CN105055301B - A kind of fenofibrate medicament composition and preparation method thereof - Google Patents
A kind of fenofibrate medicament composition and preparation method thereof Download PDFInfo
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- CN105055301B CN105055301B CN201510500131.0A CN201510500131A CN105055301B CN 105055301 B CN105055301 B CN 105055301B CN 201510500131 A CN201510500131 A CN 201510500131A CN 105055301 B CN105055301 B CN 105055301B
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Abstract
The invention discloses a kind of fenofibrate medicament compositions and preparation method thereof, belong to field of pharmaceutical preparations.The pharmaceutical composition is mainly made of fenofibrate, polyvinylpyrrolidone and titania nanotube, and the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:1~1:5, the mass ratio of fenofibrate and titania nanotube is 1:1~1:5.The dissolution rate in vitro and dissolution rate of fenofibrate can be improved in the pharmaceutical composition.The preparation method of fenofibrate medicament composition, fenofibrate and polyvinylpyrrolidone are dissolved in absolute ethyl alcohol first, after titania nanotube is added, using ultrasonic wave added heat flow back method fenofibrate is supported on titania nanotube, be dried in vacuo later.The preparation method of the fenofibrate medicament composition is simple and easy to operate, favorable reproducibility, and a kind of new method is provided for insoluble drug load.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of fenofibrate medicament composition and preparation method thereof.
Background technology
Fenofibrate is a kind of hypolipidemic, and main function mechanism is to inhibit HMG-CoA reductase, reduces cholesterol thin
Intracellular synthesizes, to reduce blood fat.Fenofibrate is suitable for endogenous hypertriglyceridemia and primary hypercholesterolemia
The treatment of equal diseases has become the choice drug for the treatment of hyperlipidemia now in the U.S., France, Japan and other countries extensive use.
But the dissolubility of fenofibrate in water is poor so that its bioavilability is relatively low, limits giving full play to for its drug effect.Therefore,
It needs to be improved the dosage form of fenofibrate.Method commonly used in the prior art is that fenofibrate is prepared into suspending agent, is done
It is dry to obtain dry powder doses, then tablet, capsule, pill is made etc..Notification number is the " fenofibrate nanometer suspension of CN101283982B
And preparation method thereof " a kind of fenofibrate suspension is disclosed, the suspension is by fenofibrate, polyvinylpyrrolidone and pool Lip river
Husky nurse composition, this suspension stability is poor, aggregation is easy between particle, therefore improve the effect one of drug bioavailability
As.
In recent years, many inorganic porous materials, such as superfine silica gel powder, calcium carbonate, aluminum magnesium silicate are used as insoluble drug
Carrier, significantly improve the dissolution rate of insoluble drug.Carbon nanotube and titania nanotube have chemical inertness, good
Good biocompatibility, larger specific surface area and Kong Rong, can use as pharmaceutical carrier.Titania nanotube at present
Carrying method is mainly infusion process.This carrying method is easy to operate, but the loading process time is long, efficiency is low, be easy to cause
The dielectric distribution being supported on titania nanotube is uneven.There are other carbon nanotubes and titania nanotube in the prior art
Carrying method, as notification number " contains the preparation of the carbon nanotubes temperature sensitive hydrogel of insoluble drug for CN103006546B
And application " method that discloses carbon nanotube loaded insoluble drug, this method first mixes poloxamer and chitosan, after
Carbon nanotube is added and carries out poloxamer/chitosan temperature sensitive hydrogel that shear treatment obtains carbon nanotubes, finally by slightly solubility
Drug be dissolved in solvent and with above-mentioned gel shear treatment to obtain the final product, what which prepared is a kind of
Temperature sensitive type drug, drug effect are restricted by certain condition, and the effect for improving insoluble drug bioavilability is limited.
Invention content
The first purpose of the invention is to provide a kind of fenofibrate medicament composition, fenofibrate in the pharmaceutical composition
With higher dissolution rate in vitro, dissolution rate and bioavilability.
Second object of the present invention is to provide a kind of preparation method of fenofibrate medicament composition.
To achieve the goals above, the present invention uses following technical scheme：
A kind of fenofibrate medicament composition, the pharmaceutical composition is mainly by fenofibrate, polyvinylpyrrolidone and two
Titanium oxide nanotubes form；The mass ratio of the fenofibrate and polyvinylpyrrolidone is 1:1~1:5, the fenofibrate
Mass ratio with titania nanotube is 1:1~1:5.
The fenofibrate medicament composition can also include pharmaceutically acceptable common drug auxiliary agent.
The titania nanotube is prepared by method comprising the following steps：
1) titania nanoparticles are dispersed in sodium hydroxide solution, obtain titanium dioxide suspension；
2) after titanium dioxide suspension obtained by step 1) being heated to 110~160 DEG C and keeping the temperature 20~30h, it is cooled to room
Temperature is separated by solid-liquid separation, after obtained solid is washed to neutrality, is handled, then be washed to neutrality, be drying to obtain with nitric acid dousing.
In step 1), the concentration of mole when sodium hydroxide solution of the sodium hydroxide and titania nanoparticles is full
Sufficient titania nanotube may be homogenously dispersed in sodium hydroxide solution, it is preferred that the sodium hydroxide solution it is a concentration of
The molar ratio of 10mol/L, the titania nanoparticles and sodium hydroxide is 1:30~50.
In step 2), the nitric acid dousing processing is the nitric acid dousing 15min using 0.1mol/L；The drying be
It is dried in vacuo at 100 DEG C.
A kind of preparation method of fenofibrate medicament composition, includes the following steps：
1) negated nobert and polyvinylpyrrolidone are dissolved in absolute ethyl alcohol, and titania nanotube is added, obtains forerunner
Liquid；
2) the step 1) precursor liquid is subjected to ultrasonic wave added heat reflux, rear vacuum drying to get.
In step 2), the temperature of the ultrasonic wave added heat reflux is 40~60 DEG C, and ultrasonic power is 175~225W, time
For 30~50min.
In step 2), titania nanotube is dried in the vacuum drying guarantee, and not breaking load system, preferably
, vacuum drying temperature is 40~50 DEG C.
Beneficial effects of the present invention：
The fenofibrate medicament composition of the present invention, is mainly received by fenofibrate, polyvinylpyrrolidone and titanium dioxide
Mitron forms, and polyvinylpyrrolidone and titania nanotube have solubilization, titania nanotube to fenofibrate
Larger specific surface area and Kong Rong realizes large dosage and uniformly loads fenofibrate, while increasing fenofibrate and dissolution
The contact area of medium improves its dissolution rate in vitro and dissolution rate, and then improves bioavilability.
The fenofibrate medicament composition of the present invention is free of toxic organic solvents, effectively organic solvent residual is avoided to bring
Toxic side effect, safe, dissolubility is good, and drugloading rate is high, and stability is good, and toxic side effect is low.
The preparation method of the fenofibrate medicament composition of the present invention, favorable reproducibility, instrument and equipment is cheap and easy to get, technique mistake
Journey is simple, is suitable for industrialized production, and a kind of new method is provided for insoluble drug load.
Description of the drawings
Fig. 1 is the transmission electron microscope picture of titania nanotube prepared by embodiment 1；
Fig. 2 is the transmission electron microscope picture of fenofibrate medicament composition prepared by embodiment 1；
Fig. 3 is the uv-visible absorption spectra of fenofibrate and the fenofibrate medicament composition of the preparation of embodiment 1；
Fig. 4 is the standard curve of fenofibrate；
Fig. 5 is the dissolution rate of fenofibrate and the fenofibrate medicament composition of Examples 1 to 6 preparation.
Specific implementation mode
With reference to specific embodiment, invention is further described in detail, but does not constitute any limit to the present invention
System.
Embodiment 1
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:3, the quality of fenofibrate and titania nanotube
Than being 1:3.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:40, it is protected from light stirring, obtains titanium dioxide suspension；
2) it is heated to step 1) the titanium dioxide suspension to keep the temperature 20h after 130 DEG C, be cooled to room temperature, centrifuge,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:3 negated noberts and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, the rear titania nanotube that 5 times of quality of fenofibrate are added obtains precursor liquid；
2) it is 40 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 200W, ultrasonic wave added heat is returned
Flow 50min, after at 50 DEG C vacuum drying to get fenofibrate medicament composition S1.
The transmission electron microscope picture of titania nanotube manufactured in the present embodiment is as shown in Figure 1, fenofibrate medicament composition
Transmission electron microscope picture as shown in Fig. 2, it will be seen from figure 1 that titania nanotube is longer, length is more than 100nm, a diameter of
10nm or so；Figure it is seen that the titania nanotube after load fenofibrate, length are reduced to 100nm or so, point
Cloth is uniform.This explanation titania nanotube during ultrasonic wave added heat flows back load fenofibrate is broken, this makes
Fenofibrate is obtained to be easier to load；The polyvinylpyrrolidone contained in fenofibrate medicament composition has peptizaiton, because
Titania nanotube after this load fenofibrate is evenly distributed.
Embodiment 2
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:1, the quality of fenofibrate and titania nanotube
Than being 1:1.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:50, it is protected from light stirring, obtains titanium dioxide suspension；
2) step 1) the titanium dioxide suspension is heated to 110 DEG C and keeps the temperature 30h, be cooled to room temperature, centrifuged,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:1 negated nobert and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, rear addition and fenofibrate titania nanotube identical in quality obtain precursor liquid；
2) it is 40 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 225W, ultrasonic wave added heat is returned
Flow 30min, after at 40 DEG C vacuum drying to get fenofibrate medicament composition S2.
Embodiment 3
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:2, the quality of fenofibrate and titania nanotube
Than being 1:3.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:30, it is protected from light stirring, obtains titanium dioxide suspension；
2) step 1) the titanium dioxide suspension is heated to 150 DEG C and kept the temperature for 24 hours, is cooled to room temperature, centrifuged,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:2 negated noberts and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, the rear titania nanotube that 3 times of quality of fenofibrate are added obtains precursor liquid；
2) it is 50 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 200W, ultrasonic wave added heat is returned
Flow 40min, after at 45 DEG C vacuum drying to get fenofibrate medicament composition S3.
Embodiment 4
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:5, the quality of fenofibrate and titania nanotube
Than being 1:5.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:40, it is protected from light stirring, obtains titanium dioxide suspension；
2) step 1) the titanium dioxide suspension is heated to 160 DEG C and keeps the temperature 20h, be cooled to room temperature, centrifuged,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:5 negated noberts and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, the rear titania nanotube that 5 times of quality of fenofibrate are added obtains precursor liquid；
2) it is 40 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 200W, ultrasonic wave added heat is returned
Flow 40min, after at 50 DEG C vacuum drying to get fenofibrate medicament composition S4.
Embodiment 5
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:3, the quality of fenofibrate and titania nanotube
Than being 1:2.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:40, it is protected from light stirring, obtains titanium dioxide suspension；
2) step 1) the titanium dioxide suspension is heated to 160 DEG C and keeps the temperature 20h, be cooled to room temperature, centrifuged,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:3 negated noberts and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, the rear titania nanotube that 2 times of quality of fenofibrate are added obtains precursor liquid；
2) it is 50 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 225W, ultrasonic wave added heat is returned
Flow 50min, after at 40 DEG C vacuum drying to get fenofibrate medicament composition S5.
Embodiment 6
The present embodiment fenofibrate medicament composition, by fenofibrate, polyvinylpyrrolidone and titania nanotube
Composition, the wherein mass ratio of fenofibrate and polyvinylpyrrolidone are 1:1, the quality of fenofibrate and titania nanotube
Than being 1:1.
Titania nanotube is prepared by method comprising the following steps：
1) compound concentration is the sodium hydroxide solution of 10mol/L, titania nanoparticles is then added, titanium dioxide is received
Rice grain is 1 with sodium hydroxide molar ratio:40, it is protected from light stirring, obtains titanium dioxide suspension；
2) step 1) the titanium dioxide suspension is heated to 150 DEG C and kept the temperature for 24 hours, is cooled to room temperature, centrifuged,
After obtained solid is washed to neutrality, with the nitric acid dousing 15min of 0.1mol/L, then it is washed to neutrality, 100 DEG C of vacuum drying,
To obtain the final product.
The preparation method of the present embodiment fenofibrate medicament composition, includes the following steps：
1) it is 1 according to the mass ratio of fenofibrate and polyvinylpyrrolidone:1 negated nobert and polyvinylpyrrolidone
It is dissolved in absolute ethyl alcohol, the rear titania nanotube being added with fenofibrate phase homogenous quantities obtains precursor liquid；
2) it is 60 DEG C in temperature by the step 1) precursor liquid, under conditions of ultrasonic power is 175W, ultrasonic wave added heat is returned
Flow 50min, after at 40 DEG C vacuum drying to get fenofibrate medicament composition S6.
Test example 1
This test example is the characterization of fenofibrate and fenofibrate medicament composition uv-visible absorption spectra.
Fenofibrate is measured to characterize it with fenofibrate medicament composition (S1) uv-visible absorption spectra.Knot
Fruit is as shown in figure 3, from figure 3, it can be seen that compared with fenofibrate bulk pharmaceutical chemicals, the addition of titania nanotube makes fenofibrate
Special result of extraction has obtained apparent improvement.Main cause has at following 2 points：On the one hand, fenofibrate/titanium dioxide is being prepared
During titanium nanotube, mechanical effect, chemical effect and the cavitation that ultrasonic wave generates make fenofibrate molecule enter simultaneously high
Degree is distributed in titania nanotube, in drying process below, effectively avoids fenofibrate particles reunion.It is another
There is larger specific surface area, fenofibrate to be supported on titania nanotube for aspect, titania nanotube, titanium dioxide
Nanotube increases the contact area of fenofibrate and dissolution medium, accelerates dissolution rate, improves bioavilability.
Test example 2
This test example is the measurement of fenofibrate medicament composition dissolution in vitro prepared by Examples 1 to 6.
The standard curve making method of fenofibrate is：Accurate negated nobert 25mg is dissolved in 50mL absolute ethyl alcohols, accurately
Above-mentioned solution 0.25,0.5,0.75,1.00,1.25mL are taken, with absolute ethyl alcohol constant volume, obtains a concentration of 5,10,15,20,25 μ g/
The fenofibrate standard solution of mL measures absorbance of the fenofibrate standard solution at 283nm using ultraviolet specrophotometer.
Using the absorbance at the maximum absorption band 283nm of fenofibrate as ordinate, it is bent that a concentration of abscissa draws fenofibrate standard
Line, the results are shown in Figure 4.
Sample is taken, according to version in 2000《Pharmacopoeia of People's Republic of China》Two the second methods of annex XC are detected, with matter
The phosphate buffer solution (pH value 6.8) for measuring a concentration of 0.5% lauryl sodium sulfate is used as dissolution medium, temperature control to exist
37 ± 0.5 DEG C, rotating speed 100rpm.Take 25mg fenofibrates and fenofibrate medicament composition containing 25mg fenofibrates in
In 900mL dissolution mediums, 5mL is sampled in 5min, 10min, 15min, 30min, 45min and 60min respectively and (while being supplemented molten
Go out medium solution 5mL), it is filtered through 0.45 μm of miillpore filter, discards primary filtrate, take subsequent filtrate spare.Subsequent filtrate dilution after according to
Determined by ultraviolet spectrophotometry absorbance calculates the dissolution rate of fenofibrate, as a result such as according to standard curve shown in Fig. 4
Shown in Fig. 5.From fig. 5, it can be seen that fenofibrate dissolution rate is up to 72%, and dissolution rate is slower；Examples 1 to 6
The dissolution rate of fenofibrate medicament composition improves the life of fenofibrate obviously higher than fenofibrate, up to 100%
Object availability, and dissolution rate is very fast, can largely dissolve out in a short time.
Claims (4)
1. a kind of fenofibrate medicament composition, which is characterized in that the pharmaceutical composition is mainly by fenofibrate, polyvinyl pyrrole
Alkanone and titania nanotube composition；The mass ratio of the fenofibrate and polyvinylpyrrolidone is 1:1~1:5, it is described non-
The mass ratio of nobert and titania nanotube is 1:1~1:5；
The fenofibrate medicament composition is made by the method included the following steps：
1）Negated nobert and polyvinylpyrrolidone are dissolved in absolute ethyl alcohol, and titania nanotube is added, obtains precursor liquid；
2）By step 1）The precursor liquid carries out ultrasonic wave added heat reflux, rear vacuum drying to get；The ultrasonic wave added heat reflux
Temperature be 40 ~ 60 DEG C, ultrasonic power be 175 ~ 225W, the time be 30 ~ 50min；The vacuum drying temperature is 40 ~ 50
℃。
2. fenofibrate medicament composition according to claim 1, which is characterized in that the titania nanotube be by
Prepared by method comprising the following steps：
1）Titania nanoparticles are dispersed in sodium hydroxide solution, titanium dioxide suspension is obtained；
2）By step 1）After gained titanium dioxide suspension is heated to 110 ~ 160 DEG C and keeps the temperature 20 ~ 30h, it is cooled to room temperature, solid-liquid
Separation, after obtained solid is washed to neutrality, is handled, then be washed to neutrality with nitric acid dousing, is drying to obtain.
3. fenofibrate medicament composition according to claim 2, which is characterized in that step 1）The sodium hydroxide solution
A concentration of 10mol/L, the molar ratio of the titania nanoparticles and sodium hydroxide is 1:30~50.
4. a kind of preparation method of fenofibrate medicament composition as described in claim 1, which is characterized in that including following step
Suddenly：
1）Negated nobert and polyvinylpyrrolidone are dissolved in absolute ethyl alcohol, and titania nanotube is added, obtains precursor liquid；
2）By step 1）The precursor liquid carries out ultrasonic wave added heat reflux, rear vacuum drying to get；The ultrasonic wave added heat reflux
Temperature be 40 ~ 60 DEG C, ultrasonic power be 175 ~ 225W, the time be 30 ~ 50min；The vacuum drying temperature is 40 ~ 50
℃。
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| CN103006546A (en) * | 2013-01-03 | 2013-04-03 | 桂林理工大学 | Preparation and application of carbon nano tube-containing thermo-sensitive type gel entrapping for indissolvable drug |
| CN103768039A (en) * | 2014-01-03 | 2014-05-07 | 郑州大学 | Active targeting solid lipid nano-particle as well as preparation method and application thereof |
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2015
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| CN103006546A (en) * | 2013-01-03 | 2013-04-03 | 桂林理工大学 | Preparation and application of carbon nano tube-containing thermo-sensitive type gel entrapping for indissolvable drug |
| CN103768039A (en) * | 2014-01-03 | 2014-05-07 | 郑州大学 | Active targeting solid lipid nano-particle as well as preparation method and application thereof |
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