CN102697763A - Double-cavity bagged lysine hydrochloride/glucose injection and preparation method - Google Patents
Double-cavity bagged lysine hydrochloride/glucose injection and preparation method Download PDFInfo
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- CN102697763A CN102697763A CN2012102123971A CN201210212397A CN102697763A CN 102697763 A CN102697763 A CN 102697763A CN 2012102123971 A CN2012102123971 A CN 2012102123971A CN 201210212397 A CN201210212397 A CN 201210212397A CN 102697763 A CN102697763 A CN 102697763A
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Abstract
The invention provides a double-cavity packaged lysine hydrochloride/glucose injection which is stable, safe and convenient for clinical use. In order to achieve the purposes, the technical scheme of the invention lies in that the medicinal composition of the double-cavity bagged lysine hydrochloride injection comprises the following raw medicine ingredients in parts by weight: 1-3 parts of arginine lysine in a powder cavity and a glucose injection in a solution cavity, wherein in every 100 volume parts, 4-11 weight parts of glucose is contained in the glucose injection, or in every 250 volume parts, 10-27.5 weight parts of glucose is contained in the glucose injection; or the medicinal composition of the double-cavity bagged hydrochloride injection comprises the following raw medicine ingredients in parts by weight: 1-3 parts of lysine hydrochloride in 5-15 volume parts in a liquid cavity 1 and 4-11 parts of glucose in 85-95 volume parts of glucose injections or 10-27.5 parts of glucose in 235-245 volume parts of glucose injections in a liquid cavity 2. The invention also discloses a preparation method for the double-cavity packaged lysine hydrochloride/glucose injection.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of medicine that is used to treat craniocerebral trauma, chronic cerebral tissue ischemia, anoxia property disease, particularly the lysine hydrochloride injection of two-chamber bag packing.
Background technology
Lysine is one of 8 kinds of essential amino acids of human body, can promote human development, raise immunity, and the effect that improves the central nervous tissue function is arranged.During as osmotic pressure regulator, the less stable of lysine hydrochloride glucose injection finds that after deliberation the content of lysine and glucose all has obvious decline with 5% glucose solution, and the related substance of lysine also has tangible rising.The stability test data of lysine hydrochloride glucose injection see the following form 1.
When yet these article did not use osmotic pressure regulator, the stability of lysine hydrochloride injection and lysine hydrochlorate for injection was all fine, and the content of lysine does not significantly reduce, and related substance does not significantly raise yet.It is unstable to explain that lysine and glucose are present in the injection jointly, and after placing 24 months, the content of lysine and glucose all has bigger reduction especially, and related substance also has bigger rising, and table 1 data are also explained this point.This phenomenon explanation lysine and glucose are present in the injection jointly, and reaction has taken place, and the content of lysine is reduced, and related substance raises, thereby influences the effectiveness and the safety of clinical use.
But lysine hydrochloride injection or lysine hydrochlorate for injection all use 5% glucose injection dilution back to use before facing usefulness.This method for using is just mixed both in use; Overcome the technical problem that lysine hydrochloride and glucose produce labile solution; But this method for using subject matter is; Also for bringing a lot of inconvenience in transportation, the clinical use, particularly the frangible fact of glass packaging has increased the security risk of medication to the packaged form of this separately packing.
The stability test data of table 1 lysine hydrochloride glucose injection
Summary of the invention
The present invention is in order to solve the problems of the technologies described above, and the lysine hydrochloride/glucose injection of a kind of stable, safety, clinical two-chamber packing easy to use is provided.To achieve these goals, technical scheme of the present invention is:
The present invention discloses a kind of lysine hydrochloride injection of two-chamber bag packing; The crude drug of this injection pharmaceutical composition consists of: the powder chamber: smart sour lysine 1～3 weight portion, sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or 250 parts by volume contain glucose 10～27.5 weight portions.
Method for preparing: 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 preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection and process the solution that concentration is 4%-11%.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 lysine hydrochloride 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.
Lysine hydrochloride injection of the present invention adopts two-chamber bag packing; Through lysine hydrochloride aseptic powder and 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 lysine hydrochloride 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.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lysine hydrochloride 1 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～6 weight portions or 250 parts by volume contain glucose 10～15 weight portions.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lysine hydrochloride 1.5 weight portions
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～6 weight portions or 250 parts by volume contain glucose 10～15 weight portions.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: lysine hydrochloride 3 weight portions
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～6 weight portions or 250 parts by volume contain glucose 10～15 weight portions.
The present invention discloses a kind of lysine hydrochloride injection of two-chamber bag packing; The crude drug of this injection pharmaceutical composition consists of: hydrochloric lysine 1～3 weight of sap cavity 1:5～15 parts by volume, sap cavity 2: glucose injection: 85～95 parts by volume contain glucose 4～11 weight portions or 235～245 parts by volume contain glucose 10～27.5 weight portions.
Method for preparing: 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 preparation of lysine hydrochloride injection: take by weighing lysine hydrochloride by formula ratio and add the injection that an amount of water for injection is processed lysine hydrochloride.The preparation of glucose injection: take by weighing glucose by formula ratio and add the injection that an amount of water for injection is processed glucose.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.
Lysine hydrochloride injection of the present invention adopts two-chamber bag packing; Through lysine hydrochloride injection and 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 lysine hydrochloride injection and glucose injection under airtight aseptic condition, accomplish rapidly dissolving mixed process, form full Drug therapy mixed liquor and directly be used for the patient.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Hydrochloric lysine 1 weight of sap cavity 1:10 parts by volume,
Sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Hydrochloric lysine 1.5 weight of sap cavity 1:10 parts by volume,
Sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
A kind of lysine hydrochloride injection that adopts two-chamber bag packing, the crude drug of this injection pharmaceutical composition consists of:
Hydrochloric lysine 3 weight of sap cavity 1:10 parts by volume,
Sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
Can know by such scheme; Lysine hydrochloride is to be present in the chamber with powder type or injection form; The self-existent glucose of adjacent chamber is that the form with injection exists, and obtains the lysine hydrochloride/glucose injection agent of clinical use through the two mixing.After lysine hydrochloride and glucose were mixed into the lysine hydrochloride/glucose injection agent that meets clinical use, the concentration of lysine hydrochloride was 0.4%-3% (W/V), and the concentration of glucose is 5%-10% (W/V).
The present invention preferably packs with the two-chamber bag; But be not limited to two-chamber bag packing; Can use three Room bags or multi-chamber-bag to pack equally, the lysine hydrochloride and the concentration that are 0.4%-3% (W/V) with the back concentration of described mixing as required are that 5%-10% (W/V) glucose solution independently is stored in one or more chambers.When the chamber of depositing lysine hydrochloride during more than 1, lysine hydrochloride can exist powder or 2 kinds of forms of solution simultaneously.
The inventor finds through test repeatedly; Needn't add any additives in the lysine hydrochloride/glucose injection formulation of multi-chamber-bag packing; Particularly pH regulator agent, obtain the lysine hydrochloride/glucose injection agent of clinical use in the two mixing after, stability very good.
Study on the stability result such as following table 2: table 2 study on the stability result
| All numbers | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| PH value | 4.2 | 4.2 | 4.3 | 4.2 | 4.2 | 4.2 | 4.3 | 4.3 |
| Particulate matter | Do not have | Do not have | Do not have | Do not have | Do not have | Do not have | Do not have | Do not have |
Last table data reflect, product stable fine do not have insoluble granule to produce, and pH value changes not quite simultaneously, has guaranteed the safety of clinical practice.
It is to be noted simultaneously; Not all medicine or medicinal liquid can be used plastics packaging material, particularly multi-chamber-bag or two-chamber bag packing, and medicine is declared in the process and need be investigated the compatibility of medicine and packaging material; Carry out compatibility test, investigate the stability problem of medicine.
Project is investigated in pharmaceutical preparation:
Medicine is investigated project before mixing
(1) lysine hydrochloride powder: the clarity of character, solution and color, PH, particulate matter, visible foreign matters.
(2) lysine hydrochloride solution: the clarity of character, solution and color, pH value, particulate matter, visible foreign matters.
(3) glucose solution: the clarity of character, solution and color, pH value, particulate matter, loading amount, visible foreign matters.
Mix the back medicine and investigate project:
The clarity of character, solution and color, pH value, particulate matter, related substance.
Experimental condition and result
Long term test (25 ℃ ± 2 ℃ RH40% ± 5%)
Test specimen is placed 25 ℃ ± 2 ℃ of temperature, and relative humidity is to keep flat under 40% ± 5% the condition, detects respectively at sampling in 0,6,12,18,24,36 month, and result of the test is seen table 3 – table 6.
Table 3 medicine long-term test results
Table 4 medicine long-term test results
Table 5 medicine long-term test results
Conclusion (of pressure testing):
(1) lysine hydrochloride/glucose injection formulation of two-chamber bag packing was investigated 36 months through long term test (25 ℃ ± 2 ℃ RH40% ± 5%), compared the equal no significant difference of each item index during packaging material investigation and pharmaceutical preparation are investigated with 0 month sample data.Show behind the compatibility that lysine hydrochloride/glucose injection agent sample is stable under the long term test condition.
(2) result of the test shows: the sealing and the compatibility of the lysine hydrochloride/glucose injection formulation of two-chamber bag packing are all better, and each item index content of sample is not made significant difference.
Lysine hydrochloride/the glucose injection formulation of multi-chamber-bag packing disclosed by the invention is as parenteral, and particularly subcutaneous or intravenous administration is used to treat craniocerebral trauma, chronic cerebral tissue ischemia, anoxia property disease.
Lysine hydrochloride/the glucose injection formulation of multi-chamber-bag disclosed by the invention packing has solved lysine hydrochloride and glucose in the injection can not long-term co-existence and the situation of the remarkable increase of lysine hydrochloride related substance; Very stable of lysine hydrochloride/glucose injection formulation provided by the invention simultaneously; Not only can not produce particulate matter; And content and related substance are all stable, simultaneously preparation technology simple, convenient clinical use and transport, storage etc.
Table 6 medicine long-term test results
Following embodiment is with the more detailed the present invention that illustrates.
Embodiment 1: lysine hydrochloride 1g
Glucose 5g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 100ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 1% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 2:
Lysine hydrochloride 1g
Glucose 12.5g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 12.5g glucose, with water for injection dissolving and process 250ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 0.4% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 3:
Lysine hydrochloride 1.5g
Glucose 5g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 100ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 1.5% (W/V), and concentration of glucose is 5% (W/V).Embodiment 4:
Lysine hydrochloride 1.5g
Glucose 12.5g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 12.5g glucose, with water for injection dissolving and process 250ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 0.6% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 5:
Lysine hydrochloride 3g
Glucose 5g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 100ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 3% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 6:
Lysine hydrochloride 3g
Glucose 10g
Lysine hydrochloride exists with powder type among this embodiment.
The preparation glucose solution: take by weighing the 10g glucose, with water for injection dissolving and process 100ml solution, add active carbon and boil, filter, pH value is stabilized in 3.8-4.5.
Above-mentioned lysine hydrochloride powder and glucose solution are filled into respectively in two two adjacent chambers of chamber bag, between separate by weak envelope portion, promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 3% (W/V), and concentration of glucose is 10% (W/V).
Embodiment 7:
Lysine hydrochloride 1g
Glucose 5g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 1g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 90ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 1% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 8:
Lysine hydrochloride 1g
Glucose 12.5g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 1g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 12.5g glucose, with water for injection dissolving and process 240ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 0.4% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 9:
Lysine hydrochloride 1.5g
Glucose 5g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 1.5g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 90ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 1.5% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 10:
Lysine hydrochloride 1.5g
Glucose 12.5g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 1.5g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 12.5g glucose, with water for injection dissolving and process 240ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 0.6% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 11:
Lysine hydrochloride 3g
Glucose 5g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 3g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 5g glucose, with water for injection dissolving and process 90ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 3% (W/V), and concentration of glucose is 5% (W/V).
Embodiment 12:
Lysine hydrochloride 3g
Glucose 10g
Preparation lysine hydrochloride solution: take by weighing lysine hydrochloride 3g, with the water for injection dissolving and process 10ml solution, filter;
The preparation glucose solution: take by weighing the 10g glucose, with water for injection dissolving and process 90ml solution, add active carbon and boil, 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 separate by weak envelope portion, high temperature sterilize promptly get lysine hydrochloride/D/W preparation that two chambers bag is packed.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 the lysine hydrochloride/glucose injection agent of clinical use, this moment, the concentration of lysine hydrochloride was 3% (W/V), and concentration of glucose is 10% (W/V).
With lysine hydrochloride glucose injection instance of the present invention, result such as following table 7 are checked in the simulation clinical practice.
Table 7
Last table explanation is independently put into two adjacent chambers respectively with lysine hydrochloride and glucose, mixes the back then and uses, and has avoided the particulate matter owing to the compatibility generation, has improved the safety of clinical practice.
Claims (8)
1. lysine hydrochloride/the glucose injection of two-chamber bag packing; It is characterized in that; This injection is by being present in two powder and/or solution compositions in the chamber bag; Separated by weak envelope portion between each chamber, wherein lysine hydrochloride and glucose preserve separately are in different chambers, and the chamber of depositing glucose is adjacent with the chamber of depositing lysine hydrochloride;
Specifically consisting of of said lysine hydrochloride and glucose:
The powder chamber: lysine hydrochloride 1～3 weight portion, sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or 250 parts by volume contain glucose 10～27.5 weight portions; Or
Hydrochloric lysine 1～3 weight of sap cavity 1:5～15 parts by volume, sap cavity 2: glucose injection: 85～95 parts by volume contain glucose 4～11 weight portions or 235～245 parts by volume contain glucose 10～27.5 weight portions.
2. lysine hydrochloride/glucose injection as claimed in claim 1 is characterized in that specifically consisting of of said lysine hydrochloride and glucose:
The powder chamber: lysine hydrochloride 1 weight portion, sap cavity: glucose injection: 100 parts by volume contain glucose 4～6 weight portions or 250 parts by volume contain glucose 10～15 weight portions; Or
Hydrochloric lysine 1 weight portion of sap cavity 1:10 parts by volume, sap cavity 2: glucose injection: 90 parts by volume contain glucose 4～6 weight portions or 240 parts by volume contain glucose 10～15 weight portions.
3. lysine hydrochloride/glucose injection as claimed in claim 1 is characterized in that specifically consisting of of said lysine hydrochloride and glucose:
The powder chamber: lysine hydrochloride 1 weight portion, sap cavity: 100 parts by volume contain glucose 5 weight portions or 250 parts by volume contain glucose 12.5 weight portions; Or
Hydrochloric lysine 1 weight of sap cavity 1:10 parts by volume, sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
4. lysine hydrochloride/glucose injection as claimed in claim 1 is characterized in that specifically consisting of of said lysine hydrochloride and glucose:
The powder chamber: lysine hydrochloride 1.5 weight portions, sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions or 250 parts by volume contain glucose 12.5 weight portions; Or
Hydrochloric lysine 1.5 weight of sap cavity 1:10 parts by volume, sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
5. lysine hydrochloride/glucose injection as claimed in claim 1 is characterized in that specifically consisting of of said lysine hydrochloride and glucose:
The powder chamber: lysine hydrochloride 3 weight portions, sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions or 250 parts by volume contain glucose 12.5 weight portions; Or
Hydrochloric lysine 3 weight of sap cavity 1:10 parts by volume, sap cavity 2: glucose injection: 90 parts by volume contain glucose 5 weight portions or 240 parts by volume contain glucose 12.5 weight portions.
6. like the arbitrary described lysine hydrochloride/glucose injection of claim 1 to 5; It is characterized in that; Only need push medicated bag during use, can open the rosin joint isolating bar, make the lysine hydrochloride of adjacent chamber and glucose be mixed into the lysine hydrochloride/glucose injection agent that meets clinical use; The concentration of mixing the back lysine hydrochloride is 0.4%-3% (W/V), and the concentration of glucose is 5%-10% (W/V).
7. one kind is the method for preparing of powder-liquid two-chamber bag packing like the arbitrary described lysine hydrochloride/glucose injection of claim 1 to 6, it is characterized in that comprising the steps:
(a) bag: 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;
(b) preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection and process the solution that concentration is 4%-11%;
(c) liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seals;
(d) sterilization, drying: packaged sample is placed sterilizing installation, and in 115 ℃～125 ℃ sterilizations 8～30 minutes, drying: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃;
(e) fill of aseptic powder: sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, the lysine hydrochloride aseptic powder is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth;
(f) 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.
8. one kind is the method for preparing of liquid-liquid two-chamber bag packing like the arbitrary described lysine hydrochloride/glucose injection of claim 1 to 6, it is characterized in that comprising the steps:
(a) bag: 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;
(b) preparation of lysine hydrochloride injection: take by weighing lysine hydrochloride by formula ratio and add the aqueous solution that an amount of water for injection is processed lysine hydrochloride;
(c) preparation of glucose injection: take by weighing glucose by formula ratio and add the aqueous solution that an amount of water for injection is processed glucose;
(d) liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seals;
(e) sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes.
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| CN102406545A (en) * | 2011-12-28 | 2012-04-11 | 四川科伦药业股份有限公司 | Double-cavity bag for containing medicine liquid |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102406545A (en) * | 2011-12-28 | 2012-04-11 | 四川科伦药业股份有限公司 | Double-cavity bag for containing medicine liquid |
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