CN105521370A - Pharmaceutical preparation for treating colon cancer and application thereof - Google Patents

Pharmaceutical preparation for treating colon cancer and application thereof Download PDF

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CN105521370A
CN105521370A CN201610121218.1A CN201610121218A CN105521370A CN 105521370 A CN105521370 A CN 105521370A CN 201610121218 A CN201610121218 A CN 201610121218A CN 105521370 A CN105521370 A CN 105521370A
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parts
pharmaceutical
radix
semen
herba
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陈红
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陈红
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    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
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    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
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    • A61K36/67Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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    • A61K36/68Plantaginaceae (Plantain Family)
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Abstract

The invention relates to a pharmaceutical preparation for treating colon cancer and application thereof. The pharmaceutical preparation comprises forsythia suspensa, chingma abutilon seed, portulaca oleracea, citrus medica, lagotis, radix adenophorae, semen platycladi, lapis chloriti, eupatorium fortune, gleditsia sinensis lam, semen armeniacae amarum, angelica sinensis, piper longum, rhizoma sparganii, elecampane inula root, herba potentillae chinensis, eupatorium japonicum, Chinese yam, semen plantaginis, radix glycyrrhizae, blighted wheat and radix astragali. Since the Chinese medical herbs with different herbal properties are adopted and scientifically compatible, the pharmaceutical preparation has the functions of promoting qi circulation to relieve pain, invigorating spleen to promote digestion, lowering the adverse flow of qi to alleviate vomiting, dissolving lumps and resolving masses and the like to achieve satisfactory curative effect, accordingly the gastric function is further improved and physical fitness of patients is improved. Pharmacological experiments and clinic tests prove that the pharmaceutical preparation has good treatment effect and is safe, low in toxic and side effects, short in curing time and less prone to recurrence, and clinical treatment and social progress become possible.

Description

A kind of pharmaceutical preparation being used for the treatment of colon cancer and uses thereof
Technical field
The present invention relates to medicine being used for the treatment of cancer in digestive system and uses thereof, particularly a kind of pharmaceutical preparation and purposes being used for the treatment of colon cancer, belongs to field of medicaments.
Background technology
Along with the change of people's life and the cataclysm of environment, the continuous adjustment of diet structure, digestive system disease constantly rises, the continuous increase of various alimentary tract cancer, and colon cancer, as the representative of digestive disease system, has the annual trend increased.
Colon cancer is the common malignant tumor of digestive tract betiding colon site, is apt to occur in rectum and sigmoid colon intersection, the highest with 40 ~ 50 years old age group sickness rate, and the ratio of men and women is 2 ~ 3:1.Sickness rate accounts for the 3rd of gastroenteric tumor.Colon cancer is mainly adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma.General form is polypoid, ulcer type etc.Colon cancer can be gone in ring along intestinal wall and be developed, and indulges footpath spread up and down or infiltrate to intestinal wall deep layer along intestinal tube, except except lymphatic vessel, blood flow transfer and local Invasion, and also can to intraperitoneal plantation or along suture, cut sides diffusion transfer.Chronic colorectal cancer patients, polyp of colon patient, male overweight person etc. are Susceptible population.
Colorectal cancer patients Early manifestation is abdominal distention, dyspepsia, then occurs that bowl evacuation habit changes, stomachache just, occurs that mucus just or mucus purulence hemafecia after a while.Tumor is festered, lose blood, after toxin absorption, often occur anemia, low grade fever, weak, become thin, the poisoning symptom such as edema.As occurred abdominal distention, stomachache, constipation or just closing, health check-up is shown in that abdomen is grand, there is tenderness visible peristalsis visible intestinal peristalsis, local, and hear and high strong borborygmus, full property or completeness Lower intestinal obstruction may appear in prompting.If tumor body and nethike embrane, surrounding tissue infiltrate bond, form irregular enclosed mass, have certain mobility.The performance of the tumors such as the hepatic metastases signs such as jaundice, seroperitoneum, edema can appear in late period, cachexia, recessed enclosed mass before rectum, supraclavicular lymph nodes enlargement diffusion transfer at a distance.
The colon cancer cause of disease and pathogenesis it be unclear that, and the Therapeutic Method of colon cancer is performed the operation into main and auxiliary with the integration scenario of chemotherapy, immunization therapy, Chinese medicine and other Supporting Therapys, to improve Resection Rate, reduces relapse rate, improve survival rate.The principle of operative treatment is radical cure as far as possible, and protection pelvic visceral resection, keeping quality function, urinary function and bowel movement function, improve life quality.Generally speaking, right hemicolectomy is applicable to the cancerous protuberance in caecum, ascending colon and hepatic flexure of colon portion; Left hemicolectomy is applicable to descending colon, left flexure of colon portion cancerous protuberance; Resection of transverse colon is applicable to transverse colon cancerous protuberance; Sigmoid colon cancerous protuberance, except excision sigmoid colon, also should do descending colon excision or part rectum resection; With ileac operative Principle, patient's condition allows, and can make One-stage Resection.As patient's condition is poor, first can make colostomy, the second stage of radical operation of row after sb.'s illness took a favorable turn.Generally carry out operative treatment, the operative Principle of radical correction can not be made, extensively tumor-infiltrated, or with surrounding tissue, internal organs are fixing can not excise time, intestinal tube has blocked and maybe may block, and can do short circuit operation, also can make colostomy.If when distant organ transfer and local tumor still allow excision, available local Palliative surgery, the symptom such as to block, chronic blood loss, infection are poisoning to remove.
The method of current treatment colon cancer is mainly Main Means with operative treatment, but operative treatment wound face is comparatively large, tumor resection is not thorough, is easy to recurrence, and operative treatment takes the growth that normal intestinal flora upset further by a large amount of antibiotic, can form dependency to medicine.The method utilizing Chinese medicine preparation to treat pharyngitis also comes into one's own day by day, but effect is difficult to ensure.
Summary of the invention
For the defect of prior art, the present invention be directed to the present situation for the treatment of at present, a kind of pharmaceutical preparation being used for the treatment of colon cancer and uses thereof is provided, has no side effect, effective.
Specifically, concrete scheme of the present invention is achieved in that
First, inventor provides a kind of pharmaceutical preparation being used for the treatment of colon cancer according to drug matching experience, and the Chinese medicine ingredients contained in prescription is: Fructus Forsythiae, Semen Abutili, Herba portulacae, Fructus Citri, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.), Radix Adenophorae, Semen Platycladi, Lapis Chloriti, Herba Eupatorii, Chinese honey locust (fruit), Semen Armeniacae Amarum, Radix Angelicae Sinensis, Fructus Piperis Longi, Rhizoma Sparganii, Radix Inulae, Herba Potentillae Chinensis, Herba Lycopi, Rhizoma Dioscoreae, Semen Plantaginis, Radix Glycyrrhizae, Fructus Tritici Levis, the Radix Astragali.
Further, inventor provides a kind of pharmaceutical preparation being used for the treatment of colon cancer according to drug matching experience, each raw material dosage of prescription all has good curative effect in weight portion scope of the present invention, described formula and weight portion are: Fructus Forsythiae 15-25 part, Semen Abutili 10-18 part, Herba portulacae 10-30 part, Fructus Citri 2-11 part, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 3-12 part, Radix Adenophorae 5-10 part, Semen Platycladi 3-8 part, Lapis Chloriti 3-9 part, Herba Eupatorii 5-10 part, Chinese honey locust (fruit) 1-5 part, Semen Armeniacae Amarum 3-8 part, Radix Angelicae Sinensis 10-25 part, Fructus Piperis Longi 3-11 part, Rhizoma Sparganii 5-12 part, Radix Inulae 6-17 part, Herba Potentillae Chinensis 10-20 part, Herba Lycopi 4-8 part, Rhizoma Dioscoreae 10-30 part, Semen Plantaginis 5-11 part, Radix Glycyrrhizae 6-12 part, Fructus Tritici Levis 10-25 part, Radix Astragali 8-17 part.
Further, carry out preferably to the formula of above-mentioned weight portion, reach better technique effect, preferred formula is: Fructus Forsythiae 20 parts, Semen Abutili 14 parts, Herba portulacae 21 parts, Fructus Citri 7 parts, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 7 parts, Radix Adenophorae 3 parts, Semen Platycladi 6 parts, Lapis Chloriti 6 parts, Herba Eupatorii 7.5 parts, Chinese honey locust (fruit) 2.5 parts, Semen Armeniacae Amarum 4.5 parts, Radix Angelicae Sinensis 17.5 parts, Fructus Piperis Longi 7 parts, Rhizoma Sparganii 8.5 parts, Radix Inulae 12.5 parts, Herba Potentillae Chinensis 15 parts, Herba Lycopi 6 parts, Rhizoma Dioscoreae 20 parts, Semen Plantaginis 8 parts, 9 parts, Radix Glycyrrhizae, Fructus Tritici Levis 15 parts, the Radix Astragali 12.5 parts.Or: Fructus Forsythiae 22 parts, Semen Abutili 15 parts, Herba portulacae 21 parts, Fructus Citri 7 parts, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 9 parts, Radix Adenophorae 4 parts, Semen Platycladi 6.5 parts, Lapis Chloriti 7 parts, Herba Eupatorii 8.5 parts, Chinese honey locust (fruit) 3 parts, Semen Armeniacae Amarum 4.5 parts, Radix Angelicae Sinensis 17.5 parts, Fructus Piperis Longi 8 parts, Rhizoma Sparganii 8.5 parts, Radix Inulae 11.5 parts, Herba Potentillae Chinensis 16 parts, Herba Lycopi 7 parts, Rhizoma Dioscoreae 22 parts, Semen Plantaginis 8.5 parts, 9 parts, Radix Glycyrrhizae, Fructus Tritici Levis 15 parts, the Radix Astragali 12.5 parts.
In pharmaceutical preparation described above, the Chinese medicine used all uses its conventional medicinal part to be used as medicine, and the dosage of drug used is reasonable, after all medicines share, the cancer for the treatment of gi system is had to the effect for the treatment of preferably, especially colon cancer.
The function of each taste Chinese crude drug used in the pharmaceutical preparation for the treatment of colon cancer of the present invention is as follows:
Fructus Forsythiae: bitter in the mouth, is slightly cold.
Gui Jing: return lung, the heart, small intestine meridian.
Function cures mainly: heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.For carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease from the beginning of, warmly join the army, high hot excessive thirst, coma sends out speckle, pyretic stranguria urine retention.
Semen Abutili: bitter in the mouth, property is put down.
Gui Jing: return large intestine, small intestinal, urinary bladder channel.
Function cures mainly: clearing away heat-damp and promoting diuresis, removing toxic substances nebula removing.For dysentery, the puckery pain of gonorrhea.
Herba portulacae: sour in the mouth, cold in nature.
Function cures mainly: clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body.For bacillary dysentery, acute gastroenteritis, acute appendicitis, mastitis, bleeding hemorrhoids, leucorrhea; Furuncle swelling toxin is controlled in external, eczema, herpes zoster.
Fructus Citri: acrid in the mouth, warm in nature.
Gui Jing: return liver, spleen, lung meridian.
Function cures mainly: liver-smoothing, qi-regulating, and alleviating distention in middle-JIAO reduces phlegm.For stagnation of liver-QI and stomach-QI, distending pain in the chest and hypochondrium, gastral cavity abdomen feeling of fullness, vomiting eructation, abundant expectoration is coughed.
Lagotis clarkei Hook. F (Lagotis brevituba Maxim.): bitter in the mouth, cold in nature.
Function cures mainly: heat-clearing and toxic substances removing, blood pressure lowering, regulating menstruation.Main acute, chronic hepatitis; Nephritis; Lung abscess; Hypertension; The moon is often uncomfortable; Breast carcinoma.
Radix Adenophorae: be slightly cold, sweet in the mouth.
Gui Jing: lung, stomach warp.
Function cures mainly: nourishing YIN and clearing away lung-heat, reduces phlegm, QI invigorating.For: lung-heat type cough, deficiency of YIN chronic cough, dry cough expectorant sticks, deficiency of both vital energy and Yin, restlessness and fever with thirst.
Semen Platycladi: sweet in the mouth, property is put down.
Gui Jing: GUIXIN, kidney, large intestine channel.
Function cures mainly: tranquilizing by nourishing the heart, hidroschesis, intestine moistening.For fidgets due to deficiency insomnia, severe palpitation, night sweat due to yin deficiency, dryness of the intestine constipation.
Lapis Chloriti: sweet in the mouth, property is put down.
Gui Jing: return lung, the heart, Liver Channel.
Function cures mainly: effect pendant expectorant therapeutic method to keep the adverse QI flowing downwards, checking hyperfunction of the liver for relieving convulsion.
Herba Eupatorii: acrid in the mouth, property is put down.
Gui Jing: return spleen, stomach, lung meridian.
Function cures mainly: removing dampness by means of aromatics, and appetizing of being amusing, delivers expelling summer-heat.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass vomiting and nausea, sweet greasy in mouth, halitosis, sialism, heat-damp in summer table disease, feeling of fullness in the head is uncomfortable in chest.
Chinese honey locust (fruit): acrid in the mouth, temperature.Function cures mainly: have one's ideas straightened out, and eliminates the phlegm, relieving constipation.For soldier's so stupor, locked mouth is not opened, and in larynx, expectorant is stopped up, bronchial asthma, constipation, lymphoid tuberculosis.
Semen Armeniacae Amarum: bitter in the mouth, warm in nature.
Gui Jing: return lung, large intestine channel.
Function cures mainly: sending down the abnormal ascending QI relieving cough and asthma, loosening bowel to relieve constipation.For cough and asthma, fullness in the chest abundant expectoration, blood deficiency Tianjin is withered, dryness of the intestine constipation.
Radix Angelicae Sinensis: sweet in the mouth, warm in nature.
Gui Jing: return liver, the heart, spleen channel.
Function cures mainly: enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores.Radix Angelicae Sinensis (processed with wine) promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea, rheumatic arthralgia, injury from falling down.
Fructus Piperis Longi: function cures mainly cold air in the heart, often twinge, abdominal distention fullness caused by stagnant QI.
Rhizoma Sparganii: acrid in the mouth, property is put down.
Gui Jing: return liver, spleen channel.
Function cures mainly: removing blood stasis circulation of qi promoting, removing food stagnancy pain relieving.For lump in the abdomen mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain.
Radix Inulae: acrid in the mouth, warm in nature.
Gui Jing: return spleen, stomach, large intestine, three burnt, gallbladder meridians.
Function cures mainly: promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion.For breast gastral cavity distending pain, heavy after dysentery, food stagnation does not disappear, anorexia.The real intestinal antidiarrheal of Radix Aucklandiae (roasted).For stomachache of having loose bowels.
Herba Potentillae Chinensis: bitter in the mouth, is slightly cold.
Function cures mainly: heat-clearing and toxic substances removing, and dissipating blood stasis stops blooding.Control bone tuberculosis, stomatitis, scrofula, traumatic injury, traumatic hemorrhage.
Herba Lycopi: bitter in the mouth, warm in nature.
Gui Jing: return liver, spleen channel.
Function cures mainly: blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
Rhizoma Dioscoreae: sweet in the mouth, property is put down.
Gui Jing: return spleen, lung, kidney channel.
Function cures mainly: spleen reinforcing nourishing the stomach, and promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.For insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, and deficiency-heat is quenched one's thirst.Rhizoma Dioscoreae (parched with bran) spleen reinforcing stomach invigorating.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, leukorrhagia.
Semen Plantaginis: sweet in the mouth, cold in nature.
Gui Jing: return liver, kidney, lung, small intestine meridian.
Function cures mainly: clearing away heat and promoting diuresis, and eliminating dampness by diuresis is treating stranguria, and improving eyesight is eliminated the phlegm.For edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: GUIXIN, lung, spleen, stomach warp.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Fructus Tritici Levis: sweet in the mouth, cool in nature.
Function cures mainly: only sweating due to debility, tranquilizing by nourishing the heart.For the empty hyperhidrosis of body, hysteria.
The Radix Astragali: sweet in the mouth, warm in nature.
Gui Jing: return lung, spleen channel.
Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Pharmaceutical dosage form of the present invention is selected from the one in granule, capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill.More preferably capsule.
The present invention is to above prescription through conscientious research, and according to the reasonability of middle medical drugs, inventors herein propose concrete a kind of preparation method for the treatment of the pharmaceutical preparation of colon cancer, concrete steps are:
(1) take Semen Abutili, Herba portulacae, Herba Eupatorii, Herba Potentillae Chinensis, Herba Lycopi, Rhizoma Dioscoreae, Semen Plantaginis and Fructus Tritici Levis mixing, add 13 times of water soakings, then decoct 2 times, 2 hours first times, second time 1.5 hours, merges decoction liquor, filter, being evaporated to relative density is 1.10, for subsequent use;
(2) take Fructus Forsythiae, Semen Platycladi, Chinese honey locust (fruit), Semen Armeniacae Amarum, Radix Glycyrrhizae mixing, be ground into coarse powder, 8 times of volumetric concentrations are the alcoholic solution reflux, extract, 3 times of 75%, each 2 hours, merge ethanol extract, for subsequent use;
(3) Fructus Citri, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.), Radix Adenophorae, Lapis Chloriti, Radix Angelicae Sinensis, Fructus Piperis Longi, Rhizoma Sparganii, Radix Inulae and astragalus membranaceus powder are broken into fine powder, 13 times of volumetric concentrations are the alcoholic solution reflux, extract, 2 times of 70%, each 2 hours, merge ethanol extract, for subsequent use;
(4) ethanol extract of step (2) and (3) is mixed the concentrated solution adding step (1) more wherein, stir, hold over night, centrifugal, supernatant is condensed into extractum, lyophilization after reclaiming ethanol, pulverize, obtain clear paste powder;
(5) step (4) gained clear paste powder is mixed homogeneously with pharmaceutically acceptable adjuvant, then wet granulation, dry, incapsulate.
In above-mentioned preparation method, described pharmaceutically acceptable adjuvant and the weight part ratio of clear paste powder are 0.1-0.3:1.
In above-mentioned preparation method, described pharmaceutically acceptable adjuvant comprises filler, binding agent, described filler be sucrose, lactose, mannitol, dextrin one or both, be preferably sucrose, the one of the aqueous solution of 50% alcoholic solution of described binding agent to be agent be 3% hypromellose, the aqueous solution of 10% PVP K30,30% starch slurry and 10% carboxymethyl cellulose.Be preferably the aqueous solution of 10% PVP K30, the weight of described capsule is 200mg.
Compared with prior art, the granule that the present invention treats colon cancer has the following advantages:
The present invention adopts the Chinese crude drug of different properties, has carried out scientific compatibility, on the basis for the treatment of colon cancer, also take into account promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion, stopping nausea and vomiting by lowering the adverse flow of QI, the functions such as dissolving lump and resolving mass can reach desirable therapeutic effect, thus improve the body constitution improving stomach function raising patient further.Good therapeutic effect is all had through pharmacology test and clinical trial, and safety, toxic and side effects is little, and healing time is short, not easily recurs after healing, for the progress of clinical application and society provides probability.
Specific embodiment
To those skilled in the art, the details of the obvious embodiment of the present invention, and when not deviating from spirit of the present invention or basic feature, the present invention can be realized in other specific forms.All should regard embodiment as exemplary, and be nonrestrictive, all changes be therefore intended in the implication of the equivalency by dropping on claim and scope are included in the present invention.
Embodiment 1: a kind of capsule being used for the treatment of colon cancer, containing following weight portion Chinese crude drug:
Fructus Forsythiae 15 grams, Semen Abutili 10 grams, Herba portulacae 10 grams, Fructus Citri 2 grams, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 3 grams, Radix Adenophorae 5 grams, Semen Platycladi 3 grams, Lapis Chloriti 3 grams, Herba Eupatorii 5 grams, Chinese honey locust (fruit) 1 gram, Semen Armeniacae Amarum 3 grams, Radix Angelicae Sinensis 10 grams, Fructus Piperis Longi 3 grams, Rhizoma Sparganii 5 grams, Radix Inulae 6 grams, Herba Potentillae Chinensis 10 grams, Herba Lycopi 4 grams, Rhizoma Dioscoreae 10 grams, Semen Plantaginis 5 grams, 6 grams, Radix Glycyrrhizae, Fructus Tritici Levis 10 grams, the Radix Astragali 8 grams.
Concrete preparation method is:
(1) take Semen Abutili, Herba portulacae, Herba Eupatorii, Herba Potentillae Chinensis, Herba Lycopi, Rhizoma Dioscoreae, Semen Plantaginis and Fructus Tritici Levis mixing, add 13 times of water soakings, then decoct 2 times, 2 hours first times, second time 1.5 hours, merges decoction liquor, filter, being evaporated to relative density is 1.10, for subsequent use;
(2) take Fructus Forsythiae, Semen Platycladi, Chinese honey locust (fruit), Semen Armeniacae Amarum, Radix Glycyrrhizae mixing, be ground into coarse powder, 8 times of volumetric concentrations are the alcoholic solution reflux, extract, 3 times of 75%, each 2 hours, merge ethanol extract, for subsequent use;
(3) Fructus Citri, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.), Radix Adenophorae, Lapis Chloriti, Radix Angelicae Sinensis, Fructus Piperis Longi, Rhizoma Sparganii, Radix Inulae and astragalus membranaceus powder are broken into fine powder, 13 times of volumetric concentrations are the alcoholic solution reflux, extract, 2 times of 70%, each 2 hours, merge ethanol extract, for subsequent use;
(4) ethanol extract of step (2) and (3) is mixed the concentrated solution adding step (1) more wherein, stir, hold over night, centrifugal, supernatant is condensed into extractum, lyophilization after reclaiming ethanol, pulverize, obtain clear paste powder;
(5) mixed with appropriate sucrose by step (4) gained clear paste powder, 50% alcoholic solution adding 3% hypromellose is granulated, and crosses 16 mesh sieves, dry, incapsulates, the heavy 200mg of capsule.
Embodiment 1: a kind of capsule being used for the treatment of colon cancer, containing following weight portion Chinese crude drug:
Fructus Forsythiae 25 grams, Semen Abutili 18 grams, Herba portulacae 30 grams, Fructus Citri 11 grams, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 12 grams, Radix Adenophorae 10 grams, Semen Platycladi 8 grams, Lapis Chloriti 9 grams, Herba Eupatorii 10 grams, Chinese honey locust (fruit) 5 grams, Semen Armeniacae Amarum 8 grams, Radix Angelicae Sinensis 25 grams, Fructus Piperis Longi 11 grams, Rhizoma Sparganii 12 grams, Radix Inulae 17 grams, Herba Potentillae Chinensis 20 grams, Herba Lycopi 8 grams, Rhizoma Dioscoreae 30 grams, Semen Plantaginis 11 grams, 12 grams, Radix Glycyrrhizae, Fructus Tritici Levis 25 grams, the Radix Astragali 17 grams.
Preparation method is with embodiment 1.
Embodiment 4: a kind of capsule being used for the treatment of colon cancer, containing following weight portion Chinese crude drug:
Fructus Forsythiae 20 grams, Semen Abutili 14 grams, Herba portulacae 21 grams, Fructus Citri 7 grams, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 7 grams, Radix Adenophorae 3 grams, Semen Platycladi 6 grams, Lapis Chloriti 6 grams, Herba Eupatorii 7.5 grams, Chinese honey locust (fruit) 2.5 grams, Semen Armeniacae Amarum 4.5 grams, Radix Angelicae Sinensis 17.5 grams, Fructus Piperis Longi 7 grams, Rhizoma Sparganii 8.5 grams, Radix Inulae 12.5 grams, Herba Potentillae Chinensis 15 grams, Herba Lycopi 6 grams, Rhizoma Dioscoreae 20 grams, Semen Plantaginis 8 grams, 9 grams, Radix Glycyrrhizae, Fructus Tritici Levis 15 grams, the Radix Astragali 12.5 grams.
Preparation method is with embodiment 1.
Embodiment 4: a kind of capsule being used for the treatment of colon cancer, containing following weight portion Chinese crude drug:
Fructus Forsythiae 22 grams, Semen Abutili 15 grams, Herba portulacae 21 grams, Fructus Citri 7 grams, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 9 grams, Radix Adenophorae 4 grams, Semen Platycladi 6.5 grams, Lapis Chloriti 7 grams, Herba Eupatorii 8.5 grams, Chinese honey locust (fruit) 3 grams, Semen Armeniacae Amarum 4.5 grams, Radix Angelicae Sinensis 17.5 grams, Fructus Piperis Longi 8 grams, Rhizoma Sparganii 8.5 grams, Radix Inulae 11.5 grams, Herba Potentillae Chinensis 16 grams, Herba Lycopi 7 grams, Rhizoma Dioscoreae 22 grams, Semen Plantaginis 8.5 grams, 9 grams, Radix Glycyrrhizae, Fructus Tritici Levis 15 grams, the Radix Astragali 12.5 grams.
Preparation method is with embodiment 1.
Embodiment 5: pharmacodynamic experiment
Dextran sulfate sodium salt (DSS) is clinical conventional modeling reagent, is used for making colon cancer mouse model.The effective ingredient of Shenyi capsule is ginsenoside, clinically main initial stage or be difficult to colon cancer for the treatment of, have improve body's immunity, it can improve the deficiency of vital energy symptom of tumor patient, therefore in this experiment using ginsenoside as positive control medicine.This experiment adopts dextran sulfate sodium salt to copy the mouse model of colon cancer, studies capsule of the present invention to the impact for the treatment of of colon cancer function.
5.1, modeling and administration
Modeling: choose the ICR mice of weight range between 18 ~ 22g 60, mice is divided into 6 groups at random, A group matched group 10: give every day enough distilled water and mice special feed; B group 3%DSS7 days model group 50: modeling first day AOM gives mouse peritoneal by 10mg/kg and injects 1 time, gives the distilled water of 7 days, then gives 3%DSS7 days, then gives the distilled water of 14 days, circulate 3 times, period gives enough mice special feeds.
Administration: get above-mentioned B group modeling mouse model group, positive controls, the high, medium and low dosage group of capsule often organize 10, administering mode, kind and dose are as table 1, and successive administration 15 days, observes therapeutic outcome.
Table 1 respectively group mice administering mode, kind and dose is as follows
5.2, the body weight of mice, times of defecation, health number of torsions measure.
Weigh after 15 days, compared with Normal group, the change of body weight further illustrates the impact of disease on health status, and the clinical presentation of colon cancer is, the change of diarrhoea, lower abdomen pain and body weight, it is the result that intuitively can reflect colon cancer, times of defecation in test statistics of the present invention mice 24 hours, another sign of colon cancer is exactly pain, and inventor by observing mouse body number of torsions in 24h, mice is reversed half-turn or is greater than half-turn is once that detailed results is in table 2.
The result of the torsion of table 2 Mouse Weight, health and times of defecation
Note:
Compared with model group, #p < 0.05, ##p < 0.01;
Compared with positive controls, p < 0.05;
Show Mouse Weight, times of defecation and health number of torsions by table 2 result, model modeling success can be known by model group.And positive controls and each dosage group of capsule all clearly can play the effect for the treatment of, main manifestations is for significantly improving body weight, reducing times of defecation and pain number of times.Wherein in body weight, pain, high, the middle dosage group of capsule has significant difference compared with positive controls, and this shows that capsule therapeutic effect is better than positive controls.
5.2, each group mice tumour inhibiting rate and lotus tumor life span
Empty stomach 24h after last administration, de-neck puts to death mice, weighs, strips tumor block and weigh, and peel off tumor body, scales/electronic balance weighing, calculates the tumour inhibiting rate of each group:
The average tumor of tumour inhibiting rate (%)=(model group average tumor weight-experimental group average tumor weight)/model group heavy × 100%.
Total data SPSS22.0 statistical software processes, and compares and adopt χ between measurement data group 2inspection, tumour inhibiting rate and lotus tumor life span are specifically in table 2.
Table 3 tumour inhibiting rate and lotus tumor life span
Note:
Compared with model group, *p < 0.05; Compared with model group, *p < 0.01
Compared with positive controls I group, p < 0.05;
From the effect of table 3, the tumour inhibiting rate of model group, lotus tumor life span is compared with Normal group, there is the difference (p<0.01) of significance, modeling of the present invention success is described, each group of capsule, positive controls has significant difference compared with model group, all there is significant difference (p<0.01), wherein lotus tumor life span capsule high dose group is apparently higher than positive controls, there is significant difference, good therapeutic effect, wherein, the lotus tumor life span of capsule high dose is obviously longer than positive controls I group.
Embodiment 6: animal model test and experiment in vitro
The capsule of the embodiment 3 used in the capsule alternate embodiment 6 that embodiment 1,2,4 is prepared, repeat embodiment 5, found that capsule prepared by embodiment 1,2,4 is still equally authentic at the therapeutic effect of colon cancer, further demonstrate that the effect of weight portion Chinese crude drug of the present invention in treatment group colon cancer.
Embodiment 7: toxicity is verified
7.1, acute toxicity test
Tested Chinese medicine preparation: the capsule manufactured by embodiment of the present invention 1-4, adds purified water by 1:2, makes solution, for subsequent use.Experimental animal: regular grade kunming mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.
The solution of mouse stomach Chinese medicine capsules preparation of the present invention, when given low reaches 735.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
7.1.1, result of the test shows
The maximum dosage-feeding of the capsule manufactured by mouse stomach embodiment 1-4 is 735.5g crude drug/kg/d (LD50 > 735.5g crude drug/kg).Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum; By weighing machine, the dosis tolerata of mouse stomach capsule is 4903.3 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
7.2, long-term toxicity test for animals
Tested Chinese medicine preparation: embodiment of the present invention 2-4 gained Chinese medicine capsules, adds purified water by 1:2, make solution, for subsequent use.Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
7.2.2, method and result:
3 kinds of Chinese medicine capsules: be divided into high, medium and low three dosage groups, per weight dosage is respectively 180,60,20 times of patient's dose; Experimental mouse is divided into 10 groups at random, and wherein the capsule solution of 9 groups of difference gavages, 3 kinds of three dosage, remains 1 group of gavage normal saline (40 times of patient's dose); All 10 groups of all continuous gavages 180 days, observe animal general toxic reaction and the order of severity, check each position, and carry out hematology, the pathological examination of the main organs such as ALT, BUN and the heart, liver, spleen, lung, kidney, stomach after execution by rule of operation; Through long-term feeding, all there is not toxic reaction in 10 groups of rats.Physically well develop.Macroscopic appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group and change without pathologic.The all not significant changes such as the pathological replacement heart, liver, spleen, lung, kidney, stomach, therefore, think through proved by pathology, 3 kinds of Chinese medicine capsules show without chronic toxicity animal.
By above two toxicity tests, prove that the present invention is safe by the Chinese medicine capsules that embodiment 1-4 makes, have no side effect, can be taken by patient.
Embodiment 8: classical case
Case 1: black certain, man 52 years old, Ningbo of Zhejiang people, over 2013, my institute checks, patient sees local filling defect through x-ray, and form rule, smooth surface, clear-cut margin, enteric cavity is narrowless, and haustra of colon is complete.Through being colon cancer and with bloodstain when districts and cities' hospital diagnosis, pale tongue with thin fur is white, through being colon cancer when districts and cities' hospital diagnosis, takes the capsule of the embodiment of the present invention 3, treat 30 days, stomachache, diarrhoea obviously alleviate, and times of defecation reduces, continue to take 60 days, patient fully recovers, and follows up a case by regular visits to without recurrence after 1 year.
Case 2: permitted certain, man 52 years old, people from Weihai in Shandong province, over 2014, my institute checks, private prosecution long-term alcohol, stomachache, diarrhoea is had a surplus for 3 years, and through often feeling alleviation of pain after rushing down, times of defecation is indefinite, and poor quality, period is long-term alcohol always, rear aggravation alleviating alcohol addiction, body weight is become thin, through being colon cancer when districts and cities' hospital diagnosis and taking relevant Western medicine preparation, it is colon cancer that warp works as districts and cities' hospital diagnosis, take the capsule of the embodiment of the present invention 4, treat 30 days, stomachache, diarrhoea obviously alleviates, times of defecation reduces, body weight increases, continue to take 60 days, patient fully recovers, follow up a case by regular visits to without recurrence after 1 year, and low alcohol consumption.
Case 3: high certain, female 58 years old, people from Xuzhou, patient's private prosecution stomachache, diarrhoea are serious, You Yichen plays typical case the most, rarer, and with bloodstain, pale tongue with thin fur is white, and through being colon cancer when districts and cities' hospital diagnosis, patient carried out left hemicolon resection operation in 2013, within 2015, recur again, introduce my institute through friend and check, take the capsule of the embodiment of the present invention 2, treat 30 days, times of defecation reduces, and quality is higher, continue to take 60 days, patient fully recovers, and follows up a case by regular visits to without recurrence after 1 year.
Case 4: wish certain, man 42 years old, people from Changsha, in the health check-up that patient's private prosecution is held in locality, detect colon cancer, live in want, sometimes defecate more than 5 times on the one, weight in patients only 55 kilograms, height 178cm, shallow complexion, emaciated physique, fatigue and weakness, pale tongue with thin fur is white, the thick greasy micro-Huang of root.Take the capsule of the embodiment of the present invention 3, treat 30 days, stomachache, diarrhoea obviously alleviate, and defecate 1-2 time on the one, body weight adds 1 kilogram, and times of defecation reduces, and continues to take 60 days, and patient fully recovers, and weight in patients is 58.5 kilograms.Follow up a case by regular visits to after 1 year without recurrence, weight in patients is 63.8 kilograms.

Claims (10)

1. be used for the treatment of a pharmaceutical preparation for colon cancer, it is characterized in that: described pharmaceutical preparation comprises following Chinese crude drug: Fructus Forsythiae, Semen Abutili, Herba portulacae, Fructus Citri, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.), Radix Adenophorae, Semen Platycladi, Lapis Chloriti, Herba Eupatorii, Chinese honey locust (fruit), Semen Armeniacae Amarum, Radix Angelicae Sinensis, Fructus Piperis Longi, Rhizoma Sparganii, Radix Inulae, Herba Potentillae Chinensis, Herba Lycopi, Rhizoma Dioscoreae, Semen Plantaginis, Radix Glycyrrhizae, Fructus Tritici Levis, the Radix Astragali.
2. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese crude drug: Fructus Forsythiae 15-25 part, Semen Abutili 10-18 part, Herba portulacae 10-30 part, Fructus Citri 2-11 part, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 3-12 part, Radix Adenophorae 5-10 part, Semen Platycladi 3-8 part, Lapis Chloriti 3-9 part, Herba Eupatorii 5-10 part, Chinese honey locust (fruit) 1-5 part, Semen Armeniacae Amarum 3-8 part, Radix Angelicae Sinensis 10-25 part, Fructus Piperis Longi 3-11 part, Rhizoma Sparganii 5-12 part, Radix Inulae 6-17 part, Herba Potentillae Chinensis 10-20 part, Herba Lycopi 4-8 part, Rhizoma Dioscoreae 10-30 part, Semen Plantaginis 5-11 part, Radix Glycyrrhizae 6-12 part, Fructus Tritici Levis 10-25 part, Radix Astragali 8-17 part.
3. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese crude drug: Fructus Forsythiae 20 parts, Semen Abutili 14 parts, Herba portulacae 21 parts, Fructus Citri 7 parts, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 7 parts, Radix Adenophorae 3 parts, Semen Platycladi 6 parts, Lapis Chloriti 6 parts, Herba Eupatorii 7.5 parts, Chinese honey locust (fruit) 2.5 parts, Semen Armeniacae Amarum 4.5 parts, Radix Angelicae Sinensis 17.5 parts, Fructus Piperis Longi 7 parts, Rhizoma Sparganii 8.5 parts, Radix Inulae 12.5 parts, Herba Potentillae Chinensis 15 parts, Herba Lycopi 6 parts, Rhizoma Dioscoreae 20 parts, Semen Plantaginis 8 parts, 9 parts, Radix Glycyrrhizae, Fructus Tritici Levis 15 parts, the Radix Astragali 12.5 parts.
4. pharmaceutical preparation according to claim 1, it is characterized in that, described pharmaceutical preparation comprises following weight portion Chinese crude drug: Fructus Forsythiae 22 parts, Semen Abutili 15 parts, Herba portulacae 21 parts, Fructus Citri 7 parts, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.) 9 parts, Radix Adenophorae 4 parts, Semen Platycladi 6.5 parts, Lapis Chloriti 7 parts, Herba Eupatorii 8.5 parts, Chinese honey locust (fruit) 3 parts, Semen Armeniacae Amarum 4.5 parts, Radix Angelicae Sinensis 17.5 parts, Fructus Piperis Longi 8 parts, Rhizoma Sparganii 8.5 parts, Radix Inulae 11.5 parts, Herba Potentillae Chinensis 16 parts, Herba Lycopi 7 parts, Rhizoma Dioscoreae 22 parts, Semen Plantaginis 8.5 parts, 9 parts, Radix Glycyrrhizae, Fructus Tritici Levis 15 parts, the Radix Astragali 12.5 parts.
5. pharmaceutical preparation according to claim 1, is characterized in that: described pharmaceutical dosage form is selected from the one in granule, capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill.
6. pharmaceutical preparation according to claim 5, is characterized in that: described pharmaceutical dosage form is selected from capsule.
7. a preparation method for pharmaceutical preparation according to claim 1, is characterized in that, concrete step is:
(1) take Semen Abutili, Herba portulacae, Herba Eupatorii, Herba Potentillae Chinensis, Herba Lycopi, Rhizoma Dioscoreae, Semen Plantaginis and Fructus Tritici Levis mixing, add 13 times of water soakings, then decoct 2 times, 2 hours first times, second time 1.5 hours, merges decoction liquor, filter, being evaporated to relative density is 1.10, for subsequent use;
(2) take Fructus Forsythiae, Semen Platycladi, Chinese honey locust (fruit), Semen Armeniacae Amarum, Radix Glycyrrhizae mixing, be ground into coarse powder, 8 times of volumetric concentrations are the alcoholic solution reflux, extract, 3 times of 75%, each 2 hours, merge ethanol extract, for subsequent use;
(3) Fructus Citri, Lagotis clarkei Hook. F (Lagotis brevituba Maxim.), Radix Adenophorae, Lapis Chloriti, Radix Angelicae Sinensis, Fructus Piperis Longi, Rhizoma Sparganii, Radix Inulae and astragalus membranaceus powder are broken into fine powder, 13 times of volumetric concentrations are the alcoholic solution reflux, extract, 2 times of 70%, each 2 hours, merge ethanol extract, for subsequent use;
(4) ethanol extract of step (2) and (3) is mixed the concentrated solution adding step (1) more wherein, stir, hold over night, centrifugal, supernatant is condensed into extractum, lyophilization after reclaiming ethanol, pulverize, obtain clear paste powder;
(5) mixed homogeneously with pharmaceutically acceptable adjuvant by step (4) gained clear paste powder, then wet granulation, dry, incapsulate, the weight of capsule is 200mg.
8. the preparation method of pharmaceutical preparation according to claim 7, is characterized in that: the pharmaceutically acceptable adjuvant described in step (5) and the weight part ratio of clear paste powder are 0.1-0.3:1; Described pharmaceutically acceptable adjuvant comprises filler, binding agent.
9. the preparation method of pharmaceutical preparation according to claim 8, is characterized in that: the filler described in step (5) be sucrose, lactose, mannitol, dextrin one or both, be preferably sucrose; The one of the aqueous solution of 50% alcoholic solution of described binding agent to be agent be 3% hypromellose, the aqueous solution of 10% PVP K30,30% starch slurry and 10% carboxymethyl cellulose, is preferably the aqueous solution of 10% PVP K30.
10. pharmaceutical preparation according to claim 1, is characterized in that: the purposes of described pharmaceutical preparation in the medicine of preparation colon cancer.
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105749127A (en) * 2016-05-14 2016-07-13 李京烨 Pharmaceutic preparation for treating stomach cancer and application thereof

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* Cited by examiner, † Cited by third party
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Application publication date: 20160427