CN105541761A - Paclitaxel crystal and preparation method of medicinal liquor and oral liquid of paclitaxel crystal - Google Patents
Paclitaxel crystal and preparation method of medicinal liquor and oral liquid of paclitaxel crystal Download PDFInfo
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- CN105541761A CN105541761A CN201510992195.7A CN201510992195A CN105541761A CN 105541761 A CN105541761 A CN 105541761A CN 201510992195 A CN201510992195 A CN 201510992195A CN 105541761 A CN105541761 A CN 105541761A
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D305/00—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms
- C07D305/14—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12G—WINE; PREPARATION THEREOF; ALCOHOLIC BEVERAGES; PREPARATION OF ALCOHOLIC BEVERAGES NOT PROVIDED FOR IN SUBCLASSES C12C OR C12H
- C12G3/00—Preparation of other alcoholic beverages
- C12G3/04—Preparation of other alcoholic beverages by mixing, e.g. for preparation of liqueurs
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Abstract
The invention provides a paclitaxel crystal, relates to the technical field of Chinese medicinal health care, and provides non-toxic extracted paclitaxel. The non-toxic extracted paclitaxel is prepared by the steps of purifying, slicing, drying, smashing, ultrafine wall-breaking, ethanol soaking delamination, primary filtration, detoxifying, low-pressure macro-porous ultrafiltration, high-pressure micro-porous ultrafiltration, chromatography, vacuum permeation and concentration, secondary detoxification, and low-temperature vacuum drying. The prepared paclitaxel crystal has the beneficial effects of freeness from chemical agents and good extraction effect.
Description
Technical field
The present invention relates to Chinese medicine health-care technical field, specifically, is the preparation method of a kind of taxol xln and medicinal liquor and oral liquid.
Background technology
The taxol extracted from the bark and branches and leaves of Ramulus et folium taxi cuspidatae is the universally acknowledged natural compounds with anticancer function, be called that 21 century has the anticarcinogen of the plant origin of Development volue most by expert, due to its researching value and application clinically, more and more receive publicity, but Ramulus et folium taxi cuspidatae extracts the production technique more use CO of taxol
2and the kinds of processes method such as ultrasonic extraction, the existence of the toxicity of its residuals after some chemical solvents process causes new injury to patient.Meanwhile, the taxol quality of nontoxic extraction is better than there being residual extraction, and physiologically active is strong, especially the retaining of Ramulus et folium taxi cuspidatae pigment small molecular compound, evident in efficacy to the growth of alleviating pain anticancer.
Summary of the invention
The invention provides a kind of method of nontoxic extraction taxol, for realizing this object, technical scheme provided by the invention is as follows:
A preparation method for taxol xln, described method comprises the steps:
1.1 impurity eliminations: the earth of Ramulus et folium taxi cuspidatae complete stool dry product surface attachment and other impurity are disposed, puts into O
3clean in water service sink;
1.2 sections: taken out by the Ramulus et folium taxi cuspidatae complete stool after cleaning after draining away the water, be cut into the thin slice that 1-3mm is thick, preferred thickness is 2mm;
1.3 dry: dried to moisture content below 5% by Ramulus et folium taxi cuspidatae thin slice, its furnace drying method is: dry 3 hours in the hot air circular drying machine of 50 degree;
1.4 pulverize: pulverized by the Ramulus et folium taxi cuspidatae thin slice after drying, granularity is below 1mm;
1.5 super-micro wall-brokens: at nanometer super-micro wall-broken machine micronizing to 300 order, obtain super-fine powder;
1.6 alcohol immersion are peeled off: the ethanol 500kg getting 100kg super-fine powder and 95%, put into the stainless steel vessel of sealing, indirect heating 35-40 degree, and constant temperature soaks after 6-8 hour, heating to 60 degree while, stir stripping 20 minutes;
1.7 initial filters: filter stirring the solution after peeling off with 500 object filter membranes, filter residue carries out secondary alcohol immersion again, filters, and the filtrate of twice merges;
1.8 detoxification treatment: the filtrate of merging is put into container, indirect heating 50-60 degree, along with the rising gradually of liquid temperature, poisonous lightweight beans China fir volatile spirits can progressively float to ethanol surface, builds up, scooped out to center;
1.9 low pressure macropore ultrafiltration: adopt Ultra filtration membrane machine, setting ultrafiltration granularity is 0.01 μm, and by the ethanolic soln pressurization after detoxification, retained by the 0.01 μm of ultrafiltration of low pressure macropore, trapped substance is robust fibre, and micronic dust, colloid etc. are without the macromolecular substance of utility value.
1.10 high pressure aperture ultrafiltration: low pressure macropore permeate is retained through the ultrafiltration through membranes of high pressure aperture 0.00l μm again, separate to obtain high pressure aperture permeate and high pressure aperture trapped fluid, high pressure aperture trapped fluid is the compound macromole liquid such as alkane diterpenes, high pressure aperture permeate is ethanol and micromolecular compound, and micromolecular compound is evident in efficacy to the growth of alleviating pain anticancer;
1.11 chromatographies: by high pressure aperture permeate, through silica gel column chromatography vacuum state infiltration absorption, then merge the trapped fluid of elutriant and high pressure aperture, obtain amalgamation liquid;
1.12 vacuum infiltrations concentrate, and are concentrated by amalgamation liquid, obtain the lotion after macromole merging;
1.13 two detoxifications: lotion is poured in container, in the thermostatic drying chamber sending into 60 degree, empty dry 5-8 hour is inhaled in sealing, by the part ethanol in its lotion and volatile oil following temperature rising high and vapor away, obtain without ethanol half hitch crystal block;
1.14 low-temperature vacuum dryings: breaking into pieces drying without ethanol half hitch crystal block, is placed in container, send in vacuum freeze drier, and under the vacuum state of negative 38 degree of-0 degree, lyophilize, after 8 hours, namely obtains the taxol xln of nontoxic extraction.
Further, in step 12, adopt thickner to carry out warm vacuum state osmosis concentration in 3 hours 40 degree, obtain the lotion after macromole merging.
Further, vacuum pump intermittent type is adopted to inhale empty dry 6 hours in step 13.
A method for taxol medicinal liquor, described medicinal liquor preparation method comprises the steps:
5.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
5.2 get the oat liquor 50kg of 38 degree, put into container, indirect heating 40 degree, then put into 5kg taxol crude product, stir, and after all dissolving, obtain taxol medicinal liquor, then metering filling, every bottle of 250ml with the membrane filtration of 0.1 μm.
A preparation method for paclitaxel oral liquid, the preparation method of described paclitaxel oral liquid comprises the steps:
6.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
7500ml distilled water is put into container by 6.2, indirect heating 40 degree, puts into rock sugar 500g, vitamins C 50, stirs after dissolving and is adding polyoxyethylene glycol 45ml, abundant stirring 10 minutes, when its whole alkene is interpreted into pink microemulsion, pour into fill 40kg propolis container in, stir 20 minutes, after miscible, metering filling, often props up 10ml, obtains paclitaxel oral liquid.
Beneficial effect of the present invention is, obtained taxol xln is not containing chemical solvents, and extraction effect is good, and particularly extract the Ramulus et folium taxi cuspidatae pigment small molecular compound obtained further, effect is very good; Ultrafiltration process carries out the secondary detoxification treatment after detoxification and processing before processing, taxol toxicity is made to reduce by more than 98%, effective active does not destroy, and it is simple to operate, only need red-tape operati pressure, flow velocity and filter liquor concentration, this is large and distribution range is wider for molecular weight, the taxol alkane diterpenes that solution viscosity is greatly and again unstable, the beyond doubt extremely potential extraction and isolation means of one.
Specific embodiment
Embodiment 1
(1) impurity elimination, O
3water cleans, and the earth of 100kg Ramulus et folium taxi cuspidatae complete stool dry product surface attachment and other impurity is disposed, puts into O
3clean in water service sink; (2) cut into slices, taken out by the Ramulus et folium taxi cuspidatae complete stool after cleaning after draining away the water, be cut into the thin slice that 1-3mm is thick, 2mm effect is better; (3) dry, Ramulus et folium taxi cuspidatae thin slice is put into Stainless Steel Disc, oven dry 3 hours in the hot air circular drying machine sending into 50 degree, when moisture content is below 5%, taking-up; (4) pulverize, the Ramulus et folium taxi cuspidatae fragment after oven dry is pulverized through stainless steel pulverizer again, and granularity is below 1mm; (5) super-micro wall-broken, by the 100kg taxus chinensis powder after pulverizing, through nanometer super-micro wall-broken machine micronizing to 300 order; (6) alcohol immersion is peeled off; adopt the medical ethanol 500kg of 95%; Ramulus et folium taxi cuspidatae complete stool super-fine powder 100kg puts into the stainless steel vessel that can seal; indirect heating 35-40 degree; preferably 38 degree, constant temperature soaks after 6-8 hour, is heating 60 degree simultaneously; after continuously stirring peels off 20 minutes, desuperheat also stops stirring; (7) initial filter, filter stirring the solution after peeling off with the filter membrane of 500 order fineness, filter residue is secondary alcohol immersion again, filters, and the filtrate of twice merges; (8) detoxification treatment, puts into a stainless steel vessel by the amalgamation liquid of initial filter, indirect heating 50-60 degree, along with the rising gradually of liquid temperature, poisonous lightweight beans China fir volatile spirits can progressively float to ethanol surface, builds up, at this moment taken out with stainless steel soup ladle to center; (9) low pressure macropore ultrafiltration, adopts Ultra filtration membrane machine, and setting ultrafiltration granularity is 0.01 μm; by the ethanolic soln pressurization after detoxification; retained by the 0.01 μm of ultrafiltration of low pressure macropore, trapped substance is robust fibre, and micronic dust, colloid etc. are without the macromolecular substance of utility value; (10) high pressure aperture ultrafiltration, retains low pressure macropore permeate through the ultrafiltration through membranes of high pressure aperture 0.00l μm again, and high pressure aperture trapped fluid is the compound macromole liquid such as alkane diterpenes, and high pressure aperture permeate is ethanol and micromolecular compound; (11) chromatography, by high pressure aperture permeate, through silica gel column chromatography vacuum state infiltration absorption, then merges the trapped fluid of elutriant and high pressure aperture; (12) vacuum infiltration concentrates, and amalgamation liquid is carried out warm vacuum state osmosis concentration in 3 hours 40 degree by thickner, obtains the paste body shape after macromole merging; (13) reclaim ethanol, by the small molecules ethanol of vacuum infiltration and chromatography through small molecules ethanol merge, recycle with distiller Distillation recovery; (14) secondary detoxification; the lotion concentrated by vacuum infiltration is poured in the Stainless Steel Disc of a thin-walled; send into the interior sealing of thermostatic drying chamber of 60 degree; empty dry 5-8 hour is inhaled with vacuum pump intermittent type; the preferred time is 6 hours, by the part ethanol in its paste body shape and volatile oil following temperature rising high and vapor away; (15) low-temperature vacuum drying, breaking into pieces substantially dry without ethanol half hitch crystal block, puts into the Stainless Steel Disc of a thin-walled, in feeding vacuum freeze drier, under the vacuum state of negative more than 38 degree, lyophilize, after 8 hours, namely becomes the taxol xln of nontoxic extraction; (16) xln is pulverized, and by dried xln by stainless steel high speed disintegrator fast-crushing 80 order, can obtain taxol crude product.
Embodiment 2
A method for taxol medicinal liquor, described medicinal liquor preparation method comprises the steps:
5.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
5.2 get the oat liquor 50kg of 38 degree, put into container, indirect heating 40 degree, put into 5kg taxol crude product again, stir, after all dissolving, taxol medicinal liquor is obtained with the membrane filtration of 0.1 μm, then metering filling, every bottle of 250ml, a rheumatoid patient, this legal system is adopted to obtain taxol medicinal liquor, daily 25ml, after 3 months, symptom alleviates greatly.
Embodiment 3
A preparation method for paclitaxel oral liquid, the preparation method of described paclitaxel oral liquid comprises the steps:
6.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
7500ml distilled water is put into container by 6.2, indirect heating 40 degree, put into rock sugar 500g, vitamins C 50, the described every sheet of VITAMIN C TABLET this product is containing major ingredient vitamins C 0.1 gram, stirring is adding polyoxyethylene glycol 45ml after dissolving, abundant stirring 10 minutes, when its whole alkene is interpreted into pink microemulsion, pour into fill 40kg propolis container in, stir 20 minutes, after miscible, metering filling, often prop up 10ml, obtain paclitaxel oral liquid, physical appearance is in Mrs Wang of subhealth state, enjoy insomnia always, skin aging is accelerated, the puzzlement of endocrine disturbance, adhere to daily two these oral liquids, after half a year, insomnia puzzlement disappears, physical appearance takes a turn for the better greatly.
Claims (6)
1. a preparation method for taxol xln, is characterized in that, described method comprises the steps:
1.1 impurity eliminations: Ramulus et folium taxi cuspidatae complete stool dry product surface cleaning is clean, put into O
3clean in water service sink;
1.2 sections: the Ramulus et folium taxi cuspidatae complete stool after cleaning is taken out after draining away the water, be cut into the thin slice that 1-3mm is thick;
1.3 dry: dried by Ramulus et folium taxi cuspidatae thin slice to moisture content below 5%;
1.4 pulverize: pulverized by the Ramulus et folium taxi cuspidatae thin slice after drying, granularity is below 1mm;
1.5 super-micro wall-brokens: at micronizing to 300 order, obtain super-fine powder;
1.6 alcohol immersion are peeled off: get 100kg super-fine powder, adopt the ethanol 500kg of 95%, put into the container of sealing, indirect heating 35-40 degree, and constant temperature soaks after 6-8 hour, heating to 60 degree while, stir stripping 20 minutes;
1.7 initial filters: filter stirring the solution after peeling off with 500 object filter membranes, filter residue carries out secondary alcohol immersion again, filters, and the filtrate of twice merges;
1.8 detoxification treatment: the filtrate of merging is put into container, indirect heating 50-60 degree, along with the rising gradually of liquid temperature, poisonous lightweight beans China fir volatile spirits can progressively float to ethanol surface, builds up, scooped out to center;
1.9 low pressure macropore ultrafiltration: adopt Ultra filtration membrane machine, setting ultrafiltration granularity is 0.01 μm, by the ethanolic soln pressurization after detoxification, is retained by the 0.01 μm of ultrafiltration of low pressure macropore;
1.10 high pressure aperture ultrafiltration: low pressure macropore permeate retained through the ultrafiltration through membranes of high pressure aperture 0.00l μm again, separate to obtain the trapped fluid of high pressure aperture permeate and high pressure aperture;
1.11 chromatographies: by high pressure aperture permeate, through silica gel column chromatography vacuum state infiltration absorption, then merge the trapped fluid of elutriant and high pressure aperture, obtain amalgamation liquid;
1.12 vacuum infiltrations concentrate, and are concentrated by amalgamation liquid, obtain the lotion after macromole merging;
1.13 two detoxifications: lotion is poured in container, in the thermostatic drying chamber sending into 60 degree, empty dry 5-8 hour is inhaled in sealing, by the part ethanol in its lotion and volatile oil following temperature rising high and vapor away, obtain without ethanol half hitch crystal block;
1.14 low-temperature vacuum dryings: breaking into pieces drying without ethanol half hitch crystal block, is placed in container, send in vacuum freeze drier, under the vacuum state of negative 38 degree of-0 degree, obtain the taxol xln of nontoxic extraction after lyophilize.
2. the preparation method of a kind of taxol xln as claimed in claim 1, is characterized in that, in step 2, the thickness of thin slice is 2mm.
3. the preparation method of a kind of taxol xln as claimed in claim 1, is characterized in that, adopts thickner to carry out warm vacuum state osmosis concentration in 3 hours 40 degree in step 12, obtains the lotion after macromole merging.
4. the preparation method of a kind of taxol xln as claimed in claim 1, is characterized in that, adopts vacuum pump intermittent type to inhale empty dry 6 hours in step 13.
5. the taxol xln adopting claim as arbitrary in claim 1-4 to prepare prepares a kind of method of taxol medicinal liquor, and it is characterized in that, described medicinal liquor preparation method comprises the steps:
5.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
5.2 get the oat liquor 50kg of 38 degree, put into container, indirect heating 40 degree, then put into 5kg taxol crude product, stir, and after all dissolving, obtain taxol medicinal liquor with the membrane filtration of 0.1 μm.
6. the taxol xln adopting claim as arbitrary in claim 1-4 to prepare prepares a kind of preparation method of paclitaxel oral liquid, and it is characterized in that, the preparation method of described paclitaxel oral liquid comprises the steps:
6.1 taxol xln are crushed to 80 orders, obtain taxol crude product;
7500ml distilled water is put into container by 6.2, indirect heating 40 degree, put into rock sugar 500g, vitamins C 50, stirring dissolve after adding polyoxyethylene glycol 45ml, fully stir, when its whole alkene is interpreted into pink microemulsion, pour into fill 40kg propolis container in, stir, after miscible, obtain paclitaxel oral liquid.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105647754A (en) * | 2014-12-15 | 2016-06-08 | 仁怀市益康红豆杉专业合作社 | Preparation method of compound Chinese yew wine |
| CN111760669A (en) * | 2020-07-02 | 2020-10-13 | 无锡紫杉药业有限公司 | Method for screening raw materials for producing paclitaxel |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720935A (en) * | 2004-07-18 | 2006-01-18 | 苏少宁 | Yew preparation and method for preparing the same |
| CN102552338A (en) * | 2012-02-13 | 2012-07-11 | 林树芳 | Paclitaxel oral anticancer preparation obtained by nontoxic extraction from complete stool of Chinese yew and preparation method thereof |
-
2015
- 2015-12-28 CN CN201510992195.7A patent/CN105541761A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720935A (en) * | 2004-07-18 | 2006-01-18 | 苏少宁 | Yew preparation and method for preparing the same |
| CN102552338A (en) * | 2012-02-13 | 2012-07-11 | 林树芳 | Paclitaxel oral anticancer preparation obtained by nontoxic extraction from complete stool of Chinese yew and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 许素文等: "红豆杉中紫杉醇的提取和纯化工艺研究", 《广州化工》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105647754A (en) * | 2014-12-15 | 2016-06-08 | 仁怀市益康红豆杉专业合作社 | Preparation method of compound Chinese yew wine |
| CN111760669A (en) * | 2020-07-02 | 2020-10-13 | 无锡紫杉药业有限公司 | Method for screening raw materials for producing paclitaxel |
| CN111760669B (en) * | 2020-07-02 | 2021-11-19 | 无锡紫杉药业有限公司 | Method for screening raw materials for producing paclitaxel |
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