Traditional Chinese medicine composition for treating mediastinal tumor and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating mediastinal tumors and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises monarch drugs and auxiliary drugs, wherein the monarch drugs comprise 15-25 parts of poria cocos, 20-30 parts of oldenlandia diffusa and 18-30 parts of astragalus membranaceus; ministerial drugs: 12-18 parts of rhizoma curcumae longae, 15-20 parts of rhizoma corydalis and 10-15 parts of pericarpium trichosanthis; adjuvant drugs: 8-12 parts of cassia twig, 8-12 parts of semen armeniacae amarae, 10-15 parts of fructus aurantii immaturus and 8-12 parts of allium macrostemon; and a conductant drug: 8-12 parts of dried orange peel. The composition is scientific and reasonable, not only follows the compatibility theory of monarch, minister, assistant and guide in traditional Chinese medicine, but also combines the modern pharmacological research result, optimizes the traditional formula, and enhances the effects of reducing phlegm and resolving masses, promoting blood circulation to remove blood stasis, detoxifying and resisting tumors.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for the treatment of mediastinal tumors and its preparation method. Background Technology

[0002] Mediastinal tumors are common thoracic tumors in clinical practice. Modern medicine mainly uses surgery, radiotherapy, and chemotherapy, but these methods have problems such as high trauma and numerous side effects. Traditional Chinese medicine has unique advantages in tumor treatment, including holistic regulation and fewer side effects.

[0003] Traditional Chinese medicine theory classifies mediastinal tumors under the categories of "chest pain," "phlegm nodules," and "accumulation," with pathogenesis primarily involving qi stagnation and blood stasis, and phlegm and toxin accumulation. While many traditional Chinese medicine formulas are used for treatment, these formulas have several shortcomings: First, they are merely traditional decoctions, resulting in low drug utilization efficiency and inconvenience for patients; second, the traditional dosages of certain herbs in traditional formulas differ from modern pharmacological research results; third, traditional formulas lack precise compatibility theory supporting the specific pathological characteristics of mediastinal tumors; and finally, the traditional preparation processes of traditional formulas make it difficult to control quality standards and achieve industrial-scale production. Therefore, this invention provides a traditional Chinese medicine composition for the treatment of mediastinal tumors and its preparation method. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for the treatment of mediastinal tumors and its preparation method. The traditional Chinese medicine composition is based on traditional Chinese medicine theory and combined with modern pharmacological research to optimize traditional prescriptions. The preparation method improves the dissolution rate and bioavailability of active ingredients through modern extraction processes and formulation technology.

[0005] The above-mentioned technical objective of the present invention is achieved through the following technical solution: A traditional Chinese medicine composition for the treatment of mediastinal tumors, the composition comprising: principal herbs: 15-25 parts of Poria cocos, 20-30 parts of Hedyotis diffusa, and 18-30 parts of Astragalus membranaceus; Assistant herbs: 12-18 parts turmeric, 15-20 parts corydalis, 10-15 parts trichosanthes peel; Adjuvant herbs: 8-12 parts cinnamon twig, 8-12 parts bitter almond, 10-15 parts immature bitter orange, 8-12 parts allium macrostemon; Used as a medicinal ingredient: 8-12 parts dried tangerine peel.

[0006] More preferably, the traditional Chinese medicine composition includes: principal ingredient: 20 parts of Poria cocos, 25 parts of Hedyotis diffusa, and 25 parts of Astragalus membranaceus; The following are the ingredients: 15 parts turmeric, 18 parts corydalis, and 12 parts trichosanthes peel; Adjuvant herbs: 10 parts cinnamon twig, 10 parts bitter almond, 12 parts immature bitter orange, 10 parts allium macrostemon; Used ingredient: 10 parts dried tangerine peel.

[0007] This invention also provides a method for preparing a traditional Chinese medicine composition for the treatment of mediastinal tumors, comprising the following steps: S1. Raw material pretreatment: Remove impurities from all medicinal materials, identify and process them according to the 2020 edition of the Chinese Pharmacopoeia, and grind Poria cocos and Astragalus membranaceus into coarse powder for later use; wash and dry Hedyotis diffusa, Curcuma longa, Corydalis yanhusuo, etc. at low temperature. S2. Extraction process: S2.1. Poria cocos and Astragalus membranaceus were extracted using hot water extraction: 10 times the amount of distilled water was added, soaked for 30 minutes, and then heated to 90°C and refluxed twice for 1.5 hours each time. The extracts were combined, filtered, and filtrate A was obtained. S2.2, Hedyotis diffusa, Curcuma longa, and Corydalis yanhusuo were extracted using the ethanol reflux method: 8 times the amount of 70% ethanol was added, and the mixture was heated and refluxed twice for 2 hours each time. The ethanol extracts were combined, the ethanol was recovered, and extract B was obtained. S2.3, Trichosanthes peel, cinnamon twig, Allium macrostemon, and dried tangerine peel were extracted by steam distillation: volatile oil components were extracted, volatile oil C was collected, and the aqueous solution after distillation was filtered to obtain filtrate D; S2.4, bitter almonds and immature bitter orange were extracted using an ultrasonic-assisted extraction method: 10 times the amount of 50% ethanol was added, ultrasonic power was 300W, temperature was 50℃, extraction was carried out for 30 minutes, and then filtered to obtain filtrate E. S3. Concentration and drying: Combine the above filtrates A, D, and E, mix them with extract B, and concentrate them under reduced pressure at 60°C to a thick extract with a relative density of 1.25-1.30. Use spray drying technology with an inlet temperature of 180°C and an outlet temperature of 80°C to obtain dry extract powder. S4. Formulation: Mix the dry extract powder with an appropriate amount of disintegrant cross-linked polyvinyl ketone and lubricant micronized silica gel evenly, add volatile oil C, mix evenly using an equal-incremental method, use 80% ethanol as a wetting agent to make a soft mass, granulate through a 20-mesh sieve, boil dry at 60℃, granulate, add magnesium stearate, mix evenly, and compress into tablets, each weighing 0.3 grams; S5. Coating and Packaging: Using Opadry film coating material, moisture-proof coating is applied, followed by aluminum-plastic packaging to obtain the finished product.

[0008] In summary, the present invention has the following beneficial effects: Firstly, the formulation in this invention is scientifically sound and reasonable. It follows the traditional Chinese medicine theory of "principal, assistant, adjuvant, and guide" in its formulation, and combines modern pharmacological research results to optimize the traditional formula and enhance its effects of resolving phlegm and dissipating nodules, promoting blood circulation and removing blood stasis, and detoxifying and fighting tumors.

[0009] Secondly, this invention significantly improves the therapeutic effect. Through modern extraction technology, the effective components in the medicinal materials, such as Poria cocos polysaccharide, total flavonoids of Hedyotis diffusa, curcumin, and astragaloside A, are fully extracted, thereby improving bioavailability.

[0010] Thirdly, the quality of this invention is controllable. Through standardized production processes, a complete quality control system has been established, including items such as properties, identification, inspection, and content determination, to ensure stable and controllable product quality.

[0011] Fourth, this invention is easy to use. After being made into tablets, it is convenient for patients to take and carry, and the dosage is accurate, which improves patient compliance.

[0012] Fifth, the invention has high safety: acute toxicity tests and long-term toxicity tests have proven that the drug of the present invention has no obvious toxic side effects and is safe for clinical use. Attached Figure Description

[0013] Figure 1 This is a flowchart of the preparation method in this invention; Detailed Implementation The present invention will be further described in detail below with reference to the accompanying drawings.

[0014] Example 1: Weigh the following raw materials according to the following weights: 200g Poria cocos, 250g Hedyotis diffusa, 250g Astragalus membranaceus, 150g Curcuma longa, 180g Corydalis yanhusuo, 120g Trichosanthes kirilowii peel, 100g Cinnamomum cassia twig, 100g Prunus armeniaca seed, 120g Citrus aurantium, 100g Allium macrostemon, and 100g Citrus reticulata peel.

[0015] Poria cocos strengthens the spleen and calms the mind, promotes diuresis and eliminates dampness; Hedyotis diffusa clears heat and detoxifies, eliminates carbuncles and dissipates nodules; Astragalus membranaceus tonifies qi and strengthens the exterior, promotes tissue regeneration and eliminates toxins. These three herbs serve as the principal herbs, targeting the main pathogenesis of mediastinal tumors: phlegm accumulation and toxin buildup, qi deficiency and blood stasis. Turmeric breaks up blood stasis, promotes qi circulation, and relieves pain; Corydalis yanhusuo invigorates blood circulation, removes blood stasis, regulates qi and relieves pain; Trichosanthes kirilowii peel widens the chest, dissipates nodules, clears heat and resolves phlegm. These three herbs assist the principal herbs in enhancing their effects of resolving phlegm and nodules, promoting blood circulation and relieving pain. Cinnamon twig warms and unblocks the meridians, assists yang and transforms qi; Bitter almond lowers qi, resolves phlegm, moistens the intestines and promotes bowel movement; Citrus aurantium breaks up qi stagnation, eliminates accumulation, resolves phlegm and dissipates masses; Allium macrostemon promotes yang, dissipates nodules, regulates qi and guides stagnation. These four herbs work together to regulate qi and assist the principal and assistant herbs in exerting their effects. Tangerine peel regulates qi, strengthens the spleen, dries dampness and resolves phlegm, coordinating the effects of the herbs and guiding their efficacy directly to the affected area.

[0016] S1. Raw material pretreatment: Remove impurities from all medicinal materials, identify and process them according to the 2020 edition of the Chinese Pharmacopoeia, and grind Poria cocos and Astragalus membranaceus into coarse powder for later use; wash and dry Hedyotis diffusa, Curcuma longa, Corydalis yanhusuo, etc. at low temperature. S2. Extraction process: S2.1. Poria cocos and Astragalus membranaceus were extracted using hot water extraction: 10 times the amount of distilled water was added, soaked for 30 minutes, and then heated to 90°C and refluxed twice for 1.5 hours each time. The extracts were combined, filtered, and filtrate A was obtained. S2.2, Hedyotis diffusa, Curcuma longa, and Corydalis yanhusuo were extracted using the ethanol reflux method: 8 times the amount of 70% ethanol was added, and the mixture was heated and refluxed twice for 2 hours each time. The ethanol extracts were combined, the ethanol was recovered, and extract B was obtained. S2.3, Trichosanthes peel, cinnamon twig, Allium macrostemon, and dried tangerine peel were extracted by steam distillation: volatile oil components were extracted, volatile oil C was collected, and the aqueous solution after distillation was filtered to obtain filtrate D; S2.4, bitter almonds and immature bitter orange were extracted using an ultrasonic-assisted extraction method: 10 times the amount of 50% ethanol was added, ultrasonic power was 300W, temperature was 50℃, extraction was carried out for 30 minutes, and then filtered to obtain filtrate E. S3. Concentration and drying: Combine the above filtrates A, D, and E, mix them with extract B, and concentrate them under reduced pressure at 60°C to a thick extract with a relative density of 1.25-1.30. Use spray drying technology with an inlet temperature of 180°C and an outlet temperature of 80°C to obtain dry extract powder. S4. Formulation: Mix the dry extract powder with an appropriate amount of disintegrant crosslinked polyvinyl acetate and lubricant micronized silica gel evenly, add volatile oil C, mix evenly using an equal incremental method, use 80% ethanol as a wetting agent to make a soft mass, granulate through a 20-mesh sieve, boil dry at 60℃, granulate, add magnesium stearate, mix evenly, and compress into 1000 tablets, each weighing 0.3 grams; S5. Coating and Packaging: Using Opadry film coating material, moisture-proof coating is applied, followed by aluminum-plastic packaging to obtain the finished product.

[0017] Example 2: Weigh the following raw materials according to the following weights: 150g Poria cocos, 200g Hedyotis diffusa, 180g Astragalus membranaceus, 120g Curcuma longa, 150g Corydalis yanhusuo, 100g Trichosanthes kirilowii peel, 80g Cinnamomum cassia twig, 80g Prunus armeniaca seed, 100g Citrus aurantium, 80g Allium macrostemon, and 80g Citrus reticulata peel.

[0018] The preparation method is the same as in Example 1, and tablets are finally obtained.

[0019] Example 3: Weigh the following raw materials according to the following weights: Poria cocos 250g, Hedyotis diffusa 300g, Astragalus membranaceus 300g, Curcuma longa 180g, Corydalis yanhusuo 200g, Trichosanthes kirilowii peel 150g, Cinnamomum cassia twig 120g, Prunus armeniaca 120g, Citrus aurantium 150g, Allium macrostemon 120g, Citrus reticulata peel 120g.

[0020] The preparation method is the same as in Example 1, and tablets are finally obtained.

[0021] Example 4, Experimental Verification: 1. Pharmacodynamic test To verify the efficacy of this invention, an in vitro antitumor experiment was conducted. The MTT assay was used to detect the inhibitory effect of the traditional Chinese medicine composition of this invention on the proliferation of human lung cancer A549 cells and human thymoma TE-671 cells in vitro.

[0022] Experimental results show that the drug of this invention, at a concentration of 100 μg / mL, inhibited the proliferation of A549 cells and TE-671 cells by 65.3% and 58.7%, respectively, which is significantly better than the original decoction.

[0023] 2. Clinical trials One hundred and twenty patients with mediastinal tumors were randomly divided into a treatment group and a control group, with sixty patients in each group. The treatment group received the drug of this invention orally, four tablets each time, three times a day; the control group received the original decoction orally, one dose per day. One course of treatment lasted three months.

[0024] Results: In the treatment group, 5 cases achieved complete remission, 32 cases achieved partial remission, 16 cases remained stable, and 7 cases progressed, with a total effective rate of 61.7%. In the control group, 2 cases achieved complete remission, 20 cases achieved partial remission, 18 cases remained stable, and 20 cases progressed, with a total effective rate of 36.7%. There was a significant difference between the two groups.

[0025] 3. Quality Standard Research Quality standards have been established for the drug of this invention: Characteristics: This product is a film-coated tablet, which is brownish-brown after removing the coating; it has a slightly fragrant odor and a slightly bitter taste.

[0026] Identification: Thin-layer chromatography was used to identify Astragalus membranaceus, Poria cocos, and Hedyotis diffusa.

[0027] Inspection: It should comply with the relevant provisions of the Tablets section of the 2020 edition of the Chinese Pharmacopoeia.

[0028] Content determination: The content of astragaloside A in the tablets was determined by high performance liquid chromatography, and each tablet contained not less than 0.8 mg of astragaloside A.

[0029] Further explanation; 1. Design and extraction of target molecules: Theoretical basis: Traditional Chinese medicine theory holds that drugs such as cinnamon twig, allium macrostemon, and tangerine peel are good at "moving upwards" and "promoting yang and dispersing stagnation", and have a special guiding effect on pathogenic factors in the chest, diaphragm and mediastinum, acting as "guiding drugs".

[0030] Modern Interpretation and Extraction: We believe that the volatile components in these guiding herbs (such as cinnamaldehyde, allicin, and tangerine peel volatile oil) can indirectly guide the accumulation of other pharmacologically active ingredients in the mediastinum by regulating metabolism or cell membrane permeability. To this end, we have developed the "Simultaneous Distillation-Inclusion Technology for Guiding Herb Component Clusters".

[0031] Process implementation: Simultaneous steam distillation: The three guiding herbs, cinnamon twig, allium macrostemon, and tangerine peel, are steam distilled together.

[0032] The collected volatile oil C (targeted guiding component) is immediately mixed with the dry extract powder obtained by spray drying, and then encapsulated. This step can encapsulate the volatile oil molecules to form a stable inclusion complex, effectively preventing them from escaping during subsequent processing and storage, and ensuring their precise release in vivo.

[0033] 2. Multi-dimensional synergistic targeting effect: The system's targeting capability is reflected in three levels: Chemical targeting: Specific components in the guiding drug may alter the permeability of capillaries in the mediastinal region or their affinity for specific tissues, acting as a "chemical GPS" to guide the main active ingredients (such as Poria cocos polysaccharide, curcumin, and total flavonoids of Hedyotis diffusa) to the lesion site for directional distribution and accumulation.

[0034] Physical targeting: After the tablets enter the gastrointestinal tract, the active ingredients modified by the guiding drug are more easily absorbed through the mesenteric lymphatic system, which is an important pathway for mediastinal tumor metastasis, thereby achieving physical targeting and tracking of primary lesions and potential metastatic lesions.

[0035] Biological targeting: the foundation of the system—principal and assistant drugs, capable of regulating immunity holistically (Astragalus membranaceus, Poria cocos) and inhibiting tumor growth (Hedyotis diffusa, Curcuma longa). The guiding drugs direct this regulatory effect to the mediastinal region, achieving targeted biological effects of "local enhancement".

[0036] Other key benefits brought about by the process flow 1. Diverse and precise extraction to achieve synergistic effects of "1+1>2": This process completely surpasses the traditional "one-pot boiling" method of simmering. For example... Figure 1 As shown in the flowchart, based on the chemical properties of the effective components of each medicinal material (such as water solubility, alcohol solubility, and volatility), four simultaneous and precise extraction pathways were designed: Hot water extraction: targeting the immunomodulatory polysaccharides in the principal herbs, Poria cocos and Astragalus membranaceus.

[0037] Ethanol reflux: targeting the antitumor fat-soluble components (such as flavonoids and curcumin) in the herbal medicines Oldenlandia diffusa and Curcuma longa.

[0038] Steam distillation: Specifically used for extracting targeted volatile oils from guiding herbs (cinnamon twig, allium macrostemon, tangerine peel).

[0039] Ultrasonic-assisted extraction: Used as an adjuvant for bitter almonds and immature bitter oranges, it efficiently extracts glycosides and flavonoids through the cavitation effect of ultrasound, avoiding damage caused by prolonged heating.

[0040] This "separate extraction and precise enrichment" model ensures that all kinds of active ingredients can be extracted with the highest efficiency and achieve the most ideal compatibility concentration in the final product.

[0041] 2. The unity of "reducing toxicity and increasing efficacy" and "holistic regulation": The process design not only pursues powerful anti-tumor effects but also prioritizes safety. By precisely controlling the extraction temperature and time, the dissolution of ineffective impurities and potentially toxic side effects is reduced. Simultaneously, the combination of the formulation itself (such as Astragalus membranaceus for strengthening the body and Citrus reticulata for regulating Qi) with the process ensures that while attacking the tumor, it also protects and enhances the body's overall functions (such as immunity and digestive function), achieving a modern interpretation of "strengthening the body's resistance and eliminating pathogens," effectively improving patients' quality of life.

[0042] 3. Controllable quality lays the foundation for industrialization: Every step of the entire process has clearly defined quantitative parameters (temperature, time, concentration), which makes the product quality highly stable and the difference between batches minimal.

[0043] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for mediastinal tumor treatment, characterized in that, The traditional Chinese medicine composition comprises: monarch drug: Poria cocos 15-25 parts, oldenlandia 20-30 parts, astragalus 18-30 parts; Ministerial drug: turmeric 12-18 parts, Corydalis 15-20 parts, gualou 10-15 parts; Assistant drug: cassia twig 8-12 parts, bitter almond 8-12 parts, citron fruit 10-15 parts, Chinese onion 8-12 parts; Making medicine: dried tangerine or orange peel 8-12 parts.

2. The traditional Chinese medicine composition for treating mediastinal tumor according to claim 1, characterized in that, The traditional Chinese medicine composition comprises: monarch drug: Poria cocos 20 parts, oldenlandia 25 parts, astragalus 25 parts; Ministerial drug: turmeric 15 parts, Corydalis 18 parts, gualou 12 parts; Assistant drug: cassia twig 10 parts, bitter almond 10 parts, citron fruit 12 parts, Chinese onion 10 parts; Making medicine: dried tangerine or orange peel 10 parts.

3. The preparation method of the traditional Chinese medicine composition for mediastinal tumor treatment according to claim 1, characterized in that, It comprises the following steps: S1, raw material pretreatment: remove impurities from all medicinal materials, identify and process according to the provisions of Chinese Pharmacopoeia 2020 edition, and grind Poria cocos and astragalus into coarse powder for later use; wash oldenlandia, turmeric, Corydalis and the like and dry them at low temperature; S2, extraction process: S2.1, Poria cocos and astragalus are extracted by hot water immersion method: add 10 times the amount of distilled water, soak for 30 minutes, heat at 90℃ and reflux extract 2 times, each for 1.5 hours, combine the extract, filter, and obtain filtrate A; S2.2, oldenlandia, turmeric and Corydalis are extracted by ethanol reflux method: add 8 times the amount of 70% ethanol, heat and reflux extract 2 times, each for 2 hours, combine the ethanol extract, recover ethanol, and obtain extract B; S2.3, gualou, cassia twig, Chinese onion and dried tangerine or orange peel are extracted by water vapor distillation method: extract volatile oil components, collect volatile oil C, filter the water solution after distillation, and obtain filtrate D; S2.4, bitter almond and citron fruit are extracted by ultrasonic assisted extraction method: add 10 times the amount of 50% ethanol, ultrasonic power 300W, temperature 50℃, extract for 30 minutes, filter, and obtain filtrate E; S3, concentration and drying: combine the above filtrates A, D and E, mix with extract B, concentrate to thick extract with relative density 1.25-1.30 at 60℃ under reduced pressure, use spray drying technology, inlet temperature 180℃, outlet temperature 80℃, and obtain dry extract powder; S4, preparation forming: mix the dry extract powder with appropriate amount of crosslinked povidone as disintegrating agent and microcrystalline silicon as lubricant, add volatile oil C, mix uniformly by equal amount incremental method, use 80% ethanol as wetting agent to prepare soft material, pass through 20 mesh sieve to granulate, boil and dry at 60℃, integrate, add magnesium stearate, mix uniformly, and press into tablets, each weighing 0.3 grams; S5, coating and packaging: use Opadry film coating material for moisture-proof coating, aluminum plastic packaging, and the finished product is obtained.

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