CN105596994A - Medicine for treating lung cancer cell proliferation - Google Patents

Medicine for treating lung cancer cell proliferation Download PDF

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Publication number
CN105596994A
CN105596994A CN201610009895.4A CN201610009895A CN105596994A CN 105596994 A CN105596994 A CN 105596994A CN 201610009895 A CN201610009895 A CN 201610009895A CN 105596994 A CN105596994 A CN 105596994A
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medicine
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李颖
阿艳妮
郑旭
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Qingdao Municipal Hospital
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Qingdao Municipal Hospital
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/34—Campanulaceae (Bellflower family)
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Abstract

The invention provides a medicine for treating lung cancer cell proliferation. The medicine is prepared from roots of pilose asiabell, Pseudostellaria heterophylla, raw bighead atractylodes rhizome, radix astragali, poria cocos, fried coix seeds, Agrimonia pilosa Ldb., heartleaf houttuynia herb, Catclaw Buttercup, Fritillaria thunbergii Miq., Lance Asiabell roots, Indian Iphigenia bulbs, Hedyotis diffusa, Herba Solani Nigri , Wall lizards, panax notoginseng, herba Rabdosiae, Akebia stems, roots and leaves of Rubus alceaefolius Poir., rhizoma curcumae, tangerine peel, Cortex Magnoliae Officinalis, rhizomaalismatis and prepared liquorice roots. The medicine has a good effect on treating lung cancer cell proliferation, the relapse rate is effectively decreased, and the medicine has a gefitinib synergism or sensitivity effect on non-small cell lung cancer.

Description

Be used for the treatment of the medicine of proliferation of lung cancer cells
Technical field
The present invention relates to medical technical field, relate in particular to a kind of medicine that is used for the treatment of proliferation of lung cancer cells.
Background technology
Lung cancer is the one of the main reasons of the current mankind because of cancer mortality, and wherein non-small cell lung cancer (NSCLC) accounts for 85%-90%, most of middle and advanced stage that belongs in the time of clinical definite. Platinum class is the basic combined chemotherapy standard care scheme as advanced Non-small cell lung, and median survival time is many between 6.9-11.3 month, and toxicity is large. For the PS low patient that marks, or the old patient that can not tolerate chemotherapy, cannot use conventional chemotherapy standard scheme, have to give low dosage list medicine chemotherapy, or traditional Chinese medicine is as maintaining treatment, often unsatisfactory curative effect.
In recent years the application study of molecular targeted agents, has obtained great development. In the research of non-small cell lung cancer, the inhibitor of EGFR and signal path thereof is of greatest concern. EGFR family member plays an important role in the evolution of lung cancer, and its overexpression in the non-small cell lung cancer of 40%-80% is closely related with the growth of tumour, propagation, motion, suddenly attached, invasion and attack, apoptosis and transfer etc. EGFR is-individual transmembrane protein that the downstream signal path of can pass through after being combined with extracellular factor-series, as RaS/Raf/MAPK, PI in HER/ErbB family3K/Akt、Jak/STAT3Deng, affect downstream albumen c-Fos, c-Jun, Bad, Caspase9, FOXO etc., thereby reach the effect that promotes cell division, increases cell proliferation, conversion, transfer. EGF tyrosinase inhibitor (EGFR-TKI) can divide
For single target spot or many target spots. Wherein at present clinical practice the most widely, the most representative medicine Gefitinib that is single target spot. Its main mechanism is to compete the binding site on EGFR with ATP, thereby reaches the effect that suppresses EGFR phosphorylation, disabling signal path.
At present existing clinical common recognition recommendation Gefitinib in EGFR gene mutation patient-line treatment, its curative effect is not only better than standard chemotherapy regimen, and toxic and side effect is lighter. So can consider for it the poor patient of old age or PS scoring. But for there not being EGFR gene mutation, or the not clear patient of gene appearance, cannot not benefit temporarily. And, along with research deeply and long-term observation, expert finds that many patients occur acquired resistance taking after Gefitinib, therefore although patient's the Progression free survival phase after targeted therapy medicine of taking extends to some extent, approach with chemotherapy overall life cycle. The therapeutic strategy of resistance at present, be mainly 1, adopt irreversible EGFR inhibitor (as BIBW2992, EKB-569), 2, use in conjunction or alone many target drugs, block many signal paths (as vandetanib, BMS--690514) simultaneously, or 3, adopt second-line chemotherapy. Although above-mentioned some drugs has entered the clinical development stage, its curative effect still remains to be confirmed.
Traditional Chinese medicine uses the history that has several thousand in China. At present traditional Chinese medicine is widely used in the control of each section disease, and normal and western modern medicine is used in conjunction with. In the treatment of non-small cell lung cancer, traditional Chinese medicine can strengthen immunity after surgery, promotes rehabilitation; In the effect that can play synergy attenuation in the time that chemicotherapy is combined; Patient's muscle power state difference, cannot tolerate treatment time, can be used as maintaining treatment, and improves integrality late. At present with the coordinating of EGF tyrosinase inhibitor aspect, traditional Chinese medicine Main Function is for alleviating its toxic and side effect, to guarantee that patient is to the compliance for the treatment of. Gefitinib common adverse effect is the sore sample fash of fullying recover from an illness, and this performance is relevant to curative effect, and fash is more serious, and prediction curative effect is better. Traditional Chinese medicine has good effect to alleviating fash, but does not affect the treatment simultaneously. Also there is a small amount of bibliographical information traditional Chinese medicine EGFR-TK work to be had to the effect of synergy for non-small cell lung cancer, but increase body at Chinese medicine, the sensitiveness of the targeted drugs such as Gefitinib is had no to report.
Preparation of the present invention is clinical proved recipe for the treatment of for many years non-small cell lung cancer. Much research shows that Patients with Non-small-cell Lung belongs to simulataneous insufficiency and excessive more, asthenia in origin and asthenia in superficiality. Clinical card type thinks that the deficiency of vital energy, the deficiency of Yin are main, doublely sees phlegm, wet, the stagnation of the circulation of vital energy. The patient of clinical also common insufficiency of the spleen intermingled phlegm and blood stasis type. By long-term observation and practice, clinical observation in early stage points out this side may have Gefitinib synergy or sensitization to non-small cell lung cancer.
Strengthening vital QI to eliminate pathogenic factors of the present invention, benefiting qi and raising yang, invigorating the spleen victory is wet, eliminates the phlegm by the stasis of blood. By clinical observation, confirm that it is in the good effect that has aspect treatment proliferation of lung cancer cells, effectively reduce recurrence rate, make progress in conjunction with modern study, pass through animal experiment study, further inquire into the related mechanism of Treatment of Lung Cancer with Chinese Medicine cell proliferation, thus the advantage of performance Chinese medicine, finally for the clinical treatment of proliferation of lung cancer cells provides strong Data support.
Summary of the invention
The invention provides a kind of medicine that is used for the treatment of proliferation of lung cancer cells, it,, in the good effect that has aspect treatment proliferation of lung cancer cells, effectively reduces recurrence rate, and non-small cell lung cancer is had to Gefitinib synergy or sensitization.
The invention provides a kind of medicine that is used for the treatment of proliferation of lung cancer cells, its bulk drug comprises Radix Codonopsis, radix pseudostellariae, the bighead atractylodes rhizome, the Radix Astragali, Poria cocos, stir-fry coix seed, hairyvein agrimony, cordate houttuynia, radix ranunculi ternati, fritillaria thunbergii, lance asiabell root, edible tulip, oldenlandia diffusa, black nightshade, house lizard, pseudo-ginseng, salvia chinensis, akebiae, She Pao le, curcuma zedoary, dried orange peel, the bark of official magnolia, rhizoma alismatis and honey-fried licorice root.
In described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 35 weight portion～50 weight portions, radix pseudostellariae 30 weight portion～40 weight portions, the bighead atractylodes rhizome 25 weight portion～40 weight portions, the Radix Astragali 35 weight portion～55 weight portions, Poria cocos 20 weight portion～30 weight portions, fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15 weight portions, cordate houttuynia 20 weight portion～35 weight portions, radix ranunculi ternati 10 weight portion～20 weight portions, fritillaria thunbergii 15 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portion～30 weight portions, oldenlandia diffusa 10 weight portion～20 weight portions, black nightshade 15 weight portion～25 weight portions, house lizard 10 weight portion～15 weight portions, pseudo-ginseng 20 weight portion～30 weight portions, salvia chinensis 5 weight portion～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, curcuma zedoary 10 weight portion～25 weight portions, dried orange peel 10 weight portion～20 weight portions, the bark of official magnolia 10 weight portion～20 weight portions, rhizoma alismatis 15 weight portion～25 weight portions and honey-fried licorice root 10 weight portion～20 weight portions.
Further preferably, in described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 40 weight portion～45 weight portions, radix pseudostellariae 35 weight portion～40 weight portions, the bighead atractylodes rhizome 30 weight portion～35 weight portions, the Radix Astragali 45 weight portion～50 weight portions, Poria cocos 25 weight portion～30 weight portions, fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15 weight portions, cordate houttuynia 20 weight portion～25 weight portions, radix ranunculi ternati 15 weight portion～20 weight portions, fritillaria thunbergii 20 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portion～25 weight portions, oldenlandia diffusa 10 weight portion～15 weight portions, black nightshade 15 weight portion～20 weight portions, house lizard 10 weight portion～15 weight portions, pseudo-ginseng 25 weight portion～30 weight portions, salvia chinensis 5 weight portion～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, curcuma zedoary 15 weight portion～20 weight portions, dried orange peel 15 weight portion～20 weight portions, the bark of official magnolia 15 weight portion～20 weight portions, rhizoma alismatis 15 weight portion～20 weight portions and honey-fried licorice root 15 weight portion～20 weight portions.
Most preferably, in described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 40 weight portions, radix pseudostellariae 35 weight portions, the bighead atractylodes rhizome 30 weight portions, the Radix Astragali 50 weight portions, Poria cocos 30 weight portions, fry coix seed 20 weight portions, hairyvein agrimony 10 weight portions, cordate houttuynia 20 weight portions, radix ranunculi ternati 20 weight portions, fritillaria thunbergii 20 weight portions, lance asiabell root 10 weight portions, edible tulip 20 weight portions, oldenlandia diffusa 10 weight portions, black nightshade 20 weight portions, house lizard 15 weight portions, pseudo-ginseng 25 weight portions, salvia chinensis 5 weight portions, akebiae 10 weight portions, She Pao le 10 weight portions, curcuma zedoary 20 weight portions, dried orange peel 20 weight portions, the bark of official magnolia 20 weight portions, rhizoma alismatis 20 weight portions and honey-fried licorice root 20 weight portions.
The formulation of described preparation is preferably tablet, capsule, granule, pill, oral liquid, preferred oral liquid.
The present invention also provides the preparation method of said medicine, is specially:
The first step, the diacolation of each bulk drug component;
Second step, the purification of percolate, dry, pulverize powdered, and micronizer is pulverized, and crosses 300 mesh sieves;
The 3rd step, the powder obtaining at second step adds auxiliary material and carrier, prepares corresponding formulation.
The described first step is further specially above-mentioned each bulk drug is taken according to above-mentioned weight portion, be placed on respectively in micronizer and pulverize 20 minutes～40 minutes, each powder after pulverizing is mixed, in the ethanol that to add with respect to the determining alcohol of the quality such as mixture quality be 85%～95%, flood 12 hours～18 hours, then the ethanol that is 80%～90% with the determining alcohol of 15～20 times of mixture weight adopts the slowly diacolation of speed of percolation with 1～2ml per minute, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtain supernatant.
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of supernatant volumes that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of supernatant volume that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of supernatant volume that obtain with respect to the first step, merge gradient ethanol eluate, decompression recycling ethanol is to most, freeze drying, and 300 object powder are pulverized and be screened into micronizer subsequently.
Described pharmaceutically acceptable carrier or auxiliary material are selected from one or more in filler, disintegrant, adhesive, lubricant, flavouring, osmotic pressure regulator or surfactant.
The 3rd step, in the time being prepared into oral liquid, gets the powder that 300g second step obtains, and adds water appropriate, be heated to 30 DEG C, be stirred to powder and dissolve completely, regulate pH value to 7.0 with 40% sodium hydroxide solution, stir evenly, 4～8 DEG C refrigerate 72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stir evenly, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
Useful technique effect
The medicine that is used for the treatment of proliferation of lung cancer cells provided by the invention, it,, in the good effect that has aspect treatment proliferation of lung cancer cells, effectively reduces recurrence rate, and non-small cell lung cancer is had to Gefitinib synergy or sensitization.
Detailed description of the invention
The invention provides a kind of medicine that is used for the treatment of proliferation of lung cancer cells, it is characterized in that bulk drug comprises Radix Codonopsis, radix pseudostellariae, the bighead atractylodes rhizome, the Radix Astragali, Poria cocos, stir-fry coix seed, hairyvein agrimony, cordate houttuynia, radix ranunculi ternati, fritillaria thunbergii, lance asiabell root, edible tulip, oldenlandia diffusa, black nightshade, house lizard, pseudo-ginseng, salvia chinensis, akebiae, She Pao le, curcuma zedoary, dried orange peel, the bark of official magnolia, rhizoma alismatis and honey-fried licorice root.
Modern Chinese medicine research shows that Patients with Non-small-cell Lung belongs to simulataneous insufficiency and excessive more, asthenia in origin and asthenia in superficiality. Clinical card type thinks that the deficiency of vital energy, the deficiency of Yin are main, doublely sees phlegm, wet, the stagnation of the circulation of vital energy. The patient of clinical also common insufficiency of the spleen intermingled phlegm and blood stasis type. In long-term observation and practice, through medicine is carried out to prescription screening, attenuation synergistic, formulate Chinese medicine preparation of the present invention, the Chinese medicine preparation differentiation of disease of the present invention and dialectical combination, the rules for the treatment of of employing righting benefit gas, slit phlegm stagnation resolvation, detoxicating and resolving a mass, replenishing the vital essence and removing heat, are now analyzed as follows with regard to prescription thinking:
1) this disease is asthenia in origin and asthenia in superficiality, taking help lung spleen as main, in side taking Radix Codonopsis, radix pseudostellariae, the bighead atractylodes rhizome, the Radix Astragali, stir-fry coix seed, honey-fried licorice root as monarch drug in a prescription group, wherein Radix Codonopsis is invigorated the spleen and benefited qi, and radix pseudostellariae boosting qi and nourishing yin promotes the production of body fluid, and Radix Astragali tonifying Qi and lifting yang, benefit are defended solid table, bighead atractylodes rhizome invigorating the spleen to dry reduces phlegm, fry coix seed invigorating the spleen excreting dampness, the bowl spares of honey-fried licorice root benefit gas, coordinating the drug actions of a prescription, six medicines are same by the effect that has strengthening the spleen and replenishing qi tonifying lung to reduce phlegm.
2) generation of lung cancer, relevant with the phlegm stagnation of blood stasis and heat of body, according to the stage of morbidity, show as pathogen being excessive but vital QI weak, good and evil two decline, no matter what stage, the existence of perverse trend, all the time be to affect advancing of disease, therefore side in add clearing heat and detoxicating, softening and resolving hard mass medicine, hairyvein agrimony, cordate houttuynia, radix ranunculi ternati, fritillaria thunbergii, lance asiabell root, edible tulip, oldenlandia diffusa, black nightshade, house lizard, pseudo-ginseng, salvia chinensis, akebiae, She Pao le, curcuma zedoary, wherein fritillaria thunbergii clearing heat and eliminating phlegm, open strongly fragrant dissipating bind; Radix ranunculi ternati mass dissipating and swelling eliminating; The pain relieving of pseudo-ginseng blood stasis-eliminating and stagnation-dissipating, edible tulip is clearing heat and detoxicating, the carbuncle that disappears dissipating bind, and oldenlandia diffusa, black nightshade are clearing heat and detoxicating, salvia chinensis is promoting blood circulation and removing blood stasis, heat-clearing dissipating bind, akebiae blood circulation promoting regulates qi, the She Pao le heat-clearing stasis of blood of faling apart, the broken blood gas of curcuma zedoary disappears long-pending, hairyvein agrimony astringing to arrest bleeding, detoxicating and fighting cancer, cordate houttuynia is clearing heat and detoxicating, the carbuncle that disappears apocenosis, and asparagus fern nourishiing yin to clear away the lung-heat is promoted the production of body fluid, and lance asiabell root removing toxicity for detumescence, apocenosis are eliminated the phlegm, house lizard eliminating stagnation to stop pain, all medicines are with merit clearing heat and detoxicating with having, eliminating stasis and resolving masses tumor suppression.
3) the generation development speed of this disease is very fast, just sharply disorderly in the operation short time of energy and blood of human body body fluid, therefore preparation of the present invention adds dried orange peel, bark of official magnolia conditioning three warmers mechanism of qi, add Poria cocos, rhizoma alismatis regulating fluid apssage, coordinate the through sick position of the monarch and his subjects' medicine, promoting body perverse trend to take, give heresy with outlet, is adjutant.
4) traditional Chinese medical science is thought and is combatted poison with poison, treatment this sick in, except associating Western medicine chemotherapeutic, itself there are some toxic medicament, therefore add heavy dose of honey-fried licorice root, except cooperation monarch drug in a prescription is strengthened the body resistance to consolidate the constitution, the more important thing is attenuation synergistic, make to cure the disease and just do not hinder, heresy is not stayed in righting, therefore for making medicine.
Combine by the differentiation of disease is dialectical, reach eliminating evil and just do not hinder, righting and do not hold back evil effect. So-called phlegm coming from spleen, lung is the device of storage Yu, effectively transporting of insufficiency of the spleen essence of water and grain, water drink is stagnated into phlegm, is above stored in lung. Blood stagnancy due to deficiency of QI, is the stasis of blood for a long time, then becomes the card of phlegm and blood stasis. We give birth to gold by ridgings such as radix pseudostellariae, the bighead atractylodes rhizome, the Radix Astragali, Radix Glycyrrhizaes, the source of blocking phlegm and retained fluid generation on the one hand, can train assisting vehicle body healthy tendency on the other hand, therefore in the time being combined with its western medicine therapy (as operation, chemotherapy), can synergy, again can attenuation. Clinical observation prompting in early stage right supporting anticancer side is to Gefitinib as second line treatment, and successful is better than second-line chemotherapy. Therefore consider that this side may have Gefitinib synergy or sensitization to non-small cell lung cancer.
Further preferably, described medicine is only prepared from by above-mentioned raw materials medicine.
Each bulk drug pharmacology is as follows:
Radix Codonopsis: latin name CodonopsisRadix, taste is sweet, and property is flat, enter lung, the spleen channel, have tonifying Qi benefit spleen, effect of nourishing blood to promote the production of body fluid, cures mainly spleen-lung Qi deficiency or qi-blood deficiency lassitude hypodynamia, breathes hard, the cards such as cough spontaneous perspiration, Radix Codonopsis is longer than tonifying spleen nourishing the stomach, adjusts regulating the function of middle-JIAO, has the effect of nourishing blood concurrently, its property is flat, invigorating the spleen fortune and not dry; Flavour is cloudy and not wet, can improve the immune state of body, improves resistance against diseases, promotes to digest and assimilate, and improves metabolism, promotes the absorption of enteron aisle to nutriment.
Radix pseudostellariae: sweet, the micro-hardship of taste, property is flat, returns spleen, lung channel, has effect that air making-up and spleen enlivening, moistening lung promote the production of body fluid, and cures mainly the poor appetite due to deficiency-weakness of spleen-QI, lassitude hypodynamia, deficiency syndrome of the lung cough caused by dryness, syndrome characterized by dyspnea is breathed hard, the convalescent stage of febrile disease, hinder in gas Tianjin two, the thirsty card that waits of interior heat.
The bighead atractylodes rhizome: latin name atractylodismacrocephalaerhizoma, taste is sweet, bitter, warm in nature, enters spleen, stomach warp, there is tonifying spleen profit gas, eliminating dampness Li Shui, strengthening exterior and reducing sweat, the effect of moisturizing of fortune spleen, is mainly used in ruffian due to the dysfunction of the spleen in transport, QI failing to transform into body fluid and has one's mind filled with and rush down, phlegm and retained fluid oedema; The vexed lazy speech of the deficiency of qi in middle-jiao, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, abnormal sweating spontaneous perspiration.
The Radix Astragali: latin name astragaliradix, taste is sweet, warm in nature, enters spleen, lung channel, there is help spleen soil, elevate a turnable ladder yang-energy, strengthening exterior and reducing sweat, the effects such as holder sore myogenic, are mainly used in the weak anorexia and loose stool due to spleen-lung Qi deficiency, palpitation, the visceral organ ptosis of the sinking of qi of middle-jiao, Qi dysfunction in blood control uterine bleeding is had blood in stool, and rushes down for a long time prolapse of the anus; The spontaneous sweating of exterior deficiency, the cards such as insufficiency of vital energy and blood.
Poria cocos: taste is sweet, light, property is flat, enters spleen, lung, bladder, the heart channel of Hang-Shaoyin, has the effect of eliminating dampness and diuresis, the peaceful heart of invigorating the spleen, is mainly used in the oedema of retention of water-damp, difficult urination; The heat of damp-heat accumulation is drenched, the cards such as the anorexia and loose stool of water retention due to hypofunction of the spleen, phlegm and retained fluid stagnation, epilepsy.
Fry coix seed: cool in nature, taste is sweet, light, returns spleen, stomach, lung channel. There is invigorating the spleen excreting dampness, clearing away heat and eliminating pus, function except numbness, Li Shui, for weakness of the spleen and the stomach, loose stool diarrhoea, or vaginal discharge diseases of women, insufficiency of the spleen with overabundance of dampness oedema, difficult urination, or beriberi swells and ache; Damp-heat arthralgia pain, brothers' contraction, miserable pain; Lung carbuncle is coughed saliva phlegm, or enterodynia is arrested colic.
Hairyvein agrimony: latin name AgrimoniaeHerba, bitter, puckery, property is flat, the thoughts of returning home, Liver Channel, have astringing to arrest bleeding, only effect of dysentery desinsection, cures mainly various hemorrhage cards, for example: haematemesis, hematuria, have blood in stool, uterine bleeding, spitting of blood, bleeding from five sense organs or subcutaneous tissue, dysentery, internal lesion caused by overexertion takes off power, and carbuncle is swollen, fall and beat, the cards such as traumatic bleeding.
Cordate houttuynia: latin name houttuyniaeherba, taste is pungent, cold nature enters lung, urinary bladder channel, have clearing heat and detoxicating, removing pus and relieving carbuncle, effect of inducing diuresis for treating strangurtia, for lung carbuncle pyemesis, phlegm heat is coughed and is breathed heavily, toxic-heat and blood stasis, damp-heat gonorrhoea, hot carbuncle carbuncle, snakeworm want first-class card.
Radix ranunculi ternati: taste is sweet, pungent, slightly warm in nature, returns liver, lung channel, has reducing phlegm and resolving masses, and effect of removing toxicity for detumescence cures mainly scrofula subcutaneous nodule, furunculosis, worm snake bite, antimigraine, malaria, toothache. Pulmonary tuberculosis, scrofula, lymphnoditis, the cards such as sphagitis.
Fritillaria thunbergii: bitter, cold in nature, enter lung, the heart channel of Hang-Shaoyin, there is clearing heat and eliminating phlegm, effect of powder detoxifcation, cures mainly cough due to wind-heat evil, lung carbuncle larynx numbness, scrofula, the cards such as sore swollen toxin.
Lance asiabell root: taste is sweet, pungent, property is flat, has supplementing qi and nourishing yin, detoxify and drain pus, logical newborn effect, cures mainly dizziness headache, lung carbuncle, acute mastitis, postpartum, breast was few, leukorrhea, the cards such as venomous snake bite.
Edible tulip: taste is sweet, micro-pungent, cool in nature, returns liver, the spleen channel, has clearing heat and detoxicatingly, and effect of reducing phlegm and resolving masses, for the swollen serious case of furuncle of carbuncle, scrofula subcutaneous nodule, scrofula, the cards such as snake bite and insect sting.
Oldenlandia diffusa: bitter, sweet, cold in nature, enter the heart, liver, spleen, large intestine channel, has clearing heat and detoxicating, the effect of clearing damp and promoting diuresis, for dyspnea and cough due to lung-heat, abscess of throat, acute appendicitis, furuncle sore, venomous snake bite, heat is drenched puckery pain, oedema, dysentery, enteritis, jaundice with damp-heat pathogen, the cards such as cancerous swelling.
Black nightshade: latin name SolanumnigrumL, bitter, cold in nature, have clearing heat and detoxicating, effect of activating blood circulation and reducing swelling. For furunculosis, carbuncle is swollen, erysipelas, osteopatia sprain, chronic cough asthma due to excessive phlegm, oedema, cancerous swelling. Root: bitter, micro-sweet, cold. For dysentery, stranguria with turbid discharge, vaginal discharge diseases, the cards such as traumatic injury.
House lizard: salty, cold, slightly poisonous, enter kidney, liver two warps. Cure mainly infantile convulsion, epilepsy, lockjaw, arthralgia due to wind-dampness, the illnesss such as scrofula tuberculosis and cancerous swelling.
Pseudo-ginseng: latin name notoginsengradixetrhizoma is the dry root of panax araliaceae plant and rhizome: warm in nature, sweet, the micro-hardship of taste, returns liver, stomach warp, there is hemostasis, the loose stasis of blood, detumescence, the effect of pain relieving, cure mainly: control haematemesis, hemoptysis, bleeding from five sense organs or subcutaneous tissue, have blood in stool, bloody flux, uterine bleeding, abdominal mass, postpartum anemic fainting, lochia not under, fall and flutter hemostasis, traumatism and bleeding, the cards such as the swollen pain of carbuncle.
Salvia chinensis: the herb of Labiatae clary Salvia chinensis, Latin literary fame Salvia, taste is pungent, bitter, and cold nature has promoting blood circulation and removing blood stasis, clearing heat and promoting diuresis, effect of mass dissipating and swelling eliminating, cures mainly dysmenorrhoea, under humid tropics, cirrhosis, liver cancer, has blood in stool, jaundice with damp-heat pathogen, and treating rheumatic ostealgia, falls the swollen card that waits of injuring.
Akebiae: be the woody stems rattan of plants of Lardizabalaceae threeleaf akebia, bitter, cold in nature, return liver, the spleen channel, there is liver-smoothing, qi-regulating, promoting blood circulation and stopping pain, effect of relieving restlessness diuresis, cures mainly the digestive system tumor such as liver cancer, cancer of the stomach, and lung cancer, breast cancer etc. Cancer pain and stomachache due to emotional depression and the hyperactive liver-qi attacking the stomach. The cards such as dysentery.
She Pao le: bitter, puckery, cold nature, has heat clearing and blood cooling, blood stasis removing analgesic, effect of inducing diuresis to reduce edema, cures mainly cold anemopyretic, abscess of throat, spitting of blood, spits blood, dysentery, enteritis, hepatitis, hepatosplenomegaly, treating swelling and pain by traumatic injury, arthralgia due to wind-dampness, the cards such as difficult urination.
Curcuma zedoary: taste is pungent, bitter, warm in nature, enters liver, the spleen channel, has broken blood gas, effect of the long-pending pain relieving that disappears, and for the abdominal mass lump in the abdomen of caused by energy stagnation and blood stasis, chest abdomen stasis of blood pain, amenorrhoea, dysmenorrhoea, abdominal distention, traumatic injury, the blood stasis card such as swell and ache.
Dried orange peel: warm in nature, taste is pungent, bitter; Return spleen, lung channel, for diseases such as fullness and oppression of chest and abdomen. The pungent loose logical temperature of orange peel, fragrant odour, is longer than and regulates the flow of vital energy, can enter spleen lung, thus can go loose sluggishness of lung-QI, again can promoting the circulation of qi wide in, gather around the diseases such as the full and taste stagnation of the circulation of vital energy of stagnant, chest diaphragm ruffian, abdominal fullness and distention for lung qi, for damp retention in middle-jiao, gastral cavity abdomen ruffian is swollen, have loose bowels in loose stool, and the phlegm card such as cough more.
The bark of official magnolia: bitter, pungent, warm in nature, return the spleen channel; Stomach warp; Large intestine channel, has promoting the circulation of qi and disappears long-pending; Eliminating dampness is except full; Effect of relieving asthma, cures mainly stagnation of QI due to dyspepsia; Abdominal distention constipation; Damp retention in middle-jiao, gastral cavity ruffian is vomited and diarrhoea; Phlegm is stopped up the circulation of vital energy in the wrong direction; The fullness sensation in chest card such as breath with cough.
Rhizoma alismatis: taste is sweet, light, cold in nature, enters kidney, urinary bladder channel, has clearing damp and promoting diuresis, purging heat and treating stranguria, the lung that clears away heart-fire, rushes down the effect of kidney fire, is mainly used in insufficiency of the spleen retention of water-damp, the wet anasarca of spreading unchecked of water; The tired resistance of heresy that water drink phlegm is wet, causes dizzy that lucid yang failing to raise voiced sound does not fall; The difficult urination of damp invasion of lower energizer, red short puckery pain, and the card such as jaundice with damp-heat pathogen.
Honey-fried licorice root: taste is sweet, property is flat, enters 12 warps, is in harmonious proportion the property of medicine, the effect of expelling phlegm and arresting coughing, and can invigorating the spleen and in, relieving spasm to stop pain, is mainly used in invigorating the spleen and benefiting qi, clearing heat and detoxicating, expelling phlegm and arresting coughing, relieving spasm to stop pain, coordinating the drug actions of a prescription.
In described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 35 weight portion～50 weight portions, radix pseudostellariae 30 weight portion～40 weight portions, the bighead atractylodes rhizome 25 weight portion～40 weight portions, the Radix Astragali 35 weight portion～55 weight portions, Poria cocos 20 weight portion～30 weight portions, fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15 weight portions, cordate houttuynia 20 weight portion～35 weight portions, radix ranunculi ternati 10 weight portion～20 weight portions, fritillaria thunbergii 15 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portion～30 weight portions, oldenlandia diffusa 10 weight portion～20 weight portions, black nightshade 15 weight portion～25 weight portions, house lizard 10 weight portion～15 weight portions, pseudo-ginseng 20 weight portion～30 weight portions, salvia chinensis 5 weight portion～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, curcuma zedoary 10 weight portion～25 weight portions, dried orange peel 10 weight portion～20 weight portions, the bark of official magnolia 10 weight portion～20 weight portions, rhizoma alismatis 15 weight portion～25 weight portions and honey-fried licorice root 10 weight portion～20 weight portions.
Further preferably, in described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 40 weight portion～45 weight portions, radix pseudostellariae 35 weight portion～40 weight portions, the bighead atractylodes rhizome 30 weight portion～35 weight portions, the Radix Astragali 45 weight portion～50 weight portions, Poria cocos 25 weight portion～30 weight portions, fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15 weight portions, cordate houttuynia 20 weight portion～25 weight portions, radix ranunculi ternati 15 weight portion～20 weight portions, fritillaria thunbergii 20 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portion～25 weight portions, oldenlandia diffusa 10 weight portion～15 weight portions, black nightshade 15 weight portion～20 weight portions, house lizard 10 weight portion～15 weight portions, pseudo-ginseng 25 weight portion～30 weight portions, salvia chinensis 5 weight portion～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, curcuma zedoary 15 weight portion～20 weight portions, dried orange peel 15 weight portion～20 weight portions, the bark of official magnolia 15 weight portion～20 weight portions, rhizoma alismatis 15 weight portion～20 weight portions and honey-fried licorice root 15 weight portion～20 weight portions.
Most preferably, in described medicine, the weight portion of each bulk drug is respectively Radix Codonopsis 40 weight portions, radix pseudostellariae 35 weight portions, the bighead atractylodes rhizome 30 weight portions, the Radix Astragali 50 weight portions, Poria cocos 30 weight portions, fry coix seed 20 weight portions, hairyvein agrimony 10 weight portions, cordate houttuynia 20 weight portions, radix ranunculi ternati 20 weight portions, fritillaria thunbergii 20 weight portions, lance asiabell root 10 weight portions, edible tulip 20 weight portions, oldenlandia diffusa 10 weight portions, black nightshade 20 weight portions, house lizard 15 weight portions, pseudo-ginseng 25 weight portions, salvia chinensis 5 weight portions, akebiae 10 weight portions, She Pao le 10 weight portions, curcuma zedoary 20 weight portions, dried orange peel 20 weight portions, the bark of official magnolia 20 weight portions, rhizoma alismatis 20 weight portions and honey-fried licorice root 20 weight portions.
The present invention also provides the preparation method of said medicine, is specially:
The first step, the diacolation of each bulk drug component;
Second step, the purification of percolate, dry, pulverize powdered, and micronizer is pulverized, and crosses 300 mesh sieves;
The 3rd step, the powder obtaining at second step adds auxiliary material and carrier, prepares corresponding formulation.
The described first step is further specially above-mentioned each bulk drug is taken according to above-mentioned weight portion, be placed on respectively in micronizer and pulverize 20 minutes～40 minutes, each powder after pulverizing is mixed, in the ethanol that to add with respect to the determining alcohol of the quality such as mixture quality be 85%～95%, flood 12 hours～18 hours, then the ethanol that is 80%～90% with the determining alcohol of 15～20 times of mixture weight adopts the slowly diacolation of speed of percolation with 1～2ml per minute, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtain supernatant.
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of supernatant volumes that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of supernatant volume that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of supernatant volume that obtain with respect to the first step, merge gradient ethanol eluate, decompression recycling ethanol is to most, freeze drying, and 300 object powder are pulverized and be screened into micronizer subsequently.
The bulk drug of described Chinese medicine preparation obtains after medicinal extract through extracting, and medicinal extract is mixed with pharmaceutically acceptable carrier or auxiliary material, is prepared into preparation, and the formulation of described preparation is preferably tablet, capsule, granule, pill, oral liquid, preferred oral liquid.
Described pharmaceutically acceptable carrier or auxiliary material are selected from one or more in filler, disintegrant, adhesive, lubricant, flavouring, osmotic pressure regulator or surfactant.
The 3rd step, in the time being prepared into oral liquid, gets the powder that 300g second step obtains, and adds water appropriate, be heated to 30 DEG C, be stirred to powder and dissolve completely, regulate pH value to 7.0 with 40% sodium hydroxide solution, stir evenly, 4～8 DEG C refrigerate 72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stir evenly, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Embodiment 1 oral liquid 1
Take Radix Codonopsis 40g, radix pseudostellariae 35g, bighead atractylodes rhizome 30g, Radix Astragali 50g, Poria cocos 30g, fry coix seed 20g, hairyvein agrimony 10g, cordate houttuynia 20g, radix ranunculi ternati 20g, fritillaria thunbergii 20g, lance asiabell root 10g, edible tulip 20g, oldenlandia diffusa 10g, black nightshade 20g, house lizard 15g, pseudo-ginseng 25g, salvia chinensis 5g, akebiae 10g, She Pao le 10g, curcuma zedoary 20g, dried orange peel 20g, bark of official magnolia 20g, rhizoma alismatis 20g and honey-fried licorice root 20g, be placed on respectively in micronizer and pulverize 30 minutes, each powder after pulverizing is mixed, in the ethanol that the determining alcohol that adds 500g is 95%, flood 18 hours, then the ethanol that is 90% with the determining alcohol of 8kg adopts the slowly diacolation of speed of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant, and the supernatant of acquisition is crossed to macroporous resin column absorption, first use with respect to the water elution of 3 times of the supernatant volumes obtaining and discard, then gradient ethanol elution, uses for the first time with respect to 4 times of determining alcohol 80% ethanol elutions of supernatant volume that obtain, then uses with respect to 5 times of determining alcohol 95% ethanol elutions of supernatant volume that obtain, merge gradient ethanol eluate, decompression recycling ethanol is to most, freeze drying, 300 object powder are pulverized and be screened into micronizer subsequently, gets the powder that 300g obtains, and adds water appropriate, be heated to 30 DEG C, be stirred to powder and dissolve completely, regulate pH value to 7.0 with 40% sodium hydroxide solution, stir evenly, 4 DEG C refrigerate 72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stir evenly, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
Embodiment 2 oral liquids 2
Take Radix Codonopsis 40g, radix pseudostellariae 35g, bighead atractylodes rhizome 30g, Radix Astragali 45g, Poria cocos 25g, fry coix seed 15g, hairyvein agrimony 10g, cordate houttuynia 20g, radix ranunculi ternati 15g, fritillaria thunbergii 20g, lance asiabell root 10g, edible tulip 20g, oldenlandia diffusa 10g, black nightshade 15g, house lizard 10g, pseudo-ginseng 25g, salvia chinensis 5g, akebiae 10g, She Pao le 5g, curcuma zedoary 15g, dried orange peel 15g, bark of official magnolia 15g, rhizoma alismatis 15g and honey-fried licorice root 15g, be placed on respectively in micronizer and pulverize 30 minutes, each powder after pulverizing is mixed, in the ethanol that the determining alcohol that adds 450g is 95%, flood 18 hours, then the ethanol that is 90% with the determining alcohol of 8kg adopts the slowly diacolation of speed of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant, and the supernatant of acquisition is crossed to macroporous resin column absorption, first use with respect to the water elution of 3 times of the supernatant volumes obtaining and discard, then gradient ethanol elution, uses for the first time with respect to 4 times of determining alcohol 80% ethanol elutions of supernatant volume that obtain, then uses with respect to 5 times of determining alcohol 95% ethanol elutions of supernatant volume that obtain, merge gradient ethanol eluate, decompression recycling ethanol is to most, freeze drying, 300 object powder are pulverized and be screened into micronizer subsequently, gets the powder that 300g obtains, and adds water appropriate, be heated to 30 DEG C, be stirred to powder and dissolve completely, regulate pH value to 7.0 with 40% sodium hydroxide solution, stir evenly, 4 DEG C refrigerate 72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stir evenly, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
Embodiment 3 oral liquids 3
Take Radix Codonopsis 45g, radix pseudostellariae 40g, bighead atractylodes rhizome 35g, Radix Astragali 50g, Poria cocos 30g, fry coix seed 20g, hairyvein agrimony 15g, cordate houttuynia 25g, radix ranunculi ternati 20g, fritillaria thunbergii 25g, lance asiabell root 15g, edible tulip 25g, oldenlandia diffusa 15g, black nightshade 20g, house lizard 15g, pseudo-ginseng 30g, salvia chinensis 10g, akebiae 15g, She Pao le 10g, curcuma zedoary 20g, dried orange peel 20g, bark of official magnolia 20g, rhizoma alismatis 20g and honey-fried licorice root 20g, be placed on respectively in micronizer and pulverize 30 minutes, each powder after pulverizing is mixed, in the ethanol that the determining alcohol that adds 550g is 95%, flood 18 hours, then the ethanol that is 90% with the determining alcohol of 8kg adopts the slowly diacolation of speed of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant, and the supernatant of acquisition is crossed to macroporous resin column absorption, first use with respect to the water elution of 3 times of the supernatant volumes obtaining and discard, then gradient ethanol elution, uses for the first time with respect to 4 times of determining alcohol 80% ethanol elutions of supernatant volume that obtain, then uses with respect to 5 times of determining alcohol 95% ethanol elutions of supernatant volume that obtain, merge gradient ethanol eluate, decompression recycling ethanol is to most, freeze drying, 300 object powder are pulverized and be screened into micronizer subsequently, gets the powder that 300g obtains, and adds water appropriate, be heated to 30 DEG C, be stirred to powder and dissolve completely, regulate pH value to 7.0 with 40% sodium hydroxide solution, stir evenly, 4 DEG C refrigerate 72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stir evenly, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
Embodiment 4 rat acute toxicity test of the present invention
Because the medicine that preparation for treating lung cancer of the present invention adopts, comparatively suitable administering mode is oral administration, and therefore the toxicologic study of preparation of the present invention adopts gastric infusion mode to carry out.
Animal used as test: clean level Wistar rat, 40, male and female half and half, are provided by Shandong Traditional Chinese Medicine University's animal center. Test preposition animal in indoor conforming-week, freely ingest and take the photograph water, 24 ± 2 DEG C of room temperatures, relative humidity 40 ± 2%, the light and shade round the clock of throwing light on replaces.
Experimental drug: oral liquid 1 gavage prepared by example of formulations 1 of the present invention, 3 times/day, make high concentration liquid, being concentrated into crude drug concentration is 0.95g/ml, 4 DEG C of preservations are for subsequent use, constant temperature to 24 DEG C when use.
Experimental technique: according to table of random number, rat is divided into control group and experimental group (oral liquid 1 prepared by the gavage embodiment of the present invention 1, is prepared into crude drug concentration 0.95g/ml, is equivalent to crude drug amount 57g/kg/d). Gavage amount is 20ml/kg, control group gavage distilled water 20ml/kg. Successive administration 7 days, drug withdrawal is observed 3 days. Record rat body weight, feed, drinking-water situation, record the every reaction of rat after gavage, the every physiological reaction of gavage interval rat, and death condition.
Result and conclusion: study by acute toxicological experiment, observe situation after 7 days rat oral gavages, before gastric infusion, each treated animal body weight, feed, drinking-water situation no difference of science of statistics, after gastric infusion, respectively organize rat body weight variation, feed drinking-water situation, no difference of science of statistics. , there are not dead and other toxic reactions in behaviouristics Non Apparent Abnormality. This experimental group dosage (crude drug concentration 57g/kg/d), 136.8 times of clinical adult's medication, modern pharmacology is thought, test for Acute toxicity, maximal tolerance dose is equivalent to the above and animal of 100 times of clinical daily dosage of people without death, while appearance without overt toxicity response situation, this medicine is safe. Verify that by this acute toxicity test non-toxic reaction can assert, the medication of this clinical drug is safe.
Embodiment 5 rat chronic toxicity test of the present invention
Study by acute toxicity test, preparation of the present invention has no side effect 136.8 times of clinical human body administration, therefore clinical middle patients with lung cancer need to be taken preparation of the present invention at least 3 months, therefore need to carry out long-term toxicological experiment research, verify the change that it has or not cumulative toxicity or delayed toxicity, particularly internal organs.
Animal used as test, the same acute toxicity test of experimental drug.
Experimental technique: according to table of random number, rat is divided into control group and high dose group (oral liquid 1 prepared by the gavage embodiment of the present invention 1, be prepared into crude drug concentration 0.55g/ml, be equivalent to crude drug amount 33g/kg/d), low dose group (oral liquid 1 prepared by the gavage embodiment of the present invention 1, be prepared into crude drug concentration 0.35g/ml, be equivalent to crude drug amount 21g/kg/d). Gavage amount is 20ml/kg, control group gavage distilled water 20ml/kg. Successive administration 60 days, drug withdrawal is observed 14 days. Record rat body weight, feed, drinking-water situation, record the every reaction of rat after gavage, the every physiological reaction of gavage interval rat, and death condition.
Result and conclusion: in experiment, high low dosage is respectively 33g/kg/d, 21g/kg/d, corresponding adult intends 79.2 times, 50.4 times of consumption for clinical day, after successive administration 60d, by with the more every detection index of control group, as no difference of science of statistics between each group of general state, body weight, food-intake, amount of drinking water. By each group of rat carried out to histopathology comparative analysis, have no obvious toxicity sensitive indicator and toxicity target organ. Drug withdrawal was observed after 2 weeks, and the every detection index of high and low dose group rat all belongs to normally, had no Delayed onset toxic reaction and cumulative toxicity reaction. Comprehensive each group long term toxicity test result, gavage mixture application of the present invention is to rat without obvious toxic-side effects, and clinical adult intends using dosage and the course for the treatment of in safe range. Therefore in the course for the treatment of of corresponding clinical use 60d, be also in safe range.
Embodiment 6 clinical researches
Data and method
Case source
Go to a doctor on December 31,1 day to 2014 March in 2014 in oncology outpatient service or the patients with lung cancer of being in hospital.
Case selection
Pulmonary cancer diagnosis standard
" the newly organized common cancer diagnosis and treatment specification " of writing according to Chinese Anti-Cancer Association.
(1) histopathology diagnosis: without the outer primary tumor of the lung that obviously can recognize, must meet the one of following each condition, can establish pathological diagnosis.
1. lung specimens from pri is through pathology, sense of organization prover;
2. lung pin puncture or branchofiberoscope adopt lung or bronchial biopsy tissue specimen, be primary bronchogenic carcinoma of lung person through histodiagnosis;
3. the MET biopsy person such as neck and axillary lymph knot, the wall of the chest, pleura or subcutaneous nodule, histology performance meets primary bronchogenic carcinoma of lung, and in lung or bronchial wall, is suspected to have lung cancer existence, can get rid of again clinically other organs primary carcinoma person;
(2) cytodiagnosis: sputum, Bronchofiberscope hairbrush, absorption etc. obtain histological specimen person, and diagnosis can be established. Should be noted and get rid of even esophageal neoplasm of the upper respiratory tract.
Stages of lung cancer standard
By the 7th edition lung cancer staging system standard of UICC revision in 2009.
Inclusive criteria
1. pathological diagnosis belongs to non-small cell lung cancer;
2. the age is between 18-80 year;
3. behavior state PS (ECOG) 0-3;
4. local lesion and/or DISTANT METASTASES IN focus can be measured maybe and can assess;
5. refusal carries out chemotherapy person;
6. marrow, liver, kidney, the heart, the normal person of lung function;
7. estimate life cycle and be longer than 3 months;
8. this research is participated in informed consent, signature Informed Consent Form, and compliance is good, can the person of following up a case by regular visits to.
Table 1RECIST the standard of curative effect evaluation
Exclusion standard
1. pregnant woman; 2. there is symptom brain to shift not controlled person; 3. there is the multiple primary carcinoma person of activity; 4. suffer from phrenoblabia disease patient; 5. merger activity tuberculosis and other serious infectious diseases persons.
Come off and processing
In experimentation, as patient requires to exit research, should record as far as possible and exit reason, and the therapeutic scheme of taking other to be ready acceptance.
In therapeutic process, there is drug allergy or unexpected serious adverse reaction person, as may be relevant with Experimental agents, should stop in time treatment, and carry out symptomatic treatment.
Enter choosing method
Meet inclusive criteria the case after exclusion standard detects, fill in clinical trial log form.
Therapeutic scheme
Control group: give and Gefitinib lozenge 250mg, oral, morning or evening are once.
Treatment group: on the basis of control group, selected patient gives oral liquid 1 preparation 200ml prepared by the embodiment of the present invention 1, oral, twice of point morning and evening.
Each treatment cycle is 30 days, and continued treatment to disease progression, side effect can not tolerance, death or drug withdrawal voluntarily. Treatment in first 6 months, in the 1.5th month, March, check in June, check once every half a year afterwards. After 3 months, observe short term efficacy.
Observation index
Before treatment, treatment in and treatment finish time inspection item as follows:
Clinical stages: rabat, breast CT, abdominal CT or B ultrasonic, head CT or MRI, bone scanning, PET-CT blood, biochemistry detection: routine blood test, liver function, renal function, tumor markers (CEA, SCC, TPA)
Index of assessment of curative effect and time
Short term effect: login is to death or follow up a case by regular visits to terminal or Time of Day lost to follow-up: by RECIST solid tumor curative effect evaluation CR, PR, SD, PD (specifically in table 1). Carry out the assessment of iconography tumour per March, be divided into and alleviate (CR), partial rcsponse (PR), stable disease (SD) and PD (PD) completely. Wherein CR, PR at least stablize 4 weeks. Disease is effectively controlled as CR+PR+SD.
Life span: OS (overall life cycle) rises to dead day or lost to follow-up day for treating the first day: PFS (Progression free survival phase) is for treating the first day to progress day, dead day that iconography confirms, or last is followed up a case by regular visits to the time. 1-yearsurvival (the annual rate of depositing) for patient receive treatment latter 1 year still survival percentage. MST (median survival interval) for Cumulative survival rate be 0.5 o'clock corresponding life span.
Statistical method
Application SPSS16.0 statistical analysis software. Patient's principal character, short term effect assessment adopt descriptive statistic, and PFS, 1-yearsurvival, MST, OS adopt Kaplan-Meier to analyze.
Result
Physical data
Patients with Non-small-cell Lung screens according to experiment inclusive criteria and exclusion standard, finally includes 251 example researchs in. After experiment finishes, totally 11 examples come off because following up a case by regular visits to. Reality can Estimating curative effect case 192 examples, dead 48 examples, and all the other 192 examples are followed up a case by regular visits to, and according to schedule, by the estimation of statistics sample number, meet therapeutic evaluation requirement. 192 patients' Clinical symptoms is summarized as table 2.
Table 2 Patients with Non-small-cell Lung principal character
Short term effect
Treat after 3 months and carry out curative effect evaluation, 23 examples obtain alleviates (CR) completely, and 59 examples obtain partial rcsponse (PR), 79 examples stable (SD), 31 routine disease progressions (PD). Efficient (ORR=CR+PR) is 42.71%, and disease control rate (DCR=CR+PR+SD) is 83.86%. In table 3.
The assessment of table 3 short term effect
Curative effect evaluation Frequency/time Percentage %
CR 23 11.98
PR 59 30.73
SD 79 41.15
PD 31 16.14
Add up to 192 100.0
Life span
Median survival interval
By finally following up a case by regular visits to the time, median survival interval (MST) is 10.18 months, in table 4.
Table 4 median survival interval (moon)
Numerical value Standard error 95% credibility interval
MST 10.18 1.67 6.65，13.42
The Progression free survival phase
By finally following up a case by regular visits to the time, the Progression free survival phase, (PFS) was 10.78 months, in table 5.
The table 5 Progression free survival phase (moon)
Numerical value Standard error 95% credibility interval
PFS 10.78 1.54 7.65，13.85
One annual survival rate
By finally following up a case by regular visits to the time, an annual survival rate (1-yearsurvival) is 53.65%, in table 6.
An annual survival rate after table 6 patient treatment
State after treatment in a year Frequency/time Percentage %
Dead 89 46.35
Survival 103 53.65
Less than 1 year 48 ----
This research of table 7 adopts the research comparison of Gefitinib list medicine as non-small cell lung cancer first-line treatment with other
Control group is not set up in this research, therefore compare with the data in literature of other clinical researches. As seen from Table 7, the research similar with other of the objective reactivity of this research is compared, and major part research is slightly high, but is low compared with the research of Lee. But this research is included colony in and is mainly gerontal patient, in the research of Lee, have no report. Gerontal patient's reaction may be poor. And this research includes pathology in and be defined as gland cancer, this research has numerical example squama cancer and large cell carcinoma patient. In addition, the disease control rate of this research (DCR) also has 72.1%, although only have 37.20% patient to obtain partial rcsponse, also has considerable part patient's situation controlled.
Use change and the analysis of right supporting anticancer side in life span
In other researchs, PFS is about 4-6 month, and in this research, gained PFS is 10.78 months, apparently higher than bibliographical information. And median survival interval and annual depositing in rate, show similar. Results suggest preparation of the present invention has effect to a certain degree on the PD time that extends patient.
Conclusion
Preparation associating Gefitinib of the present invention uses, at short term effect and suitable with other Gefitinib list medicine research effects on overall life cycle, but can effectively extend patient's the Progression free survival phase, point out preparation of the present invention and Gefitinib to share as non-small cell lung cancer first-line treatment and there is certain clinical value, by the exploitation to Chinese medicine preparation, can reduce the application of Western medicine chemotherapeutic, can better treat this disease by attenuation synergistic, improve patient's life quality, provide a good therapeutic scheme life-span for extending patient.
Embodiment 7 zooperies
Animal grouping
Select 60 of normal SD rats, be divided into 6 groups of (10 every group) administrations: blank, Gefitinib, Chinese drug-treated group, Gefitinib add Chinese drug-treated group. Raise and start perfusion after 7 days.
Medicine preparation and dosage
Chinese drug-treated group and Chinese and Western medicine are in conjunction with organizing Chinese medicine part: formulation concentrations of the present invention is 0.93g/ml (according to clinical adult's consumption), and rat dosage is according to Coming-of-Age Day consumption conversion gavage. Chinese medicine low concentration is the same amount of Coming-of-Age Day consumption; Chinese medicine high dose is Coming-of-Age Day consumption twice.
Western medicine group: Gefitinib lozenge consumption is 25mg/kg.
Blank group gives the physiological saline of equivalent.
The preparation of Contained Serum
Every day is by grouping administration (Chinese drug-treated group every day 2 times, Western medicine group every day 1 time, Chinese medicine added Western medicine and blank group every day 3 times), after fasting 12h, by above grouping medication gastric infusion. After administration 2h, same dose is administered once again for the first time. Gavage 3 days, completes after perfusion 1h on the 3rd day continuously, etherization, and abdominal aortic blood under aseptic condition, more than standing 1h, 2500r/min, centrifugal 4min, gets serum after 10min, mix 560C, 30min deactivation, packing ,-20 DEG C of Refrigerator stores by group.
Method
According to 10000/ml concentration of cell suspension, cell is inoculated on 96 orifice plates, every hole adds 100 μ L cell suspensions. After cell attachment growth, will be with 20%, 15% respectively, the culture medium of 10%, 5%, 1% Contained Serum (Chinese medicine, Gefitinib, Gefitinib+Chinese medicine) and blank serum adds cell line effect, 3 multiple holes containing blood serum medium, are established containing 100 μ L for every group in every hole. At 24h, 48h, when 72h, every hole adds 10 μ LCCK8 reagent, and lucifuge incubation, after 1 hour, is measured absorbance with ELIASA.
Statistical analysis
Application SPSS16.0 statistical analysis software, mean ± standard deviation for measurement data
Result
A549 cell line
A549 cell line is to without EGFR gene mutation, to the cell line of the low sensitivity of EGFR-TKI. As seen from the table, in the time of drug effect 24h, except Chinese medicine high dose group, Zhu Zujun to this cell line without lethal effect very. In the time of 48h, except Chinese medicine high concentration adds Western medicine group, the inhibited proliferation of each group is still slight. In the time of 72h, Chinese drug-treated group, Chinese medicine add Western medicine group and all this cell line are played to certain inhibited proliferation, but Gefitinib is without effect. In general, Gefitinib is nearly unavailable to A549 cell line. Chinese drug-treated group has certain lethal effect in the time of 72h, is obviously better than Gefitinib group, and kill capability is directly proportional to concentration. Chinese medicine adds Gefitinib, and when 72h, effect is better than Gefitinib group and is also better than Chinese drug-treated group. Obtaining 72h15% serum-concentration from table 8 observation is best dosage, and this Time and dosages will be applied in follow-up study.
The growth inhibition effect of the different group Contained Serums of table 8 to A549 cell (%,)
As can be found from Table 8, Gefitinib does not almost act on the growth inhibition of A549 cell line, comparatively meets, to the low sensitivity of this cell line definition with experimental studies results before. Meanwhile, preparation of the present invention uses separately, can obtain certain proliferation inhibiting effect. And two medicines share, when Chinese medicine coordinates Western medicine, effect is better than using merely Western medicine or Chinese medicine.
Conclusion:
Preparation of the present invention is alone and combine Western medicine chemotherapeutic, and the propagation of cancer cell is had to good inhibition. Experimental result demonstration, Chinese medicine, Western medicine are combined with the sensitiveness that can effectively promote Western medicine, use preparation associating western medicine lung cancer of the present invention to have certain curative effect to clinical expansion.
All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method. Those skilled in the art will utilize this important information, and foregoing amendment, to realize similar implementation status. But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only preferred embodiment of the present invention, is not the restriction of the present invention being made to other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations. But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (9)

1. a medicine that is used for the treatment of proliferation of lung cancer cells, is characterized in that: bulk drug comprise Radix Codonopsis,Radix pseudostellariae, the bighead atractylodes rhizome, the Radix Astragali, Poria cocos, stir-fry coix seed, hairyvein agrimony, cordate houttuynia, radix ranunculi ternati, fritillaria thunbergii,Lance asiabell root, edible tulip, oldenlandia diffusa, black nightshade, house lizard, pseudo-ginseng, salvia chinensis, akebiae, She PaoLe, curcuma zedoary, dried orange peel, the bark of official magnolia, rhizoma alismatis and honey-fried licorice root.
2. the medicine that is used for the treatment of proliferation of lung cancer cells as claimed in claim 1, is characterized in that: eachThe weight portion of bulk drug is respectively Radix Codonopsis 35 weight portion～50 weight portions, radix pseudostellariae 30 weight portion～40Weight portion, the bighead atractylodes rhizome 25 weight portion～40 weight portions, the Radix Astragali 35 weight portion～55 weight portions, Poria cocos 20Weight portion～30 weight portion, stir-fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15Weight portion, cordate houttuynia 20 weight portion～35 weight portions, radix ranunculi ternati 10 weight portion～20 weight portions, Zhejiang shellfishFemale 15 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portions～30 weight portions, oldenlandia diffusa 10 weight portion～20 weight portions, black nightshade 15 weight portion～25 weight portions,House lizard 10 weight portion～15 weight portions, pseudo-ginseng 20 weight portion～30 weight portions, salvia chinensis 5 weight portions～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, cowherbArt 10 weight portion～25 weight portions, dried orange peel 10 weight portion～20 weight portions, the bark of official magnolia 10 weight portion～20Weight portion, rhizoma alismatis 15 weight portion～25 weight portions and honey-fried licorice root 10 weight portion～20 weight portions.
3. the medicine that is used for the treatment of proliferation of lung cancer cells as claimed in claim 1 or 2, is characterized in that:The weight portion of each bulk drug is respectively Radix Codonopsis 40 weight portion～45 weight portions, radix pseudostellariae 35 weight portion～40Weight portion, the bighead atractylodes rhizome 30 weight portion～35 weight portions, the Radix Astragali 45 weight portion～50 weight portions, Poria cocos 25Weight portion～30 weight portion, stir-fry coix seed 15 weight portion～20 weight portions, hairyvein agrimony 10 weight portion～15Weight portion, cordate houttuynia 20 weight portion～25 weight portions, radix ranunculi ternati 15 weight portion～20 weight portions, Zhejiang shellfishFemale 20 weight portion～25 weight portions, lance asiabell root 10 weight portion～15 weight portions, edible tulip 20 weight portions～25 weight portions, oldenlandia diffusa 10 weight portion～15 weight portions, black nightshade 15 weight portion～20 weight portions,House lizard 10 weight portion～15 weight portions, pseudo-ginseng 25 weight portion～30 weight portions, salvia chinensis 5 weight portions～10 weight portions, akebiae 10 weight portion～15 weight portions, She Pao le 5 weight portion～10 weight portions, cowherbArt 15 weight portion～20 weight portions, dried orange peel 15 weight portion～20 weight portions, the bark of official magnolia 15 weight portion～20Weight portion, rhizoma alismatis 15 weight portion～20 weight portions and honey-fried licorice root 15 weight portion～20 weight portions.
4. the medicine that is used for the treatment of proliferation of lung cancer cells as described in claims 1 to 3, is characterized in that:The weight portion of each bulk drug be respectively Radix Codonopsis 40 weight portions, radix pseudostellariae 35 weight portions, the bighead atractylodes rhizome 30 weight portions,The Radix Astragali 50 weight portions, Poria cocos 30 weight portions, fry coix seed 20 weight portions, hairyvein agrimony 10 weight portions,Cordate houttuynia 20 weight portions, radix ranunculi ternati 20 weight portions, fritillaria thunbergii 20 weight portions, lance asiabell root 10 weight portions,Edible tulip 20 weight portions, oldenlandia diffusa 10 weight portions, black nightshade 20 weight portions, house lizard 15 weight portions,Pseudo-ginseng 25 weight portions, salvia chinensis 5 weight portions, akebiae 10 weight portions, She Pao le 10 weight portions, cowherbArt 20 weight portions, dried orange peel 20 weight portions, the bark of official magnolia 20 weight portions, rhizoma alismatis 20 weight portions and honey-fried licorice root 20Weight portion.
5. the medicine that is used for the treatment of proliferation of lung cancer cells as described in claim 1 to 4, is characterized in that:The formulation of described preparation is tablet, capsule, granule, pill, oral liquid.
6. the preparation method of medicine described in claim 1 to 5, is characterized in that, comprising:
The first step, the diacolation of each bulk drug component;
Second step, the purification of percolate, dry, pulverize powdered, and micronizer is pulverized, and crosses 300Mesh sieve;
The 3rd step, the powder obtaining at second step adds auxiliary material and carrier, prepares corresponding formulation.
7. the preparation method of medicine described in claim 6, is characterized in that: the further tool of the described first stepBody, for above-mentioned each bulk drug is taken according to above-mentioned weight portion, is placed on respectively in micronizer and pulverizes 20Minute～40 minutes, the each powder after pulverizing is mixed, add with respect to quality such as mixture qualitiesThe determining alcohol ethanol that is 85%～95% in, flood 12 hours～18 hours, then use 15～20The ethanol that the determining alcohol of times mixture weight is 80%～90% adopts percolation with 1～2ml's per minuteSpeed is diacolation slowly, collect percolate, be evaporated to 1/10 of original volume, 15000rpm pipeline fromThe heart, obtains supernatant.
8. the preparation method of medicine described in claim 6 or 7, is characterized in that: the further tool of second stepBody is that the supernatant that the first step is obtained is crossed macroporous resin column absorption, first uses obtain with respect to the first step upperThe water elution that clear liquid volume is 2～4 times discards, and then gradient ethanol elution, uses for the first time with respect to the first step3～5 times of determining alcohol 70%～80% ethanol elutions of supernatant volume that obtain, then use with respect to the first step3～5 times of determining alcohol 85%～95% ethanol elutions of supernatant volume that obtain, merge gradient ethanol elutionLiquid, decompression recycling ethanol is to most, freeze drying, and 300 objects are pulverized and be screened into micronizer subsequentlyPowder.
9. the preparation method of medicine described in claim 6 to 8, is characterized in that: the 3rd step, work as preparationWhile becoming oral liquid, get the powder that 300g second step obtains, add water appropriate, be heated to 30 DEG C, be stirred toPowder dissolves completely, regulates pH value to 7.0 with 40% sodium hydroxide solution, stirs evenly 4～8 DEG C of refrigerations72 hours, filter, filtrate adds sucrose 100g, is stirred to dissolve, and adds water and is settled to 1000ml, stirsEven, leave standstill 12 hours, filter, filling, sterilizing, to obtain final product.
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CN107233449A (en) * 2017-07-28 2017-10-10 青海九康中药饮片有限公司 A kind of Traditional Chinese medicine compound composition with antitumor activity and its preparation method and application
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CN115957285A (en) * 2022-12-09 2023-04-14 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） A Chinese medicinal granule for treating lung cancer

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Application publication date: 20160525