Famotidine injection and preparation method thereof

Abstract

The invention discloses a preparation method of a famotidine injection. 1000ml of injection contains the following raw materials: 20.0g of famotidine, 3.5g of aspartic acid, 0.2g of natrium adetate, 0.5g of medicinal carbon and the balance of injection water. The preparation method comprises the following steps: (1) adding fresh injection water which accounts for 80% of the preparation liquid to aspartic acid and natrium adetate and stirring to be thoroughly dissolved; (2) adding a formula amount of medicinal carbon and allowing to stand to absorb for 20 minutes; (3) filtering, feeding 102% of famotidine and stirring to be dissolved; (4) adjusting a pH value to 5.2-5.4 with 10% aspartic acid solution, adding injection water to a full amount and uniformly stirring; (5) sequentially filtering by a filter element of 0.45 microns and a filter element of 0.22 microns until clarity is qualified, obtaining a half finished product of famotidine injection and adopting an ultraviolet light-visible light photometry to control the quality of the half finished product; (6) finally, filtering the half finished product by a filter membrane of 0.22 microns after the half finished product is detected to be qualified, filling 2ml of nitrogen and encapsulating; and (7) sterilizing in flowing steam at 100 DEG C for 30 minutes, detecting leakage and lamps, airing, printing characters and packaging to obtain the famotidine injection.

Description

Technical field: [0001] The invention relates to an injection and a production method thereof, in particular to a formulation of famotidine injection and a preparation method thereof, belonging to the field of biomedicine. Background technique: [0002] Famotidine is the H of the guanylthiazoles 2 receptor antagonists. with pair H 2 It has the characteristics of high receptor affinity, and has obvious inhibitory effect on gastric acid excretion, and has inhibitory effect on basic excretion and the increase of gastric acid and pepsin caused by various stimuli. Famotidine injection is used for upper gastrointestinal bleeding caused by peptic ulcer, gastric and duodenal mucosal erosion and bleeding caused by various reasons other than tumor, esophagus and gastric fundus varices. This product does not change the gastric emptying rate, does not interfere with pancreatic function, and has no adverse effects on cardiovascular system and renal function. The effect is stronger th...

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Problems solved by technology

[0003] Famotidine injection is greatly affected by medicinal charcoal during the production process, and the content before and after decarburization decreases by 5%, resulting in a large loss and low yield; in addition, the pharmacopoeia stipulates that the content determination method is high performance liquid chromatography, which is the standard method. method, the finished product should be inspected according to this method, but because the inspection operation is cumbersome and time-consuming, and the prepared liquid medicine has a potting and sterilization time limit, this method is not suitable for the internal control of semi-finished products during mass production in the workshop

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