Novel detection method of tauroursodeoxycholic acid content and relevant substances

Abstract

The invention discloses a novel detection method of the tauroursodeoxycholic acid content and relevant substances. The relevant substances are taurochenodeoxycholic acid and ursodesoxycholic acid. The method includes the steps of preparing a reference substance solution and a reference substance test article solution, injecting the solutions into a liquid phase chromatographic instrument, recording the peak area of tauroursodeoxycholic acid in a chromatograph, calculating the HPLC content through anhydrous tauroursodeoxycholic acid according to an external standard method, preparing an impurity reference substance solution and a sample solution, injecting the solutions into the liquid phase chromatographic instrument, recording the peak areas of taurochenodeoxycholic acid and ursodesoxycholic acid in the chromatogram, and calculating the amounts of the relevant substances in the tauroursodeoxycholic acid sample according to the external standard method. By means of the method, an RID is applied through the efficient liquid phase chromatography. Under the same liquid phase spectrum conditions, two cholic acid substances, namely tauroursodeoxycholic acid and ursodesoxycholic acid which are large in polarity difference, can be effectively separated and accurately and quantitatively detected.

Description

technical field [0001] The invention relates to a novel detection method for tauroursodeoxycholic acid content and related substances. Background technique [0002] Tauroursodeoxycholic acid (Turoursodeoxycholic acid) chemical name is 3α, 7β dihydroxycholanoyl-N-taurine, which is composed of the carboxyl group of ursodeoxycholic acid (ursodeoxycholic acid) Conjugated bile acid formed by shrinking with the amino group of taurine. Tauroursodeoxycholic acid was discovered in bear bile in 1902. It is the main bile acid in bear bile and has antispasmodic, anticonvulsant, anti-inflammatory and gallstone-dissolving effects. Tauroursodeoxycholic acid is the active ingredient of bear bile, its chemical name is 2-[[(3α,5β,7β)-3,7-dihydroxy-24-oxocholestan-24-yl]amino] Ethanesulfonic acid dihydrate. Clinically, it is mainly used for the treatment of gallbladder cholesterol stones, primary sclerosing cholangitis, primary biliary cirrhosis and chronic hepatitis C virus. Clinical stud...

AI Technical Summary

Problems solved by technology

This method effectively separates and accurately quantitatively detects tauroursodeoxycholic acid and ursodeoxycholic acid under the same liquid chromatographic conditions.

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