CN107050419A - A kind of osmotic pump tablet of Perindopril and its salt and preparation method thereof - Google Patents
A kind of osmotic pump tablet of Perindopril and its salt and preparation method thereof Download PDFInfo
- Publication number
- CN107050419A CN107050419A CN201710260148.2A CN201710260148A CN107050419A CN 107050419 A CN107050419 A CN 107050419A CN 201710260148 A CN201710260148 A CN 201710260148A CN 107050419 A CN107050419 A CN 107050419A
- Authority
- CN
- China
- Prior art keywords
- perindopril
- controlled release
- osmotic pump
- pump type
- release tablets
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The invention provides osmotic pump controlled release tablet of Perindopril and its pharmaceutically acceptable salt and preparation method thereof, it is monocompartment osmotic pump controlled release formulation, comprising single-deck core, semi permeability film coating and small delivery aperture.The present invention is optimized by rational prescription screening, the release of the rate of release and control medicine of regulating drug, obtains the Perindopril osmotic pump type controlled release tablets with zero order release rate, realizes steady drug release, safe and efficient, reduction side effect.
Description
Technical field
The invention belongs to pharmaceutical technology field, it is related to a kind of Perindopril osmotic pump type controlled release tablets and preparation method thereof.The back of the body
Scape technology
Osmotic pump type controlled release preparation be using osmotic pressure as driving force, using zero-order release kinetics as drug release characteristic, Neng Gou
Medicine is discharged with constant speed in the range of regular hour.Relative to matrix type and reservoir devices slow release method, medicine is released
The influence for being largely independent of the physiological parameters such as pH value, gastric emptying time, wriggling is placed on, In vitro-in vivo correlation is preferable,
And can adjust the release characteristic of medicine optimizes the drug action of system；The blood medicine that common oral preparation is caused can be avoided
The larger phenomenon of fluctuation of concentration, mitigates adverse reaction, drastically increases Drug safety and validity.At present, it is external oneself
The osmotic pump type controlled release preparation kind of listing such as Nifedipine controlled-release tablet controlled release tablet, prazosin controlled release tablet, Glipizide controlled release tablets
Deng all having obtained good treatment and commercial effect.
Osmotic pump type controlled release preparation mainly has Oros, micropore permeation pump, implanted osmotic pumps.It is most widely used at present
General osmotic pump preparation is Oros, is typically made up of label and coating membrane two parts.Oros oozes including single chamber
Saturating pump, many chamber osmotic pumps and liquid osmotic pumps.Wherein, elementary osmotic pump, structure type is most simple with preparation technology, using routine
Tablet producing technology medicine and suitable osmo active substance are pressed into after label, it is high with water-insolubles such as cellulose acetates
Molecular material is coated to label etc., prepares semipermeability coating membrane, then laser or mechanical system get aperture on film
Suitable aperture.Moisture in surrounding medium can penetrate into piece in-core through semipermeability clothing film, make the infiltration of piece in-core
Active material and medicine dissolving, so as to form the saturated solution of hyperosmosis in film.Dependent on osmotic pressure constant inside and outside film
Difference, medicine is discharged by release hole and absorbed by intestines and stomach.During releasing the drug, drug concentration and osmotic pressure remain permanent in film
It is fixed, so as to ensure that rate of releasing drug is constant in this period.
Angiotensin converting enzyme inhibitor (Angiotesion Converting Enzyme Inhibitors,
ACEI), it is the class that grows up the eighties in last century new and most widely used antihypertensive and congestion heart failure
Exhaust medicine.Perindopril (perindopril) is potent, the long-acting angiotensins of the third generation that early eighties start to develop
Converting enzyme inhibitor (ACEI).Perindopril is hydrolyzed to its active metabolite Perindoprilat and plays curative effect in vivo.It is depressured
Mechanism discharges norepinephrine to block angiotensinⅠ to be converted into active angiotensinⅡ, reducing nerve endings
Formed with vascular endothelial cell, suppress bradykinin degraded, the formation of increase bradykinin and the prostaglandin for expanding blood vessel.Perindopril
Antihypertensive effect substantially and better tolerance, blood pressure can not only be effectively reduced, and the blood vessel related to hypertension can be reversed different
Often, cardiovascular morbidity and the death rate are reduced.Therefore, Perindopril has in the treatment of hypertension and the preventing and treating of angiocardiopathy
Play an important role.But, the growing amount of Perindoprilat is influenceed by diet, and it is general that food can change its active metabolite training diindyl
The bioavilability that profit is drawn, perindopril tablets must be bfore meals.Presently commercially available preparation is common matrix type sustained release preparation, one
It is administered once, and reduces the drug administration frequency, improves patient compliance.But, because the insoluble drug release of matrix type sustained release tablets holds
It is vulnerable to the influence of the gastroenteric environments such as gastrointestinal peristalsis, pH value, matrix is destroyed and loses sustained release especially in the case of gastrointestinal peristalsis
Effect, it is impossible to maintain continual and steady drug concentration, be unfavorable for the treatment of disease.Therefore, it is still necessary to have that a kind of technique is simple, release
Put the Perindopril controlled release preparation that effect is preferable, curative effect is good.
The content of the invention
It is an object of the invention to overcome the shortcomings of the perindopril tablets of current Clinical practice.Using Perindopril as main ingredient system
Into osmotic pump type controlled release tablets.The advantage of said preparation is that using zero-order release kinetics as drug release characteristic, can be when certain
Between slow constant speed release medicine, be conducive to maintaining long-term efficient blood concentration in vivo, improve the therapeutic effect of medicine.Pass through
Formulation controls the rate of release of medicine, when rate of release typically will not be by gastrointestinal physiology factor such as wriggling, pH, gastric emptying
Between etc. variable factor influence, In vitro-in vivo correlation is good.
It is elementary osmotic pump control the invention provides the osmotic pump controlled release tablet of Perindopril and its pharmaceutically acceptable salt
Release formulation, comprising single-deck core, semi permeability film coating and small delivery aperture.After moisture enters label by semi-permeable film,
Osmo active substance expansion dissolving, produces hyperosmosis, the drug solution then constant release from aperture.
The label of osmotic pump type controlled release preparation of the present invention includes 1.0~4.0mg of medicine, 20~50mg of filler,
3~6mg of osmotic pressure 20~60mg of active material, 10~30mg of adhesive, 10~32mg of solubilizer and lubricant.Semipermeability bag
Clothing film coating 10~30mg of material, 2~10mg of plasticizer and appropriate solvent.
Perindopril osmotic pump type controlled release tablets of the present invention, filler used is selected from Arabic gum, tragacanth, peach
Glue, carboxymethyl cellulose, dextrin, starch or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, osmotic pressure active material used is selected from mannitol, grape
Sugar, lactose, sucrose, sodium chloride or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, adhesive therefor be selected from starch slurry, hydroxypropyl methylcellulose,
PVP, sodium carboxymethylcellulose or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, rate of release conditioning agent used is selected from polyethylene glycol, third
Glycol, glycerine, dibutyl phthalate or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, lubricant used be selected from magnesium stearate, calcium stearate,
Talcum powder, superfine silica gel powder, lauryl sodium sulfate, polyoxyethylene glycerin monostearate, wax class or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, solubilizer used is pluronic, odium stearate, gathered
Ethylene glycol 4000 or their mixture.
Perindopril osmotic pump type controlled release tablets of the present invention, semi permeability thin film coating material from cellulose acetate or
HP-55, plasticizer is selected from dibutyl sebacate or PEG 200, and solvent is selected from acetone or alcohol.
Perindopril osmotic pump type controlled release tablets of the present invention, it is characterised in that preparation process is as follows：
(1) Perindopril is first well mixed with 15~20min of solubilizer, adds filler and osmotic pressure active material is put
15~20min is mixed in blender, with binder aqueous solution softwood, crosses at the granulation of 20 mesh sieves, 40~60 DEG C and dries 6~8h,
16 mesh sieve whole grains are crossed, tabletting is well mixed.
(2) other auxiliary materials in semi-permeable membrane coating material and coatings are dissolved with acetone or alcohol, is made half
Permeable membrane coating solution, is coated 40~50 DEG C of 6~8h of solidification after the completion of pan coating, coating.
(3) it is coated after the completion of solidifying and 0.1-0.5mm holes is beaten in semi-permeable membrane coatings with laser boring.
Brief description of the drawings
Fig. 1 be embodiment 1 to the Perindopril osmotic pump type controlled release tablets of embodiment 4 releasing in the phosphate buffers of pH 7.4
Put curve map.As seen from the figure, obvious Zero order release feature is presented in the release of medicine, illustrates that we prepare the infiltration of Perindopril
Pump-type controlled release tablet can discharge medicine with constant speed, so that stable blood concentration is maintained, it is efficient to play controlling for medicine
Treatment is acted on.
Embodiment
Embodiment 1
Prescription
Preparation technology：Perindopril and solubilizer 15min are well mixed, filler is added and osmotic pressure active material is put
15min is mixed in blender, with 1% binder aqueous solution softwood, crosses at the granulation of 20 mesh sieves, 40 DEG C and dries 6h, cross 16 mesh sieves
Whole grain, is well mixed tabletting.With other auxiliary materials in acetone solution coating material and coatings, pan coating is coated, has been coated
Into latter 40 DEG C solidification 6h.It is coated after the completion of solidifying and 0.5mm holes is beaten in coatings with laser boring.
Embodiment 2
Prescription
Preparation technology：Perindopril and solubilizer 15min are well mixed, filler is added and osmotic pressure active material is put
15min is mixed in blender, with 1% binder aqueous solution softwood, crosses at the granulation of 20 mesh sieves, 50 DEG C and dries 7h, cross 16 mesh sieves
Whole grain, is well mixed tabletting.With other auxiliary materials in acetone solution coating material and coatings, pan coating is coated, has been coated
Into latter 50 DEG C solidification 7h.It is coated after the completion of solidifying and 0.4mm holes is beaten in coatings with laser boring.
Embodiment 3
Prescription
Preparation technology：Perindopril and solubilizer 15min are well mixed, filler is added and osmotic pressure active material is put
20min is mixed in blender, with 2% binder aqueous solution softwood, crosses at the granulation of 20 mesh sieves, 40 DEG C and dries 8h, cross 16 mesh sieves
Whole grain, is well mixed tabletting.Other auxiliary materials in coating material and coatings are dissolved with ethanol, pan coating is coated, has been coated
Into latter 40 DEG C solidification 8h.It is coated after the completion of solidifying and 0.2mm holes is beaten in coatings with laser boring.
Embodiment 4
Prescription
Preparation technology：Perindopril and solubilizer 20min are well mixed, filler is added and osmotic pressure active material is put
15min is mixed in blender, with 2% binder aqueous solution softwood, crosses at the granulation of 20 mesh sieves, 50 DEG C and dries 6h, cross 16 mesh sieves
Whole grain, is well mixed tabletting.With other auxiliary materials in acetone solution coating material and coatings, pan coating is coated, has been coated
Into latter 50 DEG C solidification 8h.It is coated after the completion of solidifying and 0.1mm holes is beaten in coatings with laser boring.
Claims (9)
1. a kind of Perindopril osmotic pump type controlled release tablets, include pastille label and semi permeability film coating, semi permeability film coating
There is a small delivery aperture on layer, wherein label contains 1.0~4.0mg of Perindopril and its pharmaceutically acceptable salt, filler 20~
50mg, 20~60mg of osmotic pressure active material, 10~30mg of adhesive, 3~6mg of 10~32mg of solubilizer and lubricant.
2. Perindopril osmotic pump type controlled release tablets according to claim 1, it is characterised in that：Perindopril is pharmaceutically acceptable
Salt is perindopril tert-butylamine salt, perindopril arginine salt.
3. Perindopril osmotic pump type controlled release tablets according to claim 1, filler used is selected from sodium alginate, Arabic gum,
Tragacanth, peach gum, carbomer, glucan, carboxymethyl cellulose, beta-schardinger dextrin, dextrin, starch or their mixture.
4. Perindopril osmotic pump type controlled release tablets according to claim 1, osmotic pressure active material used is selected from mannitol, sorb
Alcohol, glucose, lactose, fructose, sucrose or their mixture.
5. Perindopril osmotic pump type controlled release tablets according to claim 1, adhesive therefor is selected from starch slurry, hypromellose
Element, PVP, sodium carboxymethylcellulose or their mixture.
6. Perindopril osmotic pump type controlled release tablets according to claim 1, lubricant used is selected from magnesium stearate, stearic acid
Calcium, talcum powder, superfine silica gel powder, lauryl sodium sulfate, polyoxyethylene glycerin monostearate, wax class or their mixture.
7. Perindopril osmotic pump type controlled release tablets according to claim 1, solubilizer used is pluronic, odium stearate,
Macrogol 4000 or their mixture.
8. Perindopril osmotic pump type controlled release tablets according to claim 1, the constituent of semi permeability film coating is coating material
Expect 10~30mg, 2~10mg of plasticizer and appropriate solvent.Coating material selects cellulose acetate or hydroxypropyl methylcellulose phthalandione
Ester, plasticizer is selected from dibutyl sebacate or PEG 200, and solvent is selected from acetone or alcohol.
9. Perindopril osmotic pump type controlled release tablets according to claims 1 to 8, it is characterised in that preparation process is as follows：
(1) Perindopril is put in blender and mixed with filler, solubilizer, adhesive and osmotic pressure active material, softwood processed,
Cross at the granulation of 20 mesh, 40~60 DEG C and dry 6~8h, add lubricant, be well mixed tabletting.
(2) other auxiliary materials in semi-permeable membrane coating material and coatings are dissolved with acetone or alcohol, pellicle is made
Coating solution.
(3) label is coated, volatilizes the coating solvent in coating tablet, with laser boring in semi-permeable membrane coatings
Upper punching.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710260148.2A CN107050419A (en) | 2017-04-20 | 2017-04-20 | A kind of osmotic pump tablet of Perindopril and its salt and preparation method thereof |
| PCT/CN2017/082099 WO2018192000A1 (en) | 2017-04-20 | 2017-04-27 | Osmotic pump tablet of perindopril and salt thereof and preparation method of same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710260148.2A CN107050419A (en) | 2017-04-20 | 2017-04-20 | A kind of osmotic pump tablet of Perindopril and its salt and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107050419A true CN107050419A (en) | 2017-08-18 |
Family
ID=59599931
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710260148.2A Pending CN107050419A (en) | 2017-04-20 | 2017-04-20 | A kind of osmotic pump tablet of Perindopril and its salt and preparation method thereof |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN107050419A (en) |
| WO (1) | WO2018192000A1 (en) |
Cited By (2)
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|---|---|---|---|---|
| CN108902163A (en) * | 2018-08-08 | 2018-11-30 | 河北威远生物化工有限公司 | A kind of emamectin benzoate B2 benzoate osmotic pump tablet and preparation method thereof |
| CN109200028A (en) * | 2017-10-02 | 2019-01-15 | 宁波西敦医药包衣科技有限公司 | A kind of dry coating process preparing drug osmotic pump preparation |
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| CN1552323A (en) * | 2003-12-19 | 2004-12-08 | 沈阳药科大学 | Monolayer osmotic pump controlled releasing tablets of nimodipine |
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- 2017-04-27 WO PCT/CN2017/082099 patent/WO2018192000A1/en active Application Filing
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| CN101342153A (en) * | 2007-07-11 | 2009-01-14 | 中国人民解放军军事医学科学院毒物药物研究所 | Risperidone osmotic pump controlled release tablets and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109200028A (en) * | 2017-10-02 | 2019-01-15 | 宁波西敦医药包衣科技有限公司 | A kind of dry coating process preparing drug osmotic pump preparation |
| CN108902163A (en) * | 2018-08-08 | 2018-11-30 | 河北威远生物化工有限公司 | A kind of emamectin benzoate B2 benzoate osmotic pump tablet and preparation method thereof |
| CN108902163B (en) * | 2018-08-08 | 2021-02-19 | 河北威远生物化工有限公司 | Emamectin benzoate B2 osmotic pump tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2018192000A1 (en) | 2018-10-25 |
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Application publication date: 20170818 |
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