CN101822672A - Compound with metformin and repaglinide, preparation method thereof and application thereof - Google Patents
Compound with metformin and repaglinide, preparation method thereof and application thereof Download PDFInfo
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- CN101822672A CN101822672A CN200910105692A CN200910105692A CN101822672A CN 101822672 A CN101822672 A CN 101822672A CN 200910105692 A CN200910105692 A CN 200910105692A CN 200910105692 A CN200910105692 A CN 200910105692A CN 101822672 A CN101822672 A CN 101822672A
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Abstract
The invention relates to a composite composition with metformin hydrochloride and repaglinide as active ingredients, a preparation method thereof and application thereof and belongs to the technical field of medicaments. The composite composition is a medicinal composition which is mixed by using the metformin hydrochloride and repaglinide as the active ingredients and by using a carrier and can be prepared into sustained-release tablets, sustained-release granules, sustained-release capsules, common troches and capsules, granules, dispersible tablets, chewable tablets, orally disintegrating tablets, buccal tablets, liquid capsules, soft capsules, drop pills and other oral preparations. The composite composition is used for treating patients with I-type diabetes or II-type diabetes (non-insulin-dependent diabetes) and has synergistic effect on controlling blood sugar.
Description
Technical field:
The present invention relates to a kind ofly,, belong to medical technical field more specifically to being the oral formulations and the purposes of active ingredient with metformin hydrochloride and repaglinide with medicinal compound.
Background technology:
The onset diabetes rate is still increasing year by year.Chinese then become the severely afflicated area of morbidity, the diabetics number is only second to India, occupies the second place of the world.According to the data that The World Health Organization (WHO) provides, developed country's diabetes prevalence then is about 3% up to 5%～10% in China, the most conservative measuring and calculating, and the annual increase of Chinese diabetics one million people just has 2,700 people's New Developments every day; To the year two thousand thirty, whole world diabetics number will be doubled than 2000.
The analyst points out that in following a period of time, type type onset diabetes rate will keep steady relatively, but type or type patient number then can steady-state growths.At US and European, type or type patient number account for all patient of diabetes at present and get 90% of number, then almost reach 100% in the Asia.
Type or type part patient are based on insulin resistant, and how fat patient is, because of insulin resistant, insulin sensitivity descends, insulin increases compensating its insulin resistant in the blood, but patient's hyperglycemia relatively, insulin secretion is relative deficiency still; Another part patient is based on defect of insulin secretion.
Metformin hydrochloride is the biguanides Remedies for diabetes, it by suppressing liver glyconeogenesis and impel of the picked-up utilization of periphery insulin target tissue to glucose, to improve the insulin sensitivity of body, it can obviously improve patient's anti-sugar amount and hyperinsulinemia, reduces blood plasma free fatty acid and triglyceride levels.Its good water solubility is difficult for accumulating in vivo, and it is low to cause the lactic acidosis incidence rate, is the biguanides antidiabetic drug of domestic and international unique use at present.Now become particularly obese patient's first-selected curative of light, moderate type 2 diabetes mellitus patient.Metformin hydrochloride can reduce diabetes patient's hyperglycemia, but after blood glucose is normal blood glucose is reduced again.Therefore use metformin not have hypoglycemic reaction separately.Recently, having again and report that metformin can reverse the initiation potential that the fatty liver that has formed can also improve cardiovascular risk factor and reduce juvenile diabetes, is a kind of hypoglycemic medicine of determined curative effect safe in utilization.
Repaglinide comes the blood sugar lowering level by stimulating the insulin uelralante, and repaglinide can combine with special site, thereby closes the ATP dependency potassium channel on the pancreatic plasma membrane.This potassium channel is closed and can be made the depolarization of beta cell clothing, makes calcium channel open then, and stream increases in the calcium as a result.Induce insulin secretion.This ion channel mechanism is the height tissue selectivity, adds very low with heart and skeletal muscle affine.
Chinese patent " compositions of a kind of hydrochloric pioglitazone and repaglinide " discloses the compositions of pioglitazone hydrochloride and repaglinide in (application number 200710156927.4, open day on June 25th, 2008);
Following document discloses the research of metformin hydrochloride and repaglinide use in conjunction:
(1)Achieving?glycosylated?hemoglobin?targets?using?the?combination?of?repaglinide?andmetformin?in?type?2diabetes：a?reanalysis?of?earlier?data?in?terms?of?current?targets.
Clin Ther.2008Mar；30(3)：552-4
(2)Oral?combination?therapy：repaglinide?plus?metformin?for?treatment?of?type?2diabetes.
Diabetes?Obes?Metab.2008Dec；10(12)：1167-77.Epub?2008May?20.
(3) type 2 diabetes mellitus was rolled up the 8th phase MMJC August the 10th in 2008 through the variation contemporary Chinese medical magazine of repaglinide and metformin treatment back LDL and tremulous pulse proteoglycan, and Aug 2008, and Vol 10, No.
(4) 2008 24 the 21st phases of volume of NovoNorm metformin treatment type 2 diabetes mellitus 40 routine observation of curative effect modern medicine health
But the reported in literature that does not have by retrieval, the compound preparation of metformin hydrochloride and repaglinide.
Summary of the invention:
The present invention is in order to overcome defective of the prior art, and providing a kind of is the medicinal compound of active ingredient with metformin hydrochloride and repaglinide.
The invention discloses a kind of is active ingredient with metformin hydrochloride and repaglinide, mixes with pharmaceutically acceptable carrier to form medicinal compound.
In every dosage unit, described metformin hydrochloride is 250mg～2g, and repaglinide is 0.1mg～4mg; Be preferably, metformin hydrochloride is 250mg, 500mg, 850mg, and repaglinide is 0.25mg～4mg.
Wherein said carrier is one or more in filler, binding agent, disintegrating agent, lubricant, fluidizer, antitack agent, slow releasing agent, the water-insoluble substrate.
Wherein said filler is one or more the mixture in lactose, starch, microcrystalline Cellulose, dextrin, sorbitol, mannitol, calcium phosphate dibasic anhydrous, corn starch, pregelatinized Starch, polacrilin potassium, 85% glycerol, hydrogenated vegetable oil, meglumin, the poloxalkol.
Wherein said binding agent is one or more the mixture in PVP solution, starch slurry, water, ethanol, dextrin slurry, the gelatine size.
Wherein said disintegrating agent is one or more the mixture in dried starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone PVPP, L-HPC, xylitol, methylcellulose, microcrystalline Cellulose, citric acid, the carbonate.
Wherein said lubricant is one or more the mixture in magnesium stearate, Pulvis Talci, micropowder silica gel (silicon dioxide), the hydrogenated vegetable oil.
Wherein said anticaking agents is the mixture of a kind of of potassium ferrocyanide, sodium aluminosilicate, tricalcium phosphate, silicon dioxide, microcrystalline Cellulose, Pulvis Talci, magnesium trisilicate or two kinds.
Wherein said slow releasing agent is cellulose derivative (methylcellulose, ethyl cellulose, hydroxyethylmethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, hydroxy methocel and Carboxymethyl cellulose sodium etc.), natural gum (glue such as pectin, sodium alginate, potassium alginate, agar, angle fork, locust bean gum, pawl ear natural gum and tragakanta etc.), polyethylene, polypropylene, polysiloxanes and polyoxyethylene, hydroxypropyl methylcellulose, Carboxymethyl cellulose sodium or tragakanta; Cera Flava, hydrogenated vegetable oil, synthetic wax, butyl stearate, stearic acid, Brazil wax, glyceryl stearate, propylene glycol-stearate and octadecanol, arabic gum, acrylic resin, Hydroxypropyl Methylcellulose Phathalate and Lac, dimethylaminoethyl methacrylate-neutral methacrylic acid esters copolymer, methacrylic acid copolymer, cellulose acetate-phthalate, the mixture of one or more in Hydroxypropyl Methylcellulose Phathalate and the phthalic acid vinyl acetate resin.Hydroxypropyl emthylcellulose comprises the hydroxypropyl emthylcellulose of different viscosities, different proportion, different molecular weight.
Wherein said water-insoluble substrate is one or more the mixture in stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, the octadecanol.
For improving the mouthfeel of compound of the present invention, particularly when being prepared into chewable tablet, oral cavity disintegration tablet, buccal tablet etc., also add suitable essence and correctives.
Described compound can the conventional formulation method be made the preparation that slow releasing tablet, slow-releasing granules, sustained-release micro-pill capsules, granule, tablet, capsule, dispersible tablet, chewable tablet, oral cavity disintegration tablet, buccal tablet, liquid capsule, soft capsule, drop pill and other can be for oral administration.
This compound is used for type or type (non-insulin-dependent) patient's treatment.Blood sugar control there is synergism.
Its usage and dosage is very complicated in the description of repaglinide sheet, compliance of patients is poor, the present invention is first with the compound preparation of unique quick-acting insulin secretion accelerating medicine repaglinides and insulin sensitivity medicine metformin hydrochloride fixed dosage, for taking medicine, the patient provides convenience, simplified patient's use, reduced and taken number of times, slow releasing agent gets final product once a day, simultaneously also can reduce the dosage that the patient takes medicine, thereby can reduce side effects of pharmaceutical drugs and increase patient's compliance, improve patient's quality of life.
On the other hand, compound provided by the invention is from two different approaches blood sugar control content and have synergism: metformin hydrochloride is treatment diabetes choice drugs, thereby it reduces fasting glucose (FPG) by suppressing hepatogenous blood glucose amount, it can obviously improve patient's anti-sugar amount and hyperinsulinemia, reduce blood plasma free fatty acid and triglyceride levels, improve the natural reaction of human body insulin.Repaglinide is a non-sulfonylurea insulin secretion accelerating medicine, stimulates pancreatic secretion insulin after the meal, thus 2 hours after the meal blood glucose (PPG) of very fast reduction, and it acts on faster than sulfonylurea.The two share has good synergistic, than independent medication blood sugar control more effectively.
The specific embodiment:
Come the present invention done further specifying by following example, but be not limited in following example.
Embodiment 1 slow releasing tablet, slow-releasing granules, slow releasing capsule
Prescription
Preparation method:
Granule 1: it is standby that principal agent and adjuvant are crossed 80 mesh sieves respectively.Take by weighing metformin hydrochloride, repaglinide, ethyl cellulose, HPMC (K4M), microcrystalline Cellulose, lactose according to prescription, behind equivalent incremental method mixing, add the 8%PVP water-alcohol solution, make material reach the state of " that pinches is agglomerating, and that touches promptly looses ", promptly make soft material, soft material is crossed 24 mesh sieves and is granulated, after 60 ℃ of-65 ℃ of dryings, cross 18 mesh sieve granulate, add the magnesium stearate mixing.
Granule 2: it is standby that principal agent and adjuvant are crossed 80 mesh sieves respectively.According to prescription take by weighing repaglinide, HPMC (K4M), microcrystalline Cellulose, lactose, with behind the equivalent incremental method mixing, add the 5%PVP aqueous solution, make material reach the state of " that pinches is agglomerating; that touches promptly looses ", promptly make soft material, soft material is crossed 24 mesh sieves and is granulated, after 60 ℃ of-65 ℃ of dryings, cross 18 mesh sieve granulate, add the magnesium stearate mixing.
Adopt suitable punch die to be pressed into 3 corresponding prescriptions of slow releasing tablet granule 1 (A, B, C) and granule 2 (A, B, C).
Can be with granule 1 (A, B, C) and the corresponding mixing of granule 2 (A, B, C), direct packaging is made 3 corresponding prescriptions of sustained-release granular formulation.
Also granule 1 (A, B, C) and the corresponding mixing of granule 2 (A, B, C) can be selected the packing of examples of suitable shell, make 3 corresponding prescriptions of slow releasing capsule.
Embodiment 2 liquid capsules
Prescription
Preparation method:
Metformin hydrochloride and repaglinide are crossed 120 mesh sieves, standby.Take by weighing Cera Flava according to prescription and add in the Semen Maydis oil, heating is stirred to dissolving, adds recipe quantity metformin hydrochloride and repaglinide, fully mixes and stirs, and makes suspension, in the suitable transparent hard capsule of packing into, and heat-sealing, both.
Embodiment 4 granules, tablet, capsule
Prescription
Preparation method:
It is standby that principal agent and adjuvant are crossed 100 mesh sieves respectively.According to prescription take by weighing metformin hydrochloride, repaglinide and except that magnesium stearate other adjuvants, behind equivalent incremental method mixing, add binding agent system soft material, soft material is crossed the granulation of 24 mesh sieves, after drying about 60 ℃, mistake 18 mesh sieve granulate add the magnesium stearate mixing again.
With above-mentioned granule direct packaging, can be made into granule.
Above-mentioned granule is selected the packing of examples of suitable shell, make capsule.
Above-mentioned granule is adopted suitable punch die compacting, make tablet.
Embodiment 5 dispersible tablets
Prescription
Preparation method:
It is standby that principal agent and adjuvant are crossed 100 mesh sieves respectively.Take by weighing half adjuvants such as cross-linked pvp of metformin hydrochloride, repaglinide and recipe quantity according to prescription, behind equivalent incremental method mixing, add adhesive and make material reach the state of " that pinches is agglomerating, and that touches promptly looses ", promptly make soft material, soft material is crossed 24 mesh sieves and is granulated, after drying about 60 ℃, cross 18 mesh sieve granulate, add the cross-linked pvp and the magnesium stearate mixing of residue recipe quantity, adopt suitable punch die tabletting, both.
Embodiment 6 chewable tablet
Prescription
Preparation method:
Metformin hydrochloride, repaglinide, lactose, xylitol, aspartame are crossed 120 mesh sieves respectively, behind equivalent incremental method mixing, add the 5%PVP water-alcohol solution, make material reach the state of " that pinches is agglomerating; that touches promptly looses ", promptly make soft material, soft material is crossed 24 mesh sieves and is granulated, after drying about 60 ℃, cross 18 mesh sieve granulate, add recipe quantity micropowder silica gel mixing, adopt suitable punch die tabletting, both.
Embodiment 7 oral cavity disintegration tablets
Prescription
Preparation method:
Half cross-linked pvp and carboxymethyl starch sodium, lactose, aspartame of metformin hydrochloride, repaglinide, recipe quantity crossed 120 mesh sieves respectively, behind equivalent incremental method mixing, add the 5%PVP water-alcohol solution, make material reach the state of " that pinches is agglomerating, and that touches promptly looses ", promptly make soft material, soft material is crossed 24 mesh sieves and is granulated, after drying about 60 ℃, cross 18 mesh sieve granulate, add cross-linked pvp and the carboxymethyl starch sodium and the micropowder silica gel mixing of residue recipe quantity, adopt suitable punch die tabletting, both.
Embodiment 8 soft capsules
Prescription
Preparation method:
Earlier about 80% Oleum Ricini is heated to 40-60 ℃, metformin hydrochloride and the repaglinide of adding after with equivalent incremental method mixing, stirring makes dissolving, the propylene glycol, the Tween 80 that add recipe quantity again after stirring, continue to add the surplus Oleum Ricini, obtain clear liquid, regulate the weight of soft capsule content, compacting, both.
Embodiment 9 drop pill
Prescription
Preparation method:
Metformin hydrochloride and repaglinide are crossed 100 mesh sieves, with standby behind the equivalent incremental method mixing; Hydrogenated vegetable oil is heated to about 80 ℃ makes fusion in addition; Standby metformin hydrochloride and repaglinide added in the fused solution stirring, move in the water dropper, be incubated about 80 ℃, regulate the water dropper size, serves as the cooling phase with 4 ℃ water, dripping system, and filtration is washed, and drying is selected ball, gets final product.
Claims (13)
1. a medicinal compound contains metformin hydrochloride and repaglinide and medicine acceptable carrier.
2. medicinal compound as claimed in claim 1 is characterized in that, described metformin hydrochloride is 250mg～2g, and repaglinide is 0.1mg～4.0mg.
3. medicinal compound as claimed in claim 1 or 2 is characterized in that, described metformin hydrochloride 250mg, 500mg, 850mg are for repaglinide is 0.25mg～4mg.
4. medicinal compound as claimed in claim 1 is characterized in that, described carrier is one or more in filler, binding agent, disintegrating agent, lubricant, anticaking agents, slow releasing agent, the water-insoluble substrate.
5. medicinal compound as claimed in claim 4 is characterized in that described filler is one or more the mixture in lactose, starch, microcrystalline Cellulose, dextrin, sorbitol, mannitol, calcium phosphate dibasic anhydrous, corn starch, pregelatinized Starch, polacrilin potassium, 85% glycerol, hydrogenated vegetable oil, meglumin, the poloxalkol.
6. medicinal compound as claimed in claim 4 is characterized in that described binding agent is one or more the mixture in PVP solution, starch slurry, water, ethanol, dextrin slurry, the gelatine size.
7. medicinal compound as claimed in claim 4 is characterized in that described disintegrating agent is one or more the mixture in dried starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone PVPP, L-HPC, xylitol, methylcellulose, microcrystalline Cellulose, citric acid, the carbonate.
8. medicinal compound as claimed in claim 4 is characterized in that described lubricant is one or more the mixture in magnesium stearate, Pulvis Talci, micropowder silica gel, the hydrogenated vegetable oil.
9. medicinal compound as claimed in claim 4 is characterized in that described anticaking agents is the mixture of a kind of of potassium ferrocyanide, sodium aluminosilicate, tricalcium phosphate, silicon dioxide, microcrystalline Cellulose, Pulvis Talci, magnesium trisilicate or two kinds.
10. medicinal compound as claimed in claim 4 is characterized in that described slow releasing agent is cellulose derivative (methylcellulose, ethyl cellulose, hydroxyethylmethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, hydroxy methocel and Carboxymethyl cellulose sodium etc.), natural gum (glue such as pectin, sodium alginate, potassium alginate, agar, angle fork, locust bean gum, pawl ear natural gum and tragakanta etc.), polyethylene, polypropylene, polysiloxanes and polyoxyethylene, hydroxypropyl methylcellulose, Carboxymethyl cellulose sodium or tragakanta; Cera Flava, hydrogenated vegetable oil, synthetic wax, butyl stearate, stearic acid, Brazil wax, glyceryl stearate, propylene glycol-stearate and octadecanol, arabic gum, acrylic resin, Hydroxypropyl Methylcellulose Phathalate and Lac, dimethylaminoethyl methacrylate-neutral methacrylic acid esters copolymer, methacrylic acid copolymer, cellulose acetate-phthalate, the mixture of one or more in Hydroxypropyl Methylcellulose Phathalate and the phthalic acid vinyl acetate resin.
11. medicinal compound as claimed in claim 4 is characterized in that described water-insoluble substrate is one or more the mixture in stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, the octadecanol.
12. medicinal compound as claimed in claim 1 can be made into slow releasing tablet, slow-releasing granules, slow releasing capsule, conventional tablet, capsule; Oral formulations such as granule, dispersible tablet, chewable tablet, oral cavity disintegration tablet, buccal tablet, liquid capsule, soft capsule, drop pill.
13. medicinal compound as claimed in claim 1 is applicable to type or type (non-insulin-dependent) patient's treatment.Blood sugar control there is synergism.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910105692A CN101822672A (en) | 2009-03-05 | 2009-03-05 | Compound with metformin and repaglinide, preparation method thereof and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910105692A CN101822672A (en) | 2009-03-05 | 2009-03-05 | Compound with metformin and repaglinide, preparation method thereof and application thereof |
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| CN101822672A true CN101822672A (en) | 2010-09-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN200910105692A Pending CN101822672A (en) | 2009-03-05 | 2009-03-05 | Compound with metformin and repaglinide, preparation method thereof and application thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102283813A (en) * | 2011-07-28 | 2011-12-21 | 北京万全阳光医学技术有限公司 | Medicinal composition containing repaglinide and preparation method thereof |
| CN102357085A (en) * | 2011-10-27 | 2012-02-22 | 苏州中化药品工业有限公司 | Stable method for preparing repaglinide compressed tablets |
| CN102784127A (en) * | 2011-05-20 | 2012-11-21 | 江苏豪森医药集团连云港宏创医药有限公司 | Solid pharmaceutical composition, preparation method and application |
| CN102813652A (en) * | 2012-07-31 | 2012-12-12 | 南京正科制药有限公司 | Repaglinide metformin hydrochloride tablet |
| CN103371981A (en) * | 2012-04-26 | 2013-10-30 | 天津药物研究院 | Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof |
| CN103385878A (en) * | 2013-07-24 | 2013-11-13 | 山东省医药工业研究所 | Repaglinide and dimethyldiguanide pharmaceutical composition and preparation method thereof |
| EP3378472A1 (en) * | 2012-08-09 | 2018-09-26 | Dynamis Therapeutics, Inc. | Combinations of meglumine |
| CN109276704A (en) * | 2017-11-07 | 2019-01-29 | 江苏省中医药研究院 | Purposes of the melittin in the drug or health care product of preparation treatment and/or prevention diabetes |
| CN112494485A (en) * | 2020-11-26 | 2021-03-16 | 北京福元医药股份有限公司 | Saxagliptin and metformin hydrochloride sustained-release tablet |
-
2009
- 2009-03-05 CN CN200910105692A patent/CN101822672A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784127A (en) * | 2011-05-20 | 2012-11-21 | 江苏豪森医药集团连云港宏创医药有限公司 | Solid pharmaceutical composition, preparation method and application |
| CN102283813A (en) * | 2011-07-28 | 2011-12-21 | 北京万全阳光医学技术有限公司 | Medicinal composition containing repaglinide and preparation method thereof |
| CN102283813B (en) * | 2011-07-28 | 2017-05-24 | 万全万特制药江苏有限公司 | Medicinal composition containing repaglinide and preparation method thereof |
| CN102357085A (en) * | 2011-10-27 | 2012-02-22 | 苏州中化药品工业有限公司 | Stable method for preparing repaglinide compressed tablets |
| CN103371981A (en) * | 2012-04-26 | 2013-10-30 | 天津药物研究院 | Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof |
| CN102813652A (en) * | 2012-07-31 | 2012-12-12 | 南京正科制药有限公司 | Repaglinide metformin hydrochloride tablet |
| EP3378472A1 (en) * | 2012-08-09 | 2018-09-26 | Dynamis Therapeutics, Inc. | Combinations of meglumine |
| CN103385878A (en) * | 2013-07-24 | 2013-11-13 | 山东省医药工业研究所 | Repaglinide and dimethyldiguanide pharmaceutical composition and preparation method thereof |
| CN109276704A (en) * | 2017-11-07 | 2019-01-29 | 江苏省中医药研究院 | Purposes of the melittin in the drug or health care product of preparation treatment and/or prevention diabetes |
| CN112494485A (en) * | 2020-11-26 | 2021-03-16 | 北京福元医药股份有限公司 | Saxagliptin and metformin hydrochloride sustained-release tablet |
| CN112494485B (en) * | 2020-11-26 | 2022-04-01 | 北京福元医药股份有限公司 | Saxagliptin and metformin hydrochloride sustained-release tablet |
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Application publication date: 20100908 |