CN105055301A - Fenofibrate drug composition and preparation method thereof - Google Patents
Fenofibrate drug composition and preparation method thereof Download PDFInfo
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- CN105055301A CN105055301A CN201510500131.0A CN201510500131A CN105055301A CN 105055301 A CN105055301 A CN 105055301A CN 201510500131 A CN201510500131 A CN 201510500131A CN 105055301 A CN105055301 A CN 105055301A
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- fenofibrate
- polyvinylpyrrolidone
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Abstract
The invention discloses a fenofibrate drug composition and a preparation method thereof and belongs to the field of pharmaceutic preparations. The drug composition is composed of fenofibrate, polyvinylpyrrolidone and a titanium dioxide nanotube, wherein the mass ratio of fenofibrate to polyvinylpyrrolidone is (1:1)-(1:5) and the mass ratio of fenofibrate to the titanium dioxide nanotube is (1:1)-(1:5). According to the drug composition, the in-vitro dissolution rate of fenofibrate is increased and dissolubility of fenofibrate is improved. The preparation method for the fenofibrate drug composition comprises the following steps: firstly, dissolving fenofibrate and polyvinylpyrrolidone into absolute ethyl alcohol, then adding the titanium dioxide nanotube, loading fenofibrate on the titanium dioxide nanotube by adopting an ultrasonic-assisted hot reflux method, and carrying out vacuum drying. The preparation method for the fenofibrate drug composition is convenient and easy to operate, reproducibility is good and a novel method is provided for insoluble drug loading.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of fenofibrate medicament composition and preparation method thereof.
Background technology
Fenofibrate is a kind of hypolipidemic, and Main Function mechanism suppresses HMG-CoA reductase, reduces cholesterol and synthesizes in cell, thus reduce blood fat.Fenofibrate is applicable to the treatment of the disease such as endogenous hypertriglyceridemia and primary hypercholesterolemia, in the U.S., France, Japan and other countries extensive use, has become now the choice drug for the treatment of hyperlipidemia.But poorly soluble in water of fenofibrate, makes its bioavailability lower, limits giving full play to of its drug effect.Therefore, need to improve the dosage form of fenofibrate.Method conventional in prior art is that fenofibrate is prepared into suspending agent, and drying obtains dry powder doses, then makes tablet, capsule, pill etc.Notification number is that " fenofibrate nanometer suspension and preparation method thereof " of CN101283982B discloses a kind of fenofibrate suspensoid, this suspensoid is made up of fenofibrate, polyvinylpyrrolidone and poloxamer, this suspension stability is poor, easily assemble between granule, the effect therefore improving drug bioavailability is general.
In recent years, many inorganic porous materials, as micropowder silica gel, calcium carbonate, Magnesiumaluminumsilicate etc. are used as the carrier of insoluble drug, improve the dissolution of insoluble drug significantly.CNT and titania nanotube have chemical inertness, good biocompatibility, larger specific surface area and pore volume, can use as pharmaceutical carrier.The carrying method of current titania nanotube is mainly infusion process.This carrying method is simple to operate, but the loading process time is long, efficiency is low, easily causes the dielectric distribution of load on titania nanotube uneven.Other CNTs and titania nanotube carrying method is had in prior art, if notification number is CN103006546B, " bag carries the Synthesis and applications of carbon nanotubes temperature sensitive hydrogel of insoluble drug " discloses the method for carbon nanotube loaded insoluble drug, the method is first by poloxamer and chitosan mixing, after add CNT and carry out poloxamer/chitosan temperature sensitive hydrogel that shear treatment obtains carbon nanotubes, finally insoluble drug is dissolved in solvent and with above-mentioned gel shear treatment and get final product, prepared by this carbon nanotube loaded insoluble drug method is a kind of temperature sensitive type medicine, drug effect restricts by certain condition, improve the limited efficiency of insoluble drug bioavailability.
Summary of the invention
First object of the present invention is to provide a kind of fenofibrate medicament composition, and in this pharmaceutical composition, fenofibrate has higher dissolution rate in vitro, dissolution and bioavailability.
Second object of the present invention is to provide a kind of preparation method of fenofibrate medicament composition.
To achieve these goals, the present invention is by the following technical solutions:
A kind of fenofibrate medicament composition, this pharmaceutical composition forms primarily of fenofibrate, polyvinylpyrrolidone and titania nanotube; The mass ratio of described fenofibrate and polyvinylpyrrolidone is 1:1 ~ 1:5, and the mass ratio of described fenofibrate and titania nanotube is 1:1 ~ 1:5.
Described fenofibrate medicament composition can also comprise pharmaceutically acceptable common drug auxiliary agent.
Described titania nanotube is prepared by the method comprised the following steps:
1) titania nanoparticles is dispersed in sodium hydroxide solution, obtains titanium dioxide suspension;
2) by step 1) gained titanium dioxide suspension is heated to 110 ~ 160 DEG C and after being incubated 20 ~ 30h, is cooled to room temperature, solid-liquid separation, after gained solid water is washed till neutrality, uses nitric acid dousing process, then be washed to neutrality, be drying to obtain.
Step 1) in, mole when concentration of sodium hydroxide solution of described sodium hydroxide and titania nanoparticles meets titania nanotube and can be dispersed in sodium hydroxide solution, preferably, the concentration of described sodium hydroxide solution is 10mol/L, and the mol ratio of described titania nanoparticles and sodium hydroxide is 1:30 ~ 50.
Step 2) in, described nitric acid dousing process is the nitric acid dousing 15min adopting 0.1mol/L; Described drying is vacuum drying at 100 DEG C.
A preparation method for fenofibrate medicament composition, comprises the following steps:
1) get fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol, add titania nanotube, obtain precursor liquid;
2) by step 1) described precursor liquid carries out ultrasonic wave added hot reflux, and final vacuum is dry, to obtain final product.
Step 2) in, the temperature of described ultrasonic wave added hot reflux is 40 ~ 60 DEG C, and ultrasonic power is 175 ~ 225W, and the time is 30 ~ 50min.
Step 2) in, described vacuum drying ensures titania nanotube dry, and not breaking load system, preferably, vacuum drying temperature is 40 ~ 50 DEG C.
Beneficial effect of the present invention:
Fenofibrate medicament composition of the present invention, form primarily of fenofibrate, polyvinylpyrrolidone and titania nanotube, polyvinylpyrrolidone and titania nanotube all have solubilization to fenofibrate, the specific surface area that titania nanotube is larger and pore volume achieve heavy dose and uniform load fenofibrate, increase the contact area of fenofibrate and dissolution medium simultaneously, improve its dissolution rate in vitro and dissolution, and then improve bioavailability.
Fenofibrate medicament composition of the present invention is not containing toxic organic solvents, and effectively avoid the toxic and side effects that organic solvent residual brings, safety is high, and dissolubility is good, and drug loading is high, good stability, and toxic and side effects is low.
The preparation method of fenofibrate medicament composition of the present invention, favorable reproducibility, instrument and equipment is cheap and easy to get, and technical process is simple, is suitable for suitability for industrialized production, for insoluble drug load provides a kind of new method.
Accompanying drawing explanation
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 medicament composition prepared by fenofibrate and embodiment 1;
Fig. 4 is the standard curve of fenofibrate;
Fig. 5 is the dissolution of fenofibrate medicament composition prepared by fenofibrate and embodiment 1 ~ 6.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described in further detail, but does not form any limitation of the invention.
Embodiment 1
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:3, and the mass ratio of fenofibrate and titania nanotube is 1:3.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:40, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is incubated 20h after being heated to 130 DEG C, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:3 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube of fenofibrate 5 times of quality, obtain precursor liquid;
2) by step 1) described precursor liquid is 40 DEG C in temperature, ultrasonic power is under the condition of 200W, ultrasonic wave added hot reflux 50min, after at 50 DEG C vacuum drying, obtain fenofibrate medicament composition S1.
As shown in Figure 1, as shown in Figure 2, as can be seen from Figure 1, titania nanotube is longer, and length is greater than 100nm for the transmission electron microscope picture of fenofibrate medicament composition, and diameter is about 10nm for the transmission electron microscope picture of titania nanotube prepared by the present embodiment; As can be seen from Figure 2, the titania nanotube after load fenofibrate, length is reduced to about 100nm, is evenly distributed.This illustrates that titania nanotube ruptures in the process of ultrasonic wave added hot reflux load fenofibrate, and this makes the easier load of fenofibrate; The polyvinylpyrrolidone contained in fenofibrate medicament composition has peptizaiton, and the titania nanotube therefore after load fenofibrate is evenly distributed.
Embodiment 2
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:1, and the mass ratio of fenofibrate and titania nanotube is 1:1.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:50, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is heated to 110 DEG C and is incubated 30h, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:1 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube identical in quality with fenofibrate, obtain precursor liquid;
2) by step 1) described precursor liquid is 40 DEG C in temperature, ultrasonic power is under the condition of 225W, ultrasonic wave added hot reflux 30min, after at 40 DEG C vacuum drying, obtain fenofibrate medicament composition S2.
Embodiment 3
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:2, and the mass ratio of fenofibrate and titania nanotube is 1:3.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:30, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is heated to 150 DEG C and is incubated 24h, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:2 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube of fenofibrate 3 times of quality, obtain precursor liquid;
2) by step 1) described precursor liquid is 50 DEG C in temperature, ultrasonic power is under the condition of 200W, ultrasonic wave added hot reflux 40min, after at 45 DEG C vacuum drying, obtain fenofibrate medicament composition S3.
Embodiment 4
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:5, and the mass ratio of fenofibrate and titania nanotube is 1:5.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:40, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is heated to 160 DEG C and is incubated 20h, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:5 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube of fenofibrate 5 times of quality, obtain precursor liquid;
2) by step 1) described precursor liquid is 40 DEG C in temperature, ultrasonic power is under the condition of 200W, ultrasonic wave added hot reflux 40min, after at 50 DEG C vacuum drying, obtain fenofibrate medicament composition S4.
Embodiment 5
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:3, and the mass ratio of fenofibrate and titania nanotube is 1:2.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:40, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is heated to 160 DEG C and is incubated 20h, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:3 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube of fenofibrate 2 times of quality, obtain precursor liquid;
2) by step 1) described precursor liquid is 50 DEG C in temperature, ultrasonic power is under the condition of 225W, ultrasonic wave added hot reflux 50min, after at 40 DEG C vacuum drying, obtain fenofibrate medicament composition S5.
Embodiment 6
The present embodiment fenofibrate medicament composition, is made up of fenofibrate, polyvinylpyrrolidone and titania nanotube, and wherein the mass ratio of fenofibrate and polyvinylpyrrolidone is 1:1, and the mass ratio of fenofibrate and titania nanotube is 1:1.
Titania nanotube is prepared by the method comprised the following steps:
1) compound concentration is the sodium hydroxide solution of 10mol/L, then adds titania nanoparticles, and titania nanoparticles and sodium hydroxide mol ratio are 1:40, and lucifuge stirs, and obtains titanium dioxide suspension;
2) by step 1) described titanium dioxide suspension is heated to 150 DEG C and is incubated 24h, and be cooled to room temperature, centrifugalize, after gained solid water is washed till neutrality, with the nitric acid dousing 15min of 0.1mol/L, then be washed to neutrality, 100 DEG C of vacuum dryings, to obtain final product.
The preparation method of the present embodiment fenofibrate medicament composition, comprises the following steps:
1) be that 1:1 gets fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol according to the mass ratio of fenofibrate and polyvinylpyrrolidone, after add the titania nanotube with fenofibrate equal in quality, obtain precursor liquid;
2) by step 1) described precursor liquid is 60 DEG C in temperature, ultrasonic power is under the condition of 175W, ultrasonic wave added hot reflux 50min, after at 40 DEG C vacuum drying, obtain fenofibrate medicament composition S6.
Test example 1
This test example is the sign of fenofibrate and fenofibrate medicament composition uv-visible absorption spectra.
Mensuration fenofibrate and fenofibrate medicament composition (S1) uv-visible absorption spectra characterize it.Result as shown in Figure 3, as can be seen from Figure 3, compared with fenofibrate crude drug, adding of titania nanotube, makes the result of extraction of fenofibrate obtain obvious improvement.Main cause has 2 points below: on the one hand, preparing in fenofibrate/titania nanotube process, the mechanical effect that ultrasound wave produces, chemical effect and cavitation, fenofibrate molecule is entered and is highly dispersed in titania nanotube, in dry run below, effectively avoid fenofibrate particles and reunite.On the other hand, titania nanotube has larger specific surface area, and fenofibrate load is on titania nanotube, and titania nanotube increases the contact area of fenofibrate and dissolution medium, accelerates dissolution rate, improves bioavailability.
Test example 2
This test example is the mensuration of fenofibrate medicament composition dissolution in vitro prepared by embodiment 1 ~ 6.
The standard curve making method of fenofibrate is: accurately get fenofibrate 25mg and be dissolved in 50mL dehydrated alcohol, accurately get above-mentioned solution 0.25,0.5,0.75,1.00,1.25mL, use dehydrated alcohol standardize solution, obtain the fenofibrate standard solution that concentration is 5,10,15,20,25 μ g/mL, adopt ultraviolet spectrophotometer to measure the absorbance of fenofibrate standard solution at 283nm place.With the absorbance at the maximum absorption band 283nm place of fenofibrate for vertical coordinate, concentration is that abscissa draws fenofibrate standard curve, and result as shown in Figure 4.
Sample thief, detect according to the version Pharmacopoeia of the People's Republic of China in 2000 two annex XC second methods, be that the phosphate buffered solution (pH value is for 6.8) of 0.5% sodium lauryl sulphate is as dissolution medium using mass concentration, temperature controls at 37 ± 0.5 DEG C, and rotating speed is 100rpm.Get 25mg fenofibrate and containing the fenofibrate medicament composition of 25mg fenofibrate in 900mL dissolution medium, 5mL (simultaneously supplementing dissolution medium solution 5mL) is sampled respectively when 5min, 10min, 15min, 30min, 45min and 60min, filter through 0.45 μm of microporous filter membrane, discard just filtrate, get subsequent filtrate for subsequent use.According to determined by ultraviolet spectrophotometry absorbance after subsequent filtrate dilution, according to the standard curve shown in Fig. 4, calculate the dissolution of fenofibrate, result as shown in Figure 5.As can be seen from Figure 5, fenofibrate dissolution is up to 72%, and dissolution rate is slower; The dissolution of the fenofibrate medicament composition of embodiment 1 ~ 6, all apparently higher than fenofibrate, is up to 100%, improves the bioavailability of fenofibrate, and dissolution rate is very fast, can a large amount of stripping at short notice.
Claims (6)
1. a fenofibrate medicament composition, is characterized in that, this pharmaceutical composition forms primarily of fenofibrate, polyvinylpyrrolidone and titania nanotube; The mass ratio of described fenofibrate and polyvinylpyrrolidone is 1:1 ~ 1:5, and the mass ratio of described fenofibrate and titania nanotube is 1:1 ~ 1:5.
2. fenofibrate medicament composition according to claim 1, is characterized in that, described titania nanotube is prepared by the method comprised the following steps:
1) titania nanoparticles is dispersed in sodium hydroxide solution, obtains titanium dioxide suspension;
2) by step 1) gained titanium dioxide suspension is heated to 110 ~ 160 DEG C and after being incubated 20 ~ 30h, is cooled to room temperature, solid-liquid separation, after gained solid water is washed till neutrality, uses nitric acid dousing process, then be washed to neutrality, be drying to obtain.
3. fenofibrate medicament composition according to claim 1 and 2, is characterized in that, step 1) concentration of described sodium hydroxide solution is 10mol/L, the mol ratio of described titania nanoparticles and sodium hydroxide is 1:30 ~ 50.
4. a preparation method for fenofibrate medicament composition as claimed in claim 1, is characterized in that, comprises the following steps:
1) get fenofibrate and polyvinylpyrrolidone is dissolved in dehydrated alcohol, add titania nanotube, obtain precursor liquid;
2) by step 1) described precursor liquid carries out ultrasonic wave added hot reflux, and final vacuum is dry, to obtain final product.
5. the preparation method of fenofibrate medicament composition according to claim 4, is characterized in that, step 2) described in the temperature of ultrasonic wave added hot reflux be 40 ~ 60 DEG C, ultrasonic power is 175 ~ 225W, and the time is 30 ~ 50min.
6. the preparation method of fenofibrate medicament composition according to claim 4, is characterized in that, step 2) described in vacuum drying temperature be 40 ~ 50 DEG C.
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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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| 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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| 王艳丽等: "《二氧化钛纳米管作为肿瘤药物载体系统的体外负载及释放》", 《上海大学学报（自然科学版）》 * |
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