Asian Ginseng
»Asian Ginseng consists of the dried roots of Panax ginsengC.A.Meyer (Fam.Araliaceae).It contains not less than 0.2%of ginsenoside Rg1and not less than 0.1%of ginsenoside Rb1,both calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers,and store in a cool,dry place.
Labeling—
The label states the Latin binomial and,following the official name,the part of the plant contained in the article.
Botanic characteristics—
Macroscopic—
Fusiform or cylindrical roots,with distinct aromatic odor,sometimes branched,typically 1to 10cm,sometimes up to 20cm in length and up to 2.5cm in diameter at the crown,with one or more stem scars.Externally pale yellow to golden,rough textured in the lower part,with prominent horizontal rings and fine longitudinal ridges as a result of drying.Root scars or fine rootlets are present.Fractures are short with the fractured surface,white to ivory,exposing a ring of secretory canals present in secondary phloem.
Histology—
Transverse section of root—
Multiple layers of thin-walled cork cells present.Secondary phloem characterized by conspicuous air lacunae,abundant starch-containing storage parenchyma,few sieve elements,and rings of schizogenous secretory cells.Xylem characterized by abundant starch-containing storage parenchyma,few tracheary elements,and a lack of secretory canals.Druse crystals are sometimes present with vascular parenchyma cells.
Identification—
A:Thin-Layer Chromatographic Identification Test á201ñ—
Test solution—
Transfer 1.0g of finely powdered Asian Ginseng to a 25-mLflask fitted with a reflux condenser.Add 10.0mLof a mixture of methanol and water (7:3),and heat under reflux for 15minutes.Cool,filter,and dilute the filtrate with methanol to 10.0mL.
Standard solution:
about 5mg per mLeach of arbutin and escin,in methanol.
Application volume:
20µL,as bands.
Developing solvent system:
the upper layer of a mixture of butyl alcohol,water,and ethyl acetate (10:5:2.5)in an unsaturated chamber.
Spray reagent—
Dissolve 0.5mLof anisaldehyde in 10mLof glacial acetic acid,add 85mLof methanol,and mix.Carefully add 5mLof sulfuric acid to this mixture,and mix.
Procedure—
Proceed as directed in the chapter.Remove the plate from the developing chamber,and allow it to dry.Spray with Spray reagent.Heat the plate at 105
to 110for about 10minutes,and examine the plate.The chromatogram of the Standard solutionshows,in the upper third,a brown zone corresponding to arbutin and,in the lower third,a gray zone corresponding to escin.Between these two zones,the chromatogram of the Test solutionexhibits violet-gray zones corresponding to ginsenoside Rg1in the upper portion and to ginsenoside Re in the middle.Aviolet-gray zone corresponding to ginsenoside Rb1is located at the same RFvalue as the gray zone corresponding to escin in the chromatogram of the Standard solution.Other,less intense bands may be observed between the zones due to ginsenosides Rb1and Re,and the zone closest to the origin corresponds to ginsenoside Rc.Other spots may be visible in the lower third of the chromatogram.
to 110for about 10minutes,and examine the plate.The chromatogram of the Standard solutionshows,in the upper third,a brown zone corresponding to arbutin and,in the lower third,a gray zone corresponding to escin.Between these two zones,the chromatogram of the Test solutionexhibits violet-gray zones corresponding to ginsenoside Rg1in the upper portion and to ginsenoside Re in the middle.Aviolet-gray zone corresponding to ginsenoside Rb1is located at the same RFvalue as the gray zone corresponding to escin in the chromatogram of the Standard solution.Other,less intense bands may be observed between the zones due to ginsenosides Rb1and Re,and the zone closest to the origin corresponds to ginsenoside Rc.Other spots may be visible in the lower third of the chromatogram.
B:
The retention times of the peaks for ginsenosides Rg1,Re,Rf,Rb1,Rc,and Rd in the chromatogram of the Test solutioncorrespond to those in the chromatogram of the Standard solution,as obtained in the test for Content of ginsenosides Rb1and Rg1.The ratio of the peak area for ginsenoside Rb2to the peak area for ginsenoside Rb1is not less than 0.4.
Microbial enumeration á2021ñ—
The total aerobic microbial count does not exceed 104cfu per g.The total combined molds and yeasts count does not exceed 100cfu per g,and it meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Loss on drying á731ñ—
Dry 1.0g of finely powdered Asian Ginseng at 105for 2hours:it loses not more than 12.0%of its weight.
for 2hours:it loses not more than 12.0%of its weight.
Foreign organic matter á561ñ:
not more than 2.0%.
Total ash á561ñ:
not more than 8.0%,determined on 1.0g of finely powdered Asian Ginseng.
Acid-insoluble ash á561ñ:
not more than 1.0%.
Alcohol-soluble extractives,Method 2á561ñ:
not less than 14.0%.
Pesticide residues á561ñ:
meets the requirements.
Heavy metals,Method IIIá231ñ:
20µg per g.
Change to read:
Content of ginsenosides Rb1and Rg1—
Solution A,Solution B,andChromatographic system—
Proceed as directed in the Content of ginsenosidesunder Powdered Asian Ginseng Extract.USP28
Standard solution—
Transfer an accurately weighed quantity of USP Powdered Asian Ginseng Extract RS,equivalent to about 2mg of ginsenoside Rg1,to a suitable container,and dissolve in 10.0mLof a mixture of water and alcohol (6:4).USP28[NOTE—The concentrations of ginsenoside Rg1and ginsenoside Rb1in this solution are not expected to be equal,and are determined on the basis of the labeled quantities present in USP Powdered Asian Ginseng Extract RS.]USP28
and dissolve in 10.0mLof a mixture of water and alcohol (6:4).USP28[NOTE—The concentrations of ginsenoside Rg1and ginsenoside Rb1in this solution are not expected to be equal,and are determined on the basis of the labeled quantities present in USP Powdered Asian Ginseng Extract RS.]USP28
Test solution—
Reduce about 100g of Asian Ginseng to a powder,and transfer about 1.0g of the powder,accurately weighed,to a 100-mLround-bottom flask fitted with a reflux condenser.Add 50mLof a mixture of water and alcohol (6:4)and a few grains of pumice,and boil on a water bath under reflux for 1hour.Cool,and filter.Wash the flask and the residue with 20mLof a mixture of water and alcohol (6:4),and pass through the same filter.Combine the filtrates,and evaporate in a rotary evaporator at 50to dryness.Dissolve the residue in 10.0mLof a mixture of water and alcohol (6:4).USP28
to dryness.Dissolve the residue in 10.0mLof a mixture of water and alcohol (6:4).USP28
Procedure—
Separately inject equal volumes (about 10µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the percentages of ginsenosides Rb1and Rg1in the portion of Asian Ginseng taken by the formula:
1000(C/W)(rU/rS),
in which Cis the concentration,in mg per mL,of ginsenoside Rg1or ginsenoside Rb1in the Standard solution;Wis the weight,in mg,of Asian Ginseng taken to prepare the Test solution;and rUand rSare the peak responses of ginsenoside Rg1or ginsenoside Rb1obtained from the Test solutionand the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2098
Pharmacopeial Forum:Volume No.30(2)Page 569
Phone Number:1-301-816-8343