TWI486183B - Method for preventing odor of medicine containing olmesartan medoxomil - Google Patents

Method for preventing odor of medicine containing olmesartan medoxomil Download PDF

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TWI486183B
TWI486183B TW102113345A TW102113345A TWI486183B TW I486183 B TWI486183 B TW I486183B TW 102113345 A TW102113345 A TW 102113345A TW 102113345 A TW102113345 A TW 102113345A TW I486183 B TWI486183 B TW I486183B
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odor
olmesartan medoxomil
layer
density polyethylene
low density
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TW102113345A
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TW201332594A (en
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Masaaki Takahashi
Takahiko Sato
Tatsuya Ogawa
Shin-Ichi Koizumi
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Daiichi Sankyo Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J20/00Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
    • B01J20/02Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
    • B01J20/10Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising silica or silicate
    • B01J20/16Alumino-silicates
    • B01J20/18Synthetic zeolitic molecular sieves
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/266Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
    • B65D81/267Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants the absorber being in sheet form

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Composite Materials (AREA)
  • Food Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Wrappers (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

含有奧美沙坦酯製劑之臭味防止方法Odor prevention method containing olmesartan medoxomil preparation

本發明係相關於含有臭味吸附劑之包裝材及包裝醫藥品之壓泡包裝或泡罩包裝。The present invention relates to a blister pack or a blister pack relating to a packaging material containing an odor sorbent and a packaged pharmaceutical product.

先前包裝醫藥品時,廣泛使用壓泡包裝(PTP)或泡罩包裝,惟醫藥品中有些具有製劑特有之臭味,實施壓泡包裝或泡罩包裝的醫療設備之調劑工作人員,時常對其臭味感到不舒服感。且服用者從壓泡包裝或泡罩包裝取出錠劑時或服用時,亦對其臭味感到不舒服感。該類製劑導致服用者的順應性降低且影響商品價值。When packaging pharmaceuticals, packaging (PTP) or blister packaging is widely used, but some of the pharmaceutical products have the odor of the preparation, and the staff of the medical equipment that implements the blister or blister packaging often The smell is uncomfortable. Moreover, the user feels uncomfortable with the odor when taking the tablet from the blister pack or the blister pack or when taking it. Such formulations result in reduced compliance of the user and affect the value of the product.

醫藥品的壓泡包裝或泡罩包裝之包裝型態中,吸附由製劑散發的臭味之方法,係以高氣體遮蔽性的鋁層壓薄片使壓泡包裝或泡罩包裝密閉(以下稱為「枕包裝」),將臭味吸附劑裝入其中,吸收由壓泡包裝或泡罩包裝釋出些微的臭味之方法。惟,為確保製劑的衛生性、長期間的安定性,通常壓泡包裝或泡罩包裝係選擇氣密性較高的包裝材,因此臭味物質殘留於壓泡包裝或泡罩包裝的袋中,抑制臭味之效果不足。雖有使沸石均勻分散混合於薄膜材之除臭薄膜材(特開平11-35077號公報),惟無任何有關於為包裝含有本發明的特定藥劑的製劑之包裝材。In the packaging form of a blister pack or a blister pack of a pharmaceutical product, the method of adsorbing the odor emitted by the preparation is to seal the blister pack or the blister pack with a high gas-shielding aluminum laminate sheet (hereinafter referred to as "Pillow packaging"), in which an odor adsorbent is incorporated, absorbs a slight odor by a blister pack or a blister pack. However, in order to ensure the hygiene of the preparation and the stability of the preparation for a long period of time, the foam packaging or the blister packaging usually selects a packaging material having a high airtightness, so that the odorous substance remains in the bag of the blister pack or the blister pack. The effect of suppressing odor is insufficient. There is a deodorant film material in which the zeolite is uniformly dispersed and mixed in a film material (Japanese Laid-Open Patent Publication No. Hei 11-35077), and there is no packaging material for a package containing the specific drug of the present invention.

專利文獻1:特開平11-35077號公報Patent Document 1: Japanese Patent Publication No. 11-35077

本發明的目的係提供一種吸附由含有奧美沙坦酯(Olmestartan Medoxomil)或2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑之製劑產生的臭味物質之包裝材。The object of the present invention is to provide an adsorption by containing olmesartan Medoxomil or 2-amino-5-isobutyl-4-{2-[5-(N,N'-bis((S)-) A packaging material for an odorous substance produced by the preparation of 1-ethoxycarbonyl)ethyl)phosphine decylamine]furanyl}thiazole.

本發明者等為完成上述目的而致力研究之結果,發現使包裝材含有臭味吸附劑,和包裝材吸附由含有奧美沙坦酯或2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑產生的臭味物質而降低其氣體濃度,藉此防止或降低從包裝體取出製劑時的臭味感覺,可減輕不舒服感而完成本發明。As a result of intensive research to accomplish the above object, the present inventors have found that the packaging material contains an odor adsorbent, and the packaging material is adsorbed by containing olmesartan medoxomil or 2-amino-5-isobutyl-4-{2 -[5-(N,N'-bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole produces an odorous substance to lower its gas concentration, thereby preventing or reducing The odor feeling at the time of taking out the preparation of the package body can reduce the discomfort and complete the present invention.

亦即,本發明係提供(1)一種包裝材,其特徵係為包裝含有奧美沙坦酯的製劑用之包裝材,且含有臭味吸附劑,(2)如第(1)項之包裝材,其中臭味吸附劑係選自於物理吸附劑及化學吸附劑之化合物中的1種或2種以上,(3)如第(1)項之包裝材,其中臭味吸附劑係選自於合成沸石、活性碳之化合物中的1種或2種以上,(4)如第(1)項之包裝材,其中臭味吸附劑係合成沸石13X,(5)如第(1)項之包裝材,其中臭味吸附劑係疏水性沸石,(6)如第(1)項之包裝材,其中臭味吸附劑係對合成沸石13X施予疏水性處理之疏水性沸石, (7)如第(1)項之包裝材,其中臭味吸附劑係高矽沸石,(8)如第(1)至(7)項中任一項之包裝材,其中包裝材係多層薄膜,(9)如第(8)項之包裝材,其中多層薄膜係具有含臭味吸附劑的吸附層及基材層,(10)如第(9)項之包裝材,其中在吸附層和基材層之間更具有黏附層,(11)如第(9)或(10)項之包裝材,其中在與基材層相對之吸附層側,更具有密封膠層,(12)如第(9)至(11)項中任一項之包裝材,其中在與基材層接觸之吸附層側,更具有外層,(13)如第(9)至(12)項中任一項之包裝材,其中吸附層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯、離子鍵聚合物、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、乙烯醋酸乙烯酯共聚物、乙烯丙烯酸乙烯酯共聚物、乙烯丙烯酸甲酯共聚物、乙烯甲基丙烯酸甲酯共聚物之化合物中的1種或2種以上,(14)如第(9)至(12)項中任一項之包裝材,其中吸附層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯之化合物中的1種或2種以上,(15)如第(9)至(12)項中任一項之包裝材,其中吸附層係含有低密度聚乙烯,(16)如第(9)至(15)項中任一項之包裝材,其中基材層係含有選自於聚氯乙烯、無延展聚丙烯、聚丙烯、聚偏 二氯乙烯、聚三氟化氯乙烯、環狀烯烴共聚物之化合物中的1種或2種以上,(17)如第(9)至(15)項中任一項之包裝材,其中基材層係含有聚氯乙烯,(18)如第(10)至(17)項中任一項之包裝材,其中黏附層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯之化合物中的1種或2種以上,(19)如第(10)至(17)項中任一項之包裝材,其中黏附層係含有低密度聚乙烯,(20)如第(11)至(19)項中任一項之包裝材,其中密封膠層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯之化合物中的1種或2種以上,(21)如第(11)至(19)項中任一項之包裝材,其中密封膠層係含有直鏈狀低密度聚乙烯,(22)如第(12)至(21)項中任一項之包裝材,其中外層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯的化合物中之1種或2種以上,(23)如第(12)至(21)項中任一項之包裝材,其中外層係含有直鏈狀低密度聚乙烯,(24)一種壓泡包裝或泡罩包裝,其係使用如第(1)至(23)項中任一項之包裝材,(25)一種壓泡包裝或泡罩包裝,其係於容器的附袋式薄片(pocket sheet)使用如第(1)至(23)項中任一項之包裝材, (26)如第(24)或(25)項之壓泡包裝或泡罩包裝,其係包裝含有奧美沙坦酯之製劑,(27)一種含有奧美沙坦酯之製劑,其係以如第(1)至(23)項中任一項之包裝材進行包裝,(28)一種含有奧美沙坦酯之製劑,其係以如第(24)或(25)項之壓泡包裝或泡罩包裝進行包裝,(29)一種含有奧美沙坦酯製劑之臭味防止方法,其特徵係以如第(1)至(23)項中任一項之包裝材進行包裝,(30)一種含有奧美沙坦酯製劑之臭味防止方法,其特徵係以如第(24)或(25)項之壓泡包裝或泡罩包裝進行包裝。That is, the present invention provides (1) a packaging material characterized by packaging a packaging material containing olmesartan medoxomil and containing an odor adsorbent, and (2) a packaging material according to item (1). The odor adsorbent is one or more selected from the group consisting of a physical adsorbent and a chemical adsorbent. (3) The packaging material according to item (1), wherein the odor adsorbent is selected from the group consisting of (1) A packaging material according to the item (1), wherein the odor adsorbent is a synthetic zeolite 13X, and (5) is packaged according to the item (1). The odor adsorbent is a hydrophobic zeolite, (6) the packaging material according to the item (1), wherein the odor adsorbent is a hydrophobic zeolite which is subjected to hydrophobic treatment to the synthetic zeolite 13X. (7) The packaging material according to the item (1), wherein the odor adsorbent is a sorghum zeolite, (8) the packaging material according to any one of (1) to (7), wherein the packaging material is a multilayer film. (9) The packaging material according to item (8), wherein the multilayer film has an adsorption layer containing a odor adsorbent and a substrate layer, (10) a packaging material according to item (9), wherein the adsorption layer and (11) A packaging material according to item (9) or (10), wherein a side of the adsorption layer opposite to the substrate layer further has a sealant layer, (12) The packaging material according to any one of the items (9), wherein the side of the adsorption layer in contact with the substrate layer further has an outer layer, (13) according to any one of items (9) to (12) a packaging material, wherein the adsorption layer comprises a material selected from the group consisting of low density polyethylene, linear low density polyethylene, polypropylene, ionomer, ethylene acrylic acid copolymer, ethylene methacrylic acid copolymer, ethylene vinyl acetate copolymer And one or more of the compounds of ethylene vinyl acrylate copolymer, ethylene methyl acrylate copolymer, and ethylene methyl methacrylate copolymer, (14) according to any one of items (9) to (12) item The packaging material, wherein the adsorption layer contains one or more selected from the group consisting of low density polyethylene, linear low density polyethylene, and polypropylene, and (15) as in items (9) to (12). The packaging material according to any one of the items (9) to (15), wherein the substrate layer is selected from the group consisting of polychlorinated materials. Ethylene, non-ducted polypropylene, polypropylene, polyposition A packaging material according to any one of the items (9) to (15), wherein the base material is one or more of the compounds of the above-mentioned (9) to (15). The packaging material of any one of (10) to (17), wherein the adhesive layer is selected from the group consisting of low density polyethylene, linear low density polyethylene, (1) The packaging material according to any one of (10) to (17), wherein the adhesive layer contains a low density polyethylene, and (20) is as The packaging material according to any one of the items of the present invention, wherein the sealant layer contains one or more selected from the group consisting of low density polyethylene, linear low density polyethylene, and polypropylene. (21) A packaging material according to any one of items (11) to (19), wherein the sealant layer contains a linear low-density polyethylene, and (22) as in any of items (12) to (21) A packaging material, wherein the outer layer contains one or more selected from the group consisting of low density polyethylene, linear low density polyethylene, and polypropylene, and (23) as in (12) to (21) The packaging material of any of the items, wherein the outer layer A linear low-density polyethylene, (24) a blister pack or a blister pack, which is a packaging material according to any one of items (1) to (23), (25) a blister pack Or a blister pack, which is attached to the pocket sheet of the container, using the packaging material according to any one of items (1) to (23), (26) A blister pack or blister pack according to item (24) or (25), which comprises a preparation containing olmesartan medoxomil, (27) a preparation containing olmesartan medoxomil, which is A packaging material according to any one of (1) to (23), (28) a preparation containing olmesartan medoxomil, which is in a blister pack or blister as in item (24) or (25) Packaging for packaging, (29) A method for preventing odors containing a formulation of olmesartan medoxomil, characterized by packaging according to any one of items (1) to (23), (30) one containing A method for preventing odor of a valsartan ester preparation characterized by being packaged in an blister pack or a blister pack as in item (24) or (25).

又從其他觀點,本發明係提供(31)一種包裝材,其係在第(1)至(23)項中,適用於以含有2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑的製劑取代含有奧美沙坦酯的製劑之包裝材,(32)一種壓泡包裝或泡罩包裝,其係在第(24)至(26)項中,適用於以含有2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑的製劑取代含有奧美沙坦酯的製劑之壓泡包裝或泡罩包裝,(33)一種製劑,其係在第(27)或(28)項中,適用於以含有2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑製劑取代含有奧美沙坦酯製劑之製劑, (34)一種臭味防止方法,其係在第(29)或(30)項中,適用於以含有2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑製劑取代含有奧美沙坦酯製劑之臭味防止方法等。Still from another viewpoint, the present invention provides (31) a packaging material which is suitable for containing 2-amino-5-isobutyl-4-{2- in the items (1) to (23). [5-(N,N'-bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole formulation replaces the packaging material containing the formulation of olmesartan medoxomil, (32) An blister pack or blister pack, which is used in items (24) through (26), and is suitable for containing 2-amino-5-isobutyl-4-{2-[5-(N,N' - a preparation of bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole in place of a blister pack or blister pack containing a formulation of olmesartan medoxomil, (33) a preparation In item (27) or (28), suitable for containing 2-amino-5-isobutyl-4-{2-[5-(N,N'-bis((S)-1-) An ethoxycarbonyl)ethyl)phosphine decylamine]furanyl}thiazole formulation replaces a formulation containing an olmesartan medoxomil formulation, (34) A method for preventing odor, which is suitable for containing 2-amino-5-isobutyl-4-{2-[5-(N,N) in the item (29) or (30) The '-bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole formulation replaces the odor prevention method containing the olmesartan medoxomil preparation.

藉由使用本發明的含有臭味吸附劑之包裝材,可提供一種當取出製劑時幾乎感覺不到臭味之包裝體。By using the packaging material containing the odor absorbing agent of the present invention, it is possible to provide a package which hardly feels odor when the preparation is taken out.

〔實施發明之最佳型態〕[Best form of implementing the invention]

本發明的包裝材係含有臭味吸附劑。使用本發明的包裝材之包裝體,係可吸附由製劑產生之臭味。The packaging material of the present invention contains an odor adsorbent. The package of the packaging material of the present invention can absorb the odor generated by the preparation.

可使用於本發明的臭味吸附劑,例如合成沸石、矽膠、氧化鋁、活性碳等物理吸附劑、以有機酸為基礎之複合化學除臭劑(大姆修,Daimushen)般可與臭味物質進行化學吸附之化學吸附劑等,宜為合成沸石、尤宜疏水性沸石,特宜為高矽沸石。緣由於對臭味物質的吸附速度及吸附特性,亦可併用物理吸附劑和化學吸附劑。The odor adsorbent used in the present invention, for example, a physical adsorbent such as synthetic zeolite, tannin, alumina, activated carbon, or a compound chemical deodorant based on an organic acid (Daimushen) can be used with an odor. The chemical adsorbent for chemically adsorbing the substance, etc., is preferably a synthetic zeolite, particularly preferably a hydrophobic zeolite, and particularly preferably a sorghum zeolite. Due to the adsorption rate and adsorption characteristics of the odorous substance, a physical adsorbent and a chemical adsorbent may be used in combination.

合成沸石係依據相異的分子大小而用於分離物質的多孔質之粒狀物質,具有均勻的細孔之結構,吸附進入細孔空洞的小分子,以進行一種分篩作用。本發明中的吸附孔徑宜為0.3nm~1nm。細孔徑約為0.3nm、0.4nm、0.5nm、1nm的合成沸石分別稱為合成沸石3A、合成沸石4A、合成沸石5A、合成沸石13X。其中,尤宜細孔徑約為1nm的合成沸石13X。The synthetic zeolite is a porous granular material for separating substances according to a different molecular size, has a uniform pore structure, and adsorbs small molecules that enter the pore cavity to perform a sieving action. The adsorption pore diameter in the present invention is preferably from 0.3 nm to 1 nm. The synthetic zeolite having a pore diameter of about 0.3 nm, 0.4 nm, 0.5 nm, and 1 nm is referred to as synthetic zeolite 3A, synthetic zeolite 4A, synthetic zeolite 5A, and synthetic zeolite 13X, respectively. Among them, synthetic zeolite 13X having a pore diameter of about 1 nm is particularly preferable.

合成沸石的平均粒徑無特別限定,係可完成本發明的 目的即可,例如宜為10μm左右之粒徑。且合成沸石之吸附特性係相關於細孔徑,為提高臭味吸附特性,藉著使合成沸石的粉末更細,可實際地增加表面積,並增加細孔數。The average particle diameter of the synthetic zeolite is not particularly limited, and the present invention can be completed. The purpose is, for example, a particle size of about 10 μm. Further, the adsorption characteristics of the synthetic zeolite are related to the pore diameter, and in order to improve the odor absorption characteristics, by making the powder of the synthetic zeolite finer, the surface area can be practically increased, and the number of pores can be increased.

疏水性沸石係指施予疏水處理之合成沸石。合成沸石係具有吸附臭味和吸濕能力,因吸濕愈多則臭味的吸附性能降低,故尤宜經疏水處理以抑制吸濕能力之合成沸石。使合成沸石進行疏水處理之方法,例如使界面活性劑吸附於沸石之方法、或使矽烷化劑與沸石表面的羥基反應之方法等表面修飾方法或進行脫鋁處理之方法等。Hydrophobic zeolite refers to a synthetic zeolite that is subjected to hydrophobic treatment. The synthetic zeolite has an adsorption odor and a moisture absorbing ability, and the more the moisture absorption, the lower the adsorption performance of the odor, so that the synthetic zeolite which is subjected to hydrophobic treatment to suppress the moisture absorbing ability is particularly preferable. A method of subjecting the synthetic zeolite to a hydrophobic treatment, for example, a method of adsorbing a surfactant to a zeolite or a method of reacting a decylating agent with a hydroxyl group on the surface of a zeolite, or a method of performing a dealumination treatment.

高矽沸石係指使合成沸石的結晶架構內之鋁原子經過脫鋁處理而減少,提高二氧化矽/氧化鋁比(SiO2 /Al2 O3 比)之合成沸石。藉由脫鋁處理,可使合成沸石失去對水等極性物質之親和性,而更強地吸附臭味物質等非極性物質。其中,尤宜二氧化矽/氧化鋁比為5以上之高矽沸石。該類高矽沸石,例如可使用聯合昭和公司製的ABSCENT、東曹公司製的HSZ系列等市售品。The sorghum zeolite refers to a synthetic zeolite which reduces aluminum atoms in the crystal framework of the synthetic zeolite by dealuminization treatment and increases the cerium oxide/alumina ratio (SiO 2 /Al 2 O 3 ratio). By the dealumination treatment, the synthetic zeolite can be deprived of affinity for polar substances such as water, and a nonpolar substance such as an odor substance can be more strongly adsorbed. Among them, a high cerium zeolite having a ceria/alumina ratio of 5 or more is particularly preferable. As such a sorghum zeolite, for example, ABSCENT manufactured by Union Co., Ltd., or HSZ series manufactured by Tosoh Corporation can be used.

本發明的包裝材係可使用熱可塑性樹脂等樹脂類、紙類、纖維類、金屬類、各種塗料、各種黏附劑等,宜為熱可塑性樹脂。The packaging material of the present invention may be a resin such as a thermoplastic resin, paper, fiber, metal, various coating materials, various kinds of adhesives, etc., and is preferably a thermoplastic resin.

熱可塑性樹脂係無特別的限制,可使用既知者,例如聚氯乙烯(PVC)、無延展聚丙烯(CPP)、聚丙烯(PP)、聚偏二氯乙烯(PVDC)、聚三氟化氯乙烯(PCTFE)、環狀烯烴共聚物(COC)、聚乙烯(PE)、聚碳酸酯(PC)、聚醯胺(PA)、乙烯-醋酸乙烯酯共聚物(EVA)、乙烯-甲基丙烯 酸酯共聚物、聚苯乙烯(PS)、聚酯(PET)、聚丙烯酸(PAA)等,宜為聚氯乙烯、無延展聚丙烯、聚丙烯、聚偏二氯乙烯、聚三氟化氯乙烯或環狀烯烴共聚物。本發明中,可單獨使用這些物質,亦可組合2種以上而使用。The thermoplastic resin is not particularly limited, and those known to use, for example, polyvinyl chloride (PVC), non-stretched polypropylene (CPP), polypropylene (PP), polyvinylidene chloride (PVDC), polychlorotrifluoride can be used. Ethylene (PCTFE), cyclic olefin copolymer (COC), polyethylene (PE), polycarbonate (PC), polyamine (PA), ethylene-vinyl acetate copolymer (EVA), ethylene-methacryl Acid ester copolymer, polystyrene (PS), polyester (PET), polyacrylic acid (PAA), etc., preferably polyvinyl chloride, non-stretched polypropylene, polypropylene, polyvinylidene chloride, polychlorotrifluoride Ethylene or cyclic olefin copolymer. In the present invention, these may be used alone or in combination of two or more.

本發明的包裝材係不限於單層者,亦可為使多層貼合之多層薄膜。多層薄膜之種類、量、厚度及層數,係無特別限制,只要完成本發明的目的即可,可廣泛地使用,因應用途而適當地選擇。The packaging material of the present invention is not limited to a single layer, and may be a multilayer film in which a plurality of layers are bonded. The type, amount, thickness, and number of layers of the multilayer film are not particularly limited, and may be widely used as long as the object of the present invention is completed, and are appropriately selected depending on the use.

如第1圖所示般,本發明的多層薄膜1係具有作為內層的含臭味吸附劑之吸附層2,和作為外層的防止水分和氧等由外氣進入之基材層(障蔽層)3。As shown in Fig. 1, the multilayer film 1 of the present invention has an adsorption layer 2 containing an odor adsorbent as an inner layer, and a base layer (barrier layer) which is prevented from moisture and oxygen and which enters from the outside air as an outer layer. ) 3.

使用於吸附層之樹脂無特別的限制,使用者可適當地選擇,惟宜為高熔融流動率、低熔點(低軟化點),且低溫收縮性優異之樹脂。若為高熔融流動率樹脂,即使因添加吸附劑而降低熔融流動率,仍可維持一定程度的流動特性。若為低熔點,則樹脂於低溫下軟化,可於低溫擠壓,亦可預防發泡。若為低溫收縮性優異之樹脂,即使添加吸附劑亦易於以擠壓成形機進行擠壓成形。其中,尤宜熔融流動率為10以上又低熔點,且低溫收縮性優異之樹脂。The resin to be used for the adsorption layer is not particularly limited, and can be appropriately selected by a user, and is preferably a resin having a high melt flow rate, a low melting point (low softening point), and excellent low-temperature shrinkability. In the case of a high melt flow rate resin, even if the melt flow rate is lowered by the addition of the adsorbent, a certain degree of flow characteristics can be maintained. If it is a low melting point, the resin softens at a low temperature, can be extruded at a low temperature, and can prevent foaming. In the case of a resin excellent in low-temperature shrinkability, it is easy to carry out extrusion molding by an extrusion molding machine even if an adsorbent is added. Among them, a resin having a melt flow rate of 10 or more and a low melting point and excellent in low-temperature shrinkage is particularly preferable.

由此觀點,使用於吸附層之樹脂例如低密度聚乙烯(LDPE)、直鏈狀低密度聚乙烯(LLDPE)、聚丙烯(PP),各種共聚物(共聚物)例如離子鍵聚合物(例如乙烯丙烯酸共聚物的鹽)、乙烯丙烯酸共聚物(EAA)、乙烯甲基丙烯酸共聚物(EMAA)、乙烯醋酸乙烯酯共聚物(EVA)、乙 烯丙烯酸甲酯共聚物(EMA)、乙烯甲基丙烯酸甲酯共聚物(EMMA)等,宜為低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯,尤宜低密度聚乙烯。本發明中,可單獨使用這些物質,亦可組合2種以上而使用。From this point of view, resins used for the adsorption layer such as low density polyethylene (LDPE), linear low density polyethylene (LLDPE), polypropylene (PP), various copolymers (copolymers) such as ionomers (for example Salt of ethylene acrylic acid copolymer), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethylene vinyl acetate copolymer (EVA), B The methacrylic acid methyl ester copolymer (EMA), the ethylene methyl methacrylate copolymer (EMMA), and the like are preferably low density polyethylene, linear low density polyethylene, polypropylene, and particularly low density polyethylene. In the present invention, these may be used alone or in combination of two or more.

吸附層中,可依需求摻合其他顏料。上述臭味吸附劑之外的顏料,係可使用不特別具有吸濕性能或氣體吸附性能之顏料,若含有具機能之顏料,即具備各種複合的效果。該類顏料例如合成沸石、氯化鈣、氧化鈣、碳酸鈣、氧化鈦、氧化鋅、氧化鋯、氧化鋁、二氧化矽、雲母、滑石、碳、活性碳等,宜為合成沸石。In the adsorption layer, other pigments may be blended as needed. As the pigment other than the odor absorbing agent, a pigment which does not particularly have hygroscopic property or gas adsorbing property can be used, and if it contains a functional pigment, it has various recombination effects. Such pigments are, for example, synthetic zeolites, calcium chloride, calcium oxide, calcium carbonate, titanium oxide, zinc oxide, zirconium oxide, aluminum oxide, cerium oxide, mica, talc, carbon, activated carbon and the like, and are preferably synthetic zeolites.

吸附層中,臭味吸附劑之含率例如為5~70重量%,宜為10~60重量%。除臭味吸附劑之外,亦含有其他顏料時,總顏料之含率例如為30~70重量%,宜為45~65重量%。The content of the odor adsorbent in the adsorption layer is, for example, 5 to 70% by weight, preferably 10 to 60% by weight. When the other pigment is contained in addition to the odor absorbent, the content of the total pigment is, for example, 30 to 70% by weight, preferably 45 to 65% by weight.

吸附層之膜厚度係無特別的限制,惟可完成本發明的目的即可,例如10μm~200μm,宜為30μm~100μm。The film thickness of the adsorption layer is not particularly limited, but may be accomplished by the object of the present invention, for example, 10 μm to 200 μm, preferably 30 μm to 100 μm.

使用於基材層的樹脂係可阻隔來自外部的水分和氧等進入之樹脂即可,無特別的限制可使用既知者,例如聚氯乙烯、無延展聚丙烯、聚丙烯、聚偏二氯乙烯、聚三氟化氯乙烯、環狀烯烴共聚物、聚乙烯、聚碳酸酯、聚醯胺、乙烯-醋酸乙烯酯共聚物、乙烯甲基丙烯酸酯共聚物、聚苯乙烯、聚酯、聚丙烯酸等,宜為聚氯乙烯、無延展聚丙烯、聚丙烯、聚偏二氯乙烯、聚對苯二甲酸乙二醇酯,尤宜聚氯乙烯。本發明中,可單獨使用這些物質,亦可組合2種 以上而使用。The resin used for the substrate layer can block the entry of moisture and oxygen from the outside, and can be used without any particular limitation, such as polyvinyl chloride, non-ductile polypropylene, polypropylene, polyvinylidene chloride. , polychlorotrifluoroethylene, cyclic olefin copolymer, polyethylene, polycarbonate, polyamide, ethylene-vinyl acetate copolymer, ethylene methacrylate copolymer, polystyrene, polyester, polyacrylic acid Etc., it should be polyvinyl chloride, non-stretched polypropylene, polypropylene, polyvinylidene chloride, polyethylene terephthalate, especially polyvinyl chloride. In the present invention, these substances may be used alone or in combination of two kinds. Use above.

基材層的厚度係無特別的限制,可完成本發明的目的即可,例如20μm~400μm,宜為50μm~300μm。The thickness of the substrate layer is not particularly limited, and the object of the present invention can be achieved, for example, 20 μm to 400 μm, preferably 50 μm to 300 μm.

吸附層和基材層之間更可含有黏附層。黏附層例如低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯等,宜為低密度聚乙烯。本發明中,可單獨使用這些物質,亦可組合2種以上而使用。An adhesive layer may be further contained between the adsorption layer and the substrate layer. The adhesive layer is, for example, low density polyethylene, linear low density polyethylene, polypropylene or the like, and is preferably low density polyethylene. In the present invention, these may be used alone or in combination of two or more.

使吸附層和基材層黏合之方法,例如擠壓層壓、乾層壓、濕層壓、熱層壓、砂層壓等,宜為乾層壓或砂層壓。擠壓層壓係指使熔融樹脂由T模頭薄薄地流於基材上,進行輥壓壓延而層積之方法。乾層壓係指將基材與預先成形的熱可塑性樹脂薄膜等相黏合方法中,將黏附劑塗布於基材後,於加熱乾燥爐中使黏附劑乾燥後將薄膜重疊,進行輥壓壓延之方法。濕層壓乃與乾層壓相異,係指不使黏附劑乾燥而使基材與薄膜黏合之方法。熱層壓係指使預先成形的熱可塑性樹脂薄膜重疊於基材,通過熱輥間而加熱壓延之方法。砂層壓係指抽出2個基材,由T模頭擠出熔融樹脂,流入兩基材之間,進行輥壓壓延而黏附之方法。The method of bonding the adsorption layer and the substrate layer, such as extrusion lamination, dry lamination, wet lamination, thermal lamination, sand lamination, etc., is preferably dry lamination or sand lamination. Extrusion lamination refers to a method in which a molten resin is thinly flowed onto a substrate from a T-die and rolled and rolled. The dry lamination method refers to a method of bonding a substrate to a preformed thermoplastic resin film or the like, applying an adhesive to a substrate, drying the adhesive in a heating drying oven, and then laminating the film to perform rolling calendering. method. Wet lamination is different from dry lamination and refers to a method of bonding a substrate to a film without drying the adhesive. The heat lamination is a method in which a preformed thermoplastic resin film is superposed on a substrate and heated and rolled by a heat roller. Sand lamination refers to a method in which two base materials are taken out, a molten resin is extruded from a T die, and flows between two substrates to be rolled by rolling and adhering.

製得的多層薄膜之厚度係無特別的限制,可完成本發明的目的即可,例如30μm~500μm,宜為100μm~400μm。The thickness of the obtained multilayer film is not particularly limited, and the object of the present invention can be achieved, for example, 30 μm to 500 μm, preferably 100 μm to 400 μm.

如第2圖所示,在本發明的其他多層薄膜1中,吸層2係可在與基材層3接觸之主吸附層2a側更含有外層4,亦可在與基材層3相對之主吸附層2a側更含有密封膠層5。為了夾住主要吸附臭味之主吸附層,亦可含有輔助吸附 臭味之副吸附層。吸附層係由主吸附層和副吸附層而形成時,主吸附層中吸附劑之含率宜多於副吸附層中的含率。藉此,可提升吸附之效率。As shown in Fig. 2, in the other multilayer film 1 of the present invention, the absorbing layer 2 may further include the outer layer 4 on the side of the main adsorption layer 2a which is in contact with the substrate layer 3, or may be opposed to the substrate layer 3. The main adsorption layer 2a side further contains a sealant layer 5. In order to sandwich the main adsorption layer which mainly adsorbs odor, it may also contain auxiliary adsorption. A sub-adsorption layer of odor. When the adsorption layer is formed by the main adsorption layer and the sub-adsorption layer, the content of the adsorbent in the main adsorption layer is preferably more than the content in the sub-adsorption layer. Thereby, the efficiency of adsorption can be improved.

密封膠層例如低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯等,宜為直鏈狀低密度聚乙烯。本發明中,可單獨使用這些物質,亦可組合2種以上而使用。The sealant layer such as low density polyethylene, linear low density polyethylene, polypropylene or the like is preferably a linear low density polyethylene. In the present invention, these may be used alone or in combination of two or more.

外層例如低密度聚乙烯、直鏈狀低密度聚乙烯、聚丙烯等,宜為直鏈狀低密度聚乙烯。本發明中,可單獨使用這些物質,亦可組合2種以上而使用。The outer layer such as low density polyethylene, linear low density polyethylene, polypropylene or the like is preferably a linear low density polyethylene. In the present invention, these may be used alone or in combination of two or more.

吸附層係以吹塑薄膜法、T模頭法、共擠壓等使樹脂和吸附劑形成薄膜狀或薄片狀,尤宜藉由吹塑薄膜法所形成之多層薄膜。又,多層吹塑薄膜法係指以複數的擠壓機將熔融的樹脂擠壓成管狀,將空氣送至其中使之膨脹,製造多層薄膜之方法。吸附層之結構,宜為由外層/主吸附層/密封膠層所形成2種3層或3種3層。The adsorption layer is formed into a film or a sheet by a blown film method, a T-die method, co-extrusion or the like to form a film or a sheet, and is preferably a multilayer film formed by a blown film method. Further, the multilayer blown film method is a method of producing a multilayer film by extruding a molten resin into a tubular shape by a plurality of extruders, and sending air therein to expand. The structure of the adsorption layer is preferably two kinds of three layers or three kinds of three layers formed by the outer layer/main adsorption layer/seal layer.

使用本發明的包裝材而製作壓泡包裝或泡罩包裝,可包裝製劑。如第3圖所示般,本發明的壓泡包裝8係由收藏製劑7的含有袋部位之多層薄膜1(附袋式薄片)和用以密封袋部位之蓋材6而構成。附袋式薄片係具有複數個收藏製劑7之凹狀袋部位,將製劑7收藏於袋部位。The blister pack or blister pack can be made using the packaging material of the present invention, and the preparation can be packaged. As shown in Fig. 3, the embossed package 8 of the present invention is composed of a multilayer film 1 (bag-attached sheet) containing a bag portion of the preparation preparation 7, and a cover member 6 for sealing the bag portion. The bag-type sheet has a plurality of concave pocket portions of the collection preparation 7, and the preparation 7 is stored in the bag portion.

包裝於壓泡包裝或泡罩包裝之製劑,例如錠劑、膠囊劑、粉劑、細粒劑、顆粒劑、片劑等,宜為錠劑。The preparation packaged in a blister pack or a blister pack, such as a tablet, a capsule, a powder, a fine granule, a granule, a tablet, etc., is preferably a tablet.

在壓泡包裝或泡罩包裝中,宜於與包裝材的製劑接觸之側含有密封膠層。藉由在多層薄膜的最內層含有密封膠 層,密封膠層則成為與蓋材料熱封之層,且可預防製劑與吸附層直接接觸。In a blister pack or blister pack, it is preferred to include a sealant layer on the side in contact with the formulation of the package. By containing a sealant in the innermost layer of the multilayer film The layer, the sealant layer, is a layer that is heat sealed to the cover material and prevents the formulation from coming into direct contact with the adsorbent layer.

蓋材料例如鋁箔、鋁箔和塑膠薄膜之層壓薄膜等。A cover material such as a laminate film of aluminum foil, aluminum foil, and plastic film.

本發明中的壓泡包裝或泡罩包裝之製作方法,係可使用如「醫藥品-食品包裝之設計、表示、材料規格、包裝工程之品質確保(技術資訊協會,2005年9月1日發刊)」刊物中記載之一般方法而製造,無特別的限制。The method for producing a foamed package or a blister package according to the present invention can be used such as "medical product-food packaging design, representation, material specification, quality assurance of packaging engineering (Technical Information Association, issued on September 1, 2005) It is manufactured by the general method described in the publication, and there is no particular limitation.

本發明中,含於製劑的有效成分係為含有臭味之藥物即可,不受限於其結構、程度,例如奧美沙坦酯、2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑、L-半胱胺酸、DL-甲硫基丁胺酸、布西拉明(Bucillamine)、甲基硫僅氯化硫鎓、鹽酸乙基半胱胺酸、鹽酸卡巴西林(Bacampicillin Hydrochloridel)、頭孢子菌素劑、甲苯礦酸舒米西林(Sultamicillin tosilate)、雙氯非那胺(Diclofenamide)、雷尼替定(Ranitidine)、啡莫替定(Famotidine)、尼薩替定(Nizatidine)等含硫化合物、奧美沙坦酯、吲哚心安(Dindolol)、丙戊酸鈉、鹽酸乙肼苯酞(Todralazine Hydrochloride)、鹽酸甲苯派丙酮、三甲環二酮、柳氮磺吡啶(Salazosulfapyridine)、氟比洛芬(Flurbiprofen)、中藥、草藥等有特殊臭味之藥物,宜為奧美沙坦酯或2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑。且奧美沙坦酯係有效於高血壓症或高血壓症引發的疾病(更具體而言,高血壓症、心臟疾病[狹心症、心肌梗塞、心律不整、心臟不 全或心臟肥大]、腎臟疾病[糖尿病性腎疾病、腎小球腎炎或腎硬化症]或腦血管性疾病[腦梗塞或腦出血])之預防或治療,可依據專利許可第2082519號公報(美國專利第5,616,599號公報)等記載之方法而易於製造。2-胺基-5-異丁基-4-{2-[5-(N,N’-雙((S)-1-乙氧羰基)乙基)膦醯胺]呋喃基}噻唑,係可依據國際公開第01/47935號手冊等記載之方法而易於製造。In the present invention, the active ingredient contained in the preparation may be a drug containing an odor, and is not limited to its structure and degree, such as olmesartan medoxomil, 2-amino-5-isobutyl-4-{2 -[5-(N,N'-bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole, L-cysteine, DL-methylthiobutyric acid, Bucillamine, methyl sulphate only sulphide chloride, ethyl cysteine hydrochloride, Bacampicillin Hydrochloridel, cephalosporin, sulinmicillin tosilate, Sulfur-containing compounds such as Diclofenamide, Ranitidine, Famotidine, Nizatidine, olmesartan medoxomil, Dindolol, C Sodium valerate, acetamidine hydrochloride (Todralazine Hydrochloride), toluidine hydrochloride, trimethylcyclodiketone, salazosulfapyridine, flurbiprofen, traditional Chinese medicine, herbal medicine and other drugs with special odor, preferably olmesartan medoxomil or 2 -Amino-5-isobutyl-4-{2-[5-(N,N'-bis((S)-1-ethoxycarbonyl)ethyl)phosphoniumamine]furanyl}thiazole. And olmesartan medoxomil is effective in diseases caused by hypertension or hypertension (more specifically, hypertension, heart disease [narrow heart disease, myocardial infarction, arrhythmia, cardiac insufficiency or cardiac hypertrophy], kidney disease The prevention or treatment of [diabetic nephropathy, glomerulonephritis or nephrosclerosis] or cerebrovascular disease [cerebral infarction or cerebral hemorrhage] can be carried out according to Patent License No. 2082519 (U.S. Patent No. 5,616,599). It is easy to manufacture by the method described. 2-Amino-5-isobutyl-4-{2-[5-(N,N'-bis((S)-1-ethoxycarbonyl)ethyl)phosphine decylamine]furanyl}thiazole It can be easily manufactured according to the method described in International Publication No. 01/47935 and the like.

又,本發明的製劑亦可依需求含有其他有效成分。該有效成分例如三氯甲苯噻(Trichloromethiazide)、氫氯苯噻(Hydrochlorothiazide)、苄基氫氯苯噻(Benzylhydrochlorothiazide)等利尿劑;阿折迪平(Azelnidipine)、脈優錠(Amlodipine)、貝尼迪平(Benidipine)、寜安錠(Nitrendipine)、瑪尼迪平(Manidipine)、尼卡迪平(Nicardipine)、尼菲迪平(Nifedipine)、西尼迪平(Cilnidipine)、愛尼迪平(Efonidipine)、巴尼迪平(Barnidipine)、順壓樂錠(Felodipine)等鈣阻斷劑;愛妥糖(Pioglitazone)、梵帝美(Rosiglitazone)、利格列酮(Rivoglitazone)、MCC-555、NN-2344、BMS-298585、AZ-242、LY-519818、TAK-559等胰島素阻抗性改良劑;普伐史達丁(Pravastatin)、喜克脂錠(Simvastatin)、立普妥錠(Atorvastatin)、羅思伐史達丁(Rosuvastatin)、薛利伐史達丁(Cerivastatin)、比他伐史達丁(Pitavastatin)、益脂可錠(Fluvastatin)等HMG-CoA還原酶抑制劑;SMP-797、派其米貝(Pactimibe)等ACAT抑制劑等,惟不受限於此。這些有效成分之量係無特別的限制,採用一般用於製劑之量即可。Further, the preparation of the present invention may contain other active ingredients as needed. The active ingredient is, for example, a diuretic such as Trichloromethiazide, Hydrochlorothiazide or Benzylhydrochlorothiazide; Azelnidipine, Amlodipine, Beni Benidipine, Nitrendipine, Manidipine, Nicardipine, Nifedipine, Cilnidipine, Ainidipine ( Calcium blockers such as Efonidipine), Barnidipine, Felodipine, Pioglitazone, Rosiglitazone, Rivoglitazone, MCC-555, Insulin resistance improvers such as NN-2344, BMS-298585, AZ-242, LY-519818, TAK-559; Pravastatin, Simvastatin, Atorvastatin , Hels-CoA reductase inhibitors such as Rosuvastatin, Cerivastatin, Pitavastatin, Fluvastatin; SMP-797 ACAT inhibitors such as Pactimibe, etc., but are not limited thereto. The amount of these active ingredients is not particularly limited, and it can be used in an amount generally used for the preparation.

以下以實施例等更詳細地說明本發明,惟本發明不受限於此。Hereinafter, the present invention will be described in more detail by way of examples, but the invention is not limited thereto.

(實施例1)(Example 1) (1)含臭味吸附劑的主膠料(master batch)之調整(1) Adjustment of master batch containing odor sorbent

相對於50重量份的高矽沸石(商品名:ABSCENTS3000聯合昭和公司製),使50重量份LDPE捏和且調整成顆粒狀樹脂,以此為主膠料(MB1)。50 parts by weight of sorghum zeolite (trade name: ABSCENTS3000, manufactured by Showa Co., Ltd.) was kneaded and adjusted to a pelletized resin as a main compound (MB1).

(2)吸附層之製作(2) Production of adsorption layer

依據多層吹塑薄膜法,製作以下的2種3層薄膜。將MB1和基礎樹脂的LDPE以2:3之比例摻合,使其吸附劑含量為20重量%而使用,於外層及密封膠層只使用LLDPE,製作2種3層的吸附層,使各層的膜厚度為外層/主吸附層/密封膠層=10μm/60μm/10μm,以此為吸附層之樹脂。The following two types of three-layer films were produced according to the multilayer blown film method. The LDPE of MB1 and the base resin was blended at a ratio of 2:3, and the adsorbent content was 20% by weight. Only LLDPE was used in the outer layer and the sealant layer to prepare two kinds of three-layer adsorption layers, so that the layers were The film thickness is the outer layer/main adsorption layer/seal layer = 10 μm / 60 μm / 10 μm, which is the resin of the adsorption layer.

(3)多層薄膜之製作(3) Production of multilayer film

使用砂層壓法以LDPE為黏附層,層積上述吸附薄膜的外層側與厚度200μm之聚氯乙烯(住友貝可萊特公司製),製作壓泡包裝用多層薄膜。The LDPE was used as an adhesive layer by a sand lamination method, and the outer layer side of the above-mentioned adsorption film and polyvinyl chloride (manufactured by Sumitomo Beacont Co., Ltd.) having a thickness of 200 μm were laminated to prepare a multilayer film for embossing.

(4)壓泡包裝之製作(4) Production of foaming packaging

壓泡包裝係使用CKD公司製M2型而製作。壓泡包裝之材料係具有臭味吸附功能的上述多層薄膜,及作為蓋材料的厚度17μm之鋁箔(東洋鋁製),填充成每一片壓泡包裝含有10錠的奧美沙坦酯(奧美德克(註冊商標)20mg 錠)之製劑。The foam packaging was produced using the M2 type manufactured by CKD Corporation. The material of the blister pack is the above-mentioned multilayer film having an odor-absorbing function, and an aluminum foil (manufactured by Toyo Aluminum) having a thickness of 17 μm as a cover material, and filled with 10 tablets of olmesartan medoxomil (Omedek) per blister pack. (registered trademark) 20mg Ingot) preparation.

(比較例1)(Comparative Example 1)

無延展聚丙烯的壓泡包裝係使用CKD公司製M2型而製作。壓泡包裝之材料係厚度250μm的無延展聚丙烯(住友貝可萊特公司製),及作為蓋材料的厚度17μm之鋁箔(東洋鋁製),填充成每一片壓泡包裝含有10錠的奧美沙坦酯之製劑(奧美德克(註冊商標)20mg錠)。The foam-free packaging of the non-stretched polypropylene was produced using the M2 type manufactured by CKD Corporation. The material of the blister pack is a non-extensible polypropylene (manufactured by Sumitomo Beclet Co., Ltd.) having a thickness of 250 μm, and an aluminum foil (manufactured by Toyo Aluminum) having a thickness of 17 μm as a cover material, and filled with 10 tablets of Omega sand per blister pack. Formulation of Tanthanum (Omedek (registered trademark) 20 mg ingot).

(試驗例1)依據氣味測試器之機能性試驗(Test Example 1) Functional test according to the odor tester

氣味測試器之測定係製作一具有可將取出錠劑時的臭味瞬間封住而測定之結構且內容量為72mL之專用容器而進行。使用該專用容器和氣味測試器(Portable Odor Meter FPO-1雙葉電子設備公司製),測定由壓泡包裝取出含有奧美沙坦酯的製劑時之臭味強度。將進行枕形密閉包裝之壓泡包裝和不進行枕形密閉包裝之壓泡包裝(開放)放入25℃的恆溫槽,1個月後開啟枕形密閉包裝,以氣味測試器來測定在專用容器內由壓泡包裝一次取出10錠時之臭味,其結果如表1所示。The measurement of the odor tester was carried out by producing a special container having a structure in which the odor at the time of taking out the tablet was immediately sealed and measured, and the content was 72 mL. Using this dedicated container and an odor tester (Portable Odor Meter FPO-1, manufactured by Futaba Electronics Co., Ltd.), the odor intensity when the olmesartan medoxomil-containing preparation was taken out from the blister pack was measured. The blister pack of the pillow-shaped sealed package and the blister pack (open) without the pillow-shaped sealed package are placed in a thermostatic bath at 25 ° C, and the pillow-shaped sealed package is opened one month later, and the odor tester is used for the measurement. The odor of the container was taken out from the blister pack at a time, and the result was as shown in Table 1.

由表1之結果可知,使用本發明的包裝材之壓泡包裝,明顯減少取出錠劑時之臭味。As is apparent from the results of Table 1, the use of the embossed package of the packaging material of the present invention significantly reduces the odor when the tablet is taken out.

(試驗例2)官能試驗(Test Example 2) Functional test

將進行枕形密閉包裝之壓泡包裝或不進行枕形密閉包裝之壓泡包裝(開放),放入40℃及25℃的恆溫槽,6個月後開啟枕形密閉包裝,藉由官能試驗來進行由壓泡包裝取出錠劑時之臭味評估。其結果如表2所示。The blister pack of the pillow-shaped sealed package or the blister pack (open) without the pillow-shaped sealed package shall be placed in a thermostatic bath at 40 ° C and 25 ° C, and the pillow-shaped sealed package shall be opened after 6 months, by functional test. To evaluate the odor when the tablet is taken out from the blister pack. The results are shown in Table 2.

(官能評估基準)(Functional Evaluation Benchmark)

評估方法0:無臭、0.5:非常稀少、1:稀少、2:弱、3:強評估值=品評員之總計值/品評員數(5)Evaluation method 0: odorless, 0.5: very rare, 1: rare, 2: weak, 3: strong evaluation value = total value of the product reviewer / number of product evaluations (5)

由表2的結果可知,使用本發明的壓泡包裝,無論於任一保存狀態,均無取出製劑時之臭味,可長期維持臭味吸附功能。As is clear from the results of Table 2, the embossed package of the present invention has no odor when the preparation is taken out in any of the storage states, and the odor absorption function can be maintained for a long period of time.

【應用於產業上之可能性】[The possibility of being applied to the industry]

依據本發明,可提供一種取出製劑時幾乎不感到臭味之醫藥品包裝體。According to the present invention, it is possible to provide a pharmaceutical package which hardly feels odor when the preparation is taken out.

1‧‧‧多層薄膜1‧‧‧Multilayer film

2‧‧‧吸附層2‧‧‧Adsorption layer

2a‧‧‧主吸附層2a‧‧‧Main adsorption layer

3‧‧‧基材層(障蔽層)3‧‧‧Substrate layer (barrier layer)

4‧‧‧外層4‧‧‧ outer layer

5‧‧‧密封膠層5‧‧‧Seal layer

6‧‧‧蓋材料6‧‧‧Cover materials

7‧‧‧製劑7‧‧‧ preparation

8‧‧‧壓泡包裝8‧‧‧Voice packaging

第1圖係本發明的多層薄膜之概略切面圖。Fig. 1 is a schematic cross-sectional view showing a multilayer film of the present invention.

第2圖係本發明的多層薄膜之其他概略切面圖。Fig. 2 is another schematic cross-sectional view of the multilayer film of the present invention.

第3圖係本發明的壓泡包裝之概略切面圖。Figure 3 is a schematic cross-sectional view of the blister pack of the present invention.

Claims (13)

一種含有奧美沙坦酯(Olmesartan Medoxomil)製劑之臭味防止方法,其特徵為以多層薄膜包裝,該多層薄膜係具有含有臭味吸附劑之吸附層及含有聚氯乙烯之基材層的多層薄膜,其中該吸附層為具有主吸附層及在與基材層相對之側具有密封膠層之吸附層,該主吸附層含有含合成沸石作為臭味吸附劑之低密度聚乙烯,該密封膠層含有直鏈狀低密度聚乙烯。An odor preventing method comprising a olmesartan Medoxomil preparation characterized by being packaged in a multilayer film having an adsorption layer containing an odor adsorbent and a multilayer film comprising a polyvinyl chloride substrate layer Wherein the adsorption layer is an adsorption layer having a main adsorption layer and a sealant layer on a side opposite to the substrate layer, the main adsorption layer containing a low density polyethylene containing a synthetic zeolite as an odor adsorbent, the sealant layer Contains linear low density polyethylene. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中臭味吸附劑係合成沸石13X。The odor preventing method containing the olmesartan medoxomil preparation according to the first aspect of the patent application, wherein the odor adsorbing agent is a synthetic zeolite 13X. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中臭味吸附劑係疏水性沸石。The odor preventing method containing the olmesartan medoxomil preparation according to the first aspect of the patent application, wherein the odor absorbing agent is a hydrophobic zeolite. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中臭味吸附劑係對合成沸石13X施予疏水性處理之疏水性沸石。The odor-preventing method containing the olmesartan medoxomil preparation according to the first aspect of the invention, wherein the odor-adsorbing agent is a hydrophobic zeolite which is subjected to hydrophobic treatment to the synthetic zeolite 13X. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中臭味吸附劑係高矽沸石。The odor preventing method containing the olmesartan medoxomil preparation according to the first aspect of the patent application, wherein the odor adsorbent is sorghum zeolite. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中在吸附層和基材層之間更具有黏附層。The odor preventing method containing the olmesartan medoxomil preparation according to the first aspect of the patent application, wherein an adhesive layer is further provided between the adsorption layer and the substrate layer. 如申請專利範圍第6項之含有奧美沙坦酯製劑之臭味防止方法,其中黏附層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、及聚丙烯之化合物中的1種或2種以上。The odor preventing method containing the olmesartan medoxomil preparation according to claim 6, wherein the adhesive layer contains one selected from the group consisting of low density polyethylene, linear low density polyethylene, and polypropylene. Or two or more. 如申請專利範圍第6項之含有奧美沙坦酯製劑之臭味防 止方法,其中黏附層係含有低密度聚乙烯。Such as the odor prevention of the olmesartan medoxomil preparation according to item 6 of the patent application scope A method in which the adhesive layer contains low density polyethylene. 如申請專利範圍第1項之含有奧美沙坦酯製劑之臭味防止方法,其中在與基材層接觸之吸附層側,更具有外層。The odor preventing method containing the olmesartan medoxomil preparation according to the first aspect of the invention, wherein the adsorbing layer side in contact with the substrate layer further has an outer layer. 如申請專利範圍第9項之含有奧美沙坦酯製劑之臭味防止方法,其中外層係含有選自於低密度聚乙烯、直鏈狀低密度聚乙烯、及聚丙烯的化合物中之1種或2種以上。The odor preventing method containing the olmesartan medoxomil preparation according to claim 9, wherein the outer layer contains one selected from the group consisting of low density polyethylene, linear low density polyethylene, and polypropylene. 2 or more types. 如申請專利範圍第9項之含有奧美沙坦酯製劑之臭味防止方法,其中外層係含有直鏈狀低密度聚乙烯。A method for preventing odor containing an olmesartan medoxomil formulation according to claim 9 wherein the outer layer contains a linear low-density polyethylene. 如申請專利範圍第1至11項中任一項之含有奧美沙坦酯製劑之臭味防止方法,其係以使用該多層薄膜之壓泡包裝或泡罩包裝來包裝。The odor preventing method containing the olmesartan medoxomil formulation according to any one of claims 1 to 11, which is packaged in a blister pack or a blister pack using the multilayer film. 如申請專利範圍第1至11項中任一項之含有奧美沙坦酯製劑之臭味防止方法,其係以於容器的附袋式薄片(pocket sheet)使用該多層薄膜之壓泡包裝或泡罩包裝來包裝。A method for preventing odor containing an olmesartan medoxomil formulation according to any one of claims 1 to 11, which is used for a pouch pack or a bubble of the multilayer film of a pocket sheet of a container. Cover the package for packaging.
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