基于AHP-CRITIC综合评分法结合D-最优混料设计优选养阴生肌膜制备工艺

Optimization of preparation process of Yangyin Shengji Membrane based on AHP-CRITIC comprehensive scoring method combined with D-optimal mixture design

关键词:  养阴生肌膜  混料设计  辅料配比  产业化

Key words:  Yangyin Shengji Membrane  mixture design  ratio of excipients  industrialization production

摘要:

目的：研究养阴生肌膜制备工艺,解决研究过程中实际生产问题,为其规模化生产提供科学依据。方法：依据《中国药典》和《中药复方制剂生产工艺研究技术指导原则(试行)》等法规和技术指导原则,采用中试规模,以膜剂的成膜性、粘附力、膜溶解时间、产品收率、韧性和抗拉强度的综合评分为评价指标,采用D-最优混料设计法对其制备工艺参数进行优化。结果：在不改变原制剂药辅比的前提下,当聚乙烯醇(17-88)为82.26%、羧甲基纤维素钠为 8.34%、甘油为9.40%时,产品的成膜性、粘附力、膜溶解时间等质量指标符合《中国药典》膜剂项下质量要求,经中试验证,产品优选的工艺参数与生产设备具有很高的适配性,符合实际生产要求。结论：养阴生肌膜的优化制备工艺合理、稳定且可行,可产业化生产提供依据。

Abstract:

Objective：To study the preparation process of Yangyin Shengji Membrane, solve the actual production problems in the research process, and provide scientific basis for its large-scale production. Methods: According to the regulations and technical guidelines such as the " Chinese Pharmacopoeia " and the " Technical Guidelines for the Study of the Production Process of Chinese Medicine Compound Preparations ( Trial ) ", the pilot scale was adopted, and the film-forming property, adhesion, membrane dissolution time, product yield, toughness and tensile strength of the film were used as evaluation indicators. The preparation process parameters were optimized by D-optimal mixture design method. Results: Under the premise of not changing the drug-assisted ratio of the original preparation, when the polyvinyl alcohol ( 17-88 ) was 82.26 %, the sodium carboxymethyl cellulose was 8.34 %, and the glycerol was 9.40 %, the film-forming property, adhesion force, film dissolution time and other quality indicators of the product met the quality requirements under the " Chinese Pharmacopoeia " film agent item. The pilot test proved that the optimized process parameters of the product had a high adaptability to the production equipment and met the actual production requirements. Conclusion: The optimized preparation process of Yin-nourishing myogenic membrane is reasonable, stable and feasible, which can provide a basis for industrial production.