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Quality controlling method for dangshen and preparation containing it

A quality control method and control method technology, applied in the field of quality control of Codonopsis pilosula and preparations containing Codonopsis pilosula, can solve the problems of ineffective quality control of medicinal materials and pharmaceutical preparations, insufficient research on active ingredients of Codonopsis pilosula, etc., and achieve accurate quantitative determination, The effect of accurate evaluation

Inactive Publication Date: 2005-02-23
南京宇道科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, a considerable part of the Chinese patent medicines and herbal medicines that have been marketed at home and abroad contain Codonopsis or Codonopsis extracts, but due to insufficient research on the active ingredients in Codonopsis pilosula, the control of Codonopsis pilosula or Codonopsis pilosula extracts in the drug standards of the above drugs Most of the methods are histological identification, examination of extracts, thin-layer identification of Codonopsis pilosula reference medicinal materials, etc. Compilation - Chinese patent medicine local standard rises to national standard part", the standard of compound Dangshen tablet is identified by TLC of Codonopsis pilosula, and Shengmai drink (Dangshen prescription) in "National Chinese patent medicine standard compilation - local standard of Chinese patent medicine rises to national standard part" Using Codonopsis Codonopsis as reference medicinal material TLC identification and n-butanol extract determination, its shortcoming is the lack of content determination and qualitative identification of effective chemical components in Codonopsis pilosula, and it is impossible to effectively control the quality of medicinal materials and pharmaceutical preparations

Method used

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  • Quality controlling method for dangshen and preparation containing it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Example 1: Determination of the Content of Adenosine and Guanosine in Codonopsis Codonopsis Medicinal Materials by High Performance Liquid Chromatography

[0014] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; column temperature is 25°C, detection wavelength is 260nm. Mobile phase A is water+glacial acetic acid (970ml+1ml), mobile phase B is acetonitrile, gradient elution: start with 3% mobile phase B (that is, mobile phase A is 97%), maintain isocratic elution for 8 minutes, and then Increase the proportion of mobile phase B at a rate of 6.7% per minute to 50% B after 15 minutes, hold for another 5 minutes, and end the gradient at 20 minutes. The flow rate was 1.0 ml / min. The injection volume is 20 μl, and the number of theoretical plates should not be less than 3000 based on adenosine, and not less than 3000 based on guanosine.

[0015] Preparation of the test solution: Grind Codonopsis pilosula, weigh 1g of t...

Embodiment 2

[0020] Example 2: Determination of the content of adenosine and guanosine in Codonopsis Codonopsis medicinal materials by high-efficiency thin-layer chromatography scanning method

[0021] Thin-layer chromatography conditions Use a fully automatic spotting instrument to spot the sample in strips on a silica gel GF254 thin-layer plate, and place it in a developing cylinder for development. Developing agent: chloroform-methanol-n-butanol-ethyl acetate-concentrated ammonia water (9 :4:3:3:1), unfolded 9cm, took out to dry, observed under ultraviolet light with a wavelength of 254nm, and scanned and integrated at a wavelength of 270nm with a thin-layer scanner.

[0022] Preparation of test solution: Pulverize Codonopsis pilosula, weigh 5g of powder (through No. 2 sieve), accurately weigh, place in a stoppered Erlenmeyer flask, add 50ml of 50% methanol, soak at 70°C for 3 hours, filter, The filtrate was concentrated to dryness at 70°C under reduced pressure, dissolved in 10ml of wa...

Embodiment 3

[0027] Example 3: Determination of the Content of Adenosine and Guanosine in Compound Dangshen Tablets by High Performance Capillary Electrophoresis

[0028] Capillary electrophoresis conditions Running buffer: 50mmol / L borax solution plus 18% methanol (pH9.7); pressure injection: 5kPa, 4s; separation voltage: 24kV: temperature of capillary and automatic sampling tray: 25°C; detection wavelength: 254nm . Before use, the capillary column was washed with 1mol / L sodium hydroxide solution, deionized water and running buffer for 10 minutes each, and washed with running buffer for 10 minutes after each electrophoresis.

[0029] Preparation of the test solution: Peel off the sugar-coated tablets of the compound Codonopsis pilosula and pulverize them, weigh 1 g of the powder (passed through a No. 2 sieve), place it in a stoppered Erlenmeyer flask, add 20 ml of 70% methanol, soak at 70 ° C for 2 hours, Take it out, place it at room temperature for 1.5 hours, filter, and take the conti...

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Abstract

A method for controlling quality of drug preparation formed by dangshen or dangshen contained or dangshen effective portion or dangshen effective portion group is one or several methods of adenosine quantitative determination, verine quantitative determination, adenosine qualitative identification and vernine identification.

Description

(1) Technical field [0001] The invention relates to a quality control method of a Chinese medicinal material and a pharmaceutical preparation containing the medicinal material, in particular to a quality control method of the Chinese medicinal material Codonopsis pilosula and a pharmaceutical preparation containing Codonopsis pilosula, or Codonopsis pilosula extract, or effective parts of Codonopsis pilosula, or a group of effective parts of Codonopsis pilosula . (2) Background technology [0002] Codonopsis pilosula, Codonopsis pilosula Nannf., Codonopsis pilosula Nannf.var.modesta L.T.Shen, Codonopsis tangshen Oliv., Codonopsis tubulosa Komar., Codonopsis tubulosa Komar. (Codonopsis subglobosa W.W.Smith), the root of gray hairy Codonopsis (Codonopsis canescens Nannf.), sweet in taste, flat in nature, belonging to the spleen and lung meridian, is a traditional Chinese medicine for invigorating Qi. At present, a considerable part of the Chinese patent medicines and herbal m...

Claims

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Application Information

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IPC IPC(8): G01N30/00G01N30/02G01N30/90
Inventor 史美耿阮锦满石海云吴锦萍
Owner 南京宇道科技开发有限公司
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