响应面法优化纳豆银杏叶丹参软胶囊的制备工艺

Optimization of the Preparation Process for Natto-Ginkgo Biloba-Salvia Soft Capsules Using Response Surface Methodology

摘要: 为优化纳豆银杏叶丹参软胶囊的制备工艺，提升产品有效成分溶出率与制剂稳定性，采用单因素实验结合Box-Behnken响应面法开展研究。以纳豆粉、银杏叶提取物、丹参提取物为核心原料，选取原料配比、聚乙二醇400添加量、压制温度为关键影响因素，以综合评分为响应值，考察各因素对制剂质量的影响。结果表明：最优制备工艺参数为原料配比2.5:2.2:1 (g:g:g)、聚乙二醇400添加量16%、压制温度30℃，在此条件下制备的软胶囊综合评分为92.3分，其中纳豆激酶活性达1280 IU/粒、总黄酮溶出率为91.5%、硬度为78 N；验证实验结果与模型预测值偏差小于2%，表明该模型拟合性良好，工艺参数稳定可靠，可为纳豆银杏叶丹参软胶囊的工业化生产提供技术支撑。

Abstract: To optimize the preparation process of Natto-Ginkgo Biloba-Salvia soft capsules and improve the dissolution rate of active ingredients and formulation stability, a study was conducted using single-factor experiments combined with Box-Behnken response surface methodology. Using natto powder, Ginkgo biloba extract, and Salvia miltiorrhiza extract as the core materials, the material ratio, PEG-400 addition amount, and soft capsule sealing temperature were selected as key influencing factors. A comprehensive evaluation score was used as the response value to systematically investigate the effects of these factors on the formulation quality. The results indicated the optimal preparation parameters as follows: material ratio of 2.5:2.2:1 (g:g:g), PEG-400 addition amount of 16%, and sealing temperature of 30˚C. Under these conditions, the soft capsules achieved a comprehensive score of 92.3 points, with nattokinase activity reaching 1280 IU/capsule, total flavonoid dissolution rate of 91.5%, and hardness of 78 N. The deviation between the verification experiment results and the model predictions was less than 2%, indicating good model fit and stable, reliable process parameters. This study provides technical support for the industrial production of Natto-Ginkgo Biloba-Salvia soft capsules.