Traditional Chinese medicine composition for treating Pi-dan disease and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating Pi-dan disease. The traditional Chinese medicine composition is prepared from the following raw materials: ramulus euonymi, radix trichosanthis, rhizoma polygonati, raw radix astragali, rhizoma polygoni cuspidati, stiff silkworm, radix scrophulariae, endothelium corneum gigeriae galli, radix puerariae, mantis egg-case, radix paeoniae rubra and radix salviae miltiorrhizae. The traditional Chinese medicine composition for treating the Pi-dan disease is convenient to use, definite in curative effect, simple in production process, high in implementation and easy for large-scale industrial development; the traditional Chinese medicine composition is used for treating shortness of breath, weakness, thirst, dizziness and heavy body of a patient suffering from Pi-dan, has a remarkable effect of improving blood sugar indexes, and has important clinical value.

Description

Technical Field

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

[0002] "Spleen Qi" is a disease name in Traditional Chinese Medicine (TCM). It comes from the "Suwen: Treatise on Strange Diseases": "A person with a sweet taste in the mouth is suffering from the overflow of the five qi, which is called spleen qi. The five flavors enter the mouth and are stored in the stomach. The spleen circulates their essence and qi, and body fluids are in the spleen, resulting in a sweet taste in the mouth. This is where the desire for fat and delicious foods arises. Such people must frequently eat sweet and fatty foods. Fat causes internal heat, and sweet foods cause fullness in the stomach. Therefore, qi overflows upward, turning into diabetes." This is a disease of spleen heat. Excessive consumption of sweet and fatty foods causes internal heat and fullness to accumulate in the spleen, causing spleen qi to overflow into the mouth, resulting in a sweet taste in the mouth. Over time, this can develop into diabetes. However, with rising living standards, the incidence of spleen qi has been increasing. The cause is closely related to changes in modern lifestyles.

[0003] Diseases of different eras, arising from different historical contexts, have vastly different causes, pathogenesis, and treatments. Modern Chinese medicine believes that spleen deficiency is primarily caused by damp-heat accumulating in the middle jiao (burner), which over time forms dampness and toxins. These toxins enter the spleen, dispersing upward to the heart and lungs, where they enter the bloodstream, hindering glucose utilization by cells. The accumulation of dampness and toxins in cells damages the intracellular ecosystem, preventing the conversion of glucose into energy and leading to elevated blood sugar. Over time, the accumulation of damp-heat further develops into phlegm and blood stasis, which obscures cell membranes, preventing them from absorbing sugar and lacking energy, leading to qi deficiency. This deprives the internal organs, limbs, and bones of energy, resulting in yin deficiency. Phlegm obscures the heart, dampness traps the spleen and stomach, and triggers spleen deficiency, manifesting as shortness of breath, fatigue, thirst, dizziness, heaviness, and elevated blood sugar. Therefore, effectively removing damp-heat, dampness and phlegm from the body is key to treating the development of spleen deficiency.

[0004] Currently, the pathogenesis of spleen disease in modern people is not fully understood. Treatment is often delayed until obvious symptoms of diabetes appear. Clinically, symptomatic treatment with Western hypoglycemic medications is often used, often leading to various serious complications. Therefore, developing a safe and effective medication that can treat spleen disease at different stages is of great significance.

[0005] The present invention is based on a full understanding of the pathogenesis of modern spleen disease, combined with clinical trials to select a traditional Chinese medicine composition for treating spleen disease with significant efficacy, providing a reference for further in-depth clinical research. Summary of the Invention

[0006] To this end, the present invention aims to provide a Chinese medicine composition for treating spleen disease and a preparation method thereof, so as to treat shortness of breath, fatigue, thirst, dizziness, heaviness and improve blood sugar indicators in patients with spleen disease by selecting appropriate medicinal raw materials and proportions.

[0007] In order to achieve the above object, according to one aspect of the present invention, a traditional Chinese medicine composition for treating spleen deficiency disease is provided, which comprises a therapeutically effective amount of Radix Psoraleae, Radix Trichosanthis, Radix Polygonati, and Radix Astragali.

[0008] In some embodiments, the Chinese medicine composition as described above further comprises a therapeutically effective amount of Polygonum cuspidatum, Bombyx batryticatus, Scrophularia ningpoensis, Gallus gallus domesticus, Pueraria root, Silkworm cocoon, Paeonia lactiflora, and Salvia miltiorrhiza.

[0009] In some embodiments, according to the above-mentioned traditional Chinese medicine composition, the composition comprises, by weight, 4-30 parts of Psoralea corylifolia, 10-15 parts of Radix Trichosanthis, 9-15 parts of Polygonatum sibiricum, and 9-30 parts of Raw Astragalus.

[0010] In some embodiments, according to the above-mentioned traditional Chinese medicine composition, it further comprises, by weight, 9-15 parts of Polygonum cuspidatum, 5-10 parts of Bombyx batryticatus, 9-15 parts of Scrophularia ningpoensis, 3-10 parts of Gallus gallifolia, 10-15 parts of Pueraria root, 5-10 parts of Silkworm Cocoon, 6-12 parts of Red Peony Root, and 10-15 parts of Salvia miltiorrhiza.

[0011] In some embodiments, according to the above-mentioned traditional Chinese medicine composition, it comprises, by weight, 30 parts of Psoralea corylifolia, 15 parts of Radix Trichosanthis, 15 parts of Polygonatum sibiricum, and 30 parts of raw Astragalus.

[0012] In some embodiments, according to the above-mentioned traditional Chinese medicine composition, it further comprises, by weight, 9 parts of Polygonum cuspidatum, 6 parts of Bombyx batryticatus, 12 parts of Scrophularia ningpoensis, 6 parts of Gallus gallus domesticus, 12 parts of Pueraria root, 6 parts of Silkworm Cocoon, 12 parts of Red Peony Root, and 12 parts of Salvia miltiorrhiza.

[0013] On the other hand, in order to achieve the above object, the present invention also provides a method for preparing a Chinese medicine composition for treating spleen disease, comprising the following steps:

[0014] Weigh the above amount of the Chinese medicine composition, add 8 times the amount of water, decoct for 1.5 hours, and filter; add 6 times the amount of water to the filter residue, decoct for 1 hour, filter, mix the two filtrates, and concentrate to obtain a decoction; or further concentrate, dry, and crush to obtain a powder; or add an appropriate amount of dextrin and flavoring agent, granulate, and package to obtain granules; or put into capsule shells to obtain capsules, etc.

[0015] On the other hand, in order to achieve the above-mentioned purpose, the present invention also provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating spleen disease.

[0016] The Chinese medicine composition for treating spleen deficiency and the preparation method thereof provided by the present invention have the following beneficial effects:

[0017] The Chinese medicine composition of the present invention uses Radix Glehniae, Radix Trichosanthis, Radix Polygonati, and Radix Astragali as main ingredients, supplemented by Polygonum cuspidatum, Bombyx batryticatus, Radix Scrophulariae, Gallus gallus domesticus, Radix Puerariae, Silkworm cocoon, Paeonia lactiflora, and Salvia miltiorrhiza. It adopts the techniques of "birth method", "robbery method" and "transformation method" in the nine prescription methods of "Treatise on Hidden Diseases". Among them, Radix Trichosanthis is used to enter the lung and stomach meridians and enter the qi division, while Radix Glehniae enters the liver and spleen meridians and can enter the blood division with the "spleen qi" to clear away dampness and toxins; it is matched with Gallus gallus domesticus to clear away dampness and heat from the source of the stomach, hinder dampness and heat from being transformed into dampness and toxins entering the spleen, and can also effectively enter the qi division of the lung meridian, blocking dampness and toxins from entering the heart from the lungs from the upper burner, strengthening Radix Glehniae to clear away dampness and toxins from the blood, and combining with Scrophulariae to nourish yin and clear away heat, treating both the symptoms and the root causes. This is based on the physiological function of the "spleen" in traditional Chinese medicine, and is in line with the "birth method" of "Treatise on Hidden Diseases"; Polygonatum is combined with Radix Trichosanthis and Scrophulariae to nourish the kidneys to prevent dampness and toxins from entering the blood along the "water channel and transporting them down to the bladder", which is more effective. It can assist the positive energy, drive out the toxins, and expel the evil spirits to the surface. This is the "robbery method" of "Treatise on Hidden Diseases"; raw Astragalus combined with Polygonatum is best at driving out the damp toxins "stored in the spleen meridian" and eliminating them through urination, and it can strengthen the middle and replenish Qi, nourish Yin, improve the digestive tract mucosal barrier, and prevent damp heat from invading the digestive system. At the same time, it can effectively improve the symptoms of spleen deficiency, such as fatigue, shortness of breath, and thirst in patients with spleen deficiency; Polygonum cuspidatum, Bombyx batryticatus, Red peony root, and Salvia miltiorrhiza are used together to clear the phlegm and blood stasis that obscure the cell membrane and help cells absorb blood sugar; at the same time, mulberry silkworm cocoons are used to replenish Yang, and Pueraria root is used to raise Yang, with both warm and cool properties, warming Yang without heat, raising Yang without burning, and Yang Qi is distributed throughout the body to restore the functions of the five internal organs, which is in line with the "transformation method" of "Treatise on Hidden Diseases". The combination of various medicines and proper compatibility can synergistically exert unconventional effects. Starting from the spleen in traditional Chinese medicine, they can work together to clear away dampness and heat, expel toxins, resolve phlegm and disperse blood stasis, thereby improving symptoms of spleen deficiency such as shortness of breath, fatigue, thirst, dizziness, heaviness, and abnormal blood sugar indicators in patients. It has important clinical value, is easy to use, has definite efficacy, simple production process, strong feasibility, and is easy to develop on a large scale. DETAILED DESCRIPTION

[0018] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0019] The pharmacological effects of the Chinese medicine composition for treating spleen disease provided by the present invention are as follows:

[0020] Herba Glehniae: Bitter and pungent in flavor, cold in nature. Enters the Liver and Spleen meridians. It promotes blood circulation, dredges menstruation, detoxifies, reduces swelling, and kills parasites. It is used for masses, abdominal pain, amenorrhea, dysmenorrhea, metrorrhagia, postpartum abdominal pain due to blood stasis, retained lochia, hernia, pain in the joints, sores, bruises, abdominal pain caused by parasites, burns, and snake bites.

[0021] As a traditional Chinese medicine for promoting blood circulation and removing blood stasis, Euonymus japonicus (also known as Euonymus japonicus or Ghost Arrow) has unique advantages in improving insulin resistance, protecting the vascular endothelium, and delaying complications in the treatment of diabetes. It is particularly suitable for patients with diabetes accompanied by blood stasis or complications.

[0022] The mechanisms of action of the active ingredients of Psoralea corylifolia in the intervention and treatment of diabetes and its various chronic complications include: lowering blood sugar, resisting oxidative stress, resisting infection, improving blood rheology, inhibiting human aldose reductase, protecting kidney cells, and protecting myocardial cells. Among them, the mechanisms of action for lowering blood sugar include regulating glucose and lipid metabolism disorders, improving insulin resistance, protecting pancreatic β cells, and inhibiting α-glucosidase; the mechanisms of action for protecting kidney cells include delaying glomerular sclerosis and protecting renal tubular epithelial cells. Studies have found that Psoralea corylifolia can improve oxidative stress damage in myocardial tissue of diabetic rats by activating the NFE2L2 / HMOX1 signaling pathway; the aqueous extract of Psoralea corylifolia can alleviate atherosclerotic lesions, inhibit blood sugar elevation, and reduce the expression of IL-6 and IL-1β; the ethanol extract of Psoralea corylifolia can alleviate atherosclerotic lesions and inhibit the secretion of inflammatory factors and the expression of RAGE receptors.

[0023] Radix Trichosanthis: Sweet, slightly bitter, and slightly cold. It enters the Lung and Stomach meridians. It clears heat and purges fire, promotes fluid production and quenches thirst, and reduces swelling and discharges pus. It is used for fever-induced thirst, dry cough due to lung heat, internal heat-induced polydipsia, and sores and swelling.

[0024] Trichosanthes root (Trichosanthes root) has been used in Traditional Chinese Medicine (TCM) to treat diabetes mellitus for thousands of years. The Shennong's Herbal Classic clearly states that it "cures thirst." Modern research reveals that its pharmacological mechanisms focus on restoring pancreatic islet function, regulating blood sugar metabolism, and delaying complications. It is particularly effective in treating yin deficiency and internal heat-related diabetes. Pharmacological and clinical studies have shown that Trichosanthes root can improve glucose and lipid metabolism in rats with type 2 diabetes and protect the pancreas and vital organs.

[0025] Polygonatum sibiricum: Sweet, neutral. Enters the spleen, lung, and kidney meridians. Replenishes qi and nourishes yin, strengthens the spleen, moistens the lungs, and benefits the kidneys. Used for spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, hemoptysis caused by exertion, deficiency of essence and blood, soreness of the waist and knees, premature graying of hair, and internal heat and thirst.

[0026] Polygonatum sibiricum has multi-target regulatory effects in the prevention and treatment of diabetes, and is particularly effective in improving prediabetes (improper glucose tolerance) and Qi and Yin deficiency-type diabetes. The main active ingredient in Polygonatum sibiricum can upregulate the expression of phosphatidylinositol 3-kinase-protein kinase B, enhancing glucose consumption and uptake by insulin-resistant cells. Polygonatum sibiricum polysaccharides can improve glucose and lipid metabolism in diabetic rats, protect cardiac function, delay the onset of myocardial fibrosis, and enhance cardiomyocyte viability. Polygonatum sibiricum polysaccharides can also lower fasting blood sugar and improve renal function in rats with diabetic nephropathy. Yunnan Polygonatum sibiricum can regulate glucose metabolism by improving intestinal flora disorders and promote the healing of diabetic skin lesions.

[0027] Raw Astragalus: Sweet, slightly warm. Enters the Lung and Spleen meridians. It tonifies Qi and raises Yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, relieves stagnation and arthritis, removes toxins and discharges pus, and heals sores and promotes tissue regeneration. It is used for Qi deficiency and fatigue, poor appetite and loose stools, Qi deficiency, chronic diarrhea and rectal prolapse, bloody stools and metrorrhagia, spontaneous perspiration due to superficial deficiency, edema due to Qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness, and persistent carbuncles and ulcers.

[0028] Astragalus's application in the treatment of diabetes is primarily manifested in its multifaceted effects, including lowering blood sugar, improving insulin resistance, protecting pancreatic islet function, and delaying complications. Studies have shown that astragalus plays a role in the pathogenesis of diabetic rats through the regulation of TNF-α. Astragalus polysaccharides can reduce the overexpression of TNF-α, thereby reducing the expression of caspase-3 in pancreatic β cells and inhibiting β-cell apoptosis. Astragalus polysaccharides can also reduce the concentrations of TNF-α, IL-1β, and IL-18, while increasing IL-10, thereby improving impaired glucose tolerance in rats. Astragaloside IV can also inhibit PI3K / Akt / FoxO1 signaling, increasing renal tissue autophagy and slowing the progression of type 2 diabetic nephropathy.

[0029] Polygonum cuspidatum: Slightly bitter and slightly cold. It enters the liver, gallbladder, and lung meridians. It dissipates dampness and reduces jaundice, clears heat and detoxifies, disperses blood stasis and relieves pain, and relieves cough and resolves phlegm. It is used for damp-heat jaundice, stranguria, leukorrhea, rheumatic pain, carbuncles, burns, amenorrhea, masses, injuries from falls, and coughs due to lung heat.

[0030] Polygonum cuspidatum has outstanding performance in improving insulin resistance, protecting pancreatic islet cells and preventing complications, and is especially suitable for damp-heat stasis type diabetes. Studies have found that Polygonum cuspidatum can improve the lipid metabolism disorder in patients with type 2 diabetes with damp-heat syndrome; Polygonum cuspidatum polysaccharide can improve the symptoms of "three mores and one less" in diabetic rats, significantly reducing glucose tolerance and fasting blood sugar; Polygonum datum glycosides can also lower blood sugar, improve renal function, and reduce podocyte damage in diabetic nephropathy.

[0031] Bombyx Batryticatus: Salty, pungent, neutral. Enters the Liver, Lung, and Stomach meridians. Calms wind and stops spasms, dispels wind and relieves pain, and resolves phlegm and disperses stagnation. Used for liver wind with phlegm, epilepsy and convulsions, acute convulsions in children, tetanus, shortness of breath due to stroke, wind-heat headache, red eyes and sore throat, pruritus caused by urticaria, and mumps.

[0032] Bombyx batryticatus is particularly effective in improving insulin resistance, protecting nerves, and preventing and treating diabetic complications, making it particularly effective for phlegm-stasis type diabetes. Bombyx batryticatus regulates endocrine and metabolic balances, increasing glucose utilization and demonstrating a therapeutic effect in type 2 diabetes. Bombyx batryticatus polysaccharides can reduce hepatic steatosis in type 2 diabetic mice, enhance their antioxidant properties, and lower blood sugar by modulating oxidative stress.

[0033] Scrophularia: Sweet, bitter, salty, slightly cold. Enters the Lung, Stomach, and Kidney meridians. Clears heat and cools blood, nourishes yin and reduces internal heat, and detoxifies and resolves stagnation. Used for heat invading the blood, fever-induced rashes, yin damage from febrile illnesses, red tongue and thirst, constipation caused by loss of fluid, bone steaming, cough due to fatigue, red eyes, sore throat, diphtheria, tuberculosis, and carbuncles and sores.

[0034] Scrophularia ningpoensis is particularly effective in improving insulin resistance, protecting pancreatic islet cells, and preventing and treating diabetic complications, making it particularly suitable for yin deficiency and fire excess type diabetes. Scrophularia ningpoensis water extract improves insulin resistance through AMPK-dependent inhibition of the NLRP3 inflammasome. Furthermore, Scrophularia ningpoensis water extract alleviates pancreatic beta cell pyroptosis in diabetic mice by inhibiting NLRP3 / GSDMD signaling. Scrophularia ningpoensis extract also regulates HRMEC cell proliferation, migration, and apoptosis through the miR-646 / VEGFA mechanism, improving and alleviating diabetic retinal edema.

[0035] Chicken Gizzard Stone: Sweet, neutral. Entries the spleen, stomach, small intestine, and bladder meridians. Strengthens the stomach and aids digestion, astringes spermatorrhea, stops nocturnal emission, and relieves stranguria and dissolves stone. Used for indigestion, vomiting, diarrhea, infantile malnutrition, enuresis, nocturnal emission, painful and astringent stranguria, and gallbladder distension and flank pain.

[0036] Chicken's gizzard lining is particularly effective in improving insulin resistance, regulating glucose and lipid metabolism, and preventing and treating diabetic complications. It is particularly suitable for treating spleen deficiency and food stagnation-type diabetes. Chicken's gizzard lining polysaccharides can promote the proliferation of pancreatic beta cells (MIN6) and inhibit apoptosis. It can also effectively lower blood sugar and lipid levels in diabetic rats with hyperlipidemia and improve their cellular immune function.

[0037] Pueraria root: Sweet, pungent, and cooling. It enters the spleen, stomach, and lung meridians. It relieves muscle tension, reduces fever, promotes fluid production, quenches thirst, clears rashes, promotes yang and stops diarrhea, promotes blood circulation, and detoxifies alcohol. It is used for exogenous fever, headache, stiff neck and back pain, thirst, polydipsia, measles that has not cleared up, febrile dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain, and alcohol toxicity.

[0038] Pueraria root can improve diabetes through multiple pathways, including improving insulin resistance, anti-oxidation, inhibiting inflammation, promoting insulin secretion, inhibiting α-glucosidase, and regulating intestinal flora. Furthermore, puerarin, the main active ingredient in puerarin, protects pancreatic beta cells and improves insulin resistance. Puerarin can inhibit the NLRP3 / caspase-1 / GSDMD pyroptosis signaling pathway, demonstrating a protective effect against myocardial damage in diabetic mice.

[0039] Mulberry Silkworm Cocoon: Sweet, salty, neutral. Enters the Liver and Kidney meridians. Strengthens essence and reduces urination, tonifies the kidneys and boosts yang. Used for spermatorrhea, spermatorrhea, enuresis, frequent urination, and turbid urine.

[0040] Mulberry silkworm cocoons are particularly effective in improving diabetic metabolic disorders and preventing and treating complications, particularly those associated with kidney deficiency. Petroleum ether, water, and alcohol extracts of mulberry silkworm cocoons can lower blood glucose levels in mice with alloxan-induced diabetes, demonstrating a promising therapeutic effect.

[0041] Red Peony Root: Bitter, slightly cold. Enters the Liver Meridian. Clears heat, cools blood, disperses blood stasis, and relieves pain. Used for heat invading the blood, warm toxins causing rash, hematemesis and epistaxis, red and swollen eyes, liver depression and flank pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, and carbuncles and ulcers.

[0042] Red peony root is particularly effective in improving insulin resistance, protecting blood vessels, and preventing and treating diabetic complications, making it particularly suitable for diabetes characterized by blood heat and stasis. Research has shown that red peony root and its active ingredients can protect against diabetic nephropathy by lowering blood sugar, alleviating insulin resistance, regulating lipid metabolism, antagonizing oxidative stress, improving hemodynamics, and inhibiting inflammatory responses. Its main component, total glycosides of red paeony root, can improve renal fibrosis in rats with diabetic nephropathy.

[0043] Salvia miltiorrhiza: Bitter, slightly cold. Enters the Heart and Liver meridians. It promotes blood circulation, dispels blood stasis, relieves menstrual pain, clears the heart and relieves restlessness, and cools blood and eliminates carbuncle. It is used for chest pain, abdominal pain, and flank pain, accumulation of masses, pain due to heat, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0044] Danshen (Salvia miltiorrhiza) regulates glucose and lipid metabolism through multiple targets, protecting blood vessels and organs, and is particularly effective in preventing and treating diabetic vascular complications. Danshen extract and its main active ingredients, such as salvianolic acid and tanshinone, improve glucose and lipid metabolism by regulating multiple signaling pathways, including inflammation and peroxidation. As a supplemental medication for clinical diabetes treatment, Danshen has demonstrated excellent efficacy in regulating blood sugar levels, with minimal adverse reactions and low toxicity.

[0045] In order to treat shortness of breath, fatigue, thirst, dizziness, and heaviness in patients with spleen deficiency, and to improve blood sugar levels, the Chinese medicine composition for treating spleen deficiency provided by the present invention is exemplified as follows:

[0046] Example 1

[0047] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 3000g of Radix Glehniae, 1500g of Radix Trichosanthis, 1500g of Polygonatum sibiricum, and 3000g of Radix Astragali. The above herbs are added to 8 times the amount of water, decocted for 1.5 hours, and filtered. The filtered residue is added to 6 times the amount of water, decocted for 1 hour, and filtered. The two filtrates are combined and concentrated to obtain a decoction.

[0048] Example 2

[0049] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 900g of Radix Glechomae Root, 1500g of Radix Trichosanthis, 1500g of Polygonatum, 1200g of Radix Astragali, 900g of Polygonum Cuspidati, 600g of Bombyx Batryticatus, 1200g of Scrophulariae, 600g of Gallus Gallus, 1200g of Puerariae Root, 600g of Ocellus Officinalis, 1200g of Paeonia lactiflora, and 1200g of Salvia miltiorrhiza. The above herbs are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, filtered, and the two filtrates are combined and concentrated to obtain a decoction.

[0050] Example 3

[0051] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 800g of Psoralea corylifolia, 1200g of Radix Trichosanthis, 1000g of Polygonatum sibiricum, 1000g of Radix Astragali, 900g of Polygonum cuspidatum, 600g of Bombyx batryticatus, 900g of Scrophularia ningpoensis, 600g of Gallus gallus domesticus, 1000g of Pueraria root, 600g of Ophiopogon japonicus, 900g of Paeonia lactiflora, and 1200g of Salvia miltiorrhiza. The above herbs are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, filtered, and the two filtrates are combined and concentrated to obtain a decoction.

[0052] Example 4

[0053] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 800g of Radix Glechomae Root, 1200g of Radix Trichosanthis, 1200g of Polygonatum, 1200g of Radix Astragali, 900g of Polygonum Cuspidati, 600g of Bombyx Batryticatus, 1200g of Scrophulariae, 600g of Gallus Gallus, 1200g of Puerariae Root, 600g of Ocellus Officinalis, 1200g of Paeonia lactiflora, and 1200g of Salvia miltiorrhiza. The above traditional Chinese medicines are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, and filtered. The two filtrates are mixed, concentrated, dried, and an appropriate amount of dextrin and flavoring agents are added. The mixture is granulated and packaged to obtain granules.

[0054] Example 5

[0055] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 600g of Radix Glechomae Root, 1000g of Radix Trichosanthis, 900g of Polygonatum, 1200g of Radix Astragali, 900g of Polygonum Cuspidati, 600g of Bombyx Batryticatus, 900g of Scrophulariae, 300g of Gallus Gallus Officinalis, 1000g of Puerariae Root, 500g of Ophiopogon japonicus, 900g of Paeonia lactiflora, and 1000g of Salvia miltiorrhiza. The above traditional Chinese medicines are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, and filtered. The two filtrates are mixed, concentrated, dried, and an appropriate amount of dextrin and flavoring agents are added. The mixture is granulated and packaged to obtain granules.

[0056] Example 6

[0057] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 3000g of Radix Glechomae Root, 1200g of Radix Trichosanthis, 1200g of Polygonatum Root, 1200g of Radix Astragali, 900g of Polygonum Cuspidati, 600g of Bombyx Batryticatus, 1000g of Scrophulariae, 300g of Gallus Gallus, 1000g of Puerariae Root, 600g of Ophiopogon japonicus, 900g of Paeonia lactiflora, and 1000g of Salvia miltiorrhiza. The above traditional Chinese medicines are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, and filtered. The two filtrates are mixed, concentrated, dried, and pulverized to obtain a powder.

[0058] Example 7

[0059] A traditional Chinese medicine composition for treating spleen deficiency disease comprises the following ingredients: 900g of Radix Glechomae Root, 1500g of Radix Trichosanthis, 1200g of Polygonatum, 1200g of Radix Astragali, 900g of Polygonum Cuspidati, 600g of Bombyx Batryticatus, 1200g of Scrophulariae, 600g of Gallus Gallus, 1200g of Puerariae Root, 600g of Ocellus Officinalis, 900g of Paeonia lactiflora, and 1000g of Salvia miltiorrhiza. The above traditional Chinese medicines are added to 8 times the amount of water, decocted for 1.5 hours, and filtered; the filtrate residue is added to 6 times the amount of water, decocted for 1 hour, and filtered. The two filtrates are mixed, concentrated, dried, and an appropriate amount of dextrin and flavoring agents are added. The mixture is granulated and filled into capsule shells to obtain capsules.

[0060] The following is the clinical trial data of the Chinese medicine composition prepared in the above examples to verify its therapeutic effect.

[0061] 1. Case selection

[0062] A total of 120 outpatients with spleen disease whose fasting blood glucose level was ≥7.0 mmol / L and who presented with symptoms such as shortness of breath, fatigue, thirst, dizziness, and heaviness were randomly divided into three groups, including 64 males and 56 females.

[0063] 2. Treatment methods

[0064] Example 1 group: Orally take the Chinese medicine decoction prepared in Example 1 of the present invention, 1 packet each morning and evening, each packet is 200 ml.

[0065] Group 2 of Example 2: Orally take the Chinese medicine decoction prepared in Example 2 of the present invention, 1 packet each morning and evening, each packet is 200 ml.

[0066] Group 3 of Example: Orally take the Chinese medicine decoction prepared in Example 3 of the present invention, 1 packet each morning and evening, each packet is 200 ml.

[0067] All groups took the drug for one week, after which their fasting blood sugar levels were measured. During treatment, patients were advised to maintain a healthy diet, exercise regularly, and abstain from smoking and alcohol.

[0068] 3. Efficacy standards

[0069] Recovery: Symptoms disappear and fasting blood sugar returns to normal;

[0070] Marked effect: symptoms are significantly alleviated and fasting blood sugar is significantly reduced;

[0071] Effective: Symptoms are alleviated and fasting blood sugar decreases;

[0072] Ineffective: No changes in symptoms or fasting blood sugar.

[0073] 4. Treatment results

[0074] Group Recovered (case) Significantly effective (example) Valid (example) Invalid (Example) Total effective (cases) Example 1 group 6 19 13 2 38 Example 2 group 8 21 11 0 40 Example 3 group 7 20 12 1 39

[0075] From the above data, it can be seen that the Chinese medicine composition of the present invention can effectively improve shortness of breath, fatigue, thirst, dizziness, heaviness, and blood sugar indicators in patients with spleen deficiency, and there is no significant difference in the therapeutic effects among Example 1 Group, Example 2 Group, and Example 3 Group.

[0076] 5. Typical Case 1

[0077] Zhang, female, 41 years old. Chief complaint: feeling weak, often thirsty at night, and high blood sugar, which has persisted for over a year. Physical examination: red tongue with little fluid, yellow greasy coating, and a wiry, slippery pulse. Diagnosis: Damp-heat in the spleen causing spleen deficiency. Treatment: After taking the decoction described in Example 1 of the present invention for one week, symptoms of thirst and fatigue improved significantly, and blood sugar also dropped significantly.

[0078] 6. Typical Case 2

[0079] Ji, female, 58 years old. Chief complaint: heavy limbs, shortness of breath at any time, fasting blood sugar around 8.0 mmol / L

[0080] Right, almost two years old. Physical examination: dark, thick tongue with greasy coating, and a wiry, slippery, and rapid pulse. Diagnosis: Dampness and toxicity in the spleen causing spleen deficiency. Treatment: After taking the capsule described in Example 7 of the present invention for one week, the symptoms of shortness of breath and heaviness improved significantly, and blood sugar dropped to approximately 7.3 mmol / L.

[0081] 7. Typical Case 3

[0082] Lv, male, 61 years old. Chief complaint: Overweight, frequent dizziness, dry mouth, and diabetes. Physical examination: Scalloped tongue, purple-black tongue, greasy coating, and a wiry, slippery pulse. Diagnosis: Phlegm and blood stasis in the spleen, causing spleen deficiency. Treatment: After taking the decoction described in Example 2 of the present invention for one week, dizziness and dry mouth symptoms improved significantly, and blood sugar decreased significantly.

[0083] The above description does not limit the present invention in any form or substance. Any person skilled in the art who is familiar with the present invention can make use of the technical contents disclosed above without departing from the scope of the technical solution of the present invention, and any equivalent changes, modifications and evolutions made to the above embodiments are equivalent embodiments of the present invention. At the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating spleen deficiency disease, comprising a therapeutically effective amount of Radix Glehniae, Radix Trichosanthis, Radix Polygonati, and Radix Astragali.

2. The Chinese medicine composition according to claim 1, further comprising Polygonum cuspidatum, Bombyx batryticatus, Scrophularia ningpoensis, Gallus gallus domesticus, Pueraria lobata, Silkworm cocoon, Red Peony Root, and Salvia miltiorrhiza.

3. The Chinese medicine composition according to claim 1, wherein the composition comprises, by weight, 4-30 parts of Radix Psoraleae, 10-15 parts of Radix Trichosanthis, 9-15 parts of Polygonatum sibiricum, and 9-30 parts of Radix Astragali.

4. The Chinese medicine composition according to claim 2, further comprising, by weight, 9-15 parts of Polygonum cuspidatum, 5-10 parts of Bombyx batryticatus, 9-15 parts of Scrophularia ningpoensis, 3-10 parts of Gallus gallifolia, 10-15 parts of Pueraria root, 5-10 parts of Silkworm Cocoon, 6-12 parts of Red Peony Root, and 10-15 parts of Salvia miltiorrhiza.

5. The Chinese medicine composition as claimed in claim 1, wherein the composition comprises 9 parts of Radix Psoraleae, 15 parts of Radix Trichosanthis, 15 parts of Polygonatum sibiricum and 12 parts of Radix Astragali, in parts by weight.

6. The Chinese medicine composition according to claim 2, further comprising, by weight, 9 parts of Polygonum cuspidatum, 6 parts of Bombyx batryticatus, 12 parts of Scrophularia ningpoensis, 6 parts of Gallus gallus domesticus, 12 parts of Pueraria root, 6 parts of Silkworm Cocoon, 12 parts of Red Peony Root, and 12 parts of Salvia miltiorrhiza.

7. A method for preparing a Chinese medicine composition for treating spleen deficiency disease, comprising the following preparation steps: Weigh the amount of the Chinese medicine composition as described in any one of claims 1 to 6, add 8 times the amount of water, decoct for 1.5 hours, and filter; add 6 times the amount of water to the filter residue, decoct for 1 hour, filter, mix the two filtrates, and concentrate to obtain a decoction; or further concentrate, dry, and crush to obtain a powder; or add an appropriate amount of dextrin and a flavoring agent, granulate, and package to obtain granules; or put into capsule shells to obtain capsules, etc.

8. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating spleen disease.