CN102178722A - Persimmon leaf general flavone sustained-release micropills and preparation method thereof - Google Patents
Persimmon leaf general flavone sustained-release micropills and preparation method thereof Download PDFInfo
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Abstract
The invention discloses persimmon leaf general flavone sustained-release micropills and a preparation method thereof. The persimmon leaf general flavone sustained-release micropills comprise the following components in percentage by mass: 1 to 25 percent of persimmon leaf general flavone, 10 to 50 percent of sodium alginate, 10 to 40 percent of chitosan, 10 to 50 percent of calcium chloride, 0.5 to 5 percent of acetic acid and the balance of water. The persimmon leaf general flavone sustained-release micropills take the persimmon leaf general flavone as active ingredients and are a novel Chinese medicinal sustained-release preparation. General flavone is used as a release amount index, the accumulative release amount of the general flavone of the persimmon leaf general flavone sustained-release micropills in artificial gastric juice and phosphate buffer saline (PBS) buffer solution is 22.97 percent and 34.93 percent respectively within 0.5 hour, does not exceed 45 percent and does not have a burst effect, and results meet the requirement on sustained-release preparations in Chinese pharmacopoeia (the guiding principle of sustained release, controlled release and delayed release in XIXD of 2010 version).
Description
Technical field
The invention belongs to Folium Kaki total flavones preparation technique field, relate to a kind of Folium Kaki total flavone sustained-release micropill and preparation method thereof.
Background technology
According to present existing document and studies show that both at home and abroad, Folium Kaki preparation, persimmon leaf tea and the Folium Kaki extract of the drying of dicotyledonous persimmon, fresh leaf has many-sided physiologically active and medical health care functions such as blood pressure lowering, diuresis, antibacterial, hemostasis, blood fat reducing, the growth of inhibition carcinoma; And the Folium Kaki total flavones main effective ingredient that is it.At present the commercially available prod brain heart is clear, promptly is to be crude drug with the Folium Kaki total flavones, the Chinese patent medicine that is prepared from, and it is with evident in efficacy and win the favorable judgment; Use but remain with the form of general formulation, administration number of times every day three times, administration number of times is more relatively, and the patient is caused bigger burden.
Adopt conventional dosage forms, its defective is that the blood concentration fluctuation of medicine is big or the weak point of holding time in treatment concentration, therefore for reaching therapeutic purposes and reducing toxic and side effects, often need often to take the multiple dosing mode, the compliance that makes the patient take medicine like this descends.
Slow releasing preparation is meant after taking medicine can continue to discharge medicine in a long time, and can reach a class preparation that prolongs drug effect.And slow releasing preparation has overcome the deficiency of conventional formulation just, steady and persistent blood drug level can be provided, thereby reduce medicining times, has improved patient's compliance.
Summary of the invention
The problem that the present invention solves is to provide a kind of Folium Kaki total flavone sustained-release micropill and preparation method thereof, Folium Kaki total flavones preparation becoming slow releasing preparation be can be the patient reduce burden, medicining times can significantly reduce, can make blood drug level steady, avoid peak valley phenomenon, thereby the medicine that has reached with minimum dose obtains drug effect to greatest extent.
The present invention is achieved through the following technical solutions:
A kind of Folium Kaki total flavone sustained-release micropill in mass fraction, comprises 1～25% Folium Kaki total flavones, 10～50% sodium alginate, 5～50% chitosan, 10～40% calcium chloride, 0.5～5% acetic acid, and all the other are water.
The particle diameter of described Folium Kaki total flavone sustained-release micropill is 1～2mm.
Described Folium Kaki total flavones is to obtain the Folium Kaki crude extract after adopting alcohol extracting method that Folium Kaki is extracted, to the Folium Kaki crude extract 55～70 ℃ carry out distilling under reduced pressure after, obtain behind the reuse ethyl acetate extraction.
The mass content of total flavones is 40～70% in the middle of the described Folium Kaki total flavones.
A kind of preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 10～50% fully being dissolved into mass concentration is in 1～5% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 1～5% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 0.5～4% chitosan; Add mass concentration then and be 1～5% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: (2～10): (0.5～10): (0.2～6); Speed with 300～1000r/min evenly stirs 2～5h, leaves standstill 2～5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze, vacuum lyophilization under-10～-60 ℃ of conditions obtains Folium Kaki total flavone sustained-release micropill.
Being prepared as of described Folium Kaki total flavones: obtain the Folium Kaki crude extract after adopting alcohol extracting method that Folium Kaki is extracted; To the Folium Kaki crude extract degree centigrade be 55～70 ℃ carry out distilling under reduced pressure after, the reuse ethyl acetate extraction is collected organic facies, redistillation obtains the Folium Kaki total flavones after removing organic solvent.
It is 0 ℃ of following pre-freeze that described pre-freeze is handled.
Compared with prior art, the present invention has following beneficial technical effects:
Folium Kaki total flavone sustained-release micropill provided by the invention, be with the Folium Kaki total flavones as effective ingredient, be a kind of new-type traditional Chinese slow releasing preparation.As the burst size index, Folium Kaki total flavone sustained-release micropill is in simulated gastric fluid, PBS (phosphate) buffer solution with total flavones, and total flavones cumulative release amount is respectively 22.97%, 34.93% under 0.5h, does not surpass 45%, does not all have burst effect; And sustained release performance is good in PBS buffer solution, and the cumulative release amount has reached 80% at the 12h place, and release profiles Higuchi equation, result meet in the Chinese Pharmacopoeia (2010 editions XIXD slow release, controlled release and slowbreak guidelines) requirement to slow releasing preparation.
Folium Kaki total flavone sustained-release micropill provided by the invention has overcome the defective of present commercially available ordinary preparation, reduces patient's burden, and medicining times can significantly reduce; Can make blood drug level steady, avoid peak valley phenomenon, help reducing the toxic and side effects of medicine, thereby the medicine that has reached with minimum dose obtains drug effect to greatest extent.
The preparation method of Folium Kaki total flavone sustained-release micropill provided by the invention, it is simple to operate, and technology is succinct, and prescription is clear and definite, has no side effect.
Description of drawings
Fig. 1 is a process chart of the present invention;
Fig. 2 is the average release profiles figure in simulated gastric fluid of Folium Kaki total flavone sustained-release micropill;
Fig. 3 is the average release profiles figure in PBS buffer solution of Folium Kaki total flavone sustained-release micropill;
Fig. 4 is the contrast figure of average release profiles in PBS buffer solution and the simulated gastric fluid.
The specific embodiment
Folium Kaki total flavone sustained-release micropill provided by the invention, be with the Folium Kaki total flavones as effective ingredient, be a kind of new-type traditional Chinese slow releasing preparation.Detect below in conjunction with the release in vitro of concrete preparation embodiment and Folium Kaki total flavone sustained-release micropill that the present invention is described in further detail, the explanation of the invention is not limited.
The preparation of Folium Kaki total flavones:
Obtain the Folium Kaki crude extract after adopting alcohol extracting method that Folium Kaki is extracted; To the Folium Kaki crude extract degree centigrade be 55～70 ℃ carry out distilling under reduced pressure after, the reuse ethyl acetate extraction is collected organic facies, redistillation obtains the Folium Kaki total flavones after removing organic solvent.
The mass content of total flavones is 40～70% in the prepared Folium Kaki total flavones.
The concrete grammar reference (Wang Lan, Zhao Lin. the response surface analysis method is optimized Folium Kaki total flavone extracting process [J]. Anhui agricultural sciences, 2011,39 (3): 1370-1373.)
The preparation of embodiment 1 Folium Kaki total flavone sustained-release micropill
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 10% fully being dissolved into mass concentration is in 1% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 1% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 0.5% chitosan; Add mass concentration then and be 1% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 10: 5: 2; Speed with 300r/min evenly stirs 2.5h, leaves standstill 2h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-58 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 8.7%, and remaining quality percentage composition is: 5.0% Folium Kaki total flavones, 50% sodium alginate, 25.8% chitosan, 10.0% calcium chloride, 0.5% acetic acid.
The preparation of embodiment 2 Folium Kaki total flavone sustained-release micropills
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 50% fully being dissolved into mass concentration is in 5% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 0.5% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 4% chitosan; Add mass concentration then and be 1% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 2: 0.5: 0.2; Speed with 700r/min evenly stirs 2h, leaves standstill 2.5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-40 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 6.5%, and remaining quality percentage composition is: the calcium chloride of 25% Folium Kaki total flavones, 50% sodium alginate, 12.5% chitosan 5%, 1.0% acetic acid.
The preparation of embodiment 3 Folium Kaki total flavone sustained-release micropills
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 40% fully being dissolved into mass concentration is in 4% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 2% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 2% chitosan; Add mass concentration then and be 3% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 2.5: 5: 1.5; Speed with 500r/min evenly stirs 5h, leaves standstill 3h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-25 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 4.5%, and remaining quality percentage composition is: the calcium chloride of 9.4% Folium Kaki total flavones, 23.5% sodium alginate, 47% chitosan 14.1%, 1.5% acetic acid.
The preparation of embodiment 4 Folium Kaki total flavone sustained-release micropills
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 25% fully being dissolved into mass concentration is in 5% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 5% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 2.5% chitosan; Add mass concentration then and be 2% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 4: 5: 2; Speed with 1000r/min evenly stirs 2h, leaves standstill 5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-20 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 4.5%, and remaining quality percentage composition is: the calcium chloride of 7.7% Folium Kaki total flavones, 30.8% sodium alginate, 38.5% chitosan 15.5%, 3.0% acetic acid.
The preparation of embodiment 5 Folium Kaki total flavone sustained-release micropills
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 40% fully being dissolved into mass concentration is in 2% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 1% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 4% chitosan; Add mass concentration then and be 5% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 2.55: 3.25: 2.05; Speed with 600r/min evenly stirs 3.5h, leaves standstill 4.5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-35 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 6.5%, and remaining quality percentage composition is: the calcium chloride of 10% Folium Kaki total flavones, 25.5% sodium alginate, 32.5% chitosan 20.5%, 5.0% acetic acid.
The preparation of embodiment 6 Folium Kaki total flavone sustained-release micropills
The preparation method of Folium Kaki total flavone sustained-release micropill may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 50% fully being dissolved into mass concentration is in 2% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 1% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 4% chitosan; Add mass concentration then and be 5% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: 2: 10: 6; Speed with 600r/min evenly stirs 3.5h, leaves standstill 4.5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze below 0 ℃, in vacuum freeze drier,, obtain Folium Kaki total flavone sustained-release micropill in-15 ℃ of dryings.
The water content of calculating Folium Kaki total flavone sustained-release micropill with dry weight method is 4.0%, and remaining quality percentage composition is: the calcium chloride of 5% Folium Kaki total flavones, 10% sodium alginate, 50% chitosan 30.5%, 0.5% acetic acid.
The release in vitro that provides the prepared Folium Kaki total flavone sustained-release micropill of the present invention below detects
Release is meant speed and the degree that medicine discharges under rated condition from slow releasing preparation, controlled release preparation, enteric coated preparation and transdermal patch etc.The preparation of all inspection releases no longer carries out the inspection of disintegration.Measure according to Chinese Pharmacopoeia (2010 version appendix XD drug release determination method and appendix XI XD slow release, controlled release and slowbreak preparation guideline).When extracorporeal releasing test, be index with the burst size of total flavones, the prepared Folium Kaki total flavone sustained-release micropill that goes out is measured.
Burst size with the Folium Kaki total flavones is an index, Folium Kaki total flavone sustained-release micropill to be detected is equally divided into 12 parts, wherein in the simulated gastric fluid medium, measure for 6 parts, in PBS buffer solution medium, measure for all the other 6 parts, measure the cumulative release amount at 0.5h, 2h, 4h, 6h, 8h, 10h, 12h, obtain its both cumulative release amount meansigma methods, draw out release profiles again.Concrete grammar is referring to Chinese Pharmacopoeia (2010 version appendix XD drug release determination method and appendix XI XD slow release, controlled release and slowbreak preparation guideline).
Average accumulated burst size result in simulated gastric fluid is as shown in table 1 for Folium Kaki total flavone sustained-release micropill, and the release profiles of being drawn as shown in Figure 2.
Average accumulated burst size result in table 1 simulated gastric fluid
| Release time (h) | 0.5h | 2h | 4h | 6h | 8h | 10h | 12h |
| Cumulative release amount (%) | 22.97 | 33.42 | 48.2 | 51.09 | 52.83 | 54.76 | 55.42 |
Average accumulated burst size result in PBS buffer solution is as shown in table 2 for Folium Kaki total flavone sustained-release micropill, and the release profiles of being drawn as shown in Figure 3.
Average accumulated burst size result in the table 2PBS buffer solution
| Release time (h) | 0.5h | 2h | 4h | 6h | 8h | 10h | 12h |
| Cumulative release amount (%) | 34.93 | 49.13 | 61.11 | 69.23 | 76.54 | 81.25 | 83.22 |
By table 1, table 2 and Fig. 1, Fig. 2 as can be known, in simulated gastric fluid and PBS buffer solution, the total flavones cumulative release amount of Folium Kaki total flavone sustained-release micropill is respectively 22.97%, 34.93% under 0.5h, do not surpass 45%, illustrate that burst effect does not all appear in prepared micropill in simulated gastric fluid, PBS buffer solution; And subsequently in 2h the cumulative release amount be 49.04%, this has illustrated that the release in PBS buffer solution of prepared micropill is good; And reached 80% in 12h place cumulative release amount, illustrate that tentatively prepared micropill meets officinal slow release requirement.
With zero level equation, one-level equation and Higuchi equation Folium Kaki total flavone sustained-release micropill is carried out match respectively at the release curve of two different mediums of 0.5h～12h respectively, the result is as shown in table 3, two release profiles are put together to be compared, and its result as shown in Figure 4.
The external curve fitting of the different release medium of table 3
More as can be known, the release property of Folium Kaki total flavone sustained-release micropill in PBS buffer solution is fine, does not have the generation of burst effect by the contrast of table 3, Fig. 4, and sustained release performance is good, the release profiles Higuchi equation, and equation is M
t/ M
∞=18.081t
1/2+ 23.665, r
2Be 0.9905; And release profiles does not have in the PBS buffer solution well in simulated gastric fluid, and what match was best is the Higuchi equation, and its equation is M
t/ M
∞=11.448t
1/2+ 19.89, r
2Be 0.8992, but it does not have the generation of burst effect yet.The result meets in the Chinese Pharmacopoeia (2010 editions XIXD slow release, controlled release and slowbreak guidelines) requirement to slow releasing preparation.
Claims (7)
1. a Folium Kaki total flavone sustained-release micropill is characterized in that, in mass fraction, comprises 1～25% Folium Kaki total flavones, 10～50% sodium alginate, 5～50% chitosan, 5～40% calcium chloride, 0.5～5% acetic acid, and all the other are water.
2. Folium Kaki total flavone sustained-release micropill as claimed in claim 1 is characterized in that the particle diameter of described Folium Kaki total flavone sustained-release micropill is 1～2mm.
3. Folium Kaki total flavone sustained-release micropill as claimed in claim 1, it is characterized in that, described Folium Kaki total flavones is to obtain the Folium Kaki crude extract after adopting alcohol extracting method that Folium Kaki is extracted, to the Folium Kaki crude extract 55～70 ℃ carry out distilling under reduced pressure after, obtain behind the reuse ethyl acetate extraction.
4. Folium Kaki total flavone sustained-release micropill as claimed in claim 1 is characterized in that, the mass content of total flavones is 40～70% in the middle of the described Folium Kaki total flavones.
5. the preparation method of a Folium Kaki total flavone sustained-release micropill is characterized in that, may further comprise the steps:
1) the Folium Kaki total flavones of sodium alginate quality 10～50% fully being dissolved into mass concentration is in 1～5% the sodium alginate aqueous solution, to obtain Folium Kaki total flavones-sodium alginate soln;
2) chitosan is dissolved in 0.5～1% the acetic acid aqueous solution, is prepared into mass concentration and is the acetic acid solution of 0.5～4% chitosan; Add mass concentration then and be 1～5% calcium chloride water, stir, obtain mixed solution;
3) Folium Kaki total flavones-sodium alginate soln is joined in the mixed solution, by quality ratio, Folium Kaki total flavones: sodium alginate: chitosan: calcium chloride=1: (2～10): (0.5～10): (0.2～6); Speed with 300～1000r/min evenly stirs 2～5h, leaves standstill 2～5h then, and sucking filtration is also collected the micropill that forms;
4) micropill of collecting is washed with water after, after handling through pre-freeze, vacuum lyophilization under-10～-60 ℃ of conditions obtains Folium Kaki total flavone sustained-release micropill.
6. the preparation method of Folium Kaki total flavone sustained-release micropill as claimed in claim 5 is characterized in that, being prepared as of described Folium Kaki total flavones: obtain the Folium Kaki crude extract after adopting alcohol extracting method that Folium Kaki is extracted; To the Folium Kaki crude extract degree centigrade be 55～70 ℃ carry out distilling under reduced pressure after, the reuse ethyl acetate extraction is collected organic facies, redistillation obtains the Folium Kaki total flavones after removing organic solvent.
7. the preparation method of Folium Kaki total flavone sustained-release micropill as claimed in claim 5 is characterized in that, it is pre-freeze below 0 ℃ that described pre-freeze is handled.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102578110A (en) * | 2011-12-23 | 2012-07-18 | 河海大学 | Preparation method of artemisinin slow-release body |
| CN103989746A (en) * | 2014-05-12 | 2014-08-20 | 武汉理工大学 | Paper mulberry flavone nanometer preparation and preparing method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101637492A (en) * | 2009-08-31 | 2010-02-03 | 陕西师范大学 | Preparation method of total flavonoids in persimmon leaves and application of total flavonoids in liver-protecting drugs and health foods |
-
2011
- 2011-05-06 CN CN 201110117036 patent/CN102178722A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101637492A (en) * | 2009-08-31 | 2010-02-03 | 陕西师范大学 | Preparation method of total flavonoids in persimmon leaves and application of total flavonoids in liver-protecting drugs and health foods |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102578110A (en) * | 2011-12-23 | 2012-07-18 | 河海大学 | Preparation method of artemisinin slow-release body |
| CN103989746A (en) * | 2014-05-12 | 2014-08-20 | 武汉理工大学 | Paper mulberry flavone nanometer preparation and preparing method thereof |
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Application publication date: 20110914 |