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目的研制红花黄色素滴眼液,并建立该制剂中羟基红花黄色素A的含量测定方法。方法按处方制备红花黄色素滴眼液,用高效液相色谱法(HPLC)测定红花黄色素中有效成分羟基红花黄色素A的含量,以十八烷基硅烷键合硅胶为填充剂,以甲醇-乙腈-0.7%磷酸溶液(26∶2∶72)为流动相,检测波长为403 nm,流速为1.0 mL·min~(-1)。结果该制剂制备工艺简单,可以过滤除菌,并无菌分装至5 mL的聚丙烯药用滴眼剂瓶中。羟基红花黄色素A在6.012~16.032μg·mL~(-1)范围内呈良好的线性关系,r=0.999 9,平均回收率为99.93%,RSD为0.92%(n=9)。该色谱方法重现性高,耐用性好,对照品溶液和供试品溶液在室温放置24 h内基本稳定。结论该制剂制备工艺简单,且含量测定方法可靠、准确,质量稳定,可用于老年性黄斑变性(AMD)的治疗。
Objective To develop safflower yellow pigment and to establish a method for the determination of hydroxysafflor yellow A in this preparation. Methods According to the prescription, safflower yellow pigment was prepared and the content of hydroxysafflor yellow A, the active ingredient in safflower yellow pigment, was determined by high performance liquid chromatography (HPLC). The octadecylsilane bonded silica gel was used as filler The mobile phase was methanol - acetonitrile - 0.7% phosphoric acid solution (26:2:72). The detection wavelength was 403 nm and the flow rate was 1.0 mL · min ~ (-1). Results The preparation of the preparation was simple and could be sterilized by filtration and aseptically dispensed into 5 mL polypropylene eye drops. The hydroxysafflor yellow A showed a good linear relationship in the range of 6.012-16.032 μg · mL -1, r = 0.999 9, the average recovery was 99.93% and the RSD was 0.92% (n = 9). The chromatographic method has high reproducibility and good durability, and the reference solution and the test solution are basically stable within 24 h at room temperature. Conclusion The preparation of the preparation is simple, and the determination of content is reliable, accurate and stable in quality. It can be used for the treatment of age-related macular degeneration (AMD).