CN109432028A - A kind of preparation method of Hericium erinaceus gastric floating tablet - Google Patents
A kind of preparation method of Hericium erinaceus gastric floating tablet Download PDFInfo
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- CN109432028A CN109432028A CN201811451128.4A CN201811451128A CN109432028A CN 109432028 A CN109432028 A CN 109432028A CN 201811451128 A CN201811451128 A CN 201811451128A CN 109432028 A CN109432028 A CN 109432028A
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- hericium erinaceus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
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- 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
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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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Abstract
The present invention relates to a kind of preparation methods of Hericium erinaceus gastric floating tablet, this method includes that above-mentioned supplementary material is mixed according to a certain percentage, obtain uniformly mixed material, mixed material is put into tablet press machine, compression force is adjusted, makes the obtained tablet hardness of compacting between 45N~55N, gained tablet is fitted into bottle or aluminum-plastic blister, packaged product mounted box, qualified vanning detection is finished product.Tablets can quickly rise in the gastric juice of different acidity to float, and the flotation time is longer.It can overcome the problems, such as that conventional oral medicament is limited by gastric emptying physiological property using the technology of the present invention, Hericium erinaceus or hedgehog fungus extract long period is set to rest on stomach, it is come into full contact with the parietal cell of pharmacological action target spot, Hericium erinaceus or hedgehog fungus extract, which can be obviously improved, improves the drug effect of chronic gastritis and gastric ulcer, reduces drug resource waste.
Description
Technical field
The present invention relates to medical field more particularly to a kind of preparation methods of Hericium erinaceus gastric floating tablet.
Background technique
Medicament made of Hericium erinaceus and hedgehog fungus extract at present, is the effective of the disease of stomach such as common gastritis and gastric ulcer
Oral drugs are treated, most of these preparations are common normal release dosage forms, in this action target spot position residence time of stomach
It is extremely limited, takes orally substantially by gastric emptying in 1 hour, drug effect fails to play completely, leads to Hericium erinaceus and hedgehog fungus extract
Manufactured medicament clinical treatment effect is limited.
Hericium erinaceus and hedgehog fungus extract have therapeutic effect to chronic gastritis, gastric ulcer, and modern scientific research discovery is main
It is that Hericium erinaceus Polysaccharides ingredient directly acts on parietal cell, improves chronic gastritis and gastric ulcer by removing the approach such as free radical；
But Hericium erinaceus Polysaccharides need the regular hour to parietal cell generation effect, when extending contact of the Hericium erinaceus Polysaccharides with parietal cell
Between, be conducive to the pharmacological effect for improving Hericium erinaceus Polysaccharides.Existing technical solution, it is most of for Hericium erinaceus conventional tablet, capsule,
Granule etc. develops Hericium erinaceus or hedgehog fungus extract for sustained release preparation although having, such as sustained release tablets, spansule, not
The time of contact of this pharmacological action target spot of energy significantly increasing medicament Yu stomach.Main cause is the gastric emptying time of most people
About between 30 minutes to 60 minutes, existing oral preparation can all be influenced by gastric emptying, can only be stopped after oral in stomach
It stays 30 minutes to 60 minutes, just by gastric emptying to enteron aisle, is disengaged with stomach.
Research and utilization auxiliary material adhesive characteristics attempt to extend Hericium erinaceus in the residence time of stomach at present, but due to chronic gastritis
Or patients w ith peptic ulcer disease gastric mucosa physicochemical property individual difference is larger, the adhesion strength of pharmaceutical adjunct is limited, leads to the suitable of adhesion preparation
It is poor with property, and be difficult to monitor the performance and quality of preparation by way of in-vitro simulated test.
Summary of the invention
To solve the above-mentioned problems, the present invention provides a kind of preparation method of Hericium erinaceus gastric floating tablet, this method comprises:
A, supplementary material: using Hericium erinaceus or Hericium erinaceus water extract-alcohol precipitation extract as raw material, auxiliary material uses hydroxypropyl methyl fiber
Element, hydroxypropyl methyl cellulose, foaming agent sodium bicarbonate, pore-foaming agent povidone, magnesium stearate lubricant；
B, mix: above-mentioned supplementary material is mixed according to a certain percentage, obtains uniformly mixed material；
C, tabletting: mixed material is put into tablet press machine, adjusts compression force, and the tablet hardness for obtaining compacting exists
Between 45N~55N, weight differential meet 2015 version " Chinese Pharmacopoeia " regulation；
D, it packs: gained tablet is fitted into bottle or aluminum-plastic blister；
E, finished product: packaged product mounted box, qualified vanning detection is finished product.
Preferably, the hydroxypropyl methyl cellulose gauge is K4M.
Preferably, the propyl methocel gauge is E5.
Preferably, the pore-foaming agent povidone gauge is k30.
Tablets can quickly rise in the gastric juice of different acidity to float, and the flotation time is longer.Using the technology of the present invention
It can overcome the problems, such as that conventional oral medicament is limited by gastric emptying physiological property, keep Hericium erinaceus or hedgehog fungus extract longer
Time rests on stomach, comes into full contact with the parietal cell of pharmacological action target spot, can be obviously improved Hericium erinaceus or Hericium erinaceus mentions
It takes object to improve the drug effect of chronic gastritis and gastric ulcer, reduces drug resource waste.
Detailed description of the invention
Embodiment of the present invention is described below with reference to attached drawing, in which:
Fig. 1 is the flow chart according to the preparation method shown in embodiment of the present invention.
Specific embodiment
Embodiment of the present invention is described in detail below with reference to accompanying drawings.
Hardness detection method: using tablet hardness instrument, places a piece of in print slot, click " beginning " key every time, from
Dynamic measurement hardness simultaneously shows measurement result automatically.General rule is detected according to general tablet, needs to take 6 to measure at random, gained
Data calculate average value, as tablet hardness.
Act float time and flotation time detection method: by 2015 editions dissolution rates of Chinese Pharmacopoeia and release detection method third
Method is operated, and the hydrochloric acid solution of pH1.2 or the acetate buffer of pH4.0 is added in 250mL stripping rotor, as simulation people
Work gastric juice sets rotating speed of agitator as 50r/min.Print is put into stripping rotor, digestion instrument is started, sample is observed in self-clocking
Floating situation of the piece in stripping rotor, has recorded the time and flotation time floatd.
Dissolution rate: being operated by 2015 editions dissolution rates of Chinese Pharmacopoeia and release detection method third method, molten in 250mL
The hydrochloric acid solution of pH1.2 or the acetate buffer of pH4.0 is added in cup out, as simulation simulated gastric fluid, setting agitating paddle turns
Speed is 50r/min.Print is put into stripping rotor, digestion instrument is started, floating feelings of the print in stripping rotor are observed in self-clocking
Condition takes 5ml dissolution fluid as sample when floating terminal, handles sample using phend-sulphuric acid, and use uv-spectrophotometric
Meter method measures dissolution rate.
Embodiment 1: Hericium erinaceus water extract-alcohol precipitation extract 150g, hydroxypropyl methyl cellulose (gauge K4M) 100g, hydroxypropyl
Ylmethyl cellulose (gauge E5) 150g, sodium bicarbonate 40g, povidone (gauge k30) 10g, magnesium stearate 1g.Above-mentioned original
Auxiliary material after mixing, is put into tablet press machine, and adjusting compression force makes tablet hardness between 45N~55N, and weight differential is 5%
Within.Gained tablet is through detecting, average hardness 53.5N；It is 606 seconds that the time of floaing is acted in pH1.2 hydrochloric acid solution, always when floating
Between be 286 points, Hericium erinaceus Polysaccharides dissolution rate be 77.54% (floating terminal is to dissolve out terminal)；In pH4.0 acetate buffer solution
In to act the time of floaing be 715 seconds, total flotation time is 305 points, and Hericium erinaceus Polysaccharides dissolution rate be 75.36% (floating terminal is to dissolve out
Terminal).
Embodiment 2: Hericium erinaceus water extract-alcohol precipitation extract 150g, hydroxypropyl methyl cellulose (gauge K4M) 125g, hydroxypropyl
Ylmethyl cellulose (gauge E5) 125g, sodium bicarbonate 40g, povidone (gauge k30) 10g, magnesium stearate 1g.Above-mentioned original
Auxiliary material after mixing, is put into tablet press machine, and adjusting compression force makes tablet hardness between 45N~55N, and weight differential is 5%
Within.Gained tablet is through detecting, average hardness 52.3N；It is 430 seconds that the time of floaing is acted in pH1.2 hydrochloric acid solution, always when floating
Between be 307 points, Hericium erinaceus Polysaccharides dissolution rate be 80.74% (floating terminal is to dissolve out terminal)；In pH4.0 acetate buffer solution
In to act the time of floaing be 514 seconds, total flotation time is 330 points, and Hericium erinaceus Polysaccharides dissolution rate be 79.66% (floating terminal is to dissolve out
Terminal).
Embodiment 3: Hericium erinaceus water extract-alcohol precipitation extract 150g, hydroxypropyl methyl cellulose (gauge K4M) 150g, hydroxypropyl
Ylmethyl cellulose (gauge E5) 100g, sodium bicarbonate 40g, povidone (gauge k30) 10g, magnesium stearate 1g.Above-mentioned original
Auxiliary material after mixing, is put into tablet press machine, and adjusting compression force makes tablet hardness between 45N~55N, and weight differential is 5%
Within.Gained tablet is through detecting, average hardness 51.1N；It is 154 seconds that the time of floaing is acted in pH1.2 hydrochloric acid solution, always when floating
Between be 340 points, Hericium erinaceus Polysaccharides dissolution rate be 83.82% (floating terminal is to dissolve out terminal)；In pH4.0 acetate buffer solution
In to act the time of floaing be 245 seconds, total flotation time is 352 points, and Hericium erinaceus Polysaccharides dissolution rate be 82.14% (floating terminal is to dissolve out
Terminal).
Comparative example: commercially available heriacium tablet (authentication code: national drug standard Z36021056), in the hydrochloric acid solution of pH1.2
It is complete with being disintegrated at about 40 minutes for pH4.0 phosphate buffer, and cannot be floated completely in disintegrating procedue.
It is understood that although the present invention has been disclosed in the preferred embodiments as above, above-described embodiment not to
Limit the present invention.For any person skilled in the art, without departing from the scope of the technical proposal of the invention,
Many possible changes and modifications all are made to technical solution of the present invention using the technology contents of the disclosure above, or are revised as
With the equivalent embodiment of variation.Therefore, anything that does not depart from the technical scheme of the invention are right according to the technical essence of the invention
Any simple modifications, equivalents, and modifications made for any of the above embodiments still fall within the range of technical solution of the present invention protection
It is interior.
Claims (4)
1. a kind of preparation method of Hericium erinaceus gastric floating tablet, this method comprises:
A, supplementary material: using Hericium erinaceus or Hericium erinaceus water extract-alcohol precipitation extract as raw material, auxiliary material uses hydroxypropyl methyl cellulose, hydroxyl
Propyl methocel, foaming agent sodium bicarbonate, pore-foaming agent povidone, magnesium stearate lubricant；
B, mix: above-mentioned supplementary material is mixed, and uniformly mixed material is obtained；
C, tabletting: mixed material is put into tablet press machine, adjusts compression force, make the obtained tablet hardness of compacting 45N~
Between 55N, weight differential meet 2015 version " Chinese Pharmacopoeia " regulation；
D, it packs: gained tablet is fitted into bottle or aluminum-plastic blister；
E, finished product: packaged product mounted box, qualified vanning detection is finished product.
2. the preparation method of Hericium erinaceus gastric floating tablet according to claim 1, which is characterized in that the hydroxypropyl methyl is fine
Tieing up plain gauge is K4M.
3. the preparation method of Hericium erinaceus gastric floating tablet according to claim 1, which is characterized in that the hydroxypropyl methyl fiber
Plain gauge is E5.
4. the preparation method of Hericium erinaceus gastric floating tablet according to claim 1, which is characterized in that the pore-foaming agent povidone
Gauge is k30.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811451128.4A CN109432028A (en) | 2018-11-30 | 2018-11-30 | A kind of preparation method of Hericium erinaceus gastric floating tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811451128.4A CN109432028A (en) | 2018-11-30 | 2018-11-30 | A kind of preparation method of Hericium erinaceus gastric floating tablet |
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| CN109432028A true CN109432028A (en) | 2019-03-08 |
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| CN201811451128.4A Pending CN109432028A (en) | 2018-11-30 | 2018-11-30 | A kind of preparation method of Hericium erinaceus gastric floating tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110448535A (en) * | 2019-09-04 | 2019-11-15 | 湖南宇山玉月农业科技有限公司 | A kind of schizophyllum abamectin gastric floating tablet |
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| CN1947707A (en) * | 2006-09-14 | 2007-04-18 | 郑州三创释药技术有限公司 | Floated in staomach type slow-release tablets contg. berberine hydrochloide and its prepn. method |
| WO2012006100A2 (en) * | 2010-06-28 | 2012-01-12 | Stemtech International, Inc. | Methods and compositions for enhancing stem cell mobilization |
| CN102151304A (en) * | 2011-01-25 | 2011-08-17 | 四川省中医药科学院 | Gastric stasis system of total alkaloids of coptis and evodia rutaecarpa as well as preparation method and application thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110448535A (en) * | 2019-09-04 | 2019-11-15 | 湖南宇山玉月农业科技有限公司 | A kind of schizophyllum abamectin gastric floating tablet |
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Application publication date: 20190308 |
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