CN100374106C - High nurity elemene anti-cancer medicine and its preparing method - Google Patents
High nurity elemene anti-cancer medicine and its preparing method Download PDFInfo
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- CN100374106C CN100374106C CNB021329842A CN02132984A CN100374106C CN 100374106 C CN100374106 C CN 100374106C CN B021329842 A CNB021329842 A CN B021329842A CN 02132984 A CN02132984 A CN 02132984A CN 100374106 C CN100374106 C CN 100374106C
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Abstract
The present invention discloses a high-purity elemene anticancer medicine which comprises the following components: 75 to 99.9 wt% of beta-elemene, 0.1 to 25 wt% of the sum of gamma-elemene and delta-elemene and other fractional impurities as the rest. A preparation method for the high-purity elemene anticancer medicine comprises the following steps: a. heating and fractionating raw materials in a precise fractionating tower, using the stainless steel of 3mm*3mm as fillers, keeping a vacuum degree of 2 to 5 mmHg, and collecting fractions at a temperature of 88 to 89 DEG C; b. using the fractions obtained in step an as raw materials, and collecting fractions at 93 to 94 DEG C under the same conditions in step a. Compared with the prior art, the present invention has the main differences that beta-elemene, gamma-elemene and delta-elemene separated from zedoary oil or lemongrass oil are proportionally prepared into a high-purity elemene medicine; the elemene in a fixed proportion can be prepared into emulsive injections, liquid injections, aerosols, soft capsules, tablets, suppositories and capsules, and partial tumor administration, regional administration and intravenous injection can be carried out; simultaneously, atomized medicines can also be distributed to the whole body by breath through the lungs to directly reach focuses; the medicine can also be taken by the mouth to be digested and absorbed by the stomach, and the purpose of cancer treatment is achieved. The preparation method for the high-purity elemene anticancer medicine of the present invention has the advantages of accurate distribution ratio, simple operation and low cost.
Description
Technical field:
The present invention relates to a kind of cancer therapy drug and preparation method thereof, especially a kind of clinical application range is wide, can be made into high nurity elemene anti-cancer medicine of various ways such as emulsion injection, aqueous injection, aerosol, soft capsule, tablet, suppository and capsule and preparation method thereof.
Background technology:
Elemene is Oleum Curcumae, Herba Cymbopogonis Citrari main body of oil, now has been widely used in treating cancer.The cancer therapy drug of Ying Yonging is to make Oleum Curcumae injection with Oleum Curcumae the earliest, this injection can only be treated cervical cancer with the mode of local tumor body administration, its course of treatment, long, administration operation inconvenience then can't effectively be treated with this injection for other various cancers.Can only be used for the administration of local tumor body, the narrower problem of range of application in order to solve Oleum Curcumae injection, people will have the elemene of fixed mixing ratio composition and separate from Oleum Curcumae, lemongrass oil, make elemene emulsion injection with other combination of components.This emulsion injection except that can the administration of local tumor body, the regional administration, but also intravenous injection can be treated multiple cancers such as cervical cancer, cerebroma, malignant tumor of digestive tract, malignant pleural effusion, malignant abdominal cavity effusion and leukemia, clinical application range is wider.As the patent No. be 93110091, patent name for a kind of so just disclosing in the patent specification of " elemene emulsion injection and preparation method thereof " be the emulsion injection of main component with the elemene, it mainly is formulated in proportion by elemene, refining fabaceous lecithin, cholesterol and phosphate buffered solution component.Wherein the fixed mixing ratio composition of elemene is 55% beta-elemene, 30% γ-elemene and δ elemene sum and other terpenoid.The elemene of this kind formulated component is that raw material is put and carried out the vacuum precision fractional distillation in the heating kettle and obtain with the Oleum Curcumae, selects vacuum to be generally 1~3mmHg during separation, and collecting temperature is 90~93 ℃.Though the elemene emulsion injection that obtains with this method fractional distillation has solved the existing problem of Oleum Curcumae injection in the past, but, fractionated elemene can only be made emulsion injection, can intravenous injection, because intravenous injection is by the venous blood administration, the content of blood vessel tip place medicine is few, to such an extent as to not really desirable for the curative effect such as tumors such as pulmonary carcinoma.In addition, fractionated elemene contains part fractional distillation impurity (terpenoid), and tumor treatment is still existed the long problem course of treatment.
Goal of the invention:
The objective of the invention is in order to solve the existing in prior technology deficiency, a kind of curative effect height, applied range are provided, and can be made into various ways such as emulsion injection, aqueous injection, aerosol, soft capsule, tablet, suppository and capsule, can be by number of ways drug treatment cancer high nurity elemene anti-cancer medicine and preparation method thereof.
Technical solution of the present invention is: a kind of high nurity elemene anti-cancer medicine is characterized in that each components by weight:
Beta-elemene 75~99.9%
γ-elemene and δ-elemene sum 0.1~25%
Surplus is other fractional distillation impurity.
A kind of preparation method of high nurity elemene anti-cancer medicine is characterized in that comprising the steps:
A. raw material being placed precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 2~5mmHg, the fraction when the collection temperature is 88~89 ℃.
B. being that raw material places precision fractionation tower still to heat fractional distillation with a step gained fraction, is filler with 3mm * 3mm rustless steel, and vacuum is 2~5mmHg, the fraction when the collection temperature is 93~94 ℃.
The compared with prior art main difference of the present invention is that beta-elemene, γ-elemene and the δ-elemene that will separate from Oleum Curcumae are prepared in proportion, makes the about thing of highly purified elemene.The elemene of this fixed mixing ratio can also be made aqueous injection, aerosol, soft capsule, tablet, suppository and capsule except that making the emulsion injection, get final product the administration of local tumor body, regional administration, intravenous injection, the medicine that also can make atomizing by breathing is by pulmonary's whole body that distributes simultaneously, through focus, also can oral drugs, digest and assimilate by stomach, reach the purpose of treatment cancer.For treatment intracranial malignant tumor, pulmonary carcinoma, hepatocarcinoma, breast carcinoma, nasopharyngeal carcinoma, bladder cancer, gastric cancer, the esophageal carcinoma, colon cancer, rectal cancer, carcinoma of prostate, leukemia, cervical cancer, ovarian cancer and coronary heart disease, angina pectoris, arteriosclerosis, cerebral infarction, peripheral angiopathy, prostatic hyperplasia, diabetes, hyperlipidemia, high blood viscosity, thrombosis, hysteromyoma etc. definite curative effect is arranged, share with other chemotherapeutics in treatment cancer process to increase curative effect.The elemene antitumor medicine composition proportion is accurate, simple to operate, cost is low and produce with preparation method of the present invention.
The specific embodiment:
Embodiment 1:
With the Oleum Curcumae is that raw material places precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 2mmHg, the fraction when the collection temperature is 88 ℃.Afterwards, fraction with gained is a raw material again, place precision fractionation tower still to heat fractional distillation, with 3mm * 3mm rustless steel is filler, vacuum is 5mmHg, collect the fraction of temperature when being 93 ℃, promptly beta-elemene is 75% in the elemene of gained, γ-elemene and δ-elemene sum be 25%, elemene and other composition proportion can be made emulsion injection, aqueous injection, aerosol formulations, soft capsule, tablet, suppository, capsule etc.
The dosage of treatment tumor is 1000~3000 milligrams/day, and 1~3 month is a course of treatment; For described other disease, dosage is 100~500 milligrams/day, and 10~30 days is a course of treatment.
Embodiment 2:
Is that raw material places precision fractionation tower still to heat fractional distillation with embodiment 1 with the Oleum Curcumae, is filler with 3mm * 3mm rustless steel, and vacuum is 5mmHg, collects the fraction of temperature when being 89 ℃.Afterwards, the fraction with gained is a raw material again, places precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 3mmHg, the fraction when the collection temperature is 94 ℃.Be that beta-elemene is 99.9% in the elemene of gained, γ-elemene and δ-elemene sum be 0.1%, elemene and other composition proportion can be made emulsion injection, aqueous injection, aerosol formulations, soft capsule, tablet, suppository, capsule etc.
The dosage of treatment tumor is 1000~3000 milligrams/day, and 1~3 month is a course of treatment; For described other disease, dosage is 100~500 milligrams/day, and 10~30 days is a course of treatment.
Embodiment 3:
Is that raw material places precision fractionation tower still to heat fractional distillation with embodiment 1 with the Oleum Curcumae, is filler with 3mm * 3mm rustless steel, and vacuum is 3mmHg, collects the fraction of temperature when being 88 ℃.Afterwards, the fraction with gained is a raw material again, places precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 4mmHg, the fraction when the collection temperature is 94 ℃.Be that beta-elemene is 80% in the elemene of gained, γ-elemene and δ-elemene sum be 20%, elemene and other composition proportion can be made emulsion injection, aqueous injection, aerosol formulations, soft capsule, tablet, suppository, capsule etc.
The dosage of treatment tumor is 1000~3000 milligrams/day, and 1~3 month is a course of treatment; For described other disease, dosage is 100~500 milligrams/day, and 10~30 days is a course of treatment.
Embodiment 4:
Is that raw material places precision fractionation tower still to heat fractional distillation with embodiment 1 with the Oleum Curcumae, is filler with 3mm * 3mm rustless steel, and vacuum is 4mmHg, collects the fraction of temperature when being 89 ℃.Afterwards, the fraction with gained is a raw material again, places precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 3mmHg, the fraction when the collection temperature is 93 ℃.Be that beta-elemene is 85% in the elemene of gained, γ-elemene and δ-elemene sum be 15%, elemene and other composition proportion can be made emulsion injection, aqueous injection, aerosol formulations, soft capsule, tablet, suppository, capsule etc.
The dosage of treatment tumor is 1000~3000 milligrams/day, and 1~3 month is a course of treatment; For described other disease, dosage is 100~500 milligrams/day, and 10~30 days is a course of treatment.
Embodiment 5:
Also can select beta-elemene, γ-elemene and δ-elemene sum of from Oleum Curcumae, separating for use.Get 90% beta-elemene, 10% γ-elemene and δ-elemene sum.Elemene and other composition proportion can be made emulsion injection, aqueous injection, aerosol formulations, soft capsule, tablet, capsule for suppository agent etc.
The dosage of treatment tumor is 1000~3000 milligrams/day, and 1~3 month is a course of treatment; For described other disease, dosage is 100~500 milligrams/day, and 10~30 days is a course of treatment.
Claims (1)
1. the preparation method of a high nurity elemene anti-cancer medicine, described method is:
A. Oleum Curcumae being placed precision fractionation tower still to heat fractional distillation, is filler with 3mm * 3mm rustless steel, and vacuum is 5mmHg, the fraction when the collection temperature is 89 ℃;
B. being that raw material places precision fractionation tower still to heat fractional distillation with a step gained fraction, is filler with 3mm * 3mm rustless steel, and vacuum is 3mmHg, the fraction when the collection temperature is 94 ℃.
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CN100404023C (en) * | 2005-09-13 | 2008-07-23 | 刘玉辉 | Elemene soft capsule and its prepn process |
CN101810593B (en) | 2010-05-10 | 2012-07-18 | 谢恬 | Elemene sustained-release tablets |
CN102871965A (en) * | 2011-07-13 | 2013-01-16 | 郭增平 | Preparation method of tumor treatment medicine spray |
CN105797417B (en) * | 2016-04-29 | 2018-07-06 | 大连德泽药业有限公司 | Monitor fractionating device, method and system that temperature prepares high-purity fraction |
JP2023504821A (en) * | 2019-12-03 | 2023-02-07 | 四川弘合生物科技有限公司 | Pharmaceutical composition containing elemen, method of preparation thereof, and use thereof |
Citations (1)
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CN1200266A (en) * | 1997-04-14 | 1998-12-02 | 中国科技开发院医药科技开发所 | Method for preparing anti-cancer medicine using beta-elemene as main effective ingredient, and components of the medicine |
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CN1200266A (en) * | 1997-04-14 | 1998-12-02 | 中国科技开发院医药科技开发所 | Method for preparing anti-cancer medicine using beta-elemene as main effective ingredient, and components of the medicine |
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