Study On The Tauroursodeoxycholic Acid Capsules Quality Consistency Evaluation

The tauroursodeoxycholic acid chemical name is 2-[[(3,5,7)-3α,7β, 2-hydroxy-24-oxygen generation cholestane-24-base] amino] ethane sulfonic acid dihydrate. It can dissolute cholesterol stone and protect the liver cells and having so many pHysiological functions, it was mainly used in clinical treatment of gallbladder cholesterol calculus, primary sclerosing cholangitis, primary biliary cirrhosis, chronic viral hepatitis c and so on. The main purpose of this paper is to research and product quality consistent tauroursodeoxycholic acid capsules in order to reduce the gap between the homemade products and the reference products. Quality by Design is the design idea, the subject of capsule prescription research, the capsule quality standard, and capsule of homemade products compared with the reference drugs quality research and so on has carried on the detailed inspection, the specific contents are as follows:1. Tauroursodeoxycholic acid capsules prescription researchIn this experiment, the in vitro dissolution was the evaluation index, we used the microcrystalline cellulose, starch, lactose, magnesium stearate as the medicinal material of tauroursodeoxycholic acid capsules, and we considered the related factors such as capsule dissolution, related substances, and content, in order to optimize the best prescription of tauroursodeoxycholic acid capsules. The three batches of samples dissolution determination results showed that the tauroursodeoxycholic acid capsules prescription is reasonable. It can produce quality qualified and uniformity of tauroursodeoxycholic acid capsules.2. Tauroursodeoxycholic Acid Capsules quality standard researchThin layer chromatograpHy (TLC) was established to determinate the taurine in tauroursodeoxycholic acid capsules. We established a HPLC method for the determination of related substances, content and the dissolution of tauroursodeoxycholic acid capsules. At the same time, the appearance of the capsule, identification and load difference of quality indexes were studied, we finally determined the quality standards of tauroursodeoxycholic acid capsules.3. The homemade products and the reference drugs quality consistency studyIn order to study the difference between the homemade products and the reference drugs (Taurolite), this experiment was carried out to the main pHysical and chemical properties, related substances and the dissolution curve. The results from the homemade products and reference drugs in addition to the capsule and the contents are different in the form of color, the rest of the indicators are consistent.In four kinds of dissolution medium dissolution curves showed that, in terms of relevant material, reference samples in total since the research on the total impurity quality products is high, since the homemade quality of the product is superior to the reference one.