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Method for inspecting related substances of menbutone injection liquid for veterinary use

A technology related to substances and inspection methods, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as feed poisoning, no imported patent information, etc., and achieve strong specificity, control internal quality, and good repeatability

Active Publication Date: 2014-12-03
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, in Europe and other regions, menbutone has been used in horses, cattle, sheep, goats, pigs and dogs for indigestion, loss of appetite, anorexia, postpartum fasting, moldy feed poisoning, colic, constipation, ketosis, Toxemia (including pregnancy toxemia), digestive dysfunction caused by liver and pancreatic diseases, etc., but there are few reports in our country, and there is no import or related patent information

Method used

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  • Method for inspecting related substances of menbutone injection liquid for veterinary use
  • Method for inspecting related substances of menbutone injection liquid for veterinary use
  • Method for inspecting related substances of menbutone injection liquid for veterinary use

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1. Establishment and methodological verification of related substance inspection method for veterinary monbuterone injection

[0030] 1. Main medicines and instruments

[0031] Veterinary menbutone injection is a small test product of Chongqing Veterinary Drug Engineering Technology Research Center, batch number 20120506, content 100.16%. The reference substance of menbuxone was provided by Dr. Ehrenstorfer Company of Germany, batch number 01117.

[0032] Mettler Ag135 electronic balance, Shimadzu LC-20AD high performance liquid chromatograph, Shimadzu SPD-M20A ultraviolet variable wavelength detector.

[0033] 2. Establishment of inspection methods for related substances in veterinary monbuterone injection

[0034] Checked by high performance liquid chromatography.

[0035] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as a filler, a mixture of 5g / L phosphoric acid solution and acetonitrile in a volume rati...

Embodiment 2

[0112] Embodiment 2, application of related substance inspection method of veterinary monbuterone injection

[0113] Using the related substance inspection method of veterinary menbutrin injection of the present invention, the pilot test samples of veterinary menbutrin injection (batch numbers 20120701, 20120702, 20120703, 20120704) produced by Chongqing Baileweike Animal Pharmaceutical Co., Ltd , specifications are 10mL: 1g and 100mL: 10g) for related substance inspection. The specific chromatographic conditions are as follows: the chromatographic column is a C18 column (250mm×4.6mm); the mobile phase is 5g / L phosphoric acid solution-acetonitrile (volume ratio 1:2); the column temperature is 30°C; the flow rate is 1.0ml / min; the detection wavelength 235nm.

[0114] The results are shown in Table 18. For 4 batches of veterinary monbutrinone injection pilot test samples with 2 loading specifications, the inspection results of related substances all meet the regulations (the co...

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Abstract

The invention discloses a method for inspecting related substances of menbutone injection liquid for veterinary use. The method includes the first step of using a high performance liquid chromatography to carry out inspection, using octadecyl silane bonded silica gel as filling agents, and using mixed liquor formed by a 5g / L phosphric acid solution and acetonitrile according to 0.9-1.1:2 volume ratio as a mobile phase, wherein the detection wavelength of the mobile phase is 230-240 nm, the second step of precisely measuring and taking the menbutone injection liquid for veterinary use, diluting the menbutone injection liquid by 500 times through the mobile phase, and using the diluted menbutone injection liquid as a test solution, the third step of precisely measuring and taking the test solution, diluting the solution by 50 times through the mobile phase to be used as a contrast solution, and the fourth step of precisely measuring and taking 20uL of the test solution and 20 uL of the contrast solution, respectively injecting the 20 uL of the test solution and the 20 uL of the contrast solution into a liquid chromatograph and recording chromatograms. If impurity peaks exist in the chromatogram of test solution, the area of a single impurity peak can not be larger than 0.5 time of the main peak area of the contrast solution, and the total sum of the areas of the impurity peaks can not be larger than the main peak area of the contrast solution. The method is strong in specificity, high in sensitivity, good in repeatability and favorable for controlling the intrinsic quality of the menbutone injection liquid for veterinary use, and ensures that drugs are safe and effective.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a related substance inspection method of veterinary drug preparations. Background technique [0002] Animal husbandry is an important industry in my country's national economy and an important part of agriculture. Literature shows that in veterinary clinics, digestive system diseases of pigs, sheep, cattle and other animals account for about 30% of the total clinical incidence, while gastrointestinal dysfunction such as loss of appetite, indigestion, constipation, abdominal distension, gastrointestinal relaxation, and rumen accumulation , concomitant or secondary to almost all diseases in animals. Animal indigestion can hinder the growth and development of animals, reduce production performance or even die, often causing large economic losses and hindering the development of animal husbandry. At present, for such diseases, cholinergic drugs such as bethanechol, bethanechol,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 罗永煌谭明国罗雷王兰周杨游龙飞王帅吴梦婉
Owner SOUTHWEST UNIV