CN104491490A - Traditional Chinese medicine preparation for treating liver cancer and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating liver cancer and preparation method thereof Download PDFInfo
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating liver cancer and a preparation method thereof, relating to the technical field of traditional Chinese medicine. The traditional Chinese medicine preparation for treating liver cancer is prepared from the following raw materials: radix notoginseng, herba hedyotis, radix rehmanniae preparata, rhizoma gastrodiae, cortex moutan radicis, herba scutellariae barbatae, scolopendra, radix salviae miltiorrhizae, scorpio, hirudo, thallus laminariae, semen ziziphi spinosae, rhizoma atractylodis macrocephalae, fructus corni, radix bupleuri, pseudobulbus cremastrae seu pleiones, bombyx batryticatus and radix glycyrrhizae. The traditional Chinese medicine preparation can avoid the damage of approaches of operation, radiotherapy and chemotherapy and the like to the body of a patient by adopting a conservative treatment approach, and the self immunity of the patient can be maximally stimulated, so that the traditional Chinese medicine preparation has the technological advantages that the treatment effect is good, people has no pain, and does not have an operation and chemotherapy and the like, the method of preparing a preparation from the traditional Chinese medicine formula also has the technological advantages that the technology is simple, convenient and easy, the medicinal efficacy is stable, popularization and application are easy, and the like.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine preparation of Hepatoma therapy.
Technical background
Hepatocarcinoma and liver malignancy are the commonly encountered diseases in surgical diseases and frequently-occurring disease, and liver malignancy can be divided into constitutional and the large class of Secondary cases two.Characters of Primary Malignant Tumors of Liver originates from epithelium or the mesenchymal tissue of liver, and the former is called primary hepatocarcinoma, is that China is occurred frequently, very harmful malignant tumor; The latter is called sarcoma, comparatively rare compared with primary hepatocarcinoma.Secondary cases or title secondary liver cancer mean that the malignant tumor of the multiple organ origin of whole body is invaded to liver.Generally 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.
Doctor trained in Western medicine still imperfectly understands the cause of disease of primary hepatocarcinoma and definite molecular mechanism, thinks that its morbidity is complex process that is multifactor, multi-step at present, by environment and therefore double factor affect.Epidemiology and experimentation data show, hepatitis B virus (HBV) is all relevant to onset of liver cancer with hepatitis C virus (HCV) infection, flavacin, contaminated drinking water, ethanol, liver cirrhosis, gonadal hormone, nitrosamines material, trace element etc.In the Analyses of major carcinogens in mainstream factor that China's HBV infection is work morbidity, flavacin and contaminated drinking water may be then most important carcinogenic factors.And secondary liver cancer (secondary liver cancer) is by different approaches, as shifted with blood, lymph fluid or directly invade profit liver and form disease.
According to the description of clinical manifestation and ancient medical book, hepatocarcinoma belongs to " the liver rump ", “ mass in the abdomen ", " gathering ", " tympanites ", " mass at the hypochondrium ", the category such as " jaundice ".The traditional Chinese medical science to the typing of hepatocarcinoma primarily of following a few class:
1, syndrome of stagnation of liver qi: disease sees side of body rib distension, and migratory pain, distension and fullness in the abdomen, uncomfortable in chest, sighing frequently, being irritable and getting angry easily, body of the tongue is light red, white and thin fur, stringy pulse.The rule for the treatment of: dispersing the stagnated live-QI to relieve the stagnation of QI, regulating qi-flowing for harmonizing stomach.
2, syndrome of qi stagnation and blood stasis: disease sees upper abdominal lump, matter is hard, nodosity sense, and pain fixes tenderness, or tugging pain over the chest and hypochondrium, becoming severe at night, or see that liver palm, spider angioma and stomach wall blue veins expose, very then squamous and dry skin, the tongue limit stasis of blood is dark or dark red, thin white fur of tongue or BOHUANG, and stringy and thready pulse is puckery unable.Have hot and suffocating person many companions dysphoria with smothery sensation bitter taste concurrently, constipation with dry stool, little volume is yellow or short red.The rule for the treatment of: blood circulation promoting and blood stasis dispelling, hard masses softening and resolving.
3, syndrome of stagnation of liver qi and spleen deficiency: disease sees distension and fullness of the chest and abdomen, lump is touched a tender spot, and asthenia is become thin, and loses heart weak after food more so, and anorexia is had a sleepless night, and mouth is caught up with not for drink, large loose stool number, very then ascites jaundice, edema of lower limbs, and body of the tongue is greatly fat, and tongue is white, soft pulse.The rule for the treatment of: soothing liver and strengthening spleen, regulate the flow of vital energy Xiao Disorder.
4, hepatic and renal YIN deficiency card: disease sees that abdominal distention limb swells, enlarged abdomen, and blue veins exposes, and extremity are become thin, dyspnea with rapid and short breath of losing heart, flushed cheeks xerostomia, indigestion and loss of appetite anorexia, hectic fever or feverish sensation in the palms and soles, irritated sleeplessness, constipation, very then unconsciousness and delirium, or two just hematochezia, the few tongue of red tongue, thready and rapid pulse without strength.The rule for the treatment of: nourishing the liver and kidney, Hua Yu Xiao Disorder.
5, damp and hot poison accumulates card: disease sees right flank distension, pain with tenderness, heating, bitter taste or halitosis, yellowish body icteric sclera, yellow urine, yellow as orange or flue dust, ascites or hydrothorax, nausea and vomiting, constipation or glutinous greasy not well, red tongue.Yellow and greasy fur, slippery and rapid pulse.The rule for the treatment of: clearing away heat-damp and promoting diuresis, Xie Du Xiao Disorder.
Summary of the invention
The technical problem to be solved in the present invention is, invent a kind of Chinese medicine preparation hepatocarcinoma being had to better therapeutic effect, and the preparation technology of this Chinese medicine preparation is simple and easy to do, efficacy stability, general adaptability is good.
The technical scheme that the present invention solves the problems of the technologies described above, fully take into account many-sided problems such as the drug effect of Chinese prescription, dosage, indication, adjustment is repeatedly practised by clinical, final invention Chinese prescription, it both had significant effect to the treatment of hepatocarcinoma, Modern preparations can be adapted to again produce, there is stable drug effect, be applicable to more patient.
Chinese prescription in this technical scheme of the present invention is (with parts by weight): Radix Notoginseng 9-21 part, Herba Hedyotidis Diffusae 17-29 part, Radix Rehmanniae Preparata 16-28 part, Rhizoma Gastrodiae 10-20 part, Cortex Moutan 8-18 part, Herba Scutellariae Barbatae 7-17 part, Scolopendra 7-19 part, Radix Salviae Miltiorrhizae 7-19 part, Scorpio 7-13 part, Hirudo 7-13 part, Thallus Laminariae (Thallus Eckloniae) 6-12 part, Semen Ziziphi Spinosae 19-31 part, Rhizoma Atractylodis Macrocephalae 9-21 part, Fructus Corni 11-23 part, Radix Bupleuri 7-17 part, Pseudobulbus Cremastrae Seu Pleiones 13-27 part, Bombyx Batryticatus 6-12 part, Radix Glycyrrhizae 9-15 part.
In the ratio range of prescription, preferred three proportionings are out:
Proportioning 1: Radix Notoginseng 15 parts, Herba Hedyotidis Diffusae 23 parts, 22 parts, Radix Rehmanniae Preparata, 15 parts, Rhizoma Gastrodiae, Cortex Moutan 13 parts, Herba Scutellariae Barbatae 12 parts, Scolopendra 13 parts, Radix Salviae Miltiorrhizae 13 parts, Scorpio 10 parts, Hirudo 10 parts, Thallus Laminariae (Thallus Eckloniae) 9 parts, Semen Ziziphi Spinosae 25 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Fructus Corni 17 parts, Radix Bupleuri 12 parts, Pseudobulbus Cremastrae Seu Pleiones 20 parts, Bombyx Batryticatus 9 parts, 12 parts, Radix Glycyrrhizae.
Proportioning 2: Radix Notoginseng 17 parts, Herba Hedyotidis Diffusae 25 parts, 20 parts, Radix Rehmanniae Preparata, 14 parts, Rhizoma Gastrodiae, Cortex Moutan 12 parts, Herba Scutellariae Barbatae 11 parts, Scolopendra 12 parts, Radix Salviae Miltiorrhizae 14 parts, Scorpio 11 parts, Hirudo 11 parts, Thallus Laminariae (Thallus Eckloniae) 8 parts, Semen Ziziphi Spinosae 23 parts, the Rhizoma Atractylodis Macrocephalae 14 parts, Fructus Corni 16 parts, Radix Bupleuri 13 parts, Pseudobulbus Cremastrae Seu Pleiones 22 parts, Bombyx Batryticatus 8 parts, 11 parts, Radix Glycyrrhizae.
Proportioning 3: Radix Notoginseng 16 parts, Herba Hedyotidis Diffusae 24 parts, 24 parts, Radix Rehmanniae Preparata, 16 parts, Rhizoma Gastrodiae, Cortex Moutan 14 parts, Herba Scutellariae Barbatae 11 parts, Scolopendra 11 parts, Radix Salviae Miltiorrhizae 11 parts, Scorpio 9 parts, Hirudo 9 parts, Thallus Laminariae (Thallus Eckloniae) 7 parts, Semen Ziziphi Spinosae 26 parts, the Rhizoma Atractylodis Macrocephalae 16 parts, Fructus Corni 18 parts, Radix Bupleuri 13 parts, Pseudobulbus Cremastrae Seu Pleiones 23 parts, Bombyx Batryticatus 8 parts, 13 parts, Radix Glycyrrhizae.
The technique this Chinese prescription being made finished product preparation is following steps:
1, various raw medicinal material is accurately taken in prescription ratio;
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 7-12 times of weight, backflow decoction 3 times, each 2-4 hour, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of the 60-75% of 5-8 times of weight, reflux, extract, 3 times, each 2-4 hour, merges alcohol extract, distilling under reduced pressure, removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make clinical required dosage form, as dosage forms such as tablet, pill, capsule, granule, syrups with the Chinese medicine preparation technology that the modern times are general.
The nature and flavor of Chinese prescription of the present invention Chinese crude drug used, return through and effect:
Radix Notoginseng: this product is the dry root of panax araliaceae plant.Sweet in the mouth, micro-hardship, warm in nature; Return liver, stomach warp; Dissipating blood stasis stops blooding, subduing swelling and relieving pain.
Herba Hedyotidis Diffusae: this product is the herb of Rubiaceae plants of Hedyotis Herba Hedyotidis Diffusae.Sweet in the mouth, light, cool in nature; Enter stomach, large intestine, small intestine meridian; Heat-clearing and toxic substances removing, inducing diuresis to remove edema, promoting blood circulation and stopping pain.
Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae.Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
Rhizoma Gastrodiae: this product is the dry tuber of orchid Rhizoma Gastrodiae.Sweet in the mouth, property is put down; Return Liver Channel; Suppressing the hyperactive liver to relieve the wind syndrome relieving convulsion.
Cortex Moutan: this product is the dry root bark of ranunculaceae peony.Bitter in the mouth, pungent, cold nature; GUIXIN, liver, kidney channel; Clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.
Herba Scutellariae Barbatae: this product is the dry herb of labiate Herba Scutellariae Barbatae.Acrid in the mouth, hardship, cold in nature; Return lung, liver, kidney channel; Heat-clearing and toxic substances removing, blood stasis dispelling diuresis.
Scolopendra: this product is the dry body of Scolopendridae animal Scolopendpa Subspinipes Mutilans L. KOCH.Acrid in the mouth, warm in nature; Return Liver Channel; Endogenous wind stopping spasmolytic, merit poison eliminating stagnation, removing obstruction in the collateral to relieve pain.
Radix Salviae Miltiorrhizae: this product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.Bitter in the mouth, cold nature; GUIXIN, Liver Channel; Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.
Scorpio: this product is the dry body of Buthidae animal Scorpio.Acrid in the mouth, property is put down; Return Liver Channel; Endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.
Hirudo: this product is the dry body of Hirudinidae animal whitmania, Hirudo or Folium Salicis Babylonicae Hirudo.Salty in the mouth, hardship, property is put down; Return Liver Channel; Removing blood stasis, removing blood stasis, stimulates the menstrual flow.
Thallus Laminariae (Thallus Eckloniae): this product is the dry thallus of Laminariaceae plant Thallus Laminariae (Thallus Eckloniae) or Alariaceae plant Thallus Laminariae (Thallus Eckloniae) (goose palm dish).Salty in the mouth, cold in nature; Return liver, stomach, kidney channel; Hard masses softening and resolving, expectorant, diuretic.
Semen Ziziphi Spinosae: this product is the dry mature seed of Rhamnaceae plant Ziziphi Spinosae.Sweet in the mouth, acid, property is put down; Return liver, gallbladder, heart channel; Tonifying liver, mind calming, arresting sweating, promotes the production of body fluid.
The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp; Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.
Fructus Corni: this product is the drying and ripening sarcocarp of Cornaceae plant Fructus Corni.Sour in the mouth, puckery, slightly warm in nature; Return liver, kidney channel; Liver and kidney tonifying, essence astringing and desertion stemming.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii..Bitter in the mouth, cold nature; Return liver, gallbladder meridian; Reconciling superficies and interior, soothing the liver, yang invigorating.
Pseudobulbus Cremastrae Seu Pleiones: this product is the dry pseudobulb of orchid Cremastra appendiculata, pleione bulbocodioides or Pleione yunnanensis.Sweet in the mouth, micro-pungent, cool in nature; Return liver, spleen channel; Heat-clearing and toxic substances removing, dissipating phlegm and resolving masses.
Bombyx Batryticatus: this product is that the larva in Bombycidae insecticide silkworm 4 ~ 5 age infects (or artificial vaccination) muscardine and lethal larva dry body.Salty in the mouth, pungent, property is put down; Return liver, lung, stomach warp; Expelling wind for relieving convulsion, dissipating phlegm and resolving masses.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; 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.
The prescription analysis of Chinese prescription of the present invention:
Chinese prescription of the present invention is with Herba Hedyotidis Diffusae, Radix Rehmanniae Preparata, Semen Ziziphi Spinosae, Pseudobulbus Cremastrae Seu Pleiones, Fructus Corni for monarch drug, promoting blood circulation and stopping pain, the liver and the kidney tonifying, tonifying liver mind calming, dissipating phlegm and resolving masses; With Radix Notoginseng, Rhizoma Gastrodiae, Scolopendra, the Rhizoma Atractylodis Macrocephalae for ministerial drug, dissipating blood stasis hemostasis, suppressing the hyperactive liver to relieve the wind syndrome, merit poison eliminating stagnation, dampness diuretic; With Scorpio, Hirudo, Thallus Laminariae (Thallus Eckloniae), Bombyx Batryticatus for adjuvant drug, removing obstruction in the collateral to relieve pain, removing blood stasis, expectorant diuretic, dispelling wind-evil and transforming calculus; With Cortex Moutan, Herba Scutellariae Barbatae, Radix Salviae Miltiorrhizae, Radix Bupleuri for making medicine, blood circulation promoting and blood stasis dispelling, blood stasis dispelling diuresis, promoting blood circulation to restore menstrual flow, reconciling superficies and interior; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicines are coordinated, promotes mutually, mutually coordinate, thus reach the effects such as the liver and the kidney tonifying, dissipating phlegm and resolving masses, dissipating blood stasis hemostasis, suppressing the hyperactive liver to relieve the wind syndrome, blood stasis dispelling diuresis, more excellent therapeutic effect is shown for hepatocarcinoma.
Compared with prior art, Chinese medicine preparation of the present invention avoids the means such as operation, chemicotherapy to the infringement of patient body from the approach of expectant treatment, excite the immunity of patient self to greatest extent; It not only can be used alone Hepatoma therapy, also can use as rehabilitation medicine after Liver Cancer Operation or after chemicotherapy, effectively can reduce the infringement of performing the operation and chemicotherapy causes to patient body.Therefore, Chinese medicine preparation of the present invention has that therapeutic effect is good, no pain, do not perform the operation, the not technical advantage such as chemotherapy, method Chinese prescription of the present invention being made preparation also has that simple process is easy, efficacy stability, be easy to technical advantages such as applying.
Detailed description of the invention
Embodiment 1
Produce by the minimum zone of Chinese prescription of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 900g, Herba Hedyotidis Diffusae 1700g, Radix Rehmanniae Preparata 1600g, Rhizoma Gastrodiae 1000g, Cortex Moutan 800g, Herba Scutellariae Barbatae 700g, Scolopendra 700g, Radix Salviae Miltiorrhizae 700g, Scorpio 700g, Hirudo 700g, Thallus Laminariae (Thallus Eckloniae) 600g, Semen Ziziphi Spinosae 1900g, Rhizoma Atractylodis Macrocephalae 900g, Fructus Corni 1100g, Radix Bupleuri 700g, Pseudobulbus Cremastrae Seu Pleiones 1300g, Bombyx Batryticatus 600g, Radix Glycyrrhizae 900g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 2
Produce by the maximum magnitude of Chinese prescription of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 2100g, Herba Hedyotidis Diffusae 2900g, Radix Rehmanniae Preparata 2800g, Rhizoma Gastrodiae 2000g, Cortex Moutan 1800g, Herba Scutellariae Barbatae 1700g, Scolopendra 1900g, Radix Salviae Miltiorrhizae 1900g, Scorpio 1300g, Hirudo 1300g, Thallus Laminariae (Thallus Eckloniae) 1200g, Semen Ziziphi Spinosae 3100g, Rhizoma Atractylodis Macrocephalae 2100g, Fructus Corni 2300g, Radix Bupleuri 1700g, Pseudobulbus Cremastrae Seu Pleiones 2700g, Bombyx Batryticatus 1200g, Radix Glycyrrhizae 1500g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 3
Produce by arbitrary proportion within the scope of Chinese prescription of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 2100g, Herba Hedyotidis Diffusae 2900g, Radix Rehmanniae Preparata 1600g, Rhizoma Gastrodiae 2000g, Cortex Moutan 800g, Herba Scutellariae Barbatae 700g, Scolopendra 1900g, Radix Salviae Miltiorrhizae 1900g, Scorpio 1300g, Hirudo 700g, Thallus Laminariae (Thallus Eckloniae) 600g, Semen Ziziphi Spinosae 3100g, Rhizoma Atractylodis Macrocephalae 2100g, Fructus Corni 1100g, Radix Bupleuri 1700g, Pseudobulbus Cremastrae Seu Pleiones 1300g, Bombyx Batryticatus 1200g, Radix Glycyrrhizae 900g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 4
Produce in the ratio of Chinese prescription optimum ratio 1 of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 1500g, Herba Hedyotidis Diffusae 2300g, Radix Rehmanniae Preparata 2200g, Rhizoma Gastrodiae 1500g, Cortex Moutan 1300g, Herba Scutellariae Barbatae 1200g, Scolopendra 1300g, Radix Salviae Miltiorrhizae 1300g, Scorpio 1000g, Hirudo 1000g, Thallus Laminariae (Thallus Eckloniae) 900g, Semen Ziziphi Spinosae 2500g, Rhizoma Atractylodis Macrocephalae 1500g, Fructus Corni 1700g, Radix Bupleuri 1200g, Pseudobulbus Cremastrae Seu Pleiones 2000g, Bombyx Batryticatus 900g, Radix Glycyrrhizae 1200g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 5
Produce in the ratio of the optimum ratio 2 of Chinese prescription of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 1700g, Herba Hedyotidis Diffusae 2500g, Radix Rehmanniae Preparata 2000g, Rhizoma Gastrodiae 1400g, Cortex Moutan 1200g, Herba Scutellariae Barbatae 1100g, Scolopendra 1200g, Radix Salviae Miltiorrhizae 1400g, Scorpio 1100g, Hirudo 1100g, Thallus Laminariae (Thallus Eckloniae) 800g, Semen Ziziphi Spinosae 2300g, Rhizoma Atractylodis Macrocephalae 1400g, Fructus Corni 1600g, Radix Bupleuri 1300g, Pseudobulbus Cremastrae Seu Pleiones 2200g, Bombyx Batryticatus 800g, Radix Glycyrrhizae 1100g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 6
Produce in the ratio of the optimum ratio 3 of Chinese prescription of the present invention:
1, various raw medicinal material is accurately taken in prescription ratio: Radix Notoginseng 1600g, Herba Hedyotidis Diffusae 2400g, Radix Rehmanniae Preparata 2400g, Rhizoma Gastrodiae 1600g, Cortex Moutan 1400g, Herba Scutellariae Barbatae 1100g, Scolopendra 1100g, Radix Salviae Miltiorrhizae 1100g, Scorpio 900g, Hirudo 900g, Thallus Laminariae (Thallus Eckloniae) 700g, Semen Ziziphi Spinosae 2600g, Rhizoma Atractylodis Macrocephalae 1600g, Fructus Corni 1800g, Radix Bupleuri 1300g, Pseudobulbus Cremastrae Seu Pleiones 2300g, Bombyx Batryticatus 800g, Radix Glycyrrhizae 1300g.
2, by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 11 times of weight, backflow decoction 3 times, each 3 hours, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
3, by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of 75% of 6 times of weight, reflux, extract, 3 times, each 3 hours, merges alcohol extract, distilling under reduced pressure, and removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
4, water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
5, in above-mentioned Chinese medical concrete, add suitable adjuvant, make granule with the Chinese medicine preparation technology that the modern times are general, amount to crude drug content and be about 0.27g crude drug/g granule.
Embodiment 7
The animal toxicity test of the Chinese medicine granules that embodiment of the present invention 1-6 produces
(1) test drug: Chinese medicine granules obtained by embodiment of the present invention 1-6, adds purified water and is modulated into scattered paste shape, for subsequent use.
Test animal used: regular grade NIH mice, body weight 24g ± 6g, male and female half and half, female mice is all without pregnant; SD rat, original body mass 225 ± 9g, male and female half and half, female rats is all without pregnant.
(2) acute toxicity test
Application mice carries out acute toxicity testing and shows: mouse stomach Chinese medicine magma of the present invention, under 709.2g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 2 hours recover normal, Continuous Observation 7 days after administration, none dead mouse, and overall health of patients, diet, take the photograph water, urine and body weight increase all normal.Experimental result shows: the maximum dosage-feeding of mouse stomach Chinese medicine granules of the present invention is 709.2g crude drug/kg/d(LD
50> 709.2g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.18g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 3940 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
(3), long term toxicity test
Select SD rat, give the Chinese medicine granules of the present invention of Three doses: 32.4g crude drug/kg, 10.8g crude drug/kg, 3.6g crude drug/kg(per weight dosage is by 20 times of calculating of clinical application amount, and clinical application amount is according to Pharmacopoeia of the People's Republic of China version in 2010).Every day gavage once, continuous 90 days, after last administration 24 hours respectively group live and kill 1/2 animal (male and female half and half), all the other 1/2 animals continue that observations are alive after 2 weeks kills.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal; Within after administration 90 days, within 2 weeks, carry out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.
Result of the test shows: Chinese medicine preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, according to result of the test: Chinese medicine preparation of the present invention has no significant effect rat in high, medium and low three dosage (32.4g crude drug/kg, 10.8g crude drug/kg, 3.6g crude drug/kg) administration in continuous 90 days, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention very high.
Embodiment 8
The anti-liver cancer drug effect of Chinese medicine preparation of the present invention learns test
(1) experiment material
1, for reagent thing
The confession reagent thing for the treatment of group 1-3: the granule of embodiment of the present invention 4-6, adds distilled water, is configured to the solution of 0.18g/ml, for subsequent use.
2, laboratory animal
SPF level Kunming mouse, male, 6-8 week age, body weight 23 ± 3g, purchased from Institute of Experimental Animals, Chinese Academy of Medical Sciences.
Animal feeding environment: room temperature is 23 ± 2 DEG C, relative humidity is 40-75%, adopts standard feed and water to raise.
3, tumor cell line
Mice H22 hepatoma cell strain, purchased from Zhongshan University's medical college animal center cell bank, after 7-8 days, aseptically extracts ascites, as the tumor kind gone down to posterity through mouse peritoneal inoculation.
4, serum IL-2, TNF-a radio immunoassay (hereinafter referred to as putting the method for exempting from) detection kit: pul great achievement bio tech ltd provides by Beijing.
(2), experimental technique
1, modeling method
The method that tumor strain inoculation method specifies according to the 3rd national oncology pharmacologies in 1989 and chemotherapy academic conference Optimal improvements.Get the milky cancer ascites of H22 Example Ascites hepatoma tumor-bearing mice, dilute with normal saline 1:3; And count cancerous cell, containing 1.2 × 10
7individual cell/ml, every right side of mice axillary fossa subcutaneous vaccination 0.2ml, preparation H22 hepatocarcinoma tumor-bearing mice.
2, inhibiting tumor assay
50 Male Kunming strain mice, prepare hepatocarcinoma bearing mouse model as stated above, after modeling 24h, mice is divided into 5 groups at random, often organize 10, be respectively: model group, treatment group 1-3 and cyclophosphamide group, wherein, the dosage for the treatment of group 1-3 is all by 3.7g/kg body weight (being equivalent to clinical medicine dose after conversion) gastric infusion, the dosage of cyclophosphamide group is by 20mg/kg body weight (being equivalent to clinical medicine dose after conversion) intraperitoneal injection, model group gives equal-volume normal saline gavage, every day 1 time, continuous 8 days, after last administration 24h, mice is weighed, after eye socket gets blood, placement is after hemopexis, centrifugalize serum,-20 DEG C frozen to be checked.Adopt disconnected neck to put to death mice, get subcutaneous tumors block and weigh, win spleen and thymus is weighed.
(3), serum IL-2, TNF-a horizontal detection:
The method of exempting from is put in employing, operates by test kit description.
(4), therapeutic evaluation
1, solid tumor therapeutic evaluation
The curative effect of solid tumor represents with tumour inhibiting rate:
Tumour inhibiting rate (%)=[(model group average tumor weight-corresponding administration group average tumor weight) the average tumor weight of/model group] × 100%
2, thymus index and index and spleen index
3, thymus index=thymic weight (mg)/body weight (g); Index and spleen index=spleen weight (mg)/body weight (g).
(5), statistical procedures
Measurement data represents with mean ± standard deviation, adopts SPSS10.0 software kit to carry out statistical analysis, and the analysis of many Sets of Measurement Datas adopts One way ANOVA, and multiple comparisons adopts LSD, represents that difference has significant with P < 0.05.
(6) result of the test
1, general status and body weight change before and after medication
Mice activity before modeling, diet, hair color are all without exception.Test the 5th day mice oxter and can touch tumor, cyclophosphamide group mice hair color is comparatively dark, and irritability, all the other are respectively organized without significant change.The increase of medication each group in early stage Mouse Weight is all very fast, and later stage cyclophosphamide group body weight increase is slowed down.Each group Mouse Weight no significant difference meaning (P > 0.05) before experiment, at the end of experiment, cyclophosphamide group compares with model group, and the weight differences of mice has significant (P < 0.05), in table 1.
Body weight change before and after table 1 medication (
± SD)
Note: compare with model group, * P < 0.05.
2, Chinese medicinal granule of the present invention is on the impact of H22 transplanted human hepatocellular carcinoma mouse tumor weight, index and spleen index, thymus index
Compare with model group, treatment group 1, treatment group 2 and treatment group 3 tumor are heavy obviously to be reduced, and difference all has significant (P < 0.01), compares with cyclophosphamide group, difference there are no significant meaning (P > 0.05).Treatment group 1, treatment group 2 and treatment group 3 thymus index compare with model group, no significant difference (P > 0.05), but compare with cyclophosphamide group, and difference all has significant (P < 0.01).Treatment group 1, treatment group 2 and treatment group 3 spleen index compare with model group, and difference has significant (P < 0.01), compares with cyclophosphamide group, and difference all has significant (P < 0.01), in table 2.
Table 2 Chinese medicinal granule on the impact of H22 transplanted human hepatocellular carcinoma mouse tumor weight, index and spleen index, thymus index (
± SD)
Note: compare with model group, * P < 0.05, * * P < 0.05; Compare with cyclophosphamide group,
△p < 0.01.
3. Chinese medicinal granule of the present invention is on the impact of H22 transplanted human hepatocellular carcinoma mice serum IL-2, TNF-a content
Treatment group 2 serum IL-2 level is apparently higher than model group, and difference has significant (P < 0.05).Treatment group 1 and treatment group 2 serum TNF-a level are starkly lower than model group, and difference has significant (P < 0.05).Treatment group 2 serum IL-2 level is apparently higher than treatment group 1 and treatment group 3, difference all has significant (P < 0.05), but compare with cyclophosphamide group, no significant difference (P > 0.05), in table 3.
Table 3 Chinese medicinal granule on the impact of H22 transplanted human hepatocellular carcinoma mice serum IL-2, TNF-a content (
± SD)
Note: compare with model group, * P < 0.05, * * P < 0.01; ， $P < 0.05 is compared with treatment group 1 and treatment group 3.Compare with cyclophosphamide group,
△p < 0.05.
(7), conclusion (of pressure testing)
Chinese medicine granules of the present invention has good Tumor suppression growth to H22 transplanted human hepatocellular carcinoma mice, especially best with the therapeutic effect for the treatment of group 3, the proportioning of prompting embodiment 5 shows the most excellent in three optimum ratios, its mechanism of action and immunity moderation function, raises mice serum IL-2 level, suppresses the TNF-a level that raises closely related.Illustrate that Chinese medicine preparation of the present invention has good tumor suppression ability.
Embodiment 9
Clinical effectiveness test is carried out with the made Chinese medicinal granule of embodiment 5
Certain tumour hospital of city amounts to 107 examples for this test provides phase morning, noon and afternoon liver cancer patient, and through the medication treatment of 6 months by a definite date, 6 examples were cured, and effectively, 18 examples are invalid, and total effective rate is 83.2% for 83 examples.Point out Chinese medicine preparation of the present invention in Hepatoma therapy, have very significant technical advantage, obtain beat all technological achievement.
Claims (7)
1. a Chinese medicine preparation for Hepatoma therapy, is characterized in that being made up of the raw material of following weight portion: Radix Notoginseng 9-21 part, Herba Hedyotidis Diffusae 17-29 part, Radix Rehmanniae Preparata 16-28 part, Rhizoma Gastrodiae 10-20 part, Cortex Moutan 8-18 part, Herba Scutellariae Barbatae 7-17 part, Scolopendra 7-19 part, Radix Salviae Miltiorrhizae 7-19 part, Scorpio 7-13 part, Hirudo 7-13 part, Thallus Laminariae (Thallus Eckloniae) 6-12 part, Semen Ziziphi Spinosae 19-31 part, Rhizoma Atractylodis Macrocephalae 9-21 part, Fructus Corni 11-23 part, Radix Bupleuri 7-17 part, Pseudobulbus Cremastrae Seu Pleiones 13-27 part, Bombyx Batryticatus 6-12 part, Radix Glycyrrhizae 9-15 part.
2. the Chinese medicine preparation of Hepatoma therapy according to claim 1, is characterized in that being made up of the raw material of following weight portion: Radix Notoginseng 15 parts, Herba Hedyotidis Diffusae 23 parts, 22 parts, Radix Rehmanniae Preparata, 15 parts, Rhizoma Gastrodiae, Cortex Moutan 13 parts, Herba Scutellariae Barbatae 12 parts, Scolopendra 13 parts, Radix Salviae Miltiorrhizae 13 parts, Scorpio 10 parts, Hirudo 10 parts, Thallus Laminariae (Thallus Eckloniae) 9 parts, Semen Ziziphi Spinosae 25 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Fructus Corni 17 parts, Radix Bupleuri 12 parts, Pseudobulbus Cremastrae Seu Pleiones 20 parts, Bombyx Batryticatus 9 parts, 12 parts, Radix Glycyrrhizae.
3. the Chinese medicine preparation of Hepatoma therapy according to claim 1, is characterized in that being made up of the raw material of following weight portion: Radix Notoginseng 17 parts, Herba Hedyotidis Diffusae 25 parts, 20 parts, Radix Rehmanniae Preparata, 14 parts, Rhizoma Gastrodiae, Cortex Moutan 12 parts, Herba Scutellariae Barbatae 11 parts, Scolopendra 12 parts, Radix Salviae Miltiorrhizae 14 parts, Scorpio 11 parts, Hirudo 11 parts, Thallus Laminariae (Thallus Eckloniae) 8 parts, Semen Ziziphi Spinosae 23 parts, the Rhizoma Atractylodis Macrocephalae 14 parts, Fructus Corni 16 parts, Radix Bupleuri 13 parts, Pseudobulbus Cremastrae Seu Pleiones 22 parts, Bombyx Batryticatus 8 parts, 11 parts, Radix Glycyrrhizae.
4. the Chinese medicine preparation of Hepatoma therapy according to claim 1, is characterized in that being made up of the raw material of following weight portion: Radix Notoginseng 16 parts, Herba Hedyotidis Diffusae 24 parts, 24 parts, Radix Rehmanniae Preparata, 16 parts, Rhizoma Gastrodiae, Cortex Moutan 14 parts, Herba Scutellariae Barbatae 11 parts, Scolopendra 11 parts, Radix Salviae Miltiorrhizae 11 parts, Scorpio 9 parts, Hirudo 9 parts, Thallus Laminariae (Thallus Eckloniae) 7 parts, Semen Ziziphi Spinosae 26 parts, the Rhizoma Atractylodis Macrocephalae 16 parts, Fructus Corni 18 parts, Radix Bupleuri 13 parts, Pseudobulbus Cremastrae Seu Pleiones 23 parts, Bombyx Batryticatus 8 parts, 13 parts, Radix Glycyrrhizae.
5. a preparation method for the Chinese medicine preparation of the Hepatoma therapy as described in as arbitrary in claim 1-4, is characterized in that comprising following processing step:
(1) various raw medicinal material is accurately taken in prescription ratio;
(2) by Radix Notoginseng, Herba Hedyotidis Diffusae, Rhizoma Gastrodiae, Cortex Moutan, Herba Scutellariae Barbatae, Thallus Laminariae (Thallus Eckloniae), Semen Ziziphi Spinosae, Fructus Corni, Radix Bupleuri, Pseudobulbus Cremastrae Seu Pleiones, Radix Glycyrrhizae, pulverize respectively, mixing, add the purified water of 7-12 times of weight, backflow decoction 3 times, each 2-4 hour, filter, merging filtrate, when being condensed into 55 DEG C, relative density is the water extracting liquid of 1.15-1.20, for subsequent use;
(3) by Radix Rehmanniae Preparata, Scolopendra, Radix Salviae Miltiorrhizae, Scorpio, Hirudo, the Rhizoma Atractylodis Macrocephalae, Bombyx Batryticatus, pulverize respectively, mixing, adds the ethanol of the 60-75% of 5-8 times of weight, reflux, extract, 3 times, each 2-4 hour, merges alcohol extract, distilling under reduced pressure, removing ethanol, obtains alcohol extraction concentrated solution, for subsequent use;
(4) water extracting liquid and alcohol extraction concentrated solution merged, relative density 1.28-1.33 when being concentrated into 55 DEG C, is Chinese medical concrete;
(5) in above-mentioned Chinese medical concrete, add suitable adjuvant, make clinical required dosage form with the Chinese medicine preparation technology that the modern times are general.
6. the Chinese medicine preparation of Hepatoma therapy according to claim 1, is characterized in that: described preparation can make tablet, pill, capsule, granule and syrup.
7. the Chinese medicine preparation of Hepatoma therapy according to claim 1 is used alone Hepatoma therapy, or uses as the rehabilitation medicine after Liver Cancer Operation or after chemicotherapy.
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