视安利胶囊的制备及其含量测定

Preparation and Content Determination of Shianli Capsule

目的:制备具有舒缓眼睛疲劳的视安利胶囊并对其主药进行含量测定。方法:以莲子壳提取物原花青素、叶黄素为主药制备视安利胶囊,采用HPLC法测定视安利胶囊中原花青素及叶黄素的含量。结果:所制备的样品为硬胶囊,除去胶囊壳后内容物为黄棕色至红棕色的颗粒,味微苦、涩。原花青素、叶黄素检测质量浓度的线性范围分别为15.03~302.42μg/m L(Y=1.54X-17.02,r=0.9993)、5.23~49.76μg/m L(Y=80.45X+1.83,r=0.9997)。平均回收率分别为100.5%(RSD=1.15%,n=6)、100.8%(RSD=0.73%,n=6)。结论:该制剂的处方和制备工艺合理可行,含量测定方法准确,可用于视安利胶囊的质量控制。

Objective： To prepare Shianli capsule which can relieve eye fatigue and the main medicine for content determination. Methods： The Shianli capsules were prepared by the extraction of Proanthocyanidins from lotus seed shell and lutein. The content of lutein and proanthocyanidins in optical amway capsules was determined by HPLC. Results： The preparation of samples for the hard capsule,remove the capsule shell contents after particles for yellow brown to reddish brown,slightly bitter,astringent. The linear range of the concentration of lutein was 15. 03 to 302. 42μg/m L（Y = 1. 54 X-17. 02,r = 0. 9993）. The average recovery was 100. 5%（RSD = 1.15%,n = 6）. The linear range of the concentration of proanthocyanidins was 15. 03 to 302. 42μg/m L（Y = 80. 45 X ＋ 1. 83,r = 0.9997）. The average recovery was 100. 8%（RSD = 0. 73%,n = 6）. Conclution： The preparations of the prescription and preparation technology is reasonable,content determination method is accurate and can be used to regard the amway capsules for quality control.