目的 制備苦參堿固體自微乳顆粒，并對(duì)其進(jìn)行質(zhì)量評(píng)價(jià)。方法 通過(guò)固體吸附材料的優(yōu)選，制備了苦參堿固體自微乳顆粒，建立了HPLC法測(cè)定顆粒中苦參堿及其體外溶出度的方法；對(duì)溶解后微乳的類(lèi)型、pH值、Zeta電位、粒徑進(jìn)行研究。結(jié)果 選擇微粉硅膠與甘露醇質(zhì)量比2∶1為固體吸附材料，每克苦參堿微乳液需加微粉硅膠0.42 g，微晶纖維素0.21 g，50 ℃恒溫干燥后成淡黃色的苦參堿自微乳顆粒，遇水快速形成澄明的液體，平均粒徑79 nm，pH值為7.95，Zeta電位?1.34 mV，載藥量23.51 mg/g，45 min內(nèi)累積溶出94.2%以上。結(jié)論 苦參堿固體自微乳的制備工藝簡(jiǎn)單，制劑穩(wěn)定，可為水難溶性藥物的開(kāi)發(fā)提供一個(gè)新方法、新思路。

Objective To develop the matrine solid self-microemulsifying drug delivery syetem (S-SMEDDS) and to evaluate its quality. Methods The matrine solid self-microemulsifying granule was prepared through the optimization of solid adsorption material, the HPLC method and dissolution test were used to determine the drug content in matrine S-SMEDDS, and the particle form, pH value, Zeta potential, and particle size were studied after it was dissolved. Results The ratio of micro powder silica gel and mannitol (2∶1) was selected as the solid adsorption material, and 1 g of matrine micro-emulsion needed to add 0.42 g of micronized silica gel and 0.21 g of microcrystalline cellulose. The color of the matrine microemulsion particle was pale yellow after 50 ℃ constant temperature drying. Transparent liquid was formed quickly after it was dissolved. The average particle size was 79 nm, the pH value was 7.95, the Zeta potential was ?1.34 mV, the drug loading was 23.51 mg/g, and the cumulative dissolution was over 94.2% within 45 min. Conclusion The preparation technology of matrine S-SMEDDS is simple and stable, and provides a means for the research and development of dissolvable drugs.