KR20040004638A - 의약 조성물 - Google Patents
의약 조성물 Download PDFInfo
- Publication number
- KR20040004638A KR20040004638A KR10-2003-7015167A KR20037015167A KR20040004638A KR 20040004638 A KR20040004638 A KR 20040004638A KR 20037015167 A KR20037015167 A KR 20037015167A KR 20040004638 A KR20040004638 A KR 20040004638A
- Authority
- KR
- South Korea
- Prior art keywords
- sodium
- acid
- powder
- hydrochloride
- oil
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title description 26
- KINWYTAUPKOPCQ-YFKPBYRVSA-N Fudosteine Chemical compound OC(=O)[C@@H](N)CSCCCO KINWYTAUPKOPCQ-YFKPBYRVSA-N 0.000 claims abstract description 48
- 229950006783 fudosteine Drugs 0.000 claims abstract description 46
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 35
- 239000003814 drug Substances 0.000 claims abstract description 32
- 229940079593 drug Drugs 0.000 claims abstract description 29
- 230000001754 anti-pyretic effect Effects 0.000 claims abstract description 18
- 239000002221 antipyretic Substances 0.000 claims abstract description 18
- 230000000202 analgesic effect Effects 0.000 claims abstract description 10
- 229940124579 cold medicine Drugs 0.000 claims abstract description 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 36
- 239000003795 chemical substances by application Substances 0.000 claims description 20
- 229960005489 paracetamol Drugs 0.000 claims description 18
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 17
- 229960001680 ibuprofen Drugs 0.000 claims description 17
- 238000002360 preparation method Methods 0.000 claims description 9
- 239000000730 antalgic agent Substances 0.000 claims description 8
- 230000000954 anitussive effect Effects 0.000 claims description 6
- 229960004025 sodium salicylate Drugs 0.000 claims description 5
- MANKSFVECICGLK-UHFFFAOYSA-K aloxiprin Chemical compound [OH-].[Al+3].CC(=O)OC1=CC=CC=C1C([O-])=O.CC(=O)OC1=CC=CC=C1C([O-])=O MANKSFVECICGLK-UHFFFAOYSA-K 0.000 claims description 4
- 229940069428 antacid Drugs 0.000 claims description 4
- 239000003159 antacid agent Substances 0.000 claims description 4
- 239000000739 antihistaminic agent Substances 0.000 claims description 4
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- 229930003231 vitamin Natural products 0.000 claims description 4
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- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 claims description 3
- 241000282320 Panthera leo Species 0.000 claims description 3
- 229960001138 acetylsalicylic acid Drugs 0.000 claims description 3
- 229940124584 antitussives Drugs 0.000 claims description 3
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- PXWLVJLKJGVOKE-UHFFFAOYSA-N propyphenazone Chemical compound O=C1C(C(C)C)=C(C)N(C)N1C1=CC=CC=C1 PXWLVJLKJGVOKE-UHFFFAOYSA-N 0.000 claims description 3
- 239000003434 antitussive agent Substances 0.000 claims description 2
- 235000008216 herbs Nutrition 0.000 claims description 2
- GHZNWXGYWUBLLI-UHFFFAOYSA-N p-Lactophenetide Chemical compound CCOC1=CC=C(NC(=O)C(C)O)C=C1 GHZNWXGYWUBLLI-UHFFFAOYSA-N 0.000 claims description 2
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- ABBQHOQBGMUPJH-UHFFFAOYSA-N sodium;2-hydroxybenzoic acid Chemical compound [Na+].OC(=O)C1=CC=CC=C1O ABBQHOQBGMUPJH-UHFFFAOYSA-N 0.000 claims 1
- 239000000021 stimulant Substances 0.000 claims 1
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 44
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 41
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 34
- 238000000034 method Methods 0.000 description 34
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 32
- 235000014113 dietary fatty acids Nutrition 0.000 description 32
- 229930195729 fatty acid Natural products 0.000 description 32
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- 239000011734 sodium Substances 0.000 description 30
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- 229940083542 sodium Drugs 0.000 description 27
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- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 23
- 235000019698 starch Nutrition 0.000 description 23
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 21
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 21
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 20
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 16
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 16
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 16
- 235000019441 ethanol Nutrition 0.000 description 15
- 229960004756 ethanol Drugs 0.000 description 15
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 14
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 14
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 11
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 11
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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Abstract
푸도스테인과 해열, 진통작용을 가지는 약제를 함유하는 것을 특징으로 하는 의약 조성물이 개시하고 있다. 이 의약 조성물은 보다 뛰어난 거담작용 및 항염증 작용을 가지는 감기약 등의 의약 조성물이다.
Description
종래부터 일반적인 감기용 의약 조성물은 수많이 시판되고 있으며, 일반적으로 감기의 여러 증상을 억제 내지 완화하기 위하여 해열, 진통 작용을 갖는 소염 진통제 이외 몇 가지의 성분이 배합되어 있다.
예를 들면, 감기에 의해 기관지 등에 염증을 일으키면, 기침 이외, 가래가 많이 발생하기 때문에, 감기용 의약 조성물에는 거담작용을 가지는 성분을 배합하는 것도 있다. 그러나, 종래의 감기용 의약조성물에 배합되어 있는 거담작용을 갖는 약물은 모두 거담효과가 낮아 만족할 만한 것은 아니었다.
가래가 목에 걸리는 것은 그 자체 괴로운 것임과 동시에 감기에 걸린 환자의 체력을 소모시키기 때문에 보다 우수한 거담작용을 가지는 감기약 등의 의약 조성물의 개발이 요망되고 있다.
본 발명은 의약 배합제로 관한 것으로, 더 상세히는, 진해작용과 거담작용을 가지며, 진해 거담약 등으로서 유리하게 이용할 수 있는 의약 조성물에 관한 것이다.
본 발명자들은 보다 우수한 거담작용을 가지는 의약 조성물을 얻기 위하여 공지의 거담약을 다른 의약 조성물에 배합되는 성분과 조합하여 그의 유효성을 검토한 바, 거담약으로서 푸도스테인을 함유한 감기용 의약조성물은 푸도스테인과 해열, 진통작용을 갖는 약제와 병용함으로써 거담작용이 증강될 뿐만 아니라, 항염증 작용도 증강시킴을 발견하고, 본 발명을 완성했다.
즉, 본 발명은 푸도스테인과 해열, 진통작용을 가지는 약제를 함유하는 것을 특징으로 하는 의약 조성물을 제공하는 것이다.
[발명을 실시하기 위한 최선의 형태]
본 발명의 의약 조성물로 있어서는, 푸도스테인과 해열, 진통약이 필수 유효성분으로 배합된다.
본 발명에서 이용되는 푸도스테인은 하기 일반식(I)으로 표시되는 S-(3-히드록시프로필)-L-시스테인이며, 이것이 거담제로서 유용함은 이미 일본국 특개평 2-3674호에 보고되어 있다.
그러나, 이 푸도스테인과 해열, 진통약을 배합한 의약 조성물은 아직 알려지지 않았다.
본 발명의 의약 조성물에 대해서는, 푸도스테인 이외, 그의 염류, 예를 들면 푸도스테인의 무기산염, 유기산염, 알칼리 금속염, 알칼리토류 금속염 등을 이용할 수가 있다.
본 발명의 의약 조성물에 있어서의 푸도스테인 또는 그의 염류의 배합량은 특히 제한되지 않지만, 통상, 성인의 1일량으로서 12mg∼2400mg 정도이고, 바람직하기로는, 성인의 1일량으로서 40mg∼1200mg 정도이다.
한편, 본 발명의 의약 조성물로 이용되는 진해작용을 가지는 약제로서는 아스피린, 아스피린 알루미늄, 아세클로페낙, 아세메타신, 아세트아미노펜, 알클로페낙, 알루미노프로펜, 암피록시캄, 암페낙 나트륨, 이소프로필안티피린, 이부프로펜, 인도메타신, 인도메타신 파르네실, 에텐자미드, 에토돌락, 에피리졸, 에모르파존, 염산 티노리딘, 염산 티아라미드, 옥사프로진, 케토페닐부타존, 케토프로펜, 사자피린, 살리실아미드, 살리실산, 콜린 살리실레이트, 나트륨 살리실레이트, 잘토프로펜, 디클로페낙 나트륨, 디플루니살, 술린닥, 술피린, 세레콕시브, 티아프로펜산, 테녹시캄, 톨메틴 나트륨, 나브메톤, 나프록센, 피록시캄, 페나세틴, 페노프로펜 칼슘, 펜티아작, 펜부펜, 플루페남산, 플루르비프로펜, 알루미늄 플루페나메이트, 프라노프로펜, 플록타페닌, 프로글루메타신 말레에이트, 메페남산, 메록시캄, 모페졸락, 락틸페네티진, 록소프로펜 나트륨, 로페콕시브, 로르녹시캄, 톨페남산, 나트륨 톨페나메이트, 티라콕시브, CS-502, T- 614 등을 들 수 있으며, 이들 중, 보다 바람직한 예로서는, 아스피린, 아스피린 알루미늄, 아세트아미노펜, 이소프로필안티피린, 이부프로펜, 에텐자미드, 사자피린, 살리실아미드, 나트륨 살리실레이트, 락틸페네티딘을 들 수 있다. 이들 해열, 진통작용을 가지는 약제는 단독 또는 2종이상을 병용할 수 있다.
본 발명의 의약 조성물에 있어서의 상기 해열, 진통작용을 가지는 약제의 배합량은 병용하는 다른 약물의 종류나 양에 의해 각각 공지의 배합방법으로 준하여 결정할 수 있으나, 통상, 성인 1 일량으로서 10∼5000mg이고, 바람직하기로는, 성인의 1일량으로서 225mg∼3000mg 이다.
본 발명의 의약 조성물에는 상기의 필수 성분 이외, 다시 다른 약효성분을 첨가해도 좋다. 이러한 약효성분의 예로서는, 항히스타민약, 흥분약, 생약, 제산제 또는 점막 보호제, 살균제로 이루어진 군에서 선택된 1종 또는 2종이상을 들 수 있다.
또한, 항히스타민약의 예로서는, 염산 이소티펜딜, 염산 디페닐피랄린, 염산 디펜히드라민, 염산 디페테롤, 염산 트리프롤리딘, 염산 트리펠레나민, 염산 톤질아민(thonzylamine hydrochloride), 염산 페네타진, 염산 메트딜라진, 디펜히드라민 살리실레이트, 카르비녹사민 디페닐디술포네이트, 알리메마진 타르타레이트, 디펜히드라민 탄네이트, 디페닐피랄린 테오클레이트, 프로메타진 메틸렌 디살리실레이트, 카르비녹사민 말레이트, ㎗-클로르페니라민 말레이트, d-클로르페니라민 말레이트, 디페테롤 포스페이트, 프로메타진, 메퀴타진, 염산 시클로헵타딘, 염산 시프로헵타진, 염산 이프로헵틴, 클레마스틴 푸말레이트, 염산 에피나스틴, 염산 올로파타딘, 염산 펙소페나딘, 로라타딘, 베포타스틴 베실레이트, 미졸라스틴, NIP-531 등을 들 수 있으며, 이것들은 단독 또는 2종이상을 병용하여 사용할 수 있다. 항히스타민약의 배합량은 병용하는 다른 약물의 종류나 양에 따라 각각 공지의 배합 방법에 준하여 결정할 수 있으나, 통상, 성인 1일량으로서 1mg∼300mg 의 범위이며, 바람직하기로는, 성인 1일량으로서 3mg∼150mg이다.
또한, 진해약으로서는 염산 알로클라미드, 염산 클로페라스틴, 티페피딘 시트레이트, 나트륨 디부타네이트, 브롬화수소산 덱스트로메토르판, 덱스트로메토르판 페놀프탈린염, 티페피딘 히벤제이트, 클로페라스틴 펜디조에이트, 코데인 포스페이트, 디히드로코데인 포스페이트, 펜톡시베린 시트레이트, 염산 노스카핀, 노스카핀, ㎗-염산 메틸에페드린, ㎗-메틸에페드린 사카린염, 카르베타펜탄 시트레이트, 디메모르판 포스페이트, 벤프로페린 포스페이트, 이소아미닐 시트레이트, 옥세라딘 시트레이트, 옥세라딘 탄네이트, 염산 에프라지논, 염산 클로부티놀, 염산 클로페다놀, 염산 포미노벤, 염산 1-메틸에페드린, 염산 트리메토퀴놀, 염산 페닐프로판올아민, 염산 메톡시페나민, 염산 클로페라스틴, 옥시메테파놀, 아편, 염산 에틸모르핀, 염산 모르핀, 황산 모르핀, 염산 아편 알카로이드, TRK-851, CS-003 등을 들 수 있다. 이것들은 단독 또는 2 종이상을 병용하여 이용할 수 있다. 본 발명의 의약 배합제의 상기 진해작용을 가지는 약제의 배합량은 병용하는 다른 약물의 종류나 양에 의해 각각 공지의 배합 방법에 준하여 결정할 수 있으나, 통상, 성인 1일량으로서 약 2mg∼900mg의 범위이고, 바람직하기로는, 성인 1일량으로 12mg∼90g이다.
또한, 흥분약의 예로서는, ㎗-염산 메틸에페드린, ㎗-메틸에페드린 사카린염, 카페인, 무수 카페인, 염산 에페드린, 염산 페닐프로판올아민, 페닐에페드린, ℓ-염산 메틸에페드린, 염산 메톡시페나민, ㎗-염산 에피네프린, ㎗-염산 이소프로테레놀, 이소프로테레놀 술페이트, 오르시프레날린 술페이트, 테르부탈린 술페이트, 살부타몰 술페이트, 염산 트리메토퀴놀, 헥소프레날린 술페이트, 염산 클로르프레날린, 염산 툴로부테롤, 염산 프로카테롤, 염산 피르부테롤, 브롬화수소산 페노테롤, 포르모테롤 푸탈레이트, 염산 클렌부테롤, 염산 마부테롤, 염산 에틸시스테인, 염산 메틸시스테인, 슈도에페드린 등을 들 수 있으며, 이것들은 단독 또는 2종이상을 병용하여 사용할 수 있다. 흥분약의 배합량은, 병용하는 다른 약물의 종류나 양에 따라 각각 공지의 배합 방법에 준하여 결정할 수 있으나, 통상, 성인 1 일량으로서 1∼900mg의 범위이며, 바람직하기로는, 성인 1 일량으로서 5∼600mg이다.
비타민류의 예로서는, 옥토티아민, 프로술티아민, 푸루술티아민, 염산 푸루술티아민, 비스벤티아민, 벤포티아민, 염산 디세티아민, 시코티아민, 코카르복시라제, 티아민디술피드, 염산 티아민, 아세트산 티아민, 염산 티아민, 질산 티아민, 질산 비스티아민, 티아민 디세틸술페이트, 비스이부티아민 등의 비타민 B1및 그의 유도체 및 그의 염류, 리보플라빈, 리보플라빈 부티레이트, 리보플라빈 나트륨 포스페이트, 플라빈 아데닌 디뉴클레오티드 나트륨 등의 비타민 B2및 그의 유도체 및 그의 염류, 아스코르빈산, 나트륨 아스코르베이트, 칼슘 아스코르베이트 등의 비타민 C 및 그의 유도체 및 그의 염류, 헤스페리딘 및 그의 유도체 및 그의 염류, 비타민 F, 레티놀 아세테이트, 레티놀 팔미테이트 등의 비타민 A 및 그의 유도체 및 그의 염류, 토코페롤 숙시네이트, 토코페롤 칼슘 숙시네이트, 토코페롤 아세테이트, 토코페롤 등의 비타민 E 및 그의 유도체 및 그의 염류 등을 들 수 있으며, 이것들은 단독 또는 2종이상을 병용할 수 있다. 비타민류의 배합량은 병용하는 다른 약물의 종류나 양에 따라, 각각 공지의 배합 방법에 준하여 결정할 수 있지만, 통상, 성인 1일량으로서 0.1mg∼2000mg의 범위이며, 바람직하기로는, 1mg∼500mg이다.
또한, 생약의 예로서는, 마황, 남천실, 앵피, 원지, 감초, 길경, 행인, 차전자, 차전초, 석산(石蒜), 세네가, 갈근, 패모, 회향, 황백, 황련, 아술(莪述), 카밀레(German chamomile), 계피, 겐티안(gentian), 우황, 수담, 사삼, 생강, 창출, 정자, 진피, 백출, 지룡, 죽절인삼, 인삼, 황금, 갈근, 행인, 향부자, 경미, 후박, 오미자, 시호, 세신(細辛), 작약, 소엽(蘇葉), 대추, 맥문동, 반하, 복령, 갈근탕, 계피당, 향소산, 시호계피탕, 소시호탕, 소청룡탕, 맥문동탕, 반하후박탕, 마황탕, 형개, 연교(連翹), 신이(辛夷), 도인, 부자 등의 생약 분말 및 그의 엑기스를 들 수 있으며, 이것들은 단독 또는 2종이상을 병용할 수 있다. 생약의 배합량은, 병용하는 다른 약물의 종류나 양에 따라 각각 공지의 배합 방법에 준하여 결정할 수 있으나, 통상, 성인 1일량은 엑기스(원생약 환산량)로서 0.001g∼300g, 분말로서 0.0001g∼60g의 범위이며, 바람직하기로는, 엑기스(원생약 환산량)로서 0.05g∼30g, 분말로서 0.002g∼6g이다.
한편, 제산제 또는 점막 보호약의 예로서는, 아미노아세트산, 산화마그네슘,탄산마그네슘, 규산마그네슘, 합성 규산알루미늄, 합성 히드로탈사이트, 디히드로알루미늄 아미노아세트산염, 수산화알루미늄겔, 건조 수산화알루미늄겔, 수산화알루미늄-탄산마그네슘 혼합 건조 겔, 수산화알루미늄-탄산수소나트륨 공침물, 수산화알루미늄-탄산칼슘-탄산마그네슘 공침물, 수산화마그네슘-황산알루미늄 칼륨 공침물, 마그네슘 알루미노메타실리케이트, 수산화마그네슘, 황산알루미늄, 수크랄페이트(sucralfate) 등을 들 수 있으며, 이것들은 단독 또는 2종이상을 병용할 수 있다. 제산제 또는 점막 보호약의 배합량은 병용하는 다른 약물의 종류나 양에 의해 각각의 공지의 배합 방법에 준하여 결정할 수 있지만, 통상, 성인 1일량으로서 10mg∼8,000mg이고, 바람직하기로는, 100mg∼4,000mg이다.
본 의약 조성물에는 다시 소염 효소약이나 푸도스테인 이외의 거담제를 약효성분으로서 배합하여도 좋다. 소염 효소약의 예로서는, 브로메라인, 프로나제, 세라펩타제, 세미알카리 프로티나제, 스트렙토키나제, 스트렙토도르나제, 염화 리소자임 등을 들 수 있으며, 이것들은 단독 또는 2종이상을 병용할 수 있다. 소염 효소약의 배합량은, 통상, 성인 1일량으로서 4mg∼300mg, 바람직하기로는 15mg∼60mg이다.
또한, 푸도스테인 이외의 거담제의 예로서는 칼륨 구아야콜 술포네이트, 구아이페네신, 요드화칼륨, 암모니아 회향 스프리트, 탄산수소나트륨, 염산 브롬헥신, 카르보시스테인, 염산 암브록솔, 염산 메틸시스테인, 아세틸시스테인, 염산 에틸시스테인, 염산 에프라지논, 아미노필린, 테오필린, 디프로필린, 프록시필린, 염화암모늄, 칼륨 크레졸술포네이트, ℓ-멘톨, 염산 트리메토퀴놀, 염산 페닐프로판올아민, 염산 메톡시페나민 등을 들 수 있으며, 이들을 단독 또는 2종이상을 함께 배합해도 좋다. 이들 거담제의 배합량은 통상, 성인 1일량으로서 1mg∼3,000mg이고, 바람직하기로는, 6mg∼900mg이다.
본 발명의 의약 조성물은 상기 각 성분과 약학적으로 허용되는 제제 첨가물을 적당히 조합하여 통상의 방법으로 따라서, 정제, 과립제, 세립제, 산제, 경질 캅셀제, 연질 캅셀제, 환약, 트로키제, 드롭제, 현탁액제, 유제, 내복 액제, 시럽제, 드라이 시럽제, 흡입제, 구강 점막 부착 제제 등의 경구투여 형태의 고형, 반고형 및 액상의 제제로 제제화함으로써 조제된다. 또한, 각 약효성분은, 마이크로 캅셀, 나노 캅셀, 마이크로스피아, 나노스피아 등의 미소 입자로 한 후, 전술의 제제로 하여도 좋다.
본 발명의 의약 조성물의 조제는 특히 제한되는 것이 아니고, 각종 방법에 따라 행할 수 있다. 예를 들면, 정제, 과립제, 세립제, 산제, 캅셀제, 환약, 드라이 시럽제 등으로 조립 분말을 조제할 필요가 있는 경우, 일반적으로 이용되는 조립법, 예를 들면, 물이나 유기용매를 포함한 용액 또는 분산액을 이용하는 분무 조립법, 교반조립법, 유동 조립법, 전동 조립법, 전동 유동 조립법 등의 습식 조립법, 분립상의 결합제를 이용하는 압밀조립법 등의 건식 조립법 등에 의해 제조된다.
그리고 제제를 과립제, 세립제, 산제로 하는 경우는, 유효성분을 포함한 분말이나 조립 분말을 혼합하여 분포로 소분하여 충전할 수 있으며, 캅셀제로 하는 경우는, 분말제, 조립분말, 소형 정제 등을 캅셀 충전기를 이용해 캅셀에 충전함으로써 제조된다. 또 정제로 하는 경우는, 유효성분의 분말, 분말제, 세립제, 과립제나 환약과 제제 첨가물을 혼합해, 압축 성형하면 좋다.
또한, 당의정, 필름 코팅정, 코팅 과립 등의 코팅 제제로 하는 경우는 판 코팅법, 유동 코팅법, 전동 코팅법 및 이들을 조합한 코팅제를 정제나 과립제 등으로 코팅하면 좋다. 코팅제는 물이나 유기용매에 용해 및/또는 분산시켜, 스프레이 코팅 할 수 있으며, 또한, 코팅제를 직접 살포해, 열이나 압력 등을 가하여 드라이코팅으로 할 수도 있다. 코팅제의 피복량은 제형 등에 의해 필요에 따라서 선택할 수 있다. 일반적으로는 정제는 0.1∼100중량%, 환약, 과립제는 0.1∼200중량%, 세립제는 0.1∼300중량% 정도이다.
더욱 또한, 시럽제, 에릭실제, 리모나데제, 엑기스제, 드링크제 등의 내복 액제 및 액상 또는 반고형물을 충전한 연질 캅셀제, 경질 캅셀제 등은 통상, 각 약효성분과 정제수 등의 용제의 일부를 혼합, 용해, 분산하고, 나머지의 용제를 가하여 액량을 조정하여 제조할 수 있다. 필요에 따라서, 산 또는 알카리를 이용하여 pH를 조정하여도 좋다. 또, 지용성 성분을 포함하는 경우에는, 계면활성제, 가용화제, 유화제, 현탁제 등의 제제 첨가물을 이용하여 가용화, 유화, 현탁화해도 좋다. 조정시의 필요에 따라 가온, 냉각, 질소 치환, 여과, 멸균 처리 등을 하여도 좋다.
본 발명의 의약 조성물로 있어서는, 필요에 따라, 제제 첨가물 등을 이용하여 약효성분의 안정화, 서방화, 지속화, 속붕화, 속용화, 용해성의 개선, 맛의 은폐, 복용감의 개선 등의 기능을 부가해도 좋다. 이들 기능을 부가하는 방법은, 일반적으로 사용하는 방법으로 행할 수 있으며, 예를 들면, 약효성분을 다른 과립에배합하는, 다층의 과립으로 하는 방법, 다층정이나 유핵정으로 하는 방법, 각각의 과립으로 하여 타정하는 방법, 마이크로캅셀로 하는 방법, 당의정, 필름 코팅정, 코팅 과립 등의 코팅 제제로 하는 방법, 발포 제제로 하는 방법, 츄어블 제제로 하는 방법, 구강내 붕괴 제제로 하는 방법, 매트릭스 제제로 하는 방법, 공분쇄하는 방법, 고용체로 하는 방법, 감미제나 청량화제를 첨가하는 방법, 항산화제나 안정(화)제를 첨가하는 방법, 특정의 pH, 점도, 침투압, 염 농도에 조정 방법 등의 각종 방법을 들 수 있으며, 이들 방법을 조합해도 좋다.
본 발명의 의약 조성물의 제조에서 이용되는 약학적으로 허용되는 제제 첨가물로서는, 안정제, 안정화제, 계면활성제, 가소제, 활택화제, 활택제, 가용제, 가용화제, 환원제, 완충제, 감미제, 기제, 흡착제, 교미제, 결합제, 현탁제, 현탁화제, 항산화제, 광택화제, 코팅제, 제피, 습윤제, 습윤 조정제, 충전제, 소포제, 청량화제, 착색제, 착향제, 향료, 당의제, 등장화제, 연화제, 유화제, 점조화제, 점조제, 발포제, pH 조정제, 희석제 및 부형제, 분산제, 붕괴제, 붕괴 보조제, 붕괴연장제, 방향제, 방습제, 방부제, 보존제, 용해제, 용해 보조제, 용제, 유동화제, 대전방지제, 증량제, 보습제, 부습제 등의 첨가제를 이용할 수 있다. 보다 구체적으로는, 이하의 제제 첨가물을 들 수 있으며, 이들은 단독으로 또는 2종이상을 혼합하여 이용해도 좋다.
우선, 부형제, 기제, 충전제의 구체적인 예로서는, DL-알라닌, ㎗-말산, D-소르비톨, D-소르비톨액, D-만니톨, L-아스파라긴산, L-글루타민, β-시클로덱스트린, 아미노에틸술폰산, 분말 전분 시럽, 아라비아 검, 아라비아 검 분말, 알긴산,나트륨 알기네이트, 프로필렌글리콜 알기네이트, 알파화 전분, 이노시톨, 에탄올, 에틸 셀루로오즈, 옥틸데실 트리글리세리드, 오파드라이 베이지, 올리브유, 올레인산, 카올린, 카카오 버터, 카세인, 카세인 나트륨, 카라기난, 캐라멜, 카르나우바 왁스, 카르복시비닐폴리머, 나트륨 카르복시메틸 스타치, 카르멜로오즈, 카르멜로오즈 칼슘, 카르멜로오즈 나트륨, 감초 분말, 한천, 한천 분말, 크산탄검, 크실리톨, 시트르산, 나트륨 시트레이트, 디나트륨 시트레이트, 글리신, 글리세린, 글리세린 지방산 에스테르, 칼슘 글루코네이트, 나트륨 글루코네이트, 크로스카르멜로오즈 나트륨, 크로스포비돈, 계피 분말, 마그네슘 알루미노실리케이트, 규산칼슘, 규산마그네슘, 현미 맥아, 숙신화 젤라틴, 참기름, 밀 전분, 밀 배아분, 쌀 전분, 콜레스테롤, 새플라워유, 백랍, 디히드록시알루미늄 아미노아세테이트, 디메틸폴리실록산(내복용), 슈크로오즈 지방산에스테르, 스테아릴알코올, 스테아린산, 칼슘 스테아레이트, 폴리옥실 40 스테아레이트, 마그네슘 스테아레이트, 제인(zein), 소르비탄 세스퀴올레에이트, 세탄올, 스테아레이트, 석고, 젤라틴, 소르비탄 지방산 에스테르, 대두 경화유, 대두유, 탈크, 덱스트란 40, 덱스트린, 나트륨 데히드로아세테이트, 칼슘 글리세로포스페이트, 옥수수 시럽, 옥수수 전분, 옥수수 전분 조립물, 트라가칸트, 트라가칸트 분말, 트리아세틴, 유채씨유, 펄 분말, 쌀보리 잎 녹즙 건조 분말, 벌꿀, 파라핀, 감자 전분, 비터 쵸코릿(bitter chocolate), 히드록시프로필 스타치, 히드록시프로필 셀루로오즈, 히드록시프로필 셀루로오즈, 히드록시프로필 메틸셀루로오즈 2208, 히드록시프로필 메틸셀루로오즈 2906, 히드록시프로필 메틸셀루로오즈 2910, 히드록시프로필 메틸셀루로오즈 프탈레이트, 피마자유,해바라기유, 피틴산, 페나세틴, 글루코오즈, 글루코오즈 수화물, 풀루란, 프로필렌글리콜, 프로필렌글리콜 지방산 에스테르, 펙틴, 벤토나이트, 포비돈, 나트륨 폴리아크릴레이트, 폴리아크릴산 부분 중화물, 폴리이소부틸렌, 폴리옥시에틸렌 (105) 폴리옥시프로피렌 (5) 글리콜, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유, 폴리옥시에틸렌 경화 피마자유 40, 폴리옥시에틸렌 경화 피마자유 60, 폴리스티렌술폰산 나트륨, 폴리소르베이트 60, 폴리소르베이트 80, 폴리비닐아세탈 디에틸아미노아세테이트, 폴리비닐알코올(부분 검화물), 폴리비닐알코올-디에틸렌글리콜 혼합물, 굴 껍질 분말, 마크로골 1500, 마크로골 1540, 마크로골 20000, 마크로골 300, 마크로골 400, 마크로골 4000, 마크로골 6000, 멀티톨, 밀납, 미리스틸알코올, 미리스틴산옥틸도데실, 메타크릴산 코폴리머 LD, 마그네슘 메타알루미노실리게이트, 메틸아크릴레이트-메타크릴산 코폴리머, 메틸 셀루로오즈, 목랍, 알루미늄 모노스테아레이트, 글리세롤 모노스테아레이트, 라우릴황산나트륨, 라우로마크로골, 땅콩유, 인산일수소칼슘, 인산수소칼슘, 인산수소칼슘 입상물, 인산수소나트륨, 인산이수소칼륨, 인산이수소칼슘, 인산이수소나트륨, 로즈유, 로진, 염화나트륨, 과당, 건조 클로렐라, 건조 효모, 건조 수산화알루미늄겔, 건조 황산마그네슘, 짭쌀떡 분말, 환원 맥아당 시럽, 함수 이산화규소, 함수 무정형 산화규소, 경질 무수규산, 경질 유동 파라핀, 경랍, 결정 셀루로오즈, 결정 셀루로오즈(입상물), 결정 셀루로오즈(미세 입상물), 결정 셀루로오즈-카르멜로오즈 나트륨, 경화유, 합성 규산알루미늄, 합성 규산알루미늄-히드록시프로필 스타치-결정 셀루로오즈, 합성 히드로탈사이트, 산화티탄, 산화마그네슘, 사유, 타르타르산, 타르타르산수소칼륨, 중질 무수규산, 소맥분, 소맥 배아유, 소독용 에탄올, 소석회, 아세트산칼슘, 아세트산 프탈산 셀루로오즈, 스타치 시럽, 수산화알루미나 마그네슘, 수산화알루미늄-탄산마그네슘-탄산칼슘 공침물, 수산화알루미늄-탄산수소나트륨 공침물, 수산화알루미늄겔, 수산화마그네슘, 수소 첨가 식물유, 생리식염액, 정제 젤라틴, 정제 셀락, 정제 벌꿀, 정제수, 정제 백당, 정제슈크로오즈 구상과립, 대두 레시틴, 대두유 비검화물, 제3인산 칼슘, 탈지분유, 단미 시럽, 탄산암모늄, 탄산칼슘, 탄산마그네슘, 중쇄지방산 트리글리세리드, 침강 탄산칼슘, 저치환도 카르복시메틸 스타치 나트륨, 저치환도 히드록시프로필 셀루로오즈, 천연 규산알루미늄, 이산화규소, 젖산, 젖산칼슘, 락토오즈, 락토오즈 입상물, 농글리세린, 백색 셀락, 백당, 백당-전분 구상과립, 반소화체 전분, 미결정 셀루로오즈, 부분 알파화 전분, 분당, 분말 셀루로오즈, 분말 시럽, 분말 환원 맥아당, 물엿, 쌀가루, 무수 시트르산, 무수규산 수가물, 무수 인산수소칼슘, 무수 인산수소칼슘 조립물, 무수 락토오즈, 무수 황산나트륨, 멸균 정제수, 면실유, 면실유-대두유 혼합물, 약용 숯, 유동 파라핀, 황산칼슘, 녹차 분말 등을 들 수 있다.
다음에, 용제, 가용화제, 용해제, 용해 보조제의 구체적인 예로서는, ㎗-캠퍼, D-만니톨, D-소르비톨, D-소르비톨액, L-아스파라긴산, L-아르기닌,α-시클로덱스트린, β-시클로덱스트린, 아디핀산, 회향유, 에스테르화 옥수수유, 에탄올, 올리브유, 올레인산, 올레일 올레에이트, 카르멜로오즈 나트륨, 시트르산, 나트륨 시트레이트, 글리신, 글리세린, 글리세린 지방산에스테르, 참기름, 사플라워유, 사플라워유 지방산, 살리실산나트륨, 자소유, 디부틸히드록시톨루엔, 슈크로오즈 지방산 에스테르, 스테아릴알코올, 폴리옥실 스테아레이트 40, 세스퀴올레인산 소르비탄, 소르비탄 지방산 에스테르, 대두유, 나트륨 데히드로아세테이트, 옥수수유, 트리아세틴, 트리올레인산 소르비탄, 트리카프리린, 유채씨유, 니코틴아미드, 박하유, 히드록시프로필셀루로오즈, 히드록시프로필 메틸셀루로오즈 2910, 피마자유, 펜프로바메이트, 글루코오즈, 프로필렌글리콜, 프로필렌글리콜 지방산 에스테르, 포비돈, 폴리옥시에틸렌 (105) 폴리옥시프로필렌(5) 글리콜, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유, 폴리옥시에틸렌 경화 피마자유 40, 폴리옥시에틸렌 경화 피마자유 60, 폴리소르베이트 20, 폴리소르베이트 60, 폴리소르베이트 80, 폴리비닐알코올(부분 검화), 마크로골 1500, 마크로골 200, 마크로골 300, 마크로골 400, 마크로골 4000, 마크로골 600, 마크로골 6000, 말레인산, 이소프로필 미리스테이트, 소르비탄 모노올레이트, 소르비탄 모노라우레이트, 야자유, 나트륨 라우릴 술페이트, 라우로마크로골, 땅콩유, 리도카인, 링게르액, 인산, 인산수소나트륨, 인산이수소칼륨, 나트륨 벤조에이트, 벤질 벤조에이트, 염화나트륨, 염화마그네슘, 건조 탄산나트륨, 희염산, 샛멸, 경화유, 산화마그네슘, 타르타르산, 소맥 배아유, 소독용 에탄올, 상수, 아세트산, 셀루로오즈 아세테이트 프탈레이트, 수산화나트륨, 생리식염액, 정제 대두유, 정제수, 정제 대두 레시틴, 석유 벤젠, 대두 레시틴, 탄산나트륨, 탄산수소나트륨, 중쇄지방산 트리글리세리드, 저치환도 히드록시프로필셀루로오즈, 젖산, 농글리세린, 백당, 빙초산, 무수 에탄올, 무수 시트르산, 무수 말레산, 무수 인산일수소나트륨, 멸균 정제수, 면실유, 유동 파라핀 등을 들 수가 있다.
붕괴제, 붕괴 보조제, 분산제, 방습제, 유동화제의 구체적인 예로서는, D-소르비톨, D-만니톨, 아디핀산, 아미노알킬메타크릴레이트 코폴리머 RS, 아라비아 검, 아라비아 검 분말, 알긴산, 나트륨 알기네이트, 프로필렌글리콜 알기네이트, 알파화 전분, 에탄올, 에틸셀루로오즈, 올리브유, 올레인산, 카르복시비닐폴리머, 나트륨 카르복시메틸 스타치, 카르멜로오즈, 카르멜로오즈 칼슘, 카르멜로오즈 나트륨, 감초 분말, 한천 분말, 구아 검, 시트르산, 칼슘 시트레이트, 나트륨 시트레이트, 글리세린, 글리세린 지방산 에스테르, 크로스카르멜로오즈 나트륨, 크로스포비돈, 규산마그네슘, 밀 전분, 쌀 전분, 콜린 인산염, 사플라워유, 백랍, 디옥틸 나트륨 술포숙시네이트, 슈크로오즈 지방산 에스테르, 스테아린산, 스테아린산칼슘, 폴리옥실 스테아레이트 40, 마그네슘 스테아레이트, 소르비탄 세스퀴올레에이트, 젤라틴, 소르비탄 지방산에스테르, 탈크, 대두유, 덱스트린, 옥수수 전분, 트라가칸트 분말, 소르비탄 트리올레에이트, 벌꿀, 파라핀, 감자 전분, 히드록시에틸셀루로오즈, 히드록시 에틸메틸 셀루로오즈, 히드록시프로필 스타치, 히드록시 프로필셀루로오즈, 히드록시프로필 메틸셀루로오즈 2910, 히드록시프로필 메틸셀루로오즈 2910 혼합물, 피마자유, 푸말산, 나트륨 푸말레이트, 프로필렌글리콜, 프로필렌글리콜 지방산 에스테르, 벤토나이트, 포비돈, 폴리옥시에틸렌 (105) 폴리옥시프로필렌 (5) 글리콜, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유, 폴리옥시에틸렌 경화 피마자유 60, 폴리옥시에틸렌 경화 피마자유 40, 폴리소르베이트 20, 폴리소르베이트 40, 폴리소르베이트 60, 폴리소르베이트 80, 폴리비닐 아세탈 디에틸아미노아세테이트, 폴리인산나트륨, 마크로골1500, 마크로골 300, 마크로골 400, 마크로골 4000, 마크로골 6000, 마그네슘 알루미노메타실리케이트, 메타인산 나트륨, 메틸셀루로오즈, 목랍, 소르비탄 모노올레에이트, 알루미늄 모노스테아레이트, 글리세롤 모노스테아레이트, 소르비탄 모노팔미테이트, 소르비탄 모노라우레이트, 나트륨 라우릴 술페이트, 라우로마크로골, 인산수소 칼슘, 인산수소 칼슘 입상물, 인산이수소칼슘, 건조 수산화알루미늄겔, 경질 산화알루미늄, 경질 무수규산, 결정 셀루로오즈, 결정 셀루로오즈-카르멜로오즈나트륨, 경화유, 함수 이산화규소, 합성 규산알루미늄, 산화티탄, 나트륨 데히드로아세테이트, 중질 무수규산, 비닐 아세테이트수지, 아세트산 프탈산 셀루로오즈, 수산화알루미늄마그네슘, 수산화나트륨, 정제 셀락, 정제 대두 레시틴, 정제 슈크로오즈, 대두 레시틴, 제3인산칼슘, 탄산마그네슘, 탄산수소나트륨, 침강 탄산칼슘, 저치환도 나트륨 카르복시메틸 스타치, 저치환도 히드록시프로필셀루로오즈, 락토오즈, 농글리세린, 백색 셀락, 백당, 부분 알파화 전분, 무수 에탄올, 무수 시트르산, 무수 나트륨 시트레이트, 무수 피로인산나트륨, 유동 파라핀 등을 들 수가 있다.
pH 조정제, 등장화제, 완충제의 구체적인 예로서는, ㎗-말산, D-소르비톨, D-소르비톨액, D-만니톨, D-타르타르산, L-아스파라긴산마그네슘, L-아르기닌, L-글루타민산, L-글루타민산나트륨, 아디핀산, 아스코르빈산, 아미노에틸술폰산, 크실리톨, 시트르산, 시트르산 칼슘, 시트르산 나트륨, 시트르산 디나트륨, 글리신, 글리세린, 글루코노-δ-락톤, 글루콘산 칼슘, 숙신산, 숙신산 디나트륨?? 6수화물, 니코틴아미드, 글루코오즈, 나트륨 푸말레이트, 프로필렌글리콜, 폴리인산나트륨,마크로골 4000, 말레인산, 메타인산나트륨, 인산, 인산디칼륨, 인산트리나트륨, 인산수소나트륨, 인산이수소칼륨, 인산이수소나트륨, 로즈유, 벤조산, 나트륨 벤조에이트, 염화칼륨, 염화칼슘, 염화나트륨, 염화 마그네슘, 염산, 염산 글루코사민, 과당, 건조 아황산나트륨, 건조 탄산나트륨, 희염산, 타르타르산, 아세트산, 수산화나트륨, 수산화마그네슘, 생리식염액, 탄산나트륨, 탄산수소나트륨, 젖산, 젖산칼슘, 락토오즈, 농글리세린, 빙초산, 무수 시트르산, 무수 나트륨 시트레이트, 무수 피로인산나트륨, 무수 인산일수소나트륨, 무수 인산트리나트륨, 무수 인산이수소나트륨, 황산수소나트륨 등을 들 수가 있다.
계면활성제, 유화제, 발포제의 구체적인 예로서는, D-소르비톨, 에탄올, 카라기난, 카르복시비닐폴리머, 카르멜로오즈나트륨, 구아 검, 글리세린, 글리세린 지방산 에스테르, 콜레스테롤, 백랍, 디옥틸나트륨 술포숙시네이트, 슈크로오즈 지방산에스테르, 스테아릴알코올, 스테아린산, 폴리옥실 스테아레이트 40, 세스퀴올레인산 소르비탄, 세탄올, 젤라틴, 소르비탄 지방산에스테르, 탈크, 소르비탄 트리올레에이트, 파라핀, 감자 전분, 히드록시프로필셀루로오즈, 프로필렌글리콜, 프로필렌글리콜 지방산 에스테르, 펙틴, 폴리옥시에틸렌 (105) 폴리옥시프로필렌 (5) 글리콜, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유, 폴리옥시에틸렌 경화 피마자유 40, 폴리옥시에틸렌 경화 피마자유 60, 폴리옥실 35 피마자유, 폴리소르베이트 20, 폴리소르베이트 60, 폴리소르베이트 80, 마크로골 400, 옥틸도데실 미리스테이트, 메틸셀루로오즈, 소르비탄 모노올레에이트, 모노스테아린산 글리세린, 소르비탄 모노팔미테이트, 소르비탄 모노라우레이트, 라우릴디메틸아민옥시드액, 나트륨 라우릴 술페이트, 라우로마크로골, 건조 탄산나트륨, 타르타르산, 수산화나트륨, 정제 대두 레시틴, 대두 레시틴, 탄산칼륨, 탄산수소나트륨, 중쇄지방산 트리글리세리드, 무수 시트르산, 면실유-대두유 혼합물, 유동 파라핀 등을 들고 있다.
습윤제, 습윤 조정제, 결합제, 현탁화제, 점조제, 점조제, 점착제, 점착 증강제, 연화제, 가소제의 구체적인 예로서는, D-소르비톨, D-소르비톨액, D-만니톨, RSS No. 1 생고무, β-캅탄, β-시클로덱스트린, 아크릴산-옥틸 아크릴레이트 공중합체, 2-에틸헥실 아크릴레이트-비닐피롤리돈 공중합체 용액, 2-에틸헥실 아크릴레이트-2-에틸헥실 메타크릴레이트-도데실 메타크릴레이트 공중합체 용액, 아크릴산 에스테르-비닐 아세테이트 코폴리머, 에틸 아크릴레이트-메틸메타크릴레이트 코폴리머 분산액, 아세틸글리세린 지방산 에스테르, 아크릴산 실크 피브로인 공중합 수지, 메틸 아크릴레이트 - 아크릴산-2-에틸헥실 공중합 수지 에멀젼, 아크릴 수지 알카놀아민액, 마그네슘 스테아레이트, 아미노알킬 메타크릴레이트 코폴리머 E, 아미노알킬 메타크릴레이트 코폴리머 RS, 아미노에틸 술폰산, 아밀로펙틴, 분말 전분 시럽, 아라비아 검, 아라비아 검 분말, 나트륨 알기네이트, 프로필렌글리콜 알기네이트, 알파화 전분, 에스테르 검, 에탄올, 에틸셀루로오즈, 나트륨 에리소르베이트(sodium erythorbate), 펠로덴드론 분말, 올리브유, 올레인산 나트륨, 카올린, 카카오 버터, 카제인 나트륨, 카라기난, 캐라멜, 카르나우바 왁스, 카르복시비닐폴리머, 카르복시비닐폴리머, 카르복시메틸에틸셀루로오즈, 나트륨 카르복시메틸 스타치, 카르멜로오즈, 카르멜로오즈 칼슘, 카르멜로오즈 나트륨, 한천,한천 분말, 크산탄검, 벤질아세테이트, 구아 검, 나트륨 시트레이트, 글리신, 글리세린, 글리세린 지방산 에스테르, 글루코노-δ-락톤, 규산마그네슘, 규산마그네슘알루미늄, 코팔 수지, 코폴리비존, 참기름, 밀 전분, 쌀 전분, 콜로디온, 콘도로이틴 황산나트륨, 백랍, 디옥틸 나트륨 술포숙시네이트, 시스폴리이소프렌 고무, 디히드록시알루미늄 아미노아세테이트, 디부틸히드록시톨루엔, 디메틸폴리실록산(내복용), 디메틸폴리실록산-이산화규소 혼합물, 슈크로오즈 지방산에스테르, 스테아릴알코올, 스테아린산, 스테아린산알루미늄, 스테아린산칼슘, 폴리옥실 스테아레이트, 폴리옥실 스테아레이트 40, 스티렌-이소프렌-스티렌 블록 공중합체, 스티렌이소프렌 고무, 소르비탄 세스퀴올레에이트, 세탄올, 젤라틴, 셀락, 소르비탄 지방산에스테르, 솔벤트 나프타, 대두 경화유, 탈크, 담마르 검, 덱스트란 70, 덱스트린, 테르펜 수지, 전분(용성), 옥수수 전분, 옥수수유, 트라가칸트, 트라가칸트 분말, 소르비탄 트리올레에이트, 유채씨유, 하이 시스폴리이소프렌고무[분자량 47000], 벌꿀, 파라핀, 감자 전분, 비검 뉴트랄, 히드록시에틸 셀루로오즈, 히드록시에틸 셀루로오즈, 히드록시에틸 메틸셀루로오즈, 히드록시프로필 스타치, 히드록시프로필 셀루로오즈, 히드록시프로필 메틸셀루로오즈 2208, 히드록시프로필 메틸셀루로오즈 2906, 히드록시프로필 메틸 셀루로오즈 2910, 히드록시프로필 메틸셀루로오즈 아세테이트 숙시네이트, 히드록시프로필 메틸셀루로오즈 프탈레이트, 비닐피롤리돈-비닐 아세테이트 공중합물, 피페로닐 부톡시드, 피마자유, 글루코오즈, 푸말산, 푸말산-스테아린산-폴리비닐 아세탈 디에틸아미노아세테이트-히드록시프로필 메틸셀루로오즈 2910 혼합물, 푸말산스테아릴 나트륨, 풀루란, 프로필렌글리콜, 프로필렌글리콜 지방산에스테르, 펙틴, 벤토나이트, 포비돈, 폴리아크릴산, 폴리아크릴산나트륨, 폴리아크릴산 수용액, 폴리아크릴산 부분 중화물, 폴리이소부틸렌, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유, 폴리옥시에틸렌 경화 피마자유 60, 폴리소르베이트 20, 폴리소르베이트 60, 폴리소르베이트 80, 폴리소르베이트 80 폴리비닐 아세탈 디에틸아미노아세테이트, 폴리비닐 알코올(완전 검화물), 폴리비닐 알코올(부분 검화물), 폴리부텐, 폴리인산나트륨, 마크로골 1500, 마크로골 20000, 마크로골 300, 마크로골 400, 마크로골 4000, 마크로골 600, 마크로골 6000, 말레인화 로진 글리세린 에스테르, 밀랍, 메타크릴산-아크릴산 n-부틸 코폴리머, 메타크릴산 코폴리머 L, 메타크릴산 코폴리머 LD, 메타크릴산 코폴리머 S, 마그네슘 알루미늄메타실리케이트, 메타인산나트륨, 메틸 셀루로오즈, 메틸비닐에테르-무수 말레산 공중합체, 목랍, 글리세롤 모노스테아레이트, 나트륨 라우릴 술페이트, 라우로마크로골, 땅콩유, 인산, 인산수소칼슘, 로진, 염화 칼슘, 염화나트륨, 염화마그네슘, 가수 라놀린, 가수분해 젤라틴말, 가수분해 전분 첨가 경질 무수규산, 과당, 건조 수산화알루미늄겔, 짭쌀떡 분말, 환원 스타치 시럽, 함수 이산화규소, 함수 무정형 산화규소, 경질 무수규산, 경질 무수규산 함유 히드록시프로필 셀루로오즈, 경질 유동 파라핀, 결정 셀루로오즈, 결정 셀루로오즈-카르멜로오즈나트륨, 경화유, 고분자 폴리비닐피롤리돈, 합성 규산알루미늄, 합성 왁스, 산화 티탄, 산화마그네슘, 지환족 포화 탄화수소 수지, 지방족 탄화수소 수지, 타르타르산나트륨 칼륨, 중질 무수규산, 소맥분, 상수, 비닐아세테이트 수지, 셀루로오즈 아세테이트 프탈레이트, 스타치 시럽, 수산화알루미늄겔, 수산화칼륨, 수산화나트륨, 수소 첨가 로진 글리세린 에스테르, 생고무, 정제 젤라틴, 정제 셀락, 정제수, 정제 백당, 석유 벤젠, 석유 수지, 대두 레시틴, 단미 시럽, 탄산칼슘, 탄산마그네슘, 중쇄지방산 트리글리세리드, 침강탄산칼슘, 저치환도 히드록시프로필 셀루로오즈, 젖산, 락토오즈, 농글리세린, 백색 셀락, 백색 바셀린, 슈크로오즈, 미결정 셀루로오즈, 부분 알파화 전분, 쌀가루, 무수 에탄올, 면실유-대두유 혼합물, 유동 파라핀, 황산칼슘, 황산화 피마자유 칼륨염-알킬 벤젠술폰산염 혼합물 등을 들 수 있다.
코팅제, 당의제, 제피, 광택화제, 소포제의 구체적인 예로서는, 2-메틸-5-비닐피리딘메틸 아크릴레이트-메타크릴산 코폴리머, ㎗-말산, D-소르비톨, D-소르비톨액, D-만니톨, 에틸아크릴레이트-메틸메타크릴레이트 코폴리머 분산액, 아세틸글리세린 지방산에스테르, 아미노알킬 메타크릴레이트 코폴리머 E, 아미노알킬 메타크릴레이트 코폴리머 RS, 아라비아 검, 아라비아 검 분말, 정제 백랍, 에탄올, 에틸셀루로오즈, 에틸셀루로오즈 수분산액, 옥틸데실 트리글리세리드, 오파드라이 OY-6950, 오파드라이 OY-S-22829, 오파드라이 OY-S-22835, 오파드라이 OY-S-22961, 오파드라이 OY-S-7135, 오파드라이 OY-S-8471, 오파드라이 OY-S-9607, 올리브유, 카올린, 카카오 버터, 하고초(夏枯草), 경화 캐스터 왁스, 캐라멜, 카르나우바 왁스, 카르복시비닐폴리머, 카르복시메틸 에틸셀루로오즈, 카르복시메틸 스타치 나트륨, 카르멜로오즈 칼슘, 카르멜로오즈 나트륨, 트리에틸시트레이트, 글리세린, 글리세린 지방산 에스테르, 규산마그네슘, 숙신화 젤라틴, 밀 전분, 쌀 전분, 백색 밀납, 디메틸아미노에틸 메타크릴레이트-메틸메타크릴레이트 코폴리머, 디메틸폴리실록산(내복용), 디메틸폴리실록산-이산화규소 혼합물, 슈크로오즈 지방산 에스테르, 실리콘 수지 에멀젼, 실리콘 소포제, 침향 분말, 스테아릴알코올, 스테아린산, 스테아린산알루미늄, 스테아린산칼슘, 폴리옥실 스테아레이트 40, 마그네슘 스테아레이트, 제인, 소르비탄 세스퀴올레에이트, 세탄올, 석고, 셀락, 소르비탄 지방산에스테르, 탈크, 테르펜 수지, 전분(용성), 옥수수 시럽, 옥수수유, 트리아세틴, 소르비탄 트리올레에이트, 펄 분말, 벌꿀, 파라핀, 감자 전분, 히드록시프로필 셀루로오즈, 히드록시프로필 메틸셀루로오즈 2208, 히드록시프로필 메틸셀루로오즈 2906, 히드록시프로필 메틸셀루로오즈 2910, 히드록시프로필 메틸셀루로오즈 2910 -산화티탄-마크로골 400 혼합물, 히드록시프로필 메틸셀루로오즈 아세테이트 숙시네이트, 히드록시프로필 메틸셀루로오즈 프탈레이트, 피페로닐부톡시드, 피마자유, 디에틸 프탈레이트, 부틸프탈릴 부틸글리코레이트, 글루코오즈, 푸말산-스테아린산-폴리비닐 아세탈 디에틸아미노 아세테이트-히드록시프로필 메틸셀루로오즈 2910 혼합물, 풀루란, 프로필렌글리콜, 벤토나이트, 포비돈, 폴리옥시에틸렌 (105) 폴리옥시프로필렌 (5) 글리콜, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유 40, 폴리옥시에틸렌 경화 피마자유 60, 폴리소르베이트 80, 폴리비닐아세탈 디에틸아미노 아세테이트, 폴리비닐알코올(부분 검화), 마크로골 1500, 마크로골 1540, 마크로골 20000, 마크로골 300, 마크로골 35000, 마크로골 400, 마크로골 4000, 마크로골 600, 마크로골 6000, 밀납, 미리스틸알코올, 메타크릴산 코폴리머 L, 메타크릴산 코폴리머 LD, 메타크릴산 코폴리머 S, 마그네슘 알루미노메타실리케이트, 메틸셀루로오즈, 목랍,알루미늄모노스테아레이트, 글리세롤 모노스테아레이트, 소르비탄 모노라우레이트, 몬탄산에스테르 왁스, 나트륨 라우릴 술페이트, 라우로마크로골, 인산일수소칼슘, 인산수소칼슘, 인산수소나트륨, 인산이수소칼슘, 로진, 건조 메타크릴산 코폴리머 LD, 건조수산화알루미늄 겔, 건조 유상쉘락, 짭쌀떡 분말, 함수 이산화규소, 샛멸, 금박, 은박, 경질 무수규산, 경질유동 파라핀, 경질 무수규산, 경질 무수규산 함유 히드록시프로필 셀루로오즈, 경랍, 결정 셀루로오즈, 경질 왁스, 경화유, 고 글루코오즈 시럽, 합성 규산알루미늄, 합성 왁스, 산화티탄, 산화마그네슘, 소맥분, 소석고, 셀루로오즈 아세테이트, 비닐아세테이트 수지, 셀루로오즈 아세테이트 프탈레이트, 스타치 시럽, 수산화알루미늄 겔, 수소 첨가 로진 글리세롤 에스테르, 정제 젤라틴, 정제 셀락, 정제 파라핀-카르나우바 왁스 혼합 왁스, 정제 백당, 제3인산칼슘, 단미 시럽, 탄산칼슘, 탄산마그네슘, 탈색 은박, 침강 탄산칼슘, 저치환도 히드록시프로필 셀루로오즈, 젖산칼슘, 락토오즈, 농글리세린, 백색 셀락, 백당, 부분 알파화 전분, 분당, 무수규산 수가물, 무수 프탈산, 무수 인산수소칼슘, 약용 숯, 유동 파라핀, 황산칼슘 등을 들 수가 있다.
안정제, 안정화제, 항산화제, 보존제, 방부제의 구체적인 예로서는, 아디핀산, DL-알라닌, ㎗-캠퍼, D-소르비톨액, d-보르네올, D-소르비톨, D-만니톨, L-아스코르빌 스테아레이트, 나트륨 L-아스코르베이트, L-아스파라긴산, 나트륨 L-아스파르테이트, L-아르기닌, l-멘톨, β-시클로덱스트린, 아스코르빈산, 아미노에틸 술폰산, 나트륨 알기네이트, 프로필렌글리콜 알기네이트, 알부민, 유황, 이노시톨, 회향 분말, 에탄올, 에데트산칼슘 디나트륨, 에데트산나트륨, 에리소르빈산,에리소르빈산나트륨, 카카오 버터, 카르복시비닐폴리머, 카르멜로오즈칼슘, 카르멜로오즈나트륨, 한천, 크산탄검, 크실리톨, 시트르산, 시트르산 칼슘, 나트륨 시트레이트, 글리신, 글리세린, 글리세린 지방산에스테르, 글루코노-δ-락톤, 글루콘산칼슘, 계피 분말, 참기름, 콘드로이틴 황산나트륨, 살리실산, 살리실산나트륨, 페닐 살리실레이트, 디부틸히드록시톨루엔, 슈크로오즈 지방산 에스테르, 스테아린산, 알루미늄 스테아레이트, 폴리옥실 스테아레이트, 마그네슘 스테아레이트, 소르비탄 세스퀴올레에이트, 세탄올, 젤라틴, 소르비탄 지방산에스테르, 소르빈산, 칼륨 소르베이트, 탈크, 덱스트란, 덱스트란 40, 덱스트란 70, 데히드로아세트산, 나트륨 데히드로아세테이트, 글리치르리친산 디나트륨, 토코페롤, 멘톨, 나프톨, 니코틴아미드, 벌꿀, 이소부틸 p-히드록시벤조에이트, 이소프로필 p-히드록시벤조에이트, 에틸 p-히드록시벤조에이트, 부틸 p-히드록시벤조에이트, 프로필 p-히드록시벤조에이트, 메틸 p-히드록시 벤조에이트, 칼슘 판토테이트, 히드록시프로필 셀루로오즈, 히드로퀴논, 피로인산 4나트륨, 피로아황산나트륨, 페나세틴, 부틸히드록시아니솔, 글루코오즈, 푸말산, 푸말산 모노나트륨, 포비돈, 폴리아크릴산 부분 중화물, 폴리옥시에틸렌 (160) 폴리옥시프로필렌 (30) 글리콜, 폴리옥시에틸렌 경화 피마자유 60, 폴리소르베이트 20, 폴리소르베이트 60, 폴리소르베이트 80, 폴리비닐 알코올 (부분 검화), 폴리인산칼륨, 폴리인산나트륨, 마크로골 300, 마크로골 400, 마크로골 4000, 말레인산, 말론산, 마그네슘 알루미노메타실리케이트, 메타인산나트륨, 메틸셀루로오즈, 메틸 헤스페리딘, 알루미늄 모노스테아레이트, 글리세롤 모노스테아레이트, 유칼립투스 오일, 나트륨 라우릴 술페이트, 보르네올 분말,말산, 인산, 인산수소나트륨, 인산이수소칼륨, 인산이수소칼슘, 아황산나트륨, 아황산수소나트륨, 벤조산, 나트륨 벤조에이트, 벤질 벤조에이트, 염화칼슘, 염화나트륨, 염화마그네슘, 염산, 염산아르기닌, 염산 시스테인, 과당, 건조 아황산나트륨, 건조 탄산나트륨, 함수 이산화규소, 희염산, 경질 무수규산, 결정 셀루로오즈, 경화유, 산화마그네슘, 타르타르산, 아세트산, 토코페롤 아세테이트, 수산화나트륨, 수산화마그네슘, 정제 젤라틴, 정제 대두 레시틴, 정제 슈크로오즈, 건조 수산화알루미늄겔, 대두 레시틴, 대두유 비검화물, 탄산칼륨, 탄산나트륨, 탄산마그네슘, 탄산수소칼륨, 탄산수소나트륨, 질소, 천연 비타민 E, 젖산, 락토오즈, 농글리세린, 백당, 미결정 셀루로오즈, 빙초산, 프로필 갈레이트, 무수 시트르산, 무수 나트륨 시트레이트, 무수피로인산나트륨, 무수 인산일수소나트륨, 약용 숯, 란백 알부민 등을 들 수 있다.
교미제, 청량화제, 방향제, 감미제의 구체적인 예로서는, 디나트륨 5'-이노시네이트, 디나트륨 5-구아닐레이트, DL-알라닌, ㎗-캠퍼, ㎗-멘톨, ㎗-말산, 나트륨 ㎗-말레이트, 나트륨 DL-타르타레이트, d-캠퍼, D-크실로오즈, D-소르비톨, D-소르비톨액, d-보르네올, D-만니톨, D-타르타르산, L-아스파라긴산, L-아스파라긴산 나트륨, L-아스파라긴산 마그네슘, L-글루타민산, L-글루타민산 L-아르기닌, 나트륨 L-글루타메이트, L-글루타민산 염산염, ℓ-멘톨, β-시클로덱스트린, 아스코르빈산, 아스파르탐, 아선약 분말, 산수국, 산수국 엑기스, 산수국 분말, 아미노에틸술폰산, 회향, 회향 팅크, 회향 분말, 회향유, 에탄올, 에틸바니린, 에리쓰리톨, 펠로덴드론 껍질 분말, 벗나무 껍질 엑기스, 황련, 황련 분말, 오노니스 뿌리 건조엑기스, 오렌지, 오렌지유, 카카오 분말, 캐라멜, 카르바콜(carbachol), 감초, 감초 엑기스, 감초 조엑기스, 감초 분말, 크실리톨, 시트르산, 칼슘 시트레이트, 나트륨 시트레이트, 글리신, 글리세린, 글리치르리친산, 디암모늄 글리치르리치네이트, 디칼륨 글리치르리치네이트, 디나트륨 글리치르리치네이트, 모노암모늄 글리치르리치네이트, 트리나트륨 글리치르리치네이트, 글루코노-δ-락톤, 클로렐라 엑기스, 클로렐라 분말, 계피 팅크, 계피 분말, 계피유, 숙신산, 숙신산 디나트륨-6수화물, 숙신산 모노나트륨, 다시마 분말, 사카린, 사카린 나트륨, 사프론, 사후론 팅크, 산초 팅크, 산초 분말, 축사 분말, 생강 팅크, 생강 분말, 생강유, 침향 분말, 신남아르데히드, 스테아린산, 스피아민트유, 당약, 소엽(蘇葉) 분말, 대두유, 대추 분말, 알리스마 리좀 뿌리/잎 건조 엑기스, 탄닌산, 정향 팅크, 정향유, 진피 팅크, 고추, 고추 분말, 고추 팅크, 등피 팅크, 등피 분말, 고목(苦木) 분말, 파인애플 분말 향료 51357, 파인애플 분말 향료 59492, 벌꿀, 박하수, 박하유, 바닐라 분말 향료 5428632, 피로인산 테트라나트륨, 포도주, 글루코오즈, 글루코오즈과당액당, 푸말산, 나트륨 푸말레이트, 페파민트 파우더, 포비돈, 말티톨, 말티톨 액, 말티톨 엑기스, 말토오즈, 밀레폴리움 잎 건조 엑기스, 메틸셀루로오즈, 멘톨 파우더, 유칼리유, 용뇌, 용뇌 분말, 링게르액, 사과 과즙, 사과식초, 사과 농축 과즙(500%), 레몬유, 로즈 수, 로즈유, 로얄 젤리, 액당, 염화나트륨, 염화마그네슘, 염산, 과당, 과당 글루코오즈액당, 건조 효모, 환원 맥아당, 스타치 시럽, 희염산, 고 글루코오즈 시럽, 고 과당액당, 흑사탕, 타르타르산, 타르타르산수소칼륨, 식용 당근 분말, 아세트산, 아세트산, 물엿, 정제 감초 엑기스 분말, 정제 벌꿀, 정제 슈크로오즈, 정제 슈크로오즈 구상과립, 탈지분유, 단미 시럽, 탄산수소나트륨, 중쇄지방산 트리글리세리드, 동클로로필 나트륨, 젖산, 락토오즈, 농글리세린, 매실 엑기스, 백당, 빙초산, 설탕 가루, 분말 환원 맥아당 시럽, 무수 에탄올, 무수 시트르산, 무수 피로인산나트륨, 에틸 락테이트, 녹차 분말 등을 들 수가 있다.
흡착제의 구체적인 예로서는, 카올린, 카르멜로오즈 칼슘, 함수 이산화규소, 규산마그네슘, 경질 무수규산, 규조토, 결정 셀루로오즈, 합성 규산알루미늄, 산화알루미늄, 수산화알루미늄, 탄산마그네슘, 침강 탄산칼슘, 덱스트린, 이산화규소, 벤토나이트, 마그네슘 알루미노메타실리케이트, 약용 숯 등을 들 수가 있다.
소포제의 구체적인 예로서는, 에탄올, 글리세린 지방산 에스테르, 디메틸폴리실록산(내복용), 디메틸폴리실록산-이산화규소 혼합물, 슈크로오즈 지방산에스테르, 실리콘 수지 에멀젼, 실리콘소포제, 폴리옥실 스테아레이트 40, 소르비탄 지방산에스테르, 소르비탄 트리올레에이트, 폴리소르베이트 80 등을 들 수 있다.
저작제(masticatory)의 구체적인 예로서는, d-보르네올 등을 들 수 있다.
착색제의 구체적인 예로서는, 아선약 탄닌 분말, 울금 추출액, 황색 삼이산화철, 오파스프레이 K-1-24904, 오렌지 엣센스, 갈색 산화철, 카본 블랙, 캐라멜, 카르민, 카로틴액,β-캐로텐, 감초 엑기스, 금박, 흑산화철, 경질 무수규산, 산화 티탄, 삼이산화철, 식용 청색 1호, 식용 황색 4호, 식용 황색 4호 알루미늄 레이크, 식용 황색 5호, 식용 적색 2호, 식용 적색 3호, 식용 적색 102호, 수산화나트륨, 탈크, 동 클로로필린 나트륨, 동클로로필, 쌀보리 녹색 잎 추출 엑기스, d-보르네올, 미리스틴산 옥틸도데실, 약용 숯, 리보플라빈 부티레이트, 리보플라빈, 녹차 분말, 리보플라빈 나트륨 포스페이트, 로즈유 등을 들 수 있다.
무통화제의 구체적인 예로서는, 이노시톨, 탄산수소나트륨, 정향유, 글루코오즈, 프로필렌글리콜, 리도카인 등을 들 수 있다.
이와 같이 하여 얻어진 본 발명의 의약 조성물은 당해 조성물에 함유되는 푸도스테인과 해열, 진통작용을 갖는 약제가 상호 타의 약제와 작용하여 그들의 효과를 증강시키기 때문에, 의약 조성물, 특히 가래의 발생이 보이는 감기 등의 질환의 치료, 완화용 의약으로서 극히 유용한 것이다.
즉, 후기 시험예에 나타난 바와 같이, 푸도스테인의 거담효과가 해열·진통작용을 가지는 약제의 병용에 의해 증강될 뿐만 아니라, 해열, 진통작용을 가지는 약제의 항염증 작용도 푸도스테인의 병용에 의해 증강되어, 보다 우수한 치료 효과가 기대된다.
실시예
이하, 실시예 및 시험예를 들어 본 발명을 구체적으로 설명하나, 본 발명은 이들 실시예 등에 의해 하등 제약되는 것은 아니다.
시험예 1
거담작용에 대한 상승효과의 확인 시험:
하기 방법에 의해, 푸도스테인과 해열, 진통작용을 가지는 약제의 병용으로거담효과가 향상되는 것을 확인했다. 그 결과를 표 1에 나타낸다.
(방법)
실험동물로서 1군 7마리의 12주령의 휘셔 계(F334) 수컷 랫트를 사용했다. 우선, 랫트를 펜토바르비탈로 마취하고, 피부를 수술용 이소딘 액으로 소독한 후, 정중 절개하여 기관을 노출했다. 인두부로부터 해밀톤 주사통에 부착한 주사바늘 (N727, 해밀톤)을 찔러 넣고, 리포폴리사카라이드(LPS, 10㎍/500㎕)를 기관내에 주입했다. 검체는 표 1에 나타낸 성분 및 양을 0.5% CMC-Na용액에 용해 또는 현탁하고, LPS 투여 전 30분, 투여 후 24시간 후 및 48시간 후의 합계 3회 경구 투여했다. LPS 투여 3일 후, 랫트를 펜토바르비탈 마취하에서 복부 대동맥 절단에 의해 탈혈 치사시켜, 기관 및 기관지의 일부를 적출하고, 10% 중성 완충 포르말린 액으로 고정했다. 고정한 기관지는 통상의 방법에 따라 파라핀에 넣고, 기관의 횡단면을 얇게 자른 후, 알시안 블루/PAS (AB/PAS) 염색을 행하였다. 각 기관의 AB/PAS 염색 표본을 현미경으로 검사하여 Enviromn. Tixicol. Pharmacol. 제 5권, 제 173페이지, 1998년에 준해 배세포수를 계측했다.
(결과)
표 1
시험군 | 배세포수 |
푸도스테인30㎎/㎏이부프로펜50㎎/㎏이부프로펜100㎎/㎏아세트아미노펜 100㎎/㎏아세트아미노펜 200㎎/㎏ | 75.7±1.3**124.9±1.8124.3±2.0125.7±2.4122.9±1.7 |
푸도스테인(30㎎/㎏) + 이부프로펜(50㎎/㎏)푸도스테인(30㎎/㎏) + 이부프로펜(100㎎/㎏)푸도스테인(30㎎/㎏) + 아세토아미노펜(100㎎/㎏)푸도스테인(30㎎/㎏) + 아세토아미노펜(200㎎/㎏) | 52.9±2.3a),$$,**45.9±1.5a),$$,**,α47.9±0.7c),$$,**43.6±0.9d),$$,**,β |
무처리군 | 23.3±0.9 |
대조군 | 122.9±2.0$$ |
**: p<0.01 대 대조군,
##: p<0.01, 대 무처리군
a): p<0.01, 대 이부프로펜 50㎎/㎏ 군
b): p<0.01, 대 이부프로펜 100㎎/㎏ 군
c): p<0.01, 대 아세트아미노펜 100㎎/㎏ 군
d): p<0.01, 대 아세트아미노펜 200㎎/㎏ 군
$$: p<0.01, 대 푸도스테인 30㎎/㎏ 군
α: p<0.01, 대 푸도스테인(30㎎/㎏) + 이부프로펜(50㎎/㎏) 군
β: p<0.01, 대 푸도스테인(30㎎/㎏) + 이부프로펜(100㎎/㎏) 군
이 결과, 우선, 푸도스테인은 단독 투여에서 배세포수의 감소가 보이며, 거담작용을 나타내는 것에 대해, 이부프로펜 및 아세트아미노펜의 단독 투여는 배세포수에 변화를 주지 않고, 거담작용이 없는 것이 나타났다. 이에 대해, 푸도스테인과 이부프로펜 또는 아세트아미노펜을 병용 투여했을 경우는, 푸도스테인의 단독투여보다 배세포수의 감소가 현저하고, 거담작용의 증강을 볼 수 있었다. 또한, 어느 쪽도 용량 반응성을 나타내고, 상승효과를 나타냈다. 이 결과, 푸도스테인과 해열, 진통작용을 가지는 약제와의 병용에 의해 거담작용이 증강되는 것이 밝혀졌다.
시험예 2
항염증 작용에 대한 상승효과의 확인 시험:
하기 방법에 의해, 푸도스테인과 해열, 진통작용을 가지는 약제의 병용으로 항염증작용이 향상하는 것을 확인했다. 이 결과를 표 2에 나타낸다.
(방법)
실험동물로서 1군 5마리의 5주령의 위스터계 수컷 랫트를 사용했다. 우선, 표 2에 나타내는 성분 및 양의 검체를 0.5% CMC-Na 용액에 용해 또는 현탁한 후, 1 일 1회, 5일간 랫트에게 경구 투여했다. 최종 투여일의 투여 2시간 후에, 염증 발생제(카라게닌) 0.1㎖를 랫트의 오른쪽 뒷다리 발바닥에 피하 주사했다. 다리 용적의 측정은 염증 발생제 주사 4시간 후에 행하고, 염증 발생제 주사전의 다리 용적으로부터 부종율을 산출했다. 랫트는 핥는 것을 방지하는 푸드를 씌운 후, 오른쪽 뒷다리 다리 용적을 플레티스모메터(Ugo Basile 사제)를 이용해 측정했다.
(결과)
표 2
시험군 | 부종율(%) |
이부프로펜50㎎/㎏이부프로펜100㎎/㎏아세트아미노펜 100㎎/㎏아세트아미노펜 200㎎/㎏ | 70.6±0.89**60.6±0.79**, a)70.6±0.68**60.6±0.88**, b) |
푸도스테인(30㎎/㎏) + 이부프로펜(50㎎/㎏)푸도스테인(30㎎/㎏) + 이부프로펜(100㎎/㎏)푸도스테인(30㎎/㎏) + 아세토아미노펜(100㎎/㎏)푸도스테인(30㎎/㎏) + 아세토아미노펜(200㎎/㎏) | 60.6±0.91**49.7±0.57**, c)60.5±0.88**49.5±0.71**, d) |
대조군(0.5% CMC-Na 투여) | 81.4±0.71 |
**: p<0.01 대 대조군,
a): p<0.01, 대 이부프로펜 50㎎/㎏ 군
b): p<0.01, 대 아세트아미노펜 100㎎/㎏ 군
c): p<0.01, 대 푸도스테인(30㎎/㎏) + 이부프로펜(50㎎/㎏) 군
d): p<0.01, 대 푸도스테인(30㎎/㎏) + 아세트아미노펜(100㎎/㎏) 군
이 결과, 이부프로펜 및 아세트아미노펜은 각각 단독 투여에 의해, 용량 의존적인 항염증 작용을 가지는 것이 나타났다. 또한, 이부프로펜 또는 아세트아미노펜과 푸도스테인과의 병용 투여에 의해, 각각의 단독 투여보다 높은 항염증 작용이 보였다. 이 결과, 푸도스테인과 해열, 진통작용을 가지는 약제와의 병용에 의해 항염증 작용의 증강되는 것이 명백해졌다.
실시예 1
정제:
푸도스테인 200g , 이부프로펜 75g, 옥수수 전분 33g, 탈크 1g 및 마그네슘스테아레이트 1g를 이용해 통상의 방법으로 타정 분말로 했다. 로터리 타정기를 이용하여 이 타정 분말을 타정하여 직경 9mm, 1 정 310mg의 정제를 제조했다.
실시예 2
정제:
푸도스테인 133.3g, 아세트아미노펜 100g, 감자 전분 44.7g, 탈크 1g 및 마그네슘 스테아레이트 1g을 이용해 통상의 방법으로 타정 분말로 했다. 로터리 타정기를 이용하여 타정 분말을 타정하여 직경 8.5mm, 1정 280mg의 정제를 제조했다.
실시예 3
액제:
푸도스테인 8g, 아세트아미노펜 6g, 에리쓰리톨 20g, 캐라멜 100mg, 나트륨 벤조에이트 70mg 및 향료 100mg을 정제수에 용해하고, 인산을 적당량 첨가해 pH 를 조정하고, 정제수로 전량 100㎖로 하여 액제를 제조했다.
실시예 4
정제:
푸도스테인 80g, 이부프로펜 45g, 디히드로코데인 포스페이트 2.4g, ㎗-염산 메틸에페드린 6g, 클로르페니라민 말레이트 0.75g, 무수 카페인 7.5g, 티아민 아세테이트 2.4g, 아스코르빈산 30g, 옥수수 전분 49.75g, 락토오즈 40g, 조 셀루로오즈 20g, 히드록시프로필 셀루로오즈 10g, 경질무수 규산 10g, 탈크 2g 및 마그네슘 스테아레이트 1g을 이용하여 통상의 방법으로 타정 분말로 했다. 로터리 타정기를 이용하여 타정 분말을 타정하여 직경 9mm, 1정 250mg의 정제를 제조했다.
실시예 5
시럽제:
푸도스테인 4g, 아세트아미노펜 3g, 디히드로코데인 포스페이트 0.08g, ㎗-염산 메틸에페드린 0.2g, 클로르페니라민 말레이트 0.025g, 무수 카페인 0.25g, 트레할로스 120g, 시트르산 0.1g, 나트륨 시트레이트 1g, 캬라멜 0.1g 및 향료 0.5g을 정제수에 용해하여 전량 240㎖로 하여 시럽제를 제조했다.
실시예 6
정제:
푸도스테인 160g, 아세트아미노펜 180g, 클레마스틴 푸말레이트 0.268g, 염화 리소자임 13.2g, 디히드로코데인 포스페이트 4.8g, 노스카핀 7.2g, ㎗-염산 메틸에페드린 12g, 칼륨 구아야콜술포네이트 48g, 무수 카페인 15g, 벤포티아민 4.8g, 옥수수 전분 47.8g, 락토오즈 209.32g, 결정 셀루로오즈 40g, 히드록시프로필 셀루로오즈 6g, 경질무수 규산 4g, 탈크 6g 및 스테아린산마그네슘 6g을 이용하여 통상의 방법으로 타정 분말로 했다. 로타리 타정기를 이용하여 타정 분말을 타정하여 직경 9mm, 1정 320mg의 정제를 제조했다.
실시예 7
과립제
푸도스테인 200g, 아세트아미노펜 150g, 염산 페닐프로판올아민 12.5g, 클로르페니라민 말레이트 1.3g, 브롬화수소산 덱스트로메토르판 8g, 세라페프타제 2.5g, 무수 카페인 12.5g, 염산 푸르술티아민 4.2g, 리보플라빈 2.0g, 옥수수 전분 333.3g, 경질 무수규산 10g, 정제 슈크로오즈 203.8g, 카르복시메틸셀룰로오즈 50g 및 아스파르탐 10g을 이용하여 통상의 방법으로 과립으로 하여 1포당 2g이 되도록 분포하여 과립의 분포제를 제조했다.
실시예 8
필름 코팅정:
푸도스테인 400g, 아세트아미노펜 600g, 염화 리소자임 44g, 디히드로코데인 포스페이트 16g, 노스카핀 32g, ㎗-염산 메틸에페드린 40g, 카르비녹사민 말레이트 5g, 구아이페네신 83.34g, 무수 카페인 50g, 비스이부티아민 16g, 리보플라빈 8g, 옥수수 전분 40g, 락토오즈 35.66g, 결정 셀루로오즈 60g, 히드록시프로필 셀루로오즈 60g, 경질무수 규산 4g, 탈크 4g 및 마그네슘 스테아레이트 2g을 이용하여 통상의 방법으로 타정하여 분말로 했다. 로터리 타정기를 이용하여 타정한 분말을 타정하여 직경 8.5mm, 1정 250mg의 정제로 했다. 다음에, 이 정제를 코팅 팬에 넣어 5중량 %의 히드록시프로필 메틸셀룰로오즈, 0.3중량%의 마크로골 6000 및 0.2중량%의 산화티탄을 함유하는 에틸 알코올: 정제수= 1: 1의 코팅액을 이용하여 1정당 중량증가가 15mg가 될 때까지 코팅을 시행하여 필름 코팅정을 제조했다.
실시예 9
캅셀제:
푸도스테인 400g, 아세트아미노펜 300g, 염산 브롬헥신 4g, 염화 리소자임 22g, 디히드로코데인 포스페이트 8g, ㎗-염산 메틸에페드린 20g, 카르비녹사민 말레이트 2.5 g, 무수 카페인 25g, 비스이부티아민 8g, 리보플라빈 4g, 옥수수 전분 96.5 g 및 히드록시프로필 셀루로오즈 10g을 이용하여 통상의 방법으로 과립으로 하여 1캅셀당 300mg이 되도록 경질 캅셀에 충전하여 캅셀제를 제조했다.
실시예 10
캅셀제:
푸도스테인 200g, 이부프로펜 300g, 디히드로코데인 포스페이트 12g, 카르비녹사민 말레이트 5g, ㎗-염산 메틸에페드린 40g, 무수 카페인 50g, 칼륨 구아야콜술포네이트 160g, 티아민 나이트레이트 16g, 리보플라빈 8g, 옥수수 전분 197g 및 히드록시프로필 셀루로오즈 12g을 이용하여 통상의 방법으로 과립으로 하여 1캅셀당 250mg이 되도록 경질 캅셀에 충전하여 캅셀제를 제조했다.
실시예 11
당의정
푸도스테인 200g, 아세트아미노펜 240g, d-클로로페니라민 말레이트 2.3g, 에텐자미드 600g, 브롬화수소산 덱스트로메토르판 32g, 노스카핀 32g, ㎗-염산 메틸 에페드린 20g, 칼륨 구아야콜술포네이트 166.7g, 감초 엑기스 분말 48g, 앵피 엑기스 53.3 g, 무수 카페인 100 g, 옥수수 전분 166.7g, 결정 셀루로오즈 82.3g, 히드록시프로필 셀루로오즈 20g, 경질무수 규산 20g, 탈크 109 및 마그네슘 스테아레이트 6.7 g을 이용하여 통상의 방법으로 타정 분말로 했다. 로터리 타정기를 이용하여 타정 분말을 타정하여 직경 9mm, 1정 300mg의 정제로 했다. 이 정제를 코팅 팬에 넣어 5중량%의 히드록시프로필 메틸셀루로오즈를 함유하는 에틸알코올: 정제수= 1: 1의 코팅액을 이용하여 1정당 중량증가가 10mg가 될 때까지 코팅을 시행하고, 이어서 2 중량%의 탈크, 2중량%의 산화티탄, 3중량%의 탄산칼슘, 1중량%의 아리비아 검 분말 및 60중량%의 정제 슈크로오즈를 함유하는 수용액으로 1정당 중량증가가 130mg이 될 때까지 언더코팅을 행한 후, 60중량%의 정제 슈크로오즈를 함유하는 수용액으로 1정당 중량증가가 10mg이 될 때까지 오버코팅하여 당의정을 제조했다.
실시예 12
산제
푸도스테인 150g, 아스피린 알루미늄 50.625g, 아세트아미노펜 50.625g, 에텐자미드 45g, 지룡 엑기스 분말 18.75 g, 염산 디페닐피랄닌 0.5g, 브롬화수소산덱스트로메토르판 6g, 칼륨 구아야콜술포네이트 18.75g, 감초 엑기스 16.875g, 세네가 건조 엑기스 3.75g, 감자 전분 129.125g, 경질 무수규산 5g, 아스파르탐 2.5g 및 히드록시프로필 셀루로오즈 2.5g을 이용하여 통상의 방법으로 산제로 하여 1포당 2g이 되도록 분포하여 산제의 분포제를 제조했다.
실시예 1 3
과립제
푸도스테인 120g, 아세트아미노펜 67.5g, 펜톡시베린 시트레이트 4.8g, 염산 이소티펜딜 0.7g, 나트륨 아스코르베이트 50g, 무수 카페인 9g, 마황 건조 엑기스 40g, 감초 엑기스 분말 35.714g, 생강 분말 15g, 감자 전분 144.486g, 정제 슈크로오즈 104.3g, 경질무수 규산 3g, 아스파르탐 3g 및 히드록시프로필 셀루로오즈 2.5g을 이용하여 통상의 방법으로 과립으로 하고, 1포당 2g이 되도록 분포하여 과립의 분포제를 제조했다.
본 발명의 의약 조성물은 약효 성분인 푸도스테인과 해열, 진통작용을 가지는 약제의 작용이, 각각의 존재에 의해 서로 증강하기 때문에, 거담효과 및 항염증 효과의 어느 것도 우수한 것이 된다.
따라서, 가래의 발생이 보이는 감기 등의 질환의 치료, 완화용의 의약으로서, 감기의 제증상, 특히, 목의 아픔, 가래, 오한, 발열, 두통, 관절통, 근육통 등을 효과적으로 개선할 수가 있는 것이며, 경구 투여되는 의약 조성물로서 현저하게 유용한 것이다.
Claims (5)
- 푸도스테인과 해열, 진통작용을 가지는 약제를 함유함을 특징으로 하는 의약 조성물.
- 제 1항에 있어서, 경구투여용 제제인 의약 조성물.
- 제 1항 또는 제 2항에 있어서, 감기약인 의약 조성물.
- 제 1항 내지 제 3항의 어느 1항에 있어서, 해열, 진통작용을 가지는 약제가 아스피린, 아스피린 알루미늄, 아세트아미노펜, 이소프로필안티피린, 이부프로펜, 에텐자미드, 사자피린, 살리실아미드, 나트륨 살리실레이트 및 락틸페네티딘으로 이루어진 군에서 선택된 1종 또는 2종이상인 의약 조성물.
- 제 1항 내지 제 4항의 어느 1항에 있어서, 다시 항히스타민약, 진해약, 흥분약, 비타민류, 생약, 제산제 또는 점막 보호제로 이루어진 군에서 선택된 1종 또는 2종이상인 의약 조성물.
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JPJP-P-2001-00156854 | 2001-05-25 | ||
JP2001156854 | 2001-05-25 | ||
PCT/JP2002/005042 WO2002096406A1 (fr) | 2001-05-25 | 2002-05-24 | Compositions medicinales |
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KR20040004638A true KR20040004638A (ko) | 2004-01-13 |
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KR10-2003-7015167A KR20040004638A (ko) | 2001-05-25 | 2002-05-24 | 의약 조성물 |
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US (1) | US20040147606A1 (ko) |
EP (1) | EP1391201A4 (ko) |
JP (1) | JP4365107B2 (ko) |
KR (1) | KR20040004638A (ko) |
CN (1) | CN1296040C (ko) |
CA (1) | CA2448081A1 (ko) |
HK (1) | HK1065944A1 (ko) |
WO (1) | WO2002096406A1 (ko) |
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-
2002
- 2002-05-24 KR KR10-2003-7015167A patent/KR20040004638A/ko not_active Application Discontinuation
- 2002-05-24 CN CNB028106520A patent/CN1296040C/zh not_active Expired - Fee Related
- 2002-05-24 US US10/477,757 patent/US20040147606A1/en not_active Abandoned
- 2002-05-24 CA CA002448081A patent/CA2448081A1/en not_active Abandoned
- 2002-05-24 EP EP02726487A patent/EP1391201A4/en not_active Withdrawn
- 2002-05-24 WO PCT/JP2002/005042 patent/WO2002096406A1/ja not_active Application Discontinuation
- 2002-05-24 JP JP2002592917A patent/JP4365107B2/ja not_active Expired - Lifetime
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20200316003A1 (en) * | 2017-12-19 | 2020-10-08 | Beijing Increase Innovation Drug Research Co., Ltd | Fudosteine Solution Preparation for Aerosol Inhalation, and Preparation Method Therefor |
KR20190117228A (ko) * | 2018-04-06 | 2019-10-16 | 농업회사법인 주식회사 한반도 | 호흡기 기능 개선용 조성물 |
Also Published As
Publication number | Publication date |
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EP1391201A1 (en) | 2004-02-25 |
JP4365107B2 (ja) | 2009-11-18 |
US20040147606A1 (en) | 2004-07-29 |
CN1296040C (zh) | 2007-01-24 |
HK1065944A1 (en) | 2005-03-11 |
WO2002096406A1 (fr) | 2002-12-05 |
CA2448081A1 (en) | 2002-12-05 |
JPWO2002096406A1 (ja) | 2004-09-09 |
CN1520292A (zh) | 2004-08-11 |
EP1391201A4 (en) | 2004-06-30 |
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