金铁锁总皂苷醇质体凝胶的制备及评价  

Preparation and evaluation of Psammosilene tunicoids total saponins ethosome gels

作　　者：尹子丽 李秀楠 吴倩 张记旋 陈凌云 王海云 YIN Zi-li;LI Xiu-nan;WU Qian;ZHANG Ji-xuan;CHEN Ling-yun;WANG Hai-yun(Yunnan University of Chinese Medicine,Yunnan Key Laboratory of Dai Medicine and Yi Medicine,Kunming Yunnan 650500,China;College of Traditional Chinese Medicine,Yunnan University of Chinese Medicine,Kunming Yunnan 650500,China;Yunnan Free Trade Zone Ruizhicheng Pharmaceutical Technology Co.Ltd.,Kunming Yunnan 650217,China)

机构地区：[1]云南中医药大学云南省傣医药与彝医药重点实验室,云南昆明650000 [2]云南中医药大学中药学院,云南昆明650000 [3]云南自由贸易试验区睿之成医药科技有限公司,云南昆明650217

出　　处：《时珍国医国药》2024年第13期2993-2998,共6页Lishizhen Medicine and Materia Medica Research

基　　金：云南省科技厅-云南中医药大学应用基础研究联合专项(202001AZ070001-034)。

摘　　要：目的优化金铁锁总皂苷醇质体凝胶的制备工艺,并对其进行质量及安全评价。方法以综合评分为主要考察指标,以卡波姆940、甘油、丙二醇用量为考察因素设计响应面实验,优化金铁锁总皂苷醇质体凝胶处方,对最优处方凝胶进行质量评价,对比醇质体凝胶及普通凝胶透皮性能,并以家兔皮肤刺激性实验对其进行用药安全评价。结果金铁锁总皂苷醇质体凝胶最优处方为卡波姆940比例1.95%、甘油比例7.69%、丙二醇比例5.75%。所制得的金铁锁总皂苷醇质体凝胶外观为乳白色、半透明状,且具有良好的物理稳定性和光稳定性,平均综合评分为91.0933分。金铁锁总皂苷醇质体凝胶的Q_(12h)为118μg/cm^(2),金铁锁总皂苷凝胶的Q_(12h)为83μg/cm^(2)。皮肤刺激性实验显示家兔皮肤刺激评分为0,病理切片无组织病理学改变。结论建立的金铁锁总皂苷醇质体凝胶制备方法稳定可行,所制备的醇质体可有效促进药物的透皮性能,并具有用药安全性,具备进一步应用于临床用药的潜能。Objective To optimize the formulation and preparation technology of Psammosilene tunicoids total saponins ethosomes gels,and to evaluate its quality and safety.Methods The response surface experiment was designed with the comprehensive score as the main evaluation index,and the proportion of carbomer 940,glycerol and propyl glycol as the investigation factors to optimize the prescription of Psammosilene tunicoids total saponins ethosome gels.Evaluate the quality of the best prescription gels,and compared the transdermal performance of ethosome gel with the ordinary gel.And evaluated the drug safety by the rabbit skin irritation experiment.Results The optimal prescription of Psammosilene tunicoids total saponins ethosome gels was carbomer 940 proportion of 1.95%,glycerol proportion of 7.69%and propyl glycol proportion of 5.75%.The prepared ethosome gels gels of Psammosilene tunicoids total saponins were milky white,translucent,and has good physical stability and light stability,the average comprehensive score was 91.0933.The Q12h of Psam⁃mosilene tunicoids ethosome gels was 118μg/cm2,The Q12h of Psammosilene tunicoids total saponins gels was 83μg/cm2.The skin irri⁃tation test showed that the rabbit skin irritation score was 0,and there were no histopathological changes in the pathological sections.Conclusion The established preparation method of Psammosilene tunicoids total saponins ethosome gels was stable and feasible,and the preparation of Psammosilene tunicoids total saponins ethosome could effectively promote the transdermal performance of drugs.And it had medication safety and the potential for further application in clinical medication.

关 键 词：金铁锁总皂苷 醇质体 凝胶 处方优先 质量评价 安全评价 

分 类 号：R283[医药卫生—中药学]