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1. Basic information of the breed to be evaluated

1.1 Common Name

Ranitidine Hydrochloride Capsules

1.2 Specifications

150mg

1.3 Dosage form

Tincture capsule

2. The history of domestic and foreign R & D of the variety to be evaluated and its current use

2.1 R & D history of domestic and foreign varieties

In 1977, ranitidine (AH19065) was first developed by John Bradshaw's Allen & Hanburys Ltd., a subsidiary of GlaxoSmithKline. Ranitidine took the lead in October 1981 Listed in the UK. The original research company was GlaxoSmithKline.

2.2 Use abroad (including clinical use and sales)

 Ranitidine hydrochloride capsules are mainly used to treat duodenal ulcer, gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome and other high gastric acid secretion diseases. The main component of ranitidine hydrochloride capsules is ranitidine hydrochloride. Ranitidine hydrochloride is a histamine H2 receptor blocker, which can inhibit basal gastric acid secretion and stimulated gastric acid secretion, and also inhibit pepsin secretion. Its acid suppression intensity is 5-8 times stronger than that of cimetidine. Ranitidine hydrochloride is an over-the-counter medicine that is very effective in alleviating gastric pain and heartburn caused by hyperacidity.

2.3 Loading of reference preparations by the US Food and Drug Administration, `` Pharmaceuticals approved for therapeutic equivalence evaluation '' (orange book) and Japanese `` quality information collection of medical drugs '' (orange book)

 GlaxoSmithKline's ranitidine hydrochloride capsules have been discontinued. The reference preparation contained in the US Food and Drug Administration is 300 mg ranitidine hydrochloride capsules produced by Sandoz, and 150 mg of Sandoz produced is not designated as a reference preparation.

Japan's "Medical Quality Information for Medical Products" (Orange Book) contains only reference preparations of ranitidine hydrochloride tablets, and does not contain reference preparations of ranitidine hydrochloride capsules.