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Method for determining content of index component derived from herba artemisiae annuae in reduning injection

A determination method and injection technology, applied in the field of analytical chemistry, to achieve the effects of simple operation, increased quality control, and accurate analysis data

Inactive Publication Date: 2018-11-02
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the determined components in Reduning injection are mainly 12 caffeoylquinines, including chlorogenic acid, neochlorogenic acid, geniposide, and anoxyloganin, which are index components in honeysuckle medicinal materials and gardenia medicinal materials. Acids and iridoids, while scopoletin and (1S,6R,7R,10R)-6-carboxy-10-methyl-α- There is no relevant detection method for the content of methylene-1-(1-oxobutyl)-cyclohexaneacrylic acid

Method used

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  • Method for determining content of index component derived from herba artemisiae annuae in reduning injection
  • Method for determining content of index component derived from herba artemisiae annuae in reduning injection
  • Method for determining content of index component derived from herba artemisiae annuae in reduning injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Examples 1-5 Quantitative detection method of index components derived from Artemisia annua in Reduning injection

[0070] Preparation of standard solution: take scopoletin and (1S,6R,7R,10R)-6-carboxy-10-methyl-α-methylene-1-(1-oxobutyl)-cyclohexane Acrylic acid reference substance, add methanol solution with a volume concentration of 50% (methanol and purified water are prepared according to the volume ratio of 1:1) to prepare mixed reference substance stock solutions with concentrations of 4.17 and 19.50 μg / mL, respectively, 0.22 μm microporous membrane filtration.

[0071] Preparation of the solution to be tested: Accurately measure 1 mL of Reduning Injection and place it in a 10 mL volumetric flask, add methanol solution with a volume concentration of 50% to dilute to the mark, shake well, and filter with a 0.22 μm microporous membrane to obtain the solution.

[0072] Column gradient elution program: 0min→2min→4min→11min→13min→13.1min→14min, mobile phase A: 5%→5%...

Embodiment 6

[0083] Embodiment 6 precision test

[0084] Using the detection method provided in Example 1, take the standard solution provided in Example 1, inject 6 needles continuously, and calculate the RSD of each index component with the peak area, which are respectively scopoletin and (1S, 6R, 7R, 10R) The RSD values ​​(n=6) of the peak areas of -6-carboxy-10-methyl-α-methylene-1-(1-oxobutyl)-cyclohexane acrylic acid were 0.46%, 2.17%, indicating that the instrument The precision is good.

Embodiment 7

[0085] The investigation of embodiment 7 linear relationship

[0086]Accurately weigh an appropriate amount of scopoletin and (1S,6R,7R,10R)-6-carboxy-10-methyl-α-methylene-1-(1-oxobutyl)-cyclohexaneacrylic acid, add Made with 50% methanol containing scopoletin 4.17μg / mL, (1S,6R,7R,10R)-6-carboxy-10-methyl-α-methylene-1-(1-oxobutyl)- The mixed standard solution of cyclohexane acrylic acid 19.50 μg / mL was used as the mother liquor and diluted step by step with 50% methanol to obtain scopoletin concentrations of 3.34 μg / mL, 1.67 μg / mL, 0.83 μg / mL, 0.42 μg / mL, 0.10 μg / mL and (1S,6R,7R,10R)-6-carboxy-10-methyl-α-methylene-1-(1-oxobutyl)-cyclohexaneacrylic acid Concentrations of 15.60 μg / mL, 7.80 μg / mL, 3.90 μg / mL, 1.95 μg / mL, 0.49 μg / mL of the standard solution, each accurately draw 1 μL, using the detection method provided in Example 1 to measure, the peak area Integral value y versus concentration x (μg·mL -1 ) for regression analysis, the linear regression equations are resp...

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Abstract

The invention provides a method for determining the content of an index component derived from herba artemisiae annuae in reduning injection. According to the invention, a triple quadrupole mass spectrometer detector is adopted as the detector, and a specific gradient elution program is combined to determine the content of the index component derived from herba artemisiae annuae in the reduning injection by adopting an ultra-high performance liquid chromatography. The determination method provided by the invention is simple in operation and accurate in analytical data, thereby increasing the quality control of the index component of herba artemisiae annuae in the reduning injection, and laying a foundation for the improvement of the quality standard of the reduning injection.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry, and specifically relates to a method for determining the content of index components derived from Artemisia annua medicinal materials in Reduning injection. Background technique [0002] Reduning Injection is an original Class II new drug independently developed by Jiangsu Kangyuan Pharmaceutical Co., Ltd. It is refined from the three commonly used traditional Chinese medicines of Artemisia annua, Honeysuckle and Gardenia. It is used to treat colds, coughs, upper respiratory tract infections, and acute bronchitis caused by exogenous wind-heat. In the prescription, Artemisia annua is the monarch drug, which has the effect of clearing heat and cooling blood, and penetrating the skin surface; honeysuckle is the minister drug, which is good at clearing away heat and detoxification, and can disperse pathogens from the exterior, helping to enhance the effect of Artemisia annua in clearing ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 萧伟李海波葛雯王振中丁岗杨彪胡晗绯
Owner JIANGSU KANION PHARMA CO LTD