CN102525982A - Stable moxifloxacin hydrochloride medicinal composition - Google Patents
Stable moxifloxacin hydrochloride medicinal composition Download PDFInfo
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- CN102525982A CN102525982A CN2012100391928A CN201210039192A CN102525982A CN 102525982 A CN102525982 A CN 102525982A CN 2012100391928 A CN2012100391928 A CN 2012100391928A CN 201210039192 A CN201210039192 A CN 201210039192A CN 102525982 A CN102525982 A CN 102525982A
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Abstract
The invention discloses a stable moxifloxacin hydrochloride medicinal composition and a preparation method thereof. The stable moxifloxacin hydrochloride medicinal composition consists of moxifloxacin hydrochloride, hydroxypropyl betacyclodextrin, mannitol, microcrystalline cellulose 12 and magnesium stearate. The stable moxifloxacin hydrochloride medicinal composition is high in stability, has the obvious advantages of improving the yield of products, reducing cost and implementing industrialization and is better applied clinically, and preparations of the stable moxifloxacin hydrochloride medicinal composition have high stability.
Description
Technical field
The present invention relates to the medicine in the field of medicaments, especially relate to moxifloxacin hydrochloride pharmaceutical composition of a kind of good stability and preparation method thereof.
Background technology
Along with being widely used even abuse of antibacterial, bacterial drug resistance increases year by year, not only serious harm human health of drug resistant bacterial infections, and become worldwide thorny problem.It is reported, annual about 2,000,000 examples of nosocomial infection that take place in U.S.'s inpatient, wherein about 90,000 examples are dead.Hospital acquired more than 70% infects antibacterials commonly used is clinically produced drug resistance; Therefore, accelerating research and development, can effectively to tackle the Perorally administrable antimicrobial medicine of the nosocomial infection that the gram positive bacteria gram-negative bacteria (Pseudomonas aeruginosa and Acinetobacter baumannii etc.) that particularly severe infection and drug resistance increase progressively due to the methicillin-resistant gold Portugal bacterium (MRSA) causes extremely urgent.
At the beginning of 2006; The U.S. infects disease association (IDSA) and has announced 6 kinds of drug resistance pathogenic bacterium that human health threatened maximum; Wherein MRSA ranks first, and next coming in order are escherichia coli, Klebsiella, Acinetobacter baumannii, vancomycin resistance enterococcus faecalis and Pseudomonas aeruginosa.Pneumonia is microbial by Grain-negative in the institute more than 60%.According to statistics, 2002--2003 year clinical isolating Klebsiella Pneumoniae to the resistant rate of methoxyimino-β one lactam antibiotics (third generation cephalosporin) up to 47%.The ratio of the nosocomial pneumonia that is caused by acinetobacter constantly increases; And mortality rate is up to 20%-50%; And the incidence rate of the nosocomial pneumonia that causes by Pseudomonas aeruginosa from 1975 9.6% be increased to 2003 18.1%, increase nearly l doubly.
Bacterial infection is the numerous disease common complication, is one of principal element that threatens critical illness patient life.The critical illness patient is because long-term being in hospital, and the state of an illness is critical, has a low resistance, and is strong to the drug resistance of antimicrobial drug, and the state of an illness reason such as easy infection of showing effect repeatedly causes.Critical illness patient's lower respiratory infection is suitable distinct issues at comprehensive serious symptom ICU (S ICU); Account for more than 50% of all infection according to domestic statistics, this is main need set up the artificial airway with critical, the many people of the most state of an illness of the patient of ICU and carry out mechanical ventilation relevant.
Because increasing sharply of continuous rising of the rate of hospital acquired infection of methicillin-resistant staphylococcus aureus, methicillin-resistant staphylococcus epidermidis and resistant rate become the risk factor of hospital infection.Have data to show, roll up although antibiotic exploitation is used, staphylococcic resistant rate is more and more wider, and the scale of kind, dosage, the course of treatment and hospital that it and antibiotic use becomes proportional relation.
Moxifloxacin hydrochloride is the 4th generation wide spectrum 8-methoxy fluoroquinolone class antimicrobial drug, is the antibacterials more widely of clinical practice in recent years, also is one type of newer synthetic antibacterial drug.Moxifloxacin hydrochloride ability facedown streptococcus pneumoniae (the most often causing RTIs), hemophilus influenza and moraxelle catarrhalis.Different with at present used fluorine caye promise ketone.Moxifloxacin hydrochloride can strengthen anti-rare G
-The activity of bacterium comprises staphylococcus aureus, atypia pathogen such as mycoplasma, chlamydia and legionella.In addition, also effective to beta-lactam and the drug-fast antibacterial of Macrolide.The former company of grinding stresses, but the moxifloxacin hydrochloride kill bacteria, and effect has concentration dependent rapidly, only antibacterial is worked the growth effect that suppresses unlike Macrolide.
The moxifloxacin hydrochloride taking convenience, medication every day once can prove effective, thereby has good tolerability.This medicine does not have phototoxicity regulating liver-QI toxicity, and is identical with other quinolones, its significant side effects for feel sick, diarrhoea.
Another advantage of moxifloxacin hydrochloride is, and is more much lower than the drug resistance degree of other Du-6859a deposits yields.But, use suitable dosage and correct medicining times and blanking time.For example, to indication, oral 400mg, qd, logotype 5-10 days.
Common name:Moxifloxacin hydrochloride;
English name: Moxifloxacin Hydrochloride;
Chemical name:1-cyclopropyl-7-{ (S, S)-2,8-diazonium-bicyclo-[4.3.0] nonanal-8-group }-6-fluoro-8-methoxy-1,4-dihydro-4-oxygen-3-quinoline carboxylic acid hydrochloride;
Structural formula is:
Molecular formula: C
21H
24FN
3O
4HCl
Molecular weight: 437.9
Physicochemical property:Faint yellow to yellow crystalline powder, slightly water-soluble and methanol is slightly soluble in ethanol, is dissolved in acetone hardly.
The pharmacology type:Moxifloxacin hydrochloride is the 8-methoxy fluoroquinolone class antimicrobial drug with broad spectrum of activity and bactericidal action.Moxifloxacin hydrochloride has broad spectrum antibiotic activity external demonstrating to gram positive bacteria, gram-negative bacteria, anaerobe, acid fast bacteria and atypical microorganism such as mycoplasma, chlamydia and legionella.
Mechanism of action:Bactericidal action mechanism is for disturbing type and IV.Topoisomerase be control DNA topological sum at dna replication dna, repair and transcribe in the enzyme of key.Moxifloxacin hydrochloride shows as the bactericidal activity of concentration dependent.Minimum bactericidal concentration and minimum inhibitory concentration basically identical.Moxifloxacin hydrochloride is also effective to beta-lactam and the drug-fast antibacterial of Macrolide.Experimental animal model through infecting confirms that the moxifloxacin hydrochloride activity in vivo is high.
Indication:The indication of moxifloxacin hydrochloride is the adult (>=18 years old) that treatment suffers from upper respiratory tract and lower respiratory infection, as: acute sinusitis, acute episode of chronic bronchitis, community acquired pneumonia, and skin and soft tissue infection.
Usage and dosage:Dosage range
:Any indication is all recommended a 400mg (1), 1 time on the one.Adult's instructions of taking: tablet send down with one glass of water, and Time of Administration is not influenced by diet.Treatment time: treatment time should be according to the order of severity or the clinical response decision of symptom.Treatment upper respiratory tract and lower respiratory tract.
Can be according to following method during infection: acute episode of chronic tracheitis: 5 days; Community acquired pneumonia: 10 days; Acute sinusitis: 7 days; Recommendation treatment time of treatment skin and soft tissue infection is 7 days; Moxifloxacin hydrochloride 400mg tablet was used 14 day course of treatment at most in clinical trial.
The old people needn't adjust dosage, child and teenager forbidding; The dosage of the need for patient adjustment moxifloxacin hydrochloride of liver dysfunction.The dosage that the patient of the impaired renal function of any degree all needn't adjust moxifloxacin hydrochloride (comprises creatinine clearance rate≤30ml/min/1.73m
2).The pharmacokinetic data that lacks dialysis patient at present.Needn't adjust drug dose for not agnate.
The moxifloxacin hydrochloride sheet is gone on the market at U.S. FDA by Beyer Co., Ltd's in December, 1999, and then the moxifloxacin hydrochloride injection goes on the market in the U.S. calendar year 2001.2002, the moxifloxacin hydrochloride sheet was through the SFDA approval of import and in China's listing, and trade name is visitd multiple pleasure
Present SFDA is the interior manufacturer production of ratifying state not.
Application number is that the invention of CN 99813124.5 relates to the oral drug preparation that contains moxifloxacin hydrochloride, its salt and/or hydrate and mannitol.The invention still further relates to the method for preparing and the application of said preparation in antagonism human or animal bacterial infection of said preparation.
Application number is the agent of a kind of moxifloxacin hydrochloride gelatine capsule of the disclosure of the Invention of CN200510092524.9; Contain moxifloxacin hydrochloride or its salt and/or its hydrate and additive in the capsule 's content, said additive is to be selected from least a in the following material: sodium sulfite, sodium sulfite, oligomeric anthocyanidin, L-glutathion, Semen Sesami polyphenol, tea polyphenols, tocopherol, ascorbic acid, arabo-ascorbic acid, vitamin B1, vitamin B2, beta-carotene, soybean isoflavone, L-cysteine, pyrophosphoric acid, polyphosphoric acids and pharmaceutical salts thereof.Can use conventional capsules preparation technique in capsule 's content, to add the additive of carrying.Additive can play the obvious suppression effect to not stripping or dissolution decline that this capsule occurs in storage process, the dissolving out capability after capsule is preserved is for a long time greatly improved.
Application number is a kind of moxifloxacin hydrochloride capsule of the disclosure of the Invention of CN200510021739.1; Contain moxifloxacin hydrochloride or its salt and/or its hydrate in the capsule 's content; Also contain at least a disintegrating agent and at least a lubricant in the said capsule 's content, and the capsule shells of said capsule is the hydroxypropyl methylcellulose capsules shell.The invention also discloses the method for preparing of above-mentioned moxifloxacin hydrochloride capsule; Comprise step: moxifloxacin hydrochloride or its salt and/or its hydrate are fully mixed with at least a disintegrating agent and at least a lubricant or process granule, fill the hydroxypropyl methylcellulose capsules shell.The moxifloxacin hydrochloride capsule of employing hydroxypropyl methylcellulose capsules shell of the present invention, dissolving out capability is stable, and it is constant basically that back stripping situation is preserved in long-time (2 years), and dissolution is compared during with firm preparation, and no significant difference is all more than 90%.
Application number is a kind of moxifloxacin hydrochloride oral drug preparation of the disclosure of the Invention of CN200510021736.8; Contain moxifloxacin hydrochloride or its salt and/or its hydrate, and filmogen at least a, that be used to prepare the preparation midbody particle: hydroxypropyl emthylcellulose, hydroxyethylmethyl-cellulose, methylcellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, sodium carboxymethyl cellulose, polyacrylic resin class, Polyethylene Glycol, polyvinylpyrrolidone-vinyl acetate co-polymer, polyvinyl alcohol-polyethyleneglycol-graft copolymer, Ka Baibo, gelatin, poloxamer, polyvinylpyrrolidone.The invention also discloses the method for preparing of this pharmaceutical preparation, tabletting after granulating with above-mentioned filmogen system granule or coating.Moxifloxacin hydrochloride oral drug preparation of the present invention, stable in properties in granulation and tabletting process does not produce metachromatism, light, good hardness, and the medicine stripping is rapid, and label is at room temperature placed and can be kept mass conservation in 2 years.
Application number is that the invention of CN200910212686.X relates to the oral drug preparation that contains moxifloxacin hydrochloride, its salt and/or its hydrate and soluble starch and pregelatinized Starch, it is characterized in that said preparation contains 2.9%～14.5% soluble starch and 1.4%～6.5% pregelatinized Starch (all percentage number averages are basic calculation with the weight of pharmaceutical preparation).The invention still further relates to the method for preparing and the application in treatment or prevention human or animal's bacterial infection of said preparation.
Application number is the invention of CN201110074564.6 pharmaceutical composition that a kind of moxifloxacin hydrochloride is provided and preparation method thereof; Said composition mainly comprises moxifloxacin hydrochloride; Mannitol and other excipient; Method for preparing is through dry granulation technology preparation drug particles, then processes pharmaceutical preparation.
Application number is the invention of CN201110074385.2 pharmaceutical composition that a kind of moxifloxacin hydrochloride is provided and preparation method thereof; Said composition mainly comprises: moxifloxacin hydrochloride; Fusing agent polyethylene glycol 6000 and other excipient; Method for preparing mainly prepares drug particles through the hot melt granulation technique, then is pressed into tablet or incapsulates.
Application number is that to relate to a kind of be the oral solid formulation of active component with the moxifloxacin hydrochloride in the invention of CN201110005690.6.It is the oral solid formulation of processing through preparation technique with moxifloxacin hydrochloride and salt thereof and acceptable accessories.Involved in the present invention to oral solid formulation include but not limited to tablet, capsule, granule and piller, this steady quality, controlled, safe and effective.
The inventor is through studying for a long period of time, and unexpected the discovery used special adjuvant; The moxifloxacin hydrochloride pharmaceutical composition of special process preparation, reliable in quality, dissolution rate is fast; Not only successfully solve moxifloxacin hydrochloride and be not easy to the industrialization problem; And reduce production costs, easy to implement, remarkable in economical benefits.
Summary of the invention
First purpose of the present invention is to provide a kind of moxifloxacin hydrochloride pharmaceutical composition, and this moxifloxacin hydrochloride pharmaceutical composition, reduces cost to improving product yield to good stability, realizes industrialization, and better application has more remarkable advantages in clinical.
Second purpose of the present invention is to provide moxifloxacin hydrochloride preparation of drug combination method of the present invention, and this method is simple, prepared moxifloxacin hydrochloride pharmaceutical composition, and steady quality is reliable.
For realizing first purpose of the present invention, the present invention adopts following technical scheme:
A kind of moxifloxacin hydrochloride pharmaceutical composition, per 1000 described moxifloxacin hydrochloride pharmaceutical compositions, its prescription consists of:
Moxifloxacin hydrochloride is in MOXIFLOXACIN 400g
HYDROXYPROPYL BETA-CYCLODEXTRIN 100g
80% alcoholic solution 5L
Mannitol 70g
Microcrystalline Cellulose 12 30g
Magnesium stearate 10g
Moxifloxacin hydrochloride pharmaceutical composition of the present invention is to adopt following method preparation:
1) moxifloxacin hydrochloride spray-dried powders preparation: the HYDROXYPROPYL BETA-CYCLODEXTRIN of recipe quantity is dissolved in stirring and dissolving in 80% alcoholic solution; The moxifloxacin hydrochloride stirring and dissolving that adds recipe quantity more fully after; Carry out spray drying and get the single-size of granularity at 80 ± 10 μ m, subsequent use;
2) with 1) with mannitol, microcrystalline Cellulose 12, the magnesium stearate mix homogeneously of recipe quantity;
3) tabletting: it is heavy to regulate suitable hardness and sheet, carries out tabletting;
4) packing: adopt aluminum aluminum blister packaging machine to pack;
5) warehouse-in.
For realizing second purpose of the present invention, the present invention adopts following technical scheme:
Moxifloxacin hydrochloride preparation of drug combination method of the present invention, wherein, this method comprises the steps:
1) moxifloxacin hydrochloride spray-dried powders preparation: the HYDROXYPROPYL BETA-CYCLODEXTRIN of recipe quantity is dissolved in stirring and dissolving in 80% alcoholic solution; The moxifloxacin hydrochloride stirring and dissolving that adds recipe quantity more fully after; Carry out spray drying and get the single-size of granularity at 80 ± 10 μ m, subsequent use;
2) with 1) with mannitol, microcrystalline Cellulose 12, the magnesium stearate mix homogeneously of recipe quantity;
3) tabletting: it is heavy to regulate suitable hardness and sheet, carries out tabletting;
4) packing: adopt aluminum aluminum blister packaging machine to pack;
5) warehouse-in.
Below to the more detailed elaboration of the present invention:
These article of red discovery should not contact with metallic iron in the moxifloxacin hydrochloride raw material stability study, especially cause moxifloxacin hydrochloride variable color (red by xanthochromia) under the wet heat condition.Moxifloxacin hydrochloride and iron content container or rustless steel drift in the preparation process, punch die contacts or rub the back changeable colour; For this reason; The granulation of said preparation, drying should avoid the use of the iron content container, and the granule of hydrochloric MOXIFLOXACIN but is inevitable with contacting of drift and punch die in the tabletting process usually.
Consider in the process of the test to adopt special pharmaceutic adjuvant that moxifloxacin hydrochloride is carried out enclose, avoid contacting with the metallic iron ion.
Pharmaceutic adjuvant is meant when preparation prescription designs, and adds the general designation of all the medicinal materials except that principal agent in the prescription for mouldability, effectiveness, stability, the safety that solves preparation.Pharmaceutic adjuvant is the basic material and the important component part of pharmaceutical preparation, is the material base that guarantees pharmaceutical preparation production and development, plays a part key at preparation formulation with in producing.
Title: HYDROXYPROPYL BETA-CYCLODEXTRIN (HP-)
English name: Hydroxypropyl-β-Cyclodextrin
CAS number: 128446-35-5
Molecular formula: (C42H70O35)-HX+ (C3H7O2) X
Molecular weight: 1431-1806
Physicochemical property: white powder, the dissolubility in water is fine, also can dissolve in ethanol 50% and the methanol.Certain relative hygroscopicity is arranged.
Advantage: in medicine, can improve drug solubility, the curative effect of medicament is increased or the dose minimizing, can adjust or control the rate of release of medicine, reduce poisonous side effect of medicine, strengthen stability of drug.
One aspect of the present invention provides a kind of moxifloxacin hydrochloride pharmaceutical composition, per 1000 described moxifloxacin hydrochloride pharmaceutical compositions, and its prescription consists of:
Moxifloxacin hydrochloride is in MOXIFLOXACIN 400g
HYDROXYPROPYL BETA-CYCLODEXTRIN 100g
80% alcoholic solution 5L
Mannitol 70g
Microcrystalline Cellulose 12 30g
Magnesium stearate 10g
Moxifloxacin hydrochloride pharmaceutical composition of the present invention is to adopt following method preparation:
1) moxifloxacin hydrochloride spray-dried powders preparation: the HYDROXYPROPYL BETA-CYCLODEXTRIN of recipe quantity is dissolved in stirring and dissolving in 80% alcoholic solution; The moxifloxacin hydrochloride stirring and dissolving that adds recipe quantity more fully after; Carry out spray drying and get the single-size of granularity at 80 ± 10 μ m, subsequent use;
2) with 1) with mannitol, microcrystalline Cellulose 12, the magnesium stearate mix homogeneously of recipe quantity;
3) tabletting: it is heavy to regulate suitable hardness and sheet, carries out tabletting;
4) packing: adopt aluminum aluminum blister packaging machine to pack;
5) warehouse-in.
Traditional moxifloxacin hydrochloride pharmaceutical composition, stripping is slow, and bioavailability is not high, and along with the time places, dissolution obviously reduces, and quality can't guarantee.
The inventor finds that through great deal of experimental when the moxifloxacin hydrochloride pharmaceutical composition was above-mentioned prescription and preparation technology, described pharmaceutical composition stripping was fast, and bioavailability is high, and dissolution rate does not reduce because of standing time is long, and quality is effectively guaranteed.
Compared with prior art, the present invention has following advantage:
1) new moxifloxacin hydrochloride compositions provided by the present invention has thoroughly solved poor stability in the moxifloxacin hydrochloride production process, and stripping waits problem slowly.
2) moxifloxacin hydrochloride pharmaceutical composition provided by the present invention is for the yield that improves this product, reduction production cost, and better application has very big help in clinical treatment.
3) new moxifloxacin hydrochloride compositions provided by the present invention proves constant product quality, through pharmacology, toxicological test through industrialized great production and study on the stability; Solution is non-stimulated to blood vessel; Do not have irritated reaction, do not have haemolysis yet, human body is not had injury.
4) new moxifloxacin hydrochloride preparation of compositions method provided by the present invention, this method is simple, prepared moxifloxacin hydrochloride pharmaceutical composition reliable in quality.
The specific embodiment
Below in conjunction with embodiment the present invention is done further explain
Embodiment 1
Per 1000 described moxifloxacin hydrochloride pharmaceutical compositions, its prescription consists of:
Moxifloxacin hydrochloride is in MOXIFLOXACIN 400g
HYDROXYPROPYL BETA-CYCLODEXTRIN 100g
80% alcoholic solution 5L
Mannitol 70g
Microcrystalline Cellulose 12 30g
Magnesium stearate 10g
Preparation technology:
1) moxifloxacin hydrochloride spray-dried powders preparation: the HYDROXYPROPYL BETA-CYCLODEXTRIN of recipe quantity is dissolved in stirring and dissolving in 80% alcoholic solution; The moxifloxacin hydrochloride stirring and dissolving that adds recipe quantity more fully after; Carry out spray drying and get the single-size of granularity at 80 ± 10 μ m, subsequent use;
2) with 1) with mannitol, microcrystalline Cellulose 12, the magnesium stearate mix homogeneously of recipe quantity;
3) tabletting: it is heavy to regulate suitable hardness and sheet, carries out tabletting;
4) packing: adopt aluminum aluminum blister packaging machine to pack;
5) warehouse-in.
Comparing embodiment 1
ZL99813124.5 embodiment 1
Contain the tablet of 50mg MOXIFLOXACIN as micronized reactive compound, the content of reactive compound is about 66% (is basic calculation with the uncoated tablets):
The MOXIFLOXACIN hydrochlorate, micronized 54.6mg
Microcrystalline Cellulose 17.0mg
Lactose 8.5mg
Sodium carboxymethyl cellulose 2.0mg
Magnesium stearate 0.6mg
HPMC coating 3.2mg
Comparing embodiment 2
CN200510021739 patent working example 1
Component: moxifloxacin hydrochloride 218.4mg
Microcrystalline Cellulose 40.0mg
Carboxymethylstach sodium 68.0mg
Magnesium stearate 3.6mg
Total amount 330mg
Method for preparing: get former, adjuvant in the said components, fully mix homogeneously promptly gets in the filling hydroxypropyl methylcellulose capsules shell.
Test Example 1
This Test Example is to investigate the stability of moxifloxacin hydrochloride compositions provided by the present invention.
The accelerated test of moxifloxacin hydrochloride pharmaceutical composition
Method according to the embodiment of the invention 1 prepares three batches of moxifloxacin hydrochloride pharmaceutical compositions according to commercially available back; At 40 ℃ ± 2 ℃, the condition of RH75% ± 5% was placed 6 months, during respectively at sampling in the 1st, 2,3,6 month; Detect according to stable inspection item, and compare with 0 day data.
1, investigation project
High spot reviews: character, related substance and content.
2, accelerated test result
Above conclusion (of pressure testing) can be found out: these article detect index in 6 months each items of long term test and accelerated test condition held and compared no significant difference, good stability with 0 month.
Comparative test example 1
Comparative test example 1, comparative test example 2 and embodiment 1 were placed the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ high temperature, 92.5% ± 5% high humidity calorstat respectively 10 days, its character, related substance, content are checked respectively at 0 day, 10 days.The result sees the following form:
Can know according to result of the test; Embodiment 1 and comparative example 1, comparative example 2 placed 10 days in the calorstat of the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ high temperature, 92.5% ± 5% high humidity; Embodiment 1 is under different condition; Each inspection item has no significant change, and quality is superior to comparative example 1, comparative example 2.
Claims (3)
1. stable moxifloxacin hydrochloride pharmaceutical composition; Form by moxifloxacin hydrochloride, HYDROXYPROPYL BETA-CYCLODEXTRIN, mannitol, microcrystalline Cellulose 12, magnesium stearate; It is characterized in that wherein moxifloxacin hydrochloride is in MOXIFLOXACIN: the weight ratio of HYDROXYPROPYL BETA-CYCLODEXTRIN is 4:1.
2. pharmaceutical composition according to claim 2 is characterized in that, its described moxifloxacin hydrochloride pharmaceutical composition, and per 1000 its prescriptions consist of:
Moxifloxacin hydrochloride is in MOXIFLOXACIN 400g
HYDROXYPROPYL BETA-CYCLODEXTRIN 100g
80% alcoholic solution 5L
Mannitol 70g
Microcrystalline Cellulose 12 30g
Magnesium stearate 10g.
3. moxifloxacin hydrochloride preparation of drug combination method according to claim 2 is characterized in that this method comprises the steps:
1) moxifloxacin hydrochloride spray-dried powders preparation: the HYDROXYPROPYL BETA-CYCLODEXTRIN of recipe quantity is dissolved in stirring and dissolving in 80% alcoholic solution; The moxifloxacin hydrochloride stirring and dissolving that adds recipe quantity more fully after; Carry out spray drying and get the single-size of granularity at 80 ± 10 μ m, subsequent use;
2) with 1) with mannitol, microcrystalline Cellulose 12, the magnesium stearate mix homogeneously of recipe quantity;
3) tabletting: it is heavy to regulate suitable hardness and sheet, carries out tabletting;
4) packing: adopt aluminum aluminum blister packaging machine to pack;
5) warehouse-in.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100391928A CN102525982A (en) | 2012-02-21 | 2012-02-21 | Stable moxifloxacin hydrochloride medicinal composition |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100391928A CN102525982A (en) | 2012-02-21 | 2012-02-21 | Stable moxifloxacin hydrochloride medicinal composition |
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| CN102525982A true CN102525982A (en) | 2012-07-04 |
Family
ID=46334816
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| CN2012100391928A Pending CN102525982A (en) | 2012-02-21 | 2012-02-21 | Stable moxifloxacin hydrochloride medicinal composition |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191114A (en) * | 2013-04-07 | 2013-07-10 | 安徽天洋药业有限公司 | Moxifloxacin-containing oral drug solid preparation and preparation method thereof |
| CN104027310A (en) * | 2013-12-26 | 2014-09-10 | 青岛大学 | Faropenem sodium granules and preparing method thereof |
| CN113288866A (en) * | 2021-07-12 | 2021-08-24 | 山东诺明康药物研究院有限公司 | Antibacterial eye drops and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1325306A (en) * | 1998-11-10 | 2001-12-05 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
| CN101954089A (en) * | 2010-09-08 | 2011-01-26 | 洛阳惠中兽药有限公司 | Animal medicine inclusion compound, preparation method and application thereof |
| CN102204911A (en) * | 2011-03-25 | 2011-10-05 | 北京赛科药业有限责任公司 | Moxifloxacin hydrochloride pharmaceutical composition and its preparation method |
| CN102247314A (en) * | 2011-01-12 | 2011-11-23 | 北京润德康医药技术有限公司 | Oral solid preparation using moxifloxacin as active component |
-
2012
- 2012-02-21 CN CN2012100391928A patent/CN102525982A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1325306A (en) * | 1998-11-10 | 2001-12-05 | 拜尔公司 | Pharmaceutical moxifloxacin preparation |
| CN101954089A (en) * | 2010-09-08 | 2011-01-26 | 洛阳惠中兽药有限公司 | Animal medicine inclusion compound, preparation method and application thereof |
| CN102247314A (en) * | 2011-01-12 | 2011-11-23 | 北京润德康医药技术有限公司 | Oral solid preparation using moxifloxacin as active component |
| CN102204911A (en) * | 2011-03-25 | 2011-10-05 | 北京赛科药业有限责任公司 | Moxifloxacin hydrochloride pharmaceutical composition and its preparation method |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191114A (en) * | 2013-04-07 | 2013-07-10 | 安徽天洋药业有限公司 | Moxifloxacin-containing oral drug solid preparation and preparation method thereof |
| CN104027310A (en) * | 2013-12-26 | 2014-09-10 | 青岛大学 | Faropenem sodium granules and preparing method thereof |
| CN104027310B (en) * | 2013-12-26 | 2016-02-03 | 青岛大学 | A kind of faropenem sodium granules and preparation method thereof |
| CN113288866A (en) * | 2021-07-12 | 2021-08-24 | 山东诺明康药物研究院有限公司 | Antibacterial eye drops and preparation method thereof |
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Application publication date: 20120704 |