Duloxetine hydrochloride enteric capsule and preparation method thereof

• Main Authors: WANG LEI, WANG CUILING, JIAO HE, JIA ZHENHUA, ZUO YANMIN, HOU HUAN, WANG YARU, REN XIAOHUI, HUANG FENGHE, YUAN XINGLI
• Format: Patent
• Language: Chinese; English
• Published: 13.06.2023
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention discloses a duloxetine hydrochloride enteric capsule, the enteric capsule comprises a capsule shell and a content, the content is a duloxetine hydrochloride-containing pellet, and the pellet comprises a blank pellet core, a drug carrying layer, an isolating layer, an enteric layer and a protective layer. The adhesive of the isolation layer of the enteric capsule pellet contains both high-viscosity hydroxypropyl methylcellulose and low-viscosity hydroxypropyl methylcellulose, the dissolution curve of the duloxetine hydrochloride enteric capsule meets the standard requirements by improving the components of the isolation layer, the 90-minute dissolution rate of the duloxetine hydrochloride enteric capsule is obviously improved, and the stability of the duloxetine hydrochloride enteric capsule is superior to that of a reference preparation. 本发明公开了一种盐酸度洛西汀肠溶胶囊，该肠溶胶囊由胶囊壳和内容物组成，其内容物为含有盐酸度洛西汀的微丸，微丸由空白丸芯、载药层、隔离层、肠溶层、保护层构成。本发明肠溶胶囊微丸隔离层的粘合剂既含有高粘度羟丙甲纤维素也含有低粘度羟丙甲纤维素，通过隔离层成分的改进，使得盐酸度洛西汀肠溶胶囊溶出曲线满足了标准的要求，同时其90