藥品的穩定性是指原料藥及制劑保持其物理、化學、生物學和微生物學的性質，通過對原料藥和制劑在不同條件（如溫度、濕度、光線等）下穩定性的研究，掌握藥品質量隨時間變化的規律，為藥品的生產、包裝、貯存條件和有效期的確定提供依據，以確保臨床用藥的安全性和臨床療效。 穩定性研究是藥品質量控制研究的主要內容之壹，與藥品質量研究和質量標準的建立緊密相關。穩定性研究具有階段性特點，貫穿藥品研究與開發全的過程，壹般始於藥品的臨床前研究，在藥品臨床研究期間和上市後還應繼續進行穩定性研究。 本文為壹般性原則，具體的試驗設計和評價應遵循具體問題具體分析的原則。 The drugs stability is refers to the bulk drugs and the preparation maintains its physical, chemistry, the biology and the microbiology nature, through to the bulk drugs and the preparation in the dissimilar condition (for example temperature, humidity, optical fiber and so on) the downward stability research, grasps the drugs quality along with the time variation rule, for the drugs production, the packing, the storing condition and the term of validity determination provides the basis, guarantees the clinical medication the security and the clinical curative effect. the investigation into stability is one of drugs quality control research primary coverages, with drugs quality research and quality specification establishment close related. The investigation into stability has the gradual characteristic, the penetration drugs studies and develops the entire process, before generally begins in the drugs clinical to study, after drugs clinical research period and going on the market should also continue to conduct the investigation into stability. this article is the general principle, the concrete experimental design and appraises should follow the concrete question concrete study the principle
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