CN108126149A - A kind of Chinese medicine preparation for treating tumour and preparation method thereof - Google Patents

A kind of Chinese medicine preparation for treating tumour and preparation method thereof Download PDF

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CN108126149A
CN108126149A CN201810021842.3A CN201810021842A CN108126149A CN 108126149 A CN108126149 A CN 108126149A CN 201810021842 A CN201810021842 A CN 201810021842A CN 108126149 A CN108126149 A CN 108126149A
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parts
preparation
chinese medicine
medicine preparation
capsule
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杨全红
张科建
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Shandong Wo Bao Pharmaceutical Co Ltd
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Shandong Wo Bao Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/344Codonopsis
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K35/56Materials from animals other than mammals
    • A61K35/58Reptiles
    • A61K35/583Snakes; Lizards, e.g. chameleons
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/88Liliopsida (monocotyledons)
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    • A61K36/9064Amomum, e.g. round cardamom

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Abstract

The invention discloses a kind of Chinese medicine preparations for treating tumour, are made of the raw material of following parts by weight:2 10 parts of Radix Codonopsis,1 30 parts of Rhizoma Atractylodis Macrocephalae,4 20 parts of cloud Siberian cocklebur,3 30 parts of honey-fried licorice root,Raw 1 40 parts of Radix Astragali,2 10 parts of Gorgon fruit,1 50 parts of Semen Nelumbinis,3 20 parts of sealwort,4 20 parts of cultivated land,1 60 parts of the root of straight ladybell,2 30 parts of fructus amomi,3 30 parts of Fructus Aurantii,1 20 parts of ochre,2 40 parts are spent again,6 40 parts of oldenlandia diffusa,2 50 parts of Ophidia black snake powder,Using the compound matching of a variety of medicinal materials,Chinese medicinal component in preparation can effectively play synergistic effect,Pass through nourishing Yin and promoting production of body fluid,Benefiting qi and nourishing blood,Strengthening the spleen and stomach,The approach such as nourishing liver and kidney achieve the purpose that righting reinforcing,So as to inhibit the development of tumour and transfer,Eliminate tumor focus position,Enhance patient's immunity,Mitigate patient suffering,Effectively extend the existence time limit of patient,Using pure Chinese medicine therapy,To the without any side effects of human body,Therapeutic effect is notable;It is simple for process the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, dosage can be prepared into, is facilitated patients.

Description

A kind of Chinese medicine preparation for treating tumour and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicine more particularly to a kind of Chinese medicine preparation for treating tumour and preparation method thereof.
Background technology
At present, malignant tumour has become the second largest disease for threatening human life's safety, and into trend occurred frequently, presents The characteristics of incidence is high, the death rate is high.Tumor invasion number in China's accounts for 1/5th of global number of the infected according to statistics, and dead Number accounts for a quarter of global death toll, is a public health that must pay much attention to and social concern.
Ancient Chinese medicine doctor just has the discussion of many " weakened body resistance tumorigenesis " in Chinese medical book.Early in《Interior warp》In just point out " healthy tendency In depositing, heresy can not be done ", " heresy is gathered, gas must void ", " empty heresy cannot solely hurt sb.'s feelings, must be because of the void then visitor of figure " be emphasized Be whether healthy tendency abundance all diseases occur, the basic reason of development.《Hardly possible warp》Described in " five product " be that ancient Chinese medicine has The earliest record of " accumulation " name of disease is closed,《Difficulty is through 55 hardly possiblies》It says:" therefore product person, the five internal organs are given birth to;Poly- person, six internal organs institute into.” This has just affirmed that the generation of accumulation is because of deficiency of vial QI, caused by visceral dysfunction.Sui Dynasty《The General Treatise on the Cause and Symptoms of Diseases》In mention:" product Poly- person, is got along well by negative and positive, and internal organs are weak, by ailment said due to cold or exposure, fight in carried out by qi of zang-fu viscera ", it is also considered as weakened body resistance to cause heresy.The Ming Dynasty 《Required Readings for Medical Professionals gathers a piece》Cloud:" product into, positive unsaturated vapor, then perverse trend crouches it, if person of low position is in court, by declining for gentleman .”《Surgery opens profound》It says:Cancer is sent out 40 years old or more, and anemia laboured breathing, savoury is excessively given birth to, and perfect 1." Qing Dynasty《Outer card case Compilation》Cloud:" the positive deficiency of vital energy then diagenesis ", even more it is manifestly intended that it is weakened body resistance be the key that product into.In treatment, examine because opinion is controlled, advocate Righting method is to treat the fundamental law of malignant tumour.Ancients' cloud:" supporting just product to remove certainly ", what is referred to is exactly by training correction gas, is reached Without the knurl that disappears, and knurl is from the purpose removed.《The Standards of Diagnosis and Treatment》In also cloud:" therefore the kind person of controlling, qi-restoratives, strengthens vim and vigour in the ban, and product disappears certainly, It is hurriedly attacked with the agent of big poison, product cannot be removed, counter to hinder healthy tendency, difficult multiple eventually." advocate to treat to gather to ask simply and attack, it emphasizes to protect Deposit the importance of healthy tendency.It can be seen that ancient physician has recognized that the treatment of accumulation then should again be subject to using building up healthful vital energy as first Heresy is attacked, just achievees the effect that heresy removes eutopic reduction.To sum up, the traditional Chinese medical science thinks:Tumour is that a kind of whole body belongs to empty, true, the asthenia in origin and asthenia in superficiality in part Disease.Human righteousness's virtual loss, powerless to resist exopathogen, six external factors which cause diseases cult poison is easy to invade, simultaneously because visceral dysfunction, leads to gas A series of generation for pathological products such as stagnant, blood stasis, phlegm coagulate, poison gathers, inside and outside pathogenic factor are combined, and with the passing of time form tumour.And Deficiency of vial QI can also accelerate the development of disease, promote sending out and shifting for tumour, and order is dangerously ill day very.
Chemotherapy, radiotherapy, endocrine therapy, operative treatment, biological therapy, targeting are broadly divided into for the treatment of tumour at present Treatment and various treatments are used in combination.Malignant tumor patient generally existing immunity of organisms is low, chemicotherapy poor resistance etc. Problem.
Chinese prescription can be by adjusting immunity of organism, anti-oxidant, inhibition tumor cell proliferation, induction in anti-tumor aspect Tumour cell is destroyed, reduces drug resistance of tumor cell and reduces chemicotherapy toxicity etc. performance unique advantage.
Invention content
For overcome the deficiencies in the prior art, one of the objects of the present invention is to provide a kind of Chinese medicine systems for treating tumour Agent by the reasonable compatibility of traditional Chinese medicine ingredients, effectively extends the life cycle of tumor patient, is matched with tumor therapeuticing methods such as chemotherapy Mutual gain mitigates patient suffering, improves life quality, extends life cycle.
The second object of the present invention is to provide the preparation method of the Chinese medicine preparation of above-mentioned treatment tumour.
An object of the present invention adopts the following technical scheme that realization:
A kind of Chinese medicine preparation for treating tumour, the Chinese medicine preparation are made of the raw material of following parts by weight:2-10 parts of Radix Codonopsis, 1-30 parts of Rhizoma Atractylodis Macrocephalae, 4-20 parts of Yun Ling, 3-30 parts of honey-fried licorice root, raw 1-40 parts of Radix Astragali, 2-10 parts of Gorgon fruit, 1-50 parts of Semen Nelumbinis, sealwort 3-20 parts, 4-20 parts of cultivated land, 1-60 parts of the root of straight ladybell, 2-30 parts of fructus amomi, 3-30 parts of Fructus Aurantii, 1-20 parts of ochre, again spend 2-40 parts, white flower 6-40 parts of HERBA HEDYOTIS DIFFUSAE, 2-50 parts of Ophidia black snake powder.
Tumour is that a kind of whole body belongs to empty, true, the disease of asthenia in origin and asthenia in superficiality in part.Human righteousness's virtual loss, it is powerless to resist exopathogen, Six external factors which cause diseases cult poison is easy to invade, simultaneously because visceral dysfunction, leads to a series of pathological products such as the stagnation of the circulation of vital energy, blood stasis, phlegm coagulate, poison gathers Generation, inside and outside pathogenic factor is combined, and with the passing of time forms tumour, and deficiency of vial QI can also accelerate the development of disease, promote to swell Knurl being sent out and shifting, and order is dangerously ill day very, it is seen that weakened body resistance is tumorigenic basic reason and disease development and the interpretation of the cause, onset and process of an illness The key point of differentiation.Treatment of disease must aim at its pathogenesis, refer to be exactly it is for cancer to catch weakened body resistance essence, righting method is controlled through tumour It treats always.It is dialectical that the present invention combines the eight principal syndromes, qi and blood, internal organs etc., distinguishes the difference of negative and positive of qi and blood virtual loss, be respectively adopted QI invigorating, The different righting methods such as blood-nourishing, enriching yin, warm sun, Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Yun Ling, honey-fried licorice root, raw Radix Astragali, Gorgon fruit, Semen Nelumbinis in formula It replenishes qi to invigorate the spleen for righting.Sealwort, cultivated land, the root of straight ladybell are used for blood-nourishing, enriching yin, promote the production of body fluid;Fructus amomi, Fructus Aurantii, ochre, multiple flower, for managing Gas appetizing, stopping nausea and vomiting by lowering the adverse flow of QI;Oldenlandia diffusa, Ophidia black snake powder disappear knurl for eliminating evil, wherein Radix Codonopsis, raw Radix Astragali, cultivated land, the root of straight ladybell, crow Tip snake, oldenlandia diffusa for monarch drug in a prescription for QI invigorating, invigorating the spleen, blood-nourishing, promote the production of body fluid, disappear knurl, Rhizoma Atractylodis Macrocephalae, Yun Ling, Semen Nelumbinis, Gorgon fruit, sealwort, For ministerial drug, play the role of strengthening QI invigorating, invigorating the spleen, blood-nourishing, promote the production of body fluid;Ochre, multiple flower, fructus amomi are adjutant for qi-regulating appetizing, drop Check is vomitted, the effect for hindering transporting and transforming function of the spleen and stomach for preventing from growing greasy medicine, and honey-fried licorice root is makes medicine for coordinating the drug actions of a prescription.
Blood-nourishing, enriching yin in formula, the medicine that promotes the production of body fluid compatibility appetizing simultaneously, qi-regulating, be amusing, the effectively alleviation of the Chinese medicine of stopping nausea and vomiting by lowering the adverse flow of QI exists In the patient of tumour, insomnia, dry, can't eat pharynx or pharynx without change etc. common symptons, compatibility appetizing, be amusing and stomach, drop it is inverse Fructus amomi, ochre, multiple flower, achieve the effect that i.e. tonifying yin deficiency of blood damage and the not impairment of the spleen, nourishing yin and nourishing blood medicine are such as used alone, can aggravate to suffer from Appetizing of being amusing is not forgotten in person's eating disorder, help, makes benefit and oiliness, grows without stagnant, while stringent control removing toxic substances disappears knurl oldenlandia The flavour of a drug and dosage of the drugs such as grass, zaocys dhumnade, and add with Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Yun Ling, honey-fried licorice root, raw Radix Astragali, Gorgon fruit, Semen Nelumbinis benefit Gas invigorating the spleen embodies the attention degree to the foundation of acquired constitution.
Further, the Chinese medicine preparation is capsule, granule or oral liquid.
The second object of the present invention adopts the following technical scheme that realization:
A kind of preparation method of above-mentioned Chinese medicine preparation for treating tumour, includes the following steps:
(1) it extracts:To Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Yun Ling, honey-fried licorice root, raw Radix Astragali, Gorgon fruit, Semen Nelumbinis, sealwort, cultivated land, the root of straight ladybell, sand In the mixture that benevolence, Fructus Aurantii, ochre, multiple flower, oldenlandia diffusa, Ophidia black snake powder form plus water extracts to obtain extracting solution, will To extracting solution be filtered;
(2) said extracted liquid is prepared into different dosage forms as needed.
Further, the extraction process is:For the first time plus 6-10 times measure Traditional Chinese drug mixture water extract 2 hours, second The secondary plus 6-8 times of water for measuring Chinese medical extract extracts 1.5 hours.
Further, when it is capsule, preparation method is:
(1) it concentrates:The extracting solution that claim 3 step (1) is obtained is concentrated under reduced pressure, and is concentrated under reduced pressure into relatively close at 60 DEG C Spend the lotion for 1.25~1.30;
(2) it is dry:The lotion that above-mentioned steps (2) obtain is being dried;
(3) mixing is crushed:The lotion of step (3) after drying is crushed into mixing;
(4) it fills:Drug powder after being crushed in step (4) is filled in capsule;
(5) it polishes:Filled capsule in step (5) is polished, removes powder extra outside capsule shells;
(6) bubble-cap:Capsule after step (7) is polished carries out bubble-cap and handles up to capsule.
Further, drying process is carries out in vacuum drying chamber in above-mentioned steps (2), 60 DEG C~70 DEG C, and -0.04 ~-0.08Mpa is dried 50~60 hours, is continued after lotion is broken into pieces 10~12 hours dry.
Further, when it is granule, preparation method is:
(1) it concentrates:The extracting solution that claim 3 step (1) is obtained is concentrated under reduced pressure, and is concentrated under reduced pressure into relatively close at 50 DEG C Spend the lotion for 1.25~1.35;
(2) dispensing is weighed:Weighing Icing Sugar, dextrin are uniformly mixed spare;
(3) granulation drying:The ingredients mixture of lotion made from step (1) and step (2) is placed in granulator and is pelletized Up to granule.
Further, when it is oral liquid, preparation method is:
(1) it clarifies:The extracting solution that claim 3 step (1) is obtained carries out clarifying treatment;
(2) it prepares, filter:The clarification extracting solution that above-mentioned steps (1) obtain is proportionally added into addition purifying by purified water Water, sucrose, sodium benzoate are stirred, and adjustment pH value filters to obtain semi-finished product to 5.0-7.0;
(3) embedding:The semi-finished product that above-mentioned steps (2) obtain are potted up to oral liquid.
Compared with prior art, the beneficial effects of the present invention are:The present invention provides a kind of Chinese medicine preparation for treating tumour, Using the compound matching of a variety of medicinal materials, the Chinese medicinal component in preparation can effectively play synergistic effect, play the whole of herbal mixture and adjust Section advantage, drug effect complement each other, and reach righting reinforcing by the approach such as nourishing Yin and promoting production of body fluid, benefiting qi and nourishing blood, strengthening the spleen and stomach, nourishing liver and kidney Purpose, so as to inhibit the development of tumour and transfer, eliminate tumor focus position, enhance patient's immunity, mitigate patient suffering, Effectively extend the existence time limit of patient, using pure Chinese medicine therapy, to the without any side effects of human body, therapeutic effect is shown It writes;It is simple for process the present invention also provides the preparation method of above-mentioned Chinese medicine preparation, a variety of dosage forms can be prepared into, are facilitated patients.
Specific embodiment
In the following, with reference to specific embodiment, the present invention is described further, it should be noted that is do not collided Under the premise of, new embodiment can be formed between various embodiments described below or between each technical characteristic in any combination.
Embodiment 1
A kind of Chinese medicine preparation for treating tumour, dosage form are capsule, and preparation method is as follows:
(1) it extracts:By 5 parts of Radix Codonopsis, 10 parts of Rhizoma Atractylodis Macrocephalae, 8 parts of Yun Ling, 15 parts of honey-fried licorice root, raw 20 parts of Radix Astragali, 10 parts of Gorgon fruit, lotus Sub- 25 parts of meat, 13 parts of cultivated land, 30 parts of the root of straight ladybell, 20 parts of fructus amomi, 10 parts of Fructus Aurantii, 8 parts of ochre, spends 12 parts, long-noded pit viper at 10 parts of sealwort again In 25 parts of 15 parts of tongue grass, Ophidia black snake powder input multi-function extractors, for the first time plus 6 times of amount water extract 2 hours, second plus 8 times It measures water to extract 1.5 hours, filter by several times, merging filtrate enters basin.
(2) it concentrates:The extracting solution that above-mentioned steps (1) are obtained, 65 DEG C, is concentrated under reduced pressure under the conditions of -0.04Mpa, is concentrated into 60 DEG C of heat survey the lotion that relative density is 1.25.
(3) it is dry:The lotion that step (2) obtains is placed in vacuum drying chamber, 60 DEG C, cream is taken out in -0.04 drying 60 hours Body is broken into pieces, is taken out and is let cool to room temperature or during close to room temperature after continuing to be put into vacuum drying 12 hours, is transferred to pulverizing process;
(4) mixing is crushed:The lotion block that step (3) obtains is put in pulverizer and is crushed to 80 mesh, by what is obtained after crushing Medicinal powder is put trough type mixing machine and is uniformly mixed within 20 ± 5 minutes with 20 revs/min of speed mixing, and it is to be tested that middle database is transferred to after mixing;
(5) it fills:The capsule medicinal powder NJP-1200 types fully-automatic capsule filling machine for taking chemical examination qualified by《NJP-1200 types Fully-automatic capsule filling machine standard practice instructions》It is filled, controls content uniformity, the method for double differences range 0.4* (1 ± 7%) g fills Negative relative should be kept with mistress between filling out, dust is excluded by dust exhaust apparatus, and temperature should be controlled at 20 DEG C, and humidity should control 45%;
(6) it polishes:Filled capsule is taken to be polished with II type drug polishing machines of YPJ-, it is extra outside capsule shells to remove Powder, and select defective work;
(7) bubble-cap:The capsule for taking chemical examination qualified with DPP-140B type aluminum-plastic blister machines by《DPP-140B type aluminum-plastic blister machines Standard practice instructions》Carry out bubble-cap, 130 DEG C ± 10 DEG C of molding heating plate set temperature, heated sealed set temperature:140℃± 10℃;
(8) it packs:It is packed by corresponding package specification.
Embodiment 2
A kind of Chinese medicine preparation for treating tumour, dosage form are capsule, and preparation method is as follows:
(1) it extracts:By 8 parts of Radix Codonopsis, 15 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Yun Ling, 20 parts of honey-fried licorice root, raw 25 parts of Radix Astragali, 5 parts of Gorgon fruit, lotus Sub- 30 parts of meat, 15 parts of cultivated land, 40 parts of the root of straight ladybell, 10 parts of fructus amomi, 20 parts of Fructus Aurantii, 15 parts of ochre, spends 10 parts, white flower at 15 parts of sealwort again In 20 parts of 20 parts of HERBA HEDYOTIS DIFFUSAE, Ophidia black snake powder input multi-function extractors, for the first time plus 8 times of amount water extract 2 hours, second plus 7 Amount water extracts 1.5 hours again, filters by several times, and merging filtrate enters basin;
(2) it concentrates:By the extracting solution that above-mentioned steps (1) obtain at 70 DEG C, it is concentrated under reduced pressure, is concentrated under the conditions of -0.06Mpa 60 DEG C of heat survey the lotion that relative density is 1.30.
(3) it is dry:The lotion that step (2) obtains is placed in vacuum drying chamber, 65 DEG C, -0.05Mpa is dried 55 hours, is taken Go out lotion to be broken into pieces, take out and let cool to room temperature or during close to room temperature after continuing to be put into vacuum drying 11 hours, be transferred to grinders Sequence.
(4) mixing is crushed:The lotion block that step (3) obtains is put in pulverizer and is crushed to 80 mesh, by what is obtained after crushing Medicinal powder is put trough type mixing machine and is uniformly mixed within 20 ± 5 minutes with 20 revs/min of speed mixing, and it is to be tested that middle database is transferred to after mixing.
(5) it fills:The capsule medicinal powder NJP-1200 types fully-automatic capsule filling machine for taking chemical examination qualified by《NJP-1200 types Fully-automatic capsule filling machine standard practice instructions》It is filled, controls content uniformity, the method for double differences range 0.4* (1 ± 7%) g fills Negative relative should be kept with mistress between filling out, dust is excluded by dust exhaust apparatus, and temperature should be controlled at 25 DEG C, and humidity should control 50%;
(6) it polishes:Filled capsule is taken to be polished with II type drug polishing machines of YPJ-, it is extra outside capsule shells to remove Powder, and select defective work;
(7) bubble-cap:The capsule for taking chemical examination qualified with DPP-140B type aluminum-plastic blister machines by《DPP-140B type aluminum-plastic blister machines Standard practice instructions》Carry out bubble-cap, 130 DEG C ± 10 DEG C of molding heating plate set temperature, heated sealed set temperature:140℃± 10℃;
(8) it packs:It is packed by corresponding package specification.
Embodiment 3
A kind of Chinese medicine preparation for treating tumour, dosage form are capsule, and preparation method is as follows:
(1) it extracts:By 10 parts of Radix Codonopsis, 20 parts of Rhizoma Atractylodis Macrocephalae, 5 parts of Yun Ling, 30 parts of honey-fried licorice root, raw 32 parts of Radix Astragali, 10 parts of Gorgon fruit, lotus Sub- 45 parts of meat, 10 parts of cultivated land, 50 parts of the root of straight ladybell, 25 parts of fructus amomi, 15 parts of Fructus Aurantii, 20 parts of ochre, spends 35 parts, white flower at 25 parts of sealwort again In 45 parts of 30 parts of HERBA HEDYOTIS DIFFUSAE, Ophidia black snake powder input multi-function extractors, for the first time plus 10 times of amount water extract 2 hours, second plus 8 Amount water extracts 1.5 hours again, filters by several times, and merging filtrate enters basin;
(2) it concentrates:The extracting solution that above-mentioned steps (1) are obtained, 75 DEG C, -0.08Mpa is concentrated under reduced pressure, and is concentrated into 60 DEG C of heat Survey the lotion that relative density is 1.25.
(3) it is dry:The lotion that step (2) obtains is placed in vacuum drying chamber, 70 DEG C, -0.08Mpa is dried 50 hours, is taken Go out lotion to be broken into pieces, take out and let cool to room temperature or during close to room temperature after continuing to be put into vacuum drying 12 hours, be transferred to grinders Sequence.
(4) mixing is crushed:The lotion block that step (3) obtains is put in pulverizer and is crushed to 80 mesh, by what is obtained after crushing Medicinal powder is put trough type mixing machine and is uniformly mixed within 20 ± 5 minutes with 20 revs/min of speed mixing, and it is to be tested that middle database is transferred to after mixing.
(5) it fills:The capsule medicinal powder NJP-1200 types fully-automatic capsule filling machine for taking chemical examination qualified by《NJP-1200 types Fully-automatic capsule filling machine standard practice instructions》It is filled, controls content uniformity, the method for double differences range 0.4* (1 ± 7%) g fills Negative relative should be kept with mistress between filling out, dust is excluded by dust exhaust apparatus, and temperature should be controlled at 26 DEG C, and humidity should control 65%;
(6) it polishes:Filled capsule is taken to be polished with II type drug polishing machines of YPJ-, it is extra outside capsule shells to remove Powder, and select defective work;
(7) bubble-cap:The capsule for taking chemical examination qualified with DPP-140B type aluminum-plastic blister machines by《DPP-140B type aluminum-plastic blister machines Standard practice instructions》Carry out bubble-cap, 130 DEG C ± 10 DEG C of molding heating plate set temperature, heated sealed set temperature:140℃± 10℃;
(8) it packs:It is packed by corresponding package specification.
Embodiment 4
A kind of Chinese medicine preparation for treating tumour, dosage form are granule, and preparation method is as follows:
(1) it extracts:By 5 parts of Radix Codonopsis, 10 parts of Rhizoma Atractylodis Macrocephalae, 8 parts of Yun Ling, 15 parts of honey-fried licorice root, raw 20 parts of Radix Astragali, 10 parts of Gorgon fruit, lotus Sub- 25 parts of meat, 13 parts of cultivated land, 30 parts of the root of straight ladybell, 20 parts of fructus amomi, 10 parts of Fructus Aurantii, 8 parts of ochre, spends 12 parts, long-noded pit viper at 10 parts of sealwort again In 25 parts of 15 parts of tongue grass, Ophidia black snake powder input multi-function extractors, for the first time plus 6 times of amount water extract 2 hours, second plus 8 times It measures water to extract 1.5 hours, filter by several times, merging filtrate enters basin;
(2) it concentrates:The extracting solution that above-mentioned steps (1) are obtained, is added in dual-effect concentrator and is concentrated, and is concentrated under reduced pressure The lotion that relative density is 1.25 is surveyed to 50 DEG C of heat;
(3) dispensing is weighed:Weighing Icing Sugar, dextrin are put in always mixed machine, and two dimension is total to mix 40 minutes;
(4) granulation drying:Dispensing after step (3) mixing is placed in wet granulator, adds in the cream that step (2) obtains Body, stirring is agglomerating to what is held, and that touches dissipates, and pelletizes, wet granular is transferred in fluid bed granulator, 80 through 14 mesh of oscillating granulator It is 50 minutes dry under the conditions of DEG C ± 2 DEG C;
(5) grain and mixing are selected:Dry particl is subjected to choosing grain, 12,40 mesh sieve is crossed, chooses intermediate particle, claim after mixing Amount packing.
Embodiment 5
A kind of Chinese medicine preparation for treating tumour, dosage form are granule, and preparation method is as follows:
(1) it extracts:By 8 parts of Radix Codonopsis, 15 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Yun Ling, 20 parts of honey-fried licorice root, raw 25 parts of Radix Astragali, 5 parts of Gorgon fruit, lotus Sub- 30 parts of meat, 15 parts of cultivated land, 40 parts of the root of straight ladybell, 10 parts of fructus amomi, 20 parts of Fructus Aurantii, 15 parts of ochre, spends 10 parts, white flower at 15 parts of sealwort again In 20 parts of 20 parts of HERBA HEDYOTIS DIFFUSAE, Ophidia black snake powder input multi-function extractors, for the first time plus 8 times of amount water extract 2 hours, second plus 7 Amount water extracts 1.5 hours again, filters by several times, and merging filtrate enters basin;
(2) it concentrates:The extracting solution that above-mentioned steps (1) are obtained, is added in dual-effect concentrator and is concentrated, and is concentrated under reduced pressure The lotion that relative density is 1.35 is surveyed to 50 DEG C of heat;
(3) dispensing is weighed:Weighing Icing Sugar, dextrin are put in always mixed machine, and two dimension is total to mix 40 minutes;
(4) granulation drying:Dispensing after step (3) mixing is placed in wet granulator, adds in the cream that step (2) obtains Body, stirring is agglomerating to what is held, and that touches dissipates, and pelletizes, wet granular is transferred in fluid bed granulator, 80 through 14 mesh of oscillating granulator It is 50 minutes dry under the conditions of DEG C ± 2 DEG C;
(5) grain and mixing are selected:Dry particl is subjected to choosing grain, 12,40 mesh sieve is crossed, chooses intermediate particle, claim after mixing Amount packing.
Embodiment 6
A kind of Chinese medicine preparation for treating tumour, dosage form are granule, and preparation method is as follows:
(1) it extracts:By 10 parts of Radix Codonopsis, 20 parts of Rhizoma Atractylodis Macrocephalae, 5 parts of Yun Ling, 30 parts of honey-fried licorice root, raw 32 parts of Radix Astragali, 10 parts of Gorgon fruit, lotus Sub- 45 parts of meat, 10 parts of cultivated land, 50 parts of the root of straight ladybell, 25 parts of fructus amomi, 15 parts of Fructus Aurantii, 20 parts of ochre, spends 35 parts, white flower at 25 parts of sealwort again In 45 parts of 30 parts of HERBA HEDYOTIS DIFFUSAE, Ophidia black snake powder input multi-function extractors, for the first time plus 10 times of amount water extract 2 hours, second plus 8 Amount water extracts 1.5 hours again, filters by several times, and merging filtrate enters basin;
(2) extracting solution for obtaining step (1) carries out clarifying treatment;
(3) it prepares, filter:First add the purified water of 1/2 amount, the extracting solution that step (2) is obtained into Agitation Tank, input is matched Flow container, addition sucrose, sodium benzoate are stirred, and finally plus purified water is to full dose, stirs 20min, adjustment pH value to 5.0- 7.0 it is filtered with filter, sampling detection, supernatant liquid of this product for rufous, slight bitter;
(4) embedding:The semi-finished product that above-mentioned steps (2) obtain are potted, debug embedding loading amount, adjustment loading amount, embedding, Lid is rolled, checks the tight ness rating of medicinal liquid clarity, loading amount and bottle cap after embedding at any time, is no more than 6 hours from filling end is formulated into, Loading amount was examined every 20 minutes, examines the leakproofness and appearance of sealing at any time.
Comparative example 1
Comparative example 1 provides a kind of Chinese medicine preparation, and dosage form is the formula group for being distinguished as comparative example 1 of capsule and embodiment 1 Become:30 parts of oldenlandia diffusa, 12 parts of cultivated land, 15 parts of Radix Codonopsis, raw 30 parts of Radix Astragali, 15 parts of Radix Glehniae, 10 parts of Diced tuckahoe, Rhizoma Atractylodis Macrocephalae 12 Part, 30 parts of Sculellaria barbata, 10 parts of black nightshade, 30 parts of the seed of jog's tears, 30 parts of rhizoma imperatae, 15 parts of Radix Ophiopogonis, 10 parts of madder, 8 parts of licorice, Radix Rehmanniae 30 Part, 8 parts of tendril-leaved fritillary bulb, 15 parts of the tuber of stemona, 15 parts of glossy ganoderma powder, 5 parts of toad, remaining preparation process is and embodiment 1 is identical.
Comparative example 2
Comparative example 2 provides a kind of Chinese medicine preparation, and dosage form is the formula group for being distinguished as comparative example 2 of capsule and embodiment 1 Become:10 parts of sealwort, 10 parts of Radix Astragali, 10 parts of prepared rehmannia root, 5-8 parts of Poria cocos, 10-15 parts of fructus amomi, 8-10 parts of inular flower, raddle 10-15 parts, 10 parts of Radix Rehmanniae, 12 parts of Radix Ophiopogonis, 15 parts of radix polygonati officinalis, 6 parts of Radix Angelicae Sinensis, 8 parts of Radix Paeoniae Alba, 5 parts of donkey-hide gelatin, 8 parts of Herba Epimedii, Morinda officinalis 10 Part, 10 parts of Cortex Eucommiae, 10 parts of pilose antler, 10 parts of ginseng, 6 parts of snake slough, 10 parts of water chestnut, 4 parts of monkshood, 8-10 parts of Chinese actinidia root, remaining preparation Process is and embodiment 1 is identical.
The technique effect of the present invention is described further with reference to clinical case:
Chinese medicine preparation is made in embodiment 1, comparative example 1 and comparative example 2 and is separately employed in 282 late gastric cancer patients, is survived Phase persistently takes, and takes orally, 3 times a day (in the morning, afternoon and evening after meal), 6 grams every time.Wherein take the patient view five of 1 capsule of embodiment Year survival rate is 22.78%, and median survival interval is 14.1 months, control rear lesion coefficient of stabilization, middle position stationary phase is respectively 62.5%, 6.5 months.Comparative example 1, life cycle persistently takes, and 3 times a day (in the morning, afternoon and evening after meal), 6 grams every time, observing five year survival rate is 16.16%, median survival interval is 10.3 months, controls rear lesion coefficient of stabilization, middle position stationary phase is respectively 48.2%, 4.5 month.Comparison 2 life cycle of example persistently takes, and 3 times a day (in the morning, afternoon and evening after meal), 6 grams every time, observation five year survival rate is 12.16%, middle position life It is 11.3 months to deposit the phase, controls rear lesion coefficient of stabilization, middle position stationary phase is respectively 43.45%, 3.95 month.It can be seen by above-mentioned data Go out and comparative example 1, comparative example 2 are compared, Chinese medicine preparation provided by the invention can significantly improve the five year survival rate of patient, treatment Lesion coefficient of stabilization and middle position stationary phase are higher afterwards, have this as it can be seen that compared with using the compatibility of comparative example 1 and comparative example 2, the present invention Life Radix Astragali, Radix Codonopsis, cultivated land, the root of straight ladybell, zaocys dhumnade, oldenlandia diffusa in the Chinese medicine preparation of offer are used for QI invigorating as monarch drug in a prescription, are good for Spleen, blood-nourishing, promote the production of body fluid, disappear knurl, add Rhizoma Atractylodis Macrocephalae, Yun Ling, Semen Nelumbinis, Gorgon fruit, sealwort and above-mentioned monarch drug in a prescription further played as ministerial drug QI invigorating, invigorating the spleen, blood-nourishing, the effect of promoting the production of body fluid, then compatibility appetizing, be amusing and fructus amomi that stomach, drop are inverse, ochre, multiple flower, reach i.e. Tonifying yin deficiency of blood damage and the not effect of the impairment of the spleen, by nourishing Yin and promoting production of body fluid, strengthen the body resistance to consolidate the constitution, dispersing swelling and dissipating binds, so as to inhibit tumor propagation, control Gastric cancer tumor diffusion transfer processed, contributes to lesion to stablize.
Chinese medicine preparation is made in the treatment of 132 malignant tumours in embodiment 4, life cycle persistently takes, and takes orally, often Day 3 times, in the morning, afternoon and evening after meal, 6 grams every time, survival rate respectively reaches 92.60%, 70.62%, 53.07% and within 1,3,5,10 year 23.48%, illustrate that Chinese medicine preparation provided by the invention is combined effectively enhancing patient's immunity by righting and eliminating evil, improve life Quality is deposited, extends patient vitals' period.
Chinese medicine preparation is made according to following metering for 90 liver cancer patients in embodiment 6, life cycle persistently takes, mouth Above-mentioned Chinese medicine preparation and Chemotherapy plus 3 times a day, in the morning, afternoon and evening after meal, 6 grams every time, as treatment group 1, are used for 52 livers by clothes Cancer patient as treatment group 2, only by the use of 31 liver cancer patients of chemotherapeutic treatment as treatment group 3, counts three groups of PR+NC respectively Rate, it is annual deposit rate and it is biennial deposit rate, the results are shown in table below:
Table 1
As can be seen from the above table individually using treatment group's 1PR+NC rates of Chinese medicine preparation provided by the invention up to 64.5%, one Year survival rate and the biennial rate of depositing are 62.3%, by the way that treatment group's 1PR+NC rates that itself and chemotherapy are used in combination are reached 73.2%, the annual rate and the biennial rate of depositing of depositing is 68.7%, is only using treatment group's 3PR+NC rates of chemotherapy individually 60.0%, annual to deposit rate 40.3%, biennial rate of depositing is 0, and the effect for illustrating Chinese medicine preparation of the present invention is used alone is better than Chemotherapy can improve the PR+NC rates and 1 year, the survival rate of 2 years of patient, and the Chinese medicine preparation of the present invention and Chemotherapy plus are made With playing certain gain effect, hence it is evident that improve PR+NC rates and 1 year, the survival rate of 2 years, be effectively improved the existence matter of patient Amount is decreased (P using Chinese medicine preparation patient IL-10 levels provided by the invention<0.05), IFN-γ level rises (P< 0.05), CTL (CD+, CD+) percentage and its ratio in CD+T cells significantly rise (P<0.05), to malignant tumor patient Symptom can be obviously improved, is put on weight, improves life quality.
The above embodiment is only the preferred embodiment of the present invention, it is impossible to the scope of protection of the invention is limited with this, The variation and replacement for any unsubstantiality that those skilled in the art is done on the basis of the present invention belong to institute of the present invention Claimed range.

Claims (8)

1. a kind of Chinese medicine preparation for treating tumour, which is characterized in that the Chinese medicine preparation is made of the raw material of following parts by weight:Party 2-10 parts of ginseng, 1-30 parts of Rhizoma Atractylodis Macrocephalae, 4-20 parts of Yun Ling, 3-30 parts of honey-fried licorice root, raw 1-40 parts of Radix Astragali, 2-10 parts of Gorgon fruit, Semen Nelumbinis 1- 50 parts, 3-20 parts of sealwort, 4-20 parts of cultivated land, 1-60 parts of the root of straight ladybell, 2-30 parts of fructus amomi, 3-30 parts of Fructus Aurantii, 1-20 parts of ochre, again spend 2- 40 parts, 6-40 parts of oldenlandia diffusa, 2-50 parts of Ophidia black snake powder.
2. a kind of Chinese medicine preparation for treating tumour according to claim 1, which is characterized in that the Chinese medicine preparation is capsule Agent, granule or oral liquid.
3. a kind of preparation method of the Chinese medicine preparation for the treatment of tumour as claimed in claim 2, which is characterized in that including following step Suddenly:
(1) it extracts:To Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Yun Ling, honey-fried licorice root, raw Radix Astragali, Gorgon fruit, Semen Nelumbinis, sealwort, cultivated land, the root of straight ladybell, fructus amomi, trifoliate orange In the mixture that shell, ochre, multiple flower, oldenlandia diffusa, Ophidia black snake powder form plus water extracts to obtain extracting solution, is carried what is obtained Liquid is taken to be filtered;
(2) said extracted liquid is prepared into different dosage forms as needed.
4. a kind of preparation method for the Chinese medicine preparation for treating tumour according to claim 3, which is characterized in that described to extract Cheng Wei:For the first time plus the 6-10 times of water for measuring Traditional Chinese drug mixture extracts 2 hours, second plus the 6-8 times of water for measuring Chinese medical extract carries It takes 1.5 hours.
5. a kind of preparation method for the Chinese medicine preparation for treating tumour according to claim 3, which is characterized in that when it is capsule During agent, preparation method is:
(1) it concentrates:The extracting solution that claim 3 step (1) is obtained is concentrated under reduced pressure, and relative density is when being concentrated under reduced pressure into 60 DEG C 1.25~1.30 lotion;
(2) it is dry:The lotion that above-mentioned steps (2) obtain is being dried;
(3) mixing is crushed:The lotion of step (3) after drying is crushed into mixing;
(4) it fills:Drug powder after being crushed in step (4) is filled in capsule;
(5) it polishes:Filled capsule in step (5) is polished, removes powder extra outside capsule shells;
(6) bubble-cap:Capsule after step (7) is polished carries out bubble-cap and handles up to capsule.
A kind of 6. preparation method for the Chinese medicine preparation for treating tumour according to claim 5, which is characterized in that above-mentioned steps (2) drying process carries out in vacuum drying chamber in, 60 DEG C~70 DEG C, and -0.04~-0.08Mpa is dried 50~60 hours, by cream Body continues 10~12 hours dry after breaking into pieces.
7. a kind of preparation method for the Chinese medicine preparation for treating tumour according to claim 3, which is characterized in that when it is particle During agent, preparation method is:
(1) it concentrates:The extracting solution that claim 3 step (1) is obtained is concentrated under reduced pressure, and relative density is when being concentrated under reduced pressure into 50 DEG C 1.25~1.35 lotion;
(2) dispensing is weighed:Weighing Icing Sugar, dextrin are uniformly mixed spare;
(3) granulation drying:The ingredients mixture of lotion made from step (1) and step (2) is placed in granulator and is pelletized to obtain the final product Granule.
8. a kind of preparation method for the Chinese medicine preparation for treating tumour according to claim 3, which is characterized in that when it is oral During liquid, preparation method is:
(1) it clarifies:The extracting solution that claim 3 step (1) is obtained carries out clarifying treatment;
(2) it prepares, filter:The clarification extracting solution that above-mentioned steps (1) obtain is proportionally added into and adds in purified water, sugarcane by purified water Sugar, sodium benzoate are stirred, and adjustment pH value filters to obtain semi-finished product to 5.0-7.0;
(3) embedding:The semi-finished product that above-mentioned steps (2) obtain are potted up to oral liquid.
CN201810021842.3A 2018-01-10 2018-01-10 A kind of Chinese medicine preparation for treating tumour and preparation method thereof Pending CN108126149A (en)

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Publication number Priority date Publication date Assignee Title
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CN1864737A (en) * 2005-05-17 2006-11-22 刘进曙 Powder dedicated for treating leukemia and preparation method thereof
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Publication number Priority date Publication date Assignee Title
CN1651064A (en) * 2004-12-23 2005-08-10 黄文珍 Medicinal composition for treating tumour and its preparation method
CN1864737A (en) * 2005-05-17 2006-11-22 刘进曙 Powder dedicated for treating leukemia and preparation method thereof
US8574636B2 (en) * 2008-09-25 2013-11-05 Lifebiotic Medical Research Ltd Herbal formulations
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Application publication date: 20180608