A traditional Chinese medicine composition for treating pathological hypotension and a preparation method thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating pathological hypotension and its preparation method, which is made from the following traditional Chinese medicinal materials in parts by weight: 6-9 parts of Cimicifuga rhizome, 6-9 parts of ginseng, 9-15 parts of Agrimonia pilosa, 9-15 parts of Polygonatum sibiricum, 6-12 parts of cinnamon, 6-12 parts of deer antler powder, 6-10 parts of dried tangerine peel, 6-12 parts of Atractylodes macrocephala, 6-12 parts of Angelica sinensis, 9-15 parts of Rehmannia glutinosa, 6-9 parts of Morinda officinalis, 6-9 parts of Rhodiola rosea, and 2-5 parts of processed Evodia rutaecarpa. This invention is based on the principle of "strengthening the body's resistance and regulating Qi". Combining the core pathogenesis of pathological hypotension, namely "deficiency of Yang Qi, insufficiency of Qi and blood, failure of clear Yang to rise and failure of turbid Yin to descend", Shengmai San invigorates Qi and generates fluids, astringes Yin and stops sweating. It has a strong and stable effect in raising blood pressure. To a certain extent, it solves the drawbacks of simply raising blood pressure, such as the superficial effect of the medicine and the easy rebound after stopping the medicine. It is particularly effective in improving the typical symptoms of pathological hypotension, such as severe fatigue, dizziness, aversion to cold and cold extremities.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically a traditional Chinese medicine composition for treating pathological hypotension and its preparation method. Background Technology

[0002] There is no universally accepted definition of hypotension, either domestically or internationally. The Chinese Academy of Medical Sciences uses the 10th percentile of the surveyed population as the cutoff value for defining hypotension, namely, systolic blood pressure (SBP) ≤ 98 mmHg and diastolic blood pressure (DBP) ≤ 60 mmHg. The National Heart Lung and Blood Institute in the United States defines it as systolic blood pressure (SBP) ≤ 90 mmHg or diastolic blood pressure (DBP) ≤ 60 mmHg. The 2013 edition of "Practical Internal Medicine (14th Edition)" states that hypotension is generally defined as systolic blood pressure (SBP) < 90 mmHg and diastolic blood pressure (DBP) < 50 mmHg in adults. Hypotension is classified into two categories based on the presence or absence of obvious symptoms: physiological hypotension and pathological hypotension. Physiological hypotension is characterized by persistently low blood pressure without any clinical manifestations (often occurring in athletes or young women) and usually does not require treatment. Pathological hypotension is accompanied by symptoms related to hypotension, such as dizziness, fatigue, blurred vision, and syncope.

[0003] Currently, there is relatively little research on traditional Chinese medicine (TCM) compositions for treating pathological hypotension. Most studies focus only on exploring risk factors for hypertension or hypotension. Chinese invention patent CN 106421348A discloses a TCM formula for regulating pathological hypotension, in which the following components by weight percentage are: 10-15% cinnamon, 10-15% cassia twig, 10-15% codonopsis, 10-15% polygonum multiflorum, 10-15% ophiopogon japonicus, 8-10% jujube, 6-8% schisandra chinensis, 6-8% licorice root, 6-8% astragalus membranaceus, and 6-8% angelica sinensis; the sum of all components is 100%. This formula primarily focuses on warming and unblocking the meridians (cinnamon and cassia twig), tonifying qi and nourishing blood (codonopsis, astragalus, angelica sinensis, jujube, and licorice root), and nourishing yin and calming the mind (ophiopogon japonicus, schisandra chinensis, and polygonum multiflorum). Its approach emphasizes "warming and unblocking" and "nourishing the heart," and may have some effect on hypotension accompanied by palpitations and insomnia. However, the formula primarily focuses on tonifying and warming the body, lacking a core herb like Cimicifuga rhizome to specifically boost Yang energy and lift the head and eyes. Therefore, it is not particularly effective in addressing the key pathogenesis of "diarrhea caused by the downward flow of clear Qi," which leads to typical symptoms of low blood pressure such as dizziness and fatigue. Furthermore, its kidney-tonifying effect is weak, and kidney deficiency is a common cause of pathological low blood pressure; this formula falls short in this aspect.

[0004] Chinese invention patent CN108310360A discloses a drug for treating hypotension and its preparation method. It is mainly composed of ginseng, cinnamon twig, ophiopogon japonicus, schisandra chinensis, poria cocos, psoralea corylifolia, wolfberry, polygonatum sibiricum, astragalus membranaceus, tangerine peel, morinda officinalis, dried ginger, chuanxiong rhizome, angelica sinensis, longan pulp, safflower, atractylodes macrocephala, kudzu root, bupleurum chinense, cimicifuga foetida, jujube seed, placenta hominis, cornus officinalis, licorice root, and deer antler glue, prepared in a specific weight ratio. This formula uses 28 medicinal materials, aiming to treat hypotension by greatly replenishing vital energy, tonifying the liver and kidneys, and nourishing qi and blood. However, the formula is overly complex: the large prescription of 28 herbs lacks clear understanding of the principal, assistant, and adjuvant relationships, and the excessive number of herbs may lead to a dispersion of their effects, increasing the potential risk of allergies or adverse reactions in patients. The formula includes herbs such as pinellia ternata, ephedra, and safflower. Pinellia tends to dry dampness and resolve phlegm, ephedra focuses on inducing sweating and relieving exterior symptoms, and safflower is effective in promoting blood circulation and removing blood stasis. For hypotension syndrome with deficiency as the core, these drugs may even deplete qi and blood (such as ephedra inducing sweating).

[0005] Chinese invention patent CN104587432A discloses a traditional Chinese medicine composition for treating primary hypotension. This composition is made from the following raw materials: deer antler glue, yellow gelatin, Eclipta prostrata, mulberry, cinnamon, jujube seed, Polygonum multiflorum vine, kudzu root, Acanthopanax senticosus, Rhodiola rosea, and ginger. This formula follows the principle of "nourishing yin and replenishing blood, invigorating qi and strengthening the spleen." Deer antler glue and yellow gelatin are used to greatly replenish yin and blood, while Acanthopanax senticosus and Rhodiola rosea strengthen the spleen and invigorate qi. Its core lies in "tonification," focusing on filling the deficiency of the material basis. However, it is insufficiently targeted at the key pathogenesis of "failure of clear yang to ascend," which leads to symptoms such as dizziness and fatigue in hypotension. The large-scale use of gelatinous materials such as deer antler glue and yellow gelatin, although powerfully tonifying, is sticky and may hinder the spleen and stomach's digestive function. For hypotension patients with weak spleen and stomach and impaired digestive function, long-term use may worsen abdominal distension, loss of appetite, and other symptoms of "inability to tolerate tonification." The formula contains a large proportion of two sedative herbs, jujube seed and fleeceflower stem. For patients without severe insomnia, this portion of the efficacy may be redundant.

[0006] Based on the deficiencies in the existing technology, the present invention aims to provide a traditional Chinese medicine composition for treating pathological hypotension. Summary of the Invention

[0007] (a) Technical problems to be solved

[0008] In order to address the problems existing in the prior art, the inventors intend to propose a traditional Chinese medicine composition for treating pathological hypotension, so as to give full play to the role of traditional Chinese medicine in regulating blood pressure, especially in raising blood pressure, and make up for the shortcomings of existing traditional Chinese medicine compositions. At the same time, the preparation method is disclosed.

[0009] (II) Technical Solution

[0010] The technical solution adopted in this invention is as follows:

[0011] A traditional Chinese medicine composition for treating pathological hypotension is made from the following medicinal materials in parts by weight: 6-9 parts of Cimicifuga rhizome, 6-9 parts of ginseng, 9-15 parts of Agrimonia pilosa, 9-15 parts of Polygonatum sibiricum, 6-12 parts of cinnamon, 6-12 parts of deer antler powder, 6-10 parts of dried tangerine peel, 6-12 parts of Atractylodes macrocephala, 6-12 parts of Angelica sinensis, 9-15 parts of Rehmannia glutinosa, 6-9 parts of Morinda officinalis, 6-9 parts of Rhodiola rosea, and 2-5 parts of processed Evodia rutaecarpa.

[0012] Made from the following Chinese medicinal herbs in parts by weight: 8 parts Cimicifuga rhizome, 6 parts ginseng, 10 parts Agrimonia pilosa, 10 parts Polygonatum sibiricum, 8 parts cinnamon, 8 parts deer antler powder, 6 parts dried tangerine peel, 12 parts Atractylodes macrocephala, 8 parts Angelica sinensis, 10 parts Rehmannia glutinosa (processed), 7 parts Morinda officinalis, 7 parts Rhodiola rosea, and 4 parts processed Evodia rutaecarpa; or...

[0013] Cimicifuga rhizome 9 parts, ginseng 7 parts, agrimony 15 parts, polygonatum rhizome 15 parts, cinnamon 12 parts, deer antler powder 12 parts, dried tangerine peel 4 parts, atractylodes rhizome 8 parts, angelica root 12 parts, prepared rehmannia root 15 parts, morinda root 9 parts, rhodiola rosea root 9 parts, and prepared evodia fruit 5 parts; or

[0014] 6 parts Cimicifuga rhizome, 9 parts ginseng, 9 parts Agrimonia pilosa, 9 parts Polygonatum sibiricum, 6 parts cinnamon, 7 parts deer antler powder, 10 parts dried tangerine peel, 6 parts Atractylodes macrocephala, 6 parts Angelica sinensis, 9 parts Rehmannia glutinosa, 6 parts Morinda officinalis, 8 parts Rhodiola rosea, and 2 parts processed Evodia rutaecarpa; or

[0015] 7 parts of Cimicifuga rhizome, 8 parts of ginseng, 12 parts of Agrimonia pilosa, 12 parts of Polygonatum sibiricum, 9 parts of cinnamon, 6 parts of deer antler powder, 7 parts of dried tangerine peel, 8 parts of Atractylodes macrocephala, 10 parts of Angelica sinensis, 9 parts of Rehmannia glutinosa, 9 parts of Morinda officinalis, 9 parts of Rhodiola rosea, and 5 parts of processed Evodia rutaecarpa.

[0016] The prepared Evodia rutaecarpa is made by processing Evodia rutaecarpa and licorice juice. The steps are as follows: place the mixed Evodia rutaecarpa in a sealed container and let it soak at room temperature for 2 to 4 hours; take licorice at 10 to 15% of the mass fraction of Evodia rutaecarpa, add water at 8 to 10 times the weight of licorice and decoct, filter to obtain licorice juice; add the soaked Evodia rutaecarpa to the licorice juice, and use a temperature-controlled stir-frying machine to stir-fry at 100℃ to 140℃ until the color of the medicinal material on the surface of Evodia rutaecarpa deepens to brown or dark brown.

[0017] The frying process is divided into two stages. First, under conditions of -0.02 to -0.05 MPa, the temperature is controlled at 100℃ to 110℃ and frying is carried out for 10 to 15 minutes. Then, the pressure is restored to normal and the temperature is raised to 130℃ to 140℃ and frying is carried out for 15 to 20 minutes.

[0018] A method for preparing a traditional Chinese medicine composition for treating pathological hypotension, wherein the traditional Chinese medicine composition is a decoction, and the preparation method includes the following steps:

[0019] S1. Crush the deer antler powder, put all the medicinal materials except cinnamon into a decoction pot, add water, the water level should be 3-5 cm above the surface of the medicinal materials, cover and soak for 30-45 minutes;

[0020] S2. First, bring the soaked herbs to a boil over high heat. After boiling, reduce to a simmer and add the prepared cinnamon. Cover the pot and continue to simmer over low heat for 40-50 minutes. After simmering, filter out the liquid. This is the first decoction.

[0021] S3. Add water to the filtered dregs again, the water level should be 2-3 cm above the surface of the herbs. First bring to a boil over high heat, then simmer over low heat for 30-40 minutes. Filter out the liquid, this is the second decoction.

[0022] S4. Thoroughly mix the first and second decoctions to obtain the prepared decoction.

[0023] A method for preparing a traditional Chinese medicine composition for treating pathological hypotension, wherein the traditional Chinese medicine composition is in granule form, and the preparation method includes the following steps:

[0024] T1. Weigh all the medicinal materials according to the proportions, crush the deer antler powder and set aside, and break the cinnamon into small pieces and set aside;

[0025] T2. Place the cinnamon pieces into a volatile oil extractor, add water to cover the cinnamon by 3-5 cm, heat under reflux for 1-2 hours until no more oil droplets are precipitated, collect the cinnamon volatile oil, seal and refrigerate for later use, and retain the cinnamon residue and cinnamon liquid after distillation.

[0026] T3. Put all the herbs except the cinnamon decoction into the decoction machine. The herbs include the crushed deer antler powder and the distilled cinnamon residue. Add water with a total weight of 8-10 times the herbs. Bring to a boil over high heat, then reduce to low heat and continue to decoct for 1.5 hours. After decoction, squeeze out the residue and filter out the decoction.

[0027] T4. Add 6-8 times the amount of water to the dregs in T3 and decoct for a second time for 1 hour. Filter out the liquid and combine it with the cinnamon liquid obtained in step T2 and the liquid obtained in step T3 to obtain a combined liquid.

[0028] T5. Filter the combined liquid obtained in step T4 through a 100-mesh sieve to remove fine medicinal residues. Concentrate the filtrate, controlling the temperature to ≤65℃, until it becomes a thick paste with a relative density of 1.10-1.15. The paste should not spread rapidly when dipped onto filter paper.

[0029] T6. Mix the thick paste, dextrin, and starch in a mass ratio of 1:1:1 to form a soft material that can be formed into a ball when squeezed in the hand but crumbles when lightly pressed.

[0030] T7. Granulate and dry the soft material to obtain dry granules;

[0031] T8. Dissolve the cinnamon volatile oil from step T2 completely with 95% ethanol, spray the cinnamon volatile oil ethanol solution evenly onto the dry granules, and after the ethanol evaporates and the mixture is dried, package it into granules.

[0032] For details of the pretreatment and processing methods of various medicinal materials in this invention, please refer to the Chinese Pharmacopoeia 2020 Edition.

[0033] The following medicinal materials require pre-treatment or pre-processing:

[0034] Prepared Evodia rutaecarpa: The prepared Evodia rutaecarpa is made by processing Evodia rutaecarpa and licorice juice. The steps are as follows: Place the mixed Evodia rutaecarpa in a sealed container and let it soak at room temperature (20-25℃) for 2-4 hours; take licorice at 10-15% of the mass fraction of Evodia rutaecarpa, add water at 8-10 times the weight of licorice and decoct, filter to obtain licorice juice; add the soaked Evodia rutaecarpa to the licorice juice, and use a temperature-controlled stir-frying machine to stir-fry at 100℃-140℃ until the color of the Evodia rutaecarpa on the surface of the medicinal material deepens to brown or dark brown, and a unique roasted aroma can be smelled, without a noticeable pungent and spicy smell.

[0035] Furthermore, the stir-frying process is divided into two stages: a low-temperature volatilization stage, where the temperature is controlled at 100℃~110℃ under a slight negative pressure of -0.02~-0.05MPa for 10-15 minutes, which efficiently and selectively removes most of the pungent and irritating low-boiling-point volatile oils while avoiding the destruction of active ingredients by high temperatures; and a high-temperature conversion stage, where the pressure is restored to normal and the temperature is raised to 130℃~140℃ for 15-20 minutes. During this stage, components such as glycyrrhizic acid that have penetrated deep into the medicinal material undergo complex chemical transformations such as Maillard reactions and compound reactions with alkaloids and bitter substances in Evodia rutaecarpa at high temperatures, generating new synergistic components, changing the color of the medicinal material to brownish-red, and producing a unique roasted aroma.

[0036] Processing with licorice juice can effectively reduce the irritation of the volatile oil components in Evodia rutaecarpa, alleviating its adverse reactions on the digestive tract; at the same time, it can moderate its drying properties, preventing excessive pungent and dispersing effects from damaging the body's vital energy. In addition, processing enhances the liver-soothing, stomach-harmonizing, and anti-nausea effects of Evodia rutaecarpa, and makes the active ingredients easier to extract, improving the bioavailability of the drug and making it suitable for treating different syndromes such as liver and stomach deficiency-cold and upward flow of turbid yin.

[0037] (III) Beneficial Effects

[0038] The beneficial effects of this invention are as follows:

[0039] 1. The boosting effect is steady and lasting: Based on the principle of "strengthening the healthy qi as the root and regulating qi as the key", and in combination with the core pathogenesis of pathological hypotension, namely "deficiency of yang qi, insufficiency of qi and blood, failure of clear yang to rise, and failure of turbid yin to descend", Shengmai San replenishes qi and generates fluid, arrests sweating with astringents. The core treatment principle of this plan can be summarized as: "Vigorously lift, with warming and tonifying as the foundation, assisted by nourishing and filling, and concurrently regulating the liver and spleen". This formula not only realizes the conventional effect of "tonifying qi and lifting" through ginseng and cimicifuga, but also introduces cornus cervi degelatinata to warm and dredge the Governor Vessel, solving the fundamental problem of yang qi decline at the extraordinary meridian level, making the blood pressure rise powerfully and firmly, and to a certain extent solving the drawbacks of possible floating of the drug effect and easy rebound after stopping the drug caused by simple lifting;

[0040] 2. Significantly improve typical symptoms: It is particularly obvious in improving typical symptoms of pathological hypotension such as severe fatigue, dizziness, fear of cold, cold limbs, etc. Among them, the strong tonifying deficiency of agrimonia pilosa (tuolicao) combined with the qi-tonifying and blood-activating effect of rhodiola rosea can quickly relieve the sense of fatigue and improve the activity endurance and quality of life of patients;

[0041] 3. Build a "steady-state regulation" mechanism: This formula does not simply "boost blood pressure". Through reasonable compatibility, it dynamically regulates the ascending and descending of qi in the human body, guides qi, blood, yin, and yang back to balance, thereby establishing an internal steady state of self-regulation of the body and realizing the transformation from "treating diseases" to "regulating people";

[0042] 4. Ministerial drug combination (cinnamon / cornus cervi degelatinata): Forms a three-dimensional warming yang network of "igniting (warming the Gate of Vitality) and penetrating (dredging the Governor Vessel)", enabling the generation of yang qi to have a root and the distribution to have a path, solving the treatment bottleneck of yang-deficiency type hypotension;

[0043] 5. The compatibility of agrimonia pilosa and ginseng forms "combination of tonifying and consolidating", strongly tonifying deficiency while consolidating primordial qi and preventing qi dispersion. After specific processing, evodia rutaecarpa becomes warm and descending turbid, not only assisting cinnamon to warm the middle jiao, but also creating space for the rise of clear yang by descending turbid yin, realizing the treatment method of "assisting rise by descending". Detailed implementation mode

[0044] For better explanation of the present invention and for easy understanding, the present invention is described in detail through specific implementation modes.

[0045] The present invention provides a traditional Chinese medicine composition for treating pathological hypotension, which is made from Chinese medicinal materials composed of the following parts by weight: cimicifuga 3 - 9 parts, ginseng 3 - 9 parts, agrimonia pilosa 9 - 15 parts, polygonatum sibiricum 9 - 15 parts, cinnamon 6 - 12 parts, cornus cervi degelatinata 6 - 12 parts, tangerine peel 6 parts, atractylodes macrocephala 6 - 12 parts, angelica sinensis 6 - 12 parts, rehmannia glutinosa 9 - 15 parts, morinda officinalis 3 - 9 parts, rhodiola rosea 3 - 9 parts, processed evodia rutaecarpa 2 - 5 parts.

[0046] The formula explanation of the present invention is as follows:

[0047] King drugs: cimicifuga, ginseng;

[0048] The following are the ingredients: Polygonatum sibiricum, cinnamon, deer antler powder, and dried tangerine peel;

[0049] Adjuvant herbs: Agrimonia pilosa, Atractylodes macrocephala, Angelica sinensis, Rehmannia glutinosa;

[0050] Used herbs: Morinda officinalis, Rhodiola rosea, and processed Evodia rutaecarpa.

[0051] The formula of this invention refers to the core ideas of Zhang Yuansu's "Medical Origins" from the Jin-Yuan period, namely "nourishing the body's resistance to eliminate stagnation" and "the laws governing the types of medicines". It takes "strengthening the body's resistance as the foundation and regulating qi as the key" as the basis. Combined with the core pathogenesis of pathological hypotension, namely "deficiency of yang qi, insufficiency of qi and blood, failure of clear yang to rise and failure of turbid yin to descend", Shengmai San invigorates qi and generates fluids, astringes yin and stops sweating.

[0052] The core principles of this treatment plan can be summarized as: "vigorously lifting and tonifying as the foundation, supplemented with nourishing and replenishing, while also regulating the liver and spleen."

[0053] The principal herbs are Cimicifuga and Ginseng. Cimicifuga is light and dispersing, and its core mission is to "lift the clear yang," like a powerful "lifting machine" that draws the clear yang qi upward, invigorates the spleen and lung yang qi to lift the sunken qi, directly addressing the root cause of "sinking clear yang and insufficient upper qi." It directly transports the qi and blood energy of the middle and lower jiao to the head and face, providing a direct solution for symptoms of low blood pressure such as dizziness and fatigue. Ginseng greatly replenishes the original qi, strengthens the spleen and lungs, generates fluids and calms the mind, directly addressing the pathogenesis of "insufficient original qi." The combination of tonifying and lifting embodies the idea of ​​"using lifting as the function and tonifying as the foundation," directly targeting the core pathogenesis of "qi deficiency and sinking, and failure of clear yang to rise," working together to achieve the effect of "tonifying qi and raising yang, lifting the sunken qi and consolidating the body." This is the core herb pair of this formula.

[0054] The assistant herbs are Polygonatum sibiricum, cinnamon, deer antler powder, and tangerine peel. They provide two major supports for "lifting" the body: "warming yang" and "regulating qi," ensuring that the lifting is powerful and unobstructed. Among them, Polygonatum sibiricum replenishes qi and nourishes yin, replenishes essence and marrow, and assists ginseng in replenishing qi to nourish acquired constitution. As an assistant herb, it first assists ginseng in enhancing its tonifying power, and secondly, with its nourishing and moistening nature, it balances the warming and drying tendencies of the principal herb and other herbs, preventing damage to yin and providing the yin and blood material basis for lifting. Cinnamon sibiricum tonifies fire and assists yang, guiding fire back to its source. As an assistant herb, its core function is to warm the fire of the lower jiao (lower burner) and the gate of life, so that the original qi replenished by ginseng can be warmed and activated, and blood circulation can be stimulated. Deer antler powder warms the kidneys and assists yang, and regulates the extraordinary meridians. This herb is warm and unobstructed, and it is good at entering the Du meridian. It can enhance the warming yang effect of cinnamon and guide the medicinal power to a deeper meridian system to treat chronic and serious illnesses. Dried tangerine peel, with its functions of regulating qi, strengthening the spleen, drying dampness, and harmonizing the middle jiao, plays the role of a "regulator" in the formula. Its pungent, dispersing, and bitter properties can regulate the qi mechanism of the middle jiao, preventing the cloying and nourishing herbs such as polygonatum and rehmannia from hindering the stomach, thus ensuring that the entire formula is nourishing yet receptive, ascending yet dispersing. The assistant herbs, from the four dimensions of "nourishing yin, warming yang, unblocking collaterals, and regulating qi," fully support the "ascending" and "qi-tonifying" functions of the principal herbs, allowing the principal herbs to exert their full power.

[0055] The adjuvant herbs are Agrimonia pilosa, Atractylodes macrocephala, Angelica sinensis, and Rehmannia glutinosa. Atractylodes macrocephala invigorates the spleen and replenishes qi, dries dampness and promotes diuresis. "The spleen is the source of qi and blood production," so it strengthens the middle jiao to nourish qi and blood, assisting ginseng and tangerine peel in strengthening the "acquired foundation," ensuring a source for qi and blood production, and extending and consolidating the qi-tonifying power. Angelica sinensis tonifies and invigorates blood, preventing stagnation; Rehmannia glutinosa nourishes the kidneys and replenishes essence, greatly replenishing true yin. "The kidneys store primordial yang," so replenishing essence consolidates yang qi. Angelica sinensis and Rehmannia glutinosa form a powerful "blood-nourishing and yin-tonifying" team, providing ample material (yin and blood) for the ascending of the principal herbs and the warming of yang by the assistant herbs, embodying the idea that "yang, aided by yin, generates endless qi." Agrimonia pilosa: astringent and tonifying, strengthens the heart, known in folk medicine as "the herb of exhaustion." Its astringent nature assists ginseng in consolidating primordial qi, and its cardiotonic effect directly improves cardiac function, targeting the weakness inherent in low blood pressure. The role of the adjuvant medicine group is to consolidate the rear, strengthen the foundation, and handle concurrent symptoms, ensuring that the main force of the monarch and ministers has no worries about the rear.

[0056] The main herbs are Morinda officinalis, Rhodiola rosea, and processed Evodia rutaecarpa. Morinda officinalis tonifies kidney yang, strengthens tendons and bones, warms the kidneys and assists yang to raise clear yang; Rhodiola rosea invigorates qi and blood, unblocks the meridians and relieves asthma, assists Cimicifuga foetida in raising yang and unblocking the heart meridian; processed Evodia rutaecarpa warms the middle jiao and dispels cold, assists yang and stops diarrhea, warms the spleen and stomach to transform cold turbidity in the middle jiao. The combination of these herbs helps the principal and assistant herbs to "tonify without stagnation, warm without dryness".

[0057] In this formula, the selection of deer antler powder is not merely for its simple "warming yang" effect; it also plays a strategic role in "unblocking and tonifying the extraordinary meridians, penetrating deep into the affected area." Its nature is warm but not harsh, its taste salty and enters the blood, with its core function being to warm and unblock the Du meridian. The Du meridian governs all the yang qi in the body and is the "main channel" for the circulation of yang qi. Pathological hypotension is a chronic condition, belonging to the category of "prolonged illness." According to the theories of "prolonged illness entering the collaterals" and "prolonged illness affecting the extraordinary meridians," its root cause lies not only in the deficiency of qi in the internal organs but also in the deficiency and obstruction of the eight extraordinary meridians (especially the Du meridian). This combination of "unblocking" and "tonifying" allows its effect to transcend the simple internal organs (such as the kidneys) and reach the deeper meridian system, which is something that conventional warming yang herbs (such as cinnamon and aconite) do not possess. Deer antler powder, together with the principal herbs Cimicifuga and ginseng, achieves a synergistic effect of "tonifying with a foundation and ascending with a pathway." Deer antler powder and cinnamon, the assistant herb, form a golden duo of "warming yang," with clear division of labor and distinct layers. Cinnamon is warm and protective, focusing on warming and invigorating the fire of the Mingmen (Gate of Life), with its core effect on the "point" (Mingmen). Deer antler powder is warm and unblocking, focusing on unblocking the yang qi of the Du meridian, with its core effect on the "line" (Du meridian). The combination of the two creates a synergistic effect of "ignition (cinnamon) and unblocking (deer antler powder)," enabling the warming yang power not only to originate in the lower jiao (lower burner) but also to be efficiently distributed throughout the body, significantly enhancing the stability and persistence of the blood pressure increase. This "point-line combination" warming yang model is one of the core creative innovations of this formula.

[0058] In this formula, Agrimonia pilosa is given the role of "powerful strengthening and astringent consolidation," exerting its significant effects in strengthening the body, invigorating the heart, and combating fatigue. This has targeted therapeutic significance for correcting the core symptoms of pathological hypotension—severe and intractable weakness, and a tendency to faint. Simultaneously, the astringent nature of Agrimonia pilosa in this formula has the effect of "consolidating vital energy and preventing its dissipation." The essence of hypotension is that qi, yang, and blood cannot be consolidated within the blood vessels. Agrimonia pilosa, used in conjunction with tonifying herbs, helps to consolidate the vital energy replenished into the body, preventing it from floating away or dissipating, thus making the tonifying effect more lasting and efficient. This is the treatment method of "consolidation within tonification, and a combination of dispersion and consolidation." At the same time, Agrimonia pilosa can assist the principal herb, ginseng, in consolidating its replenished vital energy, forming a synergistic effect of "ginseng powerfully tonifying qi, and Agrimonia pilosa powerfully consolidating qi," achieving a "one plus one is greater than two" effect in stabilizing blood pressure. Warming herbs (such as cinnamon and deer antler powder) are mostly pungent and dispersing, posing a potential risk of depleting vital energy. Agrimony's astringent properties perfectly complement these herbs. By "absorbing" to control "dispersing," it ensures that the warming energy acts steadily within the body, rather than dissipating outwards, thus enhancing the therapeutic stability and safety of the formula. Agrimony's astringent and hemostatic effects, combined with the blood-nourishing properties of Rehmannia glutinosa and Angelica sinensis, align with the principle of "nourishing yin and blood," indirectly promoting the generation and consolidation of yin blood, providing a more sufficient material basis for yang energy.

[0059] The entire formula closely adheres to the core pathogenesis of physiological hypotension, namely "deficiency of Yang Qi, insufficiency of Qi and blood, failure of clear Yang to rise, and failure of turbid Yin to descend." It takes "lifting" as the vanguard, "warming and tonifying" as the central force, and "nourishing and replenishing" as the logistics. By simultaneously strengthening the spleen, nourishing blood, and nourishing Yin, it constructs a comprehensive treatment system that combines offense and defense.

[0060] The above components play the following roles in the traditional Chinese medicine composition of this invention:

[0061] Cimicifuga rhizome: The *Shennong Bencao Jing* records that it is "sweet and pungent in taste, primarily detoxifies all poisons, kills all evil spirits, wards off epidemics, miasma, and poisons, and prolonged use prevents premature death." The *Yaoxing Fu* states that "Cimicifuga rhizome raises yang below the extreme yin, guiding sweet and warm herbs upwards to replenish the dispersed defensive qi and strengthen the exterior; it also detoxifies all poisons, kills all evil spirits, and wards off epidemics, miasma, and poisons." This herb is pungent and sweet in taste, slightly cold in nature; it enters the lung, spleen, stomach, and large intestine meridians; it has the effects of releasing exterior pathogens and promoting rash eruption, clearing heat and detoxifying, and raising yang qi. Modern pharmacological studies have found that Cimicifuga rhizome can enhance vascular tension, improve hypotension caused by vasomotor imbalance, and reduce the damage to vascular elasticity caused by chronic inflammation, indirectly maintaining stable blood pressure.

[0062] Ginseng: The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) states that it is "sweet and slightly cold in nature. It primarily nourishes the five internal organs, calms the spirit, stabilizes the soul, stops palpitations, eliminates evil influences, brightens the eyes, and improves intelligence." The *Yaoxing Fu* (Treatise on the Properties of Medicinal Herbs) says that "ginseng is most incompatible with Veratrum nigrum and is also incompatible with Trogopterus xanthipes. Its uses are threefold: greatly replenishing vital energy to consolidate the body's foundation, calming the mind and improving intelligence to stop palpitations, and generating fluids to quench thirst and treat diabetes." This herb is sweet and slightly bitter, and slightly warm in nature; it enters the spleen, lung, heart, and kidney meridians; it has the effects of greatly replenishing vital energy, restoring the pulse and consolidating the body's foundation, tonifying the spleen and lungs, generating fluids, and calming the mind. Modern pharmacological studies have found that ginseng can regulate vascular endothelial function, enhance vascular tone, and improve hypotension.

[0063] Agrimony: Also known as "exhaustion herb" in folk terms, it refers to the dried aerial parts of Agrimony, a plant in the Rosaceae family. It is harvested in summer and autumn when the stems and leaves are lush, impurities are removed, and it is then dried. It has a bitter and astringent taste, is neutral in nature, and enters the heart and liver meridians. It has astringent and hemostatic properties, treats malaria, stops dysentery, detoxifies, and tonifies deficiency. It has a very good strengthening effect on extreme fatigue and insufficient heart strength, and can assist ginseng in tonifying deficiency.

[0064] Polygonatum: The Shennong's Classic of Materia Medica states that it is "sweet and neutral in nature. It mainly tonifies the middle energizer and replenishes qi, dispels wind and dampness, and soothes the five internal organs." The Yaoxing Fu says that it "tonifies the middle energizer and replenishes qi, moistens the heart and lungs, and strengthens tendons and bones." This herb is sweet and neutral in nature; it enters the spleen, lung, and kidney meridians; it has the effects of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. Modern pharmacological studies have found that the polysaccharides, steroidal saponins, and flavonoids contained in Polygonatum can regulate immunity, reduce the damage of chronic inflammation to vascular endothelium, and improve microcirculation perfusion by promoting the proliferation and migration of vascular endothelial cells.

[0065] Cinnamon: The dried bark and branch bark of the cinnamon tree (Cinnamomum cassia), a plant in the Lauraceae family. The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) states that it is "pungent and warm in nature, treats a hundred diseases, nourishes the spirit, improves complexion, benefits joints, and replenishes the middle energizer and boosts qi. It is the first to act as a guide for other medicines, and long-term use leads to spiritual enlightenment, lightness of body, and longevity. It gives the face a radiant glow, and the eyebrows remain youthful." It is pungent and sweet in taste, extremely hot in nature, and enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians.

[0066] Deer antler powder: The bone residue remaining after boiling the antlers of sika deer or red deer to make deer antler glue. It tastes salty and astringent, is warm in nature, and enters the liver and kidney meridians. It warms the kidneys and invigorates yang, and has astringent and hemostatic properties.

[0067] Dried tangerine peel: The dried, mature peel of the citrus fruit and its cultivated varieties, belonging to the Rutaceae family. It has a bitter and pungent taste, is warm in nature, and enters the lung and spleen meridians. It regulates qi, strengthens the spleen, dries dampness, and resolves phlegm.

[0068] Atractylodes macrocephala: The Shennong's Classic of Materia Medica states that it is "bitter and warm in nature. It is used to treat wind-cold-dampness arthralgia, dead muscle, spasms, jaundice, and when decocted and taken for a long time, it can lighten the body, prolong life, and relieve hunger." The Pharmacopoeia states that "Atractylodes macrocephala is sweet and warm in nature, strengthens the spleen and stomach, stops diarrhea and eliminates dampness, and also removes phlegm and lumps." This herb is sweet and bitter in taste and warm in nature; it enters the spleen and stomach meridians; it has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus; modern pharmacological studies have found that the polysaccharides, volatile oils, and flavonoids contained in Atractylodes macrocephala can regulate hypotension caused by reduced cardiac output; and it can also protect the vascular endothelium through anti-inflammatory and antioxidant effects, improving the decreased vascular elasticity and vasomotor dysfunction caused by chronic inflammation.

[0069] Angelica sinensis: The *Shennong Bencao Jing* records that it is "sweet and warm in nature. It treats cough, shortness of breath, malaria, chills and fever, and can be washed on the skin. It also treats leukorrhea in women, infertility, various malignant sores, and metal wounds; it can be boiled and drunk." The *Yaoxing Fu* states that it is "pungent and warm, nourishes and invigorates blood, regulates menstruation, relieves pain, and moistens the intestines to relieve constipation." This herb is sweet and pungent in taste, and warm in nature; it enters the liver, heart, and spleen meridians; it has the effects of nourishing and invigorating blood, regulating menstruation, relieving pain, and moistening the intestines to relieve constipation. Modern pharmacological studies have found that the polysaccharides, ferulic acid, ligustilide, and amino acids contained in Angelica sinensis can increase blood volume by promoting hematopoiesis; and can also improve low blood pressure caused by vasomotor imbalance or microcirculatory disorders by dilating blood vessels and enhancing vascular tension.

[0070] Rehmannia glutinosa (Shu Di): The original text of *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) states that raw Rehmannia glutinosa is "sweet and cold in nature. It treats fractures, sprains, internal injuries, expels blood stasis, replenishes bone marrow, and promotes muscle growth… the raw form is especially good." Rehmannia glutinosa is prepared by steaming and processing raw Rehmannia glutinosa. *Bencao Gangmu* (Compendium of Materia Medica) explains that it "replenishes bone marrow, promotes muscle growth, generates essence and blood, and replenishes deficiencies in the five internal organs." Although *Yaoxing Fu* (Treatise on the Properties of Medicinal Herbs) does not explicitly mention Rehmannia glutinosa, its effect of "nourishing kidney water and replenishing true yin" is consistent with its core function. This herb is sweet and slightly warm in nature; it enters the liver and kidney meridians; it has the effects of nourishing blood and yin, replenishing essence and marrow. Modern pharmacological studies have found that Rehmannia glutinosa contains polysaccharides, catalpol, amino acids, and trace elements, which can increase blood volume by promoting hematopoiesis; and can also enhance vascular tone by regulating vascular endothelial function, thus improving hypotension caused by vasomotor imbalance or chronic inflammation.

[0071] Morinda officinalis: The *Shennong Bencao Jing* records that it is "pungent and slightly warm in nature. It treats severe wind-evil, impotence, strengthens tendons and bones, calms the five internal organs, tonifies the middle jiao, and enhances willpower and qi." Although the *Yaoxing Fu* does not explicitly state its name, its effects of "warming kidney yang, strengthening tendons and bones, and dispelling wind-dampness" align with the earlier description of Morinda officinalis as "tonifying primordial yang and dispelling wind-dampness." This herb is sweet and pungent in taste, and slightly warm in nature; it enters the kidney and liver meridians; it has the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind-dampness. Modern pharmacological studies have found that Morinda officinalis contains polysaccharides, methyl sucrose, flavonoids, and iridoid glycosides, which can promote the rise and circulation of qi and blood, and protect vascular endothelial function through anti-inflammatory and antioxidant effects, reducing the damage to vascular elasticity caused by chronic inflammation.

[0072] Rhodiola rosea: While not explicitly recorded in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), its medicinal history can be traced back to the Tibetan medical classic *Sitan* (Four Tantras), which refers to it as "Soromabu," describing it as "light, sharp, and warm in nature, good at moistening the lungs, tonifying the kidneys, regulating qi, and nourishing blood." Later Tibetan medical literature, *Jingzhu Bencao* (Crystal Pearl Materia Medica), also records that it "treats various deficiencies and injuries, lung diseases, and pulse disorders." Although *Yaoxing Fu* (Treatise on the Properties of Medicinal Herbs) does not explicitly state its name, its effects of "invigorating qi and blood, clearing the meridians and relieving asthma" align with ancient physicians' experience summarizing the "cold resistance and hypoxia resistance" of high-altitude medicinal herbs. This herb is sweet and bitter in taste, and neutral in nature; it enters the lung and heart meridians; it has the effects of invigorating qi and blood, clearing the meridians and relieving asthma. Modern pharmacological studies have found that Rhodiola rosea contains rhodioloside, tyrosol, flavonoids, and polysaccharides, which can both enhance myocardial contractility and dilate blood vessels, improving hypotension caused by insufficient microcirculation perfusion.

[0073] Evodia rutaecarpa: The *Shennong Bencao Jing* records that it is "pungent and warm in nature. It mainly warms the middle and lower qi, relieves pain, cough, chills and fever, eliminates dampness and blood stasis, expels wind evil, and opens the pores." The *Yaoxing Fu* states that "Evodia rutaecarpa treats cold qi in the heart and abdomen, and also eliminates stagnant food." This herb is obtained by processing Evodia rutaecarpa with licorice juice. It is pungent, bitter, and hot in nature; it enters the liver, spleen, stomach, and kidney meridians; it has the effects of dispelling cold and relieving pain, suppressing nausea and vomiting, and tonifying yang and stopping diarrhea. Modern pharmacological studies have found that processed Evodia rutaecarpa contains evodiamine, evodiamine alkaloids, and limonene, which can regulate neuroendocrine function, improve insufficient vascular tone caused by spleen and kidney yang deficiency, and reduce damage to the vascular endothelium caused by chronic inflammation through anti-inflammatory and antioxidant effects, maintaining vascular elasticity. This formula uses Cimicifuga foetida and ginseng as the chief ingredients, mainly governing "ascending clear qi." Processed Evodia rutaecarpa is warm and descends qi, able to warm and disperse the cold and turbid qi in the middle and lower jiao. Traditional Chinese medicine theory holds that "when turbid yin descends, clear yang naturally ascends." Processed Evodia rutaecarpa, through its gentle yet firm ability to descend turbidity, clears the way and creates space for the ascent of clear yang. This harmonious interplay of "descending to aid ascent" is something that raw Evodia rutaecarpa, due to its excessively pungent and dispersing nature, cannot achieve. Processed Evodia rutaecarpa synergizes with cinnamon and Morinda officinalis. Because its pungent and dispersing properties that deplete qi are effectively curbed, it no longer "internally depletes" qi with tonifying herbs like ginseng. Instead, it focuses on warming the lower abdomen, providing a warm and stable "base" for the ascending effects of ginseng and Cimicifuga. Some patients with pathological hypotension also experience symptoms of liver and stomach deficiency and upward reversal of turbid yin, such as cold extremities, abdominal pain, belching, and acid reflux. Processed Evodia rutaecarpa can precisely target this concurrent symptom, exerting its effects of soothing the liver and stomach, descending reversal, and stopping vomiting, without harming the vital qi that the formula aims to support.

[0074] The following description, in conjunction with preferred embodiments and technical effects of the present invention, illustrates these points:

[0075] Example 1

[0076] This embodiment provides a traditional Chinese medicine composition for treating pathological hypotension. This embodiment is a decoction, and its composition is as follows: 8g of Cimicifuga rhizome, 6g of ginseng, 10g of Agrimonia pilosa, 10g of Polygonatum sibiricum, 8g of cinnamon, 8g of deer antler powder, 6g of tangerine peel, 12g of Atractylodes macrocephala, 8g of Angelica sinensis, 10g of Rehmannia glutinosa, 7g of Morinda officinalis, 7g of Rhodiola rosea, and 4g of processed Evodia rutaecarpa.

[0077] Its preparation method is as follows:

[0078] S1. Crush the deer antler powder, put all the medicinal materials except cinnamon into a decoction pot, add water (the water level should be 5 cm above the surface of the herbs), cover and soak for 40 minutes.

[0079] S2. First, bring the soaked herbs to a boil over high heat. After boiling, reduce to a simmer and add the prepared cinnamon. Cover the pot and continue to simmer over low heat for 45 minutes. After simmering, filter out the liquid. This is the first decoction.

[0080] S3. Add water to the filtered dregs again, the water level should be 3 cm above the surface of the herbs. First bring it to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. This is the second decoction.

[0081] S4. Thoroughly mix the decoctions from the first and second decoctions to obtain the prepared decoction. The decoction prepared in this embodiment is one dose.

[0082] Example 2

[0083] This embodiment provides a traditional Chinese medicine composition for treating pathological hypotension. This embodiment is a decoction, and its formula is as follows: Cimicifuga rhizome 9g, ginseng 7g, Agrimonia pilosa 15g, Polygonatum sibiricum 15g, cinnamon 12g, deer antler powder 12g, tangerine peel 4g, Atractylodes macrocephala 8g, Angelica sinensis 12g, Rehmannia glutinosa 15g, Morinda officinalis 9g, Rhodiola rosea 9g, and processed Evodia rutaecarpa 5g. The preparation method is the same as in Embodiment 1. The decoction obtained in this embodiment is a single dose.

[0084] Example 3

[0085] This embodiment provides a traditional Chinese medicine composition for treating pathological hypotension. This embodiment is a decoction, and its formula is as follows: Cimicifuga rhizome 6g, ginseng 9g, Agrimonia pilosa 9g, Polygonatum sibiricum 9g, cinnamon 6g, deer antler powder 7g, tangerine peel 10g, Atractylodes macrocephala 6g, Angelica sinensis 6g, Rehmannia glutinosa 9g, Morinda officinalis 6g, Rhodiola rosea 8g, and processed Evodia rutaecarpa 2g. The preparation method is the same as in Embodiment 1. The decoction obtained in this embodiment is a single dose.

[0086] Example 4

[0087] This embodiment provides a traditional Chinese medicine composition for treating pathological hypotension. This embodiment is a granule formulation; for ease of preparation and administration, the granules prepared in this embodiment are in the form of fourteen doses. The preparation method is as follows:

[0088] T1. Weigh the various medicinal materials according to the following proportions: 98g of Cimicifuga rhizome, 112g of ginseng, 168g of Agrimonia pilosa, 168g of Polygonatum sibiricum, 126g of cinnamon, 84g of deer antler powder, 98g of dried tangerine peel, 112g of Atractylodes macrocephala, 140g of Angelica sinensis, 126g of Rehmannia glutinosa, 126g of Morinda officinalis, 126g of Rhodiola rosea, and 70g of processed Evodia rutaecarpa. Crush the deer antler powder and set aside. Break the cinnamon into small pieces and set aside.

[0089] T2. Place the cinnamon pieces into a volatile oil extractor, add water to cover the cinnamon by 5 cm, heat under reflux for 1.5 hours until no more oil droplets are precipitated, collect the cinnamon volatile oil, seal and refrigerate for later use, and retain the cinnamon residue and cinnamon liquid after distillation.

[0090] T3. Put all the herbs except the cinnamon decoction into the decoction machine. The herbs include crushed deer antler powder and distilled cinnamon residue. Add 10L of water, bring to a boil over high heat, then reduce to low heat and continue to decoct for 1.5 hours. After decoction, squeeze out the residue and filter out the decoction.

[0091] T4. Add 7L of water to the dregs in T3 and decoct for a second time for 1 hour. Filter out the liquid and combine it with the cinnamon liquid obtained in step T2 and the liquid obtained in step T3 to obtain a combined liquid.

[0092] T5. Filter the combined liquid obtained in step T4 through a 100-mesh sieve to remove fine medicinal residues. Concentrate the filtrate, controlling the temperature to ≤65℃, and concentrate it under normal pressure to a thick paste with a relative density of approximately 1.10. The paste should not spread rapidly when dipped onto filter paper. The concentration under normal pressure is carried out by gentle heating with constant stirring to prevent scorching. During the stirring process, 70% ethanol is added as a wetting agent while stirring.

[0093] T6. Mix the thick paste, dextrin, and starch in a mass ratio of 1:1:1 to form a soft material that can be formed into a ball when squeezed in the hand but crumbles when lightly pressed.

[0094] T7. Granulate and dry the soft material. The specific method is as follows: quickly put the soft material into a gyratory pellet mill and granulate it using a 14-mesh sieve to obtain wet pellets. Dry the wet pellets until the moisture content is ≤8%, which can be monitored using a rapid moisture analyzer or judged by experience: the pellets are dry and hard and easily broken when rubbed by hand. Then, pass the pellets through the gyratory pellet mill again and granulate them using a 16-mesh or 18-mesh sieve to break up the clumps and make the pellets uniform to obtain dry pellets.

[0095] T8. Dissolve the cinnamon volatile oil from step T2 thoroughly with a small amount of 95% ethanol. Place the dry granules from T7 in a slightly larger sealed container (such as a plastic bucket with a lid). While shaking the container, use a sprayer to evenly spray the volatile oil ethanol solution onto the granules, ensuring even spraying. Then, place the dry granules sprayed with the volatile oil ethanol solution in a clean environment to allow the ethanol to evaporate and dry. After drying, package them to obtain the granules.

[0096] Retaining the volatile oil of cinnamon better preserves its warming and tonifying effects. The main components of cinnamon volatile oil (such as cinnamaldehyde) are highly volatile. If added together with other herbs during a conventional long decoction process, most of the volatile oil will be lost through evaporation, leaving very little in the decoction and significantly reducing its efficacy. The distilled cinnamon residue (added in step T3) still contains water-soluble components such as glycosides and polysaccharides, which can be extracted in subsequent decoctions, ensuring that this portion of the efficacy is not lost. Collecting the volatile oil separately through distillation achieves the enrichment and purification of these highly active components. Extracting the volatile oil separately and adding it by spraying in the final stage avoids complex reactions that may occur with other herbal components (such as tannins and proteins) during co-decoction, ensuring the integrity of its chemical structure and its independent pharmacological activity.

[0097] Comparative Example 1

[0098] This comparative example provides a traditional Chinese medicine composition for treating pathological hypotension. The preparation method is the same as in Example 1, but the assistant ingredient does not contain "deer antler powder" and the adjuvant ingredient does not contain "Agrimonia pilosa". The "processed Evodia rutaecarpa" in the medicine is made from raw Evodia rutaecarpa. The traditional Chinese medicine decoction is prepared according to the method in Example 1.

[0099] Clinical trials

[0100] Case source: 210 patients with pathological hypotension who visited the Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from September 1, 2023 to August 31, 2024 were collected.

[0101] 1. Diagnostic criteria:

[0102] (1) Western medicine diagnostic criteria:

[0103] According to the statistical standards adopted by the Chinese Academy of Medical Sciences based on a large-scale population survey, low blood pressure is diagnosed as:

[0104] 1) Blood pressure measurements: The 10th percentile of systolic blood pressure (SBP) and diastolic blood pressure (DBP) are used as the cutoff values ​​for low blood pressure. Multiple measurements should be taken on different days in a resting state. Systolic blood pressure (SBP) ≤ 98 mmHg and diastolic blood pressure (DBP) ≤ 60 mmHg. Orthostatic hypotension (OH) is defined using the American Autonomic Neuroscience Society (AAS) criteria: a decrease in systolic blood pressure (SBP) ≥ 20 mmHg or a decrease in diastolic blood pressure (DBP) ≥ 10 mmHg within 3 minutes of standing.

[0105] 2) Clinical symptomatology criteria: As the core basis for diagnosing hypotension, physiological hypotension is generally asymptomatic or has mild symptoms, while pathological hypotension has obvious symptoms and signs. It mainly originates from insufficient perfusion of important organs such as the brain and heart. The following three criteria can be used as clinical diagnostic criteria for pathological hypotension:

[0106] Insufficient cerebral perfusion: dizziness, headache, blurred vision, temporary blindness, difficulty concentrating, and in severe cases, syncope.

[0107] Insufficient cardiac perfusion: symptoms include palpitations and chest tightness.

[0108] Systemic symptoms: fatigue, pale complexion, cold sweats, etc.

[0109] (2) Traditional Chinese Medicine diagnostic criteria:

[0110] The diagnostic criteria for hypotension in Traditional Chinese Medicine (TCM) are determined based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (2002)," the "Guidelines for Diagnosis and Treatment of Common Diseases in TCM Internal Medicine," and the "Expert Consensus on the Integrated Traditional Chinese and Western Medicine Management of Orthostatic Hypotension."

[0111] 1) Prerequisites: Meets the Western medicine blood pressure measurement standards; the diagnosis requires at least 2 of the main symptoms and at least 1 of the secondary symptoms, combined with tongue and pulse diagnosis.

[0112] 2) Traditional Chinese Medicine Syndrome Scoring Table: Each symptom is divided into four levels: asymptomatic, mild, moderate and severe. The severity grading scoring method is used to assign 0, 2, 4 and 6 points to the main symptom and 0, 1, 2 and 3 points to the secondary symptom.

[0113] 3) Symptoms:

[0114] Main symptoms: dizziness; fatigue; palpitations.

[0115] Secondary symptoms: dizziness; shortness of breath; pale complexion; sallow complexion.

[0116] 2. Inclusion criteria:

[0117] (1) Meets the Western medical diagnostic criteria for pathological hypotension;

[0118] (2) Meets the above-mentioned TCM diagnostic criteria;

[0119] (3) Age 18-75, gender not limited;

[0120] (4) Possesses complete clinical treatment data;

[0121] (5) Voluntarily participate in this clinical trial, understand and sign the informed consent form.

[0122] 3. Exclusion criteria:

[0123] (1) Patients who have had cardiovascular emergencies such as acute coronary syndrome, malignant arrhythmia, or hypertensive crisis within 30 days prior to enrollment;

[0124] (2) Those who have received or are expected to receive an implantable device (such as ICD, CRT) during the trial period, or who will undergo major cardiovascular surgery within 3 months;

[0125] (3) Comorbid serious primary diseases of the liver, kidneys, hematopoietic system, malignant tumors, mental illness, cognitive impairment, or other uncontrolled systemic diseases (such as Addison's disease);

[0126] (4) Individuals with hypotension caused by organic heart diseases such as severe bradycardia, severe aortic stenosis, hypertrophic obstructive cardiomyopathy, and cardiac tamponade;

[0127] (5) Those whose hypotension is clearly caused by drug factors (such as antidepressants) and who cannot stop taking the drug during the experiment;

[0128] (6) ALT and AST are ≥ 1.5 times the upper limit of normal, Scr is > 1.2 times the upper limit of normal, or there is an electrolyte imbalance that is difficult to correct;

[0129] (7) Those diagnosed with shock;

[0130] (8) Pregnant women, women planning to become pregnant, and women who are breastfeeding;

[0131] (9) Individuals with allergic constitutions or those known to be allergic to any component of the test drug (traditional Chinese medicine decoction);

[0132] (10) Those who have participated in other drug clinical trials within the past 3 months.

[0133] If any of the above conditions are met, then it is excluded.

[0134] 4. Rejection, detachment, and termination criteria:

[0135] (1) Those who are lost to follow-up or fail to come to the hospital for follow-up visits on time;

[0136] (2) The subject withdrew informed consent and requested to withdraw from the experiment;

[0137] (3) During the treatment, if the symptoms of low blood pressure continue to worsen or even cause syncope, the patient needs to withdraw from the trial and receive intensive treatment;

[0138] (4) During the trial, the subjects used medications that were prohibited by the protocol and affected blood pressure, and were unable to discontinue these medications;

[0139] (5) A serious safety problem occurred during the test;

[0140] (6) The research protocol has deviated significantly, affecting the evaluation of its effectiveness or safety.

[0141] If any of the above conditions are met, the condition is excluded.

[0142] 5. Test methods

[0143] (1) Grouping method: 210 patients with pathological hypotension were randomly divided into a control group of 70 patients, an experimental group of 70 patients, and a control group of 70 patients. During the experiment, after elimination, dropout, and termination, the effective data were 58 patients in the control group, 54 patients in the experimental group, and 56 patients in the control group.

[0144] (2) Treatment methods:

[0145] 1) General treatment: Basic treatment is given to all patients, including disease-related education, appropriate increase of water and salt intake, eating small meals frequently, quitting smoking and limiting alcohol consumption, moderate exercise, avoiding wind and cold, maintaining a good mood, and being careful about daily life.

[0146] 2) Drug treatment:

[0147] Treatment regimen for the control group:

[0148] Midojun tablets, manufacturer: Sinopharm Group Sichuan Antibiotics Co., Ltd., specification: 2.5mg x 20 tablets, dosage: 2.5mg each time, 3 times a day; medication time: 8:00 am, 12:00 pm, and 4:00 pm.

[0149] The experimental group received the traditional Chinese medicine decoction of Example 1 in addition to the treatment given to the control group. The dosage was one dose per day, divided into two doses, taken warm in the morning and evening.

[0150] The control group received the same traditional Chinese medicine decoction as the control group, administered as follows: one dose per day, divided into two administrations, taken warm in the morning and evening.

[0151] Treatment course: One treatment cycle is 4 weeks. Clinical data will be collected at the beginning of treatment and on the 28th day of treatment to observe changes before and after medication.

[0152] (3) Observation indicators

[0153] 1) Safety indicators:

[0154] Complete blood count, liver and kidney function tests, electrolytes, blood lipids, and routine urine and stool tests (one test before and one test after treatment).

[0155] 2) Therapeutic indicators:

[0156] ① Blood pressure measurement and changes in blood pressure in standing and lying positions; ② Traditional Chinese medicine syndrome score; ③ Quality of life score using the SF-36 scale; ④ Follow-up: Six months after the end of treatment, follow up by telephone regarding the patient's readmission due to hypotension within six months.

[0157] 3) Criteria for evaluating therapeutic efficacy:

[0158] ① Criteria for judging the efficacy of TCM syndromes:

[0159] According to the nimodipine efficacy evaluation criteria: Efficacy index = [(Total score of symptoms before treatment - Total score of symptoms after treatment) / Total score of symptoms before treatment] x 100%;

[0160] Significant improvement: Clinical symptoms and signs show marked improvement, and the therapeutic index decreases by ≥70%;

[0161] Effective: Clinical symptoms and signs improve, and the therapeutic index decreases by ≥30%;

[0162] Ineffective: Clinical symptoms and signs do not improve, or even worsen, and the treatment index decreases by <30%.

[0163] ② Evaluation criteria for blood pressure therapy:

[0164] Significant effect: Blood pressure rise ≥20 mmHg (SBP or DBP); or blood pressure not reaching the normal range but not meeting the diagnostic criteria for hypotension (SBP > 98 mmHg, DBP > 60 mmHg); or significant improvement in orthostatic hypotension (SBP decrease <10 mmHg after standing).

[0165] Effective: Blood pressure improved compared to previous treatment, and symptoms were alleviated; the increase in blood pressure was ≥10 mmHg but <20 mmHg (SBP or DBP); orthostatic hypotension improved, but the decrease in SBP after standing was ≥10 mmHg.

[0166] Ineffective: Blood pressure rise does not meet the "effective standard", or blood pressure does not change, or symptoms do not improve or even worsen.

[0167] 6. Statistical Analysis:

[0168] The statistical software SPSS 25.0 was used for analysis and processing. Quantitative data were analyzed using... t Tests are performed using mean ± standard deviation. For unequal variances, a rank-sum test is used. For ordinal data, a rank-sum test is used. For categorical data, a chi-square test is used. P <0.05 indicates a significant difference.

[0169] 7. Test Results

[0170] ① Comparison of general information of the three groups of patients, see Table 1, results are rounded to two decimal places.

[0171] Table 1: Comparison of general information of patients in the control group, experimental group and control group

[0172] ;

[0173] There were no statistically significant differences in gender, age, or duration of pathological hypotension among the three groups: the control group, the experimental group, and the comparison group. P (>0.05), making them comparable.

[0174] ② Comparison of the scores of the main TCM symptoms before and after treatment in the three groups of patients is shown in Table 2. The results are rounded to two decimal places.

[0175] Table 2: Comparison of the main TCM symptom scores before and after treatment in the control group, experimental group, and comparison group (Table 2: Comparison of the scores of the main TCM symptoms before and after treatment in the three groups: control group, experimental group, and comparison group) )

[0176] ;

[0177] Note: a: The scores of the main TCM symptoms after treatment were compared with those of the control group. P <0.05; b: The scores of the main TCM symptoms after treatment were compared with those of the control group. P <0.05; c: Comparison of the main TCM symptom scores before and after treatment in each group. P <0.05.

[0178] There were no statistically significant differences in the scores of the main TCM symptoms among the three groups of patients before treatment, indicating comparability. P >0.05). After treatment, the scores of the main TCM symptoms in the control group, experimental group, and control group all decreased compared with before treatment. The TCM symptom scores in the experimental group and control group were significantly lower than those in the control group, and the TCM symptom scores in the experimental group were all lower than those in the control group. The differences were statistically significant. P <0.05). In summary, the traditional Chinese medicine composition of the present invention can effectively improve the main clinical symptoms of pathological hypotension, such as dizziness, fatigue, and palpitations.

[0179] ③ Comparison of the scores of secondary TCM symptoms before and after treatment. The results are retained to two decimal places. See Table 3.

[0180] Table 3: Comparison of minor TCM symptom scores before and after treatment in the control group, experimental group, and comparison group (Table 3) )

[0181] ;

[0182] Note: a: The score of secondary TCM symptoms after treatment compared with the control group. P <0.05; b: Secondary TCM symptom scores after treatment compared to the control group.P <0.05; c: Comparison of minor TCM symptom scores before and after treatment in each group. P <0.05.

[0183] There were no statistically significant differences in the scores of secondary TCM symptoms among the three groups of patients before treatment, indicating comparability. P >0.05). After treatment, the scores of secondary TCM symptoms (dizziness, shortness of breath, pale complexion, and sallow complexion) in all three groups of patients decreased compared with before treatment. The scores of secondary TCM symptoms in the experimental group and the control group were significantly lower than those in the control group, and the scores of secondary TCM symptoms in the experimental group were lower than those in the control group. The differences were statistically significant. P <0.05). In summary, the traditional Chinese medicine composition of the present invention can effectively improve the secondary clinical symptoms of pathological hypotension in traditional Chinese medicine.

[0184] ④ Comparison of TCM syndrome scores before and after treatment in the three groups of patients. The results are rounded to two decimal places. See Table 4.

[0185] Table 4: Comparison of TCM syndrome scores before and after treatment in the control group, experimental group, and comparison group ( )

[0186] ;

[0187] Note: a: TCM syndrome scores after treatment compared with the control group. P <0.05; b: TCM syndrome score after treatment compared with the control group, P <0.05; c: Comparison of TCM syndrome scores before and after treatment in each group. P <0.05.

[0188] There were no statistically significant differences in the TCM syndrome scores among the three groups of patients before treatment, making them comparable. P >0.05). After treatment, the TCM syndrome scores of all three groups of patients decreased compared with before treatment. The TCM syndrome scores of the experimental group and the control group were significantly lower than those of the control group, and the TCM syndrome score of the experimental group was lower than that of the control group. The difference was statistically significant. P <0.05).

[0189] In summary, the traditional Chinese medicine composition of the present invention can effectively improve the clinical symptoms of patients with pathological hypotension and improve their quality of life.

[0190] ⑤ Comparison of TCM syndrome efficacy before and after treatment in the three groups of patients. Results are rounded to two decimal places. See Table 5.

[0191] Table 5: Comparison of TCM syndrome efficacy before and after treatment in three groups of patients

[0192] ;

[0193] Note: a: The therapeutic effect of TCM syndromes after treatment compared with the control group. P <0.05; b: The therapeutic effect of TCM syndrome after treatment compared with the control group. P <0.05.

[0194] As shown in the table above, after 4 weeks of treatment, the total effective rate of TCM syndrome differentiation in the experimental group was 87.04% (47 / 54), which was higher than that in the control group (62.50%, 35 / 56) and higher than that in the control group (50.00%, 29 / 58). The differences were statistically significant. P <0.05).

[0195] ⑥ Comparison of blood pressure efficacy before and after treatment in the three groups of patients. Results are rounded to two decimal places. See Table 6.

[0196] Table 6: Comparison of blood pressure efficacy before and after treatment in the three groups of patients

[0197] ;

[0198] Note: a: Blood pressure efficacy after treatment compared to the control group. P <0.05; b: Blood pressure efficacy after treatment compared to the control group, P <0.05.

[0199] As shown in the table above, after 4 weeks of treatment, the total effective rate of blood pressure treatment in the experimental group was 81.48% (44 / 54), which was higher than that in the control group (71.43%, 40 / 56) and the control group (68.97%, 40 / 58). The difference was statistically significant. P The value was <0.05, but it cannot be concluded that there is a difference between the experimental group and the control group.

[0200] ⑦ Safety assessment:

[0201] During the four-week treatment period, biochemical test indicators of the three groups of patients, including routine tests such as liver function, kidney function, complete blood count, urinalysis, blood lipids, and serum creatinine, were compared within each group. There were no cases where the results were normal before treatment but abnormalities occurred after treatment, and no patients experienced adverse reactions such as allergies.

[0202] Typical treatment cases

[0203] Case 1

[0204] Ms. Fu, female, 68 years old, presented with a 20-day history of dizziness. Present Illness: The patient experienced dizziness accompanied by lightheadedness 20 days prior to admission. Her self-measured blood pressure was 78 / 39 mmHg. Seeking further diagnosis and treatment, she came to our hospital. She was admitted with a preliminary diagnosis of hypotension. Upon admission, her symptoms included: dizziness accompanied by lightheadedness, which worsened upon changing position or turning her head; a heavy, dull headache, primarily in the vertex and occipital region, with throbbing pain in both temples; palpitations; occasional transient precordial pain; dry mouth; occasional bitter taste; frequent awakenings at night; nightmares; numbness in the ring and little fingers of both hands; normal appetite; slightly yellow urine with foam; and normal bowel movements. Her tongue was pale red with dark sublingual veins and a thin white coating; and her pulse was deep and thready. Past Medical History: She had a history of hyperglycemia (specific medication unknown); a history of hypotension and unstable angina; but denied a history of hypertension. Traditional Chinese Medicine (TCM) diagnosis: dizziness, qi and blood deficiency; Western medicine diagnosis: orthostatic hypotension. The patient, nearly 70 years old, experienced gradual qi and blood deficiency, with insufficient ascending of clear yang, leading to malnourishment of the brain, hence the dizziness, lightheadedness, and a heavy, dull headache. Changes in posture further hindered the upward flow of qi and blood, exacerbating the dizziness. Insufficient heart qi resulted in weak propulsion and blood stasis, causing occasional precordial distending pain, palpitations, and heart palpitations. Blood stasis in the vessels caused numbness in the ring fingers of both hands. The sublingual veins were dark, and the pulse was deep and thready, all signs of qi and blood deficiency, insufficient ascending of clear yang, and blood stasis. The herbal decoction described in Example 1 was administered, one dose daily divided into two administrations. After two months of treatment, a follow-up showed improvement in the patient's dizziness, absence of palpitations, occasional dry mouth, and stable condition. A repeat blood pressure reading was 130 / 80 mmHg.

[0205] Case 2

[0206] Mr. Zuo, male, 58 years old, presented with "dizziness accompanied by fatigue and poor appetite for more than one month". Present illness: One month ago, the patient was diagnosed with "right kidney stone for 4 years, accompanied by fever for 1 month" and visited the Department of Urology of our hospital. On June 10, he underwent renal biopsy, percutaneous nephrostomy, and percutaneous nephrolithotomy (right). After the operation, a right nephrostomy tube was placed. After changing position, the patient's blood pressure dropped, and he experienced significant dizziness, poor appetite, and fatigue. His symptoms were not relieved after taking midodrine orally. With continuous infusion of metaraminol in the urology department, his blood pressure was maintained at 100 / 50 mmHg. For further treatment, he was admitted to the hospital with a preliminary diagnosis of "orthostatic hypotension". Admission findings: The patient was brought into the ward on a stretcher, alert and conscious, appearing anemic, dizzy, with more pronounced dizziness when sitting, weak, poor appetite, no chest tightness or pain, no palpitations, no headache, right nephrostomy tube in place, surgical area dry and clean, no exudate, pale yellow turbid urine visible in the drainage bag, urine output approximately 900ml / day, frequent urination, urine output approximately 2500-3000ml / day, normal bowel movements, fair sleep, pale tongue with thin white coating, weak pulse. Past medical history: Denies history of hypertension, diabetes, or coronary heart disease. Underwent renal biopsy, percutaneous nephrostomy, and percutaneous nephrolithotomy (right) in June 2023. Traditional Chinese Medicine diagnosis: dizziness, deficiency of qi and blood; Western medicine diagnosis: orthostatic hypotension. The patient's qi and blood were depleted due to the renal biopsy and other surgeries, resulting in "deficiency of both qi and blood, insufficiency of spleen and kidney, and failure of clear yang to ascend." Surgical trauma depletes qi and blood, and when qi and blood cannot nourish the brain, dizziness occurs. Changes in body position further deplete qi, thus exacerbating the condition. Spleen deficiency leads to insufficient qi and blood production, resulting in fatigue and poor appetite. Kidney qi deficiency weakens the body's vital energy, causing frequent urination due to bladder dysfunction. Furthermore, insufficient kidney qi hinders the ascent of yang qi, worsening low blood pressure. A pale tongue with a thin white coating and a weak pulse are all indicative of deficiency in both qi and blood, as well as spleen and kidney. The herbal decoction described in Example 1 was administered, one dose daily divided into two administrations. After three months of treatment, a follow-up showed that the patient's dizziness had improved, fatigue had lessened, and the condition had stabilized. A repeat blood pressure reading was 120 / 81 mmHg.

[0207] Case 3

[0208] Mr. Sun, male, 63 years old, presented with a history of intermittent dizziness for more than half a year, which had worsened and was accompanied by nausea for 3 days. Present illness: The patient began experiencing dizziness without any obvious cause six months ago. The dizziness was intermittent, relieved by rest, and accompanied by mild nausea. He did not pay much attention to it. Three days ago, he experienced severe dizziness accompanied by nausea. Seeking further systematic diagnosis and treatment, he visited our outpatient department. His blood pressure was measured at 85 / 59 mmHg, and he was admitted to the hospital with a preliminary diagnosis of "hypotension." Upon admission, his symptoms included: intermittent dizziness, no headache, nausea during attacks (which he reported was worse when walking and relieved when sitting or lying down), no chest tightness or palpitations, dry mouth or bitter taste, no significant fatigue, good appetite, poor sleep, normal urination, bowel movements 3-4 times every 3-4 days, initially dry then loose, pale tongue with a thin white coating, and a deep, thready, weak pulse. He had not experienced significant weight loss recently. Past medical history: History of hypertension complicated by orthostatic hypotension; highest supine blood pressure 162 / 105 mmHg, lowest standing blood pressure 80 / 50 mmHg; currently not taking antihypertensive medication; history of diabetes; highest postprandial blood glucose 20.00 mmol / L; medications: insulin aspart, 30 units twice daily; canagliflozin, one tablet taken self-administered when blood glucose is poorly controlled; blood sugar control is generally fair; denies history of coronary heart disease. History of ankle fracture fixation surgery. Traditional Chinese Medicine diagnosis: dizziness, spleen and kidney deficiency; Western medicine diagnosis: orthostatic hypotension. The patient is nearly 70 years old, with gradual depletion of qi and blood, coupled with the depletion of yin fluids by diabetes and the damage to yang by prolonged hypertension, resulting in "yin and yang deficiency, spleen and kidney insufficiency, and failure of clear yang to ascend." Failure of clear yang to ascend causes dizziness; spleen deficiency and impaired digestion cause constipation followed by loose stools; kidney yin and yang deficiency cause unstable blood pressure. Pale tongue with thin white coating and deep, thready, weak pulse are all indicative of deficiency in the root and excess in the branch. The traditional Chinese medicine decoction used in Example 2 was taken twice a day, one dose per day. After 3 months of treatment, the patient was followed up and the frequency of dizziness attacks decreased. The patient had a slightly dry and bitter mouth, and the condition was stable. The lowest blood pressure when standing was 110 / 71 mmHg.

[0209] Case 4

[0210] Mr. Chen, male, 72 years old, presented with a one-month history of dizziness. Present illness: On November 28, 2023, the patient underwent right total knee arthroplasty at our hospital and subsequently developed low blood pressure accompanied by dizziness. Seeking further treatment, he visited our outpatient department, where his blood pressure was measured at 89 / 60 mmHg. He was admitted with a preliminary diagnosis of "idiopathic hypotension." Admission symptoms: Conscious, generally alert, slow movement, dizziness (worse when bending the head, less pronounced when turning the head), blurred vision, fatigue, shortness of breath and palpitations after exercise, no cough or sputum, postoperative pain and discomfort in the right knee joint, dry mouth, bitter taste, spontaneous sweating, poor sleep, poor appetite, normal bowel movements, pale red tongue with a thin white coating, and a thready, wiry pulse. No lower extremity edema, and no significant recent weight loss. The patient has a history of hypertension for over 20 years, which was controlled with amlodipine besylate tablets, but was discontinued one year ago due to low blood pressure. They also have a history of diabetes for over 5 years, regularly taking metformin tablets and acarbose capsules, and a history of gout for over 6 years, regularly taking febuxostat intermittently. They have a history of right total knee replacement surgery and are currently taking etoricoxib tablets. Traditional Chinese medicine diagnosis: dizziness, qi and blood deficiency; Western medicine diagnosis: idiopathic hypotension. The patient's advanced age and post-operative condition have resulted in significant qi and blood depletion, compounded by the long-term effects of hypertension, diabetes, and gout, leading to "qi and blood deficiency, failure of clear yang to ascend, combined with yin deficiency and internal heat, and spleen deficiency with impaired transport function." Qi and blood deficiency manifests as dizziness, blurred vision, and fatigue; failure of clear yang to ascend manifests as heaviness in the head; yin deficiency and internal heat manifest as dry mouth, bitter taste, and spontaneous sweating; spleen deficiency with impaired transport function manifests as poor appetite and poor sleep; a pale red tongue with a thin white coating and a wiry, thready pulse are signs of qi and blood deficiency. The Chinese herbal granules of Example 4 were used, one dose per day divided into two administrations, taken with warm water. After 3 months of treatment, the patient was followed up and found that the dizziness had improved and the fatigue had lessened. Occasionally, the patient experienced shortness of breath after activity, spontaneous sweating, and normal sleep. The patient's condition was stable, and the blood pressure was 130 / 85 mmHg upon re-examination.

[0211] Case 5

[0212] Mr. Fu, male, 78 years old, presented with a history of "recurrent dizziness accompanied by cough and sputum for over a month." Present Illness: One month ago, the patient developed dizziness without any obvious cause, without significant headache, nausea, vomiting, vertigo, or blurred vision. He experienced cough and sputum, which was scanty and yellow. He had been hospitalized at Nanchang County People's Hospital and the High-tech Zone Branch of the First Affiliated Hospital of Nanchang University in Jiangxi Province, where the cough and sputum improved slightly, but the dizziness persisted. Seeking further integrated traditional Chinese and Western medicine treatment, he came to our hospital. His blood pressure was measured at 75 / 52 mmHg at the outpatient clinic, and he was admitted to our ward with a preliminary diagnosis of "hypotension." Upon admission, the patient presented with: clear consciousness, poor mental state, fatigue, reluctance to speak, occasional dizziness, frequent cough with scanty sputum, no nausea or vomiting, recent poor appetite, dark tongue with a white coating, and a wiry pulse. He denied any history of hypertension, diabetes, or coronary heart disease. Traditional Chinese Medicine Diagnosis: Dizziness due to Qi deficiency and phlegm accumulation; Western Medicine Diagnosis: Hypotension. The patient, being elderly, experienced gradual depletion of Qi and blood, along with spleen and lung deficiency, resulting in "Qi and blood deficiency, failure of clear Yang to ascend, and concurrent lung dysfunction with mild phlegm and heat." Qi and blood deficiency manifested as dizziness, fatigue, and reluctance to speak; spleen deficiency and impaired digestion led to poor appetite; lung Qi deficiency and impaired lung function resulted in cough with little phlegm; a dark tongue and wiry pulse indicated Qi and blood stagnation. The herbal granules described in Example 4 were administered, one dose daily divided into two administrations, dissolved in warm water. A follow-up after three months of treatment showed improvement in fatigue, dizziness, and cough. The patient's condition stabilized, and a repeat blood pressure reading of 130 / 69 mmHg.

[0213] The above typical cases show that the traditional Chinese medicine composition of the present invention has a significant effect on improving pathological hypotension, and the blood pressure monitor shows that the systolic and diastolic blood pressure increases significantly after treatment.

[0214] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating pathological hypotension, characterized in that, Made from the following Chinese medicinal materials in parts by weight: Cimicifuga rhizome 6-9 parts, ginseng 6-9 parts, Agrimonia pilosa 9-15 parts, Polygonatum sibiricum 9-15 parts, cinnamon 6-12 parts, deer antler powder 6-12 parts, tangerine peel 6-10 parts, Atractylodes macrocephala 6-12 parts, Angelica sinensis 6-12 parts, Rehmannia glutinosa 9-15 parts, Morinda officinalis 6-9 parts, Rhodiola rosea 6-9 parts, and processed Evodia rutaecarpa 2-5 parts.

2. The traditional Chinese medicine composition for treating pathological hypotension according to claim 1, characterized in that, Made from the following Chinese medicinal herbs in parts by weight: 8 parts Cimicifuga rhizome, 6 parts ginseng, 10 parts Agrimonia pilosa, 10 parts Polygonatum sibiricum, 8 parts cinnamon, 8 parts deer antler powder, 6 parts dried tangerine peel, 12 parts Atractylodes macrocephala, 8 parts Angelica sinensis, 10 parts Rehmannia glutinosa (processed), 7 parts Morinda officinalis, 7 parts Rhodiola rosea, and 4 parts processed Evodia rutaecarpa; or... 6 parts Cimicifuga rhizome, 9 parts ginseng, 9 parts Agrimonia pilosa, 9 parts Polygonatum sibiricum, 6 parts cinnamon, 7 parts deer antler powder, 10 parts dried tangerine peel, 6 parts Atractylodes macrocephala, 6 parts Angelica sinensis, 9 parts Rehmannia glutinosa, 6 parts Morinda officinalis, 8 parts Rhodiola rosea, and 2 parts processed Evodia rutaecarpa; or 7 parts of Cimicifuga rhizome, 8 parts of ginseng, 12 parts of Agrimonia pilosa, 12 parts of Polygonatum sibiricum, 9 parts of cinnamon, 6 parts of deer antler powder, 7 parts of dried tangerine peel, 8 parts of Atractylodes macrocephala, 10 parts of Angelica sinensis, 9 parts of Rehmannia glutinosa, 9 parts of Morinda officinalis, 9 parts of Rhodiola rosea, and 5 parts of processed Evodia rutaecarpa.

3. A method for preparing a traditional Chinese medicine composition for treating pathological hypotension according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is a decoction, and its preparation method includes the following steps: S1. Crush the deer antler powder, put all the herbs except cinnamon into a decoction pot, add water, the water level should be 3-5 cm above the herbs, cover and soak for 30-45 minutes; S2. First, bring the soaked herbs to a boil over high heat. After boiling, reduce to a simmer and add the prepared cinnamon. Cover the pot and continue to simmer over low heat for 40-50 minutes. After simmering, filter out the liquid. This is the first decoction. S3. Add water to the filtered dregs again, the water level should be 2-3 cm above the surface of the herbs. First bring to a boil over high heat, then simmer over low heat for 30-40 minutes. Filter out the liquid, this is the second decoction. S4. Thoroughly mix the first and second decoctions to obtain the prepared decoction.

4. A method for preparing a traditional Chinese medicine composition for treating pathological hypotension according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is in granule form, and its preparation method includes the following steps: T1. Weigh all the medicinal materials according to the proportions, crush the deer antler powder and set aside, and break the cinnamon into small pieces and set aside; T2. Place the cinnamon pieces into a volatile oil extractor, add water to cover the cinnamon by 3-5 cm, heat under reflux for 1-2 hours until no more oil droplets are precipitated, collect the cinnamon volatile oil, seal and refrigerate for later use, and retain the cinnamon residue and cinnamon liquid after distillation. T3. Put all the herbs except the cinnamon decoction into the decoction machine. The herbs include crushed deer antler powder and distilled cinnamon residue. Add water with a total weight of 8-10 times the herbs. Bring to a boil over high heat, then reduce to low heat and continue to decoct for 1.5 hours. After decoction, squeeze out the residue and filter out the decoction. T4. Add 6-8 times the amount of water to the dregs in T3 and decoct for a second time for 1 hour. Filter out the liquid and combine it with the cinnamon liquid obtained in step T2 and the liquid obtained in step T3 to obtain a combined liquid. T5. Filter the combined liquid obtained in step T4 through a 100-mesh sieve to remove fine medicinal residues. Concentrate the filtrate, controlling the temperature to ≤65℃, until it becomes a thick paste with a relative density of 1.10-1.

15. The paste should not spread rapidly when dipped onto filter paper. T6. Mix the thick paste, dextrin, and starch in a mass ratio of 1:1:1 to form a soft material that can be formed into a ball by hand and crumbles when lightly pressed. T7. Granulate and dry the soft material to obtain dry granules; T8. Dissolve the cinnamon volatile oil from step T2 completely with 95% ethanol, spray the cinnamon volatile oil ethanol solution evenly onto the dry granules, and after the ethanol evaporates and the mixture is dried, package it into granules.