含丹酚酸的丹参酮微乳处方工艺研究  

Study on Microemulsion Formulation of Radix Salvia Miltiorrhiza Containing Salvianolic Acid

作　　者：蒋俏丽 刘乐环 黄瑞雪[1] 茅玉炜 黎翊君 翟文文[1] 戴俊东[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《世界科学技术-中医药现代化》2016年第3期498-504,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：北京中医药大学自主选题资助项目(2015-JYB-XS108):丹参吸入粉雾剂的制备及其特发性肺纤维化的药效学评价;负责人:翟文文

摘　　要：目的:制备丹参多组分复合微乳,优选最佳处方及制备工艺。方法:结合伪三元相图法与单纯形网格法,以微乳粒径、包封率和载药量为评价指标,通过Design Expert 8.06软件进行试验设计和模型构建,响应面数据分析优化和验证最佳处方。结果:最终优选出的微乳处方为肉豆蔻酸异丙酯?15-羟基硬脂酸聚乙二醇酯(solutrol-HS 15)-二乙二醇单乙基醚(transcutol P)(4?1)?纯化水为13.3?31.7?55.0,此时微乳粒径为12.88±0.57 nm,丹参酮IIA包封率为98.00±2.26%,丹参酮IIA和丹酚酸B的载药量分别为5.30±0.03、2.43±0.01 mg·g-1。结论:该法制得的微乳中丹参酮IIA包封率及载药量均较高,粒径较小,为丹参微乳制剂的开发与应用提供科学依据。This study aimed to optimize the formulation and preparation process of Salvia miltiorrhiza multicomponent microemulsion. Combined with pseudo three phase diagram method and simplex lattice design, particle size, entrapment efficiency and drug loading of microemulsion were selected as evaluation indexes. Experimental design and model establishment were performed by Expert Design 8.06 software. Final microemulsion formulation was optimized and validated by the response surface data analysis. It was found that the component proportion of the final optimized microemulsion formulation was as follows： ratio of isopropyl myristate（IPM） to Solutrol-HS 15-Transcutol P（4？1） to purified water was 13.3 to 31.7 to 55.0. Particle size of the final microemulsion formulation was 12.88±0.57 nm, while entrapment efficiency of tanshinone II 98.00±2.26%, and drug loading of tanshinone II A and salvianolic acid B 5.30±0.03, 2.43±0.01 mg·g^-1, respectively. It was concluded that the high entrapment efficiency and drug loading rate of tanshinone II, small particle size were obtained in the microemulsion prepared by optimized formulation, which provided scientific basis for further development and application of Salvia miltiorrhiza multicomponent microemulsion.

关 键 词：丹参总酚酸 总丹参酮 单纯形网格法 微乳 处方优化 含量测定 

分 类 号：R283[医药卫生—中药学]