CN101756928A - Dihydroergotoxine controlled release tablet and preparation method thereof - Google Patents
Dihydroergotoxine controlled release tablet and preparation method thereof Download PDFInfo
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- CN101756928A CN101756928A CN200810239715A CN200810239715A CN101756928A CN 101756928 A CN101756928 A CN 101756928A CN 200810239715 A CN200810239715 A CN 200810239715A CN 200810239715 A CN200810239715 A CN 200810239715A CN 101756928 A CN101756928 A CN 101756928A
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Abstract
The invention discloses a dihydroergotoxine controlled release tablet, which comprises a double-layer tablet core and a coating membrane. The double-layer tablet core therein contains an effective dosage of dihydroergotoxine or physiologically acceptable salts or pharmaceutically acceptable pharmaceutic adjuvant thereof, and the coating membrane is a semipermeable membrane which contains or does not contain a hole forming agent. The dihydroergotoxine controlled release tablet prepared by the invention can effectively control medicines to release in specific time and reduce times of taking the medicines, and in-vivo blood concentration is table, so as to ensure that the in-vivo blood concentration is stable and effective during a patient takes the medicines, and fundamentally improve the safety and the effectiveness of the medicines and the compliance of the patient.
Description
Technical field
The present invention relates to a kind of controlled release tablet pharmaceutical preparation, the particularly a kind of medicine dihydroergotoxine of brain, peripheral blood vessel or controlled release tablet of its physiologically acceptable salt and preparation method thereof for the treatment of.
Background technology
Along with the prolongation of the average life span, the process that Chinese society enters aging speeds rapidly, and alzheimer disease has become social hot issue.Alzheimer disease patient's pathologic basis is cerebral atrophy and degeneration, and clinical manifestation is dull-witted symptom.Scientific research result in recent years shows that " dihydroergotoxin " provides sure curative effect for the cognitive disorder person that alzheimer disease and cerebral tissue pathological changes cause.United states drug food control office (FDA) has confirmed that dihydroergotoxin is the medicine of treatment alzheimer disease and old mental function decline curative effect the best.
Cerebrovascular disease becomes " the No.1 killer " who threatens human life's health gradually, and along with increasing of proportion of aged population, dull-witted sickness rate also increases year by year.It is therefore the first to account for dementia at China's vascular dementia, and clinical common, Therapeutic Method and medicine are many, but curative effect owes desirable.
First carbonic acid dihydroergotoxine is the brain microcirculation activator, when the brain microcirculation part changes, can make cerebral blood flow normalization.Stronger alpha receptor blocking effect is arranged.Become the active drug of treatment senile dementia after the eighties in 20th century and promote in the world.Main neuron metabolism and the neurotransmission ability of strengthening activates the brain metabolic function that has gone down, and perineural nutrition is also had good influence.
In recent years, scientist finds that also it can improve cerebral blood circulation, and good brain metabolism facilitation is arranged.Methanesulfonic acid Dihydroergotoxine alkali not only has significant curative effect to Ai Ercimo type alzheimer disease, and also effective to many infractions type dementia; To above-mentioned both mixed type alzheimer disease choice drug especially.United states drug food control office thinks that methanesulfonic acid Dihydroergotoxine alkali can treat 14 symptoms of elderly patients: dizzy, headache, absent minded, memory subtracts late, lacks meaning and cuts and initiative emotion melancholy, uneasiness and fear, feeling of fatigue, take the fling, loss of appetite breaks away from the external world, can not take care of number one daily life difficulty and slight confusion etc.Especially pleasurable is, takes methanesulfonic acid Dihydroergotoxine alkali for a long time and can continue to keep significant curative effect, and be free from side effects, and shows that this medicine of take of a specified duration has function in delaying senility.
Dihydroergotoxine methanesulfonate is the unique affirmation of the U.S. FDA treatment brain effective brain metabolism reinforcing agent of degenerating, and is a kind of brain metabolism reinforcing agent, has the cranial nerve cell of enhancing metabolism; Compensate neurohumoral deficiency and the effect that improves cerebral circulation.The clinical practice dihydroergotoxine methanesulfonate has curative effect preferably in recent years, but blood fat reducing, microcirculation improvement, raising intelligence and quality of life.
The osmotic pump preparation of Chu Xianing is nineteen fifty-five two Australian scholar's inventions the earliest, be used for the administration of domestic animal gastrointestinal, it comprises: coyote hole, salt chamber and 3 chambers of hydroecium, and 6 major parts such as rigid film of the elastic diaphragm between the rigidity semipermeable membrane between hydroecium and salt chamber, salt chamber and coyote hole, whole device outsourcing, volume reaches 80cm
3The device of this Rose-Nelson of being referred to as type osmotic pumps utilizes the permeable pressure head between hydroecium and salt chamber, makes water enter the salt chamber from semipermeable membrane, thereby causes salt chamber volume expanded, and the elastic diaphragm on extruding right side forces medicine to disengage from the tapping of coyote hole.As osmotic pump type preparation the earliest, there is a great shortcoming in such device, that is: water is in case enter the salt chamber by semipermeable membrane, just will cause drug release process, this means this device in case make, just must use immediately, and can't preserve, although in the patent of delivering afterwards, this device has been carried out bigger improvement (increased impervious envelope film between hydroecium and salt chamber, face with preceding it is smashed), but because of this class device technique too complicated, volume is too huge, so be not suitable for further developing as the human preparation.
Enter phase early 1970s, Alza company simplifies on the basis of Rose-Nelson type osmotic pumps, has released the Higuchi-Leeper type osmotic pumps that suction enters the salt chamber from external environment, and volume-diminished is 35cm
3About.Subsequently, developed Higuchi-Theeuwes type osmotic pumps again, it comprises: the elastic diaphragm between salt chamber, coyote hole, two Room and the rigidity semipermeable membrane of outsourcing, its volume significantly reduces, and is 3cm
3About; Its greatest improvement part is: it changes the impermeability peplos of whole device into semipermeable membrane, thereby has established crucial basis for the further simplification of osmotic pump preparation.On this basis, 1974, Theeuwes proposed the notion and the structure of elementary single chamber type osmotic pumps, and osmotic pump preparation is simplified becomes the simple form of ordinary coating sheet, thereby made it to have moved towards suitability for industrialized production and clinical practice application.In this device, removed isolating salt chamber, change into the permeability that utilizes medicine self and some permeation-promoter be used for provide power for release: in use, moisture sucks in the sheet from semipermeable membrane, make and form very high osmotic pressure in the sheet, thereby the saturated aqueous solution that makes medicine in the sheet is disengaged by the aperture on sheet surface, because the no ductility of used semipermeable membrane (mostly being cellulose acetate), volume in the film remains constant, so as long as solid drugs not dissolving fully as yet in the sheet, its saturated solution will be released continuously, thereby reach the effect of constant speed release medicine.
Compare with common slow releasing preparation, controlled-release tablet preparation has: drug release behavior is not subjected to factor affecting such as media environment pH value, enzyme, gastrointestinal peristalsis, food, and the inside and outside dependency is good; The bigger phenomenon of blood concentration fluctuation can be avoided or reduce to its unique release mode to greatest extent, reduces toxic and side effects; Obviously reduce medicining times, improve compliance and effectiveness that patient takes medicine; With high content of technology, be developed into advantages such as power is higher, the construction cycle is short.
For this reason, the invention provides the dihydroergotoxine methanesulfonate controlled release tablet, controlled release tablet release of the present invention is complete, has improved the safety and the effectiveness of medication, and the present invention has simultaneously determined preferred prescription composition by the screening to prescription.
Summary of the invention
The purpose of this invention is to provide the stable dihydroergotoxine methanesulfonate controlled release tablet that reaches drug safety of a kind of drug release.Characteristics such as it has that convenient drug administration, effect are lasting, stable curative effect, toxic and side effects are little.
Dihydroergotoxine controlled release tablet of the present invention, be made up of effective dose dihydroergotoxine or its physiologically acceptable salt and pharmaceutically acceptable excipient, described pharmaceutically acceptable excipient is selected from one or more compositions in surfactant, osmotic pressure active substance, penetrating agent, coloring agent, lubricant, wetting agent, binding agent, filmogen, porogen, the plasticizer etc.; It constitutes double-deck label outsourcing coating membrane, described double-deck label is made up of medicated layer and boosting layer, and double-deck label outsourcing has coating membrane, and coating membrane has a small delivery aperture on the surface of medicated layer, wherein, the drug release hole diameter of coating membrane on the medicated layer surface is about 0.1～1.2 millimeter.
Wherein said effective dose is extremely about 10mg dihydroergotoxine or its physiologically acceptable salt of 1mg, is preferably 2.5mg to about 5mg dihydroergotoxine or its physiologically acceptable salt, and its physiologically acceptable salt of dihydroergotoxine is preferably mesylate.
Wherein said surfactant is selected from one or more in sodium lauryl sulphate, Stepanol MG, poloxamer or the tween etc.
Wherein said penetrating agent is selected from that polyoxyethylene, hypromellose, ethyl cellulose, methylcellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, carboxymethyl starch are received, in low-substituted hydroxypropyl cellulose, sodium alginate, cross-linking sodium carboxymethyl cellulose, cross linked polyvinyl pyrrolidone, carbopol etc. one or more.
Wherein said osmotic pressure active substance is selected from one or more in sodium chloride, potassium chloride, lactose, mannitol, fructose, glucose, the sucrose etc.
Wherein said binding agent can be selected from one or more in starch slurry, polyvidone, crospolyvinylpyrrolidone, hypromellose and/or other cellulose families etc.
Wherein said wetting agent can be selected from one or more in water, methanol, ethanol, dehydrated alcohol, chloroform, dichloromethane, the acetone etc.
Wherein said lubricant can be selected from one or more in magnesium stearate, stearic acid, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month pure magnesium sulfate of extension, starch, the paraffin etc.
The optional autoxidation ferrum of wherein said coloring agent, iron oxide red, iron oxide yellow, amaranth, carmine, erythrosine, newly red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo Huang, light blue, and be in the various pigments that strengthen the acid pigment of above-mentioned water solublity dispersibility in oils and fats etc. one or more.
Wherein said porogen is selected from one or more in sucrose, mannitol, Polyethylene Glycol, polyvidone, copolyvidone, the dibutyl sebacate etc.
Wherein said plasticizer is selected from one or more in Methyl Benzene-o-dicarboxylate, ethyl phthalate, diethyl phthalate, poly-phthalic acid vinyl acetate, polyvinyl alcohol, polystyrene, carbopol, polrvinyl chloride, dioctyl phthalate, triethyl citrate, Polyethylene Glycol, polyvidone, dibutyl sebacate, the copolyvidone etc.
Wherein said filmogen can be selected from one or more in ethyl cellulose, starch, methylcellulose, cellulose acetate, cellulose diacetate, Triafol T, acrylic resin, Opadry, the Sulisi etc.
Wherein said filmogen be dissolved in one or more solution in water, methanol, ethanol, dehydrated alcohol, chloroform, dichloromethane, acetone, the benzene etc.
Be used for the present invention prepare the active component of dihydroergotoxine methanesulfonate controlled release tablet and pharmaceutically the acceptable excipient be to form by following proportioning (accounting for the weight ratio of double-deck label):
Wherein said controlled release tablet coating membrane is about 0.1～1.2 millimeter at the drug release hole diameter of medicated layer one side.
The invention provides the preparation method of dihydroergotoxine methanesulfonate controlled release tablet.As follows:
(1) granulate behind the mix homogeneously in pharmaceutic adjuvants such as dihydroergotoxine methanesulfonate and penetrating agent are sifted out back, promptly gets the medicated layer granule.
(2) pharmaceutic adjuvants such as penetrating agent, osmotic pressure active substance are sifted out granulate behind the mix homogeneously, promptly get boosting layer granule.
(3) medicated layer granule and boosting layer granule are worth the double-layer tablet label behind the secondary tabletting, with the coating solution coating system predetermined weight that contains filmogen, porogen and/or plasticizer, with laser boring or machine punching, the drug release hole diameter is about 0.1～1.2 millimeter, promptly in medicated layer one side.
Advantages such as the present invention preferably writes out a prescription to form and is listed in the embodiments of the invention, and these are preferably write out a prescription and obtain through screening, and it is more stable compared with prior art to have quality, and release is more complete, side effect is little.
Description of drawings
Fig. 1 is the dihydroergotoxine methanesulfonate controlled release tablet of four embodiment preparations, with dihydroergotoxine methanesulfonate slow releasing capsule release characteristic comparison diagram.
The specific embodiment
Below further set forth the present invention by embodiment, but and unrestricted the present invention.
Embodiment 1
Prescription:
Preparation method:
1, according to recipe quantity granulated behind the mix homogeneously in dihydroergotoxine, polyoxyethylene, the Pulvis Talci back of sifting out, promptly get the medicated layer granule.
2, polyoxyethylene, sodium chloride, hypromellose, iron oxide red, Pulvis Talci are sifted out and are granulated behind the mix homogeneously, promptly get boosting layer granule.
3, with medicated layer granule and boosting layer granule through the secondary tabletting or adopt double-deck sheeting equipment, make the double-layer tablet label, standby.
4, coating solution preparation: Triafol T, Polyethylene Glycol and ethyl phthalate are added in an amount of dichloromethane solution, stir and make it whole dissolvings, standby.
5, the double-layer tablet label that makes is put in the high-efficiency coating machine, at the uniform velocity sprayed into the coating solution coating, get the transparent coating double-layer tablet.
6, punch with laser boring or machine in medicated layer one side, the drug release hole diameter is about 0.6 millimeter, promptly.
Prescription:
Preparation method:
1, recipe quantity dihydroergotoxine methanesulfonate, polyvidone are dissolved in an amount of dehydrated alcohol, mix homogeneously, standby.
2, polyoxyethylene, hypromellose are sifted out back mix homogeneously adds dihydroergotoxine methanesulfonate polyvidone ethanol solution, adopts wet granulation, adds magnesium stearate, promptly gets the medicated layer granule.
3, will adopt wet granulation behind polyoxyethylene, potassium chloride, hydroxypropyl cellulose, polyvidone, the ferrum oxide mix homogeneously, add magnesium stearate, promptly get boosting layer granule.
4, with medicated layer granule and boosting layer granule through the secondary tabletting or adopt double-deck sheeting equipment, make the double-layer tablet label, standby.
5, coating solution preparation: cellulose acetate, Polyethylene Glycol and carbopol are added in an amount of chloroform soln, stir and make it whole dissolvings, standby.
6, the double-layer tablet label that makes is put in the high-efficiency coating machine, at the uniform velocity sprayed into the coating solution coating, get the transparent coating double-layer tablet.
7, punch with laser boring or machine in medicated layer one side, the drug release hole diameter is about 0.55 millimeter, promptly.
Embodiment 3
Prescription:
Preparation method:
1, recipe quantity dihydroergotoxine methanesulfonate, polyvidone are dissolved in the 80% an amount of ethanol, mix homogeneously volatilizes solution, gets dihydroergotoxine methanesulfonate polyvidone powder.
2, with dihydroergotoxine methanesulfonate polyvidone powder, polyoxyethylene, sodium alginate, sucrose mix homogeneously, add stearic acid, promptly get the medicated layer granule.
3, with behind polyoxyethylene, sodium chloride, ethyl cellulose, polyvidone, the iron oxide red mix homogeneously, add stearic acid, promptly get boosting layer granule.
4, with medicated layer granule and boosting layer granule through the secondary tabletting or adopt double-deck sheeting equipment, make the double-layer tablet label, standby.
5, coating solution preparation: cellulose diacetate, Polyethylene Glycol and poly-phthalic acid vinyl acetate are added in an amount of dichloromethane solution, stir and make it whole dissolvings, standby.
6, the double-layer tablet label that makes is put in the high-efficiency coating machine, at the uniform velocity sprayed into the coating solution coating, get the transparent coating double-layer tablet.
7, punch with laser boring or machine in medicated layer one side, the drug release hole diameter is about 0.55 millimeter, promptly.
Prescription:
Preparation method is with embodiment 3.
The dihydroergotoxine methanesulfonate controlled release tablet of four embodiment preparations is as follows with the contrast of dihydroergotoxine methanesulfonate slow releasing capsule release characteristic:
Claims (9)
1. one kind contains Dihydroergotoxine controlled release tablet, described controlled release tablet is made up of effective dose dihydroergotoxine or its physiologically acceptable salt and pharmaceutically acceptable excipient, and described pharmaceutically acceptable excipient is selected from surfactant, osmotic pressure active substance, penetrating agent, coloring agent, lubricant, wetting agent, binding agent, filmogen, porogen, plasticizer; It constitutes double-deck label outsourcing coating membrane, and described double-deck label is made up of medicated layer and boosting layer, and double-deck label outsourcing has coating membrane, and coating membrane has a small delivery aperture in medicated layer one side, wherein,
Coating membrane is about 0.1～1.2 millimeter at the drug release hole diameter of medicated layer one side.
2. the described controlled release tablet of claim 1, effective dose is that 1mg is to about 10mg dihydroergotoxine or its physiologically acceptable salt, be preferably 2.5mg to about 5mg dihydroergotoxine or its physiologically acceptable salt, its physiologically acceptable salt of dihydroergotoxine is preferably mesylate.
3. the described controlled release tablet of claim 1 is characterized in that:
Described surfactant is selected from sodium lauryl sulphate, Stepanol MG, poloxamer or tween.
Described penetrating agent is selected from that polyoxyethylene, hypromellose, ethyl cellulose, methylcellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, carboxymethyl starch are received, low-substituted hydroxypropyl cellulose, sodium alginate, cross-linking sodium carboxymethyl cellulose, cross linked polyvinyl pyrrolidone, carbopol.
Described osmotic pressure active substance is selected from sodium chloride, potassium chloride, lactose, mannitol, fructose, glucose, sucrose.
Described binding agent can be selected from starch slurry, polyvidone, crospolyvinylpyrrolidone, hypromellose and/or other cellulose families.
Described wetting agent can be selected from water, methanol, ethanol, dehydrated alcohol, chloroform, dichloromethane, acetone.
Described lubricant can be selected from magnesium stearate, stearic acid, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month pure magnesium sulfate of extension, starch, paraffin.
The optional autoxidation ferrum of described coloring agent, iron oxide red, iron oxide yellow, amaranth, carmine, erythrosine, newly red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo Huang, light blue, and for strengthening the various pigments of the acid pigment of above-mentioned water solublity dispersibility in oils and fats.
Described porogen is selected from sucrose, mannitol, Polyethylene Glycol, polyvidone, copolyvidone, dibutyl sebacate.
Described plasticizer is selected from Methyl Benzene-o-dicarboxylate, ethyl phthalate, diethyl phthalate, poly-phthalic acid vinyl acetate, polyvinyl alcohol, polystyrene, carbopol, polrvinyl chloride, dioctyl phthalate, triethyl citrate, Polyethylene Glycol, polyvidone, copolyvidone, dibutyl sebacate.
Described filmogen can be selected from ethyl cellulose, starch, methylcellulose, cellulose acetate, cellulose diacetate, Triafol T, acrylic resin, Opadry, Sulisi.
Described filmogen be dissolved in one or more solution in water, methanol, ethanol, dehydrated alcohol, chloroform, dichloromethane, acetone, the benzene etc.
4. the described controlled release tablet of claim 1 is characterized in that it consists of:
5. the described controlled release tablet of claim 1 is characterized in that it consists of:
6. the described controlled release tablet of claim 1 is characterized in that it consists of:
7. the described controlled release tablet of claim 1 is characterized in that it consists of:
8. the described controlled release tablet of claim 1 is characterized in that, the drug release hole diameter of coating membrane on the medicated layer surface is about 0.1～1.2 millimeter.
9. the described controlled release tablet of claim 1 is characterized in that, the drug release hole diameter of coating membrane on the medicated layer surface is about 0.5 millimeter.
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| CN200810239715A CN101756928A (en) | 2008-12-16 | 2008-12-16 | Dihydroergotoxine controlled release tablet and preparation method thereof |
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| CN200810239715A CN101756928A (en) | 2008-12-16 | 2008-12-16 | Dihydroergotoxine controlled release tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10637393B2 (en) | 2006-12-06 | 2020-04-28 | Solaredge Technologies Ltd. | Distributed power harvesting systems using DC power sources |
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2008
- 2008-12-16 CN CN200810239715A patent/CN101756928A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10637393B2 (en) | 2006-12-06 | 2020-04-28 | Solaredge Technologies Ltd. | Distributed power harvesting systems using DC power sources |
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Address after: 100083 Haidian District, Xueyuan Road, No. 30, A building, room No. 15, room, room 15 Applicant after: Beijing Kexin Bicheng Medicine Science & Technology Developing Co., Ltd. Address before: 100190, room 1410, satellite building, No. 63, Zhichun Road, Beijing, Haidian District Applicant before: Beijing Kexin Bicheng Medicine Science & Technology Developing Co., Ltd. |
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Application publication date: 20100630 |