锯叶棕果实提取物软胶囊质量标准研究  

Quality standard of Sabal fruit extract soft capsules

作　　者：杨小唤[1,2] 蔡卓亚 蔡雄[1] 徐晓军[1] 李会军[2] 秦勇[1] 

机构地区：[1]江苏神龙药业有限公司,盐城224200 [2]中国药科大学天然药物活性组分与药效国家重点实验室,南京210009

出　　处：《中国新药杂志》2015年第24期2854-2864,共11页Chinese Journal of New Drugs

基　　金：江苏省"创新团队计划"项目(2013-043);江苏省"六大人才高峰"项目(2013-SWYY-009)

摘　　要：目的：建立进口锯叶棕果实提取物软胶囊的质量控制分析方法,提高进口质量标准。方法：采用气相色谱法（gas chromatography,GC）测定锯叶棕果实提取物软胶囊中11个脂肪酸：正己酸、辛酸、癸酸、月桂酸、肉豆蔻酸、棕榈酸、棕榈油酸、硬脂酸、油酸、亚油酸、亚麻酸的含量,同时采用高效液相色谱（high performance liquid chromatography,HPLC）法测定锯叶棕果实提取物软胶囊中β-谷甾醇的含量。结果：11个脂肪酸甲酯化反应后产生的相应甲酯线性范围分别为：0.216~0.863,0.186~0.744,0.213~0.850,2.522~10.086,1.006~4.024,0.756~3.022,0.026~0.105,0.175~0.700,2.559~10.235,0.496~1.982和0.074~0.296 mg·m L-1,平均回收率分别为102.11%,101.38%,99.89%,101.18%,101.96%,100.75%,98.76%,102.04%,101.71%,101.77%和101.33%;β-谷甾醇的线性范围为0.100~0.750 mg·m L-1,平均回收率为98.49%。结论：所建立的分析方法准确、可靠,可用于锯叶棕果实提取物软胶囊的质量控制。Objective： To establish an analytic method for improving the quality standards of imported Sabal fruit extract soft capsules. Methods： The contents of 11 kinds of fatty acids（ caproic acid,caprylic acid,capric acid,lauric acid,myristic acid,palmitic acid,palmitoleate,stearic acid,oleic acid,linoleic acid,and linolenic acid） in Sabal fruit extract soft capsules were determined by GC,and β-sitosterol was quantited by HPLC.Results： The linear ranges of methyl esters produced by relevant fatty acids through esterification were 0. 216 ~0. 863,0. 186 ~ 0. 744,0. 213 ~ 0. 850,2. 522 ~ 10. 086,1. 006 ~ 4. 024,0. 756 ~ 3. 022,0. 026 ~ 0. 105,0. 175 ~ 0. 700,2. 559 ~ 10. 235,0. 496 ~ 1. 982,and 0. 074 ~ 0. 296 mg·m L- 1,respectively. The average recoveries of the tested compounds were 102. 11%,101. 38%,99. 89%,101. 18%,101. 96%,100. 75%,98. 76%,102. 04%,101. 71%,101. 77%,and 101. 33%. For β-sitosterol,the linear range was 0. 100 ~ 0. 750 mg·m L- 1and the average recoveries was 98. 49%. Conclusion： The established method is accurate and reliable for quality control of Sabal fruit extract soft capsules.

关 键 词：锯叶棕果实提取物软胶囊 脂肪酸 Β-谷甾醇 质量标准 气相色谱法 高效液相色谱法 

分 类 号：R285[医药卫生—中药学]