摘要
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.
出处
《山东化工》
CAS
2014年第10期36-38,共3页
Shandong Chemical Industry
基金
湖北省教育厅科学技术研究项目(Q20134302)
关键词
盐酸川芎嗪
眼用温敏凝胶
制备
质量控制
ligustrazine hydrochloride
thermosensitive in situ gel for ophthalmic use
preparation
quality control