CN113663029A

CN113663029A - Compound wild buckwheat rhizome composition

Info

Publication number: CN113663029A
Application number: CN202111004044.8A
Authority: CN
Inventors: 黄传贵
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-08-30
Filing date: 2021-08-30
Publication date: 2021-11-19

Abstract

The invention relates to a compound wild buckwheat rhizome composition for treating lung cancer and a preparation method thereof. The composition comprises the following raw material medicines in parts by weight: 4-10 parts of wild buckwheat rhizome, 3-8 parts of pseudo-ginseng, 1-4 parts of radix sophorae flavescentis, 6-15 parts of Balanophora japonica, 4-9 parts of aspongopus, 3-8 parts of rhizoma bletillae and 3-8 parts of platycodon grandiflorum. The compound golden buckwheat rhizome composition has the effects of clearing heat, reducing phlegm, promoting blood circulation and resolving masses, and is used for treating chest pain, cough and asthma, hemoptysis, epistaxis, hoarseness and the like caused by pathogen invasion to lung and phlegm-blood stasis. It has definite and obvious curative effect on lung cancer.

Description

Compound wild buckwheat rhizome composition

Technical Field

The invention relates to a traditional Chinese medicine composition for treating lung cancer, in particular to a compound wild buckwheat rhizome composition.

Background

Lung cancer is a common malignant tumor of the lung, and the death rate is high. With the environmental deterioration and the bad living habits such as smoking, the incidence and death rate of lung cancer in various countries in the world are high.

Lung cancer develops on the one hand by stretching and expanding the bronchial wall and by invading the adjacent lung tissue through the bronchial wall to form a tumor, while invading the bronchi to cause narrowing or obstruction of its lumen. The cancer can further spread directly from the lung and invade the tissue of the proximal organs such as chest wall, mediastinum, heart, great vessel, etc.; transferred to other parts of the body through the lymphatic blood vessels. The growth rate and metastatic spread of a cancer depends on the histological type of the cancer, the degree of differentiation, and other biological properties. The method for treating lung cancer comprises operation, radiotherapy, chemotherapy and drug therapy or combination of the above methods.

Chinese patent application CN200710015686.1 discloses an oral Chinese medicinal composition for treating lung cancer, which comprises herba Houttuyniae, Bulbus Lilii, pericarpium Trichosanthis, folium Eriobotryae, Coicis semen, radix Platycodi, radix Ophiopogonis, cortex Lycii and pericarpium Citri Tangerinae. The Chinese medicinal composition has effects of promoting blood circulation for removing blood stasis, eliminating phlegm and resolving masses. CN200810159997.X discloses a Chinese medicinal composition for treating lung cancer and its preparation method, wherein the Chinese medicinal composition is prepared from herba Taraxaci, Glycyrrhrizae radix, Ginseng radix, rhizoma Polygoni Cuspidati, Curcumae rhizoma, herba Houttuyniae, sanguis Draxonis, indigo naturalis, herba asari, rhizoma Polygonati, and fructus Lycii. CN200810138918.7 discloses a Chinese medicinal composition for treating lung cancer, which is prepared from radix Panacis Quinquefolii, endothelium corneum gigeriae galli, Notoginseng radix, rhizoma Cyperi, and Coicis semen. The patent application CN200810195061.2 discloses a traditional Chinese medicine extract for resisting lung cancer A549 cell proliferation, which is prepared from bulk drugs of radix ranunculi ternati, wild buckwheat rhizome, houttuynia cordata, hairyvein agrimony, Chinese waxgourd seed, Pseudobulbus cremastrae seu pleiones, sappan wood, safflower, rhizoma pinellinae praeparata, arisaema cum bile, adenophora stricta, polygonatum odoratum and radix ophiopogonis according to a certain weight ratio, and pharmacodynamic test results show that the traditional Chinese medicine extract has a remarkable inhibiting effect on lung cancer A549 cell proliferation.

The traditional Chinese medicines for treating lung cancer also have defects in curative effect and/or side effect, so the inventor completes the invention through a large amount of experimental researches.

Disclosure of Invention

In view of the above, the invention provides a compound wild buckwheat rhizome composition, which comprises the following raw material medicines in parts by weight: 4-10 parts of wild buckwheat rhizome, 3-8 parts of pseudo-ginseng, 1-4 parts of radix sophorae flavescentis, 6-15 parts of Balanophora japonica, 4-9 parts of aspongopus, 3-8 parts of rhizoma bletillae and 3-8 parts of platycodon grandiflorum. The compound wild buckwheat rhizome composition has obvious curative effect on treating lung cancer.

In a preferred embodiment, the composition comprises the following raw material medicines in parts by weight: 6-9 parts of wild buckwheat rhizome, 3-7 parts of pseudo-ginseng, 1-3 parts of radix sophorae flavescentis, 7-12 parts of Balanophora japonica, 4-8 parts of aspongopus, 3-7 parts of rhizoma bletillae and 3-7 parts of platycodon grandiflorum.

In a preferred embodiment, the composition comprises the following raw material medicines in parts by weight: 7 parts of wild buckwheat rhizome, 5 parts of pseudo-ginseng, 2 parts of radix sophorae flavescentis, 10 parts of balanophora tetraphylla, 6 parts of aspongopus, 5 parts of rhizoma bletillae and 5 parts of platycodon grandiflorum.

The composition of the invention is capsule, granule, tablet, pill, oral liquid or decoction.

According to another preferred embodiment of the present invention, the Chinese medicinal composition of the present invention comprises a pharmaceutically acceptable carrier, which is one or more carriers selected from the group consisting of fillers, binders, wetting agents, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants, and flavoring agents, which are generally used in pharmacy.

The compound wild buckwheat rhizome composition has the functions of clearing heat, reducing phlegm, promoting blood circulation and removing stasis. It can be used for treating chest pain, cough, asthma, hemoptysis, etc. caused by pathogenic toxin invading lung and phlegm and blood stasis.

The compound wild buckwheat rhizome composition can be prepared by a traditional Chinese medicine decoction method, according to the weight ratio of traditional Chinese medicinal materials to water of 1-2: 4, the traditional Chinese medicinal materials in the compound wild buckwheat rhizome composition are decocted with water, the decoction is filtered, the residual medicine dregs are repeated for 2-3 times, and the combined filtrate can be taken.

The inventor bases on the traditional decocting method. Researches on a preparation method of the compound wild buckwheat rhizome composition find that the preparation prepared by extracting the wild buckwheat rhizome composition by using a modern process is not only convenient for patients to use, but also has better curative effect.

Therefore, the invention also provides a preparation method of the compound wild buckwheat rhizome composition, which comprises the following steps:

step (1): respectively extracting radix sophorae flavescentis and pseudo-ginseng for 2-4 times by using 50-75% ethanol under reflux, wherein each time lasts for 1-2 hours, combining extracting solutions, filtering, concentrating and drying for later use;

step (2): reflux-extracting the aspongopus with 50-75% ethanol for 2-4 times, each time for 1-2 hours, filtering, and concentrating into thick paste for later use;

and (3): decocting wild buckwheat rhizome, platycodon grandiflorum, bletilla striata and balanophora tetraphylla in water for 2-4 times, 1-2 hours each time, combining extracting solutions, filtering, concentrating and drying for later use;

and (4): combining the extracts of the above three steps with pharmaceutically acceptable carriers to make various dosage forms.

According to one embodiment of the invention, the preparation method of the compound wild buckwheat rhizome composition comprises the following steps:

step (1): reflux-extracting radix Sophorae Flavescentis and Notoginseng radix with 60% ethanol for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying;

step (2): reflux-extracting Aspongopus with 60% ethanol for 3 times, each for 1.5 hr, filtering, and concentrating to obtain soft extract;

and (3): decocting rhizoma Fagopyri Dibotryis, radix Platycodi, rhizoma Bletillae, and herba Pyrolae in water for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying;

The extract of the raw material drug can be combined with pharmaceutically acceptable carriers or excipients to prepare various dosage forms, such as granules, capsules, tablets, pills or oral liquids, wherein the pharmaceutically acceptable carriers or excipients can be selected according to different dosage forms, and the carriers or excipients used are easily determined by those skilled in the pharmaceutical technology field and are also obvious.

According to the present invention, the pharmaceutically acceptable carrier shall mean conventional pharmaceutical carriers in the pharmaceutical field, such as diluents, excipients, water and the like, fillers such as starch, sucrose, lactose, microcrystalline cellulose and the like; binders such as cellulose derivatives, alginates, gelatin, and polyvinylpyrrolidone; humectants such as glycerol; disintegrating agents such as sodium carboxymethyl starch, hydroxypropyl cellulose, cross-linked carboxymethyl cellulose, agar, calcium carbonate and sodium bicarbonate; absorption enhancers such as quaternary ammonium compounds; surfactants such as cetyl alcohol, sodium lauryl sulfate; adsorption carriers such as kaolin and bentonite; lubricants such as talc, calcium and magnesium stearate, aerosil and polyethylene glycol; other adjuvants such as flavoring agent, sweetener, etc.

According to the invention, the dosage form can be capsules, granules, tablets, pills or oral liquid. In one embodiment, the extract of the invention is taken, added with a proper amount of sodium carboxymethyl starch, mixed evenly, granulated, dried, added with magnesium stearate, mixed evenly, and encapsulated to prepare capsules. In another embodiment, the extract of the invention is optionally concentrated, sized, dried, and made into granules.

The invention also relates to application of the compound wild buckwheat rhizome composition in preparing a medicament for treating lung cancer.

Each Chinese medicinal material in the compound wild buckwheat rhizome composition has the following source and effect.

The rhizoma Fagopyri Dibotryis is dried rhizome of Fagopyrum dibotrys (D.Don) Hara of Polygonaceae. Slightly pungent, astringent and cool in nature. Has the functions of clearing away heat and toxic material, expelling pus and removing blood stasis. Can be used for treating lung abscess, measles pneumonia, and peritonsillar abscess.

Notoginseng radix is root and rhizome of Panax notoginseng (Burk.) F.H.Chen.) belonging to Araliaceae. Mainly contains ginsenoside Rg₁12 monomer saponins such as quercetin, acetic acid, caryophyllene, ginsenoside Re, leucine, beta-sitosterol-D-glucoside, panaxytriol and notoginsenoside and a hemostatic component of pseudo-ginseng acid. Has the functions of eliminating blood stasis, stopping bleeding, eliminating swelling and relieving pain. Belongs to the category of hemostatics and blood stasis-resolving hemostatics.

The Balanophora involucrate is a whole plant of Balanophora involucrate of Balanophoraceae. The functional indications are as follows: tonifying kidney and nourishing yin; clear heat and stop bleeding. Lumbago due to kidney deficiency; consumptive disease bleeding; haemorrhoids bleeding.

Aspongopus is a dried body of Aspongopus chinensis (Aspongopus chinensis Dallas) belonging to family Oridae. The functional indications are as follows: regulate qi to alleviate pain, warm middle energizer and strengthen yang. Can be used for treating stomach cold, distending pain, liver and stomach pain, kidney deficiency, sexual impotence, and soreness of waist and knees.

The rhizoma Bletillae is dried tuber of bletilla striata of Orchidaceae. The efficacy is mainly as follows: astringe to stop bleeding, resolve swelling and promote tissue regeneration. Can be used for treating hemoptysis, hematemesis, traumatic hemorrhage, pyocutaneous disease, toxic swelling, and chapped skin.

Platycodon grandiflorum is root of Platycodon grandiflorum of Campanulaceae. Contains various triterpenoid polysaccharide saponins. The efficacy is mainly as follows: dispersing lung qi, eliminating phlegm, relieving sore throat, and expelling pus. Belongs to heat-phlegm-clearing herbs classified under phlegm-resolving, cough-relieving and asthma-relieving herbs.

Radix Sophorae Flavescentis is root of Sophora flavescens ait of Leguminosae. Mainly contains various alkaloids, such as dextro-matrine, levo-fetuinine, matrine, sophoridine, oxymatrine, etc. The efficacy and the effect are as follows: clearing heat and drying dampness, killing parasites and promoting urination, which belong to the category of heat-clearing and dampness-drying herbs.

Advantageous effects

The composition has definite curative effect, has the total effective rate of treating the lung cancer of more than 90 percent, has no obvious toxic or side effect, and is suitable for treating the lung cancer.

The composition has the effects of clearing heat, reducing phlegm, promoting blood circulation and resolving masses, and is used for treating chest pain, cough and asthma, hemoptysis, epistaxis, hoarseness and the like caused by pathogen invasion to lung and phlegm-blood stasis; treating lung cancer with the above symptoms.

Detailed Description

Hereinafter, specific embodiments of the present invention will be described in detail.

Example 1: preparation of capsules

The formula of the compound wild buckwheat rhizome capsule is as follows: 560g of wild buckwheat rhizome, 400g of pseudo-ginseng, 160g of sophora flavescens, 800g of balanophora tetraphylla, 480g of aspongopus, 400g of rhizoma bletillae and 400g of platycodon grandiflorum.

The compound wild buckwheat rhizome capsule is prepared according to the following steps: step (1): reflux-extracting radix Sophorae Flavescentis and Notoginseng radix with 60% ethanol for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying; step (2): reflux-extracting Aspongopus with 60% ethanol for 3 times, each for 1.5 hr, filtering, and concentrating to obtain soft extract; and (3): decocting rhizoma Fagopyri Dibotryis, radix Platycodi, rhizoma Bletillae, and herba Pyrolae in water for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying; and (4): adding appropriate amount of sodium carboxymethyl starch into the above three extracts, mixing, granulating, drying, adding magnesium stearate, mixing, and making into capsule.

Example 2: preparation of granules

The formula of the compound wild buckwheat rhizome granule is as follows: 720g of wild buckwheat rhizome, 560g of pseudo-ginseng, 80g of sophora flavescens, 960g of balanophora tetraphylla, 640g of aspongopus, 560g of rhizoma bletillae and 560g of platycodon grandiflorum.

The compound wild buckwheat rhizome capsule is prepared according to the following steps: step (1): reflux-extracting radix Sophorae Flavescentis and Notoginseng radix with 50% ethanol for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying; step (2): reflux-extracting Aspongopus with 50% ethanol for 3 times, each for 1.5 hr, filtering, and concentrating to obtain soft extract; and (3): decocting rhizoma Fagopyri Dibotryis, radix Platycodi, rhizoma Bletillae, and herba Pyrolae in water for 3 times, each for 1.5 hr, mixing the three extractive solutions, filtering, concentrating, and drying; and (4): adding diluent lactose or corn starch into the extract obtained in the above three steps, mixing, grading, drying, and making into granule.

Example 3: preparation of tablets

The formula of the compound wild buckwheat rhizome tablet comprises: 480g of wild buckwheat rhizome, 320g of pseudo-ginseng, 80g of sophora flavescens, 800g of balanophora tetraphylla, 400g of aspongopus, 320g of rhizoma bletillae and 320g of platycodon grandiflorum.

The compound wild buckwheat rhizome capsule is prepared according to the following steps: step (1): respectively extracting radix sophorae flavescentis and pseudo-ginseng with 70% ethanol under reflux for 2-3 times, wherein each time lasts for 1-2 hours, combining extracting solutions, filtering, concentrating and drying for later use; step (2): extracting Aspongopus with 70% ethanol under reflux for 2-3 times, each time for 1-2 hr, filtering, and concentrating to obtain soft extract; and (3): decocting wild buckwheat rhizome, platycodon root, bletilla striata and balanophora tetraphylla in water for 3 times, 1-2 hours each time, combining three extracting solutions, filtering, concentrating and drying for later use; and (4): adding lactose and corn starch into the extract, mixing, adding magnesium stearate as lubricant, mixing, grading, and tabletting.

Example 4: preparation of pill

The formula of the compound wild buckwheat rhizome pill comprises: 480g of wild buckwheat rhizome, 320g of pseudo-ginseng, 240g of sophora flavescens, 560g of balanophora tetraphylla, 400g of aspongopus, 320g of rhizoma bletillae and 320g of platycodon grandiflorum.

The compound wild buckwheat rhizome capsule is prepared according to the following steps: step (1): respectively extracting radix Sophorae Flavescentis and Notoginseng radix with 65% ethanol under reflux for 3 times, each time for 1-2 hr, mixing the three extractive solutions, filtering, concentrating, and drying; step (2): extracting Aspongopus with 65% ethanol under reflux for 3 times, each time for 1-2 hr, filtering, and concentrating to obtain soft extract; and (3): decocting wild buckwheat rhizome, platycodon grandiflorum, bletilla striata and balanophora tetraphylla in water for 2-3 times, 1-2 hours each time, combining extracting solutions, filtering, concentrating and drying for later use; and (4): mixing the above extracts, drying, making into powder, adding Mel, and making into pill according to conventional process.

Example 5: identification of major active ingredients of compositions

Taking compound rhizoma Fagopyri Dibotryis preparation such as capsule 3, removing capsule shell, grinding, adding chloroform 10ml and concentrated ammonia solution 0.1ml, ultrasonic treating for 15 minutes, filtering, concentrating the filtrate to about 1ml, using as test solution, taking oxymatrine reference substance, adding ethanol to make into solution containing 0.2mg per 1ml, using as reference solution, according to thin layer chromatography (Chinese pharmacopoeia) test, sucking above reference solution 5 μ l, and test solution 10 μ l, respectively dropping on the same silica gel G thin layer plate, spreading with chloroform-methanol-ammonia water (10:1:0.1) as developing agent, taking out, air drying, and spraying diluted bismuth potassium iodide test solution. Spots of the same color are displayed on the chromatogram of the test solution at positions corresponding to those on the chromatogram of the control solution. This shows that the compound wild buckwheat rhizome composition contains oxymatrine as the active component.

Collecting compound rhizoma Fagopyri Dibotryis preparation such as capsule 3, removing capsule shell, grinding, adding methanol 10ml, ultrasonic treating for 20 min, filtering, evaporating filtrate to dryness, adding water 30ml into residue, dissolving, shaking with water saturated n-butanol, extracting for 2 times (20ml, 15ml), mixing n-butanol solutions, adding ammonia solution saturated with n-butanol 20ml, shaking, standing for layering, collecting n-butanol solution, evaporating to dryness, adding methanol 1ml into residue to dissolve, collecting ginsenoside R as sample solution, and collecting ginsenoside R_g1And notoginsenoside R₁Adding methanol to obtain control solutions each containing 1mg per 1ml, and making into oral liquidIn the thin layer chromatography (Chinese pharmacopoeia), 1 μ l of the above control solution and 2 μ l of the test solution are precisely absorbed, respectively spotted on the same silica gel G thin layer plate, developed with chloroform-methanol-ammonia water (7:3:0.5) as developing agent, taken out, air dried, sprayed with 10% sulfuric acid ethanol solution, and dried at 105 ℃ until the spots are clear. Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution. Inspecting under an ultraviolet lamp (365nm) to show fluorescent spots of the same color. This shows that the compound wild buckwheat rhizome composition contains ginsenoside R as the active component_g1And notoginsenoside R₁。

The method for identifying the main active ingredients of the composition is the currently used quality control method for each dosage form prepared by the preparation method.

Example 6: clinical curative effect

Selection of clinical cases

1. The lung cancer treatment composition meets the lung cancer diagnosis standard and the traditional Chinese medicine syndrome diagnosis standard, and can be brought into cases when the operation treatment effect is not good and only the chemotherapy effect is not good without operation.

2. Squamous cell lung carcinoma, undifferentiated small cell lung carcinoma and adenocarcinoma of lung can be brought into the cases.

3. Stage II, III, and IV of lung cancer.

4. The total observation rate is 1000, the age is between 21 and 72 years, wherein 672 men, 328 women and 254 lung squamous cell carcinoma account for 25.4 percent; 456 cases of lung small cell undifferentiated carcinoma, accounting for 45.6%; 290 cases of lung adenocarcinoma account for 29.0%.

II, excluding the case standard:

1. non-primary lung cancer, lung cancer stop radiotherapy, chemotherapy and two months patient.

2. Patients with serious primary diseases such as cardiovascular diseases, cerebrovascular diseases, liver diseases, kidney diseases, hemopoietic systems and the like and psychonoses.

Thirdly, a test method:

1. a random grouping method is adopted.

2. 1000 cases were observed.

3. Administration: the capsule of the invention is 5 capsules each time, each capsule is filled with 0.4g (equivalent to 3.2g of decoction pieces), and the capsule is taken 3 times a day with warm boiled water. It should not be taken with Chuan Wu, Ku Wu and Fu Zi.

4. The course of treatment is as follows: 3 months is 1 course, 1 course is used, and other treatments related to the disease are not used in the clinical verification period.

Fourthly, the treatment effect judgment standard is as follows:

basically curing: the tumor body basically disappears, the clinical symptoms disappear, and the body weight recovers or increases.

The effect is shown: the tumor body is reduced by more than 50 percent, the clinical symptoms are obviously improved, the appetite is increased, and the physical strength is recovered and kept for more than 3 months.

The method has the following advantages: the tumor volume is reduced by more than 20 percent, the disease condition is stable, and the diffusion is not seen.

And (4) invalidation: the tumor size is unchanged or spread, and the clinical symptoms are not improved.

Fifthly, test results:

TABLE 1 therapeutic effect analysis table for lung cancer

Standard of therapeutic effect	Number of cases	Basic cure, example	Significant effects, examples	Effective example of	Invalid, example	Effective rate of%
							Disorders of lung cancer	1000	181	518	204	97	90.3

Clinical treatment results show that the compound wild buckwheat rhizome composition has the effects of clearing heat, reducing phlegm, promoting blood circulation and removing stasis. Can be used for treating chest pain, cough, asthma, hemoptysis, epistaxis, hoarseness, etc. due to pathogenic toxin invading lung and phlegm and blood stasis; treating lung cancer with the above symptoms. The total effective rate for treating lung cancer reaches more than 90.0 percent, and the medicine has obvious curative effect and is an ideal medicine for treating lung cancer.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The compound wild buckwheat rhizome composition comprises the following raw material medicines in parts by weight: 4-10 parts of wild buckwheat rhizome, 3-8 parts of pseudo-ginseng, 1-4 parts of radix sophorae flavescentis, 6-15 parts of Balanophora japonica, 4-9 parts of aspongopus, 3-8 parts of rhizoma bletillae and 3-8 parts of platycodon grandiflorum.

2. The compound wild buckwheat rhizome composition according to claim 1, wherein the composition comprises the following raw material medicines in parts by weight: 6-9 parts of wild buckwheat rhizome, 3-7 parts of pseudo-ginseng, 1-3 parts of radix sophorae flavescentis, 7-12 parts of Balanophora japonica, 4-8 parts of aspongopus, 3-7 parts of rhizoma bletillae and 3-7 parts of platycodon grandiflorum.

3. The compound wild buckwheat rhizome composition according to claim 1, wherein the composition comprises the following raw material medicines in parts by weight: 7 parts of wild buckwheat rhizome, 5 parts of pseudo-ginseng, 2 parts of radix sophorae flavescentis, 10 parts of balanophora tetraphylla, 6 parts of aspongopus, 5 parts of rhizoma bletillae and 5 parts of platycodon grandiflorum.

4. The compound fagopyrum cymosum composition according to claim 1, wherein the composition is prepared into capsules, granules, tablets, pills, oral liquid or decoction.

5. The compound fagopyrum cymosum composition according to claim 1, wherein the composition comprises a pharmaceutically acceptable carrier selected from one or more of fillers, binders, wetting agents, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants or flavoring agents which are commonly used in pharmacy.

6. A method for preparing the compound wild buckwheat rhizome composition according to any one of claims 1 to 3, comprising the following steps:

7. The method of claim 6, comprising the steps of:

8. The preparation method according to claim 6, wherein the dosage form is capsule, granule, tablet, pill or oral liquid.

9. Use of the compound fagopyrum cymosum composition according to any one of claims 1-5 in preparation of a medicament for treating lung cancer.