| 复方斯亚旦生发油质量标准提升 |
| 投稿时间：2018-07-30 点此下载全文
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| 引用本文：马建文,贾春燕,夏米西奴尔·艾买提江,马娟,孟玲,王萍.复方斯亚旦生发油质量标准提升[J].中国现代中药,2019,21(4):512-516 |
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| 基金项目:《中华人民共和国药典》药品标准提高项目（No.6） |
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| 中文摘要: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。 |
| 中文关键词:复方斯亚旦生发油 质量标准 高效液相色谱 薄层色谱 苦杏仁苷 |
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| Improvement of Quality Standard of Fu-fang Si-ya-dan Oil |
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| Abstract: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. |
| keywords:Fufang Siyadan Oil quality standards HPLC TLC amygdalin |
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