CN102416007A - Metformin hydrochloride enteric-coated capsules - Google Patents
Metformin hydrochloride enteric-coated capsules Download PDFInfo
- Publication number
- CN102416007A CN102416007A CN2011104152758A CN201110415275A CN102416007A CN 102416007 A CN102416007 A CN 102416007A CN 2011104152758 A CN2011104152758 A CN 2011104152758A CN 201110415275 A CN201110415275 A CN 201110415275A CN 102416007 A CN102416007 A CN 102416007A
- Authority
- CN
- China
- Prior art keywords
- micropill
- metformin hydrochloride
- enteric
- coated
- prescription
- 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.)
- Granted
Links
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to metformin hydrochloride enteric-coated capsules, which contain the following components by weight: 125-500 g of metformin hydrochloride, 35-140 g of microcrystalline cellulose, 5-20 g of povidone K30, 23-92 g of medical talc powder, 170-680 g of polyacrylic latex and 5-20 g of triethyl citrate.
Description
Technical field:
The present invention relates to a kind of preparation of pharmaceutical preparation, particularly a kind of metformin hydrochloride enteric-coated capsule and preparation thereof.
Background technology:
Hydrochloric acid diformazan double structure formula is:
Metformin hydrochloride belongs to the biguanides antidiabetic drug, does not promote secretion of insulin, and its hypoglycemic activity is to promote to organize anaerobic glycolysis; Make tissue such as muscle utilize the effect of glucose to strengthen; The heteroplasia that suppresses hepatic glycogen simultaneously reduces the generation of glycogen, and blood glucose is reduced.Common metformin hydrochloride oral formulations is because after dissolving in gastric acid; Gastrointestinal tract there is intense stimulus property; Make easily that feeling sick appears in the patient, vomiting, anorexia, mouthful in untoward reaction such as metallic taste and halitosis are arranged; Therefore, this medicine should be processed the oral enteric preparation and avoid discharging under one's belt to reduce the untoward reaction rate, improves the compliance that the patient takes medicine.
Enteric coated preparation: mean that oral drugs do not discharge or discharge hardly in the acid medium of regulation; And in the time that requires; Enteric coated preparation most of or that all discharge in the pH6.8 phosphate buffer, and be included in the acid medium and pH6.8 phosphate buffer of regulation, do not discharge or discharge hardly; And in the time that requires, conlon targeting enteric coated preparation most of or that all discharge in pH7.5～8.0 phosphate buffers.The metformin hydrochloride enteric-coated capsule preparations and the enteric coatel tablets of existing listing are respectively through enteric capsule shell system with through the enteric coated enteric effect that reaches outside plain sheet.
The present invention is through screening and optimizing technology, prepares a kind of good looking appearance, good fluidity, is easy to packing, bioavailability is high, in intestinal, evenly discharge, act on gentle, the metformin hydrochloride enteric-coated pellet capsule that adverse reaction rate is low.Compare with enteric coatel tablets with the common metformin hydrochloride enteric coated capsule (enteric capsule shell) that has gone on the market at present; The metformin hydrochloride enteric-coated pellet capsule of the present invention's preparation has following comparatively remarkable advantages: 1. safety and effectiveness are high; Enteric-coated pellet capsule is polynary medicine-releasing system; A dosage is made up of dispersive a plurality of even enteric coated micropills unit, even indivedual clothing film rupture does not influence the safety of drug effect and medication yet.And common enteric coated capsule and enteric coatel tablets are the unit release, in case capsule shells shelling breakage or the breakage of enteric coatel tablets clothing film in patient's use, medicine can be directly exposed in the gastric acid environment or at no show intestinal position and discharge in advance, causes patient's untoward reaction.2. little to GI irritation, after taking medicine, enteric-coated pellet capsule extensively is evenly distributed in gastrointestinal tract, because dosage inclines and decentralizedly, medicine is big at gastrointestinal tract distribution table area, and is therefore little to GI irritation, bioavailability is high.3. it is little influenced by gastric emptying; Enteric coated micropill is changed at 120～180min by the gastric emptying time; And enteric coatel tablets and common enteric coated capsule change at 120～640min, and common enteric coated capsule is difficult for through stomach arrival intestinal portion, therefore; It is little that enteric-coated pellet capsule is influenced by physiologic factor, and its individual difference in clinical practice is little.
Summary of the invention:
The object of the invention is to provide a kind of metformin hydrochloride enteric-coated capsule and preparation method thereof.
Metformin hydrochloride enteric-coated capsule of the present invention, be processed into by following supplementary material:
Metformin hydrochloride enteric-coated capsule of the present invention is that metformin hydrochloride is prepared into enteric coated micropill, incapsulates then to process.
Metformin hydrochloride enteric-coated micropill of the present invention is prepared into plain ball earlier in its preparation process, and refabrication becomes the sealing coat coated micropill, is prepared into the enteric coating layer coated micropill at last.
The plain ball of metformin hydrochloride of the present invention, write out a prescription as follows:
Supplementary material title consumption (g)
Metformin hydrochloride 125-500
Microcrystalline Cellulose 35-140
Prepare as binding agent with an amount of purified water.
Metformin hydrochloride sealing coat coated micropill of the present invention, write out a prescription as follows:
Prepare as binding agent with an amount of 95% medicinal alcohol.
Metformin hydrochloride enteric-coated clothing layer coated micropill of the present invention, write out a prescription as follows:
Prepare as binding agent with an amount of purified water.
The present invention also provides metformin hydrochloride enteric-coated capsule preparation method thereof, and step is following:
1, supplementary material is pulverized, is sieved
Metformin hydrochloride is pulverized on pulverizer, crosses 80 mesh sieves; Microcrystalline Cellulose is crossed 80 mesh sieves in shaking screen.By former, the adjuvant of prescription weighing.
2, wet-mixed is granulated
Load weighted metformin hydrochloride, microcrystalline Cellulose are successively dropped in the wet granulator in order, mixed on low speed 300 seconds, the back adds the purified water of prescription (1) consumption, in 90 seconds, adds, and continues to stir 30 seconds, starts the low speed cutting knife simultaneously, makes to become to wet grain, discharging.
3, extrude, round as a ball, dry, sieve
The grain that will wet drops in the rotating granulator, and selecting the aperture is the screen cloth of 0.8-1.0mm, extrudes length, rugosity bar uniformly.Bar is made ball (bad as finding the round as a ball effect of wet grain section when round as a ball, as can to add an amount of pure water moistening) in centrifugal making in the ball machine.With the wet ball fluidized drying of metformin hydrochloride, parameter setting is: blower fan frequency 30～45Hz, and 60 ℃ of EATs, 40 ℃ of temperature of charge are dried to moisture≤3.0%.Dried pastille micropill is crossed 16 orders and 24 mesh sieves, collects the micropill between 16 to 24 orders, weighs.
4, sealing coat coating (sealing coat rate of body weight gain: 4～8%)
95% medicinal alcohol of recipe quantity drops into Agitation Tank, regulates rotating speed of agitator, makes into whirlpool and avoids being involved in too much gas and be advisable; Take by weighing the 30 POVIDONE K 30 BP/USP 30 of recipe quantity; Slowly evenly be sprinkled in the above-mentioned solution, the medicinal Pulvis Talci that solution clarification back adds recipe quantity continues to stir 15 minutes; Suspension is crossed 80 mesh sieves, process the sealing coat coating solution.Setting the fluid bed parameter is: blower fan frequency 30～40Hz, and 25～30 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 40～90r/min is with carrying out coating in the metformin hydrochloride pastille micropill input fluid bed.After coating solution has sprayed, set 40 ℃ of temperature of charge, continue dry 15-30min, be dried to moisture and be lower than 3.0%, weigh.Dried metformin hydrochloride sealing coat micropill is crossed 16 orders and 24 mesh sieves, collects 16 orders to the micropill between 24 orders, weighs.
5, enteric coating layer coating (enteric layers rate of body weight gain: 30～40%)
The medicinal Pulvis Talci of recipe quantity is added in the pure water, and middling speed stirred 15 minutes simultaneously, to the suspension that is even nothing caking; Suspension is slowly added in the polyacrylic acid resin latex, and middling speed stirred 10 minutes simultaneously, to being even suspension; Triethyl citrate is added in the above-mentioned suspension solution, and middling speed stirred 10 minutes, to being even suspension; Suspension is crossed 80 mesh sieves, make the enteric coating layer coating solution.Set the fluid bed parameter: blower fan frequency 35～45Hz, 35 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 35～80Hz drops into coating in the fluid bed with metformin hydrochloride sealing coat micropill, has sprayed to coating solution.Set 40 ℃ of temperature of charge and continue dry 20～30min, be dried to moisture and be lower than 3.0%, weigh.The QA detection of taking a sample.Dried metformin hydrochloride enteric-coated coatings micropill is crossed 14 and 20 mesh sieves, collect the micropill between 14 to 20 orders, weigh.
6, capsule is filled
Calculate loading amount according to the micropill testing result, be filled in capsule No. 0.
7, packing, warehouse-in
Aluminum-plastic packaged, outer package, finished product warehouse-in.
Wherein the used adjuvant inventory of coating needs to convert in the prescription ratio according to the intermediate products quantity that a last operation is produced.
Its prescription of metformin hydrochloride enteric-coated capsule of the present invention obtains through screening, and screening process is following:
1) the plain ball of medicine carrying prepares formulation and technology screening and result's (seeing table 1, table 2):
The plain ball of table 1. medicine carrying prepares formulation and technology screening screening
The plain ball quality of the different prescriptions of table 2
Know that by table 2 the 1 plain ball quality of writing out a prescription is better, but require too high and the workshop appliance parameter does not match for the relevant parameter of equipment, only suitable prepared in laboratory, unsuitable as final preparation prescription.Prescription 4 is all qualified with prescription 5 prepared plain balls, and the 5 cost low power consumings of writing out a prescription are few.Therefore, select for use prescription 5 as plain ball preparation prescription
2) enteric coating weightening finish screening
The different coating weightening finish of table 3 prescription screening
It is following that the gained coated product discharges the result, sees table 4
Know by table 4, enteric layer weightening finish 20～30%, the release degree of sample all meets the requirements, and the 30% o'clock releasing effect that increases weight is optimum.
3) sealing coat weightening finish screening
The different sealing coat coating weightening finishes of table 5
The plain ball of adding medicine to is carried out the sealing coat coating, wrap the enteric coating film of weightening finish 30% more respectively, its burst size and stability are seen table 6.
4) study on the stability
With above-mentioned different sealing coats weightening finish, not wrapping sealing coat lot sample article, commercially available metformin hydrochloride enteric-coated capsule (enteric capsule shell) and enteric coatel tablets, to be placed on temperature be that 30 ℃ of relative humiditys are under 65% condition; Sampling in 0,3,6 month, investigate different stability of sample results and see the following form 6 respectively:
The different sample stabilities of table 6 are investigated
Know that by last table 6 being surrounded by the sealing coat sample stability, not wrap the sealing coat sample good, wherein the most stable with sealing coat 8% enteric coated micropill that increases weight, the related substance basically identical of 3 months related substance and 6 months.Bag sealing coat enteric coated micropill is than commercially available enteric coated capsule and enteric coatel tablets good stability, and the release degree is less in acid, and is less to GI irritation.
According to the prescription of confirming, three batches of batches of continuous production are 160,000 finished product in the workshop for my company, and the sample preparation result sees table 7:
The quality testing result of table 7 Workshop Production sample
Know that by table 6 Workshop Production three lot sample quality are qualified, very close with lab scale research testing result, therefore, preparation technology of the present invention is fit to suitability for industrialized production.
The specific embodiment:
Below further specify the present invention through embodiment, but not as limitation of the present invention.
Embodiment 1, metformin enteric coated capsule
The plain ball of metformin hydrochloride
Prescription:
Supplementary material title consumption (g)
Metformin hydrochloride 125
Microcrystalline Cellulose 35
Prepare as binding agent with an amount of purified water
Metformin hydrochloride sealing coat coated micropill
Prescription:
Prepare as binding agent with an amount of 95% medicinal alcohol
Metformin hydrochloride enteric-coated clothing layer coated micropill
Prescription:
Prepare as binding agent with an amount of purified water.
Metformin hydrochloride enteric-coated capsule preparation method thereof of the present invention is following:
1, supplementary material is pulverized, is sieved
Metformin hydrochloride is pulverized on pulverizer, crosses 80 mesh sieves; Microcrystalline Cellulose is crossed 80 mesh sieves in shaking screen.By former, the adjuvant of prescription weighing.
2, wet-mixed is granulated
Load weighted metformin hydrochloride, microcrystalline Cellulose are successively dropped in the wet granulator in order, mixed on low speed 300 seconds, the back adds the purified water of prescription (1) consumption, in 90 seconds, adds, and continues to stir 30 seconds, starts the low speed cutting knife simultaneously, makes to become to wet grain, discharging.
3, extrude, round as a ball, dry, sieve
The grain that will wet drops in the rotating granulator, and selecting the aperture is the screen cloth of 0.8-1.0mm, extrudes length, rugosity bar uniformly.Bar is made ball (bad as finding the round as a ball effect of wet grain section when round as a ball, as can to add an amount of pure water moistening) in centrifugal making in the ball machine.With the wet ball fluidized drying of metformin hydrochloride, parameter setting is: blower fan frequency 30～45Hz, and 60 ℃ of EATs, 40 ℃ of temperature of charge are dried to moisture≤3.0%.Dried pastille micropill is crossed 16 orders and 24 mesh sieves, collects the micropill between 16 to 24 orders, weighs.
4, sealing coat coating (sealing coat rate of body weight gain: 4～8%)
95% medicinal alcohol of recipe quantity drops into Agitation Tank, regulates rotating speed of agitator, makes into whirlpool and avoids being involved in too much gas and be advisable; Take by weighing the 30 POVIDONE K 30 BP/USP 30 of recipe quantity; Slowly evenly be sprinkled in the above-mentioned solution, the medicinal Pulvis Talci that solution clarification back adds recipe quantity continues to stir 15 minutes; Suspension is crossed 80 mesh sieves, process the sealing coat coating solution.Setting the fluid bed parameter is: blower fan frequency 30～40Hz, and 25～30 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 40～90r/min is with carrying out coating in the metformin hydrochloride pastille micropill input fluid bed.After coating solution has sprayed, set 40 ℃ of temperature of charge, continue dry 15-30min, be dried to moisture and be lower than 3.0%, weigh.Dried metformin hydrochloride sealing coat micropill is crossed 16 orders and 24 mesh sieves, collects 16 orders to the micropill between 24 orders, weighs.
5, enteric coating layer coating (enteric layers rate of body weight gain: 30～40%)
The medicinal Pulvis Talci of recipe quantity is added in the pure water, and middling speed stirred 15 minutes simultaneously, to the suspension that is even nothing caking; Suspension is slowly added in the polyacrylic acid resin latex, and middling speed stirred 10 minutes simultaneously, to being even suspension; Triethyl citrate is added in the above-mentioned suspension solution, and middling speed stirred 10 minutes, to being even suspension; Suspension is crossed 80 mesh sieves, make the enteric coating layer coating solution.Set the fluid bed parameter: blower fan frequency 35～45Hz, 35 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 35～80Hz drops into coating in the fluid bed with metformin hydrochloride sealing coat micropill, has sprayed to coating solution.Set 40 ℃ of temperature of charge and continue dry 20～30min, be dried to moisture and be lower than 3.0%, weigh.The QA detection of taking a sample.Dried metformin hydrochloride enteric-coated coatings micropill is crossed 14 and 20 mesh sieves, collect the micropill between 14 to 20 orders, weigh.
6, capsule is filled
Calculate loading amount according to the micropill testing result, be filled in capsule No. 0.
7, packing, warehouse-in
Aluminum-plastic packaged, outer package, finished product warehouse-in.
Embodiment 2, metformin enteric coated capsule
Method for preparing is with embodiment 1
Embodiment 3, metformin enteric coated capsule
Method for preparing is with embodiment 1.
Claims (10)
1. metformin hydrochloride enteric-coated capsule, contain following component:
2. according to the metformin hydrochloride enteric-coated capsule of claim 1, be that metformin hydrochloride is prepared into enteric coated micropill, incapsulate then and process.
3. according to the metformin hydrochloride enteric-coated capsule of claim 2, wherein said metformin hydrochloride enteric-coated micropill is prepared into plain ball earlier in its preparation process, and refabrication becomes the sealing coat coated micropill, is prepared into the enteric coating layer coated micropill at last.
4. according to the metformin hydrochloride enteric-coated capsule of claim 3, its said plain ball is write out a prescription as follows:
Supplementary material title consumption (g)
Metformin hydrochloride 125-500
Microcrystalline Cellulose 35-140
Prepare as binding agent with an amount of purified water.
5. according to the metformin hydrochloride enteric-coated capsule of claim 3, wherein said plain ball sealing coat coating is write out a prescription as follows:
Prepare as binding agent with an amount of 95% ethanol.
6. according to the metformin hydrochloride enteric-coated capsule of claim 3, wherein said micropill enteric layer coating is write out a prescription as follows:
Prepare as binding agent with an amount of purified water.
7. according to the method for preparing of the metformin enteric coated capsule of claim 1, it is characterized in that step is following:
1) supplementary material is pulverized, is sieved
Metformin hydrochloride is pulverized on pulverizer, crosses 80 mesh sieves; Microcrystalline Cellulose is crossed 80 mesh sieves in shaking screen; By former, the adjuvant of prescription weighing;
2) wet-mixed is granulated
Load weighted metformin hydrochloride, microcrystalline Cellulose are successively dropped in the wet granulator in order, mixed on low speed 300 seconds, the back adds the purified water of prescription (1) consumption, in 90 seconds, adds, and continues to stir 30 seconds, starts the low speed cutting knife simultaneously, makes to become to wet grain, discharging;
3) extrude, round as a ball, dry, sieve
The grain that will wet drops in the rotating granulator, and selecting the aperture is the screen cloth of 0.8-1.0mm, extrudes length, rugosity bar uniformly; Bar is made ball in centrifugal making in the ball machine; With the wet ball fluidized drying of metformin hydrochloride, parameter setting is: blower fan frequency 30～45Hz, and 60 ℃ of EATs, 40 ℃ of temperature of charge are dried to moisture≤3.0%; Dried pastille micropill is crossed 16 orders and 24 mesh sieves, collects the micropill between 16 to 24 orders, weighs;
4) sealing coat coating
95% medicinal alcohol of recipe quantity drops into Agitation Tank, regulates rotating speed of agitator, makes into whirlpool and avoids being involved in too much gas and be advisable; Take by weighing the 30 POVIDONE K 30 BP/USP 30 of recipe quantity; Slowly evenly be sprinkled in the above-mentioned solution, the medicinal Pulvis Talci that solution clarification back adds recipe quantity continues to stir 15 minutes; Suspension is crossed 80 mesh sieves, process the sealing coat coating solution; Setting the fluid bed parameter is: blower fan frequency 30～40Hz, and 25～30 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 40～90r/min is with carrying out coating in the metformin hydrochloride pastille micropill input fluid bed; After coating solution has sprayed, set 40 ℃ of temperature of charge, continue dry 15-30min, be dried to moisture and be lower than 3.0%, weigh; Dried metformin hydrochloride sealing coat micropill is crossed 16 orders and 24 mesh sieves, collects 16 orders to the micropill between 24 orders, weighs;
5) enteric coating layer coating
The medicinal Pulvis Talci of recipe quantity is added in the pure water, and middling speed stirred 15 minutes simultaneously, to the suspension that is even nothing caking; Suspension is slowly added in the polyacrylic acid resin latex, and middling speed stirred 10 minutes simultaneously, to being even suspension; Triethyl citrate is added in the above-mentioned suspension solution, and middling speed stirred 10 minutes, to being even suspension; Suspension is crossed 80 mesh sieves, make the enteric coating layer coating solution; Set the fluid bed parameter: blower fan frequency 35～45Hz, 35 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 35～80Hz drops into coating in the fluid bed with metformin hydrochloride sealing coat micropill, has sprayed to coating solution; Set 40 ℃ of temperature of charge and continue dry 20～30min, be dried to moisture and be lower than 3.0%, weigh; The QA detection of taking a sample; Dried metformin hydrochloride enteric-coated coatings micropill is crossed 14 and 20 mesh sieves, collect the micropill between 14 to 20 orders, weigh;
6) capsule is filled
Calculate loading amount according to the micropill testing result, be filled in capsule.
8. according to the method for preparing of claim 7, it is characterized in that wherein used adjuvant inventory during coating needs convert in the prescription ratio according to the intermediate products quantity that a last operation is produced.
9. according to the metformin enteric coated capsule of claim 1, it is characterized in that,
Wherein said plain ball is write out a prescription as follows:
Supplementary material title consumption (g)
Metformin hydrochloride 125-500
Microcrystalline Cellulose 35-140
Prepare as binding agent with an amount of purified water;
Wherein said sealing coat coated micropill is write out a prescription as follows:
Prepare as binding agent with an amount of 95% ethanol;
Wherein said enteric coating layer coated micropill is write out a prescription as follows:
Prepare as binding agent with an amount of purified water.
10. according to the metformin enteric coated capsule of claim 1, it is characterized in that,
Wherein said plain ball is write out a prescription as follows:
Wherein said sealing coat coated micropill is write out a prescription as follows:
Wherein said enteric coating layer coated micropill is write out a prescription as follows:
Method for preparing is following:
1) supplementary material is pulverized, is sieved
Metformin hydrochloride is pulverized on pulverizer, crosses 80 mesh sieves; Microcrystalline Cellulose is crossed 80 mesh sieves in shaking screen; By former, the adjuvant of prescription weighing;
2) wet-mixed is granulated
Load weighted metformin hydrochloride, microcrystalline Cellulose are successively dropped in the wet granulator in order, mixed on low speed 300 seconds, the back adds the purified water of prescription (1) consumption, in 90 seconds, adds, and continues to stir 30 seconds, starts the low speed cutting knife simultaneously, makes to become to wet grain, discharging;
3) extrude, round as a ball, dry, sieve
The grain that will wet drops in the rotating granulator, and selecting the aperture is the screen cloth of 0.8-1.0mm, extrudes length, rugosity bar uniformly; Bar is made ball in centrifugal making in the ball machine; With the wet ball fluidized drying of metformin hydrochloride, parameter setting is: blower fan frequency 30～45Hz, and 60 ℃ of EATs, 40 ℃ of temperature of charge are dried to moisture≤3.0%; Dried pastille micropill is crossed 16 orders and 24 mesh sieves, collects the micropill between 16 to 24 orders, weighs;
4) sealing coat coating
95% medicinal alcohol of recipe quantity drops into Agitation Tank, regulates rotating speed of agitator, makes into whirlpool and avoids being involved in too much gas and be advisable; Take by weighing the 30 POVIDONE K 30 BP/USP 30 of recipe quantity; Slowly evenly be sprinkled in the above-mentioned solution, the medicinal Pulvis Talci that solution clarification back adds recipe quantity continues to stir 15 minutes; Suspension is crossed 80 mesh sieves, process the sealing coat coating solution; Setting the fluid bed parameter is: blower fan frequency 30～40Hz, and 25～30 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 40～90r/min is with carrying out coating in the metformin hydrochloride pastille micropill input fluid bed; After coating solution has sprayed, set 40 ℃ of temperature of charge, continue dry 15-30min, be dried to moisture and be lower than 3.0%, weigh; Dried metformin hydrochloride sealing coat micropill is crossed 16 orders and 24 mesh sieves, collects 16 orders to the micropill between 24 orders, weighs;
5) enteric coating layer coating
The medicinal Pulvis Talci of recipe quantity is added in the pure water, and middling speed stirred 15 minutes simultaneously, to the suspension that is even nothing caking; Suspension is slowly added in the polyacrylic acid resin latex, and middling speed stirred 10 minutes simultaneously, to being even suspension; Triethyl citrate is added in the above-mentioned suspension solution, and middling speed stirred 10 minutes, to being even suspension; Suspension is crossed 80 mesh sieves, make the enteric coating layer coating solution; Set the fluid bed parameter: blower fan frequency 35～45Hz, 35 ℃ of temperature of charge, atomization air pressure 0.18-0.22Mpa, hydrojet frequency 35～80Hz drops into coating in the fluid bed with metformin hydrochloride sealing coat micropill, has sprayed to coating solution; Set 40 ℃ of temperature of charge and continue dry 20～30min, be dried to moisture and be lower than 3.0%, weigh; The QA detection of taking a sample; Dried metformin hydrochloride enteric-coated coatings micropill is crossed 14 and 20 mesh sieves, collect the micropill between 14 to 20 orders, weigh;
6) capsule is filled
Calculate loading amount according to the micropill testing result, be filled in capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110415275.8A CN102416007B (en) | 2011-12-12 | 2011-12-12 | Metformin hydrochloride enteric-coated capsules |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110415275.8A CN102416007B (en) | 2011-12-12 | 2011-12-12 | Metformin hydrochloride enteric-coated capsules |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102416007A true CN102416007A (en) | 2012-04-18 |
| CN102416007B CN102416007B (en) | 2014-08-20 |
Family
ID=45940811
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110415275.8A Active CN102416007B (en) | 2011-12-12 | 2011-12-12 | Metformin hydrochloride enteric-coated capsules |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102416007B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103284975A (en) * | 2013-05-30 | 2013-09-11 | 北京圣永制药有限公司 | Metformin hydrochloride enteric capsule and preparation method thereof |
| CN108938601A (en) * | 2018-08-15 | 2018-12-07 | 珠海润都制药股份有限公司 | A kind of metformin hydrochloride enteric-coated sustained release pellet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1742730A (en) * | 2005-09-29 | 2006-03-08 | 周卓和 | Method for preparing high stripping-degree hautriwaic glipizide capsule |
| CN101190179A (en) * | 2006-11-20 | 2008-06-04 | 北京利龄恒泰药业有限公司 | Enteric medicinal composition for treating diabetes and preparation method thereof |
| CN101810628A (en) * | 2010-04-13 | 2010-08-25 | 北京四环科宝制药有限公司 | Melbine glipizide tablet and preparation method thereof |
-
2011
- 2011-12-12 CN CN201110415275.8A patent/CN102416007B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1742730A (en) * | 2005-09-29 | 2006-03-08 | 周卓和 | Method for preparing high stripping-degree hautriwaic glipizide capsule |
| CN101190179A (en) * | 2006-11-20 | 2008-06-04 | 北京利龄恒泰药业有限公司 | Enteric medicinal composition for treating diabetes and preparation method thereof |
| CN101810628A (en) * | 2010-04-13 | 2010-08-25 | 北京四环科宝制药有限公司 | Melbine glipizide tablet and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103284975A (en) * | 2013-05-30 | 2013-09-11 | 北京圣永制药有限公司 | Metformin hydrochloride enteric capsule and preparation method thereof |
| CN108938601A (en) * | 2018-08-15 | 2018-12-07 | 珠海润都制药股份有限公司 | A kind of metformin hydrochloride enteric-coated sustained release pellet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102416007B (en) | 2014-08-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102014909B (en) | Solid preparation for oral administration | |
| CN104352441B (en) | A kind of dimethyl fumarate enteric-coated micro-pill and preparation method thereof | |
| CN105769905B (en) | A kind of modified-release tablets of potassium chloride and preparation method thereof | |
| CN102416007B (en) | Metformin hydrochloride enteric-coated capsules | |
| JP6084355B2 (en) | Ambroxol-containing preparation particles | |
| CN110075082A (en) | A kind of Enrofloxacin fast release micropill and preparation method thereof | |
| CN105853384A (en) | Azilsartan tablets and preparation method thereof | |
| CN108938601A (en) | A kind of metformin hydrochloride enteric-coated sustained release pellet and preparation method thereof | |
| CN107412198A (en) | Duloxetine hydrochloride enteric slow release granule and preparation method thereof | |
| CN101596162B (en) | Doxycycline hyclate enteric-coated pellet | |
| CN107019680B (en) | A kind of preparation process of sodium rabeprazole enteric-coated capsule | |
| CN103417483B (en) | memantine hydrochloride slow-release dry suspension and preparation method thereof | |
| CN106924205A (en) | A kind of sustained release preparation containing Baricitinib | |
| CN104922091B (en) | A kind of diabecron sustained-release capsule and its preparation method and application | |
| CN108261400A (en) | A kind of digoxin microplate and preparation method thereof | |
| CN101961324A (en) | Prescription and preparation method of etofbrate release capsules | |
| CN113456639A (en) | Anti-arrhythmia pharmaceutical composition and preparation method thereof | |
| CN101797238A (en) | Method for preparing medicinal preparation for releasing rifampicin on upper part of small intestine and characteristics of medicinal preparation | |
| CN105168183A (en) | Gliclazide sustained-release capsule and preparation method and application thereof | |
| CN110237097A (en) | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof | |
| CN115227660B (en) | Metformin hydrochloride sustained release tablet and preparation method thereof | |
| WO2000062916A1 (en) | Continuous pelletizer and spheronizer | |
| CN105326813B (en) | Paroxetine slow release composition and preparation method thereof | |
| WO2019070818A2 (en) | Suspensions of encapsulated pharmaceuticals and methods of making and using the same | |
| CN102423306A (en) | Azithromycin enteric capsules |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |