CN106727404A - Diabecron sustained-release tablet and preparation method thereof - Google Patents
Diabecron sustained-release tablet and preparation method thereof Download PDFInfo
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- CN106727404A CN106727404A CN201710188664.9A CN201710188664A CN106727404A CN 106727404 A CN106727404 A CN 106727404A CN 201710188664 A CN201710188664 A CN 201710188664A CN 106727404 A CN106727404 A CN 106727404A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- 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
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- 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
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Abstract
The present invention proposes a kind of diabecron sustained-release tablet and preparation method thereof, including following parts by weight supplementary material：5~20 parts of 40~60 parts of Metformin hydrochloride, 4~10 parts of filler, 0.5~2 part of lubricant, 0.5~2 part of adhesive and coating material, coating material are hydroxypropyl methyl cellulose, Carbomer and PVP in the obtained coating solution of alcohol-soluble solvent dissolving.Preparation method：First by Metformin hydrochloride and filler wet granulation, binder solution softwood is added, add lubricant compressing tablet and obtain plain piece, be then coated with coating solution, dried.The sustained release preparation can gentle effective hypoglycemic, medicine is slowly discharged in vivo, maintain steady state plasma concentration, improve the security that medicine is used, and can reduce and take number of times (once a day), the compliance of raising patient.
Description
Technical field
The invention belongs to treat hyperglycemia technical field of medicine, and in particular to a kind of diabecron sustained-release tablet
And preparation method thereof.
Background technology
Metformin hydrochloride is mainly used in type ii diabetes people control blood sugar as one of common drug for treating diabetes
Level., mainly by strengthening intake and utilization of the surrounding tissue to glucose, making the anaerobic glycolysis of musculature increases, and has for it
Oxygen metabolism is constant, and its concentration suppresses absorption of the glucose in intestines in intestinal wall, suppresses gluconeogenesis, suppresses the release of glucagons
Or the effect of suppression insulin antagonist, and the sensitiveness for increasing insulin.Metformin hydrochloride to islet function normally or
The diabetes of forfeiture have hypoglycemic effect per capita, to normal person without hypoglycemic effect.This product can both be individually used for diet alone control
Unsatisfied light, the moderate patient of system.It does not stimulate beta cell excreting insulin, and insulin concentration becomes without obvious in blood after medication
Change.Meanwhile, it can also be shared with insulin or sulfonylurea hypoglycemic agent, be heightened the effect of a treatment.Insulin dosage can be reduced.
Because Metformin hydrochloride is a kind of very big medicine of water solubility, and dosage is larger, therefore, the medicine is made sustained release
Piece has very big difficulty.For example chip technology, such as single gel type sustained release tablets or rigid backbone piece are being sustained using conventional preparation
Deng being all difficult to reach preferable slow release effect, in particular for controlling steadily to be discharged with certain speed in 24 hours, remain steady
Therapeutic plasma concentrations to make to reach internal good therapeutic effect be more difficult.
Described diabecron sustained-release tablet is using HPMC, ethyl cellulose in patent CN1391890A
The common pharmaceutically conventional macromolecular material such as element, sodium carboxymethylcellulose, has to form the sustained release agent of gel-type, and use
Machine carboxylic acid or alcohol are pelletized under 50~60 DEG C of molten conditions, and technological operation is extremely inconvenient, and said preparation is still difficult to reach control
The purpose that medicine is steadily discharged with certain speed.
The content of the invention
The present invention proposes a kind of diabecron sustained-release tablet, the sustained release preparation can gentle effective hypoglycemic, make medicine in body
Interior slow release, maintains steady state plasma concentration, improves the security that uses of medicine, and can reduce and take number of times (once a day i.e.
Can), improve the compliance of patient.
The technical proposal of the invention is realized in this way：
A kind of diabecron sustained-release tablet, including following parts by weight supplementary material：40~60 parts of Metformin hydrochloride,
5~20 parts of 4~10 parts of filler, 0.5~2 part of lubricant, 0.5~2 part of adhesive and coating material, coating material is hydroxypropyl
Ylmethyl cellulose, Carbomer and PVP are in the obtained coating solution of alcohol-soluble solvent dissolving, wherein hydroxypropyl methyl fiber
The mass ratio of element, Carbomer and PVP is 1:0.5~0.8:0.2~0.6.
Further, alcohol-soluble solvent is 95% ethanol solution.
Further, filler be starch, lactose, microcrystalline cellulose in one or more.
Further, lubricant is superfine silica gel powder, talcum powder, stearic acid, magnesium stearate or zinc stearate.
Further, adhesive is sodium carboxymethylcellulose.
It is a further object to provide a kind of preparation method of diabecron sustained-release tablet, including following step
Suddenly：
1) Metformin hydrochloride, filler and lubricant are crushed respectively, 120 mesh sieves excessively are standby, and adhesive is dissolved in water system
Standby composite adhesives solution；
2) Metformin hydrochloride raw material is added in wet granulator with filler, after high-speed stirred is uniform, adds adhesive
Solution, continues to stir and evenly mix, and is made softwood, then granulation, dry, whole grain, adds lubricant compressing tablet to obtain plain piece；
3) by hydroxypropyl methyl cellulose, Carbomer and PVP in the obtained coating solution of alcohol-soluble solvent dissolving；
4) after plain piece being preheated into 35 DEG C~40 DEG C, whitewashed with coating solution, after whitewashing terminates, dried.
Further, film drying temperature is 40 DEG C~70 DEG C at the end of coating.
The sustained release preparation that the present invention is provided, the release system that mainly one coated formula that can make medicament slow release is constituted
System, its slow release effect is mainly what is reached by film coating technology.Hydroxypropyl methyl cellulose and Carbomer.Hydroxypropyl methyl is fine
Dimension element has good hydrophily.Contain a large amount of carboxyls in Carbomer structure, meet water energy and form gel, the free carboxylic of Carbomer
Base, can provide proton, and hydrogen bond can be formed with gastrointestinal mucosa after forming gel, stick on gastrointestinal wall, so as to extend medicine exist
Holdup time in intestines and stomach.PVP is conducive to insoluble drug release as pore-foaming agent.
In the experiment of sustained release preparation of the invention its vitro release the 2nd hour release of Metformin hydrochloride be 10%~
35%, release is 40%~70% and the 12nd hour release is more than 80% at the 6th hour.
Specific embodiment
Embodiment 1
A kind of diabecron sustained-release tablet, including following parts by weight supplementary material：51 parts of Metformin hydrochloride, lactose
12 parts of 6 parts, 1 part of magnesium stearate, 0.7 part of sodium carboxymethylcellulose and coating material, coating material is hydroxypropyl methyl fiber
Element, Carbomer and PVP are in the obtained coating solution of ethanol solution dissolving for 95%, wherein hydroxypropyl methyl cellulose, card
The mass ratio of ripple nurse and PVP is 1:0.5:0.4.
Preparation method, comprises the following steps：
1) Metformin hydrochloride, lactose and magnesium stearate are crushed respectively, 120 mesh sieves excessively are standby, sodium carboxymethylcellulose
It is made the aqueous solution；
2) Metformin hydrochloride raw material is added in wet granulator with lactose, and after high-speed stirred is uniform, addition carboxymethyl is fine
The plain sodium water solution of dimension, continues to stir and evenly mix, and is made softwood, then granulation, dry, whole grain, adds magnesium stearate compressing tablet to obtain plain piece；
3) the obtained coating of ethanol solution dissolving by hydroxypropyl methyl cellulose, Carbomer and PVP 95%
Liquid；
4) after plain piece being preheated into 40 DEG C, whitewashed with coating solution, after whitewashing terminates, 60 DEG C of dryings.
Embodiment 2
A kind of diabecron sustained-release tablet, including following parts by weight supplementary material：40 parts of Metformin hydrochloride, starch
20 parts of 1 part, 3 parts of lactose, 0.5 part of talcum powder, 0.5 part of sodium carboxymethylcellulose and coating material, coating material is hydroxypropyl
The obtained coating solution of ethanol solution dissolving of methylcellulose, Carbomer and PVP 95%, wherein hydroxypropyl methyl is fine
The mass ratio of dimension element, Carbomer and PVP is 1:0.8:0.2.
Preparation method, comprises the following steps：
1) Metformin hydrochloride, starch, lactose and talcum powder are crushed respectively, 120 mesh sieves excessively are standby, carboxymethylcellulose calcium
Sodium is dissolved in water and is made solution；
2) Metformin hydrochloride raw material, starch and lactose are added in wet granulator, after high-speed stirred is uniform, add carboxylic first
The base sodium cellulosate aqueous solution, continues to stir and evenly mix, and is made softwood, then granulation, dry, whole grain, adds talcum powder compressing tablet to obtain plain
Piece；
3) the obtained coating of ethanol solution dissolving by hydroxypropyl methyl cellulose, Carbomer and PVP 95%
Liquid；
4) after plain piece being preheated into 35 DEG C, whitewashed with coating solution, after whitewashing terminates, 40 DEG C of dryings.
Embodiment 3
A kind of diabecron sustained-release tablet, including following parts by weight supplementary material：60 parts of Metformin hydrochloride, lactose
20 parts of 10 parts, 2 parts of zinc stearate, 2 parts of sodium carboxymethylcellulose and coating material, coating material is hydroxypropyl methyl fiber
The obtained coating solution of ethanol solution dissolving of element, Carbomer and PVP 95%, wherein hydroxypropyl methyl cellulose, card ripple
The mass ratio of nurse and PVP is 1:0.7:0.6.
Preparation method, comprises the following steps：
1) Metformin hydrochloride, lactose and zinc stearate are crushed respectively, 120 mesh sieves excessively are standby, sodium carboxymethylcellulose
It is dissolved in water and is made solution；
2) Metformin hydrochloride raw material is added in wet granulator with lactose, and after high-speed stirred is uniform, addition carboxymethyl is fine
The plain sodium water solution of dimension, continues to stir and evenly mix, and is made softwood, then granulation, dry, whole grain, adds zinc stearate compressing tablet to obtain plain piece；
3) the obtained coating of ethanol solution dissolving by hydroxypropyl methyl cellulose, Carbomer and PVP 95%
Liquid；
4) after plain piece being preheated into 40 DEG C, whitewashed with coating solution, after whitewashing terminates, 70 DEG C of dryings.
Test example
The sustained release tablets of Example 1-3, according to drug release determination method (two methods of annex XD first of China's coastal port),
Using the subtraction unit of dissolution method first, as dissolution medium, rotating speed is per minute to the phosphate buffer 1 000ml with pH6.8
100 turns, operate in accordance with the law, through 2 hours, 6 hours and 12 hours, solution 10ml is taken respectively, filter, and the supplement in stripping rotor immediately
The phosphate buffer 1 0ml of mutually synthermal pH6.8；Precision measures each 1ml of subsequent filtrate respectively, puts in 100ml measuring bottles, uses water
Scale is diluted to, is shaken up, according to UV-VIS spectrophotometry (two annex IVA of China's coastal port), 233nm's
Mensuration absorbance at wavelength, by C4H11N5Absorption coefficient (the E of HCl1cm100%) it is 798 to calculate every in different time
Burst size, is shown in Table 1.
Metformin Extended-release Tablets release testing result obtained in the embodiment 1~3 of table 1
| Detection time | Embodiment 1 | Embodiment 2 | Embodiment 3 | Standard value |
| 2h | 24.3% | 25.2% | 24.8% | 10~35% |
| 6h | 62.5% | 63.7% | 63.1% | 40~70% |
| 12h | 94.8% | 95.6% | 95.3% | More than 80% |
Presently preferred embodiments of the present invention is the foregoing is only, is not intended to limit the invention, it is all in essence of the invention
Within god and principle, any modification, equivalent substitution and improvements made etc. should be included within the scope of the present invention.
Claims (7)
1. a kind of diabecron sustained-release tablet, it is characterised in that the supplementary material including following parts by weight：Metformin hydrochloride
5~20 parts of 40~60 parts, 4~10 parts of filler, 0.5~2 part of lubricant, 0.5~2 part of adhesive and coating material, are coated
Material is hydroxypropyl methyl cellulose, Carbomer and PVP in the obtained coating solution of alcohol-soluble solvent dissolving, wherein hydroxypropyl
The mass ratio of ylmethyl cellulose, Carbomer and PVP is 1:0.5~0.8:0.2~0.6.
2. diabecron sustained-release tablet according to claim 1, it is characterised in that alcohol-soluble solvent is 95% ethanol
Solution.
3. diabecron sustained-release tablet according to claim 1, it is characterised in that filler is starch, lactose, crystallite
One or more in cellulose.
4. diabecron sustained-release tablet according to claim 1, it is characterised in that lubricant is superfine silica gel powder, talcum
Powder, stearic acid, magnesium stearate or zinc stearate.
5. diabecron sustained-release tablet according to claim 1, it is characterised in that adhesive is carboxymethylcellulose calcium
Sodium.
6. the preparation method of diabecron sustained-release tablet as claimed in claim 1, it is characterised in that comprise the following steps：
1) Metformin hydrochloride, filler and lubricant are crushed respectively, 120 mesh sieves excessively are standby, and adhesive is dissolved in water and is prepared into
Binder solution；
2) Metformin hydrochloride raw material is added in wet granulator with filler, after high-speed stirred is uniform, adds binder solution,
Continue to stir and evenly mix, be made softwood, then granulation, dry, whole grain, add lubricant compressing tablet to obtain plain piece；
3) by hydroxypropyl methyl cellulose, Carbomer and PVP in the obtained coating solution of alcohol-soluble solvent dissolving；
4) after plain piece being preheated into 35 DEG C~40 DEG C, whitewashed with coating solution, after whitewashing terminates, dried.
7. the preparation method of diabecron sustained-release tablet according to claim 6, it is characterised in that film at the end of coating
Drying temperature is 40 DEG C~70 DEG C.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710188664.9A CN106727404A (en) | 2017-03-27 | 2017-03-27 | Diabecron sustained-release tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710188664.9A CN106727404A (en) | 2017-03-27 | 2017-03-27 | Diabecron sustained-release tablet and preparation method thereof |
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| CN201710188664.9A Pending CN106727404A (en) | 2017-03-27 | 2017-03-27 | Diabecron sustained-release tablet and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110115384A (en) * | 2018-02-06 | 2019-08-13 | 浙江新维士生物科技有限公司 | Vitamin C composition and the method and vitamin C coated slow release piece for preparing vitamin C coated slow release piece |
| CN110882224A (en) * | 2019-12-23 | 2020-03-17 | 天津太平洋制药有限公司 | Preparation method of novel metformin composition |
| CN111759818A (en) * | 2020-08-04 | 2020-10-13 | 重庆康刻尔制药有限公司 | Metformin hydrochloride sustained release tablet and preparation method thereof |
| CN112999182A (en) * | 2020-08-19 | 2021-06-22 | 重庆康刻尔制药股份有限公司 | Metformin hydrochloride dual sustained and controlled release composition and preparation method and application thereof |
| CN114681418A (en) * | 2020-12-30 | 2022-07-01 | 青岛黄海制药有限责任公司 | Metformin hydrochloride preparation and preparation method thereof |
| CN115245495A (en) * | 2022-09-21 | 2022-10-28 | 北京惠之衡生物科技有限公司 | Sitagliptin and metformin tablet and preparation method thereof |
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2017
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Patent Citations (1)
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| CN102579358A (en) * | 2011-12-29 | 2012-07-18 | 北京科信必成医药科技发展有限公司 | Drug sustained-release pellet and method for preparing same |
Non-Patent Citations (2)
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|---|
| J.PIAO,ET AL: "Development of Novel Mucoadhesive Pellets of Metformin Hydrochloride", 《ARCHIVES OF PHARMACAL RESEARCH》 * |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110115384A (en) * | 2018-02-06 | 2019-08-13 | 浙江新维士生物科技有限公司 | Vitamin C composition and the method and vitamin C coated slow release piece for preparing vitamin C coated slow release piece |
| CN110882224A (en) * | 2019-12-23 | 2020-03-17 | 天津太平洋制药有限公司 | Preparation method of novel metformin composition |
| CN111759818A (en) * | 2020-08-04 | 2020-10-13 | 重庆康刻尔制药有限公司 | Metformin hydrochloride sustained release tablet and preparation method thereof |
| CN112999182A (en) * | 2020-08-19 | 2021-06-22 | 重庆康刻尔制药股份有限公司 | Metformin hydrochloride dual sustained and controlled release composition and preparation method and application thereof |
| CN112999182B (en) * | 2020-08-19 | 2023-04-07 | 重庆康刻尔制药股份有限公司 | Metformin hydrochloride dual sustained and controlled release composition and preparation method and application thereof |
| CN114681418A (en) * | 2020-12-30 | 2022-07-01 | 青岛黄海制药有限责任公司 | Metformin hydrochloride preparation and preparation method thereof |
| CN115245495A (en) * | 2022-09-21 | 2022-10-28 | 北京惠之衡生物科技有限公司 | Sitagliptin and metformin tablet and preparation method thereof |
| CN115245495B (en) * | 2022-09-21 | 2022-12-23 | 北京惠之衡生物科技有限公司 | Sitagliptin and metformin tablet and preparation method thereof |
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