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奥硝唑氯化钠注射液处方筛选及初步稳定性研究
引用本文:徐志文,刘小娟,陈晓云,李瑞明. 奥硝唑氯化钠注射液处方筛选及初步稳定性研究[J]. 亚太传统医药, 2014, 0(1): 24-26
作者姓名:徐志文  刘小娟  陈晓云  李瑞明
作者单位:[1]辰欣药业股份有限公司,山东济宁272073 [2]济宁市第二人民医院,山东济宁272049 [3]济宁京华眼科医院,山东济宁272000
摘    要:
目的:筛选奥硝唑氯化钠注射液的制备工艺并进行初步稳定性研究。方法:对影响制备工艺的关键控制点活性炭用量、pH值及灭菌参数及稳定性进行研究,并以药物成分含量、有关物质等项目为评价指标对制备工艺进行评价。结果:通过科学合理评价筛选出了奥硝唑氯化钠注射液的制备工艺。结论:所筛选出的制备工艺能够制备出质量完全符合标准的产品。

关 键 词:奥硝唑氯化钠注射液  处方工艺  稳定性

Ornidazole and Sodium Chloride Injection Prescription Screening and Preliminary Stability Study
Xu Zhiwen,Liu Xiaojuan,Chen Xiaoyun,Li Ruiming. Ornidazole and Sodium Chloride Injection Prescription Screening and Preliminary Stability Study[J]. Asia-Pacific Traditional Medicine, 2014, 0(1): 24-26
Authors:Xu Zhiwen  Liu Xiaojuan  Chen Xiaoyun  Li Ruiming
Affiliation:1. Chen xin pharmaceutical co. , LTD. ,Shandong 272073,China; 2. NO. 2people,s hospital of Jingning, Shandong 272049, China; 3. Jining jinghua eye hospital, Shandong 272000, China)
Abstract:
Objective: Through the scientific method, screening of Ornidazole sodium chloride injection preparation technology and carries on the preliminary stability study. Methods : We had studied the influence of preparation technology key control point activated carbon dosage, pH value and the sterilization parameters and stability are studied, and the ingredient content and related substances such as project as evaluation index to evaluate preparation technology. Results: The evaluation of scientific and rational screening Ornidazole sodium chloride injection preparation technology. Conclusion : the preparation process can be screened out were completely conform to the standards of product quality.
Keywords:Ornidazole Sodium Chloride Injection  Formulation and Preparation  Stability
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