CN1162169C - Medicine 'Aibixiao' for treating cancer - Google Patents
Medicine 'Aibixiao' for treating cancer Download PDFInfo
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- CN1162169C CN1162169C CNB011198699A CN01119869A CN1162169C CN 1162169 C CN1162169 C CN 1162169C CN B011198699 A CNB011198699 A CN B011198699A CN 01119869 A CN01119869 A CN 01119869A CN 1162169 C CN1162169 C CN 1162169C
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Abstract
The present invention relates to a medicine 'Aibixiao' for treating cancers, which is prepared from gansui root, ginseng, milkvetch root, long-noded pit viper, sodium sulfate, rhubarb, Chinese date and auxiliary added components which are used as effective medicinal components; the auxiliary added components are allowed by pharmacy.
Description
Technical field
The present invention relates to a kind of medicine (medicine ' Aibixiao ' for treating cancer) that is used for the treatment of cancer, specifically be a kind of be the medicine that the peroral dosage form of medicinal active ingredient is used for the treatment of cancer with natural drug.
Background technology
Tumor, particularly malignant tumor are one of common diseases of still not having at present specially good effect and reliable Therapeutic Method.Employing is that the Drug therapy of active ingredient is a kind of common method in the various therapeutic modalities with the natural drug.Propose and use the existing many reports of various natural drugs or its compositions.As being that what propose in the Chinese patent literature of CN 1095274A is exactly a kind of by comprising tens of kinds of cancer therapy drugs that natural medicinal component is formed such as Radix Kansui, Radix Ginseng at publication number.
Summary of the invention
The purpose of this invention is to provide a kind of can be through multiple evidence to the pharmaceutical composition of forming by natural drug of kinds of tumors disease by therapeutic effect, its at least can for doctor and/or patient at tumor disease, a kind of valuable selection particularly is provided in the treatment of malignant tumor.
The present invention is used for the treatment of the medicine of cancer, is effective medicinal component by Radix Kansui, Radix Ginseng, the Radix Astragali, Agkistrodon, Natrii Sulfas, Radix Et Rhizoma Rhei and Fructus Jujubae, and the auxiliary interpolation sexual element composition of pharmacy permission, and its percentage by weight is:
Radix Kansui 6, Radix Ginseng 20, the Radix Astragali 15, Agkistrodon 9, Natrii Sulfas 20, Radix Et Rhizoma Rhei 15, Fructus Jujubae 15, the auxiliary interpolation composition that preparation allows is an amount of.
The preparation of said medicine of the present invention is comparatively simple, generally can make as peroral dosage form commonly used such as capsule, tablet, pill by said proportion of composing being prepared into pulverous each crude drug raw material, can be for using.As, when being prepared into the capsule preparations for clinical use, can make it become the form that every capsules contains 250 milligrams of effective medicinal components.The auxiliary interpolation sexual element that said pharmacy allowed during said medicine was formed, according to difference to the dosage form of the prepared one-tenth of medicine, its concrete composition and/or consumption can need be selected and operate by the usual manner and the preparation of relative medicine dosage form, need not other special handling and requirement.
According to the pathology etiological analysis of theory of Chinese medical science to tumor disease, carcinoma forms, be to coagulate wet gathering with expectorant, and qi depression to blood stasis, or accumulate in the pyretic toxicity, or pyretic toxicity is coalescent, or vital QI being weakened and pathogen being violent, depressed stasis of blood resistance is relevant.The capable then blood of gas is capable, and the deficiency of vital energy is blood stasis then, and water is wet to be pented up, and decocts into expectorant.Fortune functional disorders such as lung, spleen, kidney, liver cause the water pterygium in inner canthus that wets, and the cancer poison occupies for a long time in addition, evilly contain weakened body resistancely, become poly-in bulk, illegally occupy firm stone.It is early stage, invades for positive excess pathogen, and the cancer toxication is slow, controls suitable anti-cancer and inhibiting tumor, the clearing away phlegm eliminating stagnation; Mid-term, to strive for good and evil are rich, the cancer poison is dispersed, and controls suitable resolving the hard mass, and detoxicating and fighting cancer is cleansed intestinal stasis relieving; Late period, vital QI being weakened and pathogen being violent, the cancer poison is flat and superficial, controls suitable strengthening vital QI to eliminate pathogenic factors, the stagnant blood stasis dispelling of row.
In said medicine of the present invention was formed, after Radix Ginseng, the Radix Astragali and Natrii Sulfas, Radix Et Rhizoma Rhei compatibility used, the Radix Ginseng sweet in the mouth was pure, and was wet and not dry, is the certified products of strongly invigorating primordial QI; Radix Astragali yellow skin gas is thick, and sweet in the mouth is warm in nature, is the product of tonifying Qi and lifting yang strengthening superficial resistance to stop perspiration; The Radix Et Rhizoma Rhei abnormal smells from the patient is deep, and bitter cold is attacked and determined, and the property master walks to let out, and walks and does not keep, and is the product of resolving the hard mass, purging heat to relax the bowels; Natrii Sulfas is heavy to be weighed down, and bitter in the mouth gas is cold, but softening the hard mass rush down down, heat conduction is descending, has that to swing sun bright damp and hot stagnant, resolving the hard mass, it is damp and hot to wash the three warmers gastrointestinal, pushes away the old new merit that causes.The above two are based on sweet temperature compensation benefit, and it is main that both bitter colds of back are captured, so abnormal smells from the patient is opposite, function is different, and anteiso-disaccords, and can produce antagonism on pharmacological function.When Radix Kansui, the Radix Astragali, Natrii Sulfas and Fructus Jujubae were shared, Radix Kansui belonged to the product of drastic purgation, the agent that Radix Et Rhizoma Rhei, Natrii Sulfas are captured, attack high phase, get the high violent power of its drastic purgation first, the energy removing fluid-retention by purgation, dispersing swelling and dissipating binds is captured first and can be walked to rush down three warmers, on rush down the fire of high Sheng, in rush down dyspepsia and stagnate, the dryness accumulated in the stomach and intestine that drops so one high one attack, is gone on and is reached down, resolving the hard mass, the painful abdominal mass that disappears remove and expand.Though right satisfy nitron and shake that to revolve expectorant turbid, the merit of taking drink rushing down under by force has consumption impairment of QI the moon, the fraud that the damage spleen is upset one's stomach; And the Fructus Jujubae sweet in the mouth is warm in nature, and matter profit and being bored with has the spleen reinforcing tonifying YIN, a merit of the nourishing the stomach of promoting the production of body fluid.Xin Gan is a sun, and bitter cold be cloudy, and negative and positive swash mutually then can alleviate diarrhea intensity, sweet and middle QI invigorating that again can Fructus Jujubae, and benefit soil protects spleen, makes diarrhea and does not decrease spleen soil.Poison, wet, expectorant, the stasis of blood be tumor pathogenic because of, " disease of big poison, must with the medicine of big poison to attack it ", " disease of hard knot, the energy victory of non-gentle medicine must make counter taking by force to attack it ".Agkistrodon, Radix Kansui and 5 times spent of reinforcing and reducing medicine, Agkistrodon property is apt to away string, the product of poisonous, sweet in the mouth, in walk internal organs, outer thorough skin, the counteracting toxic substances of drawing out pus by applying a plaster to the affected part; Radix Kansui is poisonous, and the entry nest is taken phlegm retention by force, and removing water retention by purgation is wet, logical Central Region, broken the hollow organ for cleaning up the wastes; Go on Natrii Sulfas, Radix Et Rhizoma Rhei again and reach down, rush down intestinal stasis relieving down, the broken heavily fortified point painful abdominal mass that disappears, reinforcing and reducing are opposite like this, and malicious benefit is mutually high, one rise and one drop, one mends one rushes down, and plays the merit of antagonism altogether, reaches the purpose of " with the poison of medicine, attack the poison of its disease, anti-with medicine, it is instead to control its disease ".Therefore, in said medicine of the present invention is formed, be monarch with Radix Kansui, Agkistrodon, the entry nest, the drink of relieving oedema or abdominal distension through diuresis or purgation, the heresy of drawing out pus by applying a plaster to the affected part, the knot of assaulting fortified position opens and closes plug, swings internal organs; Radix Et Rhizoma Rhei, Natrii Sulfas hardship are attacked intestinal stasis relieving, and the painful abdominal mass of assaulting fortified position brokenly is minister; Assistant Radix Ginseng, Radix Astragali complement QI invigorating help gasified water; Make the slow property of medicine of closing of Fructus Jujubae, in and intensity, instead swash mutually highly, have in short of money, realize attacking and just do not hinder, rush down and the not treatment of impairment of YIN " having " so harmless.
Medicine of the present invention with following composition form is that the experimental drug thing has carried out the relevant toxicity test and the test of pharmacodynamics.
The experimental drug thing is formed: make the capsule-type medicine that is prepared into behind the powder mixing by the medicine of above-mentioned composition form, every capsules contains 250 milligrams of effective medicinal components.
The specific embodiment
Safety testing
1. acute toxicity test:
The healthy Kunming mouse that has concurrently with body weight 20～25 gram male and female is an experimental animal, is divided into 8 groups at random, 10 every group.With above-mentioned experiment medicine by the Chinese medicine decoction decoction method medicinal liquid that to be configured to total crude drug content respectively be 50% and 80% (grams per milliliter), observed 7 days with the single gastric infusion by various dose, observe two kinds of tests of 10 days in three days with the successive administration that is administered once every day, put down in writing general symptom and death toll.The gastric infusion amount of two kinds of content medicines respectively is respectively 1.0 milliliters, 0.8 milliliter, 0.64 milliliter and 0.52 milliliter of four dosage group.In 80% content medicine 1.0 milliliters of 1.0 milliliters of groups of single-dose test and three days medicine-feeding tests and the 0.8 milliliter of two treated animal hairiness pine and the phenomenon of suffering from diarrhoea, other each test group animal there is no abnormal response, shows the LD of medicine of the present invention in two kinds of tests
50＞40 gram/kg body weight more than 1500 times, are pressed the body surface area conversion greater than 142.8 times of clinical consumptions greater than clinical using dosage, meet the low toxicity standard greater than 5.0 gram/kilograms in the acute toxicity classification.The mtd test result of mouse stomach is 64 gram/kg body weight, is equivalent to 228.57 times of human dosage by the body surface area conversion.
2. subacute toxicity test:
With body weight is that the wistar that 80～120 gram male and female have concurrently is that 35 of rats are experimental animal, is divided into 3 groups.Two groups of medication groups are given the above-mentioned experiment medicine filling of the present invention stomach of 40% and 80% content respectively by 1.0 milliliters/100 gram body weight dosage, matched group once a day, continuous 42 days, is weighed once observation growth of animal situation weekly to irritate stomach with the volume normal saline.Tested the 30th day and off-test, broken end is got blood and is made hemogram, biological test, calculating organ coefficient and main organs is made the pathology histological observation.Rat does not see inhibition to growth generally in order as a result, and hemogram, liver, renal function are not all had obvious influence, and histopathology is observed and also do not seen tangible medicine infringement.
Above-mentioned toxicity test shows that the toxicity of medicine of the present invention is little, and clinical application is safe.
3. bring out the test of mouse bone marrow cells micronucleus in erythrocytes:
With 56 of the Kunming mouses of body weight 18～20 gram male and female half and half, be divided into totally 7 groups of 5 trial drug groups, positive controls and negative control group at random by 8 every group.The trial drug group is boiled for 100 milliliters with medicine 20 gram addings for the above-mentioned test of the present invention that will accurately take by weighing and is made into 20% suspension in the distilled water, and redilution becomes 8%, 4%, 2.67% and 2% 4 kind of Concentraton gradient, pH6.0.The positive control medicine is for to be mixed with the cyclophosphamide medicinal liquid that content is 1 mg/ml with normal saline; With Gastric lavage, the cyclophosphamide of positive controls is by 100 mg/kg body weight administrations; Drug test group of the present invention is pressed the LD of above-mentioned 40 gram/kg body weight respectively
501/2,1/5,1/10,1/15 and 1/20 of amount is divided into 5 test group, respectively irritates stomach once in 0 o'clock and 24 o'clock, puts to death in 6 hours after irritating stomach for the second time, get breastbone and make bone marrow smear, simplified with the Giemsa staining, dyeed 10 minutes by the single of Matter, microscopy is dried in the tap water flushing.Relatively and with Poisson distribution check the significance of its difference to show to each test group result and matched group result, there is not significant difference (P＞0.05) between the polychromatic erythrocyte micronuclear rates of each test group, there is not significant difference (P＞0.05) between each test group and negative control group yet, do not have significant difference (P＞0.05) between the polychromatic erythrocyte of each test group and the normocyte, do not have significant difference (P＞0.05) between test group and negative control group yet; Normocyte micronuclear rates between each test group does not have significant difference (P＞0.05), does not have significant difference between test group and negative control group yet.This brings out the micronucleus in erythrocytes evidence, though medicine of the present invention at dosage near LD
50Time also fails to cause and the increase of micronuclear rates shows that it does not have damaging action to hereditary material, do not kill and wound medullary cell or causes the effect of mitotic delay.
4. mutagenesis testing:
With the above-mentioned trial drug of the present invention, and 4-nitroquinoline-N-oxide (4-NQNO), 2-aminofluorene (2-AF) and the positive tester of mitomycin carry out Salmonella reversion test.Because of medicine of the present invention is oral drugs, can not directly dissolve, so adopt the soaked extracting solution of dimethyl sulfoxine.Salmonella reversion test uses through biological character and identifies the satisfactory Salmonella typhimurium mutant TA that needs histidine
98And TA
100Adopt bacillus subtilis to have the H of sufficient repair function in the recombination repair test
17(Rec
+, arg
-, try
-) and the strain M that derives of recombination repair defective
45(Rec
+, arg
-, try
-).In the Salmonella reversion test with minimum nutrition V-B culture medium pour plate as bottom, add 0.5mu biotin/histidine mixed liquor of 10% as the upper strata soft agar with soft agar.Use with the nutrient broth pour plate that contains 15% agar, 37 ℃ of 24 hours dry backs in the reorganization test.The examination of Salmonella reversion test point and the dull and stereotyped infiltration test result that carry out with different gradient concentration medicinal liquids all show respectively: no matter add or do not add S
9Activation system, said medicine of the present invention all can not be brought out TA
98And TA
100The back mutation of strain.In bacillus subtilis repetition repairing test, also show the DNA damage effect is arranged.
Above-mentioned every test has shown that all medicine of the present invention has the safety in utilization of requirement up to specification.
Pharmacodynamics test
With body weight is that 90～110 gram rat and body weight are that 20～24 non-mouse inbred lines and the DBA/2 that restrain are that mice is an experimental animal.The strain of test tumor is respectively murine sarcoma (S
180), liver substance type (H
22), EC, U
27, W
256, and P
388Contrast is respectively the P-235 (PINGXIAO PIAN) (contrast 1) of Xi'an traditional Chinese medicines pharmaceutical factory and " XIAOJIN DAN " (contrast 2) of Chengdu medical material company with the group medicine.Drug test group medicine of the present invention is for getting above-mentioned experimental drug thing 10 grams, adding distil water soaks after 30 minutes for 100 milliliters, heated and boiled 20～30 minutes, squeeze filter with gauze while hot, after filtering residue adds the water boil filtration again, be concentrated into 100 milliliters the merging of twice filtrate and form that to contain the crude drug amount be 10% test medicinal liquid, pH6.0.
One, to the therapeutical effect of transplantability tumor strain
1. to S
180Therapeutical effect:
Get 50～60 of healthy mices, body weight grouping administration is pressed next day in inoculation back in abdominal cavity routinely, and an equal-volume normal saline is made blank simultaneously.Each treated animal is administered once every day, continuous 7～10 days.The result is as shown in table 1.Table 1 result shows, medicine of the present invention with lumbar injection to S
180Certain inhibitory action is arranged, and suppression ratio is 26%～54%.P-235 and XIAOJIN DAN do not have tumor-inhibiting action in the body.
Table 1 couple mice transplantability tumor strain S
180Influence
| Medicine group (mg/kg/ day) | Route of administration/number of times | The animal number of elements | Average tumor weight (g ± SD) | Suppression ratio (%) | The P value |
| The present invention (80) | IP×8 | 9 | 2.18±0.67 | 47.85 | ＜0.01 |
| Contrast 1 (200) | IP×8 | 9 | 4.22±0.64 | ||
| Contrast 2 (200) | IP×8 | 9 | 4.51±1.26 | ||
| Blank | IP×8 | 16 | 4.18±1.18 |
2. to the therapeutical effect of multiple transplantability tumor strain:
Test method is the same.Result of the test is as shown in table 2.Show that by table 2 result medicine of the present invention is to H
22, U
27And W
256By inhibitory action in various degree, wherein to H
22Effect better, to EC and P
388Curative effect not obvious.
The therapeutical effect of table 2 pair multiple transplantability tumor strain
| The tumor strain | Medicine group (mg/kg/ day) | Route of administration/number of times | The animal number of elements | Heavy (The average survival time the natural law) ± SD of average tumor | Suppression ratio (or increase in life span) (%) | The P value |
| H 22 | The present invention (80) | IP×10 | 10 | 0.88±0.11 | 69.12 | ＜0.001 |
| Blank | IP×10 | 10 | 2.85±0.85 | |||
| U 27 | The present invention (80) | IP×10 | 10 | 2.43±0.67 | 28.11 | ＜0.05 |
| Blank | IP×10 | 10 | 3.38±0.98 | |||
| W 256 | The present invention (50) | IP×7 | 8 | 5.33±2.32 | 38.66 | ＜0.01 |
| Blank | IP×7 | 8 | 8.69±3.16 | |||
| EC | The present invention (80) | IP×10 | 10 | 18.1 (my god) ± 5.13 | 9.04 | |
| The present invention (80) | SC×10 | 10 | 14.2 (my god) ± 4.16 | |||
| Blank | 10 | 14.2 (my god) ± 4.26 | ||||
| P 388 | The present invention (150) | PO×10 | 10 | 11.2 (my god) ± 3.16 | 13.13 | |
| Blank | PO×10 | 10 | 9.9 (my god) ± 2.78 |
Two, to the direct cytotoxicity of oncocyte
1. external inhibition test:
Get ehrlich carcinoma, S
180, H
220.1 milliliter of tumor strain cell suspension (cell number 6,000,000/milliliter), adding fills in the test tube of 0.8 milliliter of Hank ' s culture fluid respectively, and each pipe adds 0.1 milliliter of medicinal liquid to be tested, establishes the control tube that adds 0.1 milliliter of normal saline simultaneously.Each is managed mixing and puts 37 ℃ of cultivations 24 hours.Take out the back with the dyeing of 0.5 Yihong, compare by numeration of leukocyte method counting four big lattice intrinsic color dead cell numbers.The result is as shown in table 3.Table 3 result shows that medicine of the present invention all has remarkable cytotoxicity to three strain oncocytes, and the dead cell number is higher than matched group very significantly.P-235 is to S
180And H
22The obvious in-vitro suppression effect is also arranged, but to EC cell unrestraint effect.
The external inhibition test result of table 3
| Trial drug | Dead cell under the mirror (mean ± standard error) | ||
| The EC cell | S 180Cell | H 22Cell | |
| Medicine of the present invention | 147.5±6.9 * | 145.6±11.9 ** | 138.5±9.9 ** |
| Contrast 1 | 38.1±5.2 * | 161.9±23.1 ** | 93.2±10.1 * |
| Contrast 2 | / | 99.0±6.8 | 60.7±12.0 |
| Penicillin | / | 104.67±5.6 | / |
| Normal saline | 81.8±11.3 | 94.7±10.0 | 58.0±10.6 |
Annotate: compare with matched group in the table:
*Be P＜0.05,
*Be P＜0.01.
2. at 1: 3 H
22Add 1% the above-mentioned test of the present invention in per 2.0 milliliters of the suspension respectively with medicine, contrast 1 with contrast 2 medicines and normal saline, the rearmounted refrigerator of mixing took out in 2 hours.Each suspension is inoculated healthy mice right fore oxter respectively, and conventional breeding observing 10 days is dissected the title tumor and is weighed, and calculates suppression ratio.The result is as shown in table 4.Table 4 result demonstrates medicine of the present invention and contrast 1 medicine P-235 has tumor-inhibiting action in the halfbody, does not have inhibitory action in the halfbody and contrast 2 medicine XIAOJIN DAN.
Tumor-inhibiting action result of the test in table 4 halfbody
| Test group | Number of animals (only) | Average tumor weight ± SD (g) | Suppression ratio (%) | The P value |
| Medicine of the present invention | 9 | 1.49±0.31 | 55.5 | ＜0.01 |
| Contrast 1 | 9 | 0.23±0.07 | 93.1 | ＜0.01 |
| Contrast 2 | 9 | 3.78±1.15 | / | |
| Normal saline | 10 | 3.35±1.00 | / |
Three, to the filling stomach therapeutic test of transplantability tumor strain
ICR system and Kunming mouse with body weight 18～22 gram male and female half and half are experimental animal, and the above-mentioned test of the present invention is mixed well with the distilled water suspendible with medicine, is configured to the variable concentrations of 0.2,0.4 and 0.1 grams per milliliter respectively; To contrast the cyclophosphamide that 1 medicine and Shanghai No.12 Pharmaceutical Factory produce is control drug.With S
180, H
22And cervical cancer (U
14) the tumor strain, the tumor cell suspension for preparing 1: 4 under aseptic condition is in 0.2 milliliter of healthy animal right fore oxter inoculation.Inoculate back next day with the animal random packet, 10 every group.Drug component of the present invention is not established three dosage groups of 0.5,1.0 and 2.5 (gram/kg body weight), contrasts the dosed administration of 1 medicine group by 0.32 gram/kg body weight, and cyclophosphamide medicine group is by 25 mg/kg body weight dosed administrations.Each treated animal is irritated stomach once every day, 0.5 milliliter of every animal, and blank gives the equal-volume distilled water, and successive administration 10 days carries out zoografting tumor strain treatment according to the method for " screening anticancer medicine rules " and observes.Drug withdrawal was put to death animal in 24 hours, weighed, and dissection is peeled off and claimed tumor heavy, calculates the tumor control rate of respectively organizing trial drug.
The filling stomach therapeutic test correlated results of table 5 pair transplantability tumor strain
| The tumor strain | Group | Number of animals (only) | Dosage (g/kg) | Average tumor weight ± SD | Suppression ratio (%) | The P value |
| S 180 | Blank | 16 | - | 2.25±0.49 | ||
| Contrast 1 | 10 | 0.32 | 1.54±0.48 | 31.56 | ＜0.01 | |
| Medicine of the present invention | 10 | 0.5 | 1.56±0.57 | 32.67 | ＜0.01 | |
| Medicine of the present invention | 10 | 1.0 | 1.48±0.62 | 34.22 | ＜0.01 | |
| Medicine of the present invention | 10 | 2.5 | 1.36±0.47 | 39.56 | ＜0.01 | |
| H 22 | Blank | 16 | - | 3.25±0.49 | ||
| Contrast 1 | 10 | 0.32 | 2.75±0.65 | 15.38 | ＜0.05 | |
| Medicine of the present invention | 10 | 0.5 | 1.91±0.5 | 41.23 | ＜0.01 | |
| Medicine of the present invention | 10 | 1.0 | 1.57±0.49 | 51.69 | ＜0.01 | |
| Medicine of the present invention | 10 | 2.5 | 1.75±0.73 | 46.15 | ＜0.01 | |
| Cyclophosphamide | 10 | 0.025 | 0.75±0.13 | 76.92 | ＜0.01 | |
| U 14 | Blank | 16 | - | 2.62±0.77 | ||
| Medicine of the present invention | 10 | 0.5 | 2.11±0.83 | 19.47 | ＞0.05 | |
| Medicine of the present invention | 10 | 1.0 | 1.82±0.37 | 30.53 | ＜0.05 | |
| Medicine of the present invention | 10 | 2.5 | 2.03±0.94 | 22.52 | ＜0.05 | |
| Cyclophosphamide | 10 | 0.025 | 0.82±0.41 | 69.94 | ＜0.01 |
The correlation test result is shown in above-mentioned table 5.Table 5 result shows that medicine of the present invention is to sarcoma S
180And hepatocarcinoma H
22The obvious suppression effect is all arranged, but do not have dose-effect relationship between three dosage groups.Medicine wherein of the present invention is to S
180Effect close with contrast 1 medicine P-235, the inhibitory action of hepatocarcinoma then is better than P-235.To cervical cancer U
14Though suppression ratio do not meet efficacy assessment standard, handle the back by statistics and show that the middle and high dosage group of medicine of the present invention still has the suppression ratio of 20%-30%.All there were significant differences in statistical disposition between each drug test group and blank group.
Four, external to P
388The synthetic test of leukaemia DNA
To DBA/2N mice P
388Behind the cell 7 days, get ascites and become cell suspension with the RPMI1640 inoculum preparation, make cell concentration be about 3 * 16
6Cell number/milliliter.In some flat based tubes, add 0.5 milliliter of cell suspension respectively, 0.5 milliliter of the medicinal liquid of test group adding variable concentrations, matched group adds the equivalent culture fluid, put in the CO2 gas incubator 37 ℃ of effects 1 hour, handle cell with the diaphragm suction method, with liquid scintillation counter measurement cpm value, calculate and mix suppression ratio.The result is as shown in table 6.
Table 6 couple P
388Cell
3H-TdR mixes the inhibitory action of DNA
| Drug level (mg/ml) | cpm | Mix suppression ratio (%) |
| 0 | 57067 | - |
| 0.15 | 23955 | 58 |
| 1.5 | 9324 | 84 |
| 15 | 462 | 99 |
Table 6 result shows that medicine of the present invention is right
3H-TdR mixes P
388The DNA of cell is synthetic all inhibitory action, and inhibitory action increasing progressively and strengthen gradually with drug level.
Five, to the synthetic influence test of ehrlich carcinoma mice cancerous cell biomacromolecule
Test is Kunming mouse.The present invention's test is configured to medicament contg and is respectively 5%, 2.5%, 1.25%, the 0.63% concentration medicine group different with 0.32% after transferring to pH7.0 with the first sodium hydroxide with 0.1N of medicine.Label provides for Shanghai Atomic Nucleus Inst., Chinese Academy of Sciences
3The H-breast sweet (
3H-TdR, specific activity are 27.2ci/mm),
3H-urine sweet (
3H-UdR, specific activity are 13.3ci/mm) and
3The H-leucine (
3H-Leu, specific activity are 122ci/mm), scintillation solution is the xylene solution that contains 0.4%PPO and 0.01%POPOP.
Mice is abdominal cavity inoculation mice ehrlich carcinoma (EAC) cancerous cell routinely, and disconnected neck is put to death after 7 days, extracts cancer ascites liquid, and after the NS washing, Hank ' the s liquid that reuse contains 10% calf serum is prepared into 1 * 10
6The suspension of cell number/milliliter, the trial drug medicinal liquid of the present invention that adds labelled precursor and various dose after the grouping respectively, matched group adds the NS of equivalent, putting 37 ℃ of temperature incubated 1 hour, NS cessation reaction with pre-cooling, with suction method with cell harvesting on glass fiber filter, use NS, 5% trichloroacetic acid and absolute ethanol washing successively, the oven dry filter membrane, add and be equipped with in the measurement bottle of 5 milliliters of scintillation solutions, produce 2005 type liquid flashing counting determining CPM values with Xi'an, calculate and to mix the inhibition percentage rate, and calculate that to mix suppression ratio be 50% o'clock drug level (IC
50), to estimate drug potency.The result is as shown in table 7.Table 7 result shows that medicine of the present invention has the obvious suppression effect to cancerous cell biomacromolecule synthetic, its inhibitory action shows as the effect of RNA the strongest, DNA takes second place, to protein a little less than, show that its antitumaous effect may have certain relation with the inhibitory action to cancerous cell nucleic acid and protein synthesis.
The influence of table 7 couple mice ehrlich carcinoma mice cancerous cell DNA, RNA and protein synthesis
| Drug level (%) | 3H-TdR | 3H-UdR | 3H-Leu | |||
| CPM±SD | Mix suppression ratio (C-T/C) (%) | CPM±SD | Mix suppression ratio (C-T/C) (%) | CPM±SD | Mix suppression ratio (C-T/C) (%) | |
| 5 | 1908±205 | 77.40 | 3081±146 | 89.80 | 8282±525 | 37.31 |
| 2.5 | 2809±739 | 66.77 | 6498±105 | 78.50 | 11074±500 | 16.19 |
| 1.25 | 4157±23 | 50.82 | 12726±152 | 57.89 | 10612±561 | 19.67 |
| 0.63 | 6507±708 | 23.03 | 14946±193 | 50.55 | 11222±826 | 15.08 |
| 0.32 | 7237±174 | 14.39 | 24503±235 | 18.93 | 11881±248 | 10.08 |
| Contrast | 8454±432 | - | 30226±414 | - | 13213±716 | - |
| IC 50 | 1.925％(r＝0.8872，p＜0.025) | 1.209％(r＝0.8763，p＜0.025) | 7.920％(r＝0.9654，p＜0.005) | |||
The clinical treatment test
The operation indication maybe can not be put to generally losing, in chemotherapy or 273 examples that use is put, chemotherapy is invalid, patient with advanced cancer, all treat with above-mentioned pharmaceutical capsules.Patient age is 5 years old～85 years old, and wherein 56 years old～74 years old 132 example accounts for sum 48.35%; Through pathological diagnosis person's 204 examples, account for 74.7% among the patient,, account for 25.3% through clinical diagnosis person's 69 examples; Postoperative recurrence or transferrer 20 examples account for 7.33%; Through put, chemotherapy person's 79 examples, account for 28.94%; Through obeying other anticarcinogen person 29 examples, account for 10.62%; Through general Drug therapy person's 136 examples, account for 49.82%.
Therapeutic Method: respectively take medicine once every day sooner or later, and each 8 to 12,12 days is a course of treatment; Drug withdrawal is 2 days between per course of treatment, and be to control journey two courses of treatment; Whenever controlled between journey drug withdrawal 4 days.Clothes six monarch's balls if weakness of the spleen and stomach can be held concurrently, kidney qi loss can be held concurrently and be obeyed LIUWEI DIHUANG WAN, shenqi pill.
Efficacy assessment standard:
(1) alleviate fully: the complete obiteration of tumor enclosed mass, sick inspection report transfers feminine gender to by the positive, and the not recurrence above 1 month;
(2) part is alleviated: the product of focus enclosed mass maximum gauge and maximum perpendicular diameter thereof dwindles more than 50%, and other focus does not have increase, continues above 1 month;
(3) stable: two orthogonal maximum diameter products of focus dwindle less than 50%, or increase and be no more than 25%, continue more than 1 month;
(4) worsen: two orthogonal maximum diameter products of focus surpass more than 25%, and symptom obviously increases the weight of even be dead.
The statistical result of curative effect is as shown in table 8.
The curative effect statistics of table 8 clinical treatment malignant tumor
| Tumor type | Case load | Alleviate fully | Part is alleviated | Stable | Worsen |
| Hepatocarcinoma | 58 | 3 | 51 | 4 | |
| Pulmonary carcinoma | 43 | 2 | 36 | 5 | |
| Esophageal carcinoma | 41 | 3 | 36 | 2 | |
| Gastric cancer | 39 | 2 | 34 | 3 | |
| Rectal cancer | 23 | 1 | 2 | 18 | 2 |
| Nasopharyngeal carcinoma | 20 | 3 | 13 | 4 | |
| Uterus carcinoma | 18 | 2 | 15 | 1 | |
| Breast carcinoma | 15 | 1 | 12 | 2 | |
| Lymphosarcoma | 12 | 1 | 9 | 2 | |
| Acute leukemia | 4 | 3 | 1 | ||
| Add up to | 273 | 2 | 18 | 227 | 26 |
| Curative effect percentage rate (%) | - | 0.7 | 6.6 | 83.2 | 9.5 |
Table 8 result shows that for tumor, particularly malignant tumor medicine of the present invention has certain therapeutical effect.Improving the symptom of tumor patient, dwindle enclosed mass, particularly to some patients with advanced cancer and not competent operation or put, the patient of chemotherapy, dwindling enclosed mass, alleviating pain, palliating the agonizing sufferings, prolong and positive effect and value are arranged aspect the life span.
The viewpoint that once proposed as Li Shizhen (1518-1593 A.D.): mutual inhibition person, that takes me by force can be also, mutual restraint between two drugs person, the system that is subjected to that also, the opposite neither is harmonious also.The present invention is formed, is the aforementioned pharmaceutical compositions of characteristic to cure mainly mutually high by each opposite raw material composition of abnormal smells from the patient because of what Mechanism analysis proposed oncosis according to the traditional Chinese medical science, confirm to produce oncosis through above-mentioned every test and obviously suppress and one of the major reason of therapeutical effect just comes from this, this also is a key character of medicine of the present invention.
Claims (3)
1. the medicine that is used for the treatment of cancer is effective medicinal component by Radix Kansui, Radix Ginseng, the Radix Astragali, Agkistrodon, Natrii Sulfas, Radix Et Rhizoma Rhei and Fructus Jujubae, and the auxiliary interpolation composition composition of pharmacy permission, and its percentage by weight is:
Radix Kansui 6, Radix Ginseng 20, the Radix Astragali 15, Agkistrodon 9, Natrii Sulfas 20, Radix Et Rhizoma Rhei 15, Fructus Jujubae 15, the auxiliary interpolation composition that preparation allows is an amount of.
2. the medicine that is used for the treatment of cancer as claimed in claim 1 is characterized in that described medicine is a capsule formulation.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB011198699A CN1162169C (en) | 2001-07-03 | 2001-07-03 | Medicine 'Aibixiao' for treating cancer |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011198699A CN1162169C (en) | 2001-07-03 | 2001-07-03 | Medicine 'Aibixiao' for treating cancer |
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| CN1162169C true CN1162169C (en) | 2004-08-18 |
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