Triamcinolone acetonide acetate injection and preparation method thereof

Abstract

The invention discloses a triamcinolone acetonide acetate injection and a preparation method thereof. The injection is prepared from 10.0g of triamcinolone acetonide acetate, sodium chloride which is 5.00-20 percent of the injection in a weight-to-volume ratio, sodium merthiolate which is 0.005-0.01 percent of the injection in a volume ratio, HS-15 which is 1.00-15 percent of the injection in a volume ratio, sodium carboxymethylcellulose which is 10.00-30 percent of the injection in a volume ratio and the balance of water for injecting. The preparation method comprises the following steps: putting triamcinolone acetonide acetate, sodium merthiolate, sodium chloride and sodium carboxymethylcellulose in a beaker according to the prescription, adding partial water for injecting, uniformly stirring, adding activated carbon, uniformly stirring, and filtering to obtain a solution (1); weighing a proper amount of water for injecting at 30-40 DEG C, adding HS-15 which is 1.00-15 percent of the injection in a volume ratio, and uniformly stirring to obtain a solution (2); mixing the solution (1) and the solution (2), uniformly stirring, adding the water for injecting to total amount, regulating the pH value of the mixture to be 5.5-7.0 by using acetic acid, filtering and filling and sealing. By adopting a brand-new prescription and process, a produced product has stable quality, and the safety of clinical administration can be remarkably improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a triamcinolone acetonide acetate injection and a preparation method thereof. Background technique [0002] Triamcinolone acetonide acetate is an adrenal corticosteroid drug. It has various pharmacological effects such as anti-inflammatory, anti-allergic and immune suppression. (1) Anti-inflammatory effect: Glucocorticoids reduce and prevent tissue responses to inflammation, thereby reducing the manifestations of inflammation. (2) Immunosuppressive effect: prevent or inhibit cell-mediated immune response, delay allergic reaction, and reduce the expansion of primary immune response. (3) Anti-drug and anti-shock effects: Glucocorticoids can resist the stimulation of bacterial endotoxins on the body, reduce cell damage, and play a role in protecting the body. [0003] Glucocorticoids have no obvious adverse reactions in the application of physiological dose r...

AI Technical Summary

Problems solved by technology

Now check a number of commercially available triamcinolone acetonide injections and find that the excipients in the instructions do contain Tween-80. Polysorbate 80 is a non-ionic surfactant, which is often used as a solvent and emulsifier for insoluble drugs, and sometimes has allergies The reaction occurs, and modern medical literature has confirmed that Tween-80 is the main cause of adverse reactions (anaphylaxis) during its clinical use