| 引用本文: | 邵益丹,张晶,方红英,席建军,庄让笑,琚立萍,范骁辉.影响复方利巴韦林口服液稳定性的关键因素分析及其制备工艺的优化[J].中国现代应用药学,2015,32(4):460-463. |
| SHAO Yidan,ZHANG jing,FANG Hongying,XI Jianjun,ZHUANG Rangxiao,JU Liping,FAN Xiaohui1.Analysis of the Influencing Factors of Stability of Compound Libavirin Oral Liquid and the Research of Its Optimized Preparation Process[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(4):460-463. |
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| 摘要: |
| 目的 分析影响复方利巴韦林口服液稳定性的主要因素，并开展制备工艺的优化试验，以确定合理的工艺条件，提高该产品的质量。方法 通过单因素试验考察中间品溶液pH、灭菌温度和金属离子对产品稳定性的影响，采用L9(34)正交试验方法以确定最优工艺条件，据此考察产品在加速试验和长期试验中的稳定性。结果 灭菌前中间品溶液的pH值对产品稳定性影响最大，灭菌温度的影响其次，而金属离子的影响相对较小，从而选定A3B2C2的组合，即中间品pH值7.0、105 ℃/30 min灭菌并加0.01% EDTA-2Na为最佳工艺组合。结论 复方利巴韦林口服液的稳定性受到其中间品溶液pH值、灭菌温度和溶液中的金属离子的影响，且以中间品溶液pH值和灭菌温度的影响最甚。为有效控制产品质量，最终确定复方利巴韦林口服液最佳工艺条件为中间品pH值6.9~7.0，灭菌参数105 ℃/30 min，溶媒为纯化水，并在药液中加入0.01% EDTA-2Na，使产品稳定性得到显著提高。 |
| 关键词: 利巴韦林 5-羟甲基戊醛 酸碱度 灭菌温度 金属离子 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目: |
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| Analysis of the Influencing Factors of Stability of Compound Libavirin Oral Liquid and the Research of Its Optimized Preparation Process |
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SHAO Yidan1,2, ZHANG jing2, FANG Hongying2, XI Jianjun2, ZHUANG Rangxiao2, JU Liping2, FAN Xiaohui11
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1.Zhejiang University, Hangzhou 310012, China;2.Hangzhou Xixi Hospital, Hangzhou 310023, China
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| Abstract: |
| OBJECTIVE To analysis the influencing factors of stability of compound libavirin oral liquid, and to build up a reasonable preparing method to improve the product’s quality. METHODS Use single factor tests to study the influences of preparing conditions, including intermediate product’s pH value, sterilizing temperature and metal ions, to the product’s quality, and to find out the best preparing conditions by the L9(34) orthogonal tests. Then to test the product’s accelerated and long term stability. RESULTS The orthogonal test results showed that the intermediate product’s pH had the most significant impact on the sterilized products’ stability. The next influencing factor was the sterilizing temperature and the metal ions had the minimum impact. The best preparing method group was A3B2C2 (intermediated product’s pH 7.0, sterilizing temperature 105 ℃/30 min and add 0.01% EDTA-2Na). CONCLUSION The compound libavirin oral liquid’s stability is associated with its intermediated product’s pH, sterilizing temperature and metal ions. The intermediated product’s pH and sterilizing temperature has the major impacts on the product’s stability. The final optimized preparing method is pH 6.9?7.0 of intermediated product, 105 ℃/30 min sterilizing temperature and adding 0.01% EDTA-2Na into the product. Thus to improve the product’s stability. |
| Key words: libavirin 5-hydroxymethylfurfural pH sterilization temperature metal ion |
