| 对乙酰氨基酚注射液制备工艺及稳定性研究 |
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| 引用本文： | 叶静,张晓宇,方群,张全,李长兵. 对乙酰氨基酚注射液制备工艺及稳定性研究[J]. 云南化工, 2019, 0(1): 59-61 |
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| 作者姓名： | 叶静 张晓宇 方群 张全 李长兵 |
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| 作者单位： | 成都医学院药学院;天津大学药学院 |
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| 摘 要： | 优选对乙酰氨基酚注射液的制备工艺,并考察其稳定性。通过单因素考察确定制剂的辅料用量,最适pH,灭菌工艺等,筛选出最优工艺条件,并根据确定的条件进行稳定性考察。对乙酰氨基酚注射液制备工艺最优条件为磷酸氢二钠用量为175mg,控制产品p H在6.0,并在115℃下高压蒸汽灭菌30min,可以成功制得对乙酰氨基酚注射液,产品规格为10mg/mL。此产品在常温下密封放置30d稳定性良好。合理的制备工艺和条件,可更好的保证对乙酰氨基酚注射液的质量。
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| 关 键 词： | 对乙酰氨基酚 注射液 制备工艺 稳定性 |
Preparation Process and the stability of Acetaminophen Injection and the Stability |
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| Affiliation: | ,School of pharmacy,Chengdu Medical College,School of pharmacy,Tianjin Medical College |
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| Abstract: | OBJECTIVE To optimise the preparation process of acetaminophen injection,and the stability of which was investigated.METHORD Single factor experiment was carried out to determine the dosage of adjuvants,pH of solution and sterilization process.And according to the determined conditions for the stability of the investigation.RESULTS The optimal conditions were determined as follows:The amount of disodium hydrogen phosphate was 175 mg,Control product pH at 6.0.The solution was sterilized at 115℃for 30 min.The product is stable when it is sealed at room temperature for 30 d.CONCLUSION Reasonable preparation process and conditions can better ensure the quality of acetaminophen injection. |
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| Keywords: | Acetaminophen intravenous injection preparation process stability |
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