| 制备环境对N-乙酰半胱氨酸木糖醇注射液有关物质的影响 |
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| 引用本文： | 方红英,王福根,庄让笑,席建军,邵益丹,缪樑斌,吴锡铭. 制备环境对N-乙酰半胱氨酸木糖醇注射液有关物质的影响[J]. 中国药业, 2010, 19(2): 37-38 |
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| 作者姓名： | 方红英 王福根 庄让笑 席建军 邵益丹 缪樑斌 吴锡铭 |
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| 作者单位： | 浙江中医药大学附属第六医院,浙江,杭州,310014 |
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| 摘 要： | 目的考察N-乙酰半胱氨酸木糖醇注射液在不同条件下的稳定性，为配方工艺提供依据，提高产品质量。方法用高效液相色谱法测定N-乙酰半胱氨酸木糖醇注射液的含量及有关物质。结果pH、充氮、对产品质量有不同程度的影响，温度、光照等对产品的稳定性也有一定影响。结论合适的工艺能克服不稳定因素，产品质量容易控制，能符合注射剂的质量要求。
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| 关 键 词： | N-乙酰半胱氨酸注射液 含量 有关物质 稳定性 |
Effect of Prepared Environment on Related Substances in NACX Injection |
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| Fang Hongying,Wang Fugeng,Zhuang Rangxiao,Xi Jianjun,Shao Yidan,Miao Liangbin,Wu Ximing. Effect of Prepared Environment on Related Substances in NACX Injection[J]. China Pharmaceuticals, 2010, 19(2): 37-38 |
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| Authors: | Fang Hongying Wang Fugeng Zhuang Rangxiao Xi Jianjun Shao Yidan Miao Liangbin Wu Ximing |
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| Affiliation: | (Sixth Affiliated Hospital, Zhejiang Traditional Chinese Medicine University, Hangzhou, Zhejiang, China 310014) |
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| Abstract: | Objective To investigate the stability of N-acetylcysteine xylitol （NACX） injection under different conditions to provide the basis for the formulation process and improve products quality. Methods To determinate the content and the related substances of NACX injection by HPLC. Results pH and nitrogen had some different effects to the contents of products, temperature and light had some influ- ences to the stability of the products. Conclusion The appropriate process could overcome the destabilizing factors, and the product quality is easy to control, which is able to meet the quality requirements of injection. |
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| Keywords: | NACX injection content related substances stability |
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