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Detection method of multivitamin injection impurities

A detection method and technology of vitamins, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of large mutual interference, unfeasible method, and high vitamin content

Pending Publication Date: 2020-01-21
北京藏卫信康医药研发有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing technologies have shown that the physical and chemical properties of vitamin components are complex, many are unstable, and many are sensitive to light, heat, oxygen, metal ions, acidity, etc. There are many reports on the quality control of single vitamin injections, such as fat-soluble vitamin injections (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, vitamin C sodium, biotin, folic acid and vitamin B 12 ) are recorded in the National Drug Standards (Volume 5 of the Second Part of Drug Standards). There are also some detection methods for vitamin raw materials and preparations in the literature. There are reports on the content control of compound vitamin preparations, such as invention patent 201510181413. route of administration has higher requirements for safety, and because of multi-component and complex ingredients, different from single-component injections, multi-component injections interfere with each other greatly, and the vitamin content of vitamin preparations is very small, especially for other Degradation of impurities. At present, there is a lack of relevant control measures for impurities in multi-component vitamin injections. The quality control and detection of compound vitamin injections, especially the detection of impurities, is a difficulty for this type of preparation
There are reports in existing literature related technologies to detect impurities in single preparations, such as vitamin C injection and vitamin E injection, but the detection method of impurities in single preparations interferes a lot when detecting the compound preparation of the present invention, and the method is not feasible

Method used

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  • Detection method of multivitamin injection impurities
  • Detection method of multivitamin injection impurities
  • Detection method of multivitamin injection impurities

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Oxalic acid detection

[0098] Prescription 1, Prescription 2, Prescription 3, and Prescription 6 Sample water injection: take this product, accurately measure the solution (about 200mg of vitamin C), add 1ml of dilute acetic acid and 0.5ml of calcium chloride test solution, shake well, and let it stand for 1 hour. Add 0.5ml of water, shake well, and use it as the test solution; another precise measure of this product solution (containing about 200 mg of vitamin C), and operate in the same way until it is "placed for 1 hour" before filtering, and precise measure of oxalic acid solution (take an appropriate amount of oxalic acid, Accurately weighed, dissolved in water and diluted to make 0.5ml of a solution containing 1.2mg per 1ml, added to the filtrate, shaken well, left for 1 hour, as a control solution. The turbidity produced by the test solution shall not be thicker than that of the control solution (0.3%).

[0099] Prescription 1, Prescription 2, Prescription 3, P...

Embodiment 2

[0102] Retinol detection

[0103] Prescription 1, Prescription 2, Prescription 3, Prescription 7, Prescription 8, Prescription 9 Sample water injection: Avoid light. Precisely measure the solution of this product (approximately equivalent to vitamin A 6600IU), put it in a 250ml separating funnel, add 40ml of 80% ethanol solution, shake well, add 25ml of n-hexane precisely, shake and extract for 30 minutes, and place it until the upper layer is clear , accurately pipette 10ml of the supernatant and place it in a conical flask, dry it with nitrogen, add 10ml of isopropanol to dissolve it, shake it well, and use it as the test solution; take an appropriate amount of retinol reference substance, accurately weigh Set, add isopropanol to dissolve and quantitatively dilute to make a solution containing about 1.45μg per 1ml, shake well, and use it as the reference solution. Measure according to high performance liquid chromatography (Chinese Pharmacopoeia 2015 edition Sibu general ru...

Embodiment 3

[0109] 3-aminopropanol detection

[0110] Prescription 1, Prescription 2, Prescription 3, Prescription 4 Water injection or freeze-dried powder injection: take a sample, add water to make about 3mg of dexpanthenol per 1ml, as the test solution; take another 3-aminopropanol reference substance Appropriate amount, accurately weighed, dissolved in water and quantitatively diluted to make a solution containing about 30 μg of 3-aminopropanol per 1 ml, as a reference solution. Measured according to high performance liquid chromatography (Chinese Pharmacopoeia 2015 edition Sibu General 0512), using octadecylsilane bonded silica gel as filler (250mm×4.6mm, 5μm); 0.1% heptafluorobutyric anhydride aqueous solution as mobile phase A , with 0.1% heptafluorobutyric anhydride acetonitrile solution as mobile phase B; column temperature is 30 ℃; carry out gradient elution according to the table below; ℃, the carrier gas flow rate is 2.5L per minute). Precisely measure 5 μl, 10 μl, and 20 μl...

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Abstract

The invention relates to an analysis and detection method of multivitamin injection impurities, belongs to the field of medicine analysis, and mainly relates to a detection method of oxalic acid, 3-aminopropanol, retinol, alpha-tocopherol, menadione and vitamin K1 cis-isomer impurities in a multivitamin injection.

Description

technical field [0001] The invention relates to an analysis and detection method for impurities in multivitamin injections, belonging 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 through food. Hyp...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8872
Inventor 胡军付国莉田琳谢景凤刘烽张勇
Owner 北京藏卫信康医药研发有限公司
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