Zoledronic acid injection and preparation method thereof

• Main Authors: JIAO KUILIANG, QIN YUEWEI, JING YAKUN, QI JUNCAI, NIU FENG, PAN HUIMIN
• Format: Patent
• Language: English
• Published: 24.06.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention provides a zoledronic acid injection and a preparation method thereof. The zoledronic acid injection comprises zoledronic acid monohydrate, an osmotic pressure conditioning agent, a pH value conditioning agent, injection water and impurity, wherein the impurity comprises one or two selected from the group consisting of imidazoleacetic acid and imidazole. When the zoledronic acid injection is stored at room temperature under a lightproof condition for less than 24 months, the total amount of the impurity is no more than 0.5%; when the impurity contains imidazoleacetic acid, the content of imidazoleacetic acid is no more than 0.3%; and when the impurity contains imidazole, the content of imidazole is no more than 0.1%. The zoledronic acid injection provided by the invention is simple to prepare, safe and effective, has stable quality and is applicable to clinical usage and mass production.