[关键词]
[摘要]
目的 通过对中药水凝胶巴布剂产业化过程中的技术难点进行攻关研究,为中药水凝胶巴布剂的产业化提供一种切实可行的制备工艺,以促进巴布剂的产业化发展。方法 采用设备满负荷规模生产中药水凝胶巴布剂,研究物料加入顺序、物料混合时间、静置条件(温度、湿度、时间)对于膏体涂布切割的难易程度和巴布剂的质量如凝胶强度、柔软性、黏性、残留、冷流与无纺布渗析等的影响规律;并通过3个不同的中药复方提取物进行验证。结果 保湿剂(甘油)加入真空搅拌器内,将骨架材料(聚丙烯酸钠)、填充剂(陶瓷粉)、交联剂(甘氨酸铝)、交联调节剂(EDTA)加入其中,在真空度?0.07 MPa以下,搅拌5 min,得到甘油相;再将pH调节剂(柠檬酸)与皮肤增黏剂(聚维酮)的混合水溶液与中药提取物一次性加入到甘油相中,在真空度?0.07 MPa下,搅拌12 min,得到膏体;将膏体转移至涂布切割机上,进行涂布切割,得到半成品。将半成品置于湿度55%、温度30 ℃条件下,存放18 h;再置于湿度75%、温度20 ℃条件下,存放12 h,进行包装;包装后,置于阴凉处静置96 h,即可得到膏体柔软、黏性良好、膏面光洁平整且无渗析的中药水凝胶巴布剂。结论 本实验得到一种适合于中药水凝胶巴布剂产业化的制备工艺,将极大地促进中药水凝胶巴布剂的产业化进程。
[Key word]
[Abstract]
Objective To overcome the technological difficulty in the preparation of hydrogel cataplasm of Chinese materia medica (HCCMM) during the process of industrialization, and to provide a feasible preparation technology for HCCMM development of industrialization. Methods The experiment was carried out for the HCCMM scale production with the full-load equipment. The effects of the materials feeding order, mixing time, and static condition (temperature, humidity, and time) on the spreading and cutting of the paste and on the quality of cataplasm, such as gel strength, flexibleness, adhesiveness, residues, cold flow, and non-woven fabrics permeation were investigated. The results were validated by the extracts from three different Chinese herbal formulas. Results The humectant (glycerine) was added in vacuum blender, followed by addition of framework material (sodium polyacrylate), bulking agent (ceramics), cross-linking agent (aluminum glycinate), and cross-linking regulator (EDTA); Then the blend was mixed for 5 min at ?0.07 MPa. The aqueous solution of pH regulator (citric acid) and skin tackifier (polyvidone), as well as the extract of CMM were added into the mixture above, which was mixied for another 10 min at ?0.07 MPa, and the matrix of HCCMM was obtained. The matrix was transferred to coating and cutting-off machine, after coating and cutting-off, the semi-finished products of HCCMM were made. The semi-finished products were packaged after keeping at 30 ℃ and humidity 55% for 18 h, at 20 ℃ and humidity 75% for 12 h, respectively. The HCCMM with the characteristics of better flexibleness, higher adhesive force, matrix surface temper rolling, and the non-woven fabrics without permeation was obtained, then the packaged products were placed in shady place for 96 h. Conclusion A feasible preparation technology of HCCMM for the production in industrialization is obtained, which could greatly promote the process of HCCMM development in industrialization.
[中图分类号]
[基金项目]
中央财政资金工业中小企业技术改造项目(2010-2252);山西省科技发展计划-新药创制专项(20120313016-2);西安医学院博士科研基金(2010Doc01)