目的 優(yōu)化苦參總黃酮脂質(zhì)體凝膠劑的制備工藝，并進行質(zhì)量評價。方法 薄膜分散制備苦參總黃酮脂質(zhì)體，以苦參總黃酮的包封率為指標(biāo)，正交試驗優(yōu)化處方；以脂質(zhì)體凝膠劑的成型性、涂展性、光澤度、均勻度、pH值及穩(wěn)定性等綜合評分為指標(biāo)，星點設(shè)計-效應(yīng)面法優(yōu)化苦參總黃酮脂質(zhì)體凝膠的處方及制備工藝；通過離心試驗、低溫試驗、熱恒溫試驗考察苦參總黃酮脂質(zhì)體凝膠劑穩(wěn)定性，檢測其pH值。結(jié)果 苦參總黃酮脂質(zhì)體的最佳處方為：卵磷脂與膽固醇比為9：1，磷酸緩沖鹽pH值為7.0，苦參總黃酮的質(zhì)量為0.05 g；平均包封率83.45%，平均粒徑173.00 nm?？鄥⒖傸S酮脂質(zhì)體凝膠劑最佳處方為：卡波姆0.20 g、甘油2.59 g、三乙醇胺0.20 g，其脂質(zhì)體凝膠劑的穩(wěn)定性良好，當(dāng)溫度超過60℃時，凝膠劑的顏色變淺，pH值為6.53。結(jié)論 優(yōu)化后的苦參總黃酮脂質(zhì)體凝膠制備工藝簡單可行，質(zhì)量穩(wěn)定，為苦參總黃酮經(jīng)皮制劑的開發(fā)提供依據(jù)。

Objective The preparation process of the total flavonoid liposome gel of Sophora flavescens was optimized and the quality was evaluated. Methods Sophora flavescens flavonoid liposomas was preparated by film dispersion, the encapsulation rate of total flavone of sophora flavone was used as an index to optimize the formulation by orthogonal test. Based on the formation of liposome gel, pH and stability as the index, the star point design-effect surface method was used to optimize the formulation and preparation process of the total flavonoid liposome gel of Sophora flavescens. Evaluate the product by its stability (centrifuge test, low temperature test and thermostatic test) and pH value. Results The best prescription for total flavonoids of Sophora flavescens was:lecithin to cholesterol ratio of 9:1, phosphate buffer salt pH of 7.0, the quality of total flavonoids of Sophora flavescens was 0.05 g; average encapsulation efficiency of 83.45%, the particle size was 173 nm; The best prescription of Sophora flavescens total flavonoid liposome gel was:carbomer 0.20 g, glycerol 2.59 g, triethanolamine 0.20 g. Conclusion The optimized preparation process of total flavonoid liposome gel of Sophora flavescens L. was simple and feasible, and provides a basis for the development of this plant transdermal preparation.

R944

黑龍江省自然科學(xué)基金（H2016057，H2017066）；黑龍江中醫(yī)藥大學(xué)“優(yōu)秀創(chuàng)新人才支持計劃”項目（2012，2018）