Composition for dispelling effects of alcohol and protecting liver and application thereof

Abstract

The invention relates to the field of traditional Chinese medicine compositions, in particular to a composition for dispelling effects of alcohol and protecting liver and application. The composition for dispelling the effects of alcohol and protecting the liver comprises the following raw materials: 1-4 parts of calculus bovis factitius, 1-4 parts of artificial bear gall, 35-55 parts of a pseudo-ginseng extract, 40-60 parts of a herba artemisiae scopariae extract, 50-70 parts of a rhizoma smilacis glabrae extract, 30-50 parts of a polygonum cuspidatum extract, 30-50 parts of a radix paeoniae alba extract, 70-90 parts of a pueraria flower extract, 40-60 parts of a rhizoma polygonati extract and 40-60 parts of a dark malt extract. And 25-35 parts of a fructus amomi extract. The hangover-alleviating and liver-protecting composition has the advantages that the hangover-alleviating and liver-protecting effects are similar to that of a positive medicine Haiwang Jinvessel for relieving rat body mass reduction caused by an acute drunkenness model, the hangover-alleviating rate within 6 hours and the liver-protecting and anti-oxidation effects are similar to that of a positive medicine Haiwang Jinvessel, the body mass improvement effect, the hangover-alleviating rate and the anti-oxidation capability of a body are better, and the hangover-alleviating and liver-protecting composition has good development and application values.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compositions, and particularly relates to an anti-alcohol and liver-protecting composition and its application. Background Art

[0002] Current research focuses on accelerating alcohol metabolism by activating alcohol dehydrogenase and aldehyde dehydrogenase. For example, puerarin in the extract of Pueraria lobata can reduce the peak blood ethanol concentration (by up to 40%) by delaying gastric emptying, but it cannot reduce the total alcohol intake. Moreover, existing anti-alcohol products (such as Pueraria preparations) can only delay alcohol absorption, cannot enhance the activity of aldehyde dehydrogenase, and have no direct intervention on the toxicity of acetaldehyde. Although some products accelerate alcohol excretion by adding diuretics, it will lead to increased kidney burden and electrolyte imbalance.

[0003] In addition, alcohol metabolism involves damage to multiple organs such as the liver, stomach, and brain. Existing products mostly focus on liver protection or symptom relief, ignoring the synergistic intervention of intestinal flora imbalance (such as alcohol-induced intestinal leakage) and neuroinflammation. And because the effective ingredient concentration of traditional decoctions is low, and new delivery systems such as nano-hydrogels are still in the experimental stage, the industrial production is difficult. Summary of the Invention

[0004] In view of this, the present invention discloses and provides an anti-alcohol and liver-protecting composition, which solves the problems of insufficient metabolic efficiency, single-target limitation and side effects, lack of multi-organ synergistic protection, dosage form and bioavailability in the prior art.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] The present invention discloses and provides an anti-alcohol and liver-protecting composition, comprising raw materials of the following components:

[0007] 1-4 parts of artificial bezoar, 1-4 parts of artificial bear bile, 35-55 parts of Panax notoginseng extract, 40-60 parts of Artemisia capillaris extract, 50-70 parts of Smilax glabra extract, 30-50 parts of Polygonum cuspidatum extract, 30-50 parts of Paeonia lactiflora extract, 70-90 parts of Pueraria flower extract, 40-60 parts of Polygonatum sibiricum extract, 40-60 parts of stir-fried malt extract, 25-35 parts of Amomum villosum extract.

[0008] Optionally, the anti-alcohol and liver-protecting composition comprises raw materials of the following components:

[0009] 2.5 parts of artificial bezoar, 2.5 parts of artificial bear bile, 45 parts of Panax notoginseng extract, 50 parts of Artemisia capillaris extract, 60 parts of Smilax glabra extract, 40 parts of Polygonum cuspidatum extract, 40 parts of Paeonia lactiflora extract, 80 parts of Pueraria flower extract, 50 parts of Polygonatum sibiricum extract, 50 parts of stir-fried malt extract, 30 parts of Amomum villosum extract.

[0010] It should be noted that the principle and effects of the technical solution of the present invention are as follows:

[0011] King drug (core efficacy): Pueraria flower extract, a traditional specific drug for relieving alcohol intoxication. "Compendium of Materia Medica" records that it "relieves alcohol toxicity, awakens the spleen and harmonizes the stomach". Modern research shows that it can accelerate ethanol metabolism, inhibit alcohol absorption, and reduce blood ethanol concentration. Panax notoginseng extract, promoting blood circulation to remove blood stasis, protecting the liver and reducing enzyme levels, improving microcirculation disorders caused by alcoholic liver injury, and promoting hepatocyte repair. Compatibility significance: Pueraria flower relieving alcohol toxicity is the superficial aspect, while Panax notoginseng protecting the liver is the fundamental aspect. The two together serve as the king drug, reflecting the "alcohol detoxification - liver protection" dual targets. Ministerial drug (synergistic effect): Artemisia capillaris extract, clearing away damp-heat in the liver and gallbladder, promoting bile excretion, accelerating the metabolism of fat-soluble toxins, and improving alcoholic jaundice. Polygonum cuspidatum extract, clearing heat and detoxifying, containing resveratrol to inhibit ethanol-induced oxidative stress, and synergistically enhancing the detoxification effect with Artemisia capillaris. Paeonia lactiflora extract, soothing the liver and relieving pain, alleviating the distending pain in the liver area after drinking, and the contained paeoniflorin has anti-inflammatory and liver-protecting effects. Compatibility characteristics: The three drugs form a "synergistic chain of clearing heat and promoting diuresis - detoxifying and anti-inflammatory - soothing the liver and relieving pain". Assistant drug (auxiliary conditioning): Smilax glabra extract, detoxifying and removing dampness, targeting the toxicity of the alcohol metabolite acetaldehyde, and alleviating hangover headache. Polygonatum sibiricum extract, tonifying both qi and yin, improving liver and kidney yin deficiency caused by long-term drinking, and regulating immune function. Artificial bezoar + artificial bear bile, in a micro-dose combination, clearing the heart and cooling the liver, inhibiting alcohol-induced nerve excitement and hyperactivity of liver fire. Fructus Hordei Germinatus extract, promoting digestion and regulating the stomach, improving anorexia and fullness in the epigastrium after drinking, and containing amylase to promote food digestion. Special design: Combining cold and warm herbs (bezoar / bear bile with Polygonatum sibiricum), and combining purging and tonifying (Smilax glabra with Polygonatum sibiricum). Messenger drug (harmonizing and guiding the meridian): Amomum villosum extract, promoting qi movement and resolving dampness, awakening the spleen and promoting appetite, guiding all the drugs to the middle-jiao spleen and stomach, and relieving nausea and vomiting after drinking. The finishing touch: The fragrant and dispersing property of Amomum villosum can penetrate the blockage of greasy food and alcohol, enhancing the bioavailability of the whole formula.

[0012] Furthermore, the key problems to be solved and the innovation of the formula technology of the present invention are as follows:

[0013] 1) Multi-target metabolic synergy

[0014] Control of acetaldehyde toxicity: In the formula, Pueraria flower (promoting ADH activity) is combined with Polygonum cuspidatum (containing resveratrol to inhibit oxidative stress), accelerating the conversion of ethanol → acetaldehyde → acetic acid, and reducing the accumulation of acetaldehyde.

[0015] Activation of multi-enzyme systems: Panax notoginseng improves liver microcirculation and enhances the expression efficiency of ALDH; Paeonia lactiflora extract assists in detoxification by regulating the cytochrome P450 enzyme system.

[0016] 2) Construction of organ protection network

[0017] Integration of liver - intestine - brain axis: Artemisia capillaris extract promotes bile excretion, reducing the absorption of intestinal toxins; polygonatum polysaccharide regulates the intestinal flora; artificial bezoar inhibits alcohol-induced nerve excitement, forming cross-organ protection.

[0018] Antioxidant and anti-inflammatory synergy: The extracts of Polygonum cuspidatum and Smilax glabra enhance antioxidant capacity through the Nrf2 / ARE pathway and reduce the apoptosis rate of hepatocytes.

[0019] 3) Dosage form and ingredient optimization

[0020] Standardization of extracts: Modern extraction techniques (such as supercritical CO2 extraction) are used to increase the concentration of active ingredients such as puerarin and notoginsenoside, overcoming the low efficiency of traditional decoction methods.

[0021] Sustained-release delivery system: Drawing on the idea of β-lactoglobulin nanogel, explore the embedding technology of volatile oil of Amomum villosum to extend the duration of drug efficacy.

[0022] 4) Safety improvement

[0023] Control of toxic components: Trace amounts of artificial bear bile are combined with Polygonatum sibiricum, and the cold nature is neutralized through the "adjuvant drug" mechanism to avoid the diarrhea risk caused by excessive use of bezoar in traditional hangover prescriptions.

[0024] The present invention also discloses and provides an application of the hangover and liver-protecting composition as described above in pharmaceutical preparations.

[0025] Furthermore, the application of the hangover and liver-protecting composition in the preparation of hangover and liver-protecting drugs.

[0026] Specifically, the preparation method of the hangover and liver-protecting drug is as follows:

[0027] Artificial bezoar and artificial bear bile are pulverized and reserved; 875 g of Panax notoginseng is coarsely crushed and together with the other eight herbs (975 g of Artemisia capillaris, 1170 g of Smilax glabra, 780 g of Polygonum cuspidatum, 780 g of Paeonia lactiflora, 1560 g of Pueraria lobata, 975 g of Polygonatum sibiricum, 975 g of germinated barley, 585 g of Amomum villosum), add water and decoct twice. The first time, add 20 times the amount of water and decoct for 2 hours. The second time, add 20 times the amount of water and decoct for 1.5 hours. Filter, combine the decoction, and concentrate under reduced pressure to a clear paste with a relative density of 1.05 - 1.10 (60 °C). Centrifuge, and concentrate the centrifugate under reduced pressure to a thick paste with a relative density of about 1.25 (60 °C). Vacuum dry (60 - 70 °C) to obtain 1.8 kg of dry paste. After pulverizing the dry paste, add 14.82 g of artificial bezoar and 14.82 g of artificial bear bile, add about 770 g of microcrystalline cellulose, mix well and granulate, dry and size the granules, then add 13 g of magnesium stearate, mix well, tableting, coating, and approximately make 5000 tablets.

[0028] Compared with the prior art, the beneficial effects of the present invention are:

[0029] The anti-hangover and liver-protecting composition of the present invention has similar effects on alleviating the body weight loss of rats caused by the acute drunkenness model, the hangover rate within 6 hours, liver protection and antioxidant properties as the positive drug Haiwang Jinzun, and is better in terms of improving body weight, hangover rate and enhancing the body's antioxidant capacity, and has good development and application value. Description of the Drawings

[0030] 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 the description of the embodiments or the prior art. Obviously, the drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on the provided drawings.

[0031] Figure 1 It shows the change in the body weight of rats during the experimental period.

[0032] Figure 2 It shows the hangover rate of rats in each group within 6 hours after intragastric administration of white liquor.

[0033] Figure 3 It shows the liver organ index (A) and tissue morphology (B) of rats in each group.

[0034] Figure 4 It shows the contents of ALT and AST in the serum of rats.

[0035] Figure 5 It shows the levels of antioxidant indexes in the serum of rats. Detailed Embodiments

[0036] The following will clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of them. 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.

[0037] The special term "embodiment" used here, any embodiment described as "exemplary" does not have to be interpreted as superior or better than other embodiments. For the performance index tests in the embodiments of this application, unless otherwise specified, the conventional test methods in the art are adopted. It should be understood that the terms described in this application are only used to describe specific embodiments and are not used to limit the content disclosed in this application.

[0038] Unless otherwise specified, the technical and scientific terms used herein have the same meanings as commonly understood by those of ordinary skill in the technical field to which this application belongs; the test methods and technical means not otherwise specifically noted in this application refer to the experimental methods and technical means commonly adopted by those of ordinary skill in the art.

[0039] To better illustrate the content of the present application, numerous specific details are given in the following specific embodiments. Those skilled in the art should understand that the present application can also be implemented without certain specific details. In the embodiments, some methods, means, instruments, devices, etc. well-known to those skilled in the art are not described in detail in order to highlight the gist of the present application.

[0040] On the premise of no conflict, the technical features disclosed in the embodiments of the present application can be combined arbitrarily, and the obtained technical solutions belong to the content disclosed in the embodiments of the present application.

[0041] The present invention discloses an anti-hangover and liver-protecting composition and its application.

[0042] To better understand the present invention, the following embodiments are used to further specifically elaborate on the present invention, but it should not be understood as a limitation to the present invention. For those skilled in the art, some non-essential improvements and adjustments made according to the above-mentioned invention content are also considered to fall within the protection scope of the present invention.

[0043] Example 1

[0044] A drug (Qiongjiang Zunlv Tablets) prepared from an anti-hangover and liver-protecting composition, the main components and contents per tablet:

[0045] Artificial bezoar 2.5 mg, artificial bear bile 2.5 mg, notoginseng 45 mg, Herba Artemisiae Scopariae extract 50 mg, Smilax glabra extract 60 mg, Polygonum cuspidatum extract 40 mg, Paeonia lactiflora extract 40 mg, Puerariae flos extract 80 mg, Polygonatum sibiricum extract 50 mg, Fructus Hordei Germinatus (Fried) extract 50 mg, Amomum villosum extract 30 mg.

[0046] Manufacturing process: Crush artificial bezoar and artificial bear bile and set aside; Coarsely crush 875 g of notoginseng and then together with the other eight herbs (975 g of Herba Artemisiae Scopariae, 1170 g of Smilax glabra, 780 g of Polygonum cuspidatum, 780 g of Paeonia lactiflora, 1560 g of Puerariae flos, 975 g of Polygonatum sibiricum, 975 g of Fructus Hordei Germinatus (Fried), 585 g of Amomum villosum), add water and decoct twice. For the first time, add 20 times the amount of water and decoct for 2 hours; for the second time, add 20 times the amount of water and decoct for 1.5 hours. Filter, combine the decoction liquids, and concentrate under reduced pressure to a clear paste with a relative density of 1.05 - 1.10 (60 °C). Centrifuge, and concentrate the centrifugate under reduced pressure to a thick paste with a relative density of about 1.25 (60 °C). Vacuum dry (60 - 70 °C) to obtain 1.8 kg of dry paste. After crushing the dry paste, add 14.82 g of artificial bezoar and 14.82 g of artificial bear bile, add about 770 g of microcrystalline cellulose, mix well to granulate, dry and size the granules, then add 13 g of magnesium stearate, mix well, press into tablets, coat the tablets, and approximately make 5000 tablets.

[0047] To further prove the beneficial effects of the present invention for a better understanding of the present invention, the present invention aims to study the effects of the prepared Qiongjiang Zunlv tablets in Example 1 above on the drunken behavior and liver function of rats by applying them to a rat drunken model.

[0048] 1. Test method

[0049] Twenty-four SPF-grade male SD rats, weighing 250 - 270 g. The rats were randomly divided into 4 groups, with 6 rats in each group, and each rat was taken as 1 replicate. They were respectively the control group, the model group, the Qiongjiang Zunlv tablet test group (500 mg / tablet), and the positive drug control group (Haiwang Jinzun tablets (1000 mg / tablet) (Health Food Approval No. (2002) No. 0396)). The control group was intragastrically administered an equal volume of normal saline, and the remaining rats were all intragastrically administered 56% white liquor (Hongxing brand 56° white liquor, 1 mL / 100 g / d) every day to establish an acute drunken model. Twenty minutes after administration of the drug every day, white liquor was intragastrically administered, and the test period was 14 days. The test grouping and treatment are shown in detail in Table 1. The drug dose was converted according to the daily dosage for adults, converted by the body surface area (rat dose = human dose × (37 kg / m 2 ÷6 kg / m 2 ))).

[0050] Table 1 Test grouping and treatment

[0051]

[0052] 2. Measurement indexes

[0053] After intragastric administration of white liquor every day, the sobering rate (righting reflex) within 6 h was observed and recorded to evaluate the sobering effect; body weight change; liver organ index; liver tissue morphology; serum liver function indexes and antioxidant indexes.

[0054] 3. Test results

[0055] I. Body weight change

[0056] As Figure 1 can be seen, both Qiongjiang Zunlv tablets and the positive drug can effectively relieve the weight loss of rats caused by the acute drunken model (P < 0.05), and the Qiongjiang Zunlv tablet test group is slightly better than the positive drug group (P > 0.05).

[0057] Table 2 Body weight change of rats g

[0058]

[0059]

[0060] *For the peer trial data, different superscript letters indicate significant differences between groups (P < 0.05), while the same or no letters indicate no significant differences between groups (P > 0.05). The same applies to the following table.

[0061] II. Alcohol Awakening Rate of Rats within 6 h after Gavage with Baijiu

[0062] As Figure 2 shown, the alcohol awakening rates of the rats in the Qiongjiang Zunlv Tablet test group and the positive drug group within 6 h after gavage with Baijiu were significantly higher than those in the model group (P < 0.05), and the Qiongjiang Zunlv Tablet test group was superior to the positive drug group (P < 0.05).

[0063] Table 3 Alcohol Awakening Rate of Rats within 6 h after Gavage with Baijiu %

[0064]

[0065] III. Liver Organ Index and Tissue Morphology

[0066] As Figure 3 shown, the liver organ indices of the rats in the control group, the Qiongjiang Zunlv Tablet test group, and the positive drug group were significantly lower than those in the model group (P < 0.05); through liver tissue sections, it was found that a large number of vacuoles and abnormal structures appeared in the liver cells of the model group, which were significantly alleviated in the Qiongjiang Zunlv Tablet test group and the positive drug group.

[0067] Table 4 Liver Organ Index of Rats %

[0068]

[0069] IV. Serum Biochemical and Antioxidant Indexes

[0070] As Figure 4 shown, the levels of alanine aminotransferase (ALT) in the serum of the rats in the Qiongjiang Zunlv Tablet test group and the positive drug group were significantly lower than those in the model group (P < 0.05), and the level of aspartate aminotransferase (AST) in the serum of the rats in the Qiongjiang Zunlv Tablet test group was significantly lower than those in the model group and the positive drug group (P < 0.05). As Figure 5 shown, the total antioxidant capacity (T-AOC) and glutathione peroxidase (GSH-Px) levels in the serum of the rats in the Qiongjiang Zunlv Tablet test group and the positive drug group were significantly higher than those in the model group (P < 0.05), and the level of GSH-Px in the serum of the rats in the Qiongjiang Zunlv Tablet test group was significantly higher than that in the positive drug group (P < 0.05); the content of malondialdehyde (MDA) in the serum of the rats in the Qiongjiang Zunlv Tablet test group was significantly lower than that in the model group (P < 0.05).

[0071] Table 5 Serum Biochemical and Antioxidant Indexes of Rats

[0072]

[0073] Based on the above analysis, it can be seen that the effect of Qiongjiang Zunlv tablets on alleviating the body weight loss of rats caused by the acute drunkenness model, the sobering-up rate within 6 hours, liver protection and antioxidant is similar to that of the positive drug Haiwang Jinzun, and it is better in terms of the effect of improving body weight, the sobering-up rate and enhancing the antioxidant capacity of the body, having good development and application value.

[0074] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A hangover-relieving and liver-protecting composition, characterized in that, Raw materials comprising the following components: 1-4 parts of artificial bezoar, 1-4 parts of artificial bear bile, 35-55 parts of Panax notoginseng extract, 40-60 parts of Artemisia capillaris extract, 50-70 parts of Smilax glabra extract, 30-50 parts of Polygonum cuspidatum extract, 30-50 parts of Paeonia lactiflora extract, 70-90 parts of Pueraria flower extract, 40-60 parts of Polygonatum sibiricum extract, 40-60 parts of stir-fried germinated barley extract, 25-35 parts of Amomum villosum extract.

2. The hangover-relieving and liver-protecting composition according to claim 1, wherein The hangover and liver-protecting composition comprises raw materials comprising the following components: 2.5 parts of artificial bezoar, 2.5 parts of artificial bear bile, 45 parts of Panax notoginseng extract, 50 parts of Artemisia capillaris extract, 60 parts of Smilax glabra extract, 40 parts of Polygonum cuspidatum extract, 40 parts of Paeonia lactiflora extract, 80 parts of Pueraria flower extract, 50 parts of Polygonatum sibiricum extract, 50 parts of stir-fried germinated barley extract, 30 parts of Amomum villosum extract.

3. Use of a hangover and liver-protecting composition as claimed in claim 1 in a pharmaceutical preparation.

4. The application according to claim 3, characterized in that Use of the hangover and liver-protecting composition in the preparation of a hangover and liver-protecting drug.

5. The application according to claim 4, wherein Each hangover and liver-protecting drug further comprises 20-40 wt.% of microcrystalline cellulose and 0.5 wt.% of magnesium stearate.

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