膜科学与技术

膜技术在康妇炎胶囊制剂二次开发中的应用研究

作者：刘红波#¹， ²，徐思宁#¹， ²，唐志书 ² ，朱华旭³，宋忠兴¹， ²，崔春利¹， ²，王玉娇¹， ² ，王明耿⁴，陈衍斌⁵

单位： 1. 陕西中医药大学/陕西中药资源产业化省部共建协同创新中心，陕西咸阳 712083；2. 秦药特色资源研究与开发国家重点实验室（培育）/陕西省创新药物研究中心，陕西咸阳 712083; 3. 南京中医药大学/江苏省植物药深加工工程研究中心/ 江苏省中药资源产业化过程协同创新中心，江苏南京 210023；4. 山东步长制药有限公司，山东菏泽274000；5. 陕西步长制药有限公司，陕西西安 710075

关键词：康妇炎胶囊；中药；微滤；超滤；醇沉法；纯化

出版年,卷(期):页码： 2021,41(4):117-123

摘要：

将微滤、超滤膜技术应用于康妇炎胶囊制剂二次开发中的分离纯化操作单元，研究其替代传统醇沉法的可行性。以康妇炎胶囊制剂中药水提液及其中间体干浸膏的理化性质为考察指标，分析比较膜技术与醇沉法的分离纯化效果；同时考察膜操作条件对膜通量及膜污染的影响。结果表明，经膜技术分离纯化后，康妇炎胶囊制剂中药水提液的浊度、黏度等均有不同程度降低。在杂质整体去除方面，醇沉法要优于膜技术；而在有效成分保留方面，膜技术要优于醇沉法。同时，膜技术可降低康妇炎胶囊制剂中药干膏粉的吸湿性，提高了干膏粉的稳定性。过膜压力、料液流速等工艺参数对膜通量及膜污染具有重要影响，需通过工艺优化，确定适宜的膜工艺参数。根据以上研究结果与分析，将膜技术应用于康妇炎胶囊制剂二次开发中的分离纯化具有一定的适宜性、可行性。

The microfiltration and ultrafiltration membrane technology were applied to the purification of Kangfuyan capsule to study the feasibility of replacing the traditional alcohol precipitation process in secondary development. Taking the physicochemical properties of water extract and dry extract of Kangfuyan capsule as indexes, the purification effects of membrane technology and alcohol precipitation process were analyzed and compared, and the effects of operation conditions on permeate flux and membrane fouling were also investigated. The results showed that the turbidity and viscosity of the water extract of Kangfuyan capsule decreased to some extent after the purification by membrane technology. In the aspect of overall removal of impurities, the alcohol precipitation process is better than the membrane technology, while in the aspect of effective ingredient retention, the membrane technology is better than the alcohol precipitation process. At the same time, membrane technology can reduce the hygroscopicity of dry paste powder of Kangfuyan capsule and improve the stability of dry paste powder. The process parameters, such as pressure and cross flow velocity, have an important influence on permeation flux and membrane fouling. It is necessary to optimize the process to determine the appropriate parameters. According to the research results, it is feasible for the application of membrane technology in the purification of Kangfuyan capsule in the secondary development.

刘红波（1987-），男，河南周口，讲师，硕士研究生，主要从事中药制剂新技术研究；徐思宁（1992-），女，陕西铜川，硕士研究生，主要从事中药制剂新技术研究

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