CN115607629B - Traditional Chinese medicine composition with liver protecting and alcohol effect dispelling functions and preparation method thereof - Google Patents
Traditional Chinese medicine composition with liver protecting and alcohol effect dispelling functions and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the fields of foods, health-care products and traditional Chinese medicine preparations, and in particular relates to a traditional Chinese medicine composition with the functions of protecting liver and dispelling alcohol effects. The traditional Chinese medicine composition comprises the following raw materials: dendrobium officinale, sea buckthorn, radix puerariae and liquorice. The preparation method of the traditional Chinese medicine composition comprises the steps of juicing sea buckthorn, filtering to obtain filtrate and filter residues, mixing dendrobium candidum, sea buckthorn filter residues, kudzuvine root and liquorice, sequentially extracting twice by adding water, filtering, combining with freshly squeezed sea buckthorn filtrate to obtain an extracting solution, adding additives, concentrating the filtrate, centrifuging, filling and sterilizing to obtain the traditional Chinese medicine composition. The formula is scientific and reasonable, the experiment science verifies that the functions of all the medicines are fully utilized, the components of the medicine-flavor polysaccharides and flavone are reasonably reserved, the medicine-flavor polysaccharides and flavone have the exact curative effects of preventing drunk and sobering up and preventing gastric injury and hepatic cell injury, and particularly, the medicine-flavor polysaccharides and flavone are prepared into the Chinese medicinal oral liquid, so that the immunity of liver functions is obviously enhanced.
Description
Technical Field
The invention belongs to the field of health products and traditional Chinese medicine preparations, and in particular relates to a traditional Chinese medicine composition with the functions of protecting liver and dispelling effects of alcohol and a preparation method thereof.
Background
The damage of excessive alcohol to human body is various, such as liver, nerve, reproduction toxicity, etc., and long-term damage can cause gastric ulcer, liver cirrhosis, etc. There has been a focus on the field of research and development of wine products. For example, chinese patent application CN112438333A discloses a beverage which is mainly prepared from the following raw materials: flos puerariae lobatae, radix puerariae, semen hoveniae, radix ophiopogonis, rhizoma polygonati officinalis, rhizoma alismatis, rhizoma anemarrhenae, rhizoma smilacis glabrae, herba eupatorii, radix paeoniae alba, poria cocos, magnolia officinalis, radix salviae miltiorrhizae, rhizoma pinelliae, pericarpium citri reticulatae, rhizoma nardostachyos, radix codonopsis, liquorice, mulberry, mint, dendrobe, sea buckthorn, schisandra chinensis and honeysuckle. The invention integrates the functions of dispelling the effects of alcohol, building up body and preserving health, has the good effects of clearing heat and reducing pathogenic fire, protecting and nourishing the liver, but has a plurality of medicinal flavors, more ingredients are a burden for the organism besides the effects of dispelling the effects of alcohol and the like, are not suitable for long-term administration, and have weak pertinence on dispelling the effects of alcohol.
In addition, for example, chinese patent application No. 101455354 discloses that the medicinal fungus fermentation broth is used as additive, and the active ingredients extracted from the plant herbal medicines by using solvents and superfine micropowder are used as auxiliary agents, and can be prepared into effervescent tablets, buccal tablets, chewable tablets, oral tablets, candies, chocolate, chewing gum, oral liquid, granules, medicinal granules, capsules, aerosols, liquid beverages, solid beverages and other series of health foods. The invention claims to provide a good thought for the utilization of a large amount of active fermentation liquor generated along with the production of thallus medicines in the medical fungus fermentation industry, and simultaneously provides an effective value-added way for the utilization of a large amount of wild jujube, hawthorn and other plant resources widely distributed in northern areas. The invention uses fungi and traditional Chinese medicine extract to ferment, the process is complex, the medicine has a plurality of flavors, the anti-alcohol effect is not verified, and the curative effect is not exact.
Therefore, although the existing anti-alcoholic products are more, the traditional Chinese medicine composition has a lot of medicinal flavors, the medicinal effect is not definite, and the targeted effects of anti-alcoholic, stomach-protecting and liver-protecting are urgently needed to be improved.
The dendrobium candidum contains active ingredients such as polysaccharide, alkaloid, amino acid, trace elements and the like, has pharmacological effects of resisting tumor and aging, inhibiting platelet aggregation, dilating blood vessels, reducing blood fat, reducing blood sugar, reducing fever and relieving pain and the like, and the current research is mainly focused on the modern pharmacology of the dendrobium candidum, and the research of combining the modern pharmacology with the traditional Chinese medicine theory is less. The dendrobium candidum is deficient in resources, more pharmacological, extraction and clinical researches are urgently needed to be developed, and further the medicinal components and action mechanisms of the dendrobium candidum are revealed so as to fully develop and utilize the dendrobium candidum.
At present, the extraction and purification are relatively perfect, and a plurality of extraction technologies are simultaneously synergistic, for example, the patent of the invention with the application number of CN201310018056.5 discloses that the traditional Chinese herbal medicine dendrobium huoshanense fresh strips are adopted as main raw materials, the technologies of microwave extraction, biological enzymolysis, membrane separation and the like are carried out on the dendrobium huoshanense fresh strips to obtain composite fresh juice, and then the composite fresh juice and the functional oligosaccharide are uniformly mixed, and then the oral liquid is prepared by filling, sealing and high-temperature instant sterilization. The preparation process is complex, and the biological enzymolysis and membrane separation costs are high, so that the method is not suitable for mass production and application on a large scale.
Therefore, development of a liver-protecting anti-alcoholic product which has the advantages of good liver-protecting anti-alcoholic effect, simple medicine taste, easy operation of an extraction method and high extraction rate is urgently needed.
Disclosure of Invention
The invention aims to solve the technical problems of preventing and treating adverse reactions after drinking, reducing the incidence of diseases such as hepatitis, gastritis and the like, and provides a dendrobium candidum traditional Chinese medicine composition for protecting liver and dispelling the effects of alcohol and a preparation method thereof.
Terminology and statement of the invention:
1. as used herein, the articles "a," "an," and "the": unless explicitly limited to one object(s) in other ways, plural objects are included.
2. As used herein, the numerical range: unless explicitly stated otherwise, all ranges or ratios disclosed herein are to be understood to include any and all subranges or subranges subsumed therein. For example, a stated range or ratio of 1 to 30 should be considered to be inclusive between the minimum value of 1 and the maximum value of 30, and any subrange or subrange, integer, fraction, or subrange composed of integer or fraction, including broken ends.
3. As used herein, the terms "comprising," "including," "having," "can," "containing," and variations thereof, are meant to be open-ended terms or terms that do not exclude the possibility of additional compositions or structures.
The technical scheme of the invention comprises the following steps:
in a first aspect, the invention provides a traditional Chinese medicine composition with liver protecting and anti-alcohol effects, which comprises the following raw materials: dendrobium officinale, sea buckthorn, radix puerariae and liquorice.
For some embodiments, the traditional Chinese medicine composition: the raw materials consist of the following components in parts by weight: 6-12 parts of dendrobium candidum, 3-10 parts of sea buckthorn, 10-15 parts of kudzuvine root and 2-10 parts of liquorice.
For some embodiments, the traditional Chinese medicine composition: the raw materials consist of the following components in parts by weight: 8-12 parts of dendrobium candidum, 6-10 parts of sea buckthorn, 12-15 parts of kudzuvine root and 4-10 parts of liquorice.
For some embodiments, the traditional Chinese medicine composition: the raw materials also comprise additives, wherein the additives comprise aspartic acid phenylalanine methyl ester, sodium citrate and sodium alginate.
For some embodiments, the traditional Chinese medicine composition: the additives comprise 0.10-0.50 part of aspartic acid phenylalanine methyl ester, 0.05-0.10 part of sodium citrate and 0.10-0.20 part of sodium alginate.
The dendrobium candidum, sea buckthorn, kudzuvine root and liquorice have the effects of benefiting stomach, promoting fluid production, protecting liver, improving eyesight and dispelling alcohol toxicity.
The drug properties, efficacy and the results of modern pharmacological research of the invention are presented as follows:
dendrobium officinale is sweet and slightly cold. The Chinese medicinal composition has the effects of invigorating stomach and kidney meridian, benefiting stomach, promoting fluid production, nourishing yin, clearing heat, and can be used for treating heat disease, fluid consumption, dry mouth, polydipsia, stomach yin deficiency, anorexia, retching, deficiency heat after illness, yin deficiency fire hyperactivity, bone steaming, fatigue heat, dim eyesight, and flaccidity and weakness of tendons and bones. The polysaccharide contained in the dendrobium candidum has the effects of resisting cell mutation, removing aging and dead injury cells in the body, and stabilizing the physiological state of the body, so that the dendrobium candidum has stronger anti-tumor activity. The dendrobium candidum can enhance the immunity of human bodies, so the dendrobium candidum is clinically used for the auxiliary treatment of the malignant tumor by radiotherapy and chemotherapy, reduces the side effect of the radiotherapy and the chemotherapy and prolongs the survival time of patients. The preparation process disclosed by the invention is used for preparing the anti-alcohol liver-protecting preparation which takes dendrobium candidum nutritional ingredients as a main body by matching the main raw material with other components.
Hippophae rhamnoides is sour and astringent and warm. It enters spleen, stomach, lung and heart meridians. Strengthening spleen, promoting digestion, relieving cough, eliminating phlegm, promoting blood circulation and removing blood stasis. Can be used for treating spleen deficiency, anorexia, food stagnation abdominal pain, cough, excessive phlegm, chest pain, blood stasis, amenorrhea, traumatic injury, and swelling. Fructus Hippophae can be used for treating gastric ulcer, duodenal ulcer, dyspepsia, chronic superficial gastritis, atrophic gastritis, colitis, etc.
Pueraria root, radix Puerariae, sweet, pungent and cool. Enter spleen, stomach and lung meridians. Has effects of relieving muscle and fever, promoting salivation, quenching thirst, promoting eruption, invigorating yang, relieving diarrhea, dredging meridian passage, and relieving alcoholism. Can be used for treating fever and headache due to exogenous pathogenic factor, headache, strong pain of neck and back, thirst, diabetes, measles, dysentery, diarrhea, dizziness and headache, apoplexy hemiplegia, chest pain, and alcoholic injury. Has effects in relieving fever, reducing blood sugar, and relieving viscera smooth muscle, myocardial ischemia, thrombosis, arrhythmia, and blood pressure.
Licorice root, radix Glycyrrhizae Praeparata, sweet, and Ping. It enters heart, lung, spleen and stomach meridians. Spleen invigorating, qi replenishing, heat and toxic materials clearing away, phlegm eliminating, cough relieving, pain relieving, and medicines regulating. Can be used for treating weakness of spleen and stomach, listlessness, debilitation, palpitation, short breath, cough with excessive phlegm, abdominal pain, limb spasm, carbuncle, swelling, sore and toxic materials, and relieving drug toxicity and intensity. Glycyrrhrizae radix has effects of removing toxic substances, resisting pathogenic microorganism, resisting peptic ulcer, relieving spasm, and protecting liver.
In a second aspect, the present invention provides a formulation of a Chinese medicinal composition, the formulation comprising a Chinese medicinal composition; the dosage form is selected from the group consisting of liquid formulations, syrups, tablets, capsules, powders and granules.
For some embodiments, when the dosage form of the traditional Chinese medicine composition preparation is solution or syrup, the auxiliary materials comprise one or more of cosolvent, antioxidant, correctant and preservative;
further, the cosolvent comprises polyoxyethylene sorbitan fatty alcohol ethers; polyoxyethylene fatty acid esters, i.e., the zernike; polyoxyethylene fatty alcohol ethers, such as peregal-O, peregal-A, domestic; an oxyethylene oxypropylene polymer and the like;
further, the antioxidant is selected from sodium sulfite, sodium metabisulfite, sodium bisulfite and sodium thiosulfate;
further, the flavoring agent comprises a sweetener and a flavoring agent, wherein the flavoring agent is selected from sucrose, aspartame and mannitol; the aromatic is selected from essence, specifically apple essence, banana essence and mango essence.
For some embodiments, when the dosage form of the traditional Chinese medicine composition preparation is tablets, capsules, powder and granules, the auxiliary materials comprise one or more of disintegrants, binders, lubricants and glidants.
Further, the disintegrant is selected from sodium carboxymethyl starch, dry starch, and effervescent disintegrants;
further, the lubricant is selected from magnesium stearate, talcum powder and micro silica gel;
further, the co-binder is selected from the group consisting of water, starch slurry, syrup.
In a third aspect, the preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) Squeezing fructus Hippophae, and filtering to obtain filtrate and residue;
(2) Mixing herba Dendrobii, fructus Hippophae residue, radix Puerariae, and Glycyrrhrizae radix, sequentially extracting with water twice, filtering, and mixing with freshly squeezed fructus Hippophae filtrate to obtain extractive solution;
(3) And (3) adding corresponding additives, concentrating the filtrate to a relative density of about 1.05g/mL, centrifuging, filling and sterilizing to obtain the product.
For some embodiments, the extraction mode in step (2) is heating reflux extraction, the extraction temperature is 100 ℃, and the reflux extraction time is 30min;
further, the water usage amounts were 8 times.
For some embodiments, before the centrifugation in the step (3), adding the additive into the aqueous solution for mixing, and preserving the temperature at 40-50 ℃ for 30-60min;
further, before the centrifugation, additives are then added, and then the mixture is incubated at 40-50 ℃ for 30-60min.
Further, the centrifugal parameter is 10000r/min for 10min, and the sterilization method is a damp-heat sterilization method.
In a fourth aspect, the invention also provides an application of the traditional Chinese medicine composition or the traditional Chinese medicine composition preparation or the traditional Chinese medicine composition prepared by the preparation method in preparation of products for preventing or treating alcohol effect and protecting liver.
The beneficial effects of the invention include:
(1) In the formula of the invention, dendrobium candidum is taken as a monarch drug, and has the effects of benefiting stomach and promoting fluid production, nourishing yin and clearing heat; the sea buckthorn and the kudzuvine root are used as ministerial drugs, the sea buckthorn has the effects of promoting blood circulation to remove blood stasis, invigorating stomach, promoting digestion, relieving muscle and fever, promoting the production of body fluid, promoting eruption, assisting the monarch drug to promote the production of body fluid, nourishing yin, clearing heat and detoxicating, and the liquorice is used as conductant drug, and has the effects of invigorating spleen, replenishing qi, clearing heat and detoxicating, relieving urgency and relieving pain to harmonize the drugs. The four medicines together have the effects of invigorating stomach, protecting liver, clearing heat, detoxicating, promoting the production of body fluid and dispelling the effects of alcohol.
(2) The invention has scientific and reasonable compatibility, simple preparation process, strong clinical applicability, and definite efficacy of protecting liver, protecting stomach and dispelling alcohol effects, and especially can strengthen the immunity of liver function after being prepared into the traditional Chinese medicine oral liquid, and has the function of protecting liver function.
(3) The invention further researches the preparation method of the raw materials, and the optimal preparation process is that the sea buckthorn juice is squeezed and filtered to obtain filtrate and filter residue; comprises squeezing fructus Hippophae to obtain juice, filtering to obtain filtrate and residue, mixing herba Dendrobii, fructus Hippophae residue, radix Puerariae, and Glycyrrhrizae radix, sequentially extracting with water twice, filtering, and mixing with freshly squeezed fructus Hippophae filtrate to obtain extractive solution. And (3) adding corresponding additives, concentrating the filtrate to a relative density of about 1.05g/mL, centrifuging, filling and sterilizing to obtain the product. The polysaccharide and flavonoid components obtained by the method have higher retention rate, better drug applicability, better drug effect of the component combination group and obvious anti-alcohol effect.
Drawings
FIG. 1 is a comparison of the time to intoxication and the time to sober up of an acute intoxicated mouse by a liver-light oral liquid; wherein, the bar graph in the drunk time and the anti-drunk time is a blank control group, a model control group, a positive medicament group, an example 1, 2 and 3 groups, and a comparative example 1, 2 and 3 groups in turn from left to right;
FIG. 2 is the effect of liver-light oral liquid on liver ADH levels in acute drunk mice; wherein, from left to right, the bar graph is a blank control group, a model control group, a positive drug group, example 1, 2, 3 groups and comparative example 1, 2, 3 groups;
FIG. 3 is the effect of liver light oral liquid on liver MDA levels in acute drunk mice; wherein the bar graph from left to right is a blank control group, a model control group, a positive drug group, example 1, 2, 3 groups, and comparative example 1, 2, 3 groups;
fig. 4 shows the preventive and protective effects of the liver-relaxing oral liquid on a rat stomach injury model.
Detailed Description
The invention is further illustrated by the following examples.
Example 1
The composition ratio is as follows: 12 parts of dendrobium candidum, 8 parts of sea buckthorn, 10 parts of radix puerariae and 8 parts of liquorice.
The preparation method comprises the following steps:
(1) Weighing the raw materials according to the weight of the single medicinal flavor, cleaning and juicing sea buckthorn, filtering to obtain sea buckthorn filtrate and filter residue, respectively flattening the raw materials of the other components, cleaning and drying the raw materials, respectively crushing the raw materials, sieving the crushed raw materials with a 50-mesh sieve for later use, and mixing the crushed raw materials;
(2) Placing the mixed powder and filter residues obtained in the step (1) in a container, adding 8 times of water, heating and reflux-extracting twice at 100 ℃ for 30min each time, filtering, and combining the water extract and the sea buckthorn filtrate to obtain an extract;
(3) Preserving the temperature of the extracting solution at 45 ℃ for 40min, putting the extracting solution into a vacuum concentrator, and concentrating the extracting solution to a solution with the relative density of about 1.05g/mL at 20 ℃ under reduced pressure;
(4) And centrifuging at 10000r/min for 10min, collecting supernatant, packaging, and sterilizing under damp-heat.
Example 2
The composition ratio is as follows: 11 parts of dendrobium candidum, 10 parts of sea buckthorn, 13 parts of radix puerariae and 4 parts of liquorice.
The preparation method comprises the following steps:
(1) Weighing the raw materials according to the weight of the single medicinal flavor, cleaning and juicing sea buckthorn, filtering to obtain sea buckthorn filtrate and filter residue, respectively flattening the raw materials of the other components, cleaning and drying the raw materials, respectively crushing the raw materials, sieving the crushed raw materials with a 50-mesh sieve for later use, and mixing the crushed raw materials;
(2) Placing the mixed powder and filter residues obtained in the step (1) in a container, adding 8 times of water, heating and reflux-extracting twice at 100 ℃ for 30min each time, filtering, and combining the water extract and the sea buckthorn filtrate to obtain an extract;
(3) Preserving the temperature of the extracting solution at 45 ℃ for 40min, putting the extracting solution into a vacuum concentrator, and concentrating the extracting solution to a solution with the relative density of about 1.05g/mL at 20 ℃ under reduced pressure;
(4) And centrifuging at 10000r/min for 10min, collecting supernatant, packaging, and sterilizing under damp-heat.
Example 3
The composition ratio is as follows: 12 parts of dendrobium candidum, 8 parts of sea buckthorn, 10 parts of radix puerariae and 8 parts of liquorice.
Additives: 0.22 part of aspartic acid phenylalanine methyl ester, 0.06 part of sodium citrate and 0.17 part of sodium alginate.
The preparation method comprises the following steps:
(1) Weighing the raw materials according to the weight of the single medicinal flavor, cleaning and juicing sea buckthorn, filtering to obtain sea buckthorn filtrate and filter residue, respectively flattening the raw materials of the other components, cleaning and drying the raw materials, respectively crushing the raw materials, sieving the crushed raw materials with a 50-mesh sieve for later use, and mixing the crushed raw materials;
(2) Placing the mixed powder and filter residues obtained in the step (1) in a container, adding 8 times of water, heating and reflux-extracting twice at 100 ℃ for 30min each time, filtering, and combining the water extract and the sea buckthorn filtrate to obtain an extract;
(3) Adding additives, mixing, maintaining at 45deg.C for 40min, and concentrating under reduced pressure to obtain solution with relative density of about 1.05g/mL at 20deg.C;
(4) And centrifuging at 10000r/min for 10min, collecting supernatant, packaging, and sterilizing under damp-heat.
Comparative example 1
Name: ge Zhi anti-hangover oral liquid (Ge Zhi anti-hangover oral liquid preparation method and quality standard thereof)
The composition and the proportion are as follows: 200g of kudzuvine root; 100g of semen hoveniae; 40mL of monose syrup, weighing decoction pieces with a prescription amount according to a method in literature, decocting with water twice, filtering, combining the two filtrates, concentrating, precipitating with ethanol until the ethanol content is 75%, standing for 48h, filtering, removing ethanol from the filtrate, adding 40mL of auxiliary materials, adding distilled water to 40mL, heating to 40 ℃, filling into a 10mL oral liquid bottle, and sealing to obtain the oral liquid.
Comparative example 2
Name: oral liquid for protecting stomach and dispelling effects of alcohol (CN 201710490937.5)
The composition and the proportion are as follows: 35 g (broken), 10g of magnolia officinalis, 12 g of garden burnet, 10g of fingered citron, 8g of ginger processed pinellia, 10g of flos puerariae, 15 g of semen hoveniae, 5g of rheum officinale powder, 5g of pseudo-ginseng powder (mixed for 3 times of swallowing), 10g of liquorice, 13 g of rhizoma corydalis and 8g of bamboo shavings, and is prepared by adopting the preparation method of the specific embodiment in the patent application CN 201710490937.5.
Comparative example 3
Name: an oral liquid (CN 202210230024.0) for relieving hangover and protecting liver
65 parts of kudzuvine root, 55 parts of hovenia dulcis thunb, 40 parts of kudzuvine flower, 30 parts of poria cocos, 25 parts of liquorice, 20 parts of chrysanthemum, 2 parts of cardamom slices, 5 parts of vitamin B, 2 parts of taurine and 3 parts of honey, and preparing a homogeneous mixed solution by adopting the preparation method of the embodiment 1 of the patent application CN202210230024.0, and then sterilizing, cooling and filling the mixed solution.
Experiment one, the Chinese medicinal composition has the effects of preventing, dispelling effects of alcohol and protecting liver on acute drunk mice model
1. Experimental materials:
animals: healthy ICR mice, male and female halves, SPF grade, body weight 20+ -2 g, were offered by the university of Nanjing traditional Chinese medicine animal center.
Experimental principle: the anti-alcoholic effect of the traditional Chinese medicine composition on acute drunk is judged through behavioral observation, and the liver protection effect of the traditional Chinese medicine composition is researched through detection of ADH (alcohol dehydrogenase) and MDA (malondialdehyde) contents in the liver.
Medicament: the invention comprises the components of dried orange peel, hawthorn, honeysuckle, hovenia dulcis thunb, kudzuvine root, medlar, mulberry, chrysanthemum, liquorice and the like, wherein the manufacturers are Guangdong orange aroma Zhai dried orange peel limited companies, and the preparation method is that 6g of the anti-alcoholic solid beverage is taken with boiled water.
2, the method comprises the following steps:
2.1 grouping and administration of animals
Mice were randomly grouped into blank, model, positive drug, examples 1-3 and comparative examples 1-3, 10 animals each, male and female halves 1 week after adaptive rearing. The mice in the blank group were not treated; after the mice of the model control group are irrigated with distilled water with the same volume for 30min, the mice are administrated with 53-degree red star Erguotou according to the dosage of 0.12ml/10 g; after the mice in the positive pharmaceutical group are dosed with boiled water and 6g of anti-alcoholic solid drink is taken for 30min, 53 DEG red star Erguotou is dosed according to 0.12mL/10g (the dosing amount is 0.77g/kg according to the crude drug amount, and the dosing volume is 0.10mL/10 g); examples 1-3 and comparative examples 1-3 mice were given 53 ° red star Erguotor at a dose of 0.12ml/10g 30min after the last administration of the drug prepared in the corresponding group. Wherein, the dosage of the examples 1-3 is prepared according to the crude drug dosage of 4.9g/kg, and the dosage of the comparative example 1 is prepared according to the crude drug dosage of 38.7g/kg; comparative example 2 the dosage of group was 18.2g/kg of crude drug; comparative example 3 the dose was 27.2g/kg based on the crude drug amount; the corresponding dosing solution was prepared at a lavage volume of 0.10mL/10 g.
2.2 Experimental methods
2.2.1 after each group of mice was filled with the stomach white spirit, timing was started immediately and an anti-normal reflex experiment was performed to determine whether the mice were drunk (whether the mice could be kept with their backs down for 30 seconds, if so, it was determined that the mice were drunk and not drunk otherwise), and the drunk time (last time of filling the stomach-anti-normal reflex vanishing time), and the anti-drunk time (anti-normal reflex vanishing time-anti-normal reflex recovery time) were recorded.
2.2.2 taking the liver of the mice sacrificed after 4 hours, mixing with physiological saline in a ratio of 1:9, grinding with liquid nitrogen, centrifuging for 10 minutes at 4 ℃ and 4 500r/min, and taking the supernatant. The 10% liver homogenate was taken and tested for ADH and MDA levels using the kit for 4.0 h. The results are shown in FIGS. 1-3.
3. Experimental results
TABLE 1 influence of liver-relaxing oral liquid on the intoxication time and sobering-up time of acute intoxicated mice
| Group of | Drunkenness time/min | Sobering-up time/min |
| Blank control group | 0.00±0.00 | 0.00±0.00 |
| Model control group | 25.31±3.25## | 205.33±42.38## |
| Positive pharmaceutical group | 46.28±4.27* | 162.38±56.29 |
| Example 1 | 50.33±3.86** | 122.38±47.27** |
| Example 2 | 60.32±4.57** | 103.27±38.29** |
| Example 3 | 50.89±4.27** | 121.97±48.29** |
| Comparative example 1 | 47.28±2.23* | 164.38±65.29* |
| Comparative example 2 | 38.21±4.67 | 184.25±57.83 |
| Comparative example 3 | 37.21±3.85 | 172.36±47.38 |
Note that: the "# indicates that the model group was significantly different (P < 0.05), the" # indicates that the model group was significantly different (P < 0.01), the "#" indicates that the model group was significantly different (P < 0.05), and the "#" indicates that the blank group was significantly different (P < 0.01), as follows.
TABLE 2 Effect of liver-relaxing oral liquid on acute drunk mouse liver ADH and MDA levels
The results show that the invention has better impurity removing effect in the aspects of dispelling the effects of alcohol and protecting liver, and has remarkable effects of dispelling the effects of alcohol and protecting liver compared with similar products.
3.2 conclusion of experiments
The traditional Chinese medicine considers that the wine is a damp-heat product, is easy to cause abdominal fullness, inappetence, damp evil obstruction in middle energizer and discomfort, and adopts dendrobium candidum to nourish yin, clear heat and promote urination; the sea buckthorn is compatible with the medicines for promoting blood circulation by removing blood stasis, invigorating stomach and promoting digestion, the kudzuvine root is used for clearing heat and promoting the production of body fluid, the organism is promoted to clear away heat and dispel wine, the liquorice is used for tonifying spleen and replenishing qi, and the medicines are blended to assist the organism to dispel alcohol and expel toxin. According to the pharmacodynamic experimental results, the liver-relaxing oral liquid has a better prevention result on acute alcoholism of mice, has remarkable advantages compared with a positive anti-alcoholic solid beverage, reduces the drug pair of components on one hand, and has more remarkable positive effects on drunk behaviours of the mice on the other hand; compared with comparative examples 1-3, the proportion and the preparation method of the invention have more effective anti-alcohol effect.
Experiment two, prevention and protection effect on rat stomach injury model
1. Experimental materials:
animals: 60 healthy SD rats, male, SPF grade, weight 220-250 g, provided by the university of Nanjing traditional Chinese medicine animal center.
Materials: the traditional Chinese medicine composition of the embodiment 2 of the invention, the traditional Chinese medicine composition of the comparative example 2 and 60% edible ethanol solution. 2, the method comprises the following steps:
2.1 grouping and administration of animals
The test rats were divided into 6 groups of 10 animals each, which were a normal group, a positive drug group (comparative example 2 Chinese medicinal composition), a model control group, a low dose group, a medium dose group, and a high dose group.
Normal groups of rats were bred normally without any experimental treatment; the rats in the model control group are firstly fed normally and then gastric injury is induced; 3 test groups the Chinese medicinal composition (Ganshua oral liquid) of example 2 was subjected to intragastric administration 1 time per day to SD rats of the test group at 1mL/100g, and the administration amounts of the different dose groups were 3.4, 6.8 and 13.7g/kg as crude drugs, and corresponding administration solutions were prepared at a intragastric volume of 0.10mL/10 g.
2.2 method for molding gastric injured rat
After 2 weeks, the rats of each group except the normal group were induced by gastric lavage and gastric injury with 1mL of ethanol solution (60% edible ethanol solution), and after 1 hour, the rats of each group were sacrificed and the plasma of the rats was measured.
3 method
Taking 2mL of arterial blood, centrifuging at 3000r/min at 4 ℃ for 10min, and taking upper serum. The IL-6 and TNF-alpha quantitative ELISA kit was used to detect the levels of the above 2 cytokines in serum using a Bio-Rad 550 microplate reader (USA).
4 experimental results:
cytokine levels of IL-6 in rat serum were determined by ELISA and the results are shown in FIG. 4. The factor levels of the groups of the normal group, the control group and the oral liquid of the example 2 which are used for the stomach irrigation with the concentration of 2.2 g/kg, 4.4 g/kg and 8.8g/kg are respectively 50.4 pg/ml, 240.3 pg/ml, 162.4 pg/kg, 142.6 pg/ml, 108.7 pg/ml and 65.9pg/ml. TNF- α cytokine levels were similar to IL-6, with average TNF- α cytokine levels of 108.2, 775.3, 403.2, 378.2, 206.6, 100.1pg/mL for each group of rats. As shown by the results, the levels of IL-6 and TNF-alpha cytokines decreased with the increase of the gastric lavage concentration of the oral liquid, and the levels of cytokines in the rats in each group were significantly lower than those in the control group. A decrease in IL-6 and TNF-alpha cytokine levels indicates a decrease in the degree of inflammation, indicating that oral solutions can decrease the degree of gastric injury.
5 conclusion of experiment:
the study uses the liver-relaxing oral liquid of the invention as a reference to carry out a comparative test of anti-gastric injury in animals, and the serum cytokine level proves that the product has a certain gastric injury prevention effect and is superior to similar products.
Experiment three, protective action on ethanol-induced liver cell injury
1. Experimental materials
L-02 hepatocytes; edible grade ethanol; the medicine is the traditional Chinese medicine composition in the example 2; a full-band enzyme-labeling instrument; total superoxide dismutase (total superoxide dismutase, T-SOD); tetramethyl thiazole blue [3- (4, 5-dimethyl-ylthiazol-2-yl) -2,5-diphenyltetrazolium bromid, MTT ].
2. Method of
The L-02 liver cells are divided into: blank control group, drug group (10. Mu.g/mL), ethanol model group (CH) 3 CH 2 OH,100 mmol/L) and a drug+ethanol group, wherein the L-02 liver cell control group is taken and administered with a serum-free culture medium, the drug group is administered with a liver-relaxing oral liquid for pretreatment for 8 hours, the ethanol model group is exposed to an ethanol solution containing 100mmol/L of DM EM for 12 hours, and the drug+ethanol group is firstly administered with the oral liquid of example 1 for 8 hours and then is exposed to an ethanol solution containing 100mmol/L of DMEM for 12 hours. Cell viability= (OD experimental group/OD control group) ×100% using MTT to detect OD values; the content level of the total superoxide dismutase (total superoxide dismutase, T-SOD) is measured by combining with a microplate reader.
3. Experimental results
Compared with a control group, 100mmol/L ethanol can lead the cell viability to be reduced to 0.50+/-0.03 (P is less than 0.05), and the pretreatment of the drug group can obviously improve the ethanol-induced cell viability reduction, wherein the viability level is 0.85+/-0.05 and is obviously improved compared with the ethanol group (P is less than 0.05); the T-SOD level of the drug pretreatment group is (13.95+/-0.75) U/mL, which is obviously higher than that of the ethanol group (P is less than 0.05).
4. Conclusion of the experiment
The liver-relaxing oral liquid has remarkable protection effect on ethanol-induced liver cell injury, can effectively relieve the decrease of cell activity and increase the total superoxide dismutase.
Experiment four, study on influence of liver function protection effect of mice
1. Experimental materials
Animals: SPF-class Kunming mice, 50, were used both male and female, and had a body weight of 20+ -2 g, and were supplied by the university of Nanjing, traditional Chinese medicine, animal center.
Medicament: liver protection tablet (Heilongjiang sunflower pharmaceutical Co., ltd.)
Instrument: microplate reader (Bio-Rad, USA);
2. the method comprises the following steps:
grouping: 50 Kunming mice were randomly divided into a normal control group, a model group, a liver protection tablet (0.14 g/kg) positive control group, a drug low-dose group (3.2 g/kg of the liver-soothing oral liquid of example 1) and a drug high-dose group (6.4 g/kg of the liver-soothing oral liquid of example 1), each group being 10.
And (3) molding: except for the normal control group, 2% CCl was injected subcutaneously into each of the other groups 4 Peanut oil solution, 2mL/kg,2 times/w, 8w in succession.
Administration: after molding, the following day, except the normal control group and the model group, the other groups are infused with distilled water according to the corresponding medicine doses for 1 time/d. 3 days after the last administration for 12 hours, samples are collected to determine the biochemical index of liver function.
3. Experimental results:
| group of | IL-6 | TNF-α |
| Blank control group | 24.67±5.28 | 114.21±22.56 |
| Model control group | 82.23±4.53 ## | 303.54±43.23 ## |
| Positive control group | 55.39±6.74 * | 238.53±26.53 * |
| Pharmaceutical low dose group | 58.54±6.78 ** | 244.24±32.13 * |
| High dose pharmaceutical combinations | 43.16±7.34 ** | 194.78±19.67 ** |
4. Conclusion of experiment:
the liver-relaxing oral liquid has the effects of improving and repairing the damaged liver functions and liver tissues of mice, and has obvious effects.
Clinical study of alcohol-dispelling and stomach-protecting effects of oral liquid for experimental five and liver relaxation
1. Experimental materials
The liver-soothing oral liquid prepared in example 2; the oral liquid prepared in comparative example 1;
2. the experimental object: 100 male volunteers with ages of 30-55 years and body weight of 65kg (+ -6%) and no abnormality in other aspects due to certain damage to liver or stomach viscera caused by long-term drinking were selected. The subject exclusion criteria were: (1) Patients with allergic, gastrointestinal, renal, hepatic, and cardiac medical history; (2) those who take the medication within 2 weeks prior to initiation of the trial; (3) other inappropriates.
3. Experimental method
Random volunteers were divided into 3 groups, a blank control group, a drug group (example 2), a positive control group (comparative example 1), 60 persons each; before treatment, detecting the physical condition of selected volunteers, and determining whether problems of liver and intestines and stomach before treatment exist, such as increased speech, conjunctival congestion and swelling, anxiety and insomnia; then, the control group is not dosed, each volunteer starts to take the oral liquid prepared by the corresponding group, the example group and the comparative example group take 2 oral liquids (10 mL/mL) each time, each of the oral liquids of the examples and the comparative example groups respectively has the dosage of 0.95g/mL and 7.5g/mL, each oral liquid is orally taken after meal, twice a day for 1 month, physical condition detection is carried out again, whether symptoms and the like existing before treatment are solved or relieved is checked, and the taste of the oral liquid is inquired of individuals.
4. Experimental results
The final control group of experimental results still has the problem caused by long-term drinking because of no drug administration;
the drug group and the positive drug group have different degrees of treatment effects:
the symptoms of 48 people in the medicine group are basically disappeared, and the rest symptoms are relieved to different degrees;
the positive medicine group has 35 people with symptoms basically disappeared, 2 people have symptoms of eye redness and swelling, and the rest have symptoms relieved to different degrees.
5. Conclusion of the experiment
Experiments show that the liver-relaxing oral liquid has the function of improving chronic alcoholism symptoms caused by long-term drinking, and can be used for treating the problem of body immunity reduction caused by long-term drinking.
Clinical trial cases
1: mr. king, 58 years old, feel weak, limp limbs, soreness of waist and legs, listlessness and other discomforts in month 11 of 2020, go to hospital to check the body many times, know that Mr. king has long-term drinking, cause organism immunity to decline, often feel tired, weakness, liver function is impaired. After the oral liquid is taken for 2 months for a long time, the discomfort such as consciousness fatigue weakness, soreness and weakness of waist and legs and the like are obviously improved, and the feeling is vigorous. The above-mentioned uncomfortable symptoms have not been seen so far.
2: women with kudzu vine, women, 40 years old, feel tired and weak, sleepy, pale complexion, listlessness, irregular menstruation and other uncomfortable symptoms in 2021, 3 months. The women with kudzuvine are high tubes of an external enterprise, and have great pressure when working for a long time, so that the immunity of the organism is reduced. After the invention is taken for two half months, the complexion is ruddy, the spirit is good, the irregular menstruation condition is obviously improved, and other uncomfortable symptoms are all eliminated.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (7)
1. A traditional Chinese medicine composition with the effects of protecting liver and dispelling effects of alcohol is characterized in that: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-12 parts of dendrobium candidum, 3-10 parts of sea buckthorn, 10-15 parts of kudzuvine root and 2-10 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8-12 parts of dendrobium candidum, 6-10 parts of sea buckthorn, 12-15 parts of kudzuvine root and 4-10 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of dendrobium candidum, 8 parts of sea buckthorn, 10 parts of radix puerariae and 8 parts of liquorice; or: 11 parts of dendrobium candidum, 10 parts of sea buckthorn, 13 parts of radix puerariae and 4 parts of liquorice.
4. A Chinese medicinal composition preparation with liver protecting and anti-alcohol effects is characterized in that: the traditional Chinese medicine composition preparation is prepared from the traditional Chinese medicine composition according to any one of claims 1-3; the preparation is one of syrup, tablet, capsule, powder and granule.
5. The method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that: the method comprises the following steps:
(1) Squeezing fructus Hippophae, and filtering to obtain filtrate and residue;
(2) Mixing herba Dendrobii, residue, radix Puerariae, and Glycyrrhrizae radix, sequentially extracting with water twice, filtering, and mixing with freshly squeezed fructus Hippophae filtrate to obtain extractive solution;
(3) And (3) adding the additive, concentrating to a relative density of about 1.05g/mL, centrifuging, filling and sterilizing to obtain the product.
6. The method of manufacturing according to claim 5, wherein: the extraction in the step (2) is reflux extraction, and the water adding amount is 8 times; the temperature of the reflux extraction is 100 ℃, and the time of the reflux extraction is 30min; adding additives into the step (3), mixing, and preserving heat for 30-60min at 40-50 ℃; the additive is aspartic acid phenylalanine methyl ester, sodium citrate and sodium alginate; the centrifugal parameter is 10000r/min for 10min; the sterilization method is a damp heat sterilization method.
7. Use of a Chinese medicinal composition according to any one of claims 1 to 3, or a Chinese medicinal composition preparation according to claim 4, or a Chinese medicinal composition prepared by a preparation method according to any one of claims 5 to 6, in the preparation of a product for preventing or treating anti-hangover and liver protection.
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| 复方鲜石斛口服液制备工艺研究;黄显章;赵清超;;国医论坛;-;第22卷(第04期);第45页第1段 * |
| 沙棘果汁在我国的发展;许涛;张红梅;赵梅霞;;国际沙棘研究与开发;第4卷(第02期);第7页左栏倒数第2段 * |
| 用葛根、甘草合剂治疗猪酒糟中毒;骆带喜;福建畜牧兽医;-;第23卷(第04期);第19页第4段 * |
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