银杏绞股蓝胶囊的质量控制  

Quality Control of the Ginkgo Biloba and Gynostemma Pentaphyllum Capsules

作　　者：陈鹰[1] 董少华[2] 陈湖海[1] 郑建灵[3] 胡晓[2] 朱以良[1] 

机构地区：[1]广州军区武汉总医院,武汉430070 [2]湖北中医药大学 [3]南方医科大学

出　　处：《中国药师》2011年第8期1153-1156,共4页China Pharmacist

摘　　要：目的:制定银杏绞股蓝胶囊的质量控制方法。方法:采用HPLC法测定银杏绞股蓝胶囊中含有的银杏总黄酮醇苷和人参皂苷Rb_1的含量;通过急性毒性实验验证银杏绞股蓝胶囊的安全用量。结果:HPLC法测得总黄酮醇苷中槲皮素、山柰素、异鼠李素进样量分别在0.06～0.75μg(r=0.9999)、0.06～0.75μg(r=0.9998)、0.04～0.50μg(r=0.9998)范围内与峰面积呈良好的线性关系,平均加样回收率分别为99.12%,98.96%,98.66%;HPLC梯度洗脱法测定绞股蓝总苷中人参皂苷Rb_1的含量,Rb1在进样量0.4～8.0μg(r=0.9996)范围内与峰面积呈良好的线性关系,平均加样回收率分别为96.98%;银杏绞股蓝胶囊口服途径的小鼠LD_(50)大于3 200mg·kg^(-1),表明在临床常用剂量下是安全的。结论:建立的HPLC方法简便可行,准确可靠,可用于该胶囊的质量控制。Objective：To establish the quality control method of the Ginkgo Biloba and Gynostemma Pentaphyllum capsules. Method：An HPLC method was used to determine the content of Ginkgo flavonol glycosides and Ginsenoside Rb,in the capsules.Acute toxicity test was also carried out to determine the safe dose of the capsules.Results The total Ginkgo flavonol glycosides was determined by HPLC,the linear range of quercetin,kaempferol and isorhamnetin was 0.06-0.75（r=0.999 9）,0.06-0.75（r=0.999 8） and 0.04-0.50μg（r=0.999 8）,and the average recovery was 99.12%,98.96%and 98.66%,respectively.Ginsenoside Rb1 was determined by HPLC with gradient elution,and the linear range was within 0.4-8.0μg（r=0.999 6）with the average recovery of 96.98%.The LD50 of the capsules was more than 3 200 mg·kg^-1with good safety.Conclusion：The method is simple and practical,the result is accurate and reliable,and it can be used to control the quality of the Ginkgo Biloba and Gynostemma Pentaphyllum capsules.

关 键 词：银杏总黄酮醇苷 绞股蓝总苷 人参皂苷Rb_1 高效液相色谱法 急性毒性实验 

分 类 号：R283.65[医药卫生—中药学]