CN105853816A - Pharmaceutical preparation for treating liver cancer and application thereof - Google Patents

Pharmaceutical preparation for treating liver cancer and application thereof Download PDF

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CN105853816A
CN105853816A CN201610428967.9A CN201610428967A CN105853816A CN 105853816 A CN105853816 A CN 105853816A CN 201610428967 A CN201610428967 A CN 201610428967A CN 105853816 A CN105853816 A CN 105853816A
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grams
parts
pharmaceutical preparation
herba
ganoderma
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马德亮
李京烨
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    • A61K36/06Fungi, e.g. yeasts
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Abstract

The invention relates to a pharmaceutical preparation for treating liver cancer and an application thereof. The pharmaceutical preparation comprises lucid ganoderma, ganoderma applanatum pat, tenodera aridifolia stoll, pine needles, barbed skullcap herbs, red dates, sago cycas, white atractylodes rhizomes, amur corktree bark, betel nuts, corn stigma, Chinese pyrola herbs, spreading hedyotis herbs, fructus arctii, kelp, costus roots, fructus aurantii, licorice roots, thlaspi arvense, geckoes and sedum sarmentosum. According to the pharmaceutical preparation in the traditional Chinese medicine formula, liver cancer is treated with the qi-regulating and blood-activating method, the pharmaceutical preparation in the traditional Chinese medicine formula is low in treating side effect, and the pharmaceutical preparation is prepared in the mode that traditional Chinese medicinal materials serve as raw materials, the scientific formula is adopted, and repeated verification is carried out through clinical tests; the traditional Chinese medical theory is met, and meanwhile the immunity of the body is improved; due to multiple acting targets, the effective rate is high, and the pharmaceutical preparation is suitable for clinic applications and popularization and has high development value.

Description

A kind of for pharmaceutical preparation treating hepatocarcinoma and application thereof
Technical field
The present invention relates to for medicine treating hepatocarcinoma and application thereof, particularly to a kind of pharmaceutical preparation for treating hepatocarcinoma and Purposes, belongs to field of medicaments.
Background technology
Liver is the maincenter organ of body metabolism, plays the Chinese medicine effect of the metabolism such as regulation energy, protein, aminoacid, main officer of Tibet The chronic hepatopathy that oriental cherry is, repetitious stimulation long-term by a kind of or how many causes of disease and causes, liver cirrhosis liver in early days is in the compensatory phase, Hepatocarcinoma is final product, the more difficult discovery of hepatocarcinoma, once finds to be middle and advanced stage, and treatment difficulty is bigger.
Hepatocarcinoma can be divided into constitutional and the big class of Secondary cases two.Characters of Primary Malignant Tumors of Liver originates from epithelium or the mesenchymal tissue of liver, The former is referred to as primary hepatocarcinoma, is that China is occurred frequently, very harmful malignant tumor, and the latter is referred to as sarcoma, with primary hepatocarcinoma Compare the most rare.Secondary cases or the malignant tumor claiming secondary liver cancer to mean that the multiple organ of whole body originates from are invaded to liver.One As be more common in the hepatic metastases of the organ malignant tumours such as stomach, biliary tract, pancreas, Colon and rectum, ovary, uterus, lung, mammary gland.
The cause of disease and the definite molecular mechanism of primary hepatocarcinoma are not fully understood, it is now recognized that its morbidity is multifactor, multi-step Complex process, by environment and therefore double factor affected.Epidemiology and experimentation data show, hepatitis B virus (HBV) With hepatitis C virus (HCV) infection, flavacin, contaminated drinking water, ethanol, liver cirrhosis, gonadal hormone, nitrosamines thing Matter, trace element etc. are all relevant to onset of liver cancer.The pathogeny of hepatocarcinoma is extremely complex, and world-wide medical circle is still constantly being explored In.At present, the basic skills for the treatment of hepatocarcinoma is operative treatment, chemicotherapy etc., but, said method has a following side effect: Destroy normal structure and the physiological function of internal organs, cancerous cell accelerate diffusion, cause the misery on health and serious economy to patient Burden.And hepatocarcinoma allows people be difficult to bear the pain, to live is no better than to die.
Traditional Chinese Medicine think traditional medicine think cancer be that positive QI-insufficiency, the stagnation of QI, expectorant is solidifying and blood stasis and cause, therefore the controlling of cancer Treatment with extending life with " hard masses softening and resolving " as principle, to palliate the agonizing sufferings, prevent recurrence and transfer, final realizes that long-term " band tumor is raw Deposit " purpose.On tcm clinical practice, hepatocarcinoma belongs to the categories such as " the liver rump ", " mass at the hypochondrium ", " tympanites ", " jaundice " more.Traditional medicine Think depressed emotion, functional activity of QI being not smooth, the liver failing to maintain the normal flow of QI, therefore see upper abdomen distending pain, stomach poor appetite moves back, greasy fur, stringy and thready pulse, qi stagnation blood stasis, Courage and uprightness are obstructed, and accumulate over a long period, therefore have long-pending under seeing rib, and distending pain is uncomfortable, fatigue and weakness, and darkish complexion is become thin, greasy fur, body of the tongue Purple dark, thready and hesitant pulse, insufficiency of the spleen resulting in production of dampness, damp-stagnancy heat-transformation, accumulate in pyretic toxicity, therefore see jaundice, heating, bleeding from the gum, tympanites, yellow and greasy fur and Sense, wiry and frequent pulse.
The Drug therapy of existing market is still with excision, Western medicine, chemotherapy, radiotherapy as Main Means, but side effect is big, suffers from There are the phenomenons such as drowsiness, nauseating after taking in person, although Chinese medicine preparation also has much, but can play effective effect very Few.
Summary of the invention
For the defect of prior art, the present invention be directed to the present situation treated at present, it is provided that a kind of medicine system for treating hepatocarcinoma Agent, has no side effect, effective.
Specifically, the concrete scheme of the present invention is achieved in that
First, inventor provides a kind of pharmaceutical preparation for treating hepatocarcinoma according to drug matching experience, contains in prescription Chinese medicine ingredients is: Ganoderma, Ganoderma applanatum (Pers. Ex Wallr) Pat., Ootheca Mantidis, Folium Pini, Herba Scutellariae Barbatae, Fructus Jujubae, sago cycas, the Rhizoma Atractylodis Macrocephalae, Cortex Phellodendri, Semen Arecae, jade Rice palpus, Herba Pyrolae, Herba Hedyotidis Diffusae, Fructus Arctii, Thallus Laminariae (Thallus Eckloniae), Radix Aucklandiae (Radix Vladimiriae), Fructus Aurantii, Radix Glycyrrhizae, Xi, Gecko, Herba Sedi.
Further, inventor provides a kind of pharmaceutical preparation for treating hepatocarcinoma according to drug matching experience, prescription each former Material consumption all has preferable curative effect, described formula and weight portion in the weight portion scope of the present invention and is: Ganoderma 10-20 Part, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3-7 part, Ootheca Mantidis 5-8 part, Folium Pini 6-14 part, Herba Scutellariae Barbatae 8-17 part, Fructus Jujubae 10-20 part, sago cycas 3-7 Part, Rhizoma Atractylodis Macrocephalae 6-13 part, Cortex Phellodendri 4-12 part, Semen Arecae 3-8 part, Stigma Maydis 10-20 part, Herba Pyrolae 5-13 part, Agkistrodon SHECAO 10-25 part, Fructus Arctii 15-35 part, Thallus Laminariae (Thallus Eckloniae) 6-13 part, Radix Aucklandiae (Radix Vladimiriae) 4-10 part, Fructus Aurantii 6-13 part, Radix Glycyrrhizae 9-14 Part, Xi 4-11 part, Gecko 5-11 part, Herba Sedi 8-16 part.
Further, carrying out preferably, reaching superior technique effect to the formula of above-mentioned weight portion, preferred formula is: Ganoderma 15 parts, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 parts, Ootheca Mantidis 6.5 parts, 10 parts of Folium Pini, Herba Scutellariae Barbatae 12.5 parts, Fructus Jujubae 15 parts, sago cycas 5 Part, the Rhizoma Atractylodis Macrocephalae 10 parts, Cortex Phellodendri 8 parts, Semen Arecae 5.5 parts, Stigma Maydis 15 parts, Herba Pyrolae 9 parts, Herba Hedyotidis Diffusae 17.5 parts, Fructus Arctii 25 parts, Thallus Laminariae (Thallus Eckloniae) 10 parts, Radix Aucklandiae (Radix Vladimiriae) 7 parts, Fructus Aurantii 9.5 parts, 11.5 parts of Radix Glycyrrhizae, Xi 7.5 parts, Gecko 8 Part, Herba Sedi 12 parts.
Or:
Ganoderma 16 parts, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 parts, Ootheca Mantidis 7.5 parts, 11 parts of Folium Pini, Herba Scutellariae Barbatae 13.5 parts, Fructus Jujubae 15.5 parts, Sago cycas 5.5 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Cortex Phellodendri 8.5 parts, Semen Arecae 6.5 parts, Stigma Maydis 15.5 parts, Herba Pyrolae 10 parts, spend in vain Herba Hedyotidis Diffusae 18.5 parts, Fructus Arctii 26 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, Radix Aucklandiae (Radix Vladimiriae) 7.5 parts, Fructus Aurantii 10.5 parts, 12.5 parts of Radix Glycyrrhizae, Xi 7.5 parts, Gecko 8.5 parts, Herba Sedi 13 parts.
In pharmaceutical preparation described above, the Chinese medicine used all uses its conventional medicinal part to be used as medicine, the dosage of drug used Rationally, after all medicines share, treatment hepatocarcinoma is had to the effect of preferably treatment.
The function of each taste Chinese crude drug used in the pharmaceutical preparation of the treatment hepatocarcinoma of the present invention is as follows:
Ganoderma: sweet in the mouth, flat.
Gui Jing: GUIXIN, lung, liver, kidney channel.
Function cures mainly: invigorating QI and tranquilization, relieving cough and asthma.For dizziness sleeplessness, shortness of breath and palpitation, asthenia cough with asthma.
Ganoderma applanatum (Pers. Ex Wallr) Pat.: mildly bitter flavor;Flat
Gui Jing: spleen;Stomach warp
Function cures mainly: anti-inflammatory and anticancer.Main pharyngolaryngitis;The esophageal carcinoma;Nasopharyngeal carcinoma
Ootheca Mantidis: sweet in the mouth, salty is flat.
Gui Jing: return liver, kidney channel.
Function cures mainly: supplementing the kidney to control the nocturnal, and reducing urination is the most turbid.For emission and spermatorrhea, enuresis frequent micturition, urine nebulousurine.
Folium Pini: bitter in the mouth, puckery, temperature.
Function cures mainly: expelling wind and activating blood circulation, and improving eyesight is calmed the nerves, removing toxic substances, antipruritic.For influenza, rheumatic arthritis, traumatic injury Swell and ache, nyctalopia, hypertension, neurasthenia;External treating chilblain.
Herba Scutellariae Barbatae: acrid in the mouth, micro-hardship, cool in nature, enter liver, stomach, large intestine channel.
Effect: energy heat-clearing and toxic substances removing, malignant boil carbuncle furuncle, inducing diuresis to remove edema, has anticancer effect.
Clinical practice: this product is anticancer common medicine, can be used for various cancer, is especially used for digestive tract tumor, sees damp and hot accumulateing with card Knot person be advisable, and is also widely used in the disease that tumor companion is hemorrhage, can play hemostasis and not stay the effect of the stasis of blood.
Fructus Jujubae: sweet in the mouth, warm in nature.
Function cures mainly: invigorating the spleen and replenishing QI, tranquilizing by nourishing the heart.For diarrhea due to hypofunction of the spleen, cardiopalmus, insomnia, night sweat, thrombocytopenic is purple Purplish or white patches on the skin.Bark: antiinflammatory, hemostasis, antidiarrheal.For tracheitis, enteritis, dysentery, metrorrhagia;Traumatic hemorrhage is controlled in external.Root: OK Gas, invigorates blood circulation, regulating menstruation.For menoxenia, red collapse, leucorrhea
Sago cycas: sweet in the mouth, light, flat.Slightly poisonous.
Function cures mainly: leaf: astringing to arrest bleeding, pain relieving of detoxifying.For various hemorrhage, gastritis, gastric ulcer, hypertension, neuralgia, Amenorrhea, cancer.
Flower: regulating QI to relieve pain, supplementing the kidney to control the nocturnal.For having a stomachache, seminal emission, leucorrhea, dysmenorrhea.
The Rhizoma Atractylodis Macrocephalae: bitter in the mouth, warm in nature.
Gui Jing: return spleen, stomach warp.
Function cures mainly: invigorating the spleen and benefiting QI, dampness diuretic, and for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, Frequent fetal movement.
Herba Pyrolae: sweet in the mouth, warm in nature.
Gui Jing: return liver, kidney channel.
Function cures mainly: wind-damp dispelling, bone and muscle strengthening, hemostasis.For rheumatic arthralgia, weakness of the waist and knees, menorrhagia, chronic cough due to asthenia of viscera.
Cortex Phellodendri: bitter in the mouth, cold in nature.
Gui Jing: return kidney, bladder warp.
Function cures mainly: heat clearing and damp drying, and pathogenic fire purging is except steaming, and detoxification sore treatment, sore swollen toxin, eczema pruritus, for hyperactivity of fire caused by deficiency of YIN, robber Antiperspirant hectic fever due to YIN-deficiency.
Semen Arecae: bitter in the mouth, pungent, temperature.
Gui Jing: return stomach, large intestine channel.
Function cures mainly: killing insect and eliminating accumulation, sending down the abnormal ascending QI, row water, preventing the attack (or recurrence) of malaria.For cestode, ascarid, fasciolopsiasis buski, abdominal pain due to worm stagnation, amass Stagnant dysentery, tenesmus, edema tinea pedis, malaria.
Stigma Maydis: sweet in the mouth, property is put down.
Gui Jing: kidney;Stomach;Liver;Gallbladder meridian.
Function cures mainly: inducing diuresis to remove edema;Liver heat removing function of gallbladder promoting.Main edema;Dribbling urination;Jaundice;Cholecystitis;Cholelithiasis;Hypertension; Diabetes;Galactostasis.
Herba Hedyotidis Diffusae: sweet in the mouth, cool in nature.
Gui Jing: enter stomach, large intestine, small intestine meridian.
Function cures mainly: heat-clearing and toxic substances removing, inducing diuresis to remove edema, promoting blood circulation and stopping pain.For acute appendicitis (appendicitis), furuncle toxic swelling, jaundice due to damp-heat, The diseases such as dysuria;Furuncle carbuncle, venom are controlled in external.
Fructus Arctii: acrid in the mouth, cold in nature.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat.For anemopyretic cold, cough with copious phlegm, measles, rubella, Laryngopharynx swelling and pain, mumps erysipelas, carbuncle sore tumefacting virus.
Thallus Laminariae (Thallus Eckloniae): salty in the mouth, cold.
Gui Jing: return liver, stomach, kidney channel.
Function cures mainly: hard masses softening and resolving, expectorant, diuretic.For goiter, scrofula, painful and swollen testis, phlegm retention edema.
Radix Aucklandiae (Radix Vladimiriae): sweet in the mouth, warm in nature.
Gui Jing: return spleen, stomach, large intestine, gallbladder meridian.
Function cures mainly: can lead to manner, easing stomach-QI, row irritability, dissipates stagnant gas, broken stagnation of QI, and the most distressed, by cold air, peace cholera is told Rush down, vomiting regurgitation of food from the stomach, except painful abdominal mass addiction disease block, umbilicus abdominal distention and pain, antiabortive scattered poison, control dysentery required, and ward off pestilential pathogen miasma.
Fructus Aurantii: bitter in the mouth, pungent, sour, temperature.
Gui Jing: return spleen, stomach warp.
Function cures mainly: regulating the flow of QI to ease the stomach, the stagnant relieving distension of row.Coerce the stagnation of QI, distension pain, accumulation of food in the stomach and intes tine due to indigestion for breast, stop in phlegm retention;Stomach Sagging, proctoptosis, sub-official prolapses.
Radix Glycyrrhizae: sweet in the mouth, flat.
Gui Jing: GUIXIN, lung, spleen, stomach warp.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, tired Idle weak, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, extremity contraction urgency pain, carbuncle sore tumefacting virus, cushion toxicity, strong.
Xi: acrid in the mouth;Tepor
Gui Jing: liver;Spleen;Kidney channel
Function cures mainly: improving eyesight;Wind-damp dispelling.Main conjunctival congestion and swelling pain;Hide from view bulbar conjunctiva polyp;Epiphora induced by wind;Rheumatic arthralgia
Gecko: salty in the mouth, property is put down.
Gui Jing: return lung, kidney channel.
Function cures mainly: invigorating the lung and the kidney, improving inspiration by invigorating kidney-QI Dingchuan, supporing yang benefit essence.For dyspnea due to deficiency tachypnea, chronic cough hemoptysis, impotence and seminal emission.
Herba Sedi: sweet in the mouth, light, cool in nature.
Gui Jing: return liver, gallbladder, small intestine meridian.
Function cures mainly: dampness removing jaundice eliminating, heat-clearing and toxic substances removing.For jaundice due to damp-heat, dysuria, carbuncle skin infection.
Above material medicine is extracted is prepared as pharmaceutically acceptable preparation.Pharmaceutical dosage form of the present invention selected from granule, In capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill A kind of.More preferably granule or capsule or tablet.
The application in preparing liver-cancer medicine of the above preparation, the especially application in preparation treatment Primary Hepatic cancer drug.
The preparation method of pharmaceutical preparation of the present invention is:
The preparation of decoction: weighed up according to weight by traditional Chinese medicinal material raw materials, with soak by water 3 times, each 40-60 minute, filters, Merging filtrate, filtrate reduced in volume is equivalent to raw medicinal herbs amount 1 weight portion to every 1 milliliter, obtains decoction.
The preparation of oral liquid: weighed up according to weight by traditional Chinese medicinal material raw materials, with soak by water 3 times, each 40-60 minute, filters, Merging filtrate, filtrate reduced in volume is equivalent to raw medicinal herbs amount 1 weight portion to every 1 milliliter, sterilized, and filling bottle obtains oral Liquid;
The preparation method of tablet is:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, in powdered extract powder, conventional method adds adjuvant, finally Add magnesium stearate, mixing, tabletting, coating, obtain tablet.
The preparation method of capsule is:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, the wettest Method is pelletized, and loads capsule, obtains capsule.
The preparation method of granule is:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletizing, obtain granule, granule often wraps weight 10g.
Compared with prior art, the present invention has the advantage that with good effect and is:
(1) the technical problem to be solved is to provide a kind of, few side effects, energy prolonged application better than existing curative effect of medication In the Chinese medicinal formulae controlling the liver cancer patient state of an illness.
(2) this Chinese prescription is economic and practical, and from regulating the flow of vital energy, the method treatment hepatocarcinoma invigorated blood circulation, the pharmaceutical preparation of Chinese prescription is in treatment Side effect is low, and the Chinese medicine using Chinese tradition is raw material, through the prescription of science, and is prepared by the checking repeatedly of clinical trial , meeting the theory of Chinese medicine, improve the immunity of health, multiaction target spot simultaneously, effective percentage is high, is suitable for Clinical application.
(3) prescription of the present invention, decoction is suitable for extensive patients and takes, taking convenience, and tablet, capsule and granule are suitable for industry Metaplasia is produced, and has higher Development volue.
Detailed description of the invention
The detailed description of the invention of the following stated, the only present invention, protection scope of the present invention is not limited thereto, any familiar Those skilled in the art in the technical scope that the invention discloses, the change that can readily occur in or replacement, all should contain Within protection scope of the present invention.
Embodiment 1: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 10 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3 grams, Ootheca Mantidis 5 grams, 6 grams of Folium Pini, Herba Scutellariae Barbatae 8 grams, Fructus Jujubae 10 grams, sago cycas 3 grams, The Rhizoma Atractylodis Macrocephalae 6 grams, Cortex Phellodendri 4 grams, Semen Arecae 3 grams, Stigma Maydis 10 grams, Herba Pyrolae 5 grams, Herba Hedyotidis Diffusae 10 grams, Fructus Arctii 15 grams, Thallus Laminariae (Thallus Eckloniae) 6 grams, Radix Aucklandiae (Radix Vladimiriae) 4 grams, Fructus Aurantii 6 grams, 9 grams of Radix Glycyrrhizae, Xi 4 grams, Gecko 5 grams, Herba Sedi 8 grams.
Above Chinese medicine composition is prepared as decoction, its concrete preparation method:
Being weighed up according to weight by traditional Chinese medicinal material raw materials, add pure water and soak, the water surface is higher than powder 3-5cm, after soaking 2 hours, Decocting 2 times, 1.5 hours for the first time, 1 hour for the second time, merge decoction liquor, medicinal liquid divides two grams, sooner or later respectively takes one gram.
Embodiment 2: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 20 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 7 grams, Ootheca Mantidis 8 grams, 14 grams of Folium Pini, Herba Scutellariae Barbatae 17 grams, Fructus Jujubae 20 grams, sago cycas 7 Gram, the Rhizoma Atractylodis Macrocephalae 13 grams, Cortex Phellodendri 12 grams, Semen Arecae 8 grams, Stigma Maydis 20 grams, Herba Pyrolae 13 grams, Herba Hedyotidis Diffusae 25 grams, Fructus Arctii 35 grams, Thallus Laminariae (Thallus Eckloniae) 13 grams, Radix Aucklandiae (Radix Vladimiriae) 10 grams, Fructus Aurantii 13 grams, 14 grams of Radix Glycyrrhizae, Xi 11 grams, Gecko 11 grams, Herba Sedi 16 grams..
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 3: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 15 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 grams, Ootheca Mantidis 6.5 grams, 10 grams of Folium Pini, Herba Scutellariae Barbatae 12.5 grams, Fructus Jujubae 15 grams, sago cycas 5 grams, the Rhizoma Atractylodis Macrocephalae 10 grams, Cortex Phellodendri 8 grams, Semen Arecae 5.5 grams, Stigma Maydis 15 grams, Herba Pyrolae 9 grams, Herba Hedyotidis Diffusae 17.5 grams, Fructus Arctii 25 grams, Thallus Laminariae (Thallus Eckloniae) 10 grams, Radix Aucklandiae (Radix Vladimiriae) 7 grams, Fructus Aurantii 9.5 grams, 11.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8 grams, Herba Sedi 12 grams.
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 4: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 16 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 grams, Ootheca Mantidis 7.5 grams, 11 grams of Folium Pini, Herba Scutellariae Barbatae 13.5 grams, Fructus Jujubae 15.5 grams, Sago cycas 5.5 grams, the Rhizoma Atractylodis Macrocephalae 11 grams, Cortex Phellodendri 8.5 grams, Semen Arecae 6.5 grams, Stigma Maydis 15.5 grams, Herba Pyrolae 10 grams, Agkistrodon SHECAO 18.5 grams, Fructus Arctii 26 grams, Thallus Laminariae (Thallus Eckloniae) 11 grams, Radix Aucklandiae (Radix Vladimiriae) 7.5 grams, Fructus Aurantii 10.5 grams, 12.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8.5 grams, Herba Sedi 13 grams.
Above Chinese medicine composition is prepared as decoction, and its concrete preparation method is with embodiment 1.
Embodiment 5: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 10 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3 grams, Ootheca Mantidis 5 grams, 6 grams of Folium Pini, Herba Scutellariae Barbatae 8 grams, Fructus Jujubae 10 grams, sago cycas 3 grams, The Rhizoma Atractylodis Macrocephalae 6 grams, Cortex Phellodendri 4 grams, Semen Arecae 3 grams, Stigma Maydis 10 grams, Herba Pyrolae 5 grams, Herba Hedyotidis Diffusae 10 grams, Fructus Arctii 15 grams, Thallus Laminariae (Thallus Eckloniae) 6 grams, Radix Aucklandiae (Radix Vladimiriae) 4 grams, Fructus Aurantii 6 grams, 9 grams of Radix Glycyrrhizae, Xi 4 grams, Gecko 5 grams, Herba Sedi 8 grams.
Above Chinese medicine composition is prepared as granule, its concrete preparation method:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletizing, obtain granule, granule often wraps weight 10g.
Embodiment 6: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 20 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 7 grams, Ootheca Mantidis 8 grams, 14 grams of Folium Pini, Herba Scutellariae Barbatae 17 grams, Fructus Jujubae 20 grams, sago cycas 7 Gram, the Rhizoma Atractylodis Macrocephalae 13 grams, Cortex Phellodendri 12 grams, Semen Arecae 8 grams, Stigma Maydis 20 grams, Herba Pyrolae 13 grams, Herba Hedyotidis Diffusae 25 grams, Fructus Arctii 35 grams, Thallus Laminariae (Thallus Eckloniae) 13 grams, Radix Aucklandiae (Radix Vladimiriae) 10 grams, Fructus Aurantii 13 grams, 14 grams of Radix Glycyrrhizae, Xi 11 grams, Gecko 11 grams, Herba Sedi 16 grams..
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 7: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 15 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 grams, Ootheca Mantidis 6.5 grams, 10 grams of Folium Pini, Herba Scutellariae Barbatae 12.5 grams, Fructus Jujubae 15 grams, sago cycas 5 grams, the Rhizoma Atractylodis Macrocephalae 10 grams, Cortex Phellodendri 8 grams, Semen Arecae 5.5 grams, Stigma Maydis 15 grams, Herba Pyrolae 9 grams, Herba Hedyotidis Diffusae 17.5 grams, Fructus Arctii 25 grams, Thallus Laminariae (Thallus Eckloniae) 10 grams, Radix Aucklandiae (Radix Vladimiriae) 7 grams, Fructus Aurantii 9.5 grams, 11.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8 grams, Herba Sedi 12 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 8: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 16 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 grams, Ootheca Mantidis 7.5 grams, 11 grams of Folium Pini, Herba Scutellariae Barbatae 13.5 grams, Fructus Jujubae 15.5 grams, Sago cycas 5.5 grams, the Rhizoma Atractylodis Macrocephalae 11 grams, Cortex Phellodendri 8.5 grams, Semen Arecae 6.5 grams, Stigma Maydis 15.5 grams, Herba Pyrolae 10 grams, Agkistrodon SHECAO 18.5 grams, Fructus Arctii 26 grams, Thallus Laminariae (Thallus Eckloniae) 11 grams, Radix Aucklandiae (Radix Vladimiriae) 7.5 grams, Fructus Aurantii 10.5 grams, 12.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8.5 grams, Herba Sedi 13 grams.
Above Chinese medicine composition is prepared as granule, and its concrete preparation method is with embodiment 5.
Embodiment 9: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 10 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3 grams, Ootheca Mantidis 5 grams, 6 grams of Folium Pini, Herba Scutellariae Barbatae 8 grams, Fructus Jujubae 10 grams, sago cycas 3 grams, The Rhizoma Atractylodis Macrocephalae 6 grams, Cortex Phellodendri 4 grams, Semen Arecae 3 grams, Stigma Maydis 10 grams, Herba Pyrolae 5 grams, Herba Hedyotidis Diffusae 10 grams, Fructus Arctii 15 grams, Thallus Laminariae (Thallus Eckloniae) 6 grams, Radix Aucklandiae (Radix Vladimiriae) 4 grams, Fructus Aurantii 6 grams, 9 grams of Radix Glycyrrhizae, Xi 4 grams, Gecko 5 grams, Herba Sedi 8 grams.
Above Chinese medicine composition is prepared as tablet, its concrete preparation method:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, in powdered extract powder, conventional method adds adjuvant, finally Add magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 10: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 20 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 7 grams, Ootheca Mantidis 8 grams, 14 grams of Folium Pini, Herba Scutellariae Barbatae 17 grams, Fructus Jujubae 20 grams, sago cycas 7 Gram, the Rhizoma Atractylodis Macrocephalae 13 grams, Cortex Phellodendri 12 grams, Semen Arecae 8 grams, Stigma Maydis 20 grams, Herba Pyrolae 13 grams, Herba Hedyotidis Diffusae 25 grams, Fructus Arctii 35 grams, Thallus Laminariae (Thallus Eckloniae) 13 grams, Radix Aucklandiae (Radix Vladimiriae) 10 grams, Fructus Aurantii 13 grams, 14 grams of Radix Glycyrrhizae, Xi 11 grams, Gecko 11 grams, Herba Sedi 16 grams..
Above Chinese medicine composition is prepared as tablet, and its concrete preparation method is with embodiment 9.
Embodiment 11: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 15 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 grams, Ootheca Mantidis 6.5 grams, 10 grams of Folium Pini, Herba Scutellariae Barbatae 12.5 grams, Fructus Jujubae 15 grams, sago cycas 5 grams, the Rhizoma Atractylodis Macrocephalae 10 grams, Cortex Phellodendri 8 grams, Semen Arecae 5.5 grams, Stigma Maydis 15 grams, Herba Pyrolae 9 grams, Herba Hedyotidis Diffusae 17.5 grams, Fructus Arctii 25 grams, Thallus Laminariae (Thallus Eckloniae) 10 grams, Radix Aucklandiae (Radix Vladimiriae) 7 grams, Fructus Aurantii 9.5 grams, 11.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8 grams, Herba Sedi 12 grams.
Above Chinese medicine composition is prepared as tablet, and its concrete preparation method is with embodiment 9.
Embodiment 12: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 16 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 grams, Ootheca Mantidis 7.5 grams, 11 grams of Folium Pini, Herba Scutellariae Barbatae 13.5 grams, Fructus Jujubae 15.5 grams, Sago cycas 5.5 grams, the Rhizoma Atractylodis Macrocephalae 11 grams, Cortex Phellodendri 8.5 grams, Semen Arecae 6.5 grams, Stigma Maydis 15.5 grams, Herba Pyrolae 10 grams, Agkistrodon SHECAO 18.5 grams, Fructus Arctii 26 grams, Thallus Laminariae (Thallus Eckloniae) 11 grams, Radix Aucklandiae (Radix Vladimiriae) 7.5 grams, Fructus Aurantii 10.5 grams, 12.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8.5 grams, Herba Sedi 13 grams.
Above Chinese medicine composition is prepared as tablet, and its concrete preparation method is with embodiment 9.
Embodiment 13: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 10 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3 grams, Ootheca Mantidis 5 grams, 6 grams of Folium Pini, Herba Scutellariae Barbatae 8 grams, Fructus Jujubae 10 grams, sago cycas 3 grams, The Rhizoma Atractylodis Macrocephalae 6 grams, Cortex Phellodendri 4 grams, Semen Arecae 3 grams, Stigma Maydis 10 grams, Herba Pyrolae 5 grams, Herba Hedyotidis Diffusae 10 grams, Fructus Arctii 15 grams, Thallus Laminariae (Thallus Eckloniae) 6 grams, Radix Aucklandiae (Radix Vladimiriae) 4 grams, Fructus Aurantii 6 grams, 9 grams of Radix Glycyrrhizae, Xi 4 grams, Gecko 5 grams, Herba Sedi 8 grams.
Above Chinese medicine composition is prepared as capsule, its concrete preparation method:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, the wettest Method is pelletized, and loads capsule, obtains capsule.
Embodiment 14: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 20 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 7 grams, Ootheca Mantidis 8 grams, 14 grams of Folium Pini, Herba Scutellariae Barbatae 17 grams, Fructus Jujubae 20 grams, sago cycas 7 Gram, the Rhizoma Atractylodis Macrocephalae 13 grams, Cortex Phellodendri 12 grams, Semen Arecae 8 grams, Stigma Maydis 20 grams, Herba Pyrolae 13 grams, Herba Hedyotidis Diffusae 25 grams, Fructus Arctii 35 grams, Thallus Laminariae (Thallus Eckloniae) 13 grams, Radix Aucklandiae (Radix Vladimiriae) 10 grams, Fructus Aurantii 13 grams, 14 grams of Radix Glycyrrhizae, Xi 11 grams, Gecko 11 grams, Herba Sedi 16 grams..
Above Chinese medicine composition is prepared as capsule, and its concrete preparation method is with embodiment 13.
Embodiment 15: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 15 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 grams, Ootheca Mantidis 6.5 grams, 10 grams of Folium Pini, Herba Scutellariae Barbatae 12.5 grams, Fructus Jujubae 15 grams, sago cycas 5 grams, the Rhizoma Atractylodis Macrocephalae 10 grams, Cortex Phellodendri 8 grams, Semen Arecae 5.5 grams, Stigma Maydis 15 grams, Herba Pyrolae 9 grams, Herba Hedyotidis Diffusae 17.5 grams, Fructus Arctii 25 grams, Thallus Laminariae (Thallus Eckloniae) 10 grams, Radix Aucklandiae (Radix Vladimiriae) 7 grams, Fructus Aurantii 9.5 grams, 11.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8 grams, Herba Sedi 12 grams.
Above Chinese medicine composition is prepared as capsule, and its concrete preparation method is with embodiment 13.
Embodiment 16: a kind of pharmaceutical preparation treating pulmonary carcinoma, includes than its composition according to weight fraction:
Ganoderma 16 grams, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 grams, Ootheca Mantidis 7.5 grams, 11 grams of Folium Pini, Herba Scutellariae Barbatae 13.5 grams, Fructus Jujubae 15.5 grams, Sago cycas 5.5 grams, the Rhizoma Atractylodis Macrocephalae 11 grams, Cortex Phellodendri 8.5 grams, Semen Arecae 6.5 grams, Stigma Maydis 15.5 grams, Herba Pyrolae 10 grams, Agkistrodon SHECAO 18.5 grams, Fructus Arctii 26 grams, Thallus Laminariae (Thallus Eckloniae) 11 grams, Radix Aucklandiae (Radix Vladimiriae) 7.5 grams, Fructus Aurantii 10.5 grams, 12.5 grams of Radix Glycyrrhizae, Xi 7.5 grams, Gecko 8.5 grams, Herba Sedi 13 grams.
Above Chinese medicine composition is prepared as capsule, and its concrete preparation method is with embodiment 13.
Embodiment 17: the animal test of pesticide effectiveness
DEN Diethylnitrosamine-induced Hepatocarcinoma of Rat liver cancer model is a kind of induction property liver cancer model more common in research.DEN is a kind of sub- Nitramine compound, has the dual function of denaturant and carcinogen, and the carcinogenic rate of this material is high, and specificity carcinogenic to liver is strong, The hepatocarcinoma being the most frequently used lures cancer agent
Nexavar sheet adopted name is Sorafenib Tosylate sheet, and Main Ingredients and Appearance is Sorafenib, has dual antitumor and makees With.Clinically for advanced renal cell carcinoma, the treatment of hepatocarcinoma.The present invention is used as positive control test.
17.1, modeling and packet are administered
Male SD rat 60, body weight 160~220g, all rat sub-cage rearings, 5, every cage, use standardization light According to, ad lib, regularly replace bedding and padding, adaptation environment, after 7 days, is divided into 2 groups by random digits table, is respectively normal Matched group, modeling group (M group, n=50), modeling group rat gives DEN lumbar injection, is administered by body weight 20mg/kg, 3 times a week, to drug withdrawal when 12 weeks.Take above-mentioned rat model 50, be divided into model group, positive controls, the present invention real Execute dosage group (B group 6g/kg) in example 3 tablet high dose group (A group 12g/kg), the embodiment of the present invention 3 tablet, this Bright embodiment 7 granule low dose group (C group g/kg), often group 10 are concrete such as table 1.
Table 1 respectively organizes application method and consumption is as follows
17.2, check
Liver index: last is de-vertebra execution rat after being administered 24 hours, takes liver and weighs, liver index=liver weight (mg)/ Body weight (g), each group liver index such as table 2.
The measurement result of liver index respectively organized by table 2
Note:
Compared with model group,@P<0.05、@@P<0.01;
As seen from the results in Table 2:
(1) each administration group process mice has significant difference compared with model group.
(2) A, B, C group can significantly reduce rats'liver index, by therapeutic effect it can be seen that therapeutic effect and dosage it Between in dependence.
17.3, the detection of interleukin II (IL-20)
Test kit (ELISA) by specification is used to use.Detect the IL-20 such as table 3 of each group.
The measurement result of IL-2 respectively organized by table 3
Note:
Compared with model group,@P<0.05、@@P<0.01;
Compared with positive controls,&P<0.05。
As seen from the results in Table 3: each administration group processes mice and has significant difference compared with model group, and A, B, C group can Significantly improve the content of IL-2, wherein A group compared with positive controls, there is significance (P < 0.05) difference, show this The granule of the high dose of invention is better than positive controls.
The impact on water Liver Function of 17.4 medicines
Administration group prothrombin time all has shortening (table 4) in various degree.
Testing result respectively organized by table 4
Note
# compares with normal group, and P < 0.05, ## compares with normal group, P < 0.01;
* comparing with model group, P < 0.05, * * compares with model group, P < 0.01;
As can be seen from Table 4: between normal group and model group, there is significant difference, rat modeling success is described, tests each group and mould Significant difference is there is, in dose-dependence between each group of the granule of embodiment 7 between type group.
17.5, long-term toxicity test for animals
Tested Chinese medicine preparation: the pharmaceutical preparation manufactured by embodiment of the present invention 1-16, makes solution, standby.
Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
4 kinds of pharmaceutical preparatioies: be divided into high, medium and low three dosage groups, per weight dosage be respectively patient's dose 180, 60,20 times;Experimental mouse is randomly divided into 49 groups, and wherein the pharmaceutical preparation of 48 groups of difference 3 kinds of three dosage of gavage, remains 1 group of filling Stomach normal saline (40 times of patient's dose);All 48 groups of gavages 180 days all continuously, observe animal general toxic reaction and serious Degree, place after death checks each position by rule of operation, and carries out hematology, ALT, BUN and the heart, liver, spleen, lung, kidney, The pathological examination of the main organs such as stomach;Through long-term feeding, all there is not toxic reaction in 13 groups of rats.Physically well develop.Naked eyes Outward appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group without pathologic change.Pathology report Accuse the most significant changes such as the heart, liver, spleen, lung, kidney, stomach, it is therefore contemplated that through proved by pathology, pharmaceutical preparation is to animal Show without chronic toxicity.
By two above toxicity test, it was demonstrated that the present invention is safe by the pharmaceutical preparation that embodiment 1-16 makes, nontoxic secondary work , can be taken by patient.
Embodiment 18: clinical trial
18.1, physical data:
For investigating clinical efficacy and the safety of medicine of the present invention further, we have selected 103 example patients and control medicine of the present invention Treat curative effect and carry out clinical trial.The maleest 53 examples, female 50 example, the course of disease is the shortest 2.5 months, the longest 4 years, gets rid of anemia of pregnant woman and age of sucking Women,
18.2, diagnostic criteria and packet medication
18.2.1 diagnostic criteria:
1. it is diagnosed as primary hepatocarcinoma (confirming through histological examination, AFP, imaging examination) and Chinese medical discrimination belongs to qi depression to blood stasis Card, and more than 3 months persons that can survive;
Accept the treatment of this medicine the most voluntarily or terminate more than 1 month and the person that still has solid tumor through radiotherapy, chemotherapy etc., or operations research is not Can excision person;
3. age 18-70 year;
4. liver function is normal;
5. life quality scores person's (karnofsky point system standard) more than 60 points;
6. without serious jaundice ascites, cachexia, hepatic coma and central nervous system's transferrer.
Meet above six persons and include this research in.
18.2.2 medication it is grouped:
Meet above-mentioned requirements person 103 example, be randomly divided into 2 groups.
Treatment group 52 example, male 27 examples, female 25 example, the oldest 70 years old, minimum 32 years old, average 47.5 years old, medicine of the present invention was real Execute the granule of example 7, each 10g, twice daily, the 4th, 8,12,24 months time carry out disease observation;
Matched group 51 example, male 26 examples, female 25 example, the oldest 70 years old, minimum 19 years old, average 47.3 years old, Sorafenib+Radix Ginseng Saponin, according to state of an illness medication, the 4th, 8,12,24 months time carry out disease observation.
18.3, efficacy determination and result
Efficacy determination: use WHO criterion of therapeutical effect
(1) complete incidence graph: visual tumors disappears and continues January more than.
(2) part is alleviated: the maximum orthogonal diameter product of two, tumor reduces more than 50% and persistently more than January.
(3) stable: the maximum orthogonal diameter product of two, tumor reduces less than 50%, increase less than 25% and persistently one More than Yue.
(4) deteriorate: the maximum orthogonal diameter product of two, tumor increases less than 25%.
(5) effective percentage: (complete incidence graph+part is alleviated) ill sum of/this group.
Table 5 matched group and treatment group different phase therapeutic effect compare
From the results shown in Table 5:
(1) therapeutic effect for the treatment of group is significantly higher than matched group, has the significance difference opposite sex.
(2) Chinese medicine composition prepared by the present invention produces, to hepatocarcinoma, dissipate retraction, the effect of relief of symptoms, and effectively treatment is primary Property hepatocarcinoma patient, have reality clinical meaning and Development volue, economic and social benefit is huge.
18.4, model case:
Case 1: Deng, man, 70 years old, people from Cangzhou, Hebei, in December, 2013 comes my institute and checks, patient suffers from primary hepatocarcinoma, Unbearably, cancer cell metastasis, hospitalization 3 months, is 6cm × 4cm through abdominal part CT examination discovery tumor size to patient pain.Warp Taking the granules medicine of the embodiment of the present invention 7 after 4 months, patient pain's this disappearance of sensillary base, tumor is obviously reduced, and continues to take 4 Individual month, finding that tumor size is 3cm × 1cm through abdominal part CT examination, treatment of leaving hospital, patient continues to take medicine of the present invention, follows up a case by regular visits to 1 year patient continues to take and weather is preferable.
Case 2: Lee, female, 51 years old, Shandong Tancheng people, 2014 patients were because liver pain is uncomfortable, appetite declines, becomes thin 3 The moon is admitted to hospital, and fills the air occupy-place in B ultrasonic, CT examination liver, and seen from abdominal cavity, multiple occupancy tuberositys, are diagnosed as primary hepatocarcinoma, body Heavily declining about 3kg, diet is poor, and after taking the medicine 4 months of the embodiment of the present invention 5, patient's appetite increases, and body weight increases 1kg, Tumor is obviously reduced, and continues to take 8 months, and patient, through B ultrasonic, the basic rehabilitation of CT examination, follows up a case by regular visits to do not have rebound phenomenon 1 year.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, and without departing substantially from In the case of the spirit or essential attributes of the present invention, it is possible to realize the present invention in other specific forms.Therefore, no matter from which From the point of view of Dian, all should regard embodiment as exemplary, and be nonrestrictive, the scope of the present invention is by claims Rather than described above limits, it is intended that all changes fallen in the implication of equivalency and scope of claim are included In the present invention.
Embodiment 19: human toxicity is tested
Randomly draw medical hepatocarcinoma person 50 example, age 25~60 years old, average 41.5 years old, the maleest 25 examples, female 25 example;Carry out Toxicity assessment.
19.1, toxicity assessment
Health check-up of each work after continuing one month with drug administration before medication, health check-up project:
(1) general health check-up project: temperature pulse respiration;
(2) blood, urine, stool routine examination inspection, before and after treatment, each work is once;
(3) liver function AST, ALT;Renal function BUN, CR and blood glucose;Cardiac function CPK, LDH, EKG;Coagulation function and Platelet.
19.2, to toxicity assessment classification, standard is as follows:
0 grade: avirulence Symptoms;
L level: mild toxicity Symptoms;
2 grades: moderate signs of toxicity shows;
3 grades: serious toxicity Symptoms;
4 grades: threat to life signs of toxicity shows;
Draw according to physical examination result analysis, in 50 example hepatocarcinoma, 0 grade of 44 people, 1 grade of 6 people, 3 grade of 0 people, 4 grade of 0 people.Only There are 6 example laxativeness, transference cure after drug withdrawal, occur that the probability of side reaction is little.
It can be seen that pharmaceutical preparation of the present invention can efficiently control the pathological changes process of hepatocarcinoma from curative effect and toxicity assessment, and Toxic and side effects is less.

Claims (10)

1. one kind for treating the pharmaceutical preparation of hepatocarcinoma, it is characterised in that: described pharmaceutical preparation includes following Chinese crude drug: Ganoderma, Ganoderma applanatum (Pers. Ex Wallr) Pat., Ootheca Mantidis, Folium Pini, Herba Scutellariae Barbatae, Fructus Jujubae, sago cycas, the Rhizoma Atractylodis Macrocephalae, Cortex Phellodendri, Semen Arecae, Stigma Maydis, Herba Pyrolae, spend in vain Herba Hedyotidis Diffusae, Fructus Arctii, Thallus Laminariae (Thallus Eckloniae), Radix Aucklandiae (Radix Vladimiriae), Fructus Aurantii, Radix Glycyrrhizae, Xi, Gecko, Herba Sedi.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Ganoderma 10-20 part, Ganoderma applanatum (Pers. Ex Wallr) Pat. 3-7 part, Ootheca Mantidis 5-8 part, Folium Pini 6-14 part, Herba Scutellariae Barbatae 8-17 part, Fructus Jujubae 10-20 Part, sago cycas 3-7 part, Rhizoma Atractylodis Macrocephalae 6-13 part, Cortex Phellodendri 4-12 part, Semen Arecae 3-8 part, Stigma Maydis 10-20 part, Herba Pyrolae 5-13 Part, Herba Hedyotidis Diffusae 10-25 part, Fructus Arctii 15-35 part, Thallus Laminariae (Thallus Eckloniae) 6-13 part, Radix Aucklandiae (Radix Vladimiriae) 4-10 part, Fructus Aurantii 6-13 part, Radix Glycyrrhizae 9-14 part, Xi 4-11 part, Gecko 5-11 part, Herba Sedi 8-16 part.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Ganoderma 15 parts, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5 parts, Ootheca Mantidis 6.5 parts, 10 parts of Folium Pini, Herba Scutellariae Barbatae 12.5 parts, Fructus Jujubae 15 parts, sago cycas 5 Part, the Rhizoma Atractylodis Macrocephalae 10 parts, Cortex Phellodendri 8 parts, Semen Arecae 5.5 parts, Stigma Maydis 15 parts, Herba Pyrolae 9 parts, Herba Hedyotidis Diffusae 17.5 parts, Fructus Arctii 25 parts, Thallus Laminariae (Thallus Eckloniae) 10 parts, Radix Aucklandiae (Radix Vladimiriae) 7 parts, Fructus Aurantii 9.5 parts, 11.5 parts of Radix Glycyrrhizae, Xi 7.5 parts, Gecko 8 Part, Herba Sedi 12 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Ganoderma 16 parts, Ganoderma applanatum (Pers. Ex Wallr) Pat. 5.5 parts, Ootheca Mantidis 7.5 parts, 11 parts of Folium Pini, Herba Scutellariae Barbatae 13.5 parts, Fructus Jujubae 15.5 parts, Soviet Union Ferrum 5.5 parts, the Rhizoma Atractylodis Macrocephalae 11 parts, Cortex Phellodendri 8.5 parts, Semen Arecae 6.5 parts, Stigma Maydis 15.5 parts, Herba Pyrolae 10 parts, Agkistrodon SHECAO 18.5 parts, Fructus Arctii 26 parts, Thallus Laminariae (Thallus Eckloniae) 11 parts, Radix Aucklandiae (Radix Vladimiriae) 7.5 parts, Fructus Aurantii 10.5 parts, 12.5 parts of Radix Glycyrrhizae, Xi 7.5 parts, Gecko 8.5 parts, Herba Sedi 13 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that: described pharmaceutical dosage form is selected from granule, capsule, sheet One in agent, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill.
Pharmaceutical preparation the most according to claim 5, it is characterised in that: described pharmaceutical dosage form is selected from preferably granule or capsule Or tablet is a kind of.
7. the preparation method of pharmaceutical preparation described in claim 1-6, it is characterised in that concrete step is included as:
(1) being weighed up according to weight by traditional Chinese medicinal material raw materials, add pure water and soak, the water surface is higher than powder 6-8cm, soaks 2.5 After hour, decoct 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merge decoction liquor, decompression Being concentrated into relative density is 1.06, standby;
(2) add the ethanol of 1.5 times 75% after the decocting liquid cooling of step (1), fully mix, stand overnight so that it is be heavy Form sediment, after 24h, take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, then wet method Pelletizing, obtain granule, granule often wraps weight 10g.
8. the preparation method of pharmaceutical preparation described in a claim 6, it is characterised in that concrete step is included as:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, in powdered extract powder, conventional method adds adjuvant, finally Add magnesium stearate, mixing, tabletting, coating, obtain tablet.
9. the preparation method of pharmaceutical preparation described in a claim 6, it is characterised in that concrete step is included as:
(1) traditional Chinese medicinal material raw materials is weighed up according to weight, add the pure water of 1.5 times of volumes and 75% ethanol leaching of 0.5 times of volume Bubble, after soaking 1 hour, decocts 3 times, 1.5 hours for the first time, 1 hour for the second time, 0.5 hour for the third time, merges Decoction liquor, standby;
(2) add the ethanol of 1.5 times 75% after decocting liquid cooling, fully mix, stand overnight so that it is precipitation, after 24h Take its supernatant, retain precipitate;
(3) precipitate is cleaned with 70% appropriate ethanol, and washing liquid merges with filtrate, after decompression recycling ethanol, and concentrating under reduced pressure It is 1.09 to relative density, stands 24h, precipitation, filter;
(4) filtrate mix homogeneously, low-temperature evaporation to paste, powdered extract powder adds lactose and dextrin, the wettest Method is pelletized, and loads capsule, obtains capsule.
Pharmaceutical preparation the most according to claim 1, it is characterised in that: described pharmaceutical preparation is at preparation treatment primary hepatocarcinoma Purposes in medicine.
CN201610428967.9A 2016-06-15 2016-06-15 Pharmaceutical preparation for treating liver cancer and application thereof Pending CN105853816A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103272187A (en) * 2013-06-19 2013-09-04 黄禀檐 Agent for curing liver cancer
CN103721196A (en) * 2014-01-11 2014-04-16 赵雨溪 Traditional Chinese medicine composition for treating liver cancer
CN104352870A (en) * 2014-11-25 2015-02-18 山东省立医院 Medicine for treating primary hepatic carcinoma

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103272187A (en) * 2013-06-19 2013-09-04 黄禀檐 Agent for curing liver cancer
CN103721196A (en) * 2014-01-11 2014-04-16 赵雨溪 Traditional Chinese medicine composition for treating liver cancer
CN104352870A (en) * 2014-11-25 2015-02-18 山东省立医院 Medicine for treating primary hepatic carcinoma

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Application publication date: 20160817