紫苏叶注射液的制备

Preparation of Folium perillae Injection

[目的]提取紫苏叶中有效成分迷迭香酸,研究紫苏叶注射液的制备工艺及质量控制,为血液流变学药物的开发和临床应用提供试验依据。[方法]以紫苏叶粗粉(40μm)为原料,热水浸提,酸化处理,制备成紫苏叶水提物;以乙酸乙酯为溶剂萃取水提物中迷迭香酸,旋转蒸干乙酸乙酯制成粗品;调节pH值,分离纯化后制备成紫苏叶注射液。采用高效液相色谱法(HPLC)检测注射液中迷迭香酸的含量,根据《中国药典》(2005年版)规定检测注射液的鞣质、树脂、草酸盐含量是否超标,测定该注射液的稳定性、刺激性、溶血性、凝集性、LD50和热源性等。[结果]注射液中迷迭香酸含量为2.81 mg/ml,LD50为406.82 mg/kg,其他检查指标均符合药典规定。[结论]试验所制备的紫苏叶注射液质量稳定,符合注射要求。

[ Objective] To extract the effective component rosmarinic acid from Folium perillae, to study preparation technology and quality control of rosmarinic acid injection and provide test basis for hemorheological drug development and clinic application. [ Method ] The coarse powder of Folium perillae （40 μm） was lixiviated with hot water and acidized to make aqueous extracts. Rosmarinic acid from the aqueous mixture was extracted with Ethyl Acetate. And Et Ac was evaporated to obtain primary product. The injection was purified by pH adjustment. Concentration of rosmarinic acid in the injection was detected by high perforumnce liquid chromatography （HPLC）. Contents of tannin, resin and oxalate were eliminated according to the Chinese Pharmacopeia of 2005 year edition. Stability, irritation, haemolyticus, thermogenic substance and LD50 of this injection were also detected. [ Result] The content of rosmarinic acid in Folium perillae injection was 2.81 mg/ml, and the content of LD50 was 406.82 mg/kg. This injection was consistent with the stipulation of Chinese Pharmacopeia of 2005 year edition. [ Conclusion] The stable quality of the prepared injection meets the injection requirement.