摘要
目的:筛选银杏叶口崩片的制刺处方和成型工艺,建立银杏叶口崩片中总黄酮醇苷的高效液相色谱含量测定方法。方法:以口感、可压性、崩解时间为指标筛选处方,利用预混辅料制备口崩片。采用Elite Hypersil ODS2色谱柱(250 mm×4.6 mm,5μm),以甲醇-0.4%磷酸溶液(50-50)为流动相,检测波长为360 nm;流速为1.0 ml·min^(-1),柱温为30℃,进样量为20μl。结果:经最佳制备工艺制得的银杏叶口崩片外观和口感良好,30 s内能完全崩解。在此色谱条件下,槲皮素在6.35~63.50μg·ml^(-1)范围内,线性关系良好(r=0.999 9);山奈素在5.13~51.25μg·ml^(-1)范围内,线性关系良好(r=0.999 8);异鼠李素在1.85~18.50μg·ml^(-1)范围内,线性关系良好(r=0.999 8)。槲皮素、山奈素、异鼠李素的平均回收率分别为97.84%、96.22%、95.55%,RSD分别为0.82%、1.03%、1.88%(n=5)。结论:银杏叶口崩片处方合理,制备工艺可行。建立的含量测定放法快速简便,准确可靠,重复性好,灵敏度高,专属性强,可用于银杏叶口崩片的质量控制。
Objective：To optimize the formula and preparation process of Ginkgo biloba leaf orally disintegrating tablets and establish a method for determining the total flavonoid glycoside by HPLC.Method：The formula of Ginkgo biloba leaf orally disintegrating tablets was optimized with taste,disintegrating time and compressibility as the indices.Ginkgo biloba leaf orally disintegrating tablets were prepared using co-processed excipients.An Elite Hypersil 0DS2 column（250 mm×4.6 mm,5 μm）was used with methanol and 0.4%phosphoric acid（50：50） as the mobile phase.The detection wavelength was at 360nm,the flow rale was 1.0 ml？min-1,the column temperatment was 30℃ and the injection volume was 20 μl.Result：The prepared tablets were promising in appearance and taste.The disintegrated time was in 30s.Under the chromatographic conditions,the linear range of quercelin was 6.35-63.5μg？ml-1（r = 0.999 9）,that of kaempferide.was 5.13-51.25 μg？ml-1（r = 0.999 8）,and that of isorhanmetin was 1.85-18.50 μg？ml-1（r = 0.999 8）.The recovery of quercelin,kaempferide and isorhanmetin was 97.84%,96.22%and 95.55%with RSI） of 0.82%, 1.03%and l.88%（n=5）,respectively.Conclusion：Ginkgo biloba leaf orally disintegrating tablets are rationally designed and feasibly prepared.The determination method is accurate,sensitive and rapid,and can be used in the quality control of Ginkgo biloba leaf orally disintegrating tablets.
出处
《中国药师》
CAS
2013年第12期1819-1822,共4页
China Pharmacist
关键词
银杏叶口崩片
总黄酮醇苷
高效液相色谱法
Ginkgo biloba leaf orally disintegrating tablets
Total flavonoid glycoside
HPLC
