CN1634072A - Levofloxacin dripping pills and its preparing process - Google Patents
Levofloxacin dripping pills and its preparing process Download PDFInfo
- Publication number
- CN1634072A CN1634072A CN 200310117735 CN200310117735A CN1634072A CN 1634072 A CN1634072 A CN 1634072A CN 200310117735 CN200310117735 CN 200310117735 CN 200310117735 A CN200310117735 A CN 200310117735A CN 1634072 A CN1634072 A CN 1634072A
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- levofloxacin
- drop pill
- lactate
- hydrochloride
- condensing agent
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Abstract
The invention discloses a lactic acid levofloxacin dripping pills and its preparing process, wherein each drop pill contains Levofloxacin 1-10 mg and right amount of drop pill base material, the drop pill base material is selected from one or two of polyethylene glycol 6000, polyethylene glycol 4000, polyoxyethglene monostearate, sodium stearate, glycerol gelatine, poloxamer, stearic acid, glyceryl monostearate, insect wax. And the preparing process comprises the steps of heating till melting, mixing homogeneously, instilling into condensation agent, taking-up and removing the condensation agent, checking and packaging.
Description
Technical field
The present invention relates to a kind of oral administration dripping pill, especially relate to a kind of levofloxacin lactate drop pill or levofloxacin hydrochloride drop pill and preparation method with broad-spectrum antibacterial action.
Background technology
Lactic acid or levofloxacin hydrochloride, chemistry (-) 9-fluoro-3-methyl isophthalic acid 0-[4-methyl-piperazinyl by name]-7-oxygen-2,3-dihydro-7H-pyrido [1,2,3-de]-[1,4] benzoxazinyl-6-carboxylic acid lactic acid or hydrochlorate.It is the levo form of ofloxacin S configuration, is white or little yellow crystalline powder, odorless, and bitter in the mouth is met light gradual change color.It is a third generation quinolones broad-spectrum antiseptic synthetic drug.To staphylococcus, streptococcus, streptococcus pneumoniae, gonococcus, escherichia coli, bacillus citrate, bacillus dysenteriae, Fei Yankeleishi bacillus, Enterobacter, hemophilus influenza, acinetobacter calcoaceticus, pylori etc. have antibacterial action preferably.Bacillus pyocyaneus, chlamydia trachomatis, tubercule bacillus etc. there is certain antibacterial activity.And toxicity is low, is quinolones toxic and side effects reckling in the marketed drug, and rate of side effects is lower than 3%.Be used for the treatment of the infection such as acute and chronic gram negative bacteria at positions such as respiratory tract, throat, tonsil, urinary tract, skin and soft tissue, gallbladder and bile duct, middle ear, intestinal clinically.
Levofloxacin lactate drop pill or levofloxacin hydrochloride drop pill mean behind levofloxacin lactate or levofloxacin hydrochloride and the relevant substrate heat fused mixing, splash in the immiscible condensing agent, shrink cooling and the preparation made.Be characterized in that dosage is little, bioavailability is high, the performance drug effect is rapid, side effect is little, be convenient to take and transport, increased stability of drug, production equipment is simple, processing ease, and weight differential is little, and dosage is accurate, and production cost is low.Also do not have a kind of levofloxacin lactate or levofloxacin hydrochloride of utilizing to make oral administration dripping pill at present, its effectiveness is not to give full play to.For another new levofloxacin lactate or levofloxacin hydrochloride preparation are provided in the clinical use.
Summary of the invention
The objective of the invention is to: a kind of levofloxacin lactate or levofloxacin hydrochloride drop pill and preparation method are provided.
Levofloxacin lactate of the present invention or levofloxacin hydrochloride drop pill advantage be, the bioavailability of levofloxacin lactate or levofloxacin hydrochloride increases, and the performance drug effect is rapid, and side effect reduces.
Levofloxacin lactate of the present invention or levofloxacin hydrochloride drop pill are made up of levofloxacin lactate or levofloxacin hydrochloride and substrate.
The preparation method of levofloxacin lactate of the present invention or levofloxacin hydrochloride drop pill is: get the levofloxacin lactate of recipe quantity or levofloxacin hydrochloride and an amount of drop pill substrate and mix, splash in the condensing agent after heating in water bath melts, cooling, drop pill is made in molding.Every contains levofloxacin lactate or levofloxacin hydrochloride 1-10mg and an amount of drop pill substrate in levofloxacin lactate of the present invention or the levofloxacin hydrochloride drop pill.
Drop pill substrate of the present invention contains polyethylene glycol 6000 0-50mg in being every, Macrogol 4000 0-40mg, polyoxyethylene monostearate 0-40mg, sodium stearate 0-40mg, glycerin gelatine 0-40mg, poloxamer 0-4mg, stearic acid 0-40mg, glyceryl monostearate 0-40mg, insect wax 0-40mg, one of or two or more.
Drop pill of the present invention required condensing agent when the preparation molding is one of dimethicone, liquid paraffin, vegetable oil, Oleum Camelliae or two or more.
Method for preparing drop pills of the present invention: with levofloxacin lactate or levofloxacin hydrochloride recipe quantity and certain substrate heat fused mixing, under 50 ℃ of-120 ℃ of states, the speed of dripping with per minute 10-150 splashes in the condensing agent, make drop pill, after the shaping, take out, remove condensing agent, the check, pack finished product.
The method of inspection of levofloxacin lactate or levofloxacin hydrochloride drop pill is: this product character is white or yellowish drop pill, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high performance liquid chromatography of filler.
Levofloxacin lactate drop pill of the present invention or levofloxacin hydrochloride drop pill, the infection such as acute and chronic gram negative bacteria at positions such as available treatment respiratory tract, throat, tonsil, urinary tract, skin and soft tissue, gallbladder and bile duct, middle ear, intestinal.
The specific embodiment:
The present invention is described in detail below in conjunction with embodiment
Embodiment one:
Prescription: levofloxacin lactate 10.0g
Macrogol 4000 5.0g
Glyceryl monostearate 2.0g
Poloxamer 0.5g
Polyethylene glycol 6000 10.0g
Make 1000, average every 27.5mg
Levofloxacin lactate 10.0g is added Polyethylene Glycol 6000 10.0g, glyceryl monostearate 2.0g, Macrogol 4000 5.0g, poloxamer 0.5g is behind the heat fused mixing, under 70 ℃ of-95 ℃ of states, speed with 40 of per minutes splashes in the dimethicone condensation, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain levofloxacin lactate 10.0g in per 1000 levofloxacin lactate drop pill.
The method of inspection is: this product character is white or yellowish drop pill, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Embodiment two:
Prescription: levofloxacin hydrochloride 5.0g
Macrogol 4000 15.0g
Polyethylene glycol 6000 5.0g
Make 1000, average every 25.0mg
Levofloxacin hydrochloride 5.0g is added Polyethylene Glycol 6000 5.0g, Macrogol 4000 15.0g is behind the heat fused mixing, under 80 ℃ of-95 ℃ of states, speed with 50 of per minutes splashes in the liquid paraffin cold oil, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Hydrochloric levofloxacin 5.0g in per 1000 levofloxacin hydrochloride drop pill.
The method of inspection is: this product character is yellowish drop pill, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Embodiment three:
Prescription: levofloxacin lactate 2.0g
Glycerin gelatine 5.0g
Polyoxyethylene monostearate 10.0g
Macrogol 4000 13.0g
Make 1000, average every 30.0mg
Levofloxacin lactate 2.0g is added Polyethylene Glycol 4000 13.0g, glycerin gelatine 5.0g, polyoxyethylene monostearate 10.0g, behind the heat fused mixing, under 75 ℃ of-100 ℃ of states, splash in the vegetable oil cold oil, after the shaping with the speed of 20 of per minutes, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain levofloxacin lactate 2.0g in per 1000 levofloxacin lactate drop pill.
The method of inspection is: this product character is yellowish drop pill, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Embodiment four:
Prescription: levofloxacin hydrochloride 2.5g
Stearic acid 8.0g
Glyceryl monostearate 2.5g,
Macrogol 4000 13.0g
Make 1000, average every 26.0mg
Levofloxacin hydrochloride 2.5.0g is added Polyethylene Glycol 4000 13.0g stearic acid 8.0g, glyceryl monostearate 2.5g is behind the heat fused mixing, under 80 ℃ of-95 ℃ of states, speed with 80 of per minutes splashes in the Oleum Camelliae oil cold oil, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Hydrochloric levofloxacin 2.5g in per 1000 levofloxacin hydrochloride drop pill.
The method of inspection is: this product character is white or yellowish drop pill, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Embodiment five:
Prescription: levofloxacin lactate 5.0g
Macrogol 4000 5.0g
Sodium stearate 2.0g
Poloxamer 0.5g
Polyethylene glycol 6000 10.0g
Make 1000, average every 22.5mg
Levofloxacin lactate 5.0g is added Polyethylene Glycol 6000 10.0g, sodium stearate 2.0g, Macrogol 4000 5.0g, poloxamer 0.5g is behind the heat fused mixing, under 70 ℃ of-95 ℃ of states, speed with 40 of per minutes splashes in the dimethicone condensation, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain levofloxacin lactate 5.0g in per 1000 levofloxacin lactate drop pill.
The method of inspection is: this product character is the drop pill of white, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Embodiment six:
Prescription: levofloxacin hydrochloride 8.0g
Macrogol 4000 12.0g
Polyethylene glycol 6000 6.0g
Make 1000, average every 26.0mg
Levofloxacin hydrochloride 8.0g is added Polyethylene Glycol 6000 6.0g, Macrogol 4000 12.0g is behind the heat fused mixing, under 80 ℃ of-95 ℃ of states, speed with 50 of per minutes splashes in the liquid paraffin cold oil, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Hydrochloric levofloxacin 8.0g in per 1000 levofloxacin hydrochloride drop pill.
The method of inspection is: this product character is the drop pill of white, bitter in the mouth.Content assaying method is that the employing octadecylsilane chemically bonded silica is the high-efficient phase chromatogram method of filler.
Claims (4)
1. a levofloxacin lactate drop pill or levofloxacin hydrochloride drop pill preparation technology with broad-spectrum antibacterial action is characterized in that containing levofloxacin lactate or levofloxacin hydrochloride 1-10mg and an amount of drop pill substrate in every of described levofloxacin lactate drop pill or the levofloxacin hydrochloride drop pill.
2. contain polyethylene glycol 6000 0-50mg in being every according to the substrate of described levofloxacin lactate drop pill of claim 1 or levofloxacin hydrochloride drop pill, Macrogol 4000 0-40mg, polyoxyethylene monostearate 0-40mg, sodium stearate 0-40mg, glycerin gelatine 0-40mg, poloxamer 0-4mg, stearic acid 0-40mg, glyceryl monostearate 0-40mg, insect wax 0-40mg, one of or two or more.
3. the preparation method of levofloxacin lactate drop pill according to claim 1 and 2 or levofloxacin hydrochloride drop pill, it is characterized in that, with levofloxacin lactate or levofloxacin hydrochloride recipe quantity and certain substrate heat fused mixing, under 50 ℃ of-120 ℃ of states, the speed of dripping with per minute 10-150 splashes in the condensing agent, make 1000 drop pill, after the shaping, take out, remove condensing agent, the check, pack finished product.
4. be one of dimethicone, liquid paraffin, Oleum Camelliae, vegetable oil or two or more according to required condensing agent in described levofloxacin lactate drop pill of claim 3 or the preparation of levofloxacin hydrochloride drop pill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310117735 CN1634072A (en) | 2003-12-28 | 2003-12-28 | Levofloxacin dripping pills and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310117735 CN1634072A (en) | 2003-12-28 | 2003-12-28 | Levofloxacin dripping pills and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634072A true CN1634072A (en) | 2005-07-06 |
Family
ID=34843707
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310117735 Pending CN1634072A (en) | 2003-12-28 | 2003-12-28 | Levofloxacin dripping pills and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634072A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102351881A (en) * | 2011-08-10 | 2012-02-15 | 天津市汉康医药生物技术有限公司 | Stable levofloxacin hydrochloride compound |
| CN110151712A (en) * | 2019-05-14 | 2019-08-23 | 扬子江药业集团江苏紫龙药业有限公司 | A kind of lavo-ofloxacin hydrochloride dripping pill and preparation method thereof |
-
2003
- 2003-12-28 CN CN 200310117735 patent/CN1634072A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102351881A (en) * | 2011-08-10 | 2012-02-15 | 天津市汉康医药生物技术有限公司 | Stable levofloxacin hydrochloride compound |
| CN102351881B (en) * | 2011-08-10 | 2014-04-09 | 天津市汉康医药生物技术有限公司 | Stable levofloxacin hydrochloride compound |
| CN110151712A (en) * | 2019-05-14 | 2019-08-23 | 扬子江药业集团江苏紫龙药业有限公司 | A kind of lavo-ofloxacin hydrochloride dripping pill and preparation method thereof |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |