Traditional Chinese medicine composition with effects of protecting liver and detoxifying as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and particularly provides a traditional Chinese medicine composition with liver protection and detoxification effects as well as a preparation method and application thereof. The traditional Chinese medicine composition comprises the following components: flos puerariae, cyrtomium fortunei, radix scutellariae, black beans, liquorice, poria cocos, rhizoma atractylodis macrocephalae, white hyacinth beans, rhizoma alismatis, fructus amomi, an oyster extract and vitamin C. The traditional Chinese medicine composition has the effects of protecting liver, detoxifying, tonifying spleen and promoting diuresis, can play a role aiming at the property of wine and alcoholic liver injury, and has a good application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition with liver protection and detoxification effects, its preparation method and applications. Background Art

[0002] Wine has a long history in China, and the custom of Chinese people drinking wine has long been integrated into the national culture, forming a unique wine culture. Wine is the king of all medicines and can promote the efficacy of drugs. In ancient times, people often soaked drugs in wine to enhance the drug power and achieve the purposes of health preservation, disease prevention and cold expulsion. After alcohol enters the human body, it is first absorbed in the stomach and small intestine. The liver is the main organ for metabolizing alcohol. Alcohol is oxidized to acetaldehyde by alcohol dehydrogenase in the liver, and acetaldehyde is oxidized to acetic acid through the body's own chemical reactions. The acetyl coenzyme A converted from acetic acid quickly enters the tricarboxylic acid cycle for complete oxidation to release energy, and finally is metabolized into carbon dioxide and water and excreted from the body. If the amount of alcohol ingested in a short time exceeds the liver's metabolic capacity, excessive alcohol will damage multiple systems of the human body and even cause acute alcohol poisoning. The treatment methods of Western medicine for alcohol poisoning include inducing vomiting, promoting alcohol metabolism, promoting wakefulness or sedation, protecting the stomach, etc. Most of the drugs used only target a certain symptom of alcohol poisoning, and combination drugs are often required clinically.

[0003] There are a large number of records about alcohol poisoning in traditional Chinese medicine literature. The disease names include "alcohol toxin", "alcohol accumulation", "alcohol jaundice", "alcohol addiction", etc. There are many medicinal materials recorded in ancient books that can be used for relieving alcohol intoxication, such as Hovenia dulcis, Pueraria lobata, Pueraria flower, Endothelium corneum gigeriae galli, Panax ginseng, Aucklandia lappa, Amomum villosum, Amomum kravanh, etc. Li Gao once put forward in "Treatise on the Spleen and Stomach": "Alcohol is extremely hot and poisonous... inducing sweating and promoting urination are ways to eliminate dampness from the upper and lower parts respectively", which indicates that diaphoresis and purgation are one of the principles for treating alcohol diseases, and he also put forward the milestone formula for relieving alcohol intoxication, "Pueraria flower decoction for relieving alcohol intoxication". Patent literature has also reported many traditional Chinese medicine compounds with the effect of relieving alcohol intoxication. For example, patent number CN106309959A discloses a traditional Chinese medicine composition with the effects of relieving alcohol intoxication and preventing drunkenness, which is made from the following Chinese medicinal materials: Pueraria flower, Medicated leaven, Imperata cylindrica, and Tangerine peel. This traditional Chinese medicine composition is used for treating and relieving mild acute alcohol poisoning and mild chronic alcohol poisoning, and can be used for preventing drunkenness; patent number CN112220907A discloses a traditional Chinese medicine composition with the effects of protecting the liver and relieving alcohol intoxication, which is composed of mulberry, raw hyacinth bean, Pueraria flower, and ginger, and has the effects of preventing drunkenness, protecting the liver, and improving memory impairment; patent number CN115737777A discloses a compound traditional Chinese medicine composition for relieving alcohol intoxication. The traditional Chinese medicine composition is composed of a reasonable combination of multiple ingredients such as Pueraria flower, Tangerine peel, Poria cocos, Polyporus umbellatus, Medicated leaven, Dry ginger, Salvia miltiorrhiza, Gardenia jasminoides, Scutellaria baicalensis, Coptis chinensis, Silybum marianum, Lycium barbarum, barley sprouts, curcumin, oyster extract, chitin, and vitamin C. It can reduce the ethanol content in the blood after drinking, prolong the drunkenness time, shorten the maintenance time of drunkenness, effectively relieve various discomforts after drinking, and has a rapid effect of relieving alcohol intoxication and the effect of preventing drunkenness. At the same time, it has the effect of protecting the liver and can improve the antioxidant capacity of the body.

[0004] In "Collected Annotations to the Classic of Materia Medica", the properties of alcohol were recorded, which considered that alcohol is extremely hot and poisonous; Zhu Danxi put forward the view that "the nature of alcohol is damp" in "Danxi's Heart Method". "Complete Works of Jingyue" states: "Alcohol is made by brewing, its nature is hot, its juice is transformed from water, and its quality is cold. If a person with yin deficiency drinks it excessively, the quality is not enough to nourish yin, and the nature is prone to stir up fire, so the hot person becomes hotter... If a person with yang deficiency drinks it excessively, the nature is not enough to support yang, and the quality remains as water, so the cold person becomes colder." Therefore, excessive drinkers can damage both yin and yang. The effects of alcohol on the human body will change with the changes in physical conditions. Therefore, different people may have different post-drinking manifestations when drinking the same kind of alcohol. Treating discomfort after drinking according to the characteristics of alcohol is a method of treating both the symptoms and the root causes. At the same time, the liver is the main detoxifying organ of the human body, and 90% of alcohol is metabolized in the liver. If one drinks excessively, the metabolic burden on the liver will be greater. There are a wide variety of traditional Chinese medicine products for relieving alcohol intoxication on the current market, with different functions. Most of them can only relieve discomfort after drinking such as dizziness, but they only treat the symptoms and not the root causes. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition with the effects of protecting the liver and detoxifying, its preparation method, and its application.

[0006] The technical solution of the present invention is realized as follows: The present invention provides a traditional Chinese medicine composition with liver protection and detoxification effects, which includes the following components: Pueraria flower, Dryopteris crassirhizoma, Scutellaria baicalensis, black beans, licorice, Poria cocos, Atractylodes macrocephala, white hyacinth bean, Alisma orientale, Amomum villosum, oyster extract and vitamin C.

[0007] In some embodiments, the weights of each component are: 10 - 20 g of Pueraria flower, 5 - 15 g of Dryopteris crassirhizoma, 3 - 18 g of Scutellaria baicalensis, 5 - 20 g of black beans, 5 - 20 g of licorice, 5 - 15 g of Poria cocos, 6 - 20 g of Atractylodes macrocephala, 8 - 20 g of white hyacinth bean, 4 - 15 g of Alisma orientale, 4 - 15 g of Amomum villosum, 2 - 10 g of oyster extract, and 2 - 10 mg of vitamin C.

[0008] In some embodiments, the weights of each component are: 12 - 18 g of Pueraria flower, 5 - 12 g of Dryopteris crassirhizoma, 3 - 15 g of Scutellaria baicalensis, 5 - 20 g of black beans, 6 - 18 g of licorice, 8 - 15 g of Poria cocos, 8 - 18 g of Atractylodes macrocephala, 10 - 20 g of white hyacinth bean, 5 - 15 g of Alisma orientale, 6 - 12 g of Amomum villosum, 2 - 10 g of oyster extract, and 3 - 8 mg of vitamin C.

[0009] In some embodiments, the composition is prepared into granules, powders, oral liquids or capsules.

[0010] In the second aspect, the present invention also provides a preparation method of the above traditional Chinese medicine composition, which includes the following preparation steps:

[0011] Step 1: Take Pueraria flower, Dryopteris crassirhizoma, Poria cocos, Atractylodes macrocephala, Alisma orientale, Amomum villosum, white hyacinth bean, black beans, and licorice, soak them in water and decoct for 4 - 6 times, and then combine the filtrates and concentrate.

[0012] Step 2: Take oyster shells and extract them with an ethanol aqueous solution for 2 - 3 times, and then combine the filtrates and concentrate.

[0013] Step 3: Mix the concentrates obtained in Step 1 and Step 2, and then add vitamin C.

[0014] In some embodiments, the water addition amount in Step 1 is 5 - 10 times the weight of the medicinal materials, and the decocting time is 1 - 3 h / time; in Step 2, the concentration of the ethanol aqueous solution is 40 - 70% vol, the amount of the ethanol aqueous solution used is 5 - 10 times the weight of the oyster shells, and the extraction temperature is 60 - 80°C.

[0015] In some embodiments, Step 1 includes soaking for 1 - 3 h for the first time and then decocting without soaking for subsequent decoctions; in Step 2, a dynamic countercurrent extraction process is adopted.

[0016] In the third aspect, the present invention also provides an application of the above traditional Chinese medicine composition in the preparation of anti - hangover and liver - protecting drugs.

[0017] In some embodiments, the drug is used for: accelerating ethanol metabolism to reduce blood alcohol concentration; improving liver cell damage caused by alcohol; relieving post - drinking discomfort symptoms such as headache and nausea.

[0018] In some embodiments, the drug is used for preventing or treating alcohol - related liver diseases such as alcoholic fatty liver and liver fibrosis.

[0019] The present invention has the following beneficial effects compared with the prior art:

[0020] The traditional Chinese medicine composition provided by this product is composed of a variety of Chinese herbal medicines, oyster extract with liver - protecting and anti - chemical liver injury effects, and vitamin C for preventing liver fibrosis, reducing the burden on the liver, and promoting metabolism. The ancients believed that wine is hot in nature and wet in quality, and people with different constitutions will have different manifestations after drinking. Zhang Jiebin, a medical expert in the Ming Dynasty, believed that after people with a relatively yin - deficient constitution drink a large amount of wine, the wet nature of the wine not only fails to play a role, but its hot nature will instead help fire generate heat, making people with yin - deficiency even more dry and hot. For people with a relatively yang - deficient constitution, although the hot nature of the wine can dredge the channels and activate collaterals, it cannot support the yang qi of the human body, causing water and dampness to stay in the human body and cause problems. Shu Zhao, a medical expert in the Qing Dynasty, believed that "there is wetness and heat in wine... those with a weak and cold constitution originally do not suffer from heat, but only suffer from its wetness", which proves the view that wine is hot in nature and wet in quality.

[0021] In the formula, Puerariae Flos is a specific drug for relieving alcoholism and has the effect of relieving alcoholism and awakening the spleen. Puerariae Flos enters only the Yangming meridian and can make the pathogenic dampness exude from the muscle surface. "Bielu" states that it "maintains the elimination of alcohol"; Black Soybean tastes sweet and is neutral in nature, and has the effects of benefiting essence and improving eyesight, nourishing blood and expelling wind, promoting diuresis, and detoxifying. "Ri Huazi Zhujia Bencao" records that Black Soybean can "detoxify the toxicity of metallic and stone medicines and treat the warm toxicity of cattle and horses", and "Beiji Qianjin Yaofang" records that Black Soybean can "detoxify all poisons". The two are the monarch drugs; Dryopteris Crassirhizoma tastes bitter and is slightly cold.

[0022] "Shennong Ben Cao Jing" records that Dryopteris crassirhizoma "is mainly used to treat pathogenic heat qi in the abdomen and various toxins". Dryopteris crassirhizoma mainly enters the liver meridian and can relieve all kinds of heat toxins, including food toxins, alcohol toxins, drug toxins, etc., and can assist the monarch drug in exerting the function of detoxification; Poria cocos and Alisma orientale promote diuresis and percolate dampness, enabling the dampness of alcohol to be excreted through urine. Matched with Pueraria flower, it enables the dampness of alcohol to be eliminated from both inside and outside, targeting the dampness of the alcohol quality. The three are all ministerial drugs; alcohol enters the stomach through the mouth and is digested during the transportation of the qi of the spleen earth. Therefore, the spleen and stomach are damaged first. Atractylodes macrocephala and Dolichos lablab can strengthen the spleen and replenish qi, transform dampness and promote diuresis, which can not only protect the qi consumed by the spleen and stomach, but also assist in transporting and transforming water dampness; Amomum villosum belongs to the spleen and stomach meridians, can warm the spleen and transform dampness, promote appetite and regulate qi, assist the spleen in transporting damp pathogens and warm the spleen and stomach to prevent the yang from being damaged by the cold transformation of water dampness. The three are all adjuvant drugs; Licorice can relieve the pungency of drugs and reduce the toxic and side effects of drugs, and has the function of harmonizing all kinds of drugs. It is known as the "national old". Matched with black beans, it can enhance its detoxification effect and is the adjuvant envoy. Oyster tastes salty and mainly enters the liver and kidney meridians. "Shennong Ben Cao Jing" lists it as a top-grade medicine, which has various functions such as nourishing yin and suppressing yang, calming the liver and astringing. Oyster extract has functions such as protecting the liver and antioxidation, and can inhibit or reduce the damage of liver cells; Vitamin C is one of the essential vitamins for the human body, can participate in the synthesis of antibodies, proteins, etc. and maintain immune function, and can promote metabolism and assist the human body in detoxification. The combination of the above drugs can play roles such as relieving alcohol and protecting the liver, promoting diuresis and detoxifying, strengthening the spleen and protecting the stomach. Brief Description of the Drawings

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0024] Figure 1 It is a test result graph of the liver coefficient of acute alcoholic liver injury in the present invention. Detailed Embodiments

[0025] The following will combine the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which the embodiments of the present invention belong. If the definitions stated in this section are contrary to or otherwise inconsistent with the definitions stated in the patents, patent applications, published patent applications, and other publications incorporated herein by reference, the definitions listed in this section shall prevail over the definitions incorporated herein by reference.

[0027] Unless otherwise specified, the methods used in the following embodiments are all conventional methods. The materials, reagents, and instruments used, unless otherwise specified, are all conventional materials, reagents, and instruments in this field, and those skilled in the art can obtain them through commercial channels.

[0028] When an equivalent, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values and lower preferred values, it should be understood that all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value are specifically disclosed, regardless of whether the ranges are separately disclosed. For example, when the range "1 to 5" is disclosed, the described range should be interpreted to include the ranges "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its end values and all integers and fractions within the range. In the specification and claims of this application, range limitations can be combined and / or interchanged, and if not otherwise stated, these ranges include all sub-ranges contained therein.

[0029] Example 1

[0030] This example provides a traditional Chinese medicine composition for relieving alcohol toxicity, which is prepared according to the following steps:

[0031] (1) Weigh 15 g of Puerariae Flos, 10 g of Dryopteridis Crassirhizomae Rhizoma, 8 g of Scutellariae Radix, 15 g of Glycine Max (L.) Merr. Seed, 10 g of Glycyrrhizae Radix, 12 g of Poria, 10 g of Atractylodis Macrocephalae Rhizoma, 15 g of Dolichoris Semen, 12 g of Alismatis Rhizoma, and 8 g of Amomi Fructus according to weight, add distilled water 7 times the weight of the crude drug, soak for 1 - 3 h, bring to a boil over high heat, then simmer for 2 h, filter to extract the filtrate, and decoct 4 times in the same way without soaking. After decocting, combine the filtrates and concentrate to a relative density of 1.25 (60 °C).

[0032] (2) Wash the oyster shell clean, add 60% vol aqueous ethanol solution 7 times the weight of the oyster shell, extract at 70 °C for 2 hours, filter, and extract and filter again at high temperature in the same way. Combine the two filtrates and concentrate;

[0033] (3) Mix the concentrated extract obtained in the above step (1) and the 3 g of oyster extract obtained by concentrating in step (2) evenly, and add 3 mg of vitamin C by weight to obtain the active ingredient of the traditional Chinese medicine composition.

[0034] Example 2

[0035] The difference between this example and Example 1 is that:

[0036] The weights of each raw material are: 12 g of Pueraria flower, 8 g of Dryopteris crassirhizoma, 10 g of Scutellaria baicalensis, 10 g of black beans, 12 g of licorice, 10 g of Poria cocos, 12 g of Atractylodes macrocephala, 12 g of white hyacinth bean, 10 g of Alisma orientale, 6 g of Amomum villosum, 5 g of oyster extract, and 5 mg of vitamin C.

[0037] Example 3

[0038] The difference between this example and Example 1 is that:

[0039] The weights of each raw material are: 18 g of Pueraria flower, 12 g of Dryopteris crassirhizoma, 15 g of Scutellaria baicalensis, 20 g of black beans, 18 g of licorice, 15 g of Poria cocos, 18 g of Atractylodes macrocephala, 20 g of white hyacinth bean, 15 g of Alisma orientale, 12 g of Amomum villosum, 10 g of oyster extract, and 10 mg of vitamin C.

[0040] Example 4

[0041] The difference between this example and Example 1 is that:

[0042] A dynamic countercurrent extraction device is used, the medicinal materials and the solvent flow in the reverse direction, the extraction temperature is 80 °C, the pressure is 0.2 MPa, and the extraction is carried out 3 times, each time for 1.5 hours;

[0043] Ultrasonic-assisted extraction is used for oyster shells (frequency 40 kHz, power 300 W), and the ethanol concentration is 60%.

[0044] The extraction is carried out 2 times;

[0045] The mixed concentrated solution is spray-dried to obtain granules.

[0046] Comparative Example 1

[0047] Based on Example 1, Poria cocos, Atractylodes macrocephala, and Alisma orientale are deleted in this comparative example, and the others are the same as Example 1.

[0048] Comparative Example 2

[0049] Based on Example 1, black beans and licorice are deleted in this comparative example, and the others are the same as Example 1.

[0050] Comparative Example 3

[0051] Based on Example 1, only 1 decoction is used in step (1) in this comparative example.

[0052] Comparative Example 4

[0053] The existing technology formula is adopted:

[0054] 15g of kudzu flower, 10g of Shenqu, 10g of Imperata root, and 8g of tangerine peel.

[0055] The preparation method is the same as Example 1.

[0056] Comparative Example 5

[0057] Using existing technical formula:

[0058] Hovenia dulcis 10g, Pueraria root 10g, nutmeg 8g, chrysanthemum 6g, mulberry leaf 6g, wolfberry 10g, scutellaria 10g, ebony 5g, and oriental water plantain 6g.

[0059] The preparation method is the same as Example 1.

[0060] Verification Example 1

[0061] Animal intoxication test:

[0062] Comparison of the composition of the present invention and other compositions in terms of animal intoxication, memory improvement and liver damage

[0063] 1 Animal drunkenness test

[0064] Experimental animals

[0065] 110 SPF male BALB / c mice, weighing 18-22g and aged 6-8 weeks, were selected and raised in a barrier environment. The experiment was conducted after 3-5 days of adaptive feeding.

[0066] 1.2 Trial Drugs

[0067] The medicines prepared by the above examples and comparative examples.

[0068] Control group: Kudzu flower decoction

[0069] 1.3 Experimental methods

[0070] 110 mice were randomly divided into 11 groups according to body weight, which were divided into model group, kudzu flower control group, embodiment group 1-4 group, comparative example group 1-5 group, 10 mice in each group. Before the experiment, each group fasted but could not be watered for 16h, and then gavaged the corresponding drugs in sequence. Wherein the model group was gavaged with 0.18ml / 10g of normal saline, and the remaining groups were respectively given corresponding Chinese medicine compositions, with a total amount of 0.18g / 10g of Chinese medicine crude drug. After 30min, each group was gavaged with 56° liquor 0.16ml / 10g, and the latent period and intoxication period of mice were recorded and recorded (latent period: from the beginning of gavage to falling asleep, that is, the righting reflex disappeared, intoxication period: from falling asleep to waking up time, that is, the righting reflex was restored; the righting reflex gently turned the mice over so that they were in a supine position, and it was judged as drunkenness if it could not be righted within 30s, and it was judged as sobering up if the turning reflex was restored).

[0071] 1.4 Experimental Results

[0072] From the results in Table 1, it can be seen that

[0073] Rate of not getting drunk and mortality rate:

[0074] In Example 1 and Example 4, they were significantly higher than other groups (P < 0.05), reflecting the synergistic effect of the formula and the process.

[0075] The rate of not getting drunk in Comparative Example 1 (without Poria cocos, Atractylodes macrocephala, and Alisma orientale) was 0%, indicating that the loss of the core components for promoting diuresis and strengthening the spleen would affect the efficacy.

[0076] The rate of not getting drunk in Comparative Example 2 (without black beans and liquorice) was 0%, and the mortality rate was 10%, indicating that the loss of the core detoxifying agent components would lead to a reduction or even loss of the efficacy of the formula.

[0077] Latency period and intoxication period:

[0078] The latency period in Example 1 was significantly longer than that in the model group and all comparative examples (P < 0.05);

[0079] Due to process optimization in Example 4, the latency period was further extended;

[0080] The latency period in Comparative Example 3 (single decoction) was close to that in the model group, proving that multiple decoctions are the key for the full dissolution of active ingredients.

[0081] Table 1: Drunkenness test for mice after drinking

[0082] Group Rate of non-intoxication Mortality rate Latency period Intoxication period Model group - 10％ 17.60±5.29 146.30±25.69 Pueraria lobata control group - - 19.07±6.58* 125.66±17.58* Example 1 10％ - 26.50±9.58* 117.39±28.80* Example 2 - - 20.4±6.8*# 128.8±18.6*# Example 3 - - 22.1±4.3*# 131.3±20.3*# Example 4 20％ - 28.9±7.2* 110.5±22.4* Comparative example 1 - - 17.5±4.33# 140.2±30.5# Comparative example 2 - 10％ 16.7±4.2# 138.7±24.1# Comparative example 3 - - 18.8±5.6# 135.7±23.9# Comparative example 4 - - 16.8±4.7*# 138.5±27.3*# Comparative example 5 - - 18.9±5.6*# 135.7±23.9*#

[0083] Note: Compared with the model group, *P < 0.05; compared with Example Group 1, #P < 0.05

[0084] 2 Learning and memory ability test for animals after drinking

[0085] 2.1 Experimental animals

[0086] 110 SPF-grade mice were selected, with a body weight of 18 - 22 g and an age of 6 - 8 weeks. After one week of adaptive feeding, the experiment was carried out.

[0087] 2.2 Test drugs

[0088] The above different examples and comparative examples

[0089] Control drug group: Gegen Jiedu Decoction

[0090] 2.3 Experimental methods

[0091] A total of 110 mice were randomly divided into 11 groups according to body weight, including a model group, a Pueraria flower control group, Example groups 1 - 4, and Comparative Example groups 1 - 5, with 10 mice in each group. Step-down training was conducted one day before the experiment. Before the experiment, each group was fasted but allowed to drink water for 16 h, and then the corresponding drugs were administered by gavage. Among them, the model group was gavaged with 0.18 ml / 10 g of normal saline, and the remaining groups were given the corresponding traditional Chinese medicine compositions, with the raw drug amount of the combined traditional Chinese medicine being 0.18 g / 10 g. After 30 min, each group was gavaged with 0.16 ml / 10 g of 56° liquor to cause memory acquisition impairment. An electric shock step-down apparatus was used for the experiment, and the time for the mice to first fall off the step-down platform was recorded as the latency period to observe the corrective effect of the experimental drugs on the memory impairment of the mice.

[0092] 2.4 Experimental results

[0093] As can be seen from the results in Table 2, compared with the model group, the latency periods of each experimental group and the control group were significantly prolonged. Among them, the latency period of Experimental Group 1 (i.e., the traditional Chinese medicine composition of the present invention) was the longest compared with Experimental Groups 2 - 3 and the Pueraria flower control group, indicating that the traditional Chinese medicine composition of the present invention has a relatively obvious advantage in preventing drunkenness and correcting the memory impairment of mice after drinking.

[0094] Table 2: Test of learning and memory ability of mice after drinking

[0095] Group Latency time (s) Model group 1.65±0.48 Pueraria lobata control group 14.49±5.84* Example 1 18.07±6.48* Example 2 14.48±3.37*# Example 3 16.58±8.94*# Example 4 20.15±7.12* Comparative example 1 8.76±2.53# Comparative example 2 3.82±1.24# Comparative example 3 12.37±4.21*# Comparative example 4 10.29±3.76*# Comparative example 5 14.48±3.37*#

[0096] Note: Compared with the model group, *P < 0.05; compared with Experimental Group 1, #P < 0.05.

[0097] 3 Conclusions

[0098] The above experimental conclusions can show that the composition of the present invention can prolong the drunken time of mice, shorten the maintenance time of drunkenness, and can improve the memory impairment after drinking, and has the effects of preventing drunkenness, promoting sobering up and relieving alcoholism. The latency period of Example 1 was significantly better than that of Examples 2 - 3, proving that the medicinal material composition and ratio of Example 1 group had the best effect in improving memory impairment.

[0099] Due to the process upgrade in Example 4 (dynamic countercurrent extraction + ultrasonic assistance), the latency period was further prolonged, reflecting the enhancement effect of process innovation on the drug effect.

[0100] Comparative Example 1 (without Poria cocos, Atractylodes macrocephala, and Alisma orientale): The latency period was significantly lower than that of Example 1 group, indicating that Poria cocos, Atractylodes macrocephala, and Alisma orientale are effective components for improving memory impairment after drinking.

[0101] Comparative Example 2 (without black beans and licorice): The latency period was close to that of the model group, indicating that black beans and licorice are the core components for improving memory impairment after drinking.

[0102] Comparative Example 3 (single decoction): The latent period was significantly lower than that of Example 1, indicating that multiple decoctions are the key process for the full dissolution of active ingredients.

[0103] Comparative Examples 4 - 5 (prior art): The latent period was significantly lower than that of Example 1, proving that the formulation of the present invention has a creative advantage in improving memory impairment after drinking.

[0104] Test Example 2

[0105] Comparison of different doses of the composition of the present invention in terms of animal drunkenness, memory improvement, and liver injury

[0106] 1 Animal post - drinking drunkenness test

[0107] Experimental animals

[0108] Thirty SPF - grade male BALB / c mice, weighing 18 - 22 g and aged 6 - 8 weeks, were selected. They were raised in a barrier environment and experimented after 3 - 5 days of adaptive feeding.

[0109] 1.2 Experimental method

[0110] The experimental drugs were prepared according to the drug combination method of Example 1. The 30 mice were randomly divided into 3 groups according to body weight, namely the model group, the high - dose group, and the low - dose group. Before the experiment, each group was fasted but allowed water for 16 h, and then the corresponding drugs were administered by gavage. Among them, the model group was gavaged with 0.18 ml / 10 g of normal saline, the high - dose group was gavaged with 0.20 ml / 10 g of the traditional Chinese medicine composition, and the low - dose group was gavaged with 0.12 ml / 10 g. After 30 min, each group was gavaged with 0.16 ml / 10 g of 56° white wine, and the drunkenness latency and intoxication period of the mice were recorded and well documented.

[0111] Table 3: Mouse post - drinking drunkenness test

[0112] Group Rate of non-intoxication Mortality rate Latency period Intoxication period Model group - - 18.60±4.26 157.88±28.63 High-dose group 10％ - 25.77±6.35* 124.36±18.58* Low-dose group - - 21.04±6.79* 136.23±17.33*

[0113] Note: Compared with the model group, *P < 0.05.

[0114] 1.3 Experimental results

[0115] According to the results in Table 3, compared with the model group, the post - drinking latency of each drug - administered group was significantly prolonged, and the latency of the high - dose drug - administered group was prolonged most significantly; the intoxication period of each drug - administered group was significantly shortened, and the intoxication period of the high - dose drug - administered group was shortened most significantly. One mouse in the high - dose drug - administered group did not get drunk, and no mouse in the other groups did not get drunk.

[0116] 2 Animal post - drinking learning and memory ability determination

[0117] 2.1 Experimental animals

[0118] Thirty SPF mice, weighing 18 - 22 g and aged 6 - 8 weeks, were selected. After one week of adaptive feeding, the experiment was carried out.

[0119] 2.2 Experimental method

[0120] The experimental drugs were prepared according to the drug combination method in Example 1. Thirty mice were randomly divided into 3 groups by body weight, namely the model group, the high-dose group, and the low-dose group. Step-down training was carried out one day before the experiment. Before the experiment, each group was fasted but allowed to drink water for 16 h, and then the corresponding drugs were administered by gavage in sequence. Among them, the model group was given 0.18 ml / 10 g of normal saline by gavage, the high-dose group was given 0.2 ml / 10 g of the traditional Chinese medicine composition by gavage, and the low-dose group was given 0.14 ml / 10 g by gavage. After 30 min, each group was given 0.16 ml / 10 g of 56° white wine by gavage to cause memory acquisition impairment. An electric shock step-down apparatus was used for the experiment, and the time for the mice to first fall off the step-down platform was recorded as the latency, and the corrective effect of the experimental drugs on the memory impairment of the mice was observed.

[0121] Table 4: Test of learning and memory ability of mice after drinking

[0122] Group Latency time (s) Model group 1.36±0.44 High-dose group 13.56±4.77* Low-dose group 18.50±6.87*

[0123] Note: Compared with the model group, *P < 0.05.

[0124] 2.3 Experimental results

[0125] As can be seen from the results in Table 4, compared with the model group, the latency of each drug-administered group was significantly prolonged, and the latency of the high-dose drug-administered group was prolonged most significantly, indicating that the traditional Chinese medicine composition of the present invention can effectively prevent drunkenness and correct the memory impairment of mice after drinking in the case of the high-dose drug-administered group.

[0126] 3 Determination of liver function in mice with acute liver injury

[0127] 3.1 Experimental animals

[0128] Forty SPF mice, weighing 18 - 22 g and aged 6 - 8 weeks, were selected. They were allowed to eat and drink freely. After one week of adaptive feeding, the experiment was carried out.

[0129] 3.2 Experimental method

[0130] Prepare the experimental drugs according to the drug combination method of Example 1. Randomly divide 40 mice into 4 groups according to body weight, namely the blank control group, the model group, the high-dose group, and the low-dose group, with 10 mice in each group. The blank control group and the model group were intragastrically administered 0.18 ml / 10 g of normal saline every day, and the other groups were respectively given the corresponding compositions every day. The high-dose group was intragastrically administered 0.2 ml / 10 g of traditional Chinese medicine composition, and the low-dose group was intragastrically administered 0.14 ml / 10 g of traditional Chinese medicine composition. Intragastric administration was continued for 14 days, and the mice were weighed every other day. 30 minutes after the last intragastric administration, except for the blank control group, the other groups were intragastrically administered 16 ml / kg of 56° white liquor to establish an acute alcoholic liver injury model. After fasting for 12 hours without water restriction, orbital blood was taken for determination of biochemical indicators; the liver was removed after the mice were sacrificed by cervical dislocation for subsequent determination of indicators.

[0131] Table 5: Enzyme activity test of acute alcoholic liver injury

[0132] Group ALT (U / L) AST (U / L) Blank group 8.35±2.64 29.06±5.72 Model group 28.28±5.04* 58.93±8.77* High-dose group 10.37±2.31* 38.25±6.25 Low-dose group 15.24±6.17* 41.79±6.80*

[0133] Note: Compared with the blank group, *P<0.05

[0134] 3.4 Experimental results of enzyme activity test of acute alcoholic liver injury

[0135] According to the results in Table 5, it can be seen that compared with the blank group, the ALT and AST levels in the model group and each administration group increased to varying degrees, and the increase in the model group was the most significant; compared with the model group, the decrease in ALT and AST in the high-dose administration group and the low-dose administration group was more obvious. It shows that the composition of the present invention has obvious advantages in preventing and improving acute alcoholic liver injury, and its preventive and improving effect is more obvious under high-dose administration conditions.

[0136] 3.5 Experimental results of liver coefficient test of acute alcoholic liver injury

[0137] The liver coefficient is the ratio of the wet weight of the liver to the body weight of the mouse. The liver coefficient is an index reflecting the degree of liver inflammation. When the liver shows edema, congestion or inflammation, the liver coefficient will increase significantly. According to Figure 1 the results, compared with the blank group, the liver coefficient of the mice in the model group increased significantly, indicating that the mice in the model group may have liver function disorders after intragastric administration of a large amount of alcohol, resulting in congestion and edema, and an increase in the liver weight; the liver coefficient of the administration group was lower than that of the model group but higher than that of the blank group, and the liver coefficient ratio of the high-dose administration group was close to that of the blank group, indicating that the traditional Chinese medicine composition of the present invention can reduce liver enlargement to a certain extent, relieve alcoholic liver injury, and improve the liver enlargement better within a certain range by increasing the administration dose.

[0138] 4 Summary

[0139] The above experimental conclusions can show that the composition of the present invention can prolong the drunkenness time of mice, shorten the duration of drunkenness, improve post-drinking memory impairment, relieve liver damage, has the effects of preventing drunkenness and promoting hangover, and at the same time has a certain liver-protecting effect, can relieve the damage of alcohol to the liver, reduce inflammatory reactions, and lower the level of transaminase. Within a certain dosage range, the higher the dosage, the more obvious the effects of preventing drunkenness, promoting hangover and protecting the liver.

[0140] Experimental Example 3

[0141] The composition of the present invention can be taken before or after drinking to prevent drunkenness or relieve discomfort after drinking and promote hangover. The following information is provided to further illustrate the anti-drunkenness and hangover effects of the composition of the present invention.

[0142] 1 Anti-drunkenness and Hangover Population Test

[0143] Subjects

[0144] Inclusion criteria for subjects: Select healthy drinkers aged 20 - 55 years old who can actively cooperate with the test requirements.

[0145] Exclusion criteria for subjects: Those with alcohol allergies; those suffering from serious diseases such as heart, liver, kidney, and hematopoietic systems; those with mental system diseases; those suffering from other diseases or having related physical signs that affect the results of various evaluation indicators; those engaged in special operations; those with a history of alcohol or drug abuse. Finally, 50 healthy people were selected to participate in this test, and each subject signed an informed consent form.

[0146] Test Scheme

[0147] The test subjects were divided into 2 groups, namely the control group and the experimental group, with 25 people in each group. The traditional Chinese medicine composition extract was prepared according to the drug composition of Example 1 of the present invention. The subjects in the experimental group took 100 ml of the extract 30 minutes before drinking, and then took 100 - 300 ml of 52° Baijiu according to their own alcohol tolerance. After the drinking was over, they took another 100 ml of the extract; the control group took the same dose of pure water before and after drinking. The reactions of the subjects 2 hours after drinking were recorded in both groups, and the drunkenness of the subjects was evaluated through the subjective feeling questionnaire and the drinking and drunkenness balance experiment. The subjective questionnaire evaluated the drunkenness situation according to whether the subjects had nausea, vomiting, dizziness, headache, slurred speech and other discomfort feelings; the balance experiment included the walk-and-turn test and the one-leg stand test. The one-leg stand test required the subjects to maintain the attention position, then lift one foot, and the other foot remained in the standing state for 30 seconds. If they lost balance or couldn't stand steadily within 30 seconds, they were considered drunk; the walk-and-turn test required the subjects to walk 10 steps along a straight line, count the steps while walking, and then return in the original way. If they walked disobediently, lost balance, or deviated from the standard straight line during walking, they were considered drunk.

[0148] Test Results

[0149] Subjective anti-alcohol and hangover test results of the subjects

[0150] According to the results in Table 6, 17 people in the experimental group were not drunk, accounting for 68%, and 2 people in the control group were not drunk, accounting for 8%. The proportion of people not drunk in the experimental group was significantly higher than that in the control group.

[0151] Table 6: Subjective anti-alcohol and hangover test results

[0152] Group Feeling of intoxication No feeling of intoxication Proportion of non-intoxicated people Experimental group 8 17 68％ Control group 23 2 8％

[0153] Results of the alcohol intoxication balance experiment of the subjects

[0154] According to the results in Table 7, only 4 people in the control group completed the one-leg stand experiment, and 3 people completed the walk-and-turn test. The proportion of people who did not reach the drunkenness standard was 14%. In the experimental group, 18 people completed the one-leg stand experiment, and 20 people completed the walk-and-turn test. The proportion of people who did not reach the drunkenness standard was 76%, which was significantly higher than that in the control group.

[0155] Table 7: Results of the alcohol intoxication balance experiment (number of people not drunk)

[0156] Group One-leg standing test Walk-and-turn test Proportion of non-intoxicated population Experimental group 18 20 76％ Control group 4 3 14％

[0157] Conclusion

[0158] The above test results show that the traditional Chinese medicine composition of the present invention also has an obvious anti-alcohol and hangover effect in the population experiment, and has obvious effects on improving discomfort such as headache and nausea after drinking.

[0159] The above is only the preferred embodiment of the present invention, and it is not intended to limit the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with the function of protecting the liver and detoxifying, which is characterized in that, It comprises the following components: Pueraria flower, Dryopteris crassirhizoma, Scutellaria baicalensis, black beans, liquorice, Poria cocos, Atractylodes macrocephala, white hyacinth bean, Alisma orientale, Amomum villosum, oyster extract and vitamin C.

2. The traditional Chinese medicine composition with the function of protecting the liver and detoxifying as described in claim 1, wherein, The weight of each component is: 10 - 20 g of Pueraria flower, 5 - 15 g of Dryopteris crassirhizoma, 3 - 18 g of Scutellaria baicalensis, 5 - 20 g of black beans, 5 - 20 g of liquorice, 5 - 15 g of Poria cocos, 6 - 20 g of Atractylodes macrocephala, 8 - 20 g of white hyacinth bean, 4 - 15 g of Alisma orientale, 4 - 15 g of Amomum villosum, 2 - 10 g of oyster extract, and 2 - 10 mg of vitamin C.

3. The traditional Chinese medicine composition with the function of protecting the liver and detoxifying as claimed in claim 1, wherein, The weight of each component is: 12 - 18 g of Pueraria flower, 5 - 12 g of Dryopteris crassirhizoma, 3 - 15 g of Scutellaria baicalensis, 5 - 20 g of black beans, 6 - 18 g of liquorice, 8 - 15 g of Poria cocos, 8 - 18 g of Atractylodes macrocephala, 10 - 20 g of white hyacinth bean, 5 - 15 g of Alisma orientale, 6 - 12 g of Amomum villosum, 2 - 10 g of oyster extract, and 3 - 8 mg of vitamin C.

4. The traditional Chinese medicine composition with liver protection and detoxification effects as described in any one of claims 1 to 3, characterized in that, The said composition is prepared into granules, powder, oral liquid or capsules.

5. A preparation method of the traditional Chinese medicine composition with liver protection and detoxification effects as described in claim 1, characterized in that, It includes the following steps: Step 1: Take Pueraria flower, Dryopteris crassirhizoma, Poria cocos, Atractylodes macrocephala, Alisma orientale, Amomum villosum, white hyacinth bean, black beans, and liquorice, soak them in water and decoct for 4 - 6 times, then combine the filtrates and concentrate. Step 2: Take oyster shells and extract them with an ethanol aqueous solution for 2 - 3 times, then combine the filtrates and concentrate. Step 3: Mix the concentrated liquids from Step 1 and Step 2, and then add vitamin C.

6. The preparation method according to claim 5, characterized in that, In Step 1, the water addition amount is 5 - 10 times the weight of the medicinal materials, and the decocting time is 1 - 3 h each time; in Step 2, the concentration of the ethanol aqueous solution is 40 - 70% vol, the amount of the ethanol aqueous solution used is 5 - 10 times the weight of the oyster shells, and the extraction temperature is 60 - 80°C.

7. The preparation method according to claim 6, characterized in that, Step 1 includes decocting after soaking for 1 - 3 h for the first time, and subsequent decoctions are without soaking.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 - 4 in the preparation of an anti - hangover and liver - protecting drug.

9. The application according to claim 8, wherein The said drug is used for: accelerating ethanol metabolism and reducing blood alcohol concentration; improving liver cell damage caused by alcohol; relieving post - drinking discomfort symptoms such as headache and nausea.

10. The application according to claim 8, characterized in that, The said drug is used for preventing or treating alcohol - related liver diseases such as alcoholic fatty liver and liver fibrosis.

Images