CN104829900B - Pharmaceutical preparation packages material and pharmaceutical preparation container - Google Patents
Pharmaceutical preparation packages material and pharmaceutical preparation container Download PDFInfo
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- CN104829900B CN104829900B CN201410383628.4A CN201410383628A CN104829900B CN 104829900 B CN104829900 B CN 104829900B CN 201410383628 A CN201410383628 A CN 201410383628A CN 104829900 B CN104829900 B CN 104829900B
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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 reside in provide a kind of pharmaceutical preparation packages material and pharmaceutical preparation container.Pharmaceutical preparation packages material of the present invention is formed by polyolefin, and in reduction potassium permanganate substances test, the consumption of the liquor potassic permanganate of 0.002mol/L is 0.30mL or less.
Description
Technical field
The present invention relates to pharmaceutical preparation packages materials and pharmaceutical preparation container.
Background technique
The packaging material of the original powder of the packaging material and pharmaceuticals as the various pharmaceuticals headed by antibiotic, it is desirable that
It does not add and dysgenic plasticizer etc. is generated to pharmaceuticals.I.e., it is desirable that be the material with heat sealability and flexibility
Packaging material.From this viewpoint, polyolefin film is generally used in the past, it is (following especially with straight-chain low density polyethylene (LDPE)
It is abbreviated as " LLDPE ") film.
But certain pharmaceuticals, such as cephalo-type, beta-lactam, Carbapenems, aminoglycoside, polypeptide or
The antibiotic such as macrolides are likely to that faint interaction occurs with said polyolefins film.Its result generates undesirable reaction
Product.If generating such reaction product, there is the worry that the solution in dissolution generates gonorrhoea.Therefore, in the past
These antibiotic are not packed with film, and are saved in special glass cillin bottle.
But in recent years, in order to replace glass cillin bottle, the research of the instant-matching type product of the above-mentioned antibiotic of storage has been carried out
Exploitation.Instant-matching type product is to be combined with the system of the polyolefin flexible container and dissolution liquid container of the antibiotic of enclosed single administration amount
Product.In this way, solving said vesse (especially constituting its olefin resin) and pharmaceutical preparation to keep such product practical
Contact caused by interaction gazed at as important topic.
As one of the solution countermeasure, proposing in WO94/06396 bulletin makes the substance of specific carbon atom number (just
Hexane extract) content be certain polyolefin packaging material below.In this way, completing safe dual-chamber bag according to this method
The product of type instant-matching type product.
But as such instant-matching type product is widely used, it is desirable that safety is higher, the pharmaceutical preparation that can store
The pharmaceutical preparation packages material that choice direction is also widened.
The present invention be to solve the above-mentioned problems and make, and it is an object of the present invention to provide a kind of safety is higher, can store
Pharmaceutical preparation choice direction the pharmaceutical preparation packages material and pharmaceutical preparation packages container also widened.
Summary of the invention
The relevant pharmaceutical preparation packages material of the present invention is formed by polyolefin, in reduction potassium permanganate substances test,
The consumption of the liquor potassic permanganate of 0.002mol/L is 0.30mL or less.
In said medicine preparation packaging material, in the saving 15 at 60 DEG C based on European Pharmacopoeia using Ceftriaxone Sodium
Test in, turbidity is preferably 2.0NTU or less.
In addition, in said medicine preparation packaging material, in the protecting at 60 DEG C based on European Pharmacopoeia using Cefazolin sodium
It deposits in test on the 15th, turbidity can be 5.0NTU or less.
Said polyolefins can be selected from least one of polyethylene and polypropylene.At this point, the pharmaceutical preparation packages material
Material can be used in packing antibiotic.
In addition, above-mentioned packaging material is formed as membranaceous, can make the film with a thickness of 150~300 μm.
1st pharmaceutical preparation container of the present invention using pharmaceutical preparation packages material described in above-mentioned any one and
Molding.
Moreover, it relates to the 2nd pharmaceutical preparation container have using being formed as membranaceous packaging material and be formed as
Bag-shaped container body；Said vesse main body has the 1st and the 2nd receiving room of at least two, and is separated in a manner of it can break seal
The lattice of 2 receiving rooms；The antibiotic that powdery or solid-like are stored in above-mentioned 1st receiving room, in above-mentioned 2nd receiving room
The lysate of the middle above-mentioned antibiotic of storage.
Detailed description of the invention
Fig. 1 is the plan view for indicating an embodiment of pharmaceutical preparation container of the present invention.
Specific embodiment
1. pharmaceutical preparation packages material
Hereinafter, illustrating an embodiment of pharmaceutical preparation packages material of the present invention.It is of the present embodiment
Packaging material is the material of packaged pharmaceuticals preparation, is formed by polyolefin.Polyolefin used herein is manufactured with general preparation method, example
It such as, can be former by ethene polymers, ethene-alpha-olefin copolymer, acrylic polymers, propylene-alpha-olefin copolymers, also carbon
Alpha-olefin homo and copolymer that subnumber is 3~20 etc. are independent or mix two or more manufacture.However, it is necessary to which tightly limitation is made
Environment and additive etc. are made, the consumption of the liquor potassic permanganate of 0.002mol/L in reduction potassium permanganate substances test is used
For 0.30mL resin below.In addition, the use of the consumption being more preferably 0.10mL resin below.In addition, as needed,
The attraction method (Pellet-venting method, ベ Application ト ペ レ ッ ト method) of such as granular resin, flaky resin can be utilized
Method well known to attraction method (Sheet-venting method, ベ Application ト シ ー ト method), boulton process, solvent ablution etc. is removed
Remove low molecular weight substance.
The consumption of above-mentioned liquor potassic permanganate, for example, can be tried based on the plastics drug container in Japanese Pharmacopoeia
Reduction potassium permanganate substances test in testing measures.Specifically, collecting test first in the case where packaging material is film
Piece, so that film surfaces externally and internally product adds up to 1200cm2.Then, it after being washed, being dry, is put into 200mL water and carries out high pressure
Steam sterilizing (121 DEG C, 1 hour) places cooling, using the liquid as experimental liquid.Then, it is added in the 20mL experimental liquid
The 0.002mol/L potassium permanganate solution and 1mL dilute sulfuric acid of 20.0mL, boils 3 minutes, after being cooled to, and 0.10g iodine is added
Change potassium, oscillation mixing is placed 10 minutes.Hereafter, (indicator: 5 drops is titrated using the sodium thiosulfate liquid of 0.01mol/L
Starch test solution) find out (control: water).
The research of inventor according to the present invention etc., using being found out by above-mentioned test in pharmaceutical preparation packages material
When the consumption of the liquor potassic permanganate of 0.002mol/L is greater than the resin of 0.30mL, shown according to the different pharmaceutical preparation of packaging
Undesirable reaction is generated after contact, and the problem of lysate muddiness occurs.On the other hand, if using liquor potassic permanganate consumption
Amount is less than the resin of 0.30mL, then the above problem is eliminated.
In addition, packaging material of the present embodiment is also able to use the material also having the property that in addition to above-mentioned condition
Material.That is, being preferably used in turbidity in the test for saving 15 at 60 DEG C using Ceftriaxone Sodium based on European Pharmacopoeia and being
2.0NTU resin below.Specifically, the test is to be made when forming packaging material with film in the peripheral part of sealing film
1.0g Ceftriaxone Sodium is added in bag-shaped sack, puts it into closed glass container, is saved 15 at 60 DEG C.Hereafter,
The Ceftriaxone Sodium of whole amount forms 20mL, which is made in the water of purification membrane inner wall plus water in dissolving film in water
For experimental liquid.Then, the turbidity of the experimental liquid is measured.Turbidity is more preferably 1.0NTU or less.
In addition, being also able to use in the test for saving 15 at 60 DEG C based on European Pharmacopoeia using Cefazolin sodium
Turbidity be 5.0NTU resin below.Specifically, the test is to seal the periphery of film when forming packaging material with film
Portion and addition 1.0g Cefazolin sodium is made in bag-shaped sack, put it into closed glass container, save 15 at 60 DEG C
Day.Hereafter, in water in dissolving film whole amount Cefazolin sodium, and wash with water film inner wall, merge two parts solution simultaneously
It is settled to 20mL, using the liquid as experimental liquid.Then, the turbidity of the experimental liquid is measured.
Packaging material of the invention is to make and reducing substances that the pharmaceutical preparation that is packaged interacts are specific
Measure packaging material below.Moreover, because being maintained as the packing timber of the flexibility of packaging material, the transparency, heat sealability etc.
The fundamental characteristics of material, therefore, with existing this kind of based packaging material similarly as pharmaceuticals can be packed for packaging material and
It effectively utilizes.That is, packaging material of the invention both can be directly with monolayer package pharmaceuticals, in addition, also can be according to usual
Method, as the multilayer film (stack membrane) with other resins etc. same with using on the way.For example, also can be in pharmaceutical preparation original
It is utilized in the packaging bag of powder and pharmaceutical preparation packages paper etc..
As the pharmaceutical preparation stablized by above-mentioned packaging material and safely packed, for example, cephalo can be illustrated
Carbapenems, kanamycins of beta-lactam, the imipenem of cephalo-type, the ampicillin of azoles woods etc. etc. etc. etc.
The antibiotic such as macrolides of polypeptide, the erythromycin of aminoglycoside, vancomycin etc. etc..
2. pharmaceutical preparation container
Packaging material of the invention can also be shaped to pharmaceutical preparation packages container form appropriate according to usual method, make
For the utilization of pharmaceutical preparation packages container.It is further possible to be blow molded into using the resin particle for meeting above-mentioned condition using common
Type method etc. manufactures blow-molded container.
In addition, bag-like container main body 1 is formed using above-mentioned packaging material as shown in fig. 1, it can be in the container body 1
The container of the 1st and the 2nd receiving room (2,3 in diagram) of setting at least two is made.This 2 receiving room (2,3 in diagram) is with can
The lattice 4 of unpacking separates.Lattice 4 can be formed with weak sealing.Then, powdery or solid-like are stored in the 1st receiving room 2
Antibiotic, in the 2nd receiving room 3 store antibiotic lysate.
Embodiment
Hereinafter, enumerating the Production Example and test example of packaging material of the present invention in order to which the present invention is described in more detail
As embodiment.In addition, enumerating the Production Example for comparing the packaging material used and test example as comparative example.
(embodiment 1)
Use straight-chain low density polyethylene (LDPE) (ethylene -4- methylpentene copolymer) [Mitsui Chemicals, Inc's system；It is close
Spend 0.920g/cm3(according to ASTM-D1505, same as below), MFR2.2g/10 minutes (according to ASTM-D1238, following phase
Together)], 145 μm of thickness of film is manufactured with T die forming machine.Using 2 films, pharmaceutical preparation is manufactured and heating seal periphery
Powder package bag.
Test film is collected from the bag, so that film surfaces externally and internally product adds up to 1200cm2, after washing, drying, it is put into 200mL
It is carried out in water high pressure steam sterilization (121 DEG C, 1 hour), cooling is placed, using the liquid as experimental liquid.Then, it is somebody's turn to do in 20mL
The 0.002mol/L potassium permanganate solution and 1mL dilute sulfuric acid of 20.0mL are added in experimental liquid, boils 3 minutes.After being cooled to,
0.10g potassium iodide is added, oscillation mixing is placed 10 minutes.Hereafter, it is titrated and (is referred to the sodium thiosulfate liquid of 0.01mol/L
Show agent: 5 drop starch test solutions).As a result the consumption of 0.002mol/L potassium permanganate solution is 0.05mL (average value；N=
3)。
In addition, being put into this bag in closed glass container after 1.0g ceftriaxone is added in the bag, saved at 60 DEG C
15 days.Hereafter, the ceftriaxone of whole amount forms 20mL in the water of purification membrane inner wall plus water in dissolving film in water, will
The liquid measures turbidity as experimental liquid.As a result 0.480NTU (average value；N=3).
(embodiment 2)
The film constituted by 3 layers is manufactured as follows.
(a) outer layer: straight-chain medium density polyethylene (ethylene-butene-1 copolymer) [Mitsui Chemicals, Inc's system；It is close
Spend 0.940g/cm3, MFR 2.2g/10 minutes]
(b) middle layer: polyethylene same as Example 1
(c) internal layer: make polyethylene and polypropylene (Mitsui Chemicals, Inc's system same as Example 1；Density
0.910g/cm3, MFR 7.0g/10 minutes) be 2: 1 weight ratio.
By it with the three-layer co-extruded film for being discharged cooling blow molding machine and manufacturing 250 μm of thickness.
It using the film, is heated seal, is manufactured shown in FIG. 1 double in a manner of strong seal perimeter portion, weak sealed separation portion
Room pouch-type pharmaceutical preparation kit.In the kit, normal saline solution is filled in a Room, fills antibiosis in an other Room
Element.
It after filling 100mL water to the bag, carries out high pressure steam sterilization (121 DEG C, 1 hour), places cooling, which is made
For experimental liquid.Then, the consumption for finding out 0.002mol/L potassium permanganate solution is operated similarly to Example 1.As a result, disappearing
Consumption is 0.05mL (average value；N=3).The result of time-and-motion study turbidity is 0.476NTU (average similarly to Example 1 again
Value；N=3).
(embodiment 3)
Use straight-chain low density polyethylene (LDPE) (ethylene -4- methylpentene copolymer) [Mitsui Chemicals, Inc's system；It is close
Spend 0.920g/cm3, MFR 2.2g/10 minutes；Manufactured with the manufacturing equipment different from embodiment 1], with the cooling blow molding of water
Machine manufactures 200 μm of thickness of film.
Using the film, peripheral part is heated seal, to manufacture premix formulations infusion bag.
This bag is found out by the result of 0.002mol/L potassium permanganate solution consumption is to operate similarly to Example 1
0.18mL (average value；N=3).The result of time-and-motion study turbidity is 1.776NTU (average value similarly to Example 1 again；N=
3)。
(comparative example 1)
Use straight-chain low density polyethylene (LDPE) (ethylene -4- methylpentene copolymer) [Mitsui Chemicals, Inc's system；It is close
Spend 0.920g/cm3, MFR 2.2g/10 minutes；Manufactured with the manufacturing equipment different from embodiment 1 and 3], it is blow molded into water cooling
Type machine manufactures 200 μm of thickness of film.
Using the film, peripheral part is heated seal, to manufacture premix formulations infusion bag.
To this bag with and the equally operation of embodiment 1 find out the result of 0.002mol/L potassium permanganate solution consumption and be
0.32mL (average value；N=3).The result of time-and-motion study turbidity is 2.598NTU (average value similarly to Example 1 again；N=
3)。
(comparative example 2)
Use straight-chain low density polyethylene (LDPE) [import；Density 0.920g/cm3], with the cooling blow molding mechanism of water
Make 200 μm of thickness of film.
Using the film, peripheral part is heated seal, to manufacture premix formulations infusion bag.
This bag is found out by the result of 0.002mol/L potassium permanganate solution consumption is to operate similarly to Example 1
0.35mL (average value；N=3).The result of time-and-motion study turbidity is 16.368NTU (average value similarly to Example 1 again；N=
3)。
Claims (6)
1. a kind of pharmaceutical preparation packages material whether He Ge determination method, it is characterised in that:
The pharmaceutical preparation packages material is formed by polyolefin,
In reduction potassium permanganate substances test, the liquor potassic permanganate of the 0.002mol/L of the pharmaceutical preparation packages material
When consumption is 0.30mL or less, it is qualified to be considered the pharmaceutical preparation packages material.
2. determination method as described in claim 1, it is characterised in that:
In the test for saving 15 at 60 DEG C based on European Pharmacopoeia using Ceftriaxone Sodium, the pharmaceutical preparation packages material
The turbidity of material is 2.0NTU or less.
3. determination method as described in claim 1, it is characterised in that:
In the test for saving 15 at 60 DEG C based on European Pharmacopoeia using Cefazolin sodium, the pharmaceutical preparation packages material
The turbidity of material is 5.0NTU or less.
4. determination method as described in claim 1, it is characterised in that:
The polyolefin is selected from least one of polyethylene and polypropylene.
5. determination method as claimed in claim 4, it is characterised in that:
The pharmaceutical preparation packages material is for packing antibiotic.
6. determination method as claimed in claim 4, it is characterised in that:
The pharmaceutical preparation packages material is formed as membranaceous,
The film with a thickness of 150~300 μm.
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| 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 |
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| CN104829900A CN104829900A (en) | 2015-08-12 |
| CN104829900B true CN104829900B (en) | 2019-04-05 |
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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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| CN104829900A (en) | 2015-08-12 |
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