JPH0924085A - Fasudil hydrochloride injection agent - Google Patents
Fasudil hydrochloride injection agentInfo
- Publication number
- JPH0924085A JPH0924085A JP17501095A JP17501095A JPH0924085A JP H0924085 A JPH0924085 A JP H0924085A JP 17501095 A JP17501095 A JP 17501095A JP 17501095 A JP17501095 A JP 17501095A JP H0924085 A JPH0924085 A JP H0924085A
- Authority
- JP
- Japan
- Prior art keywords
- light
- fasudil hydrochloride
- transmittance
- agent
- wavelength
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Plural Heterocyclic Compounds (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は光安定性が良好な塩酸フ
ァスジル水溶液注射剤に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a fasudil hydrochloride aqueous solution injection having good light stability.
【０００２】[0002]
【従来の技術】塩酸フアスジルは脳組織の機能、状態の
障害及びそれに伴う症状、後遺症を予防、改善し、もし
くは当該障害の進行を穏やかにする薬剤として有望であ
り、特に、脳代謝機能の変化と関連する脳機能障害の予
防、改善、さらには、脳細胞の壊死、脱落と関連する脳
機能障害の予防、改善にも有望な薬物として開発されて
いる。BACKGROUND OF THE INVENTION Fasudil hydrochloride is promising as a drug for preventing or ameliorating the function and condition of brain tissue and its associated symptoms and sequelae, or slowing down the progression of the disorder, and especially the change of brain metabolic function. It is being developed as a promising drug for the prevention and amelioration of brain dysfunction associated with and further prevention and amelioration of brain dysfunction associated with necrosis and loss of brain cells.
【０００３】本薬物は経口投与剤としては、錠剤、カプ
セル剤、顆粒剤等の形態で、また、非経口投与剤として
は水溶液アンプル剤の形態で医薬品として製造できる。
これらの製剤化例としては特開平２−２５６６１７号公
報の実施例７で示され、（２）無菌注射剤の項では２ｍ
ｌアンプル剤の調製例が示されている。The present drug can be manufactured as a pharmaceutical product in the form of tablets, capsules, granules and the like for oral administration, and in the form of an aqueous ampoule for parenteral administration.
Examples of formulation of these are shown in Example 7 of JP-A-2-256617, and 2 m in the section of (2) Aseptic injection.
An example of the preparation of 1 ampoule is shown.
【０００４】[0004]
【発明が解決しようとする課題】しかしながら、そのよ
うな塩酸ファスジルアンプル剤は光安定性が不良で、太
陽光さらには蛍光灯の３０００ルックス程度の光によっ
ても徐々に内容液が褐色に変化することが判明した。こ
の光による変化を防止するため、塩酸ファスジルアンプ
ル剤を光が全く透過しない容器に収納して商品化するこ
とも考えられるが、製造の手間やコスト高となり、ま
た、中身が全く見えないということから、製品検査さら
にユーザーの内容物確認に支障をきたしてしまう。However, such fasudil ampoule hydrochloride has poor photostability, and the content liquid gradually turns brown under sunlight or light of about 3000 lux of a fluorescent lamp. There was found. In order to prevent this change due to light, it may be possible to put the fasudil ampoule hydrochloride in a container that does not allow light to pass through, and to commercialize it, but this will increase manufacturing labor and cost, and the contents will not be visible at all. This hinders product inspection and user confirmation of contents.
【０００５】そこで本発明者らは、塩酸ファスジル水溶
液注射剤の光に対する安定性を確保し、さらに内容液等
が確認できる商品を提供することを課題として鋭意研究
した。Therefore, the inventors of the present invention have earnestly studied for the purpose of providing a product in which the stability of the fasudil hydrochloride aqueous solution injection solution against light is ensured and the content liquid and the like can be confirmed.
【０００６】[0006]
【課題を解決するための手段】発明者らは、塩酸ファス
ジルの光変化に関する調査研究や、多くの光遮光剤の性
能を調査した。その結果、治療薬として適切な塩酸ファ
スジル水溶液が、紫外線の照射を受けると塩酸ファスジ
ル自体の分解は極めてわずかであるが、水溶液が茶褐色
に変化してしまうことが判明した。そこでガラス成分を
変えたアンプルや光遮光フィルムを用いてさらに調査研
究を進めた結果、波長３５０ｎｍの光の透過を９０％制
限する波長３５０ｎｍの透過率が１０％以下であるガラ
ス容器や遮光剤を設けた容器が有効に塩酸ファスジルの
光による変化を防止し、また、そのような波長の紫外線
を遮光すれば、光安定性の目安となる１２０万Ｌｕｘ・
ｈｒ（３０００Ｌｕｘの光を連続４００時間照射）の光
に対しても塩酸ファスジル注射用水溶液の変化を防止で
きることを見いだし、本発明を完成するに至った。[Means for Solving the Problems] The inventors investigated the research on the light change of fasudil hydrochloride and the performance of many light shading agents. As a result, it was found that, when an aqueous solution of fasudil hydrochloride suitable as a therapeutic agent is irradiated with ultraviolet rays, the dissolution of fasudil hydrochloride itself is very slight, but the solution turns brownish brown. Therefore, as a result of further research using ampoules and light-shielding films with different glass components, a glass container and a light-shielding agent having a transmittance of 10% or less at a wavelength of 350 nm, which limits the transmission of light at a wavelength of 350 nm by 90%. If the provided container effectively prevents the change of fasudil hydrochloride due to light, and if it blocks ultraviolet rays of such a wavelength, it will be a measure of light stability of 1.2 million Lux.
The inventors have found that the change in the aqueous solution for injection of fasudil hydrochloride can be prevented even under the light of hr (irradiation with light of 3000 Lux for 400 hours continuously), and have completed the present invention.
【０００７】即ち本発明は、波長３５０ｎｍの透過率が
１０％以下である容器に充填した塩酸ファスジル水溶液
注射剤である。本発明における塩酸ファスジルは下記の
構造式That is, the present invention is an injection solution of aqueous solution of fasudil hydrochloride filled in a container having a transmittance of 10% or less at a wavelength of 350 nm. Fasudil hydrochloride in the present invention has the following structural formula
【０００８】[0008]
【化１】 Embedded image
【０００９】で表され、元素分析Ｃ14Ｈ17Ｎ3 Ｏ2 Ｓ・
ＨＣｌで、分子量３２７．８３からなる化合物であっ
て、脳組織の機能、状態の障害及びそれに伴う症状、後
遺症を予防、改善し、もしくは当該障害の進行を穏やか
にする薬物であり、その製造方法は特開平６−３４０６
５９号公報に示されている。通常塩酸ファスジルの注射
用水溶液は、有効成分である塩酸ファスジルを治療に適
切な濃度である１〜１００ｍｇ／ｍｌの水溶液とし、例
えば１回投与用量として１０〜６０ｍｇを使用すればよ
く、これに好ましくは等張化として塩化ナトリウム等の
塩類やブドウ糖等の糖類を適宜添加して調製される。さ
らに必要に応じてリン酸塩等のｐＨ緩衝剤、フェノール
等の無痛化剤等を添加して調製してもよい。The elemental analysis is C 14 H 17 N 3 O 2 S.
HCI, a compound having a molecular weight of 327.83, which is a drug for preventing or ameliorating the function and condition of brain tissue and the symptoms and sequelae associated therewith, or slowing the progression of the disorder, and a method for producing the same. Is JP-A-6-3406
No. 59 publication. In general, the aqueous solution for injection of fasudil hydrochloride is an aqueous solution of fasudil hydrochloride as an active ingredient at a concentration suitable for treatment of 1 to 100 mg / ml, and for example, a single dose of 10 to 60 mg may be used, which is preferable. Is prepared by adding salts such as sodium chloride and sugars such as glucose as isotonicity. Further, if necessary, a pH buffering agent such as phosphate, a soothing agent such as phenol, etc. may be added for preparation.
【００１０】次にこの注射用水溶液は通常ろ過等の除菌
処理され、アンプル、バイアルまたはプレフィルドシリ
ンジ（あらかじめ薬液が充填されたシリンジ）等の容器
に充填され、必要に応じてさらに加熱滅菌等の処理が施
される。一方、本発明の波長３５０ｎｍの透過率が１０
％以下である容器としては、例えば素材がガラスであれ
ば、通常アンプル等のガラス容器は珪素化合物（例えば
ＳｉＯ2 ）、ホウ素化合物（例えばＢ2 Ｏ 3）、ナトリ
ウム化合物（例えばＮａ 2 Ｏ）、アルミニウム化合物
（例えばＡｌ2 Ｏ 3）、カルシウム化合物（例えばＣａ
Ｏ）、バリウム化合物（例えばＢａＯ）、カリウム化合
物（例えばＫ2 Ｏ）等で構成されるが、この組成物の中
に酸化鉄（例えばＦｅ2 Ｏ 3）、酸化チタン（Ｔｉ
Ｏ2 ）等の遮光剤となる物質を添加して、着色性のアン
プル、バイアルやプレフィルドシリンジに加工すること
により得られる。例えば、このような着色性アンプル、
バイアルやプレフィルドシリンジの容器において、０．
２〜０．８％程度の酸化鉄（例えばＦｅ2 Ｏ 3）、０．
５〜４％程度の酸化チタン（ＴｉＯ 2 ）のいずれか１種
または０．５％程度の酸化鉄（例えばＦｅ2 Ｏ 3）と
２．８％程度の酸化チタン（ＴｉＯ2 ）の２種を含有す
るものであればよい。Next, this aqueous solution for injection is usually sterilized by filtration or the like.
Processed, ampoules, vials or prefilled siri
Container (syringe pre-filled with chemicals)
Be filled in, and if necessary, further processed by heat sterilization, etc.
Is done. On the other hand, the transmittance at a wavelength of 350 nm of the present invention is 10
A container whose content is less than or equal to
For example, glass containers such as ampoules are usually silicon compounds (for example,
SiOTwo), A boron compound (for example, BTwoOThree), Natori
Um compounds (eg Na TwoO), aluminum compounds
(Eg AlTwoOThree), Calcium compounds (eg Ca
O), barium compounds (eg BaO), potassium compounds
Thing (eg KTwoO) etc., but in this composition
Iron oxide (eg FeTwoOThree), Titanium oxide (Ti
OTwo) And other substances that act as light-shielding agents
Processing into pulls, vials and prefilled syringes
Is obtained by For example, such a coloring ampoule,
In vial and prefilled syringe containers,
2 to 0.8% iron oxide (eg FeTwoOThree), 0.
About 5-4% titanium oxide (TiO Two) Any one of
Or about 0.5% iron oxide (eg FeTwoOThree)When
About 2.8% titanium oxide (TiO 2Two) Is included
Anything can be used.
【００１１】また被覆材としては、まずフィルム等の被
覆剤が本発明の波長３５０ｎｍの透過率が１０％以下で
あるものを選択する。これらのフィルムは例えばポリ塩
化ビニル、ポリプロピレン等のフィルムを多層にするこ
とにより、またはインクを配合することにより、その目
的とする遮光性能を有している。これらのフィルムをラ
ベルとしてアンプル、バイアルまたはプレフィルドシリ
ンジ等に巻き付けて被覆することにより波長３５０ｍｍ
の透過率が１０％以下である被覆剤で被覆されたアンプ
ル、バイアルまたはシリンジ等の容器として調整でき
る。As the coating material, first, a coating material such as a film having a transmittance of 10% or less at the wavelength of 350 nm of the present invention is selected. These films have a desired light-shielding property by, for example, forming a film of polyvinyl chloride, polypropylene or the like into a multilayer or by blending an ink. A wavelength of 350 mm is obtained by wrapping these films as a label on an ampoule, a vial or a prefilled syringe to cover them.
Can be prepared as a container such as an ampoule, a vial or a syringe coated with a coating agent having a transmittance of 10% or less.
【００１２】このようにして得られる波長３５０ｎｍの
光の透過率が１０％以下である容器において、例えば波
長６００ｍｍの透過率が図１、図３および図４に示す通
り５０％以上であるものは内容物を肉眼的に確認できる
ことから、より好ましい形態として実施でき、このよう
な容器に充填した塩酸ファスジル水溶液注射剤は、光安
定性の良好なものとして提供できる。In the thus obtained container having a transmittance of light having a wavelength of 350 nm of 10% or less, for example, a container having a transmittance of 600 mm at a wavelength of 50% or more as shown in FIGS. 1, 3 and 4. Since the contents can be visually confirmed, it can be carried out in a more preferable form, and the Fasudil hydrochloride aqueous solution injection agent filled in such a container can be provided with good photostability.
【００１３】[0013]
【実施例】以下に実施例、対照例及び試験例を挙げて本
発明を具体的に説明するが、本発明はこれらに限定され
ない。EXAMPLES The present invention will be specifically described below with reference to examples, control examples and test examples, but the present invention is not limited thereto.
【００１４】[0014]
【実施例１】特開平６−３４０６５９号公報に記載の方
法により得られた塩酸ファスジル３０ｇ、及び塩化ナト
リウム１６ｇを２０００ｍｌの水に溶解し、除菌ろ過し
て塩酸ファスジル注射用水溶液２０００ｍｌを調製し
た。これを、ガラス容器重量に対して酸化鉄（Ｆｅ2 Ｏ
3 ）０．５％、酸化チタン（ＴｉＯ2 ）２．８％を含有
した２ｍｌ用ガラスアンプルに２ｍｌずつ充填、溶封
し、本発明の塩酸ファスジル水溶液注射剤を５００アン
プル製造した。Example 1 30 g of Fasudil hydrochloride obtained by the method described in JP-A-6-340659 and 16 g of sodium chloride were dissolved in 2000 ml of water and sterilized by filtration to prepare 2000 ml of an aqueous solution for injection of Fasudil hydrochloride. . Iron oxide (Fe 2 O
3 ) Glass ampules for 2 ml each containing 0.5% and titanium oxide (TiO 2 ) 2.8% were filled in an amount of 2 ml each, and sealed by sealing to prepare 500 ampules of the Fasudil hydrochloride aqueous solution injection of the present invention.
【００１５】なお、このアンプルの光透過性曲線を波長
２００〜７００ｎｍにて調査した結果図１に示す通りで
あって、波長３５０ｎｍの透過率は４％であった。As a result of investigating the light transmittance curve of this ampoule at a wavelength of 200 to 700 nm, it is as shown in FIG. 1, and the transmittance at a wavelength of 350 nm was 4%.
【００１６】[0016]
【対照例１】実施例１で調製した塩酸ファスジル注射用
水溶液を、波長３５０ｎｍの透過率が約８０％であった
透明な２ｍｌガラスアンプル（このアンプルの光透過性
曲線を図２に示した）に２ｍｌずつ充填、溶封し、本発
明以外の塩酸ファスジル水溶液注射剤を１００アンプル
製造した。[Comparative Example 1] The aqueous solution for injection of fasudil hydrochloride prepared in Example 1 was treated with a transparent 2 ml glass ampoule having a transmittance of about 80% at a wavelength of 350 nm (a light transmission curve of this ampoule is shown in Fig. 2). 2 ml each was filled and melt-sealed to prepare 100 ampules of the Fasudil hydrochloride aqueous solution injection other than the present invention.
【００１７】[0017]
【実施例２】塩酸ファスジル９ｇ、及び塩化ナトリウム
４．８ｇを６００ｍｌの水に溶解し、除菌ろ過して塩酸
ファスジル注射用水溶液６００ｍｌを調製した。これを
シリンジ胴部がガラス製の２ｍｌアルテ社製シリンジに
２ｍｌずつ充填し、塩酸ファスジルのプレフィルドシリ
ンジ（あらかじめ薬液を充填したシリンジのキット製
品）を２００本製造した。Example 2 Fasudil hydrochloride (9 g) and sodium chloride (4.8 g) were dissolved in 600 ml of water, and sterilized by filtration to prepare 600 ml of fasudil hydrochloride for injection. 2 ml of this was filled into a 2 ml syringe made by Arte Co., whose syringe body was made of glass, to manufacture 200 prefilled syringes of Fasudil hydrochloride (a syringe kit product prefilled with a drug solution).
【００１８】この塩酸ファスジルのプレフィルドシリン
ジの胴部に、住友ベークライト製塩化ビニル製フィルム
Ａ（透明、厚さ２００μｍ；光透過性曲線を図３に示し
た）及びＢ（薄いオレンジ色に着色、厚さ２００μｍ；
光透過性曲線を図４に示した）を巻き付け、本発明の塩
酸ファスジル水溶液注射剤のプレフィルドシリンジＡ
（シリンジＡという）及び塩酸ファスジル水溶液注射剤
のプレフィルドシリンジＢ（シリンジＢという）を各３
０本ずつ製造した。On the body of this Fasudil hydrochloride prefilled syringe, a vinyl chloride film A (transparent, thickness 200 μm; light transmission curve is shown in FIG. 3) made by Sumitomo Bakelite, and B (light orange colored, thick) 200 μm;
The light transmission curve is shown in FIG. 4) and the prefilled syringe A of the fasudil hydrochloride aqueous solution injection of the present invention is wrapped around.
(Referred to as syringe A) and prefilled syringe B (referred to as syringe B) of fasudil hydrochloride aqueous solution injection solution for each 3
0 pieces were manufactured.
【００１９】なお、このフィルムＡの光透過率は図３の
結果から波長３５０ｎｍの透過率は０％であった。ま
た、フィルムＢの光透過率は図４の結果から波長３５０
ｎｍの透過率も０％であった。The light transmittance of this film A was 0% at the wavelength of 350 nm from the result of FIG. The light transmittance of the film B is 350
The nm transmittance was also 0%.
【００２０】[0020]
【対照例２】実施例２で調製した塩酸ファスジルのプレ
フィルドシリンジに、実施例２のようなフィルムを巻き
付けないものを３０本別に製造した。なお、このシリン
ジのガラス胴部の光透過性曲線を図５に示すもので、そ
の結果、波長３５０ｎｍの透過率は約７０％であった。[Comparative Example 2] The pre-filled syringe of Fasudil hydrochloride prepared in Example 2 was manufactured in 30 units without the film as in Example 2. The light transmittance curve of the glass barrel of this syringe is shown in FIG. 5, and as a result, the transmittance at a wavelength of 350 nm was about 70%.
【００２１】[0021]
【試験例】実施例１及び実施例２で製造した本発明の塩
酸ファスジル注射剤と、本発明の要件を満たさない対照
例１及び対照例２の塩酸ファスジル注射剤について、塩
酸ファスジルの光安定性を試験した。各注射剤に蛍光灯
の３０００Ｌｕｘの照度の光を９０万Ｌｕｘ・ｈｒ（照
度×時間）及び１２０万Ｌｕｘ・ｈｒ照射した後の内容
液の着色度合いを示す波長４００ｎｍの透過率を測定し
た結果を下記表１〔内容液の波長４００ｎｍの透過率
（％）〕に示した。TEST EXAMPLE Fasudil hydrochloride photostability of Fasudil hydrochloride injections of the present invention prepared in Examples 1 and 2 and Fasudil hydrochloride injections of Controls 1 and 2 which do not satisfy the requirements of the present invention. Was tested. The results of measuring the transmittance at a wavelength of 400 nm showing the degree of coloring of the content liquid after irradiating each injection with light of illuminance of 3000 Lux of fluorescent lamp for 900,000 Lux · hr (illuminance × hour) and 1.2 million Lux · hr It is shown in the following Table 1 [transmittance (%) of the content liquid at a wavelength of 400 nm].
【００２２】[0022]
【表１】 [Table 1]
【００２３】なお試験条件は以下の通りである。 ・試験器：ナガノ科学製光試験器 ・光照射条件：蛍光灯３０００Ｌｕｘ ・温度条件：２５℃の一定温度 その結果、対照例は１、２ともに内容液が薄い褐色に変
化したが、本発明の実施例１、２の注射剤は、１２０万
Ｌｕｘ・ｈｒ照射した後も変化なかった。The test conditions are as follows. -Tester: Nagano Scientific Optical Tester-Light irradiation condition: Fluorescent lamp 3000 Lux-Temperature condition: Constant temperature of 25 ° C As a result, in both the control examples 1 and 2, the content liquid changed to a light brown color. The injections of Examples 1 and 2 did not change even after irradiation with 1.2 million Lux · hr.
【００２４】このことから、塩酸ファスジル注射用水溶
液は波長３５０ｎｍの光の透過率が１０％以下、好まし
くは５％以下である容器に充填することにより安定化し
得たものである。From this, the aqueous solution for injection of fasudil hydrochloride can be stabilized by filling it in a container having a light transmittance of 350 nm at a wavelength of 10% or less, preferably 5% or less.
【００２５】[0025]
【発明の効果】以上の結果から、波長３５０ｎｍの光の
透過率が１０％以下である容器に充填した塩酸ファスジ
ル水溶液注射剤は、１２０万Ｌｕｘ・ｈｒ（３０００Ｌ
ｕｘの光を連続４００時間照射）の光に対しても塩酸フ
ァスジル注射用水溶液の変化を防止でき、安定化された
塩酸ファスジル注射剤を得ることができた。EFFECTS OF THE INVENTION From the above results, it is possible to obtain 1.2 million Lux · hr (3000 L) of fasudil hydrochloride aqueous solution injection solution filled in a container having a light transmittance of 350% at a wavelength of 10% or less.
It was possible to prevent a change in the aqueous solution for injection of fasudil hydrochloride even under the irradiation of ux light for 400 hours continuously, and to obtain a stabilized injection of fasudil hydrochloride.
【図１】図１は、酸化鉄、酸化チタンを含有したガラス
アンプルの光透過性曲線を示す。FIG. 1 shows a light transmittance curve of a glass ampoule containing iron oxide and titanium oxide.
【図２】図２は、対照例１で用いた透明な２ｍｌガラス
アンプルの光透過性曲線を示す。FIG. 2 shows a light transmission curve of a transparent 2 ml glass ampoule used in Control Example 1.
【図３】図３は、住友ベークライト製塩化ビニル製フィ
ルムＡ（透明、厚さ２００μｍ）の光透過性曲線を示
す。FIG. 3 shows a light transmission curve of a vinyl chloride film A manufactured by Sumitomo Bakelite (transparent, thickness: 200 μm).
【図４】図４は、住友ベークライト製塩化ビニル製フィ
ルムＢ（薄いオレンジ色に着色、厚さ２００μｍ）の光
透過性曲線を示す。FIG. 4 shows a light transmission curve of a vinyl chloride film B manufactured by Sumitomo Bakelite (colored in a light orange color and a thickness of 200 μm).
【図５】図５は、フィルムを巻き付けないアルテ社製シ
リンジの光透過性曲線を示す。FIG. 5 shows the light transmission curve of an Arte syringe without wrapping the film.
Claims (3)
下である容器に充填した塩酸ファスジル水溶液注射剤。1. A solution of fasudil hydrochloride aqueous solution filled in a container having a transmittance of light having a wavelength of 350 nm of 10% or less.
１０％以下である着色性アンプルである請求項１記載の
水溶液注射剤。2. The aqueous solution injection preparation according to claim 1, wherein the container is a coloring ampoule having a transmittance of light having a wavelength of 350 nm of 10% or less.
１０％以下である被覆材で被覆されたアンプル、バイア
ルまたはシリンジである請求項１記載の水溶液注射剤。3. The aqueous solution injection preparation according to claim 1, wherein the container is an ampoule, a vial or a syringe coated with a coating material having a transmittance of light having a wavelength of 350 nm of 10% or less.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP17501095A JP3879940B2 (en) | 1995-07-11 | 1995-07-11 | Fasudil hydrochloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP17501095A JP3879940B2 (en) | 1995-07-11 | 1995-07-11 | Fasudil hydrochloride injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0924085A true JPH0924085A (en) | 1997-01-28 |
| JP3879940B2 JP3879940B2 (en) | 2007-02-14 |
Family
ID=15988644
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP17501095A Expired - Lifetime JP3879940B2 (en) | 1995-07-11 | 1995-07-11 | Fasudil hydrochloride injection |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3879940B2 (en) |
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