CN102247313A - Oral-administration slow release solid preparation by taking Moxifloxacin as active ingredient - Google Patents
Oral-administration slow release solid preparation by taking Moxifloxacin as active ingredient Download PDFInfo
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- CN102247313A CN102247313A CN2011100056446A CN201110005644A CN102247313A CN 102247313 A CN102247313 A CN 102247313A CN 2011100056446 A CN2011100056446 A CN 2011100056446A CN 201110005644 A CN201110005644 A CN 201110005644A CN 102247313 A CN102247313 A CN 102247313A
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The invention relates to an oral-administration slow release solid preparation by taking Moxifloxacin as an active ingredient. The oral-administration slow release solid preparation is prepared from Moxifloxacin, the salt thereof and pharmaceutically acceptable auxiliary materials by the preparation technology. The oral-administration slow release solid preparation disclosed by the invention not only comprises tablets, capsules, particles and slow release pillets. The oral-administration slow release solid preparation has stable and controllable quality and is safe and effective.
Description
Technical field
The present invention relates to a kind of is the oral sustained release solid preparation of main component with the Moxifloxacin.It is the solid preparation of making by preparation technique with Moxifloxacin and acceptable accessories.Oral sustained release solid preparation steady quality of the present invention, controlled, safe and effective.Belong to medical technical field.
Background technology
Moxifloxacin is a fluoroquinolone antibacterial agent of new generation, its has a broad antifungal spectrum, antimicrbial power is strong, there is not cross resistance with other antibacterials, almost there is not photosensitive reaction, strong 2～16 times to the antibacterial activity of moraxelle catarrhalis, chlamydia, bacteroides fragilis, staphylococcus, streptococcus, enterobacteria and anaerobe than ciprofloxacin and ofloxacin.At present Moxifloxacin hydrochlorate approved is used for upper and lower respiratory tract infection due to the sensitive microbial, as the treatment of acute episode of chronic bronchitis, community acquired pneumonia, acute bacterial sinusitis and uncomplicated skin and soft tissue infection etc.The moxifloxacin hydrochloride tablet is registered first in Mexico in February, 1999, in JIUYUE, 1999 is in German Initial Public Offering, infusion solution in calendar year 2001 December in the U.S. and German Initial Public Offering, at present should product go on the market in that Germany, Spain, Italy, Sweden, Switzerland, the U.S., Canada, Australia, Argentina, Brazil, Korea S, Malaysia etc. are national.
And do not see that at home its slow releasing preparation registration or listing is arranged, for filling the domestic gaps, our company is studied the moxifloxacin hydrochloride slow releasing preparation, has obtained the Moxifloxacin slow releasing tablet, capsule, granule, and slow-release pill.
Summary of the invention
The invention provides a kind of Moxifloxacin is the oral sustained release solid preparation of main component, and this preparation has improved compliance of patients.
The present invention for a kind of be the oral sustained release solid preparation of active component with the Moxifloxacin, this oral sustained release solid preparation is that main component and acceptable accessories are made by preparation technique with the Moxifloxacin, includes but not limited to tablet, capsule, granule and slow-release pill.
Described Moxifloxacin is meant Moxifloxacin and pharmaceutically acceptable salt or its hydrate, preferred moxifloxacin hydrochloride, and the consumption of the Moxifloxacin in this each prescription of oral sustained release solid preparation is per unit dosage 200-1000mg.
Described moxifloxacin oral slow-release solid preparation, its sustained-release matrix material is wax material and skeleton forming agent, wherein wax material includes but not limited to higher fatty acids, high-grade aliphatic ester, higher alcohol, high alcohol ester, wax.Wherein higher fatty acids includes but not limited to lauric acid, tridecanoic acid, myristic acid, pentadecanoic acid, heptadecanoic acid, stearic acid, nonadecylic acid, arachidonic acid, mountain Yu acid, lignoceric acid, cerinic acid, montanic acid and one or more mixture thereof; High-grade aliphatic ester includes but not limited to the glyceride of higher fatty acids, propylene glycol ester, glycol ester, sorbitol ester, macrogol ester, saturated fatty acid glyceride and one or more mixture thereof; Higher alcohol includes but not limited to pentadecanol, hexadecanol, Heptadecyl alcohol, octadecanol, nonadecanol, eicosanol, lanonol, cholesterol; The high alcohol ester derivant includes but not limited to Palmic acid cholesteryl ester and plant sterol cetylate; Wax is water-insoluble high-melting-point (＞35 ℃) wax material, includes but not limited to Brazil wax, white beeswax, Cera Flava, glyceryl monostearate, olein, paraffin, whale oil, preferred Brazil wax.
Described moxifloxacin oral slow-release solid preparation, skeleton forming agent and framework material use jointly, and wherein the skeleton forming agent includes but not limited to succinic acid, citric acid, malic acid, stearic acid, lactic acid, aspartic acid, glutamic acid, gluconic acid, acetic acid, formic acid, hydrochloric acid, sulphuric acid, phosphoric acid, and hydrophilic polymer is for example: hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, hydrophilic cellulose, polyoxyethylene and Polyethylene Glycol.
Described moxifloxacin oral slow-release solid preparation also comprises porogen, includes but not limited to lactose, mannitol, sucrose, glucose, fructose, xylitol, sorbitol and electrolyte.
Described moxifloxacin oral slow-release solid preparation also comprises other complementary adjuvants, includes but not limited to Acidifier, binding agent, filler, diluent, osmotic pressure regulator, adsorbent, pigment, dyestuff, disintegrating agent, dispersant, sealant, fluidizer, sclerosing agent, penetration enhancers, demulsifier, stabilizing agent, lubricant, plasticizer, wetting agent are used to adjust mouthfeel, outward appearance and the molding of tablet.
Slow releasing preparation can realize that also coating materials can be a hypromellose, hyprolose, polyvinylpyrrolidone, polyoxyethylene, Polyethylene Glycol, ethyl cellulose, Lac, cellulose acetate-phthalate, HPMCAS, polyacrylic by drug coating.
The characteristics of said preparation maximum are medicament slow releases, take number of times and significantly reduce, and approximately need take once in every 40-50 hour, strengthened patient's compliance, because slow release, steady plasma-drug concentration is more often released kind certain improvement, after taking through 3 times, reach steady plasma-drug concentration.It is 100-6000ug/L that the people takes the back steady plasma-drug concentration, and preferred steady plasma-drug concentration is 300-5500ug/L, and more preferably steady plasma-drug concentration is 500-5000ug/L.
As slow releasing preparation, take first reach fast blood drug level cause close important, this preparation is characterised in that taking back 1 hour blood drug level first reaches 500ug/L, preferably takes back 1 hour blood drug level first and reaches 800ug/L, more preferably takes back 1 hour blood drug level first and reaches 1200ug/L.
Described oral sustained release solid preparation is mainly used in the infection that sensitivity gram positive bacteria, gram-negative bacteria, anaerobe, acid fast bacteria and other atypical microorganisms such as mycoplasma, chlamydia and legionella etc. cause.Comprise mainly that treatment respiratory tract infection (RTI) comprises because the acute episode of chronic bronchitis (AECB) that causes of bacterial infection, light, moderate community acquired pneumonia (CAP) and acute bacterial sinusitis; Genito-urinary system infection and skin and soft tissue infection.
The specific embodiment:
Following case study on implementation is used to explain the present invention, but is not limited thereto.
Embodiment 1 moxifloxacin hydrochloride slow releasing tablet
Make 1000 moxifloxacin hydrochloride slow releasing tablet with following materials of weight proportions
The slow-released part prescription:
Slow-released part preparation technology:
1. succinic acid is crossed 100 mesh sieves, the moxifloxacin hydrochloride micropowder is crossed 500 mesh sieves, and is standby.
2. get Brazil wax, stearic acid, succinic acid, 90 ℃ of heating of water-bath are stirred, and make fusing, add succinic acid, stir, and add moxifloxacin hydrochloride, stir.Continue to stir, remove water-bath, make the material cooling.Get the waxiness block.
3. above-mentioned gained waxiness block is pulverized, crossed 60 mesh sieves, add microcrystalline Cellulose, pregelatinized Starch, colloidal silica, mix homogeneously.
4. add magnesium stearate/SDS (94/6) as lubricant, mix homogeneously.
The immediate release section prescription:
Rapid release preparation technology:
5. with the moxifloxacin hydrochloride micropowder, cross 500 mesh sieves, standby.
6. get microcrystalline Cellulose, lactose was pulverized 60 mesh sieves, and was standby.
7. get microcrystalline Cellulose, lactose, moxifloxacin hydrochloride, cross-linking sodium carboxymethyl cellulose adopts equivalent incremental method mix homogeneously, is binding agent with the purified water, the system soft material, 24 screen clothes are granulated, 60 ℃ of oven dry, moisture Control is at 3-5%, 40 eye mesh screen granulate.
8. add magnesium stearate as lubricant, mix homogeneously.Carry out double-deck tabletting with slow-released part, be the capsule matrix, wherein one deck is a slow releasing preparation, and another layer is a quick releasing formulation.
9. prepare 6% Opadry ordinary coating agent.
10. get the plain sheet of above-mentioned gained, pour coating pan into and carry out coating, about 30 ℃ of hot blast temperature, the relative label weightening finish of coating powder: 3.0-5.0%.
Embodiment 2 moxifloxacin hydrochloride slow-release dry suspensions
The slow-released part prescription:
Slow-released part preparation technology:
1. succinic acid is crossed 100 mesh sieves, the moxifloxacin hydrochloride micropowder is crossed 500 mesh sieves, and is standby.
2. get Brazil wax, stearic acid, succinic acid, 90 ℃ of heating of water-bath are stirred, and make fusing, add succinic acid, stir, and add moxifloxacin hydrochloride, stir.Continue to stir, remove water-bath, make the material cooling.Get the waxiness block.
3. above-mentioned gained waxiness block is pulverized, crossed 60 mesh sieves, add microcrystalline Cellulose, pregelatinized Starch, colloidal silica, mix homogeneously adds entry system soft material, extrudes the round as a ball piller of making, and constantly adds Pulvis Talci in round as a ball process, and particle diameter is at 0.5-1.0mm.Get slow-release pill 1.
4. get half above-mentioned piller, carry out coating with the strange L30D-55 of enteric coating powder You Te.Get slow-release pill 2.
The immediate release section prescription:
Rapid release preparation technology:
1. with the moxifloxacin hydrochloride micropowder, cross 500 mesh sieves, standby.
2. get microcrystalline Cellulose, lactose was pulverized 60 mesh sieves, and was standby.
3. get microcrystalline Cellulose, lactose, moxifloxacin hydrochloride, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose adopts equivalent incremental method mix homogeneously, is binding agent with the purified water, the system soft material, extrude round as a ball preparation piller, constantly add Pulvis Talci in the preparation process, the piller particle diameter is at 0.5-1.0mm.
4. prepare 6% Opadry ordinary coating agent.
5. get above-mentioned gained piller, carry out coating.Get release pills.
Total part prescription that mixes:
Total preparation technology that mixes:
1. sucrose was pulverized 100 sieves, and was standby.
2. sucralose, Fructus Citri sinensis powdered flavor, citric acid, cross-linking sodium carboxymethyl cellulose are crossed 100 mesh sieves, and be standby.
3. above-mentioned fine powder equivalent is increased progressively mix homogeneously.
4. get release pills, slow-release pill 1, slow-release pill 2 and fully mix all, packing, every bag of about 2 grams with last fast fine powder.
Embodiment 3: conventional tablet
Make 1000 moxifloxacin hydrochloride sheets with following materials of weight proportions, sheet heavily is 500mg.
Prescription:
Preparation technology:
1. with the moxifloxacin hydrochloride micronization, cross 500 mesh sieves, standby.
2. get microcrystalline Cellulose, lactose was pulverized 60 mesh sieves, and was standby.
3. get microcrystalline Cellulose, lactose, moxifloxacin hydrochloride, cross-linking sodium carboxymethyl cellulose adopts equivalent incremental method mix homogeneously, is binding agent with the purified water, the system soft material, 24 screen clothes are granulated, 60 ℃ of oven dry, moisture Control is at 3-5%, 40 eye mesh screen granulate.
4. add magnesium stearate as lubricant, mix homogeneously.Tabletting.
5. above-mentioned plain sheet is carried out film coating.
Description of drawings:
Fig. 1 single dose administration is as follows at the intravital blood drug level of people:
Prescription 1 and write out a prescription and 2 played very big slow releasing function with quick releasing formulation prescription 3, after 48 hours, blood drug level bigger blood drug level occurs simultaneously still greater than 500ug/L simultaneously, and blood drug level is steady, and taking in two days once becomes possibility.
Claims (18)
- The present invention for a kind of be the oral sustained release solid preparation of active component with the Moxifloxacin, it is characterized in that said preparation is that live composition and acceptable accessories made by preparation technique with the Moxifloxacin.
- 2. moxifloxacin oral slow-release solid preparation as claimed in claim 1 is characterized in that, described Moxifloxacin is meant Moxifloxacin and pharmaceutically acceptable salt or its hydrate, preferred moxifloxacin hydrochloride.
- 3. moxifloxacin oral slow-release solid preparation as claimed in claim 1 is characterized in that the consumption of the Moxifloxacin in each prescription of said preparation is counted per unit dosage 200-1000mg with Moxifloxacin.
- 4. moxifloxacin oral slow-release solid preparation as claimed in claim 1 is characterized in that the slow release mode can be by sustained-release matrix material and skeleton forming agent formation or drug coating formation.
- 5. skeleton forming material as claimed in claim 4 is characterized in that, its skeleton forming material can be a waxiness, and wherein wax material includes but not limited to higher fatty acids, high-grade aliphatic ester, higher alcohol, high alcohol ester, wax.Wherein higher fatty acids includes but not limited to lauric acid, tridecanoic acid, myristic acid, pentadecanoic acid, heptadecanoic acid, stearic acid, nonadecylic acid, arachidonic acid, mountain Yu acid, lignoceric acid, cerinic acid, montanic acid and one or more mixture thereof; High-grade aliphatic ester includes but not limited to the glyceride of higher fatty acids, propylene glycol ester, glycol ester, sorbitol ester, macrogol ester, saturated fatty acid glyceride and one or more mixture thereof; Higher alcohol includes but not limited to pentadecanol, hexadecanol, Heptadecyl alcohol, octadecanol, nonadecanol, eicosanol, lanonol, cholesterol; The high alcohol ester derivant includes but not limited to Palmic acid cholesteryl ester and plant sterol cetylate; Wax is water-insoluble high-melting-point (＞35 ℃) wax material, includes but not limited to Brazil wax, white beeswax, Cera Flava, glyceryl monostearate, olein, paraffin, whale oil, preferred Brazil wax.
- 6. framework material as claimed in claim 4 is characterized in that, its framework material can the time hydrophilic polymer, include but not limited to hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, hydrophilic cellulose, polyoxyethylene, Polyethylene Glycol, alginic acid and salt thereof.
- 7. skeleton forming agent as claimed in claim 4 is characterized in that skeleton forming agent and framework material use jointly, and wherein the skeleton forming agent includes but not limited to succinic acid, citric acid, malic acid, stearic acid, lactic acid, aspartic acid, glutamic acid, gluconic acid, acetic acid, formic acid, hydrochloric acid, sulphuric acid, phosphoric acid.
- 8. oral sustained release solid preparation as claimed in claim 4 is characterized in that wherein also comprising porogen, includes but not limited to lactose, mannitol, sucrose, glucose, fructose, xylitol, sorbitol and electrolyte.
- 9. oral sustained release solid preparation as claimed in claim 4 is characterized in that wherein also comprising other complementary adjuvants, includes but not limited to Acidifier, binding agent, filler, diluent, osmotic pressure regulator, adsorbent, pigment, dyestuff, disintegrating agent, dispersant, sealant, fluidizer, sclerosing agent, penetration enhancers, demulsifier, stabilizing agent, lubricant, plasticizer, wetting agent are used to adjust mouthfeel, outward appearance and the molding of tablet.
- 10. drug coating as claimed in claim 4 is characterized in that this drug coating can be a hypromellose, hyprolose, polyvinylpyrrolidone, polyoxyethylene, Polyethylene Glycol, ethyl cellulose, Lac, cellulose acetate-phthalate, HPMCAS, polyacrylic.
- 11. oral sustained release solid preparation as claimed in claim 1 is characterized in that, takes once in the every 40-50 of said preparation hour.
- 12. oral sustained release solid preparation as claimed in claim 11 is characterized in that, it is 100-6000ug/L that the people takes the back steady plasma-drug concentration.
- 13. oral sustained release solid preparation as claimed in claim 12 is characterized in that, it is 300-5500ug/L that the people takes the back steady plasma-drug concentration.
- 14. oral sustained release solid preparation as claimed in claim 13 is characterized in that, it is 500-5000ug/L that the people takes the back steady plasma-drug concentration.
- 15. oral sustained release solid preparation as claimed in claim 11 is characterized in that, takes back 1 hour blood drug level first and reaches 500ug/L.
- 16. oral sustained release solid preparation as claimed in claim 15 is characterized in that, takes back 1 hour blood drug level first and reaches 800ug/L.
- 17. oral sustained release solid preparation as claimed in claim 16 is characterized in that, takes back 1 hour blood drug level first and reaches 1200ug/L.
- 18. oral sustained release solid preparation as claimed in claim 1 is mainly used in the infection that sensitivity gram positive bacteria, gram-negative bacteria, anaerobe, acid fast bacteria and other atypical microorganisms such as mycoplasma, chlamydia and legionella etc. cause.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011100056446A CN102247313A (en) | 2010-06-11 | 2011-01-12 | Oral-administration slow release solid preparation by taking Moxifloxacin as active ingredient |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010198252 | 2010-06-11 | ||
| CN201010198252.1 | 2010-06-11 | ||
| CN2011100056446A CN102247313A (en) | 2010-06-11 | 2011-01-12 | Oral-administration slow release solid preparation by taking Moxifloxacin as active ingredient |
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| CN102247313A true CN102247313A (en) | 2011-11-23 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908323A (en) * | 2012-10-30 | 2013-02-06 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN103385863A (en) * | 2013-08-05 | 2013-11-13 | 四川国康药业有限公司 | Sodium azulene sulfonate sustained-release preparation |
| CN103768063A (en) * | 2012-10-19 | 2014-05-07 | 深圳信立泰药业股份有限公司 | Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof |
| CN103845279A (en) * | 2014-03-28 | 2014-06-11 | 贵州神奇药物研究院 | Sodium cantharidinate sustained release preparation and preparation method of sodium cantharidinate sustained release preparation |
| CN106619481A (en) * | 2015-10-30 | 2017-05-10 | 四川科瑞德制药股份有限公司 | Long-acting 5-HT1A receptor stimulant and preparation method thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103768063A (en) * | 2012-10-19 | 2014-05-07 | 深圳信立泰药业股份有限公司 | Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof |
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| CN103385863A (en) * | 2013-08-05 | 2013-11-13 | 四川国康药业有限公司 | Sodium azulene sulfonate sustained-release preparation |
| CN103385863B (en) * | 2013-08-05 | 2015-07-15 | 四川国康药业有限公司 | Sodium azulene sulfonate sustained-release preparation |
| CN103845279A (en) * | 2014-03-28 | 2014-06-11 | 贵州神奇药物研究院 | Sodium cantharidinate sustained release preparation and preparation method of sodium cantharidinate sustained release preparation |
| CN103845279B (en) * | 2014-03-28 | 2016-05-11 | 贵州神奇药物研究院 | A kind of disodium cantharidinate sustained release preparation and preparation method thereof |
| CN106619481A (en) * | 2015-10-30 | 2017-05-10 | 四川科瑞德制药股份有限公司 | Long-acting 5-HT1A receptor stimulant and preparation method thereof |
| CN106619481B (en) * | 2015-10-30 | 2021-07-13 | 四川科瑞德制药股份有限公司 | Long-acting 5-HT1A receptor agonist and preparation method thereof |
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Application publication date: 20111123 |