Health-care medicinal liquor and preparation method thereof

Abstract

The invention relates to health-care medicinal liquor and a preparation method thereof, the medicinal liquor is prepared from monarch drugs, ministerial drugs, adjuvant drugs, conductant drugs and a white spirit solvent according to a specific ratio, the monarch drugs comprise 16-24 parts of ginseng and 16-24 parts of saussurea involucrata, the ministerial drugs comprise 8-12 parts of beautiful millettia roots and 8-12 parts of cherokee rose fruits, the adjuvant drugs comprise 24-36 parts of Chinese wolfberry fruits, the conductant drugs comprise 8-12 parts of mulberry fruits and 8-12 parts of eucommia ulmoides, and the solvent comprises 10000 parts of white spirit. The preparation method comprises the steps of medicinal material pretreatment, wine adding and sealed soaking, regular shaking, filtering and clarifying and the like. The formula adheres to the compatibility theory of monarch, minister, assistant and guide in traditional Chinese medicine, and all the medicines cooperate to achieve the effects of tonifying kidney and strengthening bone, dispelling wind and eliminating dampness, promoting blood circulation to remove meridian obstruction, and strengthening tendons and relieving pain. The traditional Chinese medicine composition is mainly used for relieving symptoms such as waist and leg soreness, swelling and pain caused by lumbar disc herniation, and has the advantages of scientific formula, exact curative effect, lasting effect, small side effect and the like.

Description

Technical Field

[0001] This invention relates to a health-promoting medicinal wine and its preparation method. Background Technology

[0002] Lumbar disc herniation is a common orthopedic condition, mainly caused by degenerative changes in the intervertebral disc, trauma, or other factors that lead to rupture of the annulus fibrosus, protrusion of the nucleus pulposus, and compression of the nerve root, resulting in a series of symptoms such as lower back and leg pain, numbness, and soreness. Currently, Western medicine treatments primarily involve nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, or physical therapy and surgery. However, these methods often have significant side effects, a high recurrence rate, or high costs.

[0003] Traditional Chinese medicine (TCM) has unique advantages in treating these chronic musculoskeletal diseases, often employing methods such as internal and external application of medicine, massage, and acupuncture to address both the symptoms and the root cause. Medicated wine, as a traditional dosage form of TCM, combines the blood-activating and qi-regulating effects of alcohol with the therapeutic effects of medicine, making it easy to take and absorb, and thus very popular among patients.

[0004] However, many existing medicinal wine formulas for lumbar spine diseases are either limited in efficacy, poorly formulated, or slow to take effect (see Chinese Patent CN201310715634.0). Therefore, developing a health-promoting medicinal wine with scientific formulation, synergistic effects, focused on relieving soreness and pain caused by lumbar disc herniation, and with minimal side effects is of significant practical importance. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a health-preserving medicinal wine for relieving soreness and pain caused by lumbar disc herniation. The medicinal wine has a rigorous formula with clear distinction between the principal, assistant, adjuvant and guide herbs. The herbs work synergistically to achieve the effects of tonifying the kidneys and strengthening bones, dispelling wind and dampness, promoting blood circulation and unblocking collaterals, and strengthening muscles and relieving pain.

[0006] Another technical problem to be solved by the present invention is to provide a method for preparing the above-mentioned health-preserving medicinal wine, which is simple and easy to implement and can effectively extract the active ingredients in the medicine.

[0007] To solve the above-mentioned technical problems, the present invention provides a health-preserving medicinal wine, which is made from the following raw materials in parts by weight:

[0008] Principal ingredients: 16-24 parts ginseng, 16-24 parts snow lotus;

[0009] Assistant herbs: 8-12 parts of *Achyranthes bidentata* and 8-12 parts of *Rosa laevigata*;

[0010] Adjuvant: 24-36 parts of wolfberry;

[0011] Used ingredients: 8-12 parts mulberry fruit, 8-12 parts eucommia bark;

[0012] Solvent: 10,000 parts of baijiu (Chinese liquor).

[0013] As a preferred ingredient, there are 20 parts ginseng, 20 parts snow lotus, 10 parts *Smilax glabra*, 10 parts *Rosa laevigata*, 30 parts wolfberry, 10 parts mulberry, 10 parts *Eucommia ulmoides*, and 10,000 parts white wine.

[0014] Preferably, the liquor is a pure grain-brewed liquor with an alcohol content between 50° and 60°.

[0015] To solve the aforementioned technical problem, the present invention provides a method for making the above-mentioned health-promoting medicinal wine, comprising the following steps:

[0016] (1) Preparation of materials: Weigh each Chinese medicinal material according to the proportion and remove impurities;

[0017] (2) Pretreatment: Cut ginseng, snow lotus, ox scalp and eucommia into slices or segments with a thickness of 3-5mm to increase the contact area and facilitate the dissolution of active ingredients;

[0018] (3) Feeding: Place all the pre-treated Chinese medicinal materials together in a clean, dry, non-metallic container;

[0019] (4) Soaking in alcohol: Add the prescribed amount of white wine to the container, ensuring that the wine completely submerges all the medicinal materials, and seal the container.

[0020] (5) Soaking extraction: Place the sealed container in a cool, dark place to soak, shake or stir once a day, and soak for no less than 30 days;

[0021] (6) Filtration and clarification: After soaking, filter with multiple layers of gauze or filter paper to separate the dregs and obtain a clear medicinal wine liquid;

[0022] (7) Dispensing and storage: Dispense the filtered medicinal wine into brown glass bottles, seal them, and store them in a cool and dry place.

[0023] Advantages of this invention:

[0024] 1. Scientifically formulated, with clear distinctions between principal, assistant, and adjuvant herbs:

[0025] The principal herbs (ginseng and snow lotus): Ginseng greatly replenishes vital energy, strengthens qi and consolidates the body's defenses. Modern pharmacology shows that it can enhance the body's endurance and combat fatigue. Snow lotus warms the kidneys and invigorates yang, dispels wind and dampness, and promotes blood circulation, making it an essential medicine for treating rheumatic pain. The two herbs are used together as the principal herbs, targeting the root cause of the disease and supporting the body's resistance while expelling pathogens.

[0026] Assistant herbs (Niu Dali and Jin Yingzi): Niu Dali nourishes the lungs and strengthens the tendons and collaterals; Jin Yingzi consolidates essence and reduces urination, astringes the lower abdomen, and assists the principal herbs in enhancing the effects of tonifying the kidneys, strengthening tendons and collaterals, consolidating the foundation and relieving pain.

[0027] Adjuvant herb (goji berries): Goji berries nourish the liver and kidneys, benefit essence and improve eyesight. They are mild in nature and help the principal and assistant herbs nourish the yin of the liver and kidneys, so that the nourishment is not drying and the yin and yang are balanced.

[0028] Guiding herbs (mulberry fruit, eucommia bark): Mulberry fruit nourishes yin and blood, generates fluids and moistens dryness; eucommia bark tonifies the liver and kidneys, and strengthens tendons and bones. Both not only have the effect of strengthening tendons and bones themselves, but also guide other herbs directly to the liver and kidney meridians and the areas of lower back and knee pain, harmonizing the properties of the herbs; thus, they are considered guiding herbs.

[0029] Solvent (Baijiu): Baijiu is pungent and warm, which can invigorate blood circulation and promote the flow of qi, enhance the efficacy of medicine, promote the dissolution and absorption of the effective components of the medicine, and guide the medicine to the affected area.

[0030] 2. Synergistic effects, treating both the symptoms and the root cause: The whole formula takes tonifying the kidneys and strengthening bones and muscles as its foundation, and dispelling wind and dampness, clearing the meridians and relieving pain as its symptoms. It combines tonification and purgation, and has a significant relieving effect on symptoms such as kidney deficiency and back pain, muscle and bone weakness, and rheumatic pain caused by lumbar disc herniation.

[0031] 3. High safety and wide applicability: All raw materials used are either food-grade or traditional Chinese medicinal herbs, which are mild in nature and have few side effects. The preparation method is the traditional cold soaking method, which can preserve the activity of the medicine to the greatest extent and is suitable for long-term health care. Detailed Implementation

[0032] Example 1:

[0033] Weigh out 20g of ginseng, 20g of snow lotus, 10g of *Smilax glabra*, 10g of *Rosa laevigata*, 30g of wolfberry, 10g of mulberry fruit, and 10g of *Eucommia ulmoides*. Slice the ginseng, snow lotus, *Smilax glabra*, and *Eucommia ulmoides* thinly. Place all the herbs in a 10-liter glass jar, add 10kg (approximately 10 liters) of 55° pure sorghum liquor, and seal. Place in a cool, dark place to soak for 45 days, shaking once every two days during this period. After soaking, filter through eight layers of gauze; the resulting clear, amber-colored liquor is this health-preserving medicinal wine. Bottle it in 500ml brown bottles.

[0034] Example 2:

[0035] Weigh out 16g of ginseng, 24g of snow lotus, 8g of *Smilax glabra*, 12g of *Rosa laevigata*, 24g of wolfberry, 12g of mulberry fruit, and 8g of *Eucommia ulmoides*. The preparation method is the same as in Example 1, but the soaking time is 30 days.

[0036] Example 3:

[0037] Weigh out 24g of ginseng, 16g of snow lotus, 12g of *Smilax glabra*, 8g of *Rosa laevigata*, 36g of wolfberry, 8g of mulberry fruit, and 12g of *Eucommia ulmoides*. The preparation method is the same as in Example 1, but the soaking time is 60 days.

[0038] Typical usage cases

[0039] Patient Zhang, male, 45 years old, was diagnosed with L4 / L5 lumbar disc herniation and had long-term symptoms of lower back pain and radiating numbness in his right leg. He took approximately 30ml of the medicinal wine described in Example 1 of this invention with his daily dinner. After two months of continuous use, he reported a significant reduction in lower back pain, a decrease in the frequency of leg numbness, and an improvement in his mental state. He did not report any other discomfort.

[0040] Controlled experiment:

[0041] This experiment aims to scientifically evaluate the efficacy and safety of the health-preserving medicinal wine of this invention in relieving symptoms such as soreness, swelling, and pain in the lower back and legs caused by lumbar disc herniation, and to highlight its comprehensive therapeutic advantages by comparing it with the control group (conventional treatment group, positive medicinal wine control group, and blank control group).

[0042] Experimental Design

[0043] Design type: Randomized, double-blind, multicenter clinical study with positive drug and blank control.

[0044] Trial grouping: Eligible subjects were randomly divided into four groups:

[0045] Group A (the medicinal wine group of this invention): taking the health-preserving medicinal wine of this invention.

[0046] Group B (positive medicinal wine control group): Take a well-known brand of "Bone Strengthening and Wind-Expelling Pain Relief Medicinal Wine" that is already on the market and has similar effects (as a control).

[0047] Group C (Blank Control Group / Basic Formula Group): Patients consumed either "blank liquor" (containing only baijiu as a solvent and no medicinal ingredients) or "basic formula liquor" (containing only some adjuvant herbs such as wolfberry and mulberry). This group was used to eliminate the placebo effect of alcohol and to verify the necessity of the complete formula's compatibility.

[0048] Group D (conventional Western medicine group): Oral diclofenac sodium sustained-release tablets (nonsteroidal anti-inflammatory drug) served as a control for conventional Western medicine treatment.

[0049] Subject selection

[0050] Inclusion criteria:

[0051] Age 18-65, gender not limited.

[0052] The patient was diagnosed with lumbar disc herniation via CT or MRI.

[0053] The patient presents with typical symptoms of lower back and leg soreness, swelling, and pain, and the course of the illness has exceeded 3 months.

[0054] The visual analog scale (VAS) score before enrollment is ≥4.

[0055] Sign the informed consent form.

[0056] Exclusion criteria:

[0057] Individuals allergic to any component of the investigational drug or to alcohol.

[0058] Those with lumbar spondylolisthesis, tuberculosis, tumors, or severe osteoporosis.

[0059] Those suffering from severe heart, liver, or kidney dysfunction, gastric ulcers, or bleeding disorders.

[0060] Pregnant women and breastfeeding women.

[0061] Those who have received hormone injections or surgical treatment within the past month.

[0062] Treatment

[0063] Group A: Take 25ml of the health-preserving medicinal wine of this invention orally, twice a day (once in the morning and once in the evening).

[0064] Group B: Oral control medicated wine, with the same dosage and administration as Group A, and the same packaging as Group A.

[0065] Group C: Oral administration of blank wine / basic formula wine that is as similar as possible to Group A in appearance and taste, with the same usage and dosage as Group A.

[0066] Group D: Oral administration of diclofenac sodium sustained-release tablets, 75 mg each time, once a day.

[0067] Treatment duration: All groups received continuous treatment for 8 weeks. During the treatment period, all subjects received standardized basic health education (such as sleeping on a hard bed, avoiding weight-bearing, and performing specific back muscle exercises).

[0068] Therapeutic efficacy evaluation indicators

[0069] Key therapeutic indicators:

[0070] Pain level: The visual analog scale (VAS) was used to score pain before treatment and at weeks 2, 4 and 8 of treatment.

[0071] Functional impairment: The Japanese Orthopaedic Association Low Back Pain Scale (JOA score) or the Oswestry Disability Index (ODI) was used for assessment before treatment and at weeks 4 and 8 of treatment.

[0072] Secondary efficacy endpoints:

[0073] Traditional Chinese Medicine (TCM) syndrome scoring: This involves quantifying and scoring TCM syndromes such as lower back and knee pain, aversion to cold, and numbness in the limbs.

[0074] Overall efficacy evaluation: According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", it is divided into:

[0075] Clinical cure: Symptoms and signs disappear or basically disappear, and the syndrome score is reduced by ≥95%.

[0076] Significant effect: Symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%.

[0077] Effective: Symptoms and signs have improved, and the syndrome score has decreased by ≥30%.

[0078] Ineffective: Symptoms and signs show no significant improvement, or even worsen, and the syndrome score decreases by less than 30%.

[0079] Follow-up recurrence rate: One month after the end of treatment, follow-up was conducted by telephone or outpatient visit to record the recurrence of symptoms.

[0080] Safety indicators:

[0081] Routine blood, urine, and stool tests, as well as liver and kidney function tests, were performed before and after treatment.

[0082] Record all adverse events that occur and their causal relationship with the investigational drug.

[0083] Results and comparative analysis:

[0084]

[0085]

[0086] Through the rigorous comparative experiments described above, it can be expected that the health-preserving medicinal wine of this invention will not only have a rapid onset of action and good analgesic effect in relieving soreness and pain caused by lumbar disc herniation, but more importantly, it will demonstrate comprehensive advantages in improving lumbar function, regulating systemic symptoms, and preventing recurrence. Its efficacy is significantly superior to similar commercially available medicinal wine products, basic formulas, and conventional Western medicines, fully verifying the scientific nature of the "principal-assistant-adjuvant-guide" formulation theory of this invention and its unique synergistic effect across the entire formula.

Claims

1. A health-promoting medicinal wine, characterized in that, Made from the following parts by weight of raw materials: Principal ingredients: 16-24 parts ginseng, 16-24 parts snow lotus; Assistant herbs: 8-12 parts of *Achyranthes bidentata* and 8-12 parts of *Rosa laevigata*; Adjuvant: 24-36 parts of wolfberry; Used ingredients: 8-12 parts mulberry fruit, 8-12 parts eucommia bark; Solvent: 10,000 parts of baijiu (Chinese liquor).

2. The health-promoting medicinal wine according to claim 1, characterized in that: The preferred weight ratio of the raw materials is as follows: 20 parts ginseng, 20 parts snow lotus, 10 parts *Smilax glabra*, 10 parts *Rosa laevigata*, 30 parts wolfberry, 10 parts mulberry, 10 parts *Eucommia ulmoides*, and 10,000 parts white wine.

3. The health-promoting medicinal wine according to claim 1, characterized in that: The liquor in question is a pure grain-brewed liquor with an alcohol content between 50° and 60°.

4. A method for preparing a health-promoting medicinal wine as described in any one of claims 1-3, characterized in that, Includes the following steps: (1) Preparation of materials: Weigh each Chinese medicinal material according to the proportion and remove impurities; (2) Pretreatment: Cut ginseng, snow lotus, ox scalp and eucommia into slices or segments with a thickness of 3-5mm to increase the contact area and facilitate the dissolution of active ingredients; (3) Feeding: Place all the pre-treated Chinese medicinal materials together in a clean, dry, non-metallic container; (4) Soaking in alcohol: Add the prescribed amount of white wine to the container, ensuring that the wine completely submerges all the medicinal materials, and seal the container. (5) Soaking extraction: Place the sealed container in a cool, dark place to soak, shake or stir once a day, and soak for no less than 30 days; (6) Filtration and clarification: After soaking, filter with multiple layers of gauze or filter paper to separate the dregs and obtain a clear medicinal wine liquid; (7) Dispensing and storage: Dispense the filtered medicinal wine into brown glass bottles, seal them, and store them in a cool and dry place.

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