摘要
目的制备复方紫草阴道用微乳-原位凝胶并进行质量评价。方法以肉豆蔻异丙酯(IPM)为油相,分别以聚氧乙烯-35-蓖麻油(EL-35)和丙三醇为乳化剂和助乳化剂,以泊洛沙姆407(P407)和泊洛沙姆188(P188)为温敏凝胶基质,制备复方紫草微乳-原位凝胶,并对微乳及凝胶的性状、粒径、流变学性质、体外释放特性等进行考察。结果最佳微乳-原位凝胶处方中凝胶基质组成为P407100 mg·mL^(-1),P18820 mg·mL^(-1),凝胶平均粒径(23.23±0.29)nm。体外释放实验表明,复方紫草微乳-原位凝胶释放符合零级动力学特性,药物释放由凝胶溶蚀决定。结论复方紫草阴道用微乳-原位凝胶制备工艺简单可行,凝胶具有良好的理化性质及体外释放性能。
Objective To develop the formulation of the compound Lithospermum erythrorhizon microemulsion based vaginal in situ gel,and to evaluate its quality.Methods Using isopropyl myristate(IPM)as oil phase,cremophor EL-35(EL-35)as surfactant,glycerol as co-surfactant,and poloxamer 407(P407)and poloxamer 188(P188)as temperature-sensitive materials,the compound Lithospermum erythrorhizon microemulsion based vaginal in situ gel was prepared.And then we investigated the characteristics,particle size,rheological properties and in vitro release characteristics of the microemulsion gel.Results The optimal gel formula was as followed:the concentration of P407 was 100 mg·mL^(-1)and P18820 mg·mL^(-1).The average diameter was(23.23±0.29)nm.The in vitro diffusion method showed a zero-order release of the gel.And the drug release was determined by gel dissolution.Conclusion The preparation of compound Lithospermum erythrorhizon microemulsion gel is feasible in technique.The vaginal gel showed good behaviors of physicochemical properties and release properties in vitro.
作者
赵玉娜
刘青
何艳萍
高婷
陈晶
ZHAO Yuna;LIU Qing;HE Yanping;GAO Ting;CHEN Jing(Preparation Center,General Hospital of Ningxia Medical University,Yinchuan 750004,China)
出处
《医药导报》
CAS
北大核心
2022年第11期1660-1665,共6页
Herald of Medicine
基金
宁夏回族自治区重点研发一般项目(2019BEG03067)
宁夏自然科学基金资助项目(2019AAC03238)。
关键词
复方紫草
微乳-原位凝胶
体外释放
零级动力学
Compound Lithospermum erythrorhizon
In situ microemulsion gel
In vitro release
Zero-order release
