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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 develop the quality control method of Ginkgo Gynostemma. Methods: HPLC method was used to determine ginkgo ginkgo flavonoid glycosides and ginsenoside Rb 1 content in ginkgo capsules. The safe dosage of ginkgo gypenosides capsules was determined by acute toxicity test. Results: The contents of quercetin, kaempferol and isorhamnetin in total flavonol glycosides were 0.06 ~ 0.75μg (r = 0.9999), 0.06 ~ 0.75μg (r = 0.9998), 0.04 ~ 0.50μg (r = 0.9998). The average recoveries were 99.12%, 98.96% and 98.66%, respectively. The contents of ginsenoside Rb 1 in gypenosides were determined by HPLC gradient elution. The injection volume of 0.4 ~ 8.0μg (r = 0.9996) and the peak area showed a good linear relationship, the average recovery was 96.98%; mice ginkgo Gynostemma oral route of the mouse LD 50 (50) greater than 3 200mg kg ~ (-1), indicating that it is safe to use at the clinically usual dose. Conclusion: The established HPLC method is simple and feasible, accurate and reliable, and can be used for the quality control of the capsule.