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| 铂类抗肿瘤药物甲啶铂破坏性试验研究 |
| The Research of Devastating Test on Picoplatin, a Platinum-based Anti-tumor Drug |
| Received:June 04, 2014 |
| DOI： |
| 中文关键词: 药物化学 铂抗癌药 甲啶铂 破坏试验 稳定性 高效液相色谱 |
| 英文关键词: medicinal chemistry platinum-based anti-tumor drug picoplatin devastating test stability HPLC |
| 基金项目:云南省科技厅重点新产品开发计划(2013BC010):“抗肿瘤化学I类新药甲啶铂注射液的临床前预研究”。 |
| Author Name | Affiliation | E-mail | | CHEN Hong | State Key Laboratory of Advanced Technologies for Comprehensive Utilization of Platinum Metals, Kunming Institute of Precious Metals, Kunming 650106, China
Yunnan Engineering and Technology Center of Platinum-based Anti-tumor Drug, Kunming Guiyan Pharmaceutical Co.Ltd., Kunming 650106, China | | | LUAN Chunfang | Yunnan Engineering and Technology Center of Platinum-based Anti-tumor Drug, Kunming Guiyan Pharmaceutical Co.Ltd., Kunming 650106, China | | | CONG Yanwei | Yunnan Engineering and Technology Center of Platinum-based Anti-tumor Drug, Kunming Guiyan Pharmaceutical Co.Ltd., Kunming 650106, China | | | ZHANG Qi | Yunnan Engineering and Technology Center of Platinum-based Anti-tumor Drug, Kunming Guiyan Pharmaceutical Co.Ltd., Kunming 650106, China | | | PU Shaoping | Yunnan Engineering and Technology Center of Platinum-based Anti-tumor Drug, Kunming Guiyan Pharmaceutical Co.Ltd., Kunming 650106, China | pushaoping@163.com |
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| 中文摘要: |
| 根据药品稳定性试验的要求，采用高效液相色谱分析方法研究甲啶铂在酸、碱、氧化和还原条件下的稳定性，并研究了不同pH值对甲啶铂稳定性的影响，所有溶剂均用0.9% NaCl溶液配制。研究结果表明，甲啶铂在0.01 mol/L HCl溶液中放置24 h含量降解约7%；在0.01 mol/L NaOH溶液中放置24 h含量降解约78%；在0.3% H2O2溶液中放置24 h含量降解约49%；在0.01% NaHSO3溶液中放置24 h含量降解约9%；pH太高或者太低均不利于甲啶铂的稳定，最稳定的pH在3~5之间。结果说明，甲啶铂在碱性和氧化性环境中极不稳定，在还原性和酸性环境中相对稳定，但还原剂和酸的加入量需严格控制。 |
| 英文摘要: |
| Based on the requirement of the drug-stability test, HPLC analytical method was used to investigate the stability of picoplatin in acid, alkaline, oxidative and reductive conditions, and 0.9% NaCl solution was used as solvent. The results show that in 0.01% HCl solution 24 hours, picoplatin degraded about 7%, 78% in 0.01%NaOH solution, 49% in 0.3% H2O2 solution and 9% in 0.01% NaHSO3 solution 24 hours. It’s not conductive to the stability of picoplatin if the pH value is too high or too low, and the most stable pH values is between 3 and 5. It shows that, picoplation is unstable in alkaline and oxidative conditions, and is stable in acid and reductive conditions relatively, but the amount of acid and reducing agent should be controlled strictly. |
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