Traditional Chinese medicine composition for improving respiratory tract immunity and application thereof

Abstract

The traditional Chinese medicine composition is prepared from the following components in parts by weight: 8 to 15 parts of fructus lycii, 4 to 8 parts of fructus citri sarcodactylis, 3 to 7 parts of bulbus lilii, 1 to 10 parts of rhizoma dioscoreae, 5 to 10 parts of radix codonopsis, 1 to 10 parts of radix salviae miltiorrhizae, 5 to 10 parts of poria cocos, 10 to 20 parts of rhizoma polygonati, 5 to 10 parts of lucid ganoderma, 1 to 10 parts of fructus corni, 1 to 10 parts of herba cistanche, 3 to 12 parts of pericarpium citri reticulatae and 3 to 12 parts of black dates. The traditional Chinese medicine composition follows the body recuperating core of Huangdi Neijing: healthy qi is stored in the body, evil cannot be dried, the effect of improving the immunity of the organism is achieved through balanced recuperating of the liver, the heart, the spleen, the lung and the kidney, the traditional Chinese medicine composition is exact in clinical curative effect and free of toxic and side effects due to the fact that the prescription principle is reasonable correspondingly, and long-term large-scale clinical practice repeated inspection is conducted. The effect of improving the respiratory tract immunity is obvious;

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for improving respiratory immunity and application thereof. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by persistent airflow limitation, mainly manifested by symptoms such as cough, sputum, shortness of breath and dyspnea. The occurrence of COPD is related to multiple factors such as long-term smoking, air pollution, occupational exposure and genetic susceptibility. The course of the disease progresses slowly, with many complications, which seriously affect the quality of life and life expectancy of patients. Research evidence shows that abnormal immune response in the lower respiratory tract of COPD is related to the infiltration of innate and adaptive inflammatory immune cells that form lymphoid follicles into the lungs. Both cell- and antibody-mediated autoimmunity play a fundamental role in the pathogenesis of stable COPD. The increased number of regulatory T cells in COPD patients reflects immune system disorders, which reduces the body's resistance to infection and increases the risk of stimulating infection. With the improvement of the understanding of the immune pathogenesis of COPD, the current use of immunomodulatory therapies can change or interfere with destructive immune pathways, thereby slowing down the damage to lung tissue. Understanding the immunopathogenesis of airway and parenchymal injury, as well as the development of immunomodulatory interventions to restore dysfunctional tissue repair processes, could stabilize the pathological state and restore it to a normal state, thereby reducing COPD-related morbidity and mortality.

[0003] At present, the treatment of COPD mainly includes drug therapy, oxygen therapy, rehabilitation therapy and surgical treatment, among which drug therapy is the main means. Regarding drug therapy, Western medicine uses a combination of glucocorticoids and bronchodilators to treat chronic obstructive pulmonary disease. Although it can relieve symptoms, reduce the frequency of acute attacks and improve symptoms, it is difficult to block the progression of the disease. Clinically, patients will suffer from long-term and repeated chronic infections, which will cause the body's immune function to continue to decline, leading to repeated attacks and even aggravation of COPD symptoms. Traditional Chinese medicine has a bidirectional regulatory effect, which can treat chronic obstructive pulmonary disease by inhibiting inflammation, reducing oxidative stress, inhibiting cell apoptosis and improving airway remodeling. At present, most of the prescriptions used to treat COPD are mainly for airway inflammation and airway remodeling, or to relieve various complications of COPD patients during rehabilitation, and the effect on the recovery of patients' immune function is not good. Therefore, it is urgent to screen out new Chinese medicine formulas for the immune function of patients with chronic obstructive pulmonary disease to provide a new diagnosis and treatment idea for chronic obstructive pulmonary disease. Summary of the invention

[0004] In view of the defects in the prior art, the present invention proposes a Chinese medicine composition for improving respiratory immunity and its application. Traditional Chinese medicine has dual effects of immune activation and immunosuppression in immune regulation. The present invention provides a Chinese medicine composition for improving respiratory immunity by screening Chinese medicine formulas. It aims to specifically regulate the innate immunity and adaptive immunity of COPD patients through the multi-target and multi-level mechanism of action of traditional Chinese medicine to improve the body's immunity and alleviate the progression of COPD, and has good clinical application prospects.

[0005] The invention provides a traditional Chinese medicine composition for improving respiratory immunity, which comprises the following components in parts by weight: 8-15 parts of wolfberry, 4-8 parts of bergamot, 3-7 parts of lily, 1-10 parts of yam, 5-10 parts of codonopsis pilosula, 1-10 parts of salvia miltiorrhiza, 5-10 parts of tuckahoe, 10-20 parts of polygonatum, 5-10 parts of ganoderma lucidum, 1-10 parts of cornus officinalis, 1-10 parts of cistanche, 3-12 parts of tangerine peel and 3-12 parts of black dates.

[0006] This prescription is based on the core of the Huangdi Neijing to regulate the body: when the righteous energy is stored inside, the evil cannot enter. It achieves the effect of improving the body's immunity by balancing the five internal organs of the liver, heart, spleen, lungs and kidneys.

[0007] Codonopsis pilosula replenishes the middle and benefits qi, strengthens the spleen and benefits the lungs, Poria strengthens the spleen and harmonizes the middle, calms the mind and soothes the nerves, Ganoderma lucidum replenishes qi and nourishes blood, calms the mind and resolves the will, protects the liver and detoxifies, Polygonatum sibiricum replenishes qi and nourishes yin, and is suitable for the symptoms of deficiency of both qi and yin. They are all monarch medicines and play a leading role in replenishing qi, strengthening the spleen, benefiting the lungs and enhancing immunity.

[0008] Yam nourishes the spleen and stomach, benefits the lungs and relieves cough; lily clears the heart and soothes the mind, nourishes yin and moistens dryness; salvia nourishes blood and soothes the mind, promotes blood circulation and removes blood stasis; Cornus officinalis nourishes the liver and kidneys, astringes and consolidates the body; Cistanche nourishes the kidneys and aids yang. Together they are minister herbs, exerting the effects of moistening the lungs and nourishing yin, promoting blood circulation and nourishing the heart, and nourishing the kidneys, and assisting the monarch herbs in strengthening the effects of strengthening the spleen and replenishing qi, and calming the mind and tranquilizing the mind.

[0009] Codonopsis pilosula, Polygonatum sibiricum, Poria cocos, and Ganoderma lucidum focus on tonifying Qi, while yam, salvia miltiorrhiza, lily, cornus officinalis, and Cistanche deserticola can tonify Yin and Yang, maintain the balance of Yin and Yang, prevent symptoms of Yin deficiency caused by excessive Qi tonification, and effectively reconcile the potency of the monarch drug, reduce side effects, and improve the safety and efficacy of the overall prescription.

[0010] Buddha's hand can soothe the liver and regulate qi, regulate the body qi, and tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, and promote qi and relieve fullness. They are adjuvant drugs that can soothe the liver and regulate qi, wake up the spleen and nourish the stomach. Black dates can harmonize all the drugs and serve as guiding drugs.

[0011] In some embodiments, the Chinese medicine composition includes the following components in parts by weight: 10 parts of wolfberry, 7 parts of bergamot, 5 parts of lily, 5 parts of yam, 8 parts of codonopsis pilosula, 5 parts of salvia miltiorrhiza, 8 parts of poria, 15 parts of polygonatum, 8 parts of ganoderma lucidum, 5 parts of cornus officinalis, 5 parts of cistanche, 10 parts of tangerine peel, and 10 parts of black dates.

[0012] In some embodiments, the dosage form of the Chinese medicine composition is any one of a decoction, an oral solution, a tablet, a capsule, a granule, and a powder.

[0013] The present invention also provides a decoction for improving respiratory immunity, wherein the decoction is prepared from the Chinese medicine composition and water.

[0014] The present invention also provides an oral liquid for improving respiratory immunity, wherein the oral liquid is prepared from the Chinese medicine composition and preparation auxiliary materials.

[0015] The present invention also provides a tablet for improving respiratory immunity, wherein the tablet is prepared from the traditional Chinese medicine composition and preparation auxiliary materials.

[0016] The present invention also provides a capsule for improving respiratory immunity, wherein the capsule is prepared from the traditional Chinese medicine composition and preparation auxiliary materials.

[0017] The present invention also provides application of the traditional Chinese medicine composition in preparing medicine for improving respiratory immunity.

[0018] The present invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating chronic obstructive pulmonary disease.

[0019] In some embodiments, the application is specifically: application in the preparation of a drug for improving the immune function of patients with chronic obstructive pulmonary disease.

[0020] In summary, compared with the prior art, the present invention achieves the following technical effects:

[0021] 1. The present invention provides a Chinese medicine composition that can improve the immune function of COPD patients, and intervenes in the treatment from the upstream mechanism of improving respiratory immunity (allergic constitution). It has a significant effect on improving respiratory immunity and is safer. It can achieve the effect of improving immune function in a short period of time and reduce the incidence of COPD patients.

[0022] 2. The Chinese medicine composition of the present invention complies with the core of the "Yellow Emperor's Internal Classic" for regulating the body: when the righteous energy is stored inside, the evil cannot interfere. It achieves the effect of improving the body's immunity by balancing the five internal organs of the liver, heart, spleen, lungs and kidneys. Due to the reasonable correspondence of the prescription principles and repeated inspections in long-term and extensive clinical practice, the Chinese medicine composition of the present invention has a definite clinical efficacy, a significant effect in improving respiratory immunity, and no toxic side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 This is the result diagram of the effect of different prescriptions on the IL-6 concentration in the serum of COPD model rats;

[0025] Figure 2 This is the result diagram of the effect of different prescriptions on the concentration of TNF-α in the serum of COPD model rats;

[0026] Figure 3 This is the result diagram of the effect of different prescriptions on the concentration of MMP-9 in the serum of COPD model rats;

[0027] Figure 4 This is the result diagram of the effect of different prescriptions on the concentration of CXCL8 in the serum of COPD model rats;

[0028] Figure 5 This is a graph showing the effects of different prescriptions on the concentration of TGF-β1 in the serum of COPD model rats. DETAILED DESCRIPTION

[0029] In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only embodiments of a part of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work should fall within the scope of protection of the present invention.

[0030] The experimental methods used in the following examples are conventional methods unless otherwise specified. The materials and reagents used are all commercially available unless otherwise specified.

[0031] The pretreatment methods of the Chinese medicinal materials in the present invention can be found in the Chinese Pharmacopoeia 2010 Edition, and the pretreated medicinal materials are used in the preparation of the Chinese medicinal composition of the present invention.

[0032] Example 1

[0033] The raw materials were weighed by weight: 8 parts of wolfberry, 4 parts of bergamot, 3 parts of lily, 1 part of yam, 5 parts of codonopsis, 1 part of salvia, 5 parts of poria, 10 parts of polygonatum, 5 parts of ganoderma, 1 part of cornus, 1 part of cistanche, 3 parts of tangerine peel and 3 parts of black dates. All the drugs were crushed into fine powder, boiled with 800 mL of water and filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0034] Example 2

[0035] The raw materials were weighed by weight: 15 parts of wolfberry, 8 parts of bergamot, 7 parts of lily, 10 parts of yam, 10 parts of codonopsis, 10 parts of salvia, 10 parts of poria, 20 parts of polygonatum, 10 parts of ganoderma, 10 parts of cornus, 10 parts of cistanche, 12 parts of tangerine peel and 12 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water and filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0036] Example 3

[0037] The raw materials were weighed by weight: 10 parts of wolfberry, 7 parts of bergamot, 5 parts of lily, 5 parts of yam, 8 parts of codonopsis, 5 parts of salvia, 8 parts of poria, 15 parts of polygonatum, 8 parts of ganoderma, 5 parts of cornus, 5 parts of cistanche, 10 parts of tangerine peel and 10 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water and filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0038] Comparative Example 1

[0039] The raw materials were weighed by weight: 10 parts of wolfberry, 7 parts of bergamot, 5 parts of lily, 5 parts of yam, 5 parts of salvia miltiorrhiza, 5 parts of cornus officinalis, 5 parts of cistanche, 10 parts of tangerine peel, and 10 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water, and then filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0040] Comparative Example 2

[0041] The raw materials were weighed by weight: 10 parts of wolfberry, 7 parts of bergamot, 5 parts of lily, 5 parts of yam, 8 parts of adenophora, 5 parts of salvia, 8 parts of atractylodes, 8 parts of ganoderma, 8 parts of gastrodia, 5 parts of cornus, 5 parts of cistanche, 10 parts of tangerine peel and 10 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water and filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0042] Comparative Example 3

[0043] The raw materials were weighed by weight: 10 parts of wolfberry, 7 parts of bergamot, 8 parts of codonopsis, 10 parts of salvia miltiorrhiza, 8 parts of poria, 15 parts of polygonatum, 8 parts of ganoderma lucidum, 10 parts of cornus officinalis, 10 parts of cistanche, 10 parts of tangerine peel, and 10 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water, and then filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0044] Comparative Example 4

[0045] The raw materials were weighed by weight: 10 parts of wolfberry, 7 parts of bergamot, 10 parts of lily, 10 parts of yam, 8 parts of codonopsis, 8 parts of poria, 15 parts of polygonatum, 8 parts of ganoderma, 10 parts of cistanche, 10 parts of tangerine peel, and 10 parts of black dates. All the drugs were crushed into fine powder, decocted with 800 mL of water, and then filtered. 800 mL of water was used to concentrate to obtain 200 mL of concentrated solution.

[0046] Effect embodiment:

[0047] 1. Pharmacodynamic study of Chinese medicine combination on respiratory system immunity in COPD rats:

[0048] 1. Construction of COPD rat model:

[0049] Fifty Wista rats of similar weight were selected, of which 40 were anesthetized by ether inhalation on the first and 14th days, the larynx was exposed, and the tracheal tube was replaced by an intravenous cannula for tracheal intubation. LPS (200 μg / rat) was injected into the trachea of ​​the rats. After completion, the rats were rotated vertically for 20 weeks to make LPS evenly distributed in the lungs. From the 2nd to the 13th day, the rats were smoked twice a day in a 100×50×50cm self-made plexiglass sealed box with a 1.5cm diameter vent on the top. The weight of the tobacco shreds lit each time was 9.03g (the weight of each cigarette was 0.645g), the duration was about 1h, and the interval was 4h (no smoking on the day of lipopolysaccharide dripping). The model was completed after 28 days.

[0050] 2. Animal grouping and testing:

[0051] After modeling, 40 rats with a body weight of (160 ± 10) were randomly divided into 8 groups, 5 rats in each group, and the prescriptions were respectively: Example 1 group (first group), Example 2 group (second group), Example 3 group (third group), Comparative Example 1 group (fourth group), Comparative Example 2 group (fifth group), Comparative Example 3 group (sixth group), Comparative Example 4 (seventh group) and blank control group (eighth group). The above prescriptions were used for drug administration. Ten mice without modeling were divided into two groups, namely, a normal group (ninth group) taking the prescription of Example 2 and a blank group (ninth group) taking purified water. For the white group (the tenth group), the gavage volume was 3mL / rat / day, 1.5mL each time. The blank control group was gavaged with an equal amount of purified water to ensure consistency between groups. The drugs were administered continuously for 20 days. The dosage was based on the clinical recommended daily oral dosage for a 70kg adult and converted into the rat gavage dosage based on the body surface area conversion coefficient between adults and rats. Eye blood was collected from rats in each group on the 0th, 10th, 15th, and 21st days of treatment, and the serum was separated to determine the contents of IL-6, TNF-α, MMP-9, CXCL8, and TGF-β1.

[0052] The kits used for the detection were as follows: rat TNF-α enzyme-linked immunosorbent assay kit, E-EL-R2856, Elabscience; Mouse IL-6 ELISA kit, E-EL-M0044, Elabscience; rat MMP-9 detection kit, JK-E5997, Shanghai Jingkang Biological; rat IL-8 ELISA kit, YT-R21436, Yueteng Biological; rat serum TGF-β1 ELISA kit, RQ-FS6734A, Ruiqing Biological.

[0053] The test results are shown in Tables 1 to 5 and Figures 1 to 5 As shown:

[0054] Table 1 Effects of different prescriptions on serum IL-6 concentration in COPD model rats ( pg / L)

[0055]

[0056]

[0057] Table 2 Effects of different prescriptions on serum TNF-α concentration in COPD model rats ( ng / mL)

[0058]

[0059]

[0060] Table 3 Effects of different prescriptions on serum MMP-9 concentration in COPD model rats ( μg / L)

[0061]

[0062] Table 4 Effects of different prescriptions on serum CXCL8 concentration in COPD model rats ( pg / mL)

[0063]

[0064]

[0065] Table 5 Effects of different prescriptions on serum TGF-β1 concentration in COPD model rats ( pg / mL)

[0066]

[0067]

[0068] After taking the prescription of Example 2, the normal rats in the ninth group did not die or show abnormal pathological symptoms, and their immune functions were normal, indicating that the Chinese medicine composition of the present application has good safety and no toxic effects after taking it.

[0069] As shown in Tables 1 to 5, after rats took the Chinese medicine formulas of Examples 1 to 3, the levels of inflammatory response-related factors IL-6, TNF-α, MMP-9, CXCL8, and TGF-β1 in serum were significantly decreased, and there was no significant difference in expression between the rats and normal mice after taking the Chinese medicine formulas of Comparative Examples 1 to 4. After rats took the Chinese medicine formulas of Comparative Examples 1 to 4, the expression of related factors decreased, but the effect was not ideal, while there was no significant difference after normal mice took the formulas, indicating that the Chinese medicine formula of the present application can significantly improve the immune function of COPD rats, and the disease of COPD rats can be alleviated, and the effect is fast.

[0070] 2. Clinical efficacy study of Chinese medicine combination on respiratory system immunity in COPD patients:

[0071] This is a long-term (3-month) clinical efficacy study conducted in subjects with stable COPD to explore the effects of a Chinese medicine formula on the immune function of patients with stable COPD.

[0072] 1. Subject screening criteria:

[0073] (1) Aged between 40 and 90 years old and meeting the diagnostic criteria of the 2023 Global Initiative Chronic Obstructive Lung Disease (GOLD) guidelines.

[0074] (2) No history of acute exacerbation in the past 4 weeks and relevant immune indicators have been examined in the past.

[0075] (3) Patients with other respiratory diseases (severe pneumothorax, severe pleural effusion, pulmonary embolism), severe primary diseases of other major organs or systems, cancer (untreated tumors or tumors requiring treatment in the past two years), fever of unknown origin, unstable cardiovascular disease (arrhythmias (atrial flutter and fibrillation, frequent ventricular tachycardia, atrioventricular block), ischemic heart disease, myocardial infarction within the past 6 months), uncontrolled hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg, 1 mmHg = 0.133 kPa), severe pulmonary hypertension or accompanied by organ failure were excluded; patients with musculoskeletal diseases, nervous system diseases, rheumatic connective tissue diseases, systemic blood system diseases that affect the assessment and completion of rehabilitation (presence of waist, back and / or limb dysfunction or postoperative status, severe arthritis or severe peripheral vascular disease, etc.), mental disorders or cognitive disorders, and a history of lung surgery in the previous three months were excluded.

[0076] 2. Clinical grouping:

[0077] 60 subjects were randomly enrolled in a 1:1 ratio according to the random number table method and divided into an experimental group and a control group. The experimental group was the Chinese medicine combined with Western medicine group of Example 3, which was patients with stable chronic obstructive pulmonary disease who had undergone relevant immune function tests at 0 (baseline) and 3 months in the respiratory outpatient clinic and took the Chinese medicine formula of 3 for 3 months during this period; the control group was a group taking only Western medicine, which was patients with stable chronic obstructive pulmonary disease who had undergone relevant immune function tests at 0 (baseline) and 3 months in the respiratory outpatient clinic of the hospital and only received Western medicine treatment during this period. Condition assessment and health education were carried out at each outpatient follow-up. Each outpatient follow-up recorded the changes in the subject's condition and drug use in detail, and collected relevant information on the subject's acute exacerbation.

[0078] Experimental group: Take 200 mL of Chinese medicine twice a day, and take Western medicine (Compound Asme Capsules, 2 capsules twice a day, 2 capsules each time, Symbicort Inhalation 160 micrograms, once a day), and continue treatment for 3 months.

[0079] Control group: took western medicine (compound Asme capsules, 2 capsules twice a day, 160 micrograms of Symbicort inhalation, once a day), and continued treatment for 3 months.

[0080] Monitoring indicators:

[0081] 3. Immune related indicators:

[0082] T lymphocyte subsets and absolute counts, eight immune tests, total IgE assay, interleukin-6, high-sensitivity C-reactive protein, tumor necrosis factor, three iron items, and venous blood cell analysis.

[0083] Detection method: venous blood test.

[0084] 4. Statistical analysis:

[0085] SPSS25 or higher was used for statistical analysis. All data were described statistically, and the confidence interval method was used for superiority test of the main evaluation indicators. The secondary evaluation indicators and safety evaluation indicators were tested for difference, and the test level was set at 0.05 on both sides. The measurement data were analyzed by independent t-test, and the count data were analyzed by χ 2 Test or Fisher exact test.

[0086] 5. Test results:

[0087] Table 6 Analysis of T lymphocyte subsets and absolute counts

[0088]

[0089] Table 7 Analysis of tumor necrosis factor, interleukin-6, high-sensitivity C-reactive protein, iron triad and total IgE

[0090]

[0091]

[0092] Table 8 Eight immune items and venous blood cell analysis

[0093]

[0094]

[0095] Note: Compared with baseline, *P<0.05, **P<0.001.

[0096] From the results of Tables 6 to 8, it can be seen that after taking the Chinese medicine prescription for 3 months, the number and ratio of T helper lymphocytes (CD4+) / T suppressor cells (CD8+) decreased in patients in the stable phase of chronic lung disease, IgG and IgE decreased significantly (P<0.05), the tumor necrosis factor content increased, the humoral immune function of the patient was strengthened, and the resistance to infection was enhanced. It shows that the use of the Chinese medicine prescription of the present application combined with Western medicine can regulate the humoral and cellular immune function of COPD patients, and the mediated immune response of the body is significantly improved compared with the control group taking only Western medicine.

[0097] The Chinese medicine composition of the present invention follows the core of the Huangdi Neijing: when the righteousness is inside, the evil cannot enter, and the effect of improving the body's immunity is achieved by balancing the five internal organs of the liver, heart, spleen, lungs and kidneys. Due to the reasonable corresponding formula principles and repeated tests in a long-term and large-scale clinical practice, the Chinese medicine composition of the present invention has a definite clinical efficacy and a significant effect of improving the respiratory immunity of COPD patients.

[0098] 3. Other implementation methods:

[0099] The present invention can generate multiple implementations according to the types of ingredients, ingredient contents, dosage forms, etc. For example: Implementation 1: An oral liquid with the Chinese medicine composition as the medicinal ingredient.

[0100] Take oral liquid as an example. Oral liquid is a new dosage form developed on the basis of decoction and injection. It has the advantages of small dosage, fast absorption, stable quality, convenient to carry and take, and easy to store. It contains a variety of active ingredients, which have a great impact on quality and taste. How to retain the active ingredients to the maximum extent and improve the taste without changing the structure and function of the main active ingredients is a difficulty in selecting excipients. Adding excipients to oral liquid can improve taste, clarity, stability and product quality.

[0101] Common excipients for oral liquids include: solvents, aromatics, flavoring agents, clarifiers, preservatives, etc. These excipients can be added at the same time or one of them can be added. Solvents must be added, and water can be used. Different excipient combinations include sweeteners, aromatics, clarifiers or preservatives, or a combination of sweeteners and preservatives. The combination of sweeteners and preservatives is preferred. Some excipients have both sweetening and flavoring effects. In this case, only one excipient needs to be added.

[0102] For oral liquid, preferably, the sweetener is selected from one or more of protein sugar, xylitol, aspartame and sucralose.

[0103] For oral liquid, preferably, the preservative is selected from one or more of p-hydroxybenzoic acid esters, butylated hydroxyanisole, butylated hydroxytoluene and sorbic acid.

[0104] The preservative may be p-hydroxybenzoic acid ester, butyl hydroxytoluene or sorbic acid, preferably butyl hydroxytoluene. They may also be used in combination, such as a combination of p-hydroxybenzoic acid ester and butyl hydroxytoluene, or a combination of butyl hydroxytoluene and sorbic acid, or a combination of p-hydroxybenzoic acid ester, butyl hydroxytoluene and sorbic acid.

[0105] For oral liquid, preferably, the fragrance is fruit flavor.

[0106] For oral liquid, preferably, the clarifier is one of chitosan and gelatin or a mixture of the two.

[0107] Embodiment 2: Tablets with the Chinese medicine composition as the medicinal ingredient.

[0108] Tablets have the advantages of accurate dosage, stable quality, and convenient taking, carrying and transportation.

[0109] For tablets, the formulation excipients include one or more of a diluent, a binder, a lubricant and a disintegrant, preferably a combination of a diluent, a binder, a lubricant and a disintegrant.

[0110] For tablets, preferably, the diluent is one or more of cellulose and inorganic salts, such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw materials and help them to form.

[0111] For tablets, preferably, the binder is one or more of water, ethanol, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin and polyvinyl pyrrolidone.

[0112] For tablets, preferably, the lubricant is one or more of magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.

[0113] For tablets, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, cross-linked polyvinyl pyrrolidone and cross-linked sodium carboxymethyl cellulose.

[0114] Embodiment 3: Capsules with the Chinese medicine composition as the medicinal ingredient.

[0115] In the present invention, the capsule mainly improves the stability and bioavailability of the drug. The preparation auxiliary material is a capsule shell, and the capsule shell is a hard capsule shell or a soft capsule shell.

[0116] Embodiment 4: Granules with the Chinese medicine composition as the medicinal ingredient;

[0117] Granules can be swallowed directly or mixed with warm water and drunk. They are convenient to use and carry, and have a faster dissolution and absorption rate. The preparation excipients used for granules are similar to those for tablets, including one or more of fillers, binders, wetting agents, disintegrants, lubricants and film coating materials.

[0118] For granules, preferably, the filler is one or more of cellulose and inorganic salts, such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw materials and help them to form.

[0119] For granules, preferably, the binder is one or more of water, ethanol, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin and polyvinyl pyrrolidone.

[0120] For granules, preferably, the wetting agent is water or ethanol or a mixture of the two, for example, one or more of magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.

[0121] For granules, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, cross-linked polyvinyl pyrrolidone and cross-linked sodium carboxymethyl cellulose.

[0122] For granules, preferably, the film coating material is one or more of hydroxypropylmethylcellulose, polyethylene glycol, cellulose acetate phthalate and polyvinyl acetal diethylamine acetate. Embodiment 5: Powder with the Chinese medicine composition as the medicinal ingredient.

[0123] The invention can also be made into powder, which is convenient for divided dosage and taking.

[0124] Taking beverages as an example, the composition of the present invention can be made into beverages with different flavors, which will be very popular as daily beverages. The preparation auxiliary materials used in the beverages are at least one of a clarifier, a preservative and a flavoring agent.

[0125] The composition of the present invention can also be prepared into other powders.

[0126] In summary, the present invention provides a traditional Chinese medicine composition for improving respiratory immunity, which can be made into decoction, oral liquid, tablet, capsule, granule, powder, etc. The above multiple implementation methods can adjust the dosage size of the unit product to adapt to different uses, such as medicine, health care products, food, etc.

[0127] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for improving respiratory immunity, characterized in that: The invention comprises the following components in parts by weight: 8-15 parts of wolfberry, 4-8 parts of bergamot, 3-7 parts of lily, 1-10 parts of yam, 5-10 parts of codonopsis pilosula, 1-10 parts of salvia miltiorrhiza, 5-10 parts of poria, 10-20 parts of polygonatum, 5-10 parts of ganoderma lucidum, 1-10 parts of cornus officinalis, 1-10 parts of cistanche, 3-12 parts of tangerine peel and 3-12 parts of black dates.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 10 parts of wolfberry, 7 parts of bergamot, 5 parts of lily, 5 parts of yam, 8 parts of codonopsis pilosula, 5 parts of salvia miltiorrhiza, 8 parts of tuckahoe, 15 parts of polygonatum, 8 parts of ganoderma lucidum, 5 parts of cornus officinalis, 5 parts of cistanche, 10 parts of tangerine peel and 10 parts of black dates.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The dosage form of the Chinese medicine composition is any one of water decoction, oral liquid, tablet, capsule, granule and powder.

4. A decoction for improving respiratory immunity, characterized in that: The water decoction is prepared from the Chinese medicine composition according to claim 1 or 2 and water.

5. An oral liquid for improving respiratory immunity, characterized in that: The oral liquid is prepared from the Chinese medicine composition according to claim 1 or 2 and preparation excipients.

6. A tablet for improving respiratory immunity, characterized in that: The tablet is made of the traditional Chinese medicine composition according to claim 1 or 2 and preparation excipients.

7. A capsule for improving respiratory immunity, characterized in that: The capsule is made of the traditional Chinese medicine composition according to claim 1 or 2 and preparation excipients.

8. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for improving respiratory immunity.

9. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating chronic obstructive pulmonary disease.

10. The use according to claim 9, characterized in that: The application is specifically: application in the preparation of a drug for improving the immune function of patients with chronic obstructive pulmonary disease.

Images