Phloroglucinol composition and preparation method thereof

Abstract

The invention discloses a phloroglucinol composition and a preparation method thereof. The phloroglucinol composition is an aqueous solution of phloroglucinol and 1, 3, 5-trimethoxybenzene, wherein the content of phloroglucinol is 9-11 micrograms / ml, the content of 1, 3, 5-trimethoxybenzene is 9-11 micrograms / ml, and the phloroglucinol composition contains a trihydroxybenzoic acid isomer (OH)3C6H2COOH as a stabilizer. The phloroglucinol composition provided by the invention has good stability, and is free of other components except the stabilizer, a pH regulator and an osmotic pressure regulator, so the risk of drug interaction is reduced; and the stabilizer reduces the oxidative degradation of phloroglucinol, so the disadvantage of poor stability of current phloroglucinol products is effectively improved. The preparation method of the phloroglucinol composition has the advantages of simplicity, feasibility, controllable process and strong industrial operability, and lays a good foundation for the development of phloroglucinol injections.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a phloroglucinol composition and a preparation method. Background technique [0002] Phloroglucinol is a myophilic, non-atropine, non-papaverine smooth muscle antispasmodic agent, which is widely used in the treatment of diseases caused by smooth muscle spasm, and can directly act on the smooth muscles of the gastrointestinal tract, biliary tract and urinary tract to relieve the pain of smooth muscles. Spasmodic pain, and rapid antispasmodic effect, without any atropine-like adverse reactions, excellent patient tolerance, has been used in Europe and the United States for more than 60 years, becoming the first choice for antispasmodic treatment of women and children in Europe. It is clinically applicable to acute spastic pain caused by digestive system and biliary tract dysfunction; acute spastic urethra, bladder, and renal colic; gynecological spastic pain, ...

AI Technical Summary

Problems solved by technology

For example, in patent CN104323986 A, the antioxidant sodium metabisulfite and co-solvent propylene glycol are introduced to increase the stability of phloroglucinol aqueous solution. Sodium metabisulfite may be ionized under acidic conditions to interact with the main drug, and the risk of central nervous system toxicity of the organic solvent propylene glycol is relatively high. , the safety of the drug under this prescription needs to be studied; patent CN106539753A found that sorbitol has a stabilizing effect on phloroglucinol aqueous solution, but sorbitol has the limitation that the risk of patients with renal insufficiency and cardiac insufficiency is higher; patent CN104490799 A will Phloroglucinol, Tween 80, and lactose are dissolved in water for injection, and freeze-dried to make a freeze-dried preparation with good resolubility. The Tween 80 used in this method may have the risk of hemolysis, so it is not recommended for intravenous injection

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