水飞蓟宾葡甲胺眼凝胶的制备及其质量控制

Preparation and Quality Control of Silybin Meglumine Ophthalmic Gel

目的:制备水飞蓟宾葡甲胺眼用凝胶剂,并建立其质量控制方法。方法:以水飞蓟宾葡甲胺为主药,卡波姆940为凝胶基质,制备水飞蓟宾葡甲胺眼用凝胶。用高效液相色谱法测定主药的含量,并考察其粒度、pH值及微生物限度;在光照,4、40℃下各放置10d进行稳定性试验,分别考察其外观、含量、粒度、pH值。结果:所得凝胶为浅黄色透明半固体,质地均匀细腻,涂展性好。样品标示百分含量为96.35%～100.01%,粒度均小于50μm,pH值为7.89±0.06,微生物限度符合2010年版《中国药典》相关规定;样品在离心等条件下各项指标均无明显变化,但在40℃条件下,pH值略有升高。结论:本制剂制备工艺简便可行,质量稳定可控,应置于阴凉处保存。

OBJECTIVE： To prepare silybin meglumine ophthalmic gel and establish a method for its quality control. METH- ODS： Silybin meglumine ophthalmic gel was prepared with silybin meglumine as main component and carbomer 940 as matrix. HPLC method was adopted to determine the contents of main component, and the particle size, pH value and microbial limit were investigated; the stability test of the sample at 4, 40 ~C and under light was conducted after 10 days, and the appearance, content, particle size and pH value were investigated. RESULTS： Prepared gel was light yellow transparent semisolid, showing homoge- neous and fine and smooth structure and well-spread. The study showed that labeled amount of samples were between 96.35% and 100.01%, particle size were less than 50 p.m, and pH value was 7.89 ＋ 0.06; microbial limit was in line with the regulations stated in Chinese Pharmacopeia （2010 edition） ; the index of sample had no significant change under centrifugation, but pH value slight- ly increased at 40 ℃. CONCLUSIONS： The preparation technology is simple and feasible. The quality of the gel is stable and con- trollable, and it should be kept in a cool place.