CN102440975B - Metformin hydrochloride sustained-release tablets and preparation method thereof - Google Patents
Metformin hydrochloride sustained-release tablets and preparation method thereof Download PDFInfo
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- CN102440975B CN102440975B CN2011103746706A CN201110374670A CN102440975B CN 102440975 B CN102440975 B CN 102440975B CN 2011103746706 A CN2011103746706 A CN 2011103746706A CN 201110374670 A CN201110374670 A CN 201110374670A CN 102440975 B CN102440975 B CN 102440975B
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- 229960004329 metformin hydrochloride Drugs 0.000 title claims abstract description 17
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 title claims abstract description 17
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin hydrochloride Natural products CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title claims abstract description 17
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 11
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 27
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 27
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 27
- 229960003943 hypromellose Drugs 0.000 claims abstract description 27
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 22
- 239000003814 drug Substances 0.000 claims abstract description 16
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 14
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 14
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 229940079593 drug Drugs 0.000 claims abstract description 8
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 6
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 6
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000008117 stearic acid Substances 0.000 claims abstract description 6
- 239000008187 granular material Substances 0.000 claims description 25
- 239000000203 mixture Substances 0.000 claims description 5
- 239000002671 adjuvant Substances 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 239000003826 tablet Substances 0.000 abstract description 9
- 208000001072 type 2 diabetes mellitus Diseases 0.000 abstract description 7
- 239000008280 blood Substances 0.000 abstract description 5
- 210000004369 blood Anatomy 0.000 abstract description 5
- 238000001727 in vivo Methods 0.000 abstract description 3
- 231100000053 low toxicity Toxicity 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract 2
- 230000002035 prolonged effect Effects 0.000 abstract 1
- 230000001476 alcoholic effect Effects 0.000 description 6
- 239000002002 slurry Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000007779 soft material Substances 0.000 description 3
- 229940123208 Biguanide Drugs 0.000 description 2
- 230000003178 anti-diabetic effect Effects 0.000 description 2
- 239000003472 antidiabetic agent Substances 0.000 description 2
- 150000004283 biguanides Chemical class 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- -1 hydroxypropyl Chemical group 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 206010025482 malaise Diseases 0.000 description 2
- 239000011812 mixed powder Substances 0.000 description 2
- 238000005453 pelletization Methods 0.000 description 2
- 201000009104 prediabetes syndrome Diseases 0.000 description 2
- 238000007613 slurry method Methods 0.000 description 2
- 238000013268 sustained release Methods 0.000 description 2
- 239000012730 sustained-release form Substances 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 208000002705 Glucose Intolerance Diseases 0.000 description 1
- 206010018429 Glucose tolerance impaired Diseases 0.000 description 1
- 229920002527 Glycogen Polymers 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 description 1
- 208000013016 Hypoglycemia Diseases 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 208000001280 Prediabetic State Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000011841 epidemiological investigation Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229940096919 glycogen Drugs 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 description 1
- 201000008980 hyperinsulinism Diseases 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229940103776 metformin hydrochloride 500 mg Drugs 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Abstract
The invention discloses metformin hydrochloride sustained-release tablets which are characterized in that: every 10000 tablets are prepared from medicine materials and auxiliary materials of, by weight: 5000g of metformin hydrochloride, 1750g of hypromellose, 1750g of sodium carboxymethyl cellulose, 180g of stearic acid, 200g of magnesium stearate, and an appropriate amount of 75% ethanol. The metformin hydrochloride sustained-release tablets can be slowly released in vivo. With the tablets, stability of blood drug level can be maintained, and a half-life period is prolonged. The tablets are safe, can be used for treating type II diabetes, and are advantaged in high efficiency, low toxicity, and convenient administration. The invention also provides a preparation method of the metformin hydrochloride sustained-release tablets.
Description
Technical field
The invention belongs to field of medicine preparing technology, be specifically related to a kind of melbine hydrocloride slow-releasing preparation that is used for the treatment of type ii diabetes and preparation method thereof.
Background technology
Have data to show, China adult's in 1979 onset diabetes rate less than 1%, risen to 2.65% by 1997, and annual speed with 0.1% increases sharply in recent years.Show from the extensive epidemiological investigation result to 11, whole nation province, city people more than 40,000, in China crowd of present 20～74 years old, the sickness rate of diabetes is 2.2%, the sickness rate of impaired glucose tolerance (being prediabetes) is more up to 3.8%, the diabetics that this means present 20～74 years old age bracket crowd of China surpasses 2,000 ten thousand, and " reserves " reaches 3,000 ten thousand people.And 90% is type 2 diabetes mellitus, and for this reason, for the insider, researching and developing antidiabetic medicine has safely and effectively become the task of top priority.
Metformin hydrochloride is a kind of biguanides of can be oral and being used widely, it is the unique oral biguanides hyperglycemia medicine that present World Developed Countries is still using, can improve the tolerance of type-II diabetes patient to sugar, reduce basis and reach plasma glucose concentration after the meal, mechanism of action is different from other antidiabetic medicines.Metformin hydrochloride reduces glycogen and generates, and small intestinal is reduced the absorption of sugar, the opposing that picked-up and the utilization of sugar is improved insulin by increasing periphery.Do not produce hypoglycemic reaction in normal person and type-II diabetes patient, do not produce hyperinsulinemia yet.The metformin hydrochloride that uses clinically at present is conventional tablet and capsule etc., and common dose is grams every days 1.5, divides and takes for 3 times.Therefore, must medicine time is spaced apart regularly, guarantee blood drug level is kept treatment level, exists clothes for patients with inconvenience, easily forgets clothes, misses, the shortcoming such as blood concentration fluctuation is large.
Summary of the invention
It is steady that the present invention provides a kind of in order to overcome above-mentioned weak point of the prior art just and can slowly discharge in vivo, keep blood drug level, Increased Plasma Half-life, the hypoglycemic medicine that is used for the treatment of type ii diabetes of safety, efficient, low toxicity, taking convenience: diabecron sustained-release tablet.
A kind of diabecron sustained-release tablet, is characterized in that, every 10000 crude drug by following weight and adjuvant are made:
Metformin hydrochloride 5000g;
Hypromellose 1 1750g;
Sodium carboxymethyl cellulose 1750g;
Hypromellose 2 16g;
Stearic acid 180g;
Magnesium stearate 200g;
75% appropriate amount of ethanol.
In the present invention's prescription, slow releasing agent is hypromellose and sodium carboxymethyl cellulose, and ratio is 1: 1; The model of hypromellose is preferably HPMC-4000.The present invention is through experimental results demonstrate, HPMC-4000 more can make sustained release than other hypromellose model.
Diabecron sustained-release tablet of the present invention can slowly discharge in vivo, it is steady to keep blood drug level, Increased Plasma Half-life, and safety, efficient, low toxicity, taking convenience, can be used for treating type ii diabetes.
The present invention also provides the preparation method of above-mentioned diabecron sustained-release tablet, it is characterized in that, comprises the following steps:
(1) with 75% ethanol preparation mass percent concentration be 0.5% hypromellose solution and 10% magnesium stearate solution;
(2) take metformin hydrochloride, hypromellose, sodium carboxymethyl cellulose, cross 100 mesh sieves, mix; Add hypromellose solution once to granulate, then add magnesium stearate solution secondary to granulate, drying, cross 20 mesh sieve granulate, tabletting.
In pelletization, first take metformin hydrochloride, hypromellose, sodium carboxymethyl cellulose, mix.After adding the even above-mentioned mixed-powder of moistening of hydroxypropyl first fiber pulp (0.5% hypromellose-75% alcoholic solution), then add stearic acid slurry (10% stearic acid-75% alcoholic solution) soft material processed.The present invention adopts the method that adds slurry for twice to granulate, and, through experimental results demonstrate the viscosity that can improve granule, increases the tablet slow release degree, and the slow release effect of medicine is significantly improved than once adding the slurry method.
The detailed step of the inventive method is: preparation 0.5%HPMC4000-75% alcoholic solution, 10% stearic acid-75% alcoholic solution.Metformin hydrochloride, hypromellose, sodium carboxymethyl cellulose claim to cross 100 mesh sieves to recipe quantity; To drop into Fastmixinggranulator through metformin hydrochloride, hypromellose, the sodium carboxymethyl cellulose of pretreated recipe quantity.The wet granular that makes is placed in airpillow-dry in ebullated dryer, the half-dried rear granulate of granule, the half-dried granule after whole continues airpillow-dry, makes dried granule LOD at 2%-4%.Half-dried granule oscillating granulator 20 eye mesh screen granulate.The dried granule conversion that granulate is good adds magnesium stearate, and three-dimensional mixer mixes.100% tabletting by labelled amount obtains product.
The specific embodiment
The present invention, in order to explanation, but is not limited to these examples with following concrete embodiment.
Embodiment 1:
Be respectively 0.5% hypromellose solution and 10% magnesium stearate solution with 70%, 75%, 95% ethanol preparation mass percent concentration;
Take metformin hydrochloride 500mg, hypromellose 175mg,, sodium carboxymethyl cellulose 175mg, mix, and sieves.Add the hypromellose slurry for preparing, then add magnesium stearate slurry, granulate, drying.
| Concentration of alcohol (%) | 70% slurrying | 75% slurrying | 95% slurrying |
| Discharge 1 hour degree | 34.28％ | 36.53％ | 34.31％ |
| Discharge 3 hours degree | 57.79％ | 63.82％ | 61.10％ |
| Discharge 10 hours degree | 88.92％ | 97.26％ | 95.86％ |
| The granulation situation | Easily granulate, granule is harder | Easily granulate, the granule pine | Easily granulate, granule is thinner |
Embodiment 2:
The model of hypromellose has larger impact to slow release effect, and the present embodiment selects respectively hypromellose-50, hypromellose-1000 and hypromellose-4000 to use as binding agent.Common several models are done analysis, and result is as follows:
| Component | Prescription 1 (mg) | Prescription 2 (mg) | Prescription 3 (mg) |
| Metformin hydrochloride | 500 | 500 | 500 |
| Hypromellose-50 | 175 | 0 | 0 |
| Hypromellose-1000 | 0 | 175 | 0 |
| Hypromellose-4000 | 0 | 0 | 175 |
| Sodium carboxymethyl cellulose | 175 | 175 | 175 |
| Stearic acid | 18 | 18 | 18 |
| Magnesium stearate | 20 | 20 | 20 |
| Release 1 hour (%) | 42.43 | 35.67 | 33.42 |
| Release 3 hours (%) | 59.68 | 57.89 | 54.28 |
| Release 10 hours (%) | 99.34 | 97.32 | 88.73 |
Result shows: HPMC-4000 more can make sustained release than other hypromellose model.
Embodiment 3:
For taking into account critical adjuvant hypromellose and the sodium carboxymethyl cellulose slow release effect to tablet, the applicant is studied additional proportion.Once during soft material processed, select PVP K30 to replace hypromellose slurrying to increase viscosity, by tablet release reaction slow releasing function, the preferred proportion of hypromellose and sodium carboxymethyl cellulose is 1: 1.
Embodiment 4:
Viscosity agent has larger impact to the release of tablet, and the present invention selects to add for twice paste-making method increases drug particles viscosity, and slow release effect is more obvious.The release of 8 two time points in back of writing out a prescription increases a lot of and second point and has exceeded the upper limit of quality standard.Therefore, the present invention selects twice to add sizing process.Namely in pelletization, first take metformin hydrochloride, hypromellose, sodium carboxymethyl cellulose, mix.After adding the even above-mentioned mixed-powder of moistening of hydroxypropyl first fiber pulp (0.5% hypromellose-75% alcoholic solution), then add stearic acid slurry (10% stearic acid-75% alcoholic solution) soft material processed.
Result is as follows:
The results show, the present invention adopts the method that adds slurry for twice to granulate, and, through experimental results demonstrate the viscosity that can improve granule, increases the tablet slow release degree, and the slow release effect of medicine is significantly improved than once adding the slurry method.
Claims (1)
1. a diabecron sustained-release tablet, is characterized in that, every 10000 crude drug by following weight and adjuvant are made:
Metformin hydrochloride 5000g;
Hypromellose 1 1750g;
Sodium carboxymethyl cellulose 1750g;
Hypromellose 2 16g;
Stearic acid 180g;
Magnesium stearate 200g;
75% appropriate amount of ethanol; Wherein, the model of described hypromellose is HPMC-4000; Wherein, the preparation method of described diabecron sustained-release tablet comprises the following steps:
(1) with 75% ethanol preparation mass percent concentration be 0.5% hypromellose solution and 10% magnesium stearate solution;
(2) take metformin hydrochloride, hypromellose, sodium carboxymethyl cellulose, cross 100 mesh sieves, mix; Add described hypromellose solution once to granulate, then add described magnesium stearate solution secondary to granulate, drying, cross 20 mesh sieve granulate, tabletting.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011103746706A CN102440975B (en) | 2011-11-22 | 2011-11-22 | Metformin hydrochloride sustained-release tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011103746706A CN102440975B (en) | 2011-11-22 | 2011-11-22 | Metformin hydrochloride sustained-release tablets and preparation method thereof |
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| CN102440975A CN102440975A (en) | 2012-05-09 |
| CN102440975B true CN102440975B (en) | 2013-11-13 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN111588701B (en) * | 2020-05-25 | 2021-04-23 | 上海普康药业有限公司 | Metformin hydrochloride sustained release tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1415288A (en) * | 2002-10-22 | 2003-05-07 | 南京长澳医药科技有限公司 | Metformin hydrochloride slowly released tablet and its preparation method |
| CN1561980A (en) * | 2004-03-26 | 2005-01-12 | 贵州圣济堂制药有限公司 | Melbine hydrochloride enteric coatel slow-releasing preparation and its preparing method |
| CN1589782A (en) * | 2003-08-28 | 2005-03-09 | 安徽省新药研究院 | Dimethyl biguanidine hydrochloride slow release particle and its preparation method |
| CN101380311A (en) * | 2008-10-10 | 2009-03-11 | 青岛黄海制药有限责任公司 | Diabecron sustained-release tablet and preparation method thereof |
| CN101428007A (en) * | 2008-12-04 | 2009-05-13 | 上海天赐福生物工程有限公司 | Process for producing diabecron sustained release tablet |
| CN101579325A (en) * | 2009-06-16 | 2009-11-18 | 重庆康刻尔制药有限公司 | Metformin hydrochloride controlled-release tablet and preparation method thereof |
-
2011
- 2011-11-22 CN CN2011103746706A patent/CN102440975B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1415288A (en) * | 2002-10-22 | 2003-05-07 | 南京长澳医药科技有限公司 | Metformin hydrochloride slowly released tablet and its preparation method |
| CN1589782A (en) * | 2003-08-28 | 2005-03-09 | 安徽省新药研究院 | Dimethyl biguanidine hydrochloride slow release particle and its preparation method |
| CN1561980A (en) * | 2004-03-26 | 2005-01-12 | 贵州圣济堂制药有限公司 | Melbine hydrochloride enteric coatel slow-releasing preparation and its preparing method |
| CN101380311A (en) * | 2008-10-10 | 2009-03-11 | 青岛黄海制药有限责任公司 | Diabecron sustained-release tablet and preparation method thereof |
| CN101428007A (en) * | 2008-12-04 | 2009-05-13 | 上海天赐福生物工程有限公司 | Process for producing diabecron sustained release tablet |
| CN101579325A (en) * | 2009-06-16 | 2009-11-18 | 重庆康刻尔制药有限公司 | Metformin hydrochloride controlled-release tablet and preparation method thereof |
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