EFSA Compendium of Botanicals

Draft - work in progress

Ephedra sinica Stapf

Family:: Ephedraceae
Approval state:: Approved
Number of articles retrieved:: 1218
Number of processed references:: 3

Compositions

#1: Norephedrine in unspecified plant part #2: Ephedrine in unspecified plant part #3: Pseudoephedrine in unspecified plant part #4: Ephedrine #5: Total alkaloids #6: Cathinone (stem) #7: Ephedrine alkaloid: (2S,4S,5S)-2,4-dimethyl-5-phenyloxazolidine (stem) #8: (1R,2S)-norephedrine (stem) #9: (1S,2S)-norpseudoephedrine (stem) #10: Ephedrine alkaloid: (2S,4S,5R)-2,4-dimethyl-5-phenyloxazolidine (stem) #11: (1R,2S)-N-methylephedrine (stem) #12: (1S,2S)-N-methylpseudoephedrine (stem) #13: Ephedrine alkaloid: (2S,4S,5R)-2,3,4-trimethyl-5-phenyloxazolidin (stem) #14: (1R,2S)-ephedrine (stem) #15: Ephedrine alkaloid: (2S,4S,5S)-2,3,4-trimethyl-5-phenyloxazolidine (stem) #16: (1S,2S)-pseudoephedrine (stem)

Endpoint Studies

#1: Ephedrine had an anti-estrogenic effect in the uterotropic assay in immature female rats. #2: Reduced adrenal weight in female rats after dosing with ephedra extract for three day

Genotoxicity

Composition #1: Avula, B., Khan, I.A. Separation and Determination of Ephedrine Enantiomers and Synephrine by High Performance Capillary Electrophoresis in Dietary Supplements. chromatographia, 2004, vol. 59, no. 1-2, p. 71–77. .

Language:

English (en)
Plant part:

Unspecified (A07XD)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

norephedrine (RF-00003517-PAR)
Analytical method code:

Capillary (Zone) Electrophoresis (CE or CZE) (F071A)
Result unit:

Percent (G138A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.04
Internal remarks:

Norephedrine in unspecified plant part

Composition #2: Avula, B., Khan, I.A. Separation and Determination of Ephedrine Enantiomers and Synephrine by High Performance Capillary Electrophoresis in Dietary Supplements. chromatographia, 2004, vol. 59, no. 1-2, p. 71–77. .

Language:

English (en)
Plant part:

Unspecified (A07XD)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

ephedrine (RF-00003801-PAR)
Analytical method code:

Capillary (Zone) Electrophoresis (CE or CZE) (F071A)
Result unit:

Percent (G138A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.48
Internal remarks:

Ephedrine in unspecified plant part

Composition #3: Avula, B., Khan, I.A. Separation and Determination of Ephedrine Enantiomers and Synephrine by High Performance Capillary Electrophoresis in Dietary Supplements. chromatographia, 2004, vol. 59, no. 1-2, p. 71–77. .

Language:

English (en)
Plant part:

Unspecified (A07XD)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Methanol
Substance:

pseudoephedrine (RF-00004013-PAR)
Analytical method code:

Capillary (Zone) Electrophoresis (CE or CZE) (F071A)
Result unit:

Percent (G138A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.23
Internal remarks:

Pseudoephedrine in unspecified plant part

Composition #4: Arbo, Marcelo Dutra., Franco, Marcia Toniolo., Larentis, Elisa Rupp., Garcia, Solange Cristina., Sebben, Viviane Cristina., Leal, Mirna Bainy., Dallegrave, Eliane., Limberger, Renata Pereira. Screening for in vivo (anti)estrogenic activity of ephedrine and p-synephrine and their natural sources Ephedra sinica Stapf. (Ephedraceae) and Citrus aurantium L. (Rutaceae) in rats . archives of toxicology, 2009, vol. 83, no. 1, p. 95–99. DOI: 10.1007/s00204-008-0324-8. [DOI link]

Language:

English (en)
Plant part:

Unspecified (A07XD)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

acetone
Substance:

ephedrine (RF-00003801-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.41
Internal remarks:

Ephedrine

Composition #5: Arbo, Marcelo Dutra., Franco, Marcia Toniolo., Larentis, Elisa Rupp., Garcia, Solange Cristina., Sebben, Viviane Cristina., Leal, Mirna Bainy., Dallegrave, Eliane., Limberger, Renata Pereira. Screening for in vivo (anti)estrogenic activity of ephedrine and p-synephrine and their natural sources Ephedra sinica Stapf. (Ephedraceae) and Citrus aurantium L. (Rutaceae) in rats . archives of toxicology, 2009, vol. 83, no. 1, p. 95–99. DOI: 10.1007/s00204-008-0324-8. [DOI link]

Language:

English (en)
Plant part:

Unspecified (A07XD)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

acetone
Substance:

Alkaloids (RF-00004360-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Percent (G138A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.65
Internal remarks:

Total alkaloids

Composition #6: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

(-)-cathinone (RF-00004197-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

1-5
Internal remarks:

Cathinone (stem)

Composition #7: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

Alkaloids (RF-00004360-PAR)
Additional substance description:

Ephedrine alkaloid: (2S,4S,5S)-2,4-dimethyl-5-phenyloxazolidine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

1.5-625
Internal remarks:

Ephedrine alkaloid: (2S,4S,5S)-2,4-dimethyl-5-phenyloxazolidine (stem)

Composition #8: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

norephedrine (RF-00003517-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

95-722
Internal remarks:

(1R,2S)-norephedrine (stem)

Composition #9: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

pseudoephedrine (RF-00004013-PAR)
Additional substance description:

(1S,2S)-norpseudoephedrine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

11-2782
Internal remarks:

(1S,2S)-norpseudoephedrine (stem)

Composition #10: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

Alkaloids (RF-00004360-PAR)
Additional substance description:

Ephedrine alkaloid: (2S,4S,5R)-2,4-dimethyl-5-phenyloxazolidine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

8-98
Internal remarks:

Ephedrine alkaloid: (2S,4S,5R)-2,4-dimethyl-5-phenyloxazolidine (stem)

Composition #11: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

ephedrine (RF-00003801-PAR)
Additional substance description:

a derivative (1R,2S)-N-methylephedrine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

3-582
Internal remarks:

(1R,2S)-N-methylephedrine (stem)

Composition #12: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

pseudoephedrine (RF-00004013-PAR)
Additional substance description:

(1S,2S)-N-methylpseudoephedrine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.25-62
Internal remarks:

(1S,2S)-N-methylpseudoephedrine (stem)

Composition #13: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

Alkaloids (RF-00004360-PAR)
Additional substance description:

Ephedrine alkaloid: (2S,4S,5R)-2,3,4-trimethyl-5-phenyloxazolidin
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

<=23
Internal remarks:

Ephedrine alkaloid: (2S,4S,5R)-2,3,4-trimethyl-5-phenyloxazolidin (stem)

Composition #14: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

ephedrine (RF-00003801-PAR)
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

191-4120
Internal remarks:

(1R,2S)-ephedrine (stem)

Composition #15: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

Alkaloids (RF-00004360-PAR)
Additional substance description:

Ephedrine alkaloid: (2S,4S,5S)-2,3,4-trimethyl-5-phenyloxazolidine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

0.4-187
Internal remarks:

Ephedrine alkaloid: (2S,4S,5S)-2,3,4-trimethyl-5-phenyloxazolidine (stem)

Composition #16: Krizevski, Raz., Bar, Einat., Shalit, Or., Sitrit, Yaron., Ben-Shabat, Shimon., Lewinsohn, Efraim. Composition and stereochemistry of ephedrine alkaloids accumulation in Ephedra sinica Stapf . phytochemistry, 2010, vol. 71, no. 8-9, p. 895–903. DOI: 10.1016/j.phytochem.2010.03.019. [DOI link]

Language:

English (en)
Plant part:

Stem / stalk (as part-nature) (A067S)
Extraction/Preparation method:

Solvent extraction (A0BZR)
Additional extraction description:

Liquid nitrogen
Substance:

pseudoephedrine (RF-00004013-PAR)
Additional substance description:

(1S,2S)-pseudoephedrine
Analytical method code:

GC-MS (F046A)
Result unit:

Microgram/gram (G049A)
Result expression:

Whole weight (B001A)
Yes/No Qualitative:

Positive/Present (POS)
Result type:

Numerical Value (VAL)
Value (concentration, content):

3-6344
Internal remarks:

(1S,2S)-pseudoephedrine (stem)

Endpoint study #1: Arbo, Marcelo Dutra., Franco, Marcia Toniolo., Larentis, Elisa Rupp., Garcia, Solange Cristina., Sebben, Viviane Cristina., Leal, Mirna Bainy., Dallegrave, Eliane., Limberger, Renata Pereira. Screening for in vivo (anti)estrogenic activity of ephedrine and p-synephrine and their natural sources Ephedra sinica Stapf. (Ephedraceae) and Citrus aurantium L. (Rutaceae) in rats . archives of toxicology, 2009, vol. 83, no. 1, p. 95–99. DOI: 10.1007/s00204-008-0324-8. [DOI link]

Study relevance:

Human health
Substance:

ephedrine (RF-00003801-PAR)
Type of toxicological test:

short-term toxicity (CHD017TT)
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Wistar (CHD013ST)
Sex:

Female
Exposure duration:

3.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

7
Control groups used:

yes, concurrent vehicle
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligrams per kilogram body weight per day (G211A)
Effect concentration:

5
Critical effect:

ENDOCRINE (TOX12A)
Target tissue:

urogenital: Uterus (TT052A)
Effect description:

An anti-estrogenic effect of ephedrine observed as lower uterus weight observed in estrogen treated Immature female rats (uterotropic assay)
Effect or parameter linked to the endpoint:

organ weights (CHD012BE)
Internal remarks:

Ephedrine had an anti-estrogenic effect in the uterotropic assay in immature female rats.

Endpoint study #2: Arbo, Marcelo Dutra., Franco, Marcia Toniolo., Larentis, Elisa Rupp., Garcia, Solange Cristina., Sebben, Viviane Cristina., Leal, Mirna Bainy., Dallegrave, Eliane., Limberger, Renata Pereira. Screening for in vivo (anti)estrogenic activity of ephedrine and p-synephrine and their natural sources Ephedra sinica Stapf. (Ephedraceae) and Citrus aurantium L. (Rutaceae) in rats . archives of toxicology, 2009, vol. 83, no. 1, p. 95–99. DOI: 10.1007/s00204-008-0324-8. [DOI link]

Study relevance:

Human health
Plant part:

Unspecified (A07XD)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

Acetone
Type of toxicological test:

acute toxicity (CHD016TT)
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Wistar (CHD013ST)
Sex:

Female
Exposure duration:

3.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

7
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligrams per kilogram body weight per day (G211A)
Effect concentration:

85
Critical effect:

IMMUNOTOXICITY (TOX09A)
Target tissue:

Glandular (TT003A)
Effect description:

reduced adrenal weight
Effect or parameter linked to the endpoint:

organ weights (CHD012BE)
Internal remarks:

Reduced adrenal weight in female rats after dosing with ephedra extract for three day