Preparations of Taxanes for Intravenous Administration and the Preparation Method Thereof
    3.
    发明申请
    Preparations of Taxanes for Intravenous Administration and the Preparation Method Thereof 审中-公开
    静脉给药紫杉烷的制备及其制备方法

    公开(公告)号:US20110077291A1

    公开(公告)日:2011-03-31

    申请号:US12571176

    申请日:2009-09-30

    IPC分类号: A61K31/337 A61P35/00

    摘要: The present invention relates to the field of medical technology. More specifically, the present invention relates to a preparation of taxanes for intravenous administration, which consists of two parts: a drug solution and an emulsion. Said drug solution consists of paclitaxel or docetaxel, a pH regulator and a solvent for injection, wherein said solvent for injection is an organic solvent. Said emulsion includes a fat emulsion and is composed of oil for injection, an emulsifier, an antioxidant, an isotonic regulator, a stabilizer, a pH regulator and water for injection. When used, the drug solution at the clinical dosage can be added and mixed homogeneously in the emulsion to perform intravenous drip directly; or the drug solution at the clinical dosage can also be firstly added into the emulsion with no less than 5 times volume of the drug solution and then a predetermined amount of normal saline or glucose solution for injection is added to perform intravenous drip. The preparation of the present invention does not contain solubilizer and has advantages of little toxicity, safety, effectiveness, stability and economy. The fat emulsion is also used as a nutritional replenishment, thus achieving a better therapeutic effect. In addition, the normal saline or glucose solution for injection can be used to replace a considerable amount of the emulsion, which makes the preparation, therefore, not only cost-efficient, but also convenient for transportation and storage in practice.

    摘要翻译: 本发明涉及医疗技术领域。 更具体地说,本发明涉及用于静脉内给药的紫杉烷类的制剂,其由药物溶液和乳剂两部分组成。 所述药物溶液由紫杉醇或多西紫杉醇,pH调节剂和注射用溶剂组成,其中所述注射用溶剂为有机溶剂。 所述乳液包括脂肪乳剂,由注射用油,乳化剂,抗氧化剂,等渗调节剂,稳定剂,pH调节剂和注射用水组成。 使用时,可以将临床用量的药物溶液加入乳液中均匀混合,直接进行静脉滴注; 或者临床剂量的药液也可以首先加入不少于5倍体积的药物溶液的乳液中,然后加入预定量的生理盐水或注射用葡萄糖溶液进行静脉滴注。 本发明的制剂不含增溶剂,毒性小,安全性,有效性,稳定性和经济性好。 脂肪乳剂也用作营养补充剂,从而达到更好的治疗效果。 此外,用于注射的生理盐水或葡萄糖溶液可用于代替相当数量的乳液,这使得制剂不仅具有成本效益,而且在实践中也方便运输和储存。