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Construction method of hplc fingerprint of traditional Chinese medicine composition and quality detection method of traditional Chinese medicine composition

A fingerprint and construction method technology, applied in the field of quality inspection, can solve problems such as inability to comprehensively control product quality, and achieve the effect of avoiding singleness and one-sidedness and good reproducibility

Active Publication Date: 2020-11-13
吉林修正药业新药开发有限公司 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the 2015 edition of the Chinese Pharmacopoeia and related literature reports, there are only TLC qualitative identification methods for the three herbs of Fructus Aurantii, Glycyrrhizae, and Duhuo, and HPLC content determination methods for Fructus Aurantii, which cannot comprehensively control the quality of the product
[0005] Traditional Chinese medicine and its preparations are multi-component complex systems, so the evaluation of its quality should adopt detection methods that are suitable for it and can provide rich identification information, but the current methods of microscopic identification, physical and chemical identification and content determination are not enough solve this problem

Method used

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  • Construction method of hplc fingerprint of traditional Chinese medicine composition and quality detection method of traditional Chinese medicine composition
  • Construction method of hplc fingerprint of traditional Chinese medicine composition and quality detection method of traditional Chinese medicine composition
  • Construction method of hplc fingerprint of traditional Chinese medicine composition and quality detection method of traditional Chinese medicine composition

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preparation example Construction

[0043] 2. Preparation of reference substance solution: Take appropriate amount of reference substances of naringin, neohesperidin, and hesperidin respectively, weigh them accurately, and use methanol to make reference substance solutions containing 80 μg, 80 μg, and 50 μg per 1 ml respectively.

[0044] 3. Chromatographic conditions: Octadecyl bonded silica gel is used as the filler chromatographic column; acetonitrile is used as mobile phase A, 0.1% formic acid solution is used as mobile phase B; column temperature is 20-40°C; flow rate is 1ml / min; The wavelength is 210-290nm.

[0045] 4. Determination: Precisely draw the test solution and inject it into a liquid chromatograph, measure according to high performance liquid chromatography, and obtain the fingerprint of the Chinese medicine composition.

[0046] In other specific embodiments of the present invention, the construction method of the HPLC fingerprint of Chinese medicine composition is characterized in that comprisi...

Embodiment 1

[0080] The determination of embodiment 1 chromatographic conditions

[0081] Detection wavelength:

[0082] Precisely draw 10 μl of the test solution, inject it into the high-performance liquid chromatograph, use a DAD detector, and examine the spectrum at a wavelength of 200nm to 400nm. Other conditions remain the same, according to the detection wavelength at which all chromatographic peaks in the three-dimensional scanning diagram appear maximum absorption. Results At the wavelength of 283nm, the number of chromatographic peaks was more, and all the chromatographic peaks showed the maximum absorption, and the separation effect between the chromatographic peaks was better.

[0083] mobile phase:

[0084] After checking the Chinese Pharmacopoeia 2015 edition and relevant data, other conditions remained the same. The mobile phase system was investigated: ①methanol-water; ②acetonitrile-water; ③acetonitrile-0.4% phosphoric acid solution; ④acetonitrile-0.1% formic acid solution...

Embodiment 2

[0136] Chromatographic conditions and system adaptability test use octadecyl bonded silica gel as the filler chromatographic column; use acetonitrile as mobile phase A, 0.1% formic acid solution as mobile phase B, and carry out gradient elution as shown in the table below; column temperature is 30°C ; The flow rate is 1ml / min; The detection wavelength is 283nm.

[0137] Table 8 mobile phase gradient table

[0138] time (minutes) Mobile phase A(%) Mobile phase B(%) 0~15 10→20 90→80 5~30 20 80 30~50 20→34 80→66 50~51 34→10 66→90 51-56 10 90

[0139] Preparation of reference substance solution: Take appropriate amount of reference substances of naringin, neohesperidin, and hesperidin respectively, weigh them accurately, and use methanol to make reference substance solutions containing 80 μg, 80 μg, and 50 μg per 1 ml, respectively.

[0140] Need testing solution preparation: get about 1g of sample powder, weigh accurately, accurate...

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Abstract

The invention relates to the field of drugs, in particular to a traditional Chinese medicine composition for treating wind-cold common cold and a preparation method of the traditional Chinese medicinecomposition. The traditional Chinese medicine composition has the obvious curative effects in the aspects of antipyresis and anti-inflammation to rats, and analgesia, coughing suppressing and phlegmexpelling to mice, and has the obvious advantage effects compared with the same type of comparative patents, and it is indicated that the traditional Chinese medicine composition has the significant curative effects on wind-cold common cold symptoms such as cold loathing and strong heat, neck stiffness and headache, limb pain, silencing and dysentery, adiapneustia and nasal obstruction, and productive cough. According to the traditional Chinese medicine composition and the preparation method thereof, the defects such as low pertinence of the drugs for treating the cold in the market are made up, the safer and more effective method is provided for treating the wind-cold common cold, and the effective guarantee is provided for production and clinical application of the drugs.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a method for constructing an HPLC fingerprint of a Chinese medicine composition and a method for detecting the quality of the Chinese medicine composition. Background technique [0002] Wind-cold cold is caused by the attack of wind-cold evil and loss of lung energy. Symptoms can be seen: severe aversion to cold, mild fever, no sweat, headache and body pain, nasal congestion and runny nose, cough and spitting of thin white phlegm, not thirsty or thirsty for hot drinks, thin white fur. The treatment method should be based on Xin Wen Jie Biao. Ephedra, Nepeta, Fangfeng, Su Ye and other medicines for dispersing exterior and cold are often used. The representative prescriptions are "Scallion Soup Soup" and "Jing Fang Bai Du San". Chinese patent medicines can choose Ganmao Qingre Granules, Zhengchaihuyin Granules, Ganmao Soft Capsules, Chuanxiong T...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/86
CPCA61K36/076A61K36/23A61K36/232A61K36/233A61K36/236A61K36/237A61K36/344A61K36/346A61K36/484A61K36/534A61K36/752A61K36/9068A61K2236/331A61K2236/51A61P11/00A61K2300/00Y02A50/30
Inventor 徐建赵俞徐云高嵩许艳茹
Owner 吉林修正药业新药开发有限公司
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