Traditional Chinese medicine formula for treating pyotoxic cardiomyopathy and preparation method of traditional Chinese medicine formula

Abstract

The traditional Chinese medicine formula comprises inula flower, madder, cimicifugae foetidae, vinegar turtle, Chinese herbaceous peony, Chinese angelica, asarum, ricepaperplant pith, vinegar radix curcumae, blackberry lily, aster, trichosanthes kirilowii maxim, allium macrostemon, cassia twig, rhizoma pinellinae praeparata, immature bitter orange, pig heart blood, salvia miltiorrhiza, sandalwood, fructus amomi, ginger bamboo shavings, white mulberry root-bark, cortex lycii radicis, prepared polygonum multiflorum, cortex moutan, radix bupleuri, lophatherum gracile and fructus forsythiae. The invention further discloses a preparation method of the traditional Chinese medicine for treating the pyotoxic cardiomyopathy. Compared with the prior art, the traditional Chinese medicine has the effects of relieving heart arthralgia, tonifying qi and dredging collaterals, extinguishing wind and clearing fire, and dispersing blood stasis and inducing diuresis, and is suitable for pathophysiology of sepsis cardiomyopathy.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine formula for treating septic cardiomyopathy and a preparation method thereof. Background Art

[0002] Sepsis, a common and serious complication of patients with critical clinical conditions such as trauma, burns, shock, and infection, remains a significant threat to human health, characterized by high morbidity, mortality, and treatment costs. Septic cardiomyopathy, the most severe complication and leading cause of death in sepsis, is directly linked to the prognosis of sepsis patients. Studies have shown that the mortality rate in sepsis patients with cardiac dysfunction can be as high as 70%. In stark contrast, the mortality rate in sepsis patients without cardiac dysfunction is only 20%. Therefore, the prevention and early treatment of septic cardiomyopathy is crucial for improving patient survival.

[0003] Modern medical research on the pathogenesis of septic cardiomyopathy reveals that it involves multiple complex processes. In the initial stages of sepsis, the release of a large number of inflammatory cytokines triggers a cytokine storm, similar to the "endogenous heat" in Traditional Chinese Medicine (TCM) theory. Within this inflammatory state (referred to as "heat" in TCM), neutrophils are activated, receptor-mediated adhesion to endothelial cells increases, and neutrophils migrate across the endothelium into the interstitial space, inducing an increase in reactive oxygen species (ROS), lytic enzymes, and vasoactive substances. This series of changes exacerbates cardiomyocyte inflammation, vascular leakage, and edema, resembling the pathological characteristics of "endogenous dryness" in TCM, and exemplifying the pathological evolution described by the saying "all six qi originate from fire." Furthermore, tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), endothelin-1 (ET-1), lysozyme Zygote (LMZ), and Toll-like receptors, all produced during the course of sepsis, are crucial myocardial inhibitory factors that directly inhibit myocardial contractility. From the perspective of Traditional Chinese Medicine theory, it can be understood that the three Qis of "fire, heat, and dryness" damage the heart at the same time, causing decreased cardiac compliance and reduced cardiac output, which ultimately leads to reduced perfusion of tissues and organs throughout the body. This is reflected in the pathogenesis of Traditional Chinese Medicine as "blockage, insufficiency, and loss of expression" of the heart's power.

[0004] As the disease progresses, decreased perfusion triggers reflex sympathetic nerve / neurohormonal activation, increasing circulating catecholamines and, in turn, compensatory endothelial cell contraction. This spastic state is categorized as "Jueyin wind" in Traditional Chinese Medicine (TCM) theory. Simultaneously, activation of the renin-angiotensin-aldosterone system increases vascular tone and sodium and water retention, further increasing myocardial afterload and circulating plasma volume (i.e., cardiac preload). Thus, impaired cardiac function triggers a reflex response of "Jueyin wind" in the body. As the ancients said, "Depression leads to a desire for healing and release, but the desire for release ultimately leads to depression." The Jueyin meridian qi is suppressed, yet it continues to perform its function of dispersing and releasing. Conversely, left ventricular diastolic dysfunction can lead to elevated left atrial pressure and pulmonary venous pressure, causing pulmonary congestion and hypoxemia, further exacerbating myocardial ischemia and dysfunction. From the perspective of TCM theory of body and function, left ventricular diastolic dysfunction also falls under the category of "impaired dispersal," and this cardiac dysfunction can further compromise the lung's function of dispersing, descending, and descending. Decreased cardiac output and volume overload form a self-perpetuating cycle, ultimately leading to decreased coronary perfusion pressure, myocardial ischemia, worsening cardiac function, and circulatory failure.

[0005] Furthermore, post-inflammatory microcirculatory endothelial dysfunction can lead to increased cell adhesion, loss of barrier function, widespread apoptosis, and procoagulant effects, resulting in decreased microcirculatory vascular reactivity and increased leukocyte adhesion. In Traditional Chinese Medicine (TCM), this can be understood as the production of endogenous pathological products such as phlegm, fluid retention, turbidity, dryness, and stasis. Disturbances in local cardiac microcirculatory flow can trigger compensatory metabolic shutdown in hypoperfused microregions, resulting in abnormal cardiac function and energy, a manifestation of the heart's "disordered circulation."

[0006] Currently, Western medicine treatments for septic cardiomyopathy are limited and have certain limitations. For example, while dobutamine, a positive inotropic agent, can enhance myocardial contractility, it also increases cardiac oxygen consumption, potentially increasing the risk of cardiovascular events. Levosimendan, while effective in ameliorating myocardial depression in sepsis, is relatively understudied. Given this current treatment landscape, the development of a safe and effective treatment is urgent.

[0007] Traditional Chinese Medicine (TCM) offers unique advantages in the treatment of sepsis. While ancient texts lack a specific disease name for septic cardiomyopathy, its clinical manifestations suggest it falls under the TCM categories of "palpitations," "chest pain," and "asthma." Septic shock and multiple organ dysfunction are considered "syncope" and "collapse." These conditions are discussed in treatises focused on infectious diseases, such as the Treatise on Febrile Diseases, Treatise on Warm Diseases, and Treatise on Warm and Respiratory Diseases. Building on the theoretical foundations of their predecessors, contemporary physicians have a deeper understanding of the etiology and pathogenesis of septic cardiomyopathy, believing it stems from a deficiency of vital Qi, representing a syndrome characterized by both underlying deficiency and superficial excess. Current understandings of the pathogenesis of sepsis primarily focus on internal accumulation of toxic heat, blood stasis obstructing the collaterals, insufficient vital Qi, and obstructed bowel qi. During the progression of sepsis, pathogenic Qi invades the body, depleting vital Qi. If heart Yang is damaged, Yang deficiency results in insufficient blood circulation. Insufficient kidney Yang Qi prevents warming the heart Yang and transforming fluid into urine for excretion, leading to edema.

[0008] Based on an in-depth understanding of the pathogenesis of septic cardiomyopathy in both traditional Chinese and Western medicine and the limitations of existing treatment methods, a traditional Chinese medicine formula and preparation method for septic cardiomyopathy is proposed. Summary of the Invention

[0009] The present invention aims to provide a traditional Chinese medicine formula for septic cardiomyopathy and a preparation method thereof, which has the effects of "opening the heart and relieving numbness, invigorating qi and unblocking meridians, extinguishing wind and clearing fire, and removing blood stasis and promoting diuresis", and hits the pathophysiology of septic cardiomyopathy.

[0010] The above technical objectives of the present invention are achieved through the following technical solutions:

[0011] A traditional Chinese medicine formula for septic cardiomyopathy, comprising 18-22 parts by weight of Inula flower, 13-16 parts by weight of Rubia cordifolia, 13-16 parts by weight of Cimicifuga heracleifolia, 8-11 parts by weight of Carapax trichosanthis, 18-21 parts by weight of Paeonia lactiflora, 13-16 parts by weight of Angelica sinensis, 9-12 parts by weight of Asarum, 9-11 parts by weight of Smilax glabra, 13-16 parts by weight of Curcuma aromatica with vinegar, 14-17 parts by weight of Belamcanda chinensis, 18-22 parts by weight of Aster tataricus, 13-16 parts by weight of Trichosanthes kirilowii, and 28-32 parts by weight of Allium macrostemon. 1-2 parts by weight, 13-16 parts by weight of cassia twig, 18-22 parts by weight of pinellia ternata, 13-16 parts by weight of immature bitter orange, 8-12 parts by weight of salvia miltiorrhiza, 4-6 parts by weight of santalin, 4-7 parts by weight of amomum villosum, 28-32 parts by weight of rhizoma anthracis, 13-17 parts by weight of mulberry bark, 28-32 parts by weight of rehmannia root, 8-12 parts by weight of processed polygonum multiflorum, 18-22 parts by weight of moutan bark, 8-12 parts by weight of bupleurum, 8-12 parts by weight of loblolly bamboo leaf and 8-12 parts by weight of forsythia.

[0012] In a preferred embodiment, the invention comprises 22 parts by weight of Inula flower, 16 parts by weight of Rubia cordifolia, 16 parts by weight of Cimicifuga heracleifolia, 11 parts by weight of Vinegar turtle shell, 21 parts by weight of Peony root, 16 parts by weight of Angelica sinensis, 12 parts by weight of Asarum, 11 parts by weight of Smilax glabra, 16 parts by weight of Vinegar Curcuma, 17 parts by weight of Belamcanda chinensis, 22 parts by weight of Aster tataricus, 16 parts by weight of Trichosanthes kirilowii, 32 parts by weight of Allium macrostemon, 16 parts by weight of Cinnamomum cassia twig, 22 parts by weight of Pinellia ternata, 16 parts by weight of Citrus aurantium, 12 parts by weight of Salvia miltiorrhiza, 6 parts by weight of Santalum album, 7 parts by weight of Amomum villosum, 32 parts by weight of Rhizoma Zingiberis, 17 parts by weight of Morus alba, 32 parts by weight of Lycium bark, 12 parts by weight of Processed Polygonum multiflorum, 22 parts by weight of Cortex Moutan, 12 parts by weight of Bupleurum chinense, 12 parts by weight of Bambusa truncatum and 12 parts by weight of Fructus Forsythiae.

[0013] In a preferred embodiment, the invention comprises 18 parts by weight of Inula flower, 13 parts by weight of Rubia cordifolia, 13 parts by weight of Cimicifuga heracleifolia, 8 parts by weight of Vinegar turtle shell, 18 parts by weight of Paeonia lactiflora, 13 parts by weight of Angelica sinensis, 9 parts by weight of Asarum, 9 parts by weight of Smilax glabra, 13 parts by weight of Vinegar Curcuma aromatica, 14 parts by weight of Belamcanda chinensis, 18 parts by weight of Aster tataricus, 13 parts by weight of Trichosanthes kirilowii, 28 parts by weight of Allium macrostemon, 13 parts by weight of Cinnamomum cassia twig, 18 parts by weight of Pinellia ternata, 13 parts by weight of Citrus aurantium, 8 parts by weight of Salvia miltiorrhiza, 4 parts by weight of Santalum album, 4 parts by weight of Amomum villosum, 28 parts by weight of Rhizoma Zingiberis, 13 parts by weight of Morus alba, 28 parts by weight of Lycium bark, 8 parts by weight of Processed Polygonum multiflorum, 18 parts by weight of Cortex Moutan, 8 parts by weight of Bupleurum chinense, 8 parts by weight of Bambusa truncatum and 8 parts by weight of Fructus Forsythiae.

[0014] In a preferred embodiment, the invention comprises 20 parts by weight of Inula flower, 15 parts by weight of Rubia cordifolia, 15 parts by weight of Cimicifuga foetida, 10 parts by weight of Vinegar turtle shell, 20 parts by weight of Paeonia lactiflora, 15 parts by weight of Angelica sinensis, 10 parts by weight of Asarum, 10 parts by weight of Smilax glabra, 15 parts by weight of Vinegar Curcuma aromatica, 15 parts by weight of Belamcanda chinensis, 20 parts by weight of Aster tataricus, 15 parts by weight of Trichosanthes kirilowii, 30 parts by weight of Allium macrostemon, 15 parts by weight of Cinnamomum cassia, 20 parts by weight of Pinellia ternata, 15 parts by weight of Citrus aurantium, 10 parts by weight of Pig Heart Blood Salvia miltiorrhiza, 5 parts by weight of Santalum album, 5 parts by weight of Amomum villosum, 30 parts by weight of Rhizoma Zingiberis, 15 parts by weight of Morus alba, 30 parts by weight of Lycium bark, 10 parts by weight of Processed Polygonum multiflorum, 20 parts by weight of Cortex Moutan, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Bambusa truncatum and 10 parts by weight of Fructus Forsythiae.

[0015] A method for preparing a traditional Chinese medicine for septic cardiomyopathy comprises the following steps:

[0016] Ingredients: 18-22 parts by weight of Inula flower, 13-16 parts by weight of Rubia cordifolia, 13-16 parts by weight of Cimicifuga heracleifolia, 8-11 parts by weight of Vinegar Turtle Carapace, 18-21 parts by weight of Peony Root, 13-16 parts by weight of Angelica Sinensis, 9-12 parts by weight of Asarum, 9-11 parts by weight of Tongcao, 13-16 parts by weight of Vinegar Curcuma Radix, 14-17 parts by weight of Belamcanda Root, 18-22 parts by weight of Aster, 13-16 parts by weight of Trichosanthes, 28-32 parts by weight of Xiebai, 13 parts by weight of Cinnamomum cassiae. -16 parts by weight, French Pinellia 18-22 parts by weight, Citrus aurantium 13-16 parts by weight, pig heart blood salvia miltiorrhiza 8-12 parts by weight, santalin 4-6 parts by weight, amomum villosum 4-7 parts by weight, ginger bamboo 28-32 parts by weight, morus alba bark 13-17 parts by weight, lycium bark 28-32 parts by weight, prepared Polygonum multiflorum 8-12 parts by weight, moutan bark 18-22 parts by weight, bupleurum 8-12 parts by weight, bamboo leaf 8-12 parts by weight, and forsythia suspensa 8-12 parts by weight;

[0017] Decoction: soak the above medicinal materials in water, decoct over high heat, decoct again over low heat and filter; then add water, decoct and filter, mix the decoctions after the two filtrations to form a mixed liquid, and concentrate to make a medicinal liquid.

[0018] In a preferred embodiment, the ingredients are specifically: 20 parts by weight of Inula flower, 15 parts by weight of Rubia cordifolia, 15 parts by weight of Cimicifuga foetida, 10 parts by weight of Vinegar turtle shell, 20 parts by weight of Peony root, 15 parts by weight of Angelica sinensis, 10 parts by weight of Asarum, 10 parts by weight of Smilax glabra, 15 parts by weight of Vinegar Curcuma, 15 parts by weight of Belamcanda chinensis, 20 parts by weight of Aster tataricus, 15 parts by weight of Trichosanthes kirilowii, 30 parts by weight of Allium macrostemon, 15 parts by weight of Cinnamomum cassia, 20 parts by weight of Pinellia ternata, 15 parts by weight of Citrus aurantium, 10 parts by weight of Pig Heart Blood Salvia miltiorrhiza, 5 parts by weight of Santalum album, 5 parts by weight of Amomum villosum, 30 parts by weight of Anemarrhena rhizome, 15 parts by weight of Morus alba, 30 parts by weight of Lycium bark, 10 parts by weight of Processed Polygonum multiflorum, 20 parts by weight of Cortex Moutan, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Bambusa truncatum and 10 parts by weight of Forsythia suspensa.

[0019] In a preferred embodiment, during the decocting process, the Inula flower is wrapped and decocted, the Vinegar-scented Turtle Shell is decocted first, and the Sandalwood and Amomum villosum are added later.

[0020] In a preferred embodiment, the decoction step specifically includes: soaking the above medicinal materials in 5 times the volume of water for 1 hour, decocting over high heat for 10 minutes, decocting over low heat for another 20 minutes, and filtering; then adding 3 times the volume of water and decocting for 20 minutes, and filtering, mixing the decoctions after the two filtrations; and concentrating to 2.04758 crude drugs / mL of liquid medicine.

[0021] In a preferred embodiment, the concentration process includes: putting the mixed liquid into an evaporation container, and putting a number of floating balls into the evaporation container, the diameter of the floating balls is set to 1-2 cm, the lower half of the floating balls is provided with a counterweight portion, and the upper half is provided with a plurality of openings distributed circumferentially, the openings are provided with opening and closing plates, the opening and closing plates are provided with mounting holes, silica gel is provided in the mounting holes, and air holes are provided on the silica gel, the top of the opening and closing plate is adhered to the inner wall of the floating ball, and the floating ball and the opening and closing plate are made of stainless steel.

[0022] In a preferred embodiment, a silicone sealing ring is provided on the edge of the opening and closing piece.

[0023] Compared with the existing technology, the prescription of the present invention accurately combines multiple Chinese medicinal ingredients, works synergistically from multiple dimensions, intervenes in the disease in an all-round way, and demonstrates excellent therapeutic effects.

[0024] Cimicifuga and Forsythia suspensa have powerful heat-clearing and detoxifying properties. They act like powerful "fire extinguishers" in the inflammatory storm triggered by sepsis, effectively inhibiting the release of numerous inflammatory cytokines, alleviating a pathological condition similar to "endogenous heat" in Traditional Chinese Medicine (TCM), and reducing the inflammatory response of myocardial cells. Vinegar-scented turtle shell nourishes yin and suppresses yang, while angelica nourishes and activates blood circulation. The two complement each other, nourishing yin and dispersing blood stasis, replenishing yin fluid depleted by the disease while promoting blood circulation, improving myocardial blood supply, and preventing blood stasis from worsening. Pig heart blood and salvia miltiorrhiza nourish the heart and blood, complementing angelica's enhanced blood-dispersing properties, further creating favorable conditions for myocardial recovery.

[0025] Tongcao, Belamcanda, and Aster all promote lung qi. The lung governs qi and flows through all meridians, and when lung qi is promoted, the heart meridians flow smoothly. Vinegar-curcuma and moutan bark promote qi and cool the blood, dispersing stagnant qi and blood stasis in the lung meridians, allowing the lung qi to ascend and descend in an orderly manner, helping to relieve heart blockage and improve heart function. Trichosanthes root relieves chest congestion, Xiebai promotes yang and qi circulation, and cinnamon twig warms and unblocks the meridians. Together, these three ingredients effectively dispel chest phlegm, restore the flow of chest yang qi, and create a favorable environment for the heart.

[0026] Bupleurum, Pinellia ternata, and Rhizoma Zingiberis are heat-clearing and phlegm-resolving, while Citrus aurantium promotes qi and resolves stagnation, and Amomum villosum eliminates dampness and invigorates the spleen. Together, they address the pathological conditions of phlegm-heat stagnation and qi stagnation caused by sepsis, clearing away phlegm-heat and restoring spleen and stomach qi. Asarum and cinnamon twigs are pungent and warm, promoting yang and warming the heart meridian, dispelling pathogenic cold. Angelica sinensis and processed Polygonum multiflorum nourish the blood and kidneys, tonifying both heart blood and kidney essence, connecting the heart and kidneys and maintaining the body's yin and yang balance.

[0027] Inula flower and sandalwood promote qi and blood circulation, while madder root cools the blood and dissolves stasis. Working together, these three ingredients can unblock the flow of qi and blood, dissipate blood stasis, and improve cardiac circulation. Xiebai powder, composed of mulberry bark and rehmannia root, is specifically designed to clear lung heat, promote lung qi, and restore the lung's function to connect all meridians, allowing lung qi to normally disperse and descend, thereby aiding the recovery of cardiac function. Bambusa chinensis promotes diuresis and eliminates dampness, effectively reducing posterior circulation volume, alleviating cardiac workload, and relieving the stress caused by volume overload.

[0028] The various Chinese herbs in the whole formula cooperate with each other and synergistically enhance their effects, from clearing away heat and detoxifying, nourishing yin and dispersing blood stasis, to promoting lung qi and relieving heart numbness; from removing phlegm and widening the chest, promoting yang and dispersing stagnation, to clearing heat and resolving phlegm, warming and unblocking the heart meridians; from promoting qi and blood circulation, cooling blood and removing blood stasis, to promoting diuresis and reducing the burden on the heart, jointly achieving the effects of "relieving heart numbness, invigorating qi and unblocking meridians, extinguishing wind and clearing fire, removing blood stasis and promoting diuresis", accurately targeting the complex pathophysiological mechanisms of septic cardiomyopathy inflammatory storm, myocardial depression, coronary microvascular dysfunction, etc., improving heart function through multiple targets and multiple pathways, and regulating the overall state of the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The present invention relates to a structural schematic diagram of a floating ball used in a method for preparing a traditional Chinese medicine for treating septic cardiomyopathy (including a stereogram and a longitudinal cross-sectional structural schematic diagram).

[0030] In the picture

[0031] Floating ball 1; opening 2; counterweight portion 3; opening and closing piece 4; mounting hole 5; air hole 6. DETAILED DESCRIPTION

[0032] The present invention will be further described in detail below with reference to the accompanying drawings.

[0033] This specific embodiment is merely an explanation of the present invention and is not intended to limit the present invention. After reading this specification, those skilled in the art may make non-creative modifications to this embodiment as needed. However, as long as such modifications are within the scope of the claims of the present invention, they are protected by patent law.

[0034] Example 1:

[0035] A traditional Chinese medicine formula for septic cardiomyopathy comprises 22 parts by weight of inula flower, 16 parts by weight of madder root, 16 parts by weight of cimicifuga, 11 parts by weight of turtle shell with vinegar, 21 parts by weight of peony root, 16 parts by weight of angelica root, 12 parts by weight of asarum, 11 parts by weight of tongcao, 16 parts by weight of turmeric with vinegar, 17 parts by weight of belamcanda chinensis, 22 parts by weight of aster root, 16 parts by weight of trichosanthes root, 32 parts by weight of xiebai, 16 parts by weight of cinnamon twig, 22 parts by weight of pinellia tuber, 16 parts by weight of immature aurantium, 12 parts by weight of salvia miltiorrhiza, 6 parts by weight of santalin, 7 parts by weight of amomum villosum, 32 parts by weight of rhizoma annuae, 17 parts by weight of mulberry bark, 32 parts by weight of rehmannia root, 12 parts by weight of processed polygonum multiflorum, 22 parts by weight of moutan bark, 12 parts by weight of bupleurum root, 12 parts by weight of loblolly bamboo leaf, and 12 parts by weight of forsythia.

[0036] Example 2:

[0037] A traditional Chinese medicine formula for septic cardiomyopathy comprises 18 parts by weight of inula flower, 13 parts by weight of madder root, 13 parts by weight of cimicifuga, 8 parts by weight of turtle shell with vinegar, 18 parts by weight of peony root, 13 parts by weight of angelica root, 9 parts by weight of asarum, 9 parts by weight of tongcao, 13 parts by weight of turmeric with vinegar, 14 parts by weight of beam dryness, 18 parts by weight of aster root, 13 parts by weight of trichosanthes root, 28 parts by weight of allium macrostemon, 13 parts by weight of cinnamon twig, 18 parts by weight of pinellia tuber, 13 parts by weight of immature bitter orange, 8 parts by weight of salvia miltiorrhiza, 4 parts by weight of santalin, 4 parts by weight of amomum villosum, 28 parts by weight of rhizoma anthracis, 13 parts by weight of mulberry bark, 28 parts by weight of rehmannia root, 8 parts by weight of processed polygonum multiflorum, 18 parts by weight of moutan bark, 8 parts by weight of bupleurum root, 8 parts by weight of loblolly bamboo leaf, and 8 parts by weight of forsythia.

[0038] Example 3:

[0039] A traditional Chinese medicine formula for septic cardiomyopathy comprises 20 parts by weight of inula flower, 15 parts by weight of madder root, 15 parts by weight of cimicifuga, 10 parts by weight of turtle shell with vinegar, 20 parts by weight of peony root, 15 parts by weight of angelica root, 10 parts by weight of asarum, 10 parts by weight of tongcao, 15 parts by weight of turmeric with vinegar, 15 parts by weight of belamcanda chinensis, 20 parts by weight of aster root, 15 parts by weight of trichosanthes root, 30 parts by weight of allium macrostemon, 15 parts by weight of cinnamon twig, 20 parts by weight of pinellia tuber, 15 parts by weight of immature bitter orange, 10 parts by weight of salvia miltiorrhiza, 5 parts by weight of santalin, 5 parts by weight of amomum villosum, 30 parts by weight of rhizoma annuae, 15 parts by weight of mulberry bark, 30 parts by weight of rehmannia root, 10 parts by weight of processed polygonum multiflorum, 20 parts by weight of moutan bark, 10 parts by weight of bupleurum root, 10 parts by weight of loblolly bamboo leaf, and 10 parts by weight of forsythia.

[0040] Example 4:

[0041] A method for preparing a traditional Chinese medicine for septic cardiomyopathy comprises the following steps:

[0042] Ingredients: 20 parts by weight of Inula flower, 15 parts by weight of Rubia cordifolia, 15 parts by weight of Cimicifuga heracleifolia, 10 parts by weight of Vinegar turtle shell, 20 parts by weight of Peony root, 15 parts by weight of Angelica sinensis, 10 parts by weight of Asarum, 10 parts by weight of Smilax glabra, 15 parts by weight of Vinegar Curcuma aromatica, 15 parts by weight of Belamcanda chinensis, 20 parts by weight of Aster tataricus, 15 parts by weight of Trichosanthes kirilowii, 30 parts by weight of Allium macrostemon, 15 parts by weight of Cinnamomum cassia twig, 20 parts by weight of Pinellia ternata, 15 parts by weight of Citrus aurantium, 10 parts by weight of Pig Heart Blood Salvia miltiorrhiza, 5 parts by weight of Santalum album, 5 parts by weight of Amomum villosum, 30 parts by weight of Rhizoma Zingiberis, 15 parts by weight of Morus alba, 30 parts by weight of Lycium bark, 10 parts by weight of Processed Polygonum multiflorum, 20 parts by weight of Cortex Moutan, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Bambusa truncatum and 10 parts by weight of Fructus Forsythiae;

[0043] Decoction: soak the above medicinal materials in water, decoct over high heat, decoct again over low heat and filter; then add water, decoct and filter, mix the decoctions after the two filtrations to form a mixed liquid, and concentrate to make a medicinal liquid.

[0044] Furthermore, during the decoction process, the Inula flower is wrapped and decocted, the Vinegar-soaked Turtle Shell is decocted first, and the Sandalwood and Amomum villosum are added later.

[0045] Furthermore, the decoction step specifically includes: soaking the above medicinal materials in 5 times the volume of water for 1 hour, decocting with high heat for 10 minutes, decocting with low heat for another 20 minutes, and filtering; then adding 3 times the volume of water and decocting for 20 minutes, and filtering, mixing the decoctions after the two filtrations; and concentrating to 2.04758 crude drugs / mL of liquid medicine.

[0046] In this embodiment, the concentration process includes: adding the mixed liquid into an evaporation container, and adding a plurality of floating balls 1 into the evaporation container, wherein the diameter of the floating balls 1 is set to 1-2 cm, the lower half of the floating balls 1 is provided with a counterweight portion 3, and the upper half is provided with a plurality of openings 2 distributed circumferentially, the openings 2 are provided with opening and closing pieces 4, the opening and closing pieces 4 are provided with mounting holes 5, the mounting holes 5 are provided with silica gel, and the silica gel is provided with air holes 6, the top of the opening and closing piece 4 is adhered to the inner wall of the floating ball 1, and the floating ball 1 and the opening and closing piece 4 are made of stainless steel.

[0047] The setting of the floating ball 1 has many advantages. During the concentration process, the floating ball 1 is put into the mixed liquid, so that the floating ball 1 is filled with the mixed liquid through the opening 2. After the mixed liquid is filled, the floating ball 1 sinks. After heating, water vapor is generated in the floating ball 1, and the pressure increases, which pushes the opening and closing piece 4 to close, so that the opening and closing piece 4 closes the opening 2, thereby causing the pressure inside the floating ball 1 to continue to increase. When the pressure increases, the pressure will push the silicone to deform, causing the air hole 6 to open, and the liquid and gas in the floating ball 1 to spray out, which will eventually make the buoyancy of the floating ball 1 greater than its gravity, thereby achieving an upward rise. After rising to the liquid surface, the opening and closing piece 4 is higher than the liquid surface. Due to the gravity of the opening and closing piece 4 itself and the reduction of its own buoyancy, the closed state between the opening and closing piece 4 and the opening 2 is released, the gas inside the floating ball 1 is discharged, the internal pressure is reduced, and the mixed liquid re-enters the floating ball 1, thereby causing the floating ball 1 to sink again. Therefore, during the concentration process, the movement of the floating ball 1 is manifested as a cyclic sinking and rising movement. During the movement, on the one hand, the mixed liquid is stirred by the jet of air through the air hole 6, and also because of its own movement. In addition, since the internal pressure and temperature of the floating ball 1 are relatively high, the heat transfer effect can be effectively enhanced, thereby effectively increasing the speed of the concentration process overall.

[0048] In order to improve the sealing effect, a silicone sealing ring is provided on the edge of the opening and closing piece 4.

[0049] The following clinical trials are used to illustrate that the TCM prescriptions or the prepared TCMs of the above embodiments have significant technical effects:

[0050] 1. Case

[0051] There were 20 patients in the observation group and 20 in the control group. The control group included 12 males and 8 females, with a mean age of 47.52±4.62 years and a disease course of 4.62±1.76 days. The observation group included 9 males and 11 females, with a mean age of 46.71±4.85 years and a disease course of 4.83±2.10 days. No significant differences were observed between the two groups in terms of gender composition, age, or disease course (P>0.05), meeting the comparability requirements for a controlled clinical study.

[0052] 2. Diagnostic criteria

[0053] Sepsis diagnostic criteria: The diagnostic criteria are formulated with reference to the "Chinese Guidelines for the Emergency Treatment of Sepsis / Septic Shock (2018)" and the "Expert Consensus on the Diagnosis and Treatment of Sepsis with Integrated Traditional Chinese and Western Medicine": confirmed or highly suspected infection with two of the following clinical features: ① fever (body temperature >38.3°C) or hypothermia (body temperature <36°C); ② heart rate >90 beats / min or >2 standard deviations of the normal heart rate for different ages; ③ respiratory rate >30 breaths / min, and one of the following features: ① white blood cell count >12×10° / L or <4×10° / L, decreased lymphocyte count; ② C-reactive protein (CRP) >2 standard deviations above normal; ③ procalcitonin (PCT) >2 standard deviations above normal; ④ blood glucose >7.7 mmol / L or 6.1 mmol / L (without a history of diabetes).

[0054] On the basis of sepsis, a diagnosis of septic cardiomyopathy is made if one of the following conditions is met: ① acute global cardiac dysfunction (systolic / diastolic) with poor response to fluid resuscitation and catecholamines; ② a nonspecific electrocardiogram (ECG), with common sinus tachycardia and atrial fibrillation; ③ an echocardiogram showing systolic and / or diastolic dysfunction, cardiac dilatation, and an EF reduction of <50%, requiring differential diagnosis for pericardial effusion, ACS, and left ventricular outflow tract obstruction; and ④ abnormal elevations of myocardial markers cTnI and BNP (or NT-proBNP).

[0055] 3. Inclusion criteria

[0056] ① Patients diagnosed with sepsis and its complications;

[0057] ②Age 18-80, no gender restrictions;

[0058] ③Good compliance;

[0059] ④The patient or the patient's family member agrees and signs the informed consent form.

[0060] 4. Exclusion criteria

[0061] ① A history of uncontrolled, multi-site metastasis of unresectable malignant solid tumors, hematologic tumors, autoimmune diseases, etc.

[0062] ② History of hematopoietic stem cell transplantation, liver, kidney, lung, pancreas and other solid organ transplantation;

[0063] ③Expected survival time <24h;

[0064] ④ Pregnancy or lactation period;

[0065] ⑤ Allergic to the Chinese medicine ingredients in this study;

[0066] ⑥ Drug addicts who have not yet detoxified.

[0067] 5. Elimination criteria

[0068] ① Those who did not meet the inclusion criteria and were mistakenly included;

[0069] ② Failure to receive the treatment of this study as required;

[0070] ③ The data during the observation process is incomplete, which affects the judgment of efficacy.

[0071] 6. Dropout criteria

[0072] Subjects who meet the inclusion criteria but fail to complete the study for any reason are considered dropouts. This includes both voluntary withdrawal and withdrawal determined by the investigator. ① Investigator-determined withdrawal: This occurs when an enrolled subject becomes unsuitable for further study progress and the investigator decides to withdraw the subject from the study. These may include: the subject experiencing specific physiological changes that render them unsuitable for further study; poor subject compliance; or the use of a prohibited drug as specified in the protocol. ② Voluntary withdrawal: According to the informed consent form, subjects have the right to withdraw from the study midway. Alternatively, if a subject does not explicitly request withdrawal but is lost to follow-up due to no further testing, this also constitutes a "dropout" (or "dropout"). The reasons for withdrawal should be understood and recorded as much as possible, such as intolerance to certain tests; a personal circumstance preventing them from continuing the clinical study; financial factors; or loss to follow-up without a stated reason. Regardless of the reason, a case record should be maintained for each subject who withdraws from the study.

[0073] 7. Intervention Plan

[0074] Control group: With reference to relevant diagnosis and treatment guidelines, the patients were given nutritional support, anti-infection, symptomatic treatment with glucocorticoids and other drugs according to their conditions; intravenous fluid infusion; and low-flow oxygen inhalation.

[0075] The observation group was treated with a Chinese medicine prescription comprising 20 parts by weight of Inula Flos, 15 parts by weight of Rubia cordifolia, 15 parts by weight of Cimicifuga foetida, 10 parts by weight of Carapax Trichosanthis, 20 parts by weight of Paeonia lactiflora, 15 parts by weight of Angelica sinensis, 10 parts by weight of Asarum, 10 parts by weight of Smilax glabra, 15 parts by weight of Curcuma aromatica, 15 parts by weight of Belamcanda Root, 20 parts by weight of Aster tataricus, 15 parts by weight of Trichosanthes kirilowii, 30 parts by weight of Allium macrostemon, 15 parts by weight of Cinnamomum cassia, 20 parts by weight of Pinellia ternata, 15 parts by weight of Immature Citrus aurantium, 10 parts by weight of Salvia miltiorrhiza, 5 parts by weight of Santalum album, 5 parts by weight of Amomum villosum, 30 parts by weight of Rhizoma Zingiberis, 15 parts by weight of Morus alba, 30 parts by weight of Lycium bark, 10 parts by weight of Polygonum multiflorum processed, 20 parts by weight of Cortex Moutan, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Folium Bambusae and 10 parts by weight of Fructus Forsythiae for treatment.

[0076] 8. Observation indicators and results

[0077] (1) Comparison of 7-day clinical efficacy

[0078] In the observation group, 13 cases were markedly effective, 12 cases were effective, and 5 cases were ineffective, with a total effective rate of 83.33%. In the control group, 7 cases were markedly effective, 10 cases were effective, and 13 cases were ineffective, with a total effective rate of 56.67%. The difference in total clinical effective rate between the two groups was statistically significant (P < 0.05).

[0079] (2) Comparison of inflammatory indicators over 7 days

[0080] There was no statistically significant difference in TNF-α and IL-6 levels between the two groups before treatment (P>0.05). After treatment, the mean TNF-α and IL-6 levels in the observation and control groups were significantly lower than those before treatment (P<0.05). The TNF-α and IL-6 levels in the observation group were significantly lower than those in the control group (P<0.05). See Table 1 for details.

[0081] Table 1 Comparison of inflammatory indicators over 7 days

[0082]

[0083]

[0084] Note: Compared with the same group before treatment, *P<0.05; compared with the control group, #P<0.05.

[0085] (3) Comparison of myocardial function indicators at 7 days

[0086] There was no statistically significant difference in CI, MAP, and LVEF levels between the two groups before treatment (P>0.05). After treatment, CI, MAP, and LVEF levels in both the observation and control groups increased compared with those before treatment, with statistically significant differences (P<0.05). After treatment, CI, MAP, and LVEF levels in the observation group increased compared with those in the control group, with statistically significant differences (P<0.05). See Table 2 for details.

[0087] Table 2 Comparison of myocardial function indicators at 7 days

[0088]

[0089] Note: Compared with the same group before treatment, *P<0.05; compared with the control group, #P<0.05.

[0090] It should be noted that, in this document, relational terms such as first and second, etc., are used solely to distinguish one entity or operation from another, and do not necessarily require or imply any actual relationship or order between these entities or operations. Furthermore, the terms "include," "comprise," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or terminal device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or terminal device. Without further limitation, elements defined by the phrase "include..." or "comprising..." do not exclude the presence of additional elements in the process, method, article, or terminal device comprising the elements. Furthermore, in this document, "greater than," "less than," "exceeding," etc., are understood to exclude the number itself; "above," "below," "within," etc., are understood to include the number itself.

[0091] The above description of the embodiments is intended to facilitate understanding and application of the present invention by those skilled in the art. It is apparent that those skilled in the art can readily make various modifications to the embodiments and apply the general principles described herein to other embodiments without requiring creative effort. Therefore, the present invention is not limited to the above-described embodiments. Improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine formula for septic cardiomyopathy, characterized in that: The invention comprises 18-22 parts by weight of Inula flower, 13-16 parts by weight of Rubia cordifolia, 13-16 parts by weight of Cimicifuga heracleifolia, 8-11 parts by weight of Carapax trichosanthis, 18-21 parts by weight of Paeonia lactiflora, 13-16 parts by weight of Angelica sinensis, 9-12 parts by weight of Asarum, 9-11 parts by weight of Smilax glabra, 13-16 parts by weight of Curcuma aromatica, 14-17 parts by weight of Belamcanda chinensis, 18-22 parts by weight of Aster tataricus, 13-16 parts by weight of Trichosanthes kirilowii, 28-32 parts by weight of Allium macrostemon, 13-16 parts by weight of Cinnamomum cassiae. 16 parts by weight, 18-22 parts by weight of French Pinellia, 13-16 parts by weight of Citrus aurantium, 8-12 parts by weight of pig heart blood Salvia miltiorrhiza, 4-6 parts by weight of Santalum album, 4-7 parts by weight of Amomum villosum, 28-32 parts by weight of Anemarrhena rhizome, 13-17 parts by weight of Morus alba, 28-32 parts by weight of Lycium bark, 8-12 parts by weight of processed Polygonum multiflorum, 18-22 parts by weight of Moutan bark, 8-12 parts by weight of Bupleurum chinense, 8-12 parts by weight of Bambusa chinensis and 8-12 parts by weight of Forsythia suspensa.

2. A traditional Chinese medicine formula for septic cardiomyopathy according to claim 1, characterized in that: The invention comprises 22 parts by weight of inula flower, 16 parts by weight of madder root, 16 parts by weight of cimicifuga, 11 parts by weight of turtle shell with vinegar, 21 parts by weight of peony root, 16 parts by weight of angelica root, 12 parts by weight of asarum, 11 parts by weight of tongcao, 16 parts by weight of turmeric with vinegar, 17 parts by weight of beam dryness, 22 parts by weight of aster root, 16 parts by weight of trichosanthes root, 32 parts by weight of xiebai, 16 parts by weight of cassia twig, 22 parts by weight of pinellia tuber, 16 parts by weight of aurantium immaturum, 12 parts by weight of salvia miltiorrhiza, 6 parts by weight of santalin, 7 parts by weight of amomum villosum, 32 parts by weight of rhizoma annuae, 17 parts by weight of mulberry bark, 32 parts by weight of rehmannia root bark, 12 parts by weight of processed polygonum multiflorum, 22 parts by weight of moutan bark, 12 parts by weight of bupleurum root, 12 parts by weight of loblolly bamboo leaf and 12 parts by weight of forsythia.

3. A traditional Chinese medicine formula for septic cardiomyopathy according to claim 1, characterized in that: The invention comprises 18 parts by weight of inula flower, 13 parts by weight of madder root, 13 parts by weight of cimicifuga, 8 parts by weight of turtle shell with vinegar, 18 parts by weight of peony root, 13 parts by weight of angelica root, 9 parts by weight of asarum, 9 parts by weight of tongcao, 13 parts by weight of turmeric with vinegar, 14 parts by weight of beam dryness, 18 parts by weight of aster root, 13 parts by weight of trichosanthes root, 28 parts by weight of xiebai, 13 parts by weight of cassia twig, 18 parts by weight of pinellia tuber, 13 parts by weight of immature bitter orange, 8 parts by weight of salvia miltiorrhiza, 4 parts by weight of santalin, 4 parts by weight of amomum villosum, 28 parts by weight of rhizoma anthracis, 13 parts by weight of mulberry bark, 28 parts by weight of rehmannia root, 8 parts by weight of processed polygonum multiflorum, 18 parts by weight of moutan bark, 8 parts by weight of bupleurum root, 8 parts by weight of loblolly bamboo leaf and 8 parts by weight of forsythia.

4. The traditional Chinese medicine formula for septic cardiomyopathy according to claim 1, characterized in that: The invention comprises 20 parts by weight of inula flower, 15 parts by weight of madder root, 15 parts by weight of cimicifuga, 10 parts by weight of turtle shell with vinegar, 20 parts by weight of peony root, 15 parts by weight of angelica root, 10 parts by weight of asarum, 10 parts by weight of tongcao, 15 parts by weight of turmeric with vinegar, 15 parts by weight of beam dryness, 20 parts by weight of aster root, 15 parts by weight of trichosanthes root, 30 parts by weight of xiebai, 15 parts by weight of cassia twig, 20 parts by weight of pinellia tuber, 15 parts by weight of immature bitter orange, 10 parts by weight of pig heart blood salvia miltiorrhiza, 5 parts by weight of santalin, 5 parts by weight of amomum villosum, 30 parts by weight of rhizoma anthracis, 15 parts by weight of mulberry bark, 30 parts by weight of rehmannia root, 10 parts by weight of processed polygonum multiflorum, 20 parts by weight of moutan bark, 10 parts by weight of bupleurum root, 10 parts by weight of loblolly bamboo leaf and 10 parts by weight of forsythia.

5. A method for preparing a traditional Chinese medicine for septic cardiomyopathy, characterized in that: The steps include: Ingredients: 18-22 parts by weight of Inula flower, 13-16 parts by weight of Rubia cordifolia, 13-16 parts by weight of Cimicifuga heracleifolia, 8-11 parts by weight of Vinegar Turtle Carapace, 18-21 parts by weight of Peony Root, 13-16 parts by weight of Angelica Sinensis, 9-12 parts by weight of Asarum, 9-11 parts by weight of Tongcao, 13-16 parts by weight of Vinegar Curcuma Radix, 14-17 parts by weight of Belamcanda Root, 18-22 parts by weight of Aster, 13-16 parts by weight of Trichosanthes, 28-32 parts by weight of Xiebai, 13 parts by weight of Cinnamomum cassiae. -16 parts by weight, French Pinellia 18-22 parts by weight, Citrus aurantium 13-16 parts by weight, pig heart blood salvia miltiorrhiza 8-12 parts by weight, santalin 4-6 parts by weight, amomum villosum 4-7 parts by weight, ginger bamboo 28-32 parts by weight, morus alba bark 13-17 parts by weight, lycium bark 28-32 parts by weight, prepared Polygonum multiflorum 8-12 parts by weight, moutan bark 18-22 parts by weight, bupleurum 8-12 parts by weight, bamboo leaf 8-12 parts by weight, and forsythia suspensa 8-12 parts by weight; Decoction: soak the above medicinal materials in water, decoct over high heat, decoct again over low heat and filter; then add water, decoct and filter, mix the decoctions after the two filtrations to form a mixed liquid, and concentrate to make a medicinal liquid.

6. The method for preparing a traditional Chinese medicine for septic cardiomyopathy according to claim 5, characterized in that: The specific ingredients are: 20 parts by weight of Inula flower, 15 parts by weight of Rubia cordifolia, 15 parts by weight of Cimicifuga foetida, 10 parts by weight of Vinegar turtle shell, 20 parts by weight of Paeonia lactiflora, 15 parts by weight of Angelica sinensis, 10 parts by weight of Asarum, 10 parts by weight of Smilax glabra, 15 parts by weight of Vinegar Curcuma aromatica, 15 parts by weight of Belamcanda chinensis, 20 parts by weight of Aster tataricus, 15 parts by weight of Trichosanthes kirilowii, 30 parts by weight of Allium macrostemon, 15 parts by weight of Cinnamomum cassia, 20 parts by weight of Pinellia ternata, 15 parts by weight of Citrus aurantium, 10 parts by weight of Pig Heart Blood Salvia miltiorrhiza, 5 parts by weight of Santalum album, 5 parts by weight of Amomum villosum, 30 parts by weight of Rhizoma Zingiberis, 15 parts by weight of Morus alba, 30 parts by weight of Lycium bark, 10 parts by weight of Processed Polygonum multiflorum, 20 parts by weight of Cortex Moutan, 10 parts by weight of Bupleurum chinense, 10 parts by weight of Bambusa truncatum and 10 parts by weight of Fructus Forsythiae.

7. The method for preparing a traditional Chinese medicine for septic cardiomyopathy according to claim 5, characterized in that: During the decoction process, the scutellaria baicalensis is wrapped and decocted first, and the turtle shell with vinegar is decocted first, and the sandalwood and amomum villosum are added later.

8. The method for preparing a traditional Chinese medicine for septic cardiomyopathy according to claim 5, characterized in that: The decoction step specifically includes: soaking the above medicinal materials in 5 times the volume of water for 1 hour, decocting with high heat for 10 minutes, decocting with low heat for another 20 minutes, and filtering; then adding 3 times the volume of water and decocting for 20 minutes, and filtering, mixing the decoctions after the two filtrations; and concentrating to 2.04758 crude drug / mL of medicinal solution.

9. The method for preparing a traditional Chinese medicine for septic cardiomyopathy according to claim 5, characterized in that: The concentration process includes: adding the mixed liquid into an evaporation container, and adding a plurality of floating balls into the evaporation container, wherein the diameter of the floating balls is set to 1-2 cm, the lower half of the floating balls is provided with a counterweight portion, and the upper half is provided with a plurality of openings distributed circumferentially, the openings are provided with opening and closing plates, the opening and closing plates are provided with mounting holes, silica gel is provided in the mounting holes, and air holes are provided on the silica gel, the top of the opening and closing plates is adhered to the inner wall of the floating balls, and the floating balls and the opening and closing plates are made of stainless steel.

10. The method for preparing a traditional Chinese medicine for septic cardiomyopathy according to claim 9, characterized in that: A silicone sealing ring is provided on the edge of the opening and closing piece.

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