JP3535537B2 - Intravenous injection - Google Patents
Intravenous injectionInfo
- Publication number
- JP3535537B2 JP3535537B2 JP11366493A JP11366493A JP3535537B2 JP 3535537 B2 JP3535537 B2 JP 3535537B2 JP 11366493 A JP11366493 A JP 11366493A JP 11366493 A JP11366493 A JP 11366493A JP 3535537 B2 JP3535537 B2 JP 3535537B2
- Authority
- JP
- Japan
- Prior art keywords
- ritodrine hydrochloride
- added
- solution
- injection
- glucose
- 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.)
- Expired - Fee Related
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
【0001】[0001]
【産業上の利用分野】本発明はブドウ糖もしくはマルト
ースおよび塩酸リトドリンを含有する安定で静脈内投与
に適する注射剤に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a stable, intravenous injection preparation containing glucose or maltose and ritodrine hydrochloride.
【0002】[0002]
【従来の技術】塩酸リトドリンは、交感神経β2−受容
体刺激剤で、しかも子宮筋に選択的に作用し、強力な子
宮筋収縮抑制を示すことから、切迫早産の治療剤として
重要な薬物として用いられている。BACKGROUND ART ritodrine hydrochloride is exchange feeling nervous beta 2 - receptor-stimulating agent, yet act selectively to the uterine muscle, because it exhibits a strong myometrial contractions suppressed, important as a therapeutic agent for preterm labor It is used as a drug.
【0003】従来、塩酸リトドリンの注射剤は、小容量
(5ml〜10ml)のアンプルもしくは、バイアル製
剤として販売(米国Astra社製YutoparR,
ECDuphar社製Pre−parR,日本キッセイ
社製ウテメリン注R)されている。そして、この薬物は
作用が強くしかも投与後血中濃度は速やかに低下するの
で、大量の通常ブドウ糖又はマルトース液で希釈したも
のを点滴静注により緩徐かつ継続的に患者に投与してい
る。Conventionally, an injection of ritodrine hydrochloride is sold as a small volume (5 ml to 10 ml) ampoule or a vial formulation (Yutopar R , manufactured by Astra, USA).
It is a Pre-par R manufactured by ECDuphar Co., and a Utemerin injection R manufactured by Nippon Kissei Co., Ltd.). Since this drug has a strong action and its blood concentration rapidly decreases after administration, a large amount of ordinary glucose or a substance diluted with maltose solution is slowly and continuously administered to a patient by intravenous drip infusion.
【0004】ちなみに、上記の小容量の塩酸リトドリン
製剤(単味)のpHは4.7〜5.5であり、ブドウ糖
またはマルトース液と配合したときのpHは4.5〜
6.0である。Incidentally, the above-mentioned small volume of ritodrine hydrochloride preparation (simple) has a pH of 4.7 to 5.5, and the pH when blended with glucose or maltose solution is 4.5 to.
It is 6.0.
【0005】[0005]
【発明が解決しようとする課題】従来の製剤において
は、患者への投与の都度、塩酸リトドリンをブドウ糖又
はマルトース液に混合希釈する操作が不可欠である。こ
の混合希釈の操作中に、ガラス片等の異物混入や微生物
汚染等の可能性があるので厳重な管理が要求されるこ
と、並びに緊急の場合においては、混合希釈操作が煩雑
であることなどの使用上の不便さは避け難い欠点となっ
ている。In the conventional preparations, it is essential to perform an operation of mixing and diluting ritodrine hydrochloride with glucose or maltose solution each time it is administered to a patient. During this mixing and diluting operation, strict control is required because there is a possibility of contamination of foreign substances such as glass pieces and microbial contamination, and in an emergency, the mixing and diluting operation is complicated. Inconvenience in use is an unavoidable drawback.
【0006】そこで、予め塩酸リトドリンとブドウ糖ま
たはマルトース液とを配合した製剤が提供できれば、こ
のような問題点及び不便さを解決できるのであるが、塩
酸リトドリンとブドウ糖又はマルトース液を予め配合し
加熱滅菌すると、加熱により塩酸リトドリンの酸化分解
物である4−ヒドロキシベンズアルデヒドおよび安定化
剤である亜硫酸水素イオンと塩酸リトドリンとの付加物
が生成し、医薬品として要求される安定性を保てないた
めに、このような製剤は未だ開発されていない。[0006] Therefore, it is possible to solve such problems and inconveniences by providing a preparation in which ritodrine hydrochloride and glucose or maltose solution are mixed in advance. However, ritodrine hydrochloride and glucose or maltose solution are mixed in advance and heat sterilized. Then, by heating 4-hydroxybenzaldehyde, which is an oxidative decomposition product of ritodrine hydrochloride, and an adduct of bisulfite ion and ritodrine hydrochloride, which are stabilizers, are formed, and the stability required as a pharmaceutical cannot be maintained, Such a formulation has not yet been developed.
【0007】[0007]
【課題を解決するための手段】そこで本発明者らは、塩
酸リトドリンとブドウ糖またはマルトースを予め配合し
た製剤につき、鋭意研究を重ねた結果、安定化剤として
の亜硫酸塩の配合量及びpHを特定の範囲に設定するこ
とにより上記問題を解決できることを究明し、本発明に
到達した。[Means for Solving the Problems] Therefore, the inventors of the present invention have conducted intensive studies on a formulation in which ritodrine hydrochloride and glucose or maltose have been preliminarily blended, and as a result, have identified the blending amount and pH of sulfite as a stabilizer. It was clarified that the above-mentioned problems can be solved by setting the above range and reached the present invention.
【0008】本発明は等張ないし高張濃度のブドウ糖も
しくはマルトース、塩酸リトドリン0.05−2mg/
mlおよび亜硫酸塩類0.02−0.3mg/mlを溶
解した水溶液のpHを3.0−4.0に調整し、かつ加
熱減菌してなる安定な静脈注射剤である。The present invention isotonic or hypertonic glucose or maltose, ritodrine hydrochloride 0.05-2 mg /
It is a stable intravenous injection obtained by adjusting pH of an aqueous solution in which 0.02 to 0.3 mg / ml of sulfites is dissolved to 3.0 to 4.0 and sterilizing by heating.
【0009】ブドウ糖もしくはマルトースは等張ないし
高張濃度、好ましくは5−10%の濃度で配合される。
塩酸リトドリンは0.05−2mg/mlの濃度とする
のがよく、亜硫酸塩類は0.02−0.3mg/mlの
濃度で用いるのがよい(試験例1参照)。Glucose or maltose is blended in isotonic to hypertonic concentrations, preferably in concentrations of 5-10%.
Ritodrine hydrochloride is preferably used at a concentration of 0.05-2 mg / ml, and sulfites are preferably used at a concentration of 0.02-0.3 mg / ml (see Test Example 1).
【0010】亜硫酸塩類としては、たとえば、亜硫酸水
素ナトリウム、ピロ亜硫酸ナトリウムおよび亜硫酸ナト
リウムなどの亜硫酸アルカリ金属塩類を用いるのが好ま
しい。As the sulfites, for example, alkali metal sulfites such as sodium hydrogen sulfite, sodium pyrosulfite and sodium sulfite are preferably used.
【0011】pHは3.0−4.0に調整されるが、p
H調整剤としては、輸液一般で使用されている鉱酸また
は有機酸を用いることができるが、好ましいのは塩酸、
クエン酸または酢酸である。The pH is adjusted to 3.0-4.0, but p
As the H-adjusting agent, a mineral acid or an organic acid generally used for infusion can be used, but hydrochloric acid is preferable,
Citric acid or acetic acid.
【0012】本発明の注射剤は加熱滅菌においても、4
−ヒドロキシベンズアルデヒドや亜硫酸水素イオンと塩
酸リトドリンの付加物であるS1,S2の生成が抑制さ
れ、医薬品としての安定性を保つことができる(試験例
2参照)。The injectable composition of the present invention is suitable for heat sterilization.
-Production of S 1 and S 2 which are adducts of hydroxybenzaldehyde or bisulfite ion and ritodrine hydrochloride is suppressed, and stability as a drug can be maintained (see Test Example 2).
【0013】また、溶液を容器に分注した後、容器内の
空気を窒素ガスで置換することによりこの安定性は著し
く向上する。Further, after the solution is dispensed into the container and the air in the container is replaced with nitrogen gas, the stability is remarkably improved.
【0014】また、本発明の注射剤は点滴法により静脈
内に投与することができ、その場合の単位容量として
は、臨床使用上の便宜のため100〜1,000mlと
するのが好ましく、さらに好ましいのは200〜500
mlである。The injection of the present invention can be administered intravenously by the drip method, and the unit volume in that case is preferably 100 to 1,000 ml for the convenience of clinical use. 200-500 is preferred
ml.
【0015】[0015]
【実施例】以下試験例および実施例により本発明をさら
に説明する。The present invention will be further described with reference to the following test examples and examples.
【0016】試験例1
注射用水800mlにブドウ糖50gを添加溶解し、更
に塩酸リトドリン200mgを添加溶解した後、注射用
水を加えて全量を900mlにした。この液90mlず
つとり、亜硫酸水素ナトリウムを0,1,2,5,1
0,20,30,40及び50mgを加え、更にクエン
酸で各溶液のpHを3.7に調整した後、それぞれに注
射用水を加えて全量を100mlとした。各亜硫酸水素
ナトリウム濃度溶液20mlずつをアンプルに分注し、
115℃、10分間加熱滅菌した。Test Example 1 Glucose (50 g) was added to and dissolved in 800 ml of water for injection, 200 mg of ritodrine hydrochloride was further added and dissolved therein, and then water for injection was added to bring the total amount to 900 ml. Take 90 ml of this liquid and add sodium bisulfite to 0, 1, 2, 5, 1
After adding 0, 20, 30, 40 and 50 mg and adjusting the pH of each solution to 3.7 with citric acid, water for injection was added to each to make the total volume 100 ml. Dispense 20 ml of each sodium bisulfite concentration solution into ampoules,
It was heat sterilized at 115 ° C. for 10 minutes.
【0017】[0017]
【表1】 [Table 1]
【0018】*S1:スレオ−1−(4−ヒドロキシフ
ェニル)−2−〔2−(4−ヒドロキシフェニル)エチ
ルアミノ〕−1−プロパンスルフォン酸
S2:エリスロ−1−(4−ヒドロキシフェニル)−2
−〔2−(4−ヒドロキシフェニル)エチルアミノ〕−
1−プロパンスルフォン酸* S 1 : threo-1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino] -1-propanesulfonic acid S 2 : erythro-1- (4-hydroxyphenyl) ) -2
-[2- (4-hydroxyphenyl) ethylamino]-
1-propanesulfonic acid
【0019】表1の結果から、亜硫酸塩の添加量は0.
02mg/ml以上で4−ヒドロキシベンズアルデヒド
の分解物を有意に抑えるが、0.3mg/ml以上にな
ると付加物S1,S2の生成量が急激に増加し、従っ
て、0.02〜0.3mg/mlの範囲がよいことが判
る。From the results shown in Table 1, the amount of sulfite added was 0.
Although the decomposition product of 4-hydroxybenzaldehyde is significantly suppressed at 02 mg / ml or more, the production amount of the adducts S 1 and S 2 rapidly increases at 0.3 mg / ml or more, and therefore 0.02 to 0. It turns out that the range of 3 mg / ml is good.
【0020】試験例2
注射用水800mlにブドウ糖50gを添加溶解し、更
に亜硫酸水素ナトリウム200mg及び塩酸リトドリン
300mgを加えて溶解した後、注射用水を加えて全量
を900mlにした。この液90mlずつとり、塩酸で
各溶液のpHを5.0,4.5,4.0,3.8,3.
6,3.4,3.2,及び3.0に調整した後、それぞ
れの溶液に注射用水を加えて全量を100mlとした。
各pHの溶液20mlずつをアンプルに分注し、115
℃、10分間加熱滅菌した。Test Example 2 Glucose (50 g) was added and dissolved in water for injection (800 ml), and sodium bisulfite (200 mg) and ritodrine hydrochloride (300 mg) were added and dissolved therein. Then, water for injection was added to bring the total amount to 900 ml. 90 ml of this solution was taken, and the pH of each solution was adjusted to 5.0, 4.5, 4.0, 3.8, 3.
After adjusting to 6, 3.4, 3.2 and 3.0, water for injection was added to each solution to make the total volume 100 ml.
Dispense 20 ml of each pH solution into ampoules, and
It was sterilized by heating at ℃ for 10 minutes.
【0021】[0021]
【表2】 [Table 2]
【0022】表2から明かなように、pH3.0〜4.
0、好ましくは3.2〜3.8の範囲において、加熱滅
菌による付加物の生成が著るしく抑制されるが、pHが
4を超えると付加物が急増する。As is clear from Table 2, pH of 3.0-4.
In the range of 0, preferably 3.2 to 3.8, the formation of the adduct due to heat sterilization is remarkably suppressed, but when the pH exceeds 4, the adduct rapidly increases.
【0023】[0023]
【実施例1】注射用水900mlにブドウ糖50gを添
加溶解し、更に安定化剤としてピロ亜硫酸ナトリウム1
00mgを添加溶解する。次に塩酸リトドリン600m
gを添加溶解した後、クエン酸溶液でpHを3.7に調
整し、次に注射用水を加えて全量を1000mlとす
る。この液を常法に従いメンブランフィルターによって
ろ過し、200mlの点滴静注用バイアル瓶に分注し、
空間部を窒素ガス置換した後、110℃で15分間加熱
滅菌して塩酸リトドリン0.6mg/mlを含有する点
滴静注用剤とする。Example 1 50 g of glucose was added and dissolved in 900 ml of water for injection, and sodium pyrosulfite 1 was added as a stabilizer.
Add 00 mg and dissolve. Next, ritodrine hydrochloride 600m
After adding and dissolving g, the pH is adjusted to 3.7 with a citric acid solution, and then water for injection is added to make the total volume 1000 ml. This solution is filtered by a membrane filter according to a conventional method and dispensed into a 200 ml drip intravenous vial,
After the space is replaced with nitrogen gas, it is sterilized by heating at 110 ° C. for 15 minutes to give an intravenous drip infusion containing ritodrine hydrochloride 0.6 mg / ml.
【0024】[0024]
【実施例2】注射用水900mlにブドウ糖50gを添
加溶解し、更に安定化剤としてピロ亜硫酸ナトリウム4
0mgを添加溶解する。次に塩酸リトドリン200mg
を添加溶解した後、塩酸溶液でpHを3.5に調整し、
次に注射用水を加えて全量を1000mlとする。この
液を常法に従いメンブランフィルターによってろ過し、
250mlの点滴静注用バイアル瓶に分注し、空間部を
窒素ガス置換した後、115℃で10分間加熱滅菌して
塩酸リトドリン0.2mg/mlを含有する点滴静注用
剤とする。Example 2 50 g of glucose was added and dissolved in 900 ml of water for injection, and sodium pyrosulfite 4 was added as a stabilizer.
Add 0 mg to dissolve. Next 200 mg of ritodrine hydrochloride
Was added and dissolved, the pH was adjusted to 3.5 with a hydrochloric acid solution,
Next, water for injection is added to make the total volume 1000 ml. This liquid is filtered by a membrane filter according to a conventional method,
The solution is dispensed into a 250 ml vial for intravenous infusion, the space is replaced with nitrogen gas, and sterilized by heating at 115 ° C. for 10 minutes to give an intravenous infusion containing 0.2 mg / ml of ritodrine hydrochloride.
【0025】[0025]
【実施例3】注射用水900mlにマルトース100g
を添加溶解し、更に安定化剤として亜硫酸水素ナトリウ
ム200mgを添加溶解する。次に塩酸リトドリン50
mgを添加溶解した後、クエン酸溶液でpHを3.7に
調整し、次に注射用水を加えて全量を1000mlとす
る。この液を常法に従いメンブランフィルターによって
ろ過し、500mlの点滴静注用バイアル瓶に分注し、
空間部を窒素ガス置換した後、115℃で10分間加熱
滅菌して塩酸リトドリン0.05mg/mlを含有する
点滴静注用剤とする。[Example 3] 100 g of maltose in 900 ml of water for injection
Is added and dissolved, and 200 mg of sodium hydrogen sulfite is added and dissolved as a stabilizer. Next, ritodrine hydrochloride 50
After adding and dissolving mg, adjust the pH to 3.7 with a citric acid solution, and then add water for injection to make the total volume 1000 ml. This solution is filtered by a membrane filter according to a conventional method and dispensed into a 500 ml intravenous infusion vial,
After substituting the space with nitrogen gas, it is heat-sterilized at 115 ° C. for 10 minutes to give an intravenous drip infusion containing ritodrine hydrochloride 0.05 mg / ml.
【0026】[0026]
【実施例4】注射用水450mlにブドウ糖25gを添
加溶解し、更に安定化剤としてピロ亜硫酸ナトリウム2
5mgを添加溶解する。次に塩酸リトドリン100mg
を添加溶解した後、酢酸でpHを3.3に調整し、次に
注射用水を加えて全量を500mlとする。この液を常
法に従いメンブランフィルターによってろ過し、200
mlの点滴静注用バイアル瓶に分注し、空間部を窒素ガ
ス置換した後、110℃で15分間加熱滅菌して塩酸リ
トドリン0.2mg/mlを含有する点滴静注用剤とす
る。Example 4 25 g of glucose was added and dissolved in 450 ml of water for injection, and sodium pyrosulfite 2 was added as a stabilizer.
Add 5 mg and dissolve. Next, ritodrine hydrochloride 100mg
Was added and dissolved, pH was adjusted to 3.3 with acetic acid, and then water for injection was added to bring the total volume to 500 ml. This solution was filtered through a membrane filter according to a conventional method to obtain 200
The solution is dispensed into a vial for intravenous drip infusion, the space is replaced with nitrogen gas, and sterilized by heating at 110 ° C. for 15 minutes to give an intravenous drip infusion containing ritodrine hydrochloride 0.2 mg / ml.
【0027】[0027]
【実施例5】注射用水450mlにマルトース50gを
添加溶解し、更に安定化剤として亜硫酸水素ナトリウム
150mgを添加溶解する。次に塩酸リトドリン750
mgを添加溶解した後、酢酸でpHを3.7に調整し、
次に注射用水を加えて全量を500mlとする。この液
を常法に従いメンブランフィルターによってろ過し、2
00mlの点滴静注用バイアル瓶に分注し、空間部を窒
素ガス置換した後、115℃で10分間加熱滅菌して塩
酸リトドリン1.5mg/mlを含有する点滴静注用剤
とする。Example 5 Maltose (50 g) was added and dissolved in water for injection (450 ml), and further sodium bisulfite (150 mg) was added and dissolved as a stabilizer. Next ritodrine hydrochloride 750
After adding and dissolving mg, the pH was adjusted to 3.7 with acetic acid,
Next, water for injection is added to bring the total volume to 500 ml. This solution was filtered through a membrane filter according to a conventional method, and 2
Dispense into a 00 ml vial for intravenous infusion, replace the space with nitrogen gas, and sterilize by heating at 115 ° C. for 10 minutes to give an intravenous infusion containing 1.5 mg / ml of ritodrine hydrochloride.
【0028】試験例3
実施例2にしたがって調製した塩酸リトドリン0.2m
g/mlを含有する製剤及び実施例3にしたがって調製
した塩酸リトドリン0.6mg/mlを含有する製剤
と、市販の塩酸リトドリン製剤(5mlアンプル中、主
薬50mg含有)をその用法用量に従い500mlの5
%ブドウ糖溶液に加えて稀釈した塩酸リトドリン0.1
mg/mlを含有する製剤を115℃10分間加熱滅菌
(以下、これを対照品と呼ぶ)し、4−ヒドロキシベン
ズアルデヒド及び亜硫酸水素イオンと塩酸リトドリンの
付加物(S1,S2)を比較した。この結果表3に示す
ようにS1,S2の生成量は、実施例にしたがって調製
した塩酸リトドリン0.2及び0.6mg/mlの製剤
ではともに0.01%となった。市販製剤を用時溶解後
加熱滅菌したものでは0.09%となった。また、4−
ヒドロキシベンズアルデヒドの生成量は実施例2及び3
ではともに0.01%であったが、対照品では0.02
%であった。Test Example 3 0.2 m ritodrine hydrochloride prepared according to Example 2.
A formulation containing g / ml and a formulation containing ritodrine hydrochloride 0.6 mg / ml prepared according to Example 3 and a commercially available ritodrine hydrochloride formulation (containing 50 mg of the active ingredient in a 5 ml ampoule) were used in an amount of 500 ml of 5
% Ritodrine Hydrochloride diluted with% glucose solution
The preparation containing mg / ml was heat sterilized at 115 ° C. for 10 minutes (hereinafter, referred to as a control product), and 4-hydroxybenzaldehyde and bisulfite ion were adducted with ritodrine hydrochloride (S 1 , S 2 ) were compared. . As a result, as shown in Table 3, the amounts of S 1 and S 2 produced were 0.01% for both 0.2 and 0.6 mg / ml formulations of ritodrine hydrochloride prepared according to the examples. It was 0.09% when the commercially available preparation was dissolved at the time of use and then heat sterilized. Also, 4-
The amount of hydroxybenzaldehyde produced was determined in Examples 2 and 3
Both were 0.01%, but 0.02 for the control product.
%Met.
【表3】 [Table 3]
【0029】試験例4 実施例2にしたがって調整した塩酸リトドリン0.2m
g/mlを含有する製剤と、対照として市販のリトドリ
ン製剤(単味、5mlアンプル中50mg含有)のアン
プル2本分を500mlの5%ブドウ糖溶液に加えて調
整した塩酸リトドリン約0.2mg/mlを含有する点
滴静注用剤を、115℃で10分間加熱し、4−ヒドロ
キシベンズアルデヒドおよび亜硫酸水素イオンと塩酸リ
トドリンの付加物(S 1 ,S 2 )の生成状況を比較し
た。 表4に示すように、4−ヒドロキシベンズアルデヒ
ド及びS 1 ,S 2 の量は、実施例2の点滴用静注剤では
ともに0.01%であったが対照品では0.12%およ
び0.03%であった。 Test Example 4 0.2 m ritodrine hydrochloride prepared according to Example 2.
Formulation containing g / ml and a commercial littoral as a control
Of a pharmaceutical preparation (single, containing 50 mg in a 5 ml ampoule)
Add 2 pulls to 500 ml of 5% glucose solution to prepare
Prepared ritodrine hydrochloride containing about 0.2 mg / ml
The intravenous solution was heated at 115 ° C. for 10 minutes to give 4-hydrogen.
Xybenzaldehyde and bisulfite ion and hydrochloric acid
To compare the production of todrine adducts (S 1 , S 2 )
It was As shown in Table 4, 4-hydroxybenzaldehyde
And the amounts of S 1 and S 2 are the same as those of the intravenous infusion preparation of Example 2.
Both were 0.01%, but 0.1% and 0.12% in the control product.
Was 0.03%.
【表4】 [Table 4]
【0030】[0030]
【発明の効果】本発明の静脈注射剤は安定であり、用時
ブドウ糖液等と混合することなくそのまま通常の点滴装
置を用い投与できるので投与にあたっても煩雑な混合希
釈の操作等を全く必要とせず、混合操作による汚染等の
問題もなく、緊急の場合でも直ちに使用でき、医療上有
用なものである。EFFECTS OF THE INVENTION The intravenous injection of the present invention is stable and can be administered as it is by using an ordinary drip device without being mixed with a glucose solution or the like at the time of use. Therefore, administration does not require any complicated mixing / diluting operation. In addition, there is no problem such as contamination due to the mixing operation, and it can be used immediately in an emergency and is medically useful.
───────────────────────────────────────────────────── フロントページの続き (58)調査した分野(Int.Cl.7,DB名) A61K 31/135 A61K 47/02 A61K 47/26 CA(STN) REGISTRY(STN) BIOSIS/MEDLINE/BIOS IS(STN)─────────────────────────────────────────────────── ─── Continuation of front page (58) Fields surveyed (Int.Cl. 7 , DB name) A61K 31/135 A61K 47/02 A61K 47/26 CA (STN) REGISTRY (STN) BIOSIS / MEDLINE / BIOS IS ( STN)
Claims (3)
マルトース、塩酸リトドリン0.05−2mg/mlお
よび亜硫酸塩類0.02−0.3mg/mlを溶解した
水溶液のpHを3.0−4.0に調整し、かつ加熱減菌
してなる安定な静脈注射剤。1. A pH of an aqueous solution in which isotonic or hypertonic concentration glucose or maltose, ritodrine hydrochloride 0.05-2 mg / ml and sulfites 0.02-0.3 mg / ml is 3.0-4.0. A stable intravenous injection prepared by adjusting the temperature to 1 and sterilized by heating.
射剤。2. The intravenous injection according to claim 1, which is for intravenous administration.
−10%である請求項1または2記載の静脈注射剤。3. A glucose or maltose concentration of 5
The intravenous injection according to claim 1 or 2, which is -10%.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP11366493A JP3535537B2 (en) | 1993-04-15 | 1993-04-15 | Intravenous injection |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP11366493A JP3535537B2 (en) | 1993-04-15 | 1993-04-15 | Intravenous injection |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH06298640A JPH06298640A (en) | 1994-10-25 |
JP3535537B2 true JP3535537B2 (en) | 2004-06-07 |
Family
ID=14618035
Family Applications (1)
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JP11366493A Expired - Fee Related JP3535537B2 (en) | 1993-04-15 | 1993-04-15 | Intravenous injection |
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JP (1) | JP3535537B2 (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4598484B2 (en) * | 2004-11-11 | 2010-12-15 | テルモ株式会社 | Ritodrine hydrochloride injection solution |
US8628805B2 (en) | 2009-06-04 | 2014-01-14 | Alk Ag | Stabilized composition comprising at least one adrenergic compound |
SI2437781T1 (en) | 2009-06-04 | 2013-12-31 | Alk Ag | Stabilised composition comprising at least one adrenergic compound |
JP2012001493A (en) * | 2010-06-17 | 2012-01-05 | Terumo Corp | Ritodrine hydrochloride injection formulation |
-
1993
- 1993-04-15 JP JP11366493A patent/JP3535537B2/en not_active Expired - Fee Related
Non-Patent Citations (1)
Title |
---|
最近の新薬(第38集),1987年,p.284−286 |
Also Published As
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JPH06298640A (en) | 1994-10-25 |
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