[1]杨娟,甄世福,袁文珺,等.应用Box-Behnken设计-响应面法优化复方白鲜皮软膏剂的成型工艺[J].西部中医药,2025,38(04):1-5.[doi:10.12174/j.issn.2096-9600.2025.04.01]
　YANG Juan,ZHEN Shifu,YUAN Wenjun,et al.Optimization of the Molding Process of Compound Baixianpi Ointment Using the Box-Behnken Design-response Surface Methodology[J].Western Journal of Traditional Chinese Medicine,2025,38(04):1-5.[doi:10.12174/j.issn.2096-9600.2025.04.01]
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应用Box-Behnken设计-响应面法优化复方白鲜皮软膏剂的成型工艺()
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
38
期数:
2025年04期
页码:
1-5
栏目:
质量分析
出版日期:
2025-04-15

文章信息/Info

Title:
Optimization of the Molding Process of Compound Baixianpi Ointment Using the Box-Behnken Design-response Surface Methodology
作者:
杨娟1, 甄世福2, 袁文珺1, 柴露露3, 陈娟江3, 魏其云1
1.兰州市中医医院，甘肃 兰州 730050
2.甘肃省中医院，甘肃 兰州 730050
3.兰州大学药学院，甘肃 兰州 730000
Author(s):
YANG Juan1, ZHEN Shifu2, YUAN Wenjun1, CHAI Lulu3, CHEN Juanjiang3, WEI Qiyun1
1.Lanzhou Hospital of Traditional Chinese Medicine, Lanzhou 730050, China
2.Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, China
3.College of Pharmacy, Lanzhou University, Lanzhou 730000, China
关键词:
复方白鲜皮软膏剂; 基质; Box-Behnken设计-响应面法; 成型工艺
Keywords:
compound ointment; matrix; Box-Behnken design-response surface methodology; the molding process
分类号:
R283
DOI:
10.12174/j.issn.2096-9600.2025.04.01
文献标志码:
A
摘要:
目的优选复方白鲜皮湿疹方的软膏剂成型工艺。 方法通过预实验，以软膏外观均匀度、稳定性、涂展性为评价指标进行综合评分，从油脂性、水溶性和乳剂型（W/O型和O/W型）基质中筛选出最佳基质类型；采用单因素实验和Box-Behnken设计-响应面法优选制备工艺，对油相和水相的用量进行优化，确定最佳的基质处方。 结果Box-Behnken响应面模型P＜0.000 1，失拟项P＞0.05，该模型显著性高且拟合程度良好；经Design-Expert软件分析，最优制备工艺参数为：白凡士林1.600 g，羊毛脂1.102 g，液状石蜡1.799 g，甘油3.600 g，根据实际制备情况，选取白凡士林1.60 g，羊毛脂1.10 g，液状石蜡1.79 g，甘油3.60 g；工艺验证试验的OD平均值为8.66，与预测值有较小偏差，3批样品的综合评分均大于25，表明软膏剂的稳定性、涂布性、均匀性良好。 结论运用Box－Behnken设计－响应面法优选的复方白鲜皮软膏剂成型工艺稳定可行。
Abstract:
ObjectiveTo optimize the molding process for the ointment of compound Baixianpi (dictamni cortex) eczema formula. MethodsThe uniformity, stability, and spreadability of ointment were used as evaluation indicators to conduct the comprehensive scoring in the pre-experiment, and the best matrix type was selected from the oil-based, water-soluble and emulsion (W/O type and O/W type) matrix; Single factor experiment and Box-Behnken design-response surface methodology were used to optimize the preparation process, including the amount of oil phase and water phase, and then to determine the best matrix prescription. ResultsThe Box-Behnken design-response surface model P<0.000 1, and P>0.05 for the test of lack-of-fit, indicating high significance and good fit; The analysis using Design-Expert software revealed that the optimal parameters of the preparation process were: petrolatum 1.600 g, lanolin 1.102 g, liquid paraffin 1.799 g and glycerin 3.600 g, based on actual preparation conditions, 1.60 g of petrolatum, 1.10 g of lanolin, 1.79 g of liquid paraffin, and 3.60 g of glycerin were selected; the average OD value from the process validation trials was 8.66, with a small deviation from the predicted value, the comprehensive scores for all three batches of samples were greater than 25, indicating good stability, spreadability, and uniformity of the ointment. ConclusionThe molding process of compound Baixianpi ointment, optimized by Box-Behnken design-response surface methodology, is stable and feasible.

相似文献/References:

[1]黄小鸥,梁国成,陈舒茵,等.跌打巴布剂复合基质的优选研究[J].西部中医药,2015,28(11):20.

备注/Memo

备注/Memo:
杨娟（1988—），女，主管药师。研究方向：中药新制剂开发与应用。兰州市卫生健康科技发展项目（2019-025）。
更新日期/Last Update: 2025-04-15