Paeonia Species Root

DEFINITION

The article consists of the dried roots of Paeonia lactiflora Pall. or Paeonia veitchii Lynch (Family Paeoniaceae) collected in spring and fall. It meets the Acceptance criteria under the Assay.

SYNONYMS

Of Paeonia lactiflora Pall.

Paeonia lactiflora f. nuda (Nakai) Kitag.

Paeonia lactiflora f. pilosella (Nakai) Kitag.

Paeonia lactiflora var. trichocarpa (Bunge) Stern

Paeonia lactiflora var. villosa M. S. Yan & K. Sun

Of Paeonia veitchii Lynch

Paeonia veitchii subsp. altaica (K. M. Dai & T. H. Ying) Halda

Paeonia veitchii var. beresowskii (Kom.) Schipcz.

Paeonia veitchii var. leiocarpa W. T. Wang & S. H. Wang

Paeonia veitchii var. purpurea Schipcz.

Paeonia veitchii var. uniflora K. Y. Pan

Paeonia veitchii var. woodwardii (Stapf ex Cox) Stern

Paeonia anomala L. subsp. veitchii (Lynch) D. Y. Hong & K. Y. Pan

POTENTIAL CONFOUNDING MATERIALS

Paeonia lactiflora var. trichocarpa (Bunge) Stern

Paeonia japonica (Makino) Miyabe & H. Takeda

Paeonia suffruticosa Andrews syn.

Paeonia moutan Sims

Peeled Paeonia lactiflora root

SELECTED COMMON NAMES

Chinese: 赤芍

English: Red peony, Chinese peony, common garden peony

German: Chinesische pfingstrose

Japanese: シャクヤク (Shakuyaku)

Korean: 적작약 (Jukjakyak)

Pinyin: Chishao, chi shao

Swedish: Luktpion

CONSTITUENTS OF INTEREST

Monoterpene glycoside: Paeoniflorin, oxypaeoniflorin, benzoylpaeoniflorin, benzoyloxypaeoniflorin, galloylpaeoniflorin, and albiflorin

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: The root is cylindrical, slightly curved, measuring 5–40 cm long and 0.5–3 cm in diameter; the surface is brown and rough with longitudinal furrows and wrinkles; rootlet scars and transverse elongated lenticels-like protrusions; texture is hard and fragile, easily breaks with chalk-white or pink fracture showing distinct radial striations, sometimes with clefts and thin bark.

Microscopic:

Transverse section: Cork consists of a few layers of brown cells; parenchymatous cells in cortex are tangentially elongated; phloem is narrow and cambium is in rings; xylem rays are broad; vessels are arranged radially and accompanied by wood fibers. Parenchymatous cells contain clusters of calcium oxalate and starch granules.

• B. Thin-Layer Chromatography

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

Standard solution B: Sonicate 0.5 g of USP Paeonia  Species Root Powder RS (To Come) in 5 mL of methanol on a water bath at 60° C for 1 min; centrifuge, and use the supernatant.

Sample solution: Sonicate 0.5 g of Paeonia Species Root, finely powdered, in 5 mL of methanol on a water bath at 60° C for 1 min; centrifuge, and use the supernatant.

Chromatographic system

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

Adsorbent: Chromatographic silica gel mixture with an average particle size of 5 µm (HPTLC plates)

Application volume: 8 µL each of Standard solution A, 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: methanol, ethyl acetate, and formic acid (35:5:5:3)

Developing distance: 6 cm

Derivatization reagent: 10% Sulfuric acid in methanol [NOTE: Prepare fresh. Keep alcohol cold over ice, carefully and gradually add sulfuric acid.]

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 in air. Derivatize with Derivatization reagent and heat at 100° for 5 min.

System suitability: Under visible light, the chromatogram of Standard solution B exhibits six colored bands in the lower-third section as follows in order of increasing R_F: two dark brown bands, one light purple band, one light brown band, one dark brown band at an R_F corresponding to the paeoniflorin band in the chromatogram of Standard solution A, and a very light brown band. The chromatogram of Standard solution B exhibits five bands in the middle-third section as follows in order of increasing R_F: a purple band, two weak brown bands, one blackish-purple band, and a weak brown band. In the upper-third section, the chromatogram of Standard solution B exhibits three purple bands with the most intense at the highest R_F (close to solvent front).

Acceptance criteria: Under visible light, the chromatogram of the Sample solution exhibits an intense dark brown band corresponding to the band due to paeoniflorin in the chromatogram of Standard solution A, and the following bands corresponding to similar bands in the chromatogram of Standard solution B: two dark brown band, one light purple band, one light brown band right below the band due to paeoniflorin, and one light brown band in the lower-third section. It exhibits five minor bands in the middle-third section: two weak brown bands, one blackish-purple band, and a weak brown band; and three purple bands in the upper-third section with the most intense one at the highest R_F (close to solvent front).

ASSAY

   • Content of Monoterpene 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 Peonia Species Root, finely powdered, at 105° for 6 h

Acceptance criteria: NMT 14.0%

• Articles of Botanical Origin, Total Ash <561>

Analysis: 3.0 g of Paeonia Species Root, finely powdered

Acceptance criteria: NMT 7%

• Articles of Botanical Origin, Acid-Insoluble Ash <561>

Analysis:  6.0 g of Paeonia Species Root, finely powdered

Acceptance criteria: NMT 1%

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 Paeonia Species Root Powder RS (To Come)

USP Paeoniflorin RS (To Come)

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