CN110051633A - A kind of cyclovimbuxine D nanometer formulation and preparation method thereof - Google Patents
A kind of cyclovimbuxine D nanometer formulation and preparation method thereof Download PDFInfo
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- CN110051633A CN110051633A CN201811428707.7A CN201811428707A CN110051633A CN 110051633 A CN110051633 A CN 110051633A CN 201811428707 A CN201811428707 A CN 201811428707A CN 110051633 A CN110051633 A CN 110051633A
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- cyclovimbuxine
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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Abstract
The present invention relates to a kind of cyclovimbuxine D nanometer formulation and preparation method thereof, which includes bulk pharmaceutical chemicals cyclovimbuxine D and appropriate combination of stabilizers system, wherein the combination of stabilizers system is made of super-disintegrant and stabilizer.The present invention combines the super-disintegrant comprising cellulose chain and charged group with other stabilizer compatibilities, it is small with partial size, narrowly distributing, stability is good, and the dissolubility (cyclovimbuxine D dissolution rate increases 5~30 times) and dissolution rate of energy significantly increasing medicament, and then vivo biodistribution availability can be improved.Prepared cyclovimbuxine D nanometer formulation, drugloading rate are 1%~85%, and partial size is 20~300 nm.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly to a kind of cyclovimbuxine D nanometer formulation and preparation method thereof.
Background technique
Cyclovimbuxine D (molecular formula C26H46N2O, molecular weight 402.36, structural formula is shown in Fig. 1) and it is a kind of alkaloid,
From Buxaceae plant little leaf boxwood and its congener obtained by Hydrolysis kinetics, clinic proves effectively treat arrhythmia cordis, the heart
The cardiovascular diseases such as colic pain, coronary heart disease and heart failure, toxicity is lower, has broad application prospects.
Cyclovimbuxine D is colorless needle crystals, and fusing point is 219~222 DEG C, readily soluble in chloroform, in methanol or ethyl alcohol
Middle dissolution, slightly molten in acetone, solubility in water only has 0.06mg/mL, limits its application clinically.With the heart
Vascular disease's quantity increases sharply, and has the dosage form for the features such as taking and is easy to carry, compliance is strong, in new drug development
Or become first choice in the use of patient.
Nanometer suspension is one of the most effectual way of drug for improving poorly water-soluble as a kind of new form of administration.It receives
Rice suspension is to be dispersed in bulk pharmaceutical chemicals in the medium containing stabilizer with nanosized form, since the specific surface area of drug increases
Add, so that them is in thermodynamics and kinetics unstable and tend to assemble, therefore, stabilizer is added into nano suspending liquid can be with
Restrain particle buildup by electrostatic repulsion or spatial stability.But the very challenging property of the selection of stabilizer, screening process complexity and meeting
There is the limited phenomenon of types of screens.
Currently, common steric stabilizer has hydroxypropyl methyl cellulose, hydroxypropyl cellulose, poly- dimension in nanosuspension
Ketone and Families of poloxamers, electrostatic stabilization agent include Tween 80, docusate sodium and lauryl sodium sulfate etc., and usually compounding makes
With.But how compound stabilizer best for certain medicament selection the problem of still remain, to how selecting suitable stabilizer
The understanding that (and amount of stabilizer) lacks system means that researcher and pharmaceutical industry still use trial-and-error method, so nanometer
The stability problem of suspension is still a large order.
Summary of the invention
The object of the invention is that the defect for overcoming the above-mentioned prior art, in same intramolecular combinatorial chemistry functional group with reality
Existing space and electrostatic stabilization provide one kind and significantly improve suspension stability, reduce stabilizing agent dosage, improve stabilizer and medicine
Object compatibility, increases the dissolubility and dissolution rate of drug, and then can improve the cyclovimbuxine D nanometer of vivo biodistribution availability
Preparation.
It is a further object of the present invention to provide the preparation methods of above-mentioned cyclovimbuxine D nanometer formulation.
The technical solution taken for achieving the above object are as follows:
A kind of cyclovimbuxine D nanometer formulation, it is characterised in that the nanometer formulation includes bulk pharmaceutical chemicals cyclovimbuxine D and fits
Combination of stabilizers system is measured, wherein the combination of stabilizers system is made of super-disintegrant and stabilizer.
The drugloading rate of the cyclovimbuxine D nanometer formulation is 1%~85%.
In the cyclovimbuxine D nanometer formulation, combination of stabilizers system dosage is 1%~30%.
The mass ratio of super-disintegrant and stabilizer is 5:1~10 in the combination of stabilizers system.
The super-disintegrant is microcrystalline cellulose, alginic acid, sodium alginate, sodium carboxymethyl starch, cross-linked carboxymethyl fibre
Tie up any one or more in plain sodium, crospovidone, calcium carboxymethylcellulose and low-substituted hydroxypropyl cellulose.
The super-disintegrant is sodium alginate, sodium carboxymethyl starch, croscarmellose sodium, carboxymethyl cellulose
Any one or more in calcium.
The stabilizer is hydroxypropyl methyl cellulose, cyclodextrin, povidone class, glycitols, Tweens surface-active
Any one or more in agent, polyethylene glycols surfactant and polyethylene glycols surfactant.
The preparation method of above-mentioned cyclovimbuxine D nanometer formulation, it is characterised in that its processing step are as follows:
1) it disperses cyclovimbuxine D and appropriate combination of stabilizers system in medium, is uniformly mixing to obtain thick suspension；
2) the thick suspension of gained is placed in nano-milled grinding chamber, with the grinding of 1000rpm~3000rpm speed
Cyclovimbuxine D nanosuspension is made in 30min~120min；
3) cyclovimbuxine D nanosuspension is subjected to curing and drying, obtains cyclovimbuxine D nanoparticle.
The medium is purified water.
Prepared cyclovimbuxine D nanoparticle is further prepared into tablet, capsule.
Super-disintegrant is a kind of polymer containing cellulose chain and ionic structure, can provide simultaneously electrostatic repulsion and
Spatial stability can promote preparation quick humidification and disintegrate with powerful water swellability and capillarity, make effectively
Ingredient accelerates dissolution.
The present invention combines the super-disintegrant comprising cellulose chain and charged group with other stabilizer compatibilities, and 1) sufficiently
The structural advantage for playing super-disintegrant promotes stabilizer to combine or be adsorbed onto drug using its excellent water swelling ability
Microparticle surfaces prevent the aggregation of nanoparticle by providing space resistance or electrostatic repulsion, increase the steady of medicament nano system
It is qualitative；Its good hydrophily simultaneously, increases the affinity of stabilizer and drug, makes to have between stabilizer and drug good
Compatibility；2) cellulose chain for utilizing super-disintegrant, provides spatial stability, prevents nanoparticle nucleation and ionic structure,
Electrostatic repulsion is provided, nanoparticle nucleation speed is restrained；3) synergistic effect between stabilizer has been given full play to, stabilizer is reduced
Dosage improves drugloading rate while guaranteeing preparation stability, avoids anionic
The toxic side effect Deng caused by.
The partial size of the cyclovimbuxine D nano suspension prepared through the invention is small, narrowly distributing, and stability is good, and can show
The dissolubility (cyclovimbuxine D dissolution rate increases 5~30 times) and dissolution rate for increasing drug are write, and then internal life can be improved
Object availability.
Cyclovimbuxine D nanosuspension in the present invention can further be solidified by dry technology, effectively increase storage
Stability in hiding and transportational process keeps the original good nature of nanosuspension.Prepared cyclovimbuxine D nanometer system
Agent, drugloading rate are 1%~85%, and partial size is 20~300nm.
The cyclovimbuxine D nano suspension prepared through the invention passes through atomic force microscope, X-ray photoelectron energy
The characterizing methods such as spectrum, FTIR spectrum, thermogravimetric-differential scanning calorimeter, nuclear-magnetism characterize the mixed of good molecular level
Dissolubility and stronger combination can be the key that cyclovimbuxine D nanosuspension has good stability, as shown in table 1.
The granularity (PS) of the different nano suspending liquids of table 1, polydispersity index (PI) and zeta current potential (ZP).
Detailed description of the invention
Fig. 1 is the molecular structure of cyclovimbuxine D；
Fig. 2 is the Dissolution profiles figure of cyclovimbuxine D；
Fig. 3 is the 3D structure of the present invention preferably super-disintegrant croscarmellose sodium；
Fig. 4 is the atomic force microscopy diagram of cyclovimbuxine D nanoparticle of the present invention；
Fig. 5 is the x-ray photoelectron spectroscopy figure of cyclovimbuxine D nanoparticle of the present invention；
Thermogravimetric-differential scanning calorimetry figure of Fig. 6 cyclovimbuxine D nanoparticle of the present invention；
Fig. 7 is the FTIR spectrum figure of cyclovimbuxine D nanoparticle of the present invention；
Fig. 8 is the nuclear-magnetism figure of cyclovimbuxine D nanoparticle of the present invention.
Specific embodiment
The present invention will be described below by way of examples, it should be understood that example is for illustrating rather than to this
The limitation of invention.The scope of the present invention is determined with core content according to claims.
Embodiment 1
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by freeze-drying:
Preparation method:
By said ratio, at room temperature, by croscarmellose sodium and sour hydroxypropyl methyl cellulose amber
Acid esters is soluble in water, is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, is uniformly mixed, will
Obtained thick suspension all moves into wet milk, and adjusting grinder rotating speed is 2000rpm, passes through outer loop condensed water temperature control
It is ground under the conditions of (< 35 DEG C), obtains cyclovimbuxine D nanosuspension, partial size is 22.4 ± 0.7nm.
The cyclovimbuxine D nanosuspension of preparation is divided in glass evaporating dish, is set pre- in -80 DEG C of ultra low temperature freezers
Freeze, being then placed in freeze drier and adjusting temperature is -45 DEG C, and vacuum degree is 3~6Pa to get cyclovimbuxine D nanometer
Grain.
Embodiment 2
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by spray drying process:
Preparation method:
By said ratio, at room temperature, croscarmellose sodium and HYDROXYPROPYL BETA-CYCLODEXTRIN are dissolved in water
In, it is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, be uniformly mixed, it is thick mixed by what is obtained
Suspension all moves into wet milk, and adjusting grinder rotating speed is 2500rpm, passes through outer loop condensed water temperature control (< 35 DEG C) item
It is ground under part, obtains cyclovimbuxine D nanosuspension, partial size is 58.6 ± 2.3nm.
Adjustable spraying drying parameter: sample introduction speed (8mL/min), inlet air temperature (150 DEG C), rotation speed of fan (2200rpm),
Atomizing pressure (1.8MPa) carries out spray drying treatment to the cyclovimbuxine D nanosuspension of preparation to get HuanweihuangyangxingD
D nanoparticle.
Embodiment 3
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by freeze-drying:
Preparation method:
By said ratio, at room temperature, croscarmellose sodium and HYDROXYPROPYL BETA-CYCLODEXTRIN agent are dissolved in
It in water, is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, be uniformly mixed, it is thick by what is obtained
Suspension all moves into wet milk, and adjusting grinder rotating speed is 3500rpm, passes through outer loop condensed water temperature control (< 35 DEG C)
Under the conditions of grind, obtain cyclovimbuxine D nanosuspension, partial size is 49.6 ± 2.3nm.
The cyclovimbuxine D nanosuspension of preparation is divided in glass evaporating dish, is set pre- in -80 DEG C of ultra low temperature freezers
Freeze, being then placed in freeze drier and adjusting temperature is -45 DEG C, and vacuum degree is 3~6Pa to get cyclovimbuxine D nanometer
Grain.
Embodiment 4
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by spray drying process:
Preparation method:
It is at room temperature, croscarmellose sodium and two kinds of stabilizers of crospovidone is molten by said ratio
Yu Shuizhong is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, is uniformly mixed, by what is obtained
Thick suspension all moves into wet milk, and adjusting grinder rotating speed is 3000rpm, passes through outer loop condensed water temperature control (< 35
DEG C) under the conditions of grind, obtain cyclovimbuxine D nanosuspension, partial size is 23.4 ± 1.2nm.
Adjustable spraying drying parameter: sample introduction speed (8mL/min), inlet air temperature (150 DEG C), rotation speed of fan (2200rpm),
Atomizing pressure (1.8MPa) carries out spray drying treatment to the cyclovimbuxine D nanosuspension of preparation to get HuanweihuangyangxingD
D nanoparticle.
Embodiment 5
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by freeze-drying:
Preparation method:
By said ratio, at room temperature, croscarmellose sodium and HYDROXYPROPYL BETA-CYCLODEXTRIN agent are dissolved in
It in water, is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, be uniformly mixed, it is thick by what is obtained
Suspension all moves into wet milk, and adjusting grinder rotating speed is 3500rpm, passes through outer loop condensed water temperature control (< 35 DEG C)
Under the conditions of grind, obtain cyclovimbuxine D nanosuspension, partial size is 49.6 ± 2.3nm.
The cyclovimbuxine D nanosuspension of preparation is divided in glass evaporating dish, is set pre- in -80 DEG C of ultra low temperature freezers
Freeze, being then placed in freeze drier and adjusting temperature is -45 DEG C, and vacuum degree is 3~6Pa to get cyclovimbuxine D nanometer
Grain.
Embodiment 6
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by freeze-drying:
Preparation method:
By said ratio, at room temperature, croscarmellose sodium and HYDROXYPROPYL BETA-CYCLODEXTRIN agent are dissolved in
It in water, is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, be uniformly mixed, it is thick by what is obtained
Suspension all moves into wet milk, and adjusting grinder rotating speed is 3500rpm, passes through outer loop condensed water temperature control (< 35 DEG C)
Under the conditions of grind, obtain cyclovimbuxine D nanosuspension, partial size is 49.6 ± 2.3nm.
The cyclovimbuxine D nanosuspension of preparation is divided in glass evaporating dish, is set pre- in -80 DEG C of ultra low temperature freezers
Freeze, being then placed in freeze drier and adjusting temperature is -45 DEG C, and vacuum degree is 3~6Pa to get cyclovimbuxine D nanometer
Grain.
Embodiment 7
The preparation of cyclovimbuxine D nanosuspension simultaneously carries out solidification composition to it by spray drying process:
Preparation method:
It is at room temperature, croscarmellose sodium and two kinds of stabilizers of crospovidone is molten by said ratio
Yu Shuizhong is placed on magnetic stirring apparatus and mixes, and cyclovimbuxine D is added in said mixture, is uniformly mixed, by what is obtained
Thick suspension all moves into wet milk, and adjusting grinder rotating speed is 3000rpm, passes through outer loop condensed water temperature control (< 35
DEG C) under the conditions of grind, obtain cyclovimbuxine D nanosuspension, partial size is 23.4 ± 1.2nm.
Adjustable spraying drying parameter: sample introduction speed (8mL/min), inlet air temperature (150 DEG C), rotation speed of fan (2200rpm),
Atomizing pressure (1.8MPa) carries out spray drying treatment to the cyclovimbuxine D nanosuspension of preparation to get HuanweihuangyangxingD
D nanoparticle.
Claims (10)
1. a kind of cyclovimbuxine D nanometer formulation, it is characterised in that the nanometer formulation includes bulk pharmaceutical chemicals cyclovimbuxine D and appropriate
Combination of stabilizers system, wherein the combination of stabilizers system is made of super-disintegrant and stabilizer.
2. cyclovimbuxine D nanometer formulation described in accordance with the claim 1, it is characterised in that the cyclovimbuxine D nanometer formulation
Drugloading rate be 1%~85%.
3. cyclovimbuxine D nanometer formulation described in accordance with the claim 1, it is characterised in that the cyclovimbuxine D nanometer formulation
In, combination of stabilizers system dosage is 1%~30%.
4. according to cyclovimbuxine D nanometer formulation described in claim 1 or 3, it is characterised in that the combination of stabilizers system
The mass ratio of middle super-disintegrant and stabilizer is 5:1~10.
5. cyclovimbuxine D nanometer formulation according to claim 4, it is characterised in that the super-disintegrant is that crystallite is fine
Tie up element, alginic acid, sodium alginate, sodium carboxymethyl starch, croscarmellose sodium, crospovidone, carboxymethyl cellulose
Any one or more in calcium and low-substituted hydroxypropyl cellulose.
6. cyclovimbuxine D nanometer formulation according to claim 5, it is characterised in that the super-disintegrant is alginic acid
Sodium, sodium carboxymethyl starch, croscarmellose sodium, any one or more in calcium carboxymethylcellulose.
7. cyclovimbuxine D nanometer formulation according to claim 4, it is characterised in that the stabilizer is hydroxypropyl methyl
Cellulose, cyclodextrin, povidone class, glycitols, Tweens surfactant, polyethylene glycols surfactant and poly- second two
Any one or more in alcohol surfactants.
8. a kind of preparation method of cyclovimbuxine D nanometer formulation as claimed in any one of claims 1 to 7, feature exist
In its processing step are as follows:
1) it disperses cyclovimbuxine D and appropriate combination of stabilizers system in medium, is uniformly mixing to obtain thick suspension；
2) the thick suspension of gained is placed in nano-milled grinding chamber, 30 min is ground with the rpm speed of 1000 rpm~3000
Cyclovimbuxine D nanosuspension is made in~120 min；
3) cyclovimbuxine D nanosuspension is subjected to curing and drying, obtains cyclovimbuxine D nanoparticle.
9. the preparation method of cyclovimbuxine D nanometer formulation according to claim 8, it is characterised in that the medium is pure
Change water.
10. cyclovimbuxine D nanometer formulation according to claim 8, which is characterized in that prepared cyclovimbuxine D
Nanoparticle is further prepared into tablet, capsule.
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Application publication date: 20190726 |