英文药名:RHINOJET(Sodium Cromoglicate Inhalation Solution)
中文药名:色甘酸钠吸入溶液
生产厂家:协和药业
リノジェット吸入液
治疗类别名称 哮喘的治疗剂 商標名 RHINOJET 一般名 クロモグリク酸ナトリウム(Sodium Cromoglicate) 化学式 C23H14Na2O11=512.33 化学名 Disodium 5,5′-(2-hydroxytrimethylenedioxy)bis(4-oxo-4H-1-benzopyran-2-carboxylate) 構造式
性状 白色结晶粉末,没有气味,但不是最初的味道,后微苦。 易溶于水,微溶于丙二醇,乙醇(95)极微溶于,溶于2-丙醇或乙醚很差。 它是吸湿性的。 渐渐地承担一个黄色的光。 操作注意事项 稳定性试验 使用最终的包装产品的长期保存试验(25℃(当然湿度),三年7月)的结果,外观和内容等是标准,在根据正常的市场分布里诺射流吸入溶液3的范围内可以确认一年是稳定。 药效药理 由于(鼠)“对被动皮内过敏性反应行动”(鼠)和雷诺喷气吸入溶液和标准品(色甘酸钠吸入钠溶液)“关于过敏性哮喘的影响”的指标考虑类型的抑制作用我的过敏性反应这是。 其结果是,里诺喷射吸入溶液和标准配方中,既表现出抗空白一个显著抑制作用,并且,从在两种药物,里诺喷射吸入溶液和标准配方生物体的效果没有观察显著差异的事实组织学来确定等效。 适应病症 支气管哮喘 用法用量 每日3-4次次吸入,(用喷雾器援助吸入)每次吸入1安瓿。如得到的症状缓解,随后减少至1天2-3安瓿。 包装规格 2mL×60管
制造厂商 协和药业有限公司
完整处方来源附件:http://www.info.pmda.go.jp/go/pack/2259701G1039_1_05/ RHINOJET(Sodium Cromoglicate Inhalation Solution) Therapeutic category name Asthma treatment agent Brand Name Reno jet inhalation solution composition Component-quantity 1 in an ampoule (2mL) Day stations cromoglycate sodium 20mg Additive purified water Contraindication Patients with a history of hypersensitivity to components of this drug Efficacy or effect Bronchial asthma Morning, noon, and before going to bed or in the morning, noon, evening and before going to bed once addressed an ampoule and inhaled with the aid of an electric nebulizer a day 3-4 ampoule. If Rarere obtained remission of symptoms, to be reduced to 1 day 2-3 ampoule while observing the subsequent course. Clinically significant adverse reactions Bronchospasm (Frequency unknown) During or immediately after inhalation, sometimes severe bronchospasm appears. Such symptoms discontinued immediately administration if it appears, appropriate measures should be taken. PIE syndrome (Frequency unknown) PIE syndrome (pulmonary infiltrates with eosinophilia: fever, cough, it is often accompanied by sputum) may occur. Discontinue administration, administration of a steroid agent, and the like, if necessary in the case of such symptoms are observed. Anaphylactoid symptoms (Frequency unknown) Anaphylaxis-like symptoms (dyspnea, angioedema, urticaria, etc.) because they may appear, carefully observed, administration should be discontinued if any abnormalities are observed, appropriate measures should be taken. Pharmacology As an indicator of the "effect on anaphylaxis asthma" (rat) "action against passive intradermal anaphylactic reaction" (rat) and, Reno jet inhalation solution and standard preparation (cromolyn sodium inhalation solution) consider the inhibitory effect on type I allergic reaction for did. As a result, Reno jet inhalation solution and standard formulations, both showed a significant inhibitory effect against a blank, and, from the fact that no significant difference was observed in the effect of both drugs, Reno jet inhalation solution and standard formulations organisms histological to it is determined that the equivalent. Physicochemical knowledge of active ingredient Generic name Cromolyn sodium (Sodium Cromoglicate) Chemical formula C23H14Na2O11 = 512.33 Chemical name Disodium 5,5 '- (2-hydroxytrimethylenedioxy) bis (4-oxo-4H-1-benzopyran-2-carboxylate) Behavior A white crystalline powder, not smell, but not initially taste, slightly bitter after. Freely soluble in water, sparingly soluble in propylene glycol, very slightly soluble in ethanol (95), poorly soluble in 2-propanol or diethyl ether. It is hygroscopic. Gradually take on a yellow by the light.
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