摘要
目的制备健肾颗粒剂并建立质量控制标准。方法原药材经水提,低温浓缩干燥,湿法制粒,检查成品颗粒的粒度、水分、溶化性、干燥失重、装量差异、装量和微生物限度,TLC法对山茱萸、黄芪、丹参、当归与川芎、大黄6味药进行鉴别;HPLC法同时测定莫诺苷、马钱苷、毛蕊异黄酮葡萄糖苷的含量。结果颗粒剂的粒度、水分、溶化性、干燥失重符合规定。TLC法能定性检出山茱萸、黄芪、丹参、当归与川芎、大黄。HPLC法精密度、稳定性、重复性、准确性良好,莫诺苷、马钱苷、毛蕊异黄酮葡萄糖苷分别在0.054~1.080μg(r=0.9999)、0.039~0.780μg(r=0.9999)、0.011~0.220μg(r=1.0000)范围内线性关系良好。平均加样回收率分别为98.37%(RSD为1.75%)、99.69%(RSD为1.77%)、99.27%(RSD为1.79%)(n=6)。结论制备工艺合理,定性、定量方法准确可靠,可作为健肾颗粒的质量控制标准。
Objective To prepare Jianshen granules and establish the quality standard.Methods Medicinal materials were extracted with water and dried at low temperature before they were concentrated,granulated and dried.The particle size,moisture content,dissolubility,and weight loss of granules were examined.Thin layer chromatography was used for qualitative identification of Corni Fructus,Leguminosae,Salvia miltiorrhiza Bunge,Angelica sinensis,Ligusticum chuanxiong Hort and Rheum palmatum L,while high performance liquid chromatography was applied to the quantitative determination of calycosin glucoside,morroniside and loganin.Results The particle size,moisture content,loss on drying and dissolubility conformed to the Chinese Pharmacopoeia.All the characteristic spots were detected by TLC.Morroniside,loganin and calycosin glucoside were linear in the ranges of 0.054-1.080μg（r =0.9999）,0.039-0.780μg（r =0.9999）and 0.011-0.220μg（r =1.0000）,respectively.The average recovery was 98.37（RSD=1.75%）,99.69（RSD=1.77%）and 99.27（RSD=1.79%）,respectively.Conclusion The preparation process of Jianshengranules is well-designed.The method of qualitative identification and quantitative determination is accurate and reliable for quality control of Jianshengranules.
作者
吴燕
张娴勰
胡晓丹
郭双艳
袁海龙
WU Yan;ZHANG Xian-xie;HU Xiao-dan;GUO Shuang-yan;YUAN Hai-long(Department of Pharmacy,Air Force General Hospital,Beijing 100142,China)
出处
《解放军药学学报》
CAS
CSCD
2018年第2期151-154,158,共5页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
北京市科委"十病十药"课题项目
No.Z161100001816008
