烟草烟油乳膏剂的制备及其质量标准研究

Preparation and Quality Standard of Tobacco Oil Cream

目的:制备烟草烟油乳膏剂,并建立其质量标准。方法:用超声法提取制备烟草烟油,然后用乳化法制备烟草烟油乳膏剂,并分别采用薄层色谱法和高效液相色谱法对乳膏剂中主成分烟碱进行鉴别和含量测定,再进行稳定性和刺激性试验。结果:烟草烟油乳膏剂稳定好,无刺激性,其特征成分主要为烟碱,含量为0.52%,以薄层色谱法和高效液相色谱法进行鉴别和含量测定,方法准确、简便、快速。结论:烟草烟油乳膏剂制备成功,质量符合《中华人民共和国药典》乳膏剂下相关规定。

Objective ：To prepare tobacco oil cream and establish its quality standard. Methods：The ultrasonic method was used to extract the tobacco oil and emulsion method was used to prepare tobacco oil cream. And then thin layer chro- matography （TLC） and high performance liquid chromatography （HPLC） were used to identify and control the main com- ponent of nicotine in tobacco oil cream. Above all, the stability and stimulation of tobacco oil cream were also tested. Results ： Tobacco oil cream was stable and had no stimulation to the skin and the content of nicotine in tobacco oil cream was 0.52% as its characteristic component. TLC and HPLC were used to identify and control nicotine in tobacco oil cream were accurate, simple and fast. Conclusion：Tobacco oil cream was prepared successfully and its quality was in accordance with the relevant provisions of Chinese Pharmacopoeia.