Traditional Chinese medicine composition for treating Shaoyang syndrome type pneumonia as well as application and preparation method of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating Shaoyang syndrome type pneumonia as well as application and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 55 to 65 parts of raw radix astragali seu hedysari, 12 to 18 parts of radix bupleuri, 12 to 18 parts of radix glehniae, 22 to 28 parts of turtle shell, 12 to 18 parts of radix platycodonis, 12 to 18 parts of radix asteris, 12 to 18 parts of pericarpium citri reticulatae, 12 to 18 parts of rhizoma pinelliae preparata, 27 to 33 parts of cortex lycii radicis, 17 to 23 parts of radix gentianae macrophyllae, 12 to 18 parts of folium perillae, 15 to 21 parts of cortex magnoliae officinalis, 27 to 33 parts of semen coicis, 12 to 18 parts of wax gourd kernel, 12 to 18 parts of semen persicae, 12 to 18 parts of raw liquorice root, 27 to 33 parts of fructus mume and 27 to 33 parts of herba artemisiae annuae. The medicine has the advantages of remarkably improving inflammation indexes and shortening the course of disease, and is suitable for adjuvant therapy of ICU severe pneumonia. Meanwhile, the traditional Chinese medicine composition is high in safety and free of liver and kidney function damage and other side effects.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and more particularly to a traditional Chinese medicine composition for treating Shaoyang syndrome type pneumonia, and an application and a preparation method thereof. Background Art

[0002] Infections such as pneumonia primarily attack the alveoli. Besides pathogens, they can also be triggered by physical and chemical factors, immune damage, allergies, and medications. High-risk groups include children under 2 years old, people over 65 years old, those living in poor conditions, and those with negative habits such as smoking, alcoholism, and overwork. People with weakened immune systems (those suffering from immunodeficiency diseases or taking immunosuppressants), those bedridden for long periods, those using ventilators, and those with chronic respiratory diseases are also susceptible to pneumonia.

[0003] Shaoyang syndrome is a syndrome type in the Six Meridians Differentiation of Traditional Chinese Medicine. It refers to the invasion of the Shaoyang meridian by pathogenic factors, which is half superficial and half interior, leading to stagnation of Qi and unfavorable pivotal mechanism. The typical manifestations are alternating chills and fever, fullness and bitterness in the chest and flanks, bitter taste in the mouth and dry throat.

[0004] Western medicine primarily treats pneumonia with antibiotics, but drug resistance and side effects are becoming increasingly prominent. Traditional Chinese Medicine (TCM) classifies pneumonia as a "wind-heat" or "lung abscess" syndrome. Shaoyang syndrome pneumonia often presents with cough, bitter taste in the mouth, dry throat, and a wiry pulse. The pathogenesis is due to pathogenic factors invading the Shaoyang meridian, leading to adverse effects on the vital organs. These treatments require harmonizing the Shaoyang meridian and promoting lung function and resolving phlegm. Existing TCM formulas often focus on clearing heat and detoxifying, but fail to adequately address adverse effects on the Shaoyang meridian. Furthermore, clinical data supporting this approach is lacking for critically ill ICU patients. Summary of the Invention

[0005] The present invention aims to overcome at least one defect (shortcoming) of the above-mentioned prior art, provide a traditional Chinese medicine composition for treating Shaoyang syndrome pneumonia and its application and preparation method, and improve Shaoyang syndrome severe pneumonia.

[0006] One object of the present invention is to provide a traditional Chinese medicine composition for treating Shaoyang syndrome pneumonia, comprising the following components in parts by weight: 55-65 parts of raw astragalus, 12-18 parts of bupleurum, 12-18 parts of northern adenophora, 22-28 parts of turtle shell, 12-18 parts of platycodon, 12-18 parts of aster, 12-18 parts of tangerine peel, 12-18 parts of qingbanxia, 27-33 parts of lycium bark, 17-23 parts of gentiana, 12-18 parts of perilla leaf, 15-21 parts of magnolia bark, 27-33 parts of coix seed, 12-18 parts of wax gourd seed, 12-18 parts of peach kernel, 12-18 parts of raw licorice, 27-33 parts of black plum, and 27-33 parts of artemisia annua.

[0007] In this technical solution, the monarch, minister, assistant and guiding ingredients are combined to achieve synergistic effects.

[0008] The main medicine is Astragalus membranaceus. Large doses of Astragalus membranaceus can replenish qi and strengthen the exterior, expel toxins and promote tissue regeneration, enhance the body's immunity, and provide a strengthening foundation for the entire prescription.

[0009] The assistant medicine is Bupleurum, which relieves the Shaoyang pivot and is combined with Astragalus to promote and nourish the qi, thus harmonizing the qi.

[0010] The adjuvant medicines are Northern Adenophora and Turtle Shell. Northern Adenophora nourishes yin and moistens the lungs, while Turtle Shell nourishes yin and suppresses yang. Both nourish yin and clear the lungs, soften and disperse nodules, and together help Astragalus to nourish qi and yin, and relieve dryness and heat that damages body fluids.

[0011] The guiding herbs are Platycodon grandiflorum, Aster tataricus, Tangerine peel and Pinellia ternata. Platycodon grandiflorum clears the lungs and relieves sore throat, Aster tataricus resolves phlegm and relieves cough, Pinellia ternata dries dampness and resolves phlegm, Tangerine peel regulates qi and strengthens the spleen. The four work together to enhance the expectorant and antiasthmatic effects.

[0012] Rehmannia root bark, Gentiana macrophylla, and Artemisia annua are heat-clearing herbs, clearing away deficient heat; Perilla leaf and Magnolia officinalis promote qi and relieve fullness; Coix seed and wax gourd seed dissipate dampness and pus; Peach kernel promotes blood circulation and dissipates blood stasis; Coix seed, wax gourd seed, and peach kernel synergistically promote the absorption of lung inflammation. Black plum and raw glycyrrhizic acid nourish yin and harmonize the other herbs.

[0013] Furthermore, the invention includes the following components in parts by weight: 57-62 parts of raw astragalus, 13-17 parts of bupleurum, 13-17 parts of northern adenophora, 23-27 parts of turtle shell, 13-17 parts of platycodon, 13-17 parts of aster, 13-17 parts of tangerine peel, 13-17 parts of qingbanxia, 28-33 parts of rehmannia root, 18-22 parts of gentiana, 13-17 parts of perilla leaf, 16-20 parts of magnolia bark, 28-32 parts of coix seed, 13-17 parts of wax gourd seed, 13-17 parts of peach kernel, 13-17 parts of raw licorice, 28-32 parts of black plum, and 28-32 parts of artemisia annua.

[0014] Furthermore, it includes the following components in parts by weight: 60 parts of astragalus, 15 parts of bupleurum, 15 parts of northern adenophora, 25 parts of turtle shell, 15 parts of platycodon, 15 parts of aster, 15 parts of tangerine peel, 15 parts of ginger pinellia, 30 parts of rehmannia root, 20 parts of gentiana, 15 parts of perilla leaf, 18 parts of magnolia bark, 30 parts of coix seed, 15 parts of wax gourd seed, 15 parts of peach kernel, 15 parts of raw licorice, 30 parts of black plum, and 30 parts of artemisia annua.

[0015] Another object of the present invention is to provide a medicine for treating Shaoyang syndrome type pneumonia, comprising any one of the above-mentioned Chinese medicine compositions and pharmaceutically acceptable excipients.

[0016] Furthermore, the dosage form of the medicine is a decoction.

[0017] Another object of the present invention is to provide a method for preparing the above-mentioned medicine, which comprises the following steps:

[0018] S1. Soaking: Weigh the medicinal components other than Artemisia annua by weight and soak them;

[0019] S2, primary decoction: adding 8-10 times the weight of water for primary decoction, adding Artemisia annua 10-20 minutes before the end of the primary decoction and continuing to decoct, filtering to obtain a primary filtrate after the primary decoction is completed;

[0020] S3, secondary decoction: adding water to the dregs of the primary decoction for secondary decoction, and filtering to obtain a secondary filtrate;

[0021] S4. Combine the primary filtrate and the secondary filtrate.

[0022] Furthermore, in step S2, the decoction time is 0.5 to 1.2 hours;

[0023] Furthermore, in step S3, the secondary decoction is performed for 0.3 to 0.7 hours.

[0024] Furthermore, in step S1, the soaking time is 20 to 40 minutes.

[0025] Another object of the present invention is to provide the use of any of the above-mentioned Chinese medicine compositions or the medicine prepared by the above-mentioned preparation method in the preparation of products for treating Shaoyang syndrome type pneumonia.

[0026] Another object of the present invention is to provide the use of any of the above-mentioned Chinese medicine compositions or the medicine prepared by any of the above-mentioned preparation methods in combination with conventional therapy in the preparation of a product for treating Shaoyang syndrome pneumonia.

[0027] Another object of the present invention is to provide the use of any of the above-mentioned Chinese medicine compositions or the drugs prepared by any of the above-mentioned preparation methods in the preparation of products for improving the efficacy of conventional treatments for Shaoyang syndrome pneumonia.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The Chinese medicine composition of the present invention, through the combination of monarch, minister, assistant and guiding drugs, can significantly improve inflammatory indicators and shorten the course of disease, making it suitable for the adjuvant treatment of severe pneumonia in the ICU. It is also highly safe and has no side effects such as liver and kidney damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Comparison of C-reactive protein levels on the fifth day between the conventional treatment group and the traditional Chinese medicine treatment group (bar graph, marked P = 0.027). DETAILED DESCRIPTION

[0031] The accompanying drawings are for illustrative purposes only and are not to be construed as limiting the present invention. To better illustrate the following embodiments, some components in the accompanying drawings may be omitted, enlarged, or reduced in size, and do not represent actual product dimensions. Those skilled in the art will appreciate that some well-known structures and their descriptions may be omitted from the accompanying drawings.

[0032] Example 1

[0033] This embodiment provides a traditional Chinese medicine decoction for treating Shaoyang syndrome pneumonia, comprising a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0034] 60 parts of Astragalus, 15 parts of Bupleurum, 15 parts of Adenophora, 25 parts of Carapax Trionycis, 15 parts of Platycodon, 15 parts of Aster, 15 parts of Tangerine Peel, 15 parts of Pinellia, 30 parts of Rehmannia, 20 parts of Gentiana, 15 parts of Perilla, 18 parts of Magnolia, 30 parts of Coix Seed, 15 parts of Wax Gourd Seed, 15 parts of Peach Kernel, 15 parts of Licorice, 30 parts of Plum, and 30 parts of Artemisia Annua.

[0035] The preparation method of the above-mentioned Chinese medicine decoction comprises the following steps:

[0036] S1. Soaking: Weigh the medicinal components other than Artemisia annua by weight and soak for 30 minutes;

[0037] S2, a decoction: add 9 times the weight of water and decoct once, add Artemisia annua 15 minutes before the end of the decoction and continue to decoct, the decoction time is 1 hour, and after completion, filter to obtain a filtrate;

[0038] S3, secondary decoction: add water to the dregs of the first decoction and perform secondary decoction for 0.5 hours, and filter to obtain a secondary filtrate;

[0039] S4. Combining the primary filtrate and the secondary filtrate to obtain the Chinese medicine decoction.

[0040] Example 2

[0041] This embodiment provides a traditional Chinese medicine decoction for treating Shaoyang syndrome pneumonia, comprising a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0042] 55 parts of Astragalus, 12 parts of Bupleurum, 12 parts of Adenophora, 22 parts of Carapax Trionycis, 12 parts of Platycodon, 12 parts of Aster, 12 parts of Citrus Reticulata, 12 parts of Pinellia, 27 parts of Rehmannia Glutinosa, 17 parts of Gentiana Macrophylla, 12 parts of Perilla Leaf, 15 parts of Magnolia Bark, 27 parts of Coix Seed, 12 parts of Wax Gourd Seed, 12 parts of Peach Kernel, 12 parts of Licorice Root, 27 parts of Plum, and 27 parts of Artemisia Annua.

[0043] The preparation method of the above-mentioned Chinese medicine decoction comprises the following steps:

[0044] S1. Soaking: Weigh the medicinal components other than Artemisia annua by weight and soak for 40 minutes;

[0045] S2, a decoction: add 10 times the weight of water and decoct once, add Artemisia annua 20 minutes before the end of the decoction and continue to decoct, the decoction time is 1.2 hours, and after completion, filter to obtain a filtrate;

[0046] S3, secondary decoction: add water to the dregs of the first decoction for secondary decoction, the secondary decoction time is 0.3 hours, and the secondary filtrate is obtained after filtration;

[0047] S4. Combining the primary filtrate and the secondary filtrate to obtain the Chinese medicine decoction.

[0048] Test case 1 uses a retrospective case-control study

[0049] Inclusion criteria for cases:

[0050] 1. Aged 18-90 years, admitted to the ICU and diagnosed with pneumonia;

[0051] 2. The TCM diagnosis is Shaoyang syndrome (cough, bitter taste in the mouth, dry throat, red tongue with white fur, and stringy pulse).

[0052] Exclusion criteria for cases:

[0053] 1. Pregnant women, patients with AIDS, or terminal malignant tumors;

[0054] 2. Survival time < 24 hours or participation in other interventional studies;

[0055] 3. Those who cannot administer the drug through the gastrointestinal tract.

[0056] The patients were divided into a conventional treatment group (44 patients) and a traditional Chinese medicine treatment group (27 patients). All pneumonia patients received conventional pneumonia treatment. The conventional treatment group refers to patients who only received conventional treatment methods, while the traditional Chinese medicine treatment group refers to patients who received traditional Chinese medicine treatment in addition to the conventional treatment plan.

[0057] The cases in the Chinese medicine treatment group were treated with conventional treatment combined with Chinese medicine treatment, that is, the Chinese medicine decoction provided in Example 1 was used on the basis of conventional treatment, with one dose taken daily, divided into two doses for nasogastric feeding or oral administration.

[0058] The above-mentioned conventional treatment methods refer to: based on the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China", anti-infection treatment, respiratory support, fluid management and circulatory support measures are taken according to the needs of the disease.

[0059] The anti-infection treatment in this test case is:

[0060] Empirical or targeted antimicrobial drugs are selected based on the patient's clinical manifestations, imaging features, and sputum or blood culture results, including: β-lactams (such as ceftriaxone, cefuroxime, piperacillin / tazobactam), respiratory fluoroquinolones (such as levofloxacin, moxifloxacin), and macrolides (such as azithromycin).

[0061] For more severe cases, broad-spectrum antibiotics, including meropenem combined with vancomycin, are used in combination based on the pathogen risk.

[0062] Antiviral drugs, including oseltamivir or favipiravir, should be given as appropriate for cases of viral pneumonia.

[0063] Targeted drug treatments were also used for different symptoms of the cases: cough suppressants and expectorants (including ambroxol, acetylcysteine, etc., used to improve expectoration; antipyretic and analgesic drugs (acetaminophen, ibuprofen, etc. to relieve fever and muscle aches); bronchodilators (such as salbutamol, ipratropium bromide, etc.) were suitable for those with asthma or COPD.

[0064] In this test case, the oxygen therapy and respiratory support for the patient are:

[0065] When oxygen saturation (SpO2) is less than 92%, low-flow or high-flow oxygen should be given;

[0066] Patients with severe respiratory failure receive non-invasive or invasive mechanical ventilation;

[0067] ECMO support can be used for extremely serious cases.

[0068] Observe and compare the cases' pre-treatment (baseline) status, serum C-reactive protein levels 5 days after treatment, and 28-day mortality rates.

[0069] There was no significant difference in the conditions of the patients in the conventional treatment group and the traditional Chinese medicine treatment group before treatment. Their baseline conditions are shown in Table 1.

[0070] Table 1 Clinical baseline of pneumonia cases in conventional treatment group and traditional Chinese medicine treatment group

[0071]

[0072]

[0073]

[0074] The values are expressed as mean ± standard error of the mean (SEM) or number of patients (%).

[0075] Bold values indicate P values < 0.05

[0076] Comparison of clinical parameters between the conventional treatment group and the TCM treatment group (Table 2) showed that after 5 days of treatment, the C-reactive protein level of the TCM treatment group was significantly lower than that of the conventional treatment group (P=0.027) ( Figure 1 ); and compared with the 28-day mortality rate of the cases in the conventional treatment group (76.2%, P = 0.003), the 28-day mortality rate of the cases in the traditional Chinese medicine treatment group was also significantly reduced (40.7%, P = 0.003).

[0077] Table 2 Clinical characteristics and 28-day mortality of pneumonia cases in the conventional treatment group and the traditional Chinese medicine treatment group after 5 days of treatment

[0078]

[0079]

[0080] The values are expressed as mean ± standard error of the mean (SEM) or number of patients (%).

[0081] Bold values indicate P values < 0.05

[0082] Univariate and multivariate regression analyses (Table 3) revealed that TCM treatment was an independent factor in reducing 28-day mortality.

[0083] Table 3 Univariate and multivariate analysis of 28-day mortality in pneumonia patients treated with traditional Chinese medicine

[0084]

[0085] Model 1 was adjusted for age, sex, and BMI.

[0086] Model 2 was adjusted for age, sex, BMI, chronic obstructive pulmonary disease, chronic renal failure, C-reactive protein, and white blood cell count.

[0087] Model 3 was adjusted for age, sex, BMI, chronic obstructive pulmonary disease, chronic renal failure, C-reactive protein, white blood cell count, creatinine, chronic heart failure, hypertension, and diabetes mellitus.

[0088] Bold values indicate P values < 0.05.

[0089] Obviously, the above embodiments of the present invention are merely examples for the purpose of clearly illustrating the technical solutions of the present invention, and are not intended to limit the specific implementation methods of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the claims of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating Shaoyang syndrome type pneumonia, characterized in that: The composition comprises the following components in parts by weight: 55-65 parts of raw Astragalus, 12-18 parts of Bupleurum, 12-18 parts of Adenophora, 22-28 parts of Carapax Trionycis, 12-18 parts of Platycodon, 12-18 parts of Aster, 12-18 parts of Tangerine Peel, 12-18 parts of Pinellia, 27-33 parts of Rehmannia glutinosa, 17-23 parts of Gentiana macrophylla, 12-18 parts of Perilla Leaf, 15-21 parts of Magnolia officinalis, 27-33 parts of Coix Seed, 12-18 parts of Wax Gourd Seed, 12-18 parts of Peach Kernel, 12-18 parts of raw Licorice, 27-33 parts of Plum, and 27-33 parts of Artemisia Annua.

2. The Chinese medicine composition for treating Shaoyang syndrome type pneumonia according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 57-62 parts of raw Astragalus, 13-17 parts of Bupleurum, 13-17 parts of Adenophora, 23-27 parts of Carapax Trionycis, 13-17 parts of Platycodon, 13-17 parts of Aster, 13-17 parts of Tangerine Peel, 13-17 parts of Pinellia, 28-33 parts of Rehmannia glutinosa, 18-22 parts of Gentiana macrophylla, 13-17 parts of Perilla Leaf, 16-20 parts of Magnolia officinalis, 28-32 parts of Coix seeds, 13-17 parts of Wax Gourd seeds, 13-17 parts of Peach Kernel, 13-17 parts of raw Licorice, 28-32 parts of Plum, and 28-32 parts of Artemisia Annua.

3. The Chinese medicine composition for treating Shaoyang syndrome type pneumonia according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 60 parts of Astragalus, 15 parts of Bupleurum, 15 parts of Adenophora, 25 parts of Carapax Trionycis, 15 parts of Platycodon, 15 parts of Aster, 15 parts of Tangerine Peel, 15 parts of Pinellia, 30 parts of Rehmannia, 20 parts of Gentiana, 15 parts of Perilla, 18 parts of Magnolia, 30 parts of Coix Seed, 15 parts of Wax Gourd Seed, 15 parts of Peach Kernel, 15 parts of Licorice, 30 parts of Plum, and 30 parts of Artemisia Annua.

4. A medicine for treating Shaoyang syndrome type pneumonia, characterized in that: The invention comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

5. The medicine for treating Shaoyang syndrome type pneumonia according to claim 4, characterized in that The dosage form of the medicine is decoction.

6. A method for preparing the medicine for treating Shaoyang syndrome type pneumonia according to claim 5, characterized in that: The preparation method comprises the following steps: S1. Soaking: Weigh the medicinal components other than Artemisia annua by weight and soak them; S2, primary decoction: adding 8-10 times the weight of water for primary decoction, adding Artemisia annua 10-20 minutes before the end of the primary decoction and continuing to decoct, filtering to obtain a primary filtrate after the primary decoction is completed; S3, secondary decoction: adding water to the dregs of the primary decoction for secondary decoction, and filtering to obtain a secondary filtrate; S4. Combine the primary filtrate and the secondary filtrate.

7. The method for preparing the medicine for treating Shaoyang syndrome type pneumonia according to claim 6, characterized in that: In step S1, the soaking time is 20 to 40 minutes; in step S2, the first decoction time is 0.5 to 1.2 hours; in step S3, the second decoction time is 0.3 to 0.7 hours;.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the medicine prepared by the preparation method according to any one of claims 6 to 9 in preparing a product for treating Shaoyang syndrome type pneumonia.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the medicine prepared by the preparation method according to any one of claims 6 to 9 in preparing a product for improving the efficacy of conventional treatments for Shaoyang syndrome type pneumonia.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the medicine prepared by the preparation method according to any one of claims 6 to 9 in combination with conventional therapy in the preparation of a product for treating Shaoyang syndrome type pneumonia.

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