中文摘要：

目的基于组分生物药剂学性质制备银杏内酯组分（GC）自微乳释药系统（SMDDS）（GC-SMDDS），并对组分中各成分释药行为进行相似度分析。方法采用平衡溶解度方法筛选油相、乳化剂与助乳化剂；以外观、自微乳粒径、Zeta电位、表面活性剂和助表面活性剂的比例、混合表面活性剂与油相比例为考察因素，采用伪三元相图法筛选GC-SMDDS的处方工艺。对自微乳的载药量、粒径分布、Zeta电位、稳定性等进行评价，并借助溶出相似因子、曲线线性回归斜率分析，对组分中成分释药速度与程度进行相似度分析。结果GC-SMDDS最优处方为聚山梨酯80（T80）与聚乙二醇（PEG）200质量比为4：1，T80和PEG200的总质量与辛酸癸酸甘油三酯的质量比为9：1，载药量为100mg／g，粒径小于40nm。GC-SMDDS于48h内在常温、高温及低温状态下稳定性良好，通过相似度分析可知该自微乳系统能自行调节使得各成分之间的释药量相似度达到96．9％，最终基本达到同步释药。结论GC-SMDDS不仅提高难溶性药物的溶出，还能自主调节各成分的释药行为，使得组分释药保持良好的一致性。

英文摘要：

Objective Optimization of ginkgolides components （GC） self-microemulsifying drug delivery system （SMDDS） （GC- SMDDS） and similarity analysis on each drug release. Methods Using equilibrium solubility to screen the oil phase, emulsifier, and co-emulsifier; Taking appearance, the proportion of microemulsion particle size, Zeta potential, surfactants and co-surfactants, and surfactant mixing ratio of the oil phase as study factors, pseudo-ternary phase diagrams were used to screen GC-SMDDS process. SMEDDS of drug loading, particle size distribution, Zeta potential, and stability were evaluated. With the aid of the similarity factor and the curve linear regression slope analysis, the similarity between the composition of the component and the rate and extent of drug release was analyzed. Results Optimal prescription ofpolyoxyethylene and polyethylene glycol 200 mass ratio of 4 ： 1, ethoxylates and polyethylene glycol quality and bitterness total mass of 200 capric triglycerides ratio of 9 ： 1, drug content of 100 mg/g. Particle size under 40 nm, ginkgolides 48 h internal components from microemulsion to room temperature, high temperature, and low temperature stability is good. The release quantity achieves the synchronous drug release with the similarity of 96.9%. Conclusion The SMDDS not only can improve the dissolution of difficult soluble drugs, but also independently regulate the drug release behavior of each component so as to make the drug release maintain good consistency.