CN104622895B - A kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag - Google Patents
A kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag Download PDFInfo
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- CN104622895B CN104622895B CN201510028201.7A CN201510028201A CN104622895B CN 104622895 B CN104622895 B CN 104622895B CN 201510028201 A CN201510028201 A CN 201510028201A CN 104622895 B CN104622895 B CN 104622895B
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Abstract
The present invention discloses a kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag：Fructose plus water for injection is taken to be configured to solution；Take glycerine, sodium chloride plus water for injection that solution is made；Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are inserted directly into two hose ports of Double-cavity bag and welded, the closed-loop operation of chamber is completed.Canned Double-cavity bag is fitted into sterilizing installation, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.The Mannitol sodium chloride injection of the present invention is packed using Double-cavity bag, by the way that fructose soln and glycerin chlorination sodium solution is filling in the separated two chambers of rosin joint cut-off respectively, avoid glycerine and fructose in sterilizing and storage because Long Term Contact reacts, it is ensured that product uses safe and effective.
Description
Technical field
The invention belongs to pharmaceutical technology field, it is related to a kind of preparation method of Mannitol sodium chloride injection, particularly
A kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag.
Background technology
Mannitol sodium chloride injection is hypertonic preparation, is dehydrated by high osmosis, can reduce brain water content, drop
Intracranial hypotension.This product reduction intracranial pressure onset of action is slow, and the duration is longer.Indication is：Outside for cerebrovascular disease, brain
Wound, brain tumor, intracranial inflammation and the disease such as acute and chronic increased intracranial pressure, encephaledema caused by other reasonses.Glycerine originally people
The material existed in body, is the mesostate of syrup solution, while being the precursor of machine body fat or lipid synthesis again
Matter.Fructose is the isomers of glucose, has levorotation, and pharmacological action and application are substantially same with glucose, with directly feeding
Effect of heat energy, supplement body fluid and nutrition whole body, and glycogen can be metabolized in the case of without insulin, therefore more hold than glucose
Easily absorb.
But there is open defect in the transfusion kind in formula simultaneously containing glycerine and fructose：Glycerine and fructose mixed solution are special
It is not to produce interaction at high operating temperatures, causes sample relevant material increase, great shadow in production and storage process
Ring the safety in utilization of product.And the big cost of transportation of glass infusion bottle weight is high, volume occupies greatly space big, frangible, Yi Zao
It is inconvenient for use into the pollution of broken bottle.
The content of the invention
In order to solve the above-mentioned technical problem the present invention packs there is provided a kind of stabilization, safety, the convenient two-chamber of Clinical practice
Mannitol sodium chloride injection.
The present invention is achieved through the following technical solutions：
The Mannitol sodium chloride injection that the present invention is packed with Double-cavity bag is to be made by the following method：Fructose filling is taken to penetrate
The solution of concentration 5%~20% is configured to water；Take glycerine, sodium chloride plus water for injection that the solution of concentration 5%~30% is made；
Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug is direct
Insert in two hose ports of Double-cavity bag and weld, complete the closed-loop operation of chamber.Canned Double-cavity bag is loaded into sterilizing installation
In, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
The Mannitol sodium chloride injection that the present invention is packed with Double-cavity bag can also be made by the following method：Fructose is taken to add
Water for injection is configured to the solution of concentration 5%~15%；Take glycerine, sodium chloride plus water for injection be made glycerol concentration for 10%~
25% solution；Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；By loading plug,
Medicine plug is inserted directly into two hose ports of Double-cavity bag and welded, and completes the closed-loop operation of chamber.Canned two-chamber is packed
Enter in sterilizing installation, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
The Mannitol sodium chloride injection that the present invention is packed with Double-cavity bag can also be made by the following method：Fructose is taken to add
Water for injection is configured to the solution of concentration 5%~20%, by solution through 0.005%~0.2% charcoal absorption, then is taken off by titanium rod
Carbon, 0.1um~1.0um foldable filter element filtering；It is 5%~30% to take glycerine, sodium chloride plus water for injection that glycerol concentration is made
Solution, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~1.0um foldable filter element mistake
Filter；Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug is straight
Patch in two hose ports of Double-cavity bag and weld, complete the closed-loop operation of chamber.Canned Double-cavity bag is loaded into sterilizing to set
In standby, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
Experimental example and embodiment are used to further illustrate the present invention below, but are limited to the present invention.
Experimental example
Fructose injection and test for compound glycerin injection are respectively charged into double by the sample prepared using the method for embodiment 1 respectively
In the two chambers of chamber bag, load glass transfusion after fructose injection and the test for compound glycerin injection mixing prepared using same method
In bottle, seal, sterilizing.
Two groups are compared from 5 hydroxymethyl furfural content, pH value, glycerol content, fructose content, sodium chloride content respectively,
Provided in 2010 editions pharmacopeia, in Mannitol sodium chloride injection, glycerol content should be 90.0%~110.0%, fructose content
93.0%~107.0% is should be with sodium chloride content, pH value should be in the range of 3-6, and 5 hydroxymethyl furfural trap must not be big
In 0.3, experimental condition is：(1) sterilising conditions：115 DEG C~125 DEG C sterilize 8~40 minutes；(2) temperature in accelerated test is
40 DEG C, humidity 25%, illuminance 4500lx, the time be 6 months；(3) temperature in long term test be 25 DEG C, humidity 40%, light
Illumination 4500lx, time are December.Result of the test is shown in Table one.
The study on the stability result of the test of table one
By the way that fructose soln and glycerin chlorination sodium solution are respectively placed in into different chamber, it is entirely avoided the hair of side reaction
It is raw, the level about material is greatly reduced, the stability of product is significantly improved, the sample point prepared using the method for embodiment 1
Be not fitted into glass infusion bottle and Double-cavity bag, study on the stability carried out after sterilizing, it is found that sample after sterilization, 40 DEG C plus
After fast experiment investigation 6 months, 25 DEG C of long term tests are investigated 12 months, the 5 hydroxymethyl furfural of the sample in glass infusion bottle is each
Plant under experimental condition, content is all required beyond the regulation in pharmacopeia, the 5 hydroxymethyl furfural in sample in Double-cavity bag is each
Plant under experimental condition, content is all within the regulation claimed range of the national drug standards；The glycerol content of sample in Double-cavity bag,
Fructose content, sodium chloride content and pH value, excursion are significantly less than the sample in glass infusion bottle, and stability is substantially better than glass
Glass infusion bottle packs sample.
The Mannitol sodium chloride injection of Double-cavity bag packaging disclosed by the invention is solved in glass infusion bottle parenteral solution
The situation that relevant material is dramatically increased, while fructose in the Mannitol sodium chloride injection for the Double-cavity bag packaging that the present invention is provided
And sodium chloride content and relevant material are stablized, preparation technology is simple, facilitate Clinical practice and transport, storage etc..
Brief description of the drawings
Fig. 1 Dual-cavity sterile bag structural representations
Fig. 2 glass infusion bottle structural representations
Embodiment
Embodiment 1
The raw material composition of fructose soln：
Fructose 12.5kg
Inject water to 100L
Glycerin and sodium chloride solution materials are constituted：
Glycerine 25kg
Sodium chloride 2.25kg
Inject water to 150L
The structure of Double-cavity bag is as follows：
A kind of Dual-cavity sterile bag, three-layer co-extruded Double-chamber bag for trans fusion is used using the special non-three-layer co-extruded transfusions of PVC of multi-chamber-bag
Film, the non-three-layer co-extruded film for transfusion of PVC first carries out rosin joint, forms rosin joint position；Text printout is carried out again, forms the word of product
Explanation；Finally complete flexible pipe welding and the infusion bag for including two chambers independence is made in periphery heat seal, form bag periphery and flexible pipe
Welding position.Decoction is filled in two independent chambers by flexible pipe under rigorous aseptic environment, medicine plug and defeated is used
Medicine plug is sealed.
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Fructose plus water for injection is taken to be configured to
The solution of concentration 5%~20%；Take glycerine, sodium chloride plus water for injection that the solution of concentration 5%~30% is made；By fructose soln
It is simultaneously filling to the two chambers of Double-cavity bag respectively with glycerin chlorination sodium solution；Loading plug, medicine plug are inserted directly into Double-cavity bag
Two hose ports in and weld, complete chamber closed-loop operation.Canned Double-cavity bag is fitted into sterilizing installation, in 115 DEG C
~125 DEG C sterilize 8~40 minutes, you can.
Embodiment 2
The raw material composition of fructose soln：
Fructose 10kg
Inject water to 100L
Glycerin and sodium chloride solution materials are constituted：
Glycerine 20kg
Sodium chloride 1.8kg
Inject water to 100L
The structure be the same as Example 1 of Double-cavity bag.
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Fructose plus water for injection is taken to be configured to
The solution of concentration 5%~15%；Take glycerine, sodium chloride plus water for injection that the solution that glycerol concentration is 10%~25% is made；Will
Fructose soln and glycerin chlorination sodium solution are simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are directly inserted
Enter in two hose ports of Double-cavity bag and weld, complete the closed-loop operation of chamber.Canned Double-cavity bag is fitted into sterilizing installation,
Sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
Embodiment 3
The raw material composition of fructose soln：
Fructose 25kg
Inject water to 250L
Glycerin and sodium chloride solution materials are constituted：
Glycerine 50kg
Sodium chloride 4.5kg
Inject water to 250L
The structure be the same as Example 1 of Double-cavity bag
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Fructose plus water for injection is taken to be configured to
The solution of concentration 5%~20%, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~
1.0um foldable filter element filtering；Take glycerine, sodium chloride plus water for injection that the solution that glycerol concentration is 5%~30% is made, will be molten
Liquid is through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, and 0.1um~1.0um foldable filter element is filtered；Fructose is molten
Liquid and glycerin chlorination sodium solution are simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are inserted directly into two-chamber
Bag two hose ports in and weld, complete chamber closed-loop operation.Canned Double-cavity bag is fitted into sterilizing installation, in 115
DEG C~125 DEG C sterilize 8~40 minutes, you can.
Embodiment 4
The raw material composition of glycerite：
Glycerine 25kg
Inject water to 100L
Fructose sodium chloride solution raw material is constituted：
Fructose 12.5kg
Sodium chloride 2.25kg
Inject water to 150L
The structure be the same as Example 1 of Double-cavity bag
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Glycerine plus water for injection is taken to be configured to
The solution of concentration 5%~30%, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~
1.0um foldable filter element filtering；Take fructose, sodium chloride plus water for injection that the solution that glycerol concentration is 5%~30% is made, will be molten
Liquid is through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, and 0.1um~1.0um foldable filter element is filtered；Fructose is molten
Liquid and glycerin chlorination sodium solution are simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are inserted directly into two-chamber
Bag two hose ports in and weld, complete chamber closed-loop operation.Canned Double-cavity bag is fitted into sterilizing installation, in 115
DEG C~125 DEG C sterilize 8~40 minutes, you can.
Embodiment 5
The raw material composition of glycerite：
Glycerine 10kg
Inject water to 50L
Fructose sodium chloride solution raw material is constituted：
Fructose 5kg
Sodium chloride 0.9kg
Inject water to 50L
The structure be the same as Example 1 of Double-cavity bag
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Glycerine plus water for injection is taken to be configured to
The solution of concentration 5%~30%, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~
1.0um foldable filter element filtering；Take fructose, sodium chloride plus water for injection that the solution that glycerol concentration is 5%~30% is made, will be molten
Liquid is through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, and 0.1um~1.0um foldable filter element is filtered；Fructose is molten
Liquid and glycerin chlorination sodium solution are simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are inserted directly into two-chamber
Bag two hose ports in and weld, complete chamber closed-loop operation.Canned Double-cavity bag is fitted into sterilizing installation, in 115
DEG C~125 DEG C sterilize 8~40 minutes, you can.
Embodiment 6
The raw material composition of fructose soln：
Fructose 12.5kg
Inject water to 150L
Glycerin and sodium chloride solution materials are constituted：
Glycerine 25kg
Sodium chloride 2.25kg
Inject water to 100L
The structure be the same as Example 1 of Double-cavity bag
The preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag is：Fructose plus water for injection is taken to be configured to
The solution of concentration 5%~20%, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~
1.0um foldable filter element filtering；Take glycerine, sodium chloride plus water for injection that the solution that glycerol concentration is 5%~30% is made, will be molten
Liquid is through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, and 0.1um~1.0um foldable filter element is filtered；Fructose is molten
Liquid and glycerin chlorination sodium solution are simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug are inserted directly into two-chamber
Bag two hose ports in and weld, complete chamber closed-loop operation.Canned Double-cavity bag is fitted into sterilizing installation, in 115
DEG C~125 DEG C sterilize 8~40 minutes, you can.
Claims (3)
1. a kind of preparation method of Mannitol sodium chloride injection, it is characterised in that this method comprises the following steps：Take fructose
Plus water for injection is configured to the solution of concentration 5%~20%；Take glycerine, sodium chloride plus water for injection that concentration 5%~30% is made
Solution；Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；By loading plug, dosing
Plug is inserted directly into two hose ports of Double-cavity bag and welded, and completes the closed-loop operation of chamber, and canned Double-cavity bag is loaded and gone out
In bacterium equipment, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
2. preparation method as claimed in claim 1, it is characterised in that this method comprises the following steps：Take fructose plus injection
Water is configured to the solution of concentration 5%~15%；It is 10%~25% to take glycerine, sodium chloride plus water for injection that glycerol concentration is made
Solution；Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；By loading plug, medicine plug
It is inserted directly into two hose ports of Double-cavity bag and welds, complete the closed-loop operation of chamber, canned Double-cavity bag is loaded and sterilized
In equipment, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
3. preparation method as claimed in claim 1 or 2, it is characterised in that this method comprises the following steps：Fructose filling is taken to penetrate
The solution of concentration 5%~20% is configured to water, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization,
0.1um~1.0um foldable filter element filtering；Take glycerine, sodium chloride plus water for injection be made glycerol concentration for 5%~30% it is molten
Liquid, by solution through 0.005%~0.2% charcoal absorption, then by titanium rod decarburization, 0.1um~1.0um foldable filter element is filtered；
Fructose soln and glycerin chlorination sodium solution is simultaneously filling to the two chambers of Double-cavity bag respectively；Loading plug, medicine plug is direct
Insert in two hose ports of Double-cavity bag and weld, complete the closed-loop operation of chamber, canned Double-cavity bag is loaded into sterilizing installation
In, sterilized 8~40 minutes in 115 DEG C~125 DEG C, you can.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510028201.7A CN104622895B (en) | 2015-01-20 | 2015-01-20 | A kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag |
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| CN201510028201.7A CN104622895B (en) | 2015-01-20 | 2015-01-20 | A kind of preparation method for the Mannitol sodium chloride injection packed with Double-cavity bag |
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| CN104622895B true CN104622895B (en) | 2017-07-28 |
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| CN110562614A (en) * | 2019-08-29 | 2019-12-13 | 上海富仓物流有限公司 | Fructose transportation device and use method thereof |
| CN111658667A (en) * | 2020-07-16 | 2020-09-15 | 华仁药业股份有限公司 | Preparation method of double-chamber bag-packaged cerebrospinal fluid for operation |
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| GB1486880A (en) * | 1975-10-27 | 1977-09-28 | Chugai Pharmaceutical Co Ltd | Composition for reducing cerebrospinal fluid pressure |
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
| CN102600187B (en) * | 2011-01-19 | 2014-07-02 | 四川科伦药物研究有限公司 | Amino acid glucose injection packaged by double-cavity bag and preparation method thereof |
| CN103417568B (en) * | 2013-08-08 | 2015-09-09 | 张志英 | The preparation method of Mannitol sodium chloride injection |
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Address after: 050035 No. 518, Huai'an East Road, high tech Industrial Development Zone, Shijiazhuang City, Hebei Province Patentee after: SHIJIAZHUANG NO.4 PHARMACEUTICAL Co.,Ltd. Patentee after: Qu Jiguang Address before: 050035 No. 288 Pearl River Avenue, Shijiazhuang Hi-tech Industrial Development Zone, Hebei Province Patentee before: SHIJIAZHUANG NO.4 PHARMACEUTICAL Co.,Ltd. Patentee before: Qu Jiguang |