CN106109550A - Pharmaceutical composition for the treatment of colon cancer and preparation method thereof - Google Patents

Pharmaceutical composition for the treatment of colon cancer and preparation method thereof Download PDF

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CN106109550A
CN106109550A CN201610501373.6A CN201610501373A CN106109550A CN 106109550 A CN106109550 A CN 106109550A CN 201610501373 A CN201610501373 A CN 201610501373A CN 106109550 A CN106109550 A CN 106109550A
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ethanol
weight portion
pharmaceutical composition
colon cancer
herba lysimachiae
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不公告发明人
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Jinan Xingyi Medical Technology Co Ltd
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Jinan Xingyi Medical Technology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

Abstract

The invention discloses a kind of pharmaceutical composition treating colon cancer and preparation method thereof, pharmaceutical composition of the present invention be gallop along on horseback with black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis), ZANGJINJIER, uliginosin B, black bone, papiliochrome II is as crude drug, proportioning forms, can make various dosage form by preparation process routinely, treatment colon cancer is evident in efficacy.

Description

Pharmaceutical composition for the treatment of colon cancer and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition treating colon cancer and preparation side thereof Method.
Background technology
Colon cancer belong to Chinese medicine " gather ", " abdominal mass ", the category such as " anorectal carcinoma ", the modern medicine treatment master to colon cancer Operation to be had, radiotherapy, chemotherapy, biological immune etc..Chemicotherapy and antitumor drug kill cancerous cell and also suppress normal structure simultaneously Cell, and cause toxic and side effects.Along with living habit and the change of dietary structure of people, the sickness rate of colon cancer is passed year by year Increase.Most Chinese medicine scholars think, the etiology and pathogenesis of colon cancer mostly be pyretic toxicity pent up, raw in asthenia of both the spleen and kidney, insufficiency of vital energy and blood, phlegm-damp And qi depression to blood stasis etc., thus should be from sides such as corresponding heat-clearing and toxic substances removing, kidney and spleen invigorating, benefiting qi and nourishing blood, blood stasis-eliminating and stagnation-dissipating, promoting blood circulation to remove obstruction in the collateral Method is treated, and current research is achieved with certain progress.The western medical treatment means of colon cancer predominantly operation, radiotherapy and change Treat.Now there are some researches prove Chinese medicine compound or can directly suppress tumor cell, attenuation synergistic with chemotherapy combination, improving band tumor patient Life qualities etc. act on, one of its focus having had become as treatment of cancer.
Chinese medicine compound, Chinese medicine compound combined chemotherapy adjuvant drug treatment colon cancer in terms of all achieved with necessarily studying into Really.Research shows, compound of Chinese medicine colon cancer can effectively be bred and cancer cell metastasis by anticancer, and can reduce Tumor vascular generation, improves patient immune function, improves life in patients, has the effect of attenuation synergistic simultaneously.Chinese medicine Compound recipe is different from Western medicine, and it has the effect of suppression tumor of multi-level Mutiple Targets.Based on Chinese medical theory, use emerging Biotechnology launches genomics, proteomics and metabolism group research, illustrates the effect mechanism for the treatment of by Chinese herbs colon cancer. Believe along with the research of Chinese medicine antineoplastic deepens continuously, utilize Chinese medicine colon cancer will have broader prospect.But There is no effective medicine at present.
Black bone is galloped along on horseback: this product is that Icacinaceae must stamen fogfruit crin wood Gomphandra tetrandra(Wall.et Roxb.) Sleum ［ Lasian theratetrandra Wall.et Roxb.；Gomphandra hainanensis Merr. ］ Root.The whole year all can excavate, and cleans, and section is dried.[nature and flavor] are bitter；Flat.[function cures mainly] clearing away damp-heat；Relieving heat toxin.Main damp and hot Vomit and diarrhoea；Carbuncle sore tumefacting virus.[former phytomorph] crin wood shrub or dungarunga, high 2-10m.Bark Lycoperdon polymorphum Vitt, twig is green, then Raw branch, by pubescence, becomes without hair later.Leaf alternate, the long 0.5-1.5cm of petiole, just by pubescence；Leaf papery, narrow lanceolar, length Oval or oblong, long 6-15cm, wide 2-6cm, tip is tapering, base portion wedge shape, Quan Yuan, and two sides is without quilt below when hair or children Faint yellow pubescence, above dark green, below slightly weaker, the most significant protuberance of middle arteries and veins, lateral vein about 6-8 pair, net arteries and veins is inconspicuous.Male and female Different strain, cyme and leaf are to life, and axil is raw sometimes, long 2-4cm, close by yellow-white pubescence, have common peduncle, the long 0.2-of bennet 0.5cm；Male flower yellow-white or green in vain, 5 numbers, it is about 5mm, corolla 3-4mm bell, long, the nearly triangle of petal sliver, long about The 1/3 of corolla, inward curl, outside is without hair；Stamen 4-5, filigree is longer than corolla；Female flower yellow-white, is about 5mm, calyx micro-5 Split, long less than 5mm；Corolla is bell, is about 0.5mm, petal sliver Yangtze River Delta shape, tip inflection；Obsolete stamen in female flower Isometric with ovary, ovary is cylindric, without hair or sometimes by hair, stigma is little, 5 split the most downward in ovary.Drupe is oval, is about 1.2-2.5cm, footpath 0.5-1.2cm, white time ripe, berry shape, there is the most vertical rib after doing, fruit stem is slightly by pubescence.Flower, really phase Annual.Record in Chinese medicine voluminous dictionary.
Black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis): this product is Primulaceae Lysimachia plant black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) Lysimachia heterogenea Klatt. the herb of [L.paludicola Hemsl.].Summer, autumn gather, and dry.[nature and flavor] are bitter；Pungent；Property flat.[function master Control] invigorate blood circulation；Antidote against snake bite.Main amenorrhea；Venom.[former phytomorph] perennial herb.Stem is upright, high 40-80cm, Herb Without hair.Four prismatics, seamed edge has narrow wing and black gland point, the above multi-branched in middle part, and branch pole is carried out.Basal leaf sheet cochlear, long 1- 6cm, wide 0.6-3.8cm, tip circle is blunt, base portion downward one-tenth wing handle, and flower does not exists；Stem leaf is to life, stockless；Blade drapes over one's shoulders pin Shape or wire lanceolar, few long round shape lanceolar, long 4-13cm, wide 1-3cm, tip the sharpest point or blunt, base portion is blunt or ear Half armful of stem, two sides close raw black granular gland point.Raceme is born in stem end and branch end, long 8-13cm；Bract is lobate, lanceolar, Upwards gradual change is little, and be longer than or near etc. is longer than bennet；The long 3-5mm of bennet；The long 4-5mm of calyx, 5 divisions closely reach base portion, sliver wire Lanceolar, tip is tapering and crimps to back: corolla white, is about 7mm, and base portion symphysis part is about 2.5mm, 5 divisions, sliver Ovum shape Long Circle；Vertebra stamen 5, the most isometric with corolla, the middle part of filigree adhesion to corolla, separate section is about 3mm, flower pesticide gland shape, It is about 1.5mm, connective tip tool callus shape tip；Ovary is without hair, upper, Room 1, and style is about 6mm, and stigma expands.Capsule ball Shape, diameter about 3mm.The black purple of seed.The month at florescence 5-7, really the phase 8-10 month.Record in Chinese medicine voluminous dictionary.
ZANGJINJIER: this product is leguminous plant Cortes seu Caulis Caraganae jubatae Caragana jubata (pall.) Poir. and Chang Doujin The woody part heartwood of chicken Caragana changduensis fiauf.Cut and take maroon woody part, cut off, dry in the shade.[nature and flavor] puckery, Cold.[function with cure mainly] removing blood stasis, blood stasis dispelling, blood pressure lowering.For high mountain plethora, vascular hypertension and menoxenia.[character] this product is The heartwood of the many Ex-alls of appearance cork, in cylindrical or irregular block sheet, slightly curved song, long 20～40cm, diameter is up to 5cm.Table There is cutter axe mark in face, smooth, has thin vertical or reticular texture and the cicatrix of sprig, the aobvious yellow-white wood grain having of buckling.Stem branch The endothelium of yellow-white seen from residue and dark-brown phellem layer.Matter is hard and fine and close, and difficulty fractures.Annual ring seen from section.Odorless, Lightly seasoned micro-peppery.Record in health Tibetan medicine promulgated by the ministries or commissions of the Central Government standard (first), standard number: WS3-BC-0134-95.
Uliginosin B (Uliginosin B): CAS 19809-79-1, molecular formula C28H34O8, molecular weight 498.56.Fusing point 139.5-142.0 DEG C.[pharmacological action] is antibacterial, blood pressure lowering, antitumor.[ingredient origin] Hypericaceae plant Humidogene Radix Hyperici Monogyni (Herba Hyperici Monogyni).
Papiliochrome II(Papiliochrome II): CAS 68335-21-7, molecular formula C21H26N4O6, molecular weight 430.46。
The structure of 2 crude drug:
Papiliochrome II(Papiliochrome II) uliginosin B (Uliginosin B).
Summary of the invention
It is an object of the invention to overcome the deficiency of background technology, it is provided that the pharmaceutical composition of a kind of effective treatment colon cancer and Its preparation method.
The present invention adopts the following technical scheme that realization:
Composition and the weight portion of making the crude drug of the pharmaceutical composition of this treatment colon cancer be:
Black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 465-469 weight portion ZANGJINJIER 320-330 weight portion uliginosin B 24-28 weight portion is black Bone is galloped along on horseback 254-258 weight portion papiliochrome II 2-4 weight portion.
It is preferably used in the pharmaceutical composition for the treatment of colon cancer, is made up of the crude drug of following weight portion:
The black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 467 weight portion ZANGJINJIER 325 weight portion uliginosin B 26 black bone of weight portion is galloped along on horseback 256 weights Amount part papiliochrome II3 weight portion.
A kind of pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition can use the routine side of galenic pharmacy Method prepares piece agent or capsule or drop pill.
A kind of pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition and controlling that chemical drugs or Chinese medicine form Treat colon cancer drug.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 465-469 weight portion ZANGJINJIER 320-330 weight portion humidogene The black bone of hypericin B24-28 weight portion is galloped along on horseback 254-258 weight portion papiliochrome II 2-4 weight portion；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 467 weight portion ZANGJINJIER 325 weight portion uliginosin The black bone of B26 weight portion is galloped along on horseback 256 weight portion papiliochrome II3 weight portions；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition can use preparation The conventional method learned is prepared as tablet or capsule or drop pill.
A kind of preparation method of the pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition and chemical drugs or in Medicine composition treatment colon cancer drug.
Medicine composite for curing colon cancer is evident in efficacy.
Detailed description of the invention
Embodiment 1: pharmaceutical composition for the treatment of colon cancer and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of colon cancer be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 467g ZANGJINJIER The black bone of 325g uliginosin B 26g is galloped along on horseback 256g papiliochrome II 3g；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 2: pharmaceutical composition for the treatment of colon cancer and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of colon cancer be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 465g ZANGJINJIER The black bone of 330g uliginosin B 24g is galloped along on horseback 258g papiliochrome II 2g；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 3: pharmaceutical composition for the treatment of colon cancer and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of colon cancer be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 469g ZANGJINJIER The black bone of 320g uliginosin B 28g is galloped along on horseback 254g papiliochrome II 4g；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 4: the preparation of tablet
Example 1 pharmaceutical composition 144g, adds starch 266g, mixing, pelletizes, be dried, add microcrystalline Cellulose 183g, stearic Acid magnesium 10g, mixing, it is pressed into 2300, obtains medicinal composition tablets.
Embodiment 5: the preparation of capsule
Example 2 pharmaceutical composition 220g, adds starch 420g, mixing, pelletizes, be dried, granulate, add appropriate stearic acid Magnesium, mixing, encapsulated 2000, obtain medicament composition capsule.
Embodiment 6: the preparation of drop pill
Weigh polyethylene glycol 6000 248g water-bath (80 DEG C) heating and boil molten, add embodiment 3 pharmaceutical composition 10g, fully stir Mixing uniformly, with liquid paraffin as coolant, put in glass tubing (4*80cm), chilling temperature is 4 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.3cm away from liquid level, drips fast with 54 every point as optimum condition, blots the cold of drop pill surface with cotton Solidifying agent, obtains medicament composition dropping pills.
Experimental example 1: the experimental study for the treatment of colon cancer
1 clinical data
1.1 physical data
Make a definite diagnosis colorectal cancer patients and all come this city hospital outpatient and inpatient, wherein treatment group 16 example, male 10 examples, female 6 example, the age Maximum 73 years old, minimum 28 years old, the mean age (38.5 ± 14.5) year；Matched group 16 example, male 10 examples, female 6 example, the oldest 73 Year, minimum 29 years old, the mean age (39.2 ± 13.8) year.Two groups of patients are equal in aspect differences such as sex, age, the course of disease, the state of an illness Without significance (P > 0.05).
1.2 diagnostic criteria
With reference to " China's common cancer diagnosis and treatment specification " and american cancer research community " AJCC Cancer Staging Handbook " the 6th Version.
1.3 inclusive criteria
All patients enteral mirror pathological examination and postoperative pathological are diagnosed as colorectal cancer person.Age is in 18-75 year；Performance status Scoring (Karnofsky scoring) >=60 points, it is contemplated that life cycle was more than 6 months；Informed choice, compliance is good.
1.4 exclusion standard
It is associated with the severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic；Leukocyte exists 4.0×109/ below L or platelet are 1.0 × 109/ below L；Gestation or women breast-feeding their children, allergic constitution patient；Compliance is poor Person.
2 Therapeutic Method
2.1 matched group
Simple employing XELOX scheme (oxaliplatin 130mg/m2Dl+ capecitabine 850 mg/m2, every day 2 times, continue 14 d) Chemotherapy.Every patient at least completes 2 cycle XELOX chemotherapy regimens.During every 21d is 1 chemotherapy cycles, chemotherapy and the intermission is every Week looks into blood gas analysis.At leukocyte count less than 2.0 × 109During/L, support to control with granulocyte colony-stimulating factor (rhG-CSF) Treat.
2.2 treatment groups
On the basis of matched group, combination of oral medication (embodiment 1 pharmaceutical composition lot number 20100908) simultaneously, every time 1g, every day 2 times, point morning and evening is oral.
Two groups was all 1 course for the treatment of with 21 d.Carry out two groups after two courses for the treatment of to compare, observe patients symptomatic, routine blood test, blood Platelet changes, and carries out electrocardiogram, hepatic and renal function, quality of life assessment.Detection T cell subgroup and Function of lymphocyte transform Deng.
3 observation of curative effect
3.1 criterion of therapeutical effect
Evaluation quality of life is as the criterion with Ka Shi scoring (KPS), scores respectively before and after treatment.After treatment, scoring growth is divided into more than 10 Improving, reduce and be divided into reduction more than 10, change person in 10 points is stable.Clinical symptom disappearance or be clearly better as effective, disease Shape transfers to well effectively, and symptom is without improving or deteriorating as invalid.Observe digestive tract reaction and hemogram index simultaneously.
3.2 therapeutic outcome
3.2.1 total effects analysis:
It is shown in Table 1.Two groups of comparing differences have significance, treatment group curative effect to be better than matched group.
1 liang of table group comparitive study example (%), n=16
Group Effective Effectively Invalid Total effective rate (%)
Treatment group 8 7 1 93.75*
Matched group 4 6 6 62.50
Note: compare with matched group, * P < 0.05
3.2.2 quality of life compares:
It is shown in Table 2.Two groups of comparing differences have significance, treatment group quality of life to be better than matched group.
The comparison of table 2 quality of life assessment
Group n Improve Stable Reduce
Treatment group 16 9 6 1
Matched group 16 2 8 6
Note: two groups are compared, P < 0.05.
3.2.3 hemogram Indexes Comparison:
It is shown in Table 3.Two groups of blood change no significant differences, the bone marrow depression for the treatment of group is little compared with matched group.
Table 3 treatment group compares (n=16) with matched group blood change
Two groups are compared without significant difference.
3.2.4 digestive tract reaction compares:
It is shown in Table 4.Two groups of digestive tract reaction comparing differences have significance, and treatment group significant reaction is less than matched group.
Table 4 treatment group compares (example, n=16) with matched group digestive tract reaction
Note: in digestive tract reaction, two groups are compared, P < 0.05.

Claims (8)

1. the pharmaceutical composition treating colon cancer, it is characterised in that make composition and the weight of the crude drug of this pharmaceutical composition Amount part is:
Black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 465-469 weight portion ZANGJINJIER 320-330 weight portion uliginosin B 24-28 weight portion is black Bone is galloped along on horseback 254-258 weight portion papiliochrome II 2-4 weight portion.
A kind of pharmaceutical composition treating colon cancer, it is characterised in that make this pharmaceutical composition The composition of crude drug and weight portion be:
The black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 467 weight portion ZANGJINJIER 325 weight portion uliginosin B 26 black bone of weight portion is galloped along on horseback 256 weights Amount part papiliochrome II3 weight portion.
A kind of pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition can be adopted It is prepared as tablet or capsule or drop pill by the conventional method of galenic pharmacy.
A kind of pharmaceutical composition treating colon cancer, it is characterised in that pharmaceutical composition and chemistry Medicine or the treatment colon cancer drug of Chinese medicine composition.
5. the preparation method of the pharmaceutical composition treating colon cancer, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 465-469 weight portion ZANGJINJIER 320-330 weight portion humidogene The black bone of hypericin B24-28 weight portion is galloped along on horseback 254-258 weight portion papiliochrome II 2-4 weight portion；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that by as follows Prepared by step:
The composition of crude drug and weight portion be: black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) 467 weight portion ZANGJINJIER 325 weight portion uliginosin The black bone of B26 weight portion is galloped along on horseback 256 weight portion papiliochrome II3 weight portions；
Preparation method:
(1) take black gland Herba Lysimachiae Clethroids (Radix Seu Herba Lysimachiae Clethroidis) by crude drug proportioning, ZANGJINJIER, uliginosin B, black bone are galloped along on horseback, papiliochrome II, mixed Even, with weight percent concentration 19.5% ethanol as solvent, extract at 27.5 DEG C of warm macerating, extraction time is 16 times, extracts every time 17 hours time, each solvent load is 35 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A and reclaims Ethanol, is concentrated into relative density 1.08, filters, and medicinal liquid passes through LKS04 macroporous adsorptive resins, first washes with water, then uses weight Percent concentration 36% ethanol solution eluting LKS04 macroporous adsorptive resins, collects weight percent concentration 36% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract A；
(2) take step (1) medicinal residues A, with weight percent concentration 76% ethanol as solvent, heating and refluxing extraction 12 times, carry every time The time of taking is 0.55 hour, and each solvent load is 24 times of medicinal residues A weight, filters, obtains medicinal residues B and extracting solution B, extracting solution B Reclaiming ethanol, be concentrated into relative density 1.06, filter, medicinal liquid passes through DM2 macroporous adsorptive resins, first washes with water, then with heavy Amount percent concentration 69% ethanol solution eluting DM2 macroporous adsorptive resins, collects weight percent concentration 69% ethanol elution, Reclaim ethanol, concentrate drying, obtain extract B；
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that medicine group Compound can use the conventional method of galenic pharmacy to be prepared as tablet or capsule or drop pill.
The preparation method of a kind of pharmaceutical composition treating colon cancer, it is characterised in that medicine group Compound and chemical drugs or Chinese medicine composition treatment colon cancer drug.
CN201610501373.6A 2016-06-30 2016-06-30 Pharmaceutical composition for the treatment of colon cancer and preparation method thereof Withdrawn CN106109550A (en)

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Application publication date: 20161116