CN101450100A - Medicine composition for treating urgent and chronic myelocytic leukemiaia - Google Patents
Medicine composition for treating urgent and chronic myelocytic leukemiaia Download PDFInfo
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- CN101450100A CN101450100A CNA2007101505380A CN200710150538A CN101450100A CN 101450100 A CN101450100 A CN 101450100A CN A2007101505380 A CNA2007101505380 A CN A2007101505380A CN 200710150538 A CN200710150538 A CN 200710150538A CN 101450100 A CN101450100 A CN 101450100A
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- radix puerariae
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Abstract
The invention discloses a pharmaceutical composition for treating acute or chronic myeloblastic leukemia, which is characterized in that: it is made of dehydrated galactitol, kudzuvine root and pharmaceutical auxiliary materials. The composition in the invention has evident effect for treating leukemia, has an undoubted effect for treating lung cancer, multiple myeloma and nasopharyngeal carcinoma, especially has a preferable near term effect for treating chronic myeloblastic leukemia with a remission rate of 86%, has a higher effect for treating various lung cancer, and has lower poisonous and side effects.
Description
Technical field
The present invention relates to medical technical field, particularly relate to the pharmaceutical composition of the treatment acute and chronic neutrophilic leukemia that contains dulcitol
Background technology
Leukemia is a kind of malignant disease of hemopoietic system, and its characteristics are that extensively and uncontrolledly hypertrophy of a large amount of leukaemias is arranged in the body, comes across bone marrow and many other organs and tissue, and enters in the peripheral blood.Acute leukemia is anxious with its onset, progress is fast, the state of an illness is dangerous, the serious harm human health.Along with medical advance, acute leukemia is through active treatment, and most patients can both obtain alleviation, palliating leukemia no longer is the ultimate aim of treatment now, how to improve cure rate, make most of leukemia patients obtain radical cure, become the emphasis of current hematology's research.
The medicinal beginning of Radix Puerariae is stated from Shennong's Herbal, meaning ＂ Radix Puerariae, sweet in the mouth is flat.Main quenching one's thirst, high fever of the body, vomiting, all numbness plays cloudy gas, separates all malicious ＂." Mingyi Bielu " carries: the ＂ Radix Puerariae is nontoxic, and it is cold to cure the wound, middle wind headache, and expelling pathogenic factors from muscles is delivered perspiration, and loosing the interspaces of skin and muscles is treated incised wound, pain relieving side of body wind pain.The juice of taking root: Great Cold.Treatment is quenched one's thirst, the typhoid fever high fever.Leaf: main incised wound hemostasis.Flower: the main wine ＂ that disappears.After this successive dynasties book on Chinese herbal medicine and Chinese medicine books are all on the books.Modern age, the Radix Puerariae clinical practice was very extensive, and present treatable disease has: angina pectoris; Pulmonary heart disease; Cerebral arteriosclerosis and cerebral infarction disease; Hypertension; Diabetes; Gouty arthritis, blocking-up cancer take place or the like.Radix Puerariae isoflavone-containing composition puerarin, puerarin xyloside, daidzein, daidzin and cupreol, arachidic acid contain volume starch (content is 19～20% in the fresh Radix Puerariae) again.The dried root starch-containing 37% of Radix Puerariae rattan.The root of trilobated leaf vine of Herba Gelsemii Elegantis starch-containing 15～20%.From the root of the congener of India, isolate puerarin, daidzein, daidzin, cupreol, 4 ', 6 " diacetyl puerarin and stigmasterol.
The flavone that 1. pharmacological action proposes in the effect Radix Puerariae to blood circulation can increase brain and crown vascular flow amount.Behind the anesthesia Canis familiaris L. internal carotid artery injection Radix Puerariae flavone, cerebral blood flow increases, the corresponding reduction of vascular resistance, effect was kept 2～20 minutes, as intravenous injection, then the cerebral blood flow increase is lighter, can not remove epinephrine and norepinephrine and shrink cerebrovascular effect, but then can improve cerebral circulation to the hypertensive arteriosclerosis patient, its action temperature and.Radix Puerariae flavone and kudzuvine root wine extractum are injected in coronary artery and the vein of Canis familiaris L., and the coronary vasodilator blood flow is increased, and vascular resistance reduces.To the crystallization that proposes in rat abdominal cavity and subcutaneous injection kudzuvine root wine extractum and its water decoction of lumbar injection and the Radix Puerariae, caused heart ischemia reaction all has protective effect to pituitrin, and the Radix Puerariae water decoction is oral not to have tangible hypotensive effect to the hypertension Canis familiaris L..It is reported excited and two kinds of compositions of inhibition heart in Radix Puerariae (Japan produces) decoct.
2. all contain day Glycine max (L.) Merr. ketone in spasmolysis China's Radix Puerariae (kind is unreceipted) and the Japanese commercially available Radix Puerariae, mice, guinea pig in vitro intestinal tube had papaverine sample spasmolysis, but in the more Japanese product person of homemade Radix Puerariae spasmolysis strong, may be with contained big and flavone is more relevant, this spasmolytic composition can be to the effect of antihistaminic and acetylcholine; Produce other osajin derivatives of isolating the Radix Puerariae from Japan and then do not have the effect of tangible expansion acetylcholine.
Recently discover, from the Chinese medicine Radix Puerariae, extract the total flavones composition, inhale the people with nitroso-group sarcosine ethyl and coal tar pitch flue gas and bring out mice model of forestomach cancer and rat pulmonary carcinoma, carry out study on prevention with Radix Puerariae total flavones simultaneously, medicine was got rid of 90 days in front and back, found that it reaches 77.77% to mice model of forestomach cancer suppression ratio.
Melampyrin (Dulcitol), have another name called sweet and pure, hexanhexol (Dulcite).Structure is HOCH2 (CHOH) 4CH2OH, molecular weight: 182.18, be colourless monocline column crystallization.It is little sweet to distinguish the flavor of.Be slightly soluble in pure and mild ether; Water-soluble, particularly be soluble in boiling water.As far back as nineteen forties, China scientist is just at some commonly used Chinese medicines, as having found the dulcitol composition in Radix Tripterygii Wilfordii, the Caulis Seu Folium Euonymi Fortunei etc., and develops considerable Chinese medicine preparation and prescription.Through being accredited as dulcitol, find that it has significant antitumaous effect.China in 1972 has found that also Folium Mayteni hookeri distributes.After this, Chinese medicine institute in Guangxi produces from Guangxi to separate the Folium Mayteni hookeri and obtains dulcitol.For further eliminating the toxicity and the side effect of dulcitol, dulcitol with plant extract is the synthetic mitolactol (Dibromogalactitol of raw material, DBG), (Dianhydrogalactitol DAD) waits types of drugs to NSC-132313, and develops the powdering agent (dianhydrogalactitol) of DAD.DAD is the main in vivo effective metabolite of mitolactol.(Dibromogalactitol DBG) not only can be used for treating entity tumors such as cerebroma, pulmonary carcinoma, gastroenteric tumor and urogenital tract tumor, and chronic myelocytic leukemia is also had better curative effect to discover mitolactol.
In this case, if can be in conjunction with the hemopathic medicine of Chinese medicine.For example, the basic prescription of " treating leukemic pharmaceutical composition " that screening is developed from Chinese medicine is exactly from changing leukaemia's genomic constitution in essence, by the Chinese medicine blood stasis dispelling, purify the blood, set upright, a series of drug regimens such as detoxifcation, effectively suppress leukaemia's proliferate, make it gradually to transform and decompose, simultaneously can also kill the part leukaemia, by strengthening human immunity, improve the human body metabolism, it is external that toxin is got rid of, and implement dialectical treatment acute and chronic lymphoid leukemia in conjunction with patient, all play very significantly specific aim therapeutic effect on the acute and chronic neutrophilic leukemia, can eliminate clinical symptoms rapidly in a short time, improve the state of an illness.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of acute and chronic neutrophilic leukemia.Technology contents of the present invention is implemented by following scheme:
A kind of pharmaceutical composition for the treatment of acute and chronic neutrophilic leukemia is characterized in that said composition is by anhydrous dulcit, and Radix Puerariae and pharmaceutic adjuvant are formed.
Pharmaceutical composition of the present invention, the percentage by weight that it is characterized in that anhydrous dulcit is 0.01-50%, Radix Puerariae 50%-98%, the surplus pharmaceutic adjuvant is formed.
Pharmaceutical composition of the present invention, the percentage by weight that it is characterized in that anhydrous dulcit is 0.05-45%, Radix Puerariae 65%-98%, the surplus pharmaceutic adjuvant is formed.
The present invention can be mixed and made into various preparations with pharmaceutical composition and excipient substance.The preparation concrete operations of various pharmaceutical preparatioies are as follows:
(1), the percentage by weight that takes by weighing anhydrous dulcit by the configuration total amount is 0.05-45%, Radix Puerariae 50%-98%, the filler of adding 40-90%, binding agent, disintegrating agent, lubricant, correctives etc., fully mix and make granule, compacting in 60-70 ℃ of dry 2-4 hour in flakes, maybe with the wet granular made directly at 60-70 ℃ of dry 2-4 hour, be filled into then in the hungry area shell.
(2), composition material adds solvent, the antiseptic of 70-99.5%, fully mixes, and adds activated carbon decolorizing, filters, use less than 0.45 μ m microvoid membrane filtration, embedding after ultrafiltration, 100 ℃ of sterilizations 30-60 minute make every ml contain compositions 5-300mg; Or with gained filtrate by after the standard packing, lyophilized injectable powder is made in lyophilization under vacuum condition.
(3), composition material adds the filler, disintegrating agent, correctives etc. of 40%-90%, fully mix with the 12-14 mesh sieve and make granule.At 60-70 ℃ of dry 2-4 hour, make every gram granule contain compositions 100-600mg.
Can adopt water, ethanol 30-90% in the preparation method of the present invention is that solvent extracts Radix Puerariae, extracting solution separates again, organic solvent extraction, enrichment, get effective ingredient, Radix Puerariae can be rich in compositions such as flavonoid, steroidal, polysaccharide like this and fully extract.
The present invention can be mixed and made into various preparations with compositions and the excipient substance of making.Pharmaceutic adjuvant of the present invention comprises following excipient: filler: lactose, sucrose, starch, microcrystalline Cellulose, sorbitol, cellulose.Binding agent: gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, starch, dextrin.Disintegrating agent: microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, polyvinylpyrrolidone.Lubricant: magnesium stearate; High-molecular bone frame material, for example hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil, acrylic resin.Preparation of pharmaceutical compositions is as follows: use standard and conventional technology; acceptable solid or liquid-carrier are combined, and make it at random to combine and be prepared into microgranule or microsphere with acceptable adjuvant and excipient on the galenic pharmacy.Solid dosage forms comprises tablet, discrete particles, capsule, slow releasing tablet, slow-release micro-pill or the like.Solid carrier can be at least a material, and it can serve as diluent, flavouring agent, solubilizing agent, lubricant, suspending agent, binding agent, disintegrating agent and coating agent.Inert solid carrier comprises magnesium phosphate, magnesium stearate, smoothers sugar, lactose, pectin, propylene glycol, polyoxyethylene sorbitan monoleate, dextrin, starch, gelatin, cellulose substances for example methylcellulose, microcrystalline Cellulose, low melt point paraffin, Polyethylene Glycol, mannitol, cocoa butter etc.Liquid dosage form comprises solvent, suspension for example injection, powder or the like.
The amount of the active ingredient that contains in pharmaceutical composition and the unit dosage form (The compounds of this invention) can be according to patient's the state of an illness, specific being applied of situation of diagnosis, the amount of used chemical compound or concentration are regulated in the scope of a broad, usually, the weight range of reactive compound is 0.5%～90% (weight) of compositions, and another preferred range is 0.5%-70%.
How to prolong the chronic leukemia survival time of patients, the sudden turn of events that reaches the prevention chronic leukemia no longer has been the main target of treatment, finally cures chronic myelocytic leukemia by Drug therapy.Dianhydrodulcitol Dianhydrogalactitol of the present invention and Chinese medicine are mixed and made into compositions, and slow grain leukemia is had short term effect preferably, and remission rate is 86%.Pulmonary carcinoma, multiple myeloma, nasopharyngeal carcinoma etc. also there are certain curative effect, to the effective percentage of various pulmonary carcinoma, only be lower than chlormethine, ametycin and methotrexate, but toxicity are then lighter.Therapeutic Method is as follows: quiet notes or quiet: to slow grain leukemia, and each 40mg that is grown up, the every kg body weight 0.6-1mg of children's, every day 1 time, logotype 5-7 day was 1 course of treatment, drug withdrawal descended for 1 course of treatment after 2 weeks.After the state of an illness was alleviated, every month logotype medicine 5 days was as keeping treatment, preferably keep more than medication half a year for consolidating curative effect, and the dosage 25mg that is grown up every day, the every kg body weight 0.3-0.5mg of children's, to solid carcinomaes such as pulmonary carcinoma, usage and dosage is the same, is spaced apart for 2 weeks the course of treatment; Or symptomatic treatment is treated to descend for 1 course of treatment after hemogram recovers normally again.Compositions is dissolved with isotonic saline solution 10-20mg, slow quiet notes; Or, add 5% xylitol or 5% sodium chloride brine 250-500ml iv drip with after the isotonic saline solution 5ml dissolving.
The specific embodiment:
The present invention is described further below in conjunction with embodiment.Embodiment only is to explanation of the present invention, can not be used for limiting the present invention with this.
Embodiment 1
30 parts of heating of Radix Puerariae or percolation 2 times merge 2 times extracting solution, and decompression recycling ethanol gets crude extract, and medicinal residues discard.Crude extract is regulated pH to 7-8 with 5%NaOH liquid, gets alkaline medicinal liquid, with chloroform (or petroleum ether) extraction.Tell the solvent layer, discard, water layer reuse 5% sulphuric acid is transferred pH to 2-4, place, centrifugal, acidic precipitation is standby, get 30g (C) after the drying, solution extracts with chloroform (or petroleum ether), layering, water layer, concentrate 86g, the solvent layer concentrate extract, after the drying 40g (D), with the acidic precipitation mix homogeneously, get mixture 70g.With extract and 10 parts of mix homogeneously of dianhydrodulcitol, add 5% sodium chloride brine 250ml iv drip.
Embodiment 2
15 parts of usefulness of Radix Puerariae are measured 50% ethanol extraction 2 times for 18 times, merge 2 times extracting solution, decompression recycling ethanol gets crude extract, and medicinal residues discard.Crude extract is regulated pH to 7-8 with 5%NaOH liquid, gets alkaline medicinal liquid, filters, and discards precipitate, supernatant is transferred pH to 2-4 with 5% sulphuric acid, places, and is centrifugal, acidic precipitation is standby, gets 34g after the drying, and solution extracts with ethyl acetate (or n-butyl alcohol), layering, water layer discarded, the solvent layer concentrate extract, get 45g after the drying,, get mixture 79g with the acidic precipitation mix homogeneously, with extract and 5 parts of dianhydrodulcitol mix homogeneously, add 20 parts of starch, 5 parts of mixed pressuring plates of magnesium stearate.
Embodiment 3
18 times of amounts of 50 parts of usefulness of Radix Puerariae, 1% sodium hydroxide (or sodium carbonate) solution extracts 2 times, merges 2 times extracting solution, and concentrating under reduced pressure gets crude extract, and medicinal residues discard.Silicagel column on the crude extract with chloroform (or ethyl acetate, methanol) eluting, is collected each several part, carries out qualitative identification with magnesium powder-hydrochloric acid, merges positive part, and concentrating under reduced pressure must mixture 30g.With extract and 15 parts of dianhydrodulcitol mix homogeneously, add No. 2 capsule, make capsule.
Embodiment 4
80 parts of Radix Puerariaes, extract with 18 times of amount 30% ethanol (heating or percolation), get crude extract, be dissolved in water, solution organic solvent petroleum ether extraction, petroleum ether layer discards, and water layer adds ethanol, makes the alcohol amount of containing reach 75% ethanol precipitate with ethanol, filter, discard precipitate, supernatant concentrates and receives alcohol, get extractum, be dissolved in water, with counter-current distribution method continuous extraction 6 hours, aqueous solvent-n-butyl alcohol, extract concentrate mixture 55g, with extract and 40 parts of dianhydrodulcitol mix homogeneously, evaporate to dryness adds 5% glucose saline and makes injection for 100 parts.
Claims (4)
1, a kind of pharmaceutical composition for the treatment of acute and chronic neutrophilic leukemia is characterized in that, said composition is by anhydrous dulcit, and Radix Puerariae and pharmaceutic adjuvant are formed.
2, pharmaceutical composition as claimed in claim 1, the percentage by weight that it is characterized in that anhydrous dulcit is 0.01-50%, Radix Puerariae 50%-98%, the surplus pharmaceutic adjuvant is formed.
3, pharmaceutical composition as claimed in claim 1, the percentage by weight that it is characterized in that anhydrous dulcit is 0.05-45%, Radix Puerariae 65%-98%, the surplus pharmaceutic adjuvant is formed.
4, described compositions of claim 1-3 and excipient substance are mixed and made into various preparations.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007101505380A CN101450100A (en) | 2007-11-28 | 2007-11-28 | Medicine composition for treating urgent and chronic myelocytic leukemiaia |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007101505380A CN101450100A (en) | 2007-11-28 | 2007-11-28 | Medicine composition for treating urgent and chronic myelocytic leukemiaia |
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| CN101450100A true CN101450100A (en) | 2009-06-10 |
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| CNA2007101505380A Pending CN101450100A (en) | 2007-11-28 | 2007-11-28 | Medicine composition for treating urgent and chronic myelocytic leukemiaia |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014004376A2 (en) | 2012-06-26 | 2014-01-03 | Del Mar Pharmaceuticals | Methods for treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations employing dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulcitol, or analogs or derivatives thereof |
| CN106389352A (en) * | 2015-07-29 | 2017-02-15 | 广西梧州制药（集团）股份有限公司 | Stable dianhydrogalactol lyophilized powder for injection |
| CN106389351A (en) * | 2015-07-29 | 2017-02-15 | 广西梧州制药（集团）股份有限公司 | Application of controlling moisture content of dianhydrogalactol lyophilized powder for injection in keeping stability of dianhydrogalactol lyophilized powder for injection |
-
2007
- 2007-11-28 CN CNA2007101505380A patent/CN101450100A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014004376A2 (en) | 2012-06-26 | 2014-01-03 | Del Mar Pharmaceuticals | Methods for treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations employing dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulcitol, or analogs or derivatives thereof |
| CN104797267A (en) * | 2012-06-26 | 2015-07-22 | 德玛医药 | Methods for treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations employing dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulcitol, or analogs or derivatives thereof |
| JP2015526410A (en) * | 2012-06-26 | 2015-09-10 | デル マー ファーマシューティカルズ | Treating tyrosine kinase inhibitor resistant malignancies in patients with genetic polymorphisms or dysregulation or mutation of AHI1 using dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulucitol, or analogs or derivatives thereof How to |
| EP2872161A4 (en) * | 2012-06-26 | 2016-07-20 | Del Mar Pharmaceuticals | Methods for treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations employing dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulcitol, or analogs or derivatives thereof |
| CN112755193A (en) * | 2012-06-26 | 2021-05-07 | 德玛医药 | Method of treating malignancies with anti-tyrosine kinase inhibitors using dianhydrogalactitol or a derivative thereof |
| CN106389352A (en) * | 2015-07-29 | 2017-02-15 | 广西梧州制药（集团）股份有限公司 | Stable dianhydrogalactol lyophilized powder for injection |
| CN106389351A (en) * | 2015-07-29 | 2017-02-15 | 广西梧州制药（集团）股份有限公司 | Application of controlling moisture content of dianhydrogalactol lyophilized powder for injection in keeping stability of dianhydrogalactol lyophilized powder for injection |
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Open date: 20090610 |