目的 優(yōu)化烏拉草總黃酮脂質(zhì)體凝膠劑的制備工藝，并進(jìn)行質(zhì)量評價。方法 乙醇注入法制備烏拉草總黃酮（CMTF）脂質(zhì)體，以包封率為指標(biāo)，正交試驗(yàn)優(yōu)化處方；以脂質(zhì)體凝膠劑的外觀、涂展性、均勻度、黏稠度等綜合評分為指標(biāo)，采用Box-Behnken響應(yīng)面法優(yōu)化CMTF脂質(zhì)體凝膠的處方及制備工藝。通過觀察性狀、pH值、鋪展性及可洗除性，以及離心試驗(yàn)、耐寒及耐熱試驗(yàn)，考察CMTF脂質(zhì)體凝膠穩(wěn)定性；觀察其對大鼠正常及破損皮膚的刺激性。結(jié)果 CMTF脂質(zhì)體的最佳制備工藝為：大豆磷脂與膽固醇的質(zhì)量比為5：3，大豆磷脂與CMTF的質(zhì)量比為4：1，注入體積比例1：10；平均包封率為89.41%，粒徑為（119.7±3.82）nm，Zeta電位為（-20.80±0.40）mV。CMTF脂質(zhì)體凝膠劑的最佳處方為：1 g CMTF脂質(zhì)體、2 g卡波姆940、20 g甘油、2 g三乙醇胺、10 mL水，該脂質(zhì)體凝膠劑的穩(wěn)定性良好，無皮膚刺激性。結(jié)論 優(yōu)化后的CMTF脂質(zhì)體凝膠制備工藝簡單，質(zhì)量穩(wěn)定，為CMTF經(jīng)皮制劑的開發(fā)提供依據(jù)。

Objective To optimize the formulation of of Carex meyeriana Total Flavonoid Liposome Gel and evaluate its quality. Methods The total flavonoid of Carex meyeriana Kunth (CMTF) liposomas was prepared by ethanol injection method, the encapsulation rate of CMTF was used as an index to optimize the formulation by orthogonal test. Based on the formation of appearance, malleability, uniformity and viscosity as the index, the Box-Behnken response surface method was used to optimize the formulation and preparation process of the CMTF liposome gel. The stability of CMTF liposome gel was investigated by observing its properties, pH value, spreading property, washable property, and centrifugal test, cold resistance test and heat resistance test. The irritation to normal and damaged skin of rats was observed. Results The optimum technological conditions of CMTF liposome gel was:soybean lecithin to cholesterol ratio of 5:3,soybean lecithin to CMTF ratio of 4:1, the injection volume ratio of 1:10; average encapsulation efficiency of 89.41%, the particle size was (119.7±3.82) nm and the Zeta was (-20.80±0.40) mV. The best formulation of CMTF liposome gel was:1 g of CMTF liposome freeze-dried powder, 2 g of carbomer 940, 20 g of glycerol, 2 g of triethanolamine, 10 mL of water. The liposome gel has good stability and no skin irritation. Conclusion The optimized liposome gel was simple in preparation and stable in quality, which provided a basis for the development of transdermal preparations of CMTF.

R943

吉林省科技廳項(xiàng)目（20200602034ZP）；吉林省發(fā)展和改革委員會項(xiàng)目（2020C007）