Determination of Melatonin in the Mian Erkang Capsules by HPLC

The Mian Erkang capsules made by us is a high potency calcium preparation with actions of hypnosis and anti-decrepitude. Melatonin is one of the main effective components which can hypnotize, calm, relieve pain, increase the body's immunity, be used for cancer therapy, and delaydecrepitude. A rapid, sensitive, and accurate HPLC method for the determination of melatonin in Mian Erkang capsules is described in this paper.

HPLC法测定安脑胶囊中褪黑素含量

目的:建立HPLC法测定安脑胶囊中褪黑素含量的方法。方法:HPLC法,以Zorbax ODS C_(18)(15mm×6.0 mm,5μm)为色谱柱,乙腈-0.05mol·L^(-1)醋酸盐缓冲液(1:3,pH4.60),流速1mL·min^(-1),检测波长278nm,AUFS 0.16,柱温40℃,进样量20μL。结果:褪黑素测定线性范围为0.028 24～0.1412μg·μL^(-1),回收率为98.51％～99.81％,RSD<1.1%(n=5)。结论:该法准确,简便,快捷,可用于测定安脑胶囊中褪黑素的含量。

美速静胶囊的制备及其成型工艺考察

目的:对原美速静胶囊工艺进行改进,制定质量控制方法,考察成型工艺。方法:采用熔融法将聚乙二醇(PEG)4000与褪黑素制成固体分散体,粉碎后加入辅料制成胶囊。采用高效液相色谱法测定褪黑素的含量,考察美速静胶囊的含量均匀度和溶出度,并测定内容物的堆密度、休止角、临界相对湿度。结果:褪黑素检测浓度在4～24μg·mL-1范围内与其峰面积积分值线性关系良好(r=0.9998),平均回收率为99.6%(RSD=0.64%)。美速静胶囊的含量均匀度均<15.0,10min内溶出约90%。粉末堆密度为0.66g·mL-1,休止角为23.8°,临界相对湿度为60%。结论:建立的美速静胶囊制备工艺可行,且质量可控。