A medicinal pipe homologous traditional Chinese medicine composition with the effects of reducing phlegm and resolving masses and a preparation method thereof

Abstract

This invention discloses a medicinal and edible herbal composition with expectorant and nodule-dispersing effects and its preparation method, belonging to the technical field of medicinal and edible herbal compositions. The composition comprises 10-30 parts oyster shell, 10-20 parts tangerine peel, 10-20 parts Poria cocos, 10-20 parts bergamot, 8-18 parts honeysuckle, and 10-30 parts houttuynia cordata. A preferred ratio is 30 parts oyster shell, 15 parts tangerine peel, 15 parts Poria cocos, 15 parts bergamot, 9 parts honeysuckle, and 30 parts houttuynia cordata. Honey and other medicinal and edible excipients can be added. The preparation involves raw material pretreatment, volatile oil extraction, decoction, concentration, molding, and sterilization steps, and can be made into various dosage forms such as powder and granules. The raw materials used in this invention are all food and medicine homologous ingredients, which are safe for long-term use. The formula follows the theory of "softening and dispersing nodules, regulating qi and resolving phlegm, clearing heat and detoxifying". It improves the pathological microenvironment of nodules through related signaling pathways, and can effectively promote the shrinkage or dissipation of benign lung nodules, thyroid nodules and breast nodules. The preparation process is simple and has broad application prospects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions with the same origin as the medicinal material, and more specifically, to a traditional Chinese medicine composition with the same origin as the medicinal material that has the effect of resolving phlegm and dissipating nodules, and a method for preparing the same. Background Technology

[0002] In recent years, nodular diseases (including pulmonary nodules, thyroid nodules, and breast nodules) have become a prevalent health problem worldwide, especially showing a significant upward trend in East Asia. Their high incidence is closely related to environmental exposure, lifestyle, emotional stress, and genetic factors. Clinical statistics show that the detection rate of pulmonary nodules in adult CT scans is as high as 20%-35%, of which about 10% are malignant; the detection rate of thyroid nodules in ultrasound screenings exceeds 30%, with a malignant proportion of about 5%; the detection rate of breast nodules in women of childbearing age reaches 40%-60%, with approximately 10%-15% of those showing suspected malignancy according to BI-RADS 4 or higher. It is noteworthy that approximately 45% of nodule patients have a tendency towards multiple nodules (such as simultaneous detection of pulmonary and thyroid nodules), and the risk of developing the disease is 2-3 times higher for those with a family history of nodules, causing patients persistent health anxiety.

[0003] Modern medicine has made significant progress in nodule screening, with technologies such as low-dose spiral CT and high-frequency ultrasound capable of accurately identifying tiny nodules. However, treatment options remain limited. For early-stage, smaller benign nodules, there is a lack of effective drug intervention options, and clinical practice mainly relies on regular observation. Some patients require surgical treatment due to nodule progression, but surgery carries risks of trauma, postoperative complications, and recurrence, making it difficult to meet patients' needs for minimally invasive and safe treatment.

[0004] Traditional Chinese medicine believes that the core pathogenesis of nodules is "qi stagnation, phlegm coagulation, and blood stasis," belonging to the categories of "phlegm nodules," "scrofula," and "mastopathy." The Ming Dynasty medical text *Surgical Orthodox Manual* states that "nodules are caused by qi stagnation." Prolonged emotional distress leads to impaired liver function, resulting in qi stagnation and abnormal distribution of body fluids. "The spleen is the source of phlegm," meaning that improper diet damages the spleen and stomach, causing dampness to accumulate and form phlegm. This phlegm, flowing with qi, obstructs the lung vessels, neck, and breast vessels, respectively forming pulmonary nodules, thyroid nodules, and breast nodules. *Corrections of Errors in Medical Classics* emphasizes that "qi stagnation leads to blood coagulation." Prolonged qi stagnation causes sluggish blood flow, and the combination of blood stasis and phlegm hardens the nodules, worsening the condition.

[0005] Existing technologies for treating nodules using traditional Chinese medicine compositions have several drawbacks. For example, the Qi-Invigorating, Phlegm-Resolving, and Nodule-Dispersing Decoction disclosed in patent CN107596199A contains non-food and medicine homologous ingredients such as calcined oyster shell, posing safety risks with long-term use and making it unsuitable for long-term conditioning in the early stages of nodules. Furthermore, some food and medicine homologous formulas are singularly targeted, focusing only on specific syndromes such as Qi and Blood deficiency, failing to address the core pathogenesis of "Qi stagnation and phlegm accumulation, with initial manifestations of heat and toxins" in the early stages of nodules. Moreover, existing technologies involve complex preparation processes, resulting in low dissolution rates of effective components, and the lack of a clear multi-target synergistic mechanism, leading to unstable efficacy. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition with expectorant and nodule-dispersing effects and its preparation method, so as to solve the technical problems existing in the above-mentioned background art.

[0007] The present invention provides a traditional Chinese medicine composition with the effects of resolving phlegm and dissipating nodules, characterized in that it is made from the following medicinal and edible raw materials in parts by weight: 10-30 parts of oyster, 10-20 parts of tangerine peel, 10-20 parts of Poria cocos, 10-20 parts of Buddha's hand, 8-18 parts of honeysuckle, and 10-30 parts of houttuynia cordata.

[0008] In a preferred embodiment, the weight parts of each raw material are: 30 parts oyster, 15 parts orange peel, 15 parts Poria cocos, 15 parts Buddha's hand, 9 parts honeysuckle, and 30 parts houttuynia cordata.

[0009] In a preferred embodiment, the oyster is used after being calcined at a temperature of 800-1000℃ for 1-2 hours, and then pulverized to 100-200 mesh.

[0010] In a preferred embodiment, the orange peel is dried tangerine peel that has been stored for more than one year and cut into small pieces of 0.5-1cm; the Poria cocos is peeled and dried, and then pulverized and passed through a 40-60 mesh sieve.

[0011] In a preferred embodiment, the medicine also includes food-grade excipients, which are selected from one or more of honey, maltitol, fructooligosaccharides, and erythritol, and their total amount is 5-12% of the total weight of the traditional Chinese medicine composition.

[0012] In a preferred embodiment, the dosage form of the composition is powder, granules, oral liquid, capsules, or ointment; wherein, the moisture content of the powder is ≤8% and the particle size is ≥80 mesh; the particle size of the granules is 18-80 mesh and the solubility is ≤5 minutes; the pH value of the oral liquid is 4.5-6 and the relative density at 5.25℃ is 1.05-1.15; and the filling weight difference of the capsules is ≤±7.5%.

[0013] A method for preparing a traditional Chinese medicine composition with expectorant and nodule-dispersing effects includes the following steps:

[0014] S1 Raw Material Pretreatment: Oysters are calcined under set conditions and then pulverized to 100-200 mesh; honeysuckle is cleaned and impurities are removed, and then dried together with orange peel, poria cocos, citron and houttuynia cordata at 50-60℃ until the moisture content is ≤8% for later use.

[0015] S2 Extraction: Place orange peel and Buddha's hand into a distillation apparatus, add 6-8 times the amount of purified water, and extract the volatile oil using steam distillation at 80-100℃ for 2-4 hours. Collect the volatile oil and refrigerate it for later use. Mix the residue after extracting the volatile oil with Poria cocos, honeysuckle and houttuynia cordata, add purified water and decoct twice.

[0016] S3 Concentration: The two decoctions are combined, filtered through a 100-120 mesh filter, and concentrated under reduced pressure at a vacuum of 0.06-0.08 MPa and a temperature of 55-65℃ to obtain an extract with a relative density of 1.10-1.15 at 60℃.

[0017] S4 Molding: Mix the extract with the volatile oil extracted in step S2 evenly, add excipients according to the preset dosage form requirements, and process and shape it according to the corresponding process. After molding, sterilize it at 105℃ for 30 minutes to obtain the final product.

[0018] In a preferred embodiment, the specific parameters for decocting in step S2 are as follows: for the first decoction, add 8 times the amount of purified water and maintain a gentle boil for 1.5 hours; for the second decoction, add 6 times the amount of purified water and maintain a gentle boil for 1 hour.

[0019] Both decoctions were performed in a jacketed kettle, with stirring every 20 minutes during the process. For honeysuckle, the decoction temperature was controlled at 90-95℃ to improve the dissolution rate of flavonoid active ingredients.

[0020] In a preferred embodiment, when preparing the powder, the concentrated extract obtained in step S3 is spray-dried. The inlet air temperature of the spray dryer is 175-185℃, the outlet air temperature is 85-95℃, and the atomization pressure is 0.2-0.3MPa. The resulting dried powder is mixed evenly with calcined and pulverized oyster powder for 15-30 minutes, and the coefficient of variation of the mixing uniformity is ≤5%. When preparing the oral liquid, excipients and purified water are added to the extract, the pH value is adjusted, and then the mixture is filtered through a 200-mesh filter before filling and sterilization. When preparing the capsules, the dried powder is filled into empty capsules with a filling amount of 0.3-0.5g / capsule, wherein the content of honeysuckle-related effective ingredients per capsule is ≥0.5mg.

[0021] Scientific compatibility:

[0022] The principal ingredient is oyster shell. It has the effects of softening and dispersing nodules, neutralizing acid and relieving pain. Nodules are mostly formed due to phlegm and qi stagnation. Oyster shell has a hard texture and can directly penetrate the nodule site, playing a key role in dispersing nodules. It is the main ingredient in the formula for treating nodules, hence it is the principal ingredient.

[0023] Assistant herbs: Tangerine peel and Poria cocos. These herbs have the functions of regulating qi, strengthening the spleen, drying dampness, and resolving phlegm. Nodular diseases are often related to qi stagnation; tangerine peel can smooth the flow of qi, thus eliminating phlegm. Poria cocos can promote diuresis and eliminate dampness, strengthen the spleen and calm the mind, further removing dampness from the body and eliminating the source of phlegm. Combined with tangerine peel, it enhances the spleen-strengthening, dampness-drying, and phlegm-resolving effects, thereby assisting oyster shell in better dispersing nodules. Therefore, they are both assistant herbs.

[0024] Adjuvant herb: Buddha's Hand. It has the effects of soothing the liver and regulating qi, and stimulating appetite. Buddha's Hand works synergistically with Orange Peel in regulating qi, so as to promote smooth qi circulation throughout the body, which is conducive to the dissipation of phlegm. Moreover, it regulates qi without harming the body's vital energy, and can be taken for a long time to regulate the function of the internal organs. Therefore, it is an adjuvant herb.

[0025] The guiding herbs are honeysuckle and houttuynia cordata. Honeysuckle clears heat and detoxifies, and disperses wind-heat; houttuynia cordata clears heat and detoxifies, eliminates carbuncles and drains pus, and promotes urination. Both herbs in this formula play a role in clearing heat and detoxifying, eliminating local heat toxins from the nodules and helping to resolve phlegm and dissipate nodules. Furthermore, their cooling nature helps to counteract the warming and drying properties of some other herbs, making the overall formula more balanced. Therefore, they are the guiding herbs.

[0026] This formula, through the rational combination of principal, assistant, adjuvant, and guide herbs, works synergistically to resolve phlegm and dissipate nodules, regulate qi and promote blood circulation, and clear heat and detoxify. It can effectively improve the symptoms of patients with nodular diseases, promote the shrinkage or dissipation of nodules, and has mild medicinal properties, is safe and reliable, and has good prospects for clinical application.

[0027] The beneficial effects of the technical solution of this invention are:

[0028] Firstly, all raw materials are food and medicine homologous ingredients, which meet relevant national standards, are non-toxic medicinal materials, and have high safety for long-term use, thus solving the safety hazards of some existing formulas containing non-food and medicine homologous ingredients.

[0029] Secondly, the formula follows the TCM theory of "softening and dispersing nodules, regulating qi and resolving phlegm, and clearing heat and detoxifying". The combination of principal, assistant, adjuvant and guide herbs is scientific. Honeysuckle and houttuynia cordata work together to clear heat and detoxify, oyster softens and disperses nodules, and citron regulates qi and resolves phlegm. Multiple components target and regulate core genes such as AKT1, TNF, and TP53. It improves the pathological microenvironment of nodules through signaling pathways such as IL-17 and TNF. The nodule shrinkage rate and disappearance rate are significantly better than existing products and flavorless formulas, and it can effectively relieve accompanying symptoms such as chest tightness and excessive phlegm.

[0030] Third, the preparation process is optimized, combining steam distillation and water decoction to fully retain the effective components such as volatile oils and flavonoids, resulting in a high dissolution rate and various dosage forms (granules, powders, etc.) to meet the needs of different groups of people.

[0031] Fourth, it has a wide range of applications and can assist in the treatment of benign pulmonary nodules, thyroid nodules, and breast nodules, taking into account both efficacy and safety. It provides a new solution for the early and long-term treatment of nodules and has broad application prospects. Detailed Implementation

[0032] The present invention will now be described in further detail. The embodiments of the invention are given for the purpose of illustration and description, and are not intended to be exhaustive or to limit the invention to the disclosed forms. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described to better illustrate the principles and practical application of the invention, and to enable those skilled in the art to understand the invention and design various embodiments with various modifications suitable for a particular purpose.

[0033] I. Preparation of Raw Materials and Equipment

[0034] 1. Raw material specifications

[0035] Oysters: Pacific oyster shells, free from mold and impurities, meeting the standards of the 2020 edition of the Pharmacopoeia of the People's Republic of China;

[0036] Orange peel: Dried orange peel stored for 1.5 years, cut into 0.8cm pieces, with impurity content ≤1% and moisture content ≤10%;

[0037] Poria cocos: Peeled and dried Poria cocos, pulverized and passed through a 50-mesh sieve, with a polysaccharide content ≥8%;

[0038] Buddha's Hand: Dried fruit, crushed and passed through a 40-mesh sieve, with a volatile oil content ≥0.2%;

[0039] Honeysuckle: Dried flower buds of Lonicera japonica, a plant in the Caprifoliaceae family, with quercetin content ≥0.1% and luteolin content ≥0.05%;

[0040] Houttuynia cordata: The dried aerial parts of Houttuynia cordata, a plant in the Saururaceae family, with a volatile oil content of ≥0.15%;

[0041] Additional ingredients: honey (compliant with GB14963 standard), maltitol, purified water;

[0042] Comparative ingredient: Commercially available phlegm-resolving and nodule-dispersing Chinese herbal medicine composition (containing calcined oyster shell, Fritillaria thunbergii, and Prunella vulgaris, which are not food and medicine homologous), starch, and lactose (placebo).

[0043] 2. Equipment

[0044] Calcining furnace, universal pulverizer, steam distillation apparatus, jacketed kettle, vacuum concentrator, spray dryer, capsule filling machine, granulation machine, high performance liquid chromatograph (HPLC), real-time fluorescence quantitative PCR instrument.

[0045] II. Preparation of Examples and Comparative Examples

[0046] Example 1: Granule Preparation

[0047] Raw material pretreatment: Take 300g of oysters, calcine at 900℃ for 1.5 hours, and pulverize to 150 mesh to obtain oyster powder; take 150g of orange peel, 150g of Poria cocos, 150g of Buddha's hand, 90g of honeysuckle, and 300g of houttuynia cordata, clean and remove impurities, and dry at 55℃ until the moisture content is ≤6% for later use.

[0048] Extraction: Place orange peel and Buddha's hand into a distillation apparatus, add 7 times the amount of purified water, and extract by steam distillation at 90℃ for 3 hours. Collect the volatile oil (about 8.5 mL) and refrigerate (4℃) for later use. Mix the residue with Poria cocos, honeysuckle and houttuynia cordata, add 8 times the amount of purified water, and simmer at 95℃ for 1.5 hours. Filter to obtain the first decoction. Add 6 times the amount of purified water to the residue again, simmer at 95℃ for 1 hour, and filter to obtain the second decoction.

[0049] Concentration: The two decoctions were combined, filtered through a 110-mesh filter, and concentrated under reduced pressure at 0.07 MPa and 60°C to a relative density of 1.12 (60°C).

[0050] Forming: Mix the extract with the volatile oil, add 8% of the total weight of honey of the traditional Chinese medicine composition, and stir evenly; spray dry (inlet air temperature 180℃, outlet air temperature 90℃, atomization pressure 0.25MPa), mix the resulting powder with oyster powder for 30 minutes (mixing uniformity variation coefficient ≤3%), add an appropriate amount of maltitol as a filler, granulate (particle size 20-60 mesh), sterilize (105℃, 30 minutes) to obtain granules.

[0051] Example 2: Powder Preparation

[0052] Raw material pretreatment: Same as in Example 1.

[0053] Extraction and concentration: Same as in Example 1, the extract was obtained after concentration.

[0054] Forming: The extract was spray-dried (parameters same as in Example 1), the resulting dried powder was mixed with oyster powder for 25 minutes, 5% maltitol was added, the mixture was passed through an 80-mesh sieve, and sterilized to obtain the powder.

[0055] Example 3: Preparation of oral liquid

[0056] Raw material pretreatment: Same as in Example 1.

[0057] Extraction and concentration: Same as in Example 1, the extract was obtained after concentration.

[0058] Formulation: Add 8% honey and purified water to the extract, adjust the total volume to 1000mL, adjust the pH value to 5.5, filter through a 200-mesh filter, fill (10mL / vial), sterilize at 105℃ for 30 minutes to obtain oral liquid.

[0059] Comparative Example 1: Commercially available phlegm-resolving and nodule-dispersing traditional Chinese medicine composition

[0060] Commercially available expectorant and nodule-dissolving granules containing calcined oyster shell, Fritillaria thunbergii, and Prunella vulgaris were selected and prepared according to the instructions (decoction, concentration, and granulation). The dosage was as recommended in the instructions (equivalent to the dosage in Example 1).

[0061] Comparative Example 2: Composition lacking honeysuckle and houttuynia cordata

[0062] Formula: 30 parts oyster, 15 parts orange peel, 15 parts Poria cocos, 15 parts Buddha's hand (lacking honeysuckle and houttuynia cordata), preparation method is the same as in Example 1.

[0063] Comparative Example 3: Placebo

[0064] Composed of 80% starch and 20% lactose, it was prepared according to the granulation process of Example 1, and its appearance was consistent with that of Example 1.

[0065] III. Experimental Verification Scheme

[0066] 1. Subject selection

[0067] 240 patients with benign nodules (including 80 pulmonary nodules, 80 thyroid nodules, and 80 breast nodules) were selected, meeting the following criteria: ① nodules with a diameter of 3-10 mm, diagnosed as benign by imaging; ② diagnosed by Traditional Chinese Medicine (TCM) as "Qi stagnation and phlegm accumulation with heat toxicity" (symptom scores ≥4 points for chest tightness, excessive phlegm, dry throat, and irritability); ③ no history of liver or kidney dysfunction or allergies; ④ no prior treatment with nodule-related drugs or surgery. Patients were randomly divided into 4 groups (60 cases per group, 20 cases of each type of nodule), and received the treatments described in Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3, respectively, for a period of 3 months, twice daily, 15g each time (granules, dissolved in 100mL of boiling water and taken warm).

[0068] 2. Detection indicators

[0069] Efficacy indicators: ① Changes in nodule size (CT / B-ultrasound detection, calculation of shrinkage rate = (diameter before treatment - diameter after treatment) / diameter before treatment × 100%; disappearance rate = number of cases where nodules completely disappeared / total number of cases × 100%); ② Traditional Chinese medicine symptom scores (chest tightness, excessive phlegm, dry throat, irritability, abdominal distension, 0-10 points for each item, total score 0-50 points); ③ Content of effective components (HPLC detection of quercetin and kaempferol content); ④ Expression of core genes (real-time quantitative PCR detection of AKT1, TNF, and TP53 mRNA expression levels).

[0070] Safety indicators: Liver and kidney function (ALT, AST, Cr, BUN) were measured before and after treatment, and adverse reactions were recorded.

[0071] IV. Experimental Results and Data Analysis

[0072] 1. Changes in nodule size (Table 1)

[0073] Table 1

[0074] Group Nodule shrinkage rate (≥30%) Nodule disappearance rate Nodule enlargement rate (≥10%) Example 1 68.3%（41 / 60） 21.7%（13 / 60） 0%（0 / 60） Comparative Example 1 45.0%（27 / 60） 8.3%（5 / 60） 5.0%（3 / 60） Comparative Example 2 36.7%（22 / 60） 5.0%（3 / 60） 8.3%（5 / 60） Comparative Example 3 0%（0 / 60） 0%（0 / 60） 11.7%（7 / 60）

[0075] Note: When comparing Example 1 with Comparative Examples 1, 2, and 3, P < 0.05, indicating a statistically significant difference.

[0076] 2. Changes in TCM symptom scores (Table 2)

[0077] Table 2

[0078] Group Total score before treatment (mean ± SD) Total score after treatment (mean ± SD) Rating decrease value Example 1 32.6±5.8 6.4±3.2 26.2 Comparative Example 1 31.8±6.1 18.7±4.5 13.1 Comparative Example 2 32.1±5.9 19.3±4.8 12.8 Comparative Example 3 33.2±6.0 31.5±5.7 1.7

[0079] 3. Changes in core gene expression

[0080] The data on "changes in AKT1, TNF, and TP53 mRNA expression" were calculated as follows:

[0081] Real-time quantitative PCR (qPCR) was used, with GAPDH as an internal reference gene (to calibrate experimental error), to detect the mRNA expression levels of target genes (AKT1, TNF, TP53) before and after treatment in 60 samples of each group. The relative gene expression value (the fold change compared to before treatment) of each sample was calculated using the 2^-ΔΔCt method. The mean and standard deviation (SD) of the relative expression values ​​of each of the 60 samples in each group were taken and presented as "mean ± SD". The percentage change in expression = (mean after treatment - mean before treatment) / mean before treatment × 100%, with positive values ​​indicating upregulation and negative values ​​indicating downregulation.

[0082] Table 3

[0083] Group Changes in AKT1 mRNA expression (relative value) Changes in TNF mRNA expression (relative value) Changes in TP53 mRNA expression (relative value) Example 1 0.65±0.12 (down 35%) 0.58±0.10 (down 42%) 1.28±0.15 (upward adjustment of 28%) Comparative Example 1 0.85±0.15 (down 15%) 0.80±0.13 (down 20%) 1.10±0.12 (increased by 10%) Comparative Example 2 0.98±0.14 (no significant change) 0.95±0.11 (no significant change) 1.05±0.11 (increased by 5%) Comparative Example 3 1.02±0.13 (No change) 1.03±0.12 (No change) 1.01±0.10 (No change)

[0084] 4. Active ingredients and safety

[0085] Table 4

[0086] Group Quercetin content (mg / 15g) Kaempferol content (mg / 15g) Adverse reaction incidence Liver and kidney dysfunction rate Example 1 1.85±0.21 1.23±0.18 0%（0 / 60） 0%（0 / 60） Comparative Example 1 0.92±0.15 0.75±0.12 5.0%（3 / 60） 5.0%（3 / 60） Comparative Example 2 0.41±0.09 0.38±0.08 1.7%（1 / 60） 0%（0 / 60） Comparative Example 3 0 0 0%（0 / 60） 0%（0 / 60）

[0087] V. Results Analysis

[0088] (1) The nodule shrinkage rate (68.3%) and disappearance rate (21.7%) of Example 1 were significantly higher than those of Comparative Example 1 (45.0%, 8.3%) and Comparative Example 2 (36.7%, 5.0%), and there were no cases of nodule enlargement. This indicates that the integrity of the formula of the present invention (synergistic effect of honeysuckle, houttuynia cordata and other ingredients) is the key to the efficacy. Its multi-target regulation (downregulation of AKT1 and TNF proliferative / inflammatory genes, upregulation of TP53 tumor suppressor gene) fits the network pharmacology mechanism.

[0089] (2) The TCM symptom score reduction value of Example 1 (26.2 points) is twice that of Example 1, indicating that the present invention takes into account multiple pathogenesis of "qi stagnation, phlegm accumulation, and heat toxicity", and the symptoms are relieved more thoroughly.

[0090] (3) Example 1 uses food and medicine homologous raw materials, with no adverse reactions or abnormal liver and kidney function. However, Comparative Example 1 contains non-food and medicine homologous ingredients (calcined oyster shell), resulting in mild liver damage, which verifies the safety of long-term use of the present invention.

[0091] (4) The contents of quercetin and kaempferol in Example 1 were significantly higher than those in Comparative Examples 1 and 2, which confirms that the preparation process of the present invention can fully retain the effective components and that the formula synergistically promotes the dissolution of the components.

[0092] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art or related fields based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described and explained in the present invention, unless otherwise specified or limited, shall be implemented according to conventional means in the art.

Claims

1. A traditional Chinese medicine composition with expectorant and nodule-dispersing effects, characterized in that, Made from the following ingredients that are both food and medicine: 10-30 parts oyster, 10-20 parts orange peel, 10-20 parts Poria cocos, 10-20 parts Buddha's hand, 8-18 parts honeysuckle, and 10-30 parts houttuynia cordata.

2. The herbal composition with expectorant and nodule-dispersing effects according to claim 1, characterized in that, The weight proportions of each ingredient are as follows: 30 parts oyster, 15 parts orange peel, 15 parts Poria cocos, 15 parts Buddha's hand, 9 parts honeysuckle, and 30 parts houttuynia cordata.

3. A traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to claim 1 or 2, characterized in that, The oysters are used after being calcined at a temperature of 800-1000℃ for 1-2 hours, and then pulverized to 100-200 mesh.

4. A traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to claim 1 or 2, characterized in that, The orange peel is dried tangerine peel that has been stored for more than one year and cut into small pieces of 0.5-1cm; the poria cocos is peeled and dried poria cocos that has been pulverized and passed through a 40-60 mesh sieve.

5. A traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to claim 1, characterized in that, It also includes medicinal and edible excipients, which are selected from one or more of honey, maltitol, fructooligosaccharides, and erythritol, and their total amount is 5-12% of the total weight of the traditional Chinese medicine composition.

6. A traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to any one of claims 1-5, characterized in that, The dosage form of the composition is powder, granules, oral liquid, capsules or ointment; wherein, the moisture content of the powder is ≤8% and the particle size is ≥80 mesh; the particle size of the granules is 18-80 mesh and the solubility is ≤5 minutes; the pH value of the oral liquid is 4.5-6.5 and the relative density at 25℃ is 1.05-1.15; the filling weight difference of the capsules is ≤±7.5%.

7. A method for preparing a traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to any one of claims 1-5, characterized in that, Includes the following steps: S1 Raw Material Pretreatment: Oysters are calcined under set conditions and then pulverized to 100-200 mesh; honeysuckle is cleaned and impurities are removed, and then dried together with orange peel, poria cocos, citron and houttuynia cordata at 50-60℃ until the moisture content is ≤8% for later use. S2 Extraction: Place orange peel and Buddha's hand into a distillation apparatus, add 6-8 times the amount of purified water, and extract the volatile oil using steam distillation at 80-100℃ for 2-4 hours. Collect the volatile oil and refrigerate it for later use. Mix the residue after extracting the volatile oil with Poria cocos, honeysuckle and houttuynia cordata, add purified water and decoct twice. S3 Concentration: The two decoctions are combined, filtered through a 100-120 mesh filter, and concentrated under reduced pressure at a vacuum of 0.06-0.08 MPa and a temperature of 55-65℃ to obtain an extract with a relative density of 1.10-1.15 at 60℃. S4 Molding: Mix the extract with the volatile oil extracted in step S2 evenly, add excipients according to the preset dosage form requirements, and process and shape it according to the corresponding process. After molding, sterilize it at 105℃ for 30 minutes to obtain the final product.

8. The method for preparing a traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to claim 7, characterized in that, The specific parameters for decocting in step S2 are as follows: for the first decoction, add 8 times the amount of purified water and maintain a gentle boil for 1.5 hours; for the second decoction, add 6 times the amount of purified water and maintain a gentle boil for 1 hour. Both decoctions were performed in a jacketed kettle, with stirring every 20 minutes during the process. For honeysuckle, the decoction temperature was controlled at 90-95℃ to improve the dissolution rate of flavonoid active ingredients.

9. The method for preparing a traditional Chinese medicine composition with expectorant and nodule-dispersing effects according to claim 7, characterized in that, When preparing the powder, the concentrated extract obtained in step S3 is spray-dried. The inlet air temperature of the spray dryer is 175-185℃, the outlet air temperature is 85-95℃, and the atomization pressure is 0.2-0.3MPa. The resulting dried powder is mixed evenly with calcined and pulverized oyster powder for 15-30 minutes, and the coefficient of variation of the mixing uniformity is ≤5%. When preparing the oral liquid, excipients and purified water are added to the extract, the pH value is adjusted, and then the mixture is filtered through a 200-mesh filter before filling and sterilization. When preparing the capsules, the dried powder is filled into empty capsules with a filling amount of 0.3-0.5g / capsule, of which the content of honeysuckle-related effective ingredients per capsule is ≥0.5mg.