胶束增溶技术在含挥发油中药巴布剂试生产中的应用研究

目的 通过对以挥发油为主要成分的中药巴布剂的中试生产过程进行系统研究，为含挥发油中药巴布剂的中试生产提供一种合理可行的制备方法，以期促进我国中药巴布剂的快速发展。方法 对含挥发油的中药分别采用水蒸气蒸馏法、乙醇回流提取法与CO₂超临界流体萃取法提取，将3种提取物分别制备成巴布剂，考察不同提取方式对于巴布剂成型工艺与质量的影响；将水蒸气蒸馏法所得蒸馏液采用胶束增溶，并考察胶束增溶后对于巴布剂质量的影响。结果 3种不同提取方式对于巴布剂成型工艺与质量影响不同：水蒸气蒸馏法所得提取物制备过程易于进行，且巴布剂外观均匀一致、黏性良好、膏体柔软，不足之处为蒸馏液久置后发生油水分离而导致批次间有效成分的量差异过大；采用胶束增溶后，不仅能够完全避免久置后由于发生油水分离而导致的批次间差异过大的问题，还能够显著减少有效成分的挥发损失而提高其稳定性（P＜0.01）。乙醇回流提取法所得提取物由于在室温下发生分层离析现象，制备过程需要水浴加热，且加入真空搅拌器后极难与其他物料混合均匀；因而导致制备过程不易控制，巴布剂外观色泽差异大易出现黑斑，且膏体柔软性降低。CO₂超临界流体萃取法所得提取物含有大量的油脂性杂质，提取物呈半固体状而致使其不易与其他物料混合均匀，还降低了巴布剂的黏性；且能耗大，生产成本较高。结论 将含挥发油的中药采用水蒸气蒸馏法得到蒸馏液，再将蒸馏液采用胶束增溶技术得到胶束增溶体系，以胶束增溶体系作为制备巴布剂的水相应用，是一种合理可行的巴布剂中试生产方法，值得广泛推广与应用。

Application of micellar solubilization technology in pilot production of Chinese materia medica cataplasma containing volatile oil

Objective Through the studies on pilot production of the cataplasma of Chinese materia medica (CMM) containing volatile oil, to provide a rational and feasible preparation technology for the pilot production of CMM cataplasma, so as to promote the development of CMM cataplasma. Methods The CMM containing volatile oil was extracted by steam distillation method (SDM), ethanol reflux extraction (ERE), and CO₂ supercritical fluid extraction (SFE), respectively. The extracts were prepared to cataplasma in order to investigate the effects of extracting methods on the preparation process and quality of CMM cataplasma. The effects of micellar solubilization in the distilled liquid of STM on the quality of cataplasma such as adhesiveness, flexibleness, and stability were also investigated. Results There was the significant difference among the groups of STM, ERE, and SFE on the quality of cataplasma. The extract by STM was beneficial to the preparation process and enhancement of the quality of cataplasma obviously, while the distilled liquid by STM would cause some limitations such as oil-water separation and volatile oil volatilization losses, which could contribute to obvious difference among batches. These disadvantages by STM would be overcome by the adoption of micellar solubilization technology and the stability would be increased (P < 0.01); segregation happened for the extract by ERE at room temperature, thereby, the water bath heating was needed in the preparation; this characteristics would cause the homogeneous appearance of cataplasma due to some black spots, lower flexibleness of matrix, and the preparation was not easy to control; the extract by SFE contained a lot of impurity of grease and performed half solid. As a result, it was very difficult to blend the extract by SFE with other materials uniformly, the adhesive force of cataplasma was also reduced. In addition, the cost of higher energy consumption and production was another disadvantage for SFE. Conclusion The STM followed by micellar solubilization would be a feasible preparation technology for the pilot production of CMM cataplasma containing volatile oil, so it is worth popularizing and applying widely.