野菊花滴眼液的质量控制

Quality Control of Flos Chrysanthemi Indici Eye Drops

目的研制单剂量包装不合防腐剂的野菊花滴眼液，并拟定该制剂的质量控制方法。方法采用羟丙甲纤维素为增稠剂，按处方制备单剂量包装不含防腐剂的野菊花滴眼液，用高效液相色谱法测定野菊花中有效成分绿原酸和3，5-O-双咖啡酰基奎宁酸的含量。结果该制剂制备工艺简单，可以过滤除菌，并无菌分装至每支0．4mL单剂量包装的聚丙烯药用滴眼剂瓶中；绿原酸在20．020～45．045μg／mL（r=0．9986）浓度范围内、3，5-O-双咖啡酰基奎宁酸在50．0～100．0μg·mL-1（r=0．9990）浓度范围内线性关系良好，平均回收率分别为100．37％和99．92％，RSD分别为0．72％和0．69％，该色谱方法精密度高，耐用性好，对照品溶液和供试品溶液可以在24h内保持稳定。结论该制剂含量测定方法简便、准确，质量稳定，是-种较理想的眼用制剂，可用于干眼等眼部疾病的治疗。

Abstract： Objective To prepare single-dose container for Flos Chrysanthemi Indici eye drops without preservative, and to establish the quality control method. Methods Preservative-free Flos Chrysanthemi Indici eye drops in single-dose container were prepared following the formula and with hypromellose as thickening agent and. Chlorogenic acid and 3, 5-dicaffeoylquinic acid contents of Flos Chrysanthemi Indici eye drops were determined by HPLC. Results The preparation was simple, and could be sterilized by filtration and could be filled into the 0.4mL single-dose container of polypropylene medical eye drops bottles. The calibration curve of chlorogenic acid showed good linearity relationship in the range of 20.020 - 45.045μg·mL-1, r = 0.9986, and that of 3, 5-Dicaffeoylquinic acid in the range of 50.0 - 100.0 μg·mL-1, r=0.9990. The average recovery of chlorogenic acid and 3, 5-Dicaffeoylquinic acid were 100.37 % and 99.92 %, and RSD was 0.72% and 0.69 %, respectively. The established HPLC has high precision and good durability, and the reference solution and testing solution were kept steady with 24h. Conclusion The prepared Flos Chrysanthemi Indici eye drops has steady quality, and its content determination is convenient and accurate. It is an ideal ophthalmic preparation for curing dry eyes.