CN106074398A - A kind of freeze dried lentinan holoside powder injecta and preparation method thereof - Google Patents
A kind of freeze dried lentinan holoside powder injecta and preparation method thereof Download PDFInfo
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- CN106074398A CN106074398A CN201610414753.6A CN201610414753A CN106074398A CN 106074398 A CN106074398 A CN 106074398A CN 201610414753 A CN201610414753 A CN 201610414753A CN 106074398 A CN106074398 A CN 106074398A
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- lentinan
- preparation
- freeze
- freeze dried
- injecta
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Classifications
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Abstract
The present invention relates to a kind of freeze dried lentinan holoside powder injecta and preparation method thereof, belong to biological response modifier antitumour auxiliary drug technical field.The technical scheme is that and a kind of freeze dried lentinan holoside powder injecta of easily dimmable pH safely and effectively and in preparation process is provided, it is characterized in that, described freeze dried lentinan holoside powder injecta is prepared by following weight proportion: lentinan 1 part, freeze-dried excipient sorbitol or lactose 150 300 parts.The preparation method of described a kind of freeze dried lentinan holoside powder injecta of the present invention, it is characterised in that take lentinan 1 part, dissolve with sodium hydroxide solution, add freeze-dried excipient sorbitol or lactose 150 300 parts, then regulate pH with sodium dihydrogen phosphate, charcoal absorption is taken off with needle-use activated carbon, being stirred at room temperature, direct 0.22 μm nylon membrane filters, then adds the water for injection filtered through 0.22 μm nylon membrane, mix homogeneously, it is sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.
Description
Technical field
The present invention relates to a kind of freeze dried lentinan holoside powder injecta and preparation method thereof, belong to biological response modifier antitumor
Ancillary drug technical field.
Background technology
Lentinan (Lentinan) is the antitumor drug of a kind of immunity regulating type intravenously administrable, has dosage low, treats
Imitate, the advantages such as toxic and side effects is little.It is mainly used in inoperable cancer patient clinically, can significantly extend the survival of patient
Time, and prevent the recurrence of Post operation cancer.Within 1966, first Japan obtain lentinan, 20th century from mushroom fruiting body
The seventies is applied to clinic.China from Japan's import, obtained good curative effect in 1988.But import price is sufficiently expensive.
Within 1994, China succeeds in developing the freeze dried lentinan holoside powder injecta of dosage form as Japanese lentinan and goes into operation.Lentinan is
A kind of molecular weight is the beta glucan of about 600,000.Either study of pharmacy or pharmacology, toxicity, mechanism of action and clinical practice
Research is all to study a most detailed active polysaccharide so far both at home and abroad.But when clinical practice, owing to lentinan is water-soluble
Property is poor, for making lyophilized injectable powder can be dissolved in water for injection, must be added to a large amount of adjuvant when preparing lyophilized injectable powder.These are auxiliary
Expect that the curative effect to lentinan, without any effect, is purely acting as hydrotropy and figuration is used.Must be added to when preparing lyophilized injectable powder
A large amount of adjuvants.These adjuvants without any effect to the curative effect of lentinan, are purely acting as hydrotropy and figuration are used.Many with Japan's Lentinus Edodes
As a example by sugar lyophilized injectable powder preparation: every bottle of 1mg lentinan, containing major auxiliary burden mannitol 100mg, secondary adjuvant dextran
(Dextran-40, mw40000) 2mg.The major auxiliary burden mannitol consumption of this lyophilized injectable powder is too big, another adjuvant dextrorotation simultaneously
Sugar acid anhydride is owing to coming from tunning, it some times happens that the side reactions such as such as anaphylactic shock, thus have impact on lentinan application
Safety.
Document report (the most for many years, Chen Linxiang. a kind of new method [J] preparing freeze dried lentinan holoside powder injecta. food and medicine
Product, 2005,7 (4A): 41-42) a kind of new method preparing freeze dried lentinan holoside powder injecta, take lentinan and be divided into, use hydrogen-oxygen
Change sodium to dissolve.Being separately added into mannitol after dissolving, then use citric acid regulating solution pH, i.e. use 1mg lentinan, 40mg is sweet
The method of the formula of dew alcohol and about 9mg sodium citrate.
Chinese patent (application number 00112407.2, applying date 2000-07-19, patent name: lentinan freeze-dried powder
Agent and preparation method thereof) disclose freeze dried lentinan holoside powder injecta and preparation method thereof, lentinan 0.50-1.40 part, lyophilizing
Excipient mannitol, glucose, sucrose or lactose 50-140 part.Use sodium hydroxide to dissolve during preparation, then be neutralized with hydrochloric acid.With
Freeze dried lentinan holoside powder injecta prepared by this technique, then preparation mistake in Clinical practice 250mL saline i infusion process
The sodium chloride produced in journey and parenteral solutions define hyperosmotic solution, irritant to blood vessel during injection.
The untoward reaction of mannitol it has been reported that be primarily directed to has the mannitol of medicative 20% (W/V)
The research of venoclysis solution.The amount of the mannitol used as freeze-dried excipient adjuvant is far smaller than therapeutic dose, the worst
The incidence rate of reaction is relatively low.But allergy or hypersusceptibility is also there will be as adjuvant when mannitol uses.Such as document report
Road (" China national formulary " editorial board. China national formulary [M]. Beijing: People's Medical Officer Press, 2010:50,715;
Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia clinical application notice [S]. chemical drugs and biological product volume .2010 version .2011:105,
452) mannitol may result in anaphylactic shock.The safety of injection is the problem highly paid attention to.
Chinese patent (application number 200910056460.5, applying date 2009-08-14, patent name: a kind of lentinan
Lyophilized injectable powder and preparation method thereof) disclose a kind of freeze dried lentinan holoside powder injecta and preparation method thereof, it is characterised in that fragrant
The weight average molecular weight of mushroom polysaccharide is 40-80 ten thousand dalton, more than 20,000 daltonian components no less than 98%, more than 2,000,000 dongle
The component paused is no less than 2%.State Food and Drug Administration's standard (standard number: WS1-(X-032)-2004Z) regulation
The weight average molecular weight of lentinan is 400,000-80 ten thousand dalton, more than 20,000 daltonian components no less than 90%.This patent institute
Lentinan be to eliminate part too small and cross the special lentinan of macromolecular structure, it is clear that lentinan is refined
Relatively costly.
Chinese patent (application number 96116294.5, applying date 1996-03-28, patent name: lentinus edodes polysaccharide injecta and
Its preparation method) disclose lentinus edodes polysaccharide injecta and preparation method thereof, it is characterised in that single lentinan or multicomponent Lentinus Edodes
Polysaccharide is dissolved in the NaOH solution of suitable concn, and stirring is lower adds citric acid solution regulation pH to 7.0-7.5, filters, filtrate
Subpackage aequum in ampulla, high-temperature sterilization, prepare lentinus edodes polysaccharide injecta.Citric acid may to the metabolism Influence of production of calcium,
Thus cause hypocalcemia.
Chinese patent (application number 201310075745.X, applying date 2013-03-11, patent name: a kind of lentinan
Injection formulation and preparation method thereof) disclose a kind of lentinus edodes polysaccharide injecta preparation and preparation method thereof, this injection is by perfume (or spice)
Mushroom polysaccharide, the NaOH solution of suitable concn, pH adjusting agent and water for injection composition, wherein the concentration of NaOH solution is 0.1-
1mol/L, preferably 0.3-0.6mol/L;PH adjusting agent is phosphoric acid solution, potassium dihydrogen phosphate or sodium dihydrogen phosphate, excellent
Select sodium dihydrogen phosphate and phosphoric acid solution.Phosphoric acid is too much by venoclysis, may cause hyperphosphatemia, cause low blood calcium
Disease or other serious electrolyte disturbances.
Summary of the invention
It is an object of the invention to provide a kind of freeze dried lentinan holoside powder injecta without generation untoward reaction composition, this system
The cost of agent is relatively low.
It is a further object of the invention to provide a kind of freeze dried lentinan holoside powder injecta of easily dimmable pH in preparation process
Preparation method.
The present invention finds in process of the test, lentinan after dissolving with sodium hydroxide, different acid (phosphoric acid, acetic acid, lemons
Lemon acid, hydrochloric acid, sulphuric acid), different phosphate hydrochlorate (disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate) regulates at ambient temperature
The effect of pH, finds that sodium dihydrogen phosphate is more stable during regulation pH.
The different acid of table 1, the contrast of different phosphate hydrochlorate regulation pH
In order to achieve the above object, offer one safely and effectively lentinan freeze-dried powder is provided
Agent, it is characterised in that described freeze dried lentinan holoside powder injecta is prepared by following weight proportion: lentinan 1 part, lyophilizing figuration
Agent sorbitol or lactose 150-300 part.
Preferably proportioning is: lentinan 1 part, freeze-dried excipient sorbitol or lactose 180-250 part.
Described freeze-dried excipient sorbitol or lactose, preferred freeze-dried excipient is sorbitol.
Technical scheme also includes the preparation method of a kind of freeze dried lentinan holoside powder injecta.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta of the present invention, it is characterised in that take lentinan 1
Part, dissolve with sodium hydroxide solution, add freeze-dried excipient sorbitol or lactose 150-300 part, then use sodium dihydrogen phosphate
Regulation pH, takes off charcoal absorption with needle-use activated carbon, is stirred at room temperature, and direct 0.22 μm nylon membrane filters, then adds through 0.22 μm nylon
The water for injection of membrane filtration, mix homogeneously, it is sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that the concentration of sodium hydroxide solution
For 0.4-0.6mol/L.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that freeze-dried excipient sorbitol or
Lactose.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that preferably freeze-dried excipient is
Sorbitol.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that add the amount of sodium hydroxide
(mL) ratio with lentinan weight (g) is 700-900 (mL/g).
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that sodium dihydrogen phosphate dense
Degree is 0.65-0.85mol/L.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that regulation pH is 6.80-7.20.
The preparation method of described a kind of freeze dried lentinan holoside powder injecta, it is characterised in that needle-use activated carbon concentration is
0.01%-0.03% (W/V).
Freeze dried lentinan holoside powder injecta usage and dosage is: one time 1 bottle (1mg), biweekly or follow the doctor's advice.Inject with 2mL
Dissolve with water shaking, add 250mL normal saline or 5% glucose injection iv drip, or use 5% glucose injection
5-10mL is completely dissolved posterior vein injection.
The lentinan freeze-dried powder steady quality of the present invention, without the dextran that may cause allergic reaction or manna
Alcohol, Clinical practice is convenient.
Detailed description of the invention
Embodiment 1
Weigh lentinan 1g, add it in the 0.4mol/L sodium hydroxide solution of 700mL, stirring and dissolving.Will
150g lactose adds above-mentioned raw materials liquid, and stirring and dissolving becomes solution.The pH regulating above-mentioned solution with 0.65mol/L sodium dihydrogen phosphate adjusts
Joint, to 6.80, adds the needle-use activated carbon of 0.01% (W/V) in the solution, is stirred at room temperature, and direct 0.22 μm nylon membrane filters, then
Add the water for injection filtered through 0.22 μm nylon membrane, mix homogeneously, be sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.Press
According to State Food and Drug Administration's standard (standard number: WS1-(X-152)-2004Z) check acid-base value, the clarification of solution
The projects such as degree, uniformity of dosage units, loss on drying, pyrogen, aseptic, assay, all meet the regulation of this standard.
Embodiment 2
Weigh lentinan 1g, add it in the 0.6mol/L sodium hydroxide solution of 900mL, stirring and dissolving.Will
300g lactose adds above-mentioned raw materials liquid, and stirring and dissolving becomes solution.The pH regulating above-mentioned solution with 0.85mol/L sodium dihydrogen phosphate adjusts
Joint, to 7.20, adds the needle-use activated carbon of 0.03% (W/V) in the solution, is stirred at room temperature, and direct 0.22 μm nylon membrane filters, then
Add the water for injection filtered through 0.22 μm nylon membrane, mix homogeneously, be sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.Press
According to State Food and Drug Administration's standard (standard number: WS1-(X-152)-2004Z) check acid-base value, the clarification of solution
The projects such as degree, uniformity of dosage units, loss on drying, pyrogen, aseptic, assay, all meet the regulation of this standard.
Embodiment 3
Weigh lentinan 1g, add it in the 0.5mol/L sodium hydroxide solution of 850mL, stirring and dissolving.Will
180g sorbitol adds above-mentioned raw materials liquid, and stirring and dissolving becomes solution.The pH of above-mentioned solution is regulated with 0.72mol/L sodium dihydrogen phosphate
Regulation, to 7.00, adds the needle-use activated carbon of 0.02% (W/V) in the solution, is stirred at room temperature, and direct 0.22 μm nylon membrane filters,
Add the water for injection filtered through 0.22 μm nylon membrane, mix homogeneously again, be sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.
According to State Food and Drug Administration's standard (standard number: WS1-(X-152)-2004Z) check acid-base value, solution clear
The projects such as clear degree, uniformity of dosage units, loss on drying, pyrogen, aseptic, assay, all meet the regulation of this standard.
Embodiment 4
Weigh lentinan 1g, add it in the 0.5mol/L sodium hydroxide solution of 850mL, stirring and dissolving.Will
250g sorbitol adds above-mentioned raw materials liquid, and stirring and dissolving becomes solution.The pH of above-mentioned solution is regulated with 0.72mol/L sodium dihydrogen phosphate
Regulation, to 7.00, adds the needle-use activated carbon of 0.02% (W/V) in the solution, is stirred at room temperature, and direct 0.22 μm nylon membrane filters,
Add the water for injection filtered through 0.22 μm nylon membrane, mix homogeneously again, be sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.
According to State Food and Drug Administration's standard (standard number: WS1-(X-152)-2004Z) check acid-base value, solution clear
The projects such as clear degree, uniformity of dosage units, loss on drying, pyrogen, aseptic, assay, all meet the regulation of this standard.
Claims (12)
1. a freeze dried lentinan holoside powder injecta, it is characterised in that described freeze dried lentinan holoside powder injecta is joined by following weight
Than preparation: lentinan 1 part, freeze-dried excipient sorbitol or lactose 150-300 part.
A kind of freeze dried lentinan holoside powder injecta the most according to claim 1, it is characterised in that lentinan 1 part, lyophilizing is composed
Shape agent sorbitol or lactose 180-250 part.
A kind of freeze dried lentinan holoside powder injecta the most according to claim 1, it is characterised in that freeze-dried excipient sorbitol or
Lactose.
A kind of freeze dried lentinan holoside powder injecta the most according to claim 1, it is characterised in that freeze-dried excipient is Pyrusussuriensis
Alcohol.
5. the preparation method of a freeze dried lentinan holoside powder injecta, it is characterised in that take lentinan 1 part, molten with sodium hydroxide
Liquid dissolves, and adds freeze-dried excipient sorbitol or lactose 150-300 part, then regulates pH with sodium dihydrogen phosphate, lives with pin
Property charcoal take off charcoal absorption, be stirred at room temperature, direct 0.22 μm nylon membrane filter, then add through 0.22 μm nylon membrane filter injection
Water, mix homogeneously, it is sub-packed in cillin bottle, half moulding plug, lyophilizing and get final product.
The preparation method of a kind of freeze dried lentinan holoside powder injecta the most according to claim 5, it is characterised in that sodium hydroxide
The concentration of solution is 0.4-0.6mol/L.
The preparation method of a kind of freeze dried lentinan holoside powder injecta the most according to claim 5, it is characterised in that lyophilizing figuration
Agent sorbitol or lactose.
The preparation method of a kind of freeze dried lentinan holoside powder injecta the most according to claim 5, it is characterised in that preferably freeze
Dry excipient is sorbitol.
The preparation method of a kind of freeze dried lentinan holoside powder injecta the most according to claim 5, it is characterised in that add hydrogen-oxygen
Changing the amount (mL) of sodium with the ratio of lentinan weight (g) is 700-900 (mL/g).
The preparation method of a kind of freeze dried lentinan holoside powder injecta the most according to claim 5, it is characterised in that di(2-ethylhexyl)phosphate
The concentration of hydrogen sodium solution is 0.65-0.85mol/L.
The preparation method of 11. a kind of freeze dried lentinan holoside powder injectas according to claim 5, it is characterised in that regulation pH
For 6.80-7.20.
The preparation method of 12. a kind of freeze dried lentinan holoside powder injectas according to claim 5, it is characterised in that pin is lived
Property charcoal concentration is 0.01%-0.03% (W/V).
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107166881A (en) * | 2017-07-04 | 2017-09-15 | 南京晶云化工有限公司 | A kind of preparation method of decoction freeze-drier and lentinan for injection |
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CN1288729A (en) * | 2000-07-19 | 2001-03-28 | 南京振中生物工程有限公司 | Freeze dried lentinan holoside powder injecta and its preparation |
CN101632641A (en) * | 2009-08-14 | 2010-01-27 | 上海慈瑞医药科技有限公司 | Lentinan lyophilized power injection and preparation method thereof |
CN103110576A (en) * | 2013-03-11 | 2013-05-22 | 河北凯盛医药科技有限公司 | Lentinan injection preparation and preparation method thereof |
WO2013140185A1 (en) * | 2012-03-23 | 2013-09-26 | K Hughes & Co., Ltd | Lentinan extraction process from mushrooms using ionic liquid |
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2016
- 2016-06-13 CN CN201610414753.6A patent/CN106074398A/en active Pending
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CN1288729A (en) * | 2000-07-19 | 2001-03-28 | 南京振中生物工程有限公司 | Freeze dried lentinan holoside powder injecta and its preparation |
CN101632641A (en) * | 2009-08-14 | 2010-01-27 | 上海慈瑞医药科技有限公司 | Lentinan lyophilized power injection and preparation method thereof |
WO2013140185A1 (en) * | 2012-03-23 | 2013-09-26 | K Hughes & Co., Ltd | Lentinan extraction process from mushrooms using ionic liquid |
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CN107166881A (en) * | 2017-07-04 | 2017-09-15 | 南京晶云化工有限公司 | A kind of preparation method of decoction freeze-drier and lentinan for injection |
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Application publication date: 20161109 |