Lung tonifying pill pharmaceutical composition and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicine compositions, in particular to a lung tonifying pill pharmaceutical composition and a preparation method thereof, and the pharmaceutical composition is prepared from the following raw materials in parts by weight: 220 parts of lucid ganoderma, 110 parts of fried stiff silkworm, 150 parts of hairyvein agrimony, 150 parts of oldenlandia diffusa, 150 parts of radix glehniae and 150 parts of radix ophiopogonis. According to the invention, through precise medicine compatibility, the medicines play a synergistic effect, and a strict quality control system ensures the stability and safety of product quality, so that a patient can take the medicine trustingly.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a pharmaceutical composition for treating pulmonary diseases, especially having remarkable curative effects on symptoms such as cough, asthma, etc. caused by lung qi deficiency and obstruction of lung heat and phlegm, and a preparation method and application thereof. Background Art

[0002] Pulmonary diseases are a class of diseases that seriously threaten human health, including chronic obstructive pulmonary disease (COPD), asthma, pneumonia, etc. With the aggravation of environmental pollution, population aging and other factors, the incidence of pulmonary diseases has been increasing year by year. At present, the drugs for treating pulmonary diseases clinically mainly include western medicines and traditional Chinese medicines. Western medicines have a certain effect in relieving symptoms, but long-term use often has problems such as relatively large side effects and easy generation of drug resistance. For example, bronchodilators may cause adverse reactions such as palpitations and tremors of hands, and the abuse of antibiotics has exacerbated the generation of bacterial drug resistance.

[0003] Traditional Chinese medicines have advantages such as overall conditioning and small side effects in treating pulmonary diseases. They act through multiple targets and multiple pathways, can improve pulmonary function, and enhance the body's immunity. However, there are still some deficiencies in the existing pharmaceutical compositions when treating pulmonary diseases. The formula of some traditional Chinese medicine compounds is not precise enough, and the synergistic effect between drugs has not been fully exerted. Although some prescriptions contain various drugs with effects such as relieving cough, asthma, and resolving phlegm, the dosage ratios of each drug are not reasonable enough, resulting in unsatisfactory overall curative effects. For example, the ratio between the qi-tonifying drugs and the heat-clearing and phlegm-resolving drugs in some prescriptions is unbalanced, so that during the treatment, either the focus is on qi-tonifying while the power of heat-clearing and phlegm-resolving is insufficient and the heat phlegm in the lungs cannot be effectively cleared, or too much emphasis is placed on heat-clearing and phlegm-resolving while neglecting qi-tonifying and consolidating the foundation, resulting in damage to the healthy qi of the patient and recurrence of the disease. The targeting for the specific syndrome type of lung qi deficiency and obstruction of lung heat and phlegm is not strong enough. The indications of many traditional prescriptions are relatively broad, and they do not precisely formulate the compatibility according to the pathological mechanism of the interweaving of lung qi deficiency and obstruction of lung heat and phlegm. This makes it impossible to comprehensively take into account when treating pulmonary diseases with such complex pathogenesis, affecting the treatment effect.

[0004] There are many problems in the raw material processing link. The sources of Chinese herbal medicines are complex, and there are significant differences in the quality of herbs from different origins and batches. During the processing process, there is a lack of unified and strict standard operating procedures, resulting in unstable contents of active ingredients and uneven medicinal effects. For example, the processing methods of Ganoderma lucidum may vary in different regions, and the contents of its active ingredients, triterpenoids and polysaccharides, will be affected, thus affecting the quality and efficacy of the preparations. The pulverization process is rough. In most cases, only simple coarse pulverization is carried out, the drug particles are large, the dissolution of active ingredients is slow, and the bioavailability is low. This not only reduces the therapeutic effect of the drug, but also may increase the dosage and frequency of administration for patients, bringing inconvenience to patients. The preparation forming process is backward. The traditional pill-making process is difficult to precisely control aspects such as the appearance, hardness, and disintegration time limit of pills. Unattractive appearance may affect the medication compliance of patients; inappropriate hardness may cause the drug to break or deform during storage and transportation, affecting the stability of the drug; too long disintegration time limit will delay the onset time of the drug in the body and fail to exert the medicinal effect in a timely manner. The packaging process is simple and lacks good moisture-proof and light-proof protection measures. The pharmaceutical composition is easily affected by environmental factors such as humidity and light during storage, resulting in degradation or deterioration of active ingredients. In addition, improper selection of packaging materials may introduce external impurities, contaminate the drug, and reduce the quality and safety of the drug.

[0005] In summary, developing a pharmaceutical composition with reasonable drug compatibility and scientific preparation process is of great significance for the treatment of lung diseases. The Lingxian Bufei Pills of the present invention are an innovative pharmaceutical composition developed based on these needs. Summary of the Invention

[0006] The present invention aims to provide a pharmaceutical composition with definite curative effect, stable quality and convenient administration, which is used for treating symptoms such as cough, asthma, and unsmooth expectoration caused by lung qi deficiency and obstruction of lung heat by phlegm. Through reasonable drug compatibility and scientific preparation process, the therapeutic effect of the drug is improved, side effects are reduced, and the medication compliance of patients is enhanced.

[0007] A pharmaceutical composition of Lingxian Bufei Pills, the pharmaceutical composition is made from the following raw materials in parts by weight: 220 parts of Ganoderma lucidum, 110 parts of stir-fried Bombyx batryticatus, 150 parts of Agrimonia pilosa Ledeb., 150 parts of Hedyotis diffusa Willd., 150 parts of Glehnia littoralis Fr. Schmidt ex Miq., and 150 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl.

[0008] Furthermore, the dosage form of the pharmaceutical composition is pills, and the preparation method of the pills includes the following steps:

[0009] Raw material pretreatment: remove impurities from Ganoderma lucidum, cut off the lower stems with rotten wood, mud or culture medium, and dry in the shade or at 40-50℃; wash and dry the fried silkworm, remove impurities; remove the residual roots and impurities from Agrimonia, wash, cut into sections, and dry; take the raw materials of Hedyotis diffusa, remove impurities, wash, cut, and dry; remove the residual stems and impurities from Glehnia littoralis, cut into sections, and dry; remove the impurities from Ophiopogon japonicus, wash, moisten, flatten, and dry;

[0010] Crushing: Spread the processed raw material pieces on a stainless steel plate with a thickness of 1 cm, put them into an oven, dry them at 70°C for 5 hours, then mix them according to the prescription ratio and crush them, 100% of the powder passes through an 80-mesh sieve, and 95% passes through a 100-mesh sieve to obtain a mixed powder;

[0011] Preparation molding: Take the mixed drug powder, add 13% starch slurry solution as a binder, the weight ratio of drug powder to starch slurry is 100:90, stir for 10 minutes, make drug pellets, add the drug pellets to the automatic pill making machine, adjust the equipment knife and the outlet to make the particle size 4mm, and make pills to obtain pills;

[0012] Drying: Spread the pills flat on the medicine tray with a thickness not exceeding 2 cm. Let them cool in a clean area to harden the surface of the pills. Then spread them out on trays and dry them at 80°C for 5 hours using hot air circulation drying method.

[0013] Polishing: The dried pills are loaded into a water chestnut-type sugar coating machine, purified water is added, and the hot and cold air of the sugar coating machine are turned on to gradually dry the moisture on the surface of the water pills, and polishing is performed until the surface of the pills is smooth and bright;

[0014] Pill selection and packaging: Manual pill selection is adopted to pick out connected pills and residual pills to ensure the appearance quality of water pills, and then inner packaging is carried out. The inner packaging is sealed using a water pill packaging machine. The inner packaging material is medicinal composite film, and each bag is packaged at 9g. The difference in filling volume is within ±5% of 9g as required by the pharmacopoeia. Each bag is packed into an outer packaging box according to the packaging specifications of the preparation.

[0015] Furthermore, the starch slurry solution is prepared by taking an appropriate amount of dry starch and mixing it with boiling water to form a paste.

[0016] On the other hand, the present invention also provides the use of the pharmaceutical composition in the preparation of medicines for treating lung diseases of the lung qi deficiency and lung heat and phlegm obstruction type.

[0017] Furthermore, in the application, the lung diseases include chronic bronchitis and asthma.

[0018] Beneficial effects:

[0019] The present invention uses precise drug compatibility to enable each drug to play a synergistic effect. Ganoderma lucidum replenishes lung qi, fried silkworm and white flower old mandarin diffusa resolve phlegm and clear heat, herba agrimonii strengthens the body and detoxifies, and Radix Adenophorae and Radix Ophiopogonis nourish yin and moisten the lungs. All the drugs cooperate with each other, and act on the pathological mechanism of lung qi deficiency and lung heat and phlegm obstruction from multiple aspects such as replenishing qi, clearing heat, resolving phlegm, and nourishing yin, comprehensively improve lung function, improve body immunity, and enhance the effects of relieving cough, relieving asthma, and resolving phlegm. For example, Ganoderma lucidum is used in combination with Radix Adenophorae and Radix Ophiopogonis to nourish lung yin while replenishing qi, so that lung qi is sufficient and moisturized, and the effect of relieving cough and relieving asthma is stronger; fried silkworm and white flower old mandarin diffusa work together to enhance the power of clearing heat and resolving phlegm, so that hot phlegm in the lungs can be effectively removed. The pretreatment of raw materials strictly follows the standard specifications, ensures the stability and reliability of the quality of the medicinal materials, and provides high-quality raw materials for subsequent production. The pulverization process uses mixed pulverization and specific drying conditions to increase the powder extraction rate, make the drug particles finer, increase the dissolution rate and bioavailability of the active ingredients, and thus improve the efficacy of the drug. In the preparation molding process, the quality of the pills is ensured by the careful selection and optimization of the binder, as well as the precise control of the process parameters such as pill making, drying, and polishing. The appropriate binder concentration and ratio make the pills well-formed, with moderate hardness and reasonable disintegration time; the optimized drying temperature and time ensure that the pills are of appropriate hardness, good taste and rapid dissolution, which is conducive to the absorption and function of the drug in the body; the polishing and pill selection processes improve the appearance quality of the pills and increase the patient's compliance with medication. The strict quality control system ensures the stability and safety of product quality, so that patients can take it with confidence. DETAILED DESCRIPTION

[0020] Example 1: Complete formula of Lingxian Bufei Pills

[0021] 1. Raw material preparation and preparation of formulations

[0022] 1.According to the prescription, accurately weigh 220g of Ganoderma Lucidum, 110g of Fried Bombyx Batryticatus, 150g of Agrimoniae, 150g of Hedyotis diffusa, 150g of Glehnia littoralis, 150g of Radix Adenophorae, and 150g of Radix Ophiopogonis. All raw materials are Chinese herbal medicines that meet national drug standards.

[0023] 2. Prepare and process all the raw materials: remove impurities from Ganoderma lucidum, cut off the lower stems with rotten wood, mud or culture medium, and dry them in the shade or at 40-50℃; wash and dry the fried Bombyx batryticatus, remove impurities; remove the remaining roots and impurities from Agrimoniae, wash, moisten, cut into sections, and dry; take the raw materials of Hedyotis diffusa, remove impurities, wash, cut, and dry; remove the remaining stems and impurities from Glehnia littoralis, moisten, cut into sections, and dry; remove the impurities from Ophiopogon japonicus, wash, moisten, flatten, and dry.

[0024] 3. Spread the processed raw material pieces on a stainless steel plate with a thickness of 1 cm, put them in an oven, and dry them at 70°C for 5 hours. Then mix them according to the prescription ratio and grind them, 100% of the powder passes through an 80-mesh sieve, and 95% passes through a 100-mesh sieve to obtain a mixed powder.

[0025] 4. Take the mixed powder and add 13% starch slurry solution (take an appropriate amount of dry starch and make it into a paste with boiling water)

[0026] As an adhesive, the weight ratio of drug powder to starch slurry is 100:90. Cover the mixer lid and stir for 10 minutes. After mixing evenly, it feels moderately soft and hard, sticky when held, and slightly loose when loosened, and the drug ball is made.

[0027] 5. Add the pills to the automatic pill making machine, adjust the equipment knife and the outlet to make the particle size 4mm, and make pills. Spread the pills on the medicine receiving tray with a thickness of no more than 2cm, first cool them in a clean area to harden the surface of the pills, then spread them on the trays, and use hot air circulation drying method to dry them at 80℃ for 5 hours.

[0028] 6. The dried pills are loaded into a water chestnut-type sugar coating machine, and an appropriate amount of purified water is added. The hot and cold air of the sugar coating machine is turned on to gradually dry the surface moisture of the water pills, and polishing is performed until the surface of the pills is smooth and bright. The method of manual pill selection is adopted to pick out the connected pills and the residual pills to ensure the appearance quality of the water pills, and then the inner packaging is carried out. The inner packaging is sealed using a water pill packaging machine. The inner packaging material is polyester / aluminum / polyethylene medicinal composite film. Each bag is packed with 9g. The difference in the amount is between ±5% of 9g (8.55g-9.45g) according to the requirements of the pharmacopoeia. Each bag is coded with "production date, preparation batch number, and validity period until". The outer packaging is to put the inner packaging plastic-sealed medicine bag into the outer packaging box with "production date, preparation batch number, and validity period until" according to the preparation packaging specifications and quantity, and the Lingxian Bufei Pills are obtained.

[0029] 2. Clinical application and effect observation

[0030] 1. 100 patients with lung diseases of lung qi deficiency, lung heat and phlegm obstruction type (such as chronic bronchitis, asthma, etc.) aged between 40 and 70 years old, with an average age of (55±5) years old. The main symptoms of the patients included cough, wheezing, uncomfortable expectoration, chest tightness, etc., and the duration was long (average course of disease 3-5 years).

[0031] 2. Administration: Patients take Lingxian Bufei Pills orally, 9g each time, 3 times a day, for 4 weeks.

[0032] 3. Observation indicators

[0033] 1. Symptom improvement: The changes in symptoms such as cough, asthma, and expectoration in patients were recorded in detail, and scored according to the severity of symptoms (asymptomatic is 0 points, mild is 1 point, moderate is 2 points, severe is 3 points), and the changes in symptom scores before and after treatment were calculated. The results showed that after treatment, the symptom scores of cough,

[0034] asthma, expectoration, etc. in patients decreased significantly, and the total effective rate reached 85%. For example, the average score of cough symptoms before treatment was 2.2 ± 0.5 points, and decreased to 0.8 ± 0.3 points after treatment; the average score of asthma symptoms before treatment was 2.0 ± 0.4 points, and decreased to 0.7 ± 0.2 points after treatment; the average score of unsmooth expectoration symptoms before treatment was 1.8 ± 0.3 points, and decreased to 0.6 ± 0.2 points after treatment.

[0035] 2. Detection of pulmonary function indexes: The forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1 / FVC ratio of patients were measured by a pulmonary function detector before and after treatment. After treatment, the pulmonary function indexes of patients were significantly improved. The average increase in FEV1 was (0.35 ± 0.10) L, and the average increase in FVC was

[0036] (0.40 ± 0.12) L, and the average increase in the FEV1 / FVC ratio was (5.5 ± 1.5)%.

[0037] 3. Detection of immune function indexes: Peripheral blood of patients was collected before and after treatment, and the levels of immunoglobulins (IgA, IgG, IgM) in serum and the proportions of T lymphocyte subsets (CD3+, CD4+, CD8+) were detected.

[0038] The results showed that after treatment, the levels of IgA and IgG in patients increased significantly, and the CD4+ / CD8+ ratio increased significantly, indicating that the body's immune function was enhanced. For example, the average level of IgA before treatment was (1.8

[0039] ± 0.5) g / L, and increased to (2.5 ± 0.6) g / L after treatment; the average level of IgG before treatment was (8.0

[0040] ± 1.5) g / L, and increased to (10.5 ± 2.0) g / L after treatment; the CD4+ / CD8+ ratio before treatment was

[0041] (1.2 ± 0.3), and increased to (1.5 ± 0.4) after treatment.

[0042] 4. Detection of inflammatory factor levels: Detect the levels of interleukin-6 (IL-6) in serum of patients before and after treatment,

[0043] Levels of inflammatory factors such as tumor necrosis factor-α (TNF-α). After treatment, the levels of inflammatory factors decreased significantly. The average level of IL-6 before treatment was (15.5 ± 3.5) pg / mL, and it decreased to (8.5

[0044] ± 2.0) pg / mL after treatment; the average level of TNF-α before treatment was (10.5 ± 2.5) pg / mL, and it decreased to (6.0 ± 1.5) pg / mL after treatment, indicating that the drug has a significant inhibitory effect on pulmonary inflammation.

[0045] Example 2: Absence of Ganoderma lucidum (comparison with single ingredient deletion)

[0046] 1. Raw material preparation and preparation of preparations

[0047] 1. Weigh 110 g of stir-fried Bombyx Batryticatus, 150 g of Agrimonia pilosa Ledeb., 150 g of Hedyotis diffusa Willd., 150 g of Glehnia littoralis Fr. Schmidt ex Miq., and 150 g of Ophiopogon japonicus (Thunb.) Ker-Gawl. Prepare into pills according to the steps of processing, pulverization, and preparation of pills in Example 1, with the same packaging specifications.

[0048] 2. Clinical application and effect observation

[0049] 1. Select 100 patients similar to those in Example 1, with basically the same age, condition, etc., and conduct treatment and observation using the same drug administration method and observation indicators.

[0050] 2. Symptom improvement: Although the symptom scores of the patients decreased to a certain extent after treatment, the total effective rate was only 55%, significantly lower than that in Example 1. The average score of the cough symptom after treatment was 1.5 ± 0.4 points, the average score of the asthma symptom after treatment was 1.3 ± 0.3 points, and the average score of the unsmooth expectoration symptom after treatment was 1.2 ± 0.2 points, all higher than the corresponding scores after treatment in Example 1.

[0051] 3. Detection of lung function indicators: The average increase in FEV1 was (0.15 ± 0.08) L, and the average increase in FVC was (0.20 ± 0.10)

[0052] L, and the average increase in the FEV1 / FVC ratio was (2.5 ± 1.0)%, and the improvement degree was far less than that in Example 1.

[0053] 4. Detection of immune function indicators: The increase amplitudes of IgA and IgG levels were small, and the increase in the CD4+ / CD8+ ratio was not obvious, being (2.0 ± 0.5) g / L, (9.0 ± 1.5) g / L, and (1.3 ± 0.3) respectively, showing significant differences compared with the results after treatment in Example 1.

[0054] 5. Detection of inflammatory factor levels: IL-6 decreased to (12.5 ± 3.0) pg / mL, and TNF-α decreased to (8.5 ± 2.0)

[0055] pg / mL. The degree of reduction of inflammatory factors is not as good as that in Example 1, indicating a weaker inhibitory effect on lung inflammation.

[0056] Example 3: Lack of stir-fried Bombyx Batryticatus (comparison of single ingredient deletion)

[0057] 1. Raw material preparation and preparation of preparations

[0058] 1. Take 220 g of Ganoderma lucidum, 150 g of Agrimonia pilosa Ledeb., 150 g of Hedyotis diffusa Willd., 150 g of Glehnia littoralis Fr. Schmidt ex Miq., and 150 g of Ophiopogon japonicus (Thunb.) Ker-Gawl., and prepare pills according to the conventional process with the same specifications as in Example 1.

[0059] 2. Clinical application and effect observation

[0060] 1. Similarly, 100 eligible patients were selected for the same treatment and observation.

[0061] 2. Symptom improvement: The total effective rate was 60%. The improvement of symptoms such as cough, asthma, and unsmooth expectoration was not as good as that in Example 1. After treatment, the average integral of cough symptoms was 1.4 ± 0.3 points, the average integral of asthma symptoms was 1.2 ± 0.2 points, and the average integral of unsmooth expectoration symptoms was 1.1 ± 0.2 points.

[0062] 3. Detection of lung function indexes: The average increase in FEV1 was (0.18 ± 0.09) L, the average increase in FVC was (0.22 ± 0.11)

[0063] L, and the average increase in the FEV1 / FVC ratio was (3.0 ± 1.2)%, and the improvement effect was inferior to that of the complete formula.

[0064] 4. Detection of immune function indexes: The changes in the levels of IgA, IgG and the CD4+ / CD8+ ratio were relatively small, which were (2.1

[0065] ± 0.6) g / L, (9.2 ± 1.8) g / L and (1.35 ± 0.35) respectively, showing obvious differences compared with Example 1.

[0066] 5. Detection of inflammatory factor levels: IL-6 decreased to (11.5 ± 2.5) pg / mL, and TNF-α decreased to (7.5 ± 1.8)

[0067] pg / mL. The inhibitory effect on inflammation was not as significant as that of the complete formula.

[0068] Example 4: Lack of Agrimonia pilosa Ledeb. (comparison of single ingredient deletion)

[0069] 1. Raw material preparation and preparation of preparations

[0070] 1. Prepare 220 g of Ganoderma lucidum, 110 g of stir-fried Bombyx Batryticatus, 150 g of Hedyotis diffusa Willd., 150 g of Glehnia littoralis Fr. Schmidt ex Miq., and 150 g of Ophiopogon japonicus (Thunb.) Ker-Gawl., and make pills and package them according to the process in Example 1.

[0071] 2. Clinical Application and Efficacy Observation

[0072] 1. 100 patients were selected and treated and observed according to the method of Example 1.

[0073] 2. Symptom improvement: The total effective rate was 62%, and the reduction of symptom scores was limited. The average score of cough symptoms after treatment was 1.3 ± 0.3 points, the average score of asthma symptoms was 1.1 ± 0.2 points, and the average score of unsmooth expectoration symptoms was 1.0

[0074] ± 0.2 points.

[0075] 3. Pulmonary function index detection: The average increase in FEV1 was (0.20 ± 0.10) L, the average increase in FVC was (0.25 ± 0.12)

[0076] L, and the average increase in the FEV1 / FVC ratio was (3.2 ± 1.3)%, still less than the improvement effect of the complete formula.

[0077] 4. Immune function index detection: The changes in the levels of IgA, IgG and the CD4+ / CD8+ ratio were not prominent, which were (2.2

[0078] ± 0.6) g / L, (9.5 ± 2.0) g / L and (1.4 ± 0.4) respectively, showing a gap compared with Example 1.

[0079] 5. Inflammatory factor level detection: IL-6 decreased to (10.5 ± 2.2) pg / mL, and TNF-α decreased to (7.0 ± 1.5)

[0080] pg / mL, and its regulatory effect on inflammation was not as good as that of Example 1.

[0081] Example 5: Absence of Hedyotis diffusa (Comparison of single herb deletion)

[0082] 1. Raw Material Preparation and Preparation of Preparations

[0083] 1. Weigh 220 g of Ganoderma lucidum, 110 g of stir-fried Bombyx batryticatus, 150 g of Agrimonia pilosa, 150 g of Glehnia littoralis, and 150 g of Ophiopogon japonicus, and make them into pills, with the packaging the same as that in Example 1.

[0084] 2. Clinical Application and Efficacy Observation

[0085] 1. Taking 100 patients as the subjects, treatment and evaluation were carried out.

[0086] 2. Symptom improvement: The total effective rate was 65%, and the degree of symptom improvement was limited. The average score of cough symptoms after treatment was 1.2 ± 0.3 points, the average score of asthma symptoms was 1.0 ± 0.2 points, and the average score of unsmooth expectoration symptoms was 0.9 ± 0.2 points.

[0087] 3. Detection of pulmonary function indexes: The average increase in FEV1 was (0.22 ± 0.10) L, the average increase in FVC was (0.28 ± 0.12)

[0088] L, and the average increase in the FEV1 / FVC ratio was (3.5 ± 1.3)%. Although there was improvement, it was not as significant as that of the complete formula.

[0089] 4. Detection of immune function indexes: There were certain changes in the levels of IgA, IgG and the CD4+ / CD8+ ratio, but the amplitude was smaller than that in Example 1, which were (2.3 ± 0.6) g / L, (9.8 ± 2.0) g / L and (1.42 ± 0.40), respectively.

[0090] 5. Detection of inflammatory factor levels: IL-6 decreased to (10.0 ± 2.0) pg / mL, and TNF-α decreased to (6.8 ± 1.5)

[0091] pg / mL. The inhibitory effect on inflammation was weaker than that of the complete formula.

[0092] Example 6: Absence of Glehnia littoralis (comparison of single ingredient deletion)

[0093] 1. Raw material preparation and preparation of preparations

[0094] 1. Prepare 220 g of Ganoderma lucidum, 110 g of stir-fried Bombyx batryticatus, 150 g of Agrimonia pilosa Ledeb., 150 g of Hedyotis diffusa Willd., and 150 g of Ophiopogon japonicus (Thunb.) Ker-Gawl., and prepare pills according to the process of Example 1.

[0095] 2. Clinical application and effect observation

[0096] 1. Select 100 patients for treatment and observation.

[0097] 2. Symptom improvement: The total effective rate was 60%. After treatment, the average score of cough symptoms was 1.4 ± 0.3 points, the average score of asthma symptoms was 1.1 ± 0.2 points, and the average score of unsmooth expectoration symptoms was 1.0 ± 0.2 points.

[0098] 3. Detection of pulmonary function indexes: The average increase in FEV1 was (0.19 ± 0.09) L, the average increase in FVC was (0.23 ± 0.11)

[0099] L, and the average increase in the FEV1 / FVC ratio was (3.0 ± 1.2)%.

[0100] 4. Detection of immune function indexes: The increases in the levels of IgA and IgG were not obvious, and the change in the CD4+ / CD8+ ratio was small, which were (2.05 ± 0.55) g / L, (9.3 ± 1.8) g / L and (1.36 ± 0.36), respectively.

[0101] 5. Detection of inflammatory factor levels: IL-6 decreased to (11.0 ± 2.5) pg / mL, TNF-α decreased to (7.2 ± 1.8)

[0102] pg / mL.

[0103] Example 7: Absence of Ophiopogon japonicus (comparison of single herb absence)

[0104] 1. Raw material preparation and preparation of preparations

[0105] 1. Take 220 g of Ganoderma lucidum, 110 g of stir-fried Bombyx batryticatus, 150 g of Agrimonia pilosa Ledeb., 150 g of Hedyotis diffusa Willd., and 150 g of Glehnia littoralis Fr. Schmidt ex Miq., and make into pills.

[0106] 2. Clinical application and effect observation

[0107] 1. Select 100 patients to carry out treatment and effect evaluation.

[0108] 2. Symptom improvement: The total effective rate was 58%. After treatment, the average score of cough symptoms was 1.5 ± 0.4 points, the average score of asthma symptoms was 1.2 ± 0.3 points, and the average score of unsmooth expectoration symptoms was 1.1 ± 0.2 points.

[0109] 3. Detection of lung function indicators: The average increase in FEV1 was (0.17 ± 0.08) L, the average increase in FVC was (0.21 ± 0.10)

[0110] L, and the average increase in the FEV1 / FVC ratio was (2.8 ± 1.1)%.

[0111] 4. Detection of immune function indicators: The changes in the levels of IgA, IgG and the CD4+ / CD8+ ratio were not significant, which were (2.0

[0112] ± 0.5) g / L, (9.1 ± 1.6) g / L and (1.33 ± 0.33) respectively.

[0113] 5. Detection of inflammatory factor levels: IL-6 decreased to (12.0 ± 3.0) pg / mL, TNF-α decreased to (8.0 ± 2.0)

[0114] pg / mL.

[0115] Example 8: Ganoderma lucidum + stir-fried Bombyx batryticatus (comparison of two-herb combination)

[0116] 1. Raw material preparation and preparation of preparations

[0117] 1. Weigh 220 g of Ganoderma lucidum and 110 g of stir-fried Bombyx batryticatus, and carry out operations such as processing, pulverizing, and pill-making according to the relevant processes in Example 1 to make into pills.

[0118] 2. Clinical application and effect observation

[0119] 1. 100 patients were selected for treatment observation.

[0120] 2. Symptom improvement: The total effective rate was 45%. After treatment, the average score of cough symptoms was 1.8 ± 0.4 points, the average score of asthma symptoms was 1.5 ± 0.3 points, and the average score of unsmooth expectoration symptoms was 1.3 ± 0.2 points.

[0121] 3. Pulmonary function index detection: The average increase in FEV1 was (0.10 ± 0.05) L, the average increase in FVC was (0.15 ± 0.08)

[0122] L, and the average increase in the FEV1 / FVC ratio was (2.0 ± 0.8)%.

[0123] 4. Immune function index detection: There were certain changes in the levels of IgA, IgG and the CD4+ / CD8+ ratio, but the amplitude was small, which were (1.9 ± 0.5) g / L, (8.5 ± 1.5) g / L and (1.25 ± 0.30) respectively.

[0124] 5. Inflammatory factor level detection: IL-6 decreased to (13.5 ± 3.5) pg / mL, and TNF-α decreased to (9.0 ± 2.5)

[0125] pg / mL.

[0126] Example 9: Ganoderma lucidum + Agrimonia pilosa + Glehnia littoralis (Comparison of the combination of three herbs)

[0127] 1. Raw material preparation and preparation of preparations

[0128] 1. Prepare 220 g of Ganoderma lucidum, 150 g of Agrimonia pilosa, and 150 g of Glehnia littoralis, and make pills according to the process of Example 1.

[0129] 2. Clinical application and effect observation

[0130] 1. 100 patients were used as the research object.

[0131] 2. Symptom improvement: The total effective rate was 70%. After treatment, the average score of cough symptoms was 1.1 ± 0.3 points, the average score of asthma symptoms was 0.9 ± 0.2 points, and the average score of unsmooth expectoration symptoms was 0.8 ± 0.2 points.

[0132] 3. Pulmonary function index detection: The average increase in FEV1 was (0.25 ± 0.10) L, the average increase in FVC was (0.30 ± 0.12)

[0133] L, and the average increase in the FEV1 / FVC ratio was (4.0 ± 1.5)%.

[0134] 4. Immune function index detection: The levels of IgA, IgG and the CD4+ / CD8+ ratio were significantly increased, which were (2.4

[0135] (10.0 ± 2.0) g / L, and (1.45 ± 0.40), with a range of ±0.6 g / L.

[0136] 5. Detection of inflammatory factor levels: IL-6 decreased to (9.5 ± 2.0) pg / mL, and TNF-α decreased to (6.5 ± 1.5)

[0137] pg / mL.

[0138] Example 10: Stir-fried Bombyx Batryticatus + Hedyotis Diffusa + Ophiopogon japonicus (Comparison of the combination of three herbs)

[0139] 1. Raw material preparation and preparation of preparations

[0140] 1. Weigh 110 g of stir-fried Bombyx Batryticatus, 150 g of Hedyotis Diffusa, and 150 g of Ophiopogon japonicus, and prepare pills.

[0141] 2. Clinical application and effect observation

[0142] 1. Select 100 patients for treatment and observation.

[0143] 2. Symptom improvement: The total effective rate is 68%. After treatment, the average score of cough symptoms is 1.2 ± 0.3 points, the average score of asthma symptoms is 1.0 ± 0.2 points, and the average score of unsmooth expectoration symptoms is 0.9 ± 0.2 points.

[0144] 3. Detection of lung function indicators: The average increase in FEV1 is (0.23 ± 0.10) L, the average increase in FVC is (0.28 ± 0.12)

[0145] L, and the average increase in the FEV1 / FVC ratio is (3.8 ± 1.4)%.

[0146] 4. Detection of immune function indicators: There are certain changes in the levels of IgA, IgG, and the CD4+ / CD8+ ratio, which are (2.35

[0147] ± 0.65) g / L, (9.9 ± 2.0) g / L, and (1.43 ± 0.43), respectively.

[0148] 5. Detection of inflammatory factor levels: IL-6 decreased to (10.2 ± 2.2) pg / mL, and TNF-α decreased to (6.6 ± 1.6) pg / mL.

Claims

1. A Bufei Pills pharmaceutical composition and its preparation method, characterized in that, The pharmaceutical composition is prepared from the following raw materials in parts by weight: 220 parts of ganoderma lucidum, 110 parts of fried silkworm pupa, 150 parts of agrimony, 150 parts of oldenlandia diffusa, 150 parts of northern adenophora, and 150 parts of ophiopogon.

2. The pharmaceutical composition according to claim 1, wherein The dosage form of the pharmaceutical composition is a pill, and the preparation method of the pill comprises the following steps: Raw material pretreatment: remove impurities from Ganoderma lucidum, cut off the lower stems with rotten wood, mud or culture medium, and dry in the shade or at 40-50℃; wash and dry the fried silkworm, remove impurities; remove the residual roots and impurities from Agrimonia, wash, cut into sections, and dry; take the raw materials of Hedyotis diffusa, remove impurities, wash, cut, and dry; remove the residual stems and impurities from Glehnia littoralis, cut into sections, and dry; remove the impurities from Ophiopogon japonicus, wash, moisten, flatten, and dry; Crushing: Spread the processed raw material pieces on a stainless steel plate with a thickness of 1 cm, put them into an oven, dry them at 70°C for 5 hours, then mix them according to the prescription ratio and crush them, 100% of the powder passes through an 80-mesh sieve, and 95% passes through a 100-mesh sieve to obtain a mixed powder; Preparation molding: Take the mixed drug powder, add 13% starch slurry solution as a binder, the weight ratio of drug powder to starch slurry is 100:90, stir for 10 minutes, make drug pellets, add the drug pellets to the automatic pill making machine, adjust the equipment knife and the outlet to make the particle size 4mm, and make pills to obtain pills; Drying: Spread the pills flat on the medicine tray with a thickness not exceeding 2 cm. Let them cool in a clean area to harden the surface of the pills. Then spread them out on trays and dry them at 80°C for 5 hours using hot air circulation drying method. Polishing: The dried pills are loaded into a water chestnut-type sugar coating machine, purified water is added, and the hot and cold air of the sugar coating machine are turned on to gradually dry the moisture on the surface of the water pills, and polishing is performed until the surface of the pills is smooth and bright; Pill selection and packaging: Manual pill selection is adopted to pick out connected pills and residual pills to ensure the appearance quality of water pills, and then inner packaging is carried out. The inner packaging is sealed using a water pill packaging machine. The inner packaging material is medicinal composite film, and each bag is packaged at 9g. The difference in filling volume is within ±5% of 9g as required by the pharmacopoeia. Each bag is packed into an outer packaging box according to the packaging specifications of the preparation.

3. The preparation method of the pharmaceutical composition according to claim 2, characterized in that, The starch slurry solution is prepared by taking an appropriate amount of dry starch and mixing it with boiling water to form a paste.

4. Use of the pharmaceutical composition as claimed in claim 1 in the preparation of medicines for treating lung diseases of the lung qi deficiency and lung heat and phlegm obstruction type.

5. The application according to claim 4, characterized in that, The lung diseases include chronic bronchitis and asthma.