CN104997735A - Berberine hydrochloride taste-masked pellet, and preparation thereof - Google Patents
Berberine hydrochloride taste-masked pellet, and preparation thereof Download PDFInfo
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- CN104997735A CN104997735A CN201510385195.0A CN201510385195A CN104997735A CN 104997735 A CN104997735 A CN 104997735A CN 201510385195 A CN201510385195 A CN 201510385195A CN 104997735 A CN104997735 A CN 104997735A
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Abstract
The invention discloses a berberine hydrochloride taste-masked pellet prepared from a berberine hydrochloride pellet via coating. The berberine hydrochloride pellet is prepared from berberine hydrochloride and an auxiliary material via extrusion centrifugation pelleting, centrifugation lamination, or sugar coat pot rolling; the auxiliary material is one or a mixture of a plurality of ingredients randomly selected from microcrystalline cellulose, starch, saccharose, and dextrin. The adding amount of the auxiliary material accounts for, by weight, 15 to 90%. A coating material comprises a film-forming material, a plasticizer, and a caking inhibiter. The berberine hydrochloride taste-masked pellet can be prepared into granula, suspension granula, dispersible tablet, dry suspension, and pill with pharmaceutic adjuvants. The specific bitter taste of berberine hydrochloride is masked, and drug compliance of patients, especially of infants and elders with difficulty in swallowing, is improved.
Description
The application is the Chinese invention patent application (applying date: on JIUYUE 19th, 2006; Application number: 200610113218.3; Denomination of invention: Berberine hydrochloride taste masked Pill and its preparation) divisional application.
Technical field
The present invention relates to Chinese medicine micropill and preparation thereof, particularly Berberine hydrochloride taste masked Pill and its preparation.
Background technology
Berberine hydrochloride is a kind of broad spectrum antimicrobicide, and previously to be extracted as master, now complete synthesis supply market, berberine hydrochloride has quite long clinical practice history, and use safety, curative effect is reliable.In recent years, berberine hydrochloride has again many otherwise application, as treatment hypertension, diabetes etc.In the antibacterial that child can use, berberine hydrochloride is in irreplaceable critical role.But berberine hydrochloride taste is extremely bitter, tradition adopts to be prepared coated tablet or the methods such as medicine incapsulates is covered bitterness; But the berberine hydrochloride preparation adopting these methods to prepare all is not suitable for child, dysphagia patients uses.
Summary of the invention
Bitter in order to overcome berberine hydrochloride taste, the defect that existing berberine hydrochloride preparation is not suitable for child, dysphagia patients uses, the invention provides a kind of Berberine hydrochloride taste masked Pill and its preparation, meanwhile, present invention provides the preparation method of this Berberine hydrochloride taste masked Pill and its preparation.
According to this Berberine hydrochloride taste masked Pill and its preparation provided by the invention, taking convenience, swallows easily, without bitterness; Preparation method technique provided by the invention is simple, is suitable for large-scale production.
The object of the invention is to be solved by following scheme:
A kind of masked berberine hydrochloride micro pill, makes micropill by berberine hydrochloride, then is made by coating of pellets.
Above-mentioned berberine hydrochloride micropill can adopt methods such as extruding centrifugal granulation, centrifugal lamination method or coating pan spheronization to prepare; Micropill particle diameter is 100 ~ 600 μm.The micropill of gained uses water-insoluble coating material coating again, obtains masked berberine hydrochloride micro pill.
The masked berberine hydrochloride micro pill of gained adds appropriate pharmaceutic adjuvant, can be made into the more acceptant various preparation of people, as granule, is suspended the preparations such as type granule, dispersible tablet, pill.Preparation specification can be 25mg, 50mg, 100mg, 150mg etc.
Below to Berberine hydrochloride taste masked Pill and its preparation provided by the invention, and their preparation method is described in further detail:
Step 1, berberine hydrochloride micropill and preparation method thereof
Berberine hydrochloride micropill is made up of berberine hydrochloride and pharmaceutic adjuvant.Pharmaceutic adjuvant be selected from microcrystalline Cellulose, starch, sucrose, dextrin any one or a few; By weight percentage, in micropill, the consumption of adjuvant is 15 ~ 90%.
Micropill preparation technology: centrifugal granulation is extruded in employing or centrifugal lamination legal system is standby, and product yield is high, can reach more than 80%; And raw material is reusable, meet industrialized requirement.
Such as, adopt centrifugal lamination legal system for micropill:
Get berberine hydrochloride and adjuvant; Here adjuvant be selected from microcrystalline Cellulose, starch, sucrose, dextrin any one or a few; By weight percentage, in micropill, the consumption of adjuvant is 15 ~ 90%; Berberine hydrochloride is mixed homogeneously with adjuvant; Getting appropriate mixed powder puts on centrifugal granulator, sprays into binding agent appropriate, makes micropill, and screening particle diameter is the micropill of 100 ~ 600 μm, for subsequent use.
Step 2, masked berberine hydrochloride micro pill and preparation method thereof
Masked berberine hydrochloride micro pill is made by berberine hydrochloride micropill is coated.Coating material includes:
(1) filmogen: be selected from one or more in Eudragit E100 (domestic acrylic acid IV resin), Eudragit EPO, Eudragit L100, hydroxypropyl emthylcellulose; By weight percentage, in coated micropill, the consumption of filmogen is 1 ~ 8%.
Filmogen effect and advantage: a filmogen is insoluble in water or in saliva, but is dissolved in gastric juice, distribute wide at gastric and enteral after micropill is oral, comparatively fast can discharge medicine.It is low that b is made into coating solution viscosity, and when bag berberine hydrochloride micropill, micropill is adhesion not easily; C can form the soft complete film of quality, and light, thoroughly can cover bitter taste of drug, not be afraid of extruding, compatibility reaction not occur with berberine hydrochloride.
(2) plasticizer: be selected from Oleum Ricini, polyethylene glycol 6000, polyethylene glycol 1500, PEG400, any one or a few in dibutyl sebacate, triethyl citrate; By weight percentage, in coating material, the consumption of plasticizer is 5 ~ 8% of filmogen.
Plasticizer can be lowered into membrane material glass point conversion temperature effectively, makes filmogen more soft, not easily broken, can form the film that quality is soft complete, thoroughly cover bitter taste of drug.
(3) caking inhibiter: be selected from magnesium stearate, Pulvis Talci and micropowder silica gel any one or a few; By weight percentage, in coating material, the consumption of caking inhibiter is 5 ~ 15% of filmogen.
Coating material solution viscosity is comparatively large under normal circumstances, very unfavorable to coating operations, adds caking inhibiter and can reduce adhesion between micropill.
The art for coating preparing masked berberine hydrochloride micro pill is as follows:
Get the berberine hydrochloride micropill coating material coating of step 1 gained, obtain masked berberine hydrochloride micro pill; The particle diameter of odor-masking pellet be 100 ~ 600 μm better.
Here coating material used includes: water-insoluble filmogen, plasticizer, caking inhibiter.Definition and the consumption of water-insoluble filmogen here, plasticizer, caking inhibiter are described above.
Step 3, masked berberine hydrochloride micro pill preparation and preparation method thereof
Get the masked berberine hydrochloride micro pill of step 2 gained, add suitable pharmaceutic adjuvant, can make that people are more acceptant, mouthfeel is good, the satisfactory various preparation of dissolution further, as granule, be suspended the preparations such as type granule, dispersible tablet, pill.
When preparation taste masking berberine hydrochloride is suspended type granule, also comprise suspending agent in addition; Suspending agent is tragakanta, hydroxypropyl emthylcellulose or arabic gum, and suspending agent consumption accounts for recipe quantity 1 ~ 5%.
Advantage of the present invention is: by carrying out coating with coating material to berberine hydrochloride micropill, masking the distinctive bitterness of berberine hydrochloride completely, improve the compliance of patient medication; Masked berberine hydrochloride micro pill may be used for preparing the peroral dosage form (solution sensory issues) that multiple traditional handicraft cannot realize, and the special form (as granule, being suspended the preparations such as type granule, dispersible tablet) especially for some specific crowd (as infant and swallow inconvenient old man) is of great significance.
Below in conjunction with detailed description of the invention, the invention will be further described, but not limit the present invention by any way.The equivalent replacement of all any this areas done according to the disclosure of invention, all belongs within protection scope of the present invention.
Detailed description of the invention
The preparation of embodiment 1, berberine hydrochloride micropill
Berberine hydrochloride micropill is made up of berberine hydrochloride and pharmaceutic adjuvant; Pharmaceutic adjuvant used be selected from microcrystalline Cellulose, starch, sucrose, dextrin any one or a few; By weight percentage, in micropill, the consumption of adjuvant is 15 ~ 90%.
The preparation of berberine hydrochloride micropill can adopt any one method extruded in centrifugal granulation, centrifugal lamination method or coating pan spheronization.
Embodiment 2, centrifugal lamination legal system are for berberine hydrochloride micropill
Method according to embodiment 1: but the preparation of berberine hydrochloride micropill adopts centrifugal lamination method:
Berberine hydrochloride is mixed homogeneously with adjuvant; Getting appropriate mixed powder puts on centrifugal granulator, sprays into binding agent appropriate, makes micropill, and screening particle diameter is the micropill of 100 ~ 600 μm, for subsequent use.
The preparation of embodiment 3, masked berberine hydrochloride micro pill
Masked berberine hydrochloride micro pill is made by berberine hydrochloride micropill is coated.Coating material includes: filmogen, plasticizer, caking inhibiter.
Here filmogen is selected from one or more in Eudragit E100 (domestic acrylic acid IV resin), Eudragit EPO, Eudragit L100, hydroxypropyl emthylcellulose; By weight percentage, in coated micropill, the consumption of filmogen is 1 ~ 8%;
Here plasticizer is selected from Oleum Ricini, polyethylene glycol 6000, polyethylene glycol 1500, PEG400, any one or a few in dibutyl sebacate, triethyl citrate; By weight percentage, in coating material, the consumption of plasticizer is 5 ~ 8% of filmogen;
Here caking inhibiter be selected from magnesium stearate, Pulvis Talci and micropowder silica gel any one or a few; By weight percentage, in coating material, the consumption of caking inhibiter is 5 ~ 15% of filmogen.
The preparation method of masked berberine hydrochloride micro pill: the berberine hydrochloride micropill of Example 1 or 2 gained, with coating material coating described here, obtains masked berberine hydrochloride micro pill.
The particle diameter of masked berberine hydrochloride micro pill be 100 ~ 600 μm better.
Embodiment 4, taste masking berberine hydrochloride preparation, add appropriate pharmaceutic adjuvant by masked berberine hydrochloride micro pill and make.
Here preparation formulation can be granule, be suspended in type granule, dispersible tablet, dry suspension, pill etc. any one.Preparation specification can be 25mg, 50mg, 100mg, 150mg etc.
The preparation of embodiment 5, berberine hydrochloride granule for masking flavor agent:
As the taste masking berberine hydrochloride preparation of embodiment 4, but preparation formulation is plain particles agent; In every 1000 bags of granules, wherein hydrochloric masked berberine micropill 1000g, sucrose 500g, dextrin 300g, microcrystalline Cellulose 180g, cyclamate 20g.
Prepare berberine hydrochloride granule for masking flavor agent in accordance with the following methods:
Get recipe quantity masked berberine hydrochloride micro pill, sucrose, dextrin, microcrystalline Cellulose, cyclamate, add suitable quantity of water soft material, 16 mesh sieves are granulated, and 60 ~ 80 DEG C of dryings, dress up 1000 bags.
Embodiment 6, taste masking berberine hydrochloride are suspended the preparation of type granule:
As the taste masking berberine hydrochloride preparation of embodiment 4, but preparation formulation is suspended type granule; Type granule is suspended, wherein hydrochloric masked berberine micropill 1000g, sucrose 500g, dextrin 300g, microcrystalline Cellulose 160g, hypromellose (K in every 1000 bags
4M,
15M,
100M) 20g, cyclamate 20g.
Also comprise suspending agent in addition; Suspending agent is tragakanta or arabic gum, and suspending agent consumption accounts for recipe quantity 1 ~ 5%.
Prepare taste masking berberine hydrochloride in accordance with the following methods and be suspended type granule:
Get recipe quantity masked berberine hydrochloride micro pill, sucrose, dextrin, microcrystalline Cellulose, hypromellose (K
4M,
15M,
100M), cyclamate, suspending agent, with debita spissitudo ethanol soft material, 16 mesh sieves granulate, 60 ~ 80 DEG C of dryings, dress up 1000 bags.
Preparation taste masking berberine hydrochloride is suspended type granule, its objective is that this granule can form gel liquid when taking, water-insoluble hydrochloric acid berberine micropill suspends in the solution, the short time can not produce precipitation, is more conducive to child and swallows the patient that has any problem taking.
The preparation of embodiment 7, taste masking berberine hydrochloride dispensing tablet:
As the taste masking berberine hydrochloride preparation of embodiment 4, but preparation formulation is dispersible tablet; In every 1000 dispersible tablets, wherein hydrochloric masked berberine micropill 200g, microcrystalline Cellulose 150g, carboxymethylstach sodium 40g, sweet close plain 10g, sucrose 100g, Magnesium Stearate proper quantity.
Prepare taste masking berberine hydrochloride dispensing tablet in accordance with the following methods:
First recipe quantity sucrose suitable quantity of water is dissolved and make binding agent, for subsequent use; Get recipe quantity masked berberine hydrochloride micro pill, microcrystalline Cellulose mixing, add binding agent for subsequent use, mixing; 16 mesh sieves are granulated, 60 ~ 80 DEG C of dryings; Get dried particles and carboxymethylstach sodium, sweet close element mix, then add the magnesium stearate that hybrid particles weighs 0.5%, mixing; After assay, adjustment sheet refitting amount, is pressed into 1000.
The preparation of embodiment 8, taste masking berberine hydrochloride pill:
The ball footpath of taste masking berberine hydrochloride pill is 0.2 ~ 2.5mm, and specification has 25mg, 50mg, 100mg, 150mg.Pill is unit dose package, and every packed amount is about 2g, and object is taste masking, swallows conveniently, can send down with a small amount of water.
Preparation technology: for 100mg specification; get berberine hydrochloride 100g, microcrystalline Cellulose 1500g, sucrose 380g, carboxymethylstach sodium 100g mix; get 200g mixed powder 20 mesh sieves to granulate; 60 ~ 80 DEG C of dryings, sieve is got 30 ~ 40 order granule 150g and is put on centrifugal granulator machine rotation disc, opens rotation disc; be that binding agent is sprayed onto dry particle surface with water; make its moistening and spread mixed powder, this process of continuing meets the requirements to ball footpath, takes the dish out of the pot and puts drying baker in 60 ~ 80 DEG C of dryings.Sieve is got the appropriate coating of 10 ~ 30 order ball taste masking coating solution and is stopped to complete taste masking; Through after the assay was approved pack, every bag of heavily about 2g.
Adopt centrifugal lamination legal system standby during this technique, be applicable to coating pan spheronization too and prepare micropill.
Claims (7)
1. masked berberine hydrochloride micro pill, makes by berberine hydrochloride micropill is coated;
It is characterized in that berberine hydrochloride micropill here selects any one method extruded in centrifugal granulation, centrifugal lamination method or coating pan spheronization to make by berberine hydrochloride and pharmaceutic adjuvant; Adjuvant used be selected from microcrystalline Cellulose, starch, sucrose, dextrin any one or a few; By weight percentage, in micropill, the consumption of adjuvant is 15 ~ 90%;
Coating coating material used includes: filmogen, plasticizer, caking inhibiter;
Here filmogen is selected from one or more in Eudragit E 100, Eudragit E PO, Eudragit L 100, hydroxypropyl emthylcellulose; By weight percentage, in coated micropill, the consumption of filmogen is 1 ~ 8%;
Here plasticizer is selected from Oleum Ricini, polyethylene glycol 6000, polyethylene glycol 1500, PEG400, any one or a few in dibutyl sebacate, triethyl citrate; By weight percentage, in coating material, the consumption of plasticizer is 5 ~ 8% of filmogen;
Here caking inhibiter be selected from magnesium stearate, Pulvis Talci and micropowder silica gel any one or a few; By weight percentage, in coating material, the consumption of caking inhibiter is 5 ~ 15% of filmogen;
The particle diameter of preferred masked berberine hydrochloride micro pill is 100 ~ 600 μm.
2. masked berberine hydrochloride micro pill according to claim 1, is characterized in that described berberine hydrochloride micropill adopts following centrifugal lamination legal system standby:
Berberine hydrochloride is mixed homogeneously with pharmaceutic adjuvant; Getting appropriate mixed powder puts on centrifugal granulator, sprays into binding agent appropriate, makes micropill, and screening particle diameter is the micropill of 100 ~ 600 μm.
3. taste masking berberine hydrochloride preparation, adds pharmaceutic adjuvant by masked berberine hydrochloride micro pill and makes, and it is characterized in that masked berberine hydrochloride micro pill here as claimed in claim 1 or 2;
Here preparation formulation can be granule, be suspended in type granule, dispersible tablet, dry suspension, pill etc. any one.
4. taste masking berberine hydrochloride preparation according to claim 3, is characterized in that described preparation formulation is granule; Described pharmaceutic adjuvant is sucrose, dextrin, microcrystalline Cellulose, cyclamate;
Prepare berberine hydrochloride granule for masking flavor agent in accordance with the following methods:
In every 1000 bags, get masked berberine hydrochloride micro pill 1000g, sucrose 500g, dextrin 300g, microcrystalline Cellulose 180g, cyclamate 20g, add suitable quantity of water soft material, 16 mesh sieves are granulated, and 60 ~ 80 DEG C of dryings, dress up 1000 bags.
5. taste masking berberine hydrochloride preparation according to claim 3, is characterized in that described preparation formulation is suspended type granule:
Described pharmaceutic adjuvant is sucrose, dextrin, microcrystalline Cellulose, hypromellose (K
4M, 15M, 100M), cyclamate, suspending agent;
Prepare taste masking berberine hydrochloride in accordance with the following methods and be suspended type granule:
In every 1000 bags, get masked berberine hydrochloride micro pill 1000g, sucrose 500g, dextrin 300g, microcrystalline Cellulose 160g, hypromellose (K
4M, 15M, 100M) 20g, cyclamate 20g, suspending agent, with debita spissitudo ethanol soft material, 16 mesh sieves granulate, 60 ~ 80 DEG C of dryings;
Here suspending agent be selected from tragakanta or arabic gum any one, suspending agent consumption accounts for recipe quantity 1 ~ 5%.
6. taste masking berberine hydrochloride preparation according to claim 3, is characterized in that described preparation formulation is dispersible tablet:
Described pharmaceutic adjuvant is microcrystalline Cellulose, carboxymethylstach sodium, sweet close element, sucrose, magnesium stearate;
Prepare taste masking berberine hydrochloride dispensing tablet in accordance with the following methods:
In every 1000 dispersible tablets, get the dissolving of sucrose 100g suitable quantity of water and make binding agent, for subsequent use;
Get masked berberine hydrochloride micro pill 200g, microcrystalline Cellulose 150g to mix; Add binding agent for subsequent use, mixing; 16 mesh sieves are granulated, 60 ~ 80 DEG C of dryings;
Get dried particles and carboxymethylstach sodium 40g, sweet close plain 10g mix, then add the magnesium stearate that hybrid particles weighs 0.5%, mixing; Tabletting.
7. taste masking berberine hydrochloride preparation according to claim 3, is characterized in that described preparation formulation is pill, and the ball footpath of pill is 0.2 ~ 2.5mm:
Described pharmaceutic adjuvant is microcrystalline Cellulose, sucrose, carboxymethylstach sodium;
Prepare taste masking berberine hydrochloride pill in accordance with the following methods:
Get berberine hydrochloride 100 weight portion, microcrystalline Cellulose 1500 weight portion, sucrose 380 weight portion, the mixing of carboxymethylstach sodium 100 weight portion, get 200 weight portion mixed powder 20 mesh sieves to granulate, 60 ~ 80 DEG C of dryings, sieve gets 30 ~ 40 order granule 150 weight portions, puts on centrifugal granulator machine rotation disc, opens rotation disc, be that binding agent is sprayed onto dry particle surface with water, make its moistening and spread mixed powder, this process of continuing meets the requirements to ball footpath, takes the dish out of the pot and puts drying baker in 60 ~ 80 DEG C of dryings;
Sieve gets the appropriate coating of 10 ~ 30 order ball taste masking coating solution.
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CN 200610113218 CN1931137A (en) | 2006-09-19 | 2006-09-19 | Masked berberine hydrochloride micro pill and its prepn |
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CN 200610113218 Pending CN1931137A (en) | 2006-09-19 | 2006-09-19 | Masked berberine hydrochloride micro pill and its prepn |
CN201510385195.0A Pending CN104997735A (en) | 2006-09-19 | 2006-09-19 | Berberine hydrochloride taste-masked pellet, and preparation thereof |
CN201510317470.5A Pending CN105030689A (en) | 2006-09-19 | 2006-09-19 | Berberine hydrochloride taste-masking pellets and preparation thereof |
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WO2019024949A1 (en) * | 2017-08-02 | 2019-02-07 | Pro.Med.Cs Praha A.S. | Manufacturing method of oral dosage form containing berberine, oral dosage form containing berberine and use thereof |
WO2019038430A1 (en) | 2017-08-25 | 2019-02-28 | Eleonor Sprl | Composition comprising at least one protoberberine alkaloid and its production process |
CN114699384A (en) * | 2022-03-22 | 2022-07-05 | 中国科学院宁波材料技术与工程研究所 | Drug taste masking method, drug and application thereof |
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CN102525952A (en) * | 2011-11-29 | 2012-07-04 | 昆明邦宇制药有限公司 | Method for producing berberine micro-pills |
WO2015097642A1 (en) * | 2013-12-26 | 2015-07-02 | Rao Raavi Chandra Sekhar | Composition for treating cancer and method of synthesizing the same |
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JP3034592B2 (en) * | 1990-11-20 | 2000-04-17 | わかもと製薬株式会社 | Oral solid preparation and production method thereof |
CN1269478C (en) * | 2004-06-14 | 2006-08-16 | 湖北丽益医药科技有限公司 | Micro-capsules of berberine hydrochloride and their preparations |
CN1273133C (en) * | 2004-11-12 | 2006-09-06 | 北京昭衍博纳新药研究有限公司 | Berberine hydrochloride granule for masking flavor and its preparation |
CN100337627C (en) * | 2005-02-23 | 2007-09-19 | 广东怡康制药有限公司 | Berberine hydrochloride dispensing tablet and its preparing method |
-
2006
- 2006-09-19 CN CN 200610113218 patent/CN1931137A/en active Pending
- 2006-09-19 CN CN201510385195.0A patent/CN104997735A/en active Pending
- 2006-09-19 CN CN201510317470.5A patent/CN105030689A/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019024949A1 (en) * | 2017-08-02 | 2019-02-07 | Pro.Med.Cs Praha A.S. | Manufacturing method of oral dosage form containing berberine, oral dosage form containing berberine and use thereof |
WO2019038430A1 (en) | 2017-08-25 | 2019-02-28 | Eleonor Sprl | Composition comprising at least one protoberberine alkaloid and its production process |
BE1025649B1 (en) * | 2017-08-25 | 2019-05-20 | Eleonor Sprl | Composition comprising at least one protoberberine alkaloid and its method of manufacture |
CN114699384A (en) * | 2022-03-22 | 2022-07-05 | 中国科学院宁波材料技术与工程研究所 | Drug taste masking method, drug and application thereof |
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CN1931137A (en) | 2007-03-21 |
CN105030689A (en) | 2015-11-11 |
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