按照卫生部颁布的《新药审批办法》和《复方天棘胚囊质量标准》的规定要求，本文对新药“复方天棘胶囊”的性状、鉴别、水分、溶散时限、含量测定、装置差异、卫生学检查等７个项目，进行了初步稳定性试验观察，在常温下考察０、１、２、３月，测得四点数据，共考察样品５个批号。其考察结果表明，复方天棘胶囊的质量在０月至３月的结果基本一致，预示其质量稳定，可贮存２年。 In accordance with the requirements of the “Approval Methods for New Drugs” and “Quality Standards for Compound Tianqiao Embryo Sac,” promulgated by the Ministry of Health, this article describes the traits, identification, moisture content, dissolution time limit, content determination, and device differences of the new drug “Compound Tianqian Capsule”. Seven items such as hygiene inspections were subjected to preliminary stability test observations. At the normal temperature, 0, 1, 2, and 3 months were examined. Four points of data were measured and 5 batches of samples were examined. The inspection results showed that the results of the compound Tian-Jian capsules were basically the same from January to March, indicating that their quality is stable and can be stored for 2 years.