Traditional Chinese medicine composition for treating warm disease clinically belonging to same disease of defensive qi as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating a warm disease clinically belonging to the same disease of defensive qi and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 5-35 parts of bupleurum chinense, 9-50 parts of scutellaria baicalensis, 9-50 parts of artemisia apiacea, 5-35 parts of radix paeoniae rubra, 5-35 parts of moutan bark and 4-26 parts of folia perillae acutae. According to the traditional Chinese medicine composition, the effects of all the medicines are utilized to generate a synergistic effect, and the effects of relieving fever, eliminating evil and detoxifying are achieved together. The traditional Chinese medicine composition is used for treating fever or hyperpyrexia, slight aversion to wind-cold, headache, sweating, thirst, cough and pharyngalgia caused by cold, viral cold and upper respiratory tract infection febrile disease defensive qi, and can be accompanied by nausea, vomiting, neck stiffness, rash appearance, red eye swelling and pain and the like, so that the febrile disease is effectively treated.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, its preparation method, and its application. Background Technology

[0002] Fever, commonly known as a fever, is a symptom. In normal individuals, the body's heat production and dissipation processes are normally kept in dynamic balance under the regulation of the thermoregulatory center. The average normal human body temperature is between 36 and 37°C (axillary). When the body is exposed to pyrogens or when the thermoregulatory center malfunctions, heat production increases. 37.3–38°C is considered a low-grade fever, 38.1–39°C is a moderate fever, 39.1–41°C is a high fever, and hyperpyrexia is above 41°C. A body temperature ≥37.3°C is defined as a fever.

[0003] Febrile diseases: A general term for acute febrile diseases caused by external pathogenic heat. Also known as warm diseases. The main clinical manifestations are fever, predominantly heat-related symptoms (tongue appearance, pulse, urination, etc.), and a tendency to generate dryness and damage yin. The main manifestations of febrile diseases of the warm-heat type are: initially presenting as lung-wei syndrome, with predominantly heat-related symptoms, a tendency to generate dryness and damage yin, rapid onset, and rapid spread.

[0004] Traditional Chinese Medicine (TCM) Differentiation of Febrile Diseases: The *Wenbing Tiaobian* (Treatise on Febrile Diseases) uses the Sanjiao (Triple Burner) as its framework and disease names as its categories, integrating differentiation of syndromes based on the Zang-Fu organs and meridians, as well as the differentiation of syndromes based on Wei Qi Ying Xue (Defensive Qi, Nutritive Qi, and Blood). In clinical treatment of febrile diseases, the differentiation of syndromes based on the Sanjiao and Wei Qi Ying Xue complement each other. For febrile diseases: the differentiation of syndromes based on Wei Qi Ying Xue summarizes the pathology, symptoms, and course of the disease. Its clinical significance is:

[0005] 1. It summarizes four syndromes in the disease process: Wei syndrome, Qi syndrome, Ying syndrome, and Xue syndrome.

[0006] 2. It summarizes the transmission and progression of pathogenic factors and the different stages of severity in the course of febrile diseases. The transformation of febrile diseases involves the entry of pathogenic factors into the Qi level, and then into the Ying and Xue levels. Traditional Chinese medicine differentiates these into two types: simultaneous Wei-Qi disease or simultaneous Wei-Ying disease.

[0007] Warm syndrome is characterized by heat and dampness, with heat toxicity as the primary pathogenic factor. The pathogenesis involves the damage of pathogenic factors to the body's vital energy and the struggle between the body's vital energy and pathogenic factors, resulting in an excess of Yang. This excess of Yang manifests as a heat-related disease, primarily characterized by fever. As Huang Yuanyu stated, "The Qi in the body's meridians, if not stagnant, will not flourish. Stagnation leads to an excess of Yang, generating heat, and an excess of Yin, generating cold."

[0008] Traditional Chinese medicine (TCM) classifies fever into two categories: exogenous fever and endogenous fever. Exogenous fever refers to fever caused by exposure to pathogenic factors (wind, cold, dampness, heat, dryness, fire, and fire) or febrile diseases, resulting in a persistent and elevated body temperature, accompanied by chills, flushed face, thirst, and rapid pulse. It is commonly seen in colds and seasonal influenza, and as a prevalent and serious illness, it has been valued by physicians throughout history. Endogenous fever refers to fever caused by dysfunction of the internal organs due to emotional distress, dietary imbalances, overexertion, or prolonged illness.

[0009] Ye Tianshi said, "Sweating is acceptable when the fever is in the Wei level; only when it reaches the Qi level can the Qi be cleared; when it enters the Ying level, the heat can still be released and the Qi can be transformed; but when it enters the Xue level, it may consume and disturb the blood, so it is necessary to cool the blood and disperse the blood." Wang Pei believed that in clinical practice, it is rare for fever to manifest as a single Wei, Qi, Ying, or Xue level disease. More often, Wei and Qi are affected simultaneously, Qi and Ying are affected simultaneously, or even all three levels of Wei, Qi, Ying, and Xue are affected. However, the general principle can be "to release the heat outwards," with multiple methods used in parallel, taking advantage of the situation, and gradually releasing the heat layer by layer, so that the Qi can be transported and the pathogenic heat can be released.

[0010] The composition of this invention is based on the principle of syndrome differentiation and treatment: using the principles of harmonizing and reducing fever, and expelling pathogens and detoxifying, it is applied to the clinical treatment of febrile diseases belonging to the syndrome of simultaneous Wei Qi disease.

[0011] Modern medicine believes that fever is a sign of infection and inflammatory diseases in the body. It has a dual function of defense and damage. Persistent high fever can lead to cell degeneration, causing damage to multiple organ functions, and in severe cases, it can affect brain nerve and tissue functions. The mechanism of fever is that exogenous pyrogens stimulate monocytes, macrophages, lymphocytes, etc. in the body to produce various endogenous pyrogens such as IL-6, IL-1β, and tumor necrosis factor-α (TNF-α). Phospholipase C (PLC) hydrolyzes arachidonic acid (AA), which is then converted into prostaglandin E2 (PGE2) under the action of cyclooxygenase. PGE2 binds to prostaglandin E2 receptor subtype 3 (E-prostanoid 3, EP3) in the hypothalamus, causing the body temperature set point to rise. IL-6, as a key factor in the onset of fever, can induce the synthesis of cyclooxygenase-2 (COX-2). The nerve cells of EP3 receptor further trigger sympathetic nerve excitation, releasing norepinephrine (NE) and acetylcholine, increasing thermogenesis in brown fat cells, leading to vasoconstriction, thereby preventing the body from losing heat and causing a rise in body temperature.

[0012] Search results revealed that there are many Chinese herbal combinations that have the functions of clearing heat and detoxifying, and reducing fever. However, Chinese medicine emphasizes the principle of syndrome differentiation and treatment, and "the prescription is based on the method, and the method is based on the syndrome." Each combination has different principal, assistant, adjuvant, and guide ingredients according to its own treatment principles, and different focuses on different pathologies and mechanisms, so the differences are quite significant.

[0013] The composition of this invention differs from patented inventions that use pungent and cooling herbs to relieve exterior syndromes and clear heat and detoxify. Examples are provided below.

[0014] CN114699467A discloses a traditional Chinese medicine for clearing the lungs and reducing fever, characterized in that: the raw materials of the traditional Chinese medicine for clearing the lungs and reducing fever are composed of 15-30 parts of buckwheat, 9-15 parts of stir-fried scutellaria baicalensis, 4-9 parts of perilla leaf, 4-9 parts of peppermint, 4-9 parts of bupleurum chinense, 15-30 parts of artemisia annua, and 15-30 parts of isatis tinctoria leaf.

[0015] Although this composition contains four Chinese medicinal herbs—Scutellaria baicalensis, Perilla frutescens, Bupleurum chinense, and Artemisia annua—it is pungent and cool in nature, relieving exterior syndromes and reducing fever, and is used for exterior syndromes.

[0016] The composition of this invention addresses the syndrome of simultaneous Wei Qi and Wei Qi deficiency, moving from the exterior to the interior, and is tailored to different clinical conditions. Fever can be moderate or high.

[0017] From the perspective of traditional Chinese medicine (TCM) diagnosis and treatment, the composition of this invention is for relieving exterior symptoms and clearing heat, while the composition of this invention is for harmonizing and reducing fever. Furthermore, the different combinations of principal, assistant, adjuvant, and guide herbs in TCM theory lead to different clinical applications.

[0018] CN102940861A discloses a traditional Chinese medicine composition for treating fever during menstruation, characterized in that it is composed of the following traditional Chinese medicine raw materials in the indicated weight ratios: Bupleurum chinense 5-20 parts, Scutellaria baicalensis 5-15 parts, Pinellia ternata 5-15 parts, Codonopsis pilosula 5-20 parts, Glycyrrhiza uralensis (processed) 5-15 parts, Paeonia lactiflora 5-20 parts, Paeonia veitchii 5-20 parts, Ligusticum chuanxiong 5-20 parts, Prunus persica 5-20 parts, Rubia cordifolia 5-20 parts, Zingiber officinale 5-15 parts, and Paeonia suffruticosa 5-20 parts.

[0019] Although this composition contains Bupleurum, Scutellaria baicalensis, Paeonia lactiflora, and Paeonia suffruticosa, it is used for menstrual fever due to Yin deficiency, nourishing Yin, clearing heat, and promoting blood circulation. Its antipyretic effect is characterized by tidal fever and sweating, which is a type of internal heat and does not fall under the category of febrile diseases.

[0020] The composition of this invention is for exogenous fever belonging to the category of febrile diseases. According to traditional Chinese medicine theory, different types are classified, and the diagnosis and treatment methods differ, leading to different clinical applications.

[0021] CN118615353A discloses a traditional Chinese medicine composition for clearing heat and unblocking collaterals, characterized in that: the traditional Chinese medicine composition contains the following traditional Chinese medicine raw materials: Bupleurum, Scutellaria baicalensis, Artemisia annua, Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, Rheum palmatum, Sargentodoxa cuneata, Angelica dahurica, and Trachelospermum jasminoides.

[0022] Although this composition contains Bupleurum, Scutellaria baicalensis, and Artemisia annua, it is used for bleeding and blood stasis caused by blood heat syndrome. It clears heat and cools the blood, harmonizing Qi and blood. It is used for heat syndromes that damage the collaterals.

[0023] The original composition clears heat due to internal heat, while the composition of this invention treats external fever, which belongs to febrile diseases. The TCM theories and diagnostic methods used in these two compositions differ. Furthermore, the composition of this invention differs from the original composition in TCM theory, diagnostic methods, and clinical application.

[0024] CN101062253A discloses a traditional Chinese medicine preparation for treating fever during menstruation, characterized in that it is made from the following raw materials in the indicated weight ratios: 2.5-10 parts gypsum, 1.5-6 parts motherwort, 1.5-6 parts anemarrhena, 1.0-4 parts rehmannia, 1.0-4 parts white peony root, 1.0-4 parts artemisia annua, 1.0-4 parts phellodendron bark, 1.0-4 parts stir-fried gardenia, 1.0-4 parts salvia miltiorrhiza, 0.1-2 parts peony bark, 0.1-2 parts scutellaria baicalensis, and 0.1-2 parts bupleurum.

[0025] Although this composition contains Chinese herbs such as Scutellaria baicalensis, Artemisia annua, Bupleurum chinense, and Paeonia suffruticosa, it is used for menstrual fever with blood stasis, nourishing yin, clearing heat, cooling blood, and regulating menstruation.

[0026] The combination used in this invention clears heat from internal heat, while the composition of this invention treats external fever, which falls under the category of febrile diseases. The TCM theories and diagnostic methods used in these two inventions differ. Furthermore, the composition of this invention differs from the TCM composition in its TCM theory, diagnostic methods, and clinical application.

[0027] The composition of this invention is innovative, based on modern scientific and technological evidence and inherited from traditional Chinese medicine theory, and is supported by modern pharmacodynamic experimental data and verified by clinical application. It cannot be easily obtained by simply adding or subtracting ingredients. Summary of the Invention

[0028] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, and its preparation method.

[0029] Febrile diseases are common in a variety of clinical conditions. The composition of this invention is based on the theory of differentiation of syndromes by Wei Qi Ying Xue and the Six Channels, combined with the theory of meridians and collaterals, and is composed of carefully selected drugs. It is different from the traditional formulas for relieving exterior syndromes with pungent and warm herbs, relieving exterior syndromes with pungent and cool herbs, and clearing heat and detoxifying.

[0030] In this invention, Scutellaria baicalensis and Artemisia annua are the principal herbs in the composition. Scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It enters the lung, stomach, and large intestine meridians and can clear excess heat in these meridians. The main active ingredient in Scutellaria baicalensis, baicalin, has strong anti-inflammatory, antibacterial, and antiviral effects, reduces inflammatory factors, and is the main component that exerts the antipyretic effect. Artemisia annua enters the liver, gallbladder, and stomach meridians and has the effects of clearing heat and stopping malaria. It is good at reducing deficiency heat and relieving summer heat. Modern pharmacological studies have shown that Artemisia annua contains several components with antipyretic effects, mainly including artemisinic acid, artemisinin B, and total coumarins from Artemisia annua, which have effects on both excess heat and deficiency heat. Scutellaria baicalensis can clear heat evil in the qi level, while Artemisia annua can relieve heat evil in the ying level. The combination of the two herbs can clear excess heat and reduce deficiency heat, as well as regulate immunity and inhibit inflammatory responses, and can relieve high fever caused by heat in both the qi and ying levels.

[0031] Red peony root, peony bark, and bupleurum are the assistant herbs. Red peony root and peony bark enter the heart, liver, and kidney meridians, acting as blood-entering herbs. They can clear heat and cool the blood, invigorate blood circulation and dispel blood stasis, effectively clearing heat and stagnation in the blood. Modern pharmacological research confirms that the combined use of red peony root and peony bark significantly enhances their anti-inflammatory and blood-activating effects. Currently, fever is rarely a simple Wei-level syndrome, or the Wei-level syndrome is very short-lived, easily progressing to internal heat. Commonly, Wei-Qi, Qi-Ying, and even Wei-Qi-Ying-Blood syndromes are present simultaneously. Bupleurum enters the liver and gallbladder meridians, and has the effects of harmonizing and reducing fever, soothing the liver and relieving stagnation, and raising Yang Qi. Bupleurum combined with the chief herb, scutellaria, can resolve pathogenic factors in the Shaoyang half-exterior and half-interior region. Modern pharmacological research shows that this herb combination can enhance anti-inflammatory and antiviral effects, and improve antipyretic efficacy. Modern pharmacological research confirms that bupleurum volatile oil can directly act on the hypothalamic thermoregulatory center by inhibiting the upward shift of the body temperature set point, thereby achieving an antipyretic effect.

[0032] Perilla leaf is used as an adjuvant: Perilla leaf is pungent and warm, it disperses external pathogens, and also has the effect of aromatic transformation of turbidity, regulating qi and relieving chest tightness. It has multiple uses, working together with the principal and adjuvant herbs to promote qi circulation and eliminate dampness and turbidity to promote body fluid circulation. Perilla leaf has antibacterial, antipyretic, antioxidant, anti-inflammatory and anti-tumor effects, and also has certain effects on the digestive system, cardiovascular system and nervous system.

[0033] This formula treats fever primarily in cases of high fever due to the simultaneous involvement of the Wei Qi and Wei Qi, effectively dispelling pathogens and reducing fever to halt the progression of the disease and prevent severe complications such as heat entering the pericardium. Furthermore, the formula's composition also addresses fever caused by the six meridians: Bupleurum and Artemisia annua clear heat from the Shaoyang meridian; Perilla leaf clears heat from the Taiyin lung and spleen meridians; Scutellaria baicalensis clears heat from the Yangming meridian; Moutan bark clears heat from the Shaoyin meridian; and Red peony root clears heat from the Jueyin meridian. Bupleurum and Perilla leaf disperse external pathogens, clearing heat and expelling pathogens, consistent with the theory of "releasing stagnant fire." If the heat pathogen penetrates deeper, Moutan bark and Red peony root cool the blood and disperse blood stasis, effectively addressing the root cause. The entire formula addresses both the exterior and interior, clearing heat toxins and expelling pathogens, achieving the goal of relieving both exterior and interior symptoms, reducing fever and cooling the body, thus helping to halt disease progression and aiding in rapid recovery. Additionally, this formula clears heat without being excessively cold; the addition of Perilla leaf's Qi-regulating and stomach-strengthening properties protects stomach Qi, improves spleen and stomach function, and eliminates pathogens without harming the body's vital energy.

[0034] The innovation of this invention lies in:

[0035] 1. From a clinical perspective, the primary symptom of febrile diseases is fever, and the main combination of herbs that clear heat and fight viruses is Artemisia annua, Scutellaria baicalensis, and Bupleurum chinense.

[0036] 2. From the perspective of differentiating syndromes of febrile diseases based on the Wei Qi Ying Xue (defense, qi, nutritive, and blood levels): Heat evil permeates the Qi, Ying, and blood levels simultaneously. Clearing heat from the Qi, Ying, and blood levels is crucial. When febrile evil enters the body, it first affects the lungs, then spreads from the interior to the exterior. Use peony bark and red peony root to clear heat, cool the blood, detoxify, and clear heat from the Ying and blood levels. This interrupts the development of the febrile disease and prevents severe cases of heat entering the pericardium.

[0037] 3. Observing the Ascending and Descending of Qi in the Lesser Yang Channel: The *Suwen* states, "Ascending and descending, entering and exiting, are present in all things." The pivot, like the axis of a doorway, functions through the ascending and descending, entering and exiting of Qi. The key to regulating Qi lies in the pivot, especially the pivot of the Lesser Yang channel. The Lesser Yang channel relies on the pivot for its function, indicating its important role in regulating the flow of Qi between the interior and exterior, and ensuring smooth Qi circulation. When warm-heat pathogens invade the Lesser Yang channel, the Qi circulation is impaired, leading to stagnation and the transformation of heat and fire. We start with the Lesser Yang channel: Artemisia annua, Scutellaria baicalensis, and Bupleurum chinense are used to promote the flow of Qi, clear heat, moisten, and resolve turbidity, thus facilitating the Lesser Yang channel.

[0038] 4. When differentiating febrile diseases, we do not adhere to the fixed patterns of differentiation based on the Six Channels in typhoid fever and on the Wei Qi Ying Xue differentiation in febrile diseases. Instead, we unify the theories of treating febrile diseases using both methods, thus integrating the two approaches. Prescriptions and medications are then selected based on the differentiation of syndromes. The Six Channels differentiation serves as the meridian, while the Wei Qi Ying Xue differentiation serves as the weft. From the perspective of the Six Channels, both can cause fever. The focus is on the principle of harmonizing and reducing fever, while simultaneously expelling pathogens and detoxifying to facilitate the overall recovery of the body.

[0039] 5. According to the principles of TCM syndrome differentiation and treatment: This composition has the effects of harmonizing and reducing fever, expelling pathogens and detoxifying. Through TCM theoretical analysis and clinical practice, this invention's composition has revealed that the main manifestations of febrile diseases in clinical practice are: heat pathogens permeating the Qi level, Ying level, and the area between Ying and Blood, resulting in impaired Qi circulation. Based on the principles of TCM syndrome differentiation, this composition is more accurate for treating clinical cases of simultaneous Wei Qi and Wei Qi disorders.

[0040] 6. The composition of this invention conforms to traditional Chinese medicine theory, and modern science has demonstrated that its effective components possess antipyretic, antiviral, and antibacterial properties. Its formulation has also undergone pharmacodynamic and clinical application verification for its antipyretic, antibacterial, and antiviral effects, demonstrating both inheritance and innovation.

[0041] 7. In animal efficacy tests, the composition of the present invention was compared with experimental data when the composition was increased or decreased. Neither method achieved the effect of the composition of the present invention. Therefore, the composition of the present invention is more reasonable and effective.

[0042] This invention addresses clinical fever and symptoms by developing a composition specifically for febrile diseases characterized by simultaneous involvement of the Wei Qi (defensive and qi levels), a warm nature, and a predominantly Yang-type fever. It employs the principles of harmonizing and reducing fever, expelling pathogens and detoxifying, and uses medication rationally based on syndrome differentiation.

[0043] The compositions of this invention have achieved good clinical and experimental results in clinical applications and modern pharmacodynamic studies.

[0044] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, wherein the weight ratio of various components is as follows: Bupleurum chinense 5-35 parts, Scutellaria baicalensis 9-50 parts, Artemisia annua 9-50 parts, Paeonia lactiflora 5-35 parts, Paeonia suffruticosa 5-35 parts, and Perilla frutescens 4-26 parts.

[0045] In the Chinese herbal composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the preferred weight ratio of each component is as follows: Bupleurum chinense 8-28 parts, Scutellaria baicalensis 12-40 parts, Artemisia annua 12-40 parts, Paeonia lactiflora 8-28 parts, Paeonia suffruticosa 8-28 parts, and Perilla frutescens 8-22 parts.

[0046] In the Chinese herbal composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the preferred weight ratio of each component is as follows: Bupleurum chinense 10-25 parts, Scutellaria baicalensis 20-35 parts, Artemisia annua 20-35 parts, Paeonia lactiflora 10-25 parts, Paeonia suffruticosa 10-25 parts, and Perilla frutescens 12-20 parts.

[0047] The Chinese herbal composition for treating febrile diseases that clinically fall under the category of Wei Qi syndrome can be prepared into any commonly used formulation.

[0048] The Chinese herbal composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi can be prepared into preparations including tablets, capsules, granules, pills, mixtures, syrups, decoctions, powders, suppositories, gels, sprays, or injections.

[0049] The Chinese medicines described in this invention can be replaced by Chinese medicines with the same or similar effects, and these medicinal materials can all be processed in accordance with the "National Standards for Processing Chinese Medicines" or the "Dictionary of Chinese Materia Medica". For example, Scutellaria baicalensis can be replaced by Scutellaria baicalensis processed with wine, Bupleurum chinense can be replaced by Bupleurum chinense, and Paeonia lactiflora can be replaced by Paeonia veitchii. The efficacy of the replaced medicinal materials can be better than that of the original medicinal materials, but all of them are within the scope of this invention.

[0050] To address the aforementioned technical problems, this invention provides a method for preparing a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, the method comprising the following steps:

[0051] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0052] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6 to 14 times the amount of raw herbs to water, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use;

[0053] ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare the formulation.

[0054] To address the aforementioned technical problems, this invention provides a method for preparing a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, the method comprising the following steps:

[0055] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0056] ② Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 6 to 14 times the amount of raw herbs to water or ethanol, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use;

[0057] ③ Take peony bark, red peony root, and perilla leaf, add 6-14 times the amount of raw herbs to 50%-90% ethanol or water, heat and reflux for 0.5-5 hours, heat and reflux for 1-3 times, filter, combine the extracts, concentrate under reduced pressure at 40-90℃ to a density of 1.01-1.20, combine the concentrate from step ②, and continue to concentrate to a density of 1.05-1.15, for later use;

[0058] ④ Dry the concentrated liquid from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare the formulation.

[0059] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, the preparation method comprising the following steps:

[0060] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0061] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6-12 times the amount of raw herbs to 50%-90% ethanol, heat and reflux for 1-3 hours, heat and reflux for 1-3 times, filter, combine the extracts, and concentrate under reduced pressure at 50-90℃ to a density of 1.05-1.20 for later use;

[0062] ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare the formulation.

[0063] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, the preparation method comprising the following steps:

[0064] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0065] ② Take Bupleurum chinense, Scutellaria baicalensis, and Paeonia lactiflora, grind them into powder, sift them to obtain medium powder, and set aside;

[0066] ③ Take peony bark, perilla leaf, and artemisia annua, add 6 to 14 times the amount of raw herbs to water, soak for 0.5 to 1 hour, heat and reflux for 1 to 3 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, concentrate under reduced pressure at 50 to 90℃ to a density of 1.05 to 1.20, add the powder from step ②, stir evenly, and set aside.

[0067] ④ Dry the thick paste from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare the formulation.

[0068] To address the aforementioned technical problems, the present invention also provides a method for preparing a traditional Chinese medicine composition for treating febrile diseases clinically classified as Wei Qi syndrome, the preparation method comprising the following steps:

[0069] ① Weigh out the following raw materials according to the proportions: 5-35 parts of Bupleurum chinense, 9-50 parts of Scutellaria baicalensis, 9-50 parts of Artemisia annua, 5-35 parts of Paeonia lactiflora, 5-35 parts of Paeonia suffruticosa, and 4-26 parts of Perilla frutescens.

[0070] ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, grind them into powder, sift them, and set aside;

[0071] ③ Add the powder from step ② to the excipients to prepare the formulation.

[0072] To address the aforementioned technical problems, the present invention also provides the application of a traditional Chinese medicine composition in the treatment of febrile diseases clinically classified as Wei Qi syndrome. Attached Figure Description

[0073] Figure 1 This is a line graph comparing rectal temperature of the control drug in the antipyretic test with that of the composition of the present invention.

[0074] Figure 2 This is a WB diagram of HA protein expression in the composition of the present invention.

[0075] Figure 3 This is a WB diagram of NP protein expression in the composition of the present invention.

[0076] Figure 4 This is a PCR diagram of NP gene expression in the composition of the present invention. Detailed Implementation

[0077] This formula uses Scutellaria baicalensis to clear heat and dry dampness, purge fire and detoxify. Baicalin is a flavonoid compound and the main component of Scutellaria baicalensis. Baicalin has various anti-inflammatory effects, including anti-pneumonia and anti-hepatitis, as well as various biological activities such as antiviral, antibacterial, and antioxidant effects. Research results have found that high-dose baicalin has a significant antipyretic effect. This may be because the active ingredients in Scutellaria baicalensis can inhibit the release of intracellular inflammatory mediators, such as IL-1 and TNF-α, thereby reducing the stimulation of the thermoregulatory center and reducing the tendency for body temperature to rise. Scutellaria baicalensis may also exert its antipyretic effect by regulating the function of the central nervous system and affecting the sensitivity of the thermoregulatory center. Studies have shown that Bupleurum chinense and Scutellaria baicalensis can treat hepatitis B by repairing hepatocyte damage, reducing liver inflammation and cell necrosis, and inhibiting liver fibrosis. The combination of the two can enhance the anti-inflammatory and antiviral efficacy. Scutellaria baicalensis has many pharmacological effects, including antiviral, antibacterial, analgesic, antipyretic, free radical scavenging, antioxidant and anticancer effects. It also has protective effects on the digestive system, liver and immune cells.

[0078] Artemisia annua mainly contains various chemical components such as sesquiterpenes, diterpenes, flavonoids, phenylpropionic acid, coumarins, and volatile oils, possessing pharmacological activities including antimalarial, antitumor, antibacterial, insecticidal, antipyretic, anti-inflammatory, and immunomodulatory effects. The immunomodulatory mechanism of Artemisia annua may be related to its direct or indirect reduction of serum R97-116 antibody levels and inhibition of the secretion of interferon-gamma (IFN-γ) and IL-17 pro-inflammatory factors by lymph node mononuclear cells. Artemisia annua may also regulate Treg / Th17 immune balance. For heat syndromes, regardless of whether it is due to deficiency or excess, Artemisia annua has a certain effect; modern clinical applications of Artemisia annua are effective in treating internal injuries and exogenous fever. It is known that artemisinin has a relatively weak antipyretic effect, while its precursors, artemisinic acid and artemisinin B, have stronger antipyretic effects.

[0079] Bupleurum, with its functions of dispersing and reducing fever, soothing the liver and relieving depression, and raising yang qi, is a commonly used antipyretic in clinical practice with definite efficacy. Volatile oil is one of the main active components of Bupleurum. Among Bupleurum chinense (southern and northern varieties) and other plants in the Bupleurum genus, southern Bupleurum has the highest volatile oil content and the best antipyretic and anti-inflammatory effects. Laural is the material basis for the antipyretic effect of southern Bupleurum, possibly exerting its antipyretic effect by reducing inflammatory factor levels and inhibiting hypothalamic cAMP and AVP levels. Studies have confirmed that Bupleurum volatile oil can directly act on the hypothalamic thermoregulatory center by inhibiting the upward shift of the body temperature set point, thereby achieving an antipyretic effect.

[0080] Perilla leaves have the functions of relieving exterior syndromes, dispelling cold, regulating qi, and harmonizing the stomach. They contain various active ingredients, such as volatile oils, flavonoids, anthocyanins, phenolic acids, triterpenoids, and steroids. Perilla leaves possess a wide range of pharmacological activities, including antioxidant, antitumor, antibacterial, and anti-inflammatory effects. Perilla leaves have a broad antibacterial spectrum and offer certain therapeutic effects on acute and chronic inflammation, as well as local and systemic inflammation.

[0081] Paeoniflorin in Paeonia lactiflora can inhibit the upregulation of pro-inflammatory mediators such as TNF-α, IL-1β, iNOS, COX-2, and 5-lipoxygenase (5-LOX), thus reducing the levels of inflammatory factors. Studies have shown the pharmacodynamic basis of the synergistic effect of Paeonia suffruticosa and Paeonia lactiflora. Comparing the fingerprint spectra of Paeonia suffruticosa-Paeonia lactiflora combination and Paeonia lactiflora alone revealed that the content of paeoniflorin increased approximately 5.3 times after the combination. Not only did the dissolution rate of paeoniflorin increase, but the dissolution rates of gallic acid and paeonol also significantly improved. Gallic acid exhibits outstanding anti-inflammatory, antioxidant, antibacterial, and antiviral effects. The combination of the two herbs can amplify the antibacterial intensity, and the blood-activating and stasis-removing effects are also enhanced compared to the single herbs.

[0082] In summary, this composition is novel in concept. Based on traditional Chinese medicine theory and syndrome differentiation, it combines modern pharmacological research to select and formulate drugs, refine the formula, and has been clinically screened and verified. It has a significant antipyretic effect with no obvious adverse reactions.

[0083] The following examples are used to illustrate the preparation of the drug of the present invention, but they should not be construed as limiting the scope of the present invention.

[0084] Example 1

[0085] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 10 parts of Perilla frutescens.

[0086] Specific preparation steps:

[0087] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to 80% ethanol, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0088] ② Take peony bark, red peony root, and perilla leaf, add 12 times the amount of raw herbs to 80% ethanol, reflux extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux extract for 2 hours, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.08, combine the concentrate from step ①, and continue to concentrate to a density of 1.10, and set aside.

[0089] ③ The concentrate from step ② is dried at 70°C, the dried paste is pulverized and excipients are added to prepare capsules, thus obtaining the invention composition 1.

[0090] Example 2

[0091] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 25 parts of Bupleurum chinense, 35 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 15 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0092] Specific preparation steps:

[0093] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to 80% ethanol, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0094] ② Take peony bark, red peony root, and perilla leaf, add 12 times the amount of raw herbs to 80% ethanol, reflux extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux extract for 2 hours, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.08, combine the concentrate from step ①, and continue to concentrate to a density of 1.10, and set aside.

[0095] ③ The concentrate from step ② is dried at 70°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining the invention composition 2.

[0096] Example 3

[0097] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0098] Specific preparation steps:

[0099] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0100] ② The concentrate is dried at 60°C, the dried paste is pulverized and excipients are added to prepare capsules, thus obtaining the invention composition 3.

[0101] Example 4

[0102] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 15 parts of Bupleurum chinense, 35 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 30 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 10 parts of Perilla frutescens.

[0103] Specific preparation steps:

[0104] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 12 times the amount of raw herbs to water, reflux and extract for 2 hours, filter, and set aside the filtrate. Add 12 times the amount of raw herbs to the residue, reflux and extract for 2 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.08, and set aside.

[0105] ② The concentrate is dried at 60℃, the dried paste is pulverized and then excipients are added to prepare granules.

[0106] Example 5

[0107] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 18 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 20 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0108] Specific preparation steps:

[0109] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06, and set aside.

[0110] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 70℃ to a density of 1.06. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0111] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare capsules.

[0112] Example 6

[0113] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 15 parts of Bupleurum chinense, 25 parts of Scutellaria baicalensis, 35 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0114] Specific preparation steps:

[0115] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 60% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.06, and set aside.

[0116] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 70℃ to a density of 1.06. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0117] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0118] Example 7

[0119] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 30 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 25 parts of Paeonia lactiflora, 25 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0120] Specific preparation steps:

[0121] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 50% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 50% ethanol, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0122] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0123] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare capsules.

[0124] Example 8

[0125] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 30 parts of Artemisia annua, 20 parts of Paeonia lactiflora, 20 parts of Paeonia suffruticosa, and 15 parts of Perilla frutescens.

[0126] Specific preparation steps:

[0127] ① Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 10 times the amount of raw herbs to 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to 70% ethanol, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0128] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0129] ③Dry the concentrated liquid from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0130] Example 9

[0131] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0132] Specific preparation steps:

[0133] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 10 times the amount of raw herbs to 80% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue to 80% ethanol, reflux extract for 1.5 hours, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.10, and set aside.

[0134] ② The concentrated liquid from step ① is dried at 60℃, the dried paste is pulverized and excipients are added to prepare capsules.

[0135] Example 10

[0136] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 32 parts of Bupleurum chinense, 48 parts of Scutellaria baicalensis, 45 parts of Artemisia annua, 28 parts of Paeonia lactiflora, 28 parts of Paeonia suffruticosa, and 18 parts of Perilla frutescens.

[0137] Specific preparation steps:

[0138] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, grind them into powder, sift them, and set aside;

[0139] ② Add the powder from step ① to excipients to prepare capsules.

[0140] Example 11

[0141] A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi, the raw materials of which, by weight, include 20 parts of Bupleurum chinense, 30 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 15 parts of Paeonia lactiflora, 18 parts of Paeonia suffruticosa, and 12 parts of Perilla frutescens.

[0142] Specific preparation steps:

[0143] ① Take Bupleurum chinense, Scutellaria baicalensis, and Paeonia lactiflora, grind them into powder, sift them to obtain medium powder, and set aside;

[0144] ② Take peony bark, perilla leaf, and artemisia annua, add 6-14 times the amount of raw herbs to water, soak for 0.5-1 hour, heat and reflux for 1-3 hours, heat and reflux for 1-3 times, filter, combine the extracts, concentrate under reduced pressure at 50-90℃ to a density of 1.05-1.20, add the powder from step ①, stir evenly, and set aside.

[0145] ③Dry the thick paste from step ② at 60℃, pulverize the dried paste, add excipients, and prepare granules.

[0146] Comparative Example 1

[0147] The traditional Chinese medicine composition comprises, by weight, 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 40 parts of Isatis tinctoria, 30 parts of Pueraria lobata, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, 20 parts of Ligusticum chuanxiong, and 20 parts of Perilla frutescens.

[0148] Specific preparation steps:

[0149] ① Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Isatis tinctoria, and Ligusticum chuanxiong. Add 10 times the amount of raw herbs in 70% ethanol and reflux for 1.5 hours. Filter and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue and reflux for 1 hour. Filter and combine the two extracts. Concentrate under reduced pressure at 60℃ to a density of 1.05 and set aside.

[0150] ② Take kudzu root, peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0151] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 1.

[0152] Comparative Example 2

[0153] The traditional Chinese medicine composition comprises, by weight, 40 parts of Scutellaria baicalensis, 40 parts of Artemisia annua, 30 parts of Paeonia suffruticosa, and 20 parts of Perilla frutescens.

[0154] Specific preparation steps:

[0155] ① Take Scutellaria baicalensis and Artemisia annua, add 10 times the amount of raw herbs in 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0156] ② Take peony bark and perilla leaves, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, concentrate under reduced pressure at 60℃ to a density of 1.04, combine the concentrate from step ①, and continue to concentrate to a density of 1.09, and set aside.

[0157] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 2.

[0158] Comparative Example 3

[0159] The traditional Chinese medicine composition comprises, by weight, 30 parts of Bupleurum chinense, 40 parts of Scutellaria baicalensis, 40 parts of Isatis indigotica, 30 parts of Pueraria lobata, 30 parts of Paeonia lactiflora, 30 parts of Paeonia suffruticosa, 20 parts of Ligusticum chuanxiong, and 20 parts of Perilla frutescens.

[0160] Specific preparation steps:

[0161] ① Take Bupleurum chinense, Scutellaria baicalensis, Isatis indigotica, and Ligusticum chuanxiong, add 10 times the amount of raw herbs in 70% ethanol, reflux extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs in 70% ethanol to the residue, reflux extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.05, and set aside.

[0162] ② Take peony bark, red peony root, and perilla leaf, add 10 times the amount of raw herbs to water, reflux and extract for 1.5 hours, filter, and set aside the filtrate. Add 10 times the amount of raw herbs to the residue, reflux and extract for 1 hour, filter, combine the two extracts, and concentrate under reduced pressure at 60℃ to a density of 1.04. Combine the concentrate from step ① and continue to concentrate to a density of 1.09, and set aside.

[0163] ③ The concentrate from step ② is dried at 60°C, the dried paste is pulverized and then excipients are added to prepare granules, thus obtaining comparative composition 3.

[0164] Pharmacodynamic study of the traditional Chinese medicine composition of this invention:

[0165] Antipyretic test of the traditional Chinese medicine composition of this invention:

[0166] 1. Test Methods

[0167] 1.1 Adaptation period: SPF-grade male SD rats, weighing 160-180g, were acclimatized for 4 days and their rectal temperature was measured twice a day for 3 days.

[0168] 1.2 Before the experiment: Fasting was allowed for 6 hours before the experiment, but water was allowed. Rectal temperature was measured 3 times (1 time / 30min) before the experiment and the average body temperature was calculated. The group was enrolled if △T≤0.5℃ and 36.6~38.4℃.

[0169] 1.3 Modeling: 20% yeast (10mg / kg) was injected subcutaneously into the back. For the first 4 hours after modeling, the temperature was measured every 30 minutes for a total of 8 times. Patients whose body temperature rose by more than 0.8℃ were selected for the group.

[0170] 1.4 Gavage: After successful modeling, rats were randomly divided into four groups of 50 (n=10 per group). The groups included a model group, a positive control group, a low-dose administration group (0.5 times the human dose), a medium-dose administration group (human dose), and a high-dose administration group (twice the human dose). The model group received the corresponding volume of physiological saline, the positive control group received the corresponding volume of Qingkailing granules and comparative composition 1 and comparative composition 2, and the administration groups received the corresponding concentration of composition 1 of this invention. Administration was performed three times daily via gavage, with rectal temperature measured every 2 hours until 24 hours after administration, for a total of 12 times.

[0171] 1.5 Data Processing: Experimental data were expressed as mean values. SPSS 27.0 software was used for statistical analysis of the experimental data. One-way ANOVA was used for comparisons among multiple groups. A p-value less than 0.05 was considered statistically significant.

[0172] 2. The test results are shown in Tables 1 and 2, and are attached to the instruction manual. Figure 1 .

[0173] 2. Test Results

[0174] Table 1. Results of changes in body temperature over time

[0175] 0h 2h 4h 6h 8h 10h 12h 14h 16h 18h 20h 22h 24h Model 39.4 39.3 38.9 39.2 39.0 38.8 38.8 38.7 39.0 38.9 38.8 38.8 38.7 Positive control 39.2 39.3 38.8 38.7 38.8 38.8 38.7 38.5 38.5 38.3 38.1 38.3 38.1 low dose 39.2 39.4 39.0 38.9 38.5 38.9 38.8 38.7 38.6 38.4 38.1 38.3 38.1 medium dose 39.5 39.0 38.9 38.5 38.0 38.1 38.0 38.0 38.2 38.2 38.3 38.0 37.5 High dose 39.8 39.1 39.2 38.5 38.2 37.9 38.1 38.0 38.3 38.1 38.1 37.9 37.6 Comparative Example 1 39.6 39.7 39.3 39.1 39.1 38.8 38.9 38.7 38.6 38.4 38.5 38.4 38.4 Comparative Example 2 39.3 39.6 39.3 39.2 38.6 38.9 38.8 38.6 38.6 38.4 38.3 38.3 38.3

[0176] Table 2. Results of P-value variation over time

[0177] p-value 0h 2h 4h 6h 8h 10h 12h 14h 16h 18h 20h 22h 24h Model / Positive 0.537 1.000 0.712 0.215 0.264 0.788 0.260 0.258 0.074 0.138 0.050 0.048 0.014 Model / Low 0.539 0.535 0.902 0.133 0.140 0.711 0.082 0.610 0.086 0.133 0.086 0.064 0.014 Model / Middle 0.455 0.211 1.000 0.014 0.013 0.014 0.014 0.014 0.014 0.033 0.049 0.012 0.004 Model / High 0.108 0.618 0.108 0.018 0.014 0.014 0.036 0.014 0.014 0.035 0.019 0.014 0.009 Model / Comparative Example 1 0.543 0.189 0.097 0.723 0.689 0.788 0.356 0.611 0.086 0.133 0.137 0.106 0.218 Model / Comparative Example 2 0.457 0.215 0.097 1.000 0.188 0.711 0.585 0.476 0.094 0.133 0.052 0.059 0.176 Positive / Low 0.616 0.916 0.343 0.671 0.207 0.429 0.390 0.334 0.595 0.750 0.753 0.459 0.915 Positive / Medium 0.415 0.248 0.832 0.465 0.008 0.007 0.009 0.011 0.344 0.527 0.249 0.130 0.034 Positive / High 0.214 0.459 0.059 0.401 0.012 0.007 0.012 0.011 0.596 0.596 0.833 0.141 0.008 Positive / Positive Example 1 0.495 0.154 0.047 0.201 0.258 0.908 0.696 0.334 0.595 0.747 0.111 0.325 0.269 Positive / Positive Ratio 2 0.388 0.266 0.048 0.135 0.199 0.776 0.893 0.432 0.564 0.761 0.248 0.461 0.313

[0178] 3. Experimental conclusions: Compared with the rectal temperature of the model group rats, the antipyretic effects of the positive control group and the low-dose group of the composition of the present invention were comparable, while the antipyretic effects of the medium-dose group and the high-dose group of the composition of the present invention were comparable. After 3 oral boluses and 24 hours later, the body temperature showed a significant downward trend. The experimental data show that the traditional Chinese medicine composition of the present invention can play a significant antipyretic role.

[0179] Antiviral efficacy test of the traditional Chinese medicine composition of this invention:

[0180] 1. Materials

[0181] 1.1 Drugs and Reagents

[0182] Test drugs: (Inventive composition 1, Inventive composition 2, Comparative composition 1, Comparative composition 2)

[0183] Reagents:

[0184] RPMI 1640 medium (powder), Gibco;

[0185] Fetal bovine serum (FBS), BioInd;

[0186] WBRIPA cell lysis buffer, Beyotime Biotechnology Co., Ltd.

[0187] Phosphatase inhibitor, MCE Corporation;

[0188] Protease inhibitor mixture, Beijing Solarbio Science & Technology Co., Ltd.

[0189] Skim milk powder, Yili Industrial Group Co., Ltd.

[0190] Prestained Protein Maker, Thermo Fisher Scientific, Inc.

[0191] ECL luminescent fluid, Perkin Elmer;

[0192] PVDF membrane, Millipore;

[0193] DEPC, Sigma-Aldrich, Inc. (USA)

[0194] TRNzol Universal Reagent, Tiangen Biotech (Beijing) Co., Ltd.;

[0195] Isopropanol, Tianjin Bodi Chemical Co., Ltd.;

[0196] Chloroform, Tianjin Beifang Tianyi Chemical Reagent Factory;

[0197] PrimeScript™ RT reagent Kit with gDNA Eraser, TaKaRa Corporation, Japan; PowerUP™ SYBR™ Green Master Mix, Applied Biosystems, Inc.; Anhydrous ethanol, Tianjin Yongda Chemical Reagent Co., Ltd.

[0198] Rabbit anti-GAPDH primary antibody, Wuhan Sanying Biotechnology Co., Ltd.

[0199] Mouse anti-NP primary antibody, Beijing Yiqiao Shenzhou Technology Co., Ltd.;

[0200] Mouse anti-HA primary antibody, Beijing Yiqiao Shenzhou Technology Co., Ltd.;

[0201] Primers, Sangon Biotech (Shanghai) Co., Ltd.;

[0202] 1.2 Cell types:

[0203] A549 cells, virus strains: H1N1, H3N2

[0204] instrument:

[0205] Electric thermostatic CO2 cell incubator, Thermo Scientific, USA;

[0206] Pipettes, Eppendorf GmbH, Germany;

[0207] Electronic balance, Ohaus Instruments (Changzhou) Co., Ltd.;

[0208] Ultrasonic crusher (VCX800 model), SONICS, USA;

[0209] Tabletop high-speed refrigerated centrifuge (model 23R), Shanghai Lishen Company;

[0210] 7500 Real-Time PCR System, Applied Biosystems, USA;

[0211] PCR thermal cycler (S1000TM model), BIO-RAD Corporation, USA;

[0212] Protein blotting device, BIO-RAD Corporation, USA;

[0213] Basic electrophoresis apparatus power supply, BIO-RAD Corporation, USA;

[0214] ECL chemiluminescence imaging system, Syngene Corporation, USA;

[0215] 2. Method:

[0216] Using A549 cells as host cells, after 2 hours of viral infection (to complete the adsorption process), the culture medium was replaced with a drug-containing medium (final concentration of 2.5 g / L). After 36 hours of treatment, the antiviral effect was measured.

[0217] 2.1 Viral infection of A549 cells

[0218] ① The day before infection, A549 was inoculated into a 12-well plate and incubated overnight at 37°C in a 5% CO2 incubator.

[0219] ② Discard the supernatant, wash the cells 1-2 times with PBS, add 1 mL of RPMI 1640 containing 2% FBS and double antibodies to each well, add the virus to the cells, and incubate at 34℃ and 5% CO2 for 2-3 hours, shaking the plate every 15-20 minutes during this period to ensure full infection;

[0220] ③ After adsorption is complete, add 1 mL of RPMI 1640 containing 2% FBS and double antibiotics to each well, and continue to incubate in a constant temperature incubator of 34℃ and 5% CO2 for 36 h;

[0221] ④ After culturing for 36 hours, the culture medium was replaced with RPMI 1640 containing 2% FBS, double antibiotics and traditional Chinese medicine extracts (Inventory Composition 1, Inventory Composition 2, Comparative Example 1, Comparative Example 2), and cultured in a constant temperature incubator at 34℃ until the detection time point.

[0222] 2.2 Grouping and Dosing

[0223] Weigh 0.625g of the extract, dissolve it in 250mL of 2% 1640 medium, filter it through a 0.45μm filter membrane, and add it directly to the cells. The final drug concentration is 2.5g / L.

[0224] Western blot was used to detect GAPD and NP proteins. qRT-PCR was used to detect the NP gene and ACTIN.

[0225] 2.3 Experimental results are attached to the instruction manual. Figure 2 , Figure 3 and Figure 4

[0226] Conclusion 1: All four formulations can significantly inhibit H3N2 and HA protein expression levels, suggesting that the four traditional Chinese medicines can inhibit H3N2 replication. Among them, the inhibitory effects of Invented Composition 1 and Invented Composition 2 are the most significant, and the antiviral effects are the best.

[0227] Conclusion 2: Composition 1 and Composition 2 of the present invention can significantly inhibit the expression levels of H1N1 NP gene and protein, suggesting that the four traditional Chinese medicines can inhibit H1N1 replication.

[0228] Tests on the antibacterial properties of the herbal composition of this invention:

[0229] 1. Materials

[0230] Drugs and reagents

[0231] Samples: Invention Composition 1, Comparative Composition 1, Comparative Composition 2, and Comparative Composition 3 were all produced by Ping An Pharmaceutical Research Institute.

[0232] Reagent: Hydrolyzed casein agar.

[0233] Strains: 26 strains of Klebsiella pneumoniae, 26 strains of carbapenem-resistant Klebsiella pneumoniae, 26 strains of Escherichia coli, 25 strains of Pseudomonas aeruginosa, 26 strains of Acinetobacter baumannii, and 26 strains of Staphylococcus aureus isolated from the Microbiology Laboratory of Shijiazhuang Ping An Hospital in 2023.

[0234] Instrument: MIT-P multi-point inoculation instrument

[0235] method

[0236] 2.1 Preparation of Traditional Chinese Medicine Powder

[0237] Weigh 4g of each composition and place it in a 50mL sterile test tube. Add boiled sterile distilled water to 40mL, which is equivalent to 100g / L of the original drug. Dissolve completely and set aside for later use.

[0238] 2.2 Preparation of Traditional Chinese Medicine Agar Plates

[0239] Weigh 0.76g of MH agar powder and add it to eight 50mL sterile test tubes numbered 1 to 8. Add 4mL of the original drug (100g / L) to tube 1, 2mL to tube 2, and 2mL to tube 3. Serially dilute the original drug (100g / L) two-fold to prepare solutions of different concentrations. Take 2mL of each solution and serially dilute it to prepare solutions of different concentrations. Add the solution to test tubes 3-8, and add distilled water to tubes 1-8 to 20 mL. Shake well to dissolve, then autoclave. After autoclaving, pour the solution into 90 mm diameter petri dishes in a biosafety cabinet until solidified. Finally, prepare drug plates containing Chinese medicine at concentrations of 20 g / L, 10 g / L, 5 g / L, 2.5 g / L, 1.25 g / L, 0.625 g / L, 0.3125 g / L, and 0.15625 g / L.

[0240] 2.3 Preparation of bacterial suspension

[0241] The test bacteria were passaged twice on MH agar plates to ensure the purification and viability of the colonies. After the second passage at 35°C for 24 hours, the cultured colonies were taken and prepared into bacterial suspensions with sterile physiological saline at a turbidity of 0.5 McFarland.

[0242] 2.4 Cultivation and Observation

[0243] Using an MIT-P multi-point inoculation instrument, 10 μL of a prepared 0.5% McFarland turbidity bacterial suspension was inoculated onto drug plates containing different concentrations of traditional Chinese medicine and growth control plates. The plates were incubated at 35°C for 24 hours. If all growth was observed on the growth control plates and no growth was observed on the blank control plates, the minimum inhibitory concentration (MIC) of each drug plate containing traditional Chinese medicine was observed and the MIC was calculated. 50 and MIC 90 The drug concentration and cumulative inhibition percentage.

[0244] 3 Results

[0245] 3.1 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Escherichia coli

[0246] In vitro antibacterial tests were conducted on 26 strains of Escherichia coli. The results showed that the cumulative antibacterial rate against Escherichia coli increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The cumulative antibacterial rate against Escherichia coli reached 100% when the concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 5 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively, indicating that the invented composition exhibited the strongest antibacterial ability. (See Table 3)

[0247] Table 3. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Escherichia coli

[0248]

[0249] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0250] 3.2 Inhibitory effects of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Acinetobacter baumannii

[0251] In vitro antibacterial tests were conducted on 25 strains of Acinetobacter baumannii. The results showed that the cumulative inhibition rate against Acinetobacter baumannii increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The invented composition exhibited the strongest antibacterial activity when the concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 2.5 g / L, 5 g / L, 5 g / L, and 10 g / L, respectively. (See Table 4)

[0252] Table 4. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Acinetobacter baumannii

[0253]

[0254] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0255] 3.3 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Klebsiella pneumoniae

[0256] In vitro antibacterial tests were conducted on 26 strains of Klebsiella pneumoniae. The results showed that the cumulative antibacterial rate against Klebsiella pneumoniae increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 5 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively. The invented composition showed the strongest antibacterial ability.

[0257] (See Table 5)

[0258] Table 5. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Klebsiella pneumoniae

[0259]

[0260] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0261] 3.4 Antibacterial effect of the inventive composition, comparative example 1, comparative example 2, and comparative example 3 on Klebsiella pneumoniae (carbapenem-resistant)

[0262] In vitro antibacterial tests were conducted on 26 strains of Klebsiella pneumoniae (carbapenem-resistant). The results showed that the cumulative antibacterial rate against Klebsiella pneumoniae (carbapenem-resistant) increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 10 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively.

[0263] (See Table 6)

[0264] Table 6. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Klebsiella pneumoniae (carbapenem-resistant).

[0265]

[0266] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0267] 3.5 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Staphylococcus aureus

[0268] In vitro antibacterial tests were conducted on 26 strains of Staphylococcus aureus. The results showed that the cumulative antibacterial rate against Staphylococcus aureus increased with the increase of the drug concentration of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 1.25 g / L, 2.5 g / L, 2.5 g / L, and 0.625 g / L, respectively. The invented composition and other single drugs showed strong inhibitory effects against Gram-positive bacteria. (See Table 7)

[0269] Table 7. Comparison of cumulative inhibition rates (%) of various compositions against 26 strains of Staphylococcus aureus

[0270]

[0271] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0272] 3.6 Antibacterial effect of the inventive composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 on Pseudomonas aeruginosa

[0273] In vitro antibacterial tests were conducted on 26 strains of *Pseudomonas aeruginosa*. The results showed that the cumulative antibacterial rate against *Pseudomonas aeruginosa* increased with increasing drug concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3. The concentrations of the invented composition, Comparative Example 1, Comparative Example 2, and Comparative Example 3 reached 10 g / L, 10 g / L, 10 g / L, and 20 g / L, respectively. (See Table 8)

[0274] Table 8. Comparison of cumulative inhibition rates (%) of various compositions against 25 strains of Pseudomonas aeruginosa

[0275]

[0276] Note: *MIC 50 The concentration of traditional Chinese medicine on the drug agar plate; △MIC 90 The concentration of traditional Chinese medicine on the drug agar plate.

[0277] 4. Conclusion

[0278] 1. Based on the above experiments, the inhibitory effect of the invented composition and the selected comparative composition on Gram-positive bacteria (Staphylococcus aureus) is better than that on Gram-negative bacteria (Klebsiella pneumoniae, Klebsiella pneumoniae (carbapenem-resistant), Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii).

[0279] 2. The antibacterial effect of the invented composition is superior to that of the comparative example.

[0280] Typical clinical applications of the traditional Chinese medicine composition of this invention:

[0281] Case 1: Mr. Zhang, male, 26 years old, developed a fever one day prior after being caught in the rain and exposed to air conditioning, with a maximum temperature of 39.2℃. Initially, he experienced slight chills, but now his fever has increased to 38.4℃. He also experiences chills, paroxysmal cough with a small amount of phlegm, sore throat, irritability, thirst, nausea, vomiting, a red tongue with a yellow coating, and a wiry, slippery pulse. Initial consultation (July 17, 2023): Diagnosis: Wei Qi syndrome. Treatment: Harmonize and reduce fever, expel pathogens and detoxify. He was prescribed 2 granules of the composition of this invention for four days, twice a day, 15g each time. Second consultation (July 21, 2023): By the second day of treatment, the fever had subsided, and the cough had lessened. He experienced a bitter taste in his mouth upon waking, dry mouth with a desire to drink, and regular bowel movements. His tongue tip was red with a slightly yellow, greasy coating, and his pulse was slippery. He continued treatment for 3 more days, twice a day, 10g of the composition granules each time. A follow-up phone call one week later confirmed that all symptoms had subsided after completing the prescribed course of treatment.

[0282] Case 2: Mr. Zhang, male, 41 years old, first visit September 4, 2023. Present illness: mild chills and severe fever, body temperature 39.2 degrees Celsius. Dry throat, dry mouth, cough, nasal congestion and runny nose. Diagnosis: Warm-heat evil stagnating in the defensive qi. Treatment: Harmonize and reduce fever, expel evil and detoxify. He took 2 granules of the composition of this invention for 3 days, twice a day, 15g each time. On September 7, his body temperature dropped to 38.4 degrees Celsius, and all symptoms lessened. He took the granules of the composition for 4 days, twice a day, 10g each time. On July 11, his body temperature returned to normal, and all symptoms improved significantly.

[0283] Case 3: Mr. Zhang, male, 48 years old. February 18, 2024. Medical history: The patient fell ill on February 13, 2024, initially experiencing fever, chills, headache, sore throat, and two episodes of vomiting. On February 18, the fever increased to 39.5 degrees Celsius, accompanied by irritability, thirst, constipation, dark yellow urine, a red tongue with a dry yellow coating, and a wiry and rapid pulse. Diagnosis: Wind-heat syndrome. Differentiation of syndromes: The disease progressed from the Wei level to the Qi level, obstructing the Qi mechanism. Treatment principle: Harmonize and reduce fever, expel pathogens and detoxify. He took 2 granules of the composition of this invention for 3 days, twice a day, 15g each time. On February 22, his temperature was 37.2-37.5 degrees Celsius, and his irritability and thirst disappeared. He continued to take the granules for 5 days, twice a day, 10g each time. His temperature returned to normal, all symptoms improved, and he was discharged from the hospital.

[0284] Case 4: Patient Gao, male, 6 years old, visited our hospital on November 6, 2024. Chief complaint: Intermittent fever and cough for 3 days. Present illness: Cough and sore throat after a cold 3 days ago, followed by fever of 39.1℃. Symptomatic treatment could temporarily lower the temperature, but the fever recurred, and was worse at night. Current symptoms: Fever, no chills or body aches, poor mental state, poor appetite, dry and sore throat, and intermittent cough. Tongue is red with little coating. Physical examination: Temperature 39.0℃, a palpable enlarged lymph node of about 1.5*1.0cm in the left submandibular region, moderate in consistency, tender, and mobile. Pharyngeal congestion, tonsils grade I enlargement. Clear breath sounds in both lungs, no dry or wet rales heard.

[0285] Laboratory tests: Blood routine: White blood cell count 6.08×10^9 / L, neutrophils 71.9%, monocytes 14.1%, other results normal. C-reactive protein 4.8, serum amyloid protein 73.2mg / L. Influenza A and B virus surveillance: Influenza A virus antigen positive. Western medicine diagnosis: Fever, upper respiratory tract infection, influenza A virus infection; Traditional Chinese medicine diagnosis: Fever, heat obstructing the Qi mechanism. Prescription: Take 2 granules of the composition of this invention for 3 days, twice a day, 15g of granules each time. Follow-up by phone on November 10, 2024: The child's temperature dropped to 38.0℃ one hour after taking the Chinese medicine. One day later, the nighttime temperature was still 38.0℃. The child's mental state and appetite improved, and the sore throat lessened. Two days later, the highest temperature was 37.6℃, and three days later, the temperature was 36.0℃. All symptoms were relieved. No Western antipyretics were taken throughout the course of treatment. The child complained of the bitter taste of the Chinese medicine and vomited once.

[0286] Case 5: Patient Li, male, 15 years old, visited our hospital on January 10, 2025. Chief complaint: Intermittent cough for 10 days, fever for 3 days. Present illness: Intermittent cough for 10 days, coughing up yellow sputum, fever for 3 days, highest temperature 39.0℃, accompanied by sore throat, fatigue, muscle aches, no chest tightness or chest pain, symptoms fluctuated with treatment at the community clinic. Physical examination: Pharynx red, tonsils not enlarged, coarse breath sounds in both lungs, no dry or wet rales heard. Laboratory tests: Complete blood count normal; respiratory virus monitoring negative; influenza A and B pathogen monitoring negative. He took self-prepared medication orally. Second visit, January 14, 2025, still with fever, worsening cough, accompanied by chest tightness, shortness of breath, and left chest and back pain. Chest CT scan: Extensive inflammation and local consolidation in the right upper lobe and left lower lobe, with a small amount of pleural effusion on the left side. He was admitted to the hospital. Western medicine diagnosis: Feverish lobar pneumonia; Traditional Chinese medicine diagnosis: Feverish Wei Qi syndrome. Prescription: 1. Antibiotic treatment for infection; 2. Take 2 granules of the composition of this invention twice a day for 3 days, 15g of granules each time. Follow-up: One hour after taking the medication, the patient sweated profusely, and the body temperature dropped to 37.6℃. One day later, the body temperature was 36.5℃, two days later it was 37.0℃, and three days later it was 36.8℃. After two weeks of anti-infection treatment, the body temperature remained normal. On January 19, 2025, a follow-up chest CT scan showed significant improvement in lung inflammation, and the patient was discharged.

[0287] Medical Record 6: Patient Zhang, male, 13 years old, visited our hospital on January 5, 2024. Present illness: Fever, fatigue, and sore throat for 3 hours, occasional cough without sputum, lethargy, muscle aches, poor appetite, dry mouth, body temperature 40℃, red tongue with thin yellow coating, rapid pulse. Examination: Pharyngeal congestion, tonsils not enlarged.

[0288] Laboratory tests: Blood routine: White blood cell count 6.72×10^9 / L, neutrophils 83.5%, lymphocytes 8.6%, other results normal. Rapid inflammatory markers: C-reactive protein 31.5mg / L, high-sensitivity C-reactive protein >5mg / L, serum amyloid A1 12.0mg / L. Influenza A and B virus surveillance: Influenza A virus (throat swab) positive. Western medicine diagnosis: Fever, upper respiratory tract infection, influenza A virus infection; Traditional Chinese medicine diagnosis: Wind-heat syndrome, Wei Qi syndrome. Prescription: 1. Take 2 granules of the composition of this invention for 3 days, twice a day, 15g of granules each time. 2. Cefdinir 0.1g, 3 times / day, orally, for 5-7 days. Second visit, January 8, 2024. The patient reported a body temperature of 39.5℃ 1 hour after taking the medication, 39.5℃ 1 day later, with reduced sore throat and fatigue, and improved mental state. Two days later, the body temperature was 38.3℃, and the patient could eat. Three days later, the patient's temperature was 36.8℃, and the sore throat, cough, and muscle aches had significantly improved, with a generally normal appetite. Cefdinir was continued. The patient complained of diarrhea, and the traditional Chinese medicine was changed to once daily orally; the diarrhea did not recur. Third visit, January 13, 2024: All symptoms had completely subsided. Follow-up blood tests, including complete blood count, C-reactive protein, and serum amyloid A, were all normal.

[0289] Case 7: Patient Li, male, 68 years old, visited our hospital on September 18, 2024. Chief complaint: Cold for 2 days, fever for 1 day. Present illness: Two days ago, he developed runny nose and nasal congestion after catching a cold, which he did not pay attention to. Today, he developed a fever of 39.4℃, sore throat, cough with yellow-white sticky sputum, nasal congestion with yellow and turbid nasal discharge, dry mouth, and general malaise. Tongue: red, yellow coating, rapid pulse. Physical examination: No enlarged superficial lymph nodes, pharyngeal redness and congestion, tonsils not enlarged, coarse breath sounds in both lungs, no dry or wet rales heard. Laboratory tests: Complete blood count: white blood cell count 7.75×10^9 / L, neutrophils 91.1%, lymphocytes 4.5%. High-sensitivity C-reactive protein >5mg / L, serum amyloid protein 13.5mg / L. Procalcitonin 0.336ng / mL. Mycoplasma pneumoniae positive 1:80. Western medicine diagnosis: fever, upper respiratory tract infection, mycoplasma infection; Traditional Chinese medicine diagnosis: warm pathogen stagnation in the defensive qi. Prescription: Take 2 granules of the composition of this invention for 3 days, twice a day, 15g each time. Second visit, September 21, 2024. Sweating occurred 1 hour after taking the medication, body temperature was 38.0℃, body temperature was 37.5℃ 1 day later, body temperature was 38℃ 2 days later, and body temperature was 37.5℃ 3 days later. Sore throat and cough improved significantly, nasal congestion and yellow nasal discharge disappeared, but dry mouth persisted. Repeat blood routine examination showed white blood cell count of 2.99×10^9 / L, neutrophils 57.9%, and lymphocytes 32.4%. Procalcitonin was 0.314ng / mg. Mycoplasma pneumoniae was negative. Considering the recovery period of infection, the medication was discontinued, and the patient was instructed to drink plenty of water.

Claims

1. A traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi deficiency, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 5-35 parts, Scutellaria baicalensis 9-50 parts, Artemisia annua 9-50 parts, Paeonia lactiflora 5-35 parts, Paeonia suffruticosa 5-35 parts, and Perilla frutescens 4-26 parts.

2. The traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi according to claim 1, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 8-28 parts, Scutellaria baicalensis 12-40 parts, Artemisia annua 12-40 parts, Paeonia lactiflora 8-28 parts, Paeonia suffruticosa 8-28 parts, and Perilla frutescens 8-22 parts.

3. The traditional Chinese medicine composition for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi and Wei Qi according to claim 1, characterized in that, The weight ratio of the Chinese medicinal materials is as follows: Bupleurum chinense 10-25 parts, Scutellaria baicalensis 20-35 parts, Artemisia annua 20-35 parts, Paeonia lactiflora 10-25 parts, Paeonia suffruticosa 10-25 parts, and Perilla frutescens 12-20 parts.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition may be prepared into any commonly used preparation, such preparation as tablets, capsules, granules, pills, mixtures, syrups, decoctions, powders, suppositories, gels, sprays, or injections.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that... The preparation method includes the following steps: ① Weigh out each raw material according to the formula and set aside; ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6 to 14 times the amount of raw herbs to water, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use; ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare a formulation.

6. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that... The preparation method includes the following steps: ① Weigh out each raw material according to the formula and set aside; ② Take Bupleurum chinense, Scutellaria baicalensis, and Artemisia annua, add 6 to 14 times the amount of raw herbs to water or ethanol, heat and reflux for 0.5 to 5 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, and concentrate under reduced pressure at 40 to 90℃ to a density of 1.01 to 1.20 for later use; ③ Take peony bark, red peony root, and perilla leaf, add 6-14 times the amount of raw herbs to 50%-90% ethanol or water, reflux extract for 0.5-5 hours, filter, and set aside the filtrate. Add 6-14 times the amount of raw herbs to water or ethanol, heat and reflux extract for 0.5-5 hours, heat and reflux extract 1-3 times, filter, combine the extracts, and concentrate under reduced pressure at 40-90℃ to a density of 1.01-1.

20. Combine the concentrate from step ② and continue to concentrate to a density of 1.05-1.15, and set aside. ④ Dry the concentrated liquid from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare the formulation.

7. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that... The preparation method includes the following steps: ① Weigh out each raw material according to the formula and set aside; ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, add 6-12 times the amount of raw herbs to 50%-90% ethanol, heat and reflux for 1-3 hours, heat and reflux for 1-3 times, filter, combine the extracts, and concentrate under reduced pressure at 50-80℃ to a density of 1.05-1.20 for later use; ③Dry the concentrated liquid from step ② at 50-90℃, pulverize the dried paste, add excipients, and prepare a formulation.

8. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that... The preparation method includes the following steps: ① Weigh out each raw material according to the formula and set aside; ② Take Bupleurum chinense, Scutellaria baicalensis, and Paeonia lactiflora, grind them into powder, sift them to obtain medium powder, and set aside; ③ Take peony bark, perilla leaf, and artemisia annua, add 6 to 14 times the amount of raw herbs to water, soak for 0.5 to 1 hour, heat and reflux for 1 to 3 hours, heat and reflux for 1 to 3 times, filter, combine the extracts, concentrate under reduced pressure at 50 to 90℃ to a density of 1.05 to 1.20, add the powder from step ②, stir evenly, and set aside. ④ Dry the thick paste from step ③ at 50–90°C, pulverize the dried paste, add excipients, and prepare a formulation.

9. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that... The preparation method includes the following steps: ① Weigh out each raw material according to the formula and set aside; ② Take Bupleurum chinense, Scutellaria baicalensis, Artemisia annua, Paeonia lactiflora, Paeonia suffruticosa, and Perilla frutescens leaves, grind them into powder, sift them, and set aside; ③ Add the powder from step ② to the excipients to prepare the formulation.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating febrile diseases clinically belonging to the syndrome of simultaneous Wei Qi syndrome.

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