参芪补血口服液质量标准的提高  

Quality Standard Improvement for Shenqi Buxue Oral Liquid

作　　者：林兵[1] 宋洪涛[1] 李蔚[2] 吴新安[2] 

机构地区：[1]南京军区福州总医院药学科,福州350025 [2]解放军第105医院药学科

出　　处：《中国药师》2016年第8期1600-1603,共4页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研撰写课题(编号:14ZJZ17)

摘　　要：目的:提高并完善参芪补血口服液的质量标准。方法:采用薄层色谱法对方中黄芪、何首乌、丹参、陈皮及柴胡进行定性鉴别,以高效液相色谱法对方中芍药苷进行含量测定。结果:TLC斑点清晰,分离良好,阴性无干扰;芍药苷在9.58~191.52μg·ml^(-1)范围内呈良好线性关系(r=0.999 9),平均加样回收率为99.48%,RSD为1.36%(n=9)。结论:本研究建立的质量标准准确、可靠、稳定、专属性强,可有效用于参芪补血口服液的质量控制。Objective： To improve the quality standard for Shenqi Buxue oral liquid. Methods： TLC was used to identify Astragalt Radix,Fallopia miltiflora,Salvta miltiorrhiza,Citrusreticulat and Bupleurum. Chinense. The content of paeoniflorin in Paeonia lactiflora was determined by HPLC. Results： The TLC spots were clear and well-separated without any interference from the negative sample.A good linear relationship was established between the peak response and the concentration of paeoniflorin over the range of 9. 58-191. 52 μg·ml^（-1）（ r = 0. 999 9）. The mean recovery of berberine hydrochloride was 99. 48%（ RSD = 1. 36%,n = 9）. Conclusion：The established quality standard is accurate,reliable,stable and specific,which can be well used for the quality control of Shenqi Buxue oral liquid.

关 键 词：参芪补血口服液 质量标准 芍药苷 

分 类 号：TQ460.72[医药卫生—药物分析学]