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作 者:排孜也提.排孜拉 程雪梅[2] 滕亮[3] 王长虹[2] 马桂芝[1]
机构地区:[1]新疆医科大学药学院,乌鲁木齐830011 [2]上海中医药大学中药研究所中药标准化教育部重点实验室 [3]新疆医科大学第一附属医院药学部
出 处:《中国药师》2015年第11期1864-1870,共7页China Pharmacist
基 金:国家自然科学基金/新疆联合基金重点项目(编号:U1130303);乌鲁木齐市科学技术计划项目(编号:G121320004);上海市博士后科研资助计划面上项目(编号:BR21415800)
摘 要:目的:初步建立骆驼蓬生物碱乳膏剂的质量控制方法。方法:按照《中国药典》2010年版一部附录有关制剂通则要求,对制剂进行一般质量检查。以去氢骆驼蓬碱和骆驼蓬碱为指标,采用薄层色谱法对乳膏剂进行薄层色谱鉴别。以去氢骆驼蓬碱、骆驼蓬碱、鸭嘴花碱为指标,采用高效液相色谱法对制剂进行含量测定。结果:检查项目均符合《中国药典》要求。薄层色谱中供试品在与对照品相同位置上显相同颜色斑点。去氢骆驼蓬碱、骆驼蓬碱和鸭嘴花碱分别在3.440-110.000μg· ml-1、3.340-107.000μg3ml-1和1.380-22.000μg3ml-1浓度范围内线性关系良好,平均回收率分别为98.1%(RSD=1.75%, n=6)、99.8%(RSD=1.78%, n=6)和99.3%(RSD=1.95%, n=6)。结论:所建立的质量控制方法符合方法学要求,为最终制定骆驼蓬生物碱乳膏剂质量标准奠定了试验基础。Objective:To establish the quality standard for peganum harmala alkaloids cream ( CAPH) . Methods: The general quality of CAPH was inspected according to the general notices described in Chinese Pharmacopoeia volumeⅠ2010 edition. The qual-itative identification was carried out by TLC with harmine and harmaline as the index ingredients. The content determination was carried out by HPLC methods with harmine, harmaline and vasicine as the index ingredients. Results:The inspection items were all met the requirements. The experimental samples and the reference substances in TLC showed the identical spots with the same color and shape at the same position. The calibration curve of harmaline, harmine and vasicine was linear within the concentration range of 3. 440-110. 000 μg·ml-1 , 3. 340-107. 000 μg·ml-1 and 1. 380-22. 000 μg·ml-1 , respectively. The recovery was 98. 1%, 99. 8% and 99. 3% with RSD of 1. 75%, 1. 78% and 1. 95%, respectively (n=6). Conclusion: The established quality control methods meet the requirements of methodology, and the results lay foundation for the quality standard for CAPH.
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