牡荆素-2＂-O-鼠李糖苷滴丸制备工艺及质量标准研究

目的：确立牡荆素-2＂-O-鼠李糖苷滴丸的最佳成型工艺并建立牡荆素-2＂-O-鼠李糖苷滴丸的质量标准。方法：采用正交试验设计，以丸重差异、溶散时限、外观质量为评价指标，对滴丸成型的工艺进行优选。采用高效液相色谱法对滴丸中牡荆素-2＂-O-鼠李糖苷进行含量测定。结果：最佳工艺条件为：PEG6000：PEG4000=1：1为基质．滴制温度90℃，液体石蜡为冷却剂，温度为-5～0℃，滴距为4cm，滴速50滴·min-1。牡荆素-2＂-O-鼠李糖苷在2．0～20μg·mL。范围的内有良好线性，平均回收率为97．33％，RSD为0．93％。结论：制备工艺简单、合理，含量测定准确、重复性好，为牡荆素-2＂-O-鼠李糖苷滴丸新药开发提供科学依据。

Study on Preparation Technology and Quality Standard of Vitexin-2-O-Rhamnoside Dropping Pills

Objective ： To establish the optimized formulation process and quality standards of vitexin- 2-O-rhamnoside dropping pills. Methods： The pills weight variance, disintegration and appearances quality of dropping pills ,,eie as the evaluation indexes. The orthogonal test was used to optimize the forming process of dropping pill, and HPLC method was used to determine the content of vitexin-2-O-rhamnoside. Results ： The optimal conditions were： the ratio of PEG6000 ： PEG4000 was 1 ： 1 being as the matrix with temperature 90 ℃, and liquid paraffin wax as the coolant with temperature of -5-0 ℃, dropping distance of 4 era,40 drops per minute. The liner range of vitexin-2-O-rhamnoside was 2.0-20 μg · mL-1, the average recovery of vitexin-2-O-rhamnoside and relative standard deviation were 97.33% and 0.93%. Conclusion ： The preparation technology was simple, reasonable and the content determination method is accurate and reproducible. The experimental results provided scientific basis for the new drug development of vitexin-2- O-rhamnoside dropping pills.