CN1150027C - Medicine for curing tumor and its preparation method - Google Patents
Medicine for curing tumor and its preparation method Download PDFInfo
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- CN1150027C CN1150027C CNB011441615A CN01144161A CN1150027C CN 1150027 C CN1150027 C CN 1150027C CN B011441615 A CNB011441615 A CN B011441615A CN 01144161 A CN01144161 A CN 01144161A CN 1150027 C CN1150027 C CN 1150027C
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Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention discloses new medicine for treating tumors, which is prepared from membranous milkvetch root, angelica, bittersweet herb, black nightshade herb, red sage root, barbed skullcap herb, indian mockstrawberry herb and turmeric root-tuber as raw material. According to medicinal properties and functions of each kind of medicine and physicochemical properties and pharmacological functions of ingredients of the medicine, the medicine is extracted in water and alcohol respectively as solvents, and extracting solutions are prepared according to proportions; then, the extracting solutions are concentrated, dried and crushed so as to obtain powder, granular formulation, granules, tablets, capsules, liquid formulation or block formulation.
Description
Invention field
The present invention relates to a kind of medicine for treating tumor thing.It specifically is the Chinese patent medicine of feedstock production with the Chinese herbal medicine.The invention still further relates to the preparation method of this medicine.
Background technology
Malignant tumor is the malignant disease of serious threat human health, and its morbidity and mortality rate increase day by day, and hazardness is very big.World Health Organization's report in 1998 points out that there were 9,240,000 New Development tumour patients in the whole world in 1997, dead 623.5 ten thousand people.And predict that the year two thousand twenty will have 2,000 ten thousand New Development cases of cancers, death toll will reach 1,200 ten thousand.The cancer morbidity of China also is the trend that sharply rises year by year, reaches 1,600,000 people in 2000, and death toll has reached 1,300,000.The mortality rate of tumor has been listed as residence in the world second.Common methods such as the surgical operation of domestic and international at present treatment tumor, radiotherapy, chemotherapy, biotherapy, Chinese medicine therapy etc., its therapeutic effect is not significantly improved recent decades, and total cure rate is about 10%.Along with the development and the utilization of cancer therapy drug, though its curative effect has increase, be cost often with bigger toxic and side effects, do not see patient's quality of life and life cycle to be significantly improved, and the time see reduction.
The present medicine of treatment tumor commonly used both at home and abroad still runs into following thorny problem:
1. alkylating agent type antitumor drug: mainly be that cancerous cell kills and wounds, be difficult to avoid poor selectivity, the shortcoming that toxic and side effects is strong.
2. antibiotics antitumor drug: easily bone marrow depression and produce toxic and side effects such as leukopenia, anemia, blood platelet reduction and cardiac toxicity.
3. the alkaloids antineoplastic drugs with coating of plant origin (as vinca, harringtonine class, camptothecin), diterpene-kind compound (as paclitaxel, Triptolide) all produce bone marrow depression or cardiac toxicity or neurotoxicity or toxicities such as GI irritation, eye toxicity and alopecia.
4, metabolism class medicine: toxicities such as common gastrointestinal tract, bone marrow depression, liver, renal damage.
5, hormones antitumor drug: the eye toxicity of corticosteroids is more obvious, and estrogen can increase the weight of cancer or carcinogenic.
6, differentiating inducer: untoward reaction such as common lip of retinoid compounds and xerosis cutis, severe headache, osteoarthrosis pain, liver function injury and blood fat rising.
Though the Chinese patent medicine of some treatment tumors is also arranged, but because DeGrain, for example each big pharmacy Tianxian Capsule of selling all once carried out basic effect experiment with it as positive control by China Academy of TCM's Chinese medicine institute's tumor group and present inventor, its animal at the body tumour inhibiting rate all below 29%; And for example, in the study of tcm new drug guide that Ministry of Public Health is formulated relevant herbal medicine efficacy research experiment for example in unique antineoplastic agent of being mentioned set upright and swing evil mixture, to mice S
180(20g/kg) the highest tumour inhibiting rate only has 31%.To Lewis lung cancer, above-mentioned setting upright swung evil mixture tumour inhibiting rate shakiness, between 10%～40%.Above-mentioned setting upright swung evil mixture and had only attenuation and do not have potentiation.
The present inventor is devoted for years to the research in this area, obtains a series of achievement in research and great deal of experiment data.For example, the present inventor nineteen eighty-two in Chinese medical journal, 95 (7): introduced a kind of anti-tumor medicine among the 527-532, it comprises Radix Angelicae Sinensis 15.5 (weight portion), Herba Solani Lyrati 31, Herba Solani Nigri 31, Radix Salviae Miltiorrhizae 31, Radix Curcumae 9.3 and Herba Duchesneae Indicae.But said medicine is only tested at animal, and tumour inhibiting rate is more than 30%, and drug action can not enter in the cell by the diesterase signal path and has an effect.Past attempts adopts Radix Angelicae Sinensis, Herba Solani Lyrati, Herba Solani Nigri, Radix Salviae Miltiorrhizae, Radix Curcumae and Herba Duchesneae Indicae to make injection, occurs because of animal experiment has pyrogen reaction, and stops research.The present invention is intended to improve tumour inhibiting rate and its stability by improving the compositing formula of medicine, and making not only has high tumour inhibiting rate, and drug effect can enter cell by the diesterase signal path, acts on each level molecule in the cell; Attenuation but also potentiation is arranged not only simultaneously.The present invention is based on simultaneously system experiment, comprise that toxicity test and human clinical treat experiment, and take new process route, carry out biological screening, form the specific preparation method of medicine of the present invention.
Summary of the invention
Thus, the object of the present invention is to provide a kind of evident in efficacy, safe in utilization, the anti-tumor medicine of almost non-toxic side effect.This medical instrument has benefiting QI and nourishing blood, heat-clearing and toxic substances removing, regulating the flow of QI to dissipate blood stasis function, be used for the treatment of tumor, improve clinical symptoms, human body immunity improving function and life quality, the combined with chemotherapy medicine can increase its antitumor action, and has the effect of the toxic reactions such as bone marrow depression, hepatorenal damage, nausea and vomiting and alopecia that reduce caused by radiotherapy and chemotherapy.
Another object of the present invention provides the preparation method of this anti-tumor medicine.
Solution of the present invention is based on motherland's medical science to tumor and pathogenetic understanding of complication and Therapeutic Principle, simultaneously in conjunction with Contemporary Western medical science to the up-to-date theory of tumor development, with drug development directional steering life science.Oncogene, antioncogene, cyclin (cyclins), cyclin-dependent kinase (CDKs), cyclin-dependent kinases inhibitive factor (CKIs) and signal path are made as a whole theoretical system to be studied, from motherland's medicine and pharmacology treasure-house, excavate on the basis of folk remedy, adopt cellular elements biology techniques experiment sieving to go out to have the natural plant of regulate tumor cell molecule.This medicine is by the theory of Chinese medical science prescription, with strengthening vital QI to eliminate pathogenic factors, reinforcement and elimination in combination is the rule of treatment, select invigorating QI and blood medicine liver and kidney tonifying for use, the replenishing vital QI with drugs of warm nature taste to be to set upright, and the medicine that clear and definite antitumor action is arranged is with eliminating evil, the medicine dredging the meridian of dual-purpose blood circulation promoting regulates qi blood stasis dispelling, conditioning viscera, make full side's tonify without causing stagnation, attack and do not cut down, the effect of performance benefiting QI and nourishing blood, heat-clearing and toxic substances removing, regulating the flow of QI to dissipate blood stasis.Medicine of the present invention shows the short differentiation of cell significantly and goes pernicious effect in modern cellular elements biological experiment, the inhibition of a plurality of antioncogene activation and oncogene expression, and immunologic function strengthens.Particularly in the cell cycle running, the positive-negative regulating factor function of numerous diseases is tending towards the balance adjustment of normalization.
Medicine of the present invention is made by following component: (consumption is a weight portion)
The Radix Astragali 10～35 Radix Angelicae Sinensis 3～25 Herba Solani Lyratis 5～40 Herba Solani Nigris 2～30
Radix Salviae Miltiorrhizae 2～20 Herba Scutellariae Barbataes 5～36 Herba Duchesneae Indicaes 3～25 Radix Curcumaes 2～23
Formula optimization weight (part) ratio range of medicine of the present invention is:
The Radix Astragali 11～25 Radix Angelicae Sinensis 4～20 Herba Solani Lyratis 10～35 Herba Solani Nigris 5～25
Radix Salviae Miltiorrhizae 3～15 Herba Scutellariae Barbataes 8～25 Herba Duchesneae Indicaes 8～15 Radix Curcumaes 5～15
The optimum weight of medicine of the present invention (part) proportioning is:
The Radix Astragali 15～20 Radix Angelicae Sinensis 5～12 Herba Solani Lyratis 12～25 Herba Solani Nigris 9～20
Radix Salviae Miltiorrhizae 4～10 Herba Scutellariae Barbataes 10～22 certain kind of berries 9～13 Radix Curcumaes 7～12
The optimum weight of medicine of the present invention (part) proportioning obtains with the screening of Drug therapy determination of bioactive constituent through the zoobiology test.
Above-mentioned said medicament can be a said dosage form on any pharmaceutics, comprising powder, granule, electuary, tablet, capsule, liquor or piece agent.
The preparation method of making medicine of the present invention by above-mentioned each component is:
1. get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, concentrate drying; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates drying; Above-mentioned dry thing is merged pulverizing, make powder or tablet or capsule.
2. get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, concentrate; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates; Above-mentioned concentrate is merged, make mixture or oral liquid.
3. get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, concentrate; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates; Above-mentioned concentrate is merged drying, granulate, make granule or electuary or piece agent.
Wherein in said method 3, the drying steps of system granule is a spray drying, and inlet temperature is 130～160 ℃.
Wherein in above-mentioned 1,2,3 methods, all can add an amount of excipient before preparations shaping, concentration step is a concentrating under reduced pressure and to be concentrated into relative density be 1.0～1.35, and temperature is controlled at 45～80 ℃, preferably being concentrated into relative density is 1.1～1.3, and temperature is controlled at 55～60 ℃.
In addition, in above-mentioned 1,2,3 methods, Radix Salviae Miltiorrhizae adds the ethanol extraction secondary, and concentration of alcohol is 92～98% for the first time, is 40～60% for the second time.Preferred extracting method is a reflux, extract,, and alcohol reflux concentration is preferably 50% for the second time.
Wherein in above-mentioned 1 method, crushing fine powder is 100 orders.
The specific embodiment
An important feature of the present invention is to contain astragaloside, astragalus polysaccharides, Radix Angelicae Sinensis polysaccharide, ferulic acid, tanshinone, danshensu, alkaloid, volatilization wet goods in the medicament.
The pharmacodynamics test that another important feature of the present invention is this medicine shows that this medicine is to mouse bearing liver cancer (Heps), Lewis lung cancer and LA
795Pulmonary carcinoma has certain inhibitory action.Have the effect that strengthens the mice delayed hypersensitivity, and can induce activation human lymphocyte killing tumor cell.Can improve the lymphocytic multiplication capacity of T, alleviate the toxic action of chemotherapeutics such as cisplatin, cyclophosphamide.
The 3rd important feature of medicine of the present invention be, reaches acute toxicity test for a long time through toxicology and show that this medicine do not find any toxic and side effects.
Clinical drug of the present invention uses the result to show that following advantage is arranged:
1. to select natural plant for use be raw material in the present invention, and each component meets national legal drug standard.
2. preparation of the present invention meets national legal drug standard.
3. medicine of the present invention proves through animal experiment and clinical trial, finds no toxicity and untoward reaction.
4. tumors such as curable substance pulmonary carcinoma of the present invention, hepatocarcinoma, gastric cancer, esophageal carcinoma, renal carcinoma, bladder cancer, breast carcinoma, rectal cancer, osteocarcinoma.
5. medicine of the present invention can significantly improve body's immunity, improves life quality, prolongs the vital stage.
6. medicine of the present invention can improve the clinical symptoms of tumor patient significantly.
7. can cooperate radiotherapy and chemotherapy medicine to use simultaneously, can increase its antitumor action.
8. late period and can not perform the operation or the patient of chemicotherapy can take separately, may command or dwindle tumor is improved clinical symptoms significantly, and the human body immunity improving function improves life quality, prolongs life span.
9. repeatedly carry out patients undergoing chemotherapy, all because of peripheral hemogram system damage evil, leukopenia and can not treating.Medicine of the present invention can improve the peripheral hemogram system of being damaged by chemotherapeutics, and obviously leukocyte increasing makes it be able to carry out the chemotherapy level, to support the enforcement of chemotherapy regimen.
10. medicine of the present invention has the effect of protecting hepatic and renal function significantly.
11. medicine of the present invention has the toxic and side effects that reduces radiotherapy and chemotherapy medicine significantly.
12. medicine of the present invention has untoward reaction such as the alopecia of obvious minimizing radiotherapy and chemotherapy medicine and nausea and vomiting.
For verifying medicine of the present invention,, primary bronchogenic carcinoma of lung 419 routine inpatients are divided into drug combination chemotherapy group of the present invention at random treat observation with simple chemotherapy group according to Ministry of Public Health Clinical Researches of New Drugs official written reply to the tumor treatment effect.According to the TNM of the diagnostic criteria of Chinese and western medicine and Ministry of Public Health " Chinese common cancer diagnosis and treatment standard " the 6th fascicle primary bronchogenic carcinoma of lung in 1989 Standard Selection case by stages.According to the Karnofsky grading scheme standard rating in " physical situation score standard " in Ministry of Public Health " Chinese common cancer diagnosis and treatment standard " the 9th fascicle in 1989 " tumor diagnosis and treatment statistical indicator commonly used and statistical method ".All selected case 419 examples of observing are inpatient, are divided into two groups.Treatment group (304 example) is medicine group of the present invention for chemotherapy adds, and matched group (115 example) is simple chemotherapy group.Adopt the envelope method to be divided into treatment group and matched group at random, make perspective contrast therapy.Wherein:
The treatment group: oral medicine of the present invention, each 4, every 0.65g adds chemotherapy every day 3 times simultaneously, and every is one-period all around.Matched group: only use chemotherapy regimen, every is one-period all around.The course of treatment: around every is one-period, observes two cycles altogether.The treatment group is used identical chemotherapeutics and same dose with matched group.
Two groups of selected case treatments are preceding in sex, the age, and pathology, by stages, and quality of life and traditional Chinese medical science cardinal symptom, aspects such as immunologic function, credit is analysed two groups does not by statistics all have significant difference (P＞0.05), has comparability, can include clinical case in and observe sample.
Table 1 data show that clinical symptoms is improved effective percentage in the 419 routine cases, learn check by statistics, treatment back tcm syndrome clinical efficacy, and treatment group effective percentage is 92.43%, and matched group is 43.04%, two group relatively there were significant differences (P＜0.01).Medicine of the present invention is taken in prompting the effect that improves the clinical symptoms of improving patients undergoing chemotherapy, has the good clinical curative effect.
Table 1 liang group treatment back therapeutic effect of syndrome
Group example digital display is imitated the enabledisable effective percentage
Treatment organizes 304 201 80 23 92.43
Matched group 115 1 14 100 43.04
Treatment group and matched group compare: P＜0.01
The mensuration of body weight change before and after the treatment is shown: behind the 419 routine patient treatments, treatment group weight in patients enhancer is many, and the chemotherapy group enhancer is few, and credit is analysed two groups and had significant difference (P＜0.01) by statistics.The effect that medicine of the present invention has increase and stable tumor patient body weight is taken in prompting, sees Table 2.
The two groups of body weight change in table 2 treatment back
Group example number increase 〉=stablize ± alleviates≤improves coefficient of stabilization
Treatment organizes 304 201 63 40 86.84
Matched group 115 10 28 77 33.04
Treatment group and matched group compare: P＜0.01
To before and after the treatment quality of life evaluation result: behind the 419 routine patient treatments, the enhancer is many than chemotherapy group for treatment group quality of life (KPS), and credit is analysed two groups and had significant difference (p＜0.01) by statistics.The effect that medicine of the present invention has the quality of life of obvious raising tumor patient is taken in prompting.
To 419 routine tumor patient test on immune function results, treatment back treatment group immunologic function improves coefficient of stabilization and chemotherapy group ratio, and credit is analysed two groups and had significant difference (p＜0.01) by statistics.The effect that medicine of the present invention has obvious raising immunological function of cancer patients is taken in prompting.See Table 3
Table 3 liang group treatment back immune indexes total effects
The group example is proposed steady reduction and is improved coefficient of stabilization %
Treatment organizes 304 228 60 16 94.73
Matched group 115 6 31 78 32.17
Treatment group and matched group compare: P＜0.01
To natural killer cell (NK cell) activity change measurement result: treatment back treatment group NK cytoactive is significantly improved (P＜0.01) before the treatment, and matched group then obviously reduces (P＜0.01).Show that taking medicine raising coefficient of stabilization of the present invention (95.62%) compares with matched group (53.19%), learning by statistics to handle has significant difference (P＜0.01).
To treating back IL-2 activity change (measuring with enzyme linked immunosorbent assay) measurement result: treatment group treatment back IL-2 is active to be significantly improved (P＜0.01) before the treatment, and matched group then obviously reduces (P＜0.01).It improves coefficient of stabilization treatment group (95.62%) compares with matched group (32.17%), and learning by statistics to handle has significant difference (P＜0.01).
T lymphocyte and subgroup thereof are changed measurement result:
1.T lymphocyte and subgroup change treatment back treatment group CD3, all than obviously improving (P＜0.01) before the treatment, CD8 then reduces (P＜0.01) for CD4 and CD4/CD8 ratio; And matched group CD3, CD4 and CD4/CD8 ratio are all than obviously reducing (P＜0.01) before the treatment.Treatment back treatment group is compared with matched group, and notable difference (P＜0.01) has been analysed in credit by statistics.Point out the medicine of the present invention tumor patient CD3 that is significantly improved, CD4 and CD4/CD8 ratio and reduce the effect of CD8.
2.CD
4/ CD
8Ratio improves coefficient of stabilization
Treatment back treatment group CD
4/ CD
8Ratio improves coefficient of stabilization (97.27%) apparently higher than matched group (59.13%), and learning by statistics to handle has significant difference (P＜0.01).
Table 4 treatment two groups of CD in back
4/ CD
8Improve coefficient of stabilization
The group example raises, and stablizing descends improves coefficient of stabilization %
Treatment organizes 304 175 121 8 97.27
Matched group 115 19 49 53 59.13
To 419 routine tumor patient cancer situation of change observed results: after finding treatment, treatment group tumor remission rate is 13.98%, and matched group is 3.33%, and credit is analysed two groups and had significant difference (p＜0.01) by statistics.Prompting is taken medicine of the present invention and is had the potentiation of obvious treatment tumor.
The performance and the calibration standard of and subacute toxicity acute according to WHO, we detect leukocyte (WBC), hemoglobin (Hb), the platelet (Pt) of 419 routine cases.Treatment back treatment group WBC, Hb, Pt do not see obvious decline (P＞0.05), and matched group then obviously reduces (P＜0.01); Compare for two groups, notable difference (P＜0.01) has been analysed in credit by statistics.Point out medicine of the present invention that the effect of protecting significantly and improving the patients undergoing chemotherapy peripheral hemogram is arranged.
To adverse effect result of the test of the present invention:
1. to the influence of hepatic and renal function
Press WHO about anticarcinogen acute and subacute toxicity grade scale, before statistics liver, the renal function curing and the integrated value after the treatment.419 routine patients are checked treatment back treatment group is not seen the infringement of liver, renal function, matched group then has BUN I degree to damage 21 examples (P＜0.01), and Cr I degree damages 6 examples, and SGPT I degree damages 14 examples.Point out medicine of the present invention that the effect of protection patients undergoing chemotherapy hepatic and renal function is arranged, see the following form 5.
Two groups of hepatic and renal function situations before and after table 5 treatment
Example 0 degree I degree II degree III degree IV degree
The index group
Before and after before and after before and after before and after before and after the number
The BUN treatment organizes 304 303 304 00000000
Matched group 115 115 94 0 21 000000
The Cr treatment organizes 304 304 304 00000000
Matched group 115 115 109 06000000
The SGPT treatment organizes 304 304 304 00000000
Matched group 115 115 101 0 14 000000
2. the performance of treatment back signs of toxicity
Press WHO about anticarcinogen acute and subacute malicious accessory symptom grade scale statistics, before the toxicity clinical symptoms performance treatment and the integrated value after the treatment (0 degree, I degree, II degree, III degree, IV degree or represented in 0,1,2,3,4 minute).Tangible signs of toxicity (P＞0.05) does not appear in treatment back treatment group, and the signs of toxicity (P＜0.01) of tangible nausea and vomiting, alopecia etc. then appears in matched group; Aspect signs of toxicity such as nausea and vomiting, constipation, alopecia, the treatment group compares with matched group that there were significant differences (P＜0.01).Point out medicine of the present invention that the effect that reduces the chemotherapeutic toxicity symptom is arranged.
In addition, show, use than previous open (Chinesemedical journal by treatment experiment to animal (mice), 95 (7): 527-532,1982) dosage that anti-tumor medicine is much smaller, its tumour inhibiting rate are more than 40% and the stability height, and liver is had no side effect.Simultaneously, no matter the present invention all exceeds 25～50% than the positive control of commercially available Tianxian Capsule at the tumour inhibiting rate of cancers such as mouse lung, liver, cervix uteri.Moreover, in the study of tcm new drug guide of formulating with respect to Ministry of Public Health relevant herbal medicine efficacy research experiment for example in unique antineoplastic agent of being mentioned set upright and swing evil mixture, the present invention equally with 20g/kg to rat liver cancer, pulmonary carcinoma, its tumour inhibiting rate exceeds 30%; Not only stable but also statistics P＜0.01 of medicine of the present invention.Simultaneously, medicine of the present invention not only has attenuation but also potentiation is arranged.
Embodiment 1
Take by weighing raw material (kilogram) by following proportioning
The Radix Astragali 15 Radix Angelicae Sinensis 8 Herba Solani Lyratis 20 Herba Solani Nigris 12
Radix Salviae Miltiorrhizae 5 Herba Scutellariae Barbataes 20 Herba Duchesneae Indicaes 10 Radix Curcumaes 9
Preparation method is as follows:
Get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, collecting decoction filters, and filtrate is at 45 ℃ of following concentrating under reduced pressure; Radix Salviae Miltiorrhizae adds alcohol reflux secondary (wherein used concentration of ethanol is 92～95% for the first time, and used concentration of ethanol is 50～55% for the second time), filters, reclaim ethanol, merge extractive liquid, filters the residue water extraction, filter, filtrate and alcohol extract are at 45 ℃ of following concentrating under reduced pressure; Concentrated solution is 150 ℃ in inlet temperature after merging, and under 10000 situations of per minute rotation, carries out spray drying; get dry thing, add an amount of excipient (lactose, magnesium stearate), carry out the precompressed sheet behind the mixing; pulverize and granulate in oscillating granulator, packing promptly gets granule.
Embodiment 2
Take by weighing raw material (kilogram) by following proportioning
The Radix Astragali 15 Radix Angelicae Sinensis 6 Herba Solani Lyratis 18 Herba Solani Nigris 20
Radix Salviae Miltiorrhizae 5 Herba Scutellariae Barbataes 15 Herba Duchesneae Indicaes 12 Radix Curcumaes 6
Preparation method is as follows:
Get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, collecting decoction filters, and it is 1.2～1.3 (50～65 ℃) thick paste that filtrate decompression is condensed into relative density, and vacuum drying gets dry extract.Radix Salviae Miltiorrhizae adds the alcohol reflux secondary, and (wherein used concentration of ethanol is 92～96% for the first time, used concentration of ethanol is 45～50% for the second time), filter, reclaim ethanol, merge extractive liquid, filters the residue water extraction, filter, filtrate becomes relative density with the alcohol extract concentrating under reduced pressure be 1.1～1.3 (50～65 ℃) thick paste, and vacuum drying gets dry extract.Be ground into fine powder (100 order) after above-mentioned dried cream mixes, add an amount of excipient mixing, granulate, drying, tabletting, the bag film-coat, packing promptly gets film coated tablet.
Embodiment 3
Take by weighing raw material (kilogram) by following proportioning
The Radix Astragali 20 Radix Angelicae Sinensis 10 Herba Solani Lyratis 18 Herba Solani Nigris 15
Radix Salviae Miltiorrhizae 8 Herba Scutellariae Barbataes 15 Herba Duchesneae Indicaes 10 Radix Curcumaes 8
Preparation method is as follows:
Get the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae earlier and decoct with water, collecting decoction filters, and it is 1.1～1.3 thick paste (50～65 ℃) that filtrate decompression is condensed into relative density, and vacuum drying gets dry extract.Radix Salviae Miltiorrhizae adds the alcohol reflux secondary, and (wherein used concentration of ethanol is 95% for the first time, used concentration of ethanol is 50% for the second time), filter, reclaim ethanol, merge extractive liquid, filters the residue water extraction, filter, filtrate becomes relative density with the alcohol extract concentrating under reduced pressure be 1.1～1.3 thick pastes (55～65 ℃), and vacuum drying gets dry extract.Above-mentioned dried cream powder is broken, and is encapsulated with multiplication chromatography mixing, makes capsule.
Claims (15)
1. a medicine for the treatment of tumor is characterized in that it is the medicament of being made by the following weight proportion raw material
The Radix Astragali 10～35 Radix Angelicae Sinensis 3～25 Herba Solani Lyratis 5～40 Herba Solani Nigris 2～30
Radix Salviae Miltiorrhizae 2～20 Herba Scutellariae Barbataes 5～36 Herba Duchesneae Indicaes 3～25 Radix Curcumaes 2～23
2. the medicine of treatment tumor according to claim 1, wherein the weight proportion of each raw material is
The Radix Astragali 11～25 Radix Angelicae Sinensis 4～20 Herba Solani Lyratis 10～35 Herba Solani Nigris 5～25
Radix Salviae Miltiorrhizae 3～15 Herba Scutellariae Barbataes 8～25 Herba Duchesneae Indicaes 8～15 Radix Curcumaes 5～15
3. the medicine of treatment tumor according to claim 1, wherein the weight proportion of each raw material is
The Radix Astragali 15～20 Radix Angelicae Sinensis 5～12 Herba Solani Lyratis 12～25 Herba Solani Nigris 9～20
Radix Salviae Miltiorrhizae 4～10 Herba Scutellariae Barbataes 10～22 Herba Duchesneae Indicaes 9～13 Radix Curcumaes 7～12
4. according to the medicine of claim 1,2 or 3 described treatment tumors, it is characterized in that described medicament is powder, granule, electuary, tablet, capsule, liquor or piece agent.
5. the preparation method of the medicine of treatment tumor according to claim 4 is characterized in that getting earlier the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae and decocts with water, and concentrates drying; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates drying; Above-mentioned dry thing is merged pulverizing, make powder or tablet or capsule.
6. the preparation method of the medicine of treatment tumor according to claim 4 is characterized in that getting earlier the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae and decocts with water, and concentrates; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates; Above-mentioned concentrate is merged, make mixture or oral liquid.
7. the preparation method of the medicine of treatment tumor according to claim 4 is characterized in that getting earlier the Radix Astragali, Radix Angelicae Sinensis, Herba Solani Nigri, Radix Curcumae, Herba Scutellariae Barbatae, Herba Solani Lyrati, Herba Duchesneae Indicae and decocts with water, and concentrates; Radix Salviae Miltiorrhizae adds ethanol extraction, concentrates; Above-mentioned concentrate is merged drying, granulate, make granule or electuary or piece agent.
8. the preparation method of the medicine of treatment tumor according to claim 7 is characterized in that drying steps is a spray drying, and inlet temperature is 130～160 ℃.
9. the preparation method of the medicine of treatment tumor according to claim 5 is characterized in that adding an amount of excipient before preparations shaping.
10. according to the preparation method of the medicine of claim 5, one of 6 and 7 described treatment tumors, it is characterized in that described concentration step is a concentrating under reduced pressure.
11. according to the preparation method of the medicine of claim 5, one of 6 and 7 described treatment tumors, wherein being concentrated into relative density is 1.0～1.35, temperature is controlled at 45～80 ℃.
12. according to the preparation method of the medicine of claim 5, one of 6 and 7 described treatment tumors, wherein being concentrated into relative density is 1.1～1.3, temperature is controlled at 55～60 ℃.
13. according to the preparation method of the medicine of claim 5, one of 6 and 7 described treatment tumors, wherein Radix Salviae Miltiorrhizae adds the alcohol reflux secondary, used concentration of alcohol is 92～98% for the first time, and used concentration of alcohol is 40～60% for the second time.
14. the preparation method of the medicine of treatment tumor according to claim 13, wherein used concentration of alcohol is 50% for the second time.
15. the preparation method of the medicine of treatment tumor according to claim 5, wherein crushing fine powder is 100 orders.
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| CN105031527A (en) * | 2015-07-28 | 2015-11-11 | 邵世达 | Traditional Chinese medicine for treating cancer and preparation method |
| CN106692906A (en) * | 2015-11-17 | 2017-05-24 | 秦皇岛乾源科技开发股份有限公司 | Tumor removal medicine and preparation process thereof |
| CN112353925A (en) * | 2020-11-17 | 2021-02-12 | 天津中新药业集团股份有限公司隆顺榕制药厂 | Anticancer medicine and its preparation method and application |
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