CN101219123A - Tea polyphenol pellet and method for preparing the same - Google Patents
Tea polyphenol pellet and method for preparing the same Download PDFInfo
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- CN101219123A CN101219123A CNA2007101987006A CN200710198700A CN101219123A CN 101219123 A CN101219123 A CN 101219123A CN A2007101987006 A CNA2007101987006 A CN A2007101987006A CN 200710198700 A CN200710198700 A CN 200710198700A CN 101219123 A CN101219123 A CN 101219123A
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Abstract
The invention provides a tea polyphenols micro-pill that is prepared from tea polyphenols and pharmaceutical adjuvant, which is characterized in that the pharmaceutical adjuvant is an excipient and a bonding agent. The tea polyphenol micro-pill comprises (by weight percentage) that: tea polyphenols 20-80 percent, the excipient 15-79 percent and the bonding agent 1-5 percent. The tea polyphenols micro-pill can be made into sustained-release preparation or enteric-coated preparation. The pharmacological experiment indicates that the tea polyphenols micro-pill of the invention has good effect on radioresistance, anti-aging, etc.
Description
Technical field
The present invention relates to the medicine food technical field, be specifically related to micropill that a kind of tea polyphenols makes and preparation method thereof.
Background technology
Tea polyphenols (Tea Polyphenols) is the general name of polyphenols in the Folium Camelliae sinensis, comprises flavanol compound, anthocyanin class, flavonoid, flavonols and phenolic acids etc.Wherein important with flavanol compound material (a few theine).Tea polyphenols claims tea to tan or tea tannin again, is one of Main Ingredients and Appearance that forms the Folium Camelliae sinensis color, smell and taste, also is one of Main Ingredients and Appearance that has in the Folium Camelliae sinensis health care.Contain abundant tea polyphenols (formal name used at school Camelliasinensis) in the book on Chinese herbal medicine Chiba IT tea.Scientist such as Taide professor studies show that under the Chiba, Japan university mountain, detoxifcation of tea polyphenols isoreactivity material tool and radiation resistance, can stop radioactive substance to invade bone marrow effectively, and strontium 90 and cobalt 60 are excreted rapidly, be described as by health and medical circle " radiation jinx ", tea polyphenols is that human beings'health has been constructed the defence line of resisting radiation injury together.Tea polyphenols can also be removed free radical superfluous in the body, stop lipid peroxidation, human body immunity improving power, slow down aging.
At present, be subjected to consumers in general's approval deeply about the product of tea polyphenols, these products are common tablet and capsule substantially, but above-mentioned dosage form exists disintegration time long; A certain position point disintegrate in vivo has certain zest to gastric mucosa; Shortcomings such as bioavailability is low.Based on the problems referred to above, we will develop micropill technology transfer rapidly to field of food at field of medicaments, this product made discharge micro-pill type product controlled and that bioavailability is high in vivo, to satisfy consumers in general's demand better.
Generally to add pharmaceutic adjuvants such as excipient, binding agent, porogen, disintegrating agent, plasticizer [" design and development of sustained-release and controlled release preparation " Yan Yaodong etc. in the preparation process of pellet preparations, Chinese Medicine science and technology publishing house, 2006,257-258], in the research process of micropill, need carry out deep research to formulation preparation, just can prepare qualified micropill product.
Summary of the invention
For these reasons, we carry out deep analysis to tea polyphenols physics and chemical property, with the dissolution is index, test by science, determine that pharmaceutic adjuvant is excipient and binding agent, and excipient and binding agent are carried out determining of weight percentage: " pharmaceutic adjuvant is excipient and binding agent, and wherein tea polyphenols weight fraction content is 20%-80% in the pellet preparations; the excipient weight percentage is 15%-79%, and the percentage composition of binding agent is 1%-5% "; By this complete technical scheme, those skilled in the art just can prepare satisfactory pellet preparations according to the preparation method of the micropill of prior art; Above-mentioned pellet preparations can be prepared into satisfactory slow releasing preparation or enteric coated preparation, help user's compliance.We at the tea polyphenol pellet formulation preparation method on the basis of existing technology, carry out deep research, the unexpected discovery carried out sufficient pulverizing with tea polyphenols and excipient, be that micronization is pulverized, make tea polyphenols be distributed in the excipient well, make particle diameter reach micro powder grade, make micropill with such material, in the process of Shi Fanging, main constituent can discharge rapidly along with the dissolving of excipient in vivo, and this product is made up of the little micropill unit of hundreds of grain, disperse area big in vivo, the organ contacted specific surface area is also big with absorbing, admittedly onset is rapid after making this product take, and the bioavailability height.
The objective of the invention is provides a kind of novel formulation pellet preparations of tea polyphenols in order to overcome the problems of the prior art.
Another object of the present invention is to provide a kind of preparation method of tea polyphenol pellet preparation, this method is simple, convenient, easy operating.
Tea polyphenols of the present invention can be an extract, also can be effective ingredient, prepares according to existing literature method or patented method.
The objective of the invention is to be achieved through the following technical solutions:
A kind of tea polyphenol pellet preparation, it is to be prepared from by tea polyphenols and pharmaceutic adjuvant, it is characterized in that pharmaceutic adjuvant is excipient and binding agent, wherein the tea polyphenols weight percentage is 20-80% in the pellet preparations, the excipient weight percentage is 15-79%, and the percentage composition of binding agent is 1-5%.
The slow release formulation of above-mentioned tea polyphenol pellet formulation preparation.
Or the enteric dosage form of above-mentioned tea polyphenol pellet formulation preparation.
Wherein said excipient is one or more the mixture that is selected from sucrose, dextrin, starch, microcrystalline Cellulose, lactose, methylcellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, ethyl cellulose, acrylic resin, hydroxypropyl emthylcellulose and the gelatin.
Wherein said binding agent is kind in polyvinylpyrrolidone, cellulose family, resinae, saccharide, the animal acid or several mixture.
Pellet preparations of the present invention can be according to technique scheme, is prepared with the preparation method of prior art pellet preparations, also can be prepared according to following method:
A kind of preparation method of tea polyphenol pellet preparation the steps include:
(1) gets tea polyphenols, add excipient, be crushed to micronized rank, mixing;
(2) in the solution in binding agent is water-soluble, dehydrated alcohol or the aquiferous ethanol;
(3) adopt the micropill forming technique to make micropill.
Wherein said micropill forming technique comprises agitation procedure, method of extruding and kneading to pellets or the centrifugal fluidized granulation method of being selected from.
In the conventional art, the degree of grinding of medical material or extract is coarse powder (in take, particle diameter 850um ± 70um, cross 24 mesh sieves), middle powder (in take, particle diameter 250um ± 9.9um, cross 65 mesh sieves), fine powder (wound usefulness, particle diameter 150um ± 6.6um, cross 100 mesh sieves), fine powder (eye dripping usefulness, particle diameter 125um ± 5.8um, 120 mesh sieves) and impalpable powder (particle diameter 75um ± 4.1um, 200 mesh sieves), the present invention then adopts micronization technology that tea polyphenol powder is broken into micropowder, its mean diameter is generally less than 10um, mainly is distributed in 1～20um.Method of micronization can adopt method of the prior art: physical pulverization method, for example mechanical impact crusher, jet mill, ball mill, vibromill, stirring mill, Raymond mill, high-pressure micronizer machine etc.; The physical chemistry synthetic method comprises spray drying, original position micronization and supercritical fluid technology etc.Compare with traditional crushing technology, the main advantage of this technology is: increase the effective ingredient absorbance, improve bioavailability.The dissolution rate of effective ingredient is directly proportional with its specific grain surface is long-pending, and specific surface area and particle diameter are inversely proportional to.Therefore, the particle diameter of effective ingredient is thin more, and then its specific surface area is big more, helps the stripping of effective ingredient more.According to the study, the intestines and stomach is about 15um to the optimal absorption granularity of material grains, and the granule of micron composition has just reached this optimal absorption fineness level; Because the micron order effective ingredient obviously increases at the gastrointestinal dissolubility, thereby increases its bioavailability, has accelerated its onset time.
Micropill forming technique among the present invention can adopt any micropill forming technique of the prior art, and these technology include but not limited to: agitation procedure, method of extruding and kneading to pellets or centrifugal fluidized granulation method etc.
Beneficial effect of the present invention is:
(1) in the prior art, there is not Preparing Tea-polyphenol to become the technology of pellet preparations, we are by carrying out deep analysis to tea polyphenols physics and chemical property, with the dissolution is index, test by science, determine that pharmaceutic adjuvant is excipient and binding agent, and there is not other pharmaceutic adjuvant, and excipient and binding agent are carried out determining of weight percentage: " pharmaceutic adjuvant is excipient and binding agent; wherein the tea polyphenols weight percentage is 20-80% in the pellet preparations; the excipient weight percentage is 15-79%, and the percentage composition of binding agent is 1-5% "; By this complete technical scheme, those skilled in the art just can prepare satisfactory pellet preparations according to the preparation method of the micropill of prior art; Above-mentioned pellet preparations can be prepared into satisfactory slow releasing preparation or enteric coated preparation, help user's compliance.Micropill of the present invention is compared with prior art tea polyphenols technology, and supplementary product consumption is few, and steady quality has curative effect repeatability preferably, and adverse reaction rate is low; This product micropill increases at the area that absorbs the organ surface distributed, bioavailability is improved and local excitation is less or eliminate, and selects for consumers in general provide more consumption.
(2) we are at the tea polyphenol pellet formulation preparation method on the basis of existing technology, carry out deep research, the unexpected discovery carried out sufficient pulverizing with tea polyphenols and excipient, be that micronization is pulverized, make tea polyphenols be distributed in the excipient well, make particle diameter reach micro powder grade, make micropill with such material, in the process of Shi Fanging, main constituent can discharge rapidly along with the dissolving of excipient in vivo, and this product is made up of the little micropill unit of hundreds of grain, disperse area big in vivo, the organ contacted specific surface area is also big with absorbing, admittedly make that this product newspaper is rapid with the back onset, the bioavailability height.
One, dissolution contrast experiment
The micropill that micropill of the present invention can be made rapid release or discharge at a slow speed by different prescriptions as required belongs to multiple agent type, can be made up of the micropill of different drug release rates.Also can pass through packaging technique, micropill be made positioned releasing micropills such as stomach dissolution type, enteric solubility.This micropill can encapsulatedly be made capsule, or tabletting makes tablet, or makes other various packaged forms.We have carried out release in vitro contrast test (experimental technique is according to Pharmacopoeia of People's Republic of China version dissolution in 2005 check and analysis method) with this product and commercially available tablet and conventional capsule agent, and the result is as follows:
The conventional capsule agent (the Henan manufacturer production, lot number: 070503) 30 minutes dissolution rates are 45% in gastric juice;
Tablet (the Guangzhou manufacturer production, lot number: 061104) 30 minutes dissolution rates are 52% in gastric juice;
And this product 30 minutes dissolution rates in gastric juice promptly reach 90%.
Simultaneously, we can also by different coating materials, make product become the product of different sizes such as slow release, controlled release, enteric by micropill being carried out the technology of coating.
Therefore after we make slow-release micro-pill with this product, have 12 hours slow-release function, can effectively control the burst size of tea polyphenols, safety, effectiveness are better; Slow-release micro-pill can make blood drug level reach curative effect concentration rapidly, and keeps steady, long valid density, and blood concentration fluctuation is little; This product has reduced the accumulated dose of taking than common dosage form simultaneously, has reduced the number of times of taking of consumer.We find that by the release in vitro simulation test its release profiles is obvious with this product, and when 2h, release is more than 30%; During 5h, release is more than 50%; During 8h, release is more than 70%; During 12h, release is more than 90%.
Have the consumer of stomach illness for some, for fear of the influence of product to stomach, this product is absorbed by the body better, we can also make enteric coated preparation with this product, promptly by micropill is carried out enteric coated technology, make product reach the purpose of enteric.We carry out the release in vitro simulation test with this enteric coated micropill and find, micropill in simulated gastric fluid 2 hours without any stripping, outward appearance is also without any variation, and when we were put into its taking-up in the simulated intestinal fluid dissolution test, its 30 minutes releases had just reached more than 85%.
Two, pellet preparations research process
Get tea polyphenols, method [" design and development of sustained-release and controlled release preparation " Yan Yaodong etc. according to existing document micropill preparation, Chinese Medicine science and technology publishing house, 2006,257-258] be prepared, can not prepare qualified pellet preparations, therefore, we further study, and experimentize by following experimental technique:
1, the tea polyphenols weight percentage is 20% in the pellet preparations, and the excipient weight percentage is 79%, and the percentage composition of material mixture is 1%.
2, the tea polyphenols weight percentage is 80% in the pellet preparations, and the excipient weight percentage is 15%, and the percentage composition of binding agent is 5%.
3, the tea polyphenols weight percentage is 50% in the pellet preparations, and the excipient weight percentage is 47%, and the percentage composition of binding agent is 3%.
4, the tea polyphenols weight percentage is 75% in the pellet preparations, and the excipient weight percentage is 21%, and the percentage composition of binding agent is 4%.
5, the tea polyphenols weight percentage is 25% in the pellet preparations, and the excipient weight percentage is 73%, and the percentage composition of binding agent is 2%.
Get the micropill of above-mentioned different experiments scheme,, detect according to the Pharmacopoeia of the People's Republic of China (version in 2005) appendix dissolution detection method.
Experimental result: the micropill of above-mentioned different schemes reaches more than 85% at 30 minutes dissolution, proves absolutely that the pellet preparations that the present invention prepares has scientific meaning.
Three, pharmacological evaluation
1, defying age experiment
Experiment medicine: tea polyphenol pellet preparation of the present invention; Commercially available tea polyphenols sheet.
Experimental technique:
With aged Shanghai is the mice random packet, male and female half and half, and the administration group is irritated stomach preparation 90mg/kg of the present invention, 3 weeks of administration altogether every day.Blood 50 μ l are got in the mice docking, measure the activity of SOD according to the autoxidizable method of pyrogallol.With the mice sacrificed by decapitation, take out liver, inhale with filter paper and remove residual blood, shred and weigh, add normal saline, be prepared into 1% homogenate, adopt the thiobarbituricacid method to measure the content of LPO in the hepatic tissue.Experimental result sees Table 1:
The different tea polyphenol preparations of table 1 are to the influence of SOD, LPO
| Group | The group number | SODμl/l | LPOnmol/g |
| The commercially available tea polyphenols tablet of matched group group | 10 10 | 18.77±6.45 27.14±7.44 * | 501±99 397±82 ** |
| Tea polyphenol pellet group of the present invention | 10 | 35 26±8.14 **# | 324±48 **# |
Annotate: compare with matched group
*P＜0.01,
*P＜0.05; Compare #P＜0.05 with positive controls
2, radioprotective experiment
According to literature method [the scallop polypeptide is right～radiation-induced mouse chest cell effect of apoptosis and the preliminary Mechanism Study thereof of (60) cobalt gamma-rays] different tea polyphenol preparations are carried out radiation-resistant research, the result shows that tea polyphenol pellet of the present invention has better radiation resistance than commercially available tea polyphenols tablet.
Experiment conclusion: above-mentioned experiment shows that tea polyphenol pellet preparation of the present invention has better pharmacological action, proves absolutely that pellet preparations of the present invention has practical significance.
Four, preparation embodiment
Embodiment 1
A kind of tea polyphenol pellet preparation, pharmaceutic adjuvant are excipient and binding agent, and wherein the tea polyphenols weight percentage is 20% in the pellet preparations, and the excipient weight percentage is 79%, and the percentage composition of binding agent is 1%, prepares qualified pellet preparations.
Embodiment 2
A kind of tea polyphenol pellet preparation, pharmaceutic adjuvant are excipient and binding agent, and wherein the tea polyphenols weight percentage is 80% in the pellet preparations, and the excipient weight percentage is 15%, and the percentage composition of binding agent is 5%.
Embodiment 3
A kind of tea polyphenol pellet preparation, pharmaceutic adjuvant are excipient and binding agent, and wherein the tea polyphenols weight percentage is 24% in the pellet preparations, and the excipient weight percentage is 74.5%, and the percentage composition of binding agent is 1.5%.
Embodiment 4
A kind of tea polyphenol pellet preparation, pharmaceutic adjuvant are excipient and binding agent, and wherein the tea polyphenols weight percentage is 55% in the pellet preparations, and the excipient weight percentage is 42%, and the percentage composition of binding agent is 3%.
Embodiment 5
A kind of tea polyphenol pellet preparation, pharmaceutic adjuvant are excipient and binding agent, and wherein the tea polyphenols weight percentage is 70% in the pellet preparations, and the excipient weight percentage is 26%, and the percentage composition of binding agent is 4%.
Pellet preparations among the foregoing description 1-5 can require to be prepared into slow releasing preparation or enteric coated preparation according to difference.
The pellet preparations binding agent among the foregoing description 1-5 and the selection of excipient are selected to get final product according to the conventional adjuvant of pharmaceutics pellet preparations.
The preparation method of micropill gets final product according to the preparation method of existing document micropill among the foregoing description 1-5.
Embodiment 6
Get the raw material for standby of following prescription: tea polyphenols 20 grams (20%), microcrystalline Cellulose 79 grams (79%), hydroxypropyl emthylcellulose 1 gram (1%);
Embodiment 7
Get the raw material for standby of following prescription: tea polyphenols 80 grams (80%), sucrose, dextrin, starch, Celluloasun Microcrystallisatum, lactose and methylcellulose be totally 15 grams (15%), polyvinylpyrrolidone 5 grams (5%);
Embodiment 8
Get the raw material for standby of following prescription: tea polyphenols 50 grams (50%), sucrose 47 grams (47%), cellulose family, resinae and saccharide be totally 3 grams (3%);
Embodiment 9
Get the raw material for standby of following prescription: tea polyphenols 25 grams (25%), sodium carboxymethyl cellulose, ethyl cellulose, acrylic resin, hydroxypropyl emthylcellulose and gelatin be totally 73 grams (73%), resinae 2 grams (2%);
Embodiment 10
Get the raw material for standby of following prescription: tea polyphenols 65 grams (65%), starch is totally 31 grams (31%), and cellulose family, resinae and saccharide be totally 4 grams (2%);
Embodiment 11
Get the raw material for standby of following prescription: tea polyphenols 50g (50%), sucrose 48g (48%), polyvinylpyrrolidone 2g (2%);
Embodiment 12
Get the raw material for standby of following prescription: tea polyphenols 75g (75%), starch 23g (23%), polyvinylpyrrolidone 2g (2%)
The foregoing description 1-12 can also can prepare according to following method according to the art methods preparation:
Embodiment 13
(1) tea polyphenols of getting above-mentioned formula ratio adds excipient, is crushed to micronization rank, mixing with ball mill;
(2) binding agent is dissolved in 75% alcoholic solution;
(3) adopt method of extruding and kneading to pellets to make micropill.
Embodiment 14
(1) tea polyphenols of getting above-mentioned formula ratio adds excipient, is crushed to micronization rank, mixing with ball mill;
(2) binding agent is soluble in water;
(3) adopt agitation procedure to make micropill.
Embodiment 15
(1) tea polyphenols of getting above-mentioned formula ratio adds excipient, is crushed to micronization rank, mixing with ball mill;
(2) binding agent is dissolved in the dehydrated alcohol;
(3) adopt the centrifugal fluidized granulation method to make micropill.
Annotate: the present invention's concrete technical scheme required for protection is not limited to the concrete combination of the expressed technical scheme of the foregoing description.
Claims (7)
1. tea polyphenol pellet preparation, it is to be prepared from by tea polyphenols and pharmaceutic adjuvant, it is characterized in that pharmaceutic adjuvant is excipient and binding agent, wherein the tea polyphenols weight percentage is 20-80% in the pellet preparations, the excipient weight percentage is 15-79%, and the percentage composition of binding agent is 1-5%.
2. the slow release formulation of a kind of tea polyphenol pellet formulation preparation according to claim 1.
3. the enteric dosage form of a kind of tea polyphenol pellet formulation preparation according to claim 1.
4. according to described a kind of tea polyphenol pellet preparation of claim 1, wherein said excipient is one or more the mixture that is selected from sucrose, dextrin, starch, Celluloasun Microcrystallisatum, lactose, methylcellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, ethyl cellulose, acrylic resin, hydroxypropyl emthylcellulose and the gelatin.
5. a kind of tea polyphenol pellet preparation according to claim 1, wherein said binding agent are one or more the mixture in polyvinylpyrrolidone, cellulose family, resinae, saccharide, the animal acid.
6. according to the preparation method of each described a kind of tea polyphenol pellet preparation of claim 1-5, the steps include:
(1) gets tea polyphenols, add excipient, be crushed to micronized rank, mixing;
(2) in the solution in binding agent is water-soluble, dehydrated alcohol or the aquiferous ethanol;
(3) adopt the micropill forming technique to make micropill.
7. preparation method according to claim 6, wherein said micropill forming technique comprise agitation procedure, method of extruding and kneading to pellets or the centrifugal fluidized granulation method of being selected from.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007101987006A CN101219123A (en) | 2007-12-27 | 2007-12-27 | Tea polyphenol pellet and method for preparing the same |
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| CNA2007101987006A CN101219123A (en) | 2007-12-27 | 2007-12-27 | Tea polyphenol pellet and method for preparing the same |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104473775A (en) * | 2014-11-21 | 2015-04-01 | 湖州凯普秀生物科技有限公司 | Tea polyphenol coated system, as well as preparation method and product thereof |
| CN104870544A (en) * | 2012-12-11 | 2015-08-26 | 三星精密化学株式会社 | Composition for forming complex, complex formed therefrom, and composition for oral administration including said complex |
-
2007
- 2007-12-27 CN CNA2007101987006A patent/CN101219123A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104870544A (en) * | 2012-12-11 | 2015-08-26 | 三星精密化学株式会社 | Composition for forming complex, complex formed therefrom, and composition for oral administration including said complex |
| CN104870544B (en) * | 2012-12-11 | 2017-11-28 | 乐天精密化学株式会社 | For the composition for forming compound, the compound being consequently formed and for the oral composition containing the compound |
| CN104473775A (en) * | 2014-11-21 | 2015-04-01 | 湖州凯普秀生物科技有限公司 | Tea polyphenol coated system, as well as preparation method and product thereof |
| CN104473775B (en) * | 2014-11-21 | 2017-04-05 | 湖州凯普秀生物科技有限公司 | A kind of tea polyphenols parcel system and preparation method thereof and product |
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Open date: 20080716 |