Page 61 - 2020年21期

基于AHP-CRITIC法赋权的星点设计-效应面法优化瓜子金乳膏

处方及其质量评价 Δ

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李学娥 1，2＊ ，张 蜀 ，邓 红 ，吕竹芬 ，谭钰霖 ，陈佳敏 ，余予善（1.广东药科大学新药研发中心/广东省
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新剂型重点实验室，广州 510006；2.广东省局部精准药物传递制剂工程技术研究中心，广州 510006）
中图分类号 R283.6 文献标志码 A 文章编号 1001-0408（2020）21-2615-07
DOI 10.6039/j.issn.1001-0408.2020.21.10
摘 要 目的：优化瓜子金乳膏的制备处方，并对所制乳膏的质量进行评价。方法：以离心稳定性、耐热稳定性、黏稠度为考察指
标，通过层次分析法（AHP法）、基于指标相关性的指标权重确定方法（CRITIC法）、AHP-CRITIC 混合加权法确定各指标的权重并
计算综合评分，采用星点设计-效应面法筛选瓜子金乳膏处方中十八醇、十六醇、混合乳化剂（聚山梨酯60与单硬脂酸甘油酯以质
量比 2.82 混合）的用量，对优化处方进行验证。对按最优处方制备的瓜子金乳膏的外观性状、粒度、pH、稳定性及流变学特性
进行评价。结果：按照 AHP-CRITIC 混合加权法得到离心稳定性、耐热稳定性、黏稠度 3 个指标的权重分别为 0.428 5、0.415 6、
0.155 9。最优处方为十六醇1.96 g、十八醇5.17 g、混合乳化剂2.48 g、聚山梨酯60 1.83 g、单硬脂酸甘油酯0.65 g、苯甲醇1 g、丙二
醇 5 g、肉豆蔻酸异丙酯 6 g、瓜子金提取液 5 g，然后加水至 100 g。所制乳膏为浅黄色流体状膏体，粒度为 0.5～2.5 μm，pH 值为
6.5；离心、耐热及耐寒稳定性试验结果显示，乳膏均无油水分离、膏体变粗等现象；所制乳膏为剪切变稀型非牛顿流体。结论：成
功制备了瓜子金乳膏，该制剂具有良好的外观性状、粒度、酸碱性和稳定性。
关键词 瓜子金乳膏；星点设计-效应面法；处方优化；质量评价；流变学特性
Optimization of the Formulation of Polygala japonica Cream by Central Composite Design-response
Surface Methodology Based on AHP-CRITIC Analysis and Its Quality Evaluation
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LI Xue’e ，ZHANG Shu ，DENG Hong ，LYU Zhufen ，TAN Yulin ，CHEN Jiamin ，YU Yushan（1. Center
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for New Drug Research and Development，Guangdong Pharmaceutical University/Guangdong Provincial Key
Laboratory of Advanced Drug Delivery，Guangzhou 510006，China；2. Guangdong Engineering & Technology
Research Center of Local Precision Drug Delivery System，Guangzhou 510006，China）
ABSTRACT OBJECTIVE：To optimize the formulation of Polygala japonica cream，and to evaluate the quality of prepared
cream. METHODS：With centrifugal stability，heat resistance stability and viscosity as evaluation indexes，the weight coefficient
was determined by analytic hierarchy process（AHP），criteria importance through intercriteria correlation（CRITIC）method and
mixed weighted AHP-CRITIC，and the comprehensive score was calculated. The amount of octadecyl alcohol，hexadecanol and
mixed emulsifier（polysorbate 60 mixed with glycerin monostearate at the mass ratio of 2.82）in the formulation of P. japonica
cream were screened by central composite design-response surface methodology. The optimized formulation was validated. P.
japonica cream prepared by the optimal preparation was evaluated in terms of apperance，particle，pH，stability and rheological
characteristics. RESULTS：The weight coefficients of centrifugal stability，heat resistance stability and viscosity were 0.428 5，
0.415 6 and 0.155 9 respectively，according to the mixed weighted AHP-CRITIC. The optimal formulations were 1.96 g of
hexadecyl alcohol，5.17 g of octadecyl alcohol，2.48 g of mixed emulsifier，1.83 g of polysorbate 60，0.65 g of glyceride
monostearate，1 g of benzyl alcohol，5 g of propylene glycol，6 g of isopropyl myristate and 5 g of P. japonica extract，and then
added water to 100 g. Prepared cream was a light yellow fluid paste with particle size of 0.5-2.5 μm and pH value of 6.5；the
results of centrifugal test，heat resistance test and cold resistance stability test showed that the cream had no oil-water separation or
thickened paste. The prepared cream was shear-thinning non-Newtonian fluid. CONCLUSIONS：P. japonica cream is prepared
successfully，which shows good apperance，particle，acidity and stability.
KEYWORDS Polygala japonica cream；Central composite design-response surface methodology；Formulation optimization；
Quality evaluation；Rheology characteristics

瓜子金始记载于《植物名实考录》，为远志科植物瓜
Δ 基金项目：广东省自然科学基金资助项目（No.2019A15150-
子金Polygala japonica Houtt.的干燥全草，春季花开时采
11018）
[1]
挖，除去泥沙，晒干即得 。在多个本草著作中均提及了
＊ 硕 士 研 究 生 。 研 究 方 向 ：药 物 研 发 与 转 化 。 E-mail：
3042812142@qq.com 其作用及功效，如《生草药性备药》中记载：“理跌打，去
[2]
# 通信作者：教授，硕士生导师。研究方向：缓控释制剂及中药新 淤生新，能止痛消肿，散毒气”；《江西草药》中记载：“清
[3]
剂型。电话：020-39352507。E-mail：linzhangshu@tom.com 热解毒，活血止血，治毒蛇咬伤、风湿性关节炎”；2015
中国药房 2020年第31卷第21期 China Pharmacy 2020 Vol. 31 No. 21 ·2615 ·