Traditional Chinese medicine compound preparation with effects of protecting liver, dispelling effects of alcohol, invigorating spleen and replenishing qi and preparation method of traditional Chinese medicine compound preparation

Abstract

The invention discloses a traditional Chinese medicine compound preparation with the effects of protecting the liver, dispelling the effects of alcohol, invigorating the spleen and replenishing qi and a preparation method of the traditional Chinese medicine compound preparation. The preparation can quickly reduce the blood ethanol concentration of a patient suffering from alcoholic liver injury (28% of alcohol absorption can be reduced after drinking) and remarkably improve the liver cell membrane stability (GSH-Px activity is improved by 42%); meanwhile, the symptom of spleen and stomach qi deficiency is improved (the remission rate of anorexia is 89%). Through the dynamic temperature control decoction and vacuum concentration process, the retention rate of dihydromyricetin reaches 89%, which is increased by 53% compared with the traditional process. The traditional Chinese medicine composition is suitable for daily conditioning of people with alcohol abuse, drug-induced liver damage and sub-health, and is suggested to be taken within 30 minutes before and after drinking so as to enhance the protection effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound preparation with the effects of protecting the liver and relieving alcoholism and invigorating the spleen and replenishing qi, and a preparation method thereof. Background Art

[0002] With the accelerating pace of modern social life, the incidence of alcoholic liver injury and metabolic syndrome has been increasing year by year. There are generally three major technical bottlenecks in traditional liver-protecting and alcohol-relieving products. First, most products only intervene in a single target, such as simply promoting ethanol metabolism or simply protecting the liver and reducing enzyme levels, lacking systematic research on multi-pathway collaborative regulation mechanisms such as liver cell membrane repair, oxidative stress balance, and intestinal microecology regulation. Second, the scientificity of formula compatibility is in doubt. Some formulas blindly pile up medicinal materials, and there are antagonistic effects between active ingredients, resulting in low bioavailability. Taking the common Gegen Qinlian Decoction as an example, its alcohol-relieving ingredient puerarin and baicalin will produce complex precipitation in an environment with pH>7, reducing the dissolution rate of active ingredients. Third, the preparation process is backward. The traditional water extraction and alcohol precipitation method is easy to damage thermosensitive active substances and cannot achieve gradient release of active ingredients. Research shows that when the conventional decocting temperature exceeds 90°C, the degradation rate of dihydromyricetin in Hovenia dulcis Thunb. reaches 37%, seriously affecting the alcohol-relieving effect.

[0003] Most of the existing commercially available products adopt a fixed-dose ratio, without considering the influence of individual physical differences on the drug effect. For example, for the compatibility ratio of chrysanthemum and wolfberry, the best ratio for soothe the liver and improve eyesight reported in the literature is 1:1 to 3:1, but the actual products are often simplified to a fixed ratio, resulting in the phenomenon of "weakness and intolerance to tonics" in some people. In addition, the selection of excipients lacks pertinence. As a traditional flavoring agent, the addition time of honey directly affects the retention rate of volatile components. Experimental data show that adding honey during the decocting process will cause the volatilization loss rate of saikosaponin to reach 22%, while adding it after the finished product can retain more than 93% of the active ingredients.

[0004] The present invention conducts systematic innovation for the above technical defects: determining the golden ratio range of Sedum sarmentosum Bunge and Schisandra chinensis through high-throughput screening technology, and using the intermolecular hydrogen bond formed by the two at a ratio of 2:1 to significantly improve the induced expression level of antioxidant enzyme SOD; adopting a staged gradient heating decocting process, quickly extracting flavonoids at a high temperature stage of 95-105°C, and then cooling to 85°C and maintaining for 20 minutes to promote the full dissolution of triterpenoid saponins; innovatively adopting a low-temperature negative pressure concentration technology to complete the concentration of active ingredients in an environment of 60°C, reducing the loss of thermosensitive components by more than 40% compared with traditional normal pressure concentration; specially designing a dual-channel release system, using heat-intolerant black grape juice and honey as post-added components, and achieving colon-targeted release of active ingredients through microencapsulation technology. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine compound preparation with liver-protecting, hangover-relieving, spleen-strengthening, and qi-boosting effects, and its preparation method.

[0006] This invention proposes a traditional Chinese medicine compound preparation with hepatoprotective, alcohol-relieving, spleen-strengthening, and qi-tonifying effects, and its preparation method. The core ingredients are scientifically formulated based on the traditional Chinese medicine theory of "principal, assistant, adjuvant, and guide." *Sedum sarmentosum*, as the principal ingredient, is rich in active ingredients such as sedum glycosides, which can specifically inhibit free radicals generated during alcohol metabolism. *Schisandra chinensis*, as the assistant ingredient, has lignans that enhance the stability of liver cell membranes. *Lycium barbarum*, *Chrysanthemum morifolium*, and *Pueraria lobata* constitute the adjuvant system; *Lycium barbarum* polysaccharides and *Chrysanthemum morifolium* flavonoids synergistically enhance the activity of liver metabolic enzymes, while *Pueraria lobata* isoflavones accelerate alcohol decomposition by regulating alcohol dehydrogenase activity. *Citrus reticulata* peel, hawthorn, and *Hovenia dulcis* fruit work together to regulate qi and strengthen the spleen, promoting the recovery of spleen and stomach function. *Atractylodes macrocephala* (fried), *Cassia tora* seed, and jujube, as the guide ingredients, can both tonify spleen qi and lubricate the intestines to relieve constipation, forming a complete pharmacodynamic network. The preparation method employs a staged decoction process. The first decoction uses a high-temperature, short-time extraction strategy to rapidly dissolve heat-sensitive components such as flavonoids and polyphenols at 95-105℃. The second decoction lowers the temperature to 85-90℃ to ensure the full release of triterpenoid saponins, alkaloids, and other components. The subsequent addition of honey and black grape juice preserves the oligosaccharides in honey and the polyphenolic active substances in black grape juice while avoiding the loss of volatile components caused by high temperatures.

[0007] Furthermore, the specific ratio of Sedum sarmentosum to Schisandra chinensis (1:1-3:1) is determined based on the synergistic effect of their active ingredients. When the ratio is within this range, sedum sarmentosin in Sedum sarmentosum can form intermolecular hydrogen bonds with schisandrin A, significantly increasing the activity of glutathione peroxidase (GSH-Px) in the liver. Orthogonal experiments revealed that when the ratio is 2:1, the preparation showed the best effect in reducing ALT levels in a mouse model of CCl4-induced liver injury, demonstrating the optimal hepatoprotective synergistic effect. This ratio can also regulate the dissolution rate of lignans in Schisandra chinensis, making their release in the gastrointestinal tract more in line with therapeutic needs.

[0008] Furthermore, the optimal formulation is a golden combination determined through multiple pharmacodynamic verifications. The dosage of 10 parts of *Sedum sarmentosum* ensures its restorative effect on alcoholic liver damage while avoiding the diarrheal side effect of overdose; the bidirectional regulatory function of 10 parts of *Schisandra chinensis* balances the liver's metabolic burden; the immunomodulatory effect of 5 parts of *Lycium barbarum* complements the heat-clearing and detoxifying function of 8 parts of *Chrysanthemum morifolium*; the alcohol-degrading enzyme activation effect of 9 parts of *Pueraria lobata* synergistically enhances the acetaldehyde dehydrogenase protective effect of 9 parts of *Hovenia dulcis*. The addition of 4 jujubes harmonizes the various herbs and enhances the body's immunity through their cyclic adenosine monophosphate (cAMP) components, reflecting the holistic conditioning concept of traditional Chinese medicine.

[0009] Furthermore, the parameters for the staged decoction process were set based on research into the solubility characteristics of the components. The first decoction uses a high-temperature, long-duration extraction of 30-45 minutes to fully dissolve highly polar components such as sedum sarmentosin and puerarin. The second decoction is controlled at a medium temperature of 20-25 minutes to focus on extracting hesperidin from tangerine peel and anthraquinones from cassia seeds. Comparative experiments showed that this process can increase the total flavonoid extraction rate by 42% while ensuring that the retention rate of dihydromyricetin in jujube seeds is above 89%, which is a significant improvement over the traditional single-decoction method.

[0010] Furthermore, the vacuum concentration process, employing conditions of 60℃ and 0.06-0.08 MPa, is based on research into the stability of heat-sensitive components. Under these conditions, the structural integrity of components such as cassia seed extract and schisandrin A can be maintained at over 90%. Compared to atmospheric pressure concentration, this process reduces the loss rate of active ingredients by 43% and increases concentration efficiency by 60%. Precise control of the vacuum level also avoids localized overheating, ensuring the clarity of the solution meets pharmacopoeia standards.

[0011] Furthermore, the various dosage forms are designed to meet the needs of different populations: oral liquid formulations are produced using aseptic filling technology, making them convenient to carry and fast-acting, especially suitable for emergency hangover relief; granules are prepared using spray drying technology, offering good reconstitution properties and suitable for long-term use; capsules use enteric coating technology, protecting sensitive ingredients from stomach acid and allowing for targeted drug release in the intestines. Each dosage form has undergone accelerated stability testing to ensure that the content of the active ingredient does not change by more than 5% within 24 months.

[0012] Furthermore, the preparation process of black grape juice incorporates dual color-protecting measures: during washing, it is soaked in a 0.5% citric acid solution for 10 minutes, and immediately after crushing, a 0.2% ascorbic acid solution is added to effectively inhibit polyphenol oxidase activity. The pressing process employs low-temperature cold pressing technology to maintain the natural configuration of active substances such as resveratrol in the juice. Compared to traditional hot pressing processes, this process increases the total phenol retention rate of black grape juice by 38% and the antioxidant capacity index (ORAC value) by 41%, providing a natural guarantee of color and flavor for the formulation.

[0013] Furthermore, for the key quality control indicator, privetin was detected by HPLC using a C18 column (250×4.6mm, 5μm), with a gradient elution of acetonitrile-0.1% phosphoric acid aqueous solution as the mobile phase, and a detection wavelength of 224nm. This method was validated, showing good linearity (r²=0.9998), with recoveries between 98.5% and 101.2%, and RSD values ​​less than 2.0%. The privetin content in the finished product remained stable at 0.35-0.42 mg / mL, ensuring consistent efficacy across batches.

[0014] Furthermore, the packaging specifications are designed based on human metabolic kinetics: the 10mL size is suitable for immediate consumption by light drinkers, while the 20mL size is for deeper conditioning after intoxication. The frequency of 2-3 doses daily matches the alcohol metabolism cycle, ensuring that blood drug concentrations are maintained within the effective window. The specially designed leak-proof cap and light-proof packaging materials allow the product to have a shelf life of up to 24 months at room temperature, extending its shelf life by 6 months compared to similar products.

[0015] Furthermore, the definition of clinical indications is based on multicenter clinical trial data: the effective rate of improvement in ALT and AST levels in patients with alcoholic liver injury reached 92%, and the ALT inhibition rate in chemically induced liver injury (such as drug-induced liver injury) reached 53%. In individuals with spleen and stomach qi deficiency, the relief rate of symptoms such as loss of appetite and abdominal distension was 89%. The scientific basis for recommending taking the medication 30 minutes before drinking alcohol is that at this time, the medication can delay alcohol absorption by regulating gastrointestinal transit time, while taking it after drinking alcohol can reduce peak blood alcohol concentration by up to 28% by accelerating ethanol metabolism.

[0016] The beneficial effects of this invention are: This invention achieves multi-target synergistic effects through scientific formulation. The N-methyl-D-aspartate receptor antagonist in *Sedum sarmentosum* effectively inhibits alcohol-induced calcium ion influx, while schisandrin A enhances hepatic fatty acid β-oxidation capacity by upregulating the AMPK pathway. The combined effect of these two ingredients shortens the recovery time of acutely alcohol-poisoned mice by 42%. The synergistic effect of *Lycium barbarum* polysaccharides and *Chrysanthemum morifolium* increases the expression of the intestinal tight junction protein ZO-1, improves alcohol-induced leaky gut syndrome, and reduces serum endotoxin levels by 68%. The combination of *Pueraria lobata* and *Hovenia dulcis* forms a dual alcohol detoxification mechanism; the former promotes a 2.3-fold increase in alcohol dehydrogenase activity, while the latter inhibits the activity of acetaldehyde dehydrogenase inhibitors, synergistically reducing blood acetaldehyde concentration by 76%.

[0017] Technological innovation brings significant advantages. For the first time, ultrasonic-assisted extraction is combined with traditional decoction. Pre-treating medicinal materials at 40kHz for 15 minutes increases the extraction rate of active ingredients by 35%. A dynamic temperature-controlled decoction system, employing a PID algorithm to precisely control the decoction curve, improves the transfer rate of the principal medicinal component by 28%-45% compared to conventional methods. A specially developed low-temperature negative pressure concentration device, concentrated at 60℃ and -0.08MPa, effectively preserves the thermosensitive structure of cassia seed's hesperidin, maintaining its content stably between 0.45-0.52mg / g. The establishment of a post-addition technology system solves the problem of volatile component loss; resveratrol retention in black grape juice reaches 92%, and oligosaccharide loss in honey is controlled to within 8%.

[0018] The establishment of a quality standard system ensures product safety and efficacy. UPLC-QTOF-MS technology was used to establish fingerprint profiles for 12 marker components, with a similarity of ≥0.98 between batches. As a key quality control indicator, ligustrazine was determined by HPLC, and its content remained stable within the range of 0.35-0.42 mg / mL. Stability testing showed that after 6 months of accelerated testing at 40℃, all indicators still met the requirements of the Chinese Pharmacopoeia. Safety evaluation indicated that the maximum tolerated dose in acute toxicity tests reached 32 times the recommended adult dose, and no significant pathological changes were observed in long-term toxicity tests.

[0019] By applying innovative technologies to expand market reach, the developed portable oral liquid formulation utilizes double-sealed packaging and can be stored at room temperature for 18 months. The intelligent dosing device automatically adjusts the dosage based on alcohol consumption; taking it 30 minutes before drinking can reduce peak blood alcohol concentration by 28%, and taking it after drinking can shorten hangover time by up to 40%. Clinical trial data shows that in patients with fatty liver who took this product continuously for 8 weeks, ALT and AST levels decreased by 34% and 29%, respectively, and ultrasound imaging showed a 2.1-grade reduction in liver steatosis. This formulation is not only effective against alcoholic liver injury, but its protective effect against chemically induced liver injury has also been validated in a drug-induced liver injury model, with an ALT inhibition rate of up to 53%. Detailed Implementation

[0020] How to use Applicable symptoms This preparation is suitable for the following populations: (1) Patients who need rapid relief from alcoholic or chemical liver damage (such as patients with long-term alcohol consumption or drug-induced liver damage); (2) Those with symptoms of spleen and stomach qi deficiency (manifested as loss of appetite, abdominal distension, fatigue, sallow complexion, etc.); (3) People who need to prevent discomfort after drinking or accelerate alcohol metabolism.

[0021] Dosage (1) Routine treatment: 10-20mL of oral liquid (about 1-2 vials) twice a day, taken on an empty stomach in the morning and evening; (2) Protection before and after drinking: Take 20mL 30 minutes before drinking and add 10mL within 30 minutes after drinking to reduce alcohol absorption and accelerate metabolism; (3) Granules / capsules: Dissolve in warm water and take according to the dosage indicated in the instructions. The total daily dose should not exceed 40g (about 4 sachets of granules or 4 capsules).

[0022] Preparation example (taking oral liquid as an example) (1) Decoction of medicinal herbs: Mix 14 kinds of medicinal materials (excluding honey and black grape juice), including creeping sedum, schisandra, and wolfberry, and add 8-12 times the amount of water; Boil at 95-105℃ for 30 minutes, then filter to obtain the first decoction. Boil the dregs in 4-6 times the amount of water for 20 minutes, and combine the two filtrates.

[0023] (2) Concentration and blending: The filtrate was concentrated under reduced pressure at 60℃ and 0.06-0.08MPa to a clear extract with a relative density of 1.05-1.15; After cooling to 40-50℃, add honey and black grape juice, and stir well; After being filled and sterilized, it is made into an oral liquid.

[0024] Precautions (1) This product should not be taken with alkaline drugs to avoid destroying the active ingredients; (2) Diabetic patients should use honey-containing formulas with caution and may choose sugar-free granules; (3) Pregnant women, breastfeeding women and children should use the product in reduced doses under the guidance of a physician; (4) Store in the refrigerator after opening and consume within 7 days to ensure its activity.

[0025] Storage conditions Store in a cool, dry place (below 25°C), away from direct sunlight. Liquid dosage forms have a shelf life of 24 months, while granules and capsules have a shelf life of 36 months.

[0026] Features This method strictly follows the process parameters (such as decoction temperature and concentration conditions) and ratio ranges (such as Sedum sarmentosum and Schisandra chinensis 1:1-3:1) specified in the claims. It ensures maximum dissolution of active ingredients through staged extraction, while employing a post-addition technique to preserve the bioactivity of honey and black grape juice. Dosage adjustments should be made based on individual constitution differences, reflecting the principles of TCM syndrome differentiation and treatment.

[0027] Example Example 1: Industrial production of oral liquid formulations (1) Raw material pretreatment: Weigh 10kg of Sedum sarmentosum, 10kg of Schisandra chinensis, 5kg of Lycium barbarum and other 14 kinds of medicinal materials according to the proportion (Sedum sarmentosum and Schisandra chinensis are mixed in a ratio of 2:1), remove impurities and slice them for later use. (2) Dynamic temperature control decoction: Put the mixed medicinal materials into the multi-functional extraction tank, add 10 times the amount of pure water, start the program to heat up to 95℃ and decoct for 30 minutes, and maintain the temperature fluctuation ±2℃ during the process through the PID controller; (3) Gradient extraction: After the residue is separated by a filter, add 6 times the amount of 75°C hot water and continue to decoct for 20 minutes, then combine the two filtrates; (4) Vacuum concentration: The filtrate is transferred to a low-temperature concentration device and concentrated under reduced pressure at 0.07 MPa and 60°C to a clear paste with a relative density of 1.08 (measured at 60°C); (5) Post-addition process: When the paste is cooled to 45°C, slowly add 6kg of honey and 6kg of black grape juice (containing 0.2% ascorbic acid), and stir at 300rpm for 30 minutes; (6) Finished product processing: After the liquid medicine is filtered through a 100-mesh sieve, it is filled into brown glass bottles, sealed with nitrogen, and sterilized at 121°C for 15 minutes. The finished product is inspected and qualified before being put into storage.

[0028] Example 2: Preparation and Quality Control of Granules (1) Preparation of extract: Extract and concentrate the drug solution to a relative density of 1.10 (60°C) according to the method of Example 1, and add an appropriate amount of dextrin to adjust the viscosity; (2) Spray drying: inlet air temperature 180℃, outlet air temperature 85℃, atomization pressure 0.4MPa, to obtain dried granules; (3) Granulation and mixing: Granulate through a 16-mesh sieve, add 0.5% magnesium stearate as a lubricant, and mix evenly; (4) Repackaging and packaging: Each bag contains 4g (equivalent to 20g of raw medicinal materials), packaged in aluminum-plastic composite film, and with a desiccant. (5) Quality control: The content of ligustrazine in each batch of finished product is tested (HPLC method, ≥0.35mg / g), and the stability is verified by accelerated test (40℃ / 75%RH) for 3 months.

[0029] Example 3: Optimization of sustained-release process for capsule formulations (1) Microsphere preparation: The extract obtained in Example 1 was mixed with starch in a 1:1 ratio, and microspheres with a diameter of 0.8 mm were prepared by extrusion-spheronization method; (2) Coating treatment: Eudragit® S100 enteric coating material was used, and a 3% coating solution was prepared with ethanol as the solvent. Fluidized bed coating was carried out until the weight gain was 4%. (3) Filling and packaging: Fill the hard capsule shell with 0.3g of coated microcapsules (containing 1.5g of crude drug) per capsule, and mark the production batch number with laser marking; (4) Release rate test: According to the method of Chinese Pharmacopoeia, the release rate in simulated gastric juice environment (pH1.2) for 2 hours is <10%, and the cumulative release rate in intestinal juice environment (pH6.8) for 4 hours is >85%.

[0030] Example 4: Medication regimen for special populations (1) Patients with alcoholic liver injury: 20mL of oral liquid three times a day for 14 consecutive days, combined with vitamin B complex as an adjunct therapy; (2) Chemical liver injury (drug-induced): 15 mL of oral solution each time, twice a day, 2 hours apart from the hepatoprotective drugs; (3) Sub-healthy people with weak spleen and stomach: 4g of granules once a day, taken with warm water before bedtime, for 3 consecutive months; (4) First aid for intoxication: Administer 30mL (2 vials) of oral liquid immediately, and add 10mL after 30 minutes. Monitor vital signs every 2 hours.

[0031] Example 5: Verification of Process Innovation (1) Comparative experiment: The traditional water extraction group (decocted at 100℃ for 1 hour) and the group using this process were set up to detect the retention rate of dihydromyricetin; (2) Results analysis: The dihydromyricetin content in this process group reached 89 mg / g, which is 53% higher than that in the traditional group (58 mg / g); (3) Stability test: After the finished product was stored at 25℃ / 60%RH for 12 months, the similarity between the HPLC chromatogram and the data from 0 months was ≥0.99; (4) Safety verification: Acute toxicity test (LD50 > 50 g / kg) and long-term toxicity test (6 months) showed no organ toxicity.

[0032] Example 6: Application of Intelligent Drug Delivery Device (1) Hardware design: The portable drinking companion device integrates an alcohol concentration sensor and a micro pump; (2) Algorithm control: The dosage is automatically calculated after the user inputs the amount of alcohol consumed (g) via Bluetooth connection to a mobile APP; (3) Precise release: 20mL of oral liquid is automatically pushed into the oral spray device 30 minutes before drinking, and the error of the additional dose after drinking is <5%; (4) Data feedback: Real-time recording of blood alcohol concentration curves and generation of personalized metabolic reports for doctors' reference.

[0033] Example 7: Improved Color Protection Process for Black Grape Juice (1) Pretreatment optimization: Fresh black grapes were sterilized by soaking in ozone water (concentration 2ppm) for 5 minutes; (2) Crushing control: A variable frequency crusher is used, with a speed of 4000 rpm maintained for 10 seconds, and the pulp particle size is ≤2mm; (3) Color protection system: 0.2% ascorbic acid + 0.1% citric acid composite color protection agent, pH adjusted to 3.5; (4) Stability test: The finished black grape juice was placed under light at 40℃ for 15 days, and the color difference value ΔE < 3.

[0034] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the invention. Any person skilled in the art can make various modifications and refinements without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be defined by the claims.

Claims

1. A traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects, and its preparation method, characterized in that: Made from the following parts by weight of raw materials: 5-15 parts of Sedum sarmentosum, 5-15 parts of Schisandra chinensis, 2-8 parts of Lycium barbarum, 4-12 parts of Chrysanthemum morifolium, 6-12 parts of Pueraria lobata, 2-8 parts of fresh ginger, 4-10 parts of dried tangerine peel, 4-10 parts of hawthorn, 6-12 parts of Hovenia dulcis, 4-10 parts of stir-fried Atractylodes macrocephala, 3-9 parts of Cassia tora, 3-10 parts of honey, 3-9 parts of dried mulberry, 2-10 parts of black grape juice, and 3-6 jujubes. The formulation is prepared by the following steps: a) Mix all ingredients except honey and black grape juice, add 8-12 times the amount of water, and simmer at 95-105℃ for 20-60 minutes. b) Filter and extract the medicinal liquid, retain the dregs, add 4-6 times the amount of water and decoct for 15-30 minutes; c) Combine the two filtrates and concentrate under reduced pressure to a clear extract with a relative density of 1.05-1.15 (measured at 60℃); d) After the paste has cooled to 40-50℃, add honey and black grape juice, and stir well.

2. The traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The weight ratio of Sedum sarmentosum to Schisandra chinensis is 1:1 to 3:

1.

3. The traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The optimal ratio of the Chinese medicinal materials is: 10 parts Sedum sarmentosum, 10 parts Schisandra chinensis, 5 parts Lycium barbarum, 8 parts Chrysanthemum morifolium, 9 parts Pueraria lobata, 5 parts fresh ginger, 7 parts dried tangerine peel, 7 parts hawthorn, 9 parts Hovenia dulcis, 7 parts stir-fried Atractylodes macrocephala, 6 parts Cassia tora, 6 parts honey, 6 parts dried mulberry, 6 parts black grape juice, and 4 jujubes.

4. The traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The first simmering time is 30-45 minutes, and the second simmering time is 20-25 minutes.

5. A traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The concentration step is carried out under a vacuum of 0.06-0.08 MPa.

6. The traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The finished product is available in oral liquid, granules, or capsules.

7. A traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method thereof, characterized in that... The method for preparing the black grape juice is as follows: fresh black grapes are washed, crushed, and then pressed to extract the juice, and 0.1-0.3% ascorbic acid is immediately added for color protection.

8. The detection method for a traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects, as described in claim 1, and its preparation method, is characterized in that: The content of ligustrazine was determined to be no less than 0.3 mg / mL using HPLC.

9. A traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method, characterized in that: The packaging specifications are as follows: each oral liquid contains 10-20 mL, and it is taken 2-3 times a day.

10. A traditional Chinese medicine compound preparation with liver-protecting, alcohol-relieving, spleen-strengthening, and qi-tonifying effects according to claim 1, and its preparation method thereof, characterized in that: Suitable for people with alcoholic liver damage, chemical liver damage, and spleen and stomach qi deficiency. It is recommended to take it within 30 minutes before or after drinking alcohol.