人参皂苷Rd类脂质体滴丸制备及质量标准研究

Preparation and quality standard of ginsenoside Rd niosome dropping pills

目的制备人参皂苷Rd类脂质体滴丸,并对其质量标准进行研究。方法采用薄膜分散法制备人参皂苷Rd类脂质体,通过单因素实验及正交实验优选人参皂苷Rd类脂质体滴丸的制备工艺。正交实验以外观质量、溶散时限、丸重差异为评价指标,对成型工艺中的药物与基质质量比、滴制距离、熔融温度进行筛选。对滴丸的性状、溶散时限、丸重差异进行检查,利用HPLC法对人参皂苷Rd类脂质体滴丸中人参皂苷Rd含量进行测定。结果人参皂苷Rd类脂质体滴丸最终工艺是药物与基质比为1:6,滴制距离为8 cm,熔融温度70℃。滴丸的性状、溶散时限、丸重差异均符合《中国药典》2015版要求,滴丸中人参皂苷Rd含量测定平均值为2.413 mg·g^-1。结论优选的人参皂苷Rd类脂质体滴丸制备工艺合理、稳定,建立了滴丸的质量标准,为人参皂苷Rd类脂质体滴丸的后期开发提供了依据。

Objective Ginsenoside Rd niosome dropping pills were prepared,and its quality standard was studied.Methods The ginsenoside Rd niosome was prepared by thin-film dispersion method,and the preparation process of ginsenoside Rd niosome dropping pills was optimized by single factor experiment and orthogonal experiment.The traits of the dropping pills,the dissolution time limit,and the difference in the weight of the pills were examined,and the content of ginsenoside Rd in the ginsenoside Rd niosome dropping pills was measured by HPLC.Results The final process of ginsenoside Rd niosome dropping pills was a drug-substrate mass ratio of 1:6,a dropping distance was 8 cm,and the solution temperature was 70℃.The dissolution time,and the difference in pill weight were in line with the 2015 edition of Chinese Pharmacopoeia.The average value of the ginsenoside Rd content in the dropping pills was 2.413 mg∙g^-1.Conclusion The preferred preparation process of ginsenoside Rd niosome dropping pills was reasonable and stable,and the quality standard of dropping pills was established.