摘要
目的：考察血塞通软胶囊中三七皂苷R1和人参皂苷Rg1,Rb1在两种不同介质中的溶出行为。方法：参照日本《医疗用药品品质情报集》中的溶出度试验条件,并根据血塞通软胶囊处方成分的理化性质对溶出介质进行选择,分别考察了血塞通软胶囊在p H6.8磷酸盐缓冲液和水中的体外溶出行为,采用高效液相蒸发光散射法（HPLC-ELSD）测定血塞通软胶囊中三七皂苷R1和人参皂苷Rg1,Rb1三者总和的溶出度,并通过相似因子（f2）法对3种成分的溶出度曲线进行相似性比较。结果：三七皂苷R1和人参皂苷Rg1,Rb1的线性范围分别为0.8～16.0 mg·L-1（r=0.999 6）,3.0～60.0 mg·L-1（r=0.999 8）,4.0～80.0 mg·L-1（r=0.999 7）;在介质p H 6.8磷酸盐缓冲液和水中,以三七皂苷R1为参比,血塞通软胶囊中人参皂苷Rg1和Rb1的f2均大于50。结论：该方法简便、准确,重复性好,可用于该胶囊的溶出度测定;血塞通软胶囊中三七皂苷R1和人参皂苷Rg1,Rb1具有相似的溶出特点。
Objective：To study the dissolution behavior of panax notoginseng saponins R1 , ginseng saponin Rg1 and ginseng sapo-nin Rb1 in Xuesaitong soft capsules in two different dissolution media. Methods：The dissolution test conditions were confirmed accord-ing to“quality of medical drugs information set” of Japan and the dissolution media were chosen in accordance with the physicochemi-cal properties of Xuesaitong soft capsules, the in vitro dissolution of Xuesaitong soft capsules was inspected respectively in pH 6. 8 phosphate buffer and water. The dissolution rate was determined by HPLC-ELSD, and the similarity of the release curves for the three components was compared with similarity factors （ f2 ） method. Results： The assay displayed a good linearity over the concentration range of 0. 8-16. 0 mg＆#183;L-1（r=0. 999 6）, 3. 0-60. 0 mg＆#183;L-1（r=0. 999 8） and 4. 0-80. 0 mg＆#183;L-1（r=0. 999 7） for panax notog-inseng saponins R1 , ginseng saponin Rg1 and ginseng saponin Rb1 , respectively. In pH 6. 8 phosphate buffer and water, f2 of ginseng saponin Rg1 and ginseng saponin Rb1 were both above 50 when compared with panax notoginseng saponins R1 . Conclusion：The meth-od is simple, accurate and reproducible in the dissolution determination of the soft capsules. The dissolution of ginseng saponin Rg1 and ginseng saponin Rb1 has similar characteristics with that of panax notoginseng saponins R1 in Xuesaitong soft capsules.
出处
《中国药师》
CAS
2015年第3期500-503,共4页
China Pharmacist
