CN1931314A - Medicine and its prepn process - Google Patents
Medicine and its prepn process Download PDFInfo
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- CN1931314A CN1931314A CNA2006101046296A CN200610104629A CN1931314A CN 1931314 A CN1931314 A CN 1931314A CN A2006101046296 A CNA2006101046296 A CN A2006101046296A CN 200610104629 A CN200610104629 A CN 200610104629A CN 1931314 A CN1931314 A CN 1931314A
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Abstract
The present invention discloses one kind of medicine and its preparation process. The medicine has the effective components of gynostemma pentaphylla, flavescent sophora root, notoginseng, Sichuan fritillary bulb, ginkgo and other six kinds of Chinese medicinal materials. It possesses the functions of clearing lung heat, dispersing obstruction, promoting blood circulation, relieving pain, detoxicating and eliminating phlegm. It is used in treating lung cancer alone or together with operation or chemotherapy. It may be prepared into different forms, including tablet, capsule, granule, etc. Clinical application shows that the medicine can control lung cancer, improve the symptom and raise the survival quality of lung cancer patient.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, particularly a kind of lung cancer drugs and preparation method thereof that is used for the treatment of, this medicine can be applied to prepare that lung heat clearing eliminating stagnation, promoting blood circulation and stopping pain, detoxifcation are reduced phlegm, the medicine of pulmonary carcinoma deficiency of both QI and YIN, the hot stasis-eliminating disease of expectorant, or as the adjuvant drug of pulmonary carcinoma operation, chemicotherapy, be not suitable for performing the operation and put, chemotherapy person's direct drug injection.
Background technology
Pulmonary carcinoma is one of common malignancy, and its M ﹠ M all is doubled and redoubled in many countries nearly recent decades, accounts for first and second position of male's malignant tumor.It is reported that when pulmonary carcinoma was made a definite diagnosis, most of cases had belonged to middle and advanced stage, wherein have only 15% case diagnosis seasonal disease changed situation limit, and 30% existing regional lymph node metastasis, 55% existing metastasis.Therefore, treatment is difficulty relatively, and curative effect is relatively poor.
Primary lung cancer is one of China's three big cancers, and annual about 100,000 people die from this disease, account for 1/7 of the total death toll of national cancer, and diagnosis belongs to late period more, loses the surgical engine meeting.
Other system's cancer is also threatening people's life.Present stage is is not only killed and wounded cancerous tissue to the radiotherapy of pulmonary carcinoma employing and the method for chemotherapy, also kills and wounds normal structure, especially hits more serious to the organ of regenerating vigorous.Go down as alopecia, hemopoietic function.Leukocyte is the bodyguard of human body, and the neutrophilic granulocyte absolute value is lower than 1500/mm
3, human body must be in Infection Status.The cancer patient causes leukopenia because of chemotherapy, recruits to uncontrollable infection and dead there is no lack of such people.Cause attending to one thing and lose sight of another in the treatment.
Adopt pure Chinese medicine to treat at present and also become the focus that the insider pays close attention to for pulmonary carcinoma.
Summary of the invention
The objective of the invention is to, a kind of medicine and preparation method thereof is provided, this medicine adopts pure Chinese medicine preparation, has the lung heat clearing eliminating stagnation, promoting blood circulation and stopping pain, the function of reducing phlegm of detoxifying, can be used in the pulmonary carcinoma deficiency of both QI and YIN, the hot stasis-eliminating disease of expectorant, be not suitable for performing the operation and put, chemotherapy person's treatment uses.Can be used as the adjuvant drug of pulmonary carcinoma operation, chemicotherapy.
In order to realize above-mentioned task, the technical solution that the present invention takes is: a kind of medicine, the crude drug and the percentage by weight thereof that it is characterized in that this effective ingredient of making are: gynostemma pentaphyllum extract: 7%～9%, Radix Picriae felterrae extractum: 7%～9%, Radix Notoginseng: 13%～15%, Bulbus Fritillariae Cirrhosae: 5%～7%, Semen Ginkgo: 7%～9%, the Rhizoma Pinelliae: 5%～7%, Cordyceps: 7%～9%, Ganoderma: 11%～13%, Margarita: 9%～11%, Colla Corii Asini: 5%～7%, the artificial Calculus Bovis: 13%～15%, the percentage by weight sum of above-mentioned raw materials medicine is 100%; The day of this medicine control is in the dosage, the ginsenoside Rg
1(C
42H
72O
14) content in 3.0mg～20mg scope.
Said medicine prepares the method for pill, it is characterized in that:
At first get gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini nine flavor crude drug, be ground into fine powder by formulation weight percentage ratio;
Get crushing pearl by formulation weight percentage ratio in addition, and through carefully being developed into the Margarita impalpable powder;
Get the artificial Calculus Bovis by formulation weight percentage ratio and be ground into fine powder;
With Calculus Bovis fine powder and crude drug fine powder, Margarita impalpable powder facing-up, sieve, mixing is used water pill, and pill is made in oven dry below 80 ℃;
Or in the fine powder of mixing, add appropriate amount of auxiliary materials in addition, make all pharmaceutical dosage forms of tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or pharmacopeia regulation, ginsenoside Rg in each dosage form dosage on controll day
1(C
42H
72O
14) content in 3.0～20mg scope.
In this medicine, add appropriate amount of auxiliary materials in addition, make pill, tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or or all medicine agent of pharmacopeia regulation.
The another kind of preparation method of said medicine is: at first get gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, be ground into fine powder by formulation weight percentage ratio;
In addition by formulation weight percentage ratio get Margarita powder, artificial Calculus Bovis's pulverize separately becomes fine powder;
Get decoct with water after Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini crude drug are pulverized three times, filter, be condensed into extractum, crushed after being dried becomes fine powder;
, sieve above each fine powder facing-up by the formulation weight percentage, mixing is used water pill, and pill is made in oven dry below 80 ℃;
Or in the fine powder of mixing, add appropriate amount of auxiliary materials in addition, make all pharmaceutical dosage forms of tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or pharmacopeia regulation, ginsenoside Rg in each dosage form dosage on controll day
1(C
42H
72O
14) content in 3.0～20mg scope.
The ginsenoside Rg
1(C
42H
72O
14) content measure as follows:
It is an amount of to get the above-mentioned pharmaceutical dosage form of making, and prepares solution to be measured with methanol, uses the ginsenoside Rg
1Product are filler with octadecylsilane chemically bonded silica in contrast;
Acetonitrile-water is a mobile phase, and the ratio of mobile phase is: acetonitrile: water=(10～40): (90～40), the detection wavelength is 193～213nm, number of theoretical plate is by the ginsenoside Rg
1The peak calculates and is not less than 1000, accurately measures wherein ginsenoside Rg with high performance liquid chromatograph in the above conditions
1(C
42H
72O
14) content, ginsenoside Rg in the controll day dosage
1(C
42H
72O
14) content in 3.0～20mg scope.
Medicine of the present invention can be used in preparation and has lung heat clearing eliminating stagnation, promoting blood circulation and stopping pain, the reduce phlegm medicine of function of detoxifcation, this medicine is used for the pulmonary carcinoma deficiency of both QI and YIN, the hot stasis-eliminating disease of expectorant, be not suitable for operation and put, chemotherapy person's medicine for treatment, also can be used as the ancillary drug of pulmonary carcinoma operation, chemicotherapy.Prove that through pharmacology and toxicological experiment and clinical observation thereof patient's back cancerous protuberance of taking medicine is controlled, malaise symptoms improves, and has improved the life quality of patients with lung cancer greatly, prolongation in various degree life.
The specific embodiment
Below in conjunction with the present invention being described in further detail through pharmacology and toxicological experiment and clinical observation thereof.
One, prescription:
Gynostemma pentaphyllum extract: 7%～9%; Radix Picriae felterrae extractum: 7%～9%; Radix Notoginseng: 13%～15%, Bulbus Fritillariae Cirrhosae: 5%～7%, Semen Ginkgo: 7%～9%; the Rhizoma Pinelliae: 5%～7%; Cordyceps: 7%～9%, Ganoderma: 11%～13%, Margarita: 9%～11%; Colla Corii Asini: 5%～7%, artificial Calculus Bovis: 13%～15%.
Two, preparation method
The first step is at first got gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini nine flavor crude drug by formulation weight percentage ratio, is ground into fine powder;
Second step, get crushing pearl by formulation weight percentage ratio, and through carefully being developed into the Margarita impalpable powder;
The 3rd step; get the artificial Calculus Bovis by formulation weight percentage ratio and be ground into fine powder; with fine powder, Margarita impalpable powder facing-up; sieve, mixing is used water pill; oven dry below 80 ℃; make pill, or add appropriate amount of auxiliary materials in addition, all can be for oral pharmaceutical dosage form to make tablet, capsule, granule, chewable tablet, drop pill, soft capsule etc.
Perhaps will at first get gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, be ground into fine powder by formulation weight percentage ratio; In addition by formulation weight percentage ratio get Margarita powder, artificial Calculus Bovis's pulverize separately becomes fine powder; Get decoct with water after Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini crude drug are pulverized three times, filter, be condensed into extractum, crushed after being dried becomes fine powder; Press the formulation weight percentage with above fine powder facing-up, sieve, mixing, use water pill, oven dry below 80 ℃, make pill, or add appropriate amount of auxiliary materials in addition, make " all pharmaceutical dosage forms under the Chinese pharmacopoeia appendix item such as tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository.
Perhaps incite somebody to action Radix Notoginseng wherein, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma, be ground into fine powder after decocting boil three times, filter,, add 60--90% ethanol precipitation, filtration, recovery ethanol, add gynostemma pentaphyllum extract, Radix Picriae felterrae extractum is ground into fine powder again after the drying; Then with Margarita powder, artificial Calculus Bovis's fine powder facing-up; cross 80 mesh sieves; mixing after powder to be mixed all sieves; use water pill; oven dry below 80 ℃; make pill, or add appropriate amount of auxiliary materials in addition, make " all pharmaceutical dosage forms under Chinese pharmacopoeia (appendix) item such as tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository.
Perhaps wherein Radix Notoginseng, Semen Ginkgo, Ganoderma are used twice of 50--80% alcohol reflux; concentrate; medicinal residues and Bulbus Fritillariae Cirrhosae, the Rhizoma Pinelliae, Colla Corii Asini add water with boiling three times; with backflow merge be concentrated into relative density 1.10-1.25 (60 ℃ of heat are surveyed) after; add gynostemma pentaphyllum extract; Radix Picriae felterrae extractum; Margarita powder, artificial Calculus Bovis's fine powder; sieve; mixing; add appropriate amount of auxiliary materials, make " all pharmaceutical dosage forms under Chinese pharmacopoeia (appendix) item such as pill, tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository.
Below be the embodiment that the inventor provides, need to prove, the invention is not restricted to these embodiment.
Embodiment 1: get gynostemma pentaphyllum extract: 8%, and Radix Picriae felterrae extractum: 8%, Radix Notoginseng: 14%, Bulbus Fritillariae Cirrhosae: 6%, Semen Ginkgo: 8%, the Rhizoma Pinelliae: 6%, Cordyceps: 8%, Ganoderma: 12%, Margarita: 10%, Colla Corii Asini: 6%, artificial Calculus Bovis: 14%, wherein gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini nine flavor crude drug are ground into fine powder, again with crushing pearl and through carefully being developed into the Margarita impalpable powder; The artificial Calculus Bovis is ground into nine flavor crude drug fine powders such as fine powder and above-mentioned gynostemma pentaphyllum extract, Margarita impalpable powder facing-up, crosses 80 mesh sieves, and mixing after powder to be mixed all sieves is used water pill, and oven dry obtains the 1000g pill and gets final product below 80 ℃.
Embodiment 2: get gynostemma pentaphyllum extract: 8%; Radix Picriae felterrae extractum: 8%; Radix Notoginseng: 14%; Bulbus Fritillariae Cirrhosae: 6%; Semen Ginkgo: 8%; the Rhizoma Pinelliae: 6%, Cordyceps: 8%, Ganoderma: 12%; Margarita: 10%; Colla Corii Asini: 6%, the artificial Calculus Bovis: 14%, incite somebody to action wherein gynostemma pentaphyllum extract; the Radix Picriae felterrae extract powder; Radix Notoginseng; Bulbus Fritillariae Cirrhosae; Semen Ginkgo; the Rhizoma Pinelliae; Cordyceps; Ganoderma and Colla Corii Asini nine flavor crude drug; be ground into fine powder; with crushing pearl and through carefully being developed into the Margarita impalpable powder, the artificial Calculus Bovis is ground into nine flavor crude drug fine powders such as fine powder and above-mentioned gynostemma pentaphyllum extract again; Margarita impalpable powder facing-up; cross 80 mesh sieves; mixing after powder to be mixed all sieves adds appropriate amount of auxiliary materials, makes tablet; capsule; granule; chewable tablet; drop pill; soft capsule etc. all can be for oral pharmaceutical dosage form.
Embodiment 3: get gynostemma pentaphyllum extract: 8%, and Radix Picriae felterrae extractum: 8%, Radix Notoginseng: 14%, Bulbus Fritillariae Cirrhosae: 6%, Semen Ginkgo: 8%, the Rhizoma Pinelliae: 6%, Cordyceps: 8%, Ganoderma: 12%, Margarita: 10%, Colla Corii Asini: 6%, the artificial Calculus Bovis: 14%, get Radix Notoginseng wherein, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma is ground into fine powder after decocting boils three times, filtration, add gynostemma pentaphyllum extract, Radix Picriae felterrae extractum is ground into fine powder again after the drying; With Margarita powder, artificial Calculus Bovis's fine powder facing-up, cross 80 mesh sieves then, mixing after powder to be mixed all sieves adds suitable adjuvant then and makes 1000g pill, tablet according to a conventional method or incapsulate interior getting final product.
Embodiment 4: get gynostemma pentaphyllum extract: 8%, and Radix Picriae felterrae extractum: 8%, Radix Notoginseng: 14%, Bulbus Fritillariae Cirrhosae: 6%, Semen Ginkgo: 8%, the Rhizoma Pinelliae: 6%, Cordyceps: 8%, Ganoderma: 12%, Margarita: 10%, Colla Corii Asini: 6%, the artificial Calculus Bovis: 14%, get Radix Notoginseng wherein, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma is ground into fine powder after decocting boils three times, filtration, adds 80% ethanol precipitation, filtration, recovery ethanol, add gynostemma pentaphyllum extract, Radix Picriae felterrae extractum is ground into fine powder again after the drying; With Margarita powder, artificial Calculus Bovis's fine powder facing-up, cross 80 mesh sieves then, mixing after powder to be mixed all sieves adds suitable adjuvant then and makes 1000g pill, tablet according to a conventional method or incapsulate interior getting final product.
Embodiment 5: different is that preparation method changes to some extent for present embodiment and embodiment 2; be about to Radix Notoginseng; Semen Ginkgo; Ganoderma is with twice of 75% alcohol reflux; concentrate; medicinal residues and Bulbus Fritillariae Cirrhosae; the Rhizoma Pinelliae; Colla Corii Asini adds water with boiling three times; with backflow merge be concentrated into relative density 1.20-1.25 (60 ℃ of heat are surveyed) after; add gynostemma pentaphyllum extract; Radix Picriae felterrae extractum; Margarita powder; artificial Calculus Bovis's fine powder; sieve; mixing adds appropriate amount of auxiliary materials, makes pill; tablet; capsule; granule; chewable tablet; drop pill; soft capsule; syrup; oral liquid; " all pharmaceutical dosage forms under Chinese pharmacopoeia (appendix) item such as suppository.
Embodiment 6: different is to fill a prescription to change to some extent for present embodiment and embodiment 1, that is, and and gynostemma pentaphyllum extract: 90g; Radix Picriae felterrae extractum: 70g, Radix Notoginseng: 150g, Bulbus Fritillariae Cirrhosae: 50g; Semen Ginkgo: 90g; the Rhizoma Pinelliae: 70g, Cordyceps: 75g, Ganoderma: 125g; Margarita: 90g; Colla Corii Asini: 60g, artificial Calculus Bovis: 130g, all the other are with embodiment 1.
Embodiment 7: different is to fill a prescription to change to some extent for present embodiment and embodiment 2, that is, and and gynostemma pentaphyllum extract: 75g; Radix Picriae felterrae extractum: 90g, Radix Notoginseng: 145g, Bulbus Fritillariae Cirrhosae: 50g; Semen Ginkgo: 70g; the Rhizoma Pinelliae: 50g, Cordyceps: 85g, Ganoderma: 115g; Margarita: 110g; Colla Corii Asini: 70g, artificial Calculus Bovis: 140g, all the other are with embodiment 1.
Embodiment 8: different is that preparation method changes to some extent for present embodiment and embodiment 4, it is mixing after raw material fine powder to be mixed all sieves, with 50-60% Oleum Glycines is substrate, it is emulsifying agent that content adds with the soybean phospholipid, 3%PEG200---400 and 2.8% propylene glycol is a suspending agent, Cera Flava be suspension stable and, PG (Propyl gallate) (0.1%) is an antioxidant, ethyl hydroxybenzoate is an antiseptic, the preparation mixed liquor, add above-mentioned 25-35% raw material fine powder and prepare suspension, be the soft capsule implant; With 45% gelatin, 20% glycerol, 8.2% mixed plasticizer and water are the soft capsule shell material, embedding soft capsule, pro ore.Selected technology soybean phospholipid consumption is 2.5% in above prescription, and the Cera Flava consumption is 4% o'clock, the flowability of the mixed liquor that is prepared into, cuttability and optimal stability.
Embodiment 9: different is that preparation method changes to some extent for present embodiment and embodiment 4, the raw material fine powder promptly to be mixed back mixing that all sieves, in the water that newly boiled, add sucrose dissolved earlier after, boil, filter in case of necessity, make simple syrup, add the mixed raw materials fine powder then, dissolving is boiled, add the 0.5%PVP cosolvent, 0.09% sorbitol, embedding behind the standardize solution, make the syrup pro ore, and to be not less than 75% (g/ml) with sugar content be the best.
Embodiment 10: different is that preparation method changes to some extent for present embodiment and embodiment 3, it is mixing after raw material fine powder to be mixed all sieves, add the brown sugar of 1.46 times of amounts and the Mel of 0.54 times of amount, heating is dissolved and was kept little 2.2-2.5 of boiling hour, be concentrated into relative density 1.45 (80 ℃ of hot sides), get soft extract, pro ore.
Embodiment 11: different is that preparation method changes to some extent for present embodiment and embodiment 4, is about to raw material fine powder to be mixed and is divided into impalpable powder, and the back mixing that all sieves is standby.Get cacao bean ester and lanoline and mix with arbitrary proportion, heating is dissolved, and adds the 2.8-4.2% Cera Flava and melts, and is heated to the raw material impalpable powder of adding 38% after 55 ℃, stirs evenly the filling mould, makes rectal suppository, for rectal application.
Embodiment 12: it is an amount of to get all pharmaceutical dosage form such as the above-mentioned pill of making, tablet, capsule, granule, chewable tablet, drop pill, soft capsule, porphyrize, and precision takes by weighing 4g, put in the tool plug conical flask, precision adds methanol 25ml, claims to decide weight, supersound process 30 minutes is taken out, and puts cold, weight decided in title again, supplies with methanol to subtract weight loss, shakes up, filter, get subsequent filtrate, as need testing solution, precision takes by weighing the ginsenoside Rg in addition
1Reference substance is an amount of, and add methanol and make the contrast solution that every 1ml contains 0.3mg, be filler with octadecylsilane chemically bonded silica; Acetonitrile-water (22: 78) is a mobile phase; The detection wavelength is 203nm.Number of theoretical plate is by the ginsenoside Rg
1The peak calculates, and should be not less than 2000.Draw each 20 μ l of reference substance solution and need testing solution respectively, inject chromatograph of liquid, accurately measure wherein ginsenoside Rg
1(C
42H
72O
14) content, ginsenoside Rg in the controll day dosage
1(C
42H
72O
14) content in 3.0mg～20mg scope.
The all right exclusive list of the foregoing description, but as long as all can prepare qualified product at formula range of the present invention.
The lung cancer drugs that is used for the treatment of of the present invention, on treatment pulmonary carcinoma, catch vigorate qi and replenish the blood, strengthening vital QI to eliminate pathogenic factors, Yin Yang balancing three greatly at all, the anti-cancer ability of across-the-board regulation body and adaptive capacity have the theoretical basis and the material base that suppress tumor growth, human body immunity improving.This product is used for lung cancer therapy, and is applied clinical, can the enhancing human body immunity function, certain inhibition tumor growth is arranged, the effect of disease controlling.And to human body immunity improving power, especially to general state and the pain relieving that improves patients with advanced cancer, the quality of making the life better, to improve treatment confidence particularly evident; Its control to pulmonary's chronic inflammatory disease has certain effect, and not only can change the symptom of whole body after the medication, and the inflammation of pulmonary is absorbed, and it has clear and definite therapeutical effect to pulmonary carcinoma.
The Fourth Military Medical University has carried out the vivo and vitro pharmacodynamic study to this medicine proves that this product is woven with the obvious suppression effect to the mice adenoma group, especially the nude mice lung squamous cancer is had significant inhibitory effect and radiosensitizing effect; External pharmacodynamic study proves that pulmonary carcinoma, hepatocarcinoma and the strain of carcinoma of tongue glucagonoma are had obvious suppression effect inhibitory action; It duplicates the low drag of rat body's immunity to cyclophosphamide this product to CYT and has significant therapeutic effect, and is better than the levamisole of Isodose.This medicine has the cellular immunization of enhancing and humoral immune function, can improve Turnover of Mouse Peritoneal Macrophages and engulf the ability of chicken red blood cell and the activity of mouse spleen natural killer cell; Growth to 4 kinds of transplanted tumors of mice all has the obvious suppression effect, inhibitory rate 39%.
Theory of Chinese medical science thinks that lung is the source of gasification, the benefit of the five internal organs, empty as honeybee is from, following no key, suction then completely, the then void of exhaling is taken charge of the turbid change of slag, is the hinge of person QI and blood mediation.Lung being a delicate viscus is subject to evil poison invasion and attack, causes the respectful mistake department of falling of lung qi; Stasis is not declared, and venation is not smooth, stagnation of QI-blood, and the malicious stasis of blood is tied mutually, forms lump for a long time.Therefore, pulmonary carcinoma takes place with the deficient and evil poison invasion of healthy energy in close relations.The healthy energy interior-deficiency, the internal organs imbalance of YIN and YANG is the basis of suffering from primary disease.
Through a large amount of clinical observations, the present invention has the inhibition growth of tumour cell, protection hemopoietic system and functions of immune system; Reduce the infringement of chemicals and carcinous toxin to hemopoietic system; The patient take medicine the back cancerous protuberance be controlled, malaise symptoms improves, thereby has improved the life quality of patients with lung cancer greatly, prolongation in various degree life.Its function cures mainly to powder for clearing lung-heat and separates, promoting blood circulation and stopping pain, and detoxifcation is reduced phlegm, strengthening the body resistance.Be used for lung cancer therapy, the enhancing human body immunity function.
Three, the pharmacodynamic experiment data that pharmacological experiment---the present invention is relevant with therapeutical effect
1. experiment material
Medicine: medicine of the present invention is the yellow black fine granularity, becomes 40% solution for standby with physiological saline solution; 5-fluorouracil (5-fu) is produced by Nantong pharmaceutical factory, is prepared into 1.25mgml with normal saline
-1Standby.Calf serum: the Hanzhong biochemical-pharmaceutical factory is produced, RPMI1640 dry powder (U.S.), pancreatin (sigma).
Animal: the BALB/c-nu nude mice, Kunming mouse is provided by The Fourth Military Medical University zoopery center.Nude mice is raised in isolator, and experiment is all with all apparatuses, feedstuff, water etc. that sterilize in the cobalt source or autoclaving, and with the nude mice feedstuff of standard.Mice is fed 23 ± 2 ℃ of indoor temperatures with full-valence pellet feed.
Cell strain: lung squamous cancer, adenocarcinoma are provided by The Fourth Military Medical University zoopery center.
1.2 experimental technique
Cell culture: the RPMI1640 culture fluid of 10% calf serum contains glutamine 0.03%, each 100 μ g/ml of penicillin and streptomycin
-1, cell strain is the adherent growth cell, according to a conventional method at 37 ℃ CO
2Cultivate in the incubator.
Oncocyte inoculation: the oncocyte that will be in exponential phase is through 0.25% trypsinization 5min, blows and beats gently with suction pipe and takes off wall, collects, centrifugal, washing, and with the blue dyeing counting of Placenta Hominis, cell survival rate all reaches more than 95%, and cell concentration is adjusted to 1 * 10
-1.ml
-1, place the transmission box to import superclean bench into nude mice, in nude mice or mice body, inoculate.
Nude mice, body weight 16 ± 2g; Mice 18 ± 2g, the male and female dual-purpose, random packet in the body behind the inoculated tumour cell 1 day, is irritated stomach 1g of the present invention, 4g, 8g.kg respectively
-1, 5-fu25mg.kg
-1Or isometric normal saline (0.2ml.kg
-1), totally 14 days, take off neck and put to death, peel off every mice or nude mice left hind place side tumor is weighed, and calculate its suppression ratio respectively.
Irradiation source:
60The bent The Fourth Military Medical University of Co is auxilliary to hit chamber, heart cobalt source provides, irradiation distance 130cm, and dosage 186.84 rads/minute, nude mice is fixed with special lucite box, exposes tumor locus, and remainder shields with the thick stereotype of 5cm, after seven days, tumor tissues reaches 8mm at inoculated tumour and drug treatment
3Begin radiotherapy when above, the time, 2 hours irradiation treatments were once after administration.
3. experimental result
3.1 inhibitory action (table 1) to the nude mice tumor tissues
Table 1 the present invention is to the inhibitory action (X ± SD, n are all=5) of nude mice adenocarcinoma of lung tumor tissue
| Group | Tumor heavy (g) | Suppression ratio (%) |
| Matched group | 2.83±0.19 | 0 |
| 1g/kg (the present invention) | 2.80±0.21 | 1.1 |
| 4g/kg (the present invention) | 1.93±0.15＊＊ | 31.8 |
| 8g/kg (the present invention) | 1.39±0.17＊＊ | 50.8 |
| 5-Fu25mg/kg | 0.89±0.14＊＊ | 68.5 |
Compare * * P＜0.01 with matched group
As seen from Table 1: medicine 4g/kg of the present invention, 8g/kg have the obvious suppression effect to nude mice adenocarcinoma, and tumour inhibiting rate is respectively 31.8% and 50.8%; But its effect is little than 5-Fu.
3.2 inhibitory action (table 2) to lung squamous cancer
Table 2 the present invention is to the inhibitory action (X ± SD, n are all=20) of mouse lung scale cancer
| Group | Tumor heavy (mg) | Suppress (%) |
| Matched group | 312.0±70.1 | 0 |
| 4g/kg (the present invention) | 247.2±61.2＊＊ | 20.8 |
| 8g/kg (the present invention) | 121.1±50.3＊＊ | 61.2 |
| 5-Fu25mg/kg | 81.3±25.4＊＊ | 73.9 |
Compare * * P＜0.01 with matched group
3.3 the present invention is to the inhibition and the radiosensitizing effect of nude mice lung squamous cancer
Table 3 the present invention is to the inhibition and the radiosensitizing effect of nude mice lung squamous cancer
| Group | The Mus number | Tumor heavy (mg) | Suppression ratio (%) |
| Matched group | 6 | 390±41 | 0 |
| Combination radiotherapy group | 6 | 277±45＊＊ | 28.9 |
| 4g/kg (the present invention) | 6 | 284±44＊＊ | 27.2 |
| 8g/kg (the present invention) | 6 | 231±57＊＊ | 40.8 |
| 5-Fu25mg/kg 4g/kg+ radiotherapy (the present invention) 8g/kg+ radiotherapy (the present invention) 5-Fu25mg/kg+ radiotherapy | 5 7 6 6 | 204±43＊＊ 217±46＊＊△ 192±39＊＊△△ 181±38＊＊△△ | 47.7 44.4 50.8 53.6 |
Compare with matched group: * * P＜0.01; Compare △ P＜0.05 with combination radiotherapy group; △ △ P＜0.01
3.4 colony forming method is measured the present invention the tumor clonogenic cell is suppressed laboratory observation
Medicament preparation: medicine of the present invention is diluted 1g/ml with RPMI1640.To contrast medicine TIANXIAN WAN (production unit: Tonghua, Jilin Bai Shan pharmaceutical factory) with RPMI1640 dilution 1g/ml.
Experiment condition: CO
2Incubator (U.S.), inverted microscope (Japan) superclean bench (Bangbu), glass drying oven (Shanghai medical glass articles for use factory) pancreatin REMI1640, Heps is (Sgama)
Experimental technique: tumor strain: pulmonary carcinoma (Lewis); Hepatocarcinoma 7721; Carcinoma of tongue Tca8113.
The above-mentioned 3 strain cells of taking the logarithm respectively campaign transfer to 500 cell/ml (the blue dyeing meter of Placenta Hominis viable count) with each strain cell number.With above-mentioned three strain cells (500 cells/ml) add respectively in the 15ml culture bottle, each culture bottle adds 2ml, places experimental drug the present invention 20 μ l (three bottles), experimental group adds RPMI1640,20 μ l (three bottles), medicine matched group TIANXIAN WAN 20 μ l (three bottles).Each group culture bottle is put into 5%CO after shaking up
237 ℃ of incubators in cultivated 7 days.After 7 days each bottle discarded culture fluid, dyeed back 20 minutes with Ji's nurse Sa, mirror counting down contains the above colony of 50 cells.
Experimental result: 1, granulocyte colony forms percentage rate
| The pulmonary carcinoma strain | 50％ | 30％△ | 20％＊ |
| The hepatocarcinoma strain | 45％ | 25％＊ | 25％＊ |
| The carcinoma of tongue strain | 40％ | 27％＊ | 20％＊ |
＊P＜0.01 △P＜0.05
4. brief summary
By nude mice, mice are shown in the experiment of body tumor suppression: medicine 4g/kg of the present invention, 8g/kg has than obvious suppression transplanting adenocarcinoma of lung, scale cancer tumor, and tangible radiosensitizing effect is also arranged.The present invention is formed with the obvious suppression effect to pulmonary carcinoma, hepatocarcinoma and tongue scale cancer tumor line clonogenic cell colony.
Four, toxicological experiment---acute toxicity of the present invention, long term toxicity test
1. acute toxicity testing
Kunming mouse, body weight 20g ± 2g, male and female half and half amount to 80, are provided by this center.
Raising condition: 23 ℃ of temperature, full nutrition particulate material, drink ordinary water
Be subjected to the reagent product: medicine of the present invention, glass packaging, every bottle is 3g, granule is 1.5g/ml with distilled water with the present invention's dilution.
Route of administration: irritate the disposable administration of stomach (oral), observe a week.
Animal grouping: 80 Kunming mouses are divided into 4 groups at random, i.e. A, B, C, D
A group: be 20 mices of matched group, give the 20ml/kg distilled water for every
B group: be 20 mices of experimental group, give this medicine 1.5g/ml 0.1ml, i.e. 7.5g/kg for every
C group: be 20 mices of experimental group, give this medicine 1.5g/ml 0/2ml, i.e. 15g/kg for every
D group: be 20 mices of experimental group, give this medicine 1.5g/ml 0.4ml, i.e. 30g/kg for every
Observation item: observe activity, the spirit of each treated animal in the week, fur has no abnormal, and situation is tested in death condition and postmortem.
The result: through the observation in a week, each organizes mice does not all have dead and various unusual performances, and LD50 surpasses 30g/kg.
Conclusion: the medicine maximum tolerated dose of originally making sound surpasses 30g/kg, and the chmice acute toxicity test of this medicine is in safety range.
2. long term toxicity test
Experiment purpose: after this experiment purpose is observed and given medicine of the present invention continuously, because savings and to the toxic reaction and the order of severity of rat body, the target organ of toxic reaction and the probability of infringement are provided, determine nontoxic amounts of reactants, provide reference for drafting people's medication test dose.
Experiment material: SD kind rat, body weight 72g ± 8g, by the qualified animal of Shanghai secondary that family planning provides, the attached animal quality certification, male and female half and half, random packet.Raising is hospital laboratory rat special feed, and prescription omits, and the feedstuff component content reaches the G13 standard.The receptacle temperature is 22 ± 2 ℃, relative temperature 50% ± 10%, and 12 hours light photographs, dark added the part available light in 12 hours, according to regularly air draft of temperature conditions.Per 5 one cages of experimental rat are raised in standard cage tool, and enter experiment at indoor observation one all rears.
Be subjected to the reagent product: medicine of the present invention, glass bottle, every bottle of 3g, fine particulate is with distilled water preparation experiment desired concn.
Animal grouping and drug dose
Low dose group: 0.6g/kg estimates 5 times of people's consumptions, 20 male and female half and half SD rats;
Middle dosage group: 3g/kg estimates 25 times of people's consumptions, 20 male and female half and half SD rats;
High dose group: 6g/kg estimates 50 times of people's consumptions, 20 male and female half and half SD rats;
Matched group: give the distilled water of the capacity of grade, dosage 10ml/kg, 20 male and female half and half SD rats;
Administration time: administration 6d weekly, every day, administration time was identical, observed a week after the drug withdrawal in 2 months by a definite date.
Administration capacity: 1ml/100g is weekly according to weighing the adjustment dosage.
Test item
1. observe the profile sign: behavioral activity situation, feces character, to poison as finding, single immediately cage is raised.
2. claim every the weight of animals weekly once, adjust dosage, the inspection record is in time cutd open in discovery death.
Hematological indices: cell counting, hemoglobin, total white blood cells and classification thereof, platelet clotting time.
Blood parameters: serum glutamic pyruvic transminase, glutamic oxaloacetic transaminase, GOT, alkali phosphatase, blood urea nitrogen, total protein, albumin, blood glucose, total bilirubin, creatinine, T-CHOL.
Organ coefficient: every animal heart of weighing, liver, spleen, lung, stomach, adrenal gland, thyroid, testis, uterus, brain prostate.
Histological examination: do not having under the situation of finding to be poisoned to death, only check high dose group and matched group half, find that high dose group has to check that just other experimental group internal organs have adrenal gland, pancreas, stomach, duodenum, ileum, colon, hypophysis, prostate, brain, the heart, spleen, bone marrow, kidney, liver, lung, lymph node, bladder, uterus, ovary, thymus, testis (epididymis), optic nerve when unusual.
Detect the index time: this experiment periods is 2 months, and administration 24 hours and convalescent period carry out when 3 weeks finished the last time.
Convalescent period observes: last every group of 14 animals detect every index to after being subjected to the reagent thing, stay 6 animals and continue to observe for 3 weeks, detect every index again, with the degree of reversibility of understanding toxic reaction and the retardance reaction that may occur.
Three, experimental result
1, medicine of the present invention adopts 3 dosage groups and control animals, and the outward appearance sign in observing time, behavioral activity and feces character etc. do not change significantly.
2, the body weight change of laboratory animal sees Table 1,2,3.
Table 1 the weight of animals changes
| Group | Number of animals (only) | Body weight (g) X ± SD | ||||
| Before the test | Test back 7d | Experiment back 4d | Experiment back 21d | |||
| Medicine of the present invention | Matched group | 20 | 71.5±7.21 | 77.5±12.8 | 91.7±16.1 | 105.5±19.5 |
| 0.6g/kg | 20 | 73±61 | 82.2±11.9 | 92.1±15.5 | 101±18.8 | |
| 3g/kg | 20 | 72±81 | 77.7±13.1 | 90.9±16.8 | 99±17.5 | |
| 6g/kg | 20 | 70.5±91 | 79.5±11.5 | 92.7±15.9 | 104±20.1 | |
Table 2 the weight of animals changes
| Group | Number of animals (only) | Body weight (g) X ± S | ||||
| 2d before the test | Test back 35d | Experiment back 42d | Experiment back 49d | |||
| Medicine of the present invention | Matched group | 20 | 125.5±22.1 | 151.1±27.1 | 161.1±30.5 | 170.5±32.1 |
| 0.6g/kg | 20 | 123.1±23.4 | 149.1±28.3 | 163±31.5 | 171.1±35.1 | |
| 3g/kg | 20 | 117.6±21.7 | 140.4±25.5 | 153±28.7 | 164±36.4 | |
| 6g/kg | 20 | 122.8±24.1 | 150.1±26.3 | 161±29.3 | 170.9±34.1 | |
Table 3 the weight of animals changes
| Group | Number of animals (only) | Body weight (g) X ± SD | |
| This | Matched group | 20 | 182.1±38.2 |
| 0.6g/kg | 20 | 184.5±39.2 |
| Bright medicine | 3g/kg | 20 | 169.5±37.3 |
| 6g/kg | 20 | 183.4±35.3 |
According to statistical procedures: 3 dosage and matched group relatively, 60d endosome weight average does not have significant difference (P＞0.05)
3, after the drug withdrawal behind the 21d body weight change see Table 4
Table 4 the weight of animals changes
| Group | Number of animals | Body weight (g) X ± SD | |
| Medicine of the present invention | Matched group | 6 | 204.1±45.1 |
| 0.6gkg | 6 | 219.5±42.1 | |
| 3g/kg | 6 | 190.7±39.4 | |
| 6g/kg | 6 | 217.8±41.7 |
According to statistical procedures, 3 dosage groups and matched group relatively, the 21d body weight does not all have significant difference (P＞0.05) after the drug withdrawal
4, hematological indices: erythrocyte, hemoglobin, total white blood cells and classification see Table 5.
Table 5 erythrocyte, hemoglobin, total white blood cells and classification thereof
| Group | Number of animals (only) | Hematological indices X ± SD | |||||
| Erythrocyte | Hemoglobin | Leukocyte | Leukocyte differential count | ||||
| ×10 12/L | g/L | ×10 8/L | Neutral % | Lymph % | |||
| Medicine of the present invention | Control group 0.6g/kg 3g/kg 6g/kg | 14 14 14 14 | 5.80±1.41 5.29±1.13 5.35±1.34 5.49±1.39 | 112.4± 18.5 109.7± 15.1 105.3± 11.4 107.5± 12.5 | 5.56±3.6 5.16±2.7 5.06±3.0 5.14±2.5 | 57.1±2.1 58.3±2.0 59.1±2.3 58.9±2.4 | 42.9±2.1 41.7±2.0 40.9±2.3 41.1±2.4 |
Compare P＞0.05, no significant difference with matched group.
Table 6 platelet, clotting time are relatively
| Group | Size of animal (only) | Hematological indices X ± S | ||
| Platelet (10 9/L) | Clotting time (S) | |||
| Medicine of the present invention | Matched group 0.6g/kg | 14 14 | 356.4±115.2 346.3±103.1 | 112.0±27.5 106.5±29.3 |
| 3g/kg | 14 | 353.8±111.2 | 108.7±31.7 | |
| 3g/kg | 14 | 372.1±105.1 | 105.2±35.4 | |
Compare P＞0.05 with matched group and all do not have significant difference.
5, organize liquid after the drug withdrawal behind the 21d and learn index: erythrocyte, hemoglobin, total white blood cells and classification, see Table 7, platelet and clotting time see Table 8.
Table 7 erythrocyte, hemoglobin, total white blood cells and classification are relatively
| Group | Number of animals (only) | Hematological indices X ± S | |||||
| Erythrocyte | Hemoglobin | Leukocyte | White red born of the same parents' classification | ||||
| ×10 12/L | g/L | ×10 9/L | Neutral % | Beautiful jade crust % | |||
| Medicine of the present invention | Matched group 0.6g/kg | 6 6 | 5.83±1.11 5.87±1.0 | 113.4±15.2 115.7±7.3 | 7.9±2.5 7.3±2.0 | 56.4±2.3 58.5±2.7 | 43.6±2.3 41.5±2.7 |
| 3g/kg | 6 | 5.49±0.95 | 117.9±16.4 | 7.0±2.5 | 59.3±1.9 | 40.7±1.9 | |
| 6g/kg | 6 | 5.60±0.71 | 118.7±9.5 | 7.4±1.9 | 57.7±2.5 | 42.3±2.5 | |
According to statistical procedures, 3 dosage groups and matched group be P＞0.05 relatively.
21 days platelet, clotting times compare after table 8 drug withdrawal
| Group | Size of animal (only) | Hematological indices X ± S | ||
| Platelet (10 9/L) | Clotting time (S) | |||
| Medicine of the present invention | Matched group | 6 | 504.1±75.1 | 118.5±27.5 |
| 0.6g/kg | 6 | 397.5±67.4 | 120.4±24.3 | |
| 3g/kg | 6 | 485.4±101.4 | 117.4±23.1 | |
| 3g/kg | 6 | 491.9±97.5 | 115.8±25.7 | |
According to statistical procedures, 3 dosage groups and matched group relatively all do not have significant difference (P＞0.05).
6, blood parameters: glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, alkali phosphatase, blood urea nitrogen, blood glucose see Table 9, and total protein, albumin, total bilirubin, creatinine, T-CHOL see Table 10.
Table 9 the present invention is to the influence of blood parameters
| Group | Size of animal (only) | Blood parameters X ± S | |||||
| Glutamate pyruvate transaminase (μ) | Glutamic oxaloacetic transaminase, GOT (μ) | Alkali phosphatase (μ) | Blood urea nitrogen (mmol/L) | Blood glucose (mmol/L) | |||
| Medicine of the present invention | Matched group | 14 | 15.2±4.4 | 53.7±13.4 | 8.4±3.8 | 2.5±1.1 | 5.0±1.3 |
| 0.6g/kg | 14 | 15.4±4.2 | 52.9±13.1 | 7.5±3.2 | 2.9±1.5 | 5.1±1.1 | |
| 3g/kg | 14 | 17.1±3.5 | 56.7±13.0 | 8.9±4.1 | 3.3±1.7 | 5.5±1.5 | |
| 6g/kg | 14 | 15.9±4.1 | 49.8±15.1 | 7.3±3.4 | 2.8±1.2 | 4.8±1.4 | |
According to statistical procedures, 3 dosage groups are compared with matched group, and it is not remarkable that P＞0.05 all differs.
Table 10 total protein, albumin, total red sterin of gallbladder, creatinine, total bilirubin are relatively
| Group | Size of animal | Blood parameters X ± S | |||||
| Total protein (g/L) | Albumin (g/L) | T-CHOL mmol/L | Total bilirubin μ mol/L | Creatinine μ mol/L | |||
| Medicine of the present invention | Matched group | 14 | 60.0±7.6 | 25.1±2.6 | 1.56±0.36 | 8.5±2.04 | 105.9±19.0 |
| 0.6g/kg | 14 | 61.2±6.8 | 24.9±3.4 | 1.49±0.30 | 6.7±2.71 | 106.8±18.4 | |
| 3g/kg | 14 | 6.5±10.4 | 24.9±3.4 | 1.57±0.33 | 8.4±2.23 | 114±11.4 | |
| 6g/kg | 14 | 6.2±8.9 | 24.6±2.7 | 1.56±0.34 | 7.3±2.47 | 99.5±24.3 | |
Data are learned processing by statistics, 3 dosage groups and matched group relatively, total protein, albumin, T-CHOL, creatinine, total bilirubin all do not have significant difference P＞0.05.
7, the 21d blood parameters sees Table 11,12 after the drug withdrawal.
Table 11 glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, alkali phosphatase, blood urea nitrogen, blood glucose are relatively
| Group | Size of animal (only) | Blood parameters X ± S | |||||
| Glutamate pyruvate transaminase (μ) | Glutamic oxaloacetic transaminase, GOT (μ) | Alkali phosphatase (μ) | Blood urea nitrogen (mmol/L) | Blood glucose (mmol/L) | |||
| Medicine of the present invention | Matched group | 6 | 20.4±3.8 | 54.4±10.0 | 4.7±1.4 | 4.7±1.2 | 5.2±0.7 |
| 0.6g/kg | 6 | 22.0±4.0 | 52.0±11.8 | 4.82±1.2 | 3.7±1.1 | 4.9±0.4 | |
| 3g/kg | 6 | 22.2±2.4 | 55.4±12.0 | 4.88±1.1 | 4.78±1.3 | 5.5±0.5 | |
| 6g/kg | 6 | 20.1±3.5 | 53.6±10.6 | 4.71±0.9 | 4.5±1.2 | 5.0±0.6 |
Data are learned processing by statistics, and 3 dosage groups are compared with its matched group, and glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, alkali phosphatase, blood urea nitrogen, blood glucose all do not have significant difference P＞0.85.
Table 12 total protein, albumin, T-CHOL, creatinine, total bilirubin
| Group | Size of animal | Blood parameters X ± S | |||||
| Total protein (g/L) | Albumin (g/L) | T-CHOL mmol/L | Total bilirubin μ mol/L | Creatinine μ mol/L | |||
| Medicine of the present invention | Matched group | 14 | 66.4±6.2 | 22.3±3.5 | 1.56±0.43 | 17.20±2.3 | 106.08±15.67 |
| 0.6g/kg | 14 | 64.2±5.4 | 21.5±3.4 | 1.55±0.45 | 16.34±1.8 | 106.14±14.38 | |
| 3g/kg | 14 | 67.2±4.3 | 23.2±3.8 | 1.57±0.42 | 18.10±2.4 | 112.56±12.45 | |
| 6g/kg | 14 | 67.0±5.8 | 22.2±3.0 | 1.56±0.46 | 16.98±2.6 | 106.04±13.06 | |
Data are learned processing by statistics, 3 dosage groups and matched group relatively, the biochemical indicator of total protein, albumin, T-CHOL, total bilirubin, creatinine does not all have significant difference P＞0.05.
8, pathologic finding
(1) system dissects: to the heart, liver,spleen,kidney, adrenal gland, thyroid, testis (attached testis), uterus, brain, prostate, pancreas, stomach, duodenum, ileum, colon, hypophysis, breastbone, spinal cord, skin, lymph node, bladder, ovary, thymus, optic nerve, peculiar pathological changes is not all found in perusal.
(2) organ coefficient
1. animal detects organ weights such as the heart, liver, spleen, lung, kidney, adrenal gland, thyroid, testis, uterus, prostate and sees Table 13,14 in the time of two months.
The table 13 animal heart, liver, spleen, lung, kidney, adrenal gland's weight ratio are
| Group | Size of animal | Organ weights (g) X ± S | ||||||
| The heart | Liver | Spleen | Lung | Kidney | The adrenal gland | |||
| This | Matched group | 14 | 0.99±0.20 | 8.13±1.05 | 1.27±0.37 | 1.78±0.47 | 1.63±0.31 | 0.034±0.011 |
| The invention medicine | 0.6g/kg 3g/kg 6g/kg | 14 14 14 | 0.93±0.19 1.00±0.16 0.90±0.14 | 7.79±1.14 8.28±1.01 7.98±1.08 | 1.31±0.29 1.45±0.31 1.17±0.36 | 1.67±0.35 1.85±0.42 1.89±0.39 | 1.68±0.25 1.74±0.34 1.70±0.37 | 0.037±0.008 0.042±0.009 0.032±0.0014 |
Table 14 animal thyroid, testis, uterus, brain, weight of prostate are relatively
| Group | Size of animal | Organ weights (g) X ± S | |||||
| Thyroid | Testis | The uterus | Brain | Prostate | |||
| Medicine of the present invention | Matched group | 14 | 0.028±0.0021 | 2.40±0.15 | 0.35±0.12 | 1.65±0.24 | 0.14±0.07 |
| 0.6g/kg | 14 | 0.025±0.0037 | 2.18±0.17 | 0.31±0.11 | 1.64±0.27 | 0.13±0.06 | |
| 3g/kg | 14 | 0.029±0.0025 | 2.42±0.24 | 0.41±0.14 | 1.69±0.23 | 0.16±0.09 | |
| 6g/kg | 14 | 0.027±0.0031 | 2.23±0.22 | 0.37±0.15 | 1.67±0.29 | 0.17±0.04 | |
Data are learned processing by statistics, 3 dosage groups and matched group relatively, the internal organs heart, liver,spleen,kidney, adrenal gland, thyroid, testis, uterus, brain, weight of prostate all do not have significant difference.
2. 21d animal viscera weight ratio sees Table 15,16 after the drug withdrawal.
The table 15 animal heart, liver, spleen, lung, kidney, adrenal gland's weight ratio are
| Group | Size of animal | Organ weights (g) X ± S | ||||||
| The heart | Liver | Spleen | Lung | Kidney | The adrenal gland | |||
| Medicine of the present invention | Matched group | 6 | 0.95±0.10 | 6.85±1.3 | 1.26±0.44 | 1.53±0.35 | 1.75±0.211 | 0.056±0.002 |
| 0.6g/kg | 6 | 0.94±0.11 | 6.95±1.2 | 1.06±0.37 | 1.40±0.31 | 1.65±0.23 | 0.051±0.03 | |
| 3g/kg | 6 | 0.99±0.14 | 7.26±1.0 | 1.27±0.48 | 1.49±0.41 | 1.75±0.19 | 0.056±0.002 | |
| 6g/kg | 6 | 0.98±0.79 | 7.06±0.93 | 1.18±0.93 | 1.52±0.36 | 1.74±0.14 | 0.053±0.004 | |
P＞0.05
Table 16 animal thyroid, testis, uterus, brain, weight of prostate are relatively
| Group | Size of animal | Organ weights (g) X ± S | |||||
| Thyroid | Testis | The uterus | Brain | Prostate | |||
| Medicine of the present invention | Matched group | 6 | 0.016±0.0012 | 1.26±0.18 | 0.48±0.18 | 1.77±0.10 | 0.19±0.021 |
| 0.6g/kg | 6 | 0.015±0.0011 | 1.24±0.17 | 0.45±0.15 | 1.74±0.08 | 0.17±0.029 | |
| 3g/kg | 6 | 0.017±0.0013 | 1.27±0.14 | 0.49±0.19 | I.79±0.06 | 0.20±0.023 | |
| 6g/kg | 6 | 0.013±0.0012 | 1.26±0.15 | 0.47±0.10 | 1.76±0.10 | 0.16±0.026 | |
Data are learned processing by statistics, 3 dosage groups and matched group relatively, the internal organs heart, liver,spleen,kidney, adrenal gland, thyroid, testis, uterus, brain, weight of prostate all do not have significant difference (P＞0.05).
The table 17 animal heart/body, liver/body, gland/body, spleen/body, lung/body, adrenal gland/body are relatively
| Group | Size of animal | Dirty body is than X ± S | ||||||
| The heart/body | Liver/body | Gland/body | Spleen/body | Lung/body | Adrenal gland/body | |||
| Medicine of the present invention | Matched group | 14 | 0.0051±0.00073 | 0.0368±0.0034 | 0.00516±0.00305 | 0.00923±0.00305 | 0.00837±0.00240 | 0.000201±0.000031 |
| 0.6g/kg | 14 | 0.00441±0.00093 | 0.0347±0.0095 | 0.00489±0.0044 | 0.00935±0.00401 | 0.00810±0.00231 | 0.000186±0.000075 | |
| 4g/kg | 14 | 0.00460±0.00065 | 0.0379±0.0063 | 0.00584±0.0023 | 0.00998±0.00205 | 0.00946±0.00243 | 0.000286±0.000050 | |
| 6g/kg | 14 | 0.00458±0.00032 | 0.0354±0.0056 | 0.00535±0.0056 | 0.01054±0.00195 | 0.00886±0.00195 | 0.000202±0.000058 | |
Table 18 is respectively organized experimental rat thyroid/body, testis/body, uterus/body, brain/body, prostate/body relatively
| Matched group | Size of animal | Dirty body is than X ± S | |||||
| First shape fat/body | Testis/body | Uterus/body | Brain/body | Prostate/body | |||
| Medicine of the present invention | Matched group 0.6g/kg 3g/kg | 14 14 14 | 0.000154±0.000018 0.000152±0.000025 0.000166±0.000023 | 0.00987±0.0016 0.00934±0.0019 0.01185±0.0014 | 0.00167±0.00091 0.00163±0.00097 0.00194±0.00084 | 0.00863±0.0012 0.00847±0.0014 0.00875±0.0013 | 0.00076±0.00007 0.00068±0.00008 0.00084±0.00003 |
| 6g/kg | 14 | 0.000162±0.000019 | 0.010353±0.0011 | 0.00185±0.00089 | 0.00859±0.0015 | 0.00071±0.00006 | |
Data are learned processing by statistics, and 3 dosage groups are compared with matched group, and the heart/body, liver/body, spleen/body, lung/body, kidney/adrenal gland/body, testis/body, uterus/body, brain/body, prostate/body all do not have significant difference P＞0.05.
3. each dosage group internal organs of drug withdrawal 21d see Table 19,20 with the ratio of body.
The table 19 animal heart/body, liver/body, gland/body, spleen/body, lung/body, adrenal gland/body are relatively
| Group | Size of animal | Dirty body is than X ± S | ||||||
| The heart/body | Liver/body | Gland/body | Spleen/body | Lung/body | Adrenal gland/body | |||
| Medicine of the present invention | Matched group | 14 | 0.00462±0.0003 | 0.0360±0.0031 | 0.00535±0.00075 | 0.00987±0.0035 | 0.00840±0.0017 | 0.000242±0.000075 |
| 0.6g/kg | 14 | 0.00435±0.0009 | 0.0342±0.0089 | 0.00498±0.00086 | 0.00935±0.0037 | 0.00815±0.0019 | 0.000196±0.000086 | |
| 4g/kg | 14 | 0.00467±0.0005 | 0.0375±0.0061 | 0.00575±0.0061 | 0.01024±0.00245 | 0.00878±0.0012 | 0.000284±0.000070 | |
| 6g/kg | 14 | 0.00457±0.0007 | 0.0352±0.0054 | 0.00514±0.00067 | 0.00967±0.0014 | 0.00867±0.0014 | 0.000237±0.000076 | |
P＞0.05
Table 20 is respectively organized experimental rat thyroid/body, testis/body, uterus/body, brain/body, prostate/body relatively
| Matched group | Size of animal | Dirty body is than X ± S | |||||
| Thyroid/body | Testis/body | Uterus/body | Brain/body | Prostate/body | |||
| Medicine of the present invention | Matched group | 14 | 0.000149±0.000019 | 0.01024±0.0014 | 0.00185±0.00093 | 0.00835±0.0012 | 0.00070±0.00007 |
| 0.6g/kg | 14 | 0.000143±0.000024 | 0.00978±0.0017 | 0.00176±0.00098 | 0.00819±0.0013 | 0.00063±0.00009 | |
| 3g/kg | 14 | 0.000164±0.000023 | 0.01049±0.0013 | 0.00223±0.00075 | 0.00867±0.0009 | 0.00085±0.00004 | |
| 6g/kg | 14 | 0.000152±0.000028 | 0.00997±0.0012 | 0.00218±0.00084 | 0.00853±0.0010 | 0.00074±0.00005 | |
Data are learned processing by statistics, and 3 dosage groups are compared with matched group, and the heart/body, liver/body, spleen/body, lung/body, kidney/body, adrenal gland/body, testis/body, uterus/body, brain/body, prostatitis/body all do not have significant difference P＞0.05.
(3) histological examination
Medicine 6g/kg dosage group of the present invention and control rats each 10 to its heart, liver, spleen, lung, kidney, bladder, stomach, duodenum, ileum, colon, brain, spinal cord, optic nerve, hypophysis, the adrenal gland, thyroid, pancreas, testis, epididymis, prostate, the uterus, ovary, internal organs such as lymph node carry out the paraffin wax section, HE dyeing, microscopic examination: height as a result, middle dosage group has 1 routine pneumonia respectively, based on exudative inflammation, matched group has 2 routine pneumonia, pathomorphism is same as described above, do not get rid of the induced lung mycoplasma infection, may be with irrelevant with medicine of the present invention, other internal organs find no unusually.
Four, conclusion
Medicine of the present invention is given rat oral gavage 2 months, does not find hematological indices, and blood parameters and histology obviously change, so think that this medicine is in examination concentration, safer in the time.
Five, clinical observation material
1. Shanghai No.1 Pulmonary Department Hospital adopts Drug therapy pulmonary carcinoma 51 routine clinical observation on the therapeutic effect of the present invention
1.1 clinical data: inpatient's (it is that outpatient service is at one's own expense bought medicine and is hospitalized for observation that 13 routine this city patients are wherein arranged), male's 46 examples wherein, women's 5 examples, the oldest 76 years old, minimum 37 years old, the mean age was 58.46 years old, its age group 30-49 year 9 examples, 50-59 year 17 examples, 60-70 year 18 examples, 71-80 year 7 examples.
According to histologic classification, scale cancer 24 examples, adenocarcinoma 15 examples, undifferentiated small cell carcinoma 4 examples, mixed carcinoma 1 example, mesothelioma 1 example, last ditch tumor 1 example, pig fungus ball 1 example, metastatic carcinoma 1 example, not typing 3 you, and wherein 28 examples are surgical postoperative patient (squama type 19 examples, gland type 7 examples, last ditch tumor 1 example, mesothelioma 1 example, glandular scale mixes 1 example, wheat fungus ball 1 example) wherein 23 routine medical patient (scale cancer 6 examples, in 2 routine postoperatives are arranged, 1 example is with the pneumosilicosis chronic bronchitis, the 2 example companion lung hearts), have 2 routine many places heart bones to shift in adenocarcinoma 8 examples, 5 routine pleuras shift, and the simple hydrothorax of 1 example all is T4N3Mx; Do not break up minicell 4 examples, wherein 1 routine liver occupy-place, 3 routine superior vena cava syndromes, 1 routine renal carcinoma lung shifts 3 routine prepatterns.
See Table one by the Chinese medical discrimination typing, deficiency of the lung phlegm-damp type 7 examples, scale cancer 3 examples wherein, adenocarcinoma 2 examples, typing 1 example not, metastatic carcinoma 1 example, qi stagnation and blood stasis type 5 examples, scale cancer 4 examples wherein, pattern of fever 3 examples, wherein scale cancer 1 example in adenocarcinoma 1 example, the deficiency of vital energy; Do not break up minicell 2 examples, cloudy two empty type 29 examples of gas, scale cancer 15 examples wherein, adenocarcinoma 8 examples are not broken up minicell 2 examples, mixed carcinoma (glandular scale) 1 example, mesothelioma 1 example, last ditch tumor 1 example is brought up fungus ball 1 example, type of YIN-deficiency and interior-heat 8 examples, scale cancer 1 example wherein, adenocarcinoma 5 examples, not typing 2 examples.
Table one: Chinese medical discrimination typing and histopathology classification relation
| The histopathology classification | Scale cancer | Adenocarcinoma | Undifferentiated carcinoma | Mixed type carcinoma | Typing cancer not | Other |
| The cloudy two empty type type of YIN-deficiency and interior-heat of pattern of fever gas in the spleen emptiness and wet sputum type qi stagnation and blood stasis type deficiency of vital energy | 3 4 1 15 1 | 2 1 8 4 | 2 2 | 1 | 1 2 | Ditch knurl 1 is brought up bacterium ball 14 on the transfer a celiothelioma 1 |
| Add up to | 24 | 15 | 4 | 1 | 3 |
1.2. Therapeutic Method
Adopt curative effect and patient's having no adverse reaction of own control and this medicine of Chinese medical discrimination classifying method objective evaluation behind the medicine of the present invention to this medicine.
Above-mentioned 51 examples are curative with medicine of the present invention, 7 examples are wherein arranged in conjunction with chemotherapy, are in hospital and the outpatient service observation.
Dosage is taken medicine 2 times in accordance with regulations every day, each 3 grams, and 12 days little courses of treatment, be a course of treatment three little courses of treatment, full 360 grams of limit are two big courses of treatment (wherein having indivedual cases to adopt takes medicine continuously).
Observed content:
The patient of 1. all clothes medicine of the present invention must stop to do corresponding the inspection respectively before the chemotherapy and radiation and after each end course of treatment, has 7 routine patients more because of clinical symptoms in this paper 51 examples, carries out when the rabat focus makes retrogress in conjunction with little chemotherapy.
2. treat previous crops routine blood test, hepatic and renal function, CEA (carcinoembryonic antigen) and CA-50 (cancer antigen-50) conventional determining.
3. therapeutic evaluation: with reference to the short term effect of the national tcm internal medicine association of nineteen eighty-three China " pulmonary carcinoma efficacy assessment standard draft ", because of the time shorter, efficacy evaluation is so need continue the observation of taking medicine.
1.3 therapeutic outcome
1. symptom and Signs are improved, and cough, chest pain, uncomfortable in chest, expectorant blood, tachypnea, stomach are received, spirit, body weight and muscle power are obviously improved and seen Table two.
Table two: symptom and Signs before and after the treatment
| First course of treatment | Second course of treatment | ||||||||||||
| The weak Head And Face edema of poor private prosecution night sweat is received in the insomnia of breathing hard uncomfortable in chest of bitterly generating heat of symptom and Signs cough phlegm hemothorax | Example several 31 15 13 12 14 13 8987 | CR 6 5 1 2 2 2 2 3 3 2 | PR 19 8 6 8 10 6 6 6 3 5 | MR 3 2 2 2 2 3 2 | S 3 3 2 2 | P 1 | CR 10 9 2 5 4 6 3 5 5 4 | PR 15 4 4 6 9 4 3 4 3 1 | MR 5 2 2 1 1 2 2 | S 1 4 1 2 | P 1 | Total effective rate 96.7% 100% 61.5% 88% 100% 92.3% 100% 100% 100% 71.4% | |
Obeying medicine of the present invention from 51 routine lung cancer patients generates heat to the vexed chest pain of the clinical symptoms of medium and advanced lung cancer cough expectorant hemothorax in various degree improvement is arranged, and to the weak stomach of having a sleepless night receive night sweat etc. all have tangible curative effect, particularly surgery to have a routine aeg to have lung squamous cancer complication with diabetes art hands to treat 2 courses of treatment with the present invention after symptom more than three (polydipsia, polyphagia, polyuria) all disappear.
2. chest x-ray lump size relatively, because of finding early to meet the operator treatment that all operates, no surgical condition stays medical treatment part patient lump size to be difficult to estimate, list cooperates little chemotherapy with the present invention's treatment and indivedual patient, so to estimate and to generally acknowledge and examine curative effect, 30 exception sections operations (surgery 28 examples, internal medicine 2 examples) are arranged in 51 examples.Referring to following subordinate list three:
Table three: 21 routine lung cancer therapy aftereffect are treated
| The example number | Alleviate | Portion is slow | Little slow | Stable | Worsen | Effective percentage % | |
| The not little not typing of scale cancer adenocarcinoma adds up to | 6 8 4 3 21 | 3 2 5 | 2 2 2 1 7 | 1 1 1 2 5 | 1 1 2 | 2 2 | 100％ 62.5％ 75％ 100％ 80.90％ |
More than 21 routine patients with lung cancer clinical observations show that the scale cancer effect is comparatively obvious, adenocarcinoma is poor slightly than scale cancer, but more differentiation and prepattern be not for well, and littler effect is poor slightly, but little effect and stable in, though focus is in steady statue substantially, even the patient of worsening is at the symptom after taking medicine no change with increase the weight of, all because of late period cancer continue due to the development, illustrate that the present invention still has certain effect to stablizing focus.
3. all make leukocyte, erythrocyte, hemoglobin, hematoblastic routine examination before and after the 51 routine patients with lung cancer treatment with medicine of the present invention and see Table four.
Table four: leukocyte, erythrocyte, hemoglobin, hematoblastic routine examination
| Average before the treatment | Treatment back average |
| Hemoglobin platelet leukocyte erythrocyte | The preceding average 195.33 of preceding average 387.8 medications of average 1453.5 medications before average 778.9 medications before the medication | First course of treatment 856.9 after first medication courses of treatment 373.39 after first medication courses of treatment 5467 after first medication courses of treatment 1000.2 after the medication | 2102.6 second courses of treatment 1224.2 of 6,823 second courses of treatment, 3,650 second courses of treatment, second course of treatment |
Illustrating with Drug therapy patients with lung cancer of the present invention does not have obvious variation to hemogram, and the back of taking medicine on the contrary all was significantly improved after second course of treatment.
4. to not seeing obvious variation before and after the hepatic and renal function medication.
5. CEA (cancer is antigen also) and CA-50 (cancer antigen) are changed as table five:
Table five:
| Before the medication | After the medication | ||
| CEA CA-50 | 2079.8 201.02 | First course of treatment 1956.8 2381 | Second course of treatment 903.1 167.1 |
The effect that humoral immunization is also had reduction with Drug therapy advanced lung cancer of the present invention is described.
1.4 discuss
Adopt medicine of the present invention, 51 routine patients with lung cancer are observed, one or more sings and symptomses are arranged before the treatment, treatment rear section patient's symptom and sign is finished and is recovered normal, the effective percentage that improves that part patient also obtains to a certain degree is about 90%, is 80.9% eliminating or dwindling the lump effective percentage.Improving hemopoietic function, the hepatic and renal function aspect also has certain effect, the human body immunity improving function aspects there is obvious effects, total effective rate 80.9%, adhere to taking medicine always, to improving hemopoietic function, hepatic and renal function and raising immunologic function reach the purpose that prolongs life cycle, in observing the course of treatment, there are 50 examples all to survive, have only 1 routine king * * be with the medicine of the present invention treatment that goes home on leave before the Spring Festival because of advanced lung cancer whole body skeleton and subcutaneous extensive transfer, shift because of breast and pulmonary's secondary infection death the joint back.
Shanghai No.1 Pulmonary Department Hospital thinks that medicine of the present invention has following effect:
The first, medicine of the present invention has strengthening vital QI to eliminate pathogenic factors, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, heat-clearing and toxic substances removing, warming YANG removing dampness to reduce phlegm the effect of human body immunity improving function.
The second, illustrate that a part of anti-tumor function is indirect; Kill tumor cell by human body immunity improving function and activation primed lymphocyte; this medicine of clinical proof has the protection hemopoietic system; reduce the infringement of chemicals and carcinous toxin to hemopoietic function; to the protection heart; liver; renal function also has certain effect; in 28 routine internal medicine pulmonary carcinoma cases, all use chemotherapy before this medicine of overwhelming majority clothes; even surgical patient was also accepted chemotherapy in art; hematochrome when treatment; leukocyte; erythrocyte is lower than normally; improve in back about one month of treatment or its mental status of about two months; appetite increases; sleep improves, hematochrome; leukocyte; it is normal that erythrocyte recovers substantially.
The 3rd; in treatment, catch vigorate qi and replenish the blood, strengthening vital QI to eliminate pathogenic factors, Yin Yang balancing; thereby adjust the anti-cancer ability and the adaptive capacity of body; the metabolite of malignant tumor and antineoplastic chemotherapy medicine toxicity; hemopoietic system and immune system to body all have detrimental effect, and clothes the present invention proof has hemopoietic function protecting and human body immunity improving function.
2. Chengdu Traditional Chinese Medicine Hospital adopts Drug therapy pulmonary carcinoma 30 routine clinical observation on the therapeutic effect of the present invention
Adopt Drug therapy medium and advanced lung cancer of the present invention, treatment is observed with the front and back contrast method, and this medicine improves total effective rate to clinical symptoms, and the objective determination enclosed mass dwindles and is respectively 76.78%, 82.36%.Took effect in second week in the back of taking medicine, the 3rd week is remarkable gradually, and the 6th all state of an illness trend is stable, to lung squamous cancer, adenocarcinoma, cellule type undifferentiated carcinoma, and Chinese medical discrimination, pattern of fever in stagnation of QI blood wind type, the gas heat, type of deficiency of both QI and YIN person curative effect are better.This medicine was through routine clinical observation in 6 months 30, for clinical symptoms and the sign of removing the carcinoma patient, remove patient's chest pain, dwindle or suppress the tumor piece certain effect is arranged, recovery is in various degree all arranged after the treatment of sings and symptomses such as original chest pain, cough, expectorant blood, the patient that can not take care of oneself individually can the recovered part viability.
Medicine of the present invention is pure compound Chinese medicinal preparation, mainly has the tumour cell division of inhibition breeding effect, thereby hinder the secondary diffusion of growth of tumor control primary lesion and metastasis, adopt single medicine to take the present invention's front and back own control and Chinese medical discrimination classifying method, treat 30 examples, confirm that through pathology clinical confirming as is unsuitable for operating patient, be intended to estimate objectively the curative effect of this medicine and patient toleration this medicine.
2.1 clinical stages
Pulmonary cancer diagnosis standard by the WHO regulation is carried out typing by stages, II phase 1 example, III phases 19 example, IV phases 10 example.According to position, place and growth pattern typing: centre type 21 examples, peripheral 9 examples.
According to histological classification, epithelial cancer, 1. squamous cell type (epiderm-like) cancer 11 examples, spindle cell (squamous) cancer 5 examples; 2. small cell carcinoma: a oat-cell carcinoma 1 example, b intermediate cell 4 examples; 3. adenocarcinoma: a acinar cancer 4 examples, b papilloma 2 examples; 4. large cell carcinoma: glandular scale mixed type 1 example, carcinoma gigantocellulare 1 example.
Chinese medical discrimination typing: 1. spleen emptiness and wet sputum type 3 examples; 2. type of YIN-deficiency and interior-heat 8 examples; 3. type of deficiency of both QI and YIN 4 examples; 4. qi stagnation and blood stasis type 4 examples, vehement malicious Sheng type 4 examples of heat; 5. deficiency in both Qi and blood type 5 examples.The relation of Chinese medical discrimination typing and histopathology branch type sees Table 2.1.
Table 2.1 Chinese medical discrimination typing and pathology are knitted the relation of credit class
| Squama (the thin skin born of the same parents of shape table sample cancer) | Shuttle (shape scale cell shape cancer) | Swallow table cell cancer | The intermediate cell cancer | Breast bubble cancer | Papilloma | Gland (squama mixes secondary syncytial virus type cancer greatly) | Carcinoma gigantocellulare | |
| The vehement malicious Sheng type QIXUELIANGXU type of spleen emptiness and wet sputum type type of YIN-deficiency and interior-heat type of deficiency of both QI and YIN qi stagnation and blood stasis type heat adds up to | 1 5 1 1 1 2 11 | 0 2 0 2 0 1 5 | 0 0 1 0 0 0 1 | 0 1 1 4 | 1 0 0 2 0 4 | 0 1 0 0 1 2 | 0 0 0 1 0 0 1 | 0 0 0 0 0 1 1 |
See that from table 2.1 scale cancer is more common in pattern of fever in gas the moon, QIXUELIANGXU type, all the other are various roughly the same.Adenocarcinoma is common in spleen emptiness and wet sputum type and the vehement malicious Sheng type of heat, and small cell lung cancer and adenosquamous carcinoma etc. also do not find the regularity of typing because routine number reduces.
2.3 clinical data
2.3.1 patient's 30 examples, inpatient 26 examples, outpatient service 4 examples of going to a doctor continuously, the oldest 80 years old, minimum 50 years old, 67.85 years old mean age, the highest age group 60-70 year 16 examples (72.72%), secondly 50-59 year 10 examples (33.33%), 71-80 year 4 examples (18.18%).
" CT " or " X " takes the photograph position and the form thereof that sheet shows lump: left lung lump 12 examples (46.33%), wherein go up lung 5 examples, following lung 7 examples.Right lung 16 examples (53.33%) wherein go up lung 4 examples, middle lung 8 examples, following lung 2 examples.The right lung morbidity is more than left lung, and last leaf is more than inferior lobe.Belong to centre type 21 types, peripheral 7 examples, special type 1 example, lump＞5cm, 8 examples, lump＜5cm, 22 examples, the existing leaflet of lump multilist and burr and unclear 23 examples of edge blurry, thoracic cavity inequality hydrops 18 examples have 12 example performance side pulmonarys to divide and do not expand or full atelectasis.
2.3.2 metastasis site and histological type relation: 30 routine pulmonary carcinoma are with regional and metastasis person totally 19 examples (63.33%), and metastasis site and pathology relation see Table 2.2.
Table 2.2 19 routine lung cancer metastasis positions and histopathology relation thereof
| Squamous cell carcinoma (epiderm-like) | Carcinoma sarcomatodes (squamous) | Oat-cell carcinoma | The intermediate cell cancer | Acinous carcinoma | Papilloma | Glandular scale mixed type (large cell carcinoma) | Cell carcinoma far away | |
| The vertical phrenic lymph nodes stomach liver sausage bone of the weak and incompetent facial pin bone superior gluteal lymph node hilar lymph node of cranium | 0 1 0 3 1 0 0 0 1 | 0 0 1 0 0 0 0 0 0 | 0 0 0 1 0 0 0 0 0 | 1 0 0 0 0 0 0 0 0 | 2 0 2 2 1 0 0 0 1 | 0 0 1 0 0 0 0 0 0 | 0 0 1 0 0 0 0 0 0 | 0 0 0 0 0 0 0 0 0 |
2.4 Therapeutic Method
30 routine patients treat to take medicine of the present invention, adopt and are in hospital and the out-patient treatment observation.
Dosage is generally decided according to s own situation, and take medicine 2-3 every day, each 3 grams, and taking medicine continuously 36 days is a little course of treatment, withdraws 1-2 week, continues to take medicine, three months is a total course of treatment.
2.5 observed content
Selected patient must stop to put, chemotherapy and all antitumor drug, observes for two weeks, does corresponding inspection respectively before the treatment with after finishing the course of treatment, so that self contrast before and after the treatment.
Check routine blood test, platelet, routine urinalysis, hepatic and renal function, ITT, E-RFe, NK cytoactive etc. before the treatment, " CT " video picture or chest " X " are taken the photograph sheet, B-mode ultrasound tomography and are detected liver, gallbladder, pancreas, adrenal gland, electrocardiogram, pulmonary function, table place checking lymph node everywhere.
Therapeutic evaluation: with reference to changing the tumour medicine efficacy assessment standard that national tcm internal medicine association " pulmonary carcinoma efficacy assessment standard draft " and national cancer therapy drug meeting are formulated in nineteen eighty-three, formulate short term effect, calculate median survival interval, result of determination.
2.6 therapeutic outcome
2.6.1 sings and symptoms improves, cough, chest pain, uncomfortable in chest, breathe hard, expectorant blood, insomnia, dreaminess etc. obviously alleviate or part disappeared average 26.5 ± 7.5 days, contrast improvement situation sees Table 2.3 before and after the treatment.
Symptom and sign change contrast before and after table 2.3 treatment
| Symptom and sign | The example number | Produce effects | Obviously alleviate | Little slow | No change | Worsen | Remission rate % |
| Cough chest pain sensation of oppression over the chest with shortness of breath expectorant blood insomnia and dreamful sleep | 30 30 30 16 21 30 25 | 0 0 0 0 4 2 1 | 5 7 14 2 9 8 7 | 19 16 8 9 2 15 13 | 56 57 60 30 5 11 4 | 1 2 2 2 1 0 0 | 80.00％ 76.66％ 73.33％ 68.75％ 71.42％ 83.33％ 84.00％ |
Annotate: 1 routine patient has multiple sings and symptoms simultaneously.
More than 30 routine pulmonary carcinoma clinical observation result show that " the present invention " has in various degree improvement to the clinical symptoms of medium and advanced lung cancer and sign, the effective percentage average out to 88.42% to cough, insomnia, dreaminess disease has tangible curative effect; To chest pain, uncomfortable in chest, breathe hard, the effective percentage average out to 72.54% of expectorant disorders of blood disease, certain curative effect is also arranged, total effective rate 76.78%.
2.6.2 chest " CT " developing or " X " line film making lump drawdown ratio are: patient's case is taken the photograph sheet and is as the criterion with chest " CT " video picture or " X " line, is not as the criterion with Chest X-rays.
Objective determination: lump＞5cm before the treatment, 8 examples, lump＜5cm22 example, the lump variation of treatment back sees Table 2.4.
Table 2.4 30 routine patients with lung cancer treatment back lumps dwindle situation
| The example number | Produce effects | Portion is slow | Little slow | Stable | Worsen | Minification | |
| Squamous cell carcinoma small cell carcinoma adenocarcinoma large cell carcinoma adds up to | 16 5 7 2 30 | 1 1 1 0 3 | 6 2 2 0 10 | 3 1 0 1 5 | 5 1 1 0 7 | 1 0 2 1 4 | 93.75％ 100％ 85.71％ 50.00％ 82.36％ |
More than the 30 routine all types of lump patients of pulmonary, clinical observation result shows, and is obvious to scale cancer, small cell lung cancer effect, relatively poor to adenocarcinoma, maxicell effect.Average effectiveness level is 82.36%, illustrates that " the present invention " dwindles lump better effect is arranged stable.
2.6.3 hematochrome and leukocyte change: all routine examination hematochrome, leukocyte, lymphocytic variations before and after the 30 routine medications.Average 106.5 ± 2.10g/L before the hematochrome medication, 124.1 ± 2.15g/L after the medication learns processes and displays by statistics, P＜0.01.4.65 ± 1.67 * 109/L of average before the leukocyte medication, average is 4.68 ± 1.65 * 109/L after the medication, learns processes and displays P＞0.05 by statistics, sees Table V.
2.6.4 changes of liver function: 30 routine medications preceding 5 routine ZnTT＞12 μ, 6 routine ITT6-16 μ, 3 examples, 150 μ, the back 6 week check of taking medicine, 3 routine ZnTT reduce to normally, and 1 example drops to 8 μ from 12 μ, 1 routine no change.4 routine ITT reduce to normally, 2 routine no changes, and 2 routine GPT reduce to normally, 1 routine no change.
2.6.5 renal function changes: kidney function test 4 examples before the 30 example treatments, creatinine＞177 μ mol/L has 3 routine blood urea nitrogens＞7.20 μ mol/L simultaneously.3 routine creatinines after 6 weeks of treatment, blood urea nitrogen all transfers to normally, and 1 example raises to some extent, sees Table 2.5.
Routine blood test and hepatic and renal function change before and after the table 2.5 30 routine lung cancer therapies
| Hematochrome g/L | Leukocyte * 10 9/L | Total serum protein g/L | Liver acid anhydride μ mol/L | |||||
| Before controlling | After controlling | Before controlling | After controlling | Before controlling | After controlling | Before controlling | After controlling | |
| Sum mean P value | 3229 07.4 | 3730 124 | 129 4.31 | 123 43.6 | 1777 59.4 | 1897 63.4 | 3115 103.9 | 3243 108.1 |
| P＜0.01 | P＞0.05 | P＜0.01 | P＜0.01 | |||||
2.6.7 changes in immune function: all capable humoral immunization and cellular immunization inspection before and after the 30 example treatments, humoral immunization check that mainly serum IgG, IgA, IgM content and cellular immunization inspection serum LTT, E-REC formation rate, analysis result see Table 2.6.
Humoral immunization and cellular immunization change before and after the table 2.6 30 routine lung cancer therapies
| IgG | g/L | IgA | g/L | IgM | g/L | LTT | ％ | E-RFC％ | ||
| Before controlling | After controlling | Before controlling | After controlling | Before controlling | After controlling | Before controlling | After controlling | Before controlling | After controlling | |
| Sum mean P value | 244.5 8.15 | 275.3 9.18 | 56.2 1.88 | 73.6 2.45 | 27.3 0.91 | 37.5 1.25 | 1361 46.1 | 1741 58.1 | 1508 50.3 | 1786.7 59.61 |
| P＜0.01 | P＜0.01 | P＜0.01 | P＜0.01 | P＜0.01 | ||||||
See from Table V before and after the 30 routine lung cancer therapies that humoral immunization and cellular immunization illustrate that through measurement data significance test P＜0.01 " the present invention " has certain effect to improving immunological function of cancer patients.
2.7 discuss
Take to be in hospital and continuous patients with lung cancer 30 examples of going to a doctor of outpatient service with medicine of the present invention, before treating observation, treatment one or more sings and symptomses are arranged, treatment rear section patient's sings and symptoms recovers normal fully, part patient is also to a certain degree improved, effective percentage is 76.78%, eliminating or dwindling various types of pulmonarys lump effective percentage is 82.36%, certain effect is also arranged aspect hemopoietic function, liver, the renal function improving, more remarkable to human body immunity improving function aspects effect, total effective rate is 79.57%.Adhere to taking Drug therapy of the present invention, 6 months 28 examples of surviving so far account for 93.33% always, wherein 2 examples since when being admitted to hospital the tumor popularity shift, in drug administration process because multiple organs failure, the death of failing to respond to any medical treatment.
Chengdu Traditional Chinese Medicine Hospital thinks that Department of Pharmacy of the present invention selects for use 10 pleasant impression Chinese herbal medicine to adopt the modern crafts processing and refining to form, and has strengthening vital QI to eliminate pathogenic factors, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, heat-clearing and toxic substances removing, warming YANG removing dampness, reduces phlegm the effect of human body immunity improving function.Above clinical efficacy finding is the principal agent treatment to the medium and advanced lung cancer patient with " the present invention ", and the Therapeutic Principle that dialectical and differential diagnosis of diseases combines determines tumor pathological characteristic attribute, gives full play to " the present invention's " effect of treatment medium and advanced lung cancer.Data shows that this medicine all has certain effect to transfer and the rebound phenomenon that suppresses tumor, proves that fully the present invention has the tumour cell division of inhibition breeding effect, thereby hinders growth of tumor.May also have the effect of direct killing tumor cell.And also have the effect of human body immunity improving function, this may be that to contain the Chinese herbal medicine of human body immunity improving function relevant with this medicine, and Chinese herbal medicine has QI invigorating to set upright in the side, and the function of the foundation of acquired constitution is mended in training, has the immunologic function of exciting and promotes the effect of humoral immunization.Clinical observation confirms, some antitumor Chinese herbal medicine has antivirus action preferably, some malignant tumor relevant with virus there is the obvious suppression effect, therefore suppress growth of tumor, IGM is an ideal antibody, can play to regulate and coagulate acting on, the carcinoma cell has residual body in the help reticuloendothelial system elimination serum.
Illustrate that a part of anti-tumor function is indirect; kill tumor cell by human body immunity improving function and activation primed lymphocyte; this medical instrument of clinical proof has the protection hemopoietic system; reduce the infringement of chemicals and carcinous toxin to hemopoietic; the protection heart, liver, renal function are also had certain effect, and above-mentioned most cases are accepting to have accepted chemicotherapy before this medicine treatment.Hematochrome, leukocyte, erythrocyte are lower than normal value during this medicine treatment.Treat about one month mental status and improve, appetite increases, and sleep improves, hematochrome, the most recoveries of leukocyte are normally, trace it to its cause, the traditional Chinese medical science thinks that lung is the source of gasification, the benefit of the five internal organs, empty as honeybee from, under do not have key, suction then full, that exhales is then empty, but the change that slag is turbid is the hinge of person QI and blood mediation.In treatment, catch three at all: vigorate qi and replenish the blood, strengthening vital QI to eliminate pathogenic factors, Yin Yang balancing, thereby the anti-tumor ability and the adaptive capacity of adjustment body.The metabolite of malignant tumor and antitumor chemicals toxicity are to the hemopoietic system and the immune system damaging action all of body.Experimental results show that: band tumor person immunologic function is low than the normal person, if when neoplasm metastasis is arranged, immunologic function is more low.Check before from above-mentioned case observation to medication that humoral immunization and cellular immunization are low, immunologic function all has rising in various degree after the medication, and illustrating has protective effect to immunologic function.From humoral immunization and cellular immune function result, be significantly improved after the treatment, learn significance test P＜0.01 by statistics, evident difference has been described.From clinical case life cycle, median survival interval is 174 days, because observing time is shorter, can't reflect real late result, remains further to be observed.
3. Guangzhou chest hospital five internal medicine adopt Drug therapy pulmonary carcinoma clinical observation on the therapeutic effect 52 example reports of the present invention
3.1, patient's 52 examples (wherein non-small cell carcinoma 50 examples).Combined with chemotherapy 37 examples wherein, single agent the present invention treats 15 examples.
52 routine patient age are from 55 years old to 74 years old, male's 40 examples, and women's 12 examples, primary lung cancer 45 examples, transitivity pulmonary carcinoma 7 examples are pressed WHO and are formulated standard, III phases 40 example, IV phases 12 example.Merge pulmonary tuberculosis 7 examples in 52 examples, positive 5 examples of expectorant tulase, infiltrative pulmonary tuberculosis 5 examples wherein, chronic fibro cavernous pulmonary tuberculosis 2 examples.
Select routine standard: (1) chest photo and/or breast CT sheet, pathology, cytology confirm.(2) more than K ' S mark 60 marks, the age is (single agent group is relaxed) below 75 years old.(3) do not use chemotherapy, radiotherapy.(4) hemopoietic system and liver, the positive scope of kidney function test (single agent group is relaxed).
3.2, Therapeutic Method:
Single agent group: object is the age to surpass 74 years old, body constitution excessively a little less than, can not accept chemotherapy or refusal chemotherapy, or the financial difficulties patient.Every day 2 times or 3 times, each 3 grams.36 days is one-period, and drug withdrawal continues to take after observing a week.Three cycles are a course of treatment, and partly patient requires to take continuously.
The Comprehensive Treatment group: (1) the present invention: method is the same.(2) chemotherapy regimen: IFO (iphosphamide, ifosfamide) 1.5 gram/m
2, quiet three days.Vp-16 (etoposide) 0.1 gram, quiet 3-5 days.Caibop lation (carboplatin) 0.3 gram or 0.5 gram, quiet 1 day.Auxilliary mesna (Mei Sina), Eobian (ondansetron) or the paspertin metoclopramide of giving.
Check hemogram weekly 1-3 time, check rabat and/or breast CT sheet, liver, renal function, routine urinalysis before per two weeks or the chemotherapy.Partly abdominal CT sheet or ultrasound diagnosis optionally.
3.3, efficacy determination and poison, side reaction, press the standard (summary) that WHO formulates.
3.4, the result
3.4.1, in Comprehensive Treatment group 37 examples, take the present invention all more than two cycles.Chemotherapy is finished three cycles or 17 examples ready to accept a higher or a lower post, finishes one to two cycles 20 example, CR (alleviating fully) 2 examples, PR (partly alleviating) 17 examples, effective percentage (CR+PR) 19 examples (41.5%).Merge pulmonary tuberculosis 4 examples (the expectorant tulase is all positive for IV type 2 examples, III type 2 examples) in 37 examples, only add and use isoniazid, focus absorbs, the bright commentaries on classics of expectorant tulase.
3.4.2, in single agent group 15 examples, finish two cycles 11 examples, finish one-periods 4 example, the PR1 example, NC (no change) 7 examples, expansion (PD) 7 examples, it is single with different bright hydrazine (IV type 1 example, the expectorant tulase positive, III type 2 examples, spit negative) to merge pulmonary tuberculosis 3 examples in 15 examples.Treatment back focus absorbs, and the expectorant tulase is cloudy to be changeed.
3.4.3, the poison, side reaction: in Comprehensive Treatment group 37 examples, 28 examples of blood change 1-3 degree, 4 examples of liver, change in renal function 1-2 degree all can be recovered; To simple approximately similar with IVC (ifosfamide, Vp-16 carboplatin).Single agent group 15 examples, hemogram, liver, renal function all do not have obvious change.Have 30 examples to tell xerostomia in whole 52 examples, red-hot, 10 examples have constipation, can alleviate behind the polydipsia water.
3.5: model case
Beam * *, man, 70 years old, diagnosis right lung constitutional central type carcinoma of lung (adenocarcinoma) T
4N
3M
0The IIIb phase, KS ' 60 minutes.The carcinous hydropneumothorax in left side.With two cycles of Comprehensive Treatment, curative effect CR, the carcinous hydropneumothorax in left side absorbs fully.
Liu * *, the man, 53 years old, the diagnosing liver cancer head of pancreas, lung (pulmonary carcinoma) shifts.The KS60 branch.With 7 cycles of IVC scheme chemotherapy, curative effect PR-MR (the slight alleviation), hemogram, liver, renal function injury 2-3 degree, stomach poor appetite, tired.Begin August to add with the present invention and necessary auxiliary treatment, carry out two cycle Comprehensive Treatments again, pulmonary carcinoma curative effect PR, liver, pancreas cancer be development more not, hemogram, liver, renal function injury 1 degree, symptom is obviously improved, weight increase, KS ' 80 minutes.At the end of the same year because of family matters go home on leave for a long time, single agent the present invention, stable disease.
Together * *, the woman 64 years old, diagnoses left lung constitutional central type carcinoma of lung (adenocarcinoma) T
3N
1M
1(lymphonodi cervicales) IV phase, KS ' 60 minutes, pulmonary tuberculosis: III are coated with (+) progress.IVC scheme chemotherapy two all after date curative effect PR.Left side chest fluid all absorbs the single agent in the back successive treatment of the present invention of leaving hospital, and check pulmonary carcinoma does not have recurrence, and pulmonary tuberculosis absorbs and takes a turn for the better, and the expectorant tulase is cloudy to be changeed.Cause lung because of pulmonary carcinoma infects the end of the year, heart failure is died of illness in the outer court.
3.6, discuss
3.6.1, with Comprehensive Treatment 37 example non-small cell carcinoma patients in late period, the CR2 example, the PR17 example, effective percentage (CR+PR) 41.5%, 119 examples) report such as Ryoichi Honda: cisplatin, during the II phase of ifosfamide and vindesine therapeutic alliance non-small cell carcinoma studies, 40 examples can be estimated patient's 19 examples (47.5%) curative effect PR, do not have CR (" cancer " 1992 11 3 phases of volume).So the present invention cooperates the combined chemotherapy may be better than simple combined chemotherapy, and may alleviate chemotherapeutics toxicity, side effect and carcinous toxin, improve immunologic function, improve the quality of living, life-saving.
3.6.2, in single agent group 15 examples, 1 routine PR, 7 routine NC, 7 routine PD do not have obviously poison, side reaction, doing well,improving is more obvious, patient age is excessive, body constitution excessively a little less than, stress is excessive, reasons such as financial difficulties also may influence this group curative effect.
3.6.3, in the 52 routine advanced lung cancers, merge pulmonary tuberculosis 7 examples, positive 5 examples of expectorant tulase, after two kinds of therapies all focus absorb and take a turn for the better, the expectorant tulase is cloudy to be changeed, so medicine in treatment aspect tuberculosis patient's treatment, is worth further research.
3.6.4, partly patient finishes after the simple chemotherapy or after finishing Comprehensive Treatment, singly use successive treatment of the present invention, is worth the effect and the course of treatment further discussion.
3.6.5, medicine of the present invention has than obvious curative effects the clinical symptoms of advanced lung cancer such as cough, chest pain, tachypnea, bloody sputum, appetite.
Symptom variation contrast before and after the treatment
| The example number | Produce effects | Obviously alleviate | Little slow | No change | Worsen | |
| Appetite | 52 | 30 | 18 | 2 | 2 | 0 |
| Cough | 52 | 20 | 20 | 10 | 2 | 0 |
| Chest pain | 50 | 25 | 15 | 10 | 0 | 0 |
| Tachypnea | 50 | 26 | 14 | 10 | 0 | 0 |
| Bloody sputum | 40 | 20 | 16 | 2 | 2 | 0 |
Claims (10)
1. medicine is characterized in that the crude drug and the percentage by weight thereof of this effective ingredient of making is: gynostemma pentaphyllum extract: 7%～9%, and Radix Picriae felterrae extractum: 7%～9%, Radix Notoginseng: 13%～15%, Bulbus Fritillariae Cirrhosae: 5%～7%, Semen Ginkgo: 7%～9%, the Rhizoma Pinelliae: 5%～7%, Cordyceps: 7%～9%, Ganoderma: 11%～13%, Margarita: 9%～11%, Colla Corii Asini: 5%～7%, the artificial Calculus Bovis: 13%～15%, the percentage by weight sum of above-mentioned raw materials medicine is 100%; The day of this medicine control is in the dosage, the ginsenoside Rg
1(C
42H
72O
14) content in 3.0mg～20mg scope.
2. medicine as claimed in claim 1; the crude drug and the percentage by weight thereof that it is characterized in that this effective ingredient of making are: gynostemma pentaphyllum extract: 8%, and Radix Picriae felterrae extractum: 8%, Radix Notoginseng: 14%; Bulbus Fritillariae Cirrhosae: 6%; Semen Ginkgo: 8%, the Rhizoma Pinelliae: 6%, Cordyceps: 8%; Ganoderma: 12%; Margarita: 10%, Colla Corii Asini: 6%, artificial Calculus Bovis: 14%.
3. medicine as claimed in claim 1 or 2, it is characterized in that, in this medicine, add appropriate amount of auxiliary materials in addition, make all pharmaceutical dosage forms of pill, tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or Chinese Pharmacopoeia appendix regulation.
4. the preparation method of the described medicine of claim 1 is characterized in that, comprises the following steps:
The crude drug and the percentage by weight thereof of effective ingredient are: gynostemma pentaphyllum extract: 7%～9%, Radix Picriae felterrae extractum: 7%～9%, Radix Notoginseng: 13%～15%, Bulbus Fritillariae Cirrhosae: 5%～7%, Semen Ginkgo: 7%～9%, the Rhizoma Pinelliae: 5%～7%, Cordyceps: 7%～9%, Ganoderma: 11%～13%, Margarita: 9%～11%, Colla Corii Asini: 5%～7%, the artificial Calculus Bovis: 13%～15%, the percentage by weight sum of above-mentioned raw materials medicine is 100%;
At first get gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini nine flavor crude drug, be ground into fine powder by formulation weight percentage ratio;
Get crushing pearl by formulation weight percentage ratio in addition, and through carefully being developed into the Margarita impalpable powder;
Get the artificial Calculus Bovis by formulation weight percentage ratio and be ground into fine powder;
With Calculus Bovis fine powder and crude drug fine powder, Margarita impalpable powder facing-up, sieve, mixing is used water pill, and pill is made in oven dry below 80 ℃;
Or in the fine powder of mixing, add appropriate amount of auxiliary materials in addition, make all pharmaceutical dosage forms of tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or pharmacopeia regulation, ginsenoside Rg in each dosage form dosage on controll day
1(C
42H
72O
14) content in 3.0～20mg scope.
5. the preparation method of the described medicine of claim 1 is characterized in that, comprises the following steps:
The crude drug and the percentage by weight thereof of effective ingredient are: gynostemma pentaphyllum extract: 7%～9%, Radix Picriae felterrae extractum: 7%～9%, Radix Notoginseng: 13%～15%, Bulbus Fritillariae Cirrhosae: 5%～7%, Semen Ginkgo: 7%～9%, the Rhizoma Pinelliae: 5%～7%, Cordyceps: 7%～9%, Ganoderma: 11%～13%, Margarita: 9%～11%, Colla Corii Asini: 5%～7%, the artificial Calculus Bovis: 13%～15%, the percentage by weight sum of above-mentioned raw materials medicine is 100%;
At first get gynostemma pentaphyllum extract, Radix Picriae felterrae extract powder, be ground into fine powder by formulation weight percentage ratio;
In addition by formulation weight percentage ratio get Margarita powder, artificial Calculus Bovis's pulverize separately becomes fine powder;
Get decoct with water after Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini crude drug are pulverized three times, filter, be condensed into extractum, crushed after being dried becomes fine powder;
, sieve above each fine powder facing-up by the formulation weight percentage, mixing is used water pill, and pill is made in oven dry below 80 ℃;
Or in the fine powder of mixing, add appropriate amount of auxiliary materials in addition, make all pharmaceutical dosage forms of tablet, capsule, granule, chewable tablet, drop pill, soft capsule, syrup, oral liquid, suppository or Chinese Pharmacopoeia appendix regulation, ginsenoside Rg in each dosage form dosage on controll day
1(C
42H
72O
14) content in 3.0mg～20mg scope.
6. the preparation method of the described medicine of claim 5 is characterized in that, the crude drug and the percentage by weight thereof of described effective ingredient are: gynostemma pentaphyllum extract: 8%; Radix Picriae felterrae extractum: 8%; Radix Notoginseng: 14%, Bulbus Fritillariae Cirrhosae: 6%, Semen Ginkgo: 8%; the Rhizoma Pinelliae: 6%; Cordyceps: 8%, Ganoderma: 12%, Margarita: 10%; Colla Corii Asini: 6%, artificial Calculus Bovis: 14%.
7. the preparation method of the described medicine of claim 6 is characterized in that, the concrete steps that described Radix Notoginseng, Bulbus Fritillariae Cirrhosae, Semen Ginkgo, the Rhizoma Pinelliae, Cordyceps, Ganoderma and Colla Corii Asini raw material are condensed into extractum are:
Get Radix Notoginseng, Semen Ginkgo, Ganoderma with 50--80% alcohol reflux twice, concentrate, medicinal residues and Bulbus Fritillariae Cirrhosae, the Rhizoma Pinelliae, Colla Corii Asini add water with boiling three times, be concentrated into relative density with the backflow merging and be 1.10-1.35 under 60 ℃ of heat are surveyed.
8. the preparation method of the described medicine of claim 5 is characterized in that, described ginsenoside Rg
1(C
42H
72O
14) content measure as follows:
It is an amount of to get the above-mentioned pharmaceutical dosage form of making, and prepares solution to be measured with methanol, uses the ginsenoside Rg
1Product are filler with octadecylsilane chemically bonded silica in contrast;
Acetonitrile-water is a mobile phase, and the ratio of mobile phase is: acetonitrile: water=(10～40): (90～40), the detection wavelength is 193～213nm, number of theoretical plate is by the ginsenoside Rg
1The peak calculates and is not less than 1000, accurately measures wherein ginsenoside Rg with high performance liquid chromatograph in the above conditions
1(C
42H
72O
14) content, ginsenoside Rg in the controll day dosage
1(C
42H
72O
14) content in 3.0～20mg scope.
9. the described medicine of claim 1 is used to prepare the lung heat clearing eliminating stagnation, promoting blood circulation and stopping pain, the reduce phlegm application of medicine of detoxifcation.
10. the described application of claim 9 is characterized in that, this medicine is as the pulmonary carcinoma deficiency of both QI and YIN, the hot stasis-eliminating disease of expectorant, be not suitable for operation and put, chemotherapy person's medicine for treatment, also can be used as the ancillary drug of pulmonary carcinoma operation, chemicotherapy.
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| CNB2006101046296A CN100546621C (en) | 2006-09-22 | 2006-09-22 | A kind of new purposes of known drug |
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|---|---|---|---|
| CNB2006101046296A CN100546621C (en) | 2006-09-22 | 2006-09-22 | A kind of new purposes of known drug |
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| CN100546621C CN100546621C (en) | 2009-10-07 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101112504B (en) * | 2007-08-14 | 2010-05-19 | 喻国庆 | Chinese medicine for curing cancer and the method for preparing the oral liquid thereof |
| CN101301453B (en) * | 2008-06-23 | 2010-12-22 | 焦太安 | Chinese patent medicine powder for treating hematopathy |
-
2006
- 2006-09-22 CN CNB2006101046296A patent/CN100546621C/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101112504B (en) * | 2007-08-14 | 2010-05-19 | 喻国庆 | Chinese medicine for curing cancer and the method for preparing the oral liquid thereof |
| CN101301453B (en) * | 2008-06-23 | 2010-12-22 | 焦太安 | Chinese patent medicine powder for treating hematopathy |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100546621C (en) | 2009-10-07 |
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