复方斯亚旦生发油质量标准提升

Improvement of Quality Standard of Fu-fang Si-ya-dan Oil

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.