CN104997747A - Glipizide tablets and preparation method thereof - Google Patents
Glipizide tablets and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of medicines and particularly relates to glipizide tablets and a preparation method thereof. The glipizide tablets comprise raw materials in parts by weight as follows: 4-6 parts of glipizide, 87-263 parts of a filler, 5-15 parts of a disintegrating agent and 0.5-1.5 parts of a lubricant, wherein the filler preferably comprises components in parts by weight as follows: 24-72 parts of starch, 15-45 parts of mannitol, 26-78 parts of sugar and 22-68 parts of microcrystalline cellulose. The glipizide tablets have stable drug release property and high dissolution rate. The invention further provides the preparation method of the glipizide tablets. The preparation method has a simple and reasonable process and is easy to implement.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of glipizide tablet and preparation method thereof.
Background technology
Glipizide is sulfonamides orally-taken blood sugar reducing medicine, reaches its quick hypoglycemic activity by stimulating pancreas excreting insulin.Effect depends on the function of beta Cell of islet, and pancreas external effect also should play partial action in the mechanism of action of sulphanylureas orally-taken blood sugar reducing medicine.Outbalance in the mechanism of action of glipizide is acted on outside the pancreas that increase insulin sensitivity and minimizing liver glucose generate.The glipizide of current listing has the plurality of specifications such as 2.5mg, 5mg and 10mg, and dosage form has tablet, dispersible tablet, capsule, controlled release tablet, oral cavity disintegration tablet etc.
It is large that glipizide tablet takes rear blood glucose fluctuation, and accidental hypoglycemia report, patient compliance is poor.
Sustained-release preparation can extend effective drug duration, reduces blood drug level peak valley phenomenon, increases the compliance of patient.But sustained-release preparation generally adopts osmotic pumps drug-supplying system, need repeatedly coating and laser boring, complex manufacturing, cost are higher, there is the incomplete problem of final release, and it are aging to there is semipermeable membrane in storage process simultaneously, the problem that release performance declines.
Existing Glipizide controlled release tablets is mostly designed to 16 hours or the preparation of release in 24 hours, but the time that medicine is detained in vivo does not reach 16h or 24h, therefore often there is medicine and does not discharge completely and the phenomenon that excretes.The sterile region of most of oral drugs mainly in small intestinal middle and upper part absorbs.Medicine by after sterile region, by decompose by the antibacterial of increasing gradually, only have metabolite and minute quantity medicine to be absorbed.Medicine is about 2-3 hour by the shortest time of sterile region, seems too short for the time most of oral sustained-release preparation.Although most controlled release system controls the release of medicine well, the bioavailability of medicine is not high, and this is because these preparations are too short in the holdup time of gastrointestinal, and many medicines are not released and just pass through absorption site.Therefore, be necessary to extend these sustained-release preparations in the gastrointestinal retention time, thus while control, increase the absorption of medicine, improve the bioavailability of medicine.
Patent of invention CN 104434856 A discloses a kind of preparation method of floating in stomach controlled release tablet, although this invention solves Glipizide controlled release tablets in gastrointestinal holdup time problem, laser-beam drilling machine is not needed to carry out laser boring yet, but the coating of controlled release layer will be carried out in its production process, the technological parameter of coating process is comparatively complicated, comprise the higher adjuvant of the prices such as ethyl cellulose in coating material, production cost is higher.
Although common glipizide tablet needs patient's multiple dosing, there is obvious price advantage than sustained-release preparation, therefore invent that a kind of drug release is steady, the simple glipizide tablet of preparation technology seems particularly important.And in existing technology, all fail to provide a kind of dissolution high, drug release is steady, the preparation method of the simple glipizide tablet of preparation technology.
Summary of the invention
The object of this invention is to provide a kind of glipizide tablet, drug release is steady, and dissolution is high, and the present invention also provides its preparation method, and technique advantages of simple is easy to implement.
A kind of glipizide tablet of the present invention, comprises the raw material of following parts by weight:
Wherein:
Described filler be selected from following material one or more: starch, dextrin, lactose, microcrystalline Cellulose, sucrose, mannitol, sorbitol, pregelatinized Starch, calcium hydrogen phosphate, calcium sulfate, calcium carbonate, xylose, Kaolin or sodium chloride; Filler of the present invention preferably includes the component of following parts by weight: starch 24-72 part, mannitol 15-45 part, sucrose 26-78 part and microcrystalline Cellulose 22-68 part.
Described disintegrating agent be selected from following material one or more: starch and derivant, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone or microcrystalline Cellulose; Disintegrating agent is preferably low-substituted hydroxypropyl cellulose.
Described lubricant be selected from following material one or more: silicon dioxide, magnesium stearate, stearic acid, Pulvis Talci, hydrogenated vegetable oil or Polyethylene Glycol; Lubricant is preferably magnesium stearate.
Preferred as one, raw material also comprises binding agent, binding agent be selected from following material one or more: water, wax, alcohol, polyvidone, starch, hypromellose, methylcellulose, ethyl cellulose, sucrose, sodium carboxymethyl cellulose, gelatin, sodium alginate, hyprolose or Polyethylene Glycol; Binding agent is preferably that the dehydrated alcohol of 20-60 part and the purified water of 20-60 part form by parts by weight.
A preparation method for described glipizide tablet, comprises the following steps:
(1) glipizide pulverized 80-120 mesh sieve, and filler pulverized 80-120 mesh sieve;
(2) load weighted glipizide and filler are joined wet granulator, after mix homogeneously, add binding agent and prepare soft material, granulate with 14-30 eye mesh screen;
(3) product introduction Fluidbedgranulatingdrier step (2) obtained is dry;
(4) product 14-30 eye mesh screen granulate step (3) obtained;
(5) product, disintegrating agent and lubricant that step (4) obtains are joined in mixer, mixing;
(6) product of step (5) gained is added tabletting in rotary tablet machine, obtain glipizide tablet.
Wherein: in step (5), incorporation time is 5-30min.
A kind of preparation method of metformin hydrochloride glipizide capsule of high-dissolution is disclosed in patent ZL200510105796.8, the method is for the preparation of solubility degree and the method for high-dissolution product, when glipizide crosses 200 mesh sieves or micronization processes, just can make dissolution more than 90%.Common pulverization process is difficult to reach more than 200 orders, realizes more difficult in this way, and raw material, in order to improve the dissolution of glipizide, not only pulverizes and sieves by the application, is is also pulverized and sieved by filler; The present invention is by selecting kind and the consumption of suitable filler, disintegrating agent, binding agent, lubricant, and the screening of the conditions such as order number of sieving to supplementary material in preparation process, and obtained tablet has the advantages such as dissolution is good, tablet weight variation is little.
The present invention compared with prior art, has following beneficial effect:
Present invention process is simple, easy to implement, and the glipizide tablet drug release prepared is steady, and dissolution is high, and the present invention also provides its preparation method, and technique advantages of simple is easy to implement.
Detailed description of the invention
Below in conjunction with embodiment, the present invention will be further described.
In comparative example and embodiment, in all forms, " N/A " represents and does not add.
Embodiment 1
Glipizide pulverized 100 mesh sieves, and filler pulverized 100 mesh sieves.Take glipizide 50g, filler 1750g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 400g and purified water 400g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1800g, disintegrating agent low-substituted hydroxypropyl cellulose 100g and magnesium stearate lubricant 10g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Comparative example 1-8
Preparation method is identical with embodiment 1, and difference is that filler used is different.
The kind of embodiment 1 and comparative example 1-8 filler used and consumption and related performance indicators are in table 1.
Data as can be seen from table 1, embodiment 1 best performance.
The kind of table 1 embodiment 1 and comparative example 1-8 filler used and consumption and related performance indicators
Embodiment 2-3
Glipizide pulverized 100 mesh sieves, and filler pulverized 100 mesh sieves.Take glipizide 50g, starch 450g, mannitol 300g, sucrose 550g, microcrystalline Cellulose 450g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 400g and purified water 400g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1800g, disintegrating agent and magnesium stearate lubricant 10g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Comparative example 9-12
Preparation method is identical with embodiment 2-3, and difference is that disintegrating agent used is different.
The performance of the product of the kind of the disintegrating agent that embodiment 2-3 and comparative example 9-12 is used and consumption and preparation is in table 2.
Data as can be seen from table 2, embodiment 3 best performance.
The performance of the product of the kind of the disintegrating agent that table 2 embodiment 2-3 and comparative example 9-12 is used and consumption and preparation
Embodiment 4-5
Glipizide pulverized 100 mesh sieves, and filler pulverized 100 mesh sieves.Take glipizide 50g, starch 450g, mannitol 300g, sucrose 550g, microcrystalline Cellulose 450g, add in wet granulator, mix homogeneously.Add binding agent and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1800g, disintegrating agent low-substituted hydroxypropyl cellulose 100g and magnesium stearate lubricant 10g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Comparative example 13
Preparation method is identical with embodiment 4, and difference is that binding agent used is different.
The performance of embodiment 4-5 and comparative example 13 kind of binding agent used and the product of consumption and preparation is in table 3.
Data as can be seen from table 3, embodiment 4 best performance.
The performance of table 3 embodiment 4-5 and comparative example 13 kind of binding agent used and the product of consumption and preparation
Embodiment 6-7
Glipizide pulverized 100 mesh sieves, and filler pulverized 100 mesh sieves.Take glipizide 50g, starch 450g, mannitol 300g, sucrose 550g, microcrystalline Cellulose 450g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 400g and purified water 400g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1800g, disintegrating agent and lubricant are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Comparative example 14-15
Preparation method is identical with embodiment 6-7, and difference is that lubricant used is different.
The performance of embodiment 4-5 and comparative example 13 kind of lubricant used and the product of consumption and preparation is in table 4.
Data as can be seen from table 4, embodiment 4,5 best performance.
The performance of table 4 embodiment 4-5 and comparative example 13 kind of lubricant used and the product of consumption and preparation
Embodiment 8-11
Glipizide and filler pulverize and sieve respectively.Take glipizide 50g, starch 450g, mannitol 300g, sucrose 550g, microcrystalline Cellulose 450g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 400g and purified water 400g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1800g, disintegrating agent and lubricant are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
The performance of the product of the particle diameter that embodiment 8-11 supplementary material pulverizes and sieves and preparation is in table 5.
Data as can be seen from table 5, embodiment 9 best performance.
The screening of table 5 supplementary material granularity
Embodiment 12
Embodiment 12 supplementary material used is in table 6.
Table 6 embodiment 12 supplementary material used
| Glipizide | 50g |
| Pregelatinized Starch | 240g |
| Dextrin | 150g |
| Lactose | 260g |
| Microcrystalline Cellulose | 220g |
| Carboxymethyl starch sodium | 50g |
| Stearic acid | 5g |
| Be prepared into | 10000 |
Preparation technology:
Glipizide pulverized 120 mesh sieves, and filler pulverized 120 mesh sieves.Take glipizide 50g, pregelatinized Starch 240g, dextrin 150g, lactose 260g, microcrystalline Cellulose 220g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 200g and purified water 200g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 920g, disintegrating agent carboxymethyl base Starch Sodium 50g and magnesium stearate 5g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Embodiment 13
Embodiment 13 supplementary material used is in table 7.
Table 7 embodiment 13 supplementary material used
| Glipizide | 50g |
| Starch | 500g |
| Mannitol | 350g |
| Sucrose | 500g |
| Microcrystalline Cellulose | 450g |
| Low-substituted hydroxypropyl cellulose | 100g |
| Magnesium stearate | 10g |
| Be prepared into | 10000 |
Preparation technology:
Glipizide pulverized 80 mesh sieves, and filler pulverized 80 mesh sieves.Take glipizide 50g, starch 500g, mannitol 350g, sucrose 500g, microcrystalline Cellulose 450g, add in wet granulator, mix homogeneously.Add dehydrated alcohol 400g and purified water 400g and prepare soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 1850g, disintegrating agent low-substituted hydroxypropyl cellulose 100g and magnesium stearate 10g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
Embodiment 14
Embodiment 14 supplementary material used is in table 8.
Table 8 embodiment 14 supplementary material used
| Glipizide | 50g |
| Starch | 720g |
| Sorbitol | 450g |
| Xylose | 780g |
| Microcrystalline Cellulose | 680g |
| Polyvidone | 24g |
| Carboxymethyl starch sodium | 150g |
| Stearic acid | 15g |
| Be prepared into | 10000 |
Preparation technology:
Glipizide pulverized 100 mesh sieves, and filler pulverized 100 mesh sieves.Take glipizide 50g, starch 720g, sorbitol 450g, xylose 780g, microcrystalline Cellulose 680g, add in wet granulator, mix homogeneously.Take polyvidone 24g, add the solution that dehydrated alcohol is mixed with 2% and make binding agent soft material, granulate with 20 eye mesh screens.Wet granular is dry with Fluidbedgranulatingdrier, granule crushing and pelletizing machine 20 order web plate granulate.Granule 2704g, disintegrating agent carboxymethyl base Starch Sodium 150g and stearic acid 15g are added in mixer, mixes 10 minutes.Mixed-powder rotary tablet machine tabletting.
The stripping curve of embodiment 12-14 sample is detected according to the dissolution method of 2010 editions Chinese Pharmacopoeias, two glipizide tablets, table 9 is glipizide tablet dissolution testing result, as can be seen from the data of table 9, it is good that glipizide tablet prepared by the present invention has dissolution, the advantages such as relative average debiation is little.
Table 9 glipizide tablet dissolution testing result
Claims (8)
1. a glipizide tablet, is characterized in that: the raw material comprising following parts by weight:
2. glipizide tablet according to claim 1, is characterized in that: filler be selected from following material one or more: starch, dextrin, lactose, microcrystalline Cellulose, sucrose, mannitol, sorbitol, pregelatinized Starch, calcium hydrogen phosphate, calcium sulfate, calcium carbonate, xylose, Kaolin or sodium chloride; Disintegrating agent be selected from following material one or more: starch and derivant, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone or microcrystalline Cellulose; Lubricant be selected from following material one or more: silicon dioxide, magnesium stearate, stearic acid, Pulvis Talci, hydrogenated vegetable oil or Polyethylene Glycol.
3. glipizide tablet according to claim 1, is characterized in that: filler comprises the component of following parts by weight: starch 24-72 part, mannitol 15-45 part, sucrose 26-78 part and microcrystalline Cellulose 22-68 part.
4. glipizide tablet according to claim 1, is characterized in that: disintegrating agent is low-substituted hydroxypropyl cellulose.
5. glipizide tablet according to claim 1, is characterized in that: lubricant is magnesium stearate.
6., according to the arbitrary described glipizide tablet of claim 1-5, it is characterized in that: raw material also comprises binding agent, binding agent is that the dehydrated alcohol of 20-60 part and the purified water of 20-60 part form by parts by weight.
7. a preparation method for glipizide tablet according to claim 6, is characterized in that: comprise the following steps:
(1) glipizide pulverized 80-120 mesh sieve, and filler pulverized 80-120 mesh sieve;
(2) load weighted glipizide and filler are joined wet granulator, after mix homogeneously, add binding agent and prepare soft material, granulate with 14-30 eye mesh screen;
(3) product introduction Fluidbedgranulatingdrier step (2) obtained is dry;
(4) product 14-30 eye mesh screen granulate step (3) obtained;
(5) product, disintegrating agent and lubricant that step (4) obtains are joined in mixer, mixing;
(6) product of step (5) gained is added tabletting in rotary tablet machine, obtain glipizide tablet.
8. the preparation method of glipizide tablet according to claim 7, is characterized in that: in step (5), incorporation time is 5-30min.
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| CN108066300A (en) * | 2017-12-25 | 2018-05-25 | 远大医药（中国）有限公司 | A kind of glipizide tablet and preparation method thereof |
| CN108434111A (en) * | 2018-05-22 | 2018-08-24 | 远大医药（中国）有限公司 | A kind of glipizide tablet and preparation method thereof |
| CN110302226A (en) * | 2019-06-20 | 2019-10-08 | 天马（安徽）国药科技股份有限公司 | A kind of Radix Notoginseng flour producing process that can be used for being used as medicine |
| CN110638771A (en) * | 2019-10-28 | 2020-01-03 | 仁和堂药业有限公司 | Preparation process of glipizide tablets |
| CN114081866A (en) * | 2021-11-08 | 2022-02-25 | 则正(上海)生物科技有限公司 | Method for evaluating internal and external correlation of glipizide tablets |
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| CN114081866A (en) * | 2021-11-08 | 2022-02-25 | 则正(上海)生物科技有限公司 | Method for evaluating internal and external correlation of glipizide tablets |
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Address after: 256100 No. 6 Erlang Road, Yiyuan County, Zibo, Shandong Patentee after: Ruiyang Pharmaceutical Co., Ltd Address before: 256100 No. 6 Erlang Road, Yiyuan County, Zibo, Shandong Patentee before: REYOUNG PHARMACEUTICAL Co.,Ltd. |