摘要
目的研究臭氧油包合物凝胶的处方与制备工艺,并对其进行评价。方法以羟丙基-β-环糊精(hydroxypropyl-β-cyclodextrin,HP-β-CD)为包合材料,卡波姆-940为基质制备臭氧油包合物凝胶,并对其外观性状、pH值、黏度、过氧化值、保湿率、流变学性质、稳定性、抑菌性能和生物安全性进行评价。结果最终得到外观为澄清、无颗粒感、均匀细腻、有光泽、黏度适中、无油腻性的半固体凝胶;pH值为(5.48±0.01),黏度为(46.78±0.18)Pa·s,保湿率在放置24、36、48 h后分别为(96.69±0.75)%、(95.84±0.44)%、(94.12±0.89)%;流变学性质良好;稳定性试验表明臭氧油凝胶不宜放在高温保存。抑菌结果显示,臭氧油凝胶对金黄色葡萄球菌、白色念珠菌、大肠埃希菌均有抑菌效果,金黄色葡萄球菌和大肠埃希菌抑菌率达到95%以上,白色念珠菌抑菌率达到80%以上;生物安全性评价试验表明,臭氧油凝胶无阴道黏膜刺激性、无皮肤致敏反应和无急性全身毒性反应。结论此方法制备臭氧油包合物凝胶的工艺简便可行、易于操作,在药品及化妆品领域中具有一定的推广价值和应用前景,为臭氧油的进一步工业化应用奠定了实验基础。
OBJECTIVE To study and evaluate the formulation and preparation process of ozone oil inclusion compound gel.METHODS Hydroxypropyl-β-cyclodextrin(HP-β-CD)was the inclusion material and Carbome-940 was the matrix to prepare the ozone oil inclusion compound gel,and its appearance,pH value,viscosity,peroxide value,moisture retention rate,rheological properties,stability,bacteriostatic performance and biological safety were evaluated.RESULTS Finally,the semi solid gel with clear appearance,no particle feeling,uniform,fine,shiny,moderate viscosity and no greasy property was obtained.The pH value was(5.48±0.01),the viscosity was(46.78±0.18)Pa·s,and the moisture retention rates were(96.69±0.75)%,(95.84±0.44)%,and(94.12±0.89)%after 24,36,and 48 hours of storage,respectively,with good rheological properties.The stability test showed that ozone oil gel should not be stored at high temperature.The bacteriostatic results showed that the ozone oil gel had bacteriostatic effects on Staphylococcus aureus,Candida albicans and Escherichia coli.The bacteriostatic rate of Staphylococcus aureus and Escherichia coli reached more than 95%,and the bacteriostatic rate of Candida albicans reached more than 80%.The biosafety evaluation test showed that the ozone oil gel had no vaginal mucosa irritation,skin sensitization and acute systemic toxicity.CONCLUSION The process of preparing ozone oil inclusion compound gel by this method is simple,feasible and easy to operate.It has certain promotion value and application prospect in drugs and cosmetics,which lays an experimental foundation for further industrial application of ozone oil.
作者
吴玉欢
彭颖
雷晓萌
魏鑫华
张观生
王堂勋
李东勲
张国松
WU Yuhuan;PENG Ying;LEI Xiaomeng;WEI Xinhua;ZHANG Guansheng;WANG Tangxun;LI Dongxun;ZHANG Guosong(National Engineering Research Center of Chinese Medicine Solid Preparation Manufacturing Technology,Jiangxi University of Chinese Medicine,Nanchang 330006,China;Integrated Chinese and Western Medicine Institute for Children Health&Drug Innovation,Jiangxi University of Chinese Medicine,Nanchang 330006,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2024年第18期1725-1734,共10页
Chinese Pharmaceutical Journal
基金
国家自然科学基金项目资助(81960720,82260771)
江西中医药大学创新药物研究与开发创新团队项目资助(CXTD22001)。
作者简介
吴玉欢,女,硕士研究生,研究方向:药物新剂型与新技术;通信作者:张国松,男,博士,教授,研究方向:药物新剂型与新技术研究.Tel:(0791)87119617;通信作者:李东勲,男,博士,副教授,研究方向:新药开发及仿制药一致性评价研究.Tel:(0791)87119617。
