CN1931162A - Prduction process and application of ornidazole - Google Patents
Prduction process and application of ornidazole Download PDFInfo
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- CN1931162A CN1931162A CN 200610096324 CN200610096324A CN1931162A CN 1931162 A CN1931162 A CN 1931162A CN 200610096324 CN200610096324 CN 200610096324 CN 200610096324 A CN200610096324 A CN 200610096324A CN 1931162 A CN1931162 A CN 1931162A
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- ornidazole
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- bacteroides
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Abstract
The present invention discloses production process of ornidazole capsule, and belongs to the field of medicine technology. The production process has increased step of pressing pellet into rod and step of sucking the rod into capsule with special apparatus; and produces ornidazole capsule with high yield, small weight difference, stable disintegrating time and high leaching rate. The present invention also discloses the application of ornidazole in preparing medicine for treating anerobe caused diseases. The filler of the ornidazole capsule has ornidazole as active component and conventional excipient supplementary material. The production process includes the steps of mixing ornidazole and supplementary material, wet pelletizing, drying, drying, pressing into rod, sucking the rod into capsule, packing and inspection.
Description
Technical field
The invention belongs to field of pharmaceutical technology, relating in particular to a kind of is the production technology of capsule preparations of active component and the application of ornidazole with the ornidazole.
Background technology
Trichomonacide, ameba worm, giardia lamblia, anaerobic infection are a kind of common clinicals.Ameba parasitosis, higher sickness rate and the worldwide extensive distribution of giardiasis make them become human main parasitic disease; And being modal non-viral, trichomoniasis one of spreads disease.Annual about 2.5-3 1,000,000 women of the U.S., there are 1.8 hundred million people to contact this disease in the world wide.Since metronidazole succeed in developing be used for the treatment of this type of disease since, mankind's better efficacy of always trying every possible means to find, side effect medicine still less.Therefore, people develop tinidazole and ornidazole again.
Ornidazole is better than metronidazole on curative effect, slightly is better than tinidazole or suitable with tinidazole.Ornidazole does not have dead's sudden change and teratogenesis, does not have bad interaction with ethanol, and metronidazole and tinidazole have mutagenesis and teratogenesis report, and with ethanol bad interaction is arranged.Ornidazole has tablet, capsule at present.But all exist certain weak point.As capsule, tablet after taking medicine, enter blood through the gastrointestinal absorption, arrive focus by blood again, active ingredient significantly reduces, because the drug level of affected area is limited, thereby can not be very fast, kill pathogenic organisms well, also be easy to generate gastrointestinal side effects such as nauseating, vomiting, glossitis, anorexia, epigastric pain, diarrhoea.Oral in addition and drug administration by injection adds the burden of heavy patient liver, kidney easily, also influences being extensive use of of this medicine.
After the production technology of capsule is generally principal agent and adjuvant mixes at present, wet granulation, drying, granulate, fill, workshop sections such as packing, but in fill process, generally be subjected to the influence of previous process, particulate particle size distribution, flowability is to the direct decision effect of filling such as density.Particle size distribution is poor, can cause the capsular weight differential of final gained bigger; Mobile difference can cause capsules weight difference excessive; Less than normal to the little capsule filling back drug content that might cause of density.
Summary of the invention
The production technology that the purpose of this invention is to provide a kind of ornidazole capsule, this technology has increased the operation that granule is compressed into column in filling workshop section, through device specific technology column is sucked in the capsule again.The ornidazole capsule yield height that this technology is produced, weight differential is little, and disintegration time is stable, and dissolution is higher.
Another object of the present invention provides the application of ornidazole.
The objective of the invention is to realize by following manner:
A kind of production technology of ornidazole capsule, this capsule filling are active component with the ornidazole, are prepared from conventional figuration adjuvant, it is characterized in that earlier ornidazole and other adjuvants being mixed through wet granulation, and drying, granulate must be done granule; Through the presser-into-rod compression, the implant compression is formed column then, suck capsule, after the filling, the packing inspection warehouse-in is prepared from.
Conventional figuration adjuvant comprises in starch, dextrin, microcrystalline Cellulose, lactose, magnesium stearate, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium or polyvinylpolypyrrolidone and the above figuration adjuvant two or more mixture.
The application of ornidazole in the medicine of the microbial multiple disease of preparation treatment anaerobism.
Described anaerobe comprises that bacteroides fragilis, bacteroides disiens, ovum garden bacteroid, bacteroides thetaiotaomicron, clostridium, Eubacterium, dyspepsiacoccus and peptostreptococcus, helicobacter pylori, bacaeroides melaninogenicus, Fusobacterium, CO2 bite and knits dimension bacterium, gingiva bacteroid etc.
Advantage of the present invention:
Capsule of the present invention adopts before capsule is filled has increased mould, granule is compressed into the column of capsule shape earlier, again through column is sucked in the capsule, make fill process and traditional capsule manufacture technology to particulate particle size distribution, flowability, bulk density require to have reduced a lot, have largely improved capsular loading simultaneously, and capsular weight differential is very little, thus the capsular yield of bigger raising.
It is little to compare weight differential through the ornidazole capsule of this explained hereafter and other ornidazole capsules, and disintegration time is stable, and dissolution rate is very fast.
The specific embodiment
Embodiment 1
With two batches of method operations, ornidazole 2500g, starch 450g mix homogeneously, add an amount of 6% starch slurry, make wet granular,, cross 18 mesh sieve granulate through fluid bed drying, add and account for raw material gross weight 0.5% and magnesium stearate, first adopts traditional handicraft filled capsules, and filled capsules behind second batch of employing compression leg, equipment adopt the G140 fully-automatic capsule production line of Italian MGR company, implant is pressed into the column of capsule shape, sucks capsule and fill.Product specification: ornidazole content is 0.25g/ grain or 0.125g/ grain.
According to the pharmacopeia correlation technique two batches are detected, the result shows that second quality of lot obviously is better than first
| Numbering | First | Second batch |
| The capsule yield | 90.2％ | 99.1 |
| Tablet weight variation | 0.313 ± 0.172 3 surpasses 7.5% | 0.320 ± 0.005 maximum difference＜3% |
| Disintegration (n=6) | 4.52±1.22 | 3.50±0.42 |
| Dissolution (n=6) | 85.8±8.0 | 92.5±2.0 |
Embodiment 2
With two batches of method operations, ornidazole 2500g, microcrystalline Cellulose 250g, dextrin 250g, carboxymethyl starch sodium 90g, mix homogeneously adds an amount of 6% starch slurry, make wet granular, through fluid bed drying, cross 18 mesh sieve granulate, add 0.5% magnesium stearate, first adopts the traditional handicraft filled capsules, and second batch with filled capsules behind the embodiment 1 employing compression leg.
According to the pharmacopeia correlation technique two batches are detected, the result shows that second quality of lot still obviously is better than first
| Numbering | First | Second batch |
| The capsule yield | 93.1％ | 99.3 |
| Tablet weight variation | 0.327 ± 0.114 maximum difference about 6% | 0.333 ± 0.005 maximum difference＜3% |
| Disintegration (n=6) | 4.23±0.88 | 3.14±0.33 |
| Dissolution (n=6) | 88.7±6.0 | 96.5±2.0 |
Embodiment 3
With two batches of method operations, ornidazole 2500g, microcrystalline Cellulose 300g, lactose 150g, polyvinylpolypyrrolidone 75g, mix homogeneously adds an amount of 6% starch slurry, make wet granular, through fluid bed drying, cross 18 mesh sieve granulate, adding accounts for raw material gross weight 0.5% and magnesium stearate, first adopts the traditional handicraft filled capsules, and second batch with filled capsules behind the embodiment 1 employing compression leg.
According to the pharmacopeia correlation technique two batches are detected, the result shows that second quality of lot is better than first
| Numbering | First | Second batch |
| The capsule yield | 92.2％ | 99.4 |
| Tablet weight variation | 0.316 ± 0.101 maximum difference about 5% | 0.315 ± 0.005 maximum difference＜2% |
| Disintegration (n=6) | 4.75±1.03 | 2.78±0.40 |
| Dissolution (n=6) | 82.4±6.5 | 97.1±2.9 |
The application of ornidazole capsule in the medicine of the microbial multiple disease of preparation treatment anaerobism.
The ornidazole capsule of the present invention's preparation has tangible curative effect to bitten the microbial multiple diseases of anaerobism such as knitting dimension bacterium, gingiva bacteroid by bacteroides fragilis, bacteroides disiens, ovum garden bacteroid, bacteroides thetaiotaomicron, clostridium, Eubacterium, dyspepsiacoccus and peptostreptococcus, helicobacter pylori, bacaeroides melaninogenicus, Fusobacterium, CO2.
Claims (4)
1, a kind of production technology of ornidazole capsule is characterized in that this capsule filling is active component with the ornidazole, is prepared from conventional figuration adjuvant, earlier ornidazole and other figuration adjuvants are mixed through wet granulation, and drying, granulate must be done granule; Through the presser-into-rod compression, the implant compression is formed column then, suck capsule and be prepared from.
2, production technology according to claim 1 is characterized in that described conventional figuration adjuvant comprises in starch, dextrin, microcrystalline Cellulose, lactose, magnesium stearate, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium or polyvinylpolypyrrolidone and the above figuration adjuvant two or more mixture.
3, the application of the described ornidazole of claim 1 in the medicine of the microbial multiple disease of preparation treatment anaerobism.
4, anaerobe according to claim 3 comprises that bacteroides fragilis, bacteroides disiens, ovum garden bacteroid, bacteroides thetaiotaomicron, clostridium, Eubacterium, dyspepsiacoccus and peptostreptococcus, helicobacter pylori, bacaeroides melaninogenicus, Fusobacterium, CO2 bite and knits dimension bacterium and gingiva bacteroid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610096324 CN1931162A (en) | 2006-09-20 | 2006-09-20 | Prduction process and application of ornidazole |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610096324 CN1931162A (en) | 2006-09-20 | 2006-09-20 | Prduction process and application of ornidazole |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1931162A true CN1931162A (en) | 2007-03-21 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610096324 Pending CN1931162A (en) | 2006-09-20 | 2006-09-20 | Prduction process and application of ornidazole |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102357099A (en) * | 2011-11-14 | 2012-02-22 | 湖南九典制药有限公司 | Pharmaceutical composition with ornidazole |
| CN103142494A (en) * | 2013-03-19 | 2013-06-12 | 河北凯盛医药科技有限公司 | Ornidazole oral preparation and preparation method thereof |
-
2006
- 2006-09-20 CN CN 200610096324 patent/CN1931162A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102357099A (en) * | 2011-11-14 | 2012-02-22 | 湖南九典制药有限公司 | Pharmaceutical composition with ornidazole |
| CN103142494A (en) * | 2013-03-19 | 2013-06-12 | 河北凯盛医药科技有限公司 | Ornidazole oral preparation and preparation method thereof |
| CN103142494B (en) * | 2013-03-19 | 2018-06-26 | 河北凯盛医药科技有限公司 | Ornidazole oral preparation and preparation method thereof |
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