CN108159017A - A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof - Google Patents

A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof Download PDF

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Publication number
CN108159017A
CN108159017A CN201810219934.2A CN201810219934A CN108159017A CN 108159017 A CN108159017 A CN 108159017A CN 201810219934 A CN201810219934 A CN 201810219934A CN 108159017 A CN108159017 A CN 108159017A
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parts
lavo
hydrochloride
crospovidone
surfactant
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周月
韦勇
冯书影
申团结
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Anhwei New Century Pharmacy Co Ltd
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Anhwei New Century Pharmacy Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53831,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

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  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
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  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a kind of Levofloxacin Hydrochloride Capsules and preparation method thereof, the component and part of the capsule includes:25 88 parts of lavo-ofloxacin hydrochloride, 26 48 parts of starch, 10 20 parts of dextrin, 48 parts of lactose, 6 12 parts of low-substituted hydroxypropyl cellulose, 34 parts of polyethylene glycol, 12 parts of surfactant, 12 parts of crospovidone, 24 parts of magnesium stearate, 45 parts of talcum powder, 12 parts of high melting-point wax.The present invention selects low-substituted hydroxypropyl cellulose, surfactant and crospovidone as disintegrant, magnesium stearate, talcum powder and high melting-point wax are as lubricant, complementary synergistic effect between them, it can make the particle fater disintegration in capsule, make drug-eluting, drug effect is brought into play rapidly, shortens the pain time of patient, the disintegrant and lubricant that the present invention combines are also fine with effect in tablets, can quickly make drug-eluting;In addition, manufacture craft is simple, cost is saved, is suitble to large-scale industrial production.

Description

A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof
Technical field
The present invention relates to a kind of capsule and preparation method thereof more particularly to a kind of Levofloxacin Hydrochloride Capsules and its preparations Method.
Background technology
Lavo-ofloxacin hydrochloride is the levo form of Ofloxacin, and antibacterial activity is about twice of Ofloxacin, its master Mechanism of action is wanted to inhibit bacteria DNA gyrases(Bacterial topoisomerase II)Activity, hinder bacterium DNA replication.Antimicrobial spectrum Extensively, the characteristics of antibacterial action is strong.To most of enterobacteriaceae lactobacteriaceaes, such as escherichia coli, Klebsiella, Serratia, change Shape Bacillus, Shigella, Salmonella, citrobacter, acinetobacter and pseudomonas aeruginosa, the bloodthirsty bar of influenza The gram-negative bacterias such as bacterium, gonococcus have stronger antibacterial activity.To part methicillin-sensitivity staphylococcus, pneumonia streptococcus The gram positive bacterias such as bacterium, micrococcus scarlatinae, hemolytic streptococcus and Legionella, mycoplasma, Chlamydia also have good antibacterial Effect, but it is poor to anaerobic bacteria and enterococcal effect.
Suitable for caused by sensitive bacteria:1. urogenital infections, including pure, complexity urinary tract infections, bacterium Property prostatitis, NEISSERIA GONORRHOEAE urethritis or cervicitis(Including person caused by producing enzyme strain);2. respiratory tract infection is removed from office including sensitivity Bronchial infection acute attack and pulmonary infection caused by blue negative bacillus;3. alimentary infection, by Shigella, Salmonella, Caused by enterotoxigenic escherichia coli, aeromonas hydrophila, vibrio parahaemolytious etc.;4. typhoid fever;5. bone and the infection of joint;6. skin is soft Tissue infection;7. the general infections such as septicemia.
Lavo-ofloxacin hydrochloride have many uses it is general, Principle of Pain unbearably in the case of, it is better that drug effect plays a role sooner, This just needs the substance in Levofloxacin Hydrochloride Capsules that can quickly dissolve out, and then drug is made to play a role, but at present Because the selection of disintegrant and lubricant is improper, the dissolution rate for making drug is less desirable.
Invention content
The object of the present invention is to provide a kind of Levofloxacin Hydrochloride Capsules and preparation method thereof, solve hydrochloric acid levofloxacin Star pharmaceutical capsules dissolution rate is undesirable, and then prevents the problem of drug effect is from fast onset.
In order to achieve the above object, the present invention is achieved by the following technical solutions:
The present invention provides a kind of Levofloxacin Hydrochloride Capsules, and the component and part of the capsule includes:Hydrochloric acid levofloxacin 25-88 parts of star, 26-48 parts of starch, 10-20 parts of dextrin, 4-8 parts of lactose, 6-12 parts of low-substituted hydroxypropyl cellulose, polyethylene glycol 3- 4 parts, 1-2 parts of surfactant, 1-2 parts of crospovidone, 2-4 parts of magnesium stearate, 4-5 parts of talcum powder, 1-2 parts of high melting-point wax.
Preferably, the component and part of the capsule includes:25 parts of lavo-ofloxacin hydrochloride, 26 parts of starch, dextrin 10 Part, 4 parts of lactose, 6 parts of low-substituted hydroxypropyl cellulose, 3 parts of polyethylene glycol, 1 part of surfactant, 1 part of crospovidone, stearic acid 2 parts of magnesium, 4 parts of talcum powder, 1 part of high melting-point wax.
Preferably, the component and part of the capsule includes:88 parts of lavo-ofloxacin hydrochloride, 48 parts of starch, dextrin 20 Part, 8 parts of lactose, 12 parts of low-substituted hydroxypropyl cellulose, 4 parts of polyethylene glycol, 2 parts of surfactant, 2 parts of crospovidone, tristearin Sour 4 parts of magnesium, 5 parts of talcum powder, 2 parts of high melting-point wax.
Preferably, the component and part of the capsule includes:56.5 parts of lavo-ofloxacin hydrochloride, 37 parts of starch, dextrin 15 parts, 6 parts of lactose, 9 parts of low-substituted hydroxypropyl cellulose, 3.5 parts of polyethylene glycol, 1.5 parts of surfactant, crospovidone 1.5 Part, 3 parts of magnesium stearate, 4.5 parts of talcum powder, 1.5 parts of high melting-point wax.
Preferably, surfactant is polyoxyethylene sorbitan monoleate and/or lauryl sodium sulfate.
The present invention also provides a kind of preparation methods of Levofloxacin Hydrochloride Capsules, specifically include following steps:
1)By starch, dextrin, lactose, low-substituted hydroxypropyl cellulose, polyethylene glycol, surfactant, crospovidone, tristearin Sour magnesium, talcum powder and high melting-point wax sieving, and be sufficiently mixed, mixed material is obtained, mixed material is then crossed into 80 mesh Sieve;
2) lavo-ofloxacin hydrochloride crushed 90 mesh sieve by;
3) is by step 1)In obtained mixed material and step 2)It is carried out after the lavo-ofloxacin hydrochloride drying obtained after middle sieving It is sufficiently mixed;
4) lavo-ofloxacin hydrochloride material obtained in step 3) is filled capsule by by tire bagger, you can obtains product.
The present invention uses low-substituted hydroxypropyl cellulose, surfactant and crospovidone as disintegrant, general hydrophobic Property or insoluble drugs to olighydria affinity, be not easy to be penetrated by water in hole, then can when adding in proper amount of surfactant It is preferable to solve;Crospovidone is white powder, good fluidity, due to its high molecular weight and cross-linked structure, so insoluble Yu Shui, but have it is extremely strong draw moist, water absorption can exceed that the 50% of itself weight, but remain to keep complete and do not dissolve, heap Density is smaller(0.26g/ml), therefore powder has larger specific surface area, is uniformly dispersed in capsule as disintegrant, in addition strong Capillarity, promote network structure be disintegrated and generate calving disaggregation, effect is better than starch disintegrant;Low-substituted hydroxypropyl is fine Tie up element be a kind of multiduty nonionic cellulose derivative, be mainly used as solid pharmaceutical preparation disintegration and adhesive, due to it Powder has larger surface area and a porosity, thus can quick water swelling, while between its coarse structure and drug and particle Have it is larger inlay, capsule endoparticle hardness can be significantly improved, while do not influence to be disintegrated, so as to accelerate the dissolution rate of drug, carried High bioavilability;As lubricant, talcum powder is white to pale white crystals powder for magnesium stearate, talcum powder and high melting-point wax End, good with white person, density is big, Adhesion Resistance and helps good fluidity, but adhesion and lubricity are poor, high melting-point wax typical concentrations It is 3%~5%, lubricity is fine, and Adhesion Resistance is bad, helpless fluidity, and talcum powder and high melting-point wax can be fine as lubricant Complementation, magnesium stearate is hydrophobe, and dosage, which crosses multipotency, to be influenced the disintegration time of tablet or generate sliver, using this hydrophobicity During lubricant, can add in proper amount of surfactant such as lauryl sodium sulfate simultaneously can overcome.
Beneficial effects of the present invention:The present invention selects low-substituted hydroxypropyl cellulose, surfactant and crospovidone to make For disintegrant, as lubricant, the complementary synergistic effect between them can make glue for magnesium stearate, talcum powder and high melting-point wax Intracapsular particle fater disintegration, makes drug-eluting, and drug effect is brought into play rapidly, shortens the pain time of patient, of the present invention group The disintegrant and lubricant of conjunction are also fine with effect in tablets, can quickly make drug-eluting;In addition, manufacture craft is simple, Cost is saved, is suitble to large-scale industrial production.
Specific embodiment
With reference to embodiment, the specific embodiment of the present invention is further described.Following embodiment is only used for more Add and clearly demonstrate technical scheme of the present invention, and be not intended to limit the protection scope of the present invention and limit the scope of the invention.
Embodiment 1
A kind of Levofloxacin Hydrochloride Capsules, the component and part of the capsule include:25 parts of lavo-ofloxacin hydrochloride, starch 26 parts, 10 parts of dextrin, 4 parts of lactose, 6 parts of low-substituted hydroxypropyl cellulose, 3 parts of polyethylene glycol, 1 part of polyoxyethylene sorbitan monoleate, the poly- dimension of crosslinking 1 part of ketone, 2 parts of magnesium stearate, 4 parts of talcum powder, 1 part of high melting-point wax.
A kind of preparation method of Levofloxacin Hydrochloride Capsules, specifically includes following steps:
1)By starch, dextrin, lactose, low-substituted hydroxypropyl cellulose, polyethylene glycol, polyoxyethylene sorbitan monoleate, crospovidone, tristearin Sour magnesium, talcum powder and high melting-point wax sieving, and be sufficiently mixed, mixed material is obtained, mixed material is then crossed into 80 mesh Sieve;
2) lavo-ofloxacin hydrochloride crushed 90 mesh sieve by;
3) is by step 1)In obtained mixed material and step 2)It is carried out after the lavo-ofloxacin hydrochloride drying obtained after middle sieving It is sufficiently mixed;
4) lavo-ofloxacin hydrochloride material obtained in step 3) is filled capsule by by tire bagger, you can obtains product.
Application method:It oral 1 time on the one, 1~2 or is followed the doctor's advice every time according to the state of an illness.
Embodiment 2
A kind of Levofloxacin Hydrochloride Capsules, the component and part of the capsule include:88 parts of lavo-ofloxacin hydrochloride, starch 48 parts, 20 parts of dextrin, 8 parts of lactose, 12 parts of low-substituted hydroxypropyl cellulose, 4 parts of polyethylene glycol, 2 parts of lauryl sodium sulfate, crosslinking 2 parts of povidone, 4 parts of magnesium stearate, 5 parts of talcum powder, 2 parts of high melting-point wax.
A kind of preparation method of Levofloxacin Hydrochloride Capsules, specifically includes following steps:
1)By starch, dextrin, lactose, low-substituted hydroxypropyl cellulose, polyethylene glycol, surfactant, crospovidone, tristearin Sour magnesium, talcum powder and high melting-point wax sieving, and be sufficiently mixed, mixed material is obtained, mixed material is then crossed into 80 mesh Sieve;
2) lavo-ofloxacin hydrochloride crushed 90 mesh sieve by;
3) is by the step 1)In obtained mixed material and the step 2)The lavo-ofloxacin hydrochloride obtained after middle sieving is done It is sufficiently mixed after dry;
4) lavo-ofloxacin hydrochloride material obtained in the step 3) is filled capsule by by tire bagger, you can obtains product.
Application method:It oral 1 time on the one, 1~2 or is followed the doctor's advice every time according to the state of an illness.
Embodiment 3
A kind of Levofloxacin Hydrochloride Capsules, the component and part of the capsule include:56.5 parts of lavo-ofloxacin hydrochloride forms sediment 37 parts of powder, 15 parts of dextrin, 6 parts of lactose, 9 parts of low-substituted hydroxypropyl cellulose, 3.5 parts of polyethylene glycol, 0.5 part of polyoxyethylene sorbitan monoleate, ten 1 part of sodium dialkyl sulfate, 1.5 parts of crospovidone, 3 parts of magnesium stearate, 4.5 parts of talcum powder, 1.5 parts of high melting-point wax.
A kind of preparation method of Levofloxacin Hydrochloride Capsules, specifically includes following steps:
1)By starch, dextrin, lactose, low-substituted hydroxypropyl cellulose, polyethylene glycol, surfactant, crospovidone, tristearin Sour magnesium, talcum powder and high melting-point wax sieving, and be sufficiently mixed, mixed material is obtained, mixed material is then crossed into 80 mesh Sieve;
2) lavo-ofloxacin hydrochloride crushed 90 mesh sieve by;
3) is by the step 1)In obtained mixed material and the step 2)The lavo-ofloxacin hydrochloride obtained after middle sieving is done It is sufficiently mixed after dry;
4) lavo-ofloxacin hydrochloride material obtained in the step 3) is filled capsule by by tire bagger, you can obtains product.
Application method:It oral 1 time on the one, 1~2 or is followed the doctor's advice every time according to the state of an illness.
The Toxicity Analysis of the present invention:
1) clinical data
The present invention is used to treat bacterial prostatitis patient 186 and carries out clinical observation treatment, wherein age reckling 26 Year, the maximum 82 years old, average age 49 years old, course of disease 6-12 days.
2) efficacy assessment standard
It cures:Common disease is such as urinated discomfort, irritative symptoms of bladder occurs, and urethra scorching hot during such as frequent micturition, urination, early morning urethral orifice has There is dysuric feeling etc. and all disappear in the secretion such as mucus, and therapeutic process does not have Nausea and vomiting, abdominal discomfort, abdomen It rushes down, lose the appetite, abdominal pain, abdominal distension, insomnia, dizziness, headache, fash, the lavo-ofloxacin hydrochlorides side effect symptom such as itching occur.
It improves:Common disease is such as urinated discomfort, irritative symptoms of bladder occurs, urethra scorching hot during such as frequent micturition, urination, early morning urethra Mouth has a secretion such as mucus, occur it is dysuric feel etc. basic and disappear, therapeutic process do not have Nausea and vomiting, abdominal discomfort, The lavo-ofloxacin hydrochlorides side effect symptom such as diarrhea, loss of appetite, abdominal pain, abdominal distension, insomnia, dizziness, headache, fash, itching goes out It is existing.
In vain:Symptom is without being clearly better.
3) therapy
It takes orally 1 times a day, daily 1~2.
4) therapeutic effect
A kind of Levofloxacin Hydrochloride Capsules provided by the invention treat 186 patients, wherein there is 184 recoveries from illness, 2 good Turn, 0 invalid;
Through statistical analysis, for cure rate up to 98.92%, total effective rate reaches 100%, has no any bad anti-over the course for the treatment of Should, show Levofloxacin Hydrochloride Capsules drug safety of the invention.
Model case:
Case 1:In patient's summer, man, 31 years old, controlled micturition was uncomfortable, irritative symptoms of bladder occurs, urethra scorching hot during such as frequent micturition, urination Etc. symptoms it is apparent, through other drugs treat 2 weeks effects it is bad, use the present invention Levofloxacin Hydrochloride Capsules treat 6 days effect Fruit is clearly better, and fully recovers after being continuing with 6 days, during use without Nausea and vomiting, abdominal discomfort, diarrhea, loss of appetite, The lavo-ofloxacin hydrochlorides side effect such as abdominal pain, abdominal distension, insomnia, dizziness, headache, fash, itching symptom occurs.
Case 2:Patient it is military certain, man, 56 years old, patient's early morning urethral orifice had the secretion such as mucus, dysuric sense occurs The symptoms such as feel are apparent, bad through 2 weeks effects of other drugs treatment, treated 6 days using the Levofloxacin Hydrochloride Capsules of the present invention Improvement with obvious effects is fully recovered after being continuing with 6 days, during use without Nausea and vomiting, abdominal discomfort, diarrhea, appetite not It shakes, abdominal pain, abdominal distension, insomnia, dizziness, headache, fash, the lavo-ofloxacin hydrochlorides side effect symptom such as itching occur.
Case 3:Patient Zhang, man, 65 years old, controlled micturition was uncomfortable, irritative symptoms of bladder occurs, as urinated when frequent micturition, urination Road is scorching hot, and early morning urethral orifice has the symptoms such as the secretion such as mucus, the dysuric feeling of appearance apparent, and 2 are treated through other drugs Zhou Xiaoguo is bad, treats improvement with obvious effects in 6 days using the Levofloxacin Hydrochloride Capsules of the present invention, fullys recover from an illness after being continuing with 6 days More, without Nausea and vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, abdominal distension, insomnia, dizziness, headache, skin during use The lavo-ofloxacin hydrochlorides side effect such as rash, itching symptom occurs.
Case 4:Patient Zhao, man, 79 years old, urethra scorching hot during controlled micturition, early morning urethral orifice had secretion such as mucus etc. Symptom is apparent, bad through 2 weeks effects of other drugs treatment, and the Levofloxacin Hydrochloride Capsules of the present invention is used to treat 6 days effects It is clearly better, fully recovers after being continuing with 6 days, without Nausea and vomiting, abdominal discomfort, diarrhea, loss of appetite, abdomen during use Bitterly, the lavo-ofloxacin hydrochlorides side effect such as abdominal distension, insomnia, dizziness, headache, fash, itching symptom occurs.
The foregoing is only a preferred embodiment of the present invention, but protection scope of the present invention be not limited thereto, Any one skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.

Claims (6)

1. a kind of Levofloxacin Hydrochloride Capsules, which is characterized in that the component and part of the capsule includes:The left oxygen fluorine of hydrochloric acid Husky star 25-88 parts, 26-48 parts of starch, 10-20 parts of dextrin, 4-8 parts of lactose, 6-12 parts of low-substituted hydroxypropyl cellulose, polyethylene glycol 3-4 parts, 1-2 parts of surfactant, 1-2 parts of crospovidone, 2-4 parts of magnesium stearate, 4-5 parts of talcum powder, high melting-point wax 1-2 Part.
2. Levofloxacin Hydrochloride Capsules according to claim 1, it is characterised in that:The component and part of the capsule Including:25 parts of lavo-ofloxacin hydrochloride, 26 parts of starch, 10 parts of dextrin, 4 parts of lactose, 6 parts of low-substituted hydroxypropyl cellulose, poly- second two 3 parts of alcohol, 1 part of surfactant, 1 part of crospovidone, 2 parts of magnesium stearate, 4 parts of talcum powder, 1 part of high melting-point wax.
3. Levofloxacin Hydrochloride Capsules according to claim 1, which is characterized in that the component and part of the capsule Including:88 parts of lavo-ofloxacin hydrochloride, 48 parts of starch, 20 parts of dextrin, 8 parts of lactose, 12 parts of low-substituted hydroxypropyl cellulose, poly- second two 4 parts of alcohol, 2 parts of surfactant, 2 parts of crospovidone, 4 parts of magnesium stearate, 5 parts of talcum powder, 2 parts of high melting-point wax.
4. Levofloxacin Hydrochloride Capsules according to claim 1, which is characterized in that the component and part of the capsule Including:56.5 parts of lavo-ofloxacin hydrochloride, 37 parts of starch, 15 parts of dextrin, 6 parts of lactose, 9 parts of low-substituted hydroxypropyl cellulose, poly- second 3.5 parts of glycol, 1.5 parts of surfactant, 1.5 parts of crospovidone, 3 parts of magnesium stearate, 4.5 parts of talcum powder, high melting-point wax 1.5 Part.
5. according to the Levofloxacin Hydrochloride Capsules described in any one of claim 1-4, which is characterized in that the surface-active Agent is polyoxyethylene sorbitan monoleate and/or lauryl sodium sulfate.
It is 6. a kind of such as the preparation method of claim 5 Levofloxacin Hydrochloride Capsules, which is characterized in that specifically include following step Suddenly:
1)By starch, dextrin, lactose, low-substituted hydroxypropyl cellulose, polyethylene glycol, surfactant, crospovidone, tristearin Sour magnesium, talcum powder and high melting-point wax sieving, and be sufficiently mixed, mixed material is obtained, mixed material is then crossed into 80 mesh Sieve;
2) lavo-ofloxacin hydrochloride crushed 90 mesh sieve by;
3) is by the step 1)In obtained mixed material and the step 2)The lavo-ofloxacin hydrochloride obtained after middle sieving is done It is sufficiently mixed after dry;
4) lavo-ofloxacin hydrochloride material obtained in the step 3) is filled capsule by by tire bagger, you can obtains product.
CN201810219934.2A 2018-03-16 2018-03-16 A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof Pending CN108159017A (en)

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Publication number Priority date Publication date Assignee Title
CN108567761A (en) * 2018-07-25 2018-09-25 江苏黄河药业股份有限公司 A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof
CN108619157A (en) * 2018-07-25 2018-10-09 江苏黄河药业股份有限公司 A kind of Levofloxacin Hydrochloride Capsules
CN109793759A (en) * 2019-03-06 2019-05-24 华中农业大学 A kind of compound pollen cream ball and preparation method thereof

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CN105687157A (en) * 2014-11-29 2016-06-22 康普药业股份有限公司 Levofloxacin hydrochloride capsule and preparation method thereof
CN107638404A (en) * 2017-06-01 2018-01-30 合肥远志医药科技开发有限公司 A kind of norfloxacin capsule and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN105687157A (en) * 2014-11-29 2016-06-22 康普药业股份有限公司 Levofloxacin hydrochloride capsule and preparation method thereof
CN104606165A (en) * 2015-02-04 2015-05-13 上海华源安徽仁济制药有限公司 Norfloxacin capsules and preparation method thereof
CN107638404A (en) * 2017-06-01 2018-01-30 合肥远志医药科技开发有限公司 A kind of norfloxacin capsule and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108567761A (en) * 2018-07-25 2018-09-25 江苏黄河药业股份有限公司 A kind of Levofloxacin Hydrochloride Capsules and preparation method thereof
CN108619157A (en) * 2018-07-25 2018-10-09 江苏黄河药业股份有限公司 A kind of Levofloxacin Hydrochloride Capsules
CN109793759A (en) * 2019-03-06 2019-05-24 华中农业大学 A kind of compound pollen cream ball and preparation method thereof
CN109793759B (en) * 2019-03-06 2022-05-03 华中农业大学 Compound pollen paste pill and preparation method thereof

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Application publication date: 20180615