CN102406544A - Azithromycin lactobionateinjection solution packaged by double-cavity bag and preparation method - Google Patents
Azithromycin lactobionateinjection solution packaged by double-cavity bag and preparation method Download PDFInfo
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- CN102406544A CN102406544A CN2011103867679A CN201110386767A CN102406544A CN 102406544 A CN102406544 A CN 102406544A CN 2011103867679 A CN2011103867679 A CN 2011103867679A CN 201110386767 A CN201110386767 A CN 201110386767A CN 102406544 A CN102406544 A CN 102406544A
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Abstract
The invention discloses an azithromycin lactobionateinjection injection solution packaged by double-cavity bag. The medicinal composition of the injection solution comprises the following raw materials: 0.1-0.3 parts by weight of azithromycin lactobionateinjection in a powder cavity, and 4-11 parts by weight of glucose injection solution with 100 parts by volume of glucose or 0.8-1 parts by weight of sodium chloride injection solution with 100 parts by volume of sodium chloride in a solution cavity. The azithromycin lactobionateinjection injection solution is packaged by a double-cavity bag; sterilized azithromycin lactobionateinjection powder and solvent (sodium chloride injection solution or glucose injection solution) are filled in two cavities separated by pseudo soldering separations respectively; and when the azithromycin lactobionateinjection injection solution is used, pseudo soldering isolating bars can be connected by extruding a medicine bag only, and the sterilized azithromycin lactobionateinjection powder and the solvent are quickly solved and mixed under the sealed and sterilized condition to form a total medicine treatment mixed solution which can be directly applied to the patient.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, lactobionic acid azithromycin injection of particularly a kind of two-chamber bag packing and preparation method thereof.
Background technology
The lactobionic acid azithromycin chemical name is: (2R, 3S, 4R, 5R, 8R; 10R, 11R, 12S, 13S, 14R)-13-[(2; 6-dideoxy-3-C-methyl-3-O-methyl-a-L-nuclear-own pyrans glycosyl) oxygen]-2-ethyl-3,4,10-trihydroxy-3,5,6; 8,10,12,14-seven methyl isophthalic acid 1-[[3; 4,6-three deoxidations-3-(dimethylamino)-β-D-wood-own pyrans glycosyl] oxygen]-1-oxa--6-azacyclo-pentadecane-15 ketone Lactobionate, be a kind of broad ectrum antibiotic that after modifying on the erythromycin structure, obtains, be applicable to the transmissible disease due to respiratory tract, skin soft-tissue infection and the chlamydia due to the sensitive organism.
The main at home and abroad dosage form of this product is at present: freeze-dried powder, aseptic subpackaged powder pin, small-volume injection etc.; Above-mentioned preparation in being infused to the patient body before; Must use appropriate solvent (sodium chloride injection as 0.9% or 5% glucose injection) that its dissolving or dilution are become the solution that concentration is lower than 2mg/ml; Just can carry out intravenous drip, and the process of dissolving and dilution is consuming time relatively, under specific conditions such as war or emergency aid and treatment; Often because the process of making up a prescription is loaded down with trivial details, intravenously administrable fast; The on-the-spot area of rescue equipment is narrow, advances and jolts, and is difficult for carrying out malpraxis or accidents such as the dispensing operation or the mistake of making up a prescription; Give first aid to on-the-spot air and particle contamination, be prone to cause secondary pollution; Medicine is a glass bottle packaging, is prone to broken and can't drops; There is the existence of problems such as medicine and carrier transfusion quantity, effect phase coupling in the war storage, causes the environment at the scene of giving treatment to and time all not to reach conventional transfusion preparation necessary requirement.
The freeze-dried powder of market sale, aseptic subpackaged powder pin all adopt the cillin bottle packing; Seal with butyl rubber plug; In the medicine storage and transport process, when medicated powder with after plug contacts, in the plug additive composition possibly separate out or with medicated powder generation physics or chemical reaction; It is defective to cause clarity of solution to investigate the result, influences the safety that product uses.
Summary of the invention
The object of the invention has been to provide a kind of lactobionic acid azithromycin injection that adopts two-chamber bag packing and preparation method thereof.
The present invention seeks to realize through following technical scheme:
The crude drug of injection pharmaceutical composition of the present invention consists of:
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.1～0.3 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.8～1 weight portion
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.125 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.25 weight portion
Sap cavity: glucose injection: 250 parts by volume contain glucose 12.5 weight portions
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.125 weight portion
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.25 weight portion
Sap cavity: sodium chloride injection: 250 parts by volume sodium chloride-containing, 2.25 weight portions
The concrete production technology of the present invention is following:
Bag forming: use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag.
The medicinal liquid preparation
The preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection to process concentration be 4%～11% solution.
The preparation of sodium chloride injection: take by weighing sodium chloride by formula ratio and add an amount of water for injection to process concentration be 0.8%～1% solution.
Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal.
Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes.
Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃.
The fill of aseptic powder: sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, the lactobionic acid azithromycin aseptic powder is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.
The welding of aluminium foil outside the powder chamber: aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block oxygen, water vapour and illumination in outside, powder chamber.
Lactobionic acid azithromycin injection of the present invention adopts two-chamber bag packing; Through lactobionic acid azithromycin aseptic powder and solvent (sodium chloride injection or glucose injection) being distinguished fill in cutting off with rosin joint in two chambers that separate; Only need push medicated bag during use; Can open the rosin joint isolating bar, make lactobionic acid azithromycin aseptic powder and solvent under airtight aseptic condition, accomplish rapidly dissolving mixed process, form full Drug therapy mixed liquor and directly be used for the patient.
The present invention can avoid with lactobionic acid azithromycin process directly that the related substance that very easily occurs behind the bulk capacity injection increases and active constituent content under the degradation problem and also since the lactobionic acid azithromycin medicated powder in the powder chamber only contact with the film material; The packaging material composition is compared simple relatively with the used cillin bottle plug of conventional powder; Avoided in the packaging material complicated additive composition to separate out or react with medicated powder; Thereby prolonged keeping life greatly; Significantly strengthen the environmental suitability of medicine; Keep bulk capacity injection to need not the less relatively advantage of dissolved dilution, secondary pollution, can effectively improve the actual effect and the safety of lactobionic acid azithromycin intravenously administrable under emergency rating.
Description of drawings
Accompanying drawing 1: two-chamber bag plane graph;
Indicate among the figure: 1-powder chamber, the weak welding rod of 2-, 3-sap cavity, 4-composite cover
Accompanying drawing 2: process chart.
Experimental example 1
Adopt the sample of embodiment 1 preparation to be respectively charged in glass infusion bottle and the two-chamber bag; The laggard line stabilization property investigation of sterilizing; Can find; Sample is after the sterilization, after 40 ℃ of accelerated tests investigate and June, 25 ℃ of long term tests investigate December, and each item index of the sample of two-chamber bag packing has no significant change, and stability obviously is superior to glass infusion bottle packing sample.(as shown in table 1)
Table 1 product stability is investigated comparing result
Experimental example 2
(XiLin is bottled to get 10 lactobionic acid azithromycin powder pins respectively; Specification: 0.125g) with 10 bottles of glucose injection (glass transfusion bottles; Specification: 100ml:0.5g); Clinical manipulation method according to routine changes the lactobionic acid azithromycin aseptic powder over to glucose injection, and it is dissolved fully; Other gets 10 bags of two-chamber bag samples that adopt embodiment 1 preparation, opens weak welding rod, and jolting is dissolved the lactobionic acid azithromycin aseptic powder fully, and operating process is compared investigation.(as shown in table 2, test data is the meansigma methods of 10 tests.)
Table 2
Can know by comparing result; Adopt the lactobionic acid azithromycin preparation of existing ordinary packing; The operation relative complex; Environmental requirement higher (the general requirement of large hospital operated at the clean operating board that the laminar flow protection is arranged at present), and be easy to generate particulate matter, cause potential hazards such as thrombosis and granuloma; And the lactobionic acid azithromycin injection that adopts two chambers bag to pack is more convenient to operate, quick, because medicinal liquid is enclosed among the bag all the time, environmental requirement is low, is convenient to special occasions and implements first aid; Owing to need not solution transfer, the particulate matter of generation is far below the product that adopts ordinary packing, and is littler to patient's potential hazard, uses safer simultaneously.
Experimental example 3
(XiLin is bottled to get the lactobionic acid azithromycin powder pin of two producers respectively; Specification: 0.125g) each 100 and 100 bags in two-chamber bag sample adopting embodiment 1 preparation, place simultaneously under 40 ℃ of accelerated test conditions and investigate June, all samples all adopts the mode of putting upside down; Take out respectively acceleration 0,1,2,3, June by 20 (bags); The lactobionic acid azithromycin aseptic powder is mixed with the solubility of 0.1g/ml with purified water, observes the clarity of solution, result such as table 3:
Table 3
Investigation data by last table can be known, adopt two chambers bag packaged products, and the clarity of lactobionic acid azithromycin aseptic powder is investigated the cillin bottle packaging product that the result obviously is superior to present list marketing, therefore adopt two chamber bag packaged products safeties higher.
Analyzing its reason, possibly be because the plug composition is more complicated than film for transfusion, with process that medicated powder for a long time contacts in, in the plug additive composition possibly separate out or with medicine part generation physics or chemical reaction, cause clarity of solution investigation result defective.
Embodiment 1
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.125g
Sap cavity: glucose injection: 100ml:5g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing glucose 5g adds injection water standardize solution value 100ml to process concentration is 5% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 121 ℃ of sterilizations 12 minutes.Sample after the sterilization is following dry 80 minutes in 80 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, lactobionic acid azithromycin aseptic powder 0.125g is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Embodiment 2
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.25g
Sap cavity: glucose injection: 250ml:12.5g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing glucose 12.5g adds 250ml water for injection to process concentration is 5% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, lactobionic acid azithromycin aseptic powder 0.25g is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Embodiment 3
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.125g
Sap cavity: sodium chloride injection: 100ml:0.9g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing sodium chloride 0.9g by formula ratio adds 100ml water for injection to process concentration is 0.9% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, lactobionic acid azithromycin aseptic powder 0.125g is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Embodiment 4
Powder chamber: lactobionic acid azithromycin (in azithromycin) 0.25g
Sap cavity: sodium chloride injection: 250ml:2.25g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing sodium chloride 2.25g adds 250ml water for injection to process concentration is 0.9% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, lactobionic acid azithromycin aseptic powder 0.25g is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Claims (8)
1. the lactobionic acid azithromycin injection of two-chamber bag packing is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lactobionic acid azithromycin 0.1～0.3 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.8～1 weight portion;
Use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag; Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal; Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes; Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃; The relation of said weight portion and parts by volume is the relation of g/ml.
2. the lactobionic acid azithromycin injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lactobionic acid azithromycin 0.125 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions.
3. the lactobionic acid azithromycin injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lactobionic acid azithromycin 0.25 weight portion
Sap cavity: glucose injection: 250 parts by volume contain glucose 12.5 weight portions.
4. the lactobionic acid azithromycin injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lactobionic acid azithromycin 0.125 weight portion
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion.
5. the lactobionic acid azithromycin injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lactobionic acid azithromycin 0.25 weight portion
Sap cavity: sodium chloride injection: 250 parts by volume sodium chloride-containing, 2.25 weight portions.
6. method for preparing like the lactobionic acid azithromycin injection of the arbitrary described two-chamber bag packing of claim 1-5 is characterized in that this method is:
Bag forming: use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag;
Medicinal liquid preparation: the preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection to process concentration be 4%～11% solution;
The preparation of sodium chloride injection: take by weighing sodium chloride by formula ratio and add an amount of water for injection to process concentration be 0.8%～1% solution;
Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal;
Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes.
Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃.
The fill of aseptic powder: sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, the lactobionic acid azithromycin aseptic powder is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth;
The welding of aluminium foil outside the powder chamber: with welding around aluminum film and the powder chamber.
7. the method for preparing of the lactobionic acid azithromycin injection of two-chamber bag packing as claimed in claim 6 is characterized in that this method is:
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers with weak welding rod in the middle of the bag; Taking by weighing glucose 5g adds the injection water and is settled to 100ml to process concentration be 5% solution; The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals; Packaged sample is placed steam autoclave, in 121 ℃ of sterilizations 12 minutes; Sample after the sterilization is following dry 100 minutes in 80 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the lactobionic acid azithromycin aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth; Adopt full-automatic laminating machine with welding around aluminum film and the powder chamber.
8. the method for preparing of the Azithromycin injection of two-chamber bag packing as claimed in claim 6 is characterized in that:
The concentration of said glucose injection is 5%;
In the said sealing process with composite cover or other and the corresponding accessory heat sealing of interface;
Sterilising temp in the said sterilization process is 121 ℃, and sterilization time is 12 minutes;
In the said drying process, baking temperature is 80 ℃, and be 100 minutes drying time;
The equipment that adopts in the welding sequence of aluminium foil outside the said powder chamber is full-automatic laminating machine.
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| CN2011103867679A CN102406544A (en) | 2011-11-29 | 2011-11-29 | Azithromycin lactobionateinjection solution packaged by double-cavity bag and preparation method |
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| CN2011103867679A CN102406544A (en) | 2011-11-29 | 2011-11-29 | Azithromycin lactobionateinjection solution packaged by double-cavity bag and preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755252A (en) * | 2011-07-28 | 2012-10-31 | 辽宁海思科制药有限公司 | New dual-chamber transfusion bag for packaging amino acid and glucose injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1751751A (en) * | 2005-09-07 | 2006-03-29 | 华北制药集团有限责任公司 | Immediate dispensing infusion |
| CN102090976A (en) * | 2011-01-19 | 2011-06-15 | 四川科伦药业股份有限公司 | Three-cavity sterile bag and preparation method thereof |
| CN102232906A (en) * | 2011-06-13 | 2011-11-09 | 湖南科伦制药有限公司 | Production process for powder-liquid double-chamber transfusion bag products |
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2011
- 2011-11-29 CN CN2011103867679A patent/CN102406544A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1751751A (en) * | 2005-09-07 | 2006-03-29 | 华北制药集团有限责任公司 | Immediate dispensing infusion |
| CN102090976A (en) * | 2011-01-19 | 2011-06-15 | 四川科伦药业股份有限公司 | Three-cavity sterile bag and preparation method thereof |
| CN102232906A (en) * | 2011-06-13 | 2011-11-09 | 湖南科伦制药有限公司 | Production process for powder-liquid double-chamber transfusion bag products |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755252A (en) * | 2011-07-28 | 2012-10-31 | 辽宁海思科制药有限公司 | New dual-chamber transfusion bag for packaging amino acid and glucose injection |
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Application publication date: 20120411 |