CN109453131A - A kind of bangxiaoan and its preparation process - Google Patents
A kind of bangxiaoan and its preparation process Download PDFInfo
- Publication number
- CN109453131A CN109453131A CN201811603597.3A CN201811603597A CN109453131A CN 109453131 A CN109453131 A CN 109453131A CN 201811603597 A CN201811603597 A CN 201811603597A CN 109453131 A CN109453131 A CN 109453131A
- Authority
- CN
- China
- Prior art keywords
- essence
- bangxiaoan
- sweetener
- corrigent
- hydrotalcite
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Zoology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a kind of bangxiaoans, formula is in 1000 preparation units, its composition is as follows: Hydrotalcite 500g mannitol 100g-500g, pregelatinized starch 30g-150g, microcrystalline cellulose 30g-150g, sweetener 2g-10g, fragrant corrigent 0.3-1g, magnesium stearate 1-20g.The simple process, low energy consumption, reduces production cost, chewable tablets good mouthfeel obtained.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, it is related to a kind of antacids and gastric mucosal protection drug, and in particular to a kind of aluminium
Magnesium carbonate chewable tablets and preparation method thereof.
Background technique
Hydrotalcite is the compound of aluminium hydroxide, magnesium hydroxide, carbonate and water, is New-type long-acting antacids, lives
Property ingredient by layer-lattice structure arrange, be unique reticular structure, have double action.On the one hand it is rapidly achieved gastric juice
The most suitable range of pH3-5 prevents the excessively strongly active of pepsin, promotes ulcer healing.It is again reversible with cholic acid, pepsin simultaneously
Property combine, eliminate damage of the bile acid to stomach lining, be used for hyperchlorhydria, acute or chronic gastritis, bile gastritis backflows
Property esophagitis, duodenal bulbar ulcer, gastric ulcer, a variety of causes such as: excessive use coffee, alcohol, strong tea, nicotine and
It takes non-ulcer dyspepsia caused by non-steroidal anti-inflammatory drugs and alimentary canal is uncomfortable.
Currently, there are ZheJiang HangKang Pharmacy Co., Ltd, the high medicine company in Jiangsu ten thousand in the enterprise of domestic production bangxiaoan
Limited liability company, garden medicine company limited liability company, satisfies into the limited public affairs of medicine company share at Chongqing Hua Sen Pharmacy stock Co., Ltd
Application publication CN201610610562.7 is detailed in wherein there is Enterprise Application related patents in Si Deng28Jia enterprise.
Chinese patent application CN201610610562.7 discloses a kind of bangxiaoan and its preparation process, raw material
Including Hydrotalcite, lactose, mannitol, stevioside, flavoring pineapple essence, magnesium stearate, polyvinylpyrrolidone K30PVP aqueous solution.
The preparation process of bangxiaoan weighs Hydrotalcite, lactose, mannitol, stevioside by weight, and then mixing is equal
It is even, polyvinylpyrrolidone K is added30PVP aqueous solution, is made softwood, and particle is made after selecting by 20 meshes, dry, leads to again
It crosses 20 meshes and carries out whole grain, add flavoring pineapple essence, magnesium stearate, be then uniformly mixed, tabletting shapes to obtain Hydrotalcite chewing
Piece.Said preparation uses wet granule compression tablet technique, and processing step is more, and the production cycle is long compared with technique of direct powder compression, energy consumption
It is larger.
Bangxiaoan is antiacid, when clinical application require its can in human body rapid-onset, with reduction of patient
Pain, technique of direct powder compression can effectively improve the action speed of tablet.Because direct powder compression technology can be improved
Disintegration of tablet, the disintegrating agent that the disintegration of tablet relies primarily in tablet promote tablet to collapse by capillarity or expansion
Solution.The tablet prepared using technique of direct powder compression, disintegrating agent are different from the disintegrating agent in wet granulation, will not be due to preceding
Phase contact wetting and reduce disintegrating property, to ensure that good disintegration properties.In addition, due to there is no carry out pelletizing press sheet,
It not will form agglomerate shape particle after disintegration of tablet, but form the relatively large fine powder of specific surface area, can preferably be distributed in
In vivo, facilitate the release of drug, absorb.
Using rossett rice, antiacid test method(s), the external of 5 kinds of domestic bangxiaoans of investigation resist in vitro for we
Acid energy, and compared with the hydrotalcite tablet of Bayer HealthCare Co (trade name: up to happiness).Test method are as follows:
Mastication processes when patient's medication are simulated, 20 particles are made in bangxiaoan, as product to be tested；By 30ml water and
0.1mol.L-1 hydrochloric acid solution 70ml is added in reaction vessel, at magnetic heating stirrer and contact temperature meter control reaction solution
In 37 DEG C, magnetic agitation, mixing speed 400rmin-1, held with the pH meter measurement reaction equipped with glass electrode, calomel electrode
The variation of pH value in device, constant flow pump is with (2.0 ± 0.1) mlmin-1Speed 37 DEG C of constant temperature are pumped into reaction vessel
0.1mol·L-1Hydrochloric acid solution.After antiacid to be measured is added, when opening constant flow pump and magnetic stirring apparatus immediately, while recording
Between and pH value.Testing result is as follows:
Experimental result shows that the more domestic bangxiaoan of action speed up to happiness piece is fast, and difference is obvious, it may be possible to
Since domestic bangxiaoan mostly uses greatly wet granulation technology, tablet and powder is compact, and capillarity is weaker, disintegration speed
Degree is slowly caused.
For bangxiaoan as a kind of antiacid chewed and taken, there is should have good mouthfeel, and needs
Disintegration time is short, rapid-action, stablizes this good problem.The applicant is led to during researching and developing bangxiaoan
The suitable supplementary material of selection and production technology are crossed, is tested by a large amount of prescription screening and technical study, finally solves this
Problem.
Summary of the invention
The present invention provides a kind of bangxiaoan, in every 1000 preparation units, consists of the following compositions:
| Hydrotalcite | 500g |
| Mannitol | 100g~500g |
| Pregelatinized starch | 30g~150g |
| Microcrystalline cellulose | 30g~150g |
| Sweetener | 2g~10g |
| Fragrant corrigent | 0.3~1g |
| Magnesium stearate | 1~20g |
| It is made | 1000 |
The bangxiaoan is in good taste, and disintegration time is short, rapid-action, and stability is good.
The magnesium stearate granularity is preferably smaller than 180 microns；The Hydrotalcite, microcrystalline cellulose, mannitol, pregelatinated
Starch, sweetener, fragrant corrigent granularity are preferably smaller than 250 microns.
Control supplementary material partial size can dramatically increase the mixed mobility of supplementary material, be suitble to industrialized production.
The present invention further provides a kind of preparation methods of hydrotalcite tablet, comprising the following steps:
(1) supplementary material granularity requirements: magnesium stearate granularity is less than 180 microns；Hydrotalcite, mannitol, microcrystalline cellulose,
Pregelatinized starch, sweetener, fragrant corrigent granularity are less than 250 microns；
(2) Hydrotalcite, filler, microcrystalline cellulose, pregelatinized starch, the sweetener, fragrant flavoring of recipe quantity are weighed
Agent, is added in two-dimensional mixing machine magnesium stearate, incorporation time 15~45 minutes, obtains total mixture；
(3) total mixture direct tablet compressing.
The method have the benefit that: the simple process, low energy consumption, reduces production cost, chewable tablets obtained
Good mouthfeel.
Specific embodiment
The present invention is further illustrated combined with specific embodiments below, but this should not be interpreted as to the above-mentioned master of the present invention
The range of topic is only limitted to embodiment below.All technologies realized based on above content of the present invention belong to model of the invention
It encloses.Auxiliary material in following embodiment can be replaced with pharmaceutically acceptable similar auxiliary material, or reduced, increased.
Embodiment 1
1, prescription:
| Hydrotalcite | 500g |
| Mannitol | 350g |
| Pregelatinized starch | 80g |
| Microcrystalline cellulose | 80g |
| Steviosin | 5g |
| Menthol | 0.5g |
| Magnesium stearate | 10g |
| It is made | 1000 |
2, processing step:
(1) supplementary material granularity requirements: magnesium stearate granularity is less than 180 microns；Hydrotalcite, mannitol, microcrystalline cellulose,
Pregelatinized starch, Steviosin, menthol granularity are less than 250 microns；
(2) Hydrotalcite of recipe quantity, mannitol, microcrystalline cellulose, pregelatinized starch, Steviosin, menthol, hard is weighed
Fatty acid magnesium is added in two-dimensional mixing machine, incorporation time 15~45 minutes, obtains total mixture；Total mixture surveys mobility, and angle of repose (θ) is
38.5°。
(3) total mixture direct tablet compressing, every slice weight 1.0g.
3, quality testing
Referring to the bangxiaoan Guo Jiao drug standards [standard No.: WS1(X-280) -2003Z] and 2010 editions pharmacopeia
Two annex relevant regulations detect the quality of finished product obtained.
Embodiment 2
1, prescription:
| Hydrotalcite | 500g |
| Mannitol | 280g |
| Pregelatinized starch | 120g |
| Microcrystalline cellulose | 100g |
| Saccharin sodium | 5g |
| Mint Essence | 1g |
| Magnesium stearate | 15g |
| It is made | 1000 |
2, processing step:
(1) supplementary material granularity requirements: magnesium stearate granularity is less than 180 microns；Hydrotalcite, mannitol, microcrystalline cellulose,
Pregelatinized starch, saccharin sodium, Mint Essence granularity are less than 250 microns；
(2) weigh the Hydrotalcite of recipe quantity, mannitol, microcrystalline cellulose, pregelatinized starch, saccharin sodium, Mint Essence,
Magnesium stearate is added in two-dimensional mixing machine, incorporation time 15~45 minutes, obtains total mixture；Total mixture surveys mobility, angle of repose (θ)
It is 37.8 °.
(3) total mixture direct tablet compressing, every slice weight 1.0g.
3, quality testing
Referring to the bangxiaoan Guo Jiao drug standards [standard No.: WS1(X-280) -2003Z] and 2010 editions pharmacopeia
Two annex relevant regulations detect the quality of finished product obtained.
Embodiment 3
Stability test
According to the contained stability test guideline of 2010 editions pharmacopeia, two annex, laboratory sample (embodiment 1, reality are investigated
Apply example 2) 36 months long-time stability (investigate condition: 25 DEG C ± 2 DEG C, RH60% ± 10%), it is as follows to investigate result:
The result shows that: for laboratory sample during long-term investigation in 36 months, primary quality measure meets regulation, shows
The sample stability prepared by formulation and technology of the invention is good.
Embodiment 4
Mastication processes when patient's medication are simulated, laboratory sample (embodiment 1, embodiment 2) is processed into 20 mesh particles, are made
For product to be tested；Using rossett rice antiacid test method(s) in vitro, 30ml water and 0.1mol.L-1 hydrochloric acid solution 70ml are added
In reaction vessel, 37 DEG C are in magnetic heating stirrer and contact temperature meter control reaction solution, magnetic agitation, mixing speed is
400r·min-1, with the variation of pH value in the pH meter measurement reaction vessel equipped with glass electrode, calomel electrode, constant flow pump is with (2.0
±0.1)ml·min-1Speed the 0.1molL of 37 DEG C of constant temperature is pumped into reaction vessel-1Hydrochloric acid solution.It is to be measured when being added
Antiacid after, open constant flow pump and magnetic stirring apparatus immediately, while recording time and pH value.
Test result: the time for reaching pH3 of 2 sample of embodiment 1 and embodiment is close up to happiness, far faster than domestic aluminium carbonic acid
Magnesium chewable tablets shows that the bangxiaoan disintegration rate of dispersion prepared by the invention patent is fast, works rapid.
Claims (4)
1. a kind of bangxiaoan, it is characterised in that: in 1000 preparation units, composition is as follows: aluminium carbonic acid
Magnesium 500g mannitol 100g-500g, pregelatinized starch 30g-150g, microcrystalline cellulose 30g-150g, sweetener 2g-10g, fragrance
Corrigent 0.3-1g, magnesium stearate 1-20g.
2. a kind of bangxiaoan according to claim 1, it is characterised in that sweetener used is saccharin sodium, stevia rebaudianum
One or more of element, Sucralose, aspartame.
3. a kind of bangxiaoan according to claim 1, it is characterised in that it is used fragrance corrigent be menthol,
Mint Essence, orange essence, flavoring banana essence, orange flavor, strawberry essence, milk-taste essence, flavoring pineapple essence, spearmint essence, fresh milk
One or more of essence, vanillic aldehyde, lemon extract.
4. a kind of bangxiaoan preparation method according to claim 1, the preparation method include the following steps:
1) supplementary material granularity requirements: magnesium stearate granularity is less than 180 microns；It is Hydrotalcite, mannitol, microcrystalline cellulose, pre-
Gelling starch, sweetener, fragrant corrigent granularity are less than 250 microns；
2) Hydrotalcite of recipe quantity, filler, microcrystalline cellulose, pregelatinized starch, sweetener, fragrant corrigent, hard is weighed
Fatty acid magnesium is added in two-dimensional mixing machine, incorporation time 15~45 minutes, obtains total mixture；
3) total mixture direct tablet compressing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811603597.3A CN109453131A (en) | 2018-12-26 | 2018-12-26 | A kind of bangxiaoan and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811603597.3A CN109453131A (en) | 2018-12-26 | 2018-12-26 | A kind of bangxiaoan and its preparation process |
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| Publication Number | Publication Date |
|---|---|
| CN109453131A true CN109453131A (en) | 2019-03-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811603597.3A Pending CN109453131A (en) | 2018-12-26 | 2018-12-26 | A kind of bangxiaoan and its preparation process |
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| Country | Link |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110393216A (en) * | 2019-08-13 | 2019-11-01 | 江苏安泰生物技术有限公司 | A kind of anti-helicobacter pylori health food and preparation method thereof |
| CN111481568A (en) * | 2020-04-22 | 2020-08-04 | 广东一力罗定制药有限公司 | Hydrotalcite tablet and preparation process thereof |
| CN112957369A (en) * | 2021-02-20 | 2021-06-15 | 北京阳光诺和药物研究股份有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
-
2018
- 2018-12-26 CN CN201811603597.3A patent/CN109453131A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110393216A (en) * | 2019-08-13 | 2019-11-01 | 江苏安泰生物技术有限公司 | A kind of anti-helicobacter pylori health food and preparation method thereof |
| CN111481568A (en) * | 2020-04-22 | 2020-08-04 | 广东一力罗定制药有限公司 | Hydrotalcite tablet and preparation process thereof |
| CN111481568B (en) * | 2020-04-22 | 2021-04-02 | 一力制药(罗定)有限公司 | Hydrotalcite tablet and preparation process thereof |
| CN112957369A (en) * | 2021-02-20 | 2021-06-15 | 北京阳光诺和药物研究股份有限公司 | Hydrotalcite chewable tablet and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20190312 |
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| WD01 | Invention patent application deemed withdrawn after publication |