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Content analysis and detection method of twelve compound vitamins for injection

A compound vitamin and detection method technology, which is applied in the field of content analysis and detection of 12 compound vitamins for injection, can solve the problems of large detection interference, complex physical and chemical properties, poor specificity and sensitivity of vitamins, etc., and achieve improved detection efficiency and high Effect of Detection Sensitivity

Inactive Publication Date: 2016-11-23
TIBET WEIXINKANG MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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.

Method used

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  • Content analysis and detection method of twelve compound vitamins for injection
  • Content analysis and detection method of twelve compound vitamins for injection
  • Content analysis and detection method of twelve compound vitamins for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Vitamin A Palmitate, Vitamin D 3 Determination with racemic α-tocopherol according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix VD). (Operation in dark)

[0050] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler (4.6×250mm), column temperature is 40°C, methanol-ethanol (15:25) is mobile phase A, acetonitrile-water (60 : 5) is mobile phase B, carry out gradient elution according to the following procedures:

[0051]

[0052] The total flow rate is 1.0ml / min, the detection wavelength is 265nm, and the number of theoretical plates is calculated according to the vitamin A palmitate peak, which should not be less than 4000, vitamin D 3 The resolution between the peak and the peak of racemic α-tocopherol and between the peak of vitamin A palmitate and the peak of racemic α-tocopherol should meet the requirements.

[0053] Preparation of reference substance solution Take vi...

Embodiment 2

[0058] Cocarboxylase tetrahydrate, riboflavin sodium phosphate, vitamin B 6 , vitamin C, nicotinamide, folic acid, and dexpanthenol were determined according to high-performance liquid chromatography (Appendix VD of the second part of the Chinese Pharmacopoeia 2010 edition). (Operation in dark)

[0059] Chromatographic conditions and system suitability test use Inertsil 5μODS24.6×250mm chromatographic column, column temperature is 40°C, 0.1% phosphoric acid solution of 0.005mol / L sodium pentanesulfonate is used as mobile phase A, 0.005mol / L pentanesulfonate 0.1% phosphoric acid solution of sodium bicarbonate-acetonitrile (20:80) was used as mobile phase B, and the gradient elution was carried out according to the following procedure:

[0060]

[0061] The total flow rate is 1.0ml / min, the detection wavelength is 210nm, the number of theoretical plates calculated based on the riboflavin sodium phosphate peak should not be less than 15,000, and the separation between each pe...

Embodiment 3

[0067] Biotin was determined according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix VD).

[0068] Inertsil 5μODS24.6×250mm chromatographic column for chromatographic conditions and system suitability test, column temperature 40°C, dipotassium hydrogen phosphate buffer solution (accurately weigh 1.132g of dipotassium hydrogen phosphate, add water to dissolve and dilute to 3000ml, use phosphoric acid solution (1→10) adjust the pH to 3.00±0.02) as mobile phase A, methanol as mobile phase B, and carry out gradient elution according to the following procedure.

[0069]

[0070] The total flow rate is 1.2ml / min, the detection wavelength is 210nm, and the number of theoretical plates should not be less than 1800 based on the biotin peak.

[0071]Preparation of reference substance solution Take about 17.25 mg of biotin reference substance, weigh it accurately, put it in a 50ml measuring bottle, add an appropriate amount of water and a l...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 胡军付国莉刘烽张勇
Owner TIBET WEIXINKANG MEDICINE CO LTD
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