| 摘要: |
| 为了有效控制泰拉霉素原料及注射液的产品质量,研制了泰拉霉素国家对照品。采用精制后的泰拉霉素为原料进行本批对照品的研制,原料分装后进行质量检测及均匀性评价,并标定含量。采用红外分光光度法、费休氏水分测定法等对其进行理化分析,利用高效液相色谱法进行有关物质测定及均匀性检验,采用质量平衡法进行标准物质含量计算,并通过差示扫描量热法对质量平衡法的准确性进行验证。研制的泰拉霉素国家对照品的含量为98.3%,采用多种不同方法对本品进行定性与定量研究,确保了国家标准物质标定结果的准确性。本对照品可用于泰拉霉素原料及注射液的鉴别与含量测定,对于提高和保证兽药产品质量具有重要意义。 |
| 关键词: 泰拉霉素 国家对照品 质量平衡法 含量测定 |
| DOI： |
| 投稿时间：2022-04-23修订日期：2022-09-13 |
| 基金项目:兽药行业公益性重点专项“兽用化学药品检验用部分标准物质研究”(GY202003) |
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| Study on the Calibration of National Reference Standard of Tulathromycin |
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| (China Institute of Veterinary Drug Control,Beijing,100081;China) |
| Abstract: |
| In order to effectively control the quality of tulathromycin raw materials and injection products, national reference standard of tulathromycin was developed. The refined tulathromycin tartrate was used as raw material. The quality inspection and uniformity evaluation were tested after dispersal. Infrared spectrophotometry and Karl Fischer moisture method were applied for physical and chemical analysis. HPLC was applied for determination of related substances and uniformity test. The content of reference standard was calculated by mass balance method,which was also confirmed by DSC method. The content of national reference standard of tulathromycin was 98.3%. Different methods were applied for qualitative and quantitative research to ensure the accuracy of the calibration results. It is of great significance to improve and ensure the quality of veterinary drugs. |
| Key words: tulathromycin national reference substance mass balance method content determination |
