Spironolactone

针对醛固酮过度激活引发的水钠潴留、心血管重构等病理进程，螺内酯是首个应用于临床的非选择性醛固酮受体拮抗剂。其通过竞争性结合肾小管上皮细胞的醛固酮受体，阻断钠钾离子交换的异常调控，在发挥保钾利尿作用的同时，还可抑制心血管系统的醛固酮介导纤维化效应。临床主要用于治疗原发性醛固酮增多症、高血压联合用药、心力衰竭及肝硬化腹水，也是多囊卵巢综合征高雄激素血症的常用辅助治疗药物，适用人群覆盖从成年心血管病患者到育龄期内分泌紊乱患者的广泛群体。

For the pathological processes such as water and sodium retention and cardiovascular remodeling caused by excessive activation of aldosterone, spironolactone is the first non-selective aldosterone receptor antagonist applied in clinical practice. By competitively binding to aldosterone receptors on renal tubular epithelial cells, it blocks the abnormal regulation of sodium-potassium ion exchange, exerting a potassium-sparing diuretic effect while also inhibiting the aldosterone-mediated fibrosis effect in the cardiovascular system. Clinically, it is mainly used for the treatment of primary aldosteronism, combined antihypertensive therapy, heart failure and ascites due to liver cirrhosis. It is also a commonly used adjuvant therapeutic drug for hyperandrogenism in polycystic ovary syndrome, with a wide range of applicable populations covering adult cardiovascular disease patients to childbearing-age patients with endocrine disorders.

目前全球螺内酯市场规模约11.2亿美元，2023-2028年复合增长率预计保持在3.7%左右。国内市场中，该品种已被纳入国家基本药物目录和甲类医保，2024年公立医疗机构终端销售额突破12亿元人民币，其中口服制剂占比超过98%。竞争格局以仿制药为主，国内现有30余家企业持有螺内酯制剂批文，原料药供应集中在华北、华东地区的 compliant production enterprises, the winning price in centralized procurement has decreased by about 42% compared with previous years, and the overall market supply and demand are stable.

At present, the global market size of spironolactone is approximately USD 1.12 billion, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 3.7%. In the domestic market, this variety has been included in the National Essential Medicines List and Class A Medical Insurance List. In 2024, the terminal sales in public medical institutions exceeded RMB 1.2 billion, with oral preparations accounting for more than 98%. The competitive landscape is dominated by generic drugs. More than 30 domestic enterprises currently hold spironolactone preparation approval documents. The supply of active pharmaceutical ingredients (APIs) is concentrated in compliant production enterprises in North China and East China. The winning price in centralized procurement has decreased by about 42% compared with previous years, and the overall market supply and demand are stable.