不同打光包衣辅料对浓缩当归丸质量影响的研究

目的:对浓缩当归丸不同配比的打光包衣材料及工艺进行探讨,研究不同打光包衣材料对浓缩当归丸质量的影响,并筛选符合欧盟传统草药药品注册标准要求的打光辅料。方法:通过选用不同打光辅料及配比,同时对浓缩当归丸实施6种打光包衣工艺操作,以打光包衣后的产品外观、水分、溶剂残留量、溶散时限和质量标记化学成分含量等为考察指标,探讨不同的打光包衣材料对浓缩当归丸质量的影响,优选出符合欧盟传统草药药品注册指南要求的浓缩当归丸打光包衣材料及最佳的工艺流程。结果:除12D15-2和12D15-5外观较差,12D15-3批次乙醇含量轻微超标,其他指标均符合要求。结论:不同打光包衣材料及工艺对浓缩当归丸外观有较大影响,对溶剂残留影响不大,对水分、质量标准控制中的标记化学成分阿魏酸含量及溶散时限无质的影响。

Study on Different Polishing Coating Excipient for Quality of Concentrated Danggui Pill

Objective: To study the effect of different polishing coatings on the quality of concentrated Danggui (angelica sinensis) pill and select the polishing excipients which could reach the traditional herbal medicine registra-tion standards of EU by the mean of exploring their different ratios of polishing coating materials and processes. Methods: Danggui pill was processed with six polishing coatings which were made with different polishing excipi-ents and ratios. And evolution indexes included the appearance, water, solvent residue, dissolution duration, and quality mark chemical composition content of polished pills. By the mean of exploring the effect of different polish-ing coating materials on the quality of concentrated Danggui pill, the best materials and process which reached the demand of EU traditional herbal medicine registration guidance were selected. Results: All indexes were met, except for worse appearances of 12D15-2 and 12D15-5, as well as little higher ethanol content of 12D15-3. Conclusion:Different polishing coating materials and processes have a great influence on the appearance of Danggui pill, a small effect on solvent residue, and little impact on dissolution duration and the content of ferulic acid which is the mark chemical composition in water and quality standard controlling.