis"; the traditional Chinese medicine diagnostic criteria were formulated with reference to the syndrome type of damp-heat and blood stasis in the "Diagnosis and Treatment Guidelines for Chronic Glomerulonephritis", with facial and limb edema, stabbing pain in the waist, sore throat, sticky mouth and poor appetite, yellowish urine, yellow and greasy tongue coating, tortuous sublingual collaterals, and slippery and unsmooth pulse.

[0178] 1.3 Inclusion Criteria

[0179] Meeting the western medicine diagnostic criteria for chronic glomerulonephritis and the syndrome differentiation criteria of damp-heat and blood stasis; the patients and their families signed the informed consent form; no other treatment was received 1 month before treatment, and the patients were conscious and willing to cooperate with the treatment.

[0180] 1.4 Exclusion Criteria

[0181] Those who have progressed to end-stage renal disease or stage 4-5 of chronic kidney disease (CKD); those with other kidney damage diseases such as lupus nephritis, allergic purpura nephritis, acute glomerulonephritis, and pyelonephritis; those with combined coagulation function and immune function disorders, malignant tumors, and severe liver and kidney function disorders; those who need renal replacement therapy due to rapid deterioration of the condition in the short term.

[0182] 1.5 Treatment Methods

[0183] The control group adopted a low-salt, low-fat, and high-quality low-protein diet; basic treatments such as anti-infection, lipid regulation, correction of anemia, and correction of water and electrolyte disorders were carried out according to the needs of the condition; oral benazepril hydrochloride tablets (specification: 10 mg), once a day, 10 mg each time, for 2 months.

[0184] The treatment group was treated with the granules prepared from the composition of the present invention on the basis of the control group. Three times a day, 15 g each time, for 2 months.

[0185] 1.6 Observation indicators

[0186] Record the urinary protein quantification, urinary sediment red blood cell count, and clinical efficacy of the two groups of patients before and after treatment.

[0187] 1.7 Efficacy determination

[0188] (1) Cured: The 24-hour urinary protein quantification is normal, and the urinary sediment red blood cell count is normal; (2) Markedly effective: The 24-hour urinary protein quantification is reduced by ≥ 40%, and the urinary sediment red blood cell count is reduced by ≥ 40%; (3) Effective: The 24-hour urinary protein quantification is reduced by < 40%, and the urinary sediment red blood cell count is reduced by < 40%; (4) Ineffective: There is no improvement or aggravation in the clinical manifestations and the above laboratory tests. The total effective rate = cure rate + marked effective rate + effective rate.

[0189] 2. Results

[0190] 2.1 Clinical efficacy of the two groups of patients

[0191] The total effective rates of the treatment group and the control group were 84.0% and 70.0% respectively, and the total effective rate of the treatment group was significantly higher than that of the control group (P < 0.05). See Table 11.

[0192] Table 11 Comparison of the clinical efficacy of the two groups of patients

[0193] Group Number of cases Cured Markedly effective Effective Invalid Total effective rate (%) Control group 50 8 11 16 15 70.0 Treatment group 50 15 11 16 8 84.0*

[0194] Note: Compared with the control group, *P < 0.05;

[0195] 2.2 Comparison of urinary protein quantification of the two groups of patients before and after treatment

[0196] The urinary protein quantification of both groups decreased after treatment (P < 0.05); compared with the control group, the decrease in the treatment group was more obvious (P < 0.05). It shows that the experimental group is superior to the control group in reducing urinary protein. See Table 12.

[0197] Table 12 Comparison of urinary protein quantification of the two groups of patients before and after treatment

[0198]

[0199] Note: Compared with before treatment in the same group, *P < 0.05; compared with after treatment in the control group, △P < 0.05

[0200] 2.3 Comparison of urinary red blood cell count of the two groups of patients before and after treatment

[0201] The urinary red blood cell count of both groups decreased after treatment (P < 0.05), but the decrease in the treatment group was more obvious (P < 0.05). It shows that the treatment group is superior to the control group in reducing urinary red blood cells. See Table 13.

[0202] Comparison of urinary red blood cell counts between two groups before and after treatment in Table 13

[0203]

[0204] Note: Compared with before treatment in the same group, *P < 0.05; compared with the control group after treatment, △P < 0.05

[0205] 2.4 Comparison of adverse reactions between two groups of patients

[0206] During the research process, no adverse reactions occurred in either group of patients.

[0207] 3. Conclusion

[0208] In summary, after the drug combination of the present invention is formulated into a dosage form using modern pharmaceutical technology and combined with western medicine, it can improve the therapeutic effect of chronic glomerulonephritis. The total effective rate reaches 84%, and it can significantly reduce the urinary protein and red blood cells of patients. There are significant differences compared with the control group using western medicine alone, indicating that it can effectively improve the clinical symptoms of patients, has no adverse reactions, high safety, and has extremely high promotion value.

[0209] Although the present invention has been described in detail above with general descriptions, specific embodiments and experiments, based on the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A pharmaceutical composition for treating chronic glomerulonephritis, characterized in that, The pharmaceutical composition is made up of 15 - 20 parts of Smilax glabra Roxb. var. parviflora (Miq.) Hance, 10 - 15 parts of Areca peel fluff, 8 - 12 parts of Ephedra gerardiana Wall., 8 - 12 parts of Ledebouriella seseloides (Hoffm.) Wolff, 7 - 10 parts of Ulmus pumila L. twig, 7 - 10 parts of Dichondra repens Forst., 7 - 10 parts of Corydalis saxicola Bunting, 5 - 10 parts of Salvia yunnanensis C. H. Wright, and 7 - 10 parts of Achyranthes aspera L. The preparation method of the pharmaceutical composition is as follows: (1) Ethanol extraction: Weigh Smilax glabra Roxb. var. parviflora (Miq.) Hance, Areca peel fluff, Ephedra gerardiana Wall., Ledebouriella seseloides (Hoffm.) Wolff, Ulmus pumila L. twig, Dichondra repens Forst., Corydalis saxicola Bunting, Salvia yunnanensis C. H. Wright, and Achyranthes aspera L. according to the formula ratio, add 30% - 90% ethanol which is 4 - 8 times the total amount of the medicinal materials, heat and extract 1 - 2 times, each time for 0.5 - 1.5 hours, filter, and after recovering ethanol from the filtrate, obtain the ethanol extract. (2) Water extraction: Take the medicinal residues after ethanol extraction, add 6 - 10 times water, heat and extract 1 - 2 times, each time for 0.5 - 1.5 hours, filter, and obtain the water extract. (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.25 - 1.35 at 60 °C, and set aside. (4) Formulation: Add pharmaceutically acceptable excipients to the thick paste to make a pharmaceutically acceptable preparation.

2. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 1, wherein, The pharmaceutical composition is made up of 18 - 20 parts of Smilax glabra Roxb. var. parviflora (Miq.) Hance, 12 - 15 parts of Areca peel fluff, 10 - 12 parts of Ephedra gerardiana Wall., 10 - 12 parts of Ledebouriella seseloides (Hoffm.) Wolff, 8 - 10 parts of Ulmus pumila L. twig, 8 - 10 parts of Dichondra repens Forst., 8 - 10 parts of Corydalis saxicola Bunting, 8 - 10 parts of Salvia yunnanensis C. H. Wright, and 8 - 10 parts of Achyranthes aspera L.

3. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 2, wherein The pharmaceutical composition is made up of 20 parts of Smilax glabra Roxb. var. parviflora (Miq.) Hance, 15 parts of Areca peel fluff, 12 parts of Ephedra gerardiana Wall., 12 parts of Ledebouriella seseloides (Hoffm.) Wolff, 10 parts of Ulmus pumila L. twig, 10 parts of Dichondra repens Forst., 8 parts of Corydalis saxicola Bunting, 8 parts of Salvia yunnanensis C. H. Wright, and 8 parts of Achyranthes aspera L.

4. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 1, characterized in that, The preparation method of the pharmaceutical composition is as follows: (1) Ethanol extraction: Weigh Smilax glabra Roxb. var. parviflora (Miq.) Hance, Areca peel fluff, Ephedra gerardiana Wall., Ledebouriella seseloides (Hoffm.) Wolff, Ulmus pumila L. twig, Dichondra repens Forst., Corydalis saxicola Bunting, Salvia yunnanensis C. H. Wright, and Achyranthes aspera L. according to the formula ratio, add 50% - 80% ethanol which is 4 - 7 times the total amount of the medicinal materials, heat and extract 1 - 2 times, each time for 0.5 - 1 hour, filter, and after recovering ethanol from the filtrate, obtain the ethanol extract. (2) Water extraction: Take the medicinal residues after ethanol extraction, add 6 - 8 times water, heat and extract 1 - 2 times, each time for 0.5 - 1 hour, filter, and obtain the water extract. (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.30 - 1.35 at 60 °C, and set aside. (4) Formulation: Add pharmaceutically acceptable excipients to the thick paste to make a pharmaceutically acceptable preparation.

5. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 4, wherein The preparation method of the pharmaceutical composition is as follows: (1) Ethanol extraction: Weigh Smilax glabra Roxb. var. parviflora (Miq.) Hance, Areca peel fluff, Ephedra gerardiana Wall., Ledebouriella seseloides (Hoffm.) Wolff, Ulmus pumila L. twig, Dichondra repens Forst., Corydalis saxicola Bunting, Salvia yunnanensis C. H. Wright, and Achyranthes aspera L. according to the formula ratio, add 70% ethanol which is 4 times the total amount of the medicinal materials, heat and extract 1 time, each time for 0.5 hour, filter, and after recovering ethanol from the filtrate, obtain the ethanol extract. (2) Water extraction: Take the medicinal residues after ethanol extraction, add 8 times water, heat and extract 1 time, each time for 0.5 hour, filter, and obtain the water extract. (3) Concentration: Combine the ethanol extract and the water extract, concentrate to a thick paste with a relative density of 1.30 at 60 °C, and set aside. (4)Formulation: Add pharmaceutically acceptable excipients to the thick extract to prepare a pharmaceutically acceptable formulation.

6. The pharmaceutical composition for treating chronic glomerulonephritis according to any one of claims 1-5, characterized in that, The formulation is a solid preparation or a liquid preparation.

7. The pharmaceutical composition for treating chronic glomerulonephritis according to claim 6, wherein, The solid preparation is a granule, a capsule, a tablet or a pill; the liquid preparation is an oral liquid.

8. The pharmaceutical composition for treating chronic glomerulonephritis according to any one of claims 1-5, characterized in that, The excipients are one or more of microcrystalline cellulose, aspartame, soluble starch, talc, pregelatinized starch, sodium carboxymethyl starch, refined honey, simple syrup, sodium benzoate, polyethylene glycol 6000.

9. Use of the pharmaceutical composition for treating chronic glomerulonephritis according to claim 1 in the preparation of a medicament for treating chronic glomerulonephritis.

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