CN104829900A - Medicine preparation package material and medicine preparation container - Google Patents
Medicine preparation package material and medicine preparation container Download PDFInfo
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- CN104829900A CN104829900A CN201410383628.4A CN201410383628A CN104829900A CN 104829900 A CN104829900 A CN 104829900A CN 201410383628 A CN201410383628 A CN 201410383628A CN 104829900 A CN104829900 A CN 104829900A
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- pharmaceutical preparation
- container
- test
- medicine preparation
- film
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/04—Homopolymers or copolymers of ethene
- C08L23/08—Copolymers of ethene
- C08L23/0807—Copolymers of ethene with unsaturated hydrocarbons only containing more than three carbon atoms
- C08L23/0815—Copolymers of ethene with aliphatic 1-olefins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J5/00—Manufacture of articles or shaped materials containing macromolecular substances
- C08J5/18—Manufacture of films or sheets
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2323/00—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers
- C08J2323/02—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers not modified by chemical after treatment
- C08J2323/04—Homopolymers or copolymers of ethene
- C08J2323/08—Copolymers of ethene
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2203/00—Applications
- C08L2203/16—Applications used for films
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2207/00—Properties characterising the ingredient of the composition
- C08L2207/06—Properties of polyethylene
- C08L2207/066—LDPE (radical process)
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Manufacturing & Machinery (AREA)
- Organic Chemistry (AREA)
- Polymers & Plastics (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Materials Engineering (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention aims to provide a medicine preparation package material and a medicine preparation container, wherein the medicine preparation package material is prepared from polyolefin. A potassium permanganate substance reducing test proves that the consumption amount of a 0.002 mol/L permanganate substance solution is not more than 0.30 ml.
Description
Technical field
The present invention relates to pharmaceutical preparation packages material and pharmaceutical preparation container.
Background technology
As the wrapping material of the wrapping material of the various pharmaceuticals headed by microbiotic and the former powder of these pharmaceuticals, require not add to produce dysgenic softening agent etc. to pharmaceuticals.That is, requirement is the wrapping material of the material with heat sealability and flexibility.From this viewpoint, generally use polyolefin film in the past, particularly use straight-chain Low Density Polyethylene (hereinafter referred to as " LLDPE ") film.
Such as, but some pharmaceuticals, all likely there is faint interaction with said polyolefins film in the microbiotic such as cephalosporin, beta-lactam, carbapenems, aminoglycoside, polypeptide class or Macrolide.Its result produces bad resultant of reaction.If generate such resultant of reaction, then there is the solution when dissolving and produce the worry of gonorrhoea.Therefore, these microbiotic were not packed with film in the past, and preserved in special glass cillin bottle.
But, in recent years, in order to replace glass cillin bottle, carried out the research and development of the above-mentioned antibiotic instant-matching type goods of storage.Instant-matching type goods are combined with to enclose the antibiotic polyolefine flexible container of single administration amount and the goods of lysate container.Like this, in order to make such goods practical, the interaction that causes of contacting solving said vesse (particularly forming its olefin resin) and pharmaceutical preparation enjoys as important topic and gazes at.
As one of this solve scheme, the content proposing the material (n-hexane extract) making particular carbon atomicity in WO94/06396 publication be certain below polyolefine wrapping material.Like this, according to the method, complete the goods of safe two rooms pouch-type instant-matching type goods.
But along with such instant-matching type goods are widely used, the pharmaceutical preparation choice direction require that security is higher, can receiving is also by the pharmaceutical preparation packages material widened.
The present invention makes to solve the problem, and object is to provide that a kind of security is higher, the pharmaceutical preparation choice direction that can receive is also by the pharmaceutical preparation packages material widened and pharmaceutical preparation packages container.
Summary of the invention
The pharmaceutical preparation packages material that the present invention is correlated with is formed by polyolefine, and in reduction potassium permanganate substances test, the consumption of the potassium permanganate solution of 0.002mol/L is below 0.30mL.
In said medicine preparation wrapping material, using the preserving in the test of 15 days at 60 DEG C based on European Pharmacopoeia of ceftriaxone sodium, turbidity is preferably below 2.0NTU.
In addition, in said medicine preparation wrapping material, using the preserving in the test of 15 days at 60 DEG C based on European Pharmacopoeia of sodium CEZ, turbidity can be below 5.0NTU.
Said polyolefins can be selected from least one in polyethylene and polypropylene.Now, this pharmaceutical preparation packages material can be used in packing microbiotic.
In addition, above-mentioned wrapping material are formed as membranaceous, and the thickness of this film can be made to be 150 ~ 300 μm.
The 1st pharmaceutical preparation container that the present invention relates to uses the pharmaceutical preparation packages material described in above-mentioned any one and shaping.
In addition, the 2nd pharmaceutical preparation container that the present invention relates to possesses use and is formed as membranaceous wrapping material and is formed as bag-shaped container body; Said vesse main body has the 1st and the 2nd receiving room of at least 2, and separates the separating part of these 2 receiving rooms in the mode that can break seal; In above-mentioned 1st receiving room, receive the microbiotic of powdery or solid state, in above-mentioned 2nd receiving room, receive above-mentioned antibiotic lysate.
Accompanying drawing explanation
Fig. 1 is the orthographic plan of the embodiment representing the pharmaceutical preparation container that the present invention relates to.
Embodiment
1. pharmaceutical preparation packages material
Below, an embodiment of the pharmaceutical preparation packages material that the present invention relates to is described.Wrapping material of the present embodiment are materials of packaged pharmaceuticals preparation, are formed by polyolefine.Polyolefine used herein manufactures with general method for making, such as, can by ethene polymers, ethene-alpha-olefin copolymer, propene polymer, propylene-alpha-olefin copolymers, the alpha-olefin homo also having carbonatoms to be 3 ~ 20 and multipolymer etc. separately or mix two or more and manufacture.But tightly must limit manufacturing environment and additive etc., the consumption being used in the potassium permanganate solution of 0.002mol/L in reduction potassium permanganate substances test is the resin of below 0.30mL.In addition, the resin more preferably using this consumption to be below 0.10mL.In addition, as required, also attraction method (the Pellet-venting method of such as granular resin can be utilized, ベ Application ト ペ レ ッ ト method), low molecular weight substance such as known method removing such as the attraction method (Sheet-venting method, ベ Application ト シ ー ト method) of flaky resin, boulton process, solvent ablution etc.
The consumption of above-mentioned potassium permanganate solution, such as, can measure based on the reduction potassium permanganate substances test in the plastics drug container test of Japanese Pharmacopoeia.Specifically, when wrapping material are film, first collect test film, film surfaces externally and internally is amassed and adds up to 1200cm
2.Then, washed, after drying, put into 200mL water and carry out high pressure steam sterilization (121 DEG C, 1 hour), placed cooling, using this liquid as experimental liquid.Then, add 0.002mol/L potassium permanganate solution and the 1mL dilute sulphuric acid of 20.0mL, boil 3 minutes, after being cooled, add 0.10g potassiumiodide in this experimental liquid of 20mL, vibration mixing, places 10 minutes.After this, utilize the Sulfothiorine liquid of 0.01mol/L to carry out titration (indicator: 5 starch test solutions) to obtain (contrast: water).
According to the research of the present inventor etc., when utilizing the consumption of the potassium permanganate solution of the 0.002mol/L obtained by above-mentioned test to be greater than the resin of 0.30mL in pharmaceutical preparation packages material, produce bad reaction according to after the different pharmaceutical preparation display contact of packaging, the problem of lysate muddiness occurs.On the other hand, if use the consumption of potassium permanganate solution to be less than the resin of 0.30mL, then the problems referred to above are eliminated.
In addition, wrapping material of the present embodiment also can use except above-mentioned condition also has the material of following characteristic.That is, the resin that turbidity is below 2.0NTU in 60 DEG C of preservations test of 15 days based on European Pharmacopoeia using ceftriaxone sodium is preferably used in.Specifically, this test is when forming wrapping material with film, makes in bag-shaped sack and adds 1.0g ceftriaxone sodium, put it in airtight Glass Containers in the circumference of sealing membrane, preserves 15 at 60 DEG C.After this, in water, the ceftriaxone sodium of whole amount in dissolving film, adds water in the water of purification membrane inner-wall surface, forms 20mL, using this liquid as experimental liquid.Then, the turbidity of this experimental liquid is measured.Turbidity is more preferably below 1.0NTU.
In addition, the resin being below 5.0NTU based on the turbidity in 60 DEG C of preservations test of 15 days of European Pharmacopoeia using sodium CEZ can be also used in.Specifically, this test is when forming wrapping material with film, the circumference of sealing membrane and make in bag-shaped sack and add 1.0g sodium CEZ, puts it in airtight Glass Containers, preserves 15 at 60 DEG C.After this, the sodium CEZ of whole amount in dissolving film in water, and with water cleaning film inner-wall surface, merge two portions solution and be also settled to 20mL, using this liquid as experimental liquid.Then, the turbidity of this experimental liquid is measured.
Wrapping material of the present invention make, with packaged pharmaceutical preparation, the wrapping material that interactional reducing substances is below specified quantitative occur.And, owing to being maintained as the fundamental characteristics of the wrapping material of the flexibility, the transparency, heat sealability etc. of wrapping material, therefore, it is possible to effectively utilize as pharmaceuticals packaging wrapping material in the same manner as existing this kind of based packaging material.That is, wrapping material of the present invention both directly with monolayer package pharmaceuticals, in addition, also according to usual method, can use in same purposes as with the multilayer film (stack membrane) of other resin etc.Such as, also can utilize in the packing bag of the former powder of pharmaceutical preparation and pharmaceutical preparation packages paper etc.
Stablized and the pharmaceutical preparation packed safely as by above-mentioned wrapping material, such as, the microbiotic such as the Macrolide of the polypeptide class, erythromycin etc. of the aminoglycoside, vancomycin etc. of the carbapenems, kantlex etc. of the beta-lactam, imipenem etc. of the cephalosporin, penbritin etc. of Cephazolin etc. can be illustrated.
2. pharmaceutical preparation container
Wrapping material of the present invention also can be shaped to suitable pharmaceutical preparation packages container form according to usual method, utilize as pharmaceutical preparation packages container.In addition, also can use the resin particle meeting above-mentioned condition, utilize common blow molding method etc. to manufacture blow-molded container.
In addition, use above-mentioned wrapping material to form bag-like container main body 1 as shown in fig. 1, the container of the 1st and the 2nd receiving room (in diagram 2,3) of setting at least 2 can be made in this container body 1.These 2 receiving rooms (in diagram 2,3) are separated with the separating part 4 that can break seal.Separating part 4 can be formed with weak sealing.Then, in the 1st receiving room 2, receive the microbiotic of powdery or solid state, in the 2nd receiving room 3, receive antibiotic lysate.
Embodiment
Below, in order to illustrate in greater detail the present invention, enumerate the Production Example of the wrapping material that the present invention relates to and test example as embodiment.In addition, the Production Example of the wrapping material compared and test example is enumerated as comparative example.
(embodiment 1)
Use straight-chain Low Density Polyethylene (ethene-4-methylpentene copolymer) [Mitsui Chemicals, Inc's system; Density 0.920g/cm
3(according to ASTM-D1505, identical below), MFR2.2g/10 minute (according to ASTM-D1238, identical below)], the film of thickness 145 μm is manufactured with T die forming machine.Use 2 these films, by periphery heat seal is manufactured pharmaceutical preparation powder package bag.
Collect test film from this bag, film surfaces externally and internally is amassed and adds up to 1200cm
2, after washing, drying, put into 200mL water and carry out high pressure steam sterilization (121 DEG C, 1 hour), placing cooling, using this liquid as experimental liquid.Then, in this experimental liquid of 20mL, add 0.002mol/L potassium permanganate solution and the 1mL dilute sulphuric acid of 20.0mL, boil 3 minutes.After being cooled, add 0.10g potassiumiodide, vibration mixing, places 10 minutes.After this, titration (indicator: 5 starch test solutions) is carried out with the Sulfothiorine liquid of 0.01mol/L.Its result is the consumption of 0.002mol/L potassium permanganate solution is 0.05mL (mean value; N=3).
In addition, add 1.0g ceftriaxone in this bag after, this bag is put into airtight Glass Containers, preserve 15 at 60 DEG C.After this, in water, the ceftriaxone of whole amount in dissolving film, adds water in the water of purification membrane inner-wall surface, forms 20mL, using this liquid as experimental liquid, measures turbidity.Its result is 0.480NTU (mean value; N=3).
(embodiment 2)
The film that following manufacture is formed by 3 layers.
A () is outer: straight-chain medium-density polyethylene (ethene-butene-1 copolymer) [Mitsui Chemicals, Inc's system; Density 0.940g/cm
3, MFR 2.2g/10 minute]
(b) middle layer: the polyethylene identical with embodiment 1
(c) internal layer: make the polyethylene identical with embodiment 1 and polypropylene (Mitsui Chemicals, Inc's system; Density 0.910g/cm
3, MFR 7.0g/10 minute) be 2: 1 weight ratio.
By its with three-layer co-extruded go out water cooling blow molding machine manufacture the film of thickness 250 μm.
Use this film, carry out heat seal in the mode in strong seal perimeter portion, weak sealed separation portion, the two rooms pouch-type pharmaceutical preparation test kit shown in shop drawings 1.In this test kit, filling normal saline solution in a Room, filling microbiotic in an other Room.
After this bag of filling 100mL water, carry out high pressure steam sterilization (121 DEG C, 1 hour), place cooling, using this liquid as experimental liquid.Then, the consumption of 0.002mol/L potassium permanganate solution is obtained in operation similarly to Example 1.Its result, consumption is 0.05mL (mean value; N=3).The result of time-and-motion study turbidity is similarly to Example 1 0.476NTU (mean value again; N=3).
(embodiment 3)
Use straight-chain Low Density Polyethylene (ethene-4-methylpentene copolymer) [Mitsui Chemicals, Inc's system; Density 0.920g/cm
3, MFR 2.2g/10 minute; Producing apparatus manufacture with different from embodiment 1], the film of thickness 200 μm is manufactured with water cooling blow molding machine.
Use this film, heat seal circumference, thus manufacture premix formulations infusion bag.
To this bag with operate similarly to Example 1 obtain 0.002mol/L potassium permanganate solution consumption result for 0.18mL (mean value; N=3).The result of time-and-motion study turbidity is similarly to Example 1 1.776NTU (mean value again; N=3).
(comparative example 1)
Use straight-chain Low Density Polyethylene (ethene-4-methylpentene copolymer) [Mitsui Chemicals, Inc's system; Density 0.920g/cm
3, MFR 2.2g/10 minute; Producing apparatus manufacture with different from embodiment 1 and 3], the film of thickness 200 μm is manufactured with water cooling blow molding machine.
Use this film, heat seal circumference, thus manufacture premix formulations infusion bag.
To this bag with same with embodiment 1 operate obtain 0.002mol/L potassium permanganate solution consumption result for 0.32mL (mean value; N=3).The result of time-and-motion study turbidity is similarly to Example 1 2.598NTU (mean value again; N=3).
(comparative example 2)
Use straight-chain Low Density Polyethylene [inward; Density 0.920g/cm3], the film of thickness 200 μm is manufactured with water cooling blow molding machine.
Use this film, heat seal circumference, thus manufacture premix formulations infusion bag.
To this bag with operate similarly to Example 1 obtain 0.002mol/L potassium permanganate solution consumption result for 0.35mL (mean value; N=3).The result of time-and-motion study turbidity is similarly to Example 1 16.368NTU (mean value again; N=3).
Claims (8)
1. a pharmaceutical preparation packages material, is characterized in that:
Formed by polyolefine, in reduction potassium permanganate substances test, the consumption of the potassium permanganate solution of 0.002mol/L is below 0.30mL.
2. pharmaceutical preparation packages material as claimed in claim 1, is characterized in that:
Using the preserving in the test of 15 days at 60 DEG C based on European Pharmacopoeia of ceftriaxone sodium, turbidity is below 2.0NTU.
3. pharmaceutical preparation packages material as claimed in claim 1, is characterized in that:
Using the preserving in the test of 15 days at 60 DEG C based on European Pharmacopoeia of sodium CEZ, turbidity is below 5.0NTU.
4. pharmaceutical preparation packages material as claimed in claim 1, is characterized in that:
Described polyolefine is selected from least one in polyethylene and polypropylene.
5. pharmaceutical preparation packages material as claimed in claim 4, is characterized in that:
For packing microbiotic.
6. pharmaceutical preparation packages material as claimed in claim 4, is characterized in that:
Be formed as membranaceous,
The thickness of this film is 150 ~ 300 μm.
7. a pharmaceutical preparation container, is characterized in that:
Use pharmaceutical preparation packages material according to any one of claim 1 ~ 6 and shaping.
8. a pharmaceutical preparation container, is characterized in that:
Possess and use the wrapping material described in claim 6 and be formed as bag-shaped container body,
Described container body has the 1st and the 2nd receiving room of at least 2, and separates the separating part of these 2 receiving rooms in the mode that can open,
The microbiotic of powdery or solid state is received in described 1st receiving room,
Described antibiotic lysate is received in described 2nd receiving room.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410383628.4A CN104829900B (en) | 2014-02-11 | 2014-08-06 | Pharmaceutical preparation packages material and pharmaceutical preparation container |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2014200613218 | 2014-02-11 | ||
| CN201420061321 | 2014-02-11 | ||
| CN201410383628.4A CN104829900B (en) | 2014-02-11 | 2014-08-06 | Pharmaceutical preparation packages material and pharmaceutical preparation container |
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| Publication Number | Publication Date |
|---|---|
| CN104829900A true CN104829900A (en) | 2015-08-12 |
| CN104829900B CN104829900B (en) | 2019-04-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410383628.4A Active CN104829900B (en) | 2014-02-11 | 2014-08-06 | Pharmaceutical preparation packages material and pharmaceutical preparation container |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087051A (en) * | 1992-09-11 | 1994-05-25 | 株式会社大制药工场 | The polyolefin packaging material that are used for drug packages, the container of its manufacture method and drug packages |
| CN1919700A (en) * | 2006-03-31 | 2007-02-28 | 上海武杉包装制品有限公司 | Powder and liquid bag and preparation method thereof |
| CN201939693U (en) * | 2010-10-29 | 2011-08-24 | 株式会社大冢制药工场 | Medical multi-chamber container |
-
2014
- 2014-08-06 CN CN201410383628.4A patent/CN104829900B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087051A (en) * | 1992-09-11 | 1994-05-25 | 株式会社大制药工场 | The polyolefin packaging material that are used for drug packages, the container of its manufacture method and drug packages |
| CN1919700A (en) * | 2006-03-31 | 2007-02-28 | 上海武杉包装制品有限公司 | Powder and liquid bag and preparation method thereof |
| CN201939693U (en) * | 2010-10-29 | 2011-08-24 | 株式会社大冢制药工场 | Medical multi-chamber container |
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| CN104829900B (en) | 2019-04-05 |
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