基于基准关联度和AHP-CRITIC法的飞龙掌血配方颗粒制备工艺研究
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广西重点研发计划(桂科AB21196051); 广西壮族自治区高校黄大年式教师团队建设项目(桂教教师\[2023\]31号)


Study on the preparation process of Toddalia asiatica formula granules based on benchmark correlation degree and AHP-CRITIC comprehensive evaluation method
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    摘要:

    为了评价飞龙掌血配方颗粒现代工艺与传统制法的产品质量一致性,并建立稳定可控的生产工艺,从质量源于设计的理念出发,在单因素试验基础上,以浸泡时间、提取次数、提取时间、加水倍数为影响因素,以橙皮苷含量、毛两面针素含量、氯化两面针碱含量、特征峰相似度及出膏率为评价指标,采用响应面试验结合基准关联度和AHP-CRITIC综合赋权法优化提取工艺,并利用单因素考察法明确浓缩、干燥、成型过程的适用工艺参数。结果表明:药液最佳提取条件为加8倍水,提取1次,提取时间120 min,其工艺参数的综合得分为53.620;药液浓缩适宜相对密度为1.125~1.250 g/cm3,真空度范围为50~200 MPa,温度控制在50~90 ℃;药液干燥方式优选喷雾干燥,进样速度为8~14 mL/min,温度为160~180 ℃;成型工艺采用干法制粒,以糊精为填充剂,药辅质量比为1∶0.8~1∶1,轧辊压力为100~120 bar,送料速度为2.42~2.62 rad/s,轧辊速度为0.29~0.42 rad/s。所提工艺合理可行,可为飞龙掌血配方颗粒的工业化生产和质量控制研究提供依据。

    Abstract:

    This study evaluated the consistency of product quality between modern and traditional preparation processes for Toddalia asiatica formula granules, and aimed to establish a stable and controllable production process. Starting from the concept of quality by design, based on single factor experiments, the key factors affecting the extraction, soaking time, number of extractions, extraction time, and water volume were identified. Hesperidin content, toddaloactone content, nitidine chloride content, characteristic peak similarity, and extract yield were used as evaluation indicators. The extraction process using response surface methodology combined with reference correlation and an AHP-CRITIC comprehensive evaluation method was optimized, and suitable parameters for concentration, drying, and granulation were clarified through single-factor tests. The results indicate that the optimal extraction conditions are adding eight times the amount of water, extracting once, and extracting for 120 minutes. Under these conditions, the comprehensive score reaches 53.620. The suitable concentration density is 1.125-1.250 g/cm3, under a vacuum of 50-200 MPa, and temperature of 50-90 ℃. The study recommends spray drying for the liquid extract, with a feed rate of 8-14 mL/min and inlet temperature of 160-180 ℃. For granulation, dry processing is selected using dextrin as filler, with drug-excipient ratio from 1∶08 to 1∶1. Roller pressure is set at 100-120 bar, feeding speed at 242-262 rad/s, and roller speed at 0.29-0.42 rad/s. The proposed process is reasonable and feasible, which provides a basis for industrial production and quality control of Toddalia asiatica formula granules.

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梁秀珍,梁资就,张怡婕,覃慧杰,蒋 林,陈 清,黄小洪,谢孟姣,李芳婵.基于基准关联度和AHP-CRITIC法的飞龙掌血配方颗粒制备工艺研究[J].河北工业科技,2025,42(5):444-455

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  • 收稿日期:2025-04-09
  • 最后修改日期:2025-09-12
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  • 在线发布日期: 2025-10-09
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