Cistanche or its extract, composition and use thereof

Abstract

The present application discloses the use of scutellaria baicalensis or its extract in the preparation of a drug for treating and / or preventing diseases caused by liver damage, and the use of scutellaria baicalensis or its extract in the preparation of a drug for treating and / or preventing diseases and / or conditions related to diseases caused by liver damage. The scutellaria baicalensis or its extract involved in the present application can effectively alleviate liver enlargement, improve liver antioxidant function, and effectively prevent and alleviate diseases caused by liver damage. It can also effectively alleviate abnormal biochemical indicators and liver pathological abnormalities caused by liver damage, and significantly alleviate the progression of acute liver damage.

Description

Technical Field

[0001] The present application relates to the field of traditional Chinese medicine or pharmaceutical chemistry, and specifically to gentiana or its extract, its composition and use thereof. Background Art

[0002] The liver is the main organ for absorption, distribution, metabolism and elimination in the human body, and plays a key role in sugar metabolism, protein metabolism, lipid metabolism, etc. Factors such as viral infection, bacterial infection, alcohol, drug-induced liver injury, liver ischemia-reperfusion, and pathogenic liver injury will stimulate the body to produce too many highly reactive oxygen free radicals, induce oxidative stress, and trigger an inflammatory response, which will lead to liver cell apoptosis, hepatitis, liver fibrosis, liver injury and other lesions.

[0003] With the rapid development of medical technology, many studies have been conducted on drugs for the treatment of liver damage, mainly including Chinese herbal medicine, biological drugs, chemical drugs and trace elements. However, some studies have shown that some drugs against liver damage will inevitably produce biological toxicity. It can be seen that the prevention and treatment of liver damage is still a serious issue.

[0004] Traditional Chinese medicine is a treasure of traditional Chinese medicine. Many Chinese medicines and Chinese medicine ingredients that have the effects of clearing away heat and detoxifying, promoting dampness and relieving jaundice, promoting blood circulation and removing blood stasis, soothing the liver and regulating qi can directly treat liver damage without producing very obvious toxic side effects. Therefore, the research and development of these drugs has important practical significance for the treatment of clinical liver damage. Summary of the invention

[0005] At present, there is no disclosure of the protective effect of scutellaria baicalensis on liver damage. The present application has found through a large number of experiments that scutellaria baicalensis or its extract can be used to prevent and treat diseases caused by liver damage.

[0006] Specifically, this application adopts the following technical solutions:

[0007] 1. Use of Herba Cicadae or its extract in the preparation of a medicament for treating and / or preventing diseases caused by liver damage.

[0008] 2. Use of Herba Cicadae or its extract in the preparation of a medicament for treating and / or preventing diseases and / or conditions associated with diseases caused by liver damage.

[0009] 3. The use according to item 1 or 2, wherein the disease caused by liver damage is selected from any one of acute liver damage, chronic liver damage, liver fibrosis, cirrhosis, and liver cancer.

[0010] 4. The use according to item 1 or 2, wherein the cause of the liver damage is selected from any one of trauma, drugs, alcohol, chemical toxic substances, viruses or autoimmunity.

[0011] 5. The use according to item 1 or 2, wherein the drug is used in mammals.

[0012] 6. The use described in item 1 or 2, wherein the drug is used for humans, and preferably, a single dose of the drug is equivalent to 15g to 120g of raw stone grass, and more preferably 30g to 60g of raw stone grass.

[0013] 7. The use according to item 1 or 2, wherein the Herba Lycopodii extract is a Herba Lycopodii water extract or a Herba Lycopodii alcohol extract.

[0014] 8. The use described in item 7, wherein the water extract of Herba Lycopodii is extracted by the following method:

[0015] Grinding: Take the herb and grind it into coarse powder;

[0016] Water heating reflux extraction: Take the coarse powder and add pure water, reflux extraction, filter and add pure water again, reflux extraction again, filter and combine the two filtrates;

[0017] Concentration of the filtrate: The filtrate is concentrated under reduced pressure to obtain the Herba Lycopodii water extract.

[0018] 9. The use according to item 7, wherein the alcohol extract of Cicadae officinalis is extracted by the following method:

[0019] Grinding: Take the herb and grind it into coarse powder;

[0020] Ethanol heating reflux extraction: take the crude powder and add ethanol, reflux extraction, filter and add ethanol again, reflux extraction again, filter and combine the two filtrates;

[0021] Concentrating the filtrate: The filtrate is concentrated under reduced pressure to obtain the cicadae alpiniae alcohol extract.

[0022] 10. The use according to any one of items 1 to 3, wherein the drug further comprises one or more other active substances.

[0023] 11. A composition for treating and / or preventing diseases caused by liver damage, wherein the composition comprises Herba Lycopodii or an extract thereof as the sole active ingredient.

[0024] 12. The composition of item 11, wherein the composition further comprises one or more pharmaceutically acceptable carriers or excipients, or further comprises one or more other active substances.

[0025] 13. The composition according to Item 11 or 12, wherein the disease caused by liver damage is the disease according to Item 3 or 4.

[0026] 14. The composition according to item 11 or 12, wherein the extract of the Herba Lycopodii is the extract of the Herba Lycopodii as described in any one of items 7 to 9.

[0027] Effects of the Invention

[0028] The scutellaria baicalensis or its extracts involved in this application can effectively relieve liver enlargement, improve liver antioxidant function, effectively prevent and relieve diseases caused by liver damage. It can also effectively relieve abnormal biochemical indicators and liver pathological abnormalities caused by liver damage, and significantly alleviate the progression of acute liver damage.

[0029] In addition, the resources of stone grass are abundant and low in price. The preparation method of the stone grass extract of the present application is simple and the preparation cost is low, which meets the requirements of industrial production. It has practical significance and application value for development as a medicine or product, and also improves the utilization rate of stone grass to a certain extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings are used to better understand the present application and do not constitute an improper limitation on the present application.

[0031] Figure 1 Pathological sections of liver tissues of mice in each group of CCl4 liver injury model;

[0032] Figure 2 Changes of serum alanine aminotransferase (ALT) in mice of different groups (n=5);

[0033] Figure 3 The changes of serum aspartate aminotransferase (AST) in mice of different groups (n=5);

[0034] Figure 4 The changes of glutathione peroxidase (GSH) in liver tissues of mice in different groups (n=5);

[0035] Figure 5 The changes of superoxide dismutase (SOD) in liver tissue of mice in different groups (n=5);

[0036] Figure 6 The changes of catalase (CAT) in liver tissue of mice in different groups (n=5).

[0037] (Compared with model control, *, P < 0.05; **, P < 0.001; ***, P < 0.0005; ****, P < 0.0001) DETAILED DESCRIPTION

[0038] The following is a description of the exemplary embodiments of the present application, including various details of the embodiments of the present application to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be recognized by those of ordinary skill in the art that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present application. Similarly, for clarity and conciseness, the description of well-known functions and structures is omitted in the following description.

[0039] The present application provides a use of gentiana scabra or an extract thereof in the preparation of a medicament for treating and / or preventing diseases caused by liver damage.

[0040] The present application also provides a use of Herba Cicadae or an extract thereof in the preparation of a medicament for treating and / or preventing diseases and / or conditions associated with diseases caused by liver damage.

[0041] Herb of Dindygulen Peperomia, the medicinal part is the whole herb of Peperomia dindigulensis Miq. of the Piperaceae family, which is mainly distributed in Fujian, Taiwan, Guangxi, Guangdong, Yunnan, Guizhou and other places. It is also known as fire-injured leaf, pepper grass, and blood-dispersing gallbladder; it is cool in nature, light in taste, and slightly bitter. It enters the lung meridian, spleen meridian, liver meridian, and kidney meridian. It is mainly used to clear away heat and detoxify, reduce swelling and disperse blood stasis, relieve pain and promote diuresis. It is a heat-clearing and detoxifying medicine classified under heat-clearing medicine. It is commonly used clinically to treat gastric cancer, esophageal cancer, lung cancer, breast cancer, traumatic injuries, scalds and burns, carbuncles, nephritic edema, tuberculosis, asthma, tracheobronchitis, and lung heat cough.

[0042] Liver damage mainly refers to liver cell damage, liver structure and function abnormalities. Liver damage will stimulate the body to produce too many highly reactive oxygen free radicals, induce oxidative stress, trigger inflammatory reactions, lead to liver cell damage and apoptosis, and release too much transaminase into the blood, thus affecting normal liver function. If not prevented and treated in time, it may induce a series of complications or promote the development of other diseases.

[0043] The present application innovatively discovered that Herba Cicadae or its extracts have therapeutic or preventive effects on diseases caused by liver damage.

[0044] There are many causes of liver damage, mainly drug poisoning, viral infection, excessive alcohol intake, immune response, contact with chemical toxic substances in the environment, radiation damage, etc. The scutellaria baicalensis or its extract of the present application has a therapeutic or preventive effect on diseases caused by liver damage. The cause of liver damage is not limited. As long as the liver cells are damaged, the liver structure and function are abnormal, the liver damage is within the scope of the present application. In a preferred embodiment, the liver damage is caused by alcohol, viruses, drugs and chemical toxic substances.

[0045] The specific types of diseases caused by liver damage are not limited in this application, as long as they are caused by liver damage, they are within the protection scope of this application, including but not limited to acute liver damage, chronic liver damage, liver fibrosis, cirrhosis, hepatitis, liver cancer, fatty liver, liver failure, etc., such as liver damage, fatty liver, hepatitis, cirrhosis, liver failure, etc. caused by factors such as alcohol. In a preferred embodiment, the disease is acute liver damage or chronic liver damage.

[0046] The diseases and / or conditions related to diseases caused by liver damage refer to other diseases or conditions caused by liver damage. These diseases or conditions may appear due to liver damage, and may also be alleviated or disappear after the liver damage is treated.

[0047] The term "prevention and / or treatment" means that the disease or disorder described herein can be treated, prevented, alleviated and / or alleviated in a subject.

[0048] The term "disease and / or condition" refers to a physical condition of the subject, which is associated with the disease and / or condition described herein.

[0049] The drug can be used for patients or other animals that receive the drug of the present application to treat, prevent, alleviate and / or relieve the diseases or symptoms described in the present application. In a preferred embodiment, the drug is used for mammals, including but not limited to humans, cattle, horses, sheep, pigs, goats, rabbits, cats, dogs, mice and any other mammals that have livers and can cause damage.

[0050] In a preferred embodiment, the medicament is for use in humans.

[0051] The dosage of the drug of the present application depends on many factors, such as the nature and severity of the disease to be prevented or treated, the sex, age, weight and individual response of the patient or animal, the route of administration and the number of administrations, etc. The above dosage can be administered in a single dosage form or divided into several, such as two, three or four dosage forms. The dosage level must be selected based on the specific route of administration, the severity of the condition to be treated, and the condition and previous medical history of the patient to be treated.

[0052] However, it should be recognized that the total daily dosage of the drug of the present application must be determined by the attending physician within the scope of sound medical judgment. For any particular patient, the specific therapeutically effective dosage level must be determined based on a variety of factors, including the disorder being treated and the severity of the disorder; the specific composition used; the patient's age, weight, general health, sex and diet; administration time, route of administration and excretion rate; duration of treatment; drugs used in combination or concurrently; and similar factors known in the medical field. For example, the practice in the art is to start the administration of a dose lower than the level required to obtain the desired therapeutic effect and gradually increase the dose until the desired effect is obtained.

[0053] In a further preferred embodiment, the drug is administered in a single dose form, i.e., a single dose form. In a further preferred embodiment, the single dose administered is equivalent to 15g to 150g of raw stone cicada grass, for example, it can be 16g, 17g, 18g, 19g, 20g, 30g, 40g, 50g, 60g, 70g, 80g, 90g, 100g, 110g, 120g, 130g, 140g, and more preferably 30g to 60g of raw stone cicada grass. It should be understood by those skilled in the art that, under normal circumstances, a person's weight is calculated as 60kg. If the person's weight is not 60kg, it can be converted according to this standard.

[0054] The drug of the present application can be administered in a unit dosage form, and the administration route can be enteral or parenteral, such as oral, intramuscular, subcutaneous, nasal, oral mucosa, skin, peritoneum or rectum, etc. The dosage form is, for example, tablets, capsules, dripping pills, aerosols, pills, powders, solutions, suspensions, emulsions, granules, liposomes, transdermal agents, buccal tablets, suppositories, freeze-dried powder injections, etc. It can be a common preparation, a sustained-release preparation, a controlled-release preparation and various microparticle delivery systems.

[0055] The extract of gentiana scabra can be a water extract of gentiana scabra or an alcohol extract of gentiana scabra, or a mixture of water-alcohol extracts.

[0056] The whole herb of Glechoma longituba and any parts thereof, such as roots, stems, leaves, flowers, etc., can be used to prepare the Glechoma longituba extract.

[0057] The terms "drug materials", "Chinese medicinal materials", "traditional Chinese medicine", etc., can be materials of natural origin (such as minerals or plants). In addition to their pharmacologically active effects as treatments, they can also have effects for preventing and regulating physiological functions, and of course, they can also have other physiological effects not listed in this article.

[0058] The "Schizonepeta herba medicinal materials" mentioned below refer to the whole herb and / or any part of Schizonepeta herba.

[0059] The extraction method of the water extract of the Herba Lycopodii can use any water extraction method in the art. In a preferred embodiment, the present application adopts the following method to prepare the water extract of the Herba Lycopodii:

[0060] Grinding: Take the herb and grind it into coarse powder;

[0061] Water heating reflux extraction: Take the coarse powder and add pure water, reflux extraction, filter and add pure water again, reflux extraction again, filter and combine the two filtrates;

[0062] Concentrating the filtrate: The filtrate is concentrated under reduced pressure to obtain the water extract of the Herba Lycopodii.

[0063] The water can be any form of water in this field, such as purified water, deionized water, secondary water, etc.

[0064] The number of reflux extractions is not limited in this application and can be one, two, three, four or more times.

[0065] The extraction method of the scutellaria baicalensis alcohol extract can use any water extraction method in the art. In a preferred embodiment, the present application adopts the following method to prepare the scutellaria baicalensis alcohol extract:

[0066] Grinding: Take the herb and grind it into coarse powder;

[0067] Ethanol heating reflux extraction: take the crude powder and add ethanol, reflux extraction, filter and add ethanol again, reflux extraction again, filter and combine the two filtrates;

[0068] Concentrating the filtrate: The filtrate is concentrated under reduced pressure to obtain the cicadae alpiniae alcohol extract.

[0069] The ethanol may be any other common alcohol in the art, such as methanol, propanol, butanol, etc.

[0070] The number of reflux extractions is not limited in this application and can be one, two, three, four or more times.

[0071] In a preferred embodiment, the medicine optionally contains a pharmaceutically acceptable carrier or excipient. Including but not limited to lactose, glucose, sucrose, sorbitol, mannitol, starch, gum arabic, calcium phosphate, alginate, gel, calcium silicate, microcrystalline cellulose, polyvinyl pyrrolidone, cellulose, water, syrup, methylcellulose, methyl hydroxybenzoate, propyl hydroxybenzoate, talcum, magnesium stearate and mineral oil, but are not limited thereto. In addition to the above-mentioned components, the medicine of the present application may also include lubricants, wetting agents, sweeteners, flavoring agents, emulsifiers, suspending agents and preservatives, etc.

[0072] In a preferred embodiment, the drug used in the present application for treating and / or preventing diseases caused by liver damage may further contain one or more other active substances. The other active substances refer to other substances that are active and produce certain functions other than the herba scutellariae or its extracts. The active substances may be active substances for treating or preventing diseases caused by liver damage, or they may be active substances for assisting in the treatment or prevention of diseases caused by liver damage, or they may not be active substances for treating diseases caused by liver damage, but they may play a positive effect or function in other convenient ways. The active substances may be, for example, one or more of wolfberry, astragalus, mulberry leaves, artemisia capillaris, coix seeds, salvia miltiorrhiza, hawthorn, licorice, etc. or their extracts. The other active substances may be original medicinal materials or extracts thereof (e.g., water extracts, alcohol extracts, or extracts of alcohol-water mixtures).

[0073] The present application further provides a composition for treating and / or preventing diseases caused by liver damage, wherein the composition contains Herba Lycopodii or an extract thereof as the sole active ingredient.

[0074] The term "composition" is intended to encompass a product comprising the specified ingredients in the specified amounts, as well as any product which results, directly or indirectly, from combination of the specified ingredients in the specified amounts.

[0075] In a preferred embodiment, the composition further comprises one or more pharmaceutically acceptable carriers or excipients. The one or more pharmaceutically acceptable carriers or excipients are any of the carriers or excipients described above.

[0076] In a preferred embodiment, the composition further comprises one or more other active substances. The one or more other active substances are any of the other active substances described above.

[0077] The disease caused by liver damage is any of the diseases caused by liver damage described above.

[0078] The gentiana extract is any one of the gentiana extracts described above.

[0079] The composition according to any one of the present application may be in the form of an injection, oral solution, capsule, tablet, granule, or extract remix.

[0080] The composition according to any one of the items of the present application can be administered in a single dose form, and the administration route can be enteral or parenteral, such as oral, intramuscular, subcutaneous, nasal, oral mucosa, skin, peritoneum or rectum, etc. The dosage form is, for example, tablets, capsules, dripping pills, aerosols, pills, powders, solutions, suspensions, emulsions, granules, liposomes, transdermal agents, buccal tablets, suppositories, freeze-dried powder injections, etc. It can be a common preparation, a sustained-release preparation, a controlled-release preparation and various microparticle delivery systems.

[0081] The dosage of the composition according to any one of the present applications can be converted with reference to the dosage of the Herba Lycopodii or its extract as described above.

[0082] In the present application, the terms "alanine aminotransferase (ALT)" and "aspartate aminotransferase (AST)" are enzymes whose blood levels increase when the liver is damaged, and are enzymes used as liver function indicators using this property.

[0083] In the present application, the terms, "glutathione peroxidase (GSH)", reduces toxic hydrogen peroxide to non-toxic hydroxyl compounds, thereby protecting biological membranes from damage by reactive oxygen species and maintaining normal cell function; and "superoxide dismutase (SOD)" is an enzyme that can catalyze the conversion of superoxide into oxygen and hydrogen peroxide through a dismutation reaction, both of which are enzymes whose levels change in the liver when the liver is damaged, and this is an enzyme that utilizes this property to serve as the liver's antioxidant activity.

[0084] Catalase (CAT) is an enzyme that catalyzes the decomposition of H2O2 to produce H2O and O2. It is an enzyme used as an indicator of liver function by showing activity against oxidative damage by removing H2O2.

[0085] The stone cicada grass or its extract involved in the present application has the effect of treating and / or preventing diseases caused by liver damage. The present application verifies the application of stone cicada grass or its extract in the preparation of liver protection products through mouse model experiments. The stone cicada grass or its extract can effectively alleviate liver enlargement caused by CCl4, improve the liver's antioxidant function, and effectively prevent and alleviate liver damage caused by CCl4.

[0086] Drugs commonly used in the prior art for treatment or prevention, such as the positive drug DDB used in the present application, have the ability to significantly and rapidly reduce transaminase, but the histological changes on the liver are not obvious, and in fact the anti-inflammatory and hepatocyte protection effects are poor. Other drugs, such as silymarin, have low bioavailability, and the effect of being directly absorbed and utilized in the intestine after taking them is poor, and the application effect is slow and the course of treatment is relatively long. The stone cicada grass or its extract of the present application has the ability to significantly and rapidly reduce transaminase, protect the histological morphology of the liver, can be comprehensively conditioned, and is gentle and safe.

[0087] Example

[0088] Experimental Materials

[0089] Experimental animals: SPF-grade male C57BL / 6 mice, weighing (22±2) g and 8 weeks old. Purchased from Zhuhai Besttone Biotechnology Co., Ltd., animal license number: [SCXK·(Guangdong) 2022-0051];

[0090] Experimental drugs and reagents: 95% ethanol (AR), Shanghai Macklin Biochemical Co., Ltd.;

[0091] Carbon tetrachloride (HPLC), Shanghai Macklin Biochemical Co., Ltd.;

[0092] Olive oil (pharmaceutical grade), Shanghai Macklin Biochemical Co., Ltd., liver function and oxidative stress detection kits, Nanjing Jiancheng Bioengineering Research Institute Co., Ltd.;

[0093] Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag. used in the preparation of Example 1 (purchased from Anguo Digital Chinese Medicine City);

[0094] Normal saline;

[0095] Aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutathione (GSH), superoxide dismutase (SOD), catalase (CAT) kits (all the above kits were purchased from Nanjing Jiancheng Technology Co., Ltd.).

[0096] Preparation of the Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag. extract in Example 1

[0097] In this example, water extraction and alcohol extraction were carried out on Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag. respectively, and the specific methods are as follows.

[0098] 1.1 Water extraction

[0099] (1) Preliminary crushing: Take the Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag. medicinal materials and crush them into coarse drug powder.

[0100] (2) Heating under reflux extraction with pure water and ethanol: Take the dry coarse drug powder of Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag., add pure water at 8 times the mass, reflux for 1 hour, filter, then add pure water at 8 times the mass again, reflux for 1 hour, and filter. Combine the two filtrates.

[0101] (3) Concentration of the filtrate: Concentrate the above filtrate under reduced pressure to a relative content of 1 g / mL of the original medicinal materials.

[0102] 1.2 Alcohol extraction

[0103] (1) Preliminary crushing: Take the Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag. medicinal materials and crush them into coarse drug powder.

[0104] (2) Heating under reflux extraction with 95% ethanol: Take the dry coarse drug powder of Peucedanum terebinthaceum (Fisch.) Fisch. ex Turcz. var. lanceolatum (Wulf.) Kitag., add 95% ethanol at 8 times the mass, reflux for 1 hour, filter, then add 95% ethanol at 8 times the mass again, reflux for 1 hour, and filter. Combine the two filtrates.

[0105] (3) Filtrate concentration: The filtrate is concentrated under reduced pressure until the relative content of the original medicinal material is 1 g / mL.

[0106] Example 2 Experimental methods and results of the effect of gentiana scabra extract on carbon tetrachloride-induced acute liver damage in mice.

[0107] 2.1 Experimental methods

[0108] 2.1.1 Animal grouping and drug administration

[0109] Experimental method: After 7 days of animal adaptive feeding, 56 C57BL / 6J mice were randomly divided into 7 groups, including normal control group, model control group, bifendate positive control group, low-dose and high-dose water extract of gentiana, and low-dose and high-dose alcohol extract of gentiana. Each group was fed with ordinary feed and free access to food and water. The feeding cycle was 1 week. Starting from the first day, the mice in the normal control group and model control group were gavaged with physiological saline, and the mice in the low-dose and high-dose water extract / alcohol extract of gentiana were gavaged with 3.9g / kg and 7.8g / kg of gentiana, respectively, for 7 consecutive days.

[0110] 2.1.2 Establishment of CCl4 acute liver injury model

[0111] Within 1 hour after the last administration, mice in all groups except the control group were subcutaneously injected with 1% CCl4 olive oil solution to induce acute liver injury in mice.

[0112] 2.1.3 Sample collection and processing

[0113] The mice were killed after 16 hours, and the liver lobes were fixed with 4% formalin solution, embedded in paraffin and sectioned. After H&E staining, pathological changes such as hepatocyte necrosis, watery changes of hepatocytes, and inflammatory cell infiltration were observed under a light microscope. Serum and liver were collected and stored at -80°C for testing.

[0114] Statistical analysis: All experimental data were analyzed using Graphpad Prism 9.0 statistical software. p<0.05 was considered to be significantly different, and p<0.01 was considered to be extremely significantly different.

[0115] 2.2 Results

[0116] 2.2.1 Pathological sections of liver of mice in each group

[0117] The liver tissues of mice in the normal control group / blank control group (NC), model group (CCl4), bifendate group (DDB), high-dose group (SCC-SH), low-dose group (SCC-SL) of water extract of S. ciliata, and high-dose group (SCC-CH), low-dose group (SCC-CL) of alcohol extract of S. ciliata were sliced ​​and H&E staining was performed to observe the liver tissues. Figure 1 As shown in the data, the blank control group (NC) maintained a basically normal liver lobule structure, the liver plates were neatly arranged, the liver sinusoids did not show obvious expansion, no interface inflammation, and no obvious necrosis, regeneration, or degeneration of the liver cells; the model group (CCl4) had a slightly disordered liver lobule cell structure, turbid swelling of the liver cells, and watery degeneration, and the model was successfully established; a small amount of watery deformation could be observed in the diphenyl diester group (DDB), but it was somewhat improved compared with the model group; the high-dose group (SCC-SH) and low-dose group (SCC-SL) of the water extract of S. cicadae and the high-dose group (SCC-CH) and low-dose group (SCC-CL) of the alcohol extract of S. cicadae were all improved compared with the model group, especially the low-dose group of water extract and the low-dose group of alcohol extract, whose liver cells had no turbid swelling, watery degeneration, etc., and the improvement was obvious.

[0118] 2.2.2 Serum ALT and AST levels of mice in each group

[0119] After the experiment, the serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in each group of mice were measured. Figure 2 and Figure 3 shown.

[0120] Depend on Figure 2-3 It can be seen that compared with the blank control group, the serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of mice in the model control group increased significantly (p<0.01), indicating that CCl4 injection caused liver cell damage and liver function decline, and the model was successfully established. Both low and high doses of water extract and alcohol extract of Herba Cicadae can significantly reduce the activity of AST and ALT enzymes in serum (p<0.01), indicating that Herba Cicadae can effectively alleviate CCl4-induced liver damage and has a liver protective effect.

[0121] 2.2.3 Levels of GSH, SOD, and CAT in the liver of mice in each group

[0122] At the same time, the levels of glutathione (GSH), superoxide dismutase (SOD), and catalase (CAT) in the livers of mice in each group were determined. Figures 4 to 6 shown.

[0123] Depend on Figures 4 to 6 It can be seen that compared with the blank control group, the glutathione (GSH), superoxide dismutase (SOD), and catalase (CAT) in the liver of the model control group mice were significantly reduced (p<0.01), while malondialdehyde (MDA) was significantly increased, indicating that injection of CCl4 is prone to cause oxidative damage to liver cells, and the model was successfully established. Low and high doses of water extraction and low and high doses of alcohol extraction of Cicadae Herba can significantly increase the activity of SOD, GSH, and CAT enzymes in the liver (p<0.01), indicating that Cicadae Herba can effectively alleviate CCl4-induced liver oxidative damage and has an antioxidant protective effect on the liver.

[0124] Although the embodiments of the present application are described above, the present application is not limited to the above specific embodiments and application fields, and the above specific embodiments are merely illustrative and instructive, rather than restrictive. A person of ordinary skill in the art can make many forms under the guidance of this specification and without departing from the scope of protection of the claims of the present application, all of which belong to the protection of the present application.

Claims

1. Use of Herba Lycopodii or its extract in the preparation of a medicament for treating and / or preventing acute liver injury, wherein Herba Lycopodii or its extract is the sole active ingredient.

2. The use according to claim 1, wherein The cause of the acute liver injury is selected from any one of trauma, drugs, alcohol, chemical toxic substances, viruses or autoimmunity.

3. The use according to claim 1, wherein The medicament is for use in mammals.

4. The use according to claim 1, wherein A single dose of the drug is equivalent to 15g to 120g of raw stonecrop grass.

5. The use according to claim 4, wherein A single dose of the medicine is equivalent to 30g to 60g of raw stonecrop.

6. The use according to claim 1, wherein The extract of gentiana scabra is a water extract of gentiana scabra or an alcohol extract of gentiana scabra.

7. The use according to claim 6, wherein The water extract of Herba Lycopodii is extracted by the following method: Grinding: Take the herb and grind it into coarse powder; Water heating reflux extraction: Take the coarse powder and add pure water, reflux extraction, filter and add pure water again, reflux extraction again, filter and combine the two filtrates; Concentrating the filtrate: The filtrate is concentrated under reduced pressure to obtain the water extract of the Herba Lycopodii.

8. The use according to claim 6, wherein The cicadae alcohol extract is extracted by the following method: Grinding: Take the herb and grind it into coarse powder; Ethanol heating reflux extraction: take the crude powder and add ethanol, reflux extraction, filter and add ethanol again, reflux extraction again, filter and combine the two filtrates; Concentrating the filtrate: The filtrate is concentrated under reduced pressure to obtain the cicadae alpiniae alcohol extract.

9. A composition for treating and / or preventing liver damage, wherein: The composition comprises gentiana or its extract as the only effective ingredient.

10. The composition according to claim 9, wherein The composition further comprises one or more pharmaceutically acceptable carriers or excipients.

11. The composition according to claim 9 or 10, wherein The liver injury is acute liver injury.

12. The composition according to claim 9 or 10, wherein The gentiana extract is the gentiana extract involved in any one of claims 6-8.

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