Traditional Chinese medicine composition for reducing phlegm, resolving masses and promoting blood circulation to remove blood stasis and preparation process thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines and relates to a traditional Chinese medicine composition for reducing phlegm, resolving masses and promoting blood circulation to remove blood stasis and a preparation method thereof. The traditional Chinese medicine composition comprises radix scrophulariae, thunberg fritillary bulb, oyster, radix ranunculi ternati, selfheal, rhizoma paridis and airpotato yam rhizome, all the medicines generate a synergistic effect, the traditional Chinese medicine composition has the effects of reducing phlegm, resolving masses and promoting blood circulation to remove blood stasis, and pharmacological experiments verify that the traditional Chinese medicine composition can effectively eliminate thyroid nodules, pulmonary nodules and lymphadenectasis, effectively relieve pain of a patient and improve the curative effect of the patient. The pharmaceutical composition is low in toxic and side effects, high in safety and wide in market prospect.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a use of a traditional Chinese medicine composition and a preparation process thereof, and specifically relates to a traditional Chinese medicine composition for treating phlegm-blood stasis type lymphadenopathy, thyroid nodules, and lung nodules, and a preparation process thereof. Background Art

[0002] Resolving phlegm and dispersing nodules refers to dissolving phlegm and nodules in the body, and is usually used to treat symptoms such as phlegm-dampness blockage or local nodules. Phlegm is sticky and can easily hinder the flow of qi and affect the normal flow of qi, blood, and body fluids. Abnormal transportation and transformation leads to obstruction of body fluid distribution, which will cause "phlegm knots" to accumulate and form nuclei, forming lumps, which are similar to the local manifestations of lymph node enlargement.

[0003] Activating blood circulation and removing blood stasis is a method of treating blood stasis syndrome with drugs that have a dissipating effect or can attack blood stasis in the body. It has the effect of unblocking blood vessels and dissipating blood stasis. Blood stasis, also known as "bad blood", "blood stasis" and "blood accumulation", is a pathological product formed in or outside the veins due to blood condensation caused by poor blood circulation. Qi deficiency or qi stagnation leads to the inability to push blood, and blood stasis occurs over time. Blood stasis hinders the circulation of qi and blood, and forms accumulation over time. Therefore, it is believed that blood stasis is both a pathological product and a pathogenic factor. Blood stasis can be combined with other pathological factors to evolve into a variety of disease changes.

[0004] Phlegm and blood stasis are both diseases. Phlegm rises and falls with qi, affecting the body's meridians, qi, blood circulation, etc. Abnormal distribution of body fluids will condense into phlegm over time. Phlegm blocks qi, causing qi to be difficult to circulate blood, blood vessels to stagnate, or qi to fail to hold blood, blood overflows from the vessels, forming stasis. Phlegm and blood stasis have the same origin. Phlegm is a pathological product formed by body fluids. Blood stasis is blood that is not flowing smoothly or has left the meridians. It stays there and does not go away. Body fluids and blood have the same origin. Body fluid disease causes phlegm, and blood disease causes blood stasis. They are mutually causal.

[0005] TCM believes that thyroid nodules are caused by deficiency of vital energy, dysfunction of internal organs, and stagnation of qi, phlegm and blood stasis. Its pathological characteristics are deficiency in the root and excess in the superficial, with a mixture of deficiency and excess. Its main pathogenesis is endogenous phlegm and dampness, stagnation of qi and blood, and condensation of phlegm and dampness in the front of the neck, which causes blood stasis over time. The combination of qi, phlegm and stasis causes nodular goiter. The lung governs qi and respiration, governs water flow, and flows to all meridians. The basic operation form of lung qi is to spread and descend. The lung lobes are delicate and cannot tolerate the invasion of cold, heat, dryness and dampness. Phlegm, turbidity and blood stasis lead to the inability of body fluids to be normally distributed, which easily forms lung nodules. TCM believes that the above belongs to the category of "goiter", which is mostly caused by emotional disorders or improper diet, and pathological factors such as qi stagnation, blood stasis, phlegm and dampness stagnation are produced over time. Traditional Chinese medicine has a long history of treating goiter. It starts from the etiology and pathogenesis of goiter and gall tumors, promotes qi circulation, resolves phlegm, removes blood stasis and disperses nodules. It has good clinical efficacy and is an effective method for preventing and treating the above-mentioned nodules.

[0006] Lymph nodes are important immune organs in the human body. Lymph node enlargement is a phenomenon in which the cells inside the lymph nodes proliferate or the tumor cells infiltrate and the volume increases. The causes of lymph node enlargement are mainly divided into benign and malignant. Benign lymph node enlargement is mostly self-limited and benign. The treatment is mainly based on etiology, and targeted treatment is carried out according to the cause of lymph node enlargement. Benign lymph node enlargement has a good prognosis. Malignant lymph node enlargement refers to the metastasis of cancer cells to the lymph nodes, leading to lymph node enlargement. Xu Yamei, Jia Mei, Zhang Yayue, et al. A preliminary study on the common symptom elements and TCM syndrome types of malignant lymphoma (stone carbuncle) showed that among the 6 common symptom elements of lymphoma, the distribution ratios of phlegm knot and blood stasis were 92.1% and 56.1% respectively, and the proportion of phlegm and blood stasis syndrome was 57%. Lymphoma is characterized by local lymph node enlargement as the main clinical manifestation, and the pathological basis is the promotion of lymphocyte proliferation by inflammatory factors. During the development of the disease, inflammatory factors, like phlegm and blood stasis in traditional Chinese medicine, run through the entire process, providing new diagnostic and treatment ideas for the treatment of lymphoma.

[0007] At present, the treatment of nodules and lymphadenopathy is mainly based on Western medicine. Western medicine generally uses antibiotics and other drugs to enhance immunity, antibacterial, anti-inflammatory and analgesic treatment, but the effect is minimal, and long-term use will have significant side effects on the human body. Traditional Chinese medicine treatment focuses on resolving phlegm, removing blood stasis, unblocking meridians, reducing swelling and dispersing nodules. Compared with Western medicine, traditional Chinese medicine treatment is slow to take effect, but it focuses on overall prevention and treatment, and has a wide range of side effects, suitable for a wide range of people.

[0008] Scrophularia, Fritillaria thunbergii, oyster, cat's claw, Prunella vulgaris, Paris polyphylla and Dioscorea bulbifera have the effects of resolving phlegm and removing blood stasis, softening and dispersing nodules. Modern studies have shown that they have anti-tumor and anti-inflammatory effects. Therefore, it is of great practical significance to invent a Chinese medicine formula that has the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, and can effectively eliminate thyroid nodules, lung nodules and improve malignant lymphadenopathy. Summary of the invention

[0009] In view of the above-mentioned deficiencies in the prior art, the present invention provides a Chinese medicine composition with the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, which can effectively eliminate thyroid nodules, lung nodules and improve malignant lymphadenopathy, improve the quality of life of patients, have few side effects and are highly safe.

[0010] One of the purposes of the present invention is to provide a Chinese medicine composition with the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis. The Chinese medicine composition contains Scrophularia ningpoensis, Fritillaria thunbergii, Oyster, Cat's Claw, Prunella vulgaris, Paris polyphylla and Dioscorea bulbifera.

[0011] In the above formula, the Chinese medicine compositions for resolving phlegm and dispersing stagnation, promoting blood circulation and removing blood stasis have the following effects:

[0012] Scrophularia: Clears heat and cools blood, nourishes yin and reduces fire, detoxifies and disperses stagnation. Used for heat entering the blood, fever toxicity causing spots, febrile disease damaging yin, red tongue and thirst, fluid damage and constipation, bone steaming and fatigue cough, red eyes, sore throat, diphtheria, scrofula, carbuncle, swelling and ulcer.

[0013] Fritillaria thunbergii: clears away heat, resolves phlegm and relieves cough, detoxifies, disperses stagnation and eliminates carbuncle. Used for wind-heat cough, phlegm-fire cough, lung carbuncle, breast carbuncle, scrofula and sore.

[0014] Oyster: It calms the mind, subdues yang and replenishes yin, softens and disperses lumps. It is used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm, masses and lumps. Calcined oyster is astringent, acid-reducing and analgesic. It is used for spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, leukorrhea, stomachache and acid regurgitation.

[0015] Cat's Claw: It can dissipate phlegm and resolve stagnation, detoxify and reduce swelling. It is used for scrofula, phlegm nodules, carbuncle swelling and poison, and snake and insect bites.

[0016] Prunella Vulgaris: clears the liver and purges fire, improves eyesight, disperses stagnation and reduces swelling. Used for red and swollen eyes, night pain in the eyeballs, headache and dizziness, scrofula, goiter, breast abscess, breast lumps, and breast pain.

[0017] Paris polyphylla: resolves phlegm and dissipates stagnation, detoxifies and reduces swelling. Used for scrofula, phlegm nodules, carbuncle, swelling and poison, and snake and insect bites.

[0018] Dioscorea bulbifera: It has the effects of clearing away heat and detoxifying, resolving phlegm, dispersing nodules and eliminating goiters, cooling blood and stopping bleeding. It is used to treat goiters, throat paralysis, carbuncles, ulcers, snake bites, lung heat, cough and asthma, and other diseases.

[0019] In some embodiments, the Chinese medicine composition further contains the following auxiliary materials: honey, starch, ethanol, sucrose, potassium sorbate and sucrose powder.

[0020] In a more preferred embodiment, the Chinese medicine composition contains the following components: 200-800g of Scrophularia ningpoensis, 100-500g of Fritillaria thunbergii, 200-800g of Oyster, 200-800g of Cat's Claw, 200-800g of Prunella Vulgaris, 50-200g of Paris polyphylla, and 50-200g of Dioscorea bulbifera.

[0021] The second object of the present invention is to provide a Chinese medicine preparation, which is prepared from the above-mentioned Chinese medicine composition.

[0022] In some embodiments, the Chinese medicine preparation is an oral preparation.

[0023] In a more preferred embodiment, the Chinese medicine composition is one or more of a decoction, a hard capsule, an ointment, a tablet, a granule, a pill, an oral liquid, a syrup, a powder, a pill, a suspension, a solution, an injection, a lyophilized powder injection, an injection, a suppository, a plaster, a cream, a spray and a patch.

[0024] The third object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition.

[0025] In some embodiments, the preparation method of the Chinese medicine composition is:

[0026] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0027] (2) mixing all the crude powders of the medicinal materials obtained in (1) and boiling them three times, filtering, combining the decoctions, and concentrating them into an extract;

[0028] (3) The extract obtained in (2) is mixed with pharmaceutical excipients to prepare different pharmaceutical preparations.

[0029] In a more preferred embodiment, the preparation method of the Chinese medicine composition is:

[0030] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0031] (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 60-65° C. to a decoction paste with a relative density of 1.10-1.15;

[0032] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.2-1.25 at 60-65° C. to obtain a decoction.

[0033] In a more preferred embodiment, the preparation method of the Chinese medicine composition is:

[0034] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0035] (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15;

[0036] (3) drying the extract obtained in (2) at 70-80° C. under reduced pressure to obtain a dry extract, wherein the vacuum degree is 3.3-6.6 kPa and the water content of the dry extract is 3%-6%;

[0037] (4) crushing the dry extract obtained in (3), adding 10%-15% starch and mixing evenly;

[0038] (5) The mixture obtained in (4) is granulated with 70% ethanol, dried, sized, and filled into capsules to obtain hard capsules.

[0039] In a more preferred embodiment, the preparation method of the Chinese medicine composition is:

[0040] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0041] (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15;

[0042] (3) Add an appropriate amount of sucrose to boiling water to make it dissolve evenly, filter it, and make a monosaccharide syrup;

[0043] (4) adding the monosaccharide syrup obtained in (3) to the extract obtained in (2) to make the final sugar content 20%-60%, and adding purified water;

[0044] (5) Add 2% potassium sorbate to the mixture obtained in (4), mix well, and fill to obtain an oral solution.

[0045] In a more preferred embodiment, the preparation method of the Chinese medicine composition is:

[0046] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0047] (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15;

[0048] (3) Add 4 times the amount of sucrose powder to the extract obtained in (2), mix well, and granulate, dry, and size the particles to obtain granules.

[0049] The fifth object of the present invention is to provide a Chinese medicine composition for the preparation of a treatment for phlegm-blood stasis type lymphadenopathy, thyroid nodules, and lung nodules.

[0050] Compared with the prior art, the present invention has achieved the following beneficial effects:

[0051] 1. The Chinese medicine composition of the present invention has a reasonable formula, a few but fine medicinal flavors, and a reasonable compatibility of the medicinal flavors, which cooperate with each other, can produce good blood circulation and blood stasis, dispersing nodules and reducing swelling effects, has a definite therapeutic effect, can effectively alleviate the patient's pain to a certain extent, has a simple and easy preparation method, is simple to use, has no toxic side effects, and has good safety.

[0052] 2. The principle of the above scheme is low-priced compared with the western medicine required for treatment, which reduces the economic burden on patients and can be prepared into a variety of dosage forms, including decoction, capsules, oral liquids, granules or other dosage forms. These dosage forms have the advantages of easy use, good stability, good quality controllability, and good patient adaptability.

[0053] 3. Pharmacological experiments have shown that the present invention can inhibit lymphoma enlargement in mice and has an anti-lymphoma effect; it can reduce the VEGF content in the serum of rats with goiter and inhibit the expression of FGF-2 in thyroid tissue, and treat nodular goiter; it can reduce the expression of mRNA levels of TNF-α and IL-1β in mouse lung tissue, and has a certain preventive and therapeutic effect on mouse inflammation. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 : mRNA levels of TNF-α in mouse lung tissue.

[0055] Figure 2 : IL-1β mRNA levels in mouse lung tissue. Specific embodiments

[0056] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0057] Example 1: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the decoction are as follows:

[0058] 500g of Scrophularia ningpoensis, 300g of Fritillaria thunbergii, 500g of Oyster, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera.

[0059] Preparation method:

[0060] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0061] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 12 times of water for the first time and decoct for 3 h, add 8 times of water for the second time and decoct for 2 h, and add 6 times of water for the third time and decoct for 0.5 h, filter, combine the decoctions, and concentrate to a decoction paste at 60° C. to a relative density of 1.10;

[0062] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.25 at 60°C to obtain a decoction.

[0063] Example 2: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the capsule are as follows:

[0064] 500g of Scrophularia ningpoensis, 300g of Fritillaria thunbergii, 500g of Oyster, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera.

[0065] Preparation method:

[0066] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0067] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 12 times of water for the first time and decoct for 3 h, add 8 times of water for the second time and decoct for 2 h, and add 6 times of water for the third time and decoct for 0.5 h, filter, combine the decoctions, and concentrate to 80°C to a decoction paste with a relative density of 1.10;

[0068] (3) drying the extract obtained in (2) at 70° C. under reduced pressure to obtain a dry extract, wherein the dry extract has a water content of 3% to 6%;

[0069] (4) crushing the dry extract obtained in (3), adding 10% starch and mixing evenly;

[0070] (5) The mixture obtained in (4) is granulated with 70% ethanol, dried, sized, and filled into capsules to obtain hard capsules.

[0071] Example 3: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the oral liquid composition and preparation are as follows:

[0072] 500g of Scrophularia ningpoensis, 300g of Fritillaria thunbergii, 500g of Oyster, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera.

[0073] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0074] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 12 times of water for the first time and decoct for 3 h, add 8 times of water for the second time and decoct for 2 h, and add 6 times of water for the third time and decoct for 0.5 h, filter, combine the decoctions, and concentrate to 80°C to a decoction paste with a relative density of 1.10;

[0075] (3) Add an appropriate amount of sucrose to boiling water to make it dissolve evenly, filter it, and make a monosaccharide syrup;

[0076] (4) adding the monosaccharide syrup obtained in (3) to the extract obtained in (2) to make the final sugar content 20%-60%, and adding purified water;

[0077] (5) Add 2% potassium sorbate to the mixture obtained in (4), mix well, and fill to obtain an oral solution.

[0078] Example 4: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the granules are as follows:

[0079] 500g of Scrophularia ningpoensis, 300g of Fritillaria thunbergii, 500g of Oyster, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera.

[0080] Preparation process: (1) Weigh each medicinal material according to the prescribed amount, and grind the medicinal material into coarse powder by dry grinding;

[0081] (2) Mixing all the crude powders of the medicinal materials obtained in (1) and decocting them three times: adding 12 times of water for the first time and decocting for 3 h, adding 8 times of water for the second time and decocting for 2 h, and adding 6 times of water for the third time and decocting for 0.5 h, filtering, combining the decoctions, and concentrating to 80° C. to a decoction paste with a relative density of 1.10-1.15;

[0082] (3) Add 4 times the amount of sucrose powder to the extract obtained in (2), mix well, and granulate, dry, and size the particles to obtain granules.

[0083] Example 5: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the decoction are as follows:

[0084] 200g of Scrophularia ningpoensis, 100g of Fritillaria thunbergii, 200g of Oyster, 200g of Cat's Claw, 200g of Prunella Vulgaris, 50g of Paris polyphylla and 50g of Dioscorea bulbifera.

[0085] Preparation method:

[0086] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0087] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 10 times the water for the first time and decoct for 2 h, add 10 times the water for the second time and decoct for 2.5 h, and add 8 times the water for the third time and decoct for 1 h, filter, combine the decoctions, and concentrate to a decoction paste at 65° C. to a relative density of 1.15;

[0088] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.2 at 65°C to obtain a decoction.

[0089] Comparative Example 1: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the decoction are as follows:

[0090] 100g of Scrophularia ningpoensis, 500g of Fritillaria thunbergii, 100g of Oyster, 150g of Cat's Claw, 600g of Prunella Vulgaris, 150g of Paris polyphylla and 150g of Dioscorea bulbifera.

[0091] Preparation method:

[0092] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0093] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 10 times the water for the first time and decoct for 2 h, add 10 times the water for the second time and decoct for 2.5 h, and add 8 times the water for the third time and decoct for 1 h, filter, combine the decoctions, and concentrate to a decoction paste at 65° C. to a relative density of 1.15;

[0094] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.2 at 65°C to obtain a decoction.

[0095] Comparative Example 2: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the decoction are as follows:

[0096] Rehmannia glutinosa: 500g, Fritillaria thunbergii 300g, Oyster 500g, Cat's Claw 500g, Herba Prunellae 500g, Paris polyphylla 100g and Rhizoma Dioscoreae 100g;

[0097] Preparation method:

[0098] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0099] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them for 4 times, filter, combine the decoctions, and concentrate them into extracts. The water decoction technical conditions adopted are: add 6 times of water each time, soak for 1 hour, decoct for 1 hour, and concentrate to 70°C to a relative density of 1.5;

[0100] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.4 to obtain a decoction.

[0101] Comparative Example 3: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the capsule are as follows:

[0102] 500g of Scrophularia, 300g of Platycodon, 500g of Oyster, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera.

[0103] Preparation method:

[0104] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0105] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 12 times of water for the first time and decoct for 3 h, add 8 times of water for the second time and decoct for 2 h, and add 6 times of water for the third time and decoct for 0.5 h, filter, combine the decoctions, and concentrate to 80°C to a decoction paste with a relative density of 1.10;

[0106] (3) drying the extract obtained in (2) at 70° C. under reduced pressure to obtain a dry extract, wherein the dry extract has a water content of 3% to 6%;

[0107] (4) crushing the dry extract obtained in (3), adding 10% starch and mixing evenly;

[0108] (5) The mixture obtained in (4) is granulated with 70% ethanol, dried, sized, and filled into capsules to obtain hard capsules.

[0109] Comparative Example 4: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the oral liquid are as follows:

[0110] 500g of Scrophularia ningpoensis, 300g of Fritillaria thunbergii, 500g of Mother of Pearl, 500g of Cat's Claw, 500g of Prunella Vulgaris, 100g of Paris polyphylla and 100g of Dioscorea bulbifera;

[0111] Preparation process: (1) Weigh each medicinal material according to the prescribed amount, and grind the medicinal material into coarse powder by dry grinding;

[0112] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 12 times of water for the first time and decoct for 3 h, add 8 times of water for the second time and decoct for 2 h, and add 6 times of water for the third time and decoct for 0.5 h, filter, combine the decoctions, and concentrate to 80°C to a decoction paste with a relative density of 1.10;

[0113] (3) Add an appropriate amount of sucrose to boiling water to make it dissolve evenly, filter it, and make a monosaccharide syrup;

[0114] (4) adding the monosaccharide syrup obtained in (3) to the extract obtained in (2) to make the final sugar content 20%-60%, and adding purified water;

[0115] (5) Add 2% potassium sorbate to the mixture obtained in (4), mix well, and fill to obtain an oral solution.

[0116] Comparative Example 5: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the granules are as follows:

[0117] Scrophularia 600g, Fritillaria thunbergii 400g, Oyster 500g, Prunella vulgaris 600g, Paris polyphylla 100g and Dioscorea bulbifera 100g;

[0118] Preparation process: (1) Weigh each medicinal material according to the prescribed amount, and grind the medicinal material into coarse powder by dry grinding;

[0119] (2) Mixing all the crude powders of the medicinal materials obtained in (1) and decocting them three times: adding 12 times of water for the first time and decocting for 3 h, adding 8 times of water for the second time and decocting for 2 h, and adding 6 times of water for the third time and decocting for 0.5 h, filtering, combining the decoctions, and concentrating to 80° C. to a decoction paste with a relative density of 1.10-1.15;

[0120] (3) Add 4 times the amount of sucrose powder to the extract obtained in (2), mix well, and granulate, dry, and size the particles to obtain granules.

[0121] Comparative Example 6: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the decoction are as follows:

[0122] Scrophularia 200g, Fritillaria thunbergii 100g, Oyster 200g, Cat's Claw 200g, Prunella Vulgaris 200g, Arisaema 50g, Dioscorea bulbifera 50g;

[0123] Preparation method:

[0124] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0125] (2) Mix all the crude powders of medicinal materials obtained in (1) and decoct them three times: add 10 times the water for the first time and decoct for 2 h, add 10 times the water for the second time and decoct for 2.5 h, and add 8 times the water for the third time and decoct for 1 h, filter, combine the decoctions, and concentrate to a decoction paste at 65° C. to a relative density of 1.15;

[0126] (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.2 at 65°C to obtain a decoction.

[0127] Comparative Example 7: A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, the composition and preparation of the oral liquid are as follows:

[0128] Scrophularia 500g, Fritillaria thunbergii 300g, Oyster 500g, Cat's Claw 500g, Kelp 500g, Paris polyphylla 100g;

[0129] Preparation method:

[0130] (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding;

[0131] (2) Mix all the crude powders of medicinal materials obtained in (1), add 10 times the amount of water, boil for 5 h, filter, and add an appropriate amount of sucrose;

[0132] (3) Add sodium benzoate to the mixture obtained in (2), mix well, and fill the mixture to obtain an oral solution.

[0133] Pharmacodynamics experiments

[0134] In order to further prove that the Chinese medicine composition of the present invention has the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, especially for phlegm and blood stasis type lymphadenopathy, thyroid nodules and lung nodules, the inventors commissioned a third-party testing institution with relevant qualifications to carry out relevant pharmacodynamics experiments based on clinical use. The animal model used in the following pharmacodynamics experiment was prepared based on the technology of existing literature.

[0135] 1. The inhibitory effect of the present invention on lymphoma

[0136] 1. Experimental Materials

[0137] 1.1 Experimental Animals:

[0138] BALV / c-nu male nude mice aged 4-6 weeks, weighing 16-18 g, were raised under SPF conditions.

[0139] 1.2 Drugs and reagents

[0140] The tumor cell line EL-4 mouse lymphoma cells were purchased from the cell bank of Shanghai Institute of Cell Biology, Chinese Academy of Sciences.

[0141] Drugs and reagents: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2 of the present invention

[0142] Before the in vivo tumor inhibition experiment, the compositions of Example 1, Example 2, Example 3, Comparative Example 1 and Comparative Example 2 were ground in respective mortars, prepared into different concentrations with 0.5% CMC-Na, and sterilized by high pressure.

[0143] 1.3 Dosage

[0144] According to the human dosage, the human weight is calculated as 70kg, the oral dose for humans is 100mg / kg, and the dose for mice is 910mg / kg.

[0145] 2. Experimental Methods

[0146] MNU was used to induce thymic T cell lymphoma in C57BL / 6 mice. Tumor tissue was collected in a clean bench, and the concentration of the collected lymphoma single cell suspension was adjusted to 1×10 7 0.2 mL of cell suspension was inoculated under the right axilla of each BALB / c nude mouse. About 10 days after inoculation, the tumor formation rate reached 100%. Nude mice without bleeding, necrosis, infection, and tumor diameter of 0.5-0.6 cm were selected for the experiment.

[0147] Tumor-bearing nude mice were randomly divided into 7 groups according to tumor size, with 8 mice in each group. The model group was intraperitoneally injected with 0.2 ml of normal saline per mouse, and the administration was daily. The positive control group was intraperitoneally injected with 20 mg / kg of cyclophosphamide, and the administration was daily. Example 1, Example 2, Example 3, Comparative Example 1, and Comparative Example 2 were intragastrically administered with 910 mg / kg of the prepared Chinese medicine, and the administration was daily.

[0148] The activity of nude mice and the growth of subcutaneous tumors were observed every day. After 21 days of medication, the nude mice were killed by cervical dislocation, weighed, and the volume and weight of the tumor were detected. The tumor inhibition rate of each group was calculated (tumor inhibition rate = (average weight of model group - average weight of experimental group) / average weight of model group).

[0149] 3. Statistical methods

[0150] All data are SPSS 22.0 was used for data analysis.

[0151] 4. Experimental results and analysis

[0152] The inhibitory effect on the tumor weight of nude mice transplanted tumors is shown in Table 1.

[0153] Table 1 Inhibitory effect on tumor weight of nude mice transplanted tumor (n=8)

[0154] Group Tumor weight (g) Tumor inhibition rate (%) Model Group 2.67±0.38^ - Positive control group 1.55±0.27* 41.8 Example 1 Group 1.51±0.31* 43.4 Example 2 Group 1.58±0.32* 41.0 Example 3 Group 1.57±0.24* 41.1 Comparative Example 1 2.10±0.37*^ 21.5 Comparative Example 2 1.96±0.39*^ 26.6

[0155] Note: Compared with the model group, *P<0.05, compared with the positive group, ^P<0.05.

[0156] As can be seen from the above table, compared with the model group and comparative examples 1 and 2, each dosage group of the Chinese medicine of the present invention can significantly inhibit tumor weight (P < 0.05), and its tumor inhibition effect is equivalent to that of the positive control group, indicating that the Chinese medicine of the present invention has a significant anti-lymphoma effect.

[0157] II. Effect of the present invention on angiogenesis in rat nodular goiter

[0158] 1. Experimental Materials

[0159] 1.1 Experimental animals

[0160] 64 SD male rats, weighing 120-140g. All rats were housed in separate cages in the laboratory and given standard rat feed and tap water. They were randomly divided into groups, with 8 rats in each group.

[0161] 1.2 Medication and grouping

[0162] Drugs and reagents: Example 1 of the present invention, Comparative Example 6, Comparative Example 7, and Levothyroxine Sodium Tablets.

[0163] According to the human dosage, the human weight is calculated as 70kg, the oral dose for humans is 100mg / kg, the dose for normal rats is 630mg / kg, and the positive control group is 0.01mg / kg.

[0164] 2. Experimental Methods

[0165] The modeling experiment was started after the rats were fed for 14 days. The normal group was given physiological saline by gavage, and the other groups were given 0.1% propylthiouracil solution by gavage, once a day, for 8 consecutive weeks. After the administration, Doppler observation was used to show that the follicular epithelial cells of the thyroid tissue of the rats in the model group were highly swollen, the endoplasmic reticulum was dilated, and the surface ribosomes of the endoplasmic reticulum were densely distributed, indicating that the modeling was successful. Since the 9th week, the positive drug control group was given levothyroxine sodium tablets by gavage, the drug group was given low, medium and high doses of Example 1 of the present invention, Comparative Example 6, Comparative Example 7, respectively, the normal group and the model group were given distilled water by gavage, and the stomach was administered once every morning, and each group was given for 10 consecutive weeks.

[0166] After 10 weeks of oral treatment, all rats were anesthetized with 5% phenobarbital intraperitoneally. The tissue above the thyroid cartilage of the rat was cut short with scissors, and the rat was lifted to drip blood into the prepared procoagulant tube. The total blood volume was about 2mL. The neck skin was further cut to expose the organs, the thyroid cartilage was found, the thyroid tissue was completely separated, and other tissues were removed. A small part of the left thyroid gland of each rat was cut off and placed in an EP tube containing 4% paraformaldehyde for standby use. Serum and tissue section samples were prepared, and the vascular endothelial growth factor (VEGF) content in serum was detected by ELISA; the expression of fibroblast growth factor FGF-2 was detected by immunohistochemistry.

[0167] 3. Statistical methods

[0168] All data are SPSS 22.0 was used for data analysis.

[0169] 4. Experimental results and analysis

[0170] The experimental results are shown in Table 2 and Table 3.

[0171] Table 2 Effects of each group on VEGF in rat serum (n=8)

[0172]

[0173]

[0174] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the positive control group, ^P<0.05, ^^P<0.01

[0175] As shown in Table 2, compared with the model group, the concentration of VEGF in the serum of rats in each administration group decreased significantly, among which there were significant differences in each group of Example 1. With the increase of the dosage, the concentration of VEGF in the serum of rats gradually decreased. The results show that the Chinese medicine composition can reduce the concentration of VEGF in the serum of rats in the model group, and the effect is equivalent to that of the positive control group.

[0176] Table 3 Analysis of FGF-2 expression in thyroid tissue of rats in each group

[0177]

[0178] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the positive control group, ^P<0.05, ^^P<0.01

[0179] As shown in Table 3, compared with the model group, the positive expression and cumulative optical density of FGF-2 in the thyroid tissue of rats in each administration group were significantly reduced; compared with the positive control group, the positive expression area and cumulative optical density of the thyroid tissue of rats in the low-dose group of Example 1 of the present invention were significantly different, and there was no significant difference between the medium and high-dose groups, and the effect was comparable. Therefore, the Chinese medicine composition of the present invention can inhibit the expression of FGF-2 in thyroid tissue and achieve the therapeutic effect of treating nodular goiter.

[0180] III. Study on the pharmacological effects of the present invention on pulmonary nodules

[0181] 1 Medication and grouping

[0182] 1.1 Experimental Animals:

[0183] C57BL / 6 male mice, weighing 16-18 g, were raised under SPF conditions.

[0184] 1.2 Drugs and reagents

[0185] Drugs and reagents: Example 1, Example 3, Example 5, and Cat's Claw Capsules of the present invention

[0186] 1.3 Dosage

[0187] According to the human dosage, the human weight is calculated as 70kg, the oral dose for humans is 100mg / kg, and the dose for mice is 910mg / kg.

[0188] 2. Experimental Methods

[0189] A mouse model of pulmonary nodules was constructed by Propionibacterium acnes: 48 C57BL / 6 male mice were fed with conventional adaptive feeding for 7 days and divided into a blank group, a model group, an example 1 group, an example 3 group, an example 5 group and a positive drug group (cat's claw capsule), with 8 mice in each group. On the first day of modeling, 0.25 mL of a 2 mg / mL suspension of Propionibacterium acnes was injected intraperitoneally. On the 7th day, a 10 mg / mL suspension of Propionibacterium acnes was instilled orally and nasally, once every 3 days, 0.05 mL / mouse / time, and oral administration was started. The blank group and the model group were given an equal volume of normal saline by oral administration, once a day, for 30 consecutive days. Subsequently, the behavioral activities and appearance of the mice were closely observed during the experiment, and the mice were fasted 24 h before the end of the experiment, but water was not allowed.

[0190] After killing the mice by cervical dislocation, the whole lungs were quickly removed, rinsed with pre-cooled saline, dried with filter paper, ground with liquid nitrogen, and stored at -80°C for later use. The internal reference gene was β-actin, and the primers for the target genes TNF-α and IL-1β were synthesized by Jilin Kumei Biological Co., Ltd., and the working solution concentration was configured to be 10μmoL / L. After the experiment, the amplification curve and melting curve were verified, the experimental data were exported, and the Ct values ​​of each target gene were analyzed, and then 2 -(△△Ct) Methods: The relative expression level of each target gene mRNA was calculated by internal reference genes, and finally the data were statistically analyzed.

[0191] 3. Statistical methods

[0192] All data are It indicates that SPSS22.0 was used for data analysis and sigmaplot14.0 was used for drawing.

[0193] 4. Experimental results and analysis

[0194] The experimental results are shown in Figure 1 , Figure 2 Compared with the blank group, the mRNA levels of TNF-α and IL-1β in the lung tissue of the model group mice were significantly increased; the mRNA levels of TNF-α and IL-1β in the lung tissue of the mice in Examples 1, 3, 5 and the positive group were significantly reduced. The present invention has a certain preventive and therapeutic effect on early experimental pulmonary nodular inflammation.

[0195] IV. Anti-inflammatory and detumescent effects of the Chinese medicine composition of the present invention on xylene-induced mouse inflammation model

[0196] 1. Experimental Materials

[0197] 1.1 Experimental Animals: 64 Kunming mice, half male and half female, weighing 25-30 g, were randomly divided into 8 groups according to their body weight, namely, model group, positive control group, Example 1, 4, 5 groups, and Comparative Examples 3, 4, 5, with 8 mice in each group.

[0198] 1.2 Dosage

[0199] Blank group: intragastrically administered with the same volume of normal saline;

[0200] Positive group: 5 mg / kg hydrocortisone solution was administered by gavage;

[0201] Example 1, 4, 5, group, comparative example 3-5 group: calculated according to the human dosage, the human weight is calculated as 70 kg, the oral gavage dose for humans is 100 mg / kg, and the dose for mice is 910 mg / kg.

[0202] 2. Experimental Methods

[0203] Each group was given medication once a day for 7 consecutive days. After the last medication, 20 μl of xylene was taken and applied to the right ear of each mouse. After 30 minutes, 0.03 ml of each test drug was taken and evenly applied to the right ear of the mouse. The mice were killed 3.5 hours after the right ear was given xylene, and the weight difference between the left and right ears of each group of mice was measured.

[0204] Method for measuring ear weight difference: cut both ears along the auricle baseline, punch ear pieces at the same position of the left and right ears with an 8mm puncher, weigh them, and ear weight difference = right ear piece weight - left ear piece weight. Ear weight difference can be used as an indicator to evaluate anti-inflammatory.

[0205] 3. Statistical methods

[0206] Data processing: All data are processed in The T test was used for comparison among the groups, and SPSS 22.0 was used for data analysis.

[0207] 4. Experimental results and analysis

[0208] The difference in ear weight of mice in each experimental group was measured to evaluate the anti-inflammatory effect of the drugs in each medication group. The results are shown in Table 2.

[0209] Table 4 Comparison of ear differences in mice in each experimental group

[0210] Group n Ear weight difference Blank group 8 7.85±0.97 Positive group 8 4.77±0.74** Example 1 Group 8 3.10±0.89**^ Example 4 Group 8 3.65±1.17** Example 5 Group 8 3.74±1.33** Comparative Example 3 8 6.12±1.12*^^ Comparative Example 4 8 6.59±1.14*^^ Comparative Example 5 8 5.47±1.01*^

[0211] Compared with the blank group, *P<0.05, **P<0.01

[0212] Compared with the positive group, ^P<0.05, ^^P<0.01

[0213] It can be concluded from Table 4 that each group of the examples of the present invention and the positive drug can achieve anti-inflammatory effects, and the Chinese medicine composition of the present invention, especially the Chinese medicine composition of Example 1, has a significant effect, which is equivalent to the positive control group.

[0214] The above is only an embodiment of the present invention, and the common knowledge such as the known specific structure and / or characteristics in the scheme is not described in detail here. It should be pointed out that for those skilled in the art, several deformations and improvements can be made without departing from the structure of the present invention, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A Chinese medicine composition having the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, characterized in that: The Chinese medicine composition contains the following components: Scrophularia 200-500g Fritillaria thunbergii 100-300g Oyster 200-500g Cat's Claw 200-500g Prunella Vulgaris 200-500g, Paris polyphylla 50-100g, Dioscorea bulbifera 50-100g.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition also contains the following auxiliary materials: honey, starch, ethanol, sucrose, potassium sorbate and sucrose powder.

3. The Chinese medicine composition according to any one of claims 1 to 2, characterized in that: The preparation is an oral preparation.

4. The Chinese medicine composition according to claim 3, characterized in that: The Chinese medicine composition is one or more of decoction, hard capsule, ointment, tablet, granule, pill, oral liquid, syrup, powder, pill, suspension, solution, injection, lyophilized powder injection, injection, suppository, plaster, cream, spray and patch.

5. The Chinese medicine composition according to claim 4, characterized in that: The preparation method of the Chinese medicine composition is: (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder; (2) mixing all the crude powders of the medicinal materials obtained in (1) and boiling them three times, filtering, combining the decoctions, and concentrating them into an extract; (3) The extract obtained in (2) is mixed with pharmaceutical excipients to prepare different pharmaceutical preparations.

6. The Chinese medicine composition according to claim 5, characterized in that: The preparation method of the Chinese medicine composition is: (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding; (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 60-65° C. to a decoction paste with a relative density of 1.10-1.15; (3) The extract obtained in (2) is heated and mixed with honey, and concentrated to a relative density of 1.2-1.25 at 60-65° C. to obtain a decoction.

7. The Chinese medicine composition according to claim 5, characterized in that: The preparation method of the Chinese medicine composition is: (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding; (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15; (3) drying the extract obtained in (2) at 70-80° C. under reduced pressure to obtain a dry extract having a water content of 3%-6%; (4) crushing the dry extract obtained in (3), adding 10%-15% starch and mixing evenly; (5) The mixture obtained in (4) is granulated with 70% ethanol, dried, sized, and filled into capsules to obtain hard capsules.

8. The Chinese medicine composition according to claim 5, characterized in that: The preparation method of the Chinese medicine composition is: (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding; (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15; (3) Add an appropriate amount of sucrose to boiling water to make it dissolve evenly, filter it, and make a monosaccharide syrup; (4) adding the monosaccharide syrup obtained in (3) to the extract obtained in (2) to make the final sugar content 20%-60%, and adding purified water; (5) Add 2% potassium sorbate to the mixture obtained in (4), mix well, and fill to obtain an oral solution.

9. The Chinese medicine composition according to claim 5, characterized in that: The preparation method of the Chinese medicine composition is: (1) Weighing each medicinal material according to the prescribed amount, and grinding the medicinal materials into coarse powder by dry grinding; (2) mixing all the crude powders of medicinal materials obtained in (1) and decocting them three times: adding 10-12 times of water for the first time and decocting for 2-3 hours, adding 8-10 times of water for the second time and decocting for 2-2.5 hours, and adding 6-8 times of water for the third time and decocting for 0.5-1 hour, filtering, combining the decoctions, and concentrating to 80-85° C. to a decoction paste with a relative density of 1.10-1.15; (3) Add 4 times the amount of sucrose powder to the extract obtained in (2), mix well, and granulate, dry, and size the particles to obtain granules.

10. The Chinese medicine composition as claimed in claims 1 to 9 is used for preparing a medicine for treating phlegm-blood stasis type lymphadenopathy, thyroid nodules and lung nodules.

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