Rehmannia glutinosa Root

Rehmannia glutinosa Root

Proposed For Development Version 0.1

Rehmannia glutinosa Root


 

DEFINITION

The article consists of the dried root of Rehmannia glutinosa (Gaertn.) DC. (Family Plantaginaceae) collected in autumn. It meets the Acceptance criteria under the Assay.

 

SYNONYMS

Rehmannia glutinosa (Gaertn.) Libosch. ex Fisch. & C. A. Mey.

Rehmannia glutinosa var. angulata Oliv.

Rehmannia glutinosa var. hemsleyana Diels

Rehmannia glutinosa var. huechingensis Chao & Shih

Rehmannia glutinosa f. huechingensis (Chao & Shih) P. G. Xiao

Rehmannia glutinosa var. piasezkii (Maxim.) Diels

Rehmannia glutinosa f. purpurea Matsuda

 

POTENTIAL CONFOUNDING MATERIALS

Rehmannia elata N.E. Br. ex Prain

 

SELECTED COMMON NAMES

Chinese: 地黃

English: Rehmannia root, Chinese foxglove

Japanese: ジオウ

Korean: 지황 (jihwang)

Pinyin: Dihuang, di huang

 

CONSTITUENTS OF INTEREST

Iridoid glycoside: Catalpol, aucubin

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Mostly in irregular masses or oblong, swollen in the center, slightly tapering at both ends, 6–12 cm long, 2–6 cm in diameter; the surface is brownish-black or brownish-gray, with deep longitudinal wrinkles, and irregular transverse wavy lines; texture is soft, tenacious, and not uneasily broken; the fracture is brownish-black or jet-black, lustrous, viscous.

Microscopic

Transverse section: Reveals cork consisting of 7–15 layers of cells; the cortex is composed of parenchymatous cells, outer region of cortex has scattered secretory cells containing orange-yellow oil drops and occasional stone cells; phloem is broad; cambium is in a ring; xylem rays are broad with vessels in radial lines.

B. Thin-Layer Chromatography

Standard solution A: 1 mg/mL of USP Catalpol RS (To Come) in methanol

Standard solution B: Sonicate 1 g of USP Rehmannia glutinosa Root Powder RS (To Come) in 5 mL ethanol for 15 min, centrifuge, and use the supernatant.

Sample solution: Sonicate 1 g of Rehmannia glutinosa root, finely powdered, in 5 mL ethanol for 15 min, centrifuge, and use the supernatant.

Chromatographic system

(See Chromatography <621>, Thin-Layer Chromatography.)

Adsorbent: Use a silica gel with an average particle size of 5 µm (HPTLC plates).

Application volume: 5 µL of Standard solution A, and 10 µL each of Standard solution B and Sample solution; as 8-mm bands

Relative humidity: Condition the plate to a relative humidity of about 33% using a suitable device.

Developing solvent system: Dichloromethane, ethyl acetate, methanol, and water (15:40:22:9)

Developing distance: 6 cm

Derivatization reagent: Anisaldehyde reagent – 85 mL of ice-cooled methanol mixed with 10 mL glacial acetic acid, 5 mL of sulfuric acid, and 0.5 mL of p-anisaldehyde

Analysis

Samples: Standard solution A, Standard solution B, and Sample solution

Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatograms in a saturated chamber, remove the plate from the chamber, and dry. Derivatize with Derivatization reagents, heat at 100° for 5 min, and examine under visible light.

System suitability: Under visible light, the chromatogram of Standard solution B exhibits five green bands in the lower-third section of the chromatogram; the one at the highest RF is the least intense band and corresponds to the band due to catalpol in the chromatogram of Standard solution A. The chromatogram of Standard solution B exhibits four faint pink bands in the middle-third section. Standard solution B exhibits two black bands and one purple band between the two black bands in the upper-third section of the chromatogram.

Acceptance criteria: Under visible light, the chromatogram of the Sample solution exhibits a green band corresponding to the catalpol band in the chromatogram of Standard solution A, and the following bands corresponding to similar bands in the chromatogram of Standard solution B: four green bands in the lower-third section, four faint pink bands in the middle-third section; two black and one purple bands in the upper-third section of the chromatogram.

 

ASSAY

• Content of Iridoid Glycosides

CALL FOR SUBMISSION OF VALIDATED INFORMATION

 

Additional information including validation data will be required to complete the development of the Assay. For requirements, please see under "Composition" and related sections of the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesguidelines.

 

Interested parties are encouraged to submit their proposals to complete the monograph.

 

CONTAMINANTS

• Elemental Impurities—Procedures <233>

Acceptance criteria

Arsenic: NMT 5 ppm

Lead: NMT 10 ppm

• Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>: Meets the requirements

• Microbial Enumeration Tests <61>: The total aerobic bacterial count does not exceed 105 cfu/g, the total combined molds and yeasts count does not exceed 103 cfu/g, and the bile-tolerant Gram-negative bacteria does not exceed 103 cfu/g.

• Tests for Specified Microorganisms <62>: Meets the requirements of the tests for the absence of Salmonella species and Escherichia coli

• Articles of Botanical Origin, Test for Aflatoxins <561>: Meets the requirements

 

SPECIFIC TESTS

• Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 2.0%

• Loss on Drying <731>

Analysis: Dry 1.0 g of Rehmannia glutinosa Root, finely powdered, at 105° for 5 h.

Acceptance criteria: NMT 15.0%

• Articles of Botanical Origin, Total Ash <561>: NMT8.0%

Analysis: 2.0 g of Rehmannia glutinosa Root, finely powdered

Acceptance criteria: NMT 8.0%

• Articles of Botanical Origin, Acid-Insoluble Ash <561>: NMT 3.0% 

Analysis: 4.0 g of Rehmannia glutinosa Root, finely powdered

Acceptance criteria: NMT 3.0%

 

ADDITIONAL REQUIREMENTS

• Packaging and Storage: Preserve in well-closed containers, protected from light and moisture, and store at room temperature.

• Labeling: The label states the Latin binomial and the part of the plant contained in the article.

• USP Reference Standards <11>

USP Aflatoxins RS

USP Catalpol RS (To Come)

USP Rehmannia glutinosa Root Powder RS (To Come)

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