Content analysis and detection method of twelve compound vitamins for injection

Abstract

The invention discloses a content analysis and detection method of twelve compound vitamins for injection. Liposoluble components including vitamin A palmitate, vitamin D3 and racemic alpha-tocopherol are detected under the same high-performance liquid phase method conditions, a test solution is prepared by extracting a preparation content by non-polar organic solvent, and the detection wavelength is 265+/-3nm. Water-soluble components including cocarboxylase tetrahydrate, riboflavin sodium phosphate, vitamin B6, vitamin C, nicotinamide, folic acid and dexpanthenol are detected under the same high-performance liquid phase method conditions, and the detection wavelength is 210+/-3nm. Biotin and vitamin B12 are subjected to high-performance liquid phase method based detection, the detection wavelength is 200-600nm, and the preferable detection wavelength for the vitamin B12 is 550+/-3nm. The method has high applicability.

Description

technical field [0001] The invention relates to a content analysis and detection method of 12 kinds of compound vitamins for injection, which belongs to the field of drug analysis. Background technique [0002] Parenteral nutrition plays an important supporting role in the treatment of diseases, and is widely used in congenital digestive tract malformations, moderate to severe malnutrition, digestive tract diseases (severe diarrhea, necrotizing enterocolitis, early short bowel syndrome, intestinal Obstruction, intestinal fistula, necrotizing pancreatitis), critically ill newborns who cannot eat normally, severe gastrointestinal reactions caused by radiotherapy and chemotherapy, severe infection, major surgery, trauma, burns, etc. Vitamins are a kind of trace organic substances necessary to maintain human life activities. Generally, they cannot be synthesized by their own assimilation in the human body. The normal human body can obtain the vitamins needed by the human body th...

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Problems solved by technology

[0005] Existing technologies have shown that vitamin components have complex physical and chemical properties, different solubility properties, are unstable, and are sensitive to light, heat, oxygen, metal ions, acidity, etc., and their storage conditions are often strict, such as folic acid. , Vitamin D is required to be protected from light, sealed, filled with nitrogen, and stored in a cold place; the components of vitamins are also unstable, such as vitamin B 1 , Vitamin B 12 The interaction will reduce the content, vitamin B 12 It can reduce the content of vitamin C, and the vitamin content of vitamin preparations is very small, and the quality control detection of compound vitamin preparations is one of the difficulties of this kind of preparations

[0006] Fat-soluble vitamin injection (containing vitamin A palmitate, vitamin D 2 , vitamin E and vitamin K) and water-soluble vitamins for injection (containing thiamine nitrate, riboflavin sodium phosphate, nicotinamide 40mg, pyridoxine hydrochloride, sodium pantothenate, sodium vitamin C, biotin, folic acid and vitamin B 12 ) are recorded in the National Drug Standards (Volume 5 of Part Two of Drug Standards), and there are also some detection methods for vitamin raw materials and preparations in the literature. Some vitamins exist in different forms. The current literature method has a lot of interference in the detection, and the detection efficiency for a single vitamin is low, and the specificity and sensitivity for some vitamins are poor.

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