CN103505407A - Multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation - Google Patents
Multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation Download PDFInfo
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- CN103505407A CN103505407A CN201210204750.1A CN201210204750A CN103505407A CN 103505407 A CN103505407 A CN 103505407A CN 201210204750 A CN201210204750 A CN 201210204750A CN 103505407 A CN103505407 A CN 103505407A
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Abstract
The invention discloses a multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation which comprises at least two chamber bags, chambers are separated by weak sealing parts, wherein moxifloxacin hydrochloride and glucose are respectively stored in different chambers, a chamber storing the glucose and a chamber storing the moxifloxacin hydrochloride are adjacent, the moxifloxacin hydrochloride is stored in the chamber in a form of an aqueous solution or powder, and the glucose is stored in the form of an aqueous solution. Through extrusion of the chambers filled with solutions, the weak sealing parts are opened, the chambers are connected to form a closed system to mix to obtain the clinically used moxifloxacin hydrochloride/glucose injection, after mixing, the concentration of the moxifloxacin hydrochloride is 0.16%-0.4%, and the concentration of the glucose is 5%. The multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation solves the problems that at high temperature, moxifloxacin has no long term compatibility with the glucose, insoluble particles may be produced, particle solubility may be reduced by sodium chloride and the insoluble particles may also be produced due to low temperature.
Description
Technical field
The present invention relates to a kind of moxifloxacin hydrochloride/D/W preparation, be specifically related to a kind of moxifloxacin hydrochloride/D/W preparation of multi-chamber-bag packing, belong to medical technical field.
Background technology
Moxifloxacin (Moxifloxacin) be Beyer Co., Ltd's exploitation the 4th generation quinolones broad spectrum antibiotic, be wide spectrum and the 8-methoxy fluoroquinolone class antimicrobial drug with antibacterial activity.Moxifloxacin demonstrates in vitro has broad spectrum antibiotic activity to gram positive bacteria, gram-negative bacteria, anaerobe, acid fast bacteria and atypical microorganism as mycoplasma, chlamydia and legionella.Antibacterial mechanisms is for disturbing II, IV topoisomerase.Topoisomerase be control DNA topological sum DNA replication dna, the key enzyme in repairing and transcribing.Moxifloxacin is active high in vivo.
The Moxifloxacin preparation of Beyer Co., Ltd's listing is mainly moxifloxacin chloride tablets agent and injection, moxifloxacin chloride tablets agent at present and the listing of injection Jun Yi China.The structural formula of moxifloxacin hydrochloride is as follows:
Beyer Co., Ltd is moxifloxacin hydrochloride injection at the moxifloxacin hydrochloride injection of Discussion on Chinese Listed, visits simultaneously
Ear company has applied for that in China the patent No. is ZL00811427.7, and the patent of invention that denomination of invention is " Moxifloxacin sodium chloride preparation " is protected this injection product.In this patent specification, record, when during as osmotic pressure regulator, obtaining unsettled Moxifloxacin solution with 5% glucose solution, at 40 ℃, store 4-8 and can form brown amorphous pellets after week, the limit or the security concern that have surpassed regulation, so abandoned research; Therefore in order to meet clinical demand, made sodium chloride transfusion, for clinical.But this patent is pointed out simultaneously, owing to having reduced the dissolubility of Moxifloxacin adding of sodium chloride, in low temperature storage, a few weeks longer can produce insoluble granule equally, just at room temperature can recover.Can produce safety issue equally like this: 1) may have a lot of sightless granules to exist, in input patient body, produce granuloma; 2) to be what has to be identified actually for these insoluble granules, may be also new material, and its security concern exists equally.3) due to adding of sodium chloride, reduce the water solublity of Moxifloxacin, existed in the processes such as transportation in winter and produce crystal or larger insoluble granule, so more can cause safety issue, can cause the worry of quality aspect.
In order to overcome above-mentioned technical problem, number of patent application is 201110008974, denomination of invention discloses a kind of novel moxifloxacin hydrochloride injection for " a kind of new moxifloxacin hydrochloride injection ", this technical scheme outstanding behaviours is the injection with small volume that contains moxifloxacin hydrochloride, high-capacity injection, concentrated solution for injection, injection freeze-dried powder, aseptic freeze dried powder needle for injection has been equipped with special solvent, this special solvent is sugar or the sugar alcohol solution of 5%-10%, this special solvent is just moxifloxacin hydrochloride with active component before clinical use, and injection is used in conjunction with.Technique scheme can overcome the technical problem of Moxifloxacin and glucose generation labile solution in theory, but what this technical scheme was given prominence to the key points dilutes or the method for mixing little liquid drugs injection, powder pin is those skilled in the art's conventional method with special solvent, and the packaged form of this separately packing is also for bringing a lot of inconvenience in transportation, clinical use, and particularly the frangible fact of glass packaging has increased the security risk of medication.This form can produce potential safety hazard clinically equally, because be two, separate independently system, during application, just must open two packs and mixes, in the process of opening, unavoidably can introduce foreign body like this, simultaneously with air contact position, secondary pollution be can produce, medical worker's operation burden and the worry of secure context more increased.
Summary of the invention
The object of the invention is to provide a kind of moxifloxacin hydrochloride/D/W preparation of stable, safe, clinical multi-chamber-bag easy to use packing.
The present invention seeks to be achieved through the following technical solutions.
A kind of moxifloxacin hydrochloride/D/W preparation of multi-chamber-bag packing, it is characterized in that said preparation is by being at least present in two powder and/or solution compositions in chamber bag, between each chamber, by weak envelope portion, separated, wherein moxifloxacin hydrochloride and glucose leave in respectively in different chambers, and the chamber of depositing glucose is adjacent with the chamber of depositing moxifloxacin hydrochloride; Described moxifloxacin hydrochloride is to take the moxifloxacin aqueous solution form that Moxifloxacin powder type that content is 0.3g-0.8g or concentration is 0.4%-0.8% to be present in chamber, and the self-existent glucose of adjacent chamber is to take the form of the aqueous solution that concentration is 5%-10% to exist.
Preferably, moxifloxacin hydrochloride/D/W preparation You Liangge chamber bag of multi-chamber-bag packing of the present invention forms, and is respectively self-existent moxifloxacin hydrochloride solution and glucose solution in two adjacent chamber.Preferably, after mixing, the concentration of moxifloxacin hydrochloride is 0.2%(W/V).
Described moxifloxacin hydrochloride aqueous solution can be prepared as follows: moxifloxacin hydrochloride powder is dissolved in water for injection, filters, obtain; Described D/W can be prepared as follows: glucose is dissolved in water for injection, adds active carbon, filter, adjust pH value to be stabilized in 3.8-4.5, obtain.
Moxifloxacin hydrochloride/D/W preparation of multi-chamber-bag packing of the present invention is full of the chamber of solution by extruding, weak envelope portion opens, each chamber is communicated with and becomes an individual system, mix, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, after mixing, the concentration of moxifloxacin hydrochloride is 0.16%-0.4%(W/V), the concentration of glucose is 5%(W/V).
In order to obtain the concentration of moxifloxacin hydrochloride, be 0.16%-0.4%(W/V), the concentration of glucose is 5%(W/V) the agent of moxifloxacin hydrochloride/glucose injection, when moxifloxacin hydrochloride or glucose are all independently present in two adjacent two chambers of chamber bag with aqueous solution form, the concentration of moxifloxacin hydrochloride aqueous solution is for being greater than 0.16%-0.4%(W/V) (with moxifloxacin hydrochloride dissolubility, being limited), D/W concentration is less than 50% conventionally for being greater than 5%(), the two mixed moxifloxacin hydrochloride/glucose injection agent, the concentration that is moxifloxacin hydrochloride is 0.16%-0.4%(W/V), the concentration of described glucose is 5%(W/V).
The preferred Yong Shuan of the present invention chamber bag packing, but be not limited to two chambers bag packing, equally can Yong San chamber bag or multi-chamber-bag packing, by concentration after described mixing, be 0.16%-0.4%(W/V as required) moxifloxacin hydrochloride and concentration be 5%(W/V) glucose solution is independently stored in one or more chambers.When the chamber of depositing moxifloxacin hydrochloride is during more than 1, can there are powder or two kinds of forms of solution in moxifloxacin hydrochloride simultaneously.
Moxifloxacin hydrochloride and glucose are mixed into after the moxifloxacin hydrochloride/glucose injection agent that meets clinical use, and the concentration of moxifloxacin hydrochloride is 0.16%-0.4%(W/V), the concentration of described glucose is 5%(W/V).Now, the osmotic pressure of moxifloxacin hydrochloride/glucose injection agent, in the scope of normal human's colloidal osmotic pressure 285-320m0smol/kg, has guaranteed the safety of clinical use.
Term " %(W/V) " refer to unit of weight in every 100 ml volumes solvents for gram the quantity of solute, i.e. g/100ml.
Moxifloxacin/D/W preparation of multi-chamber-bag disclosed by the invention packing solved temperature when higher Moxifloxacin can not with the long-time compatibility of sugar, produce insoluble granule; Sodium chloride reduces again its dissolubility, and low temperature produces the problem of insoluble granule equally simultaneously.Simultaneously very stable of Moxifloxacin/D/W preparation provided by the invention, can not produce particulate matter, simultaneously preparation technology simple, facilitate clinical use and transport, storage etc.And be divided in two and independently in chamber, mix, in a closed system, carry out, avoided foreign body to enter and secondary pollution problem.Moxifloxacin/D/W preparation of multi-chamber-bag packing disclosed by the invention, as parenteral, particularly subcutaneous or intravenous administration, is used for the treatment of or pre-bacteriological protection infection.
Following experimental example and embodiment are used for further illustrating but are not limited to the present invention.
Experimental example 1: study on the stability
The present invention is through test repeatedly, be surprised to find, in Moxifloxacin/D/W preparation of multi-chamber-bag packing, needn't add any additives, particularly PH regulator, at the two, be mixed to get after moxifloxacin hydrochloride/glucose injection agent of clinical use, stability is very good.
(sample source: press embodiment 1 preparation).
Study on the stability result is as following table:
Table 1 study on the stability result
| All numbers | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| PH value | 4.5 | 4.4 | 4.0 | 3.9 | 4.8 | 4.5 | 4.3 | 4.6 |
| Particulate matter | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing |
| Related substance % | 0.03 | 0.03 | 0.03 | 0.04 | 0.04 | 0.05 | 0.05 | 0.06 |
| Content % | 100.5 | 100.4 | 100.4 | 100.5 | 100.4 | 100.2 | 100.2 | 100.1 |
Upper table data reflect, the stability of product is fine, do not have insoluble granule to produce, and pH value changes not quite simultaneously, has guaranteed the safety of clinical practice.
Experimental example 2: test is investigated in the compatibility of drug product of the present invention and packaging material
11, project is investigated in pharmaceutical preparation
1) mix prodrug and investigate project
Moxifloxacin hydrochloride solution: the clarity of character, solution and color, pH value, particulate matter, visible foreign matters.Glucose solution: the clarity of character, solution and color, pH value, particulate matter, loading amount, visible foreign matters.
2) mix rear medicine and investigate project: the clarity of character, solution and color, pH value, particulate matter, related substance.Sample source: press embodiment 1 preparation.
2, experimental condition and result
Long term test (25 ℃ ± 2 ℃ RH40% ± 5%): test specimen is placed in to 25 ℃ ± 2 ℃ of temperature, relative humidity is to keep flat under 40% ± 5% condition, respectively at 0,3,6,9, December sampling detects, and after 12 months, in sampling in 18,24,36 months, detects, result of the test is in Table 2-table 4.
Table 2 medicine long-term test results-1
Table 3 medicine long-term test results-2
3, conclusion (of pressure testing):
(1) Moxifloxacin/D/W preparation of two chambers bag packing is investigated 12 months through long term test (25 ℃ ± 2 ℃ RH40% ± 5%), with sample data comparison in 0 month, and the equal no significant difference of indices in packaging material investigation and pharmaceutical preparation investigation.After compatibility, show that moxifloxacin hydrochloride/glucose injection agent sample is stable under long term test condition.
(2) result of the test shows: sealing and the compatibility of Moxifloxacin/D/W preparation of two chambers bag packing are all better, and the indices content of sample is not made significant difference.
Experimental example 3:
Moxifloxacin glucose injection simulation clinical practice prepared by embodiment of the present invention 1-7 checks, result is as following table 5:
Table 5
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| PH value | 4.5 | 4.4 | 4.0 | 3.9 | 4.8 | 4.5 | 4.3 |
| Visible particulate matter (room temperature placement) | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing |
| Visible particulate matter (low temperature placement) | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing |
| Visible particulate matter (40 ℃ are accelerated to investigate June) | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing | Nothing |
Upper table explanation, independently puts into respectively two adjacent chambers by moxifloxacin hydrochloride and glucose, then mixes rear application, has avoided the particulate matter due to compatibility generation, has improved the safety of clinical practice.
Following embodiment all can realize effect described in above-mentioned experimental example.
Embodiment 1:
Moxifloxacin hydrochloride 0.41g
Glucose 12.5g
Prepare moxifloxacin hydrochloride solution: take moxifloxacin hydrochloride 0.41g, be dissolved in 100ml water for injection, filter;
Prepare glucose solution: take 12.5g glucose, be dissolved in 150ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned two kinds of solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.16%(W/V), concentration of glucose is 5%(W/V).
Embodiment 2:
Moxifloxacin hydrochloride 0.4g
Glucose 12.5g
Prepare moxifloxacin hydrochloride solution: take moxifloxacin hydrochloride 0.4g, be dissolved in 50ml water for injection, filter;
Prepare glucose solution: take 12.5g glucose, be dissolved in 200ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned two kinds of solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.16%(W/V), concentration of glucose is 5%(W/V).
Embodiment 3:
Moxifloxacin hydrochloride 0.2g
Glucose 5g
Prepare moxifloxacin hydrochloride solution: take moxifloxacin hydrochloride 0.2g, be dissolved in 50ml water for injection, filter;
Prepare glucose solution: take 5g glucose, be dissolved in 50ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned two kinds of solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.2%(W/V), concentration of glucose is 5%(W/V).
Embodiment 4:
Moxifloxacin hydrochloride 0.4g
Glucose 5g
Prepare moxifloxacin hydrochloride solution: take moxifloxacin hydrochloride 0.4g, be dissolved in 50ml water for injection, filter;
Prepare glucose solution: take 5g glucose, be dissolved in 50ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned two kinds of solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, and weak envelope portion can open, two chambers mix homogeneously that can be interconnected, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.4%(W/V), concentration of glucose is 5%(W/V).
Embodiment 5:
Moxifloxacin hydrochloride 0.8g
Glucose 12.5g
Prepare moxifloxacin hydrochloride solution: take moxifloxacin hydrochloride 0.8g, be dissolved in 100ml water for injection, filter;
Prepare glucose solution: take 12.5g glucose, be dissolved in 150ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned two kinds of solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.32%(W/V), concentration of glucose is 5%(W/V).
Embodiment 6:
Moxifloxacin hydrochloride 0.4g
Glucose 12.5g
In this embodiment, moxifloxacin hydrochloride exists with powder type.
Prepare glucose solution: take 12.5g glucose, be dissolved in 250ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned moxifloxacin hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.16%(W/V), concentration of glucose is 5%(W/V).
Embodiment 7:
Moxifloxacin hydrochloride 0.4g
Glucose 5g
In this embodiment, moxifloxacin hydrochloride exists with powder type.
Prepare glucose solution: take 5g glucose, be dissolved in 100ml water for injection, add active carbon, filter, pH value is stabilized in 3.8-4.5;
Above-mentioned moxifloxacin hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between by weak envelope portion, separated, Moxifloxacin/D/W preparation of high temperature sterilize Ji get Shuan chamber bag packing.During clinical use, extruding is full of the chamber of solution gently, weak envelope portion can open, two chambers mix homogeneously that is interconnected in closed system, obtain moxifloxacin hydrochloride/glucose injection agent of clinical use, now the concentration of moxifloxacin hydrochloride is 0.4%(W/V), concentration of glucose is 5%(W/V).
Claims (5)
1. moxifloxacin hydrochloride/D/W preparation of multi-chamber-bag packing, it is characterized in that said preparation is by being at least present in two powder and/or solution compositions in chamber bag, between each chamber, by weak envelope portion, separated, wherein moxifloxacin hydrochloride and glucose leave in respectively in different chambers, and the chamber of depositing glucose is adjacent with the chamber of depositing moxifloxacin hydrochloride; Described moxifloxacin hydrochloride is to take the moxifloxacin aqueous solution form that Moxifloxacin powder type that content is 0.3g-0.8g or concentration is 0.4%-0.8% to be present in chamber, and the self-existent glucose of adjacent chamber is to take the form of the aqueous solution that concentration is 5%-10% to exist.
2. moxifloxacin hydrochloride/D/W preparation as claimed in claim 1, it is characterized in that being full of by extruding the chamber of solution, weak envelope portion opens, and each chamber is communicated with becomes a closed system, mix, obtain the injection that moxifloxacin hydrochloride concentration is 0.16%-0.4%.
3. moxifloxacin hydrochloride/D/W preparation as claimed in claim 2, the concentration that it is characterized in that mixing rear moxifloxacin hydrochloride is 0.2%.
4. moxifloxacin hydrochloride/D/W the preparation as described in as arbitrary in claim 1-3, it is characterized in that Yong San chamber bag or multi-chamber-bag packing, the glucose solution that is 5% by the moxifloxacin hydrochloride that after described mixing, concentration is 0.16%-0.4% and concentration as required is independently stored in a plurality of chambers.
5. moxifloxacin hydrochloride/D/W the preparation as described in as arbitrary in claim 1-3, is characterized in that moxifloxacin hydrochloride exists powder and two kinds of forms of solution simultaneously when the chamber of depositing moxifloxacin hydrochloride is during more than 1.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210204750.1A CN103505407A (en) | 2012-06-20 | 2012-06-20 | Multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210204750.1A CN103505407A (en) | 2012-06-20 | 2012-06-20 | Multi-chamber bag packaged moxifloxacin hydrochloride/glucose aqueous solution preparation |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2702738Y (en) * | 2004-06-03 | 2005-06-01 | 魏雪纹 | Multi-unit soft packaging bag for medicines |
| CN1704057A (en) * | 2004-06-02 | 2005-12-07 | 上海医药科技发展有限公司 | Method for preparing lomefloxacin hydrochloride for injection |
| CN102100666A (en) * | 2011-01-17 | 2011-06-22 | 南京新港医药有限公司 | New moxifloxacin hydrochloride injection |
-
2012
- 2012-06-20 CN CN201210204750.1A patent/CN103505407A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1704057A (en) * | 2004-06-02 | 2005-12-07 | 上海医药科技发展有限公司 | Method for preparing lomefloxacin hydrochloride for injection |
| CN2702738Y (en) * | 2004-06-03 | 2005-06-01 | 魏雪纹 | Multi-unit soft packaging bag for medicines |
| CN102100666A (en) * | 2011-01-17 | 2011-06-22 | 南京新港医药有限公司 | New moxifloxacin hydrochloride injection |
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Application publication date: 20140115 |
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