CN106860411A - A kind of new pharmaceutical preparation colloidal bismmth pectin piece - Google Patents
A kind of new pharmaceutical preparation colloidal bismmth pectin piece Download PDFInfo
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- CN106860411A CN106860411A CN201510916899.6A CN201510916899A CN106860411A CN 106860411 A CN106860411 A CN 106860411A CN 201510916899 A CN201510916899 A CN 201510916899A CN 106860411 A CN106860411 A CN 106860411A
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- Prior art keywords
- colloidal bismmth
- bismmth pectin
- pharmaceutical preparation
- piece
- pectin
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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
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/245—Bismuth; Compounds thereof
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
-
- 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
- A61K9/2063—Proteins, e.g. gelatin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of new pharmaceutical preparation colloidal bismmth pectin piece.Patent of invention medicine Couoidal bismuth pectin capsules (colloidal bismuth petin) finds that the pharmaceutical preparation has water sorption to hollow capsule and pill and causes capsule friability, rupture, dew powder in prolonged application, and there are problems that disintegration time is long, dissolution rate is slow, dissolution rate is low, stability is poor, the term of validity is short, do not adapt to more extensive crowd's medication.Colloidal bismmth pectin piece of the invention has filled up the blank of colloid pectin tablet; both safety and effectiveness of the capsule to gastrointestinal disease had been remained; the above-mentioned many weak points of capsule are compensate for again; compare with capsule; with disintegration time it is short, dissolution rate is fast, dissolution rate is high, good stability, the term of validity is long, adaptation population is wide the features such as; not only had mucosa again with eliminating pylorus effect, be a new pharmaceutical preparation for the treatment of gastrointestinal disease more safely and effectively colloidal bismmth pectin.
Description
Technical field
The present invention relates to a kind of new colloidal bismmth pectin pharmaceutical preparation-colloidal bismmth pectin piece.Belong to pharmaceutical preparation to possess and control.
Technical background
Gastrointestinal disease is a kind of clinically multiple, common disease, incidence (more than 40%) high, it is refractory more, the disease of easily recurrence；Particular it should be noted that helicobacter pylori correlation ulcer is a class having the disease for causing the atrophy of scorching film, intestinal metaplasia and cAMP content.Traditional gastrointestinal disease life Neo-Confucianism thinks：" no hydrochloric acid in gastric juice is no ulcer ", the medicine for producing therefrom has antiacid, (alkaline drug such as sodium acid carbonate, aluminium hydroxide), acid inhibitor (proton pump inhibitor and H2- acceptor knot anti-agent), such as Omeprazole (PPI), ranitidine；Mucosa protective agent, such as ulcerlmin, gel aluminum hydroxide and colloid bismuth preparation.After being the pathogenic bacteria of gastrointestinal disease from Australian Scientists Barry Marshalls, sieve guest Warrens discovery helicobacter pylori (Hp), the pathogenic theory of bacterium is generated.Under this theoretical direction, antibiotic turns into the mushroom medicine for the treatment of gastrointestinal disease, but find in the treatment, helicobacter pylori (Hp) produces serious drug resistance to most antibiotic, therefore bigeminy therapy, the triple therapy of antibiotic and acid inhibitor use in conjunction are occurred in that, once the eradication therapy in helicobacter pylori (Hp) was to have sent out important function, with the triple therapy popularity application of antibiotic and acid inhibitor, the case of Endodontic failure is more and more, its reason is that Hp declines to the sensitiveness of most antibiotic, a large amount of generations of drug-fast bacteria and superbacteria；Two is that acid inhibitor is largely used for a long time, raises stomach acid pH, causes mucosal atrophy, intestinal metaplasia and canceration.To have made up the deficiency of the triple therapy based on antibiotic, acid inhibitor, quadruple chemotherapy based on bismuth salt compounds and colloid bismuth preparation or as external treatment and a medicine.Colloidal bismmth pectin and capsule are China scientist research and development successfully patent of invention product (patents of invention number with independent intellectual property right：ZL92114663.9, patentee and inventor：Medicine Inst. of Datong City is quick in learning).Colloidal bismmth pectin is used for the bismuth salt compounds and colloid bismuth preparation that macromolecular acid group (colloidal bismuth pectin acid group) replaces the small molecular organic acid such as the inorganic acid radical and citric acid radical roots such as external nitroxylic acid root, meta-aluminic acid root to prepare.Bismuth subnitrate and metabismuthic acid bismuth represent medicine as bisuc stomach tablet and readily take the opportunity to stomach; it is coarse dispersion system because its is water insoluble; colloid property is poor; stand and produce precipitation; mucosa is not obvious, and the medicine that represents of CBS is (CBS) de-nal or DELE CHONGJI (domestic imitation patent medicine), is water soluble compound; bismuth ion is produced in water, is had and is absorbed into the possibility that blood circulation produces toxicity.Colloidal bismmth pectin have it is good it is viscous tell characteristic, have repeated attraction function with gastrointestinal mucosa is damaged, isolate hydrochloric acid in gastric juice, and stimulate mucomembranous epithelial cell to produce mucus, strengthen protective effect；Particularly it plays the role of stronger killing helicobacter pylori, and its effect is neither influenceed by Gastric pH, and Hp kills Hp by not producing drug resistance, 4 μ g/ml concentration again to it, as treatment gastrointestinal disease, the safe and effective medicine of eliminating pylorus.But capsule preparations find that its disintegration time is long, dissolution rate is slow, dissolution rate is relatively low, the performance property of medicine is slow, stability is poor, the term of validity is short, capsule easily becomes fragile, leak powder, be not suitable with the deficiencies such as more many people's medication custom, dosage are big, times for spraying is more in the application.A kind of purpose of the new pharmaceutical preparation-colloidal bismmth pectin piece of colloidal bismmth pectin of the present invention compares short with disintegration time for clinic provides one with capsule, dissolution rate is fast, dissolution rate is high, drug effect plays a role quickly, it is long in the gastrointestinal retentiveness time, good stability, new colloid pectin bismuth preparation-colloidal bismmth pectin the piece of the features such as term of validity is long, for vast gastrointestinal disease patient provide one it is new more safe and effective, adapt to more extensive medication crowd demand's, it is high to helicobacter pylori eradication rate, it is high to gastrointestinal disease cure rate, recurrence rate is low, the mucosal atrophy caused to helicobacter pylori resistant, the new colloid bismuth preparation of intestinal metaplasia and the occurrence and development of canceration.
Specific embodiment
The specific embodiment hereinafter invented and to upper example, one or more the embodiment modes being merely to illustrate and explain the present invention are not used in the limit scope that invention claim is not limited.
Embodiment 1, prescription constitutes (160,000)：Colloidal bismmth pectin bulk drug (content in terms of bismuth 15%) 33.33kg, SCMC 0.5kg, CPVC 0.5kg, Celluloasun Microcrystallisatum 0.9kg, CMC-Na 0.9kg, Chitin 1.2kg, magnesium trisilicate 1.01kg, sodium glycine carbonate 0.9kg, hard paraffin 0.9kg.Above-mentioned material is crushed, mixed 100 mesh sieves, with purified water and ethanol as solvent or diluent, spray-drying process or be made softwood, granulation, drying, additional hard paraffin mixed pressuring plate.
Embodiment 2, prescription constitutes (160,000)：Colloidal bismmth pectin bulk drug (content in terms of bismuth 15%) 33.33kg, SCMC 0.9kg, CPVC 0.9kg, Celluloasun Microcrystallisatum 0.9kg, CMC-Na 0.9kg, amylase 0.5kg, crush, sieve, are well mixed dry method direct tablet compressing.
Embodiment 3, prescription constitutes (160,000)：Colloidal bismmth pectin bulk drug (content in terms of bismuth 15%) 33.33kg, SCMC 0.9kg, CPVC 0.9kg, Celluloasun Microcrystallisatum 2.5kg, Chitin 1.2kg, magnesium trisilicate 1.01kg, wet method or compressing dry granulation, with CMC-Na 2kg, PEF acetaldehyde ethylamino acetate 1.0kg, it is coated with 15% ethanol solution, airing, relieving haperacidity film-coating or sustained release tablets.
Embodiment 4, (comparative example) prescription composition (160,000) colloidal bismmth pectin bulk drug (content using in terms of bismuth 15%) 33.33kg, 16.66kg starch granules crush, cross 100 mesh sieves, mixing is made softwood, granulation, dry with 20% gelatinized corn starch or dextrinated paste as adhesive, and additional 0.2kg magnesium stearates are well mixed, load hollow capsule and pill.
A kind of comparative experimental research of new colloidal bismmth pectin pharmaceutical preparation-colloidal bismmth pectin piece and Couoidal bismuth pectin capsules
More than contrast number peace tablet disintegration time, dissolution rate, dissolution rate, dosage/day, medicament play EDD, in intestines and stomach retention time, Hp eradication rates, treatment total effective rate, be applicable the aspects such as crowd accounting and be superior to contrast medicine (capsule).
Claims (8)
1. the invention provides a kind of new pharmaceutical preparation of colloidal bismmth pectin-colloidal bismmth pectin piece.
2. a kind of new colloidal bismmth pectin pharmaceutical preparation-colloidal bismmth pectin piece described in claim 1, wraps
Include the medicinal tablets such as normal molten, Film coated tablets, sugar coated tablet, effervescent tablet, dispersible tablet, sustained release tablets.
3. described in claims 1-2, a kind of new colloidal bismmth pectin pharmaceutical preparation-colloidal bismmth pectin
Piece, compare with capsule with disintegration time it is short, dissolution rate is fast, dissolution rate is high, in gastrointestinal retentiveness
Time is long, good stability, the term of validity is long, adapt to the remarkable advantage of more extensive crowd's medication custom.
4. the new pharmaceutical preparation of a kind of colloidal bismmth pectin described in claim 1-3-colloidal bismmth pectin piece,
The best composite auxiliary material of performance and more advanced preparation method, breach with traditional auxiliary material and method without
Forbidden zone prepared by the colloidal bismmth pectin piece that method is realized, with novelty, advance, applicability, not only will
With colloid property, be difficult to prepare tablet colloidal bismmth pectin bulk drug be successfully made be adapted to it is clinical should
New pharmaceutical preparation, and said preparation overcomes many weak points of capsule, and custom is met again
Use the medication demand of tablet crowd.
5. the new pharmaceutical preparation of a kind of colloidal bismmth pectin described in claim 1-4-colloidal bismmth pectin piece,
Pharmaceutically acceptable auxiliary material used be the disintegrant, adhesive that following performance is good, price is high, consumption is few,
Mixing in the auxiliary materials such as stabilizer, effervescent agent, sustained release agent, lubricant, suspending agent from more than one is auxiliary
Material is respectively prepared often that to release piece, sustained release tablets, dispersible tablet, effervescent tablet, thin membrane coated tablet, sugar coated tablet etc. various
Different tablets.
6. pharmaceutic adjuvant described in claim 1-6, preferably SCMC (disintegrant), CPVP (disintegrations
Agent), MSC (disintegrant), Chitin (silk ribbon attached to an official seal or a medal releases agent), white bole (suspending agent), CMC-Na it is (steady
Determine agent), amylase (disintegrant), glycosides propylhomoserin sodium carbonate (effervescent agent), magnesium trisilicate (antiplastering aid),
Hard paraffin (lubricant), PEF acetal diethylin acetate (coating material), microcrystalline cellulose
(adhesive), potassium dihydrogen phosphate (effervescent agent) etc..
7. a kind of preparation of colloidal bismmth pectin pharmaceutical preparation-colloidal bismmth pectin piece described in claim 1-6
Method is, after adding adhesive slurrying, spray-drying process after dry powder blend, additional lubricant, bonding
Agent, antiplastering aid compressing tablet or main ingredient mix direct compressing dry granulation with whole supplementary material, wherein：Film coated tablets, silk ribbon attached to an official seal or a medal
Release that coating tablets technology is more novel, advanced, practicality.
8. the new pharmaceutical preparation of a kind of colloidal bismmth pectin described in claim 1-7-colloidal bismmth pectin piece,
Can be used for treat gastric ulcer, duodenal bulbar ulcer, CEG, atrophic gastritis,
The particularly treatment of helicobacter pylori correlation ulcer, can be with proton pump inhibitor, H2- acceptor knot resists
Agent and the Antibiotic combination eradication therapy of helicobacter pylori, it is more for antibiotic and acid inhibitor three
Rescue therapy after connection therapy failure, therapeutic effect and disintegration time, dissolution rate, dissolution rate, stabilization
Property, the term of validity, drug effect play the time, medicine the gastrointestinal retentiveness time, effect (property) valency than etc. be better than
Couoidal bismuth pectin capsules, clinically incidence is high, healing rate is low, the pylorus of easy recurrence for treatment for the present invention
The eradication therapy of pylori correlation gastrointestinal disease, there is provided a safely and effectively new pharmaceutical preparation,
It was found that the new pharmaceutical preparation has resistance problems of the helicobacter pylori to antibiotic, it is also easy without acid inhibitor
Cause the side effects such as mucosal atrophy.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510916899.6A CN106860411A (en) | 2015-12-14 | 2015-12-14 | A kind of new pharmaceutical preparation colloidal bismmth pectin piece |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510916899.6A CN106860411A (en) | 2015-12-14 | 2015-12-14 | A kind of new pharmaceutical preparation colloidal bismmth pectin piece |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106860411A true CN106860411A (en) | 2017-06-20 |
Family
ID=59177031
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510916899.6A Pending CN106860411A (en) | 2015-12-14 | 2015-12-14 | A kind of new pharmaceutical preparation colloidal bismmth pectin piece |
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| Country | Link |
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| CN (1) | CN106860411A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114129532A (en) * | 2021-12-10 | 2022-03-04 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634132A (en) * | 2003-12-29 | 2005-07-06 | 湖南华纳大药厂有限公司 | Dispersible tablet of colloid petcin |
| CN104147041A (en) * | 2014-08-17 | 2014-11-19 | 山西振东安特生物制药有限公司 | Dispersion preparation containing colloidal bismuth pectin and preparation method thereof |
-
2015
- 2015-12-14 CN CN201510916899.6A patent/CN106860411A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634132A (en) * | 2003-12-29 | 2005-07-06 | 湖南华纳大药厂有限公司 | Dispersible tablet of colloid petcin |
| CN104147041A (en) * | 2014-08-17 | 2014-11-19 | 山西振东安特生物制药有限公司 | Dispersion preparation containing colloidal bismuth pectin and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 崔晓彪等: "胶体果胶铋泡腾片生产工艺改进", 《北方药学》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114129532A (en) * | 2021-12-10 | 2022-03-04 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
| CN114129532B (en) * | 2021-12-10 | 2023-09-19 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
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Application publication date: 20170620 |
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