CN101011438B - Use of asafetida in the process for preparing anti-cancer medicament - Google Patents
Use of asafetida in the process for preparing anti-cancer medicament Download PDFInfo
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Abstract
The invention relates to a method for using asafetida to prepare the anti-tumor drug, which can be injection, capsule, tablet, or the like. The asafetida benzene mainly comprises a-firpene, a-terpinenes, terpin 4-alochol, pinocarveol, 2-bornyl alcohol, dimethyl disulfide, dimethyl trisulfide, N, N-thioformamide, and allyl-butyl-bisulfide. The invention uses general method to extract the asafetidabenzene, as the gel resin of XinJiang asafetida or FuKang asafetida, or the like.
Description
Technical field:
The present invention relates to the former medicine Resina Ferulae of Chinese medicine or originate in the Resina Ferulae of states such as Iran, Afghanistan, Sri Lanka and the pharmaceutical applications of volatile oil thereof.
Background technology:
Resina Ferulae is a kind of secretions of natural plants, 2005 editions 131 pages of records of the Pharmacopoeia of the People's Republic of China: Resina Ferulae nature and flavor hardship, suffering, temperature, return spleen, stomach warp, removing food stagnancy, cold expelling, parasite killing are used for meat stagnation, congestion lump in the abdomen, mass in abdomen, abdominal pain due to worm stagnation." national Chinese herbal medicine compilation " volume two People's Health Publisher, 318 pages of records in 1978: Resina Ferulae nature and flavor suffering, tepor, removing food stagnancy, parasite killing, cold expelling, cure mainly malnutrition due to parasitic infestation, abdominal mass, stomach abdominal distention and pain, malaria, dysentery, and can prevent measles.It is directly to be used as medicine with former medicine Resina Ferulae that the tradition of Resina Ferulae is used, the one, and decocting boils, and the 2nd, make other medicine of pill or compatibility, all be difficult to cover its special intensive stink, use and be subjected to very big influence.
Cancer is modal a kind of disease, is worldwide a kind of frequently-occurring disease, is seriously threatening human beings'health and life.In numerous diseases, cancer is human No.1 killer.
At present, the medicine of treatment cancer is many, therapeutic effect AC, 5-fluorouracil, methotrexate, mitomycin, cisplatin, vincristine, paclitaxel, Docetaxel etc. preferably wherein, they are to the curative effect of the single medicine of some cancer, effective percentage is generally about 30%, the medicine that can reach more than effective percentage 50% or 50% is few in number, and poison is given birth to generally bigger.
The content of invention:
The purpose of this invention is to provide the purposes that Resina Ferulae is used to prepare anticancer agent.
The present invention is achieved in that
The application of Resina Ferulae of the present invention in the preparation anticancer agent.
The dosage form of anticancer agent is selected from injection, capsule, drop pill, tablet, granule, powder, oral liquid, unguentum, tincture.
The indication of medicament is selected from esophageal carcinoma, gastric cancer, hepatocarcinoma, pulmonary carcinoma, breast carcinoma.
Resina Ferulae is the oleo-gum-resin of the glue grass of Resina Ferulae of Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen or Iran, Afghanistan, Sri Lanka, India, Iraq, Bangladesh.
Resina Ferulae is the glue grass of Resina Ferulae of Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen or Iran, Afghanistan, Sri Lanka, India, Iraq, Bangladesh.
Resina Ferulae volatile oil can be that the oleo-gum-resin of samphire Ferula sinkiangensisK.M.Shen (Ferula sinkiangensisK.M.Shen) or Ferula fukanensis K.M.Shen (Ferula fukanensis K.M.Shen) adopts common extracting method to extract volatile oil from Resina Ferulae.Send Analytical Test Center, Chengdu Branch, Chinese Academy of Sciences respectively, detect through GC-MS, all mainly contain: a-pinene, a-terpinene, 2-baras camphor, terpiene-4-ols, D fenchylalcohol, 10-Pinen-3-ol, β-ocimene A, β-ocimene B, two sec-butyl disulphide, sec-butyl-anti-form-1-cyclobutenyl disulphide, sec-butyl-cis-acrylic disulphide, sec-butyl-cis-1-butylene based bisulfide, sec-butyl-trans-2-butene based bisulfide, sulfo-sec-butyl-trans-ethylene methacrylic disulphide.
The oleo-gum-resin that Resina Ferulae volatile oil can originate in the glue grass of Resina Ferulae (F.assafoetida L) of states such as Iran, Afghanistan certainly adopts common extracting method to extract volatile oil.Send Analytical Test Center, Chengdu Branch, Chinese Academy of Sciences respectively, detect through GC-MS, all mainly contain: a-terpinene, 2-baras camphor, terpiene-4-ols, D-fenchylalcohol, 10-Pinen-3-ol, dimethyl disulphide, dimethyl trisulfide, methyl-acrylic-disulphide, 2, the two methyl sulfo-propane, 1 of 2-, the two ethylenebis dithiocarbamate propane of 2-, N, N-dimethyl thioformamide, acrylic-butyl-disulphide.Can adopt common oil-water separation method, produce Resina Ferulae volatile oil with steam distillation, azeotropic distillation method, vacuum distillation method or solvent extraction method.
Above-mentioned steam distillation separates volatile oil by oil water separator.0.1～20 part of Resina Ferulae is got in metering by weight, adds 0.1～80 part of purified water, carries out vapor distillation, carries out oil-water separation, and temperature is controlled at 105～108 ℃, collects 0.012～2.4 part of volatile oil [establishing the average volatile oil content of raw material is 12% (g/g)].
Above-mentioned azeotropic distillation method separates volatile oil by oil water separator.Resina Ferulae 0.1～20 weight portion is got in metering by weight, adds purified water 0.5～200 weight portion, and temperature is controlled at 105～108 ℃, carries out azeotropic distillation, carries out oil-water separation, collects 0.012～2.4 part of volatile oil.
Above-mentioned vacuum distillation method is separated volatile oil by oil water separator.Resina Ferulae 0.1～20 weight portion is got in metering by weight, adds purified water 0.5～200 weight portion, and controlled condition is 104～107 ℃/1300～1400Pa, carries out vacuum distillation, collects 0.012～2.4 part of volatile oil.
Above-mentioned solvent extraction method, Resina Ferulae 0.1～20 weight portion is got in metering by weight, adds organic solvent ethanol and chloroform 0.6～120 weight portion.The part by weight of ethanol and chloroform is: chloroform: ethanol=2: 1.Carry out reflux, extract,, temperature is controlled at 65～70 ℃, refluxes 2 hours, when treating that the backflow temperature is reduced to room temperature, emits backflow, reclaims organic solvent, can obtain the volatile oil crude product, adds purified water 0.1～80 weight portion.Vapor distillation carries out oil-water separation, and temperature is controlled at 105～108 ℃, collects 0.012～2.4 part of volatile oil.
Above-mentioned anticancer agent can be dosage forms such as injection, capsule, drop pill, tablet, granule, powder, oral liquid.Injection can be intramuscular injection or intravenous fluid.
In order to understand essence of the present invention better, below with the anticancer agent of Resina Ferulae volatile oil preparation, tentative by name: cancer-root injection, cancer-root capsule, cancer-root drop pill, cancer-root sheet, cancer-root granule, and the new purposes of Resina Ferulae volatile oil in pharmaceutical field is described with the animal experiment and the clinical trial of cancer-root soft capsule of Resina Ferulae volatile oil.
Prepare anticarcinogen with Resina Ferulae volatile oil: the cancer-root injection.Get Resina Ferulae volatile oil, add solubilizing agent, such as: 2,3-HP, β-CD, (before the adding, adding an amount of water for injection dissolving solubilizing agent earlier) stirs, add isoosmotic adjusting agent sodium chloride (sodium chloride for injection), add injection water to ormal weight and continue to stir, filter through mocromembrane again, embedding peace bottle, sterilization promptly gets the cancer-root injection.
Prepare anticarcinogen with Resina Ferulae volatile oil: the cancer-root capsule.By weight, Resina Ferulae volatile oil: excipient=1: 3～20, excipient are starch, amylum pregelatinisatum, low-substituted hydroxypropyl cellulose (L-HPC), at least a in microcrystalline Cellulose, the carboxymethyl starch sodium (CMS-Na).Get excipient and put in the blender, start is sprayed on volatile oil in the excipient after stirring 5min equably; spray the back and continued to stir 5min; add 5% starch slurry and make soft material, soft material is put into granulator, make wet granular by stainless steel mesh; be dried into dry granular below 60 ℃; put into granulator, by the stainless steel mesh granulate, even, smooth and easy when making filled capsules; must add magnesium stearate lubricant, its part by weight is: excipient: lubricant=1: 0.002～0.01.Dry granular behind the granulate is put in the mixer, added lubricant, start is delivered to Autocapsulefillingmachine and is made the cancer-root capsule after mixing 5min, makes every cancer-root capsule contain Resina Ferulae and is equivalent to Resina Ferulae volatile oil 0.1～2g.
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: cancer-root drop pill (having another name called the cancer-root soft capsule), adopt the conventional method pharmacy.
Extract volatile oil with steam distillation, separate obtaining Resina Ferulae volatile oil 12kg through oil water separator, be equivalent to Resina Ferulae 100kg.(1) preparation of gelatin solution: the ratio of gelatin, glycerol and water is: 1: 0.3～0.5: 0.7～1.4.Get an amount of water (water of gelatin weight 25%) of gelatin solution adding and make its imbibition, other gets glycerol and remaining water and puts and be heated to 70～80 ℃ in the stainless cylinder of steel, mix homogeneously, adding expansible gelatin stirs, make it to dissolve into uniform solution, be incubated 1～2 hour and leave standstill, remove the foam of come-up, filter with nylon cloth.(2) preparation of medicinal liquid (being fluid): get above-mentioned Resina Ferulae volatile oil, add vegetable oil and (, fully stir evenly as Oleum Arachidis hypogaeae semen 0.75kg.(3) glue ball: gelatin solution and medicinal liquid are placed respectively in the drop pill machine reservoir, through quantitative controller with quantitative gelatin and medicinal liquid, by double-deck shower nozzle, 60～70 ℃ of gelatin solutions of outer feeding, internal layer feeds medicinal liquid, glue is wrapped medicinal liquid, make every cancer-root soft gelatin capsule contain Resina Ferulae volatile oil and be equivalent to Resina Ferulae 0.1～3g, the pill of wrapping promptly splashes into coolant, temperature is in 13～17 ℃ the liquid Paraffin, drop is spherical owing to surface tension forms, and solidifies gradually to form soft gelatin capsule, on catcher soft gelatin capsule is collected.(4) whole ball is with dry: soft gelatin capsule is wiped the liquid paraffin that adheres to away with gauze earlier, again 10 ℃ of left and right sides low temperature blowings 4～6 hours, be put in 25～35 ℃ of bakings 4 hours again, take out, use ethanol: the mixed liquor of acetone=5: 1 is washed the after-blow dry-cleaning liquid twice, again in 40～45 ℃ of bakings 24 hours, lamp inspection, remove useless ball after, wash 1 time with 95% ethanol, under 40～45 ℃, dry up again, promptly get cancer-root soft gelatin capsule (soft capsule).
Prepare anticarcinogen with Resina Ferulae volatile oil: the cancer-root sheet.Meter by weight proportion, Resina Ferulae volatile oil: excipient=1: 3～20, excipient are at least a among starch, amylum pregelatinisatum L-HPC, microcrystalline Cellulose, the CMS-Na.Getting excipient puts in the blender; after 5min is stirred in start; be sprayed on Resina Ferulae volatile oil in the excipient equably; spray the back and continued to stir 5min; add 5% starch slurry and make soft material; soft material is put into granulator; make wet granular by stainless steel mesh,, put into granulator being dried into dry granular below 60 ℃; by the stainless steel mesh granulate; particle flow is smooth and easy when making tabletting, fills evenly, must add the lubricant magnesium stearate; by weight: excipient: lubricant=1: 0.002～0.01; dried granule behind the granulate is put in the mixer, added the lubricant start and mix 5min, material is delivered to tablet machine make the cancer-root sheet; again the cancer-root sheet is delivered to the coating machine and make Film coated tablets, make every to contain Resina Ferulae volatile oil and be equivalent to Resina Ferulae 0.1～2g.
Prepare anticarcinogen with Resina Ferulae volatile oil: the cancer-root granule.Count by weight proportion, Resina Ferulae volatile oil: excipient=1: 10～100, excipient are cane sugar powder, dextrin.Getting excipient puts in the blender; start is sprayed on Resina Ferulae volatile oil in the adjuvant after stirring 5min equably, has sprayed the back and has continued to stir 5min; add 2% starch slurry and make soft material; soft material is put into granulator, make wet granular, be dried into dry granular below 60 ℃ by stainless steel mesh; put into granulator; by the stainless steel mesh granulate, deliver to the granule racking machine and carry out packing, make every bag of cancer-root granule contain the Resina Ferulae volatile oil thing and be equivalent to Resina Ferulae 0.1～2g.
The clinical research of the animal experiment of Resina Ferulae volatile oil and cancer-root soft capsule
Animal experiment
Resina Ferulae volatile oil is to S
180Sarcoma, the research of ehrlich ascites tumor tumor inhibition effect
1 materials and methods
1.1 material
1.1.1 laboratory animal
160 of cleaning level kunming mices, body weight 18～20, Chengdu University of Traditional Chinese Medicine's Experimental Animal Center provides, and is male, the quality certification number:
Be real moving the pipe No. 6 in river, full-valence pellet feed is fed.
1.1.2 main agents and tumor strain
Be subjected to the reagent thing: Resina Ferulae volatile oil, the sample transparent oily liquid, every milliliter contains volatile oil 0.25ml, contains crude drug 2.2g approximately, is provided by mountain, Chengdu and drug development company limited.Lot number: 050612.According to people's consumption 0.013ml/Kg/ day,, press 0.4ml/20g filling stomach amount before using and prepare with the soybean oil dilution respectively with 5 times and 20 times of amount gastric infusions.
The positive control drug Tegafur Tablet, Jinan China pharmaceutical factory produces. lot number: 220602
S
180Sarcoma cell strain ehrlich ascites tumor cell strain sample is provided by tumor teaching and research room of pharmaceutical college of Sichuan University.
The key instrument electronic balance, model: BS110S, precision 0.1mg, Sartorius produces.
1.2 test method
1.2.1 tumor model builds in the superclean bench, gets S earlier
180Sarcoma tumor liquid 0.1ml is with 20 times of dilutions of normal saline. and optical microscope calculates live body oncocyte number in the tumor liquid down, calculates the extension rate of tumor liquid, is diluted to 2 * 10 with normal saline
6Individual/0.2ml.Place frozen water to preserve, the right axil skin of 75% alcohol disinfecting mice, it is subcutaneous to be inoculated in the right axil of mice by every Mus 0.2ml.
The ehrlich ascites tumor method for establishing model is the same.
1.2.2 weigh behind the animal grouping inoculation 24h, stratified random is divided into 4 groups: S
180Model group; S
180Positive controls; The Resina Ferulae volatile oil small dose group; The heavy dose of group of Resina Ferulae volatile oil.20 of every group of mices.
1.2.3 experimental procedure began gastric infusion in dividing into groups the same day, the administration capacity is the 0.02ml/g body weight, and positive drug dosage is equivalent to 100mg/kg every day, Resina Ferulae volatile oil small dose group, 10d continuously.Drug withdrawal is put to death mice and weigh next day, and strict standard is peeled off clean Subcutaneous tumor tissue at random, uses electronic scale weighing tumor heavy.Calculate and respectively organize tumor body average weight and tumour inhibiting rate.
2 results
2.1S
180The experimental result of sarcoma transplantation model
2.1.1S
180The tumor growth situation the results are shown in Table 1 behind the sarcoma tumor strain inoculation mice 10d.Experiment medicine two group object tumor weights and model group comparing difference all have utmost point significance (P＜0.01).
Table 1S
180Sarcoma tumor strain inoculation mice 10d tumor is heavy, body weight change (x ± s)
* with the model group comparing difference utmost point significance (P＜0.01) is arranged
2.2 the experimental result of ehrlich ascites tumor tumour transplatation model
2.2.1 the tumor growth situation the results are shown in Table 2 behind the ehrlich ascites tumor solid type inoculation kunming mice 10d.Two groups of medicines of experiment and positive controls tumor are heavy to have utmost point significance (P＜0.01) with the model group comparing difference.
Heavy, the body weight change of table 2 ehrlich ascites tumor tumor strain inoculation mice 10d tumor
* with the model group comparing difference utmost point significance (P＜0.01) is arranged
3 conclusions
The Resina Ferulae volatile oil gastric infusion is to S
180Sarcoma transplantation model and ehrlich ascites tumor tumor model all have significant inhibitory effect, and certain dose-effect relationship is arranged.
Clinical trial
1 esophageal carcinoma
1.1 esophageal carcinoma patient inclusion criteria
1.1.1 dysphagia
1.1.2 pain: chest pain or back pain, pain are dull pain, dull pain, burning pain, twinge
1.1.3 the mucus of telling, hoarseness, hemorrhage, dry cough
1.2 efficacy assessment standard
1.1.1 symptom: dysphagia, pain, tell mucus, hoarseness, hemorrhage, dry cough
1.3 therapeutic effect
Produce effects: symptom has obvious alleviation.Effectively: symptom has alleviation in various degree.Invalid: symptom does not have alleviation
1.4 therapeutic scheme
Esophageal carcinoma patient different sexes, age, divide into groups by homeostatic principle at random, be divided into cancer-root soft capsule treatment group, mitomycin (MMC) positive controls, medicine and usage that each group is used respectively:
Table 1 cancer-root soft capsule, mitomycin treatment esophageal carcinoma patient's clinical efficacy
Table 1 result shows that cancer-root soft capsule treatment esophageal carcinoma has fabulous effect, and the treatment works well.
2 gastric cancer
2.1 patients with gastric cancer inclusion criteria
2.1.1 stomach pain, no specificity
2.1.2 loss of appetite, become thin, weak, no specificity
2.1.3 nausea and vomiting
2.1.4 hemorrhage and melena
2.1.5 other symptom: diarrhoea, constipation, heating etc.
2.2 efficacy assessment standard
2.2.1 symptom: stomach pain, loss of appetite, nausea and vomiting, hemorrhage and melena, diarrhoea, constipation, heating
2.3 therapeutic effect
Produce effects: symptom has obvious alleviation.Effectively: symptom has alleviation in various degree.Invalid: symptom does not have alleviation.
2.4 therapeutic scheme
Patients with gastric cancer different sexes, age, divide into groups by homeostatic principle at random, be divided into cancer-root soft capsule treatment group, 5-fluorouracil (5-Fu) positive controls, medicine and usage that each group is used respectively:
The clinical efficacy of table 2 cancer-root soft capsule, 5-fluorouracil treatment patients with gastric cancer
Table 1 result shows that cancer-root soft capsule treatment patients with gastric cancer has fabulous effect, and the treatment works well.
3 hepatocarcinoma
3.1 liver cancer patient inclusion criteria
3.1.1 hepatalgia, the abdomen piece
3.1.2 symptom of digestive tract: appetite descends, goes up after meal multiple glutted, heating installation, dyspepsia, feels sick, diarrhoea
3.1.3 generate heat, become thin, weak
3.1.4 bleeding tendency: bleeding tendencies such as gingival hemorrhage, subcutaneous ecchymosis are often arranged
3.2 efficacy assessment standard
3.2.1 symptom: hepatalgia, abdomen piece, symptom of digestive tract, heating, it is weak to become thin, bleeding tendency
3.3 therapeutic effect
Produce effects: symptom has obvious alleviation.Effectively: symptom has alleviation in various degree.Invalid: symptom does not have alleviation.
3.4 therapeutic scheme
Liver cancer patient different sexes, age, divide into groups by homeostatic principle at random, be divided into cancer-root soft capsule treatment group, cisplatin (Cisplatin.DDP) positive controls.Medicine and usage that each group is used respectively:
The clinical efficacy of table 3 cancer-root soft capsule, plus cisplatin in treatment liver cancer patient
Table 3 result shows that cancer-root soft capsule treatment liver cancer patient has fabulous effect, and the treatment works well.
4 pulmonary carcinoma
4.1 patients with lung cancer inclusion criteria
4.1.1 chest pain, headache
4.1.2 tachypnea, cough, sputum with blood streaks
4.1.3 hoarseness, the dimness of vision, jugular varicosity
4.2 efficacy assessment standard
4.2.1 symptom: chest pain, headache, tachypnea, cough, sputum with blood streaks, hoarseness, the dimness of vision, jugular varicosity
4.3 therapeutic effect
Produce effects: symptom has obvious alleviation.Effectively: symptom has alleviation in various degree.Invalid: symptom does not have alleviation.
4.4 therapeutic scheme
Patients with lung cancer different sexes, age, divide into groups by homeostatic principle at random, be divided into cancer-root soft capsule treatment group, cyclophosphamide (CTX) positive controls.Medicine and usage that each group is used respectively:
The clinical efficacy of table 4 cancer-root soft capsule, cyclophosphamide treatment patients with lung cancer
Table 4 result shows that cancer-root soft capsule treatment patients with lung cancer has fabulous effect, and the treatment works well.
5 breast carcinoma
5.1 patient with breast cancer's inclusion criteria
5.1.1 lump in breast, nipple discharge (incidence rate is generally below 10%)
5.1.2 nipple and mammary areola change
5.1.3 axillary fossa and SC lymphadenectasis
5.2 efficacy assessment standard
5.2.1 symptom: lump in breast, nipple discharge, nipple and mammary areola change, axillary fossa and SC lymphadenectasis
5.3 therapeutic effect
Produce effects: symptom has obvious alleviation.Effectively: symptom has alleviation in various degree.Invalid: symptom does not have alleviation.
5.4 therapeutic scheme
Patient with breast cancer's all ages and classes divides into groups by homeostatic principle at random, is divided into cancer-root soft capsule treatment group, mitomycin (MMC) positive controls.Medicine and usage that each group is used respectively:
Mitomycin treatment patient with breast cancer's clinical efficacy
Table 5 result shows that cancer-root soft capsule treatment patient with breast cancer has fabulous effect, and the treatment works well.
Conclusion: when cancer-root soft capsule treatment esophageal carcinoma, gastric cancer, hepatocarcinoma, pulmonary carcinoma and breast carcinoma, all than these cancers of present treatment the most effective medicine effective, except that hepatocarcinoma, total effective rate is all more than 90%.
In sum, the present invention has developed the medical application of Resina Ferulae and Resina Ferulae volatile oil, has opened up a new application of Ah and's Resina Ferulae volatile oil Wei.The anticancer drugs that the present invention prepares with Resina Ferulae volatile oil, the treatment works well, has no side effect.Can carry out suitability for industrialized production.Dosage forms such as the injection made from modern science technology, capsule, drop pill, tablet, granule, powder, oral liquid, rapid-action, dosage accurately, taking convenience, can cover or weaken the strong odor of Resina Ferulae, it is very convenient to use.
Anticancer agent of the present invention is applicable to various cancer patients' treatment.
Below, reuse embodiment illustrates further to effect of the present invention.
The specific embodiment:
Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen are identical with state's Resina Ferulae method for makings such as Iran, Afghanistan, Sri Lanka, and following examples are example with Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen.
Embodiment 1
Resina Ferulae volatile oil of the present invention is used to prepare a kind of anticarcinogen: the cancer-root injection, adopt the conventional method pharmacy.
Resina Ferulae volatile oil is a raw material with Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen, adopts common oil-water separation legal system to get volatile oil.Resina Ferulae 0.1～20 weight portion is got in metering by weight, adds 0.1～80 part of purified water, carries out vapor distillation, and temperature is controlled at 105～108 ℃, separates through oil water separator, collects 0.012～2.4 part of volatile oil, i.e. Resina Ferulae volatile oil.
Press table 6 metering, Resina Ferulae volatile oil is added solubilizing agent, such as 2,3-HP, β-CD, (solubilizing agent adds an amount of water for injection dissolving earlier) adds an amount of water for injection after stirring 20min, add isoosmotic adjusting agent sodium chloride (sodium chloride for injection), add water for injection to 1000ml, continue to stir 10min, through the mocromembrane filtration of 0.22 μ m, embedding, sterilization promptly gets the cancer-root injection.
100 ℃ in sterilising temp: 1～2ml peace bottle, 30min; I00 ℃ in 5～10ml peace bottle, 45min promptly gets the cancer-root injection, is used for intramuscular injection or intravenous injection.Can be made into specification is that 2ml:1g/ props up, 5ml:3g/ props up, 10ml:3g/ props up etc.
Composition and content thereof in the cancer-root injection see Table 6.(water for injection adds as required)
Table 6 cancer-root injection composition and content thereof
| Embodiment | Resina Ferulae volatile oil (being equivalent to Resina Ferulae g/ml) | 2，3-HP，β-CD(g) | Sodium chloride (g) | PH value |
| 1-01 | 0.1 | 0.0012 | 0.007 | 5～7 |
| 1-02 | 0.2 | 0.0024 | 0.007 | 5～7 |
| 1-03 | 0.3 | 0.0036 | 0.007 | 5～7 |
| 1-04 | 0.4 | 0.0048 | 0.007 | 5～7 |
| 1-05 | 0.5 | 0.0060 | 0.007 | 5～7 |
| 1-06 | 0.6 | 0.0072 | 0.007 | 5～7 |
| 1-07 | 0.7 | 0.0084 | 0.007 | 5～7 |
| 1-08 | 0.8 | 0.0096 | 0.007 | 5～7 |
| 1-09 | 0.9 | 0.0108 | 0.007 | 5～7 |
| 1-10 | 1.0 | 0.0120 | 0.007 | 5～7 |
| 1-11 | 1.1 | 0.0132 | 0.007 | 5～7 |
| 1-12 | 1.2 | 0.0144 | 0.007 | 5～7 |
| 1-13 | 1.3 | 0.0156 | 0.007 | 5～7 |
| 1-14 | 1.4 | 0.0168 | 0.007 | 5～7 |
| 1-15 | 1.5 | 0.0180 | 0.007 | 5～7 |
| 1-16 | 1.6 | 0.0192 | 0.007 | 5～7 |
| 1-17 | 1.7 | 0.0204 | 0.007 | 5～7 |
| 1-18 | 1.8 | 0.0216 | 0.007 | 5～7 |
| 1-19 | 1.9 | 0.0228 | 0.007 | 5～7 |
| 1-20 | 2.0 | 0.0240 | 0.007 | 5～7 |
Embodiment 2
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: the cancer-root capsule, adopt the conventional method pharmacy.Get Resina Ferulae volatile oil 12kg, be equivalent to Resina Ferulae 100kg.Get excipient 47.74kg; it is that weight ratio is a Resina Ferulae volatile oil: excipient=1: 3.98; wherein; starch 25kg; amylum pregelatinisatum 12kg; L-HPC 8kg; microcrystalline Cellulose 2.5kg; CMS-Na 0.24kg; excipient is put in the blender; start is sprayed on Resina Ferulae volatile oil in the excipient after stirring 5min equably, has sprayed the back and has continued to stir 5min; add 5% starch slurry and make soft material; soft material is put into granulator, make wet granular, be dried into siccative below 60 ℃ by stainless steel mesh; put into granulator; behind the stainless steel mesh granulate, put in the mixer, add magnesium stearate lubricant 0.096kg; it is excipient: lubricant=1: 0.002; start is delivered to Autocapsulefillingmachine and is made the cancer-root capsule after mixing 5min, makes every capsules contain Resina Ferulae volatile oil and is equivalent to Resina Ferulae 0.5g.
Embodiment 3
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: cancer-root drop pill (having another name called the cancer-root soft capsule), adopt the conventional method pharmacy.
Extract volatile oil with steam distillation, separate obtaining Resina Ferulae volatile oil 12kg through oil water separator, be equivalent to Resina Ferulae 100kg.(1) preparation of gelatin solution: gelatin: glycerol: water=1: 0.4: 1, get gelatin 7kg, add the 1.75kg purified water and make its imbibition, other gets glycerol 2.8kg and purified water 5.25kg puts 75 ℃ of mix homogeneously of heating in the stainless cylinder of steel, adds expansible gelatin and stirs, and makes it to dissolve into uniform solution, insulation 1.5h, leave standstill, remove the foam of come-up, filter with nylon cloth.(2) preparation of medicinal liquid (being fluid): get above-mentioned volatile oil 12kg, add medicinal Oleum Arachidis hypogaeae semen 0.75kg, fully stir evenly.(3) soft capsule: above-mentioned gelatin solution and medicinal liquid are placed respectively in the drop pill machine reservoir, through quantitative controller quantitative gelatin and medicinal liquid are passed through double-deck shower nozzle, outer by 65 ℃ of gelatin solutions, internal layer feeds medicinal liquid, glue is wrapped medicinal liquid, make every cancer-root soft capsule contain Resina Ferulae volatile oil and be equivalent to Resina Ferulae 2.5g.The pill of wrapping promptly splashes into coolant, and temperature is that drop is spherical because of surface tension forms in 14.5 ℃ the liquid Paraffin, solidifies gradually and forms soft gelatin capsule, on catcher soft gelatin capsule is collected.(4) whole ball is with dry: soft gelatin capsule is wiped the liquid paraffin that adheres to away with gauze earlier, again at 9 ℃ of low temperature blowing 4.5h, be put in 28-30 ℃ of baking 4h again, take out, use ethanol: the mixed liquor 10kg of acetone=5: 1 washes the after-blow dry-cleaning liquid twice, again in 42-44 ℃ of baking 24h, lamp inspection, remove useless ball after, wash 1 time with 95% ethanol, under 42-43.5 ℃, dry up again, promptly get the cancer-root soft capsule.
Embodiment 4
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: the cancer-root sheet, adopt the conventional method pharmacy.
Get Resina Ferulae volatile oil 12kg, be equivalent to Resina Ferulae 100kg.Get excipient 42.7kg; it is Resina Ferulae volatile oil: excipient=1: 3.56; wherein; starch 22.5kg; amylum pregelatinisatum 11.5kg; L-HPC 6.5kg; microcrystalline Cellulose 2kg; CMS-Na 0.2kg; excipient is put in the blender; start is sprayed on Resina Ferulae volatile oil in the excipient after stirring 5min equably, has sprayed the back and has continued to stir 5min; add 5% starch slurry and make soft material; soft material is put into granulator, make wet granular, be dried into siccative below 60 ℃ by stainless steel mesh; put into granulator; behind the stainless steel mesh granulate, put in the mixer, add magnesium stearate 0.214kg; it is excipient: lubricant=1: 0.005; start is delivered to tablet machine with material and is made the cancer-root sheet after mixing 5min, the cancer-root sheet is delivered to the coating machine again and is made Film coated tablets and make every to contain Resina Ferulae volatile oil and be equivalent to Resina Ferulae 0.5g.
Embodiment 5
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: the cancer-root granule, adopt the conventional method pharmacy.
Get Resina Ferulae volatile oil 12kg, be equivalent to Resina Ferulae 100kg.Get excipient 196kg; it is Resina Ferulae volatile oil: excipient=1: 16.33; cane sugar powder 140kg wherein; dextrin 56kg; excipient is put in the blender; start is sprayed on Resina Ferulae volatile oil in the adjuvant after stirring 5min equably, has sprayed the back and has continued to stir 5min; add 2% starch slurry and make soft material; soft material is put into granulator, make wet granular, be dried into dry granular below 60 ℃ by stainless steel mesh; put into granulator; behind the stainless steel mesh granulate, deliver to the granule racking machine and carry out packing, make every bag of cancer-root granule contain the Resina Ferulae volatile oil thing and be equivalent to Resina Ferulae 0.5g.
Embodiment 6
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: cancer-root looses, and adopts the conventional method pharmacy.
Get Resina Ferulae volatile oil 12kg, be equivalent to Resina Ferulae 100kg and get starch 140kg, cane sugar powder 36kg puts in the blender, start is sprayed on Resina Ferulae volatile oil in the adjuvant after stirring 5min equably, has sprayed the back and has continued to stir 5min, discharging, oven dry below 60 ℃ is pulverized, and crosses 100 mesh sieves, add the 20kg Pulvis Talci, after in mixer, mixing 15min, deliver to powder quantitatively the branch machine contracting system become cancer-root to loose, make whenever to comprise Resina Ferulae volatile oil and be equivalent to Resina Ferulae 0.5g.
Embodiment 7
Resina Ferulae volatile oil of the present invention is used to prepare anticarcinogen: the cancer-root oral liquid, adopt the conventional method pharmacy.
Extract volatile oil with steam distillation through oil water separator, get Resina Ferulae volatile oil 3kg, be equivalent to Resina Ferulae 25kg, add 300g2,3-HP, β-CD, add an amount of distilled water, behind the stirring 5min, add 50% orange syrup 25kg, add an amount of distilled water again to ormal weight 12.5 ten thousand ml, behind the stirring 5min, filter through 0.45 mocromembrane, make the cancer-root oral liquid, deliver to the embedding of full-automatic oral liquid filling machine in the 10ml oral liquid bottle, 100 ℃, 45min sterilizes promptly, and specification is the 10ml:2g/ bottle.
Claims (5)
1. Resina Ferulae volatile oil is as the application of unique active component in the preparation anticarcinogen.
2. application according to claim 1, the dosage form that it is characterized in that said anticarcinogen can be capsule, tablet, granule and powder.
3. application according to claim 1, the indication of wherein said cancer is selected from esophageal carcinoma, gastric cancer, hepatocarcinoma, pulmonary carcinoma and breast carcinoma.
4. application according to claim 1, wherein said Resina Ferulae are the oleo-gum-resin of Ferula sinkiangensisK.M.Shen or Ferula fukanensis K.M.Shen.
5. application according to claim 1, wherein said Resina Ferulae are the oleo-gum-resin of the glue grass of Resina Ferulae of Iran, Afghanistan, Sri Lanka, India, Iraq and Bangladesh.
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