CN101933950A - Application of Trametes robiniophila Murr aqueous extract - Google Patents
Application of Trametes robiniophila Murr aqueous extract Download PDFInfo
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- CN101933950A CN101933950A CN2009100543632A CN200910054363A CN101933950A CN 101933950 A CN101933950 A CN 101933950A CN 2009100543632 A CN2009100543632 A CN 2009100543632A CN 200910054363 A CN200910054363 A CN 200910054363A CN 101933950 A CN101933950 A CN 101933950A
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Abstract
The invention discloses application of Trametes robiniophila Murr aqueous extract for preparing a drug composite to treat tumors. 100 parts by weight of the drug composite containTrametes robiniophila Murr aqueous extract obtained from 121-660 parts of Trametes robiniophila Murr, and the drug composite can treat tumors, such as lung cancer, breast cancer, gastric cancer or intestinal cancer.
Description
Technical field
The present invention relates to the plant extract field.Relate more specifically to the purposes of Trametes robiniophila Murr. water extract.
Background technology
Auricularia Sophorae (Chinese scholartree moth) is China's important medicinal fungi among the people, and its formal name used at school is Trametes robiniophila Murr., and it only grows in the old-age group on the Chinese scholar tree Sophora japonica trunk.Press categorizing systems in 1973 such as Ainsworth, belong to Basidiomycotina Basidiomycotina, Polyporaceae Polyporaceae, Trametes.Because it is natural Auricularia Sophorae is rare, existing many with its artificial culture thing---Trametes robiniophila Murr..
Trametes robiniophila Murr. is formed complicated, comprises Trametes robiniphila Murr filament and culture matrix.The main active of Trametes robiniophila Murr. is polysaccharide and GL-PP (PS-T), and its main effect is treatment or adjuvant therapy of tumors disease.Along with further investigation, find that not commensurability Trametes robiniophila Murr. is very big for variety classes tumor treatment difference on effect to it.
Therefore, this area presses for provides the new purposes of a kind of Trametes robiniophila Murr. water extract in oncotherapy.
Summary of the invention
The present invention aims to provide a kind of purposes of Trametes robiniophila Murr. water extract.
In the present invention, provide a kind of purposes of Trametes robiniophila Murr. water extract, be used to prepare the pharmaceutical composition for the treatment of tumor; In 100 weight portion pharmaceutical compositions, contain the Trametes robiniophila Murr. water extract that obtains from 121-660 weight portion Trametes robiniophila Murr.; Described tumor is selected from pulmonary carcinoma, breast carcinoma, gastric cancer or intestinal cancer.
In another preference,, contain the Trametes robiniophila Murr. water extract that obtains from 150-400 weight portion Trametes robiniophila Murr. in 100 weight portion pharmaceutical compositions.
In another preference,, contain the Trametes robiniophila Murr. water extract that obtains from 200-300 weight portion Trametes robiniophila Murr. in 100 weight portion pharmaceutical compositions.
In another preference, contain Trametes robiniophila Murr. water extract and pharmaceutically acceptable carrier in the described pharmaceutical composition.
In another preference, described Trametes robiniophila Murr. water extract prepares by following step:
(a) Trametes robiniophila Murr. and aqueous solution are mixed, extract and obtain the Trametes robiniophila Murr. water extract;
Described aqueous solution is selected from the inorganic salt solution of water, 0.2-10% or the water-alcohol solution of 2-50%.
In another preference, described inorganic salt is selected from: sodium salt, potassium salt, hydrochlorate, phosphate, sulfate; Described water-alcohol solution is selected from alcoholic solution or methanol solution.
In another preference, the aqueous solution of in the step (a) Trametes robiniophila Murr. and 3-12 doubly being measured mixes, and lixiviate obtains the Trametes robiniophila Murr. water extract for 3-5 time; Extract 30 ℃-100 ℃ of temperature; Extraction time 2-10 hour.
In another preference, described Trametes robiniophila Murr. water extract prepares by following step:
(1) aqueous solution mixing lixiviate 3-5 time or the reflux, extract, that Trametes robiniophila Murr. and 3-12 are doubly measured extracted 30 ℃-100 ℃ of temperature; Extraction time 2-10 hour;
(2) it is centrifugal or filter that extracting solution merges the back, gets supernatant or filtered solution, or with supernatant or filtered solution directly or be concentrated to certain density; With
(3) centrifugal or use micro-filtrate membrane filtration, with ultrafilter membrane ultrafiltration or the 50-95% alcohol precipitation of 1-30kDa, obtain the Trametes robiniophila Murr. water extract then;
Described aqueous solution is selected from the inorganic salt solution of water, 0.2-10% or the water-alcohol solution of 2-50%.
In another preference, described inorganic salt is selected from: sodium salt, potassium salt, hydrochlorate, phosphate, sulfate; Described water-alcohol solution is selected from alcoholic solution or methanol solution.
In view of the above, the invention provides the new purposes of a kind of Trametes robiniophila Murr. water extract in oncotherapy.
The specific embodiment
The inventor is surprised to find that the effect highly significant of a certain amount of Trametes robiniophila Murr. water extract for treatment pulmonary carcinoma, breast carcinoma, gastric cancer or intestinal cancer through extensively and profoundly research.
As used herein, " Trametes robiniophila Murr. " is meant Trametes robiniphila Murr Trametes robinioplila Murr on fermentation substrates such as corn core axle, Testa Tritici, under the certain condition after cultivating the dry mycoplasma of gained.Can use the method for this area routine to obtain, such as but not limited to, Chinese patent application 96116920.6 disclosed " the Chinese scholartree bolt bacterium and the application of being used as medicine thereof ".Also can obtain by the commercial channel, such as but not limited to, Qidong Gaitianli Pharmaceutical Co., Ltd. is according to the explained hereafter of State Food and Drug Administration's approval, authentication code (the accurate word Z20000108 of traditional Chinese medicines).
As used herein, " Trametes robiniophila Murr. water extract " is meant that Trametes robiniophila Murr. is extracted the material that obtains by aqueous solution.Described Trametes robiniophila Murr. water extract can be liquid condition (as suspension), semi-solid state (as extractum) or solid state (as dried powder etc.).
Described aqueous solution comprises the inorganic salt solution of water, 0.2-10% or the water-alcohol solution of 2-50%, the inorganic salt solution of preferred water, 0.2-2% or the water-alcohol solution of 2-20%.
Described inorganic salt is selected from but is not limited to: sodium salt, potassium salt, hydrochlorate, phosphate, sulfate.Wherein particular certain cancers, hydrochlorate, more preferably NaCl.
Described water-alcohol solution is selected from but is not limited to: alcoholic solution, methanol solution, preferred alcohol solution.
In one embodiment of the invention, Trametes robiniophila Murr. is put into the aqueous solutions of organic solvent of water or 2-50% or the inorganic salt solution of 0.2-10%, in 30-100 ℃ of lixiviate or reflux, extract.Extracting solution merges the centrifugal or filtration in back, get supernatant or filtered solution, or with supernatant or filtered solution directly or after being concentrated to certain density, centrifugal or use micro-filtrate membrane filtration, ultrafilter membrane ultrafiltration or 50-95% alcohol with 1-30kDa precipitates then, trapped fluid or precipitate reduced vacuum drying or spray drying obtain the Trametes robiniophila Murr. water extract.
As used herein, term " unit dosage form " is meant for taking convenience, becomes single to take required dosage form preparation of pharmaceutical compositions of the present invention, includes but not limited to various solid formulation (as tablet, granule), liquid agent, capsule, slow releasing agent.Contain in the described unit dosage form for the effective Trametes robiniophila Murr. water extract of the present invention of treatment cancer.
As used herein, term " contain " or " comprising " comprised " comprising ", " basically by ... constitute " and " by ... constitute ".
As used herein, term " basically by ... constitute " refer in compositions, except containing neccessary composition or necessary component, also can contain a spot of and not influence the submember and/or the impurity of effective ingredient.For example, can contain sweeting agent to improve taste, antioxidant in case oxidation, and other this areas additive commonly used.
As used herein, the composition of term " pharmaceutically acceptable " is applicable to people and/or animal and does not have excessive bad side reaction (as toxicity, stimulation and allergy), the material of rational benefit/risk ratio is promptly arranged.
As used herein, term " pharmaceutically acceptable carrier " refers to be used for the treatment of the carrier of agent administration, comprises various excipient and diluent.This term refers to some medicament carriers like this: they itself are not necessary active component, and do not have undue toxicity after using.Suitable carriers is well known to those of ordinary skill in the art.(Mack Pub.Co. can find discussing fully about pharmaceutically acceptable excipient in N.J.1991) at Remington ' s Pharmaceutical Sciences.Acceptable carrier can contain liquid on combination of Chinese medicine is learned, as water, saline, glycerol and ethanol.In addition, also may there be complementary material in these carriers, as diluent, excipient and water etc.Filler such as starch, mannose, dextrin, lactose, microcrystalline Cellulose etc.; Binding agent such as cellulose derivative, alginate, gelatin, polyvinylpyrrolidone; Wetting agent such as glycerol etc.; Disintegrating agent such as methyl starch sodium, hyprolose, cross-linked carboxymethyl cellulose, agar and sodium bicarbonate; Surfactant such as hexadecanol, dodecyl sodium sulfate, soil temperature-80 etc.; Lubricant such as Pulvis Talci, magnesium stearate or calcium, micropowder silica gel and Polyethylene Glycol.Can also in compositions, add other adjuvant such as pigment, flavouring agent and sweeting agent etc. in addition.
Purposes
Trametes robiniophila Murr. water extract provided by the invention can be used for treating tumor.In 100 weight portion pharmaceutical compositions, contain the Trametes robiniophila Murr. water extract that obtains from 121-660 weight portion Trametes robiniophila Murr.; Described tumor is selected from pulmonary carcinoma, breast carcinoma, gastric cancer or intestinal cancer.Contain Trametes robiniophila Murr. water extract and pharmaceutically acceptable carrier in the described pharmaceutical composition.
Compositions provided by the invention can be applied to the patient who needs this treatment by the mode of oral, rectum or parenteral.When making preparation, can be made into tablet such as enteric coatel tablets, gastric soluble tablet, chewable tablet, buccal tablet, effervescent tablet, dispersible tablet, fast disintegrating tablet etc.; Capsule such as enteric coated capsule, gastric-dissolved capsule, hard capsule and soft capsule etc.; Granule; Drop pill; Powder; Microcapsule such as enteric-coated microcapsule, gastric solubleness microcapsule; Nanoparticle; Injection such as injection, infusion solutions, lyophilized powder etc.; Syrup etc.The dosage of unit dosage form provided by the invention is preferably the granule of 20g.
The amount of application of Trametes robiniophila Murr. water extract of the present invention can change according to the type of route of administration, patient age, body weight, the disease for the treatment of and order of severity etc., its daily dose can be the 1210mg-6600mg/kg body weight/day by the crude drug Trametes robiniophila Murr., preferred 2200mg/kg body weight/day.Can use by one or many.
Major advantage of the present invention is:
1, the present invention provides the consumption that can effectively treat the Trametes robiniophila Murr. water extract of pulmonary carcinoma, breast carcinoma, gastric cancer or intestinal cancer first.
2, the consumption of Trametes robiniophila Murr. water extract provided by the invention can make the conventional chemotherapy amount of drug reduce, thereby reduces its side effect.
Below by particular specific embodiment embodiments of the present invention are described, those skilled in the art can understand other advantage of the present invention and effect easily by the content that embodiment disclosed.The present invention also can be implemented or be used by other different specific embodiment, and the every details in this description also can be based on different viewpoints and application, carries out various modifications and change under the spirit of the present invention not deviating from.The experimental technique of unreceipted actual conditions in the following example is usually according to the normal condition or the condition of advising according to manufacturer.Unless otherwise indicated, otherwise all percentage ratio and umber by weight.
Unless otherwise defined, the same meaning that employed all specialties and scientific words and one skilled in the art are familiar with in the literary composition.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.The usefulness that preferable implementation method described in the literary composition and material only present a demonstration.
The present invention selects artificial culture thing---the Trametes robiniophila Murr. of Auricularia Sophorae Trametes robiniophila Murr. for use.
Embodiment 1
Pharmaceutical compositions 1.
Get Trametes robiniophila Murr. 1100g, add 6 times of amounts of water lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 2
Pharmaceutical compositions 2.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of water lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 3
Pharmaceutical compositions 3.
Get Trametes robiniophila Murr. 1210g, add 6 times of amounts of water lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 4
Pharmaceutical compositions 4.
Get Trametes robiniophila Murr. 6600g, add 6 times of amounts of water lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 5
Pharmaceutical composition 1., 2., 3., 4. clinical trial
Carried out randomized, double-blind, placebo, the multiple center trial of four dosage groups, test group A201 example wherein, is rejected 2 examples at 13 examples that come off; Experiment group B 199 examples, 16 examples that come off, rejecting 1 example; Test group C201 example, 13 examples that come off, rejecting 2 examples; Test group D199 example, 16 examples that come off, rejecting 1 example; Matched group 202 examples, 13 examples that come off, rejecting 1 example.Lung cancer therapy group A67 example, lung cancer therapy group B65 example, lung cancer therapy group C67 example, lung cancer therapy group D65 example, matched group 64 examples; Breast cancer treatment group A63 example, breast cancer treatment group B65 example, breast cancer treatment group C63 example, breast cancer treatment group D65 example, matched group 71 examples; Gastrointestinal cancer treatment group A71 example, gastrointestinal cancer treatment group B69 example, gastrointestinal cancer treatment group C71 example, gastrointestinal cancer treatment group D69 example, matched group 67 examples (curing gastric cancer group A38 example, curing gastric cancer group B45 example, curing gastric cancer group C38 example, curing gastric cancer group D45 example, matched group 30 examples, intestinal cancer treatment group A33 example, intestinal cancer treatment group B24 example, intestinal cancer treatment group C33 example, intestinal cancer treatment group D24 example, matched group 37 examples).
Diagnostic criteria: meet the diagnosis that constitutional nonsmall-cell lung cancer, breast carcinoma and human primary gastrointestinal cancers belong to deficiency of vital QI, blood-stasis syndrome [" Chinese common cancer diagnosis and treatment standard ", the dialectical reference standard of Chinese medicine deficiency-syndrome (1986) and syndrome of blood stasis diagnostic criteria (1986)].18-75 year; Ka Shi scoring 〉=60 minutes is estimated to survive more than 3 months, can accept chemotherapeutic treatment.
Observation item: (1) pulmonary carcinoma: spiritlessness and weakness, deficiency of QI with disinclination to talk, tachypnea, cough, excessive phlegm, face color Koushi are white, few fragrant, the sputum mixed with blood of chest pain, Na Gu, fullness and distention in the chest and hypochondrium; Human primary gastrointestinal cancers: spiritlessness and weakness, deficiency of QI with disinclination to talk, epigastric pain, gastral cavity abdominal distention are vexed, few fragrant, the constipation with dry stool of Na Gu, diarrhea with loose stool; Breast carcinoma: spiritlessness and weakness, deficiency of QI with disinclination to talk, the breast side of body are uncomfortable, few fragrant, the constipation with dry stool of Na Gu, diarrhea with loose stool.(2) quality of life (Karnofsky).
Dosage regimen:
Test group A: Auricularia Sophorae granule A (Trametes robiniophila Murr. 1100g makes the 1000g granule, and promptly the pharmaceutical composition that obtains of embodiment 1 1.), specification: 20g/ bag; Oral, a 20g, 3 times on the one.
Experiment group B: Auricularia Sophorae granule B (Trametes robiniophila Murr. 2200g makes the 1000g granule, and promptly the pharmaceutical composition that obtains of embodiment 2 2.), specification: 20g/ bag; Oral, a 20g, 3 times on the one.
Test group C: Auricularia Sophorae granule C (Trametes robiniophila Murr. 1210g makes the 1000g granule, and promptly the pharmaceutical composition that obtains of embodiment 3 3.), specification: 20g/ bag; Oral, a 20g, 3 times on the one.
Test group D: Auricularia Sophorae granule D (Trametes robiniophila Murr. 6600g makes the 1000g granule, and promptly the pharmaceutical composition that obtains of embodiment 4 4.), specification: 20g/ bag; Oral, a 20g, 3 times on the one.
Matched group: placebo (dextrin, soluble starch, sucrose, natural powder caramel color etc. are made the 1000g granule), specification: 20g/ bag; Oral, a 20g, 3 times on the one.
The course of treatment: 42 days.All carry out simultaneously the chemical medicine anticancer therapy of 2 cycle criterions, the pulmonary carcinoma scheme is NP (PDD+NVB), TP (TAXOL+PDD), the human primary gastrointestinal cancers scheme is FLP (CF+5FU+PDD), 5FU+CF+ JM-216, and the breast carcinoma scheme is CAF (CTX+ADM+5FU), TP (TAXOL+PDD).
Evaluation criterion: symptom curative effect (nimodipine method): produce effects: treatment back integration reduces more than 2/3 than treatment is preceding.Effectively: treatment back integration reduces more than 1/3 than treatment is preceding, but less than 2/3.Invalid: treatment back integration reduces less than 1/3 than before treating, even increases.Quality of life (Karnofsky): improve: treating the back increases more than 10 minutes than before treating.Stable: as to treat the back than no change (in 10 minutes) before treating.Reduce: treat the back and reduce more than 10 minutes than before treating.
Result of the test:
(1) symptom curative effect (FAS):
In the test group A201 example, produce effects 38 examples (18.91%), effective 56 examples (27.86%), invalid 107 examples (53.23%), effective percentage 46.77%;
In experiment group B 200 examples, produce effects 99 examples (49.50%), effective 74 examples (37.00%), invalid 27 examples (13.50%), effective percentage 86.50%;
In the test group C203 example, produce effects 84 examples (41.38%), effective 82 examples (40.39%), invalid 37 examples (18.23%), effective percentage 81.77%;
In the test group D202 example, produce effects 100 examples (49.50%), effective 73 examples (36.14%), invalid 29 examples (14.36%), effective percentage 85.64%;
In matched group 203 examples, produce effects 33 examples (16.26%), effective 52 examples (25.62%), invalid 118 examples (58.13%), effective percentage 41.87%.
Pulmonary carcinoma:
In the test group A68 example, produce effects 16 examples (23.53%), effective 17 examples (25.00%), invalid 35 examples (51.47%), effective percentage 48.53%;
In experiment group B 65 examples, produce effects 32 examples (49.23%), effective 25 examples (38.46%), invalid 8 examples (12.31%), effective percentage 87.69%;
In the test group C66 example, produce effects 28 examples (42.42%), effective 25 examples (37.88%), invalid 13 examples (19.70%), effective percentage 80.30%;
In the test group D67 example, produce effects 34 examples (50.75%), effective 23 examples (34.33%), invalid 10 examples (14.93%), effective percentage 85.07%;
In matched group 66 examples, produce effects 15 examples (22.73%), effective 15 examples (22.73%), invalid 36 examples (54.54%), effective percentage 45.46%.
Human primary gastrointestinal cancers:
In the test group A66 example, produce effects 14 examples (21.21%), effective 20 examples (30.30%), invalid 32 examples (48.48%), effective percentage 51.52%;
In experiment group B 69 examples, produce effects 39 examples (56.52%), effective 22 examples (31.88%), invalid 80 examples (11.59%), effective percentage 88.40%;
In the test group C68 example, produce effects 29 examples (42.65%), effective 27 examples (39.71%), invalid 12 examples (17.65%), effective percentage 82.35%;
In the test group D65 example, produce effects 33 examples (50.77%), effective 22 examples (33.85%), invalid 10 examples (15.38%), effective percentage 84.62%;
In matched group 67 examples, produce effects 12 examples (17.91%), effective 18 examples (26.87%), invalid 37 examples (55.22%), effective percentage 44.78%.
Breast carcinoma:
In the test group A67 example, produce effects 8 examples (11.94%), effective 19 examples (28.36%), invalid 40 examples (59.70%), effective percentage 40.30%;
In experiment group B 66 examples, produce effects 28 examples (42.42%), effective 27 examples (40.91%), invalid 11 examples (16.67%), effective percentage 83.33%;
In the test group C69 example, produce effects 27 examples (39.13%), effective 30 examples (43.48%), invalid 12 examples (17.39%), effective percentage 82.61%;
In the test group D70 example, produce effects 33 examples (47.14%), effective 28 examples (40.00%), invalid 9 examples (12.86%), effective percentage 87.14%;
In matched group 70 examples, produce effects 6 examples (8.57%), effective 19 examples (27.14%), invalid 45 examples (64.29%), effective percentage 36.71%.
(2) quality of life (FAS)
21 examples (10.45%) that in the test group A201 example, improve 45 examples (22.39%), stablize 135 examples (67.16%), descend, raising rate 22.39%;
11 examples (5.50%) that in experiment group B 200 examples, improve 107 examples (53.50%), stablize 82 examples (41.00%), descend, raising rate 53.50%;
12 examples (5.91%) that in the test group C203 example, improve 104 examples (51.23%), stablize 87 examples (42.86%), descend, raising rate 51.23%;
9 examples (4.43%) that in the test group D202 example, improve 110 examples (54.19%), stablize 83 examples (40.89%), descend, raising rate 54.19%;
22 examples (10.84%) that in matched group 203 examples, improve 38 examples (18.72%), stablize 143 examples (70.44%), descend, raising rate 18.72%.
Pulmonary carcinoma:
11 examples (16.67%) that in the test group A66 example, improve 16 examples (24.24%), stablize 39 examples (59.09%), descend, raising rate 24.24%;
5 examples (7.69%) that in experiment group B 65 examples, improve 36 examples (55.38%), stablize 24 examples (36.92%), descend, raising rate 55.38%;
3 examples (4.48%) that in the test group C67 example, improve 35 examples (52.24%), stablize 29 examples (43.28%), descend, raising rate 52.24%;
4 examples (5.88%) that in the test group D68 example, improve 38 examples (55.88%), stablize 26 examples (38.24%), descend, raising rate 55.88%;
10 examples (15.15%) that in matched group 66 examples, improve 15 examples (22.73%), stablize 41 examples (62.12%), descend, raising rate 22.73%.
Human primary gastrointestinal cancers:
5 examples (7.14%) that in the test group A70 example, improve 14 examples (20.00%), stablize 51 examples (72.86%), descend, raising rate 20.00%;
3 examples (4.35%) that in experiment group B 69 examples, improve 39 examples (56.52%), stablize 27 examples (39.13%), descend, raising rate 56.52%;
5 examples (7.25%) that in the test group C69 example, improve 33 examples (47.83%), stablize 31 examples (44.93%), descend, raising rate 47.83%;
2 examples (2.99%) that in the test group D67 example, improve 38 examples (56.72%), stablize 27 examples (40.30%), descend, raising rate 56.72%;
6 examples (8.96%) that in matched group 67 examples, improve 11 examples (16.42%), stablize 50 examples (74.63%), descend, raising rate 16.42%.
Breast carcinoma:
5 examples (7.69%) that in the test group A65 example, improve 15 examples (23.08%), stablize 45 examples (69.23%), descend, raising rate 23.08%;
3 examples (4.55%) that in experiment group B 66 examples, improve 32 examples (48.48%), stablize 31 examples (46.97%), descend, raising rate 48.48%;
4 examples (5.97%) that in the test group C67 example, improve 36 examples (53.73%), stablize 27 examples (40.30%), descend, raising rate 53.73%;
3 examples (4.48%) that in the test group D67 example, improve 34 examples (50.75%), stablize 30 examples (44.78%), descend, raising rate 50.75%;
6 examples (8.57%) that in matched group 70 examples, improve 12 examples (17.14%), stablize 52 examples (74.29%), descend, raising rate 17.14%.
The result shows that symptom curative effect, quality of life and the matched group of experiment group B, test group C, test group D more all has significant difference (P<0.05); The symptom curative effect of test group A, quality of life and matched group be there was no significant difference (P>0.05) relatively; The symptom curative effect of experiment group B, test group D, quality of life and test group C be there was no significant difference (P>0.05) relatively, but effective in cure enhanced trend; Experiment group B, test group D curative effect are compared, symptom curative effect, quality of life there was no significant difference (P>0.05).By each group result of the test as can be seen, than the low dose group weak curative effect, but along with the curative effect of the increase correspondence of using dosage has obvious enhanced trend.
Embodiment 6
Pharmaceutical compositions 5.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of water lixiviate 3 times, 30 ℃ of temperature, 10 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 7
Pharmaceutical compositions 6.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of water lixiviate 3 times, 100 ℃ of temperature, 2 hours, filter, the extracting solution concentrating under reduced pressure gets the Auricularia Sophorae clear paste; Auricularia Sophorae clear paste that makes and an amount of mixing of sucrose, dextrin, soluble starch and correctives are granulated, and drying is sieved, and makes granule 1000g, packing, and sterilization, promptly.
Embodiment 8
Pharmaceutical compositions 7.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of 2% alcoholic solution lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, it is centrifugal or filter that extracting solution merges the back, gets supernatant or filtered solution, or with supernatant or filtered solution directly or after being concentrated to certain density, centrifugal or use micro-filtrate membrane filtration, with ultrafilter membrane ultrafiltration or the 50-95% alcohol precipitation of 1-30kDa, trapped fluid or precipitate reduced vacuum drying or spray drying obtain the Trametes robiniophila Murr. water extract then, the Trametes robiniophila Murr. water extract and the sucrose that make, dextrin, the an amount of mixing of soluble starch and correctives, granulate, drying is sieved, make granule 1000g, packing, sterilization, promptly.
Embodiment 9
Pharmaceutical compositions 8.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of 50% alcoholic solution lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, it is centrifugal or filter that extracting solution merges the back, gets supernatant or filtered solution, or with supernatant or filtered solution directly or after being concentrated to certain density, centrifugal or use micro-filtrate membrane filtration, with ultrafilter membrane ultrafiltration or the 50-95% alcohol precipitation of 1-30kDa, trapped fluid or precipitate reduced vacuum drying or spray drying obtain the Trametes robiniophila Murr. water extract then, the Trametes robiniophila Murr. water extract and the sucrose that make, dextrin, the an amount of mixing of soluble starch and correctives, granulate, drying is sieved, make granule 1000g, packing, sterilization, promptly.
Embodiment 10
Pharmaceutical compositions 9.
Get Trametes robiniophila Murr. 2200g, add 6 times of amounts of 0.2% sodium chloride solution lixiviate 3 times, 70 ℃ of temperature, 6 hours, filter, it is centrifugal or filter that extracting solution merges the back, gets supernatant or filtered solution, or with supernatant or filtered solution directly or after being concentrated to certain density, centrifugal or use micro-filtrate membrane filtration, with ultrafilter membrane ultrafiltration or the 50-95% alcohol precipitation of 1-30kDa, trapped fluid or precipitate reduced vacuum drying or spray drying obtain the Trametes robiniophila Murr. water extract then, the Trametes robiniophila Murr. water extract and the sucrose that make, dextrin, the an amount of mixing of soluble starch and correctives, granulate, drying is sieved, make granule 1000g, packing, sterilization, promptly.
Embodiment 11
Pharmaceutical composition 6., 7., 8., 9., 10. to murine sarcoma S
180Inhibition test
Kunming mouse, male and female half and half, body weight 18-22 gram, all mices are all in the S of right fore armpit subcutaneous vaccination dilution in 1: 4
180Oncocyte liquid 0.2ml/ Mus.
Be divided at random behind the inoculated tumour that 6. lotus tumor matched group, cyclophosphamide chemotherapy group, pharmaceutical composition organized, 7. pharmaceutical composition is organized, 8. pharmaceutical composition is organized, 9. pharmaceutical composition is organized, 10. pharmaceutical composition is organized.
Begin next day behind inoculated tumour, the administration component respectively lumbar injection give pharmaceutical composition 6., pharmaceutical composition 7., pharmaceutical composition 8., pharmaceutical composition 9., pharmaceutical composition 10., dosage is all in the extractive of locust tree microellobosporia in above-mentioned each pharmaceutical composition, 4.5g extract/kg, lotus tumor matched group lumbar injection gives the normal saline with volume, positive drug group intraperitoneal injection of cyclophosphamide 30mg/kg, continuous 7 days, the equal successive administration of all the other mices 10 days.After the last administration 24 hours, mice takes off cervical vertebra put to death, and peels off sarcoma, scales/electronic balance weighing.Calculate and respectively organize heavy meansigma methods of murine sarcoma and tumour inhibiting rate.The results are shown in Table 1.
Table 1 pharmaceutical composition 6., 7., 8., 9., 10. to murine sarcoma S
180Inhibitory action
Annotate: compare (t-check) with lotus tumor matched group,
*P<0.05,
*P<0.01,
* *P<0.001
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (9)
1. the purposes of a Trametes robiniophila Murr. water extract is characterized in that, is used to prepare the pharmaceutical composition for the treatment of tumor;
In 100 weight portion pharmaceutical compositions, contain the Trametes robiniophila Murr. water extract that obtains from 121-660 weight portion Trametes robiniophila Murr.;
Described tumor is selected from pulmonary carcinoma, breast carcinoma, gastric cancer or intestinal cancer.
2. purposes as claimed in claim 1 is characterized in that, in 100 weight portion pharmaceutical compositions, contains the Trametes robiniophila Murr. water extract that obtains from 150-400 weight portion Trametes robiniophila Murr..
3. purposes as claimed in claim 1 is characterized in that, in 100 weight portion pharmaceutical compositions, contains the Trametes robiniophila Murr. water extract that obtains from 200-300 weight portion Trametes robiniophila Murr..
4. purposes as claimed in claim 1 is characterized in that, contains Trametes robiniophila Murr. water extract and pharmaceutically acceptable carrier in the described pharmaceutical composition.
5. purposes as claimed in claim 1 is characterized in that, described Trametes robiniophila Murr. water extract prepares by following step:
(a) Trametes robiniophila Murr. and aqueous solution are mixed, extract and obtain the Trametes robiniophila Murr. water extract;
Described aqueous solution is selected from the inorganic salt solution of water, 0.2-10% or the water-alcohol solution of 2-50%.
6. purposes as claimed in claim 5 is characterized in that, described inorganic salt is selected from: sodium salt, potassium salt, hydrochlorate, phosphate, sulfate;
Described water-alcohol solution is selected from alcoholic solution or methanol solution.
7. purposes as claimed in claim 5 is characterized in that, the aqueous solution of in the step (a) Trametes robiniophila Murr. and 3-12 doubly being measured mixes, and lixiviate obtains the Trametes robiniophila Murr. water extract for 3-5 time; Extract 30 ℃-100 ℃ of temperature; Extraction time 2-10 hour.
8. purposes as claimed in claim 5 is characterized in that, described Trametes robiniophila Murr. water extract prepares by following step:
(1) aqueous solution mixing lixiviate 3-5 time or the reflux, extract, that Trametes robiniophila Murr. and 3-12 are doubly measured extracted 30 ℃-100 ℃ of temperature; Extraction time 2-10 hour;
(2) it is centrifugal or filter that extracting solution merges the back, gets supernatant or filtered solution, or with supernatant or filtered solution directly or be concentrated to certain density; With
(3) centrifugal or use micro-filtrate membrane filtration, with ultrafilter membrane ultrafiltration or the 50-95% alcohol precipitation of 1-30kDa, obtain the Trametes robiniophila Murr. water extract then;
Described aqueous solution is selected from the inorganic salt solution of water, 0.2-10% or the water-alcohol solution of 2-50%.
9. purposes as claimed in claim 8 is characterized in that, described inorganic salt is selected from: sodium salt, potassium salt, hydrochlorate, phosphate, sulfate;
Described water-alcohol solution is selected from alcoholic solution or methanol solution.
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CN103316051A (en) * | 2013-05-14 | 2013-09-25 | 三峡大学 | New functions and applications of trametes lactinea(Berk.)Pat. or extractives and trametenloic acid B |
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2009
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CN103316051A (en) * | 2013-05-14 | 2013-09-25 | 三峡大学 | New functions and applications of trametes lactinea(Berk.)Pat. or extractives and trametenloic acid B |
CN103316051B (en) * | 2013-05-14 | 2015-07-22 | 三峡大学 | New functions and applications of trametes lactinea(Berk.)Pat. or extractives and trametenloic acid B |
CN106974943A (en) * | 2017-01-22 | 2017-07-25 | 浙江中医药大学 | A kind of purposes and preparation method of trametes robinioplila alcohol extract |
CN106820134A (en) * | 2017-02-21 | 2017-06-13 | 南京晓庄学院 | A kind of preparation method and purposes of the immunopotentiator based on sesame stilbene mycoplasma |
CN110090233A (en) * | 2018-01-30 | 2019-08-06 | 启东盖天力药业有限公司 | Purposes of the extractive of locust tree microellobosporia in the drug of preparation prevention and/or treatment plasma cell mastitis |
CN110090233B (en) * | 2018-01-30 | 2021-11-09 | 启东盖天力药业有限公司 | Application of sophora fungus mycoplasma extract in preparation of medicine for preventing and/or treating plasma cell mastitis |
CN116217649A (en) * | 2022-12-30 | 2023-06-06 | 中国科学院沈阳应用生态研究所 | Steroid compound in sophora japonica linn and preparation method and application thereof |
CN116217649B (en) * | 2022-12-30 | 2024-05-17 | 中国科学院沈阳应用生态研究所 | Steroid compound in sophora japonica linn and preparation method and application thereof |
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