CN106727420A - A kind of net fast release micropill preparations of En Gelie, preparation method - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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Abstract
A kind of net fast release micropill preparations of En Gelie, preparation method, it is related to drug preparation technique and application field, described fast release micropill preparation administering mode is oral administration, with blank capsule core as carrier, En Gelie water purification solution containing cosolvent and adhesive is upper drug solns, the net consumptions of described En Gelie, according to weight ratio, the net consumptions of En Gelie are the 0.0025%~0.3% of the capsule core；En Gelie net oral dose is not higher than 50 micrograms.The net fast release micropill preparations of En Gelie have the features such as medicine-feeding rate is high, content uniformity is good, and drug release is rapid, analgesic activity is rapid-action.Meanwhile, the fast release micropill preparation have Clinical practice compliance it is good, it is safe the features such as.Additionally, blank capsule core fluid bed medicine-feeding method is suitable to the preparation of the net drug oral preparations of extremely low specification En Gelie.
Description
Technical field
The present invention relates to drug preparation technique and application field, specifically related to a kind of net fast release micropill preparations of En Gelie, system
Preparation Method and its application.
Background technology
En Gelie is net（empagliflozin）Belong to SGLT2 inhibitor class medicine, playing targeting directly against glucose makees
With its mechanism of action does not rely on B cell function and insulin resistance.European Union's approval is obtained on May 23rd, 2014, for drinking
Food fails to obtain the treatment of the diabetes B adult patient of abundant glycemic control with reference to motion, to improve glycemic control.Commodity
Name：Jardiance.
En Gelie is net（empagliflozin）It is tablet once a day, granted dosage is 10mg and 25mg.
Jardiance can independent medication, also can be with other antidiabetic drug drug combinations, including insulin, melbine.En Gelie is net
（empagliflozin）It is granted, be based on a number for including the large-scale Clinical Project that the III phases transnational more than 10 test
According to being related to more than 1.3 ten thousand diabetes B patients.The project data shows that empagliflozin 10mg and 25mg dosage are made
For single medication or with extensive background therapy（Including melbine, sulfonylureas, insulin, pioglitazone etc.）Joint is used
Medicine, significantly reduces the glycosylated hemoglobin of patient（HA1c）Level, while being significantly reduced body weight, blood pressure.
En Gelie is net（empagliflozin）Belong to sodium glucose co-transporter 2 white -2（SGLT-2）Inhibitor class medicine
Thing.Emerging SGLT-2 inhibitor class medicines, have been shown to block the resorption of glucose in kidney, will be excessive
Glucose be excreted in vitro, so as to reach reduce blood sugar level effect, and the hypoglycemic effect do not rely on β cell functions and
Insulin resistance.Compared with placebo, (SGLT-2) inhibitor Yi Palie is net for sodium glucose co-transport albumen 2
(empagliflozin) in addition to it effectively can reduce blood sugar, additionally aid and lose weight and reduce blood pressure.
【Sales situation】Counted according to IMS, global diabetes Market scale breaks through 40,000,000,000 dollars within 2013, beautiful up to 42,400,000,000
Unit, growth rate 8.2% ranked fourth position in global drug market.Diabetes medicament market scale 2005-2011 is compound to be increased
Up to 12.98%, diabetes Market has become the hotly contested spot of global pharmaceutical market to rate.Analyst predict, to 2019 New Year's gifts by
There is 5.18 hundred million dollars of sales volume net from En Gelie（empagliflozin）.
Micropill is a kind of spherical or spherical preparation of diameter in the range of 0.5~2.5mm, with drug release stabilization, it is reliable,
Uniformly, the advantages of good fluidity, capsule can be loaded or tablet is pressed into or other packagings supply Clinical practice.Micropill preparation is a kind of more single
First dosage disperses shape formulation, and a usual dosage is made up of tens to hundreds of pillers, compared with other one-pack types, micropill preparation clothes
Can be widely distributed in intestines and stomach after, medicine increases in intestines and stomach surface distributed area, it is to avoid medicine local concentration is excessive,
Not only increase drug bioavailability but also reduce the stimulation to intestines and stomach.The preparation method of micropill is more, wherein fluid bed system
Ball method and extrusion-round as a ball pill method are two kinds of microsphere and its preparations being most widely used at present.Extrusion-spheronization is used for
Prepare and carry pill core or blank capsule core.Fluid bed pill method completes whole operations in closed system, and supplementary material is not suffered a loss,
It is high with medicine-feeding rate, the features such as medicament contg is uniform, it is particularly suitable for the medicine-feeding of low content medicine.
The technical problem to be solved in the present invention is that drug half-life present in the net drug developments of En Gelie is short, clinical practice
The problems such as injection poor compliance (cannot be administered orally).The net clinical practice treatments of En Gelie can be expanded by providing one kind
Window, and Orally-administrable, clinical compliance good preparation solve above-mentioned technical problem.
The content of the invention
The purpose of the present invention one is to provide a kind of net fast release micropill preparations of En Gelie of Orally-administrable.Mesh of the invention
Two be that a kind of preparation method of the net fast release micropill preparations of En Gelie is provided.
To achieve the above object, solution of the invention is：A kind of net fast release micropill preparations of En Gelie are provided, it is described
Fast release micropill preparation administering mode is oral administration, with blank capsule core as carrier, the En Gelie water purification containing cosolvent and adhesive
Solution be upper drug solns, the net consumptions of described En Gelie, according to weight ratio, the net consumptions of En Gelie are the 0.0025% of the capsule core
~0.3%；En Gelie net oral dose is not higher than 50 micrograms.
Further, described blank capsule core is sucrose capsule core or microcrystalline cellulose capsule core.
Further, the cosolvent is selected from one or more in citric acid, acetic acid, hydrochloric acid, ascorbic acid.
Further, according to weight ratio, cosolvent consumption is net 20%~300% of En Gelie.
Further, described adhesive be selected from Hydroxypropyl methylcellulose (HPMC), PVP (PVP), syrup, starch slurry,
One or more in carmethose, gelatin, Arabic gum, methylcellulose.
Further, according to weight ratio, binder dosage is the 0.18%~1.68% of blank capsule core.
Further, the net fast release micropill preparations of described any one En Gelie also include overcoat membrane material；Described protection
Tunic material is selected from one or more in acrylic resin, Hydroxypropyl methylcellulose.
Further, the net fast release micropill preparations of described En Gelie, according to weight ratio, the consumption of overcoat membrane material is sky
The 1.0%~5.0% of white capsule core.
Further, described fast release micropill can be loaded on after capsule or addition proper auxiliary materials be pressed into after tablet orally to
Medicine.
To achieve the above object, solution of the invention is：A kind of En Gelie preparations of net fast release micropill preparation are provided
Method, is upper drug solns with the En Gelie water purification solution containing cosolvent and adhesive, using fluid bed with blank capsule core as carrier
Bottom is sprayed prescription method and prepares load medicine micropill, adds overcoat membrane material solution to obtain the net fast release micropill systems of En Gelie through fluidized bed coating
Agent.
A kind of preparation method of the net fast release micropill preparations of En Gelie, including：
Step one：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After dry.
Further, the step one is specially and weighs En Gelie only by formula, adds the citron acid solution of formula ratio molten
Solution, is then dissolved in being configured to quantitatively go up drug solns in the pure water solution for include adhesive；
Further, the step 2 is specially and the blank capsule core of formula ratio is placed in fluid bed, starts fluid bed, to fluidisation
The upper drug solns prepared in quantitative input step one in bed；
Further, fluid bed medicine-feeding parameter, including blower fan are set by the process conditions of optimization during drug solns in the input
150~180m3h-1 of air quantity, 2~7rmin-1 of feed flow revolution speed, 25~40 DEG C of temperature of charge, atomizing pressure 0.16MPa；
Further, the step 3 is specially and prepares 5% overcoat membrane material solution by formula ratio, and fluidized bed coating parameter is set to
150~180m3h-1 of fan delivery, feed flow 5~15rmin-1 of revolution speed, temperature of charge are controlled at 25~30 DEG C, atomization pressure
Power 0.3MPa.Further, the step 4 is specially after the completion of coating, adjusts fluid bed parameter, and coating micro-pill is in 30~40
DEG C 15~45min of fluidized drying.
Specific embodiment
The above of the invention is described in detail below in conjunction with specific embodiment, but this should not be interpreted as this hair
Bright technical scheme is only limitted to following examples.
The formula of embodiment 11
| En Gelie is net | 500mg |
| Microcrystalline cellulose blank capsule core | 4000g |
| 0.3% acetum | 200ml |
| Hydroxypropyl methylcellulose (HPMC) | 300g |
| Talcum powder | 50g |
| Water | 5500g |
Preparation method：
(1) preparation of drug solns on：The net 500mg of En Gelie are weighed by formula, 0.3% acetum 200mL dissolvings is added, then
It is dissolved in the aqueous solution for including Hydroxypropyl methylcellulose (HPMC) 100g and is configured to drug solns on 1500g；
(2) medicine is sprayed at fluid bed bottom：Microcrystalline cellulose blank capsule core 4000g is placed in fluid bed, starts fluid bed, stream is set
Change bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, mist
Change pressure 0.16MPa, added medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min；
(3) fluidized bed coating-protection film layer：Pure water 4100g is weighed by formula, is added under the lower addition stirring of stirring fine into hydroxypropyl first
Dimension element (HPMC) 200g, stirs molten clear, and prepared concentration is 5% overcoat membrane material solution, adds talcum powder 50g, is emulsified at a high speed
Homogeneous 10 minutes, crossing 60 mesh sieves must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, supplies
Liquid pump rotating speed 15rmin-1, temperature of charge is controlled at 25~35 DEG C, and atomizing pressure 0.3MPa carries out protecting film under fluidized state
Layer is coated；
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 22
| En Gelie is net | 100mg |
| Sucrose blank capsule core | 4000g |
| 0.1% citron acid solution | 300ml |
| PVP (PVP) | 8g |
| Acrylic resin | 200g |
| Water | 5000g |
Preparation method：
(1) preparation of drug solns on：The net 100mg of En Gelie are weighed by formula, 0.1% citron acid solution 300mL dissolvings is added, so
It is dissolved in afterwards in the aqueous solution for including PVP (PVP) 8g and is configured to drug solns on 1500g；
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, set on fluid bed
Medicine parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomizing pressure
Added medicine under 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min；
(3) fluidized bed coating-protection film layer：Pure water about 3600g is weighed by formula, is added under stirring into acrylic resin 200g,
Stirring is molten clear, and prepared concentration is 5% overcoat membrane material solution, and stirring is lower to add talcum powder 50g, 10 points of high-speed emulsifying homogeneous
Clock, crossing 60 mesh sieves must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed
15rmin-1, at 25~35 DEG C, atomizing pressure 0.3MPa carries out protection film layer and is coated under fluidized state for temperature of charge control；
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 33
| En Gelie is net | 1000mg |
| Sucrose blank capsule core | 4000g |
| 0.6% hydrochloric acid solution | 700ml |
| Syrup | 70g |
| Acrylic resin | 200g |
| Water | 4500g |
Preparation method：
(1) preparation of drug solns on：The net 1000mg of En Gelie are weighed by formula, 0.6% hydrochloric acid solution 700mL dissolvings is added, so
It is dissolved in afterwards in the aqueous solution for including syrup 70g and is configured to drug solns on 1500g；
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, set on fluid bed
Medicine parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomizing pressure
Added medicine under 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min；
(3) fluidized bed coating-protection film layer：Pure water about 3000g is weighed by formula, is added under stirring into acrylic resin 200g,
Stirring is molten clear, and prepared concentration is 5% overcoat membrane material solution, adds talcum powder 60g, high-speed emulsifying homogeneous 10 minutes to cross 60
Mesh sieve must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 15r
Min-1, at 25~35 DEG C, atomizing pressure 0.3MPa carries out protection film layer and is coated under fluidized state for temperature of charge control；
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 44
| En Gelie is net | 50mg |
| Sucrose blank capsule core | 400g |
| 6% ascorbic acid solution | 100ml |
| Starch slurry | 0.8g |
| HPMC | 20g |
| Water | 500g |
Preparation method：
(1) preparation of drug solns on：The net 50mg of En Gelie are weighed by formula, 6% ascorbic acid solution 100mL dissolvings is added, so
It is dissolved in afterwards in the aqueous solution for including starch slurry 0.8g and is configured to drug solns on 150g；
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 400g is placed in fluid bed, starts fluid bed, set on fluid bed
Medicine parameter:Fan delivery 150m3h-1, feed flow revolution speed 2rmin-1, temperature of charge control are in 30~40 DEG C, atomizing pressure
Added medicine under 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min；
(3) fluidized bed coating-protection film layer：Pure water about 350g is weighed by formula, stirring is lower to add HPMC 20g, stirs molten clear,
Prepared concentration is 5% overcoat membrane material solution, addition talcum powder 6g, high-speed emulsifying homogeneous 10 minutes, and crossing 60 mesh sieves must protect
Film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 5rmin-1, temperature of charge
At 25~35 DEG C, atomizing pressure 0.3MPa carries out protection film layer and is coated under fluidized state for control；
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 55
| En Gelie is net | 150mg |
| Sucrose blank capsule core | 4000g |
| 0.1% citric acid soln | 200ml |
| Carmethose | 70g |
| HPMC | 200g |
| Water | 5000g |
Preparation method：
(1) preparation of drug solns on：The net 150mg of En Gelie are weighed by formula, 0.1% citric acid soln 200mL dissolvings is added, so
It is dissolved in afterwards in the aqueous solution for including carmethose 70g and is configured to drug solns on 1500g；
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, set on fluid bed
Medicine parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomizing pressure
Added medicine under 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min；
(3) fluidized bed coating-protection film layer：Pure water about 3500g is weighed by formula, stirring is lower to add HPMC 200g, stirs molten
Clearly, prepared concentration is 5% overcoat membrane material solution, adds talcum powder 20g, high-speed emulsifying homogeneous 10 minutes to cross 60 mesh sieves and obtain
Protection film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 12rmin-1, thing
At 25~35 DEG C, atomizing pressure 0.3MPa carries out protection film layer and is coated material temperature control under fluidized state；
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
Claims (10)
1. net fast release micropill preparations of a kind of En Gelie, it is characterised in that described fast release micropill preparation administering mode is orally to give
Medicine, with blank capsule core as carrier, the En Gelie water purification solution containing cosolvent and adhesive is upper drug solns, and described En Gelie is net
Consumption, according to weight ratio, the net consumptions of En Gelie are the 0.0025~0.3% of the capsule core；En Gelie net oral dose is not high
In 50 micrograms.
2. net fast release micropill preparations of En Gelie as claimed in claim 1, it is characterised in that described blank capsule core is sucrose ball
Core or microcrystalline cellulose capsule core；The cosolvent is selected from one or more in citric acid, acetic acid, hydrochloric acid, ascorbic acid or presses
According to weight ratio, cosolvent consumption is net 20~300% of En Gelie.
3. net fast release micropill preparations of En Gelie as claimed in claim 1, it is characterised in that described adhesive is selected from hydroxypropyl first
One kind or many in cellulose, PVP, syrup, starch slurry, carmethose, gelatin, Arabic gum, methylcellulose
Kind, according to weight ratio, binder dosage is the 0.18~1.68% of blank capsule core.
4. net fast release micropill preparations of any one En Gelie as described in claims 1 to 3, it is characterised in that also including overcoat
Membrane material；Described overcoat membrane material is selected from one or more in acrylic resin, Hydroxypropyl methylcellulose；According to weight ratio, prevent
The consumption of sheath membrane material is the 1.0~5.0% of blank capsule core.
5. net fast release micropill preparations of any one En Gelie as described in Claims 1 to 4, it is characterised in that described quick-release is micro-
Ball is pressed into oral administration after tablet after being loaded on capsule or addition proper auxiliary materials.
6. the preparation method of the net fast release micropill preparations of a kind of En Gelie, it is characterised in that with blank capsule core as carrier, with containing hydrotropy
The En Gelie water purification solution of agent and adhesive is upper drug solns, and spraying prescription method using fluid bed bottom prepares load medicine micropill, adds
Overcoat membrane material solution obtains the net fast release micropill preparations of En Gelie through fluidized bed coating.
7. the preparation method of the net fast release micropill preparations of a kind of En Gelie, including：
Step one：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After dry.
8. preparation method as claimed in claim 7, it is characterised in that the step one is specially and weighs En Gelie by formula
Only, the citron acid solution dissolving of formula ratio is added, is then dissolved in being configured to quantitative medicine-feeding in the aqueous solution for include adhesive molten
Liquid.
9. preparation method as claimed in claim 7, it is characterised in that the step 2 is specially the blank capsule core of formula ratio
It is placed in fluid bed, starts fluid bed, to the upper drug solns prepared in quantitative input step one in fluid bed, the input medicine-feeding
Fluid bed medicine-feeding parameter is set by the process conditions of optimization during solution, including 150~180m3h-1 of fan delivery, solution feed pump turn
2~7rmin-1 of speed, 25~40 DEG C of temperature of charge, atomizing pressure 0.16MPa.
10. preparation method as claimed in claim 7, it is characterised in that the step 3 is specially to be prepared 5% and prevent by formula ratio
Sheath membrane material solution, fluidized bed coating parameter is set to 150~180m3h-1 of fan delivery, 5~15rmin- of feed flow revolution speed
1, temperature of charge is controlled in 25~30 DEG C, atomizing pressure 0.3MPa；The step 4 is specially after the completion of coating, adjusts fluid bed
Parameter, coating micro-pill is in 30~40 DEG C of 15~45min of fluidized drying.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107982258A (en) * | 2017-12-08 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Febustat releases pellet preparations, preparation method |
| CN113616624A (en) * | 2021-09-16 | 2021-11-09 | 南京康川济医药科技有限公司 | Empagliflozin metformin sustained release preparation and preparation method thereof |
| CN114469896A (en) * | 2020-10-26 | 2022-05-13 | 江苏万邦生化医药集团有限责任公司 | Metformin hydrochloride sustained-release empagliflozin hydrochloride quick-release pellet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105769782A (en) * | 2014-12-23 | 2016-07-20 | 中美华世通生物医药科技（武汉）有限公司 | Empagliflozin tablet, and preparation method and application thereof |
| CN106063780A (en) * | 2016-06-28 | 2016-11-02 | 国家海洋局第三海洋研究所 | A kind of tetradoxin fast release micropill preparation, preparation method and applications |
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| CN105769782A (en) * | 2014-12-23 | 2016-07-20 | 中美华世通生物医药科技（武汉）有限公司 | Empagliflozin tablet, and preparation method and application thereof |
| CN106063780A (en) * | 2016-06-28 | 2016-11-02 | 国家海洋局第三海洋研究所 | A kind of tetradoxin fast release micropill preparation, preparation method and applications |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107982258A (en) * | 2017-12-08 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Febustat releases pellet preparations, preparation method |
| CN114469896A (en) * | 2020-10-26 | 2022-05-13 | 江苏万邦生化医药集团有限责任公司 | Metformin hydrochloride sustained-release empagliflozin hydrochloride quick-release pellet and preparation method thereof |
| CN113616624A (en) * | 2021-09-16 | 2021-11-09 | 南京康川济医药科技有限公司 | Empagliflozin metformin sustained release preparation and preparation method thereof |
| CN113616624B (en) * | 2021-09-16 | 2023-01-31 | 南京康川济医药科技有限公司 | Empagliflozin metformin sustained release preparation and preparation method thereof |
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Application publication date: 20170531 |