CN103191197B - Targeting formula antitumor anticancer agent and preparation method thereof - Google Patents
Targeting formula antitumor anticancer agent and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of targeting formula antitumor anticancer agent, polyrhachis after preparing, Placenta Hominis, Radix Hedysari, cordycepin, after Rhizoma Corydalis mixing, the medicinal distilled water of injection secondary is made liquor and is inserted container, filters after adding activated carbon treatment, add in water for injection and containing in the container of sodium chloride solution and dilute, stir.Water for injection regulates osmotic pressure through sodium hydroxide, and again uses metre filter, and filtrate should meet national GMP standard and assert that infusion solutions enterprise up to standard produces on request; Be sub-packed in the vial of 250ml or 500ml, pressure setting is set under 116 DEG C of conditions namely obtains targeting formula antitumor anticancer agent after sterilization in 0.39 MPa, temperature.The present invention is safe, nontoxic, have no side effect, and plays broad-spectrum anti-tumor, anticancer, anti-infectious function; This product, also containing abundant nutritional labeling, participates in Immunity regulation, improves generation level and the receptor expression level of interleukin II (1L-2).
Description
Technical field
Involved in the present invention is conventional Chinese medicinal preparation method and the chemical classes medicament using nothing taboo in " state-promulgated pharmacopoeia ", is one novel targeted formula antitumor anticancer agent after integrating and preparation method thereof specifically.
Background technology
Cancer remains and threatens one of topmost disease of human health at present, and it seizes the life of thousands of patients every year; Current atmospheric pollution, environmental pollution, tumor patient increase year by year.As far back as 50 to the seventies, the U.S. once dropped into a large amount of financial strengths, manpower, was determined to capture cancer in last century end.But; Even to this day, cancer remains global problem, and countries in the world, all at exploratory development exploitation cancer therapy drug, have multiple anticancer kind medicine newly to come out every year, but the various problems such as these medicine ubiquity weak curative effects, toxicity are large, appoint and so significantly do not break through in treatment.For the treatment of cancer, be still confined to operation so far, chemotherapy, radiotherapy is treatment means.
Summary of the invention
Usually carry out performing the operation to overcome tumor patient, radiotherapy, toxicity brings after chemotherapy means misery; The object of the present invention is to provide a kind of targeting formula antitumor anticancer agent.So-called molecular targeted therapy, on cellular and molecular level, corresponding medicine is designed for clear and definite carcinogenic site, medicine enters in body can be selected carcinogenic site to combine to have an effect specifically, make tumor cell specific dead, and the normal cell tissue that can not involve around tumor, so being meant to of targeting formula: have targeted, absorb more thoroughly, effect is better.
Another object of the present invention is to provide the preparation method of targeting formula antitumor anticancer agent.This method cost is low, production technology advanced simple, safety reliable, be produced on a large scale.
Object of the present invention realizes by following technical scheme:
A kind of targeting formula antitumor anticancer agent, containing following materials: polyrhachis 56% ~ 59%, Placenta Hominis 27% ~ 29%, Radix Hedysari 13% ~ 15%, cordycepin 0.05% ~ 0.15%, Rhizoma Corydalis 0.05% ~ 0.10%.
The preparation method of above-mentioned medicament, its step is as follows:
1. polyrhachis preparation
Polyrhachis: spring, summer, dig wild live body at western height above sea level more than 3500 meters Mining autumn to clean → in pure water biotechnology lethal after raising 7 → dry or 60 DEG C dry 7h dry → be stored in refrigerator for subsequent use → get refrigerator polyrhachis for subsequent use → pulverizings → mistakes 24 mesh sieve select dry powder → dry powder to be placed in CO extractor → regulate the molten device flow velocity 15L/h → extracting pressure 30MPa → temperature of extraction to be 60 DEG C at carry out 3h → collections extraction 80 DEG C of petroleum ether be separated → collect separating medium distillator be heated to 125 DEG C → control flow check liquid measure → distillate flow out cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by,
2. Healthy People Placenta Hominis preparation
Get Healthy People Placenta Hominis → centrifugal after pasteurizer → quick-freezing-20 DEG C → cutter section → with colloid mill grinds to form the appropriate Radix Hedysari enzyme hydrolysis of colloidization → add → boil the static 12h of ethanol of enzyme denaturing → injection 95%, 8000 turns per minute, centrifugal 20 minutes → removal precipitation → retain supernatant with cross-flow ultrafiltration equipment, gets the daltonian intacellin of molecular weight < 3000; Carry out filtering and obtain → load molten device degerming stand-by;
3. Radix Hedysari concocts preparation;
Removing impurity, size separate → get Radix Hedysari → clean → run through → cut sheet → drying → pulverizings → mistakes 24 mesh sieve select dry powder for subsequent use → inject distillator → add deionized water 23000ml to be heated to 125 DEG C → control flow check liquid measure → distillate outflow and to cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by;
4.. cordycepin: finished product is buied by domestic manufacturers or Tianfeng Biological Science & Technology Co., Ltd., Xi'an;
5.. Rhizoma Corydalis: finished product is buied by domestic manufacturers or national drug inspection institute.
The above medicinal distilled water 25000ml of secondary that 1. 2. 3. 4. 5. injects after raw material mixing for subsequent use is made liquor and inserts container, filter after adding activated carbon treatment, to add in total 380 liter waters for injection and containing 0.9% sodium chloride solution container in dilute, stir.Water for injection regulates osmotic pressure through sodium hydroxide, and again uses metre filter, and filtrate should meet national GMP standard and assert that infusion solutions enterprise up to standard produces on request; Be sub-packed in the vial of 250ml or 500ml, pressure setting is set under 116 DEG C of conditions namely obtains targeting formula antitumor anticancer agent after sterilization in 0.39 MPa, temperature.
[administrated method and consumption]: an adult patient slow intravenous injection of 250ml ~ 500ml (being advisable for 40 per minute), cuts down according to the circumstance or honor doctor's advice to patient with severe symptoms and child.It within 35 days, is a course for the treatment of; Interval 2 ~ 5 days start second course for the treatment of, total course for the treatment of 2 ~ 4, check clinical indices is up to standard can drug withdrawal for a long time.Reusable if desired to serious symptom patient.
[storage practice]: shady and cool, dry, sun-proof, moistureproof, leave the indoor of 10 DEG C ~ 25 DEG C in.
Efficacy of drugs
Polyrhachis has abundant nutritive value, and ant ovum contains the high quality protein of 42-69%, 28 kinds of free amino acids, and the trace element of more than 20 kind of needed by human, as zinc, calcium, ferrum, selenium, manganese etc.; Vitamin A, B1, B2, B5, B6, B12, C, D, E etc., and triterpenoid compound.Formic acid, cursive script formaldehyde, adenosine triphosphate etc. amount to more than 70 and plant nourishing composition.The nutritional labeling of Formica fusca the most comprehensively, the abundantest, the most balanced, there is most biological activity, the most natural, absorbance is the highest, and effect is the fastest.Formica fusca energy active cell, activating cell, regenerative cell, the division improving cell increases, and delays cell senescence, life lengthening.Formica fusca contains formic acid, has antiheumatic ability effective.
There is cursive script formaldehyde in Formica fusca, there is two-way immunoregulatory effect, mediator's body immunity function, balancing nutrients in body.Make functions of expelling toxin reach balance normal, Formica fusca has the effect of anti inflammatory detoxication.Polyrhachis antitumor, anticancer; The selenium unit contained have the effect of anticancer growth.Formica fusca is proved by expert clinical test, and anticancer rate reaches 38%.
Polyrhachis is a kind of tonic medicine of gentleness, has effect of strengthening the body resistance, life lengthening, kidney invigorating and YANG supporting, strong muscles and bones, eliminating blood stasis and smoothing collaterals, beauty treatment lactogenic, wherein particularly remarkable with the merit of the kidney invigorating.All applicable to the deficiency of YIN, yang deficiency, blood deficiency and deficiency in both Qi and blood, play the effects such as hepatoprotective, antiinflammatory, antibacterial, anti-cancer, anticancer, spasmolytic, calmness, analgesia after edible.Meanwhile, be used for the treatment of rheumatoid clinically, rheumatism, hepatitis B, expelling pathogens by strengthening vital QI, poliosis, sexual dysfunction, neurasthenia, the after being ill deficient property disease such as to be short of physical strength all have good curative effect.
The essence of human senility with blood stasis due to qi deficiency, QI and blood is unbalance.Benefiting QI for activating blood circulation, qi blood balance then delaying sanility, polyrhachis has significant effect in strengthening vital QI to eliminate pathogenic factors and blood circulation promoting and blood stasis dispelling.Thus, polyrhachis is again a kind of effective antidotal agent.
[effect]
1, trophocyte, activating cell, promotion cell;
2, there is broad-spectrum two-ways regulation, promote immunologic function;
3, antioxidation, antibacterial, rheumatism, blood fat reducing, blood sugar lowering, cholesterol reducing, anti-cancer, anticancer, prevent various diseases;
4, beauty and skin care, increase, increase intelligence, reinforcement, enhancing function, improve vision;
5, reconcile humanbody biological rhythm, regulate sleep;
6, be food and medicine and health product, the agent of complementary immunopotentiation dietetic therapy;
7, be a kind of immunostimulant and regulator;
8, be that one strengthens immune function of human body, anti-senile preparation comprehensively;
Therefore, polyrhachis it there is special physiological function in vivo, be one of indispensable composition in organism.
Placenta Hominis pharmacological action: after Placenta Hominis enters human body, can be used as antigen, does not need the auxiliary B cell that just can directly stimulate of T cell to produce antibody.Can induce and promote that T cell is broken up, maturation; Stimulate B cell to produce also secretory immune ball Radix Hedysari (antibody) and participate in Human immune responses, improve NKT (NK) vigor, when without antibody, target killing tumor (cancer) cell, play broad-spectrum anti-tumor, anti-infectious function, participate in immunomodulating, improve generation level and the receptor expression level of interleukin II (1L-2), strengthen the generation of exopathogenic factor mononuclear cell Y-interferon; Strengthen the active sk of SOD in serum and significantly increase lymphocyte function, the growth of tumour cell that effectively can prevent radiation kernel chemicotherapy and cause in polluting, the CD4+ that can prevent concurrent chemoradiotherapy of malignant tumor from causing reduces.Being a kind of Novel immune agent of modern medicine in a word, is modern immune treasure.The feature extracting Placenta Hominis is: high-purity property Placenta Hominis Placenta Hominis molecular weight is minimum, is only 3000 dalton, can intravenous injection and intramuscular injection.So it is more thorough to have selected intravenous injection to absorb in this product research manufacture process, effect is more obvious.
Effect of Radix Hedysari and effect: Radix Hedysari is the general designation of plant and Chinese crude drug.It is domestic that wild plant Radix Hedysari mainly originates in Gansu Province, is distributed in remote Dangchang, high and cold mountain area, Wudu, Xia Xian, Zhouqu County, Lintan, Jone, Wen County, Li County, Wushan, west and and the ground such as Linxia.Because Radix Hedysari root is used as medicine, the capable of using as feed or fuel of stem, leaf, mostly is artificial culture Radix Hedysari.For state three level protecting plant.
[function cures mainly] invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation., anorexia and loose stool weak for the deficiency of vital energy, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and blood deficiency and yellow complexion, interior-heat is quenched one's thirst, chronic nephritis proteinuria, diabetes.
[storage] puts aeration-drying place, moistureproof, mothproof.
Pharmacological action
1, normal rat is raised and after 1 week with the affairs containing Radix Astragali powder, is surveyed before its oxygen consumption ratio is taken medicine and increase gradually.
2, normal heart can be strengthened shrink, have cardiotonic to the heart of exhaustion.
3, this product can make tubular blood vessel and renal blood vessels expansion, and makes whole body peripheral vasodilation, and skin circulation is freely contained, and makes hyperpietic's blood pressure drops.
4, experimenter has carried out diuretic test on one's body, proves that the Radix Astragali has medium diuresis.
5, the Radix Astragali is clayed into power and is added feedstuff and feed 3 to rat, has and prevents Jishengshenqiwan effect.
6, the Radix Astragali has sedation to white mice, can maintain a few hours.
7, rabbit oral administration astragalus, can make blood glucose obviously decline.
8, to rat isolated uterine, there is excitation-contraction effect.
9, bacteriostatic test: this product all has inhibitory action to dysentery bacterium, anthrax bacillus, α-hemolytic streptococcus, beta hemolytic streptococcus, diphtheria corynebacterium, bacillus pseudodiphthericus, Diplococcus pneumoniae, staphylococcus aureus, Staphylococcus citreus, bacillus subtilis etc. in vitro.
Cordycepin: be a kind of natural bioactivity substance extracted from Cordyceps.Can water-soluble, ethanol.Cordycepin is the nucleic acid derivative of nitrogenous glycocide, belongs to purine alkaloid.Cordycepin is a kind of nucleoside kind new medicine, and 20 century 70s find that there is Tumor suppression antitumaous effect, causes the great attention of medical circle.Cordycepin entered for three clinic trial stages phase in the U.S. as anticancer, new antiviral drug at present; This kind also show the importance applied in this synthetics.
Rhizoma Corydalis: containing multiple isoquinoline alkaloid, have corydalis A,B,C,D, penta element, oneself element, heptan plain, Xin Su, the ninth of the ten Heavenly Stems element, certain herbaceous plants with big flowers is plain, son is plain, Chou prime, the third of the twelve Earthly Branches element, coptisine, dehydrogenation Corydaline, Rhizoma Corydalis amine alkali, dehydrogenation Rhizoma Corydalis amine alkali and ancient human relations amine alkali etc. the pharmacological action of Rhizoma Corydalis: analgesic activity, Rhizoma Corydalis powder has analgesic activity, and its pain relieving is tired and is about 1/100 of opium; Rhizoma Corydalis total alkaloids, Corydaline, B prime, Chou prime, Kui prime all have analgesic activity, stronger with B prime. various dosage form with alcohol extractum and powder effect strong; Calm, stable, syngignoscism: tetrahydropalmatine has certain calmness, stable effect, and its levo form is novel central inhibitor, has obvious syngignoscism during larger dose to rabbit, Canis familiaris L., monkey; Impact on digestive system: dehydrogenation Corydaline has significant anti-Experimental Gastric Ulcer in Rats effect to cardiovascular effect: tetrahydropalmatine, Chou prime have slight blood pressure lowering, decreased heart rate effect; Dehydrocory daline has blood pressure lowering, increases CBSF effect.In order to make patient remove pain as early as possible in this agent, have employed the use of intravenous injection agent method and absorbing more thoroughly, act on more obvious effect.
Above polyrhachis, Placenta Hominis, Radix Hedysari, cordycepin, Rhizoma Corydalis are made the overall merit after medicament and be: the indispensable required trace element of human body, we consider this point when selecting batching; Because: the feature of cancer major part patient " overabundance of pathogen causing excess syndrome, lack of vital essence resulting in deficiency syndrome ", take two-ways regulation, treat and promote immunologic function and get; The Therapeutic Principle of " strengthening vital QI to eliminate pathogenic factors, treating both the principal and secondary aspects of a disease ", improves immune function of human body very soon while targeting formula kills cancerous cell, removes the pain of patient, improves clinical symptoms, makes weak patient originally have the courage defeating cancer.This prescription is furtherd investigate from western medicine composition composition compatibility, make composition of prescription rationally more scientific, Technology is more advanced, after prescription mixing, its composition there occurs change, its pharmacodynamic feature there occurs new integration and works in coordination with, be different from the simple addition of single medicine effect, but their mechanism of action there occurs the change of matter, create a kind of effective peculiar effect of killing cancerous cell antitumor mechanism for cancer newly.
Animal is long anxious toxicology test repeatedly
This medicament is at the rat every day of lumbar injection 1.5g crude drug respectively, and 0.75g crude drug/kg, continuous 3 months, with the general status of NS group rat, to ingest, the indifference such as diet, feces character; Body weight increases; Peripheral hemogram; Liver and kidney function biochemical analysis; Important organ coefficient changes substantially identical with histopathology.The rat (often organizing each 10) stayed after drug withdrawal continues observation 3 weeks, and its histology's no abnormality seen changes.Have no in 3 weeks after drug withdrawal and produce Secondary cases toxic reaction.Show that this product life-time service in this dosage range is reliable and secure.
According to another test: according to the Toxicity test Methods of medicine, can not find the dosage that the intravenous injection of this medicament or lumbar injection cause mice 0% and 100% death, therefore this product intravenous injection or lumbar injection cannot be measured to the LD50 of mice.Use maximum tolerance determination method, with 0.05g crude drug/20g body weight, 3 times on the one mouse peritoneal injections, total dosage 7.5 crude drugs/kg, Continuous Observation 7 days, there is not toxic reaction or death in animal.Calculate 250 times that this product mice maximum tolerated dose on the one is equivalent to quantity, show that this product toxicity is very low, have no side effect, clinical application is safe; Have no adverse reaction.
These product are according to " Chinese Pharmacopoeia " version 2005
Pharmacodynamic study report shows: study this parenteral solution of preparation to the molecular mechanism of human liver cell HepG-2 antitumor action and the impact on cytoactive thereof.Method: with the Ultrastructural change of transmission electron microscope observing; The change of Hoechst33258 Fluorescent Staining Observation karyomorphism; Apply the change of the drip change of formula cell instrument (FCM) PI staining examine cell cycle and bcl-2, the two dye of AV/PI detects the change of cell membrane; ImmunohistochemistryMethods Methods measures the expression of Survivin albumen and NF-kBp65; With TRAP-PCR argentation, hepatoma carcinoma cell activity is detected.Result: Hoechst33258 fluorescence staining shows this product makes nucleus slightly concentrate; SABC shows the down-regulated expression (p < 0.0005) that this product makes Survivin albumen and NF-kBp65; After FCM testing result shows this product effect, S phase cell proportion increases, and G0/G1 phase and G2/M phase cell proportion decline (p < 0.01).Conclusion: this product, to the effect of human liver cancer cell mainly cancerous cell autophagy, causes cytoplasm vacuolar degeneration, endochylema content is degraded, and slight dyeing concentrates; Obvious change cell cycle, blocks cellular is in the S phase, and cell membrane phospholipid acyl serine turns up, and membrane structure changes; Its Induces Autophagy mechanism of action is main relevant with anticancer activity.This test is intended to study the mechanism of action of this medicament to human cancer cell.
The tumor-inhibiting action of this medicament medicine to mice-transplanted tumor and the laboratory observation of increase in life span
This medicament is the injection of a kind of western method processed of Chinese medicine, and the mechanism of action of its effect and Clinical practice is, the after birth structure of targeting formula destruction of cancer cells and sick cell, includes and separates cancer element 6000ppm, do not find toxic and side effects to human normal tissue.
In order to verify that this drug injection is to whether Tumor suppression growth and the effect of prolongation time-to-live of Mouse Transplantable tumor, this laboratory mice hepatocarcinoma (H22); Three kinds of tumor models such as murine fore-stomach carcinoma (FC) and mouse carcinoma of uterine cervix (U14) carry out curative effect evaluation and laboratory observation.
Materials and methods:
One, medicine
1. this drug injection liquid is that colourless transparent liquid 250ml is bottled, includes and separates cancer element 6000ppm, is a kind of material with the western method synthesis processed of Chinese medicine, is produced the finished medicines provided by Mr. He Zhonglin.
2. Matelin Gnhusheye injection, vivo antitumor experiment was once proved to be all has obvious antitumaous effect to mice S-180, EAC solid tumor and Lewis lung cancer, and this experiment act as positive controls medication, and produced by Harbin No.3 Pharmaceutical Factory and produce, lot number is: 961201.
Two, tumor model
1. rat liver cancer (H22), rate of vaccination 100%, within after subcutaneous transplantation 10 days, can have in the lymph node of 80% and shift, specimen laboratory is preserved.
2. murine fore-stomach carcinoma (FC) is high metastasis model in a strain lung, and subcutaneous vaccination can be survived 13-15 days.The tumor model that test chamber is set up with Methyl jasmonate.
3. mouse carcinoma of uterine cervix (U14): subcutaneous transplantation is solid carcinoma, and intraperitoneal injection can become ascites tumor, 12-14 days of generally can surviving after intraperitoneal injection oncocyte.It is the tumor strain that test chamber is set up and preserved.
Three, animal; 615 mices, are inbred line secondary animal, are bought by Chinese Academy of Medical Sciences's tumor, No. 9209M19, the animal quality certification, and this experiment is often criticized experiment and used same sex, and body weight is generally 18 ± 2 grams.
Four, tumour transplatation;
Three kinds of tumor cells, take out in liquid nitrogen, after recovery, the first subcutaneous and intraperitoneal inoculation at the axillary fossa of several mices of each oncocyte, solid tumor is when tumor body grows to 2cm size, put to death animal, the tumor tissue that growth selection is good, filter with stainless (steel) wire again after being cut into small pieces and make single cell suspension, after cell counting, often criticize experiment all to inoculate under mouse armpit by 2 × 10/0.2ml oncocyte, 5 groups are all inoculated in same area with identical oncocyte simultaneously, ascites tumor is generally take out ascites in 6-8 days after tumour transplatation, after normal saline adjustment cell number, 2 × 10/0.2ml tumor cell suspension is inoculated in mouse peritoneal.Often criticize experiment all identical.
Five, experiment grouping;
Tumor-like hyperplasia, often criticizes experiment at random after H22 and FC oncocyte axil subcutaneous transplantation and is divided into 5 groups to carry out simultaneously.
1, this drug injection liquid group: high, neutralize low three dosage groups, high dose group: after cancer cell transplantation 24 hours, by the intraperitoneal injection of 20ml/kg body weight, (2-4 of this dosage behaviour consumption is doubly)
2, middle dosage group is 10ml/kg body weight, dilutes 1 times by stock solution, and it is molten long-pending constant.
3, low dose group is 5ml/kg body weight, and it is molten long-pending still identical with high dose group.Every day 1 time, often criticize experiment, equal successive administration 11 days.
4, positive controls (Matelin Gnhusheye) group: every bottle of 10ml includes 500mg, this experiment dilution 50 times, by the intraperitoneal injection of 15mg/kg body weight, once a day, injection 11 times continuously, experiment dosage is lower than the maximum dose level of people.
5, negative control group, after tumour transplatation, intraperitoneal injection normal saline 0.3-0.4ml once a day, continuously injection 11 times.
Six, Index for examination;
1, tumor-like hyperplasia: after drug withdrawal, second day each treated animal is put to death simultaneously, peel off tumor body, weigh, by formula:
2, increase in life span: with rat liver cancer (H22) and mouse carcinoma of uterine cervix (U14) ascites tumor, by 2 × 10
6be divided at random after/0.2ml/ lumbar injection this product medicine injection high, neutralize low three dosage groups; Matelin Gnhusheye positive controls and normal saline negative control group.Often criticize 5 groups, totally four batches of experiments, the dosage of its medicine is all identical with tumor-like hyperplasia group with administration number of times.The natural death time is let alone after drug withdrawal, and with lower routine formulae discovery increase in life span:
Experimental result and discussion
Tumor-like hyperplasia experiment H22 and FC two strain tumor model, has carried out 4 batches of experiments altogether, often a collection of oncocyte inoculum concentration and transplantation site and dosage all identical with number of times etc., experimental result: Matelin Gnhusheye positive controls.4 batches of its suppression ratio of experiment are respectively 18.7%; 30%; 18.4% and 19.8% shows Matelin Gnhusheye in this experiment to rat liver cancer and murine fore-stomach carcinoma all not too sensitivity, therefore tumor-like hyperplasia is not high.Claim in Matelin Gnhusheye injection description, all have obvious inhibitory action to mice S-180, EAC solid tumor and Lewis lung cancer, and this tests tumor strain used difference, possible Matelin Gnhusheye is to the not too responsive event of H22 and FC tumor strain; The consumption of its two experiment dosage used and clinical patient is close, and whether dosage is lower relevant.Must checking further.
This product medicine injection tumor-like hyperplasia, the high dose group of four batches of experiments is respectively: 38.1%, P < 0.05,32.9%, p < 0.05; 32.7%, p < 0.05 and 31.3%, p < 0.05, and in and low dose group all lower than high dose group, particularly the 3rd batch and the 4th batch of experiment, namely this product injection all more than more than 30%, and has notable difference to the high dose group of murine fore-stomach carcinoma its tumor-like hyperplasia compared with negative control group, shows that this product medicine injection high dose has good experimental treatment effect to murine fore-stomach carcinoma (FC).
The result of this experiment also shows, this product medicine injection to rat liver cancer (H22) be no matter in and low dosage, its tumour inhibiting rate all more than 30%, but high dose group all higher than in and low dose group.
Increase in life span, in 4 batches of experiments, Matelin Gnhusheye positive controls its increase in life span compared with negative control group is respectively 5.78%-7.71%; 3.34% and 12.29%, show the extremely low even negative of its increase in life span.And its increase in life span of this product injection is compared with negative control group, be up to 19%, be generally about 5.5 ~ 15%, show that this product medicine injection also has certain life prolongation effect.
This experiment is entrusted: Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and preclinical medicine institute of China Concord Medical Science University, pathology room provides laboratory report.
The beneficial effect of advantage of the present invention and generation is:
1, solution of the present invention is based on to tumor and the understanding of cancer patient's state of an illness mechanism and the principle of Integrative medicine therapy, meticulously screens, tests, manufactures experimently out the Chinese medicine western goods kind pharmaceutical preparations of five kinds of effective chemical composition assemblys.The most important feature of the present invention is containing abundant nutritional labeling in medicament, plays broad-spectrum anti-tumor, anti-infectious function, participates in immunomodulating, improves generation level and the receptor expression level of interleukin II (1L-2).
2, can ease the pain for patient after using this medicine, rapidly strengthen patient's immunity of organisms, improve anorexia, a series of Signs such as tired, recover rapidly the confidence of existence, improve life in patients, extending life.Suitable therapeutic polytype tumor early, in, patient with advanced cancer.Clinic trial research shows: kind of the present invention can effectively Tumor suppression, anticancer, the health care effect of waiting for a long time.Through animal repeatedly toxicology test show, this pharmacy security, nontoxic, have no side effect, clinical application is safe.
3, the present invention prepares the crude drug of medicament use is " state-promulgated pharmacopoeia " kind without taboo, and kind raw material is many, use is wide, Functionality, quality and appealing design, cost of material are low, and crude drug is in liberal supply generally.This medicament compatibility is scientific and reasonable, the advanced science of production Technology, simple, convenience.This medicament medication has popularity, evident in efficacy, treatment cycle is short, without toxicity, have and the feature such as high safety.In sum, family members and patient are easy to accept use.
4, production technology of the present invention simple, be easy to operation, product has good stability, safety, evident in efficacy.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described:
Embodiment 1:
A kind of targeting formula antitumor anticarcinogen, its component is polyrhachis 57kg containing (% by weight), Placenta Hominis 28.5kg, Radix Hedysari 14.3kg, cordycepin 0.13kg, Rhizoma Corydalis 0.07kg.
Each for the present invention single medicine is extracted preparation method to be below described as follows:
Polyrhachis: spring, summer, autumn dig wild live body at western height above sea level more than 3500 meters Mining to clean → in pure water biotechnology lethal after raising 7 → dry or 60 DEG C dry 7h dry → be stored in refrigerator for subsequent use → to get from refrigerator polyrhachis 57kg → pulverizings → mistakes 24 mesh sieve select dry powder → dry powder to be placed in CO extractor → regulate the molten device flow velocity 15L/h → extracting pressure 30MPa → temperature of extraction to be 60 DEG C carry out 3h → collections extraction 80 DEG C of petroleum ether be separated → collect separating medium distillator be heated to 125 DEG C → control flow check liquid measure → distillate flow out cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by.
2. Placenta Hominis extraction and preparation technique: get 28.5kg Healthy People Placenta Hominis → centrifugal after pasteurizer → quick-freezing-20 DEG C → cutter is cut 1mm section → to grind to form with colloid mill colloidization → add 1300ml Radix Hedysari enzyme and is hydrolyzed → boils the static 12h of ethanol of enzyme denaturing → injection 95%, with 8000 turns per minute, centrifugal 20 minutes → removal precipitation → retain supernatant with cross-flow ultrafiltration equipment, gets the daltonian intacellin of molecular weight < 3000; Carry out filtering and obtain → load molten device degerming stand-by.
3. Radix Hedysari concocts preparation technology: removing impurity, size separate → get 14.3kg Radix Hedysari → clean → run through → cut 3mm sheet → drying → pulverizings → mistakes 24 mesh sieve select dry powder for subsequent use → inject distillator → add deionized water 23000ml to be heated to 125 DEG C → control flow check liquid measure 1200ml-1500ml → distillate outflow and to cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by.
4.. get 0.13kg cordycepin (finished product is buied by domestic manufacturers or Tianfeng Biological Science & Technology Co., Ltd., Xi'an)
5.. get 0.07kg Rhizoma Corydalis (finished product at home manufacturer or national drug inspection institute is buied)
The above medicinal distilled water 25000ml of secondary that 1. 2. 3. 4. 5. injects after raw material mixing for subsequent use is made liquor and inserts container, filter after adding activated carbon 370g process, to add in total 380 liter waters for injection and containing 0.9% sodium chloride solution container in dilute, stir.Water for injection regulates osmotic pressure through sodium hydroxide, and again uses metre filter, and filtrate should meet national GMP standard and assert that infusion solutions enterprise up to standard produces on request; Be sub-packed in the vial of 250ml or 500ml, pressure setting is set under 116 DEG C of conditions namely obtains targeting formula antitumor anticarcinogen after sterilization in 0.39 MPa, temperature.
[administrated method and consumption]: an adult patient slow intravenous injection of 250ml ~ 500ml (being advisable for 40 per minute), cuts down according to the circumstance or honor doctor's advice to patient with severe symptoms and child.It within 35 days, is a course for the treatment of; Interval 2 ~ 5 days start second course for the treatment of, total course for the treatment of 2 ~ 4, check clinical indices is up to standard can drug withdrawal for a long time.Reusable if desired to serious symptom patient.
[storage practice]: shady and cool, dry, sun-proof, moistureproof, leave the indoor of 10 DEG C ~ 25 DEG C in.
It is clinical that the present invention is applicable to each phase multiple types, the patient operated as being reluctant, lose surgical engine can patient and finish postoperative patient, the treatment of early, middle and late phase cancer.Especially with: pulmonary carcinoma, hepatocarcinoma, breast carcinoma, esophageal carcinoma, urological cancer, gynecological tumor etc. effect highly significant.Example one: hepatocarcinoma patient thank certain, man, 66 years old, feel uneasy hospital general of Beijing PLA 301 for 2005, do CT examination, to report the result display: see in liver that irregular lumps radioactive uptake increases stove, SUV maximum 16.81, average 7.56, delayed imaging SUV maximum 16.52, average 7.65, radioactive uptake is uneven, and center is the not dead band of radiation defect; Lower with the unenhanced corresponding site Density inhomogeneity of machine CT, visible 3 ~ 4 slightly low-density lump or tuberosity merge mutually, its boundary owes clear.Several little lump low-density shadow is still seen, CT value about 10HU, larger lump shadow about 2.7 × 2.2 × 2.5, edge clear in another liver.Patient diagnosed suffers from low-density hepatocarcinoma.After patient and family members recognize this product, determine to treat by this product.Patient's stable disease after medication first course for the treatment of, after medication second course for the treatment of, the state of an illness is controlled completely, and after medication the 3rd course for the treatment of, patient goes hospital's review result to show: lump shadow about 0.15 × 0.05 × 0.1, lump obviously reduces.Liver morphology normal in size, shows no obvious abnormalities acoustic image.Patient and family members determine that the course for the treatment of is carried out after treatment in use the 4th.Within 5 years, pay a return visit patient body to be afterwards in a good state of health.Example two: patient's flood certain, female, 43 years old, within 2007, Zhejiang tumour hospital carries out cervix uteri squama Ca total hysterectomy inside fascia+double accessory+pelvic cavity Radical dissection, and after 2 years, SCC continues to raise, health many places lymph metastasis.Aortic arch takes up left hilus pulumonis visible multiple hypermetabolic lymph node shadow, and maximum 14mm × 17mm part that is about merges as seen.The visible multiple lymph node shadow of both sides groin, maximum gauge is about 15mm, and the metabolism of PET corresponding position is not high.Family members and patient determine that medication is treated after recognizing this product, and after medication first course for the treatment of, patient's self-induction physical distress is alleviated to some extent, and appetite increases.After medication second course for the treatment of, patient's pain is removed completely, freedom of movement.After medication the 3rd course for the treatment of, patient goes hospital's review result to show: many places lymph node shadow obviously reduces, and aortic arch takes up left hilar lymph node shadow, is reduced into that 3mm × 1.5mm part is visible to be merged.Both sides inguinal lymph nodes shadow, is reduced into 3mm.Systemic sites and articular morphology, density and increased radioactivity show no obvious abnormalities.Visible conditions of patients obtains effectively significant treatment.The patient treated by this product is a lot, repeats no longer one by one; Some patients reaches complete.Since two thousand, this product antitumor anticarcinogen successively in Gansu, there is the patient come because of respect for the fame on Shandong, Heilungkiang, Liaoning, Beijing, Tianjin, Shenzhen, Guangdong, Zhejiang, the Inner Mongol, Hong Kong, the ground such as Taiwan, through various tumors, existing 3000 many cases of cancer patient that this product is effectively treated.Show according to our statistical data, total effective rate reaches more than 98%, and cure rate reaches more than 38%, and this pharmaceutical treatment is soon effective, and average medication just can be observed for 5 ~ 16 days, and patient oneself can experience, and 35 days medication phases were 1 course for the treatment of.Can remove the misery of cancer patient after using this product rapidly, the state of an illness of patient is controlled very soon, and some patients is cured and extended survival period, improves life quality.Shown in observation of curative effect statistical table:
The different tumor patient invention medicament clinical therapeutic efficacy of table 1:3006 example
| Sick kind | Case load | Invalid | Effective | Effective percentage | Cure | Cure rate | Appetite | Side reaction |
| Gastric cancer | 978 | 0 | 978 | 100％ | 324 | 33.1％ | Obvious increase | Nothing |
| Pulmonary carcinoma | 882 | 0 | 882 | 100％ | 354 | 40.1％ | Obvious increase | Nothing |
| Esophageal carcinoma | 354 | 6 | 348 | 98.3％ | 84 | 24.1％ | Obvious increase | Nothing |
| Hepatocarcinoma | 198 | 12 | 186 | 93.9％ | 30 | 15.1％ | Obvious increase | Nothing |
| Breast carcinoma | 234 | 12 | 222 | 94.9％ | 144 | 61.5％ | Obvious increase | Nothing |
| Cervical cancer | 144 | 6 | 138 | 95.8％ | 66 | 45.6％ | Obvious increase | Nothing |
| Hysteromyoma | 90 | 0 | 90 | 100％ | 84 | 93.3％ | Obvious increase | Nothing |
| Colorectal cancer | 60 | 6 | 54 | 90％ | 36 | 60％ | Obvious increase | Nothing |
| Cancer of pancreas | 48 | 12 | 36 | 75％ | 0 | 0 | Obvious increase | Nothing |
| Lymphatic cancer | 18 | 6 | 12 | 66％ | 0 | 0 | Obvious increase | Nothing |
| Sum | 3006 | 60 | 2946 | 98％ | 1122 | 38.8％ |
Different case observation is treated, treatment patient 3006 example, invalid 60 examples, effective 2946 examples, healing 1122 example from above-mentioned table 1; Total effective rate reaches more than 98%, and cure rate reaches more than 38%.Show that the present invention is significant in the curative effect of antitumor anticancer aspect.
Embodiment 2:
The present embodiment targeting formula antitumor anticancer agent adopts polyrhachis, Placenta Hominis, Radix Hedysari, cordycepin, Rhizoma Corydalis to be that raw material obtains, and its component (% by weight) is polyrhachis 57.8kg, Placenta Hominis 28kg, Radix Hedysari 14kg, cordycepin 0.13kg, Rhizoma Corydalis 0.07kg;
First by the refinement extraction of raw material list medicine and related art method as follows:
1. polyrhachis: the spring, the summer, autumn western height above sea level more than 3500 meters wild live bodies of exploration drilling clean → in pure water biotechnology lethal after raising 7 → dry or 60 DEG C dry 7h dry → be stored in refrigerator for subsequent use → to get from refrigerator polyrhachis 57.8kg → pulverizings → mistakes 24 mesh sieve select dry powder → dry powder to be placed in CO extractor → regulate the molten device flow velocity 15L/h → extracting pressure 30MPa → temperature of extraction to be 60 DEG C carry out 3h → collections extraction 80 DEG C of petroleum ether be separated → collect separating medium distillator be heated to 125 DEG C → control flow check liquid measure → distillate flow out cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by.
2. Placenta Hominis extraction and preparation technique: get 28kg Healthy People Placenta Hominis → centrifugal after pasteurizer → quick-freezing-20 DEG C → cutter is cut 1mm section → to grind to form with colloid mill colloidization → add 1300ml Radix Hedysari enzyme and is hydrolyzed → boils the static 12h of ethanol of enzyme denaturing → injection 95%, with 8000 turns per minute, centrifugal 20 minutes → removal precipitation → retain supernatant with cross-flow ultrafiltration equipment, gets the daltonian intacellin of molecular weight < 3000; Carry out filtering and obtain → load molten device degerming stand-by.
3. Radix Hedysari concocts preparation technology: removing impurity, size separate → get 14kg Radix Hedysari → clean → run through → cut 2mm sheet → drying → pulverizings → mistakes 24 mesh sieve select dry powder for subsequent use → inject distillator → add deionized water 23000ml to be heated to 125 DEG C → control flow check liquid measure 1200ml → 1500ml → distillate outflow and to cool in the molten device sterilizing of the rear loading of 0 DEG C → filtration stand-by.
4.. get 0.13kg cordycepin (finished product is buied by domestic manufacturers or Tianfeng Biological Science & Technology Co., Ltd., Xi'an)
5.. get 0.07kg Rhizoma Corydalis (finished product at home manufacturer or national drug inspection institute is buied)
The above medicinal distilled water 25000ml of secondary that 1. 2. 3. 4. 5. injects after raw material mixing for subsequent use is made liquor and inserts container, filter after adding activated carbon 370g process, to add in total 380 liter waters for injection and containing 0.9% sodium chloride solution container in dilute, stir.Water for injection regulates osmotic pressure through sodium hydroxide, and again uses metre filter, and filtrate should meet national GMP standard and assert that infusion solutions enterprise up to standard produces on request; Be sub-packed in the vial of 250ml or 500ml, pressure setting is set under 116 DEG C of conditions namely obtains targeting formula antitumor anticarcinogen after sterilization in 0.39 MPa, temperature.
[administrated method and consumption]: an adult patient slow intravenous injection of 250ml ~ 500ml (being advisable for 40 per minute), cuts down according to the circumstance or honor doctor's advice to patient with severe symptoms and child.It within 35 days, is a course for the treatment of; Interval 2 ~ 5 days start second course for the treatment of, total course for the treatment of 2 ~ 4, check clinical indices is up to standard can drug withdrawal for a long time.Reusable if desired to serious symptom patient.
[storage practice]: shady and cool, dry, sun-proof, moistureproof, leave the indoor of 10 DEG C ~ 25 DEG C in.
This research invention can also be realized by following embodiment: concrete preparation method and clean raw material gross weight and embodiment one, embodiment two are identical, no longer repeat below.
Embodiment 3:
Targeting formula antitumor anticarcinogen of the present invention obtain material by (% by weight) for following proportioning takes:
Polyrhachis 57.8%, Placenta Hominis 27.5%, Radix Hedysari 14.5%, cordycepin 0.10%, Rhizoma Corydalis 0.10%.
Complete strictly observe the condition of GMP standard operation in the process of processing under
Sterilization, sterilising temp are set in 116 DEG C;
Pressure setting is in 0.39 MPa.
Embodiment 4:
The material that obtains of targeting formula antitumor anticarcinogen of the present invention takes by (% by weight) following proportioning:
Polyrhachis 57.9kg, Placenta Hominis 27.8kg, Radix Hedysari 14.1kg, cordycepin 0.11kg, Rhizoma Corydalis 0.09kg.
Complete strictly observe the condition of GMP standard operation in the process of processing under
Sterilization, sterilising temp are set in 116 DEG C;
Pressure setting is in 0.39 MPa.
Embodiment 5:
The material that obtains of targeting formula antitumor anticarcinogen of the present invention takes by (% by weight) following proportioning:
Polyrhachis 58kg, Placenta Hominis 28.8kg, Radix Hedysari 13kg cordycepin 0.14kg, Rhizoma Corydalis 0.06kg.
Complete strictly observe the condition of GMP standard operation in the process of processing under
Sterilization, sterilising temp are set in 116 DEG C;
Pressure setting is in 0.39 MPa.
Embodiment 6:
The material that obtains of targeting formula antitumor anticarcinogen of the present invention takes by (% by weight) following proportioning:
Polyrhachis 58.8kg, Placenta Hominis 27.2kg, Radix Hedysari 13.8kg, cordycepin 0.15kg, Rhizoma Corydalis 0.05kg.
Complete strictly observe the condition of GMP standard operation in the process of processing under
Sterilization, sterilising temp are set in 116 DEG C;
Pressure setting is in 0.39 MPa.
In use process of the present invention, preferred 1st embodiment; Because this programme result of implementation shows:
Production technology is simple, be easy to operation, product has good stability, safety, evident in efficacy.
Claims (2)
1. a targeting formula antitumor anticancer agent, is made up of following materials medicine: polyrhachis 56% ~ 59%, Placenta Hominis 27% ~ 29%, Radix Hedysari 13% ~ 15%, cordycepin 0.05% ~ 0.15%, Rhizoma Corydalis 0.05% ~ 0.10%.
2. prepare the method for a kind of targeting formula antitumor anticancer agent described in claim 1, its step is as follows:
1. polyrhachis preparation
Polyrhachis: spring, summer, autumn excavate wild live body western height above sea level more than 3500 meters to clean → in pure water biotechnology lethal after raising 7 → dry or 60 DEG C dry 7h dry → be stored in refrigerator for subsequent use → get refrigerator polyrhachis for subsequent use → pulverizing → mistake 24 mesh sieve to select dry powder → dry powder to be placed in CO
2in extractor → regulate extraction container flow velocity 15L/h → extracting pressure 30MPa → temperature be carry out at 60 DEG C 3h → collections extraction 80 DEG C of petroleum ether be separated → collect separating medium distillator be heated to 125 DEG C → control flow check liquid measure → distillate flow out cooling 0 DEG C → to filter rear loading sterilizing containers stand-by;
2. Radix Hedysari concocts preparation;
Removing impurity, size separate → get Radix Hedysari → clean → run through → cut sheet → drying → pulverizings → mistakes 24 mesh sieve select dry powder for subsequent use → inject distillator → add deionized water 23000ml to be heated to 125 DEG C → control flow check liquid measure → distillate outflow and to cool at 0 DEG C → filtration rear loading sterilizing containers stand-by;
3. it is centrifugal after the ethanol getting Healthy People Placenta Hominis → grind to form colloidization → add Radix Hedysari enzyme hydrolysis → boil enzyme denaturing → injection 95% through pasteurizer → quick-freezing-20 DEG C → cutter section → with colloid mill leaves standstill 12h, 8000 turns per minute, centrifugal 20 minutes → removal precipitation → retain supernatant with cross-flow ultrafiltration equipment, gets the daltonian intacellin of molecular weight < 3000; Carry out filtering and obtain → load container degerming stand-by;
4.. cordycepin
5.. Rhizoma Corydalis
The above medicinal distilled water 25000ml of secondary that 1. 2. 3. 4. 5. injects after raw material mixing for subsequent use is made liquor and inserts container, filter after adding activated carbon treatment, add in the container containing the sodium chloride solution of 0.9% in total 380 liter waters for injection and dilute, stir; Water for injection regulates osmotic pressure through sodium hydroxide, and again uses metre filter, and filtrate should meet national GMP standard and assert up to standard, and enterprise produces on request; Be sub-packed in the vial of 250ml or 500ml, pressure setting is set under 116 DEG C of conditions namely obtains targeting formula antitumor anticancer agent after sterilization in 0.39 MPa, temperature.
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