A Yao medicine composition for treating dizziness, preparation, preparation method and application

Abstract

This disclosure provides a Yao medicine composition, preparation, preparation method, and application for treating vertigo, belonging to the field of ethnic medicine technology. The composition comprises the following components in parts by weight: 5-20 parts of Bidens pilosa, 5-20 parts of Apocynum venetum leaf, 5-50 parts of Achyranthes bidentata, 5-50 parts of Achyranthes bidentata, 5-50 parts of Prunus persica kernel, 5-20 parts of Carthamus tinctorius, 5-20 parts of Paeonia lactiflora, 5-20 parts of Ligusticum chuanxiong, 5-20 parts of Achyranthes bidentata, 5-20 parts of Zanthoxylum bungeanum, 5-20 parts of Pueraria lobata, and 5-20 parts of Angelica sinensis. The composition and preparation of this invention can effectively treat vertigo caused by hypertension, cervical spondylosis, etc., and have high safety, providing a new and effective solution for the treatment of related diseases.

Description

Technical Field

[0001] This disclosure relates to the field of ethnic medicine technology, specifically a Yao medicine composition, preparation, preparation method, and application for treating vertigo. Background Technology

[0002] Vertigo is a common clinical symptom that can be caused by various diseases such as hypertension, cervical spondylosis, hyperlipidemia, and cerebral arteriosclerosis, seriously affecting patients' quality of life. Modern medicine often uses chemically synthesized drugs, such as statins and calcium channel blockers, to treat underlying diseases like hypertension and hyperlipidemia. While these drugs are effective, long-term use can lead to a series of side effects, such as liver damage, muscle pain, and elevated transaminase levels, resulting in poor tolerance and adherence in some patients. Furthermore, patients with hypertension and hyperlipidemia often have metabolic syndrome, making their conditions complex, and single-target Western medicine treatments sometimes fail to achieve the desired comprehensive regulatory effect.

[0003] Yao medicine, as an important part of traditional ethnic medicine in my country, has a long history and unique theories. Yao medicine believes that vertigo is mostly related to "imbalance of yin and yang," "internal wind," and "blood stasis." Treatment emphasizes the holistic principle of "regulating yin and yang, soothing the liver and relieving vertigo, and promoting blood circulation and removing blood stasis." Compared with Western medicine, Yao medicine compound formulas have the advantages of multiple components, multiple targets, and holistic regulation. They can not only effectively improve clinical symptoms such as vertigo and headaches, but also improve the patient's constitution while regulating blood pressure and blood lipids, aligning with the preventive concept of "treating disease before it occurs."

[0004] Therefore, developing a Yao medicine composition based on Yao medicine theory, with definite efficacy, high safety, and effective treatment for vertigo and its related underlying diseases, is of great clinical significance and application value for providing alternative or combined treatment options for patients who cannot tolerate the side effects of Western medicine. Summary of the Invention

[0005] Based on the first aspect of this disclosure, a Yao medicine composition for treating vertigo is provided, comprising the following components in parts by weight: 5-20 parts of Bidens pilosa, 5-20 parts of Apocynum venetum leaf, 5-50 parts of Achyranthes bidentata, 5-50 parts of Achyranthes bidentata, 5-50 parts of Achyranthes bidentata, 5-20 parts of Prunus persica kernel, 5-20 parts of Carthamus tinctorius, 5-20 parts of Paeonia lactiflora, 5-20 parts of Ligusticum chuanxiong, 5-20 parts of Achyranthes bidentata, 5-20 parts of Zanthoxylum bungeanum, 5-20 parts of Pueraria lobata, and 5-20 parts of Angelica sinensis.

[0006] In one or more embodiments, the Yao medicine composition comprises the following components in parts by weight: 15 parts Bidens pilosa, 15 parts Apocynum venetum leaves, 30 parts Black Achyranthes bidentata, 25 parts Achyranthes bidentata, 25 parts Achyranthes bidentata, 10 parts Prunus persica kernel, 10 parts Carthamus tinctorius, 10 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Achyranthes bidentata, 15 parts Smilax china, 20 parts Pueraria lobata, and 10 parts Angelica sinensis.

[0007] Based on a second aspect of this disclosure, a pharmaceutical preparation is provided, which is a preparation made from the above-mentioned Yao medicine composition as the raw material, and the preparation process refers to the conventional process of traditional Chinese medicine to produce the required dosage form.

[0008] In one or more embodiments, the pharmaceutical formulation further comprises pharmaceutically acceptable excipients.

[0009] In one or more embodiments, the dosage form of the pharmaceutical preparation is a decoction or pills.

[0010] Based on a third aspect of this disclosure, a method for preparing the above-mentioned pharmaceutical preparation is provided, comprising the following steps:

[0011] (1) Take Bidens pilosa, Apocynum venetum leaves, black ox and golden thread wind, soak them in water, heat and extract several times, filter, combine the filtrates, concentrate the filtrates to make a thick paste with a relative density of 1.12 to 1.18 at 60℃;

[0012] (2) Take nine-layered wind, peach kernel, safflower, red peony root, chuanxiong, chuanniuxi, double hook drill, kudzu root and angelica, grind them into fine powder, mix the fine powder with the thick paste to obtain soft material;

[0013] (3) The soft material is transferred to a pelleting machine, extruded into pellets, and the resulting wet pellets are polished, dried, sieved and packaged to obtain a pharmaceutical preparation.

[0014] In one or more embodiments, in step (1), the soaking time is 20 to 60 minutes, the heating extraction method is to heat to boiling and then maintain a slight boiling state, the heating extraction is performed 1 to 3 times, the amount of water added each time is 6 to 10 times the total weight of the raw materials taken for soaking, and the extraction time each time is 0.5 to 1.5 hours.

[0015] In one or more embodiments, in step (3), the polishing method is to fully wet the material with 75% ethanol by volume and then polish it by rolling for 5 to 10 minutes; the drying method is to dry the material at 52 to 58°C until the mass fraction of moisture is less than 5% and then let it cool.

[0016] Based on the fourth aspect of this disclosure, another method for preparing the above-mentioned pharmaceutical preparation is provided, comprising: weighing the raw material in parts by weight, soaking it in water for 20-60 minutes, extracting it by heating 1-3 times, wherein the heating extraction is performed by heating to boiling and then maintaining a gentle boil, the amount of water added each time is 6-10 times the total weight of the raw material, the extraction time each time is 0.5-1.5 hours, filtering, combining the filtrates, and obtaining the pharmaceutical preparation.

[0017] Based on the fifth aspect of this disclosure, the use of the above-mentioned Yao medicine composition or the above-mentioned pharmaceutical preparation in a medicament for treating hypertension, cervical spondylosis or vertigo is provided.

[0018] The efficacy of Yao medicine compositions or preparations: They have the effects of regulating balance and replenishing deficiencies, calming the liver and relieving dizziness, and promoting blood circulation and removing blood stasis. Main indications: Suitable for patients with hypertension, cervical spondylosis, dizziness, and related diseases.

[0019] Compared with the prior art, this disclosure achieves at least the following beneficial effects:

[0020] 1. The Yao medicine composition and preparation disclosed herein can effectively reduce systolic and diastolic blood pressure in hypertensive patients and synergistically regulate blood lipid indicators. Clinical trials have shown that adding the drugs disclosed herein to conventional Western medicine treatment can more significantly reduce patients' vertigo symptom scores, effectively relieve discomfort symptoms such as dizziness, tinnitus, and nausea, and the efficacy is superior to Western medicine alone.

[0021] 2. This disclosed drug is a natural drug composition with minimal toxicity and side effects. Clinical observations show that combined use did not significantly increase the incidence of adverse reactions, and patients tolerated it well, making it suitable for long-term conditioning. This invention can serve as a beneficial supplement to Western medicine treatment. Through combined use, it is expected to enhance efficacy while reducing the dosage of Western medicine, thereby mitigating the potential risks associated with long-term, high-dose use of Western medicine.

[0022] 3. By using the drugs disclosed herein to intervene early in blood pressure and blood lipid abnormalities, prevent cardiovascular and cerebrovascular diseases, improve physical constitution (such as phlegm-dampness and blood stasis constitution), thereby regulating metabolic function, reducing recurrence, and having the effect of "treating diseases before they occur". Detailed Implementation

[0023] The present disclosure will now be described in detail with reference to exemplary embodiments. However, it should be understood that the present disclosure may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided herein to make the disclosure more complete and to fully convey the concept of the present disclosure to those skilled in the art.

[0024] The Yao medicine composition for treating vertigo provided in this embodiment includes the following components in parts by weight: 5-20 parts of Bidens pilosa, 5-20 parts of Apocynum venetum leaves, 5-50 parts of Achyranthes bidentata, 5-50 parts of Achyranthes bidentata, 5-50 parts of Achyranthes bidentata, 5-20 parts of Prunus persica kernel, 5-20 parts of Carthamus tinctorius, 5-20 parts of Paeonia lactiflora, 5-20 parts of Ligusticum chuanxiong, 5-20 parts of Achyranthes bidentata, 5-20 parts of Smilax china, 5-20 parts of Pueraria lobata, and 5-20 parts of Angelica sinensis. The preferred parts by weight of the components are: 15 parts of Bidens pilosa, 15 parts of Apocynum venetum leaves, 30 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 10 parts of Prunus persica kernel, 10 parts of Carthamus tinctorius, 10 parts of Paeonia lactiflora, 15 parts of Ligusticum chuanxiong, 15 parts of Achyranthes bidentata, 15 parts of Smilax china, 20 parts of Pueraria lobata, and 10 parts of Angelica sinensis. The above composition can be made into common decoctions or further processed into other preparations; preferably, it can be made into pills, which have good stability and long shelf life, and can be stored at room temperature for one year.

[0025] The sources of the above components are described in detail below, mainly focusing on the core components or components commonly used in Yao medicine, among which:

[0026] Bidens pilosa, or Bidens pilosa Linn. or B. pilosa Linn. var. radiata Sch.-Bip. of the Asteraceae family, is a plant with a warm nature, bitter taste, and is non-toxic. The whole plant can be used medicinally, and has the effects of clearing heat, detoxifying, dispersing blood stasis, and reducing swelling. Bidens pilosa also has a good biphasic regulatory effect on blood pressure.

[0027] Black Nine Ox, also known as Tiger Whisker, Black Tiger, Crow Whisker, Green Dragon Whisker, and One-Grab Root, is the root and rhizome of Clematis chinensis Osbeck, a plant in the Ranunculaceae family. It is pungent, salty, and warm, and belongs to the category of wind-dispelling and dampness-removing herbs. It dispels wind and dampness, unblocks the meridians and relieves pain, and promotes diuresis and reduces swelling. It is used for metrorrhagia (in Yao language, meaning "rheumatic pain, rheumatoid arthritis," similar to the annotations below), lumbar muscle strain, dysuria, and edema due to spleen deficiency, as well as traumatic injuries.

[0028] Golden Thread Wind, also known as Golden Key, Silver Key, Hundred-Solution Vine, Hairy Dung Basket, and Black Skin Snake, is the root of Cyclea hypoglauca (Schaier) Diels, a plant in the Menispermaceae family. It is bitter and cold in nature, belonging to the category of wind-dispelling and wind-dispelling herbs. It clears heat and detoxifies, dispels wind and relieves pain. It is used for colds and fever, sore throat, tonsillitis, toothache, stomachache, enteritis, dysentery, hematuria, and boils and carbuncles.

[0029] Nine-layered wind, also known as blood vine, chicken blood vine, three-leaf chicken blood vine, menstrual vine, and nine-blood vine, is the vine stem of Spatholobus suberectus Dunn., a legume. It is slightly bitter, sweet, and astringent, and neutral in nature. It is classified as a wind-dispelling herb. It invigorates blood circulation, nourishes blood, unblocks meridians, and dispels wind and dampness. It is used for metrorrhagia (rheumatic pain, rheumatoid arthritis), osteoproliferation (osteophyte syndrome), irregular menstruation (menstrual disorders), and dizziness due to anemia.

[0030] Double-hooked stems, specifically the hooked stems of *Uncaria rhynchophylla* (Miq.) Miq. ex Havil., a plant in the Rubiaceae family, are one of the "Eighteen Stems" in the classic Yao ethnic medicine formula. They clear heat and calm the liver, extinguish wind and relieve spasms, and lower blood pressure. They are used for dizziness, wind-heat headache, infantile febrile convulsions, hypertension, rheumatoid arthritis, rheumatic bone pain, hemiplegia, sciatica, and traumatic injuries.

[0031] In addition, *Apocynum venetum* leaves are the dried leaves of *Apocynum venetum* L., a plant in the Apocynaceae family. Peach kernels are the dried, mature seeds of *Prunus persica* (L.) Batsch or *Prunus davidiana* (Carr.) Franch., plants in the Rosaceae family. Safflower is the dried flower of *Carthamus tinctorius* L., a plant in the Asteraceae family. It invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain. Red peony root is the dried root of *Paeonia lactiflora* Pall. or *Paeonia veitchii* Lynch, plants in the Paeoniaceae family. Ligusticum chuanxiong Hort. is the dried rhizome of *Ligusticum chuanxiong* Hort., a plant in the Apiaceae family. Achyranthes bidentata is the dried root of *Cyathula officinalis* Kuan, a plant in the Amaranthaceae family. Kudzu root is the dried root of *Pueraria lobata* (Willd.) Ohwi, a plant in the Fabaceae family. Angelica sinensis (Oliv) Diels. is the root of Angelica sinensis, a plant belonging to the genus Angelica in the family Apiaceae.

[0032] The Yao medicine theory behind this publicly disclosed medicine states that vertigo is often related to climate and soil conditions, excessive consumption of rich and greasy foods, overwork, and external pathogenic factors. The causes of this disease can be divided into two types: deficiency and excess. If a patient is exposed to external pathogenic factors such as miasma, malaria, or poisoning, and their diet is rich and greasy, it can lead to a disharmony of the "Heaven, Earth, and Man" triad in Yao medicine. This causes pathogenic factors to easily remain in the body, preventing the transformation of nutrients and eventually leading to phlegm or blood stasis. This results in an accumulation of phlegm and blood stasis, which disturbs the clear orifices, or blood stasis obstructing the meridians, causing stagnation of qi and blood, and ultimately, vertigo. Furthermore, overwork, excessive sexual activity, or a constitution with yin deficiency or qi and blood deficiency can lead to tuberculosis over time, resulting in an imbalance of yin and yang. This imbalance leads to liver and kidney yin deficiency, depletion of kidney essence, and malnourishment of the marrow, causing this disease. Simultaneously, yin deficiency can lead to yang excess, with liver yang transforming into wind, which disturbs the clear orifices, resulting in a multitude of symptoms including vertigo and headache.

[0033] The compatibility characteristics of this drug are as follows: Apocynum venetum leaves and black ox are used to dispel dampness and detoxify, and strengthen muscles and bones; golden thread wind, nine-layered wind, peach kernel, safflower, red peony root, and chuanxiong rhizome are used to invigorate blood and remove blood stasis, which are the main drugs; Bidens pilosa clears heat and disperses blood stasis; double hook burr and kudzu root dredge the meridians; angelica and chuanniuxi are used to invigorate blood, moisten dryness, and promote bowel movement, which are the auxiliary drugs. The entire formula is carefully formulated, and the drugs work together to regulate the body's balance, soothe the liver, stop dizziness, invigorate blood and remove blood stasis.

[0034] The modern pharmacological basis of this drug:

[0035] 1. Mechanism of Action for Lowering Blood Pressure: Bidens pilosa has a good bidirectional regulatory effect on blood pressure. After taking this medicine, hypertensive patients can experience a reduction in blood pressure, while those with low blood pressure can experience a rise in blood pressure to normal levels. Studies have shown that the mechanism of Bidens pilosa's adjuvant antihypertensive effect is mainly related to its active ingredients such as flavonoids. Specific pathways include: inhibiting the renin-angiotensin-aldosterone (RAAS) system, inhibiting sympathetic nerve activity, inhibiting endothelin (ET) release, promoting nitric oxide (NO) production, activating potassium channels and blocking calcium ion channels, and improving cardiovascular remodeling. Furthermore, studies have confirmed that the ethyl acetate extract of Bidens pilosa has a protective effect against non-specific NO inhibitor-induced hypertensive rats, and its antihypertensive effect may be related to quercetin 3,3'-dimethyl ether-7-O-β-D-glucoside.

[0036] 2. Lipid-lowering mechanism: Network pharmacology analysis shows that the active ingredients in Apocynum venetum leaves, such as rutin, quercetin, and chlorogenic acid, have good binding potential with core targets such as BCL2, AKT1, MMP9, PTGS2, TP53, and ESR1. In vivo experiments in related studies have confirmed that Apocynum venetum leaves can significantly reduce serum TC, TG, and LDL-C levels in hyperlipidemic rats, increase HDL-C levels, and improve liver tissue pathological changes. Angelica sinensis volatile oil can also effectively reduce TC and LDL-C levels, synergistically playing a role in regulating blood lipid balance.

[0037] 3. Blood-activating mechanism: Nine-layered wind, also known as chicken blood vine, has the regulatory properties of "promoting blood circulation without breaking it and replenishing blood without stagnation". It can not only promote hematopoietic function, increase hemoglobin, and improve blood deficiency and anemia, but also effectively inhibit platelet aggregation and anti-thrombosis, thereby playing a role in activating blood circulation and removing blood stasis. Secondly, in terms of improving microcirculation and relaxing muscles and tendons, it can dilate blood vessels and improve local blood circulation. For the meridian blockage caused by wind-cold-dampness invasion or qi stagnation and blood stasis, nine-layered wind can effectively relieve symptoms such as numbness of limbs, joint pain and soreness of waist and knees.

[0038] 4. Liver Protection Mechanism: The combination of white peony root and angelica root is a classic pairing for nourishing blood, softening the liver, relieving spasms, and alleviating pain. The two herbs work synergistically, one dispersing and the other astringing, combining activity and restorative effects to nourish the liver while preventing dryness and heat from damaging yin, thus relieving dull pain in the liver area and muscle spasms. Modern pharmacology has confirmed that this herb, rich in ferulic acid and paeoniflorin, has multi-target liver-protective effects: it can resist oxidation and inflammation, reducing liver stress damage; promote hepatocyte repair and regeneration, lower transaminase levels; and bidirectionally regulate immunity, enhancing the liver's defense and repair capabilities.

[0039] Using the above-described composition as a raw material, not only can it be formulated into decoctions, but it can also be formulated into other common preparations according to conventional traditional Chinese medicine preparation processes. These preparations include liquid, semi-solid, or solid formulations. These forms of pharmaceutical preparations contain the Yao medicine composition disclosed herein or its extracts as active ingredients, and may also contain pharmaceutically acceptable excipients. The active ingredient can be compounded with commonly used non-toxic pharmaceutical excipients to formulate decoctions, oral liquids, drops, ointments, pills, powders, tablets, capsules, and any other usable dosage forms.

[0040] This disclosure also provides several specific embodiments illustrating the composition of the active pharmaceutical ingredient and the preparation method of a pharmaceutical formulation for treating vertigo.

[0041] Example 1

[0042] (1) Weigh the raw materials according to the following weight parts: 15 parts of Bidens pilosa, 15 parts of Apocynum venetum leaf, 30 parts of Black Achyranthes bidentata, 25 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 10 parts of Prunus persica kernel, 10 parts of Carthamus tinctorius, 10 parts of Paeonia lactiflora, 15 parts of Ligusticum chuanxiong, 15 parts of Achyranthes bidentata, 15 parts of Smilax china, 20 parts of Pueraria lobata, and 10 parts of Angelica sinensis.

[0043] (2) After soaking Bidens pilosa, Apocynum venetum leaves, black ox and golden thread grass in water for 30 minutes, heat and extract twice. The method of heating and extraction is to heat to boiling and then keep it at a slight boil. The amount of water added each time is 8 times the total weight of the raw materials taken from the soaking. The extraction time each time is 1 hour. Filter, combine the filtrates, and concentrate the filtrate to form a thick paste with a relative density of 1.15 at 60℃.

[0044] (3) Grind the following ingredients into fine powder: ginseng, peach kernel, safflower, red peony root, chuanxiong rhizome, chuanniuxi, double hook drill, kudzu root and angelica root. Mix the fine powder with the thick paste. Transfer the resulting soft material to a pelleting machine and extrude it into pellets. The resulting wet pellets are fully moistened with 75% ethanol and then rolled and polished for 8 minutes. After drying at 55°C until the moisture content is less than 5%, the pellets are cooled, sieved, and packaged to obtain the pills.

[0045] Example 2

[0046] (1) Weigh the raw materials according to the following weight parts: 5 parts of Bidens pilosa, 20 parts of Apocynum venetum leaf, 5 parts of Black Achyranthes bidentata, 50 parts of Achyranthes bidentata, 5 parts of Achyranthes bidentata, 20 parts of Prunus persica kernel, 5 parts of Carthamus tinctorius, 20 parts of Paeonia lactiflora, 5 parts of Ligusticum chuanxiong, 20 parts of Achyranthes bidentata, 5 parts of Smilax china, 19 parts of Pueraria lobata, and 5 parts of Angelica sinensis.

[0047] (2) After soaking Bidens pilosa, Apocynum venetum leaves, black ox and golden thread grass in water for 20 minutes, heat and extract three times. The method of heating and extraction is to heat to boiling and then keep it at a slight boil. The amount of water added each time is 6 times the total weight of the raw materials taken from the soaking. The extraction time each time is 1.5 hours. Filter, combine the filtrates, and concentrate the filtrate to form a thick paste with a relative density of 1.12 at 60℃.

[0048] (3) Grind the following ingredients into fine powder: ginseng, peach kernel, safflower, red peony root, chuanxiong rhizome, chuanniuxi, double hook drill, kudzu root and angelica root. Mix the fine powder with the thick paste. Transfer the resulting soft material to a pelleting machine and extrude it into pellets. The resulting wet pellets are fully moistened with 75% ethanol and then rolled and polished for 5 minutes. After drying at 58°C until the moisture content is less than 5%, the pellets are cooled, sieved, and packaged to obtain the pills.

[0049] Example 3

[0050] (1) Weigh the raw materials according to the following weight parts: 20 parts of Bidens pilosa, 5 parts of Apocynum venetum leaves, 50 parts of Black Achyranthes bidentata, 5 parts of Achyranthes bidentata, 50 parts of Achyranthes bidentata, 5 parts of Prunus persica kernel, 20 parts of Carthamus tinctorius, 5 parts of Paeonia lactiflora, 20 parts of Ligusticum chuanxiong, 5 parts of Achyranthes bidentata, 20 parts of Smilax china, 5 parts of Pueraria lobata, and 20 parts of Angelica sinensis.

[0051] (2) After soaking Bidens pilosa, Apocynum venetum leaves, black ox and golden thread wind in water for 60 minutes, heat and extract once. The heating extraction method is to heat to boiling and then keep it at a slight boil. The amount of water added is 10 times the total weight of the raw materials taken for soaking. The extraction time is 0.5 hours. Filter and concentrate the filtrate to obtain a thick paste with a relative density of 1.18 at 60℃.

[0052] (3) Grind the following ingredients into fine powder: ginseng, peach kernel, safflower, red peony root, chuanxiong rhizome, chuanniuxi, double hook drill, kudzu root and angelica root. Mix the fine powder with the thick paste. Transfer the resulting soft material to a pelleting machine and extrude it into pellets. The resulting wet pellets are fully moistened with 75% ethanol and then rolled and polished for 10 minutes. After drying at 52°C until the moisture content is less than 5%, the pellets are cooled, sieved, and packaged to obtain the pills.

[0053] Example 4

[0054] (1) Weigh the raw materials according to the following weight parts: 15 parts of Bidens pilosa, 15 parts of Apocynum venetum leaf, 30 parts of Black Achyranthes bidentata, 25 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 10 parts of Prunus persica kernel, 10 parts of Carthamus tinctorius, 10 parts of Paeonia lactiflora, 15 parts of Ligusticum chuanxiong, 15 parts of Achyranthes bidentata, 15 parts of Smilax china, 20 parts of Pueraria lobata, and 10 parts of Angelica sinensis.

[0055] (2) Soak the raw material in water for 40 minutes, and heat it twice. The heating extraction method is to heat it to boiling and then keep it at a slight boil. The amount of water added each time is 8 times the total weight of the raw material, and the extraction time each time is 1 hour. Filter, combine the filtrates, and obtain the decoction.

[0056] Example 5

[0057] (1) Weigh the raw materials according to the following weight parts: 5 parts of Bidens pilosa, 20 parts of Apocynum venetum leaf, 5 parts of Black Achyranthes bidentata, 50 parts of Achyranthes bidentata, 5 parts of Achyranthes bidentata, 20 parts of Prunus persica kernel, 5 parts of Carthamus tinctorius, 20 parts of Paeonia lactiflora, 5 parts of Ligusticum chuanxiong, 20 parts of Achyranthes bidentata, 5 parts of Smilax china, 19 parts of Pueraria lobata, and 5 parts of Angelica sinensis.

[0058] (2) Soak the raw material in water for 20 minutes, and heat and extract 3 times. The heating and extraction method is to heat to boiling and then keep it at a slight boil. The amount of water added each time is 6 times the total weight of the raw material, and the extraction time each time is 1.5 hours. Filter, combine the filtrates, and obtain the decoction.

[0059] Example 6

[0060] (1) Weigh the raw materials according to the following weight parts: 20 parts of Bidens pilosa, 5 parts of Apocynum venetum leaves, 50 parts of Black Achyranthes bidentata, 5 parts of Achyranthes bidentata, 50 parts of Achyranthes bidentata, 5 parts of Prunus persica kernel, 20 parts of Carthamus tinctorius, 5 parts of Paeonia lactiflora, 20 parts of Ligusticum chuanxiong, 5 parts of Achyranthes bidentata, 20 parts of Smilax china, 5 parts of Pueraria lobata, and 20 parts of Angelica sinensis.

[0061] (2) Soak the raw material in water for 60 minutes, heat and extract once. The heating extraction method is to heat to boiling and then keep it at a slight boil. The amount of water added is 10 times the total weight of the raw material. The extraction time is 0.5 hours. Filter and take the filtrate to obtain the decoction.

[0062] Experimental Example 1: Animal Experiment Comparison

[0063] 1. Materials and Instruments

[0064] 1.1 Experimental animals

[0065] Sixty SPF-grade healthy male SD rats weighing 180-220 g were provided by Hunan Sila Jingda Experimental Animal Co., Ltd., with the production license number: SCXK (Xiang) 2019-0001. The animals were housed in an SPF-grade animal room at a room temperature of (22±2)°C, a relative humidity of (50±10)%, with a 12 h light / 12 h dark cycle and free access to food and water. The experiment was started after 1 week of adaptive feeding.

[0066] 1.2 Test drugs

[0067] Yao ethnic medicine prescription: 15 g of *Bidens pilosa*, 15 g of *Apocynum venetum* leaves, 30 g of *Radix Eleutherococci*, 25 g of *Cyclea hypoglauca*, 25 g of *Entada phaseoloides*, 10 g of peach kernel, 10 g of safflower, 10 g of red peony root, 15 g of Sichuan lovage rhizome, 15 g of Sichuan achyranthes root, 15 g of *Dichroa febrifuga* (added later), 20 g of pueraria root, 10 g of Chinese angelica. Add 10 times the amount of distilled water to soak for 30 min, decoct twice for 1 h each time, combine the filtrates, and store at 4 °C for later use. Positive control drug: Difenidol Hydrochloride Tablets (Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., batch number: National Drug Approval Number H43020325).

[0068] 2. Experimental methods

[0069] 2.1 Escape shock reflex training

[0070] Before modeling, all rats were placed in the electric shock box of a balanced rotator, after 3 min of adaptation, appropriate electric shock stimulation (voltage 30 V, duration 1 s) was given. The training was regarded as up to standard when the rat jumped onto the platform and completed the escape reflex within 3 s. The training was conducted twice a day for 3 consecutive days to establish the escape shock reflex.

[0071] 2.2 Establishment of PCIV rat model

[0072] An ischemic vertigo model was established by ligating the right common carotid artery and the right subclavian artery. Rats were fasted for 12 hours preoperatively but allowed free access to water. They were anesthetized with 2.5% isoflurane inhalation. The rats were immobilized in a supine position, their necks were shaved and disinfected, and a midline incision was made. Subcutaneous tissue and muscle were bluntly dissected, and the right common carotid artery (CCA) and right subclavian artery (SCA) were separated and sutured for later use. The rats were then fixed on a stereotaxic apparatus in a head-level position. The location of the right vestibular nucleus was 10.2 mm below the anterior fontanelle, 2.2 mm to the right of the midline, and 5.0 mm deep. A 1.5 cm incision was made in the midline of the scalp to expose the anterior fontanelle. A 1.5 mm diameter circular hole was drilled 1.5 mm lateral to and downward from the anterior fontanelle using a dental drill. Cerebral blood flow to the right vestibular nucleus was measured using a laser Doppler flowmeter, and the blood flow was recorded for 5 minutes after the blood flow stabilized before modeling. Cerebral blood flow in the right vestibular nucleus of rats was recorded 5 minutes after ligation of the right CCA and SCA. Successful model establishment was defined as a decrease in cerebral blood flow in the right vestibular nucleus of rats exceeding 20%, accompanied by unsteady gait, gait deviation, and reduced spontaneous activity. In the sham-operated group, only the right CCA and SCA were separated without ligation; sutures were placed directly.

[0073] 2.3 Grouping and Dosing

[0074] After successful modeling, 60 rats were randomly divided into four groups using a random number table: sham-operated group, model group, low-dose Yao medicine formula group, medium-dose Yao medicine formula group, high-dose Yao medicine formula group, and difenidol group, with 10 rats in each group. The difenidol group was administered difenidol hydrochloride 3 mg / kg by gavage; the low, medium, and high-dose Yao medicine formula groups were administered Yao medicine formula 11, 22, and 44 g / kg (based on raw herbs) by gavage, respectively; the sham-operated group and the model group were administered an equal volume of physiological saline by gavage once daily.

[0075] 2.4 Observation Indicators

[0076] 2.4.1 Latency period for escaping electric shock

[0077] Seven days after administration, one hour after the last administration, the rats were placed on a balance rotating device and rotated at 1000 r / min for 5 minutes. Immediately after rotation, they were placed in an electric shock box, and the time required for the rat to complete its escape reflex from placement (latency period) was recorded.

[0078] 2.4.2 Blood flow in the vestibular nuclei

[0079] After the latency period for escaping electric shock was measured, rats were anesthetized with isoflurane, their heads were fixed, and the skull base was exposed. Blood flow in the right vestibular nucleus was measured using a laser Doppler flowmeter. The rate of decrease in blood flow was calculated as follows: Blood flow decrease rate (%) = (Blood flow in the sham-operated group - Blood flow in all groups) / Blood flow in the sham-operated group × 100%.

[0080] 2.4.3 Measurement of energy metabolism in brain tissue

[0081] After blood flow measurement, rats were euthanized, and brain tissue was quickly removed. The right vestibular nucleus and hippocampus were separated on ice. An appropriate amount of brain tissue was weighed, and 9 volumes of pre-cooled PBS were added. The mixture was centrifuged at 4 ℃ and 3000 r / min for 15 min, and the supernatant was collected. The levels of lactate (Lac) and lactate dehydrogenase (LDH) in the brain tissue were measured according to the kit instructions.

[0082] 2.5 Statistical Methods

[0083] Statistical analysis was performed using SPSS 26.0 software. All measurement data are expressed as mean ± standard deviation (SD). The results are indicated by (). One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were used for pairwise comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0084] 3. Results

[0085] 3.1 Effects of Yao herbal formulas on the latency of escape from electric shock in rats with ischemic vertigo

[0086] Compared with the sham-operated group, the latency to escape electric shock in the model group was significantly prolonged (P<0.01), indicating successful model establishment. Compared with the model group, the latency to escape electric shock in the difenidol group and each dose group of Yao medicine formula was significantly shortened (P<0.05), and the effect was dose-dependent, as shown in Table 1.

[0087] Table 1. Comparison of latency periods for rats to escape electric shock in each group ( )

[0088]

[0089] Note: Compared with the sham surgery group ## P<0.01, # P<0.05; compared with the model group ★★ P<0.01, ★ P<0.05.

[0090] 3.2 Effects of Yao herbal formulas on blood flow in the vestibular nucleus of rats with ischemic vertigo

[0091] Compared with the sham-operated group, the blood flow in the vestibular nucleus of rats in the model group was significantly reduced (P<0.01), and the rate of decrease in blood flow was significantly increased (P<0.01). Compared with the model group, the blood flow in the vestibular nucleus of the difenidol group and the medium and high dose groups of Yao medicine formula were significantly increased (P<0.05), and the rate of decrease in blood flow was significantly reduced (P<0.05), as shown in Table 2.

[0092] Table 2. Comparison of blood flow in the vestibular nucleus of rats in each group ( )

[0093]

[0094] Note: Compared with the sham surgery group ## P<0.01, # P<0.05; compared with the model group ★★ P<0.01, ★ P<0.05.

[0095] 3.3 Effects of Yao herbal formulas on energy metabolism in the brain tissue of rats with ischemic vertigo

[0096] Compared with the sham-operated group, the levels of Lac and LDH in the brain tissue of rats in the model group were significantly increased (P<0.01), indicating impaired energy metabolism in the brain tissue; compared with the model group, the levels of Lac and LDH in the brain tissue of the difenidol group and the medium and high dose groups of Yao medicine formula were significantly decreased (P<0.05), as shown in Table 3.

[0097] Table 3. Comparison of Lac and LDH in rat brain tissue of each group ( )

[0098]

[0099] Note: Compared with the sham surgery group ## P<0.01, # P<0.05; compared with the model group ★★ P<0.01, ★ P<0.05.

[0100] 4. Conclusion

[0101] Experimental results showed that the Yao herbal formula dose-dependently shortened the latency to escape electric shock in model rats, increased blood flow to the vestibular nuclei, and reduced the levels of lactate and lactate dehydrogenase in brain tissue, suggesting that this compound can improve vertigo symptoms and correct brain energy metabolism disorders. The medium and high dose groups showed significant effects on most indicators, comparable to the efficacy of the positive control drug diphenhydramine group. Its mechanism may be closely related to improving blood supply to the vestibular nuclei and alleviating energy metabolism disorders caused by ischemia and hypoxia, providing experimental evidence for the clinical application of this compound in vertigo.

[0102] Experimental Example 2: Comparison of Formula Optimization Screening

[0103] 1. Experimental Design

[0104] To verify the synergistic effect of each herb in the disclosed formulation, a flavor-deficient control group was set up in this experiment. Based on the formulation of Example 4 (15 parts of Bidens pilosa, 15 parts of Apocynum venetum leaf, 30 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 25 parts of Achyranthes bidentata, 10 parts of Prunus persica kernel, 10 parts of Carthamus tinctorius, 10 parts of Paeonia lactiflora, 15 parts of Ligusticum chuanxiong, 15 parts of Achyranthes bidentata, 15 parts of Smilax china, 20 parts of Pueraria lobata, and 10 parts of Angelica sinensis), one herb was removed from each of the ingredients to prepare the corresponding flavor-deficient compositions.

[0105] The specific groupings are as follows: The complete formula group, with components weighed according to the formula of Example 4; the Bidens pilosa-deficient group, with Bidens pilosa removed from the formula of Example 4, while the remaining components and proportions remain unchanged; the Apocynum venetum-deficient group, with Apocynum venetum-deficient from the formula of Example 4, while the remaining components and proportions remain unchanged; the Hei Jiu Niu group, with Hei Jiu Niu removed from the formula of Example 4, while the remaining components and proportions remain unchanged; the Jiu Ceng Feng group, with Jiu Ceng Feng removed from the formula of Example 4, while the remaining components and proportions remain unchanged; and the Shuang Gou Zuan group, with Shuang Gou Zuan removed from the formula of Example 4, while the remaining components and proportions remain unchanged.

[0106] All groups were prepared into aqueous extracts (decoctions) according to the same method described in Example 4, and the test solutions were prepared at the same concentration. This experiment used an angiotensin II (Ang II)-induced HUVEC (human umbilical vein endothelial cell) injury model to evaluate the efficacy of each drug by detecting its protective effect on cell viability. Specifically, HUVEC cells were divided into a normal control group, a model group (treated with Ang II only), and each drug-treated group (pretreated with the test solution first, then induced with Ang II). After 24 hours of culture, cell viability was detected using the CCK-8 assay, and cell survival rate was calculated.

[0107] 2. Experimental Results

[0108] Experimental results showed that in the Ang II-induced cell damage model, all treatment groups exhibited varying degrees of cell protection, but the effects differed significantly. The group with the complete formula showed the highest cell survival rate, reaching 85.6%. The cell survival rate decreased to 68.3% in the group lacking Bidens pilosa. The cell survival rate decreased to 65.7% in the group lacking Apocynum venetum. The cell survival rate decreased to 63.5% in the group lacking Achyranthes bidentata. The cell survival rate decreased to 70.1% in the group lacking Achyranthes bidentata. The cell survival rate decreased to 75.4% in the group lacking Zanthoxylum bungeanum.

[0109] 3. Conclusion

[0110] Experimental results show that the protective effect of the complete formula group on vascular endothelial cells is significantly better than any of the control groups lacking any ingredient. Removing any key ingredient from the formula leads to a significant decrease in overall efficacy. This fully demonstrates that the components of the disclosed composition do not simply have additive effects, but rather achieve a significant synergistic effect through scientific compatibility, jointly realizing the therapeutic objectives of "regulating excess and replenishing deficiency, calming the liver and relieving dizziness, and promoting blood circulation and removing blood stasis".

[0111] Trial Example 3: Clinical Trial

[0112] 1. Materials and Methods

[0113] 1.1 General Information

[0114] Forty patients with essential hypertension who met the inclusion criteria and were admitted to a hospital between April 2018 and April 2020 were selected and randomly divided into two groups of 20 each. The observation group consisted of 11 males and 9 females, aged 48–75 years, with a mean age of (61.44±10.35) years; the control group consisted of 10 males and 10 females, aged 47–75 years, with a mean age of (61.20±10.44) years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability. This study was approved by the hospital's ethics committee.

[0115] Inclusion criteria: ① Primary hypertension; ② Signed informed consent form; ③ No other medications that may affect the efficacy of treatment were used before treatment; ④ Patient informed consent.

[0116] Exclusion criteria: ① those with other serious diseases; ② those allergic to the drugs used in this study; ③ those unwilling to receive traditional Chinese medicine treatment; ④ those unable to cooperate with the study; ⑤ pregnant or lactating women.

[0117] 1.2 Methods

[0118] The control group received routine Western medicine treatment, including amlodipine besylate tablets (5 mg, once daily). The dose was adjusted to 10 mg once daily based on the patients' response, and continued for 2 weeks.

[0119] The observation group received the same medication as the control group, plus a Yao herbal formula: 15g of Bidens pilosa, 15g of Apocynum venetum leaf, 30g of Achyranthes bidentata, 25g of Achyranthes bidentata, 25g of Achyranthes bidentata, 10g of Prunus persica kernel, 10g of Carthamus tinctorius, 10g of Paeonia lactiflora, 15g of Ligusticum chuanxiong, 15g of Achyranthes bidentata, 15g of Smilax china (added later), 20g of Pueraria lobata, and 10g of Angelica sinensis. The above herbs were prepared into a liquid at the pharmacy, and 300ml was taken warm in the morning, noon, and evening; alternatively, patients could decoct the herbs at home, taking one dose daily, divided into three warm doses. The observation group received treatment for two weeks.

[0120] 1.3 Observation Indicators

[0121] After treatment, compare the patient's blood pressure levels before and after treatment.

[0122] The hypertension dizziness syndrome score is based on the severity of the primary symptom, dizziness, and vertigo, and is scored from 0 to 6 points. The secondary symptoms, such as tinnitus, nausea, and fatigue, are scored from 0 to 2 points. The lower the score, the milder the symptom.

[0123] Compare the incidence of adverse reactions during treatment.

[0124] 1.4 Statistical Methods

[0125] SPSS 23.0 statistical software was used to analyze the data. If the continuous data conformed to a normal distribution, the mean ± standard deviation was used as the statistical unit. The data indicates that independent samples t-tests were used for comparisons between groups; count data are expressed as frequency and percentage [n(%)], and chi-square tests were used for comparisons between groups. 2 Test. A p-value < 0.05 is considered statistically significant.

[0126] 2. Results

[0127] 2.1 Comparing blood pressure levels

[0128] Before treatment, there was no statistically significant difference in blood pressure indicators between the two groups (P>0.05); after treatment, the blood pressure indicators in the observation group were better than those in the control group (P<0.05), and the difference was statistically significant. See Table 4 for details.

[0129] Table 4. Comparison of blood pressure indicators (mmHg) between the two groups

[0130]

[0131] 2.2 Comparison of dizziness scores

[0132] Before treatment, there was no statistically significant difference in vertigo scores between the two groups (P>0.05); after treatment, the vertigo symptom score in the observation group was lower than that in the control group (P<0.05), and the difference was statistically significant. See Table 5 for details.

[0133] Table 5. Comparison of dizziness scores (points) between the two groups

[0134]

[0135] 2.3 Comparison of adverse reaction rates

[0136] After treatment, there was no statistically significant difference in the adverse reaction rates between the two groups (P>0.05), as shown in Table 6.

[0137] Table 6. Comparison of adverse reaction rates between the two groups [n(%)]

[0138]

[0139] 3. Conclusion

[0140] The results showed that after two weeks of treatment, the observation group outperformed the control group, which received only conventional Western medicine treatment, in several key indicators. Regarding blood pressure reduction, the observation group experienced a more significant decrease in both systolic and diastolic blood pressure. In terms of improving clinical symptoms, the observation group had a significantly lower score for hypertension-related dizziness symptoms than the control group, and symptoms such as dizziness and vertigo were effectively relieved. Regarding safety, the incidence of adverse reactions during treatment was lower in the observation group than in the control group, and the difference between the two groups was not statistically significant, indicating that this combined treatment regimen did not increase any additional safety risks.

[0141] In conclusion, the combination of conventional Western medicine and this Yao medicine formula can not only more effectively control the blood pressure level of patients with primary hypertension, but also significantly improve TCM symptoms such as dizziness, and has good safety, making it worthy of further promotion and application in clinical practice.

Claims

1. A Yao medicine composition for treating vertigo, characterized in that, The formula includes the following components by weight: Bidens pilosa 5-20 parts, Apocynum venetum leaf 5-20 parts, Achyranthes bidentata 5-50 parts, Achyranthes bidentata 5-50 parts, Prunus persica kernel 5-20 parts, Carthamus tinctorius 5-20 parts, Paeonia lactiflora 5-20 parts, Ligusticum chuanxiong 5-20 parts, Achyranthes bidentata 5-20 parts, Smilax china 5-20 parts, Pueraria lobata 5-20 parts, Angelica sinensis 5-20 parts.

2. The Yao medicine composition according to claim 1, characterized in that, The ingredients include the following components by weight: 15 parts Bidens pilosa, 15 parts Apocynum venetum leaves, 30 parts Black Achyranthes bidentata, 25 parts Achyranthes bidentata, 25 parts Achyranthes bidentata, 10 parts Prunus persica kernel, 10 parts Carthamus tinctorius, 10 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 15 parts Achyranthes bidentata, 15 parts Smilax china, 20 parts Pueraria lobata, and 10 parts Angelica sinensis.

3. A pharmaceutical preparation, characterized in that, This pharmaceutical preparation is made from the Yao medicine composition described in claim 1 or 2 as the active pharmaceutical ingredient.

4. The pharmaceutical preparation according to claim 3, characterized in that: It also contains pharmaceutically acceptable excipients.

5. The pharmaceutical preparation according to claim 3, characterized in that: The dosage form of the drug preparation is a decoction or pills.

6. A method for preparing a pharmaceutical formulation as described in claim 3, characterized in that, Includes the following steps: (1) Take Bidens pilosa, Apocynum venetum leaves, black ox and golden thread wind, soak them in water, heat and extract several times, filter, combine the filtrates, concentrate the filtrates to make a thick paste with a relative density of 1.12 to 1.18 at 60℃; (2) Take nine-layered wind, peach kernel, safflower, red peony root, chuanxiong, chuanniuxi, double hook drill, kudzu root and angelica, grind them into fine powder, mix the fine powder with the thick paste to obtain soft material; (3) The soft material is transferred to a pelleting machine, extruded into pellets, and the resulting wet pellets are polished, dried, sieved and packaged to obtain a pharmaceutical preparation.

7. The preparation method according to claim 6, characterized in that: In step (1), the soaking time is 20 to 60 minutes, the heating extraction method is to heat to boiling and then maintain a slight boiling state, the heating extraction is performed 1 to 3 times, the amount of water added each time is 6 to 10 times the total weight of the raw materials taken for soaking, and the extraction time each time is 0.5 to 1.5 hours.

8. The preparation method according to claim 6, characterized in that: In step (3), the polishing method is to fully wet the product with 75% ethanol by volume and then polish it by rolling for 5 to 10 minutes; the drying method is to dry the product at 52 to 58°C until the mass fraction of moisture is less than 5% and then let it cool.

9. A method for preparing a pharmaceutical formulation as described in claim 3, characterized in that, include: Weigh the raw materials according to the weight proportions, soak them in water for 20-60 minutes, and heat them for extraction 1-3 times. The heating extraction method is to heat to boiling and then maintain a gentle boil. The amount of water added each time is 6-10 times the total weight of the raw materials, and the extraction time each time is 0.5-1.5 hours. Filter, combine the filtrates, and obtain the pharmaceutical preparation.

10. The use of the Yao medicine composition according to any one of claims 1 to 2 or the pharmaceutical preparation according to any one of claims 3 to 5 in the preparation of a medicament for treating hypertension, cervical spondylosis or vertigo.

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