CN101862363B - General ginsenoside primary osmotic pump tablet and preparation method thereof - Google Patents
General ginsenoside primary osmotic pump tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of medicine, in particular to a general ginsenoside primary osmotic pump tablet. The general ginsenoside primary osmotic pump tablet comprises two parts: a tablet core and a tablet coating, and the general ginsenoside primary osmotic pump tablet is prepared from the following ingredients in percentage by weight: (1) the tablet core; 1 to 2 parts of general ginsenoside, 1/3 to 2/3 part of osmotic pressing active substances, a mixture of lactose and starch according to a weight ratio of 1 to 2/0.5 to 1, and 3 to 4 weight percent of talcum powder, wherein the content of the general ginsenoside is higher than or equal to 80 percent, and the osmotic active substances are one kind or several kinds of materials in sodium chloride, glucose, sucrose and mannite; and (2) coating liquid: release-control coating auxiliary materials of 2 percent GA/PEG400 acetone solution, wherein the volume ratio of the CA to the PEG 400 is 3 to 4/1. The general ginsenoside in the preparation of the invention can be released into acting organs at a constant speed to exert the effect, the medicine release speed and the internal absorption are constant, the effective blood medicine concentration undulation is small, the maintenance time is long, the medicine taking times are few, the occurrence of the peak valley phenomenon is avoided, and the safety and the effectiveness are improved.
Description
The application is that application number is: 200610021969.2, and denomination of invention is: a kind of controlled releasing penetrant pump and its production and use, the applying date is dividing an application of 28 days application for a patent for invention of JIUYUE in 2006.
Technical field
The present invention relates to a kind of controlled releasing penetrant pump, is to be the controlled release preparation that feedstock production forms with the Radix Ginseng total saponins, specifically is elementary osmotic pump tablet, belongs to field of medicaments.
Background technology
The Oros preparation is the preparation that the even constant speed of the energy that utilizes the osmotic pressure principle to make ground discharges medicine, is ideal a kind of in the controlled release formulations for oral administration up to now.Its rate of releasing drug is comparable by diffusion controlled release barrier release (as the skeleton medicine-releasing system) high several magnitude, and perseverance to release feature more obvious, its advantage has: 1. can provide the strong dose thing; 2. the character of scalable semipermeable membrane, thickness, surface area and release aperture etc. are to obtain required rate of releasing drug or program; 3. rate of releasing drug is constant, and irrelevant with environment (as pH, stirring, feed situation etc.), and the inside and outside dependency is good, and individual variation is little; 4. can be used for regulating blood level, it is low to be suitable for therapeutic index especially, the medicine that the half-life is short; 5. can be by the multiple medicine of different rates while controlled release; 6. reduce medicining times, improve patient's compliance; 7. abirritate and untoward reaction; 8. same prescription can be suitable for multiple different medicine with technology.
Osmotic pump preparation is mainly used in the half-life weak point or needs frequent drug administration at present, or the narrow medicine of treatment window, and the medicine for the treatment of chronic diseases such as cardiovascular disease, angina pectoris, hypertension, asthma.Preparation requires: the consumption of principal agent is no more than 0.5g; Have favorable dissolution properties, the medicine that dissolubility is excessive and too small, the medicine of half-life too short (less than 1h) or half-life long (greater than 24h) all is not suitable for making controlled releasing penetrant pump.
Chinese medicine Radix Ginseng Panax ginseng C.A.Mey. medicinal history is long, is one of maximum Chinese medicine of clinical practice, and drug effect is conclusive, effective.(2) basic research such as the chemical constituent of relevant Radix Ginseng, pharmacological action are more, proved that ginsenoside (ginsenoside) is a topmost active component in the Radix Ginseng, can represent Radix Ginseng overwhelming majority drug effect.The extraction of Radix Ginseng total saponins, separation, purification process maturation, existing marketable material, and effective dose is less.Modern a large amount of experimental study shows that the main active component Radix Ginseng total saponins of Radix Ginseng is having definite curative effect aspect defying age and the treatment alzheimer disease (alzheimer disease is called for short AD).
At present, be that the ordinary preparation of active component mainly contains tablet, injection, granule, capsule, oral liquid etc. with the Radix Ginseng total saponins, must frequent drug administration, and " peak valley " phenomenon, clinical practice inconvenience appear easily; Untoward reaction is more, can produce than serious adverse nervous system, cardiovascular system, digestive system etc., even occur deadly, also can cause allergic reaction, electrolyte disturbance, ring be from side reactions such as reaction, blurring of visions.In addition because saponin component complexity in the Radix Ginseng total saponins, various saponin component indication differences, drug release time difference, the drug release time of Radix Ginseng total saponins preparation has uncertainty.
Still do not have effective dosage form at present and overcome defectives such as " peak valley " phenomenon, untoward reaction are many, be convenient to clinical use.
Summary of the invention
Technical problem to be solved by this invention provides a kind of general ginsenoside primary osmotic pump tablet, to overcome " peak valley " problem that the clinical application of Radix Ginseng total saponins ordinary preparation occurs.
The invention provides a kind of Radix Ginseng total saponins controlled releasing penetrant pump, it is to be raw material by Radix Ginseng total saponins, the preparation that adding osmotic pressure active substance, controlled release coat adjuvant are prepared from, Radix Ginseng total saponins is contained in the ginsenoside Re in wherein every preparation unit, 60mg～150mg, drug release time: 0～12 hour.
The used Radix Ginseng total saponins of preparation of the present invention is in ginsenoside Re's content 〉=80%, Radix Ginseng total saponins of the present invention is that commercially available Radix Ginseng total saponins product, commercially available total Radix Ginseng total saponins product are to extract with each agents area of Radix Ginseng that get saponin extract be that active component prepares the controlled release preparation that gets, extract can be extracted by agents areas such as root, stem, leaves, purification, preferably ginseng's stem and leaf total saponins extract.
Wherein, according to test determination release rate result, controlled release preparation of the present invention begins steadily to discharge medicine about 6～8 hours, and control blood drug level is in a long time than stable status, avoids occurring " peak valley " phenomenon.
Radix Ginseng total saponins is contained in the ginsenoside Re in every preparation unit, is 80mg; The unit of being meant of preparation unit wherein of the present invention taking dose, as every in tablet, every of capsule, the every 10ml of oral liquid or the like, said preparation unit is the direct reflection of people's taking dose.Because the clinical daily dose of taking of Radix Ginseng total saponins is little, only be 75～150mg, it is that 75～150mg designs that the every preparation unit of controlled release preparation content of dispersion is based on clinical common daily dose, and controlled release preparation is administered twice every day, and the Radix Ginseng total saponins content of every preparation unit is 80mg.
Controlled releasing penetrant pump of the present invention is to contain the preparation that following weight proportion raw material and adjuvant are prepared from:
Proportioning raw materials is divided into the sheet heart or capsule heart prescription and coating fluid prescription two parts:
(1) each composition weight proportioning of the sheet heart or the capsule heart: the adjuvant of 1～2 part of Radix Ginseng total saponins, 1/3～2/3 part of osmotic pressure active substance, adding conventional preparation tablet or capsule prepares the heart in blocks or the capsule heart;
(2) coating solution component: one or both mixing among ethyl cellulose or the cellulose acetate CA, plasticizer, porogen, solvent.
Wherein, Radix Ginseng total saponins content is in ginsenoside Re 〉=80%, osmo active substance be sodium chloride, glucose, sucrose, mannitol wherein one or more; Plasticizer is one or more in dibutyl phthalate DBP, diethyl phthalate DEP, triethyl citrate TEC, PEG class, glycerol, the propylene glycol; Porogen is a class or the multiclass of PEG class, PVP, sucrose, salt apoplexy due to endogenous wind; Solvent is one or more in the organic solvents such as acetone, isopropyl alcohol, ethanol, chloroform or methyl acetate.
The selection of plasticizer is because during low temperature, the easy embrittlement of cellulose acetate membrane is so need adding; Porogen is used to control drug release rate; The coating solvent can make coating material have dissolubility preferably, makes coating material be dispersed in dosage surface.
Controlled releasing penetrant pump of the present invention is: micro-porous osmotic pump tablet, double-layer osmotic pump tablet (push-pull osmotic pump tablet), elementary osmotic pump tablet, osmotic pump capsule.
Wherein, the thickness of the coating membrane of controlled release preparation of the present invention is 2.5～5%w/w, and its underpants' film thickness is represented with clothing film rate of body weight gain.
The invention provides a kind of method for preparing controlled releasing penetrant pump, key step is for granulating, prepare the sheet heart or capsule, coating, punching.Concrete steps are as follows:
(1) the preparation sheet heart or the capsule heart: get Radix Ginseng total saponins extract, lactose, starch and sodium chloride, make granule behind the mixing, suppress in blocks or encapsulated;
(2) preparation coating solution;
(3) art for coating: the sheet heart or the capsule heart are placed coating pan, under rolling, spray into coating solution, the clothing film increase weight to thickness be 2.5～5%, promptly get controlled releasing penetrant pump of the present invention.
Elementary osmotic pump tablet of the present invention is to be prepared from by the following weight proportion raw material:
Proportioning raw materials is divided into sheet heart prescription and coating prescription two parts:
(1) each composition weight of the sheet heart: 1～2 part of Radix Ginseng total saponins, 1/3～2/3 part of osmotic pressure active substance, lactose, starch are with weight proportion 1～2: 0.5～1 to mix, Pulvis Talci percentage by weight heavy in order to adjustment sheet be 3～4%;
Wherein, Radix Ginseng total saponins content 〉=80%, osmo active substance be sodium chloride, glucose, sucrose, mannitol wherein one or more;
(2) each amounts of components of coating solution: controlled release coat adjuvant 2%CA/PEG400 (3～4: 1) acetone soln;
Wherein the consumption of coating prescription is not limited to above-mentioned consumption, can or dwindle according to above-mentioned adjuvant use amount ratio expansion.
The preparation method of elementary osmotic pump tablet of the present invention comprises the steps:
(1) sheet heart preparation: take by weighing following weight proportion raw material and adjuvant: Radix Ginseng total saponins 75～150g, lactose 210～250g, starch 100～136g, sodium chloride 25～41g, an amount of, the Pulvis Talci 2～4% of 5%PVP ethanol liquid, mixing granulation, granulate, tabletting get the sheet heart;
(2) ratio of the preparation of coating solution: CA and PEG400 is 3～4: 1;
(3) art for coating: select turnadle pan coating for use, adopt set art for coating parameter that the sheet heart is carried out coating, get Radix Ginseng total saponins extract, lactose, starch and sodium chloride, make granule behind the mixing, compacting places coating pan in flakes, under rolling, spray into coating solution, the clothing film increase weight to thickness be 2%～5%, the drug release hole of making a call to a diameter 0.54um in medicated layer one side center, promptly.
The technology of elementary osmotic pump tablet is simple, can be used for general medicine, gastrointestinal moisture enters label by semipermeable membrane behind the drug oral, make medicine be dissolved into saturated solution or suspension, osmotic pressure in the film is higher, owing to have big permeable pressure head inside and outside the film, drug solution then continues to pump by small delivery aperture, its discharge water yield interior with penetrating into film equates, and be molten most up to the medicine of label; The double-layer osmotic pump tablet complex process can be used for the medicine of poorly water-soluble, and coyote hole is divided into two chambers with a flexible polymeric film, the top indoor medicine that contains.Forming solution or suspension after meeting water, be salt or extender below, and sheet wraps outward with semipermeable membrane again, makes a call to a small delivery aperture on leaning on a Room above the tablet unilateral.The material dissolution expansion produced pressure after hydrone penetrated into lower floor.Promote barrier film the upper strata medicinal liquid is ejected aperture; The micropore permeation pump blade technolgy is simple, is used for water solublity medicine preferably, and the porogen by selecting to suit, permeation-promoter etc., and the thickness of control coating membrane, the size and the number of drug release hole flow out medicine equably from small delivery aperture; Controlled release capsule technology is simple, and it is big or the medicine of special odor arranged to be used for zest; Can select different preparations to use according to clinical needs.
According to the experimental study gained, because it is various to influence the factor complexity of osmotic pump preparation rate of releasing drug and time, and cross action is arranged, can not know by inference by general theoretical logic research.And the consumption selection of raw material of the present invention, adjuvant, supplementary material and preparation process and the selection of process parameters report by existing controlled release preparation can't come in direct derivation, is to need through a large amount of experiment sieving combining with theoretical analysis and next.
At present, influence the inhomogeneity principal element of clothing film and have (the Zhang Zhaowang such as roundness of the kind of the rotating speed of coating pan, coating material and concentration and consumption, coating temperature, plain sheet, the Fan Biting chief editor. pharmacy of Chinese materia medica [M] Shanghai: Shanghai science tech publishing house, 2002:427～429), because factor is more, the clothing film uniformity is wayward.Osmotic pump controlled-releasing tablet of the present invention has solved the uppity defective of existing osmotic pumps technology clothing film uniformity: by selecting the prescription of coating solution among the present invention, and the coating preparation technology parameter screened, The selection result is as follows: the concentration 2% of 35～40 ℃ of coating kettle temperatures, coating solution, coating solution flow velocity 2ml/min, atomizing pressure are 45 ° at 0.6kg/cm2, coating pan rotating speed 20r/min, coating pan inclination angle.
Because Radix Ginseng total saponins is soluble in water, " prominent releasing " phenomenon may take place in the osmotic pump tablet of making, and does not reach the purpose of controlled release, slows down its release so add blocker in controlled releasing penetrant pump of the present invention in addition.Used blocker is CMC-Na:HPMC (weight proportion 1: 1), adds when granulating.
The present invention also provides the purposes of this controlled releasing penetrant pump in the medicine of preparation defying age, the treatment deficiency of vital energy.Controlled releasing penetrant pump of the present invention is mainly used in the cardiopalmus that the deficiency of vital energy causes, breathes hard, and fatigue and weak, indigestion and loss of appetite diseases such as grade etc. also can be used for daily health caring, reach the effect of slow down aging, building body.Drug release behavior according to the Radix Ginseng total saponins osmotic pump preparation studies show that: the pH of dissolving-out method, blade rotating speed and dissolution medium drug release behavior to the Radix Ginseng total saponins osmotic pump preparation in 3.5～7.6 scope does not have the significance influence, and these factors and internal milieu factor have certain dependency.And saponin component complexity in the Radix Ginseng total saponins, various saponin component drug release time differences, at the indication difference, therefore different indication drug release time difference.
Preparation of the present invention is that Radix Ginseng total saponins is developed into osmotic pump controlled release administration system, Radix Ginseng total saponins wherein can be discharged into the effect organ to constant speed and bring into play therapeutical effect, absorb constant in its drug release rate and the body, the effective blood drug concentration fluctuation is little, and can keep the long period, not only can reduce medicining times, and " peak valley " phenomenon that can avoid the ordinary preparation frequent drug administration to occur, thereby avoid the generation of side effect, safety and effectiveness are improved.Radix Ginseng total saponins is developed to the senile dementia disease therapeuticing medicine of novel drug-supplying system, its toxic and side effects is little than chemical drugs, and comprehensive therapeutic effect with multicomponent, many target spots, the AD that is fit to the pathogeny complexity, it is few that the clinical medicining times that provides is provided, safety and effectiveness are high, the new product of Chinese medicine of treatment senile dementia.
Description of drawings
Fig. 1 elementary osmotic pump tablet sheet heart rate of release.
The different coating membranes of Fig. 2 primary osmotic sheet discharge the result.
The different apertures of Fig. 3 primary osmotic sheet discharge the result.
The specific embodiment
The preparation of embodiment 1 elementary osmotic pump tablet of the present invention
Sheet heart prescription (directly adopting the sheet heart prescription of first kind micro-porous osmotic pump tablet)
Extract of Radix Ginseng total saponins 100g, lactose 235g, starch 118g, sodium chloride 33g, Pulvis Talci 3% are made 1000 altogether.
Coating fluid prescription: 2%CA/PEG4000 (4: 1) acetone soln.The drug release hole of making a call to a diameter 0.54um in medicated layer one side center.
Select turnadle pan coating for use, adopt set art for coating parameter that the sheet heart is carried out coating, get Radix Ginseng total saponins extract, lactose, starch and sodium chloride, make granule behind the mixing, compacting places coating pan in flakes, under rolling, spray into coating solution, the clothing film increase weight to thickness be 5%, the drug release hole of making a call to a diameter 0.54um in medicated layer one side center, promptly.
Following external its beneficial effect of drug release behavior evidence by Radix Ginseng total saponins controlled releasing penetrant pump of the present invention.
The research of test example 1 Radix Ginseng total saponins primary osmotic pump tablet recipe of the present invention
Final sheet heart prescription (directly adopting the sheet heart prescription of first kind micro-porous osmotic pump tablet)
Extract of Radix Ginseng total saponins 100g, lactose 235g, starch 118g, sodium chloride 33g, Pulvis Talci 3%.(making 1000 altogether)
Final coating fluid prescription
2%CA/PEG4000 (4: 1) acetone soln.The drug release hole of making a call to a diameter 0.54um in medicated layer one side center.
The correlation test of elementary osmotic pump tablet
Technology is investigated
3.1 tablet producing technology: because selection is effective ingredient in Chinese extract Radix Ginseng total saponins, to in human body, continue to reach effective treatment concentration, obeyed effective dose in sweet day in conjunction with the drug loading and the Radix Ginseng soap of Oros sheet again, therefore tablet is made 0.5 gram, every content of dispersion must not be lower than 100mg, one day two.
3.2 the preparation of label: the label technology of selective maturation, short penetrating agent NaCl, diluent lactose, the total soap of medicine Radix Ginseng is sweet.Select to cross 20 mesh sieves together with medicine after the proper supplementary material, the an amount of back of the ethanol of adding 90% system soft material, cross 20 mesh sieves, cross 18 mesh sieve granulate then,, add an amount of Pulvis Talci in 60 ℃ of dryings 12 hours, cross 120 mesh sieves and remove fine particle, tabletting, lay particular stress on be controlled at 0.48 the gram about, keep an amount of plain sheet.
3.3 the investigation of tablet weight variation: get 20 of test samples, gross weight decided in accurate title, ask its average weight, from the accurate weight that claims fixed every respectively, compare with on average laying particular stress on, according to 05 edition pharmacopeia regulation, what exceed qualification must not be more than two, and one times of a slice overrun must not be arranged, the above tablet that gets of 0.3g, limit test of weight variation is ± 5%.
3.4 the investigation of label:
Label is formed: Nacl:7% medicine: 20% starch: lactose=1: 2 (70%) Pulvis Talci: 3%.
Selected coating solution rollover coating increases weight respectively to certain proportion, measures dissolution in vitro, finds in experimentation, and starch is because starch is not dissolved in the water, and visible a large amount of insoluble electrodeposition substances are at the bottom of cup in stripping rotor.Result such as Fig. 1, R=0.974.Conclusion: can reach reasonable release effect with this label, and cause when not having tangible release, but total release amount is not high.
3.5 the coating membrane weightening finish is investigated: commonly used is that the CA acetone soln is a coating solution, add PEG4000 as plasticizer, examine the thickness of coating membrane with single factor method, select thickness to be respectively 2%, 2%, 4%, 5%, the thickness of coating membrane with the heavy gain in weight of sheet as quantizating index.It is 4: 1 that preparation of the present invention is selected the ratio of CA and PEG4000, and total amount is 2%, and the drug release effect is better, the form that coating membrane can remain intact behind the 12h drug release.Release the results are shown in Figure 2:
Weightening finish 2.2%:R=0.966, weightening finish 2.8%:R=0.960, weightening finish 4.1%:R=0.971, weightening finish 4.9%:R=0.968.
Conclusion: discharge 2% the time better when coating membrane increases weight, release can surpass 80%, discharges when surpassing 3% when increasing weight to obviously to reduce.So select weightening finish 2% as the weightening finish of prescription coating membrane.
3.6 drilling technology is investigated: the tablet behind the coating was in 40 ℃ of dryings 12 hours, because of pore size all bigger to the influence of release in vitro degree, with the release in vitro degree is index, with single factor method it is investigated, find out the critical aperture, be medicine minimum-value aperture that can discharge and medicine the pressure differential of osmotic pumps be the maximum diameter of hole that motive force is released medicine, determine a best release aperture.When pore size during at 300-600um, the release pore size does not have tangible influence to the medicine in-vitro release rate.Release rate of drugs obviously reduces when the aperture is 250um, the interior hydrostatic pressure of Drug Storage this moment be can not ignore, and the pressure reduction inside and outside the film is reduced, and the motive force that water penetrates film reduces, thereby its speed that penetrates film reduces, and drug release rate also correspondingly reduces.
| Level | 1 | 2 | 3 | 4 |
| Pore size (mm) | 0.2 | 0.4 | 0.6 | 0.7 |
Release the results are shown in Figure 3: aperture 0.26mm R=0.951; Aperture 0.46mm R=0.947; Aperture 0.54mm R=0.995; Aperture 0.68mm R=0.982.
Conclusion: the release aperture is from 0.26mm to 0.68mm, and the release in vitro degree does not have significant change, because this batch sample, coating membrane increases weight 3.77%, so the release amount is little.
3.7 result: the elementary osmotic pump tablet that above-mentioned prescription is made single chamber punching increases weight 2% the time when coating membrane, release was imitated best, and the aperture is from 0.26mm to 0.68mm, and the release effect does not have significant difference, but can not reach the requirement of constant release, analyzing reason may be that the label prescription needs to adjust.
Claims (3)
1. general ginsenoside primary osmotic pump tablet, it is characterized in that: it is to be prepared from by the following weight proportion raw material:
Proportioning raw materials is divided into sheet heart prescription and coating prescription two parts:
(1) each composition weight of the sheet heart: 1～2 part of Radix Ginseng total saponins, 1/3～2/3 part of osmotic pressure active substance, lactose, starch are with weight proportion 1～2: 0.5～1 mix, the Pulvis Talci percentage by weight is 3～4%;
Wherein, Radix Ginseng total saponins content 〉=80%, osmo active substance be sodium chloride, glucose, sucrose, mannitol wherein one or more;
(2) each amounts of components of coating solution: the acetone soln of controlled release coat adjuvant 2%CA/PEG400, wherein, the ratio of CA, PEG400 is 3～4: 1.
2. the preparation method of general ginsenoside primary osmotic pump tablet is characterized in that: comprise the steps
(1) sheet heart preparation: take by weighing following weight proportion raw material and adjuvant: Radix Ginseng total saponins 75～150g, lactose 210～250g, starch 100～136g, sodium chloride 25～41g, an amount of, the Pulvis Talci 2～4% of 5%PVP ethanol liquid, mixing granulation, granulate, tabletting get the sheet heart;
(2) acetone soln of the preparation of coating solution: 2%CA/PEG400, wherein, the ratio of CA, PEG400 is 3～4: 1;
(3) art for coating: select turnadle pan coating for use, the sheet heart is placed coating pan, spray into coating solution under rolling, clothing film rate of body weight gain is 2%～5%, and the drug release hole in that a diameter 0.54um is made a call in medicated layer one side center gets final product.
3. the preparation method of general ginsenoside primary osmotic pump tablet according to claim 2 is characterized in that: add blocker when granulating, wherein the weight proportion of CMC-Na and HPMC is 1: 1.
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| CN2006100219692A Division CN101152228B (en) | 2006-09-28 | 2006-09-28 | Genseng total sapnin micropore permeation pump, and its preparing method |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1480137A (en) * | 2003-07-04 | 2004-03-10 | 沈阳药科大学 | Osmotic pump type controlled release preparation of kurarinone and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1480137A (en) * | 2003-07-04 | 2004-03-10 | 沈阳药科大学 | Osmotic pump type controlled release preparation of kurarinone and its preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 陈修毅.人参茎叶总皂苷固体缓释制剂研究.《中国优秀博硕士学位论文全文数据库 (硕士) 医药卫生科技辑》.2004,(第E057-25期),摘要. * |
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