CN101972257A - Medicine composite containing moxifloxacin - Google Patents
Medicine composite containing moxifloxacin Download PDFInfo
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- CN101972257A CN101972257A CN2010102800412A CN201010280041A CN101972257A CN 101972257 A CN101972257 A CN 101972257A CN 2010102800412 A CN2010102800412 A CN 2010102800412A CN 201010280041 A CN201010280041 A CN 201010280041A CN 101972257 A CN101972257 A CN 101972257A
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- moxifloxacin
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Abstract
The invention relates to a medicine composite containing moxifloxacin, which is characterized in that the medicine composite contains the moxifloxacin or salts thereof and an electrolyte balanced solution, wherein the electrolyte balance solution is selected from a sodium lactate Ringer injection or a sodium acetate Ringer injection. The medicine composite of the invention has the advantages that the dissolubility of the moxifloxacin or the salts thereof is good; the occurrence of metabolic acidosis is reduced; the balance of body liquid, electrolytes, acid and alkali can be regulated when antibiosis treatment is carried out; and the properties of the medicine composite are stable.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, specifically, relate to a kind of pharmaceutical composition that contains Moxifloxacin, belong to field of pharmaceutical preparations.
Background technology
The quinolonecarboxylic acid class antibiotics with broad spectrum antibiotic activity of Moxifloxacin (Moxifloxacin) for generally using clinically, the activity of its anti-non-zymocyte, staphylococcus, streptococcus pneumoniae, enterococcus and anaerobe is ciprofloxacin and ofloxacin 2～16 times, has broad spectrum antibiotic activity, as pathogenic organisms of respiratory tract, comprise Gram-positive and negative bacterium, anaerobe and rare pathogenic bacteria; It also has low-level bacterial drug resistance simultaneously, can obtain higher drug level at the infection key position.
For patient with severe symptoms that can not oral administration, the development injection has clinical meaning.
Chinese patent ZL00811427.7 provides the water formulation that contains 0.04%～0.4%w/v Moxifloxacin hydrochlorate (based on Moxifloxacin) and 0.4%～0.9%w/v sodium chloride.Find that add 5% commercially available glucose or other sugar and sugar alcohol, the glycerol as 2.5% waits and oozes adjusting, can only obtain the labile solution of Moxifloxacin during exploitation moxifloxacin hydrochloride injection, this instability shows and occurs inferior visual granule in the solution.The Moxifloxacin hydrochlorate pharmaceutical preparation of oozing adjusting with sodium chloride etc. is insensitive to iron ion.Said preparation is made up of Moxifloxacin and sodium chloride, when it uses, has the deficiency that causes the perchloric acid metabolic acidosis easily.
The prescription of aqueous solution described in the US6916484 can comprise Moxifloxacin or its salt, but the contained ferrum of its described aqueous solution preparation will be lower than 20ppb, or more preferably less than 10ppb.The poor operability that this controls in commercial production, and production cost height.
Chinese patent application 200710158325 provides a kind of Aspartic Acid carbostyril family antibacterial drugs water soluble salt and injection type thereof, and described quinolones comprises Moxifloxacin.But statement in the Chinese patent application 200910255714.6, the Moxifloxacin solution that adds Aspartic Acid or glycine was placed 10 days down at 60 ℃, and solution colour becomes brown.
WO2007037330, Chinese patent application 200410053321.4, Chinese patent application 200510093595.0, Chinese patent application 200510092828.5 disclose the lyophilized formulations that contains Moxifloxacin or quinolones, but lyophilized formulations is because can not pressure sterilizing, low than the aseptic assurance level of injection, the production cost height, and face with before needing to add solvent and redissolve, use inconvenient.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition that contains Moxifloxacin, it is made up of Moxifloxacin or its salt and balanced electrolyte solution.
The present invention is achieved through the following technical solutions:
Pharmaceutical composition of the present invention is made up of Moxifloxacin or its salt and balanced electrolyte solution, and described balanced electrolyte solution is selected from sodium lactate ringer's injection or sodium acetate ringer's injection.
The content of Moxifloxacin or its salt is 0.1～0.4 gram (by Moxifloxacin) in every 100ml pharmaceutical composition.
Sodium lactate ringer's injection in the pharmaceutical composition of the present invention, sodium chloride-containing 0.54～0.66 gram, sodium lactate 0.28～0.34 gram, potassium chloride 0.027～0.033 gram, calcium chloride (CaCl in every 100ml drug regimen
2.2H
2O) 0.018～0.022 gram.
Sodium acetate ringer's injection in the pharmaceutical composition of the present invention, sodium chloride-containing 0.54～0.66 gram, sodium acetate (C in every 100ml pharmaceutical composition
2H
3NaO
2.3H
2O) 0.25～0.38 gram, potassium chloride 0.036～0.044 gram, magnesium chloride (MgCl
2.6H
2O) 0.016～0.024 gram, calcium chloride (CaCl
2.2H
2O) 0.011～0.016 gram.
The salt of Moxifloxacin can be selected from hydrochlorate, acetate, lactate etc., preferably from hydrochlorate.
The present invention also provides the described preparation of drug combination method that contains Moxifloxacin.Described method comprises following steps:
Take by weighing recipe quantity calcium chloride or magnesium chloride and calcium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain calcium chloride concentrated solution or calcium magnesium concentrated solution;
Recipe quantity sodium chloride, sodium lactate or sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity Moxifloxacin or its salt, potassium chloride, calcium chloride concentrated solution or calcium magnesium concentrated solution, add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
In preparation process, earlier that recipe quantity is bigger sodium chloride, sodium lactate or sodium acetate, and the calcium chloride or calcium chloride and the magnesium chloride that contain polyvalent metal ion, use the activated carbon adsorption of Sq respectively, add the Moxifloxacin hydrochlorate then, thereby can prepare stable moxifloxacin hydrochloride solution.By this preparation technology, can reduce the impurity that influences in the solution to greatest extent, increase stability of solution; Can improve simultaneously the Adsorption Effect of active carbon again, reduce the component loss in process of production of respectively writing out a prescription each component.
The pharmaceutical composition that contains Moxifloxacin of the present invention is preferably injection, and its packing specification can be 50ml, 100ml, 250ml and 500ml.
The present invention also provides the described application of pharmaceutical composition in the medicine of preparation treatment human or animal bacterial infection that contains Moxifloxacin.
The present invention compared with prior art has following advantage:
1, safety is better, lessly cause metabolic acidosis, and reduced in the water incidence rate and to the influence of liver, renal function.Thing of the present invention can also be regulated body fluid, electrolyte and acid-base balance when carrying out antibacterial therapy.
The pharmaceutical composition that contains Moxifloxacin of the present invention, can be used for treating human or animal's bacterial infection, as be used for the treatment of upper respiratory tract and lower respiratory infection, and as: acute sinusitis, acute episode of chronic bronchitis, community acquired pneumonia and skin and soft tissue infection.
Electrolyte among the present invention is formed the electrolyte solution of similar extracellular fluid, contains cation potassium, sodium, calcium and anion chlorine near normal plasma concentration, and organic anion acetate or lactate.The electrolyte of the electrolyte solution compositional modeling blood plasma in the composition is formed, and making this product is isosmotic solution, avoids bringing such as destructive consequences such as craniocerebral injuries.
The difference of the present invention and moxifloxacin hydrochloride sodium chloride injection maximum is significantly to have reduced chloride ion, and replaces metabolizable anion: acetate or lactate.Acetate or lactate ion can be discharged CO by oxidative metabolism
2, produce alkaline environment, avoided the acidosic risk of high chlorine metabolic.The present invention is by adding potassium, calcium, magnesium to reduce the sodium load.
2, Moxifloxacin or its salt dissolubility are strong in the Moxifloxacin electrolyte solution, and finished product is stable.After the present invention placed 10 days through 60 ℃, its character, pH value, particulate matter, visible foreign matters, related substance, each Main Ingredients and Appearance content did not all have significant change, and pharmaceutical composition stable in properties of the present invention is described.Sodium lactate ringer's injection or sodium acetate ringer's injection can improve the stability of the water solublity and the aqueous solution of moxifloxacin hydrochloride.
The dissolubility (20 ℃) of table 1 Moxifloxacin hydrochlorate in each solution
| Solution | Dissolubility % (w/v) |
| 0.9% sodium chloride injection | 0.174 |
| Sodium lactate ringer's injection | 0.205 |
| The sodium acetate ringer's injection | 0.201 |
Put down in writing among this and the Chinese patent ZL00811427.7, in the presence of 5 ℃ of temperature and 0.9% sodium chloride (w/v), the dissolubility of Moxifloxacin hydrochlorate is that 0.1% (w/v) is variant, reason is that the present invention requires to select 20 ℃ of dissolubility situations of investigating moxifloxacin hydrochloride of room temperature condition according to final formulation products storage, in the hope of reacting the steadiness of moxifloxacin hydrochloride in normal put procedure more accurately.
The specific embodiment
Comparative Examples 1
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium lactate 2.8 grams
Potassium chloride 0.27 gram
Calcium chloride (CaCl
2.2H
2O) 0.18 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate, moxifloxacin hydrochloride, potassium chloride, calcium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 2
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium lactate 3.1 grams
Potassium chloride 0.30 gram
Calcium chloride (CaCl
2.2H
2O) 0.20 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate, moxifloxacin hydrochloride, potassium chloride, calcium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 3
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium lactate 3.4 grams
Potassium chloride 0.33 gram
Calcium chloride (CaCl
2.2H
2O) 0.22 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate, moxifloxacin hydrochloride, potassium chloride, calcium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 4
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 2.58 grams
Potassium chloride 0.36 gram
Magnesium chloride (MgCl
2.6H
2O) 0.16 gram
Calcium chloride (CaCl
2.2H
2O) 0.11 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate, moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 5
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.17 grams
Potassium chloride 0.40 gram
Magnesium chloride (MgCl
2.6H
2O) 0.20 gram
Calcium chloride (CaCl
2.2H
2O) 0.13 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate, moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 6
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.80 grams
Potassium chloride 0.44 gram
Magnesium chloride (MgCl
2.6H
2O) 0.24 gram
Calcium chloride (CaCl
2.2H
2O) 0.16 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate, moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank, add the injection water to full amount through the titanium rod, and adjusting pH4.5～7.0, filter packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes through the 0.2um filter.
Comparative Examples 7
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium lactate 2.8 grams
Potassium chloride 0.27 gram
Calcium chloride (CaCl
2.2H
2O) 0.18 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Comparative Examples 8
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium lactate 3.1 grams
Potassium chloride 0.30 gram
Calcium chloride (CaCl
2.2H
2O) 0.20 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Comparative Examples 9
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium lactate 3.4 grams
Potassium chloride 0.33 gram
Calcium chloride (CaCl
2.2H
2O) 0.22 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Comparative Examples 10
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 2.58 grams
Potassium chloride 0.36 gram
Magnesium chloride (MgCl
2.6H
2O) 0.16 gram
Calcium chloride (CaCl
2.2H
2O) 0.11 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Comparative Examples 11
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.17 grams
Potassium chloride 0.40 gram
Magnesium chloride (MgCl
2.6H
2O) 0.20 gram
Calcium chloride (CaCl
2.2H
2O) 0.13 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Comparative Examples 12
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.80 grams
Potassium chloride 0.44 gram
Magnesium chloride (MgCl
2.6H
2O) 0.24 gram
Calcium chloride (CaCl
2.2H
2O) 0.16 gram
Water for injection to 1000 milliliter
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
To place 10 days for 60 ℃ by the moxifloxacin hydrochloride sodium lactate ringer's injection and the moxifloxacin hydrochloride sodium acetate ringer's injection sample of Comparative Examples preparation, measure every quality standard,, the results are shown in Table 2 with comparison in 0 day.
Conclusion: by the moxifloxacin hydrochloride sodium lactate ringer's injection and the moxifloxacin hydrochloride sodium acetate ringer's injection of Comparative Examples 1～6 preparation, the content of Moxifloxacin, potassium chloride, calcium chloride and magnesium chloride is against regulation in the time of 0 day, shows that active carbon has bigger absorption to the few component of recipe quantity; After 10 days, character, visible foreign matters, particulate matter are all undesirable 60 ℃ of placements, show moxifloxacin hydrochloride sodium lactate ringer's injection and moxifloxacin hydrochloride sodium acetate ringer's injection instability by Comparative Examples 1～6 preparation.
Moxifloxacin hydrochloride sodium lactate ringer's injection and moxifloxacin hydrochloride sodium acetate ringer's injection by Comparative Examples 7～12 preparations, the content of Moxifloxacin, potassium chloride, calcium chloride and magnesium chloride is up to specification in the time of 0 day, but 60 ℃ place 10 days after, character, visible foreign matters, particulate matter are all undesirable, show moxifloxacin hydrochloride sodium lactate ringer's injection and moxifloxacin hydrochloride sodium acetate ringer's injection instability by Comparative Examples 7～12 preparations.
Embodiment 1
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium lactate 2.8 grams
Potassium chloride 0.27 gram
Calcium chloride (CaCl
2.2H
2O) 0.18 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain the calcium chloride concentrated solution.
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Embodiment 2
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium lactate 3.1 grams
Potassium chloride 0.30 gram
Calcium chloride (CaCl
2.2H
2O) 0.20 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain the calcium chloride concentrated solution.
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Embodiment 3
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium lactate 3.4 grams
Potassium chloride 0.33 gram
Calcium chloride (CaCl
2.2H
2O) 0.22 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain the calcium chloride concentrated solution.
Recipe quantity sodium chloride, sodium lactate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Embodiment 4
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
Sodium chloride 5.4 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 2.58 grams
Potassium chloride 0.36 gram
Magnesium chloride (MgCl
2.6H
2O) 0.16 gram
Calcium chloride (CaCl
2.2H
2O) 0.11 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, magnesium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain calcium magnesium concentrated solution.
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Embodiment 5
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
Sodium chloride 6.0 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.17 grams
Potassium chloride 0.40 gram
Magnesium chloride (MgCl
2.6H
2O) 0.20 gram
Calcium chloride (CaCl
2.2H
2O) 0.13 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, magnesium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain calcium magnesium concentrated solution.
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
Embodiment 6
The preparation of Moxifloxacin sodium acetate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
Sodium chloride 6.6 grams
Sodium acetate (C
2H
3NaO
2.3H
2O) 3.80 grams
Potassium chloride 0.44 gram
Magnesium chloride (MgCl
2.6H
2O) 0.24 gram
Calcium chloride (CaCl
2.2H
2O) 0.16 gram
Water for injection to 1000 milliliter
Take by weighing recipe quantity calcium chloride, magnesium chloride, add an amount of water for injection dissolving, and add proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain calcium magnesium concentrated solution.
Recipe quantity sodium chloride, sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
To place 10 days for 60 ℃ by the moxifloxacin hydrochloride sodium lactate ringer's injection and the moxifloxacin hydrochloride sodium acetate ringer's injection sample of embodiment preparation, measure every quality standard,, the results are shown in Table 3 with comparison in 0 day.
Conclusion: moxifloxacin hydrochloride sodium lactate ringer's injection and moxifloxacin hydrochloride sodium acetate ringer's injection by embodiment of the invention preparation were placed 10 days at 60 ℃, with comparison in 0 day, every quality index does not have significant change, all meet the requirements, moxifloxacin hydrochloride balanced electrolyte solution steady quality of the present invention is described.
Claims (8)
1. pharmaceutical composition that contains Moxifloxacin is characterized in that said composition is made up of Moxifloxacin or its salt and balanced electrolyte solution, and described balanced electrolyte solution is selected from sodium lactate ringer's injection or sodium acetate ringer's injection.
2. pharmaceutical composition according to claim 1 is characterized in that the content range of Moxifloxacin in this pharmaceutical composition or its salt (by Moxifloxacin) is: contain 0.1～0.4 gram among every 100ml.
3. pharmaceutical composition according to claim 1 is characterized in that the sodium lactate ringer's injection electrolyte consists of in this pharmaceutical composition: sodium chloride-containing 0.54～0.66 gram, sodium lactate 0.28～0.34 gram, potassium chloride 0.027～0.033 gram, calcium chloride (CaCl among every 100ml
2.2H
2O) 0.018～0.022 gram.
4. pharmaceutical composition according to claim 1 is characterized in that sodium acetate ringer's injection electrolyte consists of in this pharmaceutical composition: sodium chloride-containing 0.54～0.66 gram, sodium acetate (C among every 100ml
2H
3NaO
2.3H
2O) 0.25～0.38 gram, potassium chloride 0.036～0.044 gram, magnesium chloride (MgCl
2.6H
2O) 0.016～0.024 gram, calcium chloride (CaCl
2.2H
2O) 0.011～0.016 gram.
5. each described preparation of drug combination method in the claim 1～4, it is characterized in that comprising following steps: take by weighing recipe quantity calcium chloride or magnesium chloride and calcium chloride, add an amount of water for injection dissolving, and adding proper amount of active carbon, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes obtain calcium chloride concentrated solution or calcium magnesium concentrated solution;
Recipe quantity sodium chloride, sodium lactate or sodium acetate are added in the dense preparing tank, add an amount of water for injection, the heated and stirred dissolving, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through the titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution or calcium magnesium concentrated solution, add the injection water to full amount, and regulate pH4.5～7.0, filter through the 0.2um filter, packing, the damp and hot 115 degree sterilizations in sealing back 30 minutes.
6. each described pharmaceutical composition in the claim 1～4, it is an injection.
7. the described pharmaceutical composition of claim 6, the specification of wherein said injection is 50ml, 100ml, 250ml or 500ml.
8. the application of each described pharmaceutical composition in the medicine of preparation treatment human or animal bacterial infection in the claim 1～4.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010280041.2A CN101972257B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
| CN201410132555.1A CN103919779B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010280041.2A CN101972257B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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| CN201410132555.1A Division CN103919779B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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| CN101972257A true CN101972257A (en) | 2011-02-16 |
| CN101972257B CN101972257B (en) | 2015-08-05 |
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| CN201010280041.2A Expired - Fee Related CN101972257B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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| CN201410132555.1A Active CN103919779B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432163A (en) * | 2013-09-05 | 2013-12-11 | 王杰华 | Acetate Ringer's injection and preparation method thereof |
| CN107184547A (en) * | 2017-05-27 | 2017-09-22 | 江苏苏南药业实业有限公司 | Moxifloxacin hydrochloride injection for treating respiratory tract infection |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1368891A (en) * | 1999-08-06 | 2002-09-11 | 拜尔公司 | Moxilfloxacin formulation containing common salt |
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|---|---|---|---|---|
| CN1184963C (en) * | 2002-09-10 | 2005-01-19 | 张嵩 | Bromhexine hydrochloride injection and its preparation method |
| CN1726917A (en) * | 2005-07-26 | 2006-02-01 | 湖北丽益医药科技有限公司 | Ganciclovir lactated ringer solution and preparation method |
| CN1729977A (en) * | 2005-08-22 | 2006-02-08 | 吴祥根 | Freeze dry powdered injection of moxfloxacin or its salts and preparation process thereof |
| CN101822690B (en) * | 2010-05-20 | 2012-08-08 | 西安万隆制药有限责任公司 | Composition of dextran 40 and sodium lactate Ringer' solution and preparation method |
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2010
- 2010-09-10 CN CN201410132555.1A patent/CN103919779B/en active Active
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1368891A (en) * | 1999-08-06 | 2002-09-11 | 拜尔公司 | Moxilfloxacin formulation containing common salt |
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| （杨章群 等: "《复方醋酸钠注射液处方的改进及临床应用》", 《中国药师》, vol. 9, no. 12, 31 December 2006 (2006-12-31), pages 1166 * |
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| 李文硕: "《临床应用复方乳酸钠系列输液剂的评价》", 《中国急救医学》, vol. 7, no. 1, 31 December 1987 (1987-12-31), pages 41 - 1 * |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432163A (en) * | 2013-09-05 | 2013-12-11 | 王杰华 | Acetate Ringer's injection and preparation method thereof |
| CN107184547A (en) * | 2017-05-27 | 2017-09-22 | 江苏苏南药业实业有限公司 | Moxifloxacin hydrochloride injection for treating respiratory tract infection |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103919779A (en) | 2014-07-16 |
| CN101972257B (en) | 2015-08-05 |
| CN103919779B (en) | 2016-02-10 |
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