Traditional Chinese medicine compositions for treating viral upper respiratory tract infections, their preparation methods and applications

Abstract

This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections, its preparation method, and its application. The composition is made from the following medicinal materials in parts by weight: 500-800g of Artemisia annua and 250-550g of Hypericum perforatum. This composition addresses the long-term clinical application needs and can effectively treat patients with viral upper respiratory tract infections, demonstrating significant application value. This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections and establishes its preparation method. The safety and efficacy of this composition have been confirmed through various animal model experiments.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology for treating viral upper respiratory tract infections, and more specifically, to a traditional Chinese medicine composition for treating viral upper respiratory tract infections, its preparation method, and its application. Background Technology

[0002] Upper respiratory tract infection (URTI) is a common term for viral infections. More than 80% of URTIs are caused by viruses. Viral URTIs are characterized by high incidence and strong infectivity, occurring year-round but more frequently in winter and spring. For viral URTIs, alleviating symptoms, shortening the course of illness, and reducing mortality are of great significance.

[0003] Modern medicine treats viral upper respiratory tract infections primarily through: ① early use of antiviral drugs; ② active symptomatic treatment; and ③ prevention and treatment of secondary bacterial infections. However, there are currently no specific treatments available clinically, and many drugs have various adverse reactions, including teratogenic effects, thus limiting their use. Chemotherapy is effective only against specific viruses and lacks broad-spectrum therapeutic effects. Traditional Chinese medicine, with its multi-target synergistic effects, can effectively prevent and treat various viral infections, exhibiting broad-spectrum antiviral activity and demonstrating good efficacy in treating viral upper respiratory tract infections.

[0004] Currently, there are no specific drugs for viral upper respiratory tract infections. To address this clinical need, it is urgent to develop traditional Chinese medicine compositions for the treatment of viral upper respiratory tract infections. Summary of the Invention

[0005] The main objective of this invention is to provide a traditional Chinese medicine composition for treating viral upper respiratory tract infections, its preparation method, and its application, so as to at least solve the problem of the lack of traditional Chinese medicines for viral upper respiratory tract infections in the prior art.

[0006] To achieve the above objectives, according to one aspect of the present invention, a traditional Chinese medicine composition for treating viral upper respiratory tract infections is provided, the composition being made from the following traditional Chinese medicinal materials in parts by weight: 500-800g of Artemisia annua and 250-550g of Hypericum perforatum.

[0007] Furthermore, the traditional Chinese medicine composition is made from the following parts by weight of traditional Chinese medicinal materials: 650g of Artemisia annua and 400g of St. John's wort.

[0008] According to another aspect of the present invention, a method for preparing a traditional Chinese medicine composition for treating viral upper respiratory tract infections is provided. The preparation method is used to prepare a traditional Chinese medicine composition and includes: weighing traditional Chinese medicinal materials according to a weight ratio, pulverizing the traditional Chinese medicinal materials separately and then mixing them to obtain a drug mixture; extracting the drug mixture by reflux multiple times with an organic solvent to obtain an extract; filtering, concentrating and drying the extract to obtain the traditional Chinese medicine composition.

[0009] Furthermore, the organic solvent is an aqueous ethanol solution with a 50%-80% ethanol content. The extraction is refluxed 2-3 times, with each reflux extraction lasting 1-2 hours. Filtration, concentration, and drying include filtering the extract under reduced pressure using a 100-mesh sieve at 0.08 MPa and 65°C, concentrating the filtered extract to a clear paste with a relative density of 1.10-1.15 at 60°C, and vacuum drying the paste at 0.08 MPa and 60°C.

[0010] Furthermore, the reflux extraction was performed three times.

[0011] According to another aspect of the present invention, an application of a traditional Chinese medicine composition for treating viral upper respiratory tract infections is provided, wherein the application is the use of the traditional Chinese medicine composition in the preparation of an agent for treating viral upper respiratory tract infections.

[0012] Furthermore, the formulation includes a traditional Chinese medicine composition and various excipients.

[0013] Furthermore, the dosage form of the preparation is an oral preparation.

[0014] Furthermore, the dosage form of the preparation is capsules, tablets, or granules.

[0015] Furthermore, viral upper respiratory tract infections are upper respiratory tract infections caused by parainfluenza virus or respiratory syncytial virus.

[0016] The advantages of this invention are as follows: This traditional Chinese medicine composition addresses long-term clinical application needs and can effectively treat patients with viral upper respiratory tract infections, demonstrating significant application value. This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections and establishes its preparation method. Through advanced preparation process conditions, high-quality and efficient traditional Chinese medicine products are produced. Furthermore, the safety and efficacy of this traditional Chinese medicine composition have been confirmed through various animal model experiments. Attached Figure Description

[0017] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings:

[0018] Figure 1 This is a flowchart of a method for preparing a traditional Chinese medicine composition for treating viral upper respiratory tract infections, which is optional according to an embodiment of the present invention. Detailed Implementation

[0019] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0020] This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections. The composition is made from the following traditional Chinese medicinal materials in parts by weight: 500-800g of Artemisia annua and 250-550g of Hypericum perforatum.

[0021] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicinal materials in parts by weight: 650g of Artemisia annua and 400g of St. John's wort.

[0022] Artemisia rupestris L., a Chinese medicinal herb, is the whole plant of the plant, belonging to the Asteraceae family. It has a pungent taste and slightly warm properties. It is used to dispel wind and release the exterior, strengthen the stomach and eliminate food stagnation, and promote blood circulation and remove blood stasis. It is used for colds due to wind-cold, food stagnation, traumatic injuries with swelling and bruises, urticaria, and snake bites.

[0023] St. John's wort (Hypericum foratum L.), a Chinese medicinal herb. It refers to the dried aerial parts of the plant, belonging to the Clusiaceae family. It has a pungent taste and is cold in nature. It is harvested during the flowering season in summer and autumn, and then air-dried or dried at low temperature. It is used to soothe the liver and relieve depression, clear heat and promote diuresis, reduce swelling and promote lactation. It is used for liver qi stagnation, emotional distress, chest tightness, joint swelling and pain, mastitis, and insufficient lactation.

[0024] This traditional Chinese medicine composition addresses long-term clinical application needs and is effective in treating patients with viral upper respiratory tract infections, demonstrating significant application value. This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections and establishes its preparation method. Through advanced preparation processes, high-quality and efficient traditional Chinese medicine products are produced. Furthermore, the safety and efficacy of this traditional Chinese medicine composition have been confirmed through various animal model experiments.

[0025] Lung tissue and hypothalamus were removed from a -80°C freezer and treated with high-efficiency protein lysis buffer (with added PMSF and protease inhibitors) before centrifugation. The protein supernatant was collected. RT-PCR was used to detect viral load in lung tissue; ELISA was used to detect the levels of cytokines TNF-α, IL-6, and IL-10 in lung tissue and cAMP and PGE2 levels in the hypothalamus; flow cytometry was used to detect the percentage of T lymphocyte subsets and B lymphocytes (CD4+, CD8+ T percentage) in peripheral blood. These experiments showed that this traditional Chinese medicine composition reduces the levels of inflammatory factors TNF-α, IL-6, and IL-10 in lung tissue, decreases cAMP and PGE2 levels in the hypothalamus, and significantly increases CD4+ levels in peripheral blood. + CD8 + The percentage of T cells reduces the lung index in infected mice, decreases the viral load in mouse lung tissue, and alleviates the degree of pathological damage to the lungs and bronchi after infection, thereby treating lung inflammation caused by common respiratory pathogens such as parainfluenza virus and respiratory syncytial virus.

[0026] The traditional Chinese medicine composition protected by this patent has clinical use in treating viral upper respiratory tract infections. In vivo animal experiments were conducted against two common viruses that cause viral upper respiratory tract infections to verify the product's effectiveness. Animal experiments against these two common viruses demonstrate the product's effectiveness against viral upper respiratory tract infections.

[0027] 1. Therapeutic effect on a mouse model of pneumonia induced by parainfluenza virus (PIV-1) infection.

[0028] The specific experimental method is as follows:

[0029] Fifty ICR mice, weighing 14±1g, half male and half female, were randomly divided into 5 groups according to weight class: a normal control group, a model control group, and three dosage groups (high, medium, and low) of the traditional Chinese medicine composition, with 10 mice in each group. Except for the normal control group, mice were infected by nasal instillation of parainfluenza virus solution. Administration of the medicine began on the day of infection, with 0.2ml / 10g administered by gavage once daily for 4 consecutive days. The normal control and model control groups were administered distilled water by gavage under the same conditions. On day 5, the weight of each group of mice was measured; lung weight was measured by dissection, and lung tissue was collected for pathological examination. The lung index and lung index inhibition rate were calculated.

[0030] Lung Index (%) = Lung wet weight (g) / Body weight (g) × 100%

[0031]

[0032] Test results

[0033] As shown in Table 1, after mice were infected with parainfluenza virus solution, the lung index of the model group mice was significantly increased, which was significantly different from that of the normal control group (P<0.01). After 4 days of treatment with the traditional Chinese medicine composition administered on the day of infection, the lung index of the three dosage groups was significantly reduced, which was significantly different from that of the model control group (P<0.01, P<0.05). The lung index inhibition rates of the high, medium and low dose groups of Yiye Anti-influenza Capsules were 89%, 78% and 63%, respectively.

[0034] Table 1: Effects of the treatment on parainfluenza virus-induced pneumonia in mice

[0035]

[0036] 2. Therapeutic effect on a mouse model of respiratory syncytial virus (RSV)-induced pneumonia.

[0037] The specific experimental method is as follows:

[0038] Fifty BALB / c mice, weighing 14±1g, half male and half female, were randomly divided into 5 groups according to weight class: a normal control group, a model control group, and three dosage groups (high, medium, and low) of the traditional Chinese medicine composition, with 10 mice in each group. Except for the normal control group, the mice were infected with RSV virus via nasal drops. Drug administration began on the day of infection, with 0.2ml / 10g administered by gavage once daily for 4 consecutive days. The normal control and model control groups were administered distilled water by gavage under the same conditions. On day 5, the mice in each group were weighed; lung weight was measured by dissection, and lung tissue was collected for pathological examination. The lung index and lung index inhibition rate were calculated.

[0039] Lung Index (%) = Lung wet weight (g) / Body weight (g) × 100%

[0040]

[0041] Experimental results

[0042] As shown in Table 2, after mice were infected with RSV virus fluid, the lung index of the model group mice was significantly increased, showing a significant difference compared with the normal control group (P<0.01). After four days of treatment starting on the day of infection, the lung index of the three dosage groups was significantly reduced, showing a significant difference compared with the model control group (P<0.01). The lung index inhibition rates of the high, medium, and low dosage groups were 92%, 86%, and 62%, respectively. These results suggest that this product has a good therapeutic effect on RSV virus-induced pneumonia in mice.

[0043] Table 2: Effects of treatment on RSV virus-induced pneumonia in mice

[0044]

[0045] 3. In vitro efficacy experiment against parainfluenza virus (PIV-1)

[0046] The in vitro inhibitory effect of the traditional Chinese medicine composition on parainfluenza virus PIV-1 was evaluated by observing the values ​​of TC0, TC50, IC50, and TI. The results showed that the capsules made from this traditional Chinese medicine composition had a TC0 value of 0.056 mg / ml and a TC50 value of 0.039 mg / ml. At a non-toxic concentration, the capsules made from this traditional Chinese medicine composition significantly inhibited Hep-2 cell lesions induced by PIV-1 virus infection in vitro.

[0047] 4. In vitro efficacy test against respiratory syncytial virus (RSV)

[0048] The in vitro inhibitory effect of capsules made from this traditional Chinese medicine composition on respiratory syncytial virus (RSV) was evaluated using the CPE method. The results showed that the TC0 value of the capsules made from this traditional Chinese medicine composition was 0.056 mg / ml, and the TC50 value was 0.039 mg / ml. At a non-toxic concentration, the capsules made from this traditional Chinese medicine composition significantly inhibited the Hep-2 cell lesions induced by RSV infection in vitro.

[0049] like Figure 1 As shown, the present invention provides a method for preparing a traditional Chinese medicine composition, the preparation method comprising:

[0050] Step S102: Weigh the Chinese medicinal materials according to the weight ratio, pulverize the Chinese medicinal materials separately and then mix them to obtain a drug mixture;

[0051] Step S104: Extract the drug mixture by reflux multiple times with an organic solvent to obtain an extract;

[0052] Step S106: Filter, concentrate and dry the extract to obtain the traditional Chinese medicine composition.

[0053] The traditional Chinese medicine composition provided by this invention can be formulated into capsules, tablets, and granules;

[0054] The preparation method of the capsules is as follows: Weigh the Chinese medicinal materials according to the specified weight ratio, pulverize each material separately, and then mix them to obtain a drug mixture; extract the drug mixture by reflux multiple times with an organic solvent to obtain an extract; filter, concentrate, and dry the extract to obtain a Chinese herbal composition. Add excipients and a wetting agent to the concentrated and dried Chinese herbal composition, stir evenly, and then granulate. Granulate, shape, and dry the granules before filling them into capsules to form capsules.

[0055] The preparation method of granules is as follows: Chinese medicinal materials are weighed according to the specified weight ratio, pulverized separately, and then mixed to obtain a drug mixture; the drug mixture is extracted multiple times by reflux with an organic solvent to obtain an extract; the extract is filtered, concentrated, and dried to obtain a Chinese medicine composition. The concentrated and dried Chinese medicine composition is then mixed with excipients and a wetting agent, stirred evenly, and granulated. The granules are then obtained through granulation, sizing, and drying, and finally filled into pharmaceutical composite films to form bags.

[0056] The tablet preparation method is as follows: Weigh the Chinese medicinal materials according to the specified weight ratio, pulverize each material separately, and then mix them to obtain a drug mixture; extract the drug mixture by reflux multiple times with an organic solvent to obtain an extract; filter, concentrate, and dry the extract to obtain a Chinese medicine composition. Add appropriate excipients to the concentrated and dried Chinese medicine composition, and compress it into tablets.

[0057] The following examples illustrate the preparation method of the traditional Chinese medicine composition provided by the present invention.

[0058] Example 1: Weigh 600g of Artemisia annua and 450g of Hypericum perforatum, crush them and mix them, add 8400ml of 60% ethanol and reflux extract three times, each time for 1 hour. After filtering the extract, concentrate it using a vacuum concentrator to obtain extract granules. Add an appropriate amount of excipients and granulate to obtain the traditional Chinese medicine composition, which can be made into capsules, tablets and granules.

[0059] Example 2: Weigh 550g of Artemisia annua and 500g of Hypericum perforatum, crush them and mix them, add 10500ml of 50% ethanol and reflux extract twice, each time for 2 hours. Filter the extract and concentrate it using a vacuum concentrator to obtain extract granules. Add an appropriate amount of excipients and granulate to obtain the traditional Chinese medicine composition, which can be made into capsules, tablets and granules.

[0060] Example 3: 650g of Artemisia annua and 400g of Hypericum perforatum were pulverized and mixed. 10500ml of 50% ethanol was added and refluxed three times, each time for 2 hours. The mixture was then filtered under reduced pressure using a 100-mesh sieve at 0.08MPa and 65℃. The filtered extract was concentrated to a clear paste with a relative density of 1.10-1.15 at 60℃. The clear paste was then vacuum dried at 0.08MPa and 60℃. Extract granules were obtained by concentration. An appropriate amount of excipients was added, and the mixture was granulated to obtain a traditional Chinese medicine composition. The concentrated and dried traditional Chinese medicine composition was then mixed with excipients and a wetting agent, stirred evenly, and granulated. After granulation, sizing, and drying, the mixture was filled into capsules to produce 1000 capsules.

[0061] Example 4: 700g of Artemisia annua and 350g of Hypericum perforatum were pulverized and mixed. 10500 ml of 50% ethanol was added and refluxed three times, each time for 2 hours. The mixture was then filtered under reduced pressure using a 100-mesh sieve at 0.08 MPa and 65°C. The filtered extract was concentrated to a clear paste with a relative density of 1.10-1.15 at 60°C. The paste was then vacuum dried at 0.08 MPa and 60°C. Extract granules were obtained by concentration. An appropriate amount of excipients was added, and the mixture was granulated to obtain a traditional Chinese medicine composition. The concentrated and dried traditional Chinese medicine composition was then mixed with excipients and a wetting agent, stirred evenly, and granulated. Granulation, sizing, and drying were then used to obtain granules, which were then filled into pharmaceutical composite films to make 500 bags.

[0062] Example 5: 750g of Artemisia annua and 300g of Hypericum perforatum were pulverized and mixed. 10500 ml of 50% ethanol was added and refluxed three times, each time for 2 hours. The mixture was then filtered under reduced pressure using a 100-mesh sieve at 0.08 MPa and 65°C. The filtered extract was concentrated to a clear paste with a relative density of 1.10-1.15 at 60°C. The paste was then vacuum dried at 0.08 MPa and 60°C. Extract granules were obtained by concentration. An appropriate amount of excipients was added, and the mixture was granulated to obtain a traditional Chinese medicine composition. The concentrated and dried traditional Chinese medicine composition was then further granulated with an appropriate amount of excipients to produce 1000 tablets.

[0063] This invention provides a traditional Chinese medicine composition for treating viral upper respiratory tract infections and its preparation method. The composition consists of two herbs: Artemisia annua and Hypericum perforatum, with Artemisia annua comprising 40-70% by weight and Hypericum perforatum comprising 30%-60% by weight. The herbs are pulverized and thoroughly mixed. The mixture is then extracted with an organic solvent, preferably an aqueous solution of ethanol, with an ethanol content preferably of 50%-80%. The extraction is performed 2-3 times, preferably 3 times, with each extraction lasting 1-2 hours. The extract is then concentrated and dried to obtain the final extract. This process effectively increases the extract yield from 12% to 20%, resulting in a richer product content, superior quality, and enhanced clinical value and application.

[0064] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating viral infections, characterized in that, The traditional Chinese medicine composition is prepared by pulverizing and mixing the following traditional Chinese medicinal materials and then extracting them with an ethanol aqueous solution with a ratio of 50%-80%: 650g of Artemisia annua and 400g of Hypericum perforatum; the viral infection is lung inflammation caused by parainfluenza virus and respiratory syncytial virus.

2. A method for preparing a traditional Chinese medicine composition for treating viral infections, wherein the preparation method is used to prepare the traditional Chinese medicine composition of claim 1, characterized in that, The preparation method includes: Weigh the Chinese medicinal materials according to the specified weight ratio, pulverize the Chinese medicinal materials separately and then mix them to obtain a drug mixture; The drug mixture was repeatedly extracted by reflux with an organic solvent to obtain an extract; The extract is filtered, concentrated, and dried to obtain the traditional Chinese medicine composition.

3. The preparation method according to claim 2, characterized in that, The reflux extraction is performed 2-3 times, and each reflux extraction takes 1-2 hours. The filtration, concentration, and drying process includes filtering the extract under reduced pressure using a 100-mesh sieve at 0.08 MPa and 65°C, concentrating the filtered extract to a clear paste with a relative density of 1.10–1.15 at 60°C, and vacuum drying the clear paste at 0.08 MPa and 60°C.

4. The preparation method according to claim 3, characterized in that, The reflux extraction was performed three times.

5. The application of a traditional Chinese medicine composition for treating viral infections, wherein the application is the use of the traditional Chinese medicine composition according to claim 1 in the preparation of an agent for treating lung inflammation caused by parainfluenza virus and respiratory syncytial virus.

6. The application according to claim 5, characterized in that, The preparation is made from the traditional Chinese medicine composition as described in claim 1 and a variety of excipients.

7. The application according to claim 6, characterized in that, The dosage form of the preparation is an oral preparation.

8. The application according to claim 7, characterized in that, The dosage form of the preparation is capsules, tablets, or granules.

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