匹多莫德水溶液稳定性研究
|
摘要
目的探讨不同条件下匹多莫德水溶液的稳定性,为其相关制剂质量标准的制订提供依据。方法配制不同pH的匹多莫德水溶液样品,采用高效液相色谱(HPLC)法分别对室温普通光照、60℃光照、室温强光(4 500 lx)3种条件下匹多莫德的含量进行测定,考察其稳定性。结果匹多莫德水溶液含量前后变化趋势基本相同,pH在6～8范围内最稳定;室温普通光照下稳定性最好,60℃光照稳定性最差。结论匹多莫德水溶液应调节pH为6～8,在室温、避光条件下可保持最佳稳定性。
Objective To investigate the stability of pidotimod aqueous solution under different conditions,and to provide a basis for the formulation of quality standards of related preparations. Method Pidotimod aqueous samples with different p H were made up, and the content of pidotimod samples were determined by HPLC under three conditions: room temperature and normal light,60 ℃ and normal light,room temperature and hard light( 4 500 lx),and its stability was inspected. Results Under the three kinds of conditions,the content of pidotimod aqueous solution had the same change trend,its most stable pH range was 6-8. According to content change degree,the stability of room temperature and normal light was the best and the stability of 60 ℃ and normal light was the worst. Conclusion Pidotimod queous solution can maintain the best stability at room temperature without light and its pH should be adjusted to 6-8.
Objective To investigate the stability of pidotimod aqueous solution under different conditions,and to provide a basis for the formulation of quality standards of related preparations. Method Pidotimod aqueous samples with different p H were made up, and the content of pidotimod samples were determined by HPLC under three conditions: room temperature and normal light,60 ℃ and normal light,room temperature and hard light( 4 500 lx),and its stability was inspected. Results Under the three kinds of conditions,the content of pidotimod aqueous solution had the same change trend,its most stable pH range was 6-8. According to content change degree,the stability of room temperature and normal light was the best and the stability of 60 ℃ and normal light was the worst. Conclusion Pidotimod queous solution can maintain the best stability at room temperature without light and its pH should be adjusted to 6-8.
引文
[1]周越,戴玉旋.匹多莫德和脾氨肽对反复呼吸道感染患儿的临床症状及Th1/Th2细胞因子影响的比较[J].中国生化药物杂志,2012,33(1):64-66.
[2]张磊.匹多莫德联合孟鲁司特钠治疗小儿支气管哮喘120例疗效观察[J].中国保健营养,2016,26(1):376-377.
[3]瑛,堵伟锋.盐酸安妥沙星注射液的稳定性试验[J].中国药业,2012,21(6):27-29.
[4]尚海巍,孙英华,何仲贵. pH值对匹多莫德氯化钠注射液稳定性的影响[J].中国药剂学杂志,2007,5(6):315-319.
[5]王敬敏,李慧,孙进.匹多莫德注射液的制备及其质量和稳定性研究[J].中国药剂学杂志,2012,10(6):93-98.
[6]黄敏,蒋伟哲,黄兴振,等.盐酸左旋多巴甲酯水溶液稳定性研究[J].中国药业,2008,17(8):29-30.
[7]刘晓,陈晓辉,戴锦娜,等.溶液pH、温度和光照等因素对盐酸阿比朵尔稳定性影响的考察[J].药物分析杂志,2009,29(5):833-836.
[8]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:354-356.
[9]蒋军喜,张超群,阙海勇,等.车前草穗枯病研究[J].江西农业大学学报,2007,29(5):740-750.
[10]周施诗,李健和.碘帕醇注射液的稳定性研究[J].中南药学,2018,16(1):68-71.
[2]张磊.匹多莫德联合孟鲁司特钠治疗小儿支气管哮喘120例疗效观察[J].中国保健营养,2016,26(1):376-377.
[3]瑛,堵伟锋.盐酸安妥沙星注射液的稳定性试验[J].中国药业,2012,21(6):27-29.
[4]尚海巍,孙英华,何仲贵. pH值对匹多莫德氯化钠注射液稳定性的影响[J].中国药剂学杂志,2007,5(6):315-319.
[5]王敬敏,李慧,孙进.匹多莫德注射液的制备及其质量和稳定性研究[J].中国药剂学杂志,2012,10(6):93-98.
[6]黄敏,蒋伟哲,黄兴振,等.盐酸左旋多巴甲酯水溶液稳定性研究[J].中国药业,2008,17(8):29-30.
[7]刘晓,陈晓辉,戴锦娜,等.溶液pH、温度和光照等因素对盐酸阿比朵尔稳定性影响的考察[J].药物分析杂志,2009,29(5):833-836.
[8]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:354-356.
[9]蒋军喜,张超群,阙海勇,等.车前草穗枯病研究[J].江西农业大学学报,2007,29(5):740-750.
[10]周施诗,李健和.碘帕醇注射液的稳定性研究[J].中南药学,2018,16(1):68-71.