ZTC1＋1沉淀剂制备银杏口服液及其质量标准研究

目的改进原银杏口服液醇沉法的制备工艺，提高产品质量。方法将银杏叶提取物原料（含黄酮16％）溶于蒸馏水中，加热，煮沸30min，冷却至80℃，加入ZTC1＋1沉淀剂A与B，拌匀，放置24h，过滤即得。用高效液相色谱（HPLC）法测定含量，流动相为0．4％磷酸-甲醇（1：1），检测波长370nm。结果槲皮素进样量线性范围是0．12—0．60μg，r=0．9998，平均加样回收率为100％，RSD=0．33％（n=9）。结论采用ZTC 1＋1沉淀剂制备的银杏口服液杂质去除较完全，质量、澄清度、色泽均较好。HPLC法测定含量快速、准确、重现性好。

New Prepartion Procedure and Quality Criteria of Ginkgo Oral Liquid

Objective To improve the quality of Ginkgo Oral Liquid by modifying the original alcohol precipitation so as to provide scientific basis for the preparation technology. Methods The raw materials of Ginkgo biloba extract （containing 16% flavonoids ） were dissolved in distilled water. The solution was heated and lowed the temperature to 80℃ after boiling 30 min. Adding ZTC 1 ＋ 1 clarificant A and B, the solution was mixed evenly, placed for 24 h and filtered. The content was determined by HPLC. Results The mobile phase was 0. 4% phosphoric acid - methanol（ 1 ： 1 ） and the detective wavelength was 370 nm. The calibration curve of quercetin was linear within the range of 0. 12-0.60 μg（r =0.999 8）. The average recovery rate was 100% ,RSD was 0.33% （n=9）. Conclusion Impurities of Ginkgo Oral Liquid are removed more completely by ZTC 1 ＋ 1. The quality, clarity and color become better. HPLC is rapid, accurate and reproducible.