盐酸川芎嗪眼用温敏凝胶的制备及质量控制

Preparation and Quality Control of Thermosensitive in Situ Gel System Containing Ligustrazine Hydrochloride for Ophthalmic Use

制备盐酸川芎嗪眼用温敏凝胶并建立其质量控制方法。以盐酸川芎嗪为主药，以泊洛沙姆为基质制备眼用凝胶，采用HPLC法测定凝胶中盐酸川芎嗪的含量。所制得的眼用凝胶为类白色透明状，盐酸川芎嗪在20．0—100．0μg·mL^-1浓度范围内线性关系良好，A=61．107C＋50．48，精密度、稳定性、重复性等良好，眼部刺激性小。该法制备工艺简单，质量可控，有关项目符合眼用凝胶的质量要求。

To prepare thermosensitive in situ gel system containing ligustrazine hydrochloride for ophthalmic and establish its quality control methods. The gel was prepared based on ligustrazine hydrochloride medicine and taking poloxamer as a substrate. The content of ligustrazine hydrochloride was determinated by HPLC. The obtained eye gel is transparent off - white color, within the scope of ligustrazine hydrochloride in 20.0 - 100.01μg·mL^-1 good linear relationship, A = 61. 107C ＋ 50.48. The preparation process is simple, quality control, the project meets the quality requirements of the gel.