CN103948736B

CN103948736B - The compound Chinese medicinal preparation for the treatment of hepatocarcinoma and production method thereof

Info

Publication number: CN103948736B
Application number: CN201410147463.0A
Authority: CN
Inventors: 张树球; 刘燕; 朱晓莹; 梁伟江; 何胜; 黄鸥飞; 龙奇军
Original assignee: Individual
Current assignee: Guangxi Yunqiu Biotechnology Co ltd
Priority date: 2014-04-14
Filing date: 2014-04-14
Publication date: 2016-10-12
Anticipated expiration: 2034-04-14
Also published as: CN103948736A

Abstract

The invention discloses a kind of compound Chinese medicinal preparation treating hepatocarcinoma and production method thereof, its Chinese herbal medicine primary raw material parts by weight are: containing 1 15 parts of pearl in leaf, Herba Sarcandrae 5 30 parts, Herba vallisneriae Spiralis 5 15 parts, Radix Scrophulariae 5 15 parts, its production method is by said medicine water extraction, precipitate with ethanol concentrates, the modern pharmaceutical production technologies such as powder process make oral liquid, capsule, tablet, granule etc., this Chinese medicine preparation has dispelling wind and removing obstruction in the collateral, the effects such as blood circulation promoting and blood stasis dispelling, and have cancer suppressing action, it passes through anticancer telomerase activation, make cancerous cell telomeric dna replicate to slow down and be gradually shortened, growth of cancer cells slows down, it is eventually striking to apoptosis, it is applicable to hepatocarcinoma, gastric cancer etc..

Description

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma and production method thereof

Technical field

The present invention relates to a kind of Chinese medicine preparation treating cancer, particularly treat compound Chinese medicinal preparation and the production thereof of hepatocarcinoma Method.

Background technology

Primary hepatocarcinoma (primary liver cancer, PLC) refers to hepatoma carcinoma cell or the cytogenetic cancer of stones in intrahepatic bile duct, For one of China's common cancer, its mortality rate is 20.4/10 ten thousand, accounts for the 18.8% of national malignant tumor death, is only second to stomach Cancer, occupies second.The whole world has 110,000 people to die from hepatocarcinoma every year.Guangxi Hepatocellular mortality rate is 27.31/10 ten thousand, flat higher than the whole nation All levels.The investigation report of the different regions, 20th century Chinese countryside eighties that univ cambridge uk pan issued according to 2006, Analyze 67 county's hepatocarcinoma case fatality rate situations of China, find that the different geographical age is issued significantly different.Epidemiological study shows, The reason of onset of liver cancer and viral hepatitis, drinking-water, diet (as in food containing aflatoxin B1 etc.) etc. factor relevant, but closely Year research shows, the sudden change having multiple gene is relevant with hepatocarcinoma, and finally goes back neither one conclusion certainly, still falls within morbidity former Because of not clear, the disease of complicated mechanism, hence without a kind of method of radical cure, current Therapeutic Method substantially has operative treatment, aunt Breath property surgical intervention, multimodal Comprehensive Treatment, transcatheter hepatic arterial chemoembolization (TAE), anhydrous alcohol intratumor injection, radiotherapy, The methods such as targeted therapy, chemotherapy, Biotherapeutics, treatment by Chinese herbs.TCM Literature does not has the name of disease of " hepatocarcinoma ", clinical according to it Performance, can belong to " costalgia ", " gathering ", " jaundice ", " expansion " etc..Ancients' cloud " without long-pending, empty people then has it to strong people ".Typically recognize For, tumor is that the stagnation of QI, blood stasis, expectorant are solidifying, poison is poly-and are formed due to positive QI-insufficiency, visceral dysfunction.The disease of hepatocarcinoma Machine generally speaking deficiency in origin and excess in superficiality, with insufficiency of the spleen for this, the stagnation of QI, blood stasis, heresy damp and hot, malicious are mark.Clinically, country variant has difference Research experience, has again different emphasis.Yu Shi thinks: insufficiency of the spleen for this, due to insufficiency of the spleen existence, the most just have the stagnation of QI, blood stasis, Damp and hot, so that the appearance of the deficiency of YIN.Qian Shi then thinks: insufficiency of the spleen stagnation of liver-QI is this, and early metaphase is attached most importance to stagnation of liver-QI, and middle and advanced stage with insufficiency of the spleen is Very.Pan Shi thinks: " ecchymosis, void " is the basic pathogenesis of deficiency of the liver.Upper abdominal lump, hepatalgia are the objective evidence of " stasis of blood "；Hepatocarcinoma Development is fast, and change of illness state is fierce, and B-mode and infection with hepatitis C virus, flavacin and contaminated drinking water are the main diseases of hepatocarcinoma Cause, these broadly fall into the category of the traditional Chinese medical science " malicious "；The common poor appetite of hepatocarcinoma patient, abdominal distention, Mental fatigue, weak, nausea,vomiting,diarrhea, disappear Insufficiency of the spleen disease such as thin；And the stasis of blood, poison, empty three all the time and deposit, reciprocal causation, vicious cycle, through the hepatocarcinoma course of disease.In treatment Aspect, the method that the traditional Chinese medical science uses has: determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, treatment based on differentiation of disease, folk prescription proved recipe, external treatment etc..In recent years use Chinese medicine or Therapy of combining Chinese and Western medicine primary hepatocarcinoma, achieves large development and certain curative effect, before presenting anticancer gratifying of Chinese medicine Scape, but still suffer from many problems.As lacked unified CM syndrome differentiation criterion and curative effect judging standard, the dynamic of verification recognizes the most not Enough, Therapeutic Method also lacks standardization etc..Chinese medicine preparation about treatment hepatocarcinoma (or other cancers) is more, such as:

1. ［ autograph ］ Chinese medicine is main treatment advanced primary liver cancer 30 example clinical observation.［ author ］ appoints sword, Zhu Li Beautiful.［ periodical name ］ Jiangxi Chinese medicine, 1999；30(5): 21.［ digest ］ 30 example mid and late liver cancer patient, is divided into stagnation of liver-QI with deficiency of the spleen, the stagnation of QI Blood stasis, dampness-heat in the liver and gallbladder, weakened body resistance stasis four type, control respectively with soothing liver and strengthening spleen (XIAOYAO POWDER plus-minus), blood circulation promoting and blood stasis dispelling (Ramulus Cinnamomi Poria pill conjunction Bupleurum powder for relieving liver-qi is added and subtracted), the method for removing toxic substances removing dampness function of gallbladder promoting (Decoction of Gentiana for Purging the Liver-fire close Herba Artemisiae Scopariae Decoction plus-minus), result patient is the shortest for life cycle 2 months, the longest 78 months, median survival interval 5.75 months, 3 months persons of survival rate are 76.67%, and within 1,2,3,5 years, person is respectively 25.59%、16.56%、11.04%、7.36%。

2. ［ autograph ］ treats 128 example primary hepatocarcinoma from plan tortoise beetle Bai Longtang.［ author ］ Wang Donghui.［ periodical name ］ Liaoning traditional Chinese medical science Magazine, 1998；14(9): 5.［ digest ］ treats liver cancer patient 128 example from intending tortoise beetle Bai Longtang, with card plus-minus, result: clinic is controlled More, effective each 5 examples, account for 4%, effective 79 examples, account for 62%, invalid 39 examples, account for 30%.

3. ［ autograph ］ Herba Hyperici Japonici treatment primary hepatocarcinoma 30 example.［ author ］ Sun Zhongyi.［ periodical name ］ combination of Chinese and Western medicine hepatopathy is miscellaneous Will, 1995；5(4): 29.［ digest ］ Herba Hyperici Japonici treatment primary hepatocarcinoma 30 example, result clinical symptoms is clearly better, and B ultrasonic, CT examine Look into, each 8 examples of the person of turning out cloudy after treatment.

4. ［ autograph ］ Agkistrodon treatment primary hepatocarcinoma.［ author ］ Xu Hefang.［ periodical name ］ Zhejiang College Of Traditional Chinese Medicine journal, 1992；16 (1): 28.［ digest ］ treats primary hepatocarcinoma 4 example, result survival more than 14 years and 6 years each 1 examples of person, 2 years person 2 examples of surviving with Agkistrodon.

5. ［ autograph ］ plaster for treating cancerous pain external application for curing hepatocarcinoma pain 46 example.［ author ］ Hu Huaiqiang, Li Jie.［ periodical name ］ external treatment with Chinese medicine is miscellaneous Will, 1998；7(2): 18.［ digest ］ plaster for treating cancerous pain (Thallus Laminariae (Thallus Eckloniae), Sargassum, Ganoderma etc. form) external application hepatic region, treating the liver cancer pain 46 example, result Effective (pain disappearance) 36 examples, take a turn for the better (pain relief) 10 example, total effective rate 100%.

6. the progress of ［ autograph ］ Herba Sarcandrae.［ author ］ Lu Songgui.［ periodical name ］ Chinese crude drug, 2001；24(8): 606.［ digest ］ The 373 various tumor patients of example are used 'Zhongjiefeng ' to carry out clinical observation by 17 clinical units such as Xuhui District Central Hospital, Shanghai, Total effective rate is 53.9%, and obvious effective rate is 15.3%, wherein 113 example alone this product treatment, and effective percentage is 62.8%, and obvious effective rate is 22.1%.

7. ［ inscribe one's name ］ effect and the toxicity of ZHONGJIEFENG ZHUSHEYE anti-mouse hepatoma cell HepA-22.［ author ］ Sun Wenjuan, Li Jing, Lan Fengying, etc..［ periodical name ］ Chinese patent medicine, 2008；25(4): 313 ［ digest ］ ZHONGJIEFENG ZHUSHEYE body is interior, external to rat liver cancer HepA-22 and glandular stomach PC cell are respectively provided with antitumor action.

8. ［ autograph ］ ZHONGJIEFENG ZHUSHEYE treatment cancerous pain 60 example.［ author ］ Yang Huanbiao.［ periodical name ］ China Pharmaceutical, 2008；17(20): 90 example middle and advanced stage canurous ache patients are divided into two groups by 59 ［ digests ］, all use Three ladders analgesia treatment, Treatment group (60 example) adds uses ZHONGJIEFENG ZHUSHEYE, and result: total effective rate treatment group is 85.0%, matched group (30 example) is 60.0%.

Some medical facility and medical personnel have delivered the more public affairs utilizing Chinese herbal treatment hepatopathy or hepatocarcinoma in recent years Open document report, such as:

1, Chinese patent, title: a kind of Chinese medicine preparation treating hepatocarcinoma, application number: CN201110009652.8 applies for Day: open (bulletin) day: the 2011.06.01 of 2011.01.17, open (bulletin) number: CN102078409A, applies for (patent Power) people: Traditional Chinese Medicine University Of Guangzhou, Zeli Medicine Science-Technology Co., Ltd., Guangzhou, summary: the present invention relates to medical configuration product, tool Body relates to a kind of Chinese medicine preparation treating hepatocarcinoma, and said preparation is made up of the acceptable adjuvant of active ingredient and medical science, wherein said Active ingredient be made up of following crude drug by mass percentage: Cacumen Securinegae Suffruticosae 5-30%, Radix Sophorae Flavescentis 5-20%, Herba Rabdosiae Lophanthoidis 5- 30%, Radix Notoginseng 4-10%, Radix Salviae Miltiorrhizae 5-25%, Semen Persicae 4-15%, Radix Bupleuri 4-10%, Fructus Ligustri Lucidi 5-25%, Herba Ecliptae 5-25%, too Son ginseng 2-25%, Radix Glycyrrhizae 2-10%.Above-mentioned 11 tastes share, gather altogether heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dispersing the stagnated live-QI to relieve the stagnation of QI and strengthening spleen, tonifying kidney it Effect, and then suppression tumor growth, reach to treat the purpose of hepatocarcinoma.

2, Chinese patent, title: a kind of Chinese medicine preparation treating hepatocarcinoma and preparation method thereof, application number: The CN201110003318.1 applying date: 2011.01.10, open (bulletin) number: CN102078569A open (bulletin) day: 2011.06.01, apply for (patent right) people: Li Xiuju;Summary: a kind of Chinese medicine preparation treating hepatocarcinoma, in described Chinese medicine preparation The ratio of weight and number of various crude drug can be: Radix Et Caulis Acanthopanacis Senticosi 10～20 parts, Herba Hedyotidis Diffusae 10～20 parts, the Radix Astragali 10～20 parts, Resina garciniae 10～20 parts, Fructus Ligustri Lucidi 10～20 parts, the Rhizoma Atractylodis Macrocephalae 10～20 parts, Radix Polygoni Multiflori Preparata 10～20 parts, Herba Artemisiae Scopariae 10～20 parts, Rhizoma Curcumae Longae 10～ 20 parts, Spica Prunellae 10～20 parts, Polyporus 10～20 parts, Fructus Schisandrae Chinensis 10～20 parts, Rhizoma Curcumae 10～20 parts, Poria 10～20 parts, ink Fructus seu radix camptothecae acuminatae (Fructus Camptothecae Acuminatae) 10～20 parts, Radix Salviae Miltiorrhizae 10～20 parts, the Radix Paeoniae Alba 10～20 parts, Herba Scutellariae Barbatae 10～20 parts, Radix Scutellariae 10～20 parts, Herba Epimedii 10～ 20 parts, Venenum Bufonis 1～10 parts, Scorpio 1～10 parts.Have the advantages that and inoperable patient can be extended life cycle.Right Patient with operation, radiotherapy, chemotherapy as main treatment can play auxiliary treatment effect, to hepatopathy background hepatitis specific to hepatocarcinoma with Liver cirrhosis, also has certain curative effect.

3, Chinese patent, title: the Chinese medicine preparation for the treatment of hepatocarcinoma, application number: the CN201210063149.5 applying date: 2012.03.11, open (bulletin) day: the 2012.07.04 of open (bulletin) number: CN102526638A, applies for (patent right) People: Qin Deguang;Summary: a kind of Chinese medicine preparation treating hepatocarcinoma, this Chinese medicine preparation comprises: the Radix Aucklandiae, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Gentianae, Rhizoma Alismatis, Radix Curcumae, Radix Bupleuri, Semen Arecae, Pericarpium Citri Reticulatae Viride, Pericarpium Arecae, Fructus Aurantii, Herba Scutellariae Barbatae, Herba Lobeliae Chinensis, Herba Solani Nigri, Carapax et Plastrum Testudinis, Carapax Trionycis, Squama Manis, male Oyster, Spica Prunellae, Herba Hedyotidis Diffusae.Inventor have passed through more than 40 year and puts into practice, improves, improves and clinical proves, has that curative effect is fast, nothing Side effect, reduction patient medical expense, total effective rate about 90%.

4, Chinese patent, title: a kind of anticancer dispersing tumor toxin expelling soup Application Number (patent): CN200410038090.X Shen Please apply for (patent by open (bulletin) day: the 2005.11.23 of day: 2004.05.19, open (bulletin) number: CN1698684 Power) people: the big address of clock: Linhe West Road, Guangzhou City, Guangdong Province 89 Guangzhou out-patient department of Friendship Hospital invention (design) people: clock Big summary: a kind of anticancer dispersing tumor toxin expelling soup, uses and has heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, the Chinese medicine of anticancer dispersing tumor effect, wherein With animal drugs such as Bufo siccus, ground beetle, Hirudo, Mylabris, Gekko Swinhonis as principal agent, be aided with the Radix Astragali, Radix Ginseng, Ganoderma, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, Rhizoma Sparganii, Chinese herbal medicine is fried forms for Rhizoma Curcumae, Semen Persicae, Flos Carthami, Herba Hedyotidis Diffusae etc..The present invention both can directly kill tumor cell, destroys focus knot Closing, antiviral, antiinflammatory, destruction tumor vessel can prevent cell from shift again, anti-cell suddenlys change, improves cellular informatics pipeline, The drug resistance of reversing tumor cell, improves body's immunity simultaneously, thus effectively treats various innocent and malignant tumour, especially treat Hepatocarcinoma, pulmonary carcinoma, breast carcinoma best results.

5, Chinese patent, title: a kind of Chinese medicine composition treating liver cirrhosis disease and preparation method thereof, application is (specially Profit) number: open (bulletin) number: the CN101869686A of the CN200910309349.2 applying date: 2009.11.05, open (public Accusing) day: 2010.10.27 apply for (patent right) people: safe one and company limited of Pu (Beijing) Chinese medicine study institute, address: northern No. 16 No. 9 building 2027B invention (design) people: Wang Feng summaries of the rich pipeline in Jing Shi Fengtai District: a kind of Chinese medicine treating liver cirrhosis disease Compositions and preparation method thereof, Chinese medicine composition is mainly made up of following crude drug: Sanguis Draxonis, Squama Manis, Rhizoma Chuanxiong, Radix Paeoniae Rubra, the Radix Paeoniae Alba, Fu Siberian cocklebur, the Rhizoma Atractylodis Macrocephalae, Semen Persicae, Flos Carthami, Ganoderma, Sanguis Draxonis, Rhizoma Corydalis, Radix Angelicae Sinensis, Rhizoma Sparganii, Rhizoma Curcumae, Pericarpium Citri Reticulatae, Fructus Aurantii Immaturus, Radix Et Rhizoma Rhei, Radix Ginseng, Radix Astragali, ripe Radix Rehmanniae, Radix Puerariae, Colla Plastri Testudinis, Cornu Cervi Degelatinatum, Colla carapax Trionycis, Radix Rehmanniae, Radix Scrophulariae, Fructus Corni, the Radix Linderae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, the Radix Aucklandiae, heavy Perfume, Cortex Magnoliae Officinalis, Fructus Evodiae, Bulbus Allii Macrostemonis, Aspongopus.Chinese medicine composition of the present invention can be prepared as any according to conventional method of Chinese medicinal A kind of conventional oral formulations.It is main that the present invention can significantly improve lassitude and weak, loss of appetite and dyspepsia, can have nauseating, detest Oil, abdominal part flatulence, epigastric discomfort, dull pain and diarrhoea, ordinary circumstance are poor with nutriture, become thin weak, lassitude, serious symptom Person is weak and is unable to leave the bed, and coarse with xerosis cutis, and complexion is gloomy pitch-dark, anemia, glossitis, angular cheilitis, nyctalopia, multiple Neuritis and edema and water and the symptom such as electrolyte disturbance, portal hypertension, clinical efficacy is definite, evident in efficacy, takes effect rapidly.

The Chinese medicine preparation for the treatment of cancer disclosed above, achieves gratifying effect, but still suffers from many shortcomings, as lacked Unified CM syndrome differentiation criterion and curative effect judging standard, Therapeutic Method also lacks standardization, and the life extending patient also falls short of.

Summary of the invention

Present invention aim to address that the Chinese medicine preparation for the treatment of cancer at present lacks unified CM syndrome differentiation criterion and Outcome measure Standard, Therapeutic Method lacks standardization, extends the problems such as the life of patient falls short of, it is provided that one has dispelling wind and removing obstruction in the collateral, work The effects such as blood and dissolving stasis, curative effect is obvious, extends life time longer, safety, the Chinese medicine preparation having no side effect and production method thereof.

The present invention treats what the compound Chinese medicinal preparation principle active component of hepatocarcinoma was made up of the raw material of Chinese medicine of following parts by weight:

Ye Li 5-15 part on pearl；

Herba Sarcandrae 5-30 part；

Herba vallisneriae Spiralis 5-15 part；

Radix Scrophulariae 5-15 part.

Above Chinese medicine all can find its another name or Latin from Chinese medicine pharmacopeia or Chinese herbal medicine handbook, Chinese periodical, with And the place of production, function, usage.For understanding the drug action mechanism of the present invention, take passages each Chinese medicinal ingredients and performance be as follows:

1. containing pearl in leaf: (Acalypha australis L.), also known as hiding pearl, Acalypha australis, people Herba Amaranthi tricoloris, Herba Acalyphae in leaf Deng, for annual or perennial herb or shrub, belonging to a lot of money section (Euphorbiaceae) plant, the whole world there are about 450 kinds, extensively It is distributed in the torrid zone, the world, subtropical zone.China there are about 17 kinds, with the most common containing pearl in leaf, and all herbal medicine, there is heat clearing away profit Wet, effect of hemostasis convergence, among the people for treating diarrhea due to damp-heat disease, skin eczema, cough, hemorrhage, the disease such as have blood in stool, Guangdong is among the people also Have for treating cancer.This group proves from anticancer experiment, and hepatoma cell strain is grown to have and significantly suppresses and lead by folk prescription Aqueous extracts Causing apoptotic effect, clinical have obvious therapeutic effect to oral cancer etc.;With hybrid combinations such as Herba Sarcandraes, effect is remarkably reinforced.

Chemical composition: terpenoid and steroidal compounds (such as betulinic acid etc.), organic acid (such as gallic acid etc.), flavonoid (such as rutin etc.), quinones, alkaloid, soft quality etc..

Pharmacological action: 1. wound, treating for skin disease;2. antioxidation, the experiment of this group proves, Aqueous extracts has significantly Remove superoxide anion radical effect;3. antibacterial action;4. antitumaous effect, the experiment of this group and clinical proof, aqueous extract has Significantly cancer suppressing action.

2. Herba Sarcandrae: ［ Sarcandra glabra (Thunb.) Nakai ］, has another name called Herba Pileae Scriptae, Herba Pileae Scriptae, Herba Pileae Scriptae, joint Bone tea, connect chu lan tree etc., be the herb of Chloranthaceae plant plait Corallium Japonicum Kishinouye, be the Pharmacopoeia of the People's Republic of China 2000,2005 The legal medical material that version is recorded.On the south the Changjiang river, all there is distribution each province, can artificial growth.Nature and flavor with return through Herba Sarcandrae bitter in the mouth, pungent, property Flat, GUIXIN, Liver Channel.Function with cure mainly: there is clearing away heat and cooling blood, blood circulation promoting and dispersing pathogen accumulation, dispelling wind and removing obstruction in the collateral effect.Can be used for treating heat in blood purple The diseases such as speckle, purpura, rheumatalgia, traumatic injury, tumor.Consumption and usage: 9-30 gram.

Biological characteristics: Herba Sarcandrae is evergreen undershrub, high 1 ~ 1.5m；Stem is upright, without hair.Joint significantly expands.Leaf to life, Papery, oval, avette or ovum shape lanceolar, long 6 ~ 17 cm, wide 2 ~ 6 cm, top is tapering, and base portion is narrow or wedge shape, and edge removes Having rough sawn tooth outside basilar part, increment has a body of gland, and two sides is all without hair；Lateral vein 5 ~ 7 is right, connects from edge camber arch, and petiole length 5 ~ 15mm, without hair, base portion symphysis becomes sheath shape；Stipule is caducous.Spending little, Xia Qiu is open, yellow green, without perianth, is gathered into the steady of top life Locusta or branch form panicle shape；Bract triangle, yellow green, 1 piece of stamen, meat, bar-shaped, flower pesticide 2 Room, and is born in The both sides on connective top；Gynoecium is made up of, without style 1 lamination.Drupe is spherical, diameter 3 ~ 4mm, shiny red time ripe.

Chemical composition: the chemical composition of antitumor active site has the double Isofraxidin (3,3'-of 3,3'- Biisofraxidin, 1), pinostrobin (pinostrobin, 2), Isofraxidin (isofraxidin, 3), Palmic acid (palmitic acid, 4), atractylodes lactone III (atractylenolide III, 5), chloranthalactone E (chloranthalactone E, 6), Pentadecane acid (pentadecanoic acid, 7), 5-hydroxyl-7,4'-dimethoxy Flavanone (5-hydroxy-7,4'-dimethoxyflavanone, 8), Yi Si tambulin A (istanbulin A, 9), 2', 4'-dihydroxy-6'-melonia chalcone (uvangoletin, 10), 6,7-dimethoxy coumarin (scoparone, 11), cupreol (β-sitosterol, 12), daucosterol (daucosterol, 13).Result shows, 1～ 7,9～11 have weak effect to suppression growth of tumour cell, and effective site tumor-inhibiting action is relatively strong in vivo, and individualized compound is in vitro Test performance is not outstanding, shows cytotoxic activity when high dose, traces it to its cause, it may be possible to the compound in effective site The most collaborative, strengthen antitumor action；Being likely to effective site in vivo is to play antitumor action by non-cytotoxicity approach, But not can determine that.

Pharmacological action: 1. resisting pathogenic microbes effect.Experiment shows, Herba Sarcandrae has extensive antibacterial action, to golden yellow Glucose coccus and Resistant strain thereof, will Hayes, Boydii, shigella flexneri, typhoid fever, Salmonella paratyphi, escherichia coli, as pus Bacillus etc. all have inhibitory action in various degree.Infected by influenza has notable deactivation.2. antitumor action.This group experiment card Bright, Herba Sarcandrae crude extract, extract, injection etc. all have antitumor activity in various degree.3. immunization.Extract is to cell The immune indexes such as phagocytic function have facilitation, good immunoloregulation function to be probably one of its antineoplastic action mechanism. 4. anti-ulcer effect.5. promote union of fracture.Additionally, still there is analgesic activity, eliminating phlegm and relieving asthma effect etc..

Toxicological effect: Herba Sarcandrae extractum (1g extractum is equivalent to swollen joint point dry product 10g) is to large and small Mus acute oral female, male LD50 is all higher than 10g/kg.Belonging to commercial sterility, the nuclear test of mouse inbred strain, bone marrow cells in mice and Salmonella reversion test are Feminine gender, does not finds mutagenicity.

3. Herba vallisneriae Spiralis: (picria fel-tarrae Lour.), has another name called Radix Picriae felterrae, Radix Picriae felterrae, Herba Houttuyniae, Radix Gentianae, is wide Western genuine medicinal materials Herba vallisneriae Spiralis Scrophulariaceae Radix Picriae felterrae platymiscium.Belong to traditional herbal medicine.It is mainly distributed on Guangxi, Guangdong, Guizhou and Yunnan etc. Ground.

Medicinal Materials Characters: be dried vegetation, high 40 ~ 60cm.Stem is polygon, and by undercoat, joint expands, multi-branched.Single leaf to life, In oval, long 3 ~ 5cm, wide 2 ~ 3cm, yellow green to celadon, the sharp point of tip, often more or less for base portion, prolongs in lower handle, two sides The most coarse, edge has blunt crenature.Top is raw or axillary-racemes, floral white, lip-like, sepal 4 pieces, outer two pieces relatively big, avette, Interior two pieces less, bar shaped, feeble QI, bitter in the mouth.

Biological characteristics: Herba vallisneriae Spiralis is grown in the torrid zone, Subtropical hill, under the rainforest in mountain valley or monsoon rainforest, is that a kind of happiness is warm Moistening, the plant of resistance to the moon.Growing environment requires: average temperature of the whole year is at 20 ~ 22.8 DEG C, and absolute high temperature 40.5 DEG C, the January is average Temperature more than 12 DEG C.Annual rainfall 135 ~ 1500mm, relative humidity about 80%.It is 40% ~ 50% at shade rate, the loose fertilizer of soil layer Fertile, moistening, good rich in plant strain growth in the sand of humus.Seed development requires more than 15 DEG C.Tolerance to cold is poor, In plant division successively in 4 ~ August, bloom, result.Happiness fertilizer, needs large quantity of moisture and nutrient in growth course.Can adopt after planting 5 ~ 6 months Receive, generally carry out between 9 ~ October.When gathering, medical material is cut together, wash away silt, remove impurity, be spread out under the sun and shine to 6- Do for 7 one-tenth, continue to shine the most absolutely dry being bundled into again after being bundled into wisp and deposit putting to be dried greatly.

Chemical composition: mainly calabash storehouse element (Cucurbitacin) Triterpenoid and flavone compound, has now been found that Its effective ingredient is mainly tetracyclic triterpene glycoside and (including: Radix Picriae felterrae aglycon I, picfeltarraenin I A, picfeltarraenin I B, picfeltarraenin Unit III, picfeltarraenin III, Radix Picriae felterrae aglycon IV, picfeltarraenin IV etc. 12 kinds).Wherein picfeltarraenin I A is Radix Picriae felterrae triterpene position The composition that middle content is the highest, in dry plant, content is about 0.25%, has central inhibitory action and anticomplementary action, is Herba vallisneriae Spiralis Main active, is also the main component of quantitative analysis mensuration.With high-performance liquid chromatogram determination, and C18ODS2 post, second is fine- 0.3% phosphoric acid (34:66) is flowing phase, flow velocity 1ml/min, column temperature 25 DEG C, and wavelength is 264nm ］.Pharmacological action: pharmacological evaluation is demonstrate,proved Bright, picfeltarraenin have antiinflammatory action, Detoxication, calmness, ease pain, stable effect, antitumaous effect.

Function with cure mainly: cold in nature, bitter in the mouth, there is the function of heat-clearing and toxic substances removing, reducing swelling and alleviating pain.For cold anemopyretic, swelling throat Bitterly, the disease such as mumps, gastric heat stomachache, dysentery, traumatic injury, furuncle carbuncle, venom.

Usage and consumption: 9 ~ 15g.It is decocted in water for oral dose.

4. Radix Scrophulariae: for the dry root of goatweed Radix Scrophulariae (Scrophularia ningpoensls Hemsl), begin to carry In Shennong's Herbal.

Another name: Radix Scrophulariae, black ginseng, wash rice Radix Scrophulariae, crow Radix Scrophulariae, etc..

Biological characteristics: for perennial herb, root is cylindrical, the normal bifurcated in bottom, crust ash yellowish-brown.Stem is upright, four ribs Shape, smooth or have gland shape pubescence.Leaf is to life；Blade is avette or ovum shape oval, and tip gradually presss from both sides, basal circular or closely carry shape, limit Edge tool crenation, cyme, in coniform；The long 1-3cm of bennet, inflorescence and bennet have obvious glandular hair；Sepal 5 splits, ovum Circular；Corolla mulberry, the oblique gyalectiform in pipe portion, there are 5 slivers, stamen 4；Floral disc is obvious；Ovary is upper, Room 2, and style is elongated.Capsule Oval, the short point of tip, dark green or shallow bottle green, calyx harbors, the month at florescence 7-8, really the phase 8-9 month.

The place of production: the ground such as Zhejiang, Jiangsu, Anhui, Hunan, Guizhou, Shaanxi, cultivates or is born in hillside sylvan life.

Gather: excavate in the Beginning of Winter of around, remove stem, leaf, fibrous root, outwash silt, be exposed to the sun 5-6 days, to time half-dried, pile up 2-3 The internal blackening of angel, then row Exposure to Sunlight, and repeatedly heap, shine for several times, until being completely dried.

Medicinal Materials Characters: this product is that class is cylindrical, and centre is the thickest or upper coarse and lower fine, the micro-change song having, long 6-20cm, diameter 1- 3cm, surface lark or taupe, there is irregular longitudinal furrow, hole skin sample projection of growing crosswise and sparse transverse crack and mark of fibrous root.Matter Solid, it is not easily broken, section black, micro-glossy.Gas is special like caramel, bitter in the mouth, micro-hardship.

Nature and flavor with return through: sweet, bitter, salty, be slightly cold.Return lung, stomach, kidney channel.

Function with cure mainly: removing heat from blood YIN nourishing, eliminating fire and detoxication.Hinder for consumption of YIN caused by febrile disease, tongue cutting edge of a knife or a sword excessive thirst, maculae caused by violent heat pathogen, Tianjin constipation, Hectic fever due to YIN-deficiency chronic cough, conjunctival congestion, pharyngalgia, scrofula, Bai Shun, carbuncle disease poison etc..

Usage and consumption: 9-15g.

Note: should not be with Rhizoma et radix veratri (Radix Rhizoma Veratri) with using.

Chemical composition:

Radix Scrophulariae mainly containing iridoids, Phenylpropanoid Glycosides glycoside, still containing plant sterol, organic acid, flavonoid, triterpene soap Glycosides, performance oil, saccharide, alkaloid, the monoterpene of trace, Diterpene etc..Wherein filter out 6 kinds with mtt assay and there is antitumor work Property with compound in phenolic hydroxyl group number have substantial connection.With the extract of dichloromethane and ethyl acetate extract people multiple Cancerous cell has cytotoxicity, and the material wherein with the strongest active anticancer has: oleanonic acid derivant and ursodeoxycholic Acid derivative, all has good inhibiting effect to breast carcinoma, leukemia, skin carcinoma, pulmonary carcinoma etc..The formation of blood vessel can make cancer thin Born of the same parents' growth rate is that Logarithmic degree is accelerated, and research finds, the activity of the water extract suppression angiogenesis of Radix Scrophulariae is the most prominent, it may be possible to profound One of effective way of ginseng antitumor action.Effective ingredient Phenylpropanoid Glycosides glycosides has good anti-oxidation protection and makees hereditary material With, thus stablize hereditary material, reduce its mutation rate, it is also possible to one of approach of Radix Scrophulariae antitumaous effect.

Pharmacological action:

1. pair neural effect.(1). protection nerve；(2). antidepressant；(3). improve memory；2. antiinflammatory, antioxygen Change effect；3. the liver protecting；4. anticoagulation；5. antitumor；6. enhancing immunity；7. gout；8. resist myocardial ischemia；The most anti-brain Ischemia；10. anti-diabetic；11. antibacterial actions.

Toxicological effect: toxicity is low, few side effects.

The production method of described oral liquid:

(1) medicine is claimed: take in leaf containing pearl, Herba Sarcandrae, Herba vallisneriae Spiralis, Radix Scrophulariae by above parts by weight.

(2) water extraction: above Chinese medicine adds 10-15 times amount water heated and boiled 1-2 hour in putting Chinese medicine extracting tank, releases medicine Liquid, filters, and medicinal residues add 5-10 times of water and add thermogravimetric and boil 0.5-1 hour, and medicinal residues are released, filtering liquid medicine.

(3) concentration of liquid medicine: in medicinal liquid puts concentration tank, heating is concentrated into 2-3 times of medicine volume, cooling.

(4) ethanol precipitation: above medicinal liquid adds volumetric concentration 95% ethanol and reaches 60-70% to concentration of alcohol, is put in 4 after stirring DEG C-8 DEG C stand 12-24 hour, filter to get filtrate.

(5) reclaim ethanol: above medicinal liquid puts heating recovery ethanol in ethanol recycling can, release medicinal liquid, cooling, filter medicine Liquid.

(6) concentration of liquid medicine: above filtrate is heated to 80 DEG C of cream being concentrated to give relative density 1.10-1.15 in putting concentration tank Shape medicine.

(7) oral liquid preparation: above cream drug adds the pure water of 5-6 times, then adds the sucrose syrup of overall volume 20% Make oral liquid, quantitatively, fill, sealing, sterilizing, pack to obtain finished product.

The production method of described capsule:

(7) pharmacy powder: above cream drug adds adjuvant, powder process is dried to obtain medicated powder.

(8) glue capsule and encapsulation: above medicated powder capsule machine makes capsule, encapsulates to obtain capsule finished product.

The production method of described tablet:

(1) medicine is claimed: take Herba Sarcandrae by weight.

(2) ethanol extraction: put by Herba Sarcandrae in reflux, extract, pot, adds volumetric concentration 95% ethanol 5-10 times, is heated to reflux 1- 2 hours, filtering liquid medicine, medicinal residues added volumetric concentration 50% ethanol 3-7 times, and second time is heated to reflux 1-1.5 hour, releases medicinal liquid mistake Filter to obtain filtrate a.

(3) water extraction: take by above parts by weight and put decoct medicinal herbs containing pearl, Radix Scrophulariae and above (2) remaining medicinal residues in Herba vallisneriae Spiralis, leaf In pot, adding water 10-15 times to heat and boil 1-2 hour, release medicinal liquid, filter, medicinal residues add water 5-10 times, and adding thermogravimetric, to boil 0.5-1 little Time, release medicinal liquid, filter to obtain medicinal liquid.

(4) concentration of liquid medicine: in above (3) medicinal liquid puts concentration pan, heating is concentrated into 2-3 times of volume of medicine, cooling.

(5) ethanol precipitation: above (4th) step concentrated medicament adds volumetric concentration 95% ethanol and reaches 60-70% to concentration of alcohol, stirs Putting 4 DEG C-8 DEG C after mixing and stand 12-24 hour, filter to get filtrate b.

(6) reclaim ethanol: by 2-in-1 also for above (2nd) step filtrate 1 and (5th) step filtrate, put in ethanol reclaims pot and heat back Receive ethanol, release medicinal liquid, cooling, filter to obtain medicinal liquid.

(7) concentration of liquid medicine: in (6th) step gained medicinal liquid puts concentration pan, heating is concentrated to give paste.

(8) pharmacy powder: above paste adds adjuvant, powder process is dried to obtain medicated powder.

(9) film-making: above medicated powder adds right amount of auxiliary materials, mixing, pelletizes, and is dried, and tabletting, bag sheet, coating, subpackage obtains sheet Agent.

The production method of described granule:

(1) medicine is claimed: weigh Herba Sarcandrae by weight；

(2) ethanol extraction: put by Herba Sarcandrae in reflux, extract, pot, adds volumetric concentration 95% ethanol 5-10 times, is heated to reflux 1- 2 hours, filtering liquid medicine, medicinal residues added volumetric concentration 50% ethanol 3-7 times, and second time is heated to reflux 1-1.5 hour, releases medicinal liquid mistake Filter to obtain filtrate a；

(3) water extraction: take by above parts by weight and put decoct medicinal herbs containing pearl, Radix Scrophulariae and (2nd) the remaining medicinal residues of step in Herba vallisneriae Spiralis, leaf In pot, adding water 10-15 times to heat and boil 1-2 hour, release medicinal liquid, filter, medicinal residues add water 5-10 times, and adding thermogravimetric, to boil 0.5-1 little Time, release medicinal liquid, filter to obtain medicinal liquid；

(4) concentration of liquid medicine: in above (3rd) step medicinal liquid puts concentration pan, heating is concentrated into 2-3 times of volume of medicine, cooling；

(5) ethanol precipitation: above (4th) step concentrated medicament adds volumetric concentration 95% ethanol and reaches 60-70% to concentration of alcohol, stirs Putting 4 DEG C-8 DEG C after mixing and stand 12-24 hour, filter to get filtrate b；

(6) reclaim ethanol: by 2-in-1 also for above (2nd) step filtrate 1 and (5th) step filtrate, put in ethanol reclaims pot and heat back Receive ethanol, release medicinal liquid, cooling, filter to obtain medicinal liquid；

(7) concentration of liquid medicine: in (6th) step gained medicinal liquid puts concentration pan, heating is concentrated to give paste；

(8) pharmacy powder: above paste is with sucrose by 2 times of mixing of crude drug total amount, and powder process is dried to obtain medicated powder；Use granulator Pelletize, quantitatively, encapsulate to obtain finished product.

Described adjuvant includes: including filler, disintegrating agent, lubricant, coating materials etc., filler is starch, dextrin, carboxylic first Base starch, calcium hydrogen phosphate, Starch 1500 and other pharmaceutic adjuvants；Disintegrating agent be sodium carboxymethyl cellulose, hydroxypropyl cellulose, Starch 1500, The kind pharmaceutic adjuvant flowed and there is water swelling；Lubricant is Polyethylene Glycol, magnesium stearate, Pulvis Talci and has lubrication Pharmaceutic adjuvant；Coating materials is Opadry 11 type, Opadry Chinese medicine, Opadry tm type, (hydroxypropyl methyl cellulose gathers in U.S. many shows Compound), ethyl cellulose (IDALL's show), refined gram suitable (water-borne acrylic type enteric coating system) etc..

The invention has the beneficial effects as follows:

The present invention has by theory of Chinese medical science activating blood flow and removing blood stasis, effect of dispelling wind and removing obstruction in the collateral, dispel that blood stasis in liver, poison be poly-, the stagnation of QI, Recovering healthy energy, have preferable anticancer cancer inhibitor cell effect, the anticancer cancer result of the test that presses down of this laboratory shows, to hepatoma carcinoma cell Strain growth has obvious inhibitory action, and compound preparation becomes apparent from than single pharmaceutical preparation, embodies its synergism；Medicine is by pressing down Cancerous cell telomerase activation processed, makes cancerous cell telomeric dna replicate and slows down and be gradually shortened, and growth of cancer cells slows down, and is eventually striking to Apoptosis, this is the mechanism of this medicine effect;Therapeutic efficacy for hepatic carcinoma be observation indicate that by clinical trial, the obvious pain relief of curative effect, swollen Block expansion slows down, and extends longest-lived and reaches 16 years, belongs to cancerous cell poison, and several drugs compatibility curative effect is aobvious to be increased, except there being hepatocarcinoma Outside effect, the most effective in cure to gastric cancer test and the kinds cancer such as pulmonary carcinoma, lymphatic cancer, but little to normal cytotoxicity (several avirulence), And conventional anticarcinogen toxicity is big, infringement normal cell, this Chinese medicine compound has prominent advantage and progress.Therefore recurrence due to taking drug in this Side have obvious cancer suppressing action, safety non-toxic, can take for a long time, the advantage such as medicine source is abundant.

Accompanying drawing explanation

Fig. 1 is table 1 (1) group (adding compound recipe) hepG2 hepatoma carcinoma cell detection figure in above 1.1 inhibition of cancer cell tests.

Fig. 2 is table 1 (2) group (Jia Yeli contains pearl) hepatoma carcinoma cell detection figure in above 1.1 inhibition of cancer cell tests.

Fig. 3 is table 1 (3) group (adding Folium et Ramulus Cephalotaxi) hepatoma carcinoma cell detection figure in above 1.1 inhibition of cancer cell tests.

Fig. 4 is table 1 (4) group (not adding) hepG2 hepatoma carcinoma cell detection figure in above 1.1 inhibition of cancer cell tests.

Fig. 5 is hepG2 hepatoma carcinoma cell detection figure (matched group) of non-dosing.

Fig. 6 is the hepG2 hepatoma carcinoma cell detection figure before dosing.

Fig. 7 is to add hepG2 hepatoma carcinoma cell detection figure after compound anti-cancer medicine.

Fig. 8 is to add hepG2 hepatoma carcinoma cell detection figure after compound anti-cancer medicine.

Fig. 9 is the hepG2 hepatoma carcinoma cell detection figure of non-dosing.

Detailed description of the invention

Embodiment of the invention below:

Embodiment 1:

Weigh in leaf containing 6 kilograms of pearl, Herba Sarcandrae 9 kilograms, Herba vallisneriae Spiralis 8 kilograms, Radix Scrophulariae 9 kilograms.Above-mentioned Chinese medicine → put Chinese medicine carries In taking tank → add 10-15 times of water → heated and boiled 1-2 hour → releasing medicinal liquid → medicinal residues and add 5-10 times amount water again, reheating is boiled 05.-1 hour, medicinal liquid was released, and filters, merges twice medicinal liquid, put by medicinal liquid in concentration tank, and heating is concentrated into 2-3 times of medicine volume, Cooling.Then medicinal liquid adds volumetric concentration 95% ethanol of 3 times amount and reaches 60-70% to concentration of alcohol, puts 4 DEG C-8 DEG C, stand after stirring 12-24 hour, filter；Filtrate heating recovery ethanol, obtains medicinal liquid, filters, put in concentration pan after cooling, heating is concentrated into paste. With sucrose 4 kilograms the syrup of 80% (the most heated turn to), add pure water to cumulative volume 2000ml, hybrid filtering post package, often Prop up (bottle) 10ml.Sterilization.Pack to obtain finished product.Consumption: adult can be each serving 10ml, oral 2-3 time.

Embodiment 2:

Weigh in leaf containing 15 kilograms of pearl, Herba Sarcandrae 30 kilograms, Herba vallisneriae Spiralis 15 kilograms, Radix Scrophulariae 10 kilograms.In said medicine → put In medicine extraction pot → and adding the 10-15 times of water yield → heated and boiled 1-2 hour → releasing medicinal liquid, medicinal residues add 5-10 times amount water → heavily boil again Boil 0.5-1 hour → releasing medicinal residues.Above twice medicinal liquid mixing → filtration → medicinal liquid is put in concentration pan, and heating is concentrated into 2-3 times Medicine volume, cooling.Then medicinal liquid adds 3-4 times of volume volumetric concentration 95% ethanol and reaches 60-70% to concentration of alcohol, puts 4 after stirring DEG C-8 DEG C, stand 12-24 hour, filter；Filtrate is put in ethanol recycling can, reclaims ethanol, gained medicinal liquid after cooling, filters, put In concentration pan, heating concentrates, to paste.With sucrose 4-6 kilogram the syrup of 80% (the most heated turn to), add pure water and be diluted to Oral liquid, constant volume, making oral liquid sugar content is 20%(weight: volume ratio), filter, fill, sealing.Sterilization.After packaging Finished product.

Embodiment 3:

Ye Li contains 15 kilograms of pearl, Herba Sarcandrae 15 kilograms, Herba vallisneriae Spiralis 12 kilograms, Radix Scrophulariae 12 kilograms.Above Chinese medicine, puts Chinese medicine extraction In tank → and adding 10-15 times of dose water → heated and boiled 1-2 hour → releasing medicinal liquid, medicinal residues add 5-10 times amount water → heavily boil again 05.-1 hour → release medicinal liquid, above twice medicinal liquid merged, and in filtration → medicinal liquid puts concentration pan, heating concentrates, to 2-3 times of medicine body Long-pending, cooling.Then add 3-4 times amount volumetric concentration 95% ethanol and reach 60-70% to concentration of alcohol, after stirring, put 4 DEG C-8 DEG C, stand 12-24 hour, filter；Filtrate puts heating recovery ethanol in alcohol recovery device, and medicinal liquid is released, and cooling is filtered, and medicinal liquid puts concentration In pot, heating is concentrated into paste.Add adjuvant, make medicated powder, on capsule machine on glue capsule → sealing/pouring apparatus encapsulate → capsule finished product.

Embodiment 4:

Ye Li contains 15 kilograms of pearl, Herba Sarcandrae 9 kilograms, Herba vallisneriae Spiralis 8 kilograms, Radix Scrophulariae 15 kilograms.Above-mentioned Chinese medicine Herba Sarcandrae is first put into Ethanol extraction in alcohol reflux tank → add volumetric concentration 95% ethanol 5-10 times amount → be heated to reflux 1-2 hour → release medicinal liquid, mistake In filter → tank, medicinal residues add 3-7 times → twice medicinal liquid of volumetric concentration 50% ethanol again and merge (medicinal liquid containing ethanol)；Medicinal residues are with other Chinese medicine Radix Picriae felterrae, Herba Andrographis together, are put in Chinese medicine extracting tank → 10-15 times → heated and boiled 1-2 hour that adds water → releasing medicine Liquid (filtration) → medicinal residues add water 5-10 times → reheat boil 0.5-1 hour → release medicinal liquid (filtration) → the conjunction of twice medicinal liquid And → put heating in concentration pan concentrate → to dose 2-3 times → cooling → stirring, put 4 DEG C-8 DEG C, stand 12-24 hour → filtration → filtrate merge with above twice medicinal liquid Han ethanol → reclaim ethanol → medicinal liquid cool down → filter → put concentration pan in heating concentrate → it is dried → goes up machine tabletting → upper machine coating → subpackage to paste → add adjuvant → powder process, obtain tablet.

Embodiment 5:

Ye Li contains 10 kilograms of pearl, Herba Sarcandrae 15 kilograms, Herba vallisneriae Spiralis 8 kilograms, Radix Scrophulariae 15 kilograms.Above-mentioned Chinese medicine Herba Sarcandrae is first put into Ethanol extraction in alcohol reflux tank → add volumetric concentration 95% ethanol 5-10 times amount → be heated to reflux 1-2 hour → release medicinal liquid, mistake In filter → tank, medicinal residues add 3-7 times → twice medicinal liquid of volumetric concentration 50% ethanol again and merge (medicinal liquid containing ethanol)；Medicinal residues are with other Chinese medicine Radix Picriae felterrae, Herba Andrographis together, are put in Chinese medicine extracting tank → 10-15 times → heated and boiled 1-2 hour that adds water → releasing medicine Liquid (filtration) → medicinal residues add water 5-10 times → reheat boil 0.5-1 hour → release medicinal liquid (filtration) → the conjunction of twice medicinal liquid And → put heating in concentration pan concentrate → to dose 2-3 times → cooling → stirring, put 4 DEG C-8 DEG C, stand 12-24 hour → filtration → filtrate merge with above twice medicinal liquid Han ethanol → reclaim ethanol → medicinal liquid cool down → filter → put concentration pan in heating concentrate → to paste → with sucrose by 2 times of mixing of crude drug total amount → be dried medicated powder → with granulator pelletize → quantitatively → encapsulate Granule finished product.

Described in above example, adjuvant includes: filler, disintegrating agent, lubricant, coating materials etc., filler is starch, paste Essence, carboxymethyl starch, calcium hydrogen phosphate, Starch 1500 and other pharmaceutic adjuvants；Disintegrating agent is sodium carboxymethyl cellulose, hydroxy propyl cellulose Element, Starch 1500, the kind pharmaceutic adjuvant flowed and there is water swelling；Lubricant is Polyethylene Glycol, magnesium stearate, Pulvis Talci and has The pharmaceutic adjuvant of lubrication；Coating materials is Opadry 11 type, Opadry Chinese medicine, Opadry tm type, U.S. many elegant (hydroxypropyl methyls Cellulosic polymer), ethyl cellulose (IDALL's show), refined gram suitable (water-borne acrylic type enteric coating system) etc..

The following is experimentation and clinical research data: 1. experimentation data:

1.1 inhibition of cancer cell tests.With 1640 culture medium culturing hepatoma carcinoma cell (Hepg2) be separately added into different anticancer in Medicine is cultivated together, and (1) is organized as adding this compound extract (anticancer No. 1), and (2) group is Jia Yeli (anticancer No. 2) Han pearl extracting solution, (3) group is for adding tricuspid shirt extracting solution, and (4) are organized as compareing not dosing.The cell number statistical result of each group.Result shows, matched group (4) Cell number is most, is followed successively by thereafter (3), (2), (1) group.It is shown in Table 1

Table 1 is respectively organized cell number and is compared

Variance analysis: compare with (4) group^△P ＜ 0.05,^△△P ＜ 0.01, compares with (3) group,^*P ＜ 0.05, with (2) group ratio Relatively,^▲▲P ＜ 0.01.

Each group cellular morphology change after 1.2 medications.Result shows, (4) group is adherent for blank group hepatoma carcinoma cell, is not added with Medicine, shows hepatic cell growth speed in photograph, cell is polygon, has pseudopodium, subregion to occur that cladding grows, density Greatly, cell is bright, and granule is few, without peeling phenomenon, sees Fig. 4；(1) group is compound recipe (anticancer No. 1) group, and liver cancer cell growth is all subject to Suppression, cell enlargement, gradually become round, pseudopodium reduces, and iuntercellular is away from increase, and along with the increase of medicine, local cells comes off substantially, Bottle end vacancy, density is little, and intracellular granular is many, coarse, shows aging, sees Fig. 1；(2) group, (3) group are respectively the most anticancer No. 2 and three Point China fir group also occurs organizing similar phenomenon to (1), but the display of (three) group is lighter.

The 1.3 anticancer compound recipes inhibition test to hepatocellular carcinoma H22 cell proliferation. it is thin that variable concentrations compound recipe acts on hepatocarcinoma After born of the same parents 24h, A value all declines, compound recipe concentration the highest A value the lowest (F=174.130, P=0.000)；Hepatoma cell proliferation is had aobvious Write inhibitory action, the highest (X of the highest suppression ratio of concentration²=48.971, P=0.000).It is shown in Table 2.

Table 2 variable concentrations compound recipe group and matched group hepatoma carcinoma cell HepG₂A value, suppression ratio compares

Variance analysis: A value, compares with blank group^*P ＜ 0.05, respectively organizes suppression ratio, compares with blank group,^△P ＜ 0.01.

1.4 the impact that anticancer compound recipe is on hepatoma carcinoma cell telomerase activation. compare with blank group, in compound recipe, leaf containing pearl, Folium et Ramulus Cephalotaxi group all can suppress hepatoma carcinoma cell telomerase activation (F=7.942, P=0.010), three groups of anticarcinogen differences of inhibitory action Not statistically significant (P > 0.05). show that medicine passes through anticancer telomerase activation, make cancerous cell telomeric dna replicate and slow down And be gradually shortened, growth of cancer cells slows down, and is eventually striking to apoptosis, and this is the mechanism of this medicine effect. it is shown in Table 3.

Each group of table 3 is to hepatoma carcinoma cell HepG₂The comparison of telomerase activation

Variance analysis: compare with blank group^*P ＜ 0.05,^△P ＜ 0.05.

2. clinical research data:

This formula began one's study from nineteen eighty-two, observes and treats liver cancer patient, and clinical statistics patient 20 example is evident in efficacy, always Effective percentage is 68.8%, the longest 16 years life-spans of prolongation.(clinical case and formula were not delivered on magazine). model case:

Clinical case 1:

Patient Zhu, this city epidemic prevention station doctor.Nineteen eighty-two is diagnosed as constitutional in The People's Hospital, Guangxi Zhuang Autonomous Region Hepatocarcinoma.Entire patient's edema sees medical expert's consultation, checks liver enlargement, hard, rough surface, through chemical examination, rocket electrophoresis, alpha-fetoprotein Mensuration, B ultrasonic, biopsy etc. check, being diagnosed as primary hepatocarcinoma, receipts are hospitalized for treatment.Adhere to being reluctant to stay in Nanning by patient Doctor is in hospital, and unit sends ambulance to take back original place treatment.Medicinal: compound anti-cancer 1 is (containing pearl 6g, Herba Pileae Scriptae 10g, Herba vallisneriae Spiralis in leaf 10g, Radix Scrophulariae 9g), be decocted in water for oral dose, every day potion；After this medicine is done piece agent, each 3-4 sheet, every day 2-3 time.Long-term taking.Fixed Phase is to Nanning autonomous region hospital, the check of hospital of city.Review result, hepatic neoplasms has no expansion, does not also reduce, also without transfer disease Stove, can the basic controlling state of an illness.Daily life can be taken care of oneself, and due to illness early retirement is in rest.The end of the year 1997, because catching a cold into local county Hospitalize, penicillin anaphylaxis causes anuria, fecal incontinence, dyspnea, heart failure, stupor, escape danger after swinging and rescuing, and Hou Zhuan city cures Institute's oncology continual cure, the state of an illness is the most stable, checks: X-ray and CT sheet check that hepatic neoplasms exists, and has no expansion and turns Moving, chemical examination liver function is normal, but is associated with chronic constrictive pericarditis, and calcification, it is impossible to carry out operative treatment, the heart Decline.After being admitted to hospital about one month, the state of an illness is more stable, during just meeting the Spring Festival, it is desirable to leave hospital, but continues medication treatment.Leave hospital about two Many months, heart failure, dyspnea not yet solved, and the rear state of an illness increases the weight of the most suddenly, back into Affiliated Hospital's surgical intervention, after a few days Turning again internal medicine, after one week, because of heart failure, that all rescue measures proved ineffectual is dead.The course of disease is made a definite diagnosis hepatocarcinoma from first half of the year nineteen eighty-two and is gone to the first half of the year in 1998 Generation, terminal hour 65 years old.

Clinical case 2:

Li Linguo, man, 45 years old, Bose City factory worker, within 1998, December was diagnosed as constitutional in Bose City hospital on 10th Hepatocarcinoma is admitted to hospital hospitalization, and the state of an illness deteriorates rapidly seriously, ascites, abdominal distention occurred, it is impossible to walking of leaving the bed, and is unable to leave the bed.In On January 5th, 1999 takes No. 1 mixture of compound anti-cancer, every day 1 bottle (100ml), takes in three times.Treat one the course for the treatment of (two stars Phase).Controlling the rear state of an illness to be clearly better, walking of can leaving the bed voluntarily, take a walk in city, spirit, appetite the most all take a favorable turn, and cure from city farthest Institute is feasible goes to about 2 km steps, and the state of an illness relatively stably is left hospital to be in and recuperated.To in May, 1999, it is in and crosses play motion because of unexpected Cause esophageal vein Rupture haemorrhag, the invalid death of first aid.

Clinical case 3:

Huang, man, the ground large hospital treatments such as 40 years old, nineteen ninety suffered from oral cancer, once arrived Nanning, Guangzhou, due to diffusingsurface Long-pending excessive, cannot operative treatment, take this medicine and carry out conservative treatment, cancerous protuberance is obviously reduced, for the several years.

Claims

1. the compound Chinese medicinal preparation treating hepatocarcinoma, it is characterised in that: its effective ingredient is by the Chinese medicine of following parts by weight Raw material is made:

Ye Li 5-15 part on pearl；

Herba Sarcandrae 5-30 part；

Herba vallisneriae Spiralis 5-15 part；

Radix Scrophulariae 5-15 part；

Described compound Chinese medicinal preparation is oral liquid, capsule, tablet, granule or other peroral dosage form.

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma the most according to claim 1, it is characterised in that: the production method of oral liquid is such as Under:

(1) medicine is claimed: weigh by weight in leaf containing pearl, Herba Sarcandrae, Herba vallisneriae Spiralis and Radix Scrophulariae；

(2) water extraction: add 10-15 times amount water heated and boiled 1-2 hour in Chinese medicine is put Chinese medicine extracting tank, releases medicinal liquid, filters, Medicinal residues add 5-10 times of water and add thermogravimetric and boil 0.5-1 hour, and medicinal residues are released, filtering liquid medicine；

(3) concentration of liquid medicine: in medicinal liquid puts concentration tank, heating is concentrated into 2-3 times of medicine volume, cooling；

(4) ethanol precipitation: above medicinal liquid adds volumetric concentration 95% ethanol and reaches 60-70% to concentration of alcohol, is put in 4 DEG C-8 DEG C after stirring Stand 12-24 hour, filter to get filtrate；

(5) reclaim ethanol: above medicinal liquid puts heating recovery ethanol in ethanol recycling can, release medicinal liquid, cooling, filtering liquid medicine；

(6) concentration of liquid medicine: above filtrate is heated to 80 DEG C of poultices being concentrated to give relative density 1.10-1.15 in putting concentration tank Thing；

(7) oral liquid preparation: above cream drug adds the pure water of 5-6 times, then the sucrose syrup adding overall volume 20% is made Oral liquid, quantitatively, fill, sealing, sterilizing, pack to obtain finished product.

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma the most according to claim 1, it is characterised in that: the production method of capsule is such as Under:

(7) pharmacy powder: above cream drug adds adjuvant, powder process is dried to obtain medicated powder；

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma the most according to claim 1, it is characterised in that: the production method of tablet is such as Under:

(1) medicine is claimed: weigh Herba Sarcandrae by weight；

(2) ethanol extraction: put by Herba Sarcandrae in reflux, extract, pot, adds volumetric concentration 95% ethanol 5-10 times, is heated to reflux 1-2 little Time, filtering liquid medicine, medicinal residues add volumetric concentration 50% ethanol 3-7 times, and second time is heated to reflux 1-1.5 hour, release medical filtration and obtain Filtrate a；

(3) water extraction: take by above parts by weight and put medicine boiler containing pearl, Radix Scrophulariae and (2nd) the remaining medicinal residues of step in Herba vallisneriae Spiralis, leaf In, adding water 10-15 times to heat and boil 1-2 hour, release medicinal liquid, filter, medicinal residues add water 5-10 times, add thermogravimetric and boil 0.5-1 hour, Release medicinal liquid, filter to obtain medicinal liquid；

(5) ethanol precipitation: above (4th) step concentrated medicament adds volumetric concentration 95% ethanol to concentration of alcohol and reaches 60-70%, after stirring Putting 4 DEG C-8 DEG C and stand 12-24 hour, filter to get filtrate b；

(6) reclaim ethanol: merged by above (2nd) step filtrate a and (5th) step filtrate b, put ethanol and reclaim heating recovery second in pot Alcohol, releases medicinal liquid, cooling, filters to obtain medicinal liquid；

(8) pharmacy powder: above paste adds adjuvant, powder process is dried to obtain medicated powder；

(9) film-making: above medicated powder adds right amount of auxiliary materials, mixing, pelletizes, and is dried, and tabletting, bag sheet, coating, subpackage obtains tablet.

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma the most according to claim 1, it is characterised in that: the production method of granule is such as Under:

(1) medicine is claimed: weigh Herba Sarcandrae by weight；

(8) pharmacy powder: above paste is with sucrose by 2 times of mixing of crude drug total amount, and powder process is dried to obtain medicated powder；By the mechanism of pelletizing Grain, quantitatively, encapsulates to obtain finished product.

6. according to the compound Chinese medicinal preparation of the treatment hepatocarcinoma described in claim 3 or 4, it is characterised in that: described adjuvant includes: fill out Filling agent, disintegrating agent, lubricant and coating materials, described filler is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate or Starch 1500； Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose, Starch 1500 or kind stream；Described lubricant is Polyethylene Glycol, tristearin Acid magnesium or Pulvis Talci；Described coating materials be Opadry 11 type, Opadry Chinese medicine, Opadry tm type, hydroxypropyl methyl cellulose gather Compound or ethyl cellulose.

The compound Chinese medicinal preparation for the treatment of hepatocarcinoma the most according to claim 1 answering in terms of the medicine of preparation treatment hepatocarcinoma With.