中药驱螨软膏剂癣螨灵的制备及质量评价

Preparation and Quality Control of Traditional Chinese Herbal Medicines “Xian manling” Ointment for Treating Mite Disease

关键词:  中药软膏剂  螨虫  皮肤病  质量评价

Key words:  traditional chinese medicine ointment  mite  skin disease  quality appraisemen

摘要:

为了研发安全性,低残留的动物驱螨制剂,本试验选用大风子,苦参、百部、蛇床子、老鹮草5味中药联合使用制备复方中药软膏剂“癣螨灵”。在前期正交试验及动物临床实验设计下,筛选出最优中药配比,采用水提醇沉法提取中药的有效成分,并优选O/W乳剂型作为软膏基质,配制成25%浓度软膏。通过对中药软膏剂外观性状、稳定性、皮肤刺激性及毒副反应等质量标准进行综合评价。试验结果表明,中药软膏剂“癣螨灵”外观细腻,质地均匀,稳定性高,安全性高,未见毒副反应,具有良好研发前景。

Abstract:

In order to prepare a safety and low residual animal mite repellent, in this study, five traditional chinese medicine was used for preparing ointment “Xian manling”. After orthogonal experiment and animal clinical experiment, the best proportion of traditional chinese medicines was selected. Effective components of traditional medicine was extracted by water extraction and precipitation method. Then, O/W emulsion was choosed for ointment bases, and the concentration of traditiona chinese meidicine ointment was 25%. To appraise the security evaluation of traditiona chinese meidicine ointment, the cutaneous acute toxicity, irritation and allergic tests were carried out on rabbits. The tests showed that, traditional chinese medicine ointment “Xian manling” has fine appearance, uniform texture, high stability, no toxic and side effects. It would have a good research and development prospect.