CN104382881A - Thiamphenicol enteric micropellet and preparation method thereof - Google Patents
Thiamphenicol enteric micropellet and preparation method thereof Download PDFInfo
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- CN104382881A CN104382881A CN201410666593.5A CN201410666593A CN104382881A CN 104382881 A CN104382881 A CN 104382881A CN 201410666593 A CN201410666593 A CN 201410666593A CN 104382881 A CN104382881 A CN 104382881A
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Abstract
The invention discloses a thiamphenicol enteric micropellet and a preparation method thereof. The thiamphenicol enteric micropellet is mainly prepared from an enteric premix coating agent, hydroxypropyl methylcellulose, cane sugar, talcum powder, purified water, thiamphenicol, blank pellet cores, filler, a lubricant and a binder. According to the enteric micropellet, of which an effective ingredient is thiamphenicol, disclosed by the invention, the micropellet is prepared through preparing a medicated micropellet from thiamphenicol, a proper amount of blank pellet core, a proper amount of filler, a proper amount of binder and a proper amount of lubricant and then coating the medicated micropellet with an isolating layer and an enteric coating layer, wherein thiamphenicol serves as a main ingredient. According to the thiamphenicol sustained-release enteric micropellet prepared by the method, the dosage form is novel, the release of a drug is stable, the controllability is good, the technical advantages are obvious compared with the tablets currently on the market, and the bioavailability is improved.
Description
Technical field
the present invention relates to a kind of pharmaceutical preparation, particularly relate to a kind of thiamphenicol enteric coated micropill and preparation method thereof.
Background technology
thiamphenicol is the congener of chloromycetin, antimicrobial spectrum and antibacterial action and chloromycetin similar, the effect of tool broad spectrum antimicrobial, comprises aerobic gram-negative bacteria and gram positive bacteria, anaerobe, rickettsiae, spirillum and chlamydiaceae.Thiamphenicol is to the bactericidal action of following antibacterial tool: hemophilus influenza, streptococcus pneumoniae and Neisseria meningitidis.Bacteriostasis only had to following antibacterial: the anaerobe such as staphylococcus aureus, micrococcus scarlatinae, Streptococcus viridans, B group Hemolytic streptococcus, escherichia coli, Klebsiella Pneumoniae, proteus mirabilis, Salmonella typhi, bacillus paratyphosus, Shigella, bacteroides fragilis.Following antibacterial is usually to chloramphenicol resistance: Pseudomonas aeruginosa, acinetobacter, Enterobacter, serratia marcesens, indole-positive Proteus, methicillin-resistant Staphylococci and Enterococcus.
current research shows, thiamphenicol to treatment difficulty, there is multiple Drug resistance, the multiple pathogens of crowd's susceptible has good therapeutical effect, has the isolated strains of drug resistance, atypical pathogens mycoplasma as former in lung and chlamydia etc. 3 comprising the VI SA bacterial strain of the streptococcus pneumoniae to penicillin tool drug resistance, staphylococcus aureus, great majority to methicillin.So thiamphenicol is the precious medicine with extensive antibacterial activity few in number really.
at present, it is low to there is drug release stablizing effect in the existing product on market, poor controllability, and bioavailability is low waits deficiency.
Summary of the invention
the object of this invention is to provide one, to have drug release stablizing effect high, and controllability is good, a kind of thiamphenicol enteric coated micropill that bioavailability is high.
in order to realize object of the present invention, the present invention is achieved by the following technical solutions: a kind of thiamphenicol enteric coated micropill, comprises enteric layer, sealing coat, pastille micropill; It is characterized in that: described enteric layer is wrapped in outside sealing coat, sealing coat is wrapped in outside pastille micropill; Described enteric layer comprises: enteric premix coating materials 178mg; Described sealing coat comprises: hypromellose 16-32mg, sucrose 3-20mg, Pulvis Talci 6-22mg, purified water 280-420mg; Described pastille micropill comprises: thiamphenicol 125mg, celphere 50mg, filler 28-90mg, lubricant 5-28mg, binding agent 5-6mg.
in described sealing coat, preferred weight proportion is: cellulose 24mg, sucrose 8mg, Pulvis Talci 10mg, purified water 350mg.
in described pastille micropill, preferred weight proportion is: thiamphenicol 125mg, celphere 50mg, filler 75mg, lubricant 25mg, binding agent 5mg.
its manufacture method comprises following operation:
1, purified water is used by binding agent to make the binder solution that concentration is 2%;
2, thiamphenicol raw material, filler, mix lubricant is even;
3, celphere is put into centrifugal pellet processing machine, spray with binding agent and by mixed powder slowly spread as wherein, after completing, fluid bed is dried;
4, hypromellose, sucrose, Pulvis Talci, purified water are configured to sealing coat coating materials;
5, fluidized bed coating agent will be put into containing pill, adjustment parameter, and adopt the sealing coat coating materials configured to carry out coating;
6, enteric premix coating materials and purified water are configured to enteric coating agents;
7, sealing coat pill is put into fluidized bed coating agent, adjustment parameter, adopt the enteric coating agents configured to carry out coating;
8, in the pill after coating being incapsulated.
the present invention relates to the enteric coated micropill that thiamphenicol is effective ingredient, described micropill is take thiamphenicol as main component, appropriate celphere, filler, binding agent, lubricant make pastille micropill, then wrap with sealing coat, enteric coat layer.Thiamphenicol enteric sustained-release pellet prepared by the present invention, dosage form is novel, and the release of medicine is steady, controllability good, has obvious technical advantage, improve bioavailability compared with the tablet that goes on the market.
the present invention is applicable to the sensitive organism infection such as respiratory tract, urinary tract, intestinal as caused in hemophilus influenza, escherichia coli, Salmonella etc.
first time clinical verification: the present invention is through two groups of clinical verifications, and wherein one group is that treatment group uses capsule of the present invention, every day uses once, within 7 days, be a course for the treatment of, another group contrast uses existing thiamphenicol tablet, every group selection outpatient 95 example, wherein man 45 example, female 50 example, measures 70 years old large age, minimal ages 25 years old, every day uses once, within 7 days, is a course for the treatment of, clinical manifestation is respiratory tract infection, urinary tract infection, gastroenteritis, table one is for taking the contrasting data after the course for the treatment of:
table 1 is taken front and back and is compared (unit: people) two groups of courses for the treatment of
there were significant differences for treatment group and matched group, thus can find out that the present invention's application clinically has significant curative effect.
second time clinical verification: two groups of patients all give heat-clearing and toxic substances removing Chinese patent medicine (SHUANGHUANGLIAN, QINGKAILING) intravenous drip, every day 1 time, 15d altogether, add with antihistaminic, fluid infusion, cooling according to individual patients situation, supplement the Supporting Therapy of suiting the medicine to the illness such as albumin, correction Electrolyte imbalance simultaneously, external used medicine is selected to the ill.Treatment group adds uses thiamphenicol enteric coated micropill, adult 1.0g/d, and points 2 times oral, and 15d was 1 course for the treatment of, decrement gradually after Morbidity control.
as a result, treatment group cures 30 examples, and cure rate is 78.94%, and show as temperature recovery normal, pustule disappears, and erythema, squama disappear, effective 5 examples, total effective rate 92.10%.Matched group clinical cure 18 example, cure rate is 54.54%, effective 8 examples, total effective rate 78.79%.Two groups of cure rates and total effective rate comparing difference all have significance (P<0.05).
| Group | Number of cases | Cure | Effective | Effectively | Invalid | Cure rate | Total effective rate |
| Treatment group | 38 | 30 | 5 | 2 | 1 | 78.94 | 92.10 |
| Matched group | 33 | 18 | 8 | 4 | 3 | 54.54 | 78.79 |
process characteristic of the present invention: 1, select raw material science, production technology is advanced, and its product is conveniently deposited and used; 2, product Chinese medicine composition is easily absorbed by the body; 3, raw material sources are extensive, add process line short, the easy processing and manufacturing of product.
detailed description of the invention:
embodiment 1
a kind of thiamphenicol enteric coated micropill, comprises enteric layer, sealing coat, pastille micropill; It is characterized in that: described enteric layer is wrapped in outside sealing coat, sealing coat is wrapped in outside pastille micropill; Described enteric layer comprises: enteric premix coating materials 178mg; Described sealing coat comprises: hypromellose 16-32mg, sucrose 3-20mg, Pulvis Talci 6-22mg, purified water 280-420mg; Described pastille micropill comprises: thiamphenicol 125mg, celphere 50mg, filler 28-90mg, lubricant 5-28mg, binding agent 5-6mg.
in described sealing coat, preferred weight proportion is: cellulose 24mg, sucrose 8mg, Pulvis Talci 10mg, purified water 350mg.
in described pastille micropill, preferred weight proportion is: thiamphenicol 125mg, celphere 50mg, filler 75mg, lubricant 25mg, binding agent 5mg.
its manufacture method comprises following operation:
1, purified water is used by binding agent to make the binder solution that concentration is 2%;
2, thiamphenicol raw material, filler, mix lubricant is even;
3, celphere is put into centrifugal pellet processing machine, spray with binding agent and by mixed powder slowly spread as wherein, after completing, fluid bed is dried;
4, hypromellose, sucrose, Pulvis Talci, purified water are configured to sealing coat coating materials;
5, fluidized bed coating agent will be put into containing pill, adjustment parameter, and adopt the sealing coat coating materials configured to carry out coating;
6, enteric premix coating materials and purified water are configured to enteric coating agents;
7, sealing coat pill is put into fluidized bed coating agent, adjustment parameter, adopt the enteric coating agents configured to carry out coating;
8,during pill after coating is incapsulated.
Claims (4)
1. a thiamphenicol enteric coated micropill, comprises enteric layer, sealing coat, pastille micropill; It is characterized in that: described enteric layer is wrapped in outside sealing coat, sealing coat is wrapped in outside pastille micropill; Described enteric layer comprises: enteric premix coating materials 178mg; Described sealing coat comprises: hypromellose 16-32mg, sucrose 3-20mg, Pulvis Talci 6-22mg, purified water 280-420mg; Described pastille micropill comprises: thiamphenicol 125mg, celphere 50mg, filler 28-90mg, lubricant 5-28mg, binding agent 5-6mg.
2. a kind of thiamphenicol enteric coated micropill according to claim 1, is characterized in that: in described sealing coat, preferred weight proportion is: cellulose 24mg, sucrose 8mg, Pulvis Talci 10mg, purified water 350mg.
3. a kind of thiamphenicol enteric coated micropill according to claim 1, is characterized in that: in described pastille micropill, preferred weight proportion is: thiamphenicol 125mg, celphere 50mg, filler 75mg, lubricant 25mg, binding agent 5mg.
4. the preparation method of a kind of thiamphenicol enteric coated micropill according to claim 1-3, is characterized in that: comprise following operation:
Used by binding agent purified water to make binder solution that concentration is 2%;
Thiamphenicol raw material, filler, mix lubricant is even;
Celphere is put into centrifugal pellet processing machine, spray with binding agent and by mixed powder slowly spread as wherein, after completing, fluid bed is dried;
Hypromellose, sucrose, Pulvis Talci, purified water are configured to sealing coat coating materials;
Fluidized bed coating agent will be put into containing pill, adjustment parameter, and adopt the sealing coat coating materials configured to carry out coating;
Enteric premix coating materials and purified water are configured to enteric coating agents;
Sealing coat pill is put into fluidized bed coating agent, adjustment parameter, adopt the enteric coating agents configured to carry out coating;
During pill after coating is incapsulated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410666593.5A CN104382881A (en) | 2014-11-20 | 2014-11-20 | Thiamphenicol enteric micropellet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410666593.5A CN104382881A (en) | 2014-11-20 | 2014-11-20 | Thiamphenicol enteric micropellet and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
| CN101897670A (en) * | 2009-05-25 | 2010-12-01 | 范敏华 | Azithromycin enteric-coated pellet capsule and preparation method thereof |
| EP1746980B1 (en) * | 2004-05-07 | 2011-11-02 | Nycomed GmbH | Pharmaceutical dosage form comprising pellets as well as its manufacturing process |
-
2014
- 2014-11-20 CN CN201410666593.5A patent/CN104382881A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1746980B1 (en) * | 2004-05-07 | 2011-11-02 | Nycomed GmbH | Pharmaceutical dosage form comprising pellets as well as its manufacturing process |
| CN101897670A (en) * | 2009-05-25 | 2010-12-01 | 范敏华 | Azithromycin enteric-coated pellet capsule and preparation method thereof |
| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
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Application publication date: 20150304 |