复方斯亚旦生发油质量标准提升
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摘要
目的:提升复方斯亚旦生发油的质量标准。方法:采用薄层色谱法对复方斯亚旦生发油中的桃仁进行定性鉴别;按照《中华人民共和国药典》2015年版四部通则0713项下脂肪与脂肪油测定法有关的各项规定,测定10批复方斯亚旦生发油样品的酸值、皂化值、羟值、碘值、过氧化值,并制订各自的限度值;采用高效液相色谱法测定复方斯亚旦生发油中苦杏仁苷的含量。结果:制剂中桃仁的薄层斑点清晰,分离度好,专属性强,阴性对照无干扰。苦杏仁苷含量在0.009 8～0.058 8 mg·mL~(-1)(r=0.999 9),峰面积与进样浓度具有良好的线性关系。平均加样回收率为98.68%,RSD为1.6%。结论:所建立的方法可靠、准确、专属性强,可以用于该制剂的质量控制。
Objective:To improve the quality standard of Fu-fang Si-ya-dan Oil.Methods:The TLC method was used to identify the Persicae Semen in Fu-fang Si-ya-dan Oil.The content of acid value,saponification value,hydroxyl value,iodine value and peroxide value of the 10 batches of Fu-fang Si-ya-dan Oil were determined based on the methods of Pharmacopoeia of the People's Republic of China,and then their limits were determined.The content of amygdalin was determined by HPLC.Results:The developed TLC spots were clear,separation was good and specific,and the blank test showed no interference.Determination of amygdalin in Fu-fang Si-ya-dan Oil showed a good linear relationship in the range of 0.009 8～0.058 8 mg·mL~(-1)(r=0.999 9),its average recovery rate was 98.68%,and RSD was 1.6%.Conclusion:The method is reliable,accurate and specific.It can be used for quality control of Fu-fang Si-ya-dan Oil.
Objective:To improve the quality standard of Fu-fang Si-ya-dan Oil.Methods:The TLC method was used to identify the Persicae Semen in Fu-fang Si-ya-dan Oil.The content of acid value,saponification value,hydroxyl value,iodine value and peroxide value of the 10 batches of Fu-fang Si-ya-dan Oil were determined based on the methods of Pharmacopoeia of the People's Republic of China,and then their limits were determined.The content of amygdalin was determined by HPLC.Results:The developed TLC spots were clear,separation was good and specific,and the blank test showed no interference.Determination of amygdalin in Fu-fang Si-ya-dan Oil showed a good linear relationship in the range of 0.009 8～0.058 8 mg·mL~(-1)(r=0.999 9),its average recovery rate was 98.68%,and RSD was 1.6%.Conclusion:The method is reliable,accurate and specific.It can be used for quality control of Fu-fang Si-ya-dan Oil.
引文
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[14] 海热尼沙·黑提甫,凯赛尔·阿不拉,苏来曼·哈力克.RP-HPLC法测定维吾尔药材黑种草子中常春藤皂苷元的含量[J].中国民族医药杂志,2011,40(8):40-42.
[15] 蔡霞,李聪颖,张雨欣,等.石榴皮、石榴子质量标准提高研究[J].世界科学技术—中医药现代化,2015,17(5):1007-1011.
[16] 刘晓芳,马新玉,刘晓方.石榴籽质量标准的研究[J].新疆中医药,2007,25(4):14-16.
[2] 赵慧,周素琴,杨飞,等.赤芍桃仁颗粒质量标准研究[J].中国药房,2007,18(24):1882-1885.
[3] 张璐,翁立冬.金嗓散结丸质量标准的研究[J].山西医科大学学报,2011,42(8):641-644.
[4] 次旦扎西,刘松青,林彩.脑伤泰颗粒剂中红花和桃仁的薄层色谱鉴别[J].中国药业,2003,12(9):57.
[5] 庞会明,李爽,范玲,等.清肺消痤颗粒的薄层鉴别研究[J].中国实验方剂学杂志,2013,19(18):123-125.
[6] 翟艳丽,万丹.伤痛舒胶囊的质量标准研究[J].湖南中医杂志,2012,28(3):142-143.
[7] 谭洪泉,马玉梅,李岩.安肾丸质量标准研究[J].中国现代中药,2013,15(6):510-513.
[8] 国家药典委员会.中华人民共和国药典:一部[M].北京:中国医药科技出版社,2015:93,277,345.
[9] 李正洪,彭霞,姜明辉,等.傣药黑种草籽质量标准研究[J].中国民族民间医药,2009,37(4),166-167.
[11] 彭霞,陈才义,林艳芳.傣药七味木盍藤子丸质量标准研究[J].中成药,2005,27(7):780-783.
[11] 刘晓芳,党向红,任永凤.黑种草子质量标准的研究[J].中国民族医药杂志,2007,35(3):47-49.
[12] 王园姬,陈文,骆从艳,等.维药瘤果黑种草子质量标准研究[J].中成药,2010,32(7):1268-1270.
[13] 史荣梅,耿东升,李新霞.HPLC 法测定瘤果黑种草子中常春藤皂苷元及齐墩果酸含量[J].解放军药学学报,2012,28(3):245-247.
[14] 海热尼沙·黑提甫,凯赛尔·阿不拉,苏来曼·哈力克.RP-HPLC法测定维吾尔药材黑种草子中常春藤皂苷元的含量[J].中国民族医药杂志,2011,40(8):40-42.
[15] 蔡霞,李聪颖,张雨欣,等.石榴皮、石榴子质量标准提高研究[J].世界科学技术—中医药现代化,2015,17(5):1007-1011.
[16] 刘晓芳,马新玉,刘晓方.石榴籽质量标准的研究[J].新疆中医药,2007,25(4):14-16.