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Pharmaceutical composition detecting method

A detection method and composition technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inability to accurately identify and quantify active ingredients, fail to detect active ingredient bellflower saponin D, and interfere with each other in qualitative and quantitative detection. , to achieve the effect of ensuring clinical efficacy, high recovery rate, and low background interference

Active Publication Date: 2019-06-25
SICHUAN JISHENGTANG PHARMLS
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because Xuanmai Ganju Capsules also contain a variety of chemical components of the four medicinal materials of Radix Scrophulariae, Ophiopogon japonicus, Licorice and Platycodon grandiflorum, including: iridoid compound harpagoside, phenylpropanoid compound cinnamic acid, flavonoid component licorice Glycyrrhizic acid, saponins, crude saponins ophioposide Ra, platycodon saponin D and other parent nuclei have similar structures and properties, and often interfere with each other in qualitative and quantitative detection. It is necessary to use HPLC to accurately separate the target substance from other impurities. Effective separation and quantitative analysis are more difficult, and the quality control of prescription preparations is even more difficult
[0003] Existing technology "Chinese Pharmacopoeia" 2015 edition, Guo Wenting, etc. [RP-HPLC gradient elution method to determine the content of harpagoside and cinnamic acid in Xuanmai Ganju capsules, Chinese medicinal materials, Volume 31, Issue 8, August 2008], Jiang Huake [Determination of Glycyrrhizic Acid Content in Xuanmai Ganju Granules by High Performance Liquid Chromatography, Zhongnan Pharmaceutical Sciences, Volume 10, Issue 2, February 2012] or Xu Xiuying et al. The content of asapenoside A, Chinese Pharmacy, Vol. 2l, No. 39, 2010] and other HPLC detection methods only detect the specific components of specific medicinal materials in Xuanmai Ganju capsules, but cannot effectively control the prescription of Xuanmai Ganju. Accurate qualitative and quantitative analysis of the active ingredients of multi-flavored medicinal materials in preparations
The HPLC detection method introduced by Zhang Ping, Guo Yadong, etc. [RP-HPLC Determination of Liquiritin, Glycyrrhizic Acid, Harpagoside and Cinnamic Acid in Xuanmai Ganju Granules, Journal of Pharmaceutical Analysis, 2008, 28 (5 )] Although the active ingredients liquiritin, glycyrrhizic acid, harpagoside and cinnamic acid were detected by the dual-wavelength detection method, the active ingredients platycodon saponin D and radix radix There are miscellaneous peaks wrapped around the glycoside peak, and tailing phenomenon occurs, and the entire baseline is too high, and the interference is serious, so it is impossible to conduct accurate qualitative and quantitative analysis of the active ingredients in the prescription preparation of Xuanmai Ganju

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0149] Scrophulariaceae extract, Radix Ophiopogon japonicus extract, Licorice root extract, Platycodon grandiflorum extract are prepared according to the following conventional extraction process:

[0150] Scrophulariaceae extract: Take Scrophulariaceae medicinal material, add water and decoct 3 times, 1 hour each time, combine the decoction, filter, let stand for 12 hours, concentrate the clear paste with a density of 1.10 (65-80°C), and dry it to obtain The extract powder is the Scrophulariaceae extract.

[0151] Extract of Ophiopogon japonicus: take Ophiopogon japonicus herb, add water to decoct 3 times, 1 hour each time, combine the decoction, filter, let stand for 12 hours, concentrate the clear paste with a density of 1.10 (65-80°C), and dry it to obtain The extract powder is the Ophiopogon japonicus extract.

[0152] Licorice extract: Take the licorice medicinal material, add water and decoct 3 times, 1 hour each time, combine the decoction, filter, let stand for 12 ho...

Embodiment 2

[0161] Need testing solution preparation and reference substance solution preparation are with embodiment 1;

[0162] Content detection: get each 10 μ l of reference substance solution and need testing solution and inject liquid chromatograph to detect, and its detection condition is as follows: with 0.05% phosphoric acid as mobile phase B, all the other detection conditions are with embodiment 1;

[0163] Carry out high-performance liquid chromatography detection according to above-mentioned method, the result is as follows Figure 9 shown. according to Figure 9 As shown, the retention time of the six index components is moderate, the resolution is greater than 1.5, the baseline drift value D is 5.0mAU / 30min, and the detection effect is achieved.

Embodiment 3

[0165] Need testing solution preparation and reference substance solution preparation are with embodiment 2;

[0166] Content detection: get each 10 μ l of reference substance solution and need testing solution and inject liquid chromatograph to detect, and its detection condition is as follows: with 0.2% phosphoric acid as mobile phase B, all the other detection conditions are the same as embodiment 1.

[0167] Carry out high-performance liquid chromatography detection according to above-mentioned method, the result is as follows Figure 10 shown. according to Figure 10 As shown, the retention time of the six index components is moderate, the resolution is greater than 1.5, and the baseline drift value D is 4.8mAU / 30min, achieving the detection effect.

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Abstract

The invention provides a pharmaceutical composition detecting method. A pharmaceutical composition is a composition which comprises a Scrophularia sinensis extract, an Ophiopogon japonicus extract, alicorice extract or a platycodon extract, and is detected by using high performance liquid chromatography. According to the liquid chromatographic detection conditions, a chromatography column is octadecylsilane-bonded silica gel as a filler; mobile phase A is a phosphoric acid solution, and mobile phase B is acetonitrile; and gradient elution and dual wavelength switching are used for detection.The method is fast, efficient, stable, accurate and effective, and can simultaneously quickly and effectively detect multiple index components of the pharmaceutical composition.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a detection method of a drug composition. Background technique [0002] Xuanmai Ganju capsules, granules and other prescription preparations are recorded in the first part of the "Chinese Pharmacopoeia" 2015 edition. It has the functions of clearing heat and nourishing yin, eliminating phlegm and relieving sore throat. It is used for hyperactivity of fire due to yin deficiency, rising of asthenic fire, dry mouth and nose, and sore throat. Because Xuanmai Ganju Capsules also contain a variety of chemical components of the four medicinal materials of Radix Scrophulariae, Ophiopogon japonicus, Licorice and Platycodon grandiflorum, including: iridoid compound harpagoside, phenylpropanoid compound cinnamic acid, flavonoid component licorice Glycyrrhizic acid, saponins, crude saponins ophioposide Ra, platycodon saponin D and other parent nuclei have similar structures and properties, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 柯潇陈海燕杨宋琪罗旭
Owner SICHUAN JISHENGTANG PHARMLS
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