CN103386024A - Traditional Chinese medicine preparation for treating pancreas cancer and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating pancreas cancer and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating pancreas cancer and a preparation method thereof, wherein the raw materials of the traditional Chinese medicine preparation comprises the following medicinal materials: herbal sarcandrae, aspongopus, Tripterygium wilfordii Hook f, cremastra, cuttlefish bone, forged concha arcae, flat shaft wood, rhizoma atractylodis, bighead atractylodes rhizome, crab shell, ovalleaf dutchmanspipe root, Chinese yam, magnolia cortex, flat bamboo root, fried white peony root, honey-fried licorice root, herb of false indigo, moonseed, root of caudate milkwort, solanum dulcamara, wrinkled giant hyssop, pinellia and Radix Codonopsis. The beneficial effects of the traditional Chinese medicine preparation are as follows: the traditional Chinese medicine preparation can be used alone or together with chemicotherapy, and is clinically applied for treating pancreas cancer treatment, reducing the phyma in a short period, effectively controlling the transfer and diffusion of the cancer cell, inhibiting the growth of the cancer cell without any side-effect at the same time, enhancing body immunity, alleviating pain, stabilizing condition, prolonging lifetime and increasing clinic healing proportion while curing cancer and preventing cancer, and can prevent the residual cancer cell from starting over, and substantially reduce recurrence and transfer.
Description
Technical field
The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine preparation that is used for the treatment of cancer of pancreas and preparation method thereof.
Background technology
Cancer of pancreas is more rare in malignant tumor of digestive tract, is more common in 40～60 years old, and the man is more than the female, and cancer of pancreas mostly occurs at Diseases In Pancreatic Head, and only minority occurs in body of pancreas and tail of pancreas section.Cancer of pancreas is due to the position of cancerous protuberance generation and the morning and evening difference of the course of disease, and clinical symptoms is different.The symptom of stomachache for occurring the earliest, be more common in body of pancreas and tail of pancreas section, large multidirectional lower back radiation.The state of an illness can have jaundice in evolution, abdominal mass can appear in late period, heating, and supraclavicular lymph nodes is modal metastasis site.Modern medicine thinks that primary disease may be relevant with chronic pancreatic diseases with carcinogen in environment, coffee, smoking.Cancer of pancreas is a kind of comparatively dangerous malignant tumor, and is although in every 20,000 people of China, nearly 1 people suffers from cancer of pancreas, should the fast-growth case fatality rate of disease high.The NIH report, 1 year survival rate of cancer of pancreas is 8%, 5 year survival rate 3%.5 years survival rates of China's Statistical data are 5% left and right only.Sickness rate significantly rises year by year in recent years, and U.S.'s cancer of pancreas sickness rate raise 3 times between 10 years, neopathy 43140 examples in 2010, and dead 36800 examples, occupy the tenth of Incidence, and mortality rate but is in the 4th.China's cancer of pancreas morbidity and death toll ascendant trend be highly significant especially, and nearly 20 annual morbidities increase approximately 6 times.According to 38 registry, whole nation tumor registration data in 2007, the cancer of pancreas morbidity occupies the 7th of malignant tumor, and case fatality rate occupies the 6th of malignant tumor.
The total pathogenesis of cancer of pancreas is that weakness of the spleen and stomach, depression of liver-QI cause the stagnation of QI, blood stasis, damp and hot for suffering from, and forms for a long time hard piece.Carcinoma of head of pancreas shows as manyly with damp and hot, and body of pancreas, carcinoma of tail of pancreas be the card of the common insufficiency of the spleen stagnation of QI.The treatment in cancer of pancreas late period should or be attacked or mend or reinforcement and elimination in combination according to the disease different phase.
Cancer of pancreas is in early days take operative treatment as main, and postoperative suitable chemotherapy,, in conjunction with long-term Chinese medicine, likely obtain good efficacy; Many operations palliative treatments in mid-term, as unresectable, feasible cholecystojejunostomy to be to alleviate jaundice, Chinese medicine simultaneously, but also Combined with Radiotherapy, chemotherapy etc.; Late period is take Chinese medicine and symptomatic treatment as main, or in conjunction with small dose chemotherapy.The method of heat-clearing and toxic substances removing, dissipating phlegm and resolving masses, regulating qi-flowing for strengthening spleen is adopted in cancer of pancreas Chinese traditional treatment in late period more.
Cancer of pancreas belongs to the categories such as the traditional Chinese medical science " fullness in the epigastrium especially referring to the abcess of the abdomen in ancient times ", " mass in the abdomen ", " jaundice ", " gathering ", its cause of disease, pathogenesis are mainly internal injury caused by excess of seven emotions, eating and drinking without temperance and cause that the liver spleen is impaired, internal organs are become estranged, turbid damp blocks, qi depression to blood stasis, with the passing of time form primary disease, also early have recognized that the relation of primary disease and diet delicious food and jaundice at " interior warp ", say as " the logical deficiency and excess opinion of commenting of Plain Questions ": " fullness caused by stagnant QI is sent out contrary for diseases due to endogenous heat of ZANG FU organs sudden falling down, hemiplegia flaccidity with cold limbs; sweet fertile high official, and the disease of Sorghum vulgare Pers. also ".The traditional Chinese medical science thinks that primary disease is many by depression of liver-QI, due to functional activity of QI being not smooth, insufficiency of the spleen for a long time, insufficiency of the spleen resulting in production of dampness, strongly fragrant and heat-transformation, with the passing of time delay, causes qi depression to blood stasis, knot in pyretic toxicity.Therefore the methods such as depressed liver-energy dispersing and function of gallbladder promoting, blood circulation promoting and blood stasis dispelling, clearing away heat-damp and promoting diuresis, removing mass eliminating stagnation that adopt in treatment more.
The cancer of pancreas early symptom also is not true to type, often show as the symptom that is similar to the other organs pathological changes, cause some Symptomatic by sing misdiagnosis and mistreatment, great majority are diagnosed as the cancer of pancreas, and the person has been metastasis or to the advanced pancreatic cancer of metastasis sign, but doctor trained in Western medicine can only be operation, radiotherapy, chemotherapy to cancer of pancreas treatment of late stage poor effect, cut again and cut, until life finishes, patient spends always in misery, only have less than 20% patient to exist radical operation to wish.Most of Pancreas cancer patients there will be the symptoms such as weight loss, stomachache, jaundice, appetite be poor, epigastric discomfort, abdominal distention, weak symptom can occur in half left and right patient, approximately the twenty percent patient has lumbago and backache, diarrhoea, melena, and losing weight is the most common symptom of Pancreas cancer patients.The early stage patient cardinal symptom is that epigastric discomfort, appetite are poor, abdominal distention, weak, in case weight loss, stomachache, jaundice occur point out to be middle and advanced stage.The traditional Chinese medical science claims that pancreas is that spleen is long-pending, and pancreas jaundice, stomachache are all caused by insufficiency of the spleen.At present, clinical many single method treatment advanced pancreatic cancer that do not adopt, adopt the Chinese medicine integrated approach more,, to control to greatest extent the evolution of tumor, alleviate patient's misery, improve quality of life of patients, extend patients ' lives.
Summary of the invention
Technical problem to be solved by this invention is, utilize the traditional theory of Chinese medical science of China, provide that a kind of side effect is little, good effect, cost are low, have no drug resistance, alleviate patient's misery, improve quality of life of patients, extend the Chinese medicine preparation and preparation method thereof of the treatment cancer of pancreas of patients ' lives.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of cancer of pancreas, its raw medicinal material comprises: Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae, Cortex Magnoliae Officinalis, Rhizoma Iridis Japonicae, Radix Paeoniae Alba (parched), Radix Glycyrrhizae Preparata, Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae, Herba Solani Lyrati, Herba Pogostemonis, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) and Radix Codonopsis.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～45 weight portions, Aspongopus 15～25 weight portions, Radix Tripterygii Wilfordii 6～15 weight portions, Pseudobulbus cremastrae seu pleiones 15～30 weight portions, Os Sepiae 20～40 weight portions, Concha Arcae (calcined) 15～35 weight portions, Radix Parkinsoniae 10～20 weight portions, Rhizoma Atractylodis 10～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～30 weight portions, Carapax Eriocheir sinensis 10～20 weight portions, Radix Aristolochiae Tagalae 20～30 weight portions, Rhizoma Dioscoreae 25～40 weight portions, Cortex Magnoliae Officinalis 15～25 weight portions, Rhizoma Iridis Japonicae 10～15 weight portions, Radix Paeoniae Alba (parched) 15～20 weight portions, Radix Glycyrrhizae Preparata 20～35 weight portions, Herba indigoferae Pseudotinctoriae 10～25 weight portions, asiatic moonseed 15～35 weight portions, Radix Polygalae Caudatae 20～35 weight portions, Herba Solani Lyrati 15～30 weight portions, Herba Pogostemonis 15～30 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～20 weight portions and Radix Codonopsis 20～30 weight portions.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～40 weight portions, Aspongopus 20～25 weight portions, Radix Tripterygii Wilfordii 6～12 weight portions, Pseudobulbus cremastrae seu pleiones 15～20 weight portions, Os Sepiae 20～30 weight portions, Concha Arcae (calcined) 25～30 weight portions, Radix Parkinsoniae 15～20 weight portions, Rhizoma Atractylodis 15～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～20 weight portions, Carapax Eriocheir sinensis 10～15 weight portions, Radix Aristolochiae Tagalae 20～25 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Cortex Magnoliae Officinalis 20～25 weight portions, Rhizoma Iridis Japonicae 12～15 weight portions, Radix Paeoniae Alba (parched) 18～20 weight portions, Radix Glycyrrhizae Preparata 20～30 weight portions, Herba indigoferae Pseudotinctoriae 10～20 weight portions, asiatic moonseed 20～30 weight portions, Radix Polygalae Caudatae 25～35 weight portions, Herba Solani Lyrati 15～25 weight portions, Herba Pogostemonis 18～25 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～17 weight portions and Radix Codonopsis 20～26 weight portions.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 37 weight portions, Aspongopus 23 weight portions, Radix Tripterygii Wilfordii 8 weight portions, Pseudobulbus cremastrae seu pleiones 18 weight portions, Os Sepiae 26 weight portions, Concha Arcae (calcined) 28 weight portions, Radix Parkinsoniae 17 weight portions, Rhizoma Atractylodis 22 weight portions, the Rhizoma Atractylodis Macrocephalae 16 weight portions, Carapax Eriocheir sinensis 14 weight portions, Radix Aristolochiae Tagalae 21 weight portions, Rhizoma Dioscoreae 37 weight portions, Cortex Magnoliae Officinalis 22 weight portions, Rhizoma Iridis Japonicae 14 weight portions, Radix Paeoniae Alba (parched) 18 weight portions, Radix Glycyrrhizae Preparata 25 weight portions, Herba indigoferae Pseudotinctoriae 12 weight portions, asiatic moonseed 29 weight portions, Radix Polygalae Caudatae 33 weight portions, Herba Solani Lyrati 18 weight portions, Herba Pogostemonis 21 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 16 weight portions and Radix Codonopsis 23 weight portions.
When the dosage form of described Chinese medicine preparation was tablet, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae magnolia obovata are mixed, adding with respect to 5 times～8 times, mixture amount determining alcohols is 70%～85% alcohol reflux 2 times～4 times, each 3～6 hours, filter; Each time filtrate merges, and reclaims ethanol, is concentrated into 70 ℃ of relative densities and is 1.34～1.36 mastic, and is standby;
Second step, be mixed in proportion the surplus stock medical material, adds with respect to 4～8 times of water gagings of mixture, boiled 3～6 hours, filters, and is concentrated into 70 ℃ of relative densities and is 1.29～1.31 mastic;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 60 ℃～70 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, mix processing with described dried cream powder and starch, obtains the mastic mixture; The weight ratio of described dried cream powder and starch is 1: 0.05～0.15; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
In the 5th step, mix processing, tabletting processing, Cotton seeds successively with described mastic compound particles and Pulvis Talci, magnesium stearate, obtains Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, Pulvis Talci, magnesium stearate is 100: 2～6: 0.1～0.25.
When the dosage form of described Chinese medicine preparation was oral solutions, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae and Herba Solani Lyrati are mixed in proportion, be that 80%～90% methanol is as solvent with determining alcohol, adopt percolation with the speed of 1～3ml per minute percolation slowly, collect percolate, concentrating under reduced pressure is also dry, obtains and gets dry extract, be ground into powder, the quality of the methanol that adds is 5～10 times of first step mixture quality;
Second step, be mixed in proportion the surplus stock medical material, is ground into powder; Add the distilled water with respect to 4～8 times of powder qualities, decocted 3～6 hours, filter, obtain the first filtrate; Filtering residue is added distilled water with respect to 3～5 times of its quality, decocted 2～4 hours, filter, obtain the second filtrate; Merge the first filtrate and the second filtrate, concentrate away the water of 2/3～3/4 volume, adding determining alcohol is 90%～95% ethanol, makes determining alcohol reach 60%～75%, standing 18～36 hours, filter, and concentrating under reduced pressure, drying, obtain and get dry extract, and is ground into powder;
The 3rd step, the powder of the first step and second step acquisition is mixed, add the distilled water with respect to 2～6 times of amounts of mixed-powder quality, the sucrose of 0.15～0.35 times, 0.02 the sodium benzoate of～0.04 times, stir, and boils, and is cooling, filter packing, the sterilizing oral liquid that namely obtains.
beneficial effect of the present invention: Chinese medicine preparation provided by the invention, can use separately, also can the Combined with Radiotherapy chemotherapy use, utilize the traditional theory of Chinese medical science of China, clinical practice is in the treatment of cancer of pancreas, its effect can be dwindled lump in a short time, effectively control the cancer cell metastasis diffusion, the anticancer growth, do not have side effects again simultaneously, for cancer anticancer in, enhancing human body immunity power, and alleviate the patient suffering, stablize the state of an illness, the purpose that extends life cycle and increase clinical cure patient's ratio, and can prevent that remaining cancerous cell from staging a comeback, greatly reduce relapse and metastasis.
The specific embodiment
The invention provides a kind of Chinese medicine preparation for the treatment of cancer of pancreas, its raw medicinal material comprises: Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae, Cortex Magnoliae Officinalis, Rhizoma Iridis Japonicae, Radix Paeoniae Alba (parched), Radix Glycyrrhizae Preparata, Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae, Herba Solani Lyrati, Herba Pogostemonis, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) and Radix Codonopsis.
The herbal pharmacology of each raw medicinal material is as follows:
Herba Sarcandrae: be the dry herb of Chloranthaceae plant plait Corallium Japonicum Kishinouye Sarcandra glabra (Thunb.) Nakai.Summer, Qiu Erji gather, and remove impurity, shine in.Another name: the Psychotria rubra (Lour.) Poir. bitter edible plant, Herba Pileae Scriptae, synthetism lotus, Vanda amesiana Reichb. F.Bitter in the mouth, suffering, property is flat.GUIXIN, Liver Channel.Clearing away heat and cooling blood, the speckle removing of invigorating blood circulation, dispelling wind and removing obstruction in the collateral.Be used for heat in blood and send out speckle dermexanthesis, rheumatic arthralgia, traumatic injury.Cure mainly pneumonia, appendicitis, cellulitis, rheumatic arthralgia, injury from falling down, tumor etc.
Aspongopus: become temperature.Return the liver,spleen,kidney warp.Regulating QI to relieve pain, warming middle-JIAO is supporing yang.Be used for the cold syndrome of the stomach distending pain, stomachache due to hyperactive liver-QI attacking the stomach, impotence due to deficiency of the kidney, soreness of waist and knee joint.
Radix Tripterygii Wilfordii: hardship; Hot; Large poison.GUIXIN; Liver Channel.Expelling wind and removing dampness; Promoting blood circulation to remove obstruction in the collateral; Reducing swelling and alleviating pain; The parasite killing detoxifcation.Main classes rheumatic arthritis; Rheumatic arthritis; Glomerulonephritis; Nephrotic syndrome; Lupus erythematosus; Mouth xerophthalmia scheorma syndrome; Behcet disease; Eczema; Psoriasis; Leprosy; Scabies; Stubborn dermatitis
Pseudobulbus cremastrae seu pleiones: sweet, little suffering, cold.Enter liver, spleen channel.Detumescence, eliminating stagnation, reduce phlegm, detoxifcation.Control the carbuncle furuncle swollen, scrofula, sore throat swells and ache, Serpentis, worm, mad dog wound.
Os Sepiae: one-tenth, puckery, temperature.Return spleen, kidney channel.Astringing to arrest bleeding, relieving leukorrhea by astringents, antacid, sore.Be used for the stomachache acid regurgitation, hematemesis and epistaxis, metrorrhagia is had blood in stool, emission and spermatorrhea, leucorrhea with red and white discharge; Peptic Ulcers.The external treatment bleeding due to trauma, the many pus of skin ulcer.
Concha Arcae: become, flat.Return lung, stomach, Liver Channel.The expectorant blood stasis dispelling, hard masses softening and resolving, relieving gastric hyperacidity to alleviate stomachache.Be used for the long-pending knot of pertinacious phlegm, sticky difficulty is coughed up, goiter, scrofula, lump in the abdomen mass in the abdomen, stomachache pantothenic acid.Concha Arcae (calcined): the Concha Arcae that will clean is put in pot, and upper cover is slightly little pot flatly, and obturaging with yellow mud in the place, gap, does not make gas leakage, above the bottom of a pan paste a blank sheet of paper and press with weight, be calcined to the flavescence of subsides blank sheet of paper, taking-up is dried in the air cool, pulverizes and gets final product.Also Concha Arcae can be put in crucible or in other vessel, be calcined to and be popular in smokeless stove fire, taking-up is dried in the air cool, pulverizes and gets final product.
Radix Parkinsoniae: distinguish the flavor of little sweet; Property is put down.Return kidney; Spleen channel.Tonification.Main health is weak; Impairment caused by overstrain is weak; Deficiency-heat; Spontaneous perspiration; Night sweat.
Rhizoma Atractylodis: hot, bitter, temperature.Return spleen, stomach, Liver Channel.Drying damp and strengthening spleen, expelling wind and cold, improving eyesight.Be used for distension and fullness in the abdomen, have loose bowels, edema, the beriberi flaccidity is preesed, rheumatic arthralgia, anemofrigid cold, nyctalopia.
The Rhizoma Atractylodis Macrocephalae: bitter, sweet, temperature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, the dampness diuretic, hidroschesis, antiabortive.Be used for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.The Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.Be used for insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, frequent fetal movement.
Carapax Eriocheir sinensis: distinguish the flavor of into; Cold in nature.Return liver; Spleen channel.The scattered silt hemostasis; Removing toxic substances and promoting subsidence of swelling.Main jaundice due to accumulation of stagnant blood; Hemostagnant metrorrhagia; The carbuncle pyogenic infections from tumour or sore; Acute gangrenous stomatitis; Insect bite.
Radix Aristolochiae Tagalae: hardship; Hot; Temperature; Mild toxicity.Return lung; Stomach; Kidney channel.Dispel the wind; Analgesia; Detumescence; Detoxifcation.The main air osteodynia that wets; Gastric abscess; Stomachache; Pharyngolaryngitis; Traumatic injury; Infantile convulsion; Venom
Rhizoma Dioscoreae: sweet, flat.Return spleen, lung, kidney channel.The spleen reinforcing nourishing the stomach, the lung benefiting that promotes the production of body fluid, the kidney invigorating arresting seminal emission.Be used for insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, deficiency-heat is quenched one's thirst.Rhizoma Dioscoreae (parched with bran) spleen reinforcing stomach invigorating.Be used for insufficiency of the spleen lack of appetite, the loose stool of having loose bowels, leukorrhagia.
Cortex Magnoliae Officinalis: bitter, hot, temperature.Return spleen, stomach, lung, large intestine channel.The dampness expectorant, the therapeutic method to keep the adverse QI flowing downwards is except full.Be used for the humidity hysteresis damaging the spleen and stomach, the gastral cavity painful abdominal mass is vomited and diarrhoea, stagnation of QI due to dyspepsia, and abdominal distention constipation, phlegm retention is breathed with cough.
Rhizoma Iridis Japonicae: hardship; Hot; Cold; Slightly poisonous.Help digestion; Parasite killing; Relieving constipation; Diuretic; Invigorate blood circulation; Pain relieving; Detoxifcation.Staple food amasss abdominal distention; Abdominal pain due to worm stagnation; Pyroretentional abdominalgia; Constipation with heat retention; Edema; WEIJIA; Cruel for a long time; Toothache; Laryngopharynx swelling and pain; Skin ulcer is swollen; Scrofula; Traumatic injury; Uterine prolapse; Serpentis lyssodexis wound.
The Radix Paeoniae Alba: bitter, sour, be slightly cold.Return liver, spleen channel.The suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Be used for having a headache dizzy, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.Radix Paeoniae Alba (parched): get clean Radix Paeoniae Alba sheet, fry to little yellow in pot.
Radix Glycyrrhizae: sweet, flat.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.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.Radix Glycyrrhizae Preparata: Radix Glycyrrhizae tabellae is added cooked Mel and a little boiled water, slightly vexed after mixing thoroughly, put in pot and fry to buff with when tack-free, take out dry in the air cool (25～30 jin of the cooked Mel of every 100 jin of use).
Herba indigoferae Pseudotinctoriae: bitter in the mouth; Puckery; Property is put down.Return spleen, the stomach warp.Clearing away heat and expelling pathogen in the exterior; The dissipating blood stasis removing food stagnancy.Main anemopyretic cold; The cough due to lung-heat; Burn and scald; Furuncle; Venom; Scrofula; Traumatic injury; Dyspeptic abdominal distention.
Asiatic moonseed: hardship; Cold.Return liver; Lung; The intestinal warp.Heat-clearing and toxic substances removing; Reducing swelling and alleviating pain.Main lumbago; Scrofula; Laryngopharynx swelling and pain; Diarrhoea dysentery; Swelling and pain of hemorrhoid.
Radix Polygalae Caudatae: sweet; Little hardship; Cool in nature.GUIXIN; Liver; Kidney channel.Clearing away heat-damp and promoting diuresis; Preventing phlegm from forming and stopping coughing.Main laryngopharynx swelling and pain; Jaundice due to damp-heat; Bronchitis.
Herba Solani Lyrati: hardship is slightly cold.Slightly poisonous.Enter liver, stomach warp.Heat-clearing and toxic substances removing, inducing diuresis and reducing edema, anticancer.Herb: be used for cold, fever, acute mastitis, malignant boil, jaundice due to damp-heat, ascites, leucorrhea, oedema due to nephritis; Carbuncle furuncle and phyma poison is controlled in external.Root: rheumatic arthralgia.(selecting from " national Chinese herbal medicine compilation ").In the present invention with all herbal medicine.
Herba Pogostemonis: acrid in the mouth; Slightly warm in nature.Return lung; Spleen; The stomach warp.Dispelling summer-heat from superficies of the body; Removing dampness to restore normal function of the stomach.Main summertime flu; The cold and heat headache; Breast gastral cavity painful abdominal mass is vexed; Vomiting is had loose bowels; Vomiting during pregnancy; Nasal sinusitis; Hands; Tinea pedis.
The Rhizoma Pinelliae: suffering, temperature; Poisonous.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.Be used for the abundant expectoration cough with asthma, the phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, the syncope due to accumulation of phlegm headache, vomiting regurgitation, breast gastral cavity painful abdominal mass is vexed, globus hystericus; Give birth to external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is multiplex in stopping nausea and vomiting by lowering the adverse flow of QI.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens): get the clean Rhizoma Pinelliae, size separately, is soaked in water to interior during without the dried heart; Separately get the Rhizoma Zingiberis Recens section and decoct soup, add Alumen and the Rhizoma Pinelliae well-done altogether, take out, dry in the air to half-dried, shave, drying.Every 100kg Rhizoma Pinelliae, with Rhizoma Zingiberis Recens 25kg, Alumen 12.5kg.This product is that lamellar, irregular particle shape or class are spherical.Surface is brown to sepia.Matter is firmly crisp, and section is fallow, normal tool cutin sample gloss.Feeble QI is fragrant, and lightly seasoned, little have a numb feeling in the tongue, and that chews slightly sticks to one's teeth.
Radix Codonopsis: sweet in the mouth, property is flat.Return spleen, lung meridian.Invigorating the spleen and replenishing QI, the spleen invigorating lung benefiting.Be used for deficiency of the spleen and lung, the cardiopalmus of breathing hard, anorexia and loose stool, the dyspnea due to deficiency cough, interior-heat is quenched one's thirst." book on Chinese herbal medicine justice " carries: Radix Codonopsis power energy spleen reinforcing nourishing the stomach, and the lung moistening and production of body fluid promoting, gas in tendon fortune, this is very mutually not far away with Radix Ginseng.Its outstanding valuable person, spleen invigorating fortune and not dry, grow stomach-Yin and wet, and lung moistening and do not violate is cold and coolly nourished blood and is not partially grown greasyly, inspires clear sun, gas in vibration, and without just dry fraud.Radix Codonopsis has the QI invigorating strengthening the spleen, the effect of nourishing blood to promote the production of body fluid, be mainly used in deficiency of both the splenic and pulmonary QI or QI and blood deficiency fatigue and weakness, breathe hard, symptom such as cough spontaneous perspiration etc., Radix Codonopsis is longer than the spleen reinforcing nourishing the stomach, transfers regulating the function of middle-JIAO, has the effect of nourishing blood concurrently, its property is flat, spleen invigorating fortune and not dry; Flavour is cloudy and not wet, can improve the immune state of body, improves resistance against diseases, facilitating digestion absorbs, and improves metabolism, promotes the absorption of intestinal to nutrient substance, Radix Codonopsis has certain antitumor assosting effect, can suppress the growth of gross tumor volume and weight, and reduces and shift.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～45 weight portions, Aspongopus 15～25 weight portions, Radix Tripterygii Wilfordii 6～15 weight portions, Pseudobulbus cremastrae seu pleiones 15～30 weight portions, Os Sepiae 20～40 weight portions, Concha Arcae (calcined) 15～35 weight portions, Radix Parkinsoniae 10～20 weight portions, Rhizoma Atractylodis 10～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～30 weight portions, Carapax Eriocheir sinensis 10～20 weight portions, Radix Aristolochiae Tagalae 20～30 weight portions, Rhizoma Dioscoreae 25～40 weight portions, Cortex Magnoliae Officinalis 15～25 weight portions, Rhizoma Iridis Japonicae 10～15 weight portions, Radix Paeoniae Alba (parched) 15～20 weight portions, Radix Glycyrrhizae Preparata 20～35 weight portions, Herba indigoferae Pseudotinctoriae 10～25 weight portions, asiatic moonseed 15～35 weight portions, Radix Polygalae Caudatae 20～35 weight portions, Herba Solani Lyrati 15～30 weight portions, Herba Pogostemonis 15～30 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～20 weight portions and Radix Codonopsis 20～30 weight portions.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～40 weight portions, Aspongopus 20～25 weight portions, Radix Tripterygii Wilfordii 6～12 weight portions, Pseudobulbus cremastrae seu pleiones 15～20 weight portions, Os Sepiae 20～30 weight portions, Concha Arcae (calcined) 25～30 weight portions, Radix Parkinsoniae 15～20 weight portions, Rhizoma Atractylodis 15～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～20 weight portions, Carapax Eriocheir sinensis 10～15, weight portion, Radix Aristolochiae Tagalae 20～25 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Cortex Magnoliae Officinalis 20～25 weight portions, Rhizoma Iridis Japonicae 12～15 weight portions, Radix Paeoniae Alba (parched) 18～20 weight portions, Radix Glycyrrhizae Preparata 20～30 weight portions, Herba indigoferae Pseudotinctoriae 10～20 weight portions, asiatic moonseed 20～30 weight portions, Radix Polygalae Caudatae 25～35 weight portions, Herba Solani Lyrati 15～25 weight portions, Herba Pogostemonis 18～25 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～17 weight portions and Radix Codonopsis 20～26 weight portions.
wherein, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 37 weight portions, Aspongopus 23 weight portions, Radix Tripterygii Wilfordii 8 weight portions, Pseudobulbus cremastrae seu pleiones 18 weight portions, Os Sepiae 26 weight portions, Concha Arcae (calcined) 28 weight portions, Radix Parkinsoniae 17 weight portions, Rhizoma Atractylodis 22 weight portions, the Rhizoma Atractylodis Macrocephalae 16 weight portions, Carapax Eriocheir sinensis 14 weight portions, Radix Aristolochiae Tagalae 21 weight portions, Rhizoma Dioscoreae 37 weight portions, Cortex Magnoliae Officinalis 22 weight portions, Rhizoma Iridis Japonicae 14 weight portions, Radix Paeoniae Alba (parched) 18 weight portions, Radix Glycyrrhizae Preparata 25 weight portions, Herba indigoferae Pseudotinctoriae 12 weight portions, asiatic moonseed 29 weight portions, Radix Polygalae Caudatae 33 weight portions, Herba Solani Lyrati 18 weight portions, Herba Pogostemonis 21 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 16 weight portions and Radix Codonopsis 23 weight portions.
When the dosage form of described Chinese medicine preparation was tablet, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae magnolia obovata are mixed, adding with respect to 5 times～8 times, mixture amount determining alcohols is 70%～85% alcohol reflux 2 times～4 times, each 3～6 hours, filter; Each time filtrate merges, and reclaims ethanol, is concentrated into 70 ℃ of relative densities and is 1.34～1.36 mastic, and is standby;
Second step, be mixed in proportion the surplus stock medical material, adds with respect to 4～8 times of water gagings of mixture, boiled 3～6 hours, filters, and is concentrated into 70 ℃ of relative densities and is 1.29～1.31 mastic;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 60 ℃～70 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, mix processing with described dried cream powder and starch, obtains the mastic mixture; The weight ratio of described dried cream powder and starch is 1: 0.05～0.15; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
In the 5th step, mix processing, tabletting processing, Cotton seeds successively with described mastic compound particles and Pulvis Talci, magnesium stearate, obtains Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, Pulvis Talci, magnesium stearate is 100: 2～6: 0.1～0.25.
When the dosage form of described Chinese medicine preparation was oral solutions, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae and Herba Solani Lyrati are mixed in proportion, be that 80%～90% methanol is as solvent with determining alcohol, adopt percolation with the speed of 1～3ml per minute percolation slowly, collect percolate, concentrating under reduced pressure is also dry, obtains and gets dry extract, be ground into powder, the quality of the methanol that adds is 5～10 times of first step mixture quality;
Second step, be mixed in proportion the surplus stock medical material, is ground into powder; Add the distilled water with respect to 4～8 times of powder qualities, decocted 3～6 hours, filter, obtain the first filtrate; Filtering residue is added distilled water with respect to 3～5 times of its quality, decocted 2～4 hours, filter, obtain the second filtrate; Merge the first filtrate and the second filtrate, concentrate away the water of 2/3～3/4 volume, adding determining alcohol is 90%～95% ethanol, makes determining alcohol reach 60%～75%, standing 18～36 hours, filter, and concentrating under reduced pressure, drying, obtain and get dry extract, and is ground into powder;
The 3rd step, the powder of the first step and second step acquisition is mixed, add the distilled water with respect to 2～6 times of amounts of mixed-powder quality, the sucrose of 0.15～0.35 times, 0.02 the sodium benzoate of～0.04 times, stir, and boils, and is cooling, filter packing, the sterilizing oral liquid that namely obtains.
Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Embodiment 1: the tablet of the present invention's preparation
Get Herba Sarcandrae 370g, Aspongopus 230g, Radix Tripterygii Wilfordii 80g, Pseudobulbus cremastrae seu pleiones 180g, Os Sepiae 260g, Concha Arcae (calcined) 280g, Radix Parkinsoniae 170g, Rhizoma Atractylodis 220g, Rhizoma Atractylodis Macrocephalae 160g, Carapax Eriocheir sinensis 140g, Radix Aristolochiae Tagalae 210g, Rhizoma Dioscoreae 370g, Cortex Magnoliae Officinalis 220g, Rhizoma Iridis Japonicae 140g, Radix Paeoniae Alba (parched) 180g, Radix Glycyrrhizae Preparata 250g, Herba indigoferae Pseudotinctoriae 120g, asiatic moonseed 290g, Radix Polygalae Caudatae 330g, Herba Solani Lyrati 180g, Herba Pogostemonis 210g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 160g and Radix Codonopsis 230g;
Its preparation method comprises the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae magnolia obovata are mixed, adding with respect to 7 times, mixture amount determining alcohols is 70% alcohol reflux 3 times, each 5 hours, filters; Each time filtrate merges, and reclaims ethanol, is concentrated into 70 ℃ of relative densities and is 1.35 mastic, and is standby;
Second step, be mixed in proportion the surplus stock medical material, adds with respect to 8 times of water gagings of mixture, boiled 5 hours, filters, and is concentrated into 70 ℃ of relative densities and is 1.31 mastic;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 65 ℃ of reduced vacuum dryings, and powder gets dry extract;
In the 4th step, mix processing with dried cream powder and starch, obtains the mastic mixture; The weight ratio of dried cream powder and starch is 1: 0.09; The mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
In the 5th step, mix processing, tabletting processing, Cotton seeds successively with mastic compound particles and Pulvis Talci, magnesium stearate, obtains Chinese medicine preparation tablet finished product; The weight ratio of mastic compound particles, Pulvis Talci, magnesium stearate is 100: 5: 0.15.
The oral solutions of embodiment 2 the present invention's preparations
Get Herba Sarcandrae 390g, Aspongopus 210g, Radix Tripterygii Wilfordii 110g, Pseudobulbus cremastrae seu pleiones 160g, Os Sepiae 230g, Concha Arcae (calcined) 260g, Radix Parkinsoniae 190g, Rhizoma Atractylodis 170g, Rhizoma Atractylodis Macrocephalae 200g, Carapax Eriocheir sinensis 120g, Radix Aristolochiae Tagalae 240g, Rhizoma Dioscoreae 320g, Cortex Magnoliae Officinalis 240g, Rhizoma Iridis Japonicae 120g, Radix Paeoniae Alba (parched) 190g, Radix Glycyrrhizae Preparata 280g, Herba indigoferae Pseudotinctoriae 170g, asiatic moonseed 230g, Radix Polygalae Caudatae 270g, Herba Solani Lyrati 150g, Herba Pogostemonis 230g, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 150g and Radix Codonopsis 210g;
Its preparation method comprises the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae and Herba Solani Lyrati are mixed in proportion, be that 90% methanol is as solvent with determining alcohol, adopt percolation with the speed of 1～3ml per minute percolation slowly, collect percolate, concentrating under reduced pressure is also dry, obtains and gets dry extract, be ground into powder, the quality of the methanol that adds is 7 times of first step mixture quality;
Second step, be mixed in proportion the surplus stock medical material, is ground into powder; Add the distilled water with respect to 6 times of powder qualities, decocted 5 hours, filter, obtain the first filtrate; Filtering residue is added distilled water with respect to 4 times of its quality, decocted 3 hours, filter, obtain the second filtrate; Merge the first filtrate and the second filtrate, concentrate away the water of 2/3 volume, adding determining alcohol is 90% ethanol, makes determining alcohol reach 70%, standing 26 hours, filter, and concentrating under reduced pressure, drying, obtain and get dry extract, and is ground into powder;
The 3rd step, the powder of the first step and second step acquisition is mixed, add the distilled water with respect to 4 times of amounts of mixed-powder quality, the sucrose of 0.3 times, the sodium benzoate of 0.03 times, stir, and boils, and is cooling, filters packing, the sterilizing oral liquid that namely obtains.
Toxicity test:
Acute toxicity testing:
60 of application NIH mices, the SPF level, male and female half and half, body weight 18～22g, carry out acute toxicity test.Mice is divided into two groups at random, and 30 every group, namely matched group and administration group, test front fasting 12 hours; With the tablet dissolved of embodiments of the invention 1 preparation in water, (concentration is 6.58g crude drug/ml, maximum concentration) gavage, the gavage volume is that 5ml/kg (is that single-dose dosage is 32.9 crude drugs/kg), matched group gives the equivalent normal saline, administration in a day 2 times, delivery time 6 hours, after administration, Continuous Observation is 14 days, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, after administration, mice has no notable difference, experiment Continuous Observation 14 days, and mice overall health of patients, diet, drinking-water, body weight gain are all normal.Mice oral administration gavage tablet LD50 of the present invention＞32.9 crude drugs/kg, every day, maximum dosage-feeding was 65.8 crude drugs/kg/ day.Chinese medicine clinical application amount of the present invention is 4.4g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.073g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is take 20g) oral administration gavage Chinese medicine preparation of the present invention is 901 times of quantity.Therefore Chinese medicine preparation acute toxicity of the present invention is low, clinical drug safety.
Long term toxicity test:
The tablet of the embodiment of the present invention 1 to mice by 10.78,20.35 and the 33.48g crude drug/16 weeks of kg continuous use (1.0ml/100g body weight, every day 2 times) and after 4 weeks of drug withdrawal, result shows: Chinese medicine preparation of the present invention all has no significant effect indexs such as the hair of rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, the internal organs naked eyes do not find that difference changes and the histological examination result shows, after 16 weeks of medication and 4 weeks of drug withdrawal, each internal organs of rat are all without obviously changing.Illustrate that toxicity is little after Chinese medicine preparation of the present invention is to the rat long-term prescription, also there is no the difference reaction after drug withdrawal, application safety.
The tumor-inhibiting action test:
Subjects: 100 of ICR mices, body weight 19-24g, male.
Test inoculation content: S180 solid tumor.
Get the ICR mice, in the subcutaneous conventional inoculation S180 cancerous cell suspension 0.2ml of right axil (approximately 5 * 10
6Individual cell/ml), be divided at random 5 groups next day.Treatment group is divided into three groups, is respectively high dose group, middle dosage group and low dose group, adopts the tablet of the embodiment of the present invention 1, and after pulverizing, distilled water dissolves, and every day is gastric infusion 1.2ml, 0.8ml and 0.4ml respectively, continuous 10 days; Matched group is divided into two groups, is respectively normal saline group and CTX group, and normal saline group stomach every day is raised the 0.4ml normal saline, continuous 10 days; CTX group administration cyclophosphamide, administration every day 0.2g, gastric infusion after distilled water dissolves, continuous 10 days; 5 groups are after drug withdrawal and put to death animal next day, the stripping tumor is weighed, calculate tumour inhibiting rate, the tumour inhibiting rate formula is: the average tumor of tumour inhibiting rate (%)=(the average tumor weight of the average tumor weight-medication of normal saline matched group group)/normal saline matched group heavy * 100%, result shows, growth has inhibitory action to medicine of the present invention to S180, and its tumour inhibiting rate increases and increases progressively with dosage, has compared significant difference P＜0.05 with matched group.To the inhibitory action of S180 and tumor killing effect in Table 1.
Table 1: to inhibitory action and the tumor killing effect of S180
| Group | Average tumor heavy (g) | The mice average weight changes (g) | Tumour inhibiting rate (%) |
| High dose group | 1.41±0.38 | +3.95 | 56.88 |
| Middle dosage group | 1.56±0.62 | +4.42 | 52.29 |
| Low dose group | 1.67±0.26 | +4.84 | 48.93 |
| The CTX group | 1.34±0.42 | -1.68 | 59.02 |
| The normal saline group | 3.27±0.89 | +5.03 | 0 |
By table 1 as can be known: adopt the treatment group of Chinese medicine preparation of the present invention, with the normal saline group relatively, can suppress the tumor bulk-growth, and tumour inhibiting rate increases progressively with the increase of dosage, significant difference P＜0.05 is arranged, (n=10, X ± SD); Adopt the treatment group of Chinese medicine preparation of the present invention, with the CTX group relatively, the body weight of the mice for the treatment of group has increase, and the Mouse Weight of CTX group alleviates, both significant difference P＜0.05 of having compared, (n=10, X ± SD).
Measure by the fluid cell instrument in addition, result shows, Chinese medicine preparation of the present invention has stoped tumor cell by S → G2 process, also affected simultaneously the carrying out of G1 → S, S and the cell of G1 phase are obviously increased, the cell of G2 and M phase is relatively low, has disturbed the propagation activity of tumor cell, reaches antineoplastic action.
Clinical experiment:
1, case grouping and therapeutic scheme: with cancer of pancreas case 228 examples, male 127 examples wherein, female's 101 examples, the age, from 23 years old～69 years old, is adopted the random table method, patient is divided into Chinese drug-treated group, chemotherapy group and Chinese medicine at random adds chemotherapy group;
Chinese drug-treated group 76 people, male 42 people, female 34 people, the tablet of the oral embodiment of the present invention 1, every day 3 times, each 3, every surrounding is one-period.
Chemotherapy group 76 people, male 43 people, female 33 people, chemotherapeutics is selected cisplatin (CDDP) 30mg/M2d1-3, gemzar 1000mg/M2d1,8,15, fluorouracil (5-Fu) 500mg/M2d1-5, select wherein 2 kinds or 3 kinds of drug combinations during chemotherapy, intravenously administrable, 28 days is one-period.
Chinese medicine adds chemotherapy group 76 people, male 42 people, and female 34 people, the oral solutions of the oral embodiment of the present invention 2, every day 3 times, each 10ml, every surrounding is one-period; While intravenously administrable chemotherapeutics (the same chemotherapy group of method).
All through pathology, confirm before all patient's radiotherapies, and all there is x-ray to take the photograph sheet, CT scan or nuclear magnetic resonance check for clinical TNM by stages, check confirmation without the chemicotherapy contraindication before all doing chemotherapy by clinical criteria before chemotherapy, all patients are all without shifting cancer of pancreas (MO).
International cancer of pancreas TNM by stages with clinical stages:
International cancer of pancreas TNM is (UICC, 1987) by stages, and T refers to the primary tumo(u)r situation, and N refers to the lymph metastasis situation, and M refers to the metastasis situation.
(1) primary tumo(u)r (T) is by stages:
Tx: can not judge; T0: without the primary tumo(u)r evidence; T1: former swelling do not exceed pancreas; T1a: tumor≤2cm; T1b: tumor＞2cm; T2: tumor invading duodenum, biliary tract or pancreas surrounding tissue; T3: tumor invading stomach, spleen, colon, trunk.
(2) zonule lymph node (N) is by stages:
Nx: can not judge; NO: regional lymph nodes is without transfer; Nl: regional lymph node metastasis is arranged;
(3) metastasis (M) is by stages:
Mx: can not judge; MO: without metastasis; Ml: metastasis is arranged.
Clinical stages
The I phase: T1 NO MO; T1 NX MO; TX NO MO; TX NX MO.
The II phase: T2 NO MO; T2 NX MO; T3 NO MO; T3 NX MO.
The III phase: any T, N1, MO:.
The IV phase: any T, any N, Ml.
2, evaluation criteria: according to WHO treatment malignant tumor evaluation criteria evaluation curative effect, divide and alleviate (CR) fully: all visible pathological changes disappeared for 4 weeks fully at least: partial rcsponse (PR): tumor size is estimated to dwindle 〉=50% at least 4 week: unchanged (NC): without at least 4 weeks of significant change, comprise that pathological changes is stable, tumor size is estimated to enlarge less than 25%, dwindles less than 50%: pathological changes expansion (PD): new focus occurs or original pathological changes is estimated to enlarge＞25%; 4 ranking pancreas section's primary tumors and Metastatic Lymph Nodes gross tumor volume change.
3, statistical method:
Meet rank test, paired t-test and independent sample t check with statistical package SPSS1010Wileoxon.
4, result of the test:
According to above-mentioned WHO evaluation criteria, drug treatment after 4 months, carries out the short term effect statistical effect respectively, the results are shown in Table 2.
Table 2: each group short term effect tracking table record
| Group | CR | PR | NC | PD | Effective percentage (%) |
| Chinese drug-treated group | 10 | 40 | 19 | 7 | 65.79 |
| Chemotherapy group | 5 | 25 | 32 | 14 | 39.47 |
| Chinese medicine adds chemotherapy group | 14 | 42 | 16 | 4 | 73.68 |
By table 2 as can be known, Chinese medicine preparation of the present invention (general 3-6 month) in a short time obviously dwindles lump, effectively control the cancerous cell diffusion, increase clinical cure patient's ratio, and by clinical observation, patient's patient's condition inquiry every day, sum up and regular x-ray, CT or ultrasound diagnosis etc., determine that Chinese medicine preparation of the present invention can be in a short time (general 3-6 month) and alleviate fast or eliminate epigastrium distension discomfort or distending pain, jaundice, tired, loss of appetite, become thin, the symptoms such as diarrhoea or constipation, alleviate the patient suffering, stablize the state of an illness; Can also increase simultaneously the therapeutic effect of chemotherapy, and reduce the side effect of chemotherapy.
All patients are carried out the long-term follow record, and add up respectively survival number and survival rate when 1 year, 2 years, 3 years and 5 years, concrete data are in Table 3.
Table 3: each group long-term survival rate is followed the tracks of survival number and survival rate
| Group | 1 year | 2 years | 3 years | 5 years |
| Chinese drug-treated group | 35(46.1) | 29(38.2) | 20(26.3) | 14(18.4) |
| Chemotherapy group | 17(22.4) | 7(9.2) | 1(1.3) | 0(0) |
| Chinese medicine adds chemotherapy group | 40(52.6) | 32(42.1) | 22(28.9) | 17(22.4) |
By table 3 as can be known, Chinese medicine preparation of the present invention can obviously improve the life span of Pancreas cancer patients, improves clinical cure patient's ratio, increases simultaneously the therapeutic effect of chemotherapy and the side effect of minimizing chemotherapy; Chinese drug-treated group and Chinese medicine add chemotherapy group, with chemotherapy group, compare, and have significant difference.
5, model case:
Mrs Zhao, 68 years old, cancer of pancreas late period., because health is become thin, stomach is swollen and jaundice is admitted to hospital, check and to be diagnosed as cancer of pancreas late period.Done the chemotherapy in two stages, intravenous drip and oral chemotherapeutics combination, reaction is little, the tablet in treatment of the rear employing embodiment of the present invention 1, every day 3 times, each 3, after taking medicine three months, patient's symptom disappears substantially, ailing basic the alleviation, the after treatment in 1 month that continues to take medicine, followed up a case by regular visits to 2 years, patient's life aspect is all better than in the past, and appetite, spiritual complexion is all pretty good.
This intellectual property of primary enforcement that all are above-mentioned, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only preferred embodiment of the present invention, is not the present invention to be done the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away from,, to any simple modification, equivalent variations and remodeling that above embodiment does, still belong to the protection domain of technical solution of the present invention according to technical spirit of the present invention.
Claims (8)
1. Chinese medicine preparation for the treatment of cancer of pancreas, it is characterized in that, its raw medicinal material comprises: Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae, Cortex Magnoliae Officinalis, Rhizoma Iridis Japonicae, Radix Paeoniae Alba (parched), Radix Glycyrrhizae Preparata, Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae, Herba Solani Lyrati, Herba Pogostemonis, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) and Radix Codonopsis.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～45 weight portions, Aspongopus 15～25 weight portions, Radix Tripterygii Wilfordii 6～15 weight portions, Pseudobulbus cremastrae seu pleiones 15～30 weight portions, Os Sepiae 20～40 weight portions, Concha Arcae (calcined) 15～35 weight portions, Radix Parkinsoniae 10～20 weight portions, Rhizoma Atractylodis 10～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～30 weight portions, Carapax Eriocheir sinensis 10～20 weight portions, Radix Aristolochiae Tagalae 20～30 weight portions, Rhizoma Dioscoreae 25～40 weight portions, Cortex Magnoliae Officinalis 15～25 weight portions, Rhizoma Iridis Japonicae 10～15 weight portions, Radix Paeoniae Alba (parched) 15～20 weight portions, Radix Glycyrrhizae Preparata 20～35 weight portions, Herba indigoferae Pseudotinctoriae 10～25 weight portions, asiatic moonseed 15～35 weight portions, Radix Polygalae Caudatae 20～35 weight portions, Herba Solani Lyrati 15～30 weight portions, Herba Pogostemonis 15～30 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～20 weight portions and Radix Codonopsis 20～30 weight portions.
3. Chinese medicine preparation as claimed in claim 1 or 2, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 35～40 weight portions, Aspongopus 20～25 weight portions, Radix Tripterygii Wilfordii 6～12 weight portions, Pseudobulbus cremastrae seu pleiones 15～20 weight portions, Os Sepiae 20～30 weight portions, Concha Arcae (calcined) 25～30 weight portions, Radix Parkinsoniae 15～20 weight portions, Rhizoma Atractylodis 15～25 weight portions, the Rhizoma Atractylodis Macrocephalae 15～20 weight portions, Carapax Eriocheir sinensis 10～15 weight portions, Radix Aristolochiae Tagalae 20～25 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Cortex Magnoliae Officinalis 20～25 weight portions, Rhizoma Iridis Japonicae 12～15 weight portions, Radix Paeoniae Alba (parched) 18～20 weight portions, Radix Glycyrrhizae Preparata 20～30 weight portions, Herba indigoferae Pseudotinctoriae 10～20 weight portions, asiatic moonseed 20～30 weight portions, Radix Polygalae Caudatae 25～35 weight portions, Herba Solani Lyrati 15～25 weight portions, Herba Pogostemonis 18～25 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 15～17 weight portions and Radix Codonopsis 20～26 weight portions.
4. Chinese medicine preparation as described in claims 1 to 3, it is characterized in that, in described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is: Herba Sarcandrae 37 weight portions, Aspongopus 23 weight portions, Radix Tripterygii Wilfordii 8 weight portions, Pseudobulbus cremastrae seu pleiones 18 weight portions, Os Sepiae 26 weight portions, Concha Arcae (calcined) 28 weight portions, Radix Parkinsoniae 17 weight portions, Rhizoma Atractylodis 22 weight portions, the Rhizoma Atractylodis Macrocephalae 16 weight portions, Carapax Eriocheir sinensis 14 weight portions, Radix Aristolochiae Tagalae 21 weight portions, Rhizoma Dioscoreae 37 weight portions, Cortex Magnoliae Officinalis 22 weight portions, Rhizoma Iridis Japonicae 14 weight portions, Radix Paeoniae Alba (parched) 18 weight portions, Radix Glycyrrhizae Preparata 25 weight portions, Herba indigoferae Pseudotinctoriae 12 weight portions, asiatic moonseed 29 weight portions, Radix Polygalae Caudatae 33 weight portions, Herba Solani Lyrati 18 weight portions, Herba Pogostemonis 21 weight portions, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 16 weight portions and Radix Codonopsis 23 weight portions.
5. Chinese medicine preparation as described in claim 1 to 4, is characterized in that, when the dosage form of described Chinese medicine preparation was tablet, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae magnolia obovata are mixed, adding with respect to 5 times～8 times, mixture amount determining alcohols is 70%～85% alcohol reflux 2 times～4 times, each 3～6 hours, filter; Each time filtrate merges, and reclaims ethanol, is concentrated into 70 ℃ of relative densities and is 1.34～1.36 mastic, and is standby;
Second step, be mixed in proportion the surplus stock medical material, adds with respect to 4～8 times of water gagings of mixture, boiled 3～6 hours, filters, and is concentrated into 70 ℃ of relative densities and is 1.29～1.31 mastic;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 60 ℃～70 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, mix processing with described dried cream powder and starch, obtains the mastic mixture; The weight ratio of described dried cream powder and starch is 1: 0.05～0.15; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
In the 5th step, mix processing, tabletting processing, Cotton seeds successively with described mastic compound particles and Pulvis Talci, magnesium stearate, obtains Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, Pulvis Talci, magnesium stearate is 100: 2～6: 0.1～0.25.
6. Chinese medicine preparation as described in claim 1 to 4, is characterized in that, when the dosage form of described Chinese medicine preparation was oral solutions, its preparation method comprised the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae and Herba Solani Lyrati are mixed in proportion, be that 80%～90% methanol is as solvent with determining alcohol, adopt percolation with the speed of 1～3ml per minute percolation slowly, collect percolate, concentrating under reduced pressure is also dry, obtains and gets dry extract, be ground into powder, the quality of the methanol that adds is 5～10 times of first step mixture quality;
Second step, be mixed in proportion the surplus stock medical material, is ground into powder; Add the distilled water with respect to 4～8 times of powder qualities, decocted 3～6 hours, filter, obtain the first filtrate; Filtering residue is added distilled water with respect to 3～5 times of its quality, decocted 2～4 hours, filter, obtain the second filtrate; Merge the first filtrate and the second filtrate, concentrate away the water of 2/3～3/4 volume, adding determining alcohol is 90%～95% ethanol, makes determining alcohol reach 60%～75%, standing 18～36 hours, filter, and concentrating under reduced pressure, drying, obtain and get dry extract, and is ground into powder;
The 3rd step, the powder of the first step and second step acquisition is mixed, add the distilled water with respect to 2～6 times of amounts of mixed-powder quality, the sucrose of 0.15～0.35 times, 0.02 the sodium benzoate of～0.04 times, stir, and boils, and is cooling, filter packing, the sterilizing oral liquid that namely obtains.
7., as the preparation method of the described Chinese medicine preparation of claim 1 to 4, it is characterized in that, the dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Radix Parkinsoniae, Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Carapax Eriocheir sinensis, Radix Aristolochiae Tagalae, Rhizoma Dioscoreae magnolia obovata are mixed, adding with respect to 5 times～8 times, mixture amount determining alcohols is 70%～85% alcohol reflux 2 times～4 times, each 3～6 hours, filter; Each time filtrate merges, and reclaims ethanol, is concentrated into 70 ℃ of relative densities and is 1.34～1.36 mastic, and is standby;
Second step, be mixed in proportion the surplus stock medical material, adds with respect to 4～8 times of water gagings of mixture, boiled 3～6 hours, filters, and is concentrated into 70 ℃ of relative densities and is 1.29～1.31 mastic;
In the 3rd step, the mastic that the first step, second step are obtained mixes, 60 ℃～70 ℃ reduced vacuum dryings, and powder gets dry extract;
In the 4th step, mix processing with described dried cream powder and starch, obtains the mastic mixture; The weight ratio of described dried cream powder and starch is 1: 0.05～0.15; Described mastic mixture is carried out pelletization treatment, dried, obtain the mastic compound particles;
In the 5th step, mix processing, tabletting processing, Cotton seeds successively with described mastic compound particles and Pulvis Talci, magnesium stearate, obtains Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, Pulvis Talci, magnesium stearate is 100: 2～6: 0.1～0.25.
8. the preparation method of the described Chinese medicine preparation of claim 1 to 4, is characterized in that, the dosage form of described Chinese medicine preparation is oral solutions, and its preparation method comprises the following steps:
The first step, Herba Sarcandrae, Aspongopus, Radix Tripterygii Wilfordii, Pseudobulbus cremastrae seu pleiones, Os Sepiae, Concha Arcae (calcined), Herba indigoferae Pseudotinctoriae, asiatic moonseed, Radix Polygalae Caudatae and Herba Solani Lyrati are mixed in proportion, be that 80%～90% methanol is as solvent with determining alcohol, adopt percolation with the speed of 1～3ml per minute percolation slowly, collect percolate, concentrating under reduced pressure is also dry, obtains and gets dry extract, be ground into powder, the quality of the methanol that adds is 5～10 times of first step mixture quality;
Second step, be mixed in proportion the surplus stock medical material, is ground into powder; Add the distilled water with respect to 4～8 times of powder qualities, decocted 3～6 hours, filter, obtain the first filtrate; Filtering residue is added distilled water with respect to 3～5 times of its quality, decocted 2～4 hours, filter, obtain the second filtrate; Merge the first filtrate and the second filtrate, concentrate away the water of 2/3～3/4 volume, adding determining alcohol is 90%～95% ethanol, makes determining alcohol reach 60%～75%, standing 18～36 hours, filter, and concentrating under reduced pressure, drying, obtain and get dry extract, and is ground into powder;
The 3rd step, the powder of the first step and second step acquisition is mixed, add the distilled water with respect to 2～6 times of amounts of mixed-powder quality, the sucrose of 0.15～0.35 times, 0.02 the sodium benzoate of～0.04 times, stir, and boils, and is cooling, filter packing, the sterilizing oral liquid that namely obtains.
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