| 摘要: |
| 目的：研制首批苄星氯唑西林国家对照品。方法：对质量标准中的关键项目进行考察。采用红外分光光度法、高效液相色谱法对原料进行鉴别，采用高效液相色谱法进行含量测定。结果：红外光吸收图谱与USP溯源对照品图谱一致，高效液相色谱法测定氯唑西林与二苄基乙二胺的含量和为92.1%。结论：本研究建立的苄星氯唑西林国家对照品可用于苄星氯唑西林及其制剂的鉴别。 |
| 关键词: 苄星氯唑西林 国家对照品 高效液相色谱 鉴别 |
| DOI： |
| 投稿时间：2019-03-27修订日期：2019-06-23 |
| 基金项目: |
|
| Development of Benzathine Cloxacillin as National Reference |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| Objective: To develop the first batch of national reference of benzathine cloxacillin. Methods: The key items in the quality standard were inspected. Infrared spectrophotometry and HPLC was applied to identify raw materials. HPLC was applied to determine the content. Results: The IR spectrum was consistent with the USP traceable reference. The content of cloxacillin and dibenzylethylenediamine was 92.1%. Conclusion: The first batch of national reference of benzathine cloxacillin established in this study can be used for the identification of benzathine cloxacillin and its preparations. |
| Key words: benzathine cloxacillin national reference HPLC identification |
