CN101972257B - A kind of pharmaceutical composition containing Moxifloxacin - Google Patents
A kind of pharmaceutical composition containing Moxifloxacin Download PDFInfo
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- CN101972257B CN101972257B CN201010280041.2A CN201010280041A CN101972257B CN 101972257 B CN101972257 B CN 101972257B CN 201010280041 A CN201010280041 A CN 201010280041A CN 101972257 B CN101972257 B CN 101972257B
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- moxifloxacin
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Abstract
The present invention relates to a kind of pharmaceutical composition containing Moxifloxacin, it is characterized in that it is made up of Moxifloxacin or its salt and balanced electrolyte solution, balanced electrolyte solution is selected from sodium lactate ringer's injection or sodium acetate ringer injection.Pharmaceutical composition of the present invention, Moxifloxacin or its salt dissolubility good, lessly cause metabolic acidosis, while carrying out antibacterial therapy, body fluid, electrolyte and acid-base balance can also be regulated.Pharmaceutical composition stable in properties of the present invention.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, specifically, relate to a kind of pharmaceutical composition containing Moxifloxacin, belong to field of pharmaceutical preparations.
Background technology
Moxifloxacin (Moxifloxacin) is the quinolonecarboxylic acid class antibiotics with broad spectrum antibiotic activity generally used clinically, the activity of its anti-non-zymocyte, staphylococcus, streptococcus pneumoniae, enterococcus and anaerobe is 2 ~ 16 times of ciprofloxacin and ofloxacin, there is 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 infection key position.
For can not the patient with severe symptoms of oral administration, development injection has clinical meaning.
Chinese patent ZL00811427.7 provides the water formulation containing 0.04% ~ 0.4%w/v moxifloxacin hydrochloride (based on Moxifloxacin) and 0.4% ~ 0.9%w/v sodium chloride.Find during exploitation Moxifloxacin hydrochloride injection, add 5% commercial glucose or other Saccharide and saccharide alcohols, the glycerol as 2.5% carries out isotonic adjustment, can only obtain the labile solution of Moxifloxacin, and sub-visual granule appears in this instability performance in the solution.Insensitive to iron ion with the moxifloxacin hydrochloride pharmaceutical preparation of the isotonic adjustment of sodium chloride.Said preparation is made up of Moxifloxacin and sodium chloride, when it uses, there is the deficiency easily causing perchloric acid metabolic acidosis.
The prescription of aqueous solution described in US6916484 can comprise Moxifloxacin or its salt, but ferrum described in it contained by aqueous solution preparation will lower than 20ppb, or more preferably less than 10ppb.This poor operability controlled in the industrial production, and production cost is high.
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 declare in Chinese patent application 200910255714.6, the Moxifloxacin solution adding Aspartic Acid or glycine is placed 10 days at 60 DEG C, 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 containing Moxifloxacin or quinolones, but lyophilized formulations is due to can not pressure sterilizing, low compared to injection sterility assurance level, production cost is high, and need to add solvent before use to redissolve, use inconvenience.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition containing 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, be made up of Moxifloxacin or its salt and balanced electrolyte solution, described balanced electrolyte solution is selected from sodium lactate ringer's injection or sodium acetate ringer injection.
In every 100ml pharmaceutical composition, the content of Moxifloxacin or its salt is 0.1 ~ 0.4 gram (by Moxifloxacin).
Sodium lactate ringer's injection in pharmaceutical composition of the present invention, sodium chloride-containing 0.54 ~ 0.66 gram, sodium lactate 0.28 ~ 0.34 gram, 0.027 ~ 0.033 gram, potassium chloride, calcium chloride (CaCl in every 100ml drug regimen
2.2H
2o) 0.018 ~ 0.022 gram.
Sodium acetate ringer injection in 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, 0.036 ~ 0.044 gram, potassium chloride, 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 preparation method of the described pharmaceutical composition containing Moxifloxacin.Described method comprises following steps:
Take recipe quantity calcium chloride or magnesium chloride and calcium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium chloride concentrated solution or calcium magnesium concentrated solution;
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate or sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity Moxifloxacin or its salt, potassium chloride, calcium chloride concentrated solution or calcium magnesium concentrated solution, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
In preparation process, first by sodium chloride larger for recipe quantity, sodium lactate or sodium acetate, and containing the calcium chloride of polyvalent metal ion or calcium chloride and magnesium chloride, use the activated carbon adsorption of Sq respectively, then add moxifloxacin hydrochloride, thus stable moxifloxacin hydrochloride solution can be prepared.By this preparation technology, can reduce to greatest extent affects impurity in solution, increases stability of solution; The Adsorption Effect of active carbon to each component can be improved again simultaneously, reduce the loss in process of production of each prescription component.
Pharmaceutical composition containing 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 the pharmaceutical composition containing Moxifloxacin in the medicine of preparation treatment human or animal bacteriological infection.
The present invention compared with prior art has following advantage:
1, safety is better, lessly causes metabolic acidosis, and the incidence rate reduced in water and the impact on Liver and kidney function.Thing of the present invention, while carrying out antibacterial therapy, can also regulate body fluid, electrolyte and acid-base balance.
Pharmaceutical composition containing Moxifloxacin of the present invention, can be used for the bacteriological infection for the treatment of human or animal, as being used for the treatment of upper respiratory tract and lower respiratory infection, as: acute sinusitis, acute episode of chronic bronchitis, community acquired pneumonia and Skin and soft tissue infection.
Electrolyte in the present invention forms the electrolyte solution of similar extracellular fluid, containing close to the cation potassium of normal plasma concentration, sodium, calcium and anion chlorine, and organic anion acetate or lactate.The electrolyte composition of the electrolyte solution compositional modeling blood plasma in composition, makes this product be isosmotic solution, avoids bringing the destructive consequences such as such as craniocerebral injury.
The present invention and the maximum difference of moxifloxacin hydrochloride injection are to significantly reduce chloride ion, and replace metabolizable anion: acetate or lactate.Acetate or lactate ion can discharge CO by oxidative metabolism
2, produce alkaline environment, avoid the acidosic risk of high chlorine metabolic.The present invention is by adding potassium, calcium, magnesium to reduce sodium load.
2, in Moxifloxacin electrolyte solution, Moxifloxacin or its salt dissolubility are strong, and finished product is stablized.The present invention is after 60 DEG C are placed 10 days, and its character, pH value, particulate matter, visible foreign matters, related substance, each Main Ingredients and Appearance content all do not have significant change, and pharmaceutical composition stable in properties of the present invention is described.Sodium lactate ringer's injection or sodium acetate ringer injection can improve the water solublity of moxifloxacin hydrochloride and the stability of aqueous solution.
The dissolubility of table 1 moxifloxacin hydrochloride in each solution (20 DEG C)
| Solution | Dissolubility % (w/v) |
| 0.9% sodium chloride injection | 0.174 |
| Sodium lactate ringer's injection | 0.205 |
| Sodium acetate ringer injection | 0.201 |
Record in this and Chinese patent ZL00811427.7, under 5 DEG C of temperature and 0.9% sodium chloride (w/v) exist, the dissolubility of moxifloxacin hydrochloride is that 0.1% (w/v) is variant, reason is that the present invention selects room temperature condition 20 DEG C to investigate the dissolubility situation of moxifloxacin hydrochloride, to reacting the steadiness of moxifloxacin hydrochloride in normal put procedure more accurately according to final formulation products Storage Requirement.
Detailed description of the invention
Comparative example 1
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium lactate 2.8 grams
0.27 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 2
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium lactate 3.1 grams
0.30 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 3
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium lactate 3.4 grams
0.33 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 4
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 2.58 grams
0.36 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 5
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.17 grams
0.40 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 6
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.80 grams
0.44 gram, potassium chloride
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 dense preparing tank, add appropriate water for injection, heated and stirred is dissolved, and adds proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 7
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium lactate 2.8 grams
0.27 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.18 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 8
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium lactate 3.1 grams
0.30 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.20 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 9
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium lactate 3.4 grams
0.33 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.22 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 10
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 2.58 grams
0.36 gram, potassium chloride
Magnesium chloride (MgCl
2.6H
2o) 0.16 gram
Calcium chloride (CaCl
2.2H
2o) 0.11 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 11
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.17 grams
0.40 gram, potassium chloride
Magnesium chloride (MgCl
2.6H
2o) 0.20 gram
Calcium chloride (CaCl
2.2H
2o) 0.13 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Comparative example 12
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.80 grams
0.44 gram, potassium chloride
Magnesium chloride (MgCl
2.6H
2o) 0.24 gram
Calcium chloride (CaCl
2.2H
2o) 0.16 gram
Water for injection to 1000 milliliter
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride, magnesium chloride, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
The moxifloxacin hydrochloride sodium lactate ringer's injection prepared by comparative example and 60 DEG C, moxifloxacin hydrochloride sodium acetate ringer injection sample are placed 10 days, measures every quality standard, compared with 0 day, the results are shown in Table 2.
Conclusion: the moxifloxacin hydrochloride sodium lactate ringer's injection prepared by comparative example 1 ~ 6 and moxifloxacin hydrochloride sodium acetate ringer injection, when 0 day, the content of Moxifloxacin, potassium chloride, calcium chloride and magnesium chloride is against regulation, shows that the component that active carbon is few to recipe quantity has larger absorption; After placing 10 days at 60 DEG C, character, visible foreign matters, particulate matter are all undesirable, show the moxifloxacin hydrochloride sodium lactate ringer's injection by comparative example 1 ~ 6 preparation and moxifloxacin hydrochloride sodium acetate ringer injection instability.
The moxifloxacin hydrochloride sodium lactate ringer's injection prepared by comparative example 7 ~ 12 and moxifloxacin hydrochloride sodium acetate ringer injection, when 0 day, the content of Moxifloxacin, potassium chloride, calcium chloride and magnesium chloride conforms with the regulations, but after placing 10 days at 60 DEG C, character, visible foreign matters, particulate matter are all undesirable, show the moxifloxacin hydrochloride sodium lactate ringer's injection by comparative example 7 ~ 12 preparation and moxifloxacin hydrochloride sodium acetate ringer injection instability.
Embodiment 1
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium lactate 2.8 grams
0.27 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.18 gram
Water for injection to 1000 milliliter
Take recipe quantity calcium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium chloride concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Embodiment 2
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium lactate 3.1 grams
0.30 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.20 gram
Water for injection to 1000 milliliter
Take recipe quantity calcium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium chloride concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Embodiment 3
The preparation of Moxifloxacin sodium lactate ringer's injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium lactate 3.4 grams
0.33 gram, potassium chloride
Calcium chloride (CaCl
2.2H
2o) 0.22 gram
Water for injection to 1000 milliliter
Take recipe quantity calcium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium chloride concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium lactate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Embodiment 4
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.0 grams (by Moxifloxacin)
5.4 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 2.58 grams
0.36 gram, potassium chloride
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 recipe quantity calcium chloride, magnesium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium magnesium concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Embodiment 5
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 1.6 grams (by Moxifloxacin)
6.0 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.17 grams
0.40 gram, potassium chloride
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 recipe quantity calcium chloride, magnesium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium magnesium concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
Embodiment 6
The preparation of Moxifloxacin sodium acetate ringer injection:
Moxifloxacin hydrochloride 2.0 grams (by Moxifloxacin)
6.6 grams, sodium chloride
Sodium acetate (C
2h
3naO
2.3H
2o) 3.80 grams
0.44 gram, potassium chloride
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 recipe quantity calcium chloride, magnesium chloride, add appropriate water for injection and dissolve, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium magnesium concentrated solution.
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium magnesium concentrated solution, and inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
The moxifloxacin hydrochloride sodium lactate ringer's injection prepared by embodiment and 60 DEG C, moxifloxacin hydrochloride sodium acetate ringer injection sample are placed 10 days, measures every quality standard, compared with 0 day, the results are shown in Table 3.
Conclusion: the moxifloxacin hydrochloride sodium lactate ringer's injection prepared by the embodiment of the present invention and moxifloxacin hydrochloride sodium acetate ringer injection are placed 10 days at 60 DEG C, compared with 0 day, every quality index is without significant change, all meet the requirements, moxifloxacin hydrochloride balanced electrolyte solution steady quality of the present invention is described.
Claims (4)
1. the pharmaceutical composition containing Moxifloxacin, it is characterized in that said composition is made up of Moxifloxacin or its salt and sodium acetate ringer injection, specifically consist of: in every 100ml containing Moxifloxacin or its salt 0.1 ~ 0.4 gram by Moxifloxacin, 0.54 ~ 0.66 gram, sodium chloride, sodium acetate C
2h
3naO
2.3H
200.25 ~ 0.38 gram, 0.036 ~ 0.044 gram, potassium chloride, magnesium chloride Mg Cl
2.6H
200.016 ~ 0.024 gram, calcium chloride CaCl
2.2H
200.011 ~ 0.016 gram.
2. the preparation method of pharmaceutical composition according to claim 1, is characterized in that preparing according to the following steps: take recipe quantity magnesium chloride and calcium chloride, adds appropriate water for injection and dissolves, and add proper amount of active carbon, subpackage, after sealing, damp and hot 115 degree of sterilizings 30 minutes, obtain calcium chloride magnesium concentrated solution;
Add in dense preparing tank by recipe quantity sodium chloride, sodium acetate, add appropriate water for injection, heated and stirred is dissolved, add proper amount of active carbon, stir, boil insulation 30 minutes, be filtered to dilute preparing tank through titanium rod, add recipe quantity moxifloxacin hydrochloride, potassium chloride, calcium chloride magnesium concentrated solution, inject water to full amount, and regulate pH4.5 ~ 7.0, through 0.2um frit, subpackage, damp and hot 115 degree of sterilizings 30 minutes after sealing.
3. pharmaceutical composition according to claim 1, it is injection, and the specification of injection is 50ml, 100ml, 250ml or 500ml.
4. the application of pharmaceutical composition according to claim 1 in the medicine of preparation treatment human or animal bacteriological infection.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410132555.1A CN103919779B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
| CN201010280041.2A CN101972257B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010280041.2A CN101972257B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410132555.1A Division CN103919779B (en) | 2010-09-10 | 2010-09-10 | A kind of pharmaceutical composition containing Moxifloxacin |
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| CN103432163B (en) * | 2013-09-05 | 2015-06-17 | 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 |
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| 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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| CN1368891A (en) * | 1999-08-06 | 2002-09-11 | 拜尔公司 | Moxilfloxacin formulation containing common salt |
Non-Patent Citations (4)
| Title |
|---|
| (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》.2006,第9卷(第12期),第1166页. * |
| 《临床上输液的进展》;幸保文治;《日本医学介绍》;19851231;第6卷(第11期);第493页 * |
| 《临床应用复方乳酸钠系列输液剂的评价》;李文硕;《中国急救医学》;19871231;第7卷(第1期);第41页左栏第1段 * |
| 平衡液在临床上的应用;梁陪茂;《右江医学》;19811231(第1期);第17页 * |
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| CN103919779A (en) | 2014-07-16 |
| CN103919779B (en) | 2016-02-10 |
| CN101972257A (en) | 2011-02-16 |
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