抗纤软肝冲剂的制备及质量研究

Study on Preparation and Quality of Kangxian Ruangan Granule

目的:介绍抗纤软肝冲剂的制备方法并对其进行定性定量研究。方法:用水提醇沉法制备抗纤软肝冲剂;对方中山楂进行薄层定性鉴别;对方中主药丹参所含主要有效成份原儿荼醛的含量进行了双波长薄层扫描测定。检测波长为λ_s=280nm,参比波长为λ_R=400nm;采用硅胶G薄层板,展开剂为氯仿-丙酮-甲酸(8:1:1)。结果:山植薄层鉴别结果显示供试品色谱与对照品及对照药材色谱在相应的位置上,显示相同颜色斑点;双波长薄层扫描测定结果显示原儿茶醛在0.509～5.599μg/μl浓度范围内呈良好的线性关系,相关系数r=0.9995,其平均加样回收率为96.74%,RSD为3.2%。结论:抗纤软肝冲剂制剂稳定,检测方法可靠,结果准确。丹参中原儿茶醛含量应控制在大于0.090mg/10g的范围。该冲剂可作为治疗肝硬变患者的常用药物。

Aim: To introduce the methed of production of Kangxian Ruangan granule and to analyze the quality of granule .qualitatively and quantitatively. Methods: The granule was prepared by the processes of extraction with water and purification with ethanol. Fructus crataegi was identified by TLC and the content of protocatechuic aldehyde was determined by TLC-scanning at wavelength of λs = 280nm and λR = 400nm, Silica gels were used as sorbents and mobile phase was chloroform-acetone-methanoic acid (8 :1:1). Results. Same spots from samples. Contrasted Fructus crataegi and protocatechuic aldehyde were observed. The linear relation for protocatechuic aldehyde was obtained in the range of 0. 509-5. 599μg/μl with r = 0. 9995. The average recovery rate was 96. 74% with RSD=3. 2% , Conclusions: The granule is stable, the method of assay is reliable and the result is accurate. The content of protocatechuic aldehyde in the granule should be higher than 0. 09mg/10g. The Granule can be regarded as a common medicine for treatment of hepatic fibrosis.