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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4 cm,滴速50滴·min-1。牡荆素-2’’-O-鼠李糖苷在2.0~20μg·mL-1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。
Objective: To establish the optimum forming process of vitexin - 2 “- O - rhamnoside dropping pills and establish the quality standard of vitexin - 2” - O - rhamnoside dropping pills. Methods: Orthogonal experiment design was used to optimize the dropping pill forming process based on the difference of pill weight, dissolution time limit and appearance quality. The content of vitexin -2 ’- O - rhamnoside in dropping pills was determined by high performance liquid chromatography. Results: The optimum conditions were as follows: PEG6000: PEG4000 = 1: 1 was used as substrate, dropping temperature was 90 ℃, liquid paraffin was used as coolant, temperature was -5 ~ 0 ℃, dripping distance was 4 cm, -1. Vitexin -2’-O-rhamnoside showed a good linearity within the range of 2.0 ~ 20μg · mL-1 with an average recovery of 97.33% and a RSD of 0.93%. Conclusion: The preparation process is simple, reasonable, accurate determination of content, good reproducibility, and provide a scientific basis for the development of new drug Vitexin -2 ’- O - rhamnoside dropping pills.