CN110037993A - A kind of composition and preparation method of ginsenoside nano controlled-release piece - Google Patents
A kind of composition and preparation method of ginsenoside nano controlled-release piece Download PDFInfo
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- CN110037993A CN110037993A CN201910335707.0A CN201910335707A CN110037993A CN 110037993 A CN110037993 A CN 110037993A CN 201910335707 A CN201910335707 A CN 201910335707A CN 110037993 A CN110037993 A CN 110037993A
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- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A61K9/20—Pills, tablets, discs, rods
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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Abstract
The present invention relates to the compositions and preparation method of a kind of ginsenoside nano controlled-release piece.The composition of the sustained release tablets includes ginsenoside, surfactant, curcuma oil and slow-release material.Nano controlled-release piece obtained can be with slow release active constituent ginsenoside, to promote its bioavilability.This method preparation is simple mild, and bioavilability is high, is conducive to absorption of human body.
Description
Technical field
The present invention relates to the compositions and preparation method of a kind of ginsenoside nano controlled-release piece.
Background technique
Ginsenoside is the main active in ginseng, be the key that evaluation ginseng medical value, with anti-aging,
Improve immunity, antitumor, raising memory isoreactivity.In addition, the panaxan in ginseng also has inhibiting tumour cells living
Property and promote apoptosis of tumor cells activity, while also there is immunoregulation effect, therefore it is wider in antitumor field application.
But ingredient such as Rg3, Rh2, Re, Rk2, Rg5, Rk3, appD with anti-tumor activity etc. are insoluble in ginsenoside
Yu Shui is insoluble in water, causes stomach absorption in human body to be not easy, bioavilability is low, therefore improves the dissolubility of ginsenoside
It is the key that improve it in tumor area clinical application effect.
Patent CN103271891B reports a kind of ginsenoside nano-micelle and preparation method thereof, application and pharmaceutical composition
Ginsenoside is dissolved in organic solvent by object, is removed organic solvent later and is obtained ginsenoside nano-micelle.Patent
CN103585937A report is that ginsenoside is dissolved in organic solvent, is then injected into reaction kettle, is passed through CO2, is adjusted
Pressure is precipitated ginsenoside from reaction kettle to obtain ginsenoside transparent aqueous phase dispersion.Although these methods can lead to
The nanosizing for crossing ginsenoside promotes its dissolution rate, but the limitation of itself is it is also obvious that for example: needing to use in preparation process
To organic solvent, environmental hazard is easily caused, cannot achieve anti-tumor active ingredient in intracorporal sustained release of people etc..
The nanocrystal suspension technology to grow up the 1990s is not necessarily to carrier material, only needs a small amount of surface-active
Agent can directly disperse the submicron colloidal dispersion of referred to as 10-1000nm, be remarkably improved the solubility and dissolution speed of drug
Rate.Preparation method generally includes " Bottom-up " method (precipitation method, emulsion process) and " Top-down " method (media milling process, high pressure
Homogeneous method), the partial size of drug material is effectively reduced in the use of these methods, it is absorbed and utilized to increase it people is intracorporal, from
And preferably play its curative effect.
Bio-adhesive agent can effectively improve the residence time of drug gastrointestinal tract in vivo, increases drug and absorption site is thin
The contact of after birth to improve human body to the bioavilability of drug, and nanocrystalline and bio-adhesive agent combination can be had
Effect realizes the rapid absorption of drug in vivo from the sustained release and drug of bio-adhesive agent, to effectively improve bioavilability.Still
There is not document report that ginsenoside with anti-tumor activity is realized it by nanometer crystal technique combination bio-adhesive technology
The improvement of solubility, to promote its antitumor properties.
Summary of the invention
In view of the deficiencies of the prior art, the present invention provides the compositions and preparation method of a kind of ginsenoside nano controlled-release piece.
The present invention is realized by following technical solution:
A kind of ginsenoside nano controlled-release piece, which is characterized in that raw material composition is as follows, is parts by weight: ginsenoside 10-
80 parts, 10~30 parts of surfactant, 0.1-10 parts of curcuma oil, 1-20 parts of slow-release material；60 parts of preferably ginseng's saponin(e, surface is living
20 parts of agent, 10 parts of curcuma oil, 5 parts of slow-release material of property.
The ginsenoside nano controlled-release piece, which is characterized in that the ginsenoside be Rg3, Rh2, Re, Rk2,
One or more of Rg5, Rk3, appD, preferably Rg3, Rh2.
The ginseng soap nano controlled-release piece, which is characterized in that the surfactant is Tween 80, polyethylene pyrrole Lip river
Alkanone (PVP), methylcellulose (MC), Tai Luoshamu, sodium taurocholate, poloxamer, phosphatidyl choline or lecithin, cholyltaurine
One of sodium or polyethylene glycol are a variety of.
The ginsenoside nano controlled-release piece, which is characterized in that slow-release material includes hydroxypropyl methyl cellulose
(HPMC), carbomer
The preparation method of the ginsenoside nano controlled-release piece, it is characterised in that steps are as follows:
(1) dissolving surfactant as claimed in claim 3 according to weight ratio is 0.1-10:100 in distilled water, is obtained
Solution a；
(2) it disperses ginsenoside as claimed in claim 2 in step (1) the solution a, wherein ginsenoside and molten
The weight ratio of liquid a is 0.5-30:100, stirs to obtain suspension b；
(3) by curcuma oil according to weight ratio 0.1-1:100, curcuma oil is added in the suspension b described in step (2), surpasses
Sound disperses to obtain suspension c；
(4) the suspension c that step (3) obtains is recycled into 10- at 1000bar-3000bar using high pressure homogenization method respectively
35 times to get the nanocrystalline suspension of ginsenoside.
(5) after the nanocrystalline suspension of above-mentioned ginsenoside being carried out filtering with microporous membrane, 0.1-10 parts by weight jelly is added
Dry protective agent is freeze-dried up to lyophilized preparation.
(6) lyophilized preparation and slow-release material that step (5) obtains are ground according to the method for weight ratio 1:0.01-0.1
Mill is uniformly mixed, and 50% ethanol solution softwood is added, and crosses 20-50 mesh, and 60 DEG C of dryings whole grain tabletting in 1 hour obtains ginseng soap
Glycosides nano controlled-release piece.
The ginsenoside nano controlled-release piece, it is characterised in that freeze drying protectant described in step (5) be selected from it is following it
One: glucose, lactose, mannitol, sucrose, trehalose.
Detailed description of the invention
The nanocrystalline SEM electromicroscopic photograph figure of the ginseng sapoglycoside Rg 3 of Fig. 1 preparation
Fig. 2 is the Dissolution profiles of embodiment 1
Fig. 3 is the Dissolution profiles of embodiment 2
Fig. 4 is the Dissolution profiles of embodiment 3
Specific embodiment
Detailed elaboration is made to the present invention below with reference to embodiment, but is not limited to these embodiments specifically recorded.
One, embodiment
Embodiment 1:
Tween 80 and the total 5g of Tylenol sand nurse (weight ratio 6:1) are weighed, is added in 200ml distilled water, dissolution constitutes dispersion and is situated between
Matter (solution a).Ginseng sapoglycoside Rg 3 20g is added, stirs to obtain solution b, adds curcuma oil 2g, ultrasonic disperse obtains suspension c.It will
Acquired solution c continue using high pressure homogenizer at 1500bar homogeneous 25 times to get ginsenoside nanocrystal suspension.
It is fitted into cillin bottle after filtering with microporous membrane after suspension addition 2.7g mannitol made above, set in refrigerator-
80 DEG C of pre-freezes for 24 hours, are then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.
1:0.05 in mass ratio mixes with HPMC and carbomer to carry out ground and mixed uniform, 50% ethanol solution softwood, mistake is added
20 meshes, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 2:
Tween 80 and the total 3g of lecithin (weight ratio 6:1) are weighed, is added in 100ml distilled water, dissolution constitutes decentralized medium
(solution a).Ginseng sapoglycoside Rg 3 10g is added, stirs to obtain solution b, adds curcuma oil 1g, ultrasonic disperse obtains suspension c.Continue
Using high pressure homogenizer at 2000bar homogeneous 30 times to get the nanocrystalline suspension of ginsenoside.
It is fitted into cillin bottle, sets -80 in refrigerator after filtering with microporous membrane after suspension addition 1g mannitol made above
DEG C pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will
1:0.07 in mass ratio mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 30
Mesh, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 3:
Polyvinylpyrrolidone and the total 7g of sodium taurocholate (weight ratio 3:1) are weighed, is added in 100ml distilled water, dissolution is constituted
Decentralized medium (solution a).Ginseng sapoglycoside Rg 3 8g is added, stirs to obtain solution b, curcuma oil 1g is added, ultrasonic disperse is uniform, ultrasound
Disperse to obtain suspension c.Continue using high pressure homogenizer at 2500bar homogeneous 28 times to get the nanocrystalline suspension of ginsenoside.
It is fitted into cillin bottle, sets -80 in refrigerator after filtering with microporous membrane after suspension addition 1.5g sucrose made above
DEG C pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will
1:0.07 in mass ratio mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 40
Mesh, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 4:
Claim polyethylene glycol and the total 10g of sodium taurocholate (weight ratio 4:1), add in 200ml distilled water, dissolution constitutes decentralized medium
(solution a).Ginseng sapoglycoside Rg 3, Re (the two mass ratio 1:1) total 10g is added, stirs to obtain solution b, curcuma oil 1.5g is added, surpasses
Sound is uniformly dispersed, and obtains suspension c.Continue using high pressure homogenizer at 3000bar homogeneous 25 times it is nanocrystalline to get ginsenoside
Suspension.
It is fitted into cillin bottle, sets -80 in refrigerator after filtering with microporous membrane after suspension addition 1g glucose made above
DEG C pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will
1:0.03 in mass ratio mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 40
Mesh, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 5:
Claim polyvinylpyrrolidone and the total 2g of polyethylene glycol (weight ratio 3:1), add in 100ml distilled water, dissolution is constituted
Decentralized medium (solution a).Ginseng saponin Rh 2, Rk2 (the two mass ratio 3:1) total 10g is added, stirs to obtain solution b, turmeric is added
Oily 3g, ultrasonic disperse is uniform, obtains suspension c.Continue using high pressure homogenizer at 2000bar homogeneous 28 times to get ginseng soap
The nanocrystalline suspension of glycosides.
It is fitted into cillin bottle, sets -80 in refrigerator after filtering with microporous membrane after suspension addition 3g glucose made above
DEG C pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will
1:0.3 in mass ratio mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 20 mesh
Sieve, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 6:
Claim sodium taurocholate and the total 4g of poloxamer (weight ratio 4:1), add in 300ml distilled water, dissolution constitutes decentralized medium
(solution a).Ginsenoside appD, Rg5 (the two mass ratio 1:1) total 10g is added, stirs to obtain solution b, curcuma oil 0.5g is added,
Ultrasonic disperse is uniform, obtains suspension c.Continue using high pressure homogenizer at 2000bar homogeneous 30 times to get ginsenoside nanometer
Brilliant suspension.
It is fitted into cillin bottle after filtering with microporous membrane after suspension addition 1g sucrose made above, sets in refrigerator -80 DEG C
Pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will be by
Mass ratio 1:0.3 mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 20 mesh
Sieve, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 7:
Claim phosphatidyl choline and the total 10g of sodium taurocholate (weight ratio 5:1), add in 100ml distilled water, dissolution constitutes dispersion and is situated between
Matter (solution a).Ginseng saponin Rh 2, appD (the two mass ratio 1:1) total 7g is added, stirs to obtain solution b, curcuma oil 2g is added, surpasses
Sound is uniformly dispersed, and obtains suspension c.Continue using high pressure homogenizer at 2500bar homogeneous 27 times it is nanocrystalline to get ginsenoside
Suspension.
It is fitted into cillin bottle, sets -80 in refrigerator after filtering with microporous membrane after suspension addition 2g trehalose made above
DEG C pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will
1:0.07 in mass ratio mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 20
Mesh, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Embodiment 8:
Claim polyethylene glycol and the total 10g of sodium taurocholate (weight ratio 4:1), add in 200ml distilled water, dissolution constitutes decentralized medium
(solution a).Ginseng sapoglycoside Rg 3, Re (the two mass ratio 1:1) total 10g is added, stirs to obtain solution b, curcuma oil 1g, ultrasound is added
It is uniformly dispersed, obtains suspension c.Continue that high pressure homogenizer is used to mix at 2800bar to get ginsenoside is nanocrystalline for homogeneous 25 times
Suspension.
It is fitted into cillin bottle after filtering with microporous membrane after suspension addition 3g lactose made above, sets in refrigerator -80 DEG C
Pre-freeze for 24 hours, is then placed in freeze drier -40 DEG C, 0.10mbar48h is to get the nanocrystalline lyophilized preparation of ginsenoside.It will be by
Mass ratio 1:0.1 mixed with HPMC and carbomer carry out ground and mixed it is uniform, be added 50% ethanol solution softwood, cross 20 mesh
Sieve, 60 DEG C of dryings whole grain tabletting in 1 hour obtain ginsenoside nano controlled-release piece.
Two, the nanocrystalline characterization of ginsenoside
By SEM it can be observed that the nanocrystalline diameter range of ginsenoside obtained in 1 preparation process of embodiment is in 100-
300 nanometers.
Three, the measurement of solubility and slow release effect
Dissolution rate is measured according to 2015 editions the 4th annex XC the second methods of dissolution determination method of Chinese Pharmacopoeia.It measures respectively
Nanocrystalline (i.e. ginsenoside is nanocrystalline straight with ginsenoside bulk pharmaceutical chemicals, the ginsenoside of the equal ginseng sapoglycoside Rg 3s content of embodiment 1
Connect freeze-drying and obtain) and embodiment 1 dissolution in vitro.As a result as shown in Figure of description 2.As a result it can be seen that implementing
Example 1 has more dissolution accumulation degree compared to ginsenoside bulk pharmaceutical chemicals, nanocrystalline compared to ginsenoside has longer release time.
The ginsenoside bulk pharmaceutical chemicals with ginseng sapoglycoside Rg 3s contents such as embodiment 2 and embodiments 3 are determined with same method
Ginsenoside bulk pharmaceutical chemicals, ginsenoside nanocrystalline (i.e. the nanocrystalline directly freezed of ginsenoside dry and obtain) and 2 He of embodiment
The dissolution in vitro of embodiment 3.Display result can be seen that embodiment 2 is compared ginsenoside bulk pharmaceutical chemicals with embodiment 3 and had more
Dissolution accumulation degree, nanocrystalline compared to ginsenoside have longer release time.
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, it is all in spirit of the invention and
Within principle, any modification, equivalent replacement, improvement and so on be should all be included in the protection scope of the present invention.
Claims (6)
1. a kind of ginsenoside nano controlled-release piece, which is characterized in that raw material composition is as follows, is parts by weight: ginsenoside 10-80
Part, 10~30 parts of surfactant, 0.1-10 parts of curcuma oil, 1-20 parts of slow-release material.
2. ginsenoside nano controlled-release piece according to claim 1, which is characterized in that the ginsenoside be Rg3,
One or more of Rh2, Re, Rk2, Rg5, Rk3, appD.
3. ginsenoside nano controlled-release piece according to claim 1, which is characterized in that the surfactant is tween
80, polyvinylpyrrolidone (PVP), methylcellulose (MC), Tai Luoshamu, sodium taurocholate, poloxamer, phosphatidyl choline or ovum
One of phosphatide, Bile Salts or polyethylene glycol are a variety of.
4. ginsenoside nano controlled-release piece according to claim 1, which is characterized in that slow-release material includes hydroxypropyl methyl
Cellulose (HPMC), carbomer.
5. a kind of preparation method of ginsenoside nano controlled-release piece, it is characterised in that steps are as follows:
(1) dissolving surfactant as claimed in claim 3 according to weight ratio is 0.1-10:100 in distilled water, obtains solution
a；
(2) it disperses ginsenoside as claimed in claim 2 in step (1) the solution a, wherein ginsenoside and solution a
Weight ratio be 0.5-30:100, stir to obtain suspension b；
(3) by curcuma oil according to weight ratio 0.1-1:100, curcuma oil, ultrasound point are added in the suspension b described in step (2)
Dissipate to obtain suspension c；
(4) the suspension c that step (3) obtains is recycled into 10-35 at 1000bar-3000bar using high pressure homogenization method respectively
It is secondary to get the nanocrystalline suspension of ginsenoside.
(5) it after the nanocrystalline suspension of above-mentioned ginsenoside being carried out filtering with microporous membrane, adds the freeze-drying of 0.1-10 parts by weight and protects
Shield agent is freeze-dried up to lyophilized preparation.
(6) lyophilized preparation and slow-release material that step (5) obtains grinding is carried out according to the method for weight ratio 1:0.01-0.1 to mix
It closes uniformly, 50% ethanol solution softwood is added, cross 20-50 mesh, 60 DEG C of dryings whole grain tabletting in 1 hour obtains ginsenoside and receives
Rice sustained release tablets.
6. preparation method as claimed in claim 4, it is characterised in that freeze drying protectant described in step (5) be selected from it is following it
One: glucose, lactose, mannitol, sucrose, trehalose.
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