Chinese medicine composition for treating viseral organ dysfunction and use thereof

Abstract

The present disclosure provides a Chinese Medicine composition for treating visceral organ dysfunction and use of the same, wherein the Chinese Medicine composition consists of Artemisia argyi, Ohwia caudate, Ophiopogon japonicas, Houttuynia cordata, Platycodon grandifloras, Glycyrrhiza uralensis, Perilla frutescens, Chrysanthemum × morifolium, Anisomeles indica, Zingiber officinale and Carthamus tinctorius, and can treat the dysfunction of the visceral organs such as liver, gallbladder and / or kidney.

Description

Technical Field

[0001] This disclosure relates to a traditional Chinese medicine composition for treating visceral dysfunction, and more particularly to a traditional Chinese medicine composition for treating visceral dysfunction and its pharmaceutical uses. Prior Technology

[0002] Aging is the process of bodily functions declining with age, naturally including organ deterioration. Organ deterioration can lead to diseases such as kidney disease, dementia, cardiovascular disease, liver disease, and cancer, negatively impacting an individual's life and ultimately causing death. Among these, the liver and kidneys are the body's main organs for clearing metabolic waste products; once they lose their function, toxins cannot be metabolized and excreted, causing systemic imbalances with significant consequences.

[0003] The mechanisms of aging are complex and cannot be simply described, but previous studies have identified some proteins that can serve as indicators of aging and / or health. One such indicator protein is the transmembrane protein klotho, whose expression levels are inversely proportional to age. Although the detailed physiological mechanisms of klotho remain unclear, genetic engineering studies have shown that a lack of klotho leads to premature aging, while overexpression of klotho can prolong lifespan. Therefore, klotho can serve as an indicator protein for assessing organ aging and / or health.

[0004] Besides aging, environmental pollutants or medications can also damage organs. The liver and kidneys, as the first-line organs for metabolizing and eliminating these toxins, are also prone to accumulating damage from pollutants and medications, leading to loss of function.

[0005] In summary, there is still a great need in the field for drugs that can treat visceral damage and dysfunction caused by endogenous or extrinsic factors. Summary of the Invention

[0006] This disclosure provides a traditional Chinese medicine composition comprising: Artemisia argyi, Artemisia argyi, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandiflorus, Glycyrrhiza uralensis, Perilla frutescens, Chrysanthemum morifolium, Gynostemma pentaphyllum, old ginger, and Carthamus tinctorius.

[0007] In one specific embodiment disclosed herein, based on the total weight of the Chinese herbal medicine components, the content of Artemisia argyi is 10 to 20%, the content of Artemisia argyi is 10 to 20%, the content of Ophiopogon japonicus is 5.0 to 15%, the content of Houttuynia cordata is 5.0 to 15%, the content of Platycodon grandiflorus is 5.0 to 15%, the content of Glycyrrhiza uralensis is 1.0 to 10%, the content of Perilla frutescens is 1.0 to 10%, the content of Chrysanthemum morifolium is 0.1 to 1.0%, the content of Gynostemma pentaphyllum is 10 to 20%, the content of Zingiber officinale is 10 to 30%, and the content of Carthamus tinctorius is 1.0 to 10%.

[0008] In one specific embodiment disclosed herein, based on the total weight of the Chinese herbal medicine components, the content of Artemisia argyi is 12.76%, the content of Artemisia argyi is 12.76%, the content of Ophiopogon japonicus is 8.51%, the content of Houttuynia cordata is 8.51%, the content of Platycodon grandiflorus is 8.51%, the content of Glycyrrhiza uralensis is 4.25%, the content of Perilla frutescens is 4.25%, the content of Chrysanthemum morifolium is 0.45%, the content of Gynostemma pentaphyllum is 15%, the content of Zingiber officinale is 20%, and the content of Carthamus tinctorius is 5%.

[0009] This disclosure further provides the use of the traditional Chinese medicine composition disclosed herein in the preparation of a medicament for treating visceral dysfunction in an individual.

[0010] This disclosure further provides a method for treating visceral dysfunction, comprising administering the Chinese herbal composition or the drug disclosed herein to an individual in need.

[0011] This disclosure further provides a drug for treating visceral dysfunction in individuals, comprising the traditional Chinese medicine components disclosed herein, wherein the traditional Chinese medicine components include Artemisia argyi, Artemisia argyi, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandiflorus, Glycyrrhiza uralensis, Perilla frutescens, Chrysanthemum morifolium, Gynostemma pentaphyllum, old ginger, and Carthamus tinctorius.

[0012] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the content of the following traditional Chinese medicine components, by total weight, is as follows: Artemisia argyi 10-20%, Artemisia argyi 10-20%, Ophiopogon japonicus 5.0-15%, Houttuynia cordata 5.0-15%, Platycodon grandiflorus 5.0-15%, Glycyrrhiza uralensis 1.0-10%, Perilla frutescens 1.0-10%, Chrysanthemum morifolium 0.1-1.0%, Euphorbia fischeriana 10-20%, Zingiber officinale 10-30%, and Carthamus tinctorius 1.0-10%.

[0013] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the total weight of the traditional Chinese medicine components is as follows: Artemisia argyi contains 12.76%, Artemisia argyi contains 12.76%, Ophiopogon japonicus contains 8.51%, Houttuynia cordata contains 8.51%, Platycodon grandiflorus contains 8.51%, Glycyrrhiza uralensis contains 4.25%, Perilla frutescens contains 4.25%, Chrysanthemum morifolium contains 0.45%, Clematis armandii contains 15%, Zingiber officinale contains 20%, and Carthamus tinctorius contains 5%.

[0014] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the viscera are the liver, gallbladder, and kidneys.

[0015] In some specific embodiments of the uses, methods and traditional Chinese medicine components disclosed herein for treating visceral dysfunction, the visceral dysfunction includes visceral dysfunction caused by aging and visceral dysfunction caused by chemotherapy drugs.

[0016] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the drug is an aqueous extract of the traditional Chinese medicine component extracted with boiling water.

[0017] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the effective amount of the drug is 10 mg to 500 mg per kilogram of body weight. For example, the dosage for an individual in need is 10 mg to 500 mg per kilogram of body weight.

[0018] In some specific embodiments of the uses, methods, and traditional Chinese medicine compositions for treating visceral dysfunction disclosed herein, the medicine further includes pharmaceutically acceptable excipients.

[0019] In the uses, methods, and specific embodiments of traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the medicine is an oral dosage form.

[0020] In some specific embodiments of the uses, methods, and traditional Chinese medicine compositions for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine compositions or drugs for treating visceral dysfunction reduce an individual's total bilirubin.

[0021] In some specific embodiments of the uses, methods, and traditional Chinese medicine compositions for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine compositions or drugs for treating visceral dysfunction reduce an individual's GOT and GPT.

[0022] In some specific embodiments of the uses, methods, and traditional Chinese medicine compositions for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine compositions or drugs for treating visceral dysfunction reduce an individual's Alb, Cre, BUN, and UA.

[0023] In some specific embodiments of the uses, methods, and traditional Chinese medicine compositions for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine compositions or drugs for treating visceral dysfunction reduce an individual's T-Cho, TG, and T-pro.

[0024] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine components or drugs for treating visceral dysfunction enhance the expression of Klotho protein and PGC-1α protein in individuals.

[0025] In some specific embodiments of the uses, methods, and traditional Chinese medicine components for treating visceral dysfunction disclosed herein, the uses, methods, and traditional Chinese medicine components or drugs for treating visceral dysfunction are for treating individuals with acute hepatitis, cirrhosis, drug-induced liver injury including chemotherapy, alcohol-induced liver injury, intrahepatic cholestasis, obliterative jaundice, viral hepatitis including type B or C, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, non-alcoholic steatohepatitis (NASH), age-related liver dysfunction, age-related biliary dysfunction, drug-induced kidney injury from chemotherapy, glomerulonephritis, glomerulosclerosis, nephrotic syndrome, hypertensive nephrosclerosis, hyperuricemia, end-stage renal disease, uremia, and age-related renal dysfunction.

[0026] This disclosure aims to treat visceral dysfunction and related diseases, such as liver, gallbladder and / or kidney dysfunction, by administering the Chinese herbal ingredients disclosed herein to an individual. Simple Explanation of the Diagram

[0027] Figure 1 shows a staining image of the kidney tissue of mice injected with cranberry after being given the Chinese medicine composition disclosed herein.

[0028] Figure 2 shows the serum biochemical analysis of total bilirubin (T-Bil) in naturally aged mice treated with the Chinese herbal medicine composition disclosed herein, and the ratio based on the biochemical analysis values ​​of young mice.

[0029] Figures 3A and 3B show the serum biochemical analysis of aspartate transaminase (GOT) and alanine transaminase (GPT) in naturally aged mice treated with the Chinese herbal medicine components disclosed herein, and the ratios based on the biochemical analysis values ​​of young mice, respectively.

[0030] Figures 4A, 4B, 4C, and 4D show the serum biochemical analysis of albumin (Alb), creatinine (Cre), urinary nitrogen (BUN), and uric acid (UA) in naturally aged mice treated with the Chinese herbal medicine composition disclosed herein, and the ratios based on the biochemical analysis values ​​of young mice.

[0031] Figures 5A, 5B, and 5C show the serum biochemical analysis of cholesterol (T-Cho), triglycerides (TG), and total protein (T-pro) in naturally aged mice treated with the Chinese herbal medicine components disclosed herein, and the ratios based on the biochemical analysis values ​​of young mice.

[0032] Figure 6 shows a stained image of kidney tissue from naturally aged mice that were given the Chinese herbal medicine composition disclosed herein starting at 48 weeks of age. Implementation

[0033] The technical solutions described in the embodiments of this disclosure will be described more clearly and completely below. Obviously, the described embodiments are only a part of the many embodiments covered by this disclosure and are not intended to limit the scope of this disclosure. This disclosure can also be implemented or applied in similar or different embodiments. Other embodiments obtained by those skilled in the art without creation, such as modifications, alterations, substitutions of elements, or combinations thereof, are all included within the scope of this disclosure.

[0034] Note further that the singular forms “a” and “the” used herein, unless explicitly limited to a single referent, imply the inclusion of a plural referent. Additionally, unless the context clearly indicates otherwise, the term “or” is used interchangeably with the term “and / or”.

[0035] The terms "comprising," "including," "containing," and "having" as used herein refer to the presence of a certain element (such as a component or step) in the object, method, or use disclosed herein. Unless the context clearly indicates otherwise, undescribed or unspecified elements are also openly present in the object, method, or use disclosed herein, whether or not they are necessary. That is, undescribed or unspecified elements are not excluded restrictively.

[0036] The term "individual" as used herein refers to an animal, such as a mammal, including but not limited to primates (e.g., humans), cattle, sheep, goats, horses, dogs, cats, rabbits, rats, mice, etc. In one embodiment disclosed herein, the individual is a human.

[0037] The terms “effective dose or therapeutically effective dose,” “sufficient therapeutic dose,” or “effective or sufficient dose” as used herein refer to a dose that produces a therapeutic effect on the individual to which the medication is administered.

[0038] The term "treatment" as used herein refers to any indicator of success in the treatment or improvement of discomfort or symptoms (such as decreased liver function), including any objective or subjective parameters such as relief; mitigation; reduction of symptoms, or making symptoms, injury, pathology, or condition more tolerable for an individual; reduction of the frequency or duration of symptoms or discomfort, or, in some cases, prevention of the onset of symptoms or discomfort. Symptoms include conditions caused by disease and age-related functional disorders. Treatment or improvement of symptoms can be based on any objective or subjective parameters, including, for example, test parameters obtained from serum biochemical analysis.

[0039] As used herein, the term "approximately" means that the error or range of the stated value, range, or proportion is within 20%, preferably within 10%, and more preferably within 5%. The quantified values ​​used herein are approximate and are intended to be inferred even if the term "approximately" is not used.

[0040] The numerical ranges described herein are inclusive and combinable. Any value falling within the numerical ranges described herein can be used as a maximum or minimum value to derive sub-ranges. For example, the numerical range of "10 to 30%" should be understood to include any sub-range between the minimum value of 10% and the maximum value of 30%, such as: 10% to 15% by weight, 20% to 30%, and 15% to 25%, etc. Furthermore, the multiple numerical endpoints described herein can be arbitrarily chosen as maximum or minimum values ​​to derive numerical ranges; for example, 50, 60, 70, 80, 90, and 100 mg per kilogram of body weight can derive numerical ranges of 50 to 70 mg, 80 to 100 mg, or 60 to 90 mg per kilogram of body weight.

[0041] The purpose of this disclosure is to provide a safe and effective traditional Chinese medicine composition for treating visceral dysfunction and its uses.

[0042] This disclosure provides a traditional Chinese medicine composition for treating visceral dysfunction, the components of which include Artemisia argyi, Artemisia argyi, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandiflorus, Glycyrrhiza uralensis, Perilla frutescens, Chrysanthemum morifolium, Gynostemma pentaphyllum, old ginger, and Carthamus tinctorius.

[0043] Artemisia argyi (Artemisia argyi) belongs to the Asteraceae family, and its leaves are used medicinally; Ohwia caudata (Ohwia caudata), also known as small locust flower, belongs to the Leguminosae family, and the whole plant is used medicinally; Ophiopogon japonicus (Ophiopogon japonicus) belongs to the Asparagaceae family, and its tuberous roots are used medicinally; Houttuynia cordata (Houttuynia cordata) belongs to the Saururaceae family, and the whole plant is used medicinally; Platycodon grandifloras belongs to the Campanulaceae family, and its roots are used medicinally; Glycyrrhiza uralensis (Glycyrrhiza uralensis) belongs to the Leguminosae family, and its roots and rhizomes are used medicinally; Perilla frutescens (Perilla frutescens) belongs to the Lamiaceae family, and its stems, leaves, and seeds are all used medicinally; Chrysanthemum × *Morifolium* belongs to the Asteraceae family, and its flowers are used medicinally; *Anisomeles indica* belongs to the Lamiaceae family, and the whole plant is used medicinally; *Zingiber officinale* belongs to the Zingiberaceae family, and only plants cultivated for more than 10 months are considered "old ginger," and its roots are used medicinally; and *Carthamus tinctorius* belongs to the Asteraceae family, and its flowers are used medicinally. All of the above are common traditional Chinese medicinal herbs.

[0044] In one embodiment disclosed herein, based on the total weight of the Chinese herbal medicine components, the content of Artemisia argyi is 10 to 20%, the content of Artemisia argyi is 10 to 20%, the content of Ophiopogon japonicus is 5.0 to 15%, the content of Houttuynia cordata is 5.0 to 15%, the content of Platycodon grandiflorus is 5.0 to 15%, the content of Glycyrrhiza uralensis is 1.0 to 10%, the content of Perilla frutescens is 1.0 to 10%, the content of Chrysanthemum morifolium is 0.1 to 1.0%, the content of Gynostemma pentaphyllum is 10 to 20%, the content of Zingiber officinale is 10 to 30%, and the content of Carthamus tinctorius is 1.0 to 10%.

[0045] In some embodiments disclosed herein, the content of Artemisia argyi is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20%. In some embodiments disclosed herein, the content of Artemisia annua is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20%. In some embodiments disclosed herein, the content of Ophiopogon japonicus is 5.0, 6.0, 7.0, 8.0, 9.0, 10, 11, 12, 13, 14, or 15%. In some embodiments disclosed herein, the content of Houttuynia cordata is 5.0, 6.0, 7.0, 8.0, 9.0, 10, 11, 12, 13, 14, or 15%. In some embodiments disclosed herein, the content of Platycodon grandiflorus is 5.0, 6.0, 7.0, 8.0, 9.0, 10, 11, 12, 13, 14, or 15%. In some embodiments disclosed herein, the content of Glycyrrhiza uralensis is 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, or 10%. In some embodiments disclosed herein, the content of Perilla frutescens is 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, or 10%. In some embodiments disclosed herein, the content of Chrysanthemum morifolium is 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0%. In some embodiments disclosed herein, the content of *Gnaphalium affine* is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20%. In some embodiments disclosed herein, the content of *Zingiber officinale* is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30%. In some embodiments disclosed herein, the content of *Carthamus tinctorius* is 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, or 10%.

[0046] For example, based on the total weight of the Chinese herbal composition or medicine, the content of Artemisia argyi is 12.76%, the content of Artemisia annua is 12.76%, the content of Ophiopogon japonicus is 8.51%, the content of Houttuynia cordata is 8.51%, the content of Platycodon grandiflorus is 8.51%, the content of Glycyrrhiza uralensis is 4.25%, the content of Perilla frutescens is 4.25%, the content of Chrysanthemum morifolium is 0.45%, the content of Achyranthes bidentata is 15%, the content of Zingiber officinale is 20%, and the content of Carthamus tinctorius is 5%.

[0047] This disclosure provides a traditional Chinese medicine composition for treating visceral dysfunction, wherein the viscera include the heart, stomach, small intestine, large intestine, liver and gallbladder, pancreas, lungs, kidneys, bladder, spleen, uterus, and ovaries. In one embodiment of this disclosure, the traditional Chinese medicine composition can be used to treat dysfunction of the heart, stomach, small intestine, large intestine, liver and gallbladder, pancreas, lungs, and kidneys, or to treat dysfunction of the stomach, liver and gallbladder, pancreas, lungs, and kidneys, particularly liver and gallbladder and kidney dysfunction.

[0048] In one embodiment disclosed herein, an effective amount of the traditional Chinese medicine component can reduce the levels of GOT, GPT, and total bilirubin in the blood, and has therapeutic effects on acute hepatitis, cirrhosis, drug-induced liver injury including chemotherapy, alcohol-induced liver injury, intrahepatic cholestasis, obliterative jaundice, viral hepatitis including type B or type C, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, non-alcoholic steatohepatitis (NASH), age-related liver dysfunction, age-related biliary dysfunction, and other hepatobiliary system disorders.

[0049] In one embodiment disclosed herein, an effective amount of the traditional Chinese medicine component can lower blood creatinine and uric acid levels, and has the effect of treating drug-induced kidney damage including chemotherapy, glomerulonephritis, glomerulosclerosis, nephrotic syndrome, hypertensive nephrosclerosis, uric acidemia, end-stage renal disease, uremia, and age-related renal dysfunction.

[0050] This disclosure provides the use of this traditional Chinese medicine component in the preparation of a drug for treating visceral dysfunction.

[0051] In one embodiment of this disclosure, the drug is administered to a mammal. In another embodiment of this disclosure, the mammal is a human. In yet another embodiment of this disclosure, the mammal is a non-human mammal.

[0052] In one embodiment of this disclosure, the traditional Chinese medicine component is a medicinal herb. In another embodiment of this disclosure, the traditional Chinese medicine component is an aqueous extract of the medicinal herb extracted with water. For example, the aqueous extract is obtained by extracting the medicinal herb with boiling water. In yet another embodiment of this disclosure, the traditional Chinese medicine component is the aqueous extract dried and solidified.

[0053] In one embodiment disclosed herein, the effective amount of the total amount of the Chinese herbal medicine in the Chinese medicine composition is about 100 mg to 4000 mg per kilogram of body weight, for example, about 100, about 200, about 300, about 400, about 500, about 600, about 700, about 800, about 900, about 1000, about 1500, about 2000, about 2500, about 3000, about 3500, or about 4000; the aforementioned multiple numerical endpoints can be selected as the maximum or minimum values ​​to derive the numerical range.

[0054] In one embodiment of this disclosure, the effective amount of the solid aqueous extract in the traditional Chinese medicine composition is approximately 10 mg to 500 mg per kilogram of body weight, for example, approximately 10, approximately 20, approximately 30, approximately 40, approximately 50, approximately 60, approximately 70, approximately 80, approximately 90, approximately 100, approximately 150, approximately 200, approximately 250, approximately 300, approximately 350, approximately 400, approximately 450, or approximately 500 mg; the aforementioned multiple numerical endpoints can be selected as the maximum or minimum values ​​to derive a numerical range. In a specific embodiment of this disclosure, the effective amount of the solid aqueous extract in the traditional Chinese medicine composition is approximately 50 mg to 100 mg per kilogram of body weight.

[0055] In one embodiment disclosed herein, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable carrier or excipient.

[0056] In one embodiment of this disclosure, the pharmaceutically acceptable carrier or excipient includes, but is not limited to: dextran, sucrose, sorbitol, mannitol, starch, gum arabic, calcium phosphate, alginate, tragacanth gum, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, and methylcellulose.

[0057] In one embodiment disclosed herein, the traditional Chinese medicine composition may include, but is not limited to, other components such as pharmaceutically acceptable carriers, additives, adjuvants, and / or excipients. For example, the composition may include, but is not limited to, any combination of one or more of the group consisting of gelling agents, solvents, solubilizers, stabilizers, tension enhancers, penetration enhancers, pH adjusters, wetting agents, surfactants, buffers, preservatives, viscosity modifiers, emulsifiers, suspending agents, flavoring agents, coloring agents, and antibacterial agents.

[0058] In one embodiment of this disclosure, the traditional Chinese medicine composition is administered to an individual in an oral form. In another embodiment of this disclosure, the traditional Chinese medicine composition is an oral dosage form.

[0059] In one embodiment of this disclosure, the traditional Chinese medicine composition can be administered in various forms, and can be used as a pharmaceutical composition or a food composition. In one embodiment of this disclosure, the traditional Chinese medicine composition is in the form of powder, tablets, capsules, solution, tonic, or food.

[0060] In one embodiment of this disclosure, the traditional Chinese medicine composition can be used daily. In another embodiment of this disclosure, the traditional Chinese medicine composition can be used every 1, 2, 3, 4, 5, 6, or 7 days.

[0061] In one embodiment disclosed herein, the traditional Chinese medicine composition can be used continuously for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 30 days, 2 months, 3 months or more than 4 months, for example, for more than 90 days.

[0062] The present disclosure is further illustrated below with specific embodiments so that those skilled in the art can better understand the advantages and effects of the present disclosure and implement it. However, the embodiments should not be regarded as limiting the scope of the present disclosure. [Preparation Example: Preparation of Traditional Chinese Medicine Components Revised in this Paper] [ ]

[0063] Take 12.76g of Artemisia argyi, 12.76g of Artemisia annua, 8.51g of Ophiopogon japonicus, 8.51g of Houttuynia cordata, 8.51g of Platycodon grandiflorus, 4.25g of Glycyrrhiza uralensis, 4.25g of Perilla frutescens, 0.45g of Chrysanthemum morifolium, 15g of Artemisia argyi, 20g of old ginger, and 5g of Carthamus tinctorius, and mix them to form a composition with a total weight of 100g. First, grind the 100g composition into powder, then add 700mL of water and heat to a boil at 100℃, and continue heating to a boil to concentrate the volume to 100mL.

[0064] Next, the mixture was centrifuged twice at 12,000 rpm for 10 minutes each time. The supernatant was collected to remove impurities, and then dried at 60°C to obtain the extract of the herbal composition disclosed herein.

[0065] The extract of the herbal composition was weighed to 5 g to 10 g, and reconstituted with 1 mL to 5 mL of pure water to prepare extracts with low concentrations of 1 mg / mL and high concentrations of 2 mg / mL. These extracts were used in the following experimental examples, and large particles were removed using a 0.45 µm filter before use. For convenience, the above-prepared aqueous solution of the herbal composition extract disclosed herein will be referred to as "Fuhua Yin" below. [Experimental Example] [1] [The physiological functions of mice receiving chemotherapy with Cranberry Extract protected by Fuhua Drink] [ ]

[0066] Healthy male mice (C57BL / 6) aged 12 weeks were randomly divided into four groups of six each. One group served as the control group, consisting of normal mice that had not received doxorubicin injections. These mice received intraperitoneal injections of physiological saline on days 0 and 10 of the experiment. The other three groups received intraperitoneal injections of the chemotherapy drug doxorubicin, with mice receiving 5 mg / kg of doxorubicin solution on days 0 and 10 of the experiment. This doxorubicin solution was dissolved and diluted with physiological saline.

[0067] On day 15 of the experiment, each mouse in the experimental group was fed 200 μL of physiological saline, 50 mg / kgw of Fuhua Drink, or 100 mg / kgw of Fuhua Drink, respectively. After four weeks of continuous daily feeding, the mice were sacrificed and samples were taken for tissue staining.

[0068] The tissue staining method involved immersing kidney samples in a 4% formalin solution and fixing them overnight at 4°C. After dehydration with 6% and 30% sucrose solutions, the kidney tissue was embedded in cryo-embedding medium (OCT; Leica) and cut into 10 µm frozen sections. The sections were then incubated in phosphate-buffered saline (PBS) containing 0.5% Triton X-100 for 30 minutes. Next, the sections were incubated at room temperature with 5% goat serum solution (PBS containing 0.25% Triton X-100) for 1 hour. Finally, the sections were incubated overnight at 4°C with a mixture of Klotho (Abclonal, A12028) and PGC-1α (Santa Cruz, sc-518025) antibodies. The following day, after washing with PBS, the slides were stained with secondary antibodies (Alexa Fluor™ 488, F(ab')2-Rabbit anti-Goat IgG (H+L) Cross-Adsorbed Secondary Antibody, Invitrogen, and NorthernLights™ 557-conjugated Anti-Mouse IgG Secondary Antibody [red; NL007], Biotechne) for 1 hour at room temperature. After washing again, the samples were covered with coverslips containing DAPI-containing ProLong Gold anti-fading mounting medium (Invitrogen) and immunofluorescence images were captured using a fluorescence microscope (40x, BX53, Olympus). Slides stained with secondary antibodies only were used as negative controls.

[0069] Figure 1 shows the results of kidney tissue staining, indicating that the chemotherapy drug cranberry caused a decrease in Klotho protein expression in mouse kidney tissue; while mice fed with Fuhua Drink showed a significant overall increase in Klotho protein expression, and the expression of Klotho protein also tended to increase with the increase of Fuhua Drink concentration. [Experimental Example] [2] [Fuhua Drink protects the physiological functions of naturally aging mice] [ ]

[0070] Naturally aged male mice (C57BL / 6) at 36 weeks of age were randomly divided into three groups of six each. Mice in each group were fed physiological saline, 50 mg / kgw of Fuhua solution, or 100 mg / kgw of Fuhua solution, respectively, daily for 12 weeks until 48 weeks of age. Mice in each group were then sacrificed, and samples were collected for tissue staining and / or serum biochemical analysis. Additionally, six 12-week-old mice served as a control group. After serum biochemical analysis, these healthy mice were sacrificed, and samples were collected for tissue staining to compare with the 48-week-old naturally aged mice.

[0071] Whole blood samples were collected from all groups of animals and centrifuged at 4°C and 3000 rpm for 25 minutes to collect the supernatant (i.e., serum). Further serum biochemical analysis was performed using a SPOTCHEM EZ (SP-4430) fully automated animal dry biochemical analyzer. The analyzed parameters included total bilirubin (T-Bil), with high values ​​potentially indicating hepatobiliary problems or hemolytic diseases; glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT), with high values ​​indicating hepatocellular damage, hepatitis, intrahepatic biliary obstruction, cirrhosis, skeletal muscle or myocardial inflammation, etc.; serum albumin (Alb), the concentration of which usually represents the state of the kidneys and the degree of inflammatory response; and creatinine (Cre), with high values ​​indicating renal insufficiency and urinary tract obstruction. In addition, protein metabolism produces urea nitrogen (BUN), which is then excreted by the kidneys. Therefore, when kidney function begins to decline, the ability to excrete urea nitrogen also declines. Other items analyzed include uric acid (UA), a metabolite of purines in the body. Uric acid levels are high in conditions such as excessive alcohol consumption, diabetes, gout, nephritis, lead poisoning, and hyperparathyroidism. Serum cholesterol (T-Cho) and triglycerides (TG) represent blood lipid levels; abnormal blood lipids can cause fatty liver, fatty liver inflammation, and chronic kidney disease. Total protein (T-pro), representing the sum of albumin and globulin, can also lead to liver and kidney abnormalities if abnormal.

[0072] The tissue staining method involved immersing kidney samples in 4% formalin solution and fixing them overnight at 4°C. After dehydration with 6% and 30% sucrose solutions sequentially, the kidney tissue was embedded in cryo-embedding medium (OCT; Leica) and cut into 10 µm frozen sections. The sections were then incubated in PBS containing 0.5% Triton X-100 for 30 minutes. Next, the sections were incubated at room temperature with 5% goat serum solution (PBS containing 0.25% Triton X-100) for 1 hour, followed by incubation overnight at 4°C with a mixture of Klotho (Abclonal, A12028) and PGC-1α (Santa Cruz, sc-518025) antibodies. The following day, after washing with PBS, the sections were stained with secondary antibody at room temperature for 1 hour. After washing again, the samples were covered with coverslips using ProLong Gold anti-fading mounting medium (Invitrogen) containing DAPI. Immunofluorescence images were captured using a fluorescence microscope (40x, BX53, Olympus). A slide stained only with secondary antibody was used as a negative control.

[0073] Blood biochemical analysis showed that in mice that aged naturally for 48 weeks, serum bile function indicators (T-Bil; Figure 2), liver function indicators (GOT and GPT; Figures 3A and 3B), and kidney function indicators (Alb, Cre, BUN, and UA; Figures 4A, 4B, 4C, and 4D) all showed an increasing trend; however, after 12 weeks of feeding with Fuhua Drink, all indicators showed a significant decreasing trend. Furthermore, after 12 weeks of feeding with Fuhua Drink, improvements in blood lipid indicators (T-Cho, TG, and T-pro; Figures 5A, 5B, and 5C) were observed, which helped delay liver and kidney lesions.

[0074] In addition, the results of kidney tissue staining showed that natural aging caused a decrease in the expression of Klotho protein and PGC-1α protein in kidney tissue; while in mice that were fed Fuhua Drink for 12 weeks at age 48, the expression of Klotho protein and PGC-1α protein was significantly restored overall (Figure 6), and the expression of Klotho protein and PGC-1α protein also tended to increase with the increase of the concentration of Fuhua Drink.

[0075] The above results show that the Chinese herbal medicine composition (Fuhua Yin) disclosed in this study can effectively protect liver, gallbladder and kidney function and prevent functional disorders caused by aging.

[0076] While some specific embodiments of the present disclosure have been described in detail above, those skilled in the art can make various modifications and alterations to the illustrated embodiments without substantially departing from the teachings and advantages of the present disclosure. Therefore, such modifications and alterations should still be included within the scope of the present disclosure as set forth in the appended claims.

[0077] none.

Claims

1. A traditional Chinese medicine composition comprising: Artemisia argyi, Ohwia caudata, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandifloras, Glycyrrhiza uralensis, Perilla frutescens, Chrysanthemum × morifolium, Anisoles indica, Zingiber officinale, and Carthamus tinctorius; wherein, Based on the total weight of the Chinese herbal medicine components, the content of Artemisia argyi is 10 to 20%, the content of Artemisia argyi is 10 to 20%, the content of Ophiopogon japonicus is 5.0 to 15%, the content of Houttuynia cordata is 5.0 to 15%, the content of Platycodon grandiflorus is 5.0 to 15%, the content of Glycyrrhiza uralensis is 1.0 to 10%, the content of Perilla frutescens is 1.0 to 10%, the content of Chrysanthemum morifolium is 0.1 to 1.0%, the content of Gynostemma pentaphyllum is 10 to 20%, the content of Zingiber officinale is 10 to 30%, and the content of Carthamus tinctorius is 1.0 to 10%.

2. The traditional Chinese medicine composition as described in claim 1, based on the total weight of the traditional Chinese medicine composition, contains 12.76% of Artemisia argyi, 12.76% of Artemisia argyi, 8.51% of Ophiopogon japonicus, 8.51% of Houttuynia cordata, 8.51% of Platycodon grandiflorus, 4.25% of Glycyrrhiza uralensis, 4.25% of Perilla frutescens, 0.45% of Chrysanthemum morifolium, 15% of Clematis armandii, 20% of Zingiber officinale, and 5% of Carthamus tinctorius.

3. Use of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a medicament for treating visceral dysfunction in an individual; wherein, The internal organs are the liver, gallbladder, and kidneys.

4. The use as described in claim 3, wherein, This visceral dysfunction includes visceral dysfunction caused by aging and visceral dysfunction caused by chemotherapy drugs.

5. The use as described in claim 3, wherein, The drug is an aqueous extract of the traditional Chinese medicine composition as described in claim 1 or 2, obtained by boiling water extraction.

6. The use as described in claim 3, wherein, The effective dose of this drug is 10 mg to 500 mg per kilogram of body weight.

7. The use as described in claim 5, wherein, The drug contains pharmaceutically acceptable excipients.

8. The use as described in claim 3, wherein, This medication is an oral dosage form.

9. The use as described in claim 3, wherein, The drug lowers the individual's total bilirubin.

10. The use as described in claim 3, wherein, The drug lowers the individual's GOT and GPT.

11. The use as described in claim 3, wherein, The drug lowers the individual's Alb, Cre, BUN, and UA.

12. The use as described in claim 3, wherein, The drug lowers the individual's T-Cho, TG, and T-pro.

13. The use as described in claim 3, wherein, The drug enhances the expression of Klotho and PGC-1α proteins in this individual.

14. The use as described in claim 3, wherein, This medication is intended to treat the individual's acute hepatitis, cirrhosis, drug-induced liver injury including chemotherapy, alcohol-induced liver injury, intrahepatic cholestasis, obliterative jaundice, viral hepatitis including type B or C, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, non-alcoholic steatohepatitis (NASH), age-related liver dysfunction, age-related biliary dysfunction, drug-induced kidney injury from chemotherapy, glomerulonephritis, glomerulosclerosis, nephrotic syndrome, hypertensive nephrosclerosis, hyperuricemia, end-stage renal disease, uremia, and age-related renal dysfunction.

Images