Yang activating, numbness dispersing and lung tonifying formula as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a prescription for activating yang, dispersing arthralgia and tonifying lung as well as a preparation method and application thereof. In the formula, allium macrostemon, ginseng and astragalus mongholicus are used as monarch drugs, ginseng and astragalus mongholicus tonify qi and raise yang, allium macrostemon tonifies yang, removes stasis and releases arthralgia, and the three drugs jointly achieve the effects of reinforcing vital energy, strengthening yang and consolidating foundation. The trichosanthes kirilowii maxim is used for opening chest and relieving arthralgia, helping the allium macrostemon to activate yang and benefiting qi in chest; radix paeoniae rubra and ligusticum wallichii promote blood circulation to remove blood stasis; platycodon grandiflorum, fructus aurantii and mangnolia officinalis are combined, and the platycodon grandiflorum and the fructus aurantii have the effects of ascending and descending once and relieving chest stuffiness and promoting qi Radix ophiopogonis is sweet and cold, nourishes yin, moistens the lung and promotes the secretion of saliva or body fluid; schisandra chinensis is sour and warm for astringing, tonifying qi and securing essence, cassia twig is compatible to seek yang from yin, yang is assisted by yin, cassia twig can calm adverse-rising energy and calm thoroughfare energy, allium macrostemon is combined to activate yang and disperse arthralgia, and the medicines are used as adjuvant drugs. Honey-fried licorice root is used for harmonizing the medicines and is a conductant medicine. All the components are combined, heart yang and lung qi are recovered, and the effects of activating yang, freeing impediment, promoting qi, activating blood and tonifying lung are achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a formula for promoting Yang, relieving Bi syndrome, and tonifying the lungs, as well as its preparation method and uses. Background Technology

[0002] The earliest record of the clinical manifestations of chest pain and angina pectoris is found in the *Neijing* (Inner Canon of Medicine), which mentions "sudden heart pain," "fainting heart pain," and "true heart pain." The *Lingshu* (Spiritual Pivot), in its chapter "Five Evils," states, "When evil resides in the heart, it causes heart pain." The *Suwen* (Plain Questions), in its chapter "On the Timing of Organ Functions," also says, "Heart disease manifests as chest pain, fullness in the hypochondrium, pain under the ribs, pain in the chest, back, and between the shoulder blades, and pain in the inner arms." Zhang Zhongjing of the Han Dynasty formally proposed the disease name "chest pain" in his *Jinkui Yaolue* (Essential Prescriptions of the Golden Chamber). Chest pain and angina pectoris mainly manifest as dull pain in the chest, sometimes radiating to the back, accompanied by shortness of breath and inability to lie down. Mild cases may only present with difficulty breathing and a feeling of suffocation in the chest, while severe cases may experience chest pain radiating to the back and vice versa.

[0003] Currently, traditional Chinese medicine (TCM) offers various theories on the pathogenesis of chest pain and heart pain, including "Qi deficiency and blood stasis theory," "phlegm and blood stasis theory," "heart blood stasis theory," and "heart Qi deficiency theory." Due to the diverse ways of describing symptoms and the complexity of the underlying pathogenesis, these theories present certain obstacles in actual diagnosis, treatment, and academic research.

[0004] Traditional Chinese medicine (TCM) has a theoretical basis and clinical practice in treating chest pain (angina pectoris) by focusing on the lungs. This approach to treating heart-related diseases also fully embodies TCM's principles of "treating different diseases with the same method" and "holistic view." The heart and lungs both belong to the upper burner (upper jiao), with the lungs governing qi (vital energy) and the heart governing blood. Regulating lung qi and unblocking blood vessels helps the heart circulate blood and harmonizes the flow of qi and blood. If lung qi is weak, the generation of ancestral qi is insufficient, failing to "circulate qi and blood through the heart vessels," leading to blood stasis in the heart, which is described as "heart pain due to obstructed blood vessels" and "pain due to obstruction." Therefore, the two are closely related physiologically and influence each other pathologically.

[0005] Coronary artery disease and angina pectoris are clinical syndromes caused by acute and transient myocardial ischemia and hypoxia due to the narrowing of the coronary artery lumen caused by coronary atherosclerosis, resulting in chest tightness and chest pain. In modern times, it is generally recognized as belonging to the category of "chest pain and heart pain" in traditional Chinese medicine. Modern physicians mostly consider coronary artery disease to be a condition of deficiency in the root and excess in the branch.

[0006] Zhi Shi Xie Bai Gui Zhi Tang is a classic formula for treating chest pain, first recorded in Zhang Ji's *Jin Gui Yao Lue* (Essential Prescriptions of the Golden Chamber) from the Han Dynasty. Due to its particularly significant clinical efficacy, precise use of herbs, rigorous formulation, ingenious combination of ingredients, and remarkable effects, it was included in the first batch of the *Catalogue of Ancient Classical Prescriptions* published by the State Administration of Traditional Chinese Medicine. This formula consists of five Chinese herbs: Zhi Shi (Fructus Aurantii Immaturus), Hou Po (Cortex Magnoliae Officinalis), Gua Lou (Fructus Trichosanthis), Xie Bai (Radix Alliumeum), and Gui Zhi (Radix Cinnamomi). It invigorates Yang, relieves stagnation, and alleviates fullness and rebellious Qi. It is particularly effective for treating chest pain with a strong excess pattern, especially in cases of severe phlegm and Qi stagnation. Based on Gua Lou Xie Bai Bai Jiu Tang (Decoction of Radix Trichosanthis and Radix Alliumeum), the addition of Zhi Shi, Hou Po, and Gui Zhi pioneered the treatment of chest pain from the perspective of the spleen and stomach.

[0007] Although the theory of treating chest pain based on the lungs has been reported in the existing technology, how to further improve the treatment effectiveness is still a technical problem that needs to be solved by those skilled in the art. Summary of the Invention

[0008] In view of this, the present invention provides a formula for promoting Yang, relieving Bi syndrome, and tonifying the lungs, along with its preparation method and uses. This formula is derived from a modified version of the Zhi Shi Xie Bai Gui Zhi Tang formula. Based on the theory that "the heart governs blood, the lungs govern Qi, and Qi and blood are mutually dependent," and that chest pain is located in the heart and closely related to the lungs, this formula effectively promotes Yang, relieves Bi syndrome, regulates Qi and blood circulation, and tonifies the lungs, significantly improving symptoms of chest pain and angina, with a definite therapeutic effect.

[0009] This invention also provides a method for preparing the above-mentioned Tongyang Xuanbi Bufei formula.

[0010] This invention also provides the application of the above-mentioned Tongyang Xuanbi Bufei formula in the preparation of drugs for treating chest pain and heart pain.

[0011] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a formula for promoting Yang, relieving pain, and tonifying the lungs, prepared from the following raw materials in the following weight proportions: Allium macrostemon 6-12 parts, ginseng 4-8 parts, Astragalus membranaceus 12-18 parts, Trichosanthes kirilowii 10-15 parts, Paeonia lactiflora 6-12 parts, Ligusticum chuanxiong 10-15 parts, Platycodon grandiflorus 4-8 parts, Citrus aurantium 10-15 parts, Magnolia officinalis 6-12 parts, Rehmannia glutinosa 10-15 parts, Angelica sinensis 10-15 parts, Ophiopogon japonicus 12-18 parts, Schisandra chinensis 4-8 parts, Cinnamomum cassia 6-12 parts, and Glycyrrhiza uralensis 4-8 parts.

[0012] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in the following weights: 9 parts of Allium macrostemon, 6 parts of ginseng, 15 parts of Astragalus membranaceus, 12 parts of Trichosanthes kirilowii, 9 parts of Paeonia lactiflora, 12 parts of Ligusticum chuanxiong, 6 parts of Platycodon grandiflorus, 12 parts of Citrus aurantium, 9 parts of Magnolia officinalis, 12 parts of Rehmannia glutinosa, 12 parts of Angelica sinensis, 15 parts of Ophiopogon japonicus, 6 parts of Schisandra chinensis, 9 parts of Cinnamomum cassia, and 6 parts of Glycyrrhiza uralensis (processed).

[0013] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in the following weights: 6 parts of Allium macrostemon, 8 parts of ginseng, 12 parts of Astragalus membranaceus, 10 parts of Trichosanthes kirilowii, 12 parts of Paeonia lactiflora, 15 parts of Ligusticum chuanxiong, 4 parts of Platycodon grandiflorus, 10 parts of Citrus aurantium, 12 parts of Magnolia officinalis, 10 parts of Rehmannia glutinosa, 15 parts of Angelica sinensis, 12 parts of Ophiopogon japonicus, 4 parts of Schisandra chinensis, 6 parts of Cinnamomum cassia, and 4 parts of Glycyrrhiza uralensis (processed).

[0014] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in the following weights: 12 parts of Allium macrostemon, 8 parts of ginseng, 18 parts of Astragalus membranaceus, 15 parts of Trichosanthes kirilowii, 6 parts of Paeonia lactiflora, 10 parts of Ligusticum chuanxiong, 8 parts of Platycodon grandiflorus, 15 parts of Citrus aurantium, 6 parts of Magnolia officinalis, 15 parts of Rehmannia glutinosa, 10 parts of Angelica sinensis, 18 parts of Ophiopogon japonicus, 8 parts of Schisandra chinensis, 12 parts of Cinnamomum cassia, and 8 parts of Glycyrrhiza uralensis (processed).

[0015] In a second aspect, the present invention provides a method for preparing the above-mentioned Tongyang Xuanbi Bufei formula, comprising the following steps: weighing the raw materials according to the formula, mixing them, adding 8-10 times the amount of water and decocting twice, each time for 0.5-2 hours, combining the decoctions, filtering, and concentrating to 2-4 times the amount to obtain the final product.

[0016] As a preferred technical solution of the present invention, the preparation method of the Tongyang Xuanbi Bufei Formula includes the following steps: weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 1 hour each time, combine the decoctions, filter, and concentrate to 3 times the amount to obtain the final product.

[0017] A third aspect of the present invention provides a traditional Chinese medicine preparation of Tongyang Xuanbi Bufei Formula, characterized in that the traditional Chinese medicine preparation is made from the above-mentioned Tongyang Xuanbi Bufei Formula as raw material.

[0018] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients. The dosage forms of the traditional Chinese medicine preparation include decoctions, granules, capsules, tablets, powders, pills, or oral liquids.

[0019] A fourth aspect of the present invention provides the use of the Tongyang Xuanbi Bufei formula in the preparation of a drug for the prevention or treatment of chest pain and heart pain.

[0020] A fifth aspect of the present invention provides the use of the Tongyang Xuanbi Bufei formula in the preparation of drugs for the prevention or treatment of coronary heart disease.

[0021] Formula analysis: 1. Principal herbs: Allium macrostemon, ginseng, and astragalus membranaceus Allium macrostemon: It has a pungent and bitter taste, is warm in nature, and is non-toxic. It has the effects of regulating qi, relieving chest tightness, promoting yang, and dispersing nodules. Traditional Chinese medicine has long used it to treat diseases such as chest tightness and stabbing pain, tenesmus after diarrhea, and shortness of breath.

[0022] Ginseng: It tastes sweet and slightly bitter, and is slightly warm in nature. It enters the spleen, lung, heart, and kidney meridians. It is strong in qi and moist in body, and its ascending function is greater than its descending function. It has the effects of tonifying and strengthening the body, replenishing qi and consolidating the body, tonifying the lungs and strengthening the spleen, promoting body fluid and quenching thirst, and calming the mind and improving intelligence.

[0023] Astragalus: It is sweet and slightly warm in nature, and enters the lung and spleen meridians. It tonifies qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes the elimination of toxins and pus, and promotes wound healing and tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to ulcerate, and chronic ulcers that do not heal.

[0024] 2. Assistant herbs: Trichosanthes kirilowii, Paeonia lactiflora, Ligusticum chuanxiong, Platycodon grandiflorus, Citrus aurantium, Magnolia officinalis Trichosanthes kirilowii: sweet and slightly bitter in taste, cold in nature, enters the lung, stomach and large intestine meridians. It clears heat and eliminates phlegm, relieves chest congestion and dissipates nodules, moistens dryness and lubricates the intestines. It is used for cough due to lung heat, thick yellow phlegm, chest pain, chest congestion and fullness, mastitis, lung abscess, intestinal abscess, and constipation.

[0025] Red peony root: bitter in taste, slightly cold in nature, enters the liver meridian, clears heat and cools blood, invigorates blood and removes blood stasis; used for heat entering the blood, febrile rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0026] Chuanxiong (Ligusticum striatum): pungent and warm in nature, it enters the liver and gallbladder meridians. It promotes qi circulation, relieves stagnation, dispels wind and dampness, invigorates blood, and relieves pain. It treats wind-cold headaches and dizziness, hypochondriac pain and abdominal pain, cold-induced muscle spasms, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncles and sores. It is also used for irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to masses, chest and hypochondriac pain, traumatic swelling and pain, headache, and rheumatic pain.

[0027] Platycodon grandiflorus: bitter and pungent in taste, neutral in nature, enters the lung meridian, promotes lung function, soothes the throat, eliminates phlegm, and drains pus; used for cough with excessive phlegm, chest tightness, sore throat and hoarseness, lung abscess with purulent sputum, etc.

[0028] Fructus Aurantii Immaturus: It tastes bitter, pungent, and sour, and is slightly cold in nature. It enters the spleen and stomach meridians, regulates qi and relieves chest tightness, and promotes the flow of qi and relieves bloating. It is used for qi stagnation in the chest and ribs, fullness and pain, food stagnation, phlegm retention, and organ prolapse.

[0029] Magnolia officinalis: It tastes bitter and pungent, and is warm in nature. It enters the spleen, stomach, and large intestine meridians. It promotes qi circulation and eliminates food stagnation; dries dampness and relieves fullness; and relieves nausea and asthma. It is mainly used to treat food stagnation and qi stagnation; abdominal distension and constipation; dampness obstructing the middle jiao, causing epigastric fullness, vomiting, and diarrhea; phlegm accumulation and qi reversal; and chest fullness, wheezing, and cough.

[0030] 3. Adjuvant herbs: Rehmannia glutinosa, Angelica sinensis, Ophiopogon japonicus, Schisandra chinensis, Cinnamomum cassia Rehmannia glutinosa: It tastes sweet and bitter, is cold in nature, and enters the heart, liver, and lung meridians. It clears heat and cools the blood, nourishes yin and generates fluids. It is mainly used to treat heat entering the blood, red tongue with thirst, rashes with vomiting and nosebleeds, yin deficiency with internal heat, bone steaming fever, thirst due to fluid depletion, internal heat with thirst, and constipation due to intestinal dryness.

[0031] Angelica sinensis: It is pungent and bitter in taste, and warm in nature. It enters the heart, liver and spleen meridians. It nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens dryness and lubricates the intestines. It is used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal masses, metrorrhagia, abdominal pain due to deficiency and cold, weakness and numbness, numbness of the skin, constipation due to intestinal dryness, tenesmus after dysentery, carbuncles and sores, and injuries from falls and blows.

[0032] Ophiopogon japonicus: Sweet, slightly bitter, and slightly cold in nature. It enters the heart, lung, and stomach meridians. Functions and indications: Nourishes yin and generates fluids, moistens the lungs and clears the heart; used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0033] Schisandra chinensis: It tastes sour and sweet, and is warm in nature. It enters the lung, heart, and kidney meridians. It has astringent and consolidating properties, replenishes qi and generates fluids, and tonifies the kidneys and calms the mind. It is used for chronic cough and wheezing, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations and insomnia.

[0034] Cinnamon twig: sweet in taste, slightly warm in nature, enters the lung and spleen meridians, tonifies qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes the elimination of toxins and pus, and promotes tissue regeneration and wound healing; used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, and edema due to qi deficiency.

[0035] 4. Medicinal herb: Prepared licorice root Prepared licorice root: It is warm in nature and sweet in taste. It enters the heart, lung, stomach, and spleen meridians. It tonifies the spleen and stomach, and replenishes qi and restores the pulse. It is used for spleen and stomach weakness, fatigue, palpitations, and irregular pulse.

[0036] The secrets of compatibility: Based on the theory that "the heart governs blood, the lungs govern qi, and qi and blood are mutually dependent," traditional Chinese medicine believes that chest pain (angina pectoris) is located in the heart and is closely related to the lungs. Zhang Zhongjing, in his *Synopsis of Prescriptions of the Golden Chamber*, summarized the etiology and pathogenesis of chest pain as "deficient yang and stagnant yin," meaning that the yang in the chest is weak, and yin-cold congeals, a condition of deficiency in the root and excess in the branch. The treatment principle is to treat both the heart and lungs simultaneously. A self-formulated formula for promoting yang, relieving chest pain, and tonifying the lungs is derived from a modified version of Zhi Shi Xie Bai Gui Zhi Tang, Xue Fu Zhu Yu Tang, and Bu Fei Huang Qi Tang, embodying the principle of treating both the heart and lungs.

[0037] Xuefu Zhuyu Decoction is a classic Chinese medicine formula composed of various herbs including peach kernel, safflower, chuanxiong rhizome, and angelica root. Studies have shown that Xuefu Zhuyu Decoction can reduce lipid deposition on blood vessel walls, inhibit plaque formation, and exert anti-atherosclerotic effects. Its mechanism of action is related to the regulation of PPAR-γ expression. Xuefu Zhuyu Decoction has significant conditioning effects on problems such as blood stasis and poor meridian circulation.

[0038] Lung-Nourishing Astragalus Decoction consists of Astragalus membranaceus, Ginseng, Atractylodes macrocephala, Rehmannia glutinosa, Schisandra chinensis, Cinnamomum cassia, Achyranthes bidentata, Citrus reticulata, Ophiopogon japonicus, Angelica sinensis, and Glycyrrhiza uralensis. Astragalus membranaceus tonifies the kidneys and raises yang, strengthens the exterior and stops sweating; Ginseng greatly replenishes vital energy and nourishes the lungs and kidneys; Atractylodes macrocephala tonifies the lung and spleen qi, generates fluids and moistens dryness; Rehmannia glutinosa tonifies the kidneys and benefits essence, nourishes yin and fills marrow; Schisandra chinensis astringes the lungs and generates fluids, benefits qi and nourishes the kidneys; Cinnamomum cassia is a very hot herb, tonifying fire and assisting yang, warming the meridians and dispelling cold; Achyranthes bidentata tonifies the liver and kidneys, and unblocks blood vessels; Angelica sinensis nourishes blood and invigorates blood circulation, regulates menstruation and unblocks meridians; Ophiopogon japonicus nourishes yin and moistens the lungs, generates fluids and moistens dryness; Citrus reticulata regulates qi and strengthens the spleen; Poria cocos and Paeonia lactiflora are removed, and Xanthium sibiricum is added, which is pungent and warm in nature, and opens the nasal passages; Zingiber officinale is added to enter the lung meridian, warms the middle jiao and unblocks the meridians, warms the lungs and transforms phlegm; Glycyrrhiza uralensis harmonizes the properties of the herbs. The combined effects of these herbs warm and tonify the lungs and kidneys, benefit qi and unblock the

[0039] The formula for promoting Yang, relieving pain, and tonifying the lungs uses 9g of Allium macrostemon, 6g of ginseng, and 15g of Astragalus membranaceus as the principal herbs. Ginseng and Astragalus membranaceus tonify Qi and raise Yang, while Allium macrostemon promotes Yang, disperses stagnation, and relieves pain. Together, these three herbs greatly tonify the original Qi and strengthen Yang. The assistant herbs include 12g of Trichosanthes kirilowii to open the chest and relieve pain, assisting Allium macrostemon in promoting Yang and benefiting the Qi in the chest; 9g of Paeonia lactiflora and 12g of Ligusticum chuanxiong to invigorate blood and remove blood stasis; and 6g of Platycodon grandiflorus, 12g of Citrus aurantium, and 9g of Magnolia officinalis. The three herbs work together: Platycodon grandiflorus and Citrus aurantium, one ascending and the other descending, widen the chest and promote Qi circulation; Magnolia officinalis promotes Qi circulation, relieves bloating, dries dampness, and eliminates fullness. When used together with Platycodon grandiflorus and Citrus aurantium, it is particularly effective in regulating Qi and removing stagnation, so that when Qi flows, blood flows. Rehmannia glutinosa (12g) and Angelica sinensis (12g) nourish blood, benefit yin, and invigorate blood circulation; Ophiopogon japonicus (15g) and Schisandra chinensis (6g) are combined. Ophiopogon japonicus is sweet and cold, nourishing yin, moistening the lungs, and generating fluids; Schisandra chinensis is sour and warm, astringent, and invigorating qi and consolidating essence. The combination of these two herbs, one moistening and the other astringent, nourishes yin without stagnation and consolidates without dryness, working together to invigorate qi and nourish yin. Cinnamomum cassia (9g) is added, which "seeks yang within yin," allowing yang to be aided by yin, and cinnamon twig can also descend rebellious qi and calm the upward flow of qi. Combined with Allium macrostemon (6g), it promotes yang and relieves numbness. All these herbs serve as adjuvant herbs. Glycyrrhiza uralensis (6g) harmonizes the other herbs and acts as the guiding herb; Platycodon grandiflorus also carries the herbs upward, serving as a guiding herb as well. The entire formula, when used together, restores heart yang and lung qi, working together to promote yang, relieve numbness, invigorate qi, invigorate blood, and tonify the lungs.

[0040] The beneficial effects of the Tongyang Xuanbi Bufei formula of this invention are as follows: The Tongyang Xuanbi Bufei Formula of this invention improves blood viscosity, increases blood flow rate, and reduces the degree of myocardial ischemia-induced damage caused by cold-induced chest pain, thus having a significant therapeutic effect on myocardial damage caused by cold-induced chest pain.

[0041] The theory of treating coronary heart disease from the perspective of the lungs can not only guide clinical diagnosis and prescription, but also provide new ideas for other TCM therapies, better leverage the advantages of TCM, and contribute to the further development of TCM theory and the improvement of clinical efficacy. Attached Figure Description

[0042] Figure 1 The elevation values ​​of the J point in rats in each group are shown in the bar chart. Different lowercase letters above the bar indicate significant differences between different groups (P < 0.05).

[0043] Figure 2 The serum CK levels of rats in each group were compared. Different lowercase letters above the bars indicate significant differences between different groups (P < 0.05).

[0044] Figure 3 The serum LDH levels of rats in each group were compared. Different lowercase letters above the bars indicate significant differences between different groups (P < 0.05). Detailed Implementation

[0045] To verify the efficacy of the Tongyang Xuanbi Bufei Formula of this invention, the inventors conducted pharmacodynamic experiments. It should be noted that the drugs selected for the pharmacodynamic experiments of this invention are those obtained from the representative formulas and preparation methods of this invention. Due to space limitations, the experiments and results related to other formulas and preparation methods included in this invention are not exhaustively listed here.

[0046] Example 1: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 9g, Ginseng 6g, Astragalus membranaceus 15g, Trichosanthes kirilowii 12g, Paeonia lactiflora 9g, Ligusticum chuanxiong 12g, Platycodon grandiflorus 6g, Citrus aurantium 12g, Magnolia officinalis 9g, Rehmannia glutinosa 12g, Angelica sinensis 12g, Ophiopogon japonicus 15g, Schisandra chinensis 6g, Cinnamomum cassia 9g, Glycyrrhiza uralensis 6g.

[0047] Weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 1 hour each time. Combine the decoctions, filter, and concentrate to 3 times the amount to obtain the final product.

[0048] Example 2: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 6g, ginseng 8g, astragalus membranaceus 12g, trichosanthes kirilowii 10g, peony root 12g, chuanxiong rhizome 15g, platycodon grandiflorus 4g, immature bitter orange peel 10g, magnolia bark 12g, rehmannia root 10g, angelica sinensis 15g, ophiopogon japonicus 12g, schisandra chinensis 4g, cinnamon twig 6g, prepared licorice root 4g.

[0049] Weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 2 hours each time. Combine the decoctions, filter, and concentrate to twice the amount to obtain the final product.

[0050] Example 3: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 12g, Ginseng 8g, Astragalus membranaceus 18g, Trichosanthes kirilowii 15g, Paeonia lactiflora 6g, Ligusticum chuanxiong 10g, Platycodon grandiflorus 8g, Citrus aurantium 15g, Magnolia officinalis 6g, Rehmannia glutinosa 15g, Angelica sinensis 10g, Ophiopogon japonicus 18g, Schisandra chinensis 8g, Cinnamomum cassia 12g, Glycyrrhiza uralensis (processed) 8g.

[0051] Weigh the raw materials according to the formula, mix them, add 10 times the amount of water and decoct twice, 2 hours each time. Combine the decoctions, filter, and concentrate to 4 times the amount to obtain the final product.

[0052] Example 4: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 9g, Ginseng 4g, Astragalus membranaceus 15g, Trichosanthes kirilowii 15g, Paeonia lactiflora 9g, Ligusticum chuanxiong 15g, Platycodon grandiflorus 6g, Citrus aurantium 10g, Magnolia officinalis 9g, Rehmannia glutinosa 15g, Angelica sinensis 10g, Ophiopogon japonicus 15g, Schisandra chinensis 4g, Cinnamomum cassia 12g, Glycyrrhiza uralensis 8g.

[0053] Weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 0.5 hours each time. Combine the decoctions, filter, and concentrate to twice the amount to obtain the final product.

[0054] Example 5: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 12g, ginseng 6g, astragalus membranaceus 12g, trichosanthes kirilowii 12g, peony root 6g, chuanxiong rhizome 12g, platycodon root 8g, immature bitter orange peel 12g, magnolia bark 6g, rehmannia root 12g, angelica sinensis 12g, ophiopogon japonicus 12g, schisandra fruit 6g, cinnamon twig 9g, prepared licorice root 6g.

[0055] Weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 1 hour each time. Combine the decoctions, filter, and concentrate to twice the amount to obtain the final product.

[0056] Example 6: A formula for promoting Yang, relieving pain, and tonifying the lungs Allium macrostemon 12g, Ginseng 4g, Astragalus membranaceus 15g, Trichosanthes kirilowii 15g, Paeonia lactiflora 12g, Ligusticum chuanxiong 10g, Platycodon grandiflorus 4g, Citrus aurantium 15g, Magnolia officinalis 9g, Rehmannia glutinosa 12g, Angelica sinensis 15g, Ophiopogon japonicus 15g, Schisandra chinensis 6g, Cinnamomum cassia 6g, Glycyrrhiza uralensis 4g.

[0057] Weigh the raw materials according to the formula, mix them, add 8 times the amount of water and decoct twice, 2 hours each time. Combine the decoctions, filter, and concentrate to twice the amount to obtain the final product.

[0058] Comparative Example 1 Allium macrostemon 9g, Trichosanthes kirilowii 12g, Paeonia lactiflora 9g, Ligusticum chuanxiong 12g, Platycodon grandiflorus 6g, Citrus aurantium 12g, Magnolia officinalis 9g, Rehmannia glutinosa 12g, Angelica sinensis 12g, Ophiopogon japonicus 15g, Schisandra chinensis 6g, Cinnamomum cassia 9g, Glycyrrhiza uralensis (processed) 6g.

[0059] Compared with Example 1, the difference is that it does not contain ginseng or astragalus, while the other components and dosages remain the same.

[0060] The preparation method is the same as in Example 1.

[0061] Comparative Example 2 Allium macrostemon 9g, Ginseng 6g, Astragalus membranaceus 15g, Platycodon grandiflorus 6g, Citrus aurantium 12g, Magnolia officinalis 9g, Rehmannia glutinosa 12g, Angelica sinensis 12g, Ophiopogon japonicus 15g, Schisandra chinensis 6g, Cinnamomum cassia 9g, Glycyrrhiza uralensis 6g.

[0062] Compared with Example 1, the difference is that it does not contain Trichosanthes kirilowii, Paeonia lactiflora, and Ligusticum chuanxiong, while the other components and dosages remain the same.

[0063] The preparation method is the same as in Example 1.

[0064] Comparative Example 3 A modified formula of Zhi Shi Xie Bai Gui Zhi Tang, Xue Fu Zhu Yu Tang combined with Bu Fei Huang Qi Tang 1 12g of Citrus aurantium, 12g of Magnolia officinalis, 9g of Allium macrostemon, 3g of Cinnamomum cassia, 12g of Trichosanthes kirilowii, 12g of Prunus persica, 9g of Carthamus tinctorius, 9g of Angelica sinensis, 9g of Rehmannia glutinosa, 9g of Achyranthes bidentata, 4.5g of Ligusticum chuanxiong, 4.5g of Platycodon grandiflorus, 6g of Paeonia lactiflora, 6g of Citrus aurantium, 3g of Bupleurum chinense, 6g of Glycyrrhiza uralensis, 6g of Panax ginseng, 15g of Astragalus membranaceus, 15g of Ophiopogon japonicus, and 6g of Schisandra

[0065] The preparation method is the same as in Example 1.

[0066] Comparative Example 4 Zhi Shi Xie Bai Gui Zhi Tang combined with Xue Fu Zhu Yu Tang 12g of Citrus aurantium, 12g of Magnolia officinalis, 9g of Allium macrostemon, 3g of Cinnamomum cassia, 12g of Trichosanthes kirilowii, 12g of Prunus persica, 9g of Carthamus tinctorius, 9g of Angelica sinensis, 9g of Rehmannia glutinosa, 9g of Achyranthes bidentata, 4.5g of Ligusticum chuanxiong, 4.5g of Platycodon grandiflorus, 6g of Paeonia lactiflora, 6g of Citrus aurantium, 3g of Bupleurum chinense, and 6g of Glycyrrhiza uralensis.

[0067] The preparation method is the same as in Example 1.

[0068] Study on the effect of the Tongyang Xuanbi Bufei formula of this invention on a rat model of cold-induced chest pain. 1. Experimental Methods Ninety SD rats, weighing 180-220g, were acclimatized for one week and then randomly divided into four groups: blank control group, model control group, experimental group 1, experimental group 2, experimental group 3, control group 1, control group 2, control group 3, and control group 4, with 10 rats in each group.

[0069] The blank control group and the model control group were given physiological saline by gavage, while the other groups were given the corresponding drugs by gavage once a day for 14 consecutive days.

[0070] The experimental groups and gavage protocols are shown in Table 1.

[0071] Table 1. Gavage regimens for each group of rats The rat model group was induced to develop a rat model of chest pain due to yang deficiency and cold stagnation by swimming in ice water and injecting posterior pituitary extract.

[0072] Except for the blank control group, rats in all other groups were administered oral gavage for 30 minutes daily, followed by swimming in 0℃ ice water for 5 minutes. After the last swimming session, rats were anesthetized with an intraperitoneal injection of 35 mg / kg sodium pentobarbital, fixed in a dorsal position on the operating table, and connected to a biosignal acquisition system to record electrocardiograms in lead II. Except for the blank control group, rats in all other groups were intraperitoneally injected with 20 U / kg posterior pituitary extract to establish the model, and changes in electrocardiograms in the leads were recorded over 30 minutes. ST segment elevation and J point elevation indicated successful model establishment. During the modeling process, 4, 0, 1, 1, 3, 3, 2, and 3 rats died in the model control group, experimental group 1, experimental group 2, experimental group 3, control group 1, control group 2, control group 3, and control group 4, respectively.

[0073] Twenty-four hours after the injection of posterior pituitary extract, rats in each group were anesthetized with sodium pentobarbital, and blood was collected from the common carotid artery. The collected blood was divided into three parts: two parts were anticoagulated and one part was not anticoagulated.

[0074] Measurement of serum CK, LDH and blood viscosity Non-anticoagulated blood was left to stand at room temperature for 2 hours. After coagulation, it was centrifuged at 3000 rpm for 10 minutes. Serum was collected, and serum CK and LDH levels were determined by colorimetric method. One sample of anticoagulated blood was centrifuged using the same method, and plasma viscosity (100s) was measured. -1 Another anticoagulation test showed low-shear whole blood viscosity (5s). -1 ).

[0075] 2. Statistical Methods Data processing was performed using GraphPad Prism 7.0 software, with the measurement data presented in... ±s indicates the mean. One-way ANOVA was used for comparisons between groups, and LSD-t test was used for pairwise comparisons between groups. P < 0.05 was considered statistically significant.

[0076] 3. Experimental Results 3.1 Effects on rat electrocardiograms Figure II Effect of changes in lead J point The elevation value of the J point in the model control group rats was significantly greater than that in the blank control group, and the difference was statistically significant.

[0077] The J-point elevation values ​​of rats in experimental groups 1, 2, and 3 were significantly lower than those in the model control group, with statistically significant differences. This suggests that the Tongyang Xuanbi Bufei formula of this invention has a significant therapeutic effect on myocardial injury in rats with cold-induced chest pain and can improve myocardial damage. The J-point elevation values ​​of rats in experimental groups 1, 2, and 3 were significantly lower than those in control groups 1-4, with statistically significant differences. (See results below.) Figure 1 .

[0078] 3.2 Effects on serum CK and LDH levels in rats Compared with the blank control group, the serum CK and LDH levels of rats in the model control group were significantly increased.

[0079] Compared with the model control group, the serum CK and LDH levels of rats in experimental groups 1, 2, and 3 were significantly reduced, suggesting that the Tongyang Xuanbi Bufei formula of this invention significantly alleviated the degree of myocardial damage in the model rats. Compared with control groups 1-4, experimental groups 1, 2, and 3 showed significant differences in reducing serum CK and LDH levels. Results are shown below. Figure 2 , Figure 3 .

[0080] 3.3 Effects on whole blood and plasma viscosity in rats Compared with the blank control group, the viscosity of whole blood and plasma of rats in the model control group was significantly increased.

[0081] Compared with the model control group, the whole blood and plasma viscosity of rats in experimental groups 1, 2, and 3 were significantly reduced, suggesting that the Tongyang Xuanbi Bufei formula of this invention significantly reduces blood viscosity, increases blood flow velocity, and improves myocardial blood supply in rats with cold-induced chest pain, thereby achieving a protective effect on the myocardium. Compared with control groups 1-4, experimental groups 1, 2, and 3 showed significant differences in reducing whole blood and plasma viscosity in rats. The results are shown in Table 2.

[0082] Table 2 Comparison of whole blood and plasma viscosity among groups ( ±s) Note: Different lowercase letters in the same column indicate significant differences between different groups (P < 0.05).

[0083] Changing the components of the formula in this invention will weaken the therapeutic effect of Tongyang Xuanbi Bufei Decoction on cold-induced chest pain. The ingredients in this invention exert a synergistic effect. The therapeutic effect of Tongyang Xuanbi Bufei Decoction on cold-induced chest pain is superior to that of Zhishi Xiebai Guizhi Decoction, Xuefu Zhuyu Decoction combined with Bufei Huangqi Decoction (reduced formula 1), and superior to Zhishi Xiebai Guizhi Decoction combined with Xuefu Zhuyu Decoction.

[0084] The above embodiments are not intended to limit the present invention in any way. For those skilled in the art, any modifications or substitutions made within the scope of the present invention based on its technical essence shall still fall within the protection scope of the present invention.

Claims

1. A formula for invigorating Yang, relieving pain, and tonifying the lungs, characterized in that: The formula for promoting Yang, relieving pain, and tonifying the lungs includes the following ingredients by weight: Allium macrostemon 6-12 parts, ginseng 4-8 parts, Astragalus membranaceus 12-18 parts, Trichosanthes kirilowii 10-15 parts, Paeonia lactiflora 6-12 parts, Ligusticum chuanxiong 10-15 parts, Platycodon grandiflorus 4-8 parts, Citrus aurantium 10-15 parts, Magnolia officinalis 6-12 parts, Rehmannia glutinosa 10-15 parts, Angelica sinensis 10-15 parts, Ophiopogon japonicus 12-18 parts, Schisandra chinensis 4-8 parts, Cinnamomum cassia 6-12 parts, and Glycyrrhiza uralensis (processed) 4-8 parts.

2. The formula for promoting Yang, relieving pain, and tonifying the lungs according to claim 1, characterized in that, The formula for promoting Yang, relieving pain, and tonifying the lungs is made from the following components by weight: Allium macrostemon 9 parts, ginseng 6 parts, Astragalus membranaceus 15 parts, Trichosanthes kirilowii 12 parts, Paeonia lactiflora 9 parts, Ligusticum chuanxiong 12 parts, Platycodon grandiflorus 6 parts, Citrus aurantium 12 parts, Magnolia officinalis 9 parts, Rehmannia glutinosa 12 parts, Angelica sinensis 12 parts, Ophiopogon japonicus 15 parts, Schisandra chinensis 6 parts, Cinnamomum cassia 9 parts, and Glycyrrhiza uralensis 6 parts.

3. The formula for promoting Yang, relieving pain, and tonifying the lungs according to claim 1, characterized in that, The formula for promoting Yang, relieving pain, and tonifying the lungs is made from the following ingredients by weight: 6 parts Allium macrostemon, 8 parts Ginseng, 12 parts Astragalus membranaceus, 10 parts Trichosanthes kirilowii, 12 parts Paeonia lactiflora, 15 parts Ligusticum chuanxiong, 4 parts Platycodon grandiflorus, 10 parts Citrus aurantium, 12 parts Magnolia officinalis, 10 parts Rehmannia glutinosa, 15 parts Angelica sinensis, 12 parts Ophiopogon japonicus, 4 parts Schisandra chinensis, 6 parts Cinnamomum cassia, and 4 parts Glycyrrhiza uralensis (processed).

4. The formula for promoting Yang, relieving pain, and tonifying the lungs according to claim 1, characterized in that, The formula for promoting Yang, relieving pain, and tonifying the lungs is made from the following ingredients by weight: 12 parts Allium macrostemon, 8 parts Ginseng, 18 parts Astragalus membranaceus, 15 parts Trichosanthes kirilowii, 6 parts Paeonia lactiflora, 10 parts Ligusticum chuanxiong, 8 parts Platycodon grandiflorus, 15 parts Citrus aurantium, 6 parts Magnolia officinalis, 15 parts Rehmannia glutinosa, 10 parts Angelica sinensis, 18 parts Ophiopogon japonicus, 8 parts Schisandra chinensis, 12 parts Cinnamomum cassia, and 8 parts Glycyrrhiza uralensis (processed).

5. The preparation method of the Tongyang Xuanbi Bufei formula according to any one of claims 1-4, characterized in that, The preparation method includes the following steps: weigh the raw materials according to the formula, mix them, add 8-10 times the amount of water and decoct twice, each time for 0.5-2 hours, combine the decoctions, filter, and concentrate to 2-4 times the amount to obtain the final product.

6. A traditional Chinese medicine preparation of a formula for promoting Yang, relieving pain, and tonifying the lungs, characterized in that, The traditional Chinese medicine preparation is made from the Tongyang Xuanbi Bufei formula as described in any one of claims 1-4.

7. The traditional Chinese medicine preparation of the Tongyang Xuanbi Bufei formula according to claim 6, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

8. The traditional Chinese medicine preparation of the Tongyang Xuanbi Bufei formula according to claim 6 or 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, granules, capsules, tablets, powders, pills, or oral liquids.

9. The use of the Tongyang Xuanbi Bufei formula according to any one of claims 1-4 in the preparation of drugs for the prevention or treatment of chest pain and heart pain.

10. The use of the Tongyang Xuanbi Bufei formula according to any one of claims 1-4 in the preparation of drugs for the prevention or treatment of coronary heart disease.

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