CN101991542A - Lansoprazole enteric dry suspension and preparation method thereof - Google Patents
Lansoprazole enteric dry suspension and preparation method thereof Download PDFInfo
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- CN101991542A CN101991542A CN2009101009549A CN200910100954A CN101991542A CN 101991542 A CN101991542 A CN 101991542A CN 2009101009549 A CN2009101009549 A CN 2009101009549A CN 200910100954 A CN200910100954 A CN 200910100954A CN 101991542 A CN101991542 A CN 101991542A
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- lansoprazole
- dry suspension
- essence
- micropill
- sucrose
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Abstract
The invention relates to lansoprazole enteric dry suspension and a preparation method thereof. The lansoprazole enteric dry suspension comprises the following components in percentage by weight: 15 percent-50 percent of lansoprazole pellets or particles, 1 percent-10 percent of suspending agents and 50 percent-85 percent of flavoring agents. The prepared lansoprazole enteric dry suspension has the advantages of stable quality, quick response, good suspension effect and high biological utilization degree, and is convenient for old people, children and patients suffered from dysphagia.
Description
Technical field
The present invention relates to field of medicine preparations, relate in particular to the preparation of lansoprazole, particularly a kind of Lansoprazole intestine dry suspension and preparation method thereof.
Background technology
Its chemical name of lansoprazole 2-[[[3-methyl-4-(2,2, the 2-trifluoro ethoxy)-2-pyridine radicals] methyl] sulfinyl]-the 1H-benzimidazole).Lansoprazole is a second in the world proton pump inhibitor class antiulcerative of being developed by Wu Tian company after omeprazole.This product is formally put on market in France by military field pharmaceutical factory and Houde company at the beginning of 1992, the excretory medicine of gastric acid inhibitory of this product substituted benzimidazole class.Be the potent inhibitor of the most advanced and sophisticated secretion of parietal cell film inner proton pump, the mechanism of action is the same with omeprazole, also is the H by the excretory final tache of gastric acid inhibitory
+-K
+-ATP enzyme (proton pump) and playing a role.Because this product is a weakly basic drugs, former medicine activity is minimum, be transported to Gastric Mucosal Cells after being absorbed into blood, finally reach secretory duct and acid chamber, the PH at this place＜1, former medicine is by protonated back positively charged and constantly enrichment, and is converted to the sulfenic acids of biologically active and the medicine of sulfenic acids amine form under the catalysis of acid, this active medicine and H
+-K
+-ATP enzyme transporting mechanism and bring into play and suppress sour secretory action.Therefore lansoprazole fully the chemical mediator of blockage of acetylcholine, gastrin and histamine stimulate the gastric acid secretion that causes, have and press down acid and act on strongly and persistently.The disease that can effectively treat various types of peptic ulcers and be caused by sour hypersecretion, its effect is better than common bisfentidine, especially the intractable ulcer and the collagen ulcer of failing to respond to any medical treatment the latter is had better effects.Because this medicine is at the company that brings out a ulcer cause of disease---sour hypersecretion and H.P infect, so treatment ulcer is relatively rapider, effective and relapse rate is low.Be applicable to gastric ulcer, duodenal ulcer, erosive stomach-esophageal reflux disease, helicobacter pylori, Zollimger-ellison syndrome.Lansoprazole and phenylpropyl alcohol thiazolyl product thereof show very fast bactericidal activity, the easier formation of phenylpropyl alcohol thiazole in human stomach, thereby the bactericidal action of lansoprazole is strengthened, more than these effects all help the healing of peptic ulcer, add that lansoprazole has imported fluorine element on its structure, make that it absorbs rapidly, bioavailability is high, thus can very fast relief of symptoms, the quickening ulcer healing.
Lansoprazole is insoluble in water, and is unstable under acidic condition, destroyed easily in gastric acid, make tablet or capsule oral absorb slow and bioavailability lower, stability is also very poor.The main dosage form of lansoprazole product has Lansoprazole enteric-coated tablet and lansoprazole intestine dissolving capsule at present, but these dosage forms and the patient who is not suitable for child, old people and dysphagia use, so it is important developing a kind of lansoprazole novel form that is fit to these patients' uses, also possesses very strong practicality.
Summary of the invention
The object of the present invention is to provide that a kind of compliance is good, steady quality, rapid-action, Lansoprazole intestine dry suspension that bioavailability is high so that the patient of child, old man and dysphagia uses.
In order to realize the foregoing invention purpose, the present invention adopts following technical scheme:
A kind of Lansoprazole intestine dry suspension comprises lansoprazole micropill or granule 15%～50%, suspending agent 1%～10%, correctives 50%～85%, and described percentage ratio is weight percentage.
Described lansoprazole micropill or granule comprise pharmaceutically active layer, sealing coat, enteric layer, wherein the pharmaceutically active layer accounts for 30%～60% of micropill or particle weight, sealing coat accounts for 15%～30% of micropill or particle weight, and enteric layer accounts for 15%～30% of micropill or particle weight.
Described pharmaceutically active layer comprises lansoprazole, filler, surfactant, disintegrating agent and binding agent.
Described pharmaceutically active layer can also comprise stabilizing agent, surfactant, and wherein stabilizing agent is selected from magnesium carbonate or calcium carbonate; Surfactant can be selected from sodium lauryl sulphate or Tween 80.
Described sealing coat coating material is one or more mixing in starch, pregelatinized Starch, lactose, sucrose, microcrystalline Cellulose, mannitol, hydroxypropyl cellulose, L-HPC, hydroxypropyl methylcellulose, methylcellulose, carboxymethyl cellulose, the ethyl cellulose.
Described enteric layer coating material is one or more mixing in acrylic resin, hydroxypropyl methylcellulose acetic acid succinate (HPMCPCAS), hydroxypropyl methylcellulose dimethyl phthalate (HPMCP), the cellulose acetate dimethyl phthalate (CAP).
Described enteric layer can also contain other adjuvants such as starch, sucrose, Pulvis Talci, Polyethylene Glycol, magnesium stearate, micropowder silica gel, titanium dioxide, certain herbaceous plants with big flowers two dibutyl phthalates, triethyl citrate, stearic acid, glyceryl monostearate, diethyl phthalate etc.
Described suspending agent is one or more mixing in xanthan gum, carrageenan, arabic gum, gelatin, sodium carboxymethyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvidone, pectin, guar gum, sodium alginate, the carboxymethyl cellulose.
Described correctives is one or more mixing in sucrose, vine, Mel, aspartame, egg albumen powder, xylitol, mannitol, lactose, sorbitol, maltose alcohol, glycyrrhizin, citric acid, sodium citrate, flavoring banana essence, flavoring pineapple essence, orange flavor essence, Herba Menthae essence, Fructus Citri Limoniae essence, peach essence, Fructus Crataegi essence, blue berry essence, the rose essence.
The prescription of 1000 bags of enteric dry suspension of preparation is: lansoprazole 30g, sucrose ball core 110g, magnesium carbonate 22.4g, sucrose 1000g, starch 36.4g, HPC 1.4g, L-HPC 40g, acrylic resin aqueous dispersion 148.7g, titanium dioxide 4.4g, Tween 80 2.0g, Pulvis Talci 13.4g, polyethylene glycol 6000 4.4g, xanthan gum 18.75g, micropowder silica gel 22.5g, Herba Menthae essence 15g.
The prescription of 1000 bags of enteric dry suspension of preparation is: lansoprazole 30g, magnesium carbonate 22.4g, sucrose 1060g, starch 86g, HPMC 1.4g, L-HPC 40g, acrylic resin aqueous dispersion 148.4g, titanium dioxide 4.4g, Tween 80 2.0g, Pulvis Talci 13.4g, xanthan gum 18.75g, micropowder silica gel 22.5g, orange flavor essence 15g.
A kind of preparation method of Lansoprazole intestine dry suspension, this preparation method comprises the steps:
(1) preparation lansoprazole pastille micropill or granule;
(2) bag sealing coat;
(3) bag enteric layer;
(4) be mixed with and obtain the Lansoprazole intestine dry suspension with the residue adjuvant.
The Lansoprazole intestine dry suspension steady quality that the present invention obtains, rapid-action, suspendible is effective, bioavailability is high, makes things convenient for the patient of old people, child and dysphagia to use.
The specific embodiment
Embodiment 1: 1000 bags of Lansoprazole intestine dry suspension of present embodiment preparation, adopt following prescription:
Lansoprazole 30g sucrose ball core 110g
Magnesium carbonate 22.4g sucrose 1000g
Starch 36.4g Tween 80 2.0g
HPC 1.4g acrylic resin aqueous dispersion 148.7g
L-HPC 40g titanium dioxide 4.4g
Pulvis Talci 13.4g polyethylene glycol 6000 4.4g
Xanthan gum 18.75g micropowder silica gel 22.5g
Herba Menthae essence 15g
Preparation technology:
(1), the lansoprazole of recipe quantity and sucrose, starch, magnesium carbonate, the Tween 80 of recipe quantity 4% 120 mesh sieve mix homogeneously excessively, standby; Preparation 2%HPC solution for standby; Sucrose ball core is placed centrifugal granulator, adds medicine to as binding agent with above-mentioned 2%HPC solution, the medicine-feeding finish after in 40 ℃ of oven dryings;
(2) above-mentioned dried lansoprazole micropill is placed centrifugal granulator, with 2%HPC solution bag sealing coat, coating is finished and is placed on 40 ℃ of oven dryings;
(3) with dried micropill, place centrifugal granulator,, add titanium dioxide and polyethylene glycol 6000 in the acrylic resin aqueous dispersion coating solution with acrylic resin aqueous dispersion coating solution coating, after coating was finished, taking-up placed 40 ℃ of oven dryings to obtain the Lansoprazole intestine micropill;
(4) will remain sucrose and cross 30 mesh sieve granulate, get sucrose granules with 70% alcohol granulation, dry back;
(5) with Lansoprazole intestine micropill and sucrose granules, xanthan gum mix homogeneously, again with micropowder silica gel, Herba Menthae essence mix homogeneously promptly.
The Lansoprazole intestine dry suspension that present embodiment makes has steady quality, rapid-action, advantage such as suspendible is effective.
Embodiment 2: 1000 bags of Lansoprazole intestine dry suspension of present embodiment preparation, adopt following prescription:
Lansoprazole 30g magnesium carbonate 22.4g
Sucrose 1060g
Starch 86.4g Tween 80 2.0g
HPMC 1.4g acrylic resin aqueous dispersion 148.7g
L-HPC 40g titanium dioxide 4.4g
Pulvis Talci 13.4g xanthan gum 18.75g
Micropowder silica gel 22.5g orange flavor essence 15g
Preparation technology:
(1), the lansoprazole of recipe quantity and sucrose, starch, magnesium carbonate, the Tween 80 of recipe quantity 3.5% 120 mesh sieve mix homogeneously excessively, standby; Preparation 2%HPC solution is granulated, and places 40 ℃ of oven dryings;
(2) above-mentioned dried lansoprazole micropill is placed centrifugal granulator, with 2%HPMC solution bag sealing coat, coating is finished and is placed on 40 ℃ of oven dryings;
(3) with dried micropill, place centrifugal granulator, with acrylic resin aqueous dispersion coating solution coating, add titanium dioxide in the acrylic resin aqueous dispersion coating solution, after coating was finished, taking-up placed 40 ℃ of oven dryings to obtain the Lansoprazole intestine micropill;
(4) will remain sucrose and cross 30 mesh sieve granulate, get sucrose granules with 70% alcohol granulation, dry back;
(5) with Lansoprazole intestine micropill and sucrose granules, xanthan gum mix homogeneously, again with micropowder silica gel, orange flavor essence mix homogeneously promptly.
Embodiment 3: 1000 bags of Lansoprazole intestine dry suspension of present embodiment preparation, adopt following prescription:
Lansoprazole 40g calcium carbonate 22.4g
Sucrose 1000g microcrystalline Cellulose ball core 100g
Starch 75g Tween 80 1.6g
HPMC 1.8g HPMCPCAS 156g
L-HPC 35g titanium dioxide 5g
Pulvis Talci 14g sodium carboxymethyl cellulose 22g
Micropowder silica gel 20g orange flavor essence 13g
Preparation technology:
(1), the lansoprazole of recipe quantity and sucrose, starch, calcium carbonate, the Tween 80 of recipe quantity 3.5% 120 mesh sieve mix homogeneously excessively, standby; Preparation 2%HPC solution for standby; Microcrystalline Cellulose ball core is placed centrifugal granulator, adds medicine to as binding agent with above-mentioned 2%HPC solution, the medicine-feeding finish after in 40 ℃ of oven dryings;
(2) above-mentioned dried lansoprazole micropill is placed centrifugal granulator, with 2%HPMC solution bag sealing coat, coating is finished and is placed on 40 ℃ of oven dryings;
(3) with dried micropill, place centrifugal granulator, with HPMCPCAS coating solution coating, add titanium dioxide in the HPMCPCAS coating solution, after coating was finished, taking-up placed 40 ℃ of oven dryings to obtain the Lansoprazole intestine micropill;
(4) will remain sucrose and cross 30 mesh sieve granulate, get sucrose granules with 70% alcohol granulation, dry back;
(5) with Lansoprazole intestine micropill and sucrose granules, sodium carboxymethyl cellulose mix homogeneously, again with micropowder silica gel, orange flavor essence mix homogeneously promptly.
Claims (10)
1. a Lansoprazole intestine dry suspension is characterized in that comprising lansoprazole micropill or granule 15%～50%, suspending agent 1%～10%, correctives 50%～85%, and described percentage ratio is weight percentage.
2. a kind of Lansoprazole intestine dry suspension according to claim 1, it is characterized in that described lansoprazole micropill or granule comprise pharmaceutically active layer, sealing coat, enteric layer, wherein the pharmaceutically active layer accounts for 30%～60% of micropill or particle weight, sealing coat accounts for 15%～30% of micropill or particle weight, and enteric layer accounts for 15%～30% of micropill or particle weight.
3. a kind of Lansoprazole intestine dry suspension according to claim 2 is characterized in that described pharmaceutically active layer comprises lansoprazole, filler, surfactant, disintegrating agent and binding agent.
4. a kind of Lansoprazole intestine dry suspension according to claim 2 is characterized in that described sealing coat coating material is one or more mixing in starch, pregelatinized Starch, lactose, sucrose, microcrystalline Cellulose, mannitol, hydroxypropyl cellulose, L-HPC, hydroxypropyl methylcellulose, methylcellulose, carboxymethyl cellulose, the ethyl cellulose.
5. a kind of Lansoprazole intestine dry suspension according to claim 2 is characterized in that described enteric layer coating material is one or more mixing in acrylic resin, hydroxypropyl methylcellulose acetic acid succinate (HPMCPCAS), hydroxypropyl methylcellulose dimethyl phthalate (HPMCP), the cellulose acetate dimethyl phthalate (CAP).
6. a kind of omeprazole enteric-coated dry suspension according to claim 1 is characterized in that described suspending agent is one or more mixing in xanthan gum, carrageenan, arabic gum, gelatin, sodium carboxymethyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvidone, pectin, guar gum, sodium alginate, the carboxymethyl cellulose.
7. a kind of Lansoprazole intestine dry suspension according to claim 1 is characterized in that described correctives is one or more mixing in sucrose, vine, Mel, aspartame, egg albumen powder, xylitol, mannitol, lactose, sorbitol, maltose alcohol, glycyrrhizin, citric acid, sodium citrate, flavoring banana essence, flavoring pineapple essence, orange flavor essence, Herba Menthae essence, Fructus Citri Limoniae essence, peach essence, Fructus Crataegi essence, blue berry essence, the rose essence.
8. a kind of Lansoprazole intestine dry suspension according to claim 1 is characterized in that the prescription for preparing 1000 bags of enteric dry suspension is: lansoprazole 30g, sucrose ball core 110g, magnesium carbonate 22.4g, sucrose 1000g, starch 36.4g, HPC 1.4g, L-HPC 40g, acrylic resin aqueous dispersion 148.7g, titanium dioxide 4.4g, Tween 80 2.0g, Pulvis Talci 13.4g, polyethylene glycol 6000 4.4g, xanthan gum 18.75g, micropowder silica gel 22.5g, Herba Menthae essence 15g.
9. a kind of Lansoprazole intestine dry suspension according to claim 1 is characterized in that the prescription for preparing 1000 bags of enteric dry suspension is: lansoprazole 30g, magnesium carbonate 22.4g, sucrose 1060g, starch 86g, HPMC 1.4g, L-HPC 40g, acrylic resin aqueous dispersion 148.4g, titanium dioxide 4.4g, Tween 80 2.0g, Pulvis Talci 13.4g, xanthan gum 18.75g, micropowder silica gel 22.5g, orange flavor essence 15g.
10. according to the preparation method of the described a kind of Lansoprazole intestine dry suspension of claim 1～9, it is characterized in that this preparation method comprises the steps:
(1) preparation lansoprazole pastille micropill or granule;
(2) bag sealing coat;
(3) bag enteric layer;
(4) be mixed with and obtain the Lansoprazole intestine dry suspension with the residue adjuvant.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009101009549A CN101991542A (en) | 2009-08-10 | 2009-08-10 | Lansoprazole enteric dry suspension and preparation method thereof |
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|---|---|---|---|
| CN2009101009549A CN101991542A (en) | 2009-08-10 | 2009-08-10 | Lansoprazole enteric dry suspension and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479583A (en) * | 2013-09-17 | 2014-01-01 | 司鹏 | Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof |
| CN107802613A (en) * | 2017-11-13 | 2018-03-16 | 郑州大学 | Micro-nano dry suspensoid agent of a kind of taste masking enteron aisle quick-releasing type Tilmicosin and preparation method thereof |
| CN108201527A (en) * | 2016-12-16 | 2018-06-26 | 广州共禾医药科技有限公司 | A kind of slow-release dry suspension comprising proton pump inhibitor and preparation method thereof |
| CN109125282A (en) * | 2018-09-05 | 2019-01-04 | 珠海润都制药股份有限公司 | A kind of omeprazole enteric-coated capsules and preparation method thereof |
| CN111388425A (en) * | 2020-04-22 | 2020-07-10 | 广东一力罗定制药有限公司 | Omeprazole dry suspension and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103479583A (en) * | 2013-09-17 | 2014-01-01 | 司鹏 | Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof |
| CN103479583B (en) * | 2013-09-17 | 2015-02-11 | 司鹏 | Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof |
| CN108201527A (en) * | 2016-12-16 | 2018-06-26 | 广州共禾医药科技有限公司 | A kind of slow-release dry suspension comprising proton pump inhibitor and preparation method thereof |
| CN107802613A (en) * | 2017-11-13 | 2018-03-16 | 郑州大学 | Micro-nano dry suspensoid agent of a kind of taste masking enteron aisle quick-releasing type Tilmicosin and preparation method thereof |
| CN107802613B (en) * | 2017-11-13 | 2020-01-31 | 郑州大学 | taste-masking intestinal immediate-release tilmicosin micro-nano dry suspension and preparation method thereof |
| CN109125282A (en) * | 2018-09-05 | 2019-01-04 | 珠海润都制药股份有限公司 | A kind of omeprazole enteric-coated capsules and preparation method thereof |
| CN111388425A (en) * | 2020-04-22 | 2020-07-10 | 广东一力罗定制药有限公司 | Omeprazole dry suspension and preparation method thereof |
| CN111388425B (en) * | 2020-04-22 | 2020-12-08 | 一力制药(罗定)有限公司 | Omeprazole dry suspension and preparation method thereof |
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Application publication date: 20110330 |