CN102512377A - Tasteless quick-releasing berberine hydrochloride pellet - Google Patents
Tasteless quick-releasing berberine hydrochloride pellet Download PDFInfo
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- CN102512377A CN102512377A CN2011104513756A CN201110451375A CN102512377A CN 102512377 A CN102512377 A CN 102512377A CN 2011104513756 A CN2011104513756 A CN 2011104513756A CN 201110451375 A CN201110451375 A CN 201110451375A CN 102512377 A CN102512377 A CN 102512377A
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- berberine hydrochloride
- tasteless
- coating material
- pellet
- adjuvant
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Abstract
The invention discloses a tasteless quick-releasing berberine hydrochloride pellet, which is prepared by main-drug berberine hydrochloride, an auxiliary material, a taste-masking coating material and an adhesive. The auxiliary material is prepared into a base bill core of the pellet, and the outer surface of the base bill core coats a layer of main-drug berberine hydrochloride, and the outer surface of the main-drug berberine hydrochloride coats a layer of taste-masking coating material. The quick-releasing berberine hydrochloride pellet is prepared by adopting a reasonable formula, then the taste-masking coating material is used for masking bitter taste through a coating method, and the release of the pellet in the mouth is delayed, so that the pellet releasing speed in gastric juice is ensured. More than 80 percent of the pellet can be released within 10 minutes, so that the pellet is quickly released in the stomach. Thus, the pellet is particularly suitable for children for direct taking.
Description
Technical field
The present invention relates to is a kind of tasteless rapid release berberine hydrochloride micropill that is used to treat the infant gastroenteropathy, belongs to the pharmaceutical production technical field.
Background technology
The intestinal infection (comprising bacillary dysentery) that berberine hydrochloride causes dysentery bacterium, escherichia coli, golden Portugal bacterium etc., eye conjunctivitis, suppurative otitis media etc. are effective.It also has effect to helicobacter pylori, and gastritis, gastric and duodenal ulcers are alleviated.Recently find also that berberine hydrochloride has blocking-up alpha-receptor, antiarrhythmic effect.Berberine hydrochloride is mainly used in the treatment intestinal infection, but its flavor is extremely bitter, especially is not suitable for the child and directly takes.Berberine hydrochloride absorbs not good in intestinal, influences its bioavailability.Therefore press for the dosage form that exploitation hides rapid release in the stomach of distinguishing the flavor of.
Summary of the invention
The objective of the invention is to overcome the deficiency of above-mentioned existence, a kind of tasteless rapid release berberine hydrochloride micropill that is specifically designed to treatment infant gastroenteropathy is provided, can satisfy patient's rapid release administration needs.
For realizing above-mentioned purpose, the present invention has taked following technical scheme:
A kind of tasteless rapid release berberine hydrochloride micropill of the present invention, it is made up of principal agent berberine hydrochloride, adjuvant, screening flavor coating material and adhesive; Basic ball nuclear core so that adjuvant is made coats principal agent berberine hydrochloride layer in the outside of basic ball nuclear core, in the outside of principal agent berberine hydrochloride layer, coats and hides flavor coating material layer.
The weight percent proportioning of described principal agent berberine hydrochloride, adjuvant, screening flavor coating material and adhesive is:
Principal agent: berberine hydrochloride: 1-55%;
Adjuvant: 5-75%;
Hide flavor coating material: 2-40%;
Adhesive: 1-8%.
Described adjuvant is mixed by microcrystalline Cellulose, starch, L-hydroxypropyl cellulose, and its percentage by weight is:
Microcrystalline Cellulose: 50-70%;
Starch: 20-30%;
L-hydroxypropyl cellulose: 10-20%.
Described screening flavor coating material is mixed by acrylic resin IV, magnesium stearate, Pulvis Talci, and its percentage by weight is:
Acrylic resin IV:25-55%;
Magnesium stearate: 10-35%;
Pulvis Talci: 15-40%;
After above-mentioned percentage by weight mixing, adding ethanol is mixed with 5% solution.
Described adhesive is the derivant of 8% polyvinylpyrrolidone aqueous solution or gelatin or natural gum or natural gum.
Microcrystalline Cellulose in the described adjuvant also comprises the derivant of microcrystalline Cellulose.
Described L-hydroxypropyl cellulose also comprises sodium carboxymethyl cellulose.
Described Pulvis Talci can be a silicon dioxide.
The present invention is owing to adopted rational prescription to process quick-releasing type berberine hydrochloride micropill, and reuse hides the coating material of flavor, through the method for coating; Cover its bitterness; Delay medicine in intraoral release, guarantee that its release in gastric juice is rapid, can reach release more than 80% in 10 minutes; It is absorbed rapidly under one's belt, directly take so be particularly suitable for the child.
Description of drawings
Fig. 1 is a structural representation of the present invention
Wherein: 1-base ball nuclear core 2-principal agent layer 3-hides the flavor coatings
The specific embodiment
To combine specific embodiment that the present invention is done further detailed description below, but be not restriction protection scope of the present invention.
Embodiment one:
Step 1: the making of basic ball nuclear core:
By weight percentage: microcrystalline Cellulose: starch 50%: L-hydroxypropyl cellulose 30%: 20%, use 8% polyvinylpyrrolidone aqueous solution to process diameter and be 0.2-0.7mm subcircular granule; Through fluid bed drying, sub-sieve, make moisture≤5% of finished product.
Step 2: the making that hides the flavor coating powder:
By weight percentage: with acrylic resin IV:30%, magnesium stearate: Pulvis Talci 45%: after 25% fine powder mixes, add ethanol and be mixed with 5% solution.
Step 3: the making of tasteless rapid release berberine hydrochloride micropill:
According to percentage by weight: berberine hydrochloride: adjuvant 30%; 50% (process speed and collapse type base ball nuclear core), screening flavor coating material: 20% requirement; The made basic ball nuclear core that performs is placed in the fluid bed; Spray into the berberine hydrochloride polyvinylpyrrolidone mixed solution for preparing, and then spray into the screening flavor coating powder solution for preparing, become tasteless quick-releasing type berberine hydrochloride micropill through fluidized bed coating; Through dry, sieve, operations such as inner packing, outer package, promptly become finished product.
Embodiment two:
Step 1: the making of basic ball nuclear core:
By weight percentage: microcrystalline Cellulose: starch 45%: L-hydroxypropyl cellulose 38%: 17%; Use 8% polyvinylpyrrolidone aqueous solution to process diameter and be 0.2-0.7mm subcircular granule; Through fluid bed drying, sub-sieve, make moisture≤5% of finished product.
Step 2: the making that hides the flavor coating powder:
By weight percentage: acrylic resin IV solution is prepared: acrylic resin IV40%, magnesium stearate 35%, Pulvis Talci 25%: add ethanol and be mixed with 8% solution.
Step 3: the making of tasteless rapid release berberine hydrochloride micropill:
According to percentage by weight: berberine hydrochloride: adjuvant 35%; 40% (process speed and collapse type base ball nuclear core), screening flavor coating material: 25% requirement; The made basic ball that performs is added in the fluid bed; Be injected to the berberine hydrochloride polyvinylpyrrolidone mixed solution for preparing earlier, and then spray into the screening flavor coating powder solution that processes, become tasteless quick-releasing type berberine hydrochloride micropill through fluidized bed coating; Through dry, sieve, operations such as inner packing, outer package, promptly become finished product.
Embodiment three:
Step 1: the making of basic ball nuclear core:
By weight percentage: microcrystalline Cellulose: starch 45%: L-hydroxypropyl cellulose 40%: 15%, use 8% polyvinylpyrrolidone aqueous solution to process diameter and be 0.2-0.The yellow subcircular granule of 7mm through fluid bed drying, sub-sieve, makes moisture≤5% of finished product.
Step 2: the making that hides the flavor coating powder:
By weight percentage: with acrylic resin IV:35%, magnesium stearate: 30% and Pulvis Talci: 35%, add ethanol and be mixed with 6% solution.
Step 3: the making of tasteless rapid release berberine hydrochloride micropill:
According to percentage by weight: berberine hydrochloride: adjuvant 32%; 40% (process speed and collapse type base ball nuclear core), screening flavor coating material: 28%; The made basic ball nuclear core that performs is placed in the fluid bed; Spray into the berberine hydrochloride and the polyvinylpyrrolidone mixed solution that prepare earlier, and then add the screening flavor coating powder for preparing, become tasteless quick-releasing type berberine hydrochloride micropill through fluidized bed coating; Through dry, sieve, operations such as inner packing, outer package, promptly become finished product.
Claims (5)
1. tasteless rapid release berberine hydrochloride micropill is characterized in that it is made up of principal agent berberine hydrochloride, adjuvant, screening flavor coating material and adhesive; Basic ball nuclear core so that adjuvant is made coats principal agent berberine hydrochloride layer in the outside of basic ball nuclear core, in the outside of principal agent berberine hydrochloride layer, coats and hides flavor coating material layer; The weight percent proportioning of described principal agent berberine hydrochloride, adjuvant, screening flavor coating material and adhesive is:
Principal agent: berberine hydrochloride: 1-55%;
Adjuvant: 5-75%;
Hide flavor coating material: 2-40%;
Adhesive: 1-8%;
Described adjuvant is mixed by microcrystalline Cellulose, starch, L-hydroxypropyl cellulose, and its percentage by weight is:
Microcrystalline Cellulose: 50-70%;
Starch: 20-30%;
L-hydroxypropyl cellulose: 10-20%;
Described screening flavor coating material is mixed by acrylic resin IV, magnesium stearate, Pulvis Talci, and its percentage by weight is:
Acrylic resin IV:25-55%;
Magnesium stearate: 10-35%;
Pulvis Talci: 15-40%.
2. a kind of tasteless rapid release berberine hydrochloride micropill according to claim 1 is characterized in that described adhesive is the derivant of 8% polyvinylpyrrolidone aqueous solution or gelatin or natural gum or natural gum.
3. a kind of tasteless rapid release berberine hydrochloride micropill according to claim 1 is characterized in that the microcrystalline Cellulose in the described adjuvant, also comprises the derivant of microcrystalline Cellulose.
4. a kind of tasteless rapid release berberine hydrochloride micropill according to claim 1 is characterized in that described L-hydroxypropyl cellulose, also comprises sodium carboxymethyl cellulose.
5. a kind of tasteless rapid release berberine hydrochloride micropill according to claim 1 is characterized in that described Pulvis Talci, can be silicon dioxide.
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CN 201110451375 CN102512377B (en) | 2011-12-22 | 2011-12-22 | Tasteless quick-releasing berberine hydrochloride pellet |
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CN 201110451375 CN102512377B (en) | 2011-12-22 | 2011-12-22 | Tasteless quick-releasing berberine hydrochloride pellet |
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CN102512377A true CN102512377A (en) | 2012-06-27 |
CN102512377B CN102512377B (en) | 2013-10-23 |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103393602A (en) * | 2013-07-19 | 2013-11-20 | 东北制药(沈阳)科技发展有限公司 | Berberine ultrafine-particle intestinal adhesion-type sustained-release pellet and preparation method thereof |
CN112587499A (en) * | 2020-12-29 | 2021-04-02 | 成都锦华药业有限责任公司 | Berberine hydrochloride pellet and preparation method thereof |
Citations (4)
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CN1634048A (en) * | 2004-11-12 | 2005-07-06 | 北京昭衍博纳新药研究有限公司 | Berberine hydrochloride granule for masking flavor and its preparation |
CN1994468A (en) * | 2006-01-06 | 2007-07-11 | 牛祝琴 | Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof |
CN101152159A (en) * | 2006-09-28 | 2008-04-02 | 莫敬柱 | Cefuroxime axetil taste masking pellet and method of preparing the same |
CN102085252A (en) * | 2011-01-21 | 2011-06-08 | 中国人民解放军第二军医大学 | Pharmaceutical composition for treating ulcerative colitis and colon-targeted micro-pill preparation thereof |
-
2011
- 2011-12-22 CN CN 201110451375 patent/CN102512377B/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1634048A (en) * | 2004-11-12 | 2005-07-06 | 北京昭衍博纳新药研究有限公司 | Berberine hydrochloride granule for masking flavor and its preparation |
CN1994468A (en) * | 2006-01-06 | 2007-07-11 | 牛祝琴 | Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof |
CN101152159A (en) * | 2006-09-28 | 2008-04-02 | 莫敬柱 | Cefuroxime axetil taste masking pellet and method of preparing the same |
CN102085252A (en) * | 2011-01-21 | 2011-06-08 | 中国人民解放军第二军医大学 | Pharmaceutical composition for treating ulcerative colitis and colon-targeted micro-pill preparation thereof |
Non-Patent Citations (1)
Title |
---|
耿革霞: "苦豆子总碱微丸的研究", 《中国优秀硕士学位论文全文数据库 医药生物科技辑》 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103393602A (en) * | 2013-07-19 | 2013-11-20 | 东北制药(沈阳)科技发展有限公司 | Berberine ultrafine-particle intestinal adhesion-type sustained-release pellet and preparation method thereof |
CN103393602B (en) * | 2013-07-19 | 2016-01-27 | 东北制药集团沈阳第一制药有限公司 | A kind of berberine ultrafine-particle intestinal adhesion-type sustained-release pellet and preparation method thereof |
CN112587499A (en) * | 2020-12-29 | 2021-04-02 | 成都锦华药业有限责任公司 | Berberine hydrochloride pellet and preparation method thereof |
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