CN106860416A - Metformin hydrochloride tablet and preparation method thereof - Google Patents
Metformin hydrochloride tablet and preparation method thereof Download PDFInfo
- Publication number
- CN106860416A CN106860416A CN201710118544.1A CN201710118544A CN106860416A CN 106860416 A CN106860416 A CN 106860416A CN 201710118544 A CN201710118544 A CN 201710118544A CN 106860416 A CN106860416 A CN 106860416A
- Authority
- CN
- China
- Prior art keywords
- metformin hydrochloride
- tablet
- slow
- preparation
- parts
- 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
Links
Classifications
-
- 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
-
- 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)
-
- 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
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of metformin hydrochloride tablet and preparation method thereof, the metformin hydrochloride tablet includes the Metformin hydrochloride of 400~600 weight portions, the lactose of 40~85 weight portions, the anhydrous silica gel of 5~15 weight portions, the gelatin of 15~30 weight portions, the carboxyrnethyl starch sodium of 5~18 weight portions, the magnesium stearate of 3~7 weight portions, the slow-release material of 3~8 weight portions.Metformin hydrochloride tablet not only has a good therapeutic effect to diabetes in the present invention, and can reduce the adverse reaction rate of Metformin hydrochloride, improves the metabolic capability of body；And the had good sustained release effect of the metformin hydrochloride tablet that the present invention is provided, its active component can slowly discharge in vivo so that metformin hydrochloride tablet have it is long-lasting.In addition, the present invention is using metformin hydrochloride tablet low cost obtained in above-mentioned formula, good drug efficacy, long-lasting good such that it is able to reduce times for spraying, treatment cost is greatly reduced.
Description
Technical field
The present invention relates to Metformin hydrochloride field, more particularly to a kind of metformin hydrochloride tablet and preparation method thereof.
Background technology
Metformin hydrochloride, belongs to biguanides, with the glucose tolerance for improving diabetes B patient, reduces
Basis and the effect of postprandial blood sugar.The mechanism of action of Metformin hydrochloride is different from other types of oral anti-blood sugar medicine, and it can
The generation of glycogen is reduced, absorption of the intestines to sugar is reduced, and insulin can be improved by increasing the intake and utilization of periphery sugar
Sensitiveness, from unlike sulfonylureas, Metformin hydrochloride will not be to diabetes B patient or the trouble of euglycemia
Person produces hypoglycemia.After Metformin hydrochloride treatment, the secretion of insulin keeps constant, and reduces empty stomach pancreas islet.But it is existing
The disintegration rate of some metformin hydrochloride tablets is fast, and the burst size of Metformin hydrochloride is big, easily increases the generation of adverse reaction.
The content of the invention
In view of this, it is an object of the invention to provide a kind of Metformin hydrochloride and preparation method thereof, first biguanides piece it is slow
Release effect good, its active component can slowly discharge in vivo.
A kind of metformin hydrochloride tablet, including following parts by weight raw material：
Preferably, including following parts by weight raw material：
Preferably, the slow-release material includes talcum powder, sodium alginate, shitosan.
Preferably, the talcum powder, the sodium alginate, the mass ratio of the PLA are (0.5~0.8)：(1~2)：
(1.5~3.6).
Present invention also offers a kind of above-mentioned preparation method of metformin hydrochloride tablet, comprise the following steps：
A) by Metformin hydrochloride, lactose, anhydrous silica gel, gelatin, carboxyrnethyl starch sodium, magnesium stearate, slow-release material, Ou Ba
For sieving for standby；
B) Metformin hydrochloride, lactose, anhydrous silica gel are weighed, dry-mixed, 5~15min in efficient wet granulator is incorporated into；
Purified water, gelatin are added, is pelletized；
C) by step b) make particle be dried, whole grain, obtain Metformin hydrochloride dry particl；
D) the Metformin hydrochloride dry particl that obtains step c), carboxyrnethyl starch sodium, magnesium stearate, slow-release material add respectively
Enter in Mixers with Multi-direction Movement, mixing, compressing tablet obtain label；
E) add Opadry solution to be coated in the label for obtaining to step d), obtain metformin hydrochloride tablet.
Preferably, the Metformin hydrochloride crosses 20 mesh sieves, the lactose, the magnesium stearate, the anhydrous silica gel, institute
State slow-release material, the carboxyrnethyl starch sodium and cross 30 mesh sieves.
Preferably, drying time is 10~20min in step c), and drying temperature is 50~60 DEG C.
Preferably, in step b) purified water 30~40 parts of parts by weight, Opadry in Opadry solution in step e)
Percentage by weight is 9~11%.
Preferably, the screen size of the vibratory sieve that whole grain process is used is 1.18~1.5mm in step c).
Preferably, the slow-release material includes talcum powder, sodium alginate, shitosan.
A kind of metformin hydrochloride tablet that the present invention is provided and preparation method thereof, the metformin hydrochloride tablet includes 400
The Metformin hydrochloride of~600 weight portions, the lactose of 40~85 weight portions, the anhydrous silica gel of 5~15 weight portions, 15~30 weight
The gelatin, the carboxyrnethyl starch sodium of 5~18 weight portions, the magnesium stearate of 3~7 weight portions, the slow-release material of 3~8 weight portions of part.This
Metformin hydrochloride tablet not only has good therapeutic effect to diabetes in invention, and can reduce Metformin hydrochloride not
Good reaction incidence, improves the metabolic capability of body；And the had good sustained release effect of the metformin hydrochloride tablet that the present invention is provided, its
Active component can slowly discharge in vivo so that metformin hydrochloride tablet have it is long-lasting.In addition, the present invention is using upper
State the obtained metformin hydrochloride tablet low cost of formula, good drug efficacy, long-lasting good such that it is able to reduce times for spraying, treat into
Originally it is greatly reduced.
Brief description of the drawings
Fig. 1 is the mean blood plasma concentration-time graph of experimental group and control group.
Specific embodiment
The invention discloses a kind of Metformin hydrochloride and preparation method thereof, those skilled in the art can be used for reference in herein
Hold, be suitably modified technological parameter realization.In particular, the similar replacement and change are to those skilled in the art
For be it will be apparent that they are considered as being included in the present invention.The method of the present invention and reference have passed through preferably implementation
Example is described, related personnel substantially can not departing from present invention, spirit and scope to method described herein and
Realize and apply the technology of the present invention using being modified or suitably changing with combining.
The present invention provide a kind of metformin hydrochloride tablet, including following parts by weight supplementary material：
In above-mentioned technical proposal, metformin hydrochloride tablet not only has good therapeutic effect to diabetes, and can drop
The adverse reaction rate of low Metformin hydrochloride, improves the metabolic capability of body；And the hydrochloride that the present invention is provided is double
The had good sustained release effect of guanidine piece, its active component can slowly discharge in vivo so that metformin hydrochloride tablet have it is long-acting
Property.In addition, the present invention is using metformin hydrochloride tablet low cost obtained in above-mentioned formula, good drug efficacy, long-lasting good such that it is able to
Times for spraying is reduced, treatment cost is greatly reduced.
In the present invention, the parts by weight of Metformin hydrochloride are 400~600 parts；In an embodiment of the present invention, hydrochloric acid
The parts by weight of melbine are 440~560 parts；In other embodiments, the parts by weight of Metformin hydrochloride be 470~
520 parts.
In the present invention, the parts by weight of lactose are 40~85 parts；In an embodiment of the present invention, the parts by weight of lactose
It is 50~75 parts；In other embodiments, the parts by weight of lactose are 60~70 parts.
In the present invention, the parts by weight of anhydrous silica gel are 5~15 parts；In an embodiment of the present invention, anhydrous silica gel
Parts by weight are 7~12 parts；In other embodiments, the parts by weight of anhydrous silica gel are 9~11 parts.
In the present invention, the parts by weight of gelatin are 15~30 parts；In an embodiment of the present invention, the parts by weight of gelatin
It is 18~26 parts；In other embodiments, the parts by weight of gelatin are 20~24 parts.
In the present invention, 5~18 parts of the parts by weight of carboxyrnethyl starch sodium；In an embodiment of the present invention, first sodium starch is locked
Parts by weight are 7~15 parts；In other embodiments, the parts by weight of carboxyrnethyl starch sodium are 10~12 parts.
In the present invention, the parts by weight of odium stearate are 3~7 parts；In an embodiment of the present invention, the weight of odium stearate
Amount number is 4~6 parts；In other embodiments, the parts by weight of stearic acid sodium are 4.5~5.5 parts.
In the present invention, 3~8 parts of the parts by weight of slow-release material；In other embodiments, the parts by weight of slow-release material
It is 4~7 parts；In other embodiments, the parts by weight of slow-release material are 5~6 parts.
In an embodiment of the present invention, slow-release material includes talcum powder, sodium alginate, shitosan, the slow-release material energy
Enough so that metformin hydrochloride tablet has good slow release effect.
In an embodiment of the present invention, talcum powder, sodium alginate, the mass ratio of PLA are (0.5~0.8)：(1~2)：
(1.5~3.6).
Present invention also offers a kind of preparation method of metformin hydrochloride tablet, comprise the following steps：
A) by Metformin hydrochloride, lactose, anhydrous silica gel, gelatin, carboxyrnethyl starch sodium, magnesium stearate, slow-release material sieving
It is standby；
B) Metformin hydrochloride, lactose, anhydrous silica gel are weighed, dry-mixed, 5~15min in efficient wet granulator is incorporated into；
Purified water, gelatin are added, is pelletized；
C) by step b) make particle be dried, whole grain, obtain Metformin hydrochloride dry particl；
D) the Metformin hydrochloride dry particl that obtains step c), carboxyrnethyl starch sodium, magnesium stearate are added separately to multidirectional
In movement mixer, mixing, compressing tablet obtain label；
E) add Opadry solution to be coated in the label for obtaining to step d), obtain metformin hydrochloride tablet.
Wherein, Metformin hydrochloride, lactose, anhydrous silica gel, gelatin, carboxyrnethyl starch sodium, magnesium stearate, slow-release material be ibid
It is described, will not be repeated here.
In above-mentioned technical proposal, preparation method is simple, with short production cycle, and production efficiency is high, the hydrochloride for preparing
Biguanides piece not only has a good therapeutic effect to diabetes, and can reduce the adverse reaction rate of Metformin hydrochloride,
Improve the metabolic capability of body；And the metformin hydrochloride tablet for preparing has good had good sustained release effect, its activity into
Point can slowly discharge in vivo so that metformin hydrochloride tablet have it is long-lasting.Present invention process is simply operable, work
Skill controllability is high, is adapted to the big production of industrialization.
In order to ensure the release of product stable homogeneous, product property stable homogeneous are good simultaneously, and differences between batches are small, reappearance
It is excellent.In an embodiment of the present invention, Metformin hydrochloride crosses 20 mesh sieves, lactose, magnesium stearate, anhydrous silica gel, carboxymethylstarch
Sodium crosses 30 mesh sieves.
In an embodiment of the present invention, drying time is 10~20min in step c), and drying temperature is 50~60 DEG C, from
And moisture is in 1.00wt%-3.50wt% in causing dried particle.
In an embodiment of the present invention, in step b) purified water 30~40 parts of parts by weight, Opadry solution in step e
The percentage by weight of middle Opadry is 9~11%.
In an embodiment of the present invention, in step c) screen size of the vibratory sieve that whole grain process is used for 1.18~
1.5mm, so that every metformin hydrochloride tablet is 500mg.
In order to further illustrate the present invention, the metformin hydrochloride tablet and its system provided the present invention with reference to embodiment
Preparation Method is described in detail.
Embodiment 1
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 400g Metformin hydrochlorides, 40g lactose, 15g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；40g purified waters, 24g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 60 DEG C, is dried
Time is 15min；Use screen size again carries out whole grain for the vibratory sieve of 1.3mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that arrives, 11g carboxyrnethyl starch sodiums, 4.5g magnesium stearates, 1.33g talcum powder, 2.67g sodium alginates,
4g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding quality in the label for obtaining
Concentration is coated for the Opadry solution of 11wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 2
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 440g Metformin hydrochlorides, 75g lactose, 12g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；30g purified waters, 26g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 54 DEG C, is dried
Time is 10min；Use screen size again carries out whole grain for the vibratory sieve of 1.4mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that arrives, 10g carboxyrnethyl starch sodiums, 5.5g magnesium stearates, 1.11g talcum powder, 2.22g sodium alginates,
3.68 shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding matter in the label for obtaining
Amount concentration is coated for the Opadry solution of 9wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 3
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 470g Metformin hydrochlorides, 85g lactose, 11g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；40g purified waters, 18g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 56 DEG C, is dried
Time is 20min；Use screen size again carries out whole grain for the vibratory sieve of 1.2mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that arrives, 7g carboxyrnethyl starch sodiums, 6g magnesium stearates, 0.82g talcum powder, 1.65g sodium alginates,
4.13g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding matter in the label for obtaining
Amount concentration is coated for the Opadry solution of 10wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 4
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 520g Metformin hydrochlorides, 70g lactose, 9g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；40g purified waters, 15g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 56 DEG C, is dried
Time is 18min；Use screen size again carries out whole grain for the vibratory sieve of 1.5mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that arrives, 5g carboxyrnethyl starch sodiums, 4g magnesium stearates, 0.67g talcum powder, 1.34g sodium alginates,
2.99g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding matter in the label for obtaining
Amount concentration is coated for the Opadry solution of 11wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 5
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 560g Metformin hydrochlorides, 60g lactose, 5g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；38g purified waters, 20g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 60 DEG C, is dried
Time is 12min；Use screen size again carries out whole grain for the vibratory sieve of 1.18mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that obtains, 18g carboxyrnethyl starch sodiums, 3g magnesium stearates, 0.39g talcum powder, 1.29g sodium alginates,
2.44g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding matter in the label for obtaining
Amount concentration is coated for the Opadry solution of 10wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 6
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；Weigh 600g Metformin hydrochlorides, 50g lactose, 7g anhydrous silica gels, be incorporated into it is dry-mixed in efficient wet granulator, 5
~15min；36g purified waters, 30g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 50 DEG C, is dried
Time is 15min；Use screen size again carries out whole grain for the vibratory sieve of 1.5mm, obtains Metformin hydrochloride dry particl；Will
The Metformin hydrochloride dry particl that arrives, 15g carboxyrnethyl starch sodiums, 7g magnesium stearates, 0.38g talcum powder, 1.16g sodium alginates,
1.46g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To adding matter in the label for obtaining
Amount concentration is coated for the Opadry solution of 9wt%, and 500mg metformin hydrochloride tablets are obtained.
Embodiment 7
Metformin hydrochloride crosses 20 mesh sieves, and lactose, magnesium stearate, anhydrous silica gel, carboxyrnethyl starch sodium, slow-release material cross 30 mesh
Sieve, it is standby；500g Metformin hydrochlorides, 66.6g lactose, 10g anhydrous silica gels are weighed, is incorporated into efficient wet granulator and is done
It is mixed, 5~15min；35g purified waters, 21g gelatin are added, is pelletized；Obtained particle is dried, drying temperature is 55 DEG C,
Drying time is 15min；Use screen size again carries out whole grain for the vibratory sieve of 1.18mm, obtains dry of Metformin hydrochloride
Grain；Metformin hydrochloride dry particl, 12g carboxyrnethyl starch sodiums, 4.5g magnesium stearates, 0.82g talcum powder, the 1.63g seas that will be obtained
Mosanom, 3.05g shitosans are added separately in Mixers with Multi-direction Movement, mixing, compressing tablet, obtain label；To the label for obtaining
It is middle to add mass concentration to be coated for the Opadry solution of 10wt%, 500mg metformin hydrochloride tablets are obtained.
First, the measure of release is carried out to metformin hydrochloride tablet obtained in embodiment 1~7
The release to the metformin hydrochloride tablet of 1~7 kind of embodiment production detects respectively, testing result such as following table
Shown in 1：
2nd, blood concentration test
40 subjects, the age is 20~60 years old, masculinity and femininity half and half.Medicine uses hydrochloric acid two obtained in embodiment 7
The diabecron sustained-release tablet of every 500mg of Shi Guibao companies when first biguanides piece, contrast medicine are the U.S. hundred, consumption is daily
Once, one at a time, taken during dinner.Respectively at medication before and take medicine after 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,
7th, 8,10,12,14,16,18,20,24h takes ulnar vein blood 4ml, and centrifugation point takes blood plasma, and -20 DEG C of preservations are to be measured.
Blood concentration is detected with LC-MS/MS methods, Fig. 1 shows that the medicine of embodiment 7 (experimental group) and comparative example medicine are (right
According to group) mean blood plasma concentration-time graph.Cmax=2780 μ g/mL, tmax=2.0h.From Blood drug monitoring result, this
Inventing the medicine for preparing can slowly discharge, and efficacy stability.
The foregoing description of the disclosed embodiments, enables professional and technical personnel in the field to realize or public to institute using this
The described above of the embodiment opened, enables professional and technical personnel in the field to realize or uses the present invention.To these embodiments
Various modifications will be apparent for those skilled in the art, and generic principles defined herein can be
In the case of not departing from the spirit or scope of the present invention, realize in other embodiments.Therefore, the present invention is not intended to be limited to
The embodiments shown herein, and it is to fit to the most wide model consistent with principles disclosed herein and novel features
Enclose.
Claims (10)
1. a kind of metformin hydrochloride tablet, it is characterised in that the raw material including following parts by weight：
2. metformin hydrochloride tablet as claimed in claim 1, it is characterised in that the raw material including following parts by weight：
3. metformin hydrochloride tablet as claimed in claim 1 or 2, it is characterised in that the slow-release material includes talcum powder, sea
Mosanom, shitosan.
4. metformin hydrochloride tablet as claimed in claim 3, it is characterised in that the talcum powder, the sodium alginate, described
The mass ratio of PLA is (0.5~0.8)：(1~2)：(1.5~3.6).
5. a kind of preparation method of metformin hydrochloride tablet as claimed in claim 1 or 2, it is characterised in that including following step
Suddenly：
A) by Metformin hydrochloride, lactose, anhydrous silica gel, gelatin, carboxyrnethyl starch sodium, magnesium stearate, slow-release material, Opadry mistake
Sieve is standby；
B) Metformin hydrochloride, lactose, anhydrous silica gel are weighed, dry-mixed, 5~15min in efficient wet granulator is incorporated into；Again plus
Enter purified water, gelatin, pelletize；
C) by step b) make particle be dried, whole grain, obtain Metformin hydrochloride dry particl；
D) the Metformin hydrochloride dry particl that obtains step c), carboxyrnethyl starch sodium, magnesium stearate, slow-release material are added separately to
In Mixers with Multi-direction Movement, mixing, compressing tablet obtain label；
E) add Opadry solution to be coated in the label for obtaining to step d), obtain metformin hydrochloride tablet.
6. preparation method as claimed in claim 5, it is characterised in that the Metformin hydrochloride crosses 20 mesh sieves, the lactose,
The magnesium stearate, the anhydrous silica gel, the slow-release material, the carboxyrnethyl starch sodium cross 30 mesh sieves.
7. preparation method as claimed in claim 5, it is characterised in that drying time is 10~20min in step c), dries temperature
Spend is 50~60 DEG C.
8. preparation method as claimed in claim 5, it is characterised in that 30~40 parts of the parts by weight of purified water in step b),
The percentage by weight of Opadry is 9~11% in Opadry solution in step e).
9. preparation method as claimed in claim 5, it is characterised in that the sieve aperture of the vibratory sieve that whole grain process is used in step c)
Size is 1.18~1.5mm.
10. preparation method as claimed in claim 5, it is characterised in that the slow-release material include talcum powder, sodium alginate,
Shitosan.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118544.1A CN106860416A (en) | 2017-03-01 | 2017-03-01 | Metformin hydrochloride tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118544.1A CN106860416A (en) | 2017-03-01 | 2017-03-01 | Metformin hydrochloride tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106860416A true CN106860416A (en) | 2017-06-20 |
Family
ID=59168286
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710118544.1A Pending CN106860416A (en) | 2017-03-01 | 2017-03-01 | Metformin hydrochloride tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106860416A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108714144A (en) * | 2018-06-08 | 2018-10-30 | 华益药业科技(安徽)有限公司 | A kind of dosulepin piece and preparation method thereof |
| CN110256300A (en) * | 2019-06-26 | 2019-09-20 | 武汉大学 | A kind of Metformin hydrochloride compound and metformin hydrochloride tablet composition |
Citations (3)
| 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 |
| CN102119931A (en) * | 2011-02-21 | 2011-07-13 | 寿光富康制药有限公司 | Novel metformin hydrochloride slow-releasing tablet and preparation method thereof |
| CN104458924A (en) * | 2013-09-12 | 2015-03-25 | 成都康弘药业集团股份有限公司 | Method for detecting related substances in preparation containing hydrophilic gel framework material |
-
2017
- 2017-03-01 CN CN201710118544.1A patent/CN106860416A/en active Pending
Patent Citations (3)
| 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 |
| CN102119931A (en) * | 2011-02-21 | 2011-07-13 | 寿光富康制药有限公司 | Novel metformin hydrochloride slow-releasing tablet and preparation method thereof |
| CN104458924A (en) * | 2013-09-12 | 2015-03-25 | 成都康弘药业集团股份有限公司 | Method for detecting related substances in preparation containing hydrophilic gel framework material |
Non-Patent Citations (4)
| Title |
|---|
| 李珍辉等: "盐酸二甲双胍壳聚糖－海藻酸钠缓释微囊的制备及性能研究", 《解放军医学杂志》 * |
| 王晓波主编: "《药物运释系统》", 31 August 2007, 中国医药科技出版社 * |
| 王福洲等: "海藻酸钠在盐酸二甲双胍缓释片中的应用", 《药学研究》 * |
| 陈燕忠等: "盐酸二甲双胍缓释片处方筛选及工艺研究", 《药学进展》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108714144A (en) * | 2018-06-08 | 2018-10-30 | 华益药业科技(安徽)有限公司 | A kind of dosulepin piece and preparation method thereof |
| CN110256300A (en) * | 2019-06-26 | 2019-09-20 | 武汉大学 | A kind of Metformin hydrochloride compound and metformin hydrochloride tablet composition |
| CN110256300B (en) * | 2019-06-26 | 2022-04-05 | 武汉大学 | Metformin hydrochloride compound and metformin hydrochloride tablet composition |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1146427C (en) | Solid oral dosage form containing metformin and glyburide | |
| CN101785763A (en) | Metformin hydrochloride enteric-coated sustained release tablet and preparation method thereof | |
| CN101579325B (en) | Metformin hydrochloride controlled-release tablet and preparation method thereof | |
| CN107184559B (en) | A kind of diabecron sustained-release tablet and preparation method thereof | |
| CN106924208A (en) | A kind of compound Dapagliflozin Metformin Extended-release Tablets and preparation method thereof | |
| CN106860416A (en) | Metformin hydrochloride tablet and preparation method thereof | |
| CN109924336A (en) | A kind of preparation method of high-selenium corn lutein ester zeaxanthin soft sweets | |
| CN104997747B (en) | Glipizide tablet and preparation method thereof | |
| CN102114005B (en) | Tracleer capsule and preparation method thereof | |
| CN101810628B (en) | Metformin glipizide tablet and preparation method thereof | |
| CN101711751A (en) | Febuxostat dispersing tablet preparation and preparation method thereof | |
| CN101744852B (en) | Preparation method of acanthopanax effervescent tablet and products thereof | |
| CN102119931B (en) | Novel metformin hydrochloride slow-releasing tablet and preparation method thereof | |
| CN105030793A (en) | Metformin hydrochloride and glibenclamide capsule and preparation method thereof | |
| CN101167731A (en) | Dispersible tablet containing metformin and glibenclamide and preparation method thereof | |
| CN103251594B (en) | Repaglinide/metformin combo tablet | |
| CN102755301A (en) | Glimepiride tablet and preparation method thereof | |
| CN103705515B (en) | The preparation method of the pharmaceutical composition that contains Repaglinide and Metformin hydrochloride | |
| CN101011362A (en) | Dispersible tablet of pidotimod and its preparing process and use | |
| CN101984970A (en) | Dihydroartemisinin piperaquine phosphate tablets and preparation process thereof | |
| CN109010298A (en) | A kind of melbine glipizide compound and preparation method thereof | |
| CN108066300A (en) | A kind of glipizide tablet and preparation method thereof | |
| CN101721414B (en) | Composition containing pioglitazone hydrochloride and metformin hydrochloride and preparation thereof | |
| CN111450071A (en) | Metformin hydrochloride tablet and preparation method thereof | |
| CN110876728A (en) | Preparation method of metformin hydrochloride quick-release preparation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170620 |
|
| RJ01 | Rejection of invention patent application after publication |