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New quality index of Jingfukang preparation and detection method

A technology of quality indicators and detection methods, applied in anti-inflammatory agents, measuring devices, pharmaceutical formulations, etc., can solve the problems of less reports and achieve reliable and reproducible detection results

Active Publication Date: 2010-06-23
CHENGDE TRADITIONAL CHINESE MEDICINE GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, so far, there are many reports on the determination of ferulic acid and ligustrazine in Chuanxiong, but less reports on the determination of the important active ingredient ligustilide content in Chuanxiong.

Method used

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  • New quality index of Jingfukang preparation and detection method
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  • New quality index of Jingfukang preparation and detection method

Examples

Experimental program
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Effect test

preparation example Construction

[0066] (3) Preparation of internal standard solution

[0067] ① Accurately weigh 0.1120g of diethyl phthalate, and set methanol to a 10ml volumetric flask;

[0068] ②Take 1.0mL of the solution in step (3)①, place it in a 10mL volumetric flask, and set the volume to the mark with methanol to obtain an internal standard solution of diethyl phthalate with a concentration of 1.12mg·mL^-1;

[0069] (4) Preparation of standard solution

[0070] ① Precisely weigh 0.0099g of ligustilide standard substance, put it in a 10mL brown volumetric flask, and dilute to the mark with methanol to obtain a standard solution of 0.99mg·mL^-1, and store it in a -18°C refrigerator with light blocked. ready for use;

[0071] ② Accurately measure 0.51 mL of the standard solution in step (4) ①, add 1.12 mg·mL^-1 diethyl phthalate internal standard solution 50 μL, prepare a methanol solution, and the internal standard concentration in the solution is 0.224 mg· mL^-1, the concentration of ligustilide i...

Embodiment 1

[0150] With ligustilide content as the detection index of Jingfukang preparation quality, measure according to appendix VI E gas chromatography of " Pharmacopoeia of the People's Republic of China " (version one in 2005):

[0151] (1) Chromatographic conditions and system suitability: 5% phenylmethylpolysiloxane capillary column (30m×0.32mm×0.25m); temperature program: initial column temperature 80°C, keep for 2 minutes, increase to 10-20°C Min^-1 heating rate to 250°C, keep for 16 minutes; FID detector; the number of theoretical plates based on ligustilide is not less than 10,000;

[0152] (2) Preparation of internal standard solution

[0153] ① Accurately weigh 0.1120g of diethyl phthalate, and set the volume of methanol in a 10ml volumetric flask,

[0154] ②Put 1.0 mL of the above solution in a 10 mL volumetric flask, and dilute to the mark with methanol to obtain an internal standard solution with a concentration of 1.12 mg·mL^-1;

[0155] (3) Preparation of standard sol...

Embodiment 2

[0174] Measure according to "Pharmacopoeia of the People's Republic of China (version one in 2005) Appendix VI D high performance liquid chromatography:

[0175] (1) Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; 60-95:40-5 methanol-water as mobile phase, gradient elution; column temperature 25°C; detection wavelength 320nm ;The number of theoretical plates should not be less than 10,000 based on the peak of ligustilide;

[0176] (2) Precisely weigh 0.0101g of the reference substance of ligustilide, place it in a 10mL brown volumetric flask, and dilute to the mark with methanol to obtain a solution containing 1.01mg of the reference substance in 1.0mL, and store it in a refrigerator at -18°C middle.

[0177] (3) Preparation of the test solution: take 50g of Jingfukang preparation, add 8 times the amount of water 400mL, extract the volatile oil according to the 2005 edition pharmacopoeia appendix 57 volatile oil determi...

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Abstract

The invention provides a new quality index of a Jingfukang preparation and a detection method. The content of ligustilide is adopted as a detection index for the quality of the Jingfukang preparation. The detection is carried out by adopting a GC (gas chromatogram) internal standard method and an HPLC (high performance liquid chromatography) external standard method. The new quality index is as follows: the content of the ligustilide per 5g Jingfukang preparation is from 0.1 to 1.0mg; the content of the ligustilide per 5g Jingfukang preparation is not lower than 0.1mg, and the content of puerarin is not lower than 8.0mg. The invention has the following positive effects: the suggestion that the ligustilide is adopted as the quality control index of the Jingfukang preparation is put forward for the first time; the content of the ligustilide in the Jingfukang preparation can be detected by adopting a liquid chromatography and the GC internal standard method; the detecting result is reliable, and the repeatability is good; therefore, the invention provides the new quality control index and the detection method for safety production and better clinical application of the Jingfukang preparation.

Description

【Technical field】 [0001] The invention relates to the technical field of preparation and monitoring of medicines, in particular to a new quality index and detection method of Jingfukang preparations, in particular to a detection method of ligustilide. 【technical background】 [0002] Jingfukang preparations are pure Chinese medicine granules, composed of astragalus, Codonopsis pilosula, Salvia miltiorrhiza, Paeoniae Alba, Rehmannia glutinosa, Cassia clematis, stamens (calcined), Pueraria lobata, Cortex Phellodendri, Gentiana chinensis, Buliuxing (stir-fried), Ligusticum chuanxiong , Cangzhu, Qianghuo, peach kernel (peeled), frankincense (made), myrrh (made), safflower, earthworm (wine-roasted), wood beetle (wine-roasted) 21 medicines, have the functions of dispelling wind and cold, relieving pain, It has the effects of dredging meridians, activating blood circulation and removing blood stasis, nourishing qi and nourishing blood, etc. It is used for the treatment of insufficie...

Claims

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Application Information

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IPC IPC(8): A61K36/804A61P19/08A61P29/00A61P9/10G01N30/02A61K35/64A61K35/56A61K33/10A61K35/618A61K35/62
Inventor 倪力军王春民董海荣张立国郭美兰党晓伟刘刚
Owner CHENGDE TRADITIONAL CHINESE MEDICINE GROUP
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