Schisandra chinensis Fruit

Schisandra chinensis Fruit

Proposed For Development Version 0.1

Schisandra chinensis Fruit


 

DEFINITION

The article consists of dried ripe fruits of Schisandra chinensis (Turcz.) Baill. (Family Schisandraceae) collected in the fall. It contains NLT 0.95% of lignans, calculated as the sum of schisandrin, schisandrol B, deoxyschizandrin, and γ-schisandrin on the dried bases.

 

SYNONYMS

Kadsura chinensis Turcz.

Maximowiczia amurensis Rupr.

Maximowiczia chinensis (Turcz.) Rupr.

Maximowiczia japonica (A.Gray) K. Koch

Maximowiczia sinensis Rob.

Sphaerostema japonicum A.Gray

 

POTENTIAL CONFOUNDING MATERIALS

Kadsura japonica (L.) Dunal

Schisandra sphenanthera Rehder & E. H. Wilson

 

SELECTED COMMON NAMES

Chinese: 五味子

English: Schisandra, Northern schisandra, Chinese magnolia vine, five flavor fruit, magnolia vine

Finnish: Palsamiköynnös

French: Schisandra de Chine

German: Chinesisches Spaltkölbchen, Chinesischer Limonenbaum

Japanese: ゴミシ

Korean: 오미자

Pinyin: Wu wei zi, nan wu wei zi

Russian: Лимонник китайский

Swedish: fjärilsranka

 

CONSTITUENTS OF INTEREST

Lignans: Schisandrin, schisandrol B, deoxyschisandrin, γ-schisandrin

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Irregularly spheroidal or compressed-spheroidal, 5–8 mm in diameter; externally red, purplish-red or dull red, shrunken, oily, with soft pulp, sometimes externally blackish-red or covered with “white frost”. One or two seeds, reniform, externally brownish-yellow, shiny; testa thin and fragile.

Microscopic

Transverse section: Pericarp consisting of one layer of square or rectangular epidermal cells, walls relatively thickened, covered with cuticle, oil cells present scattered; mesocarp consists of 10 or more layers of parenchymatous cells containing starch granules, small collateral vascular bundles present scattered; endocarp consists of one layer of square parenchymatous cells; most outer layer of testa consists of radially elongated stone cells, thick-walled, with fine and close pit canals; beneath showing several layers of stone cells, subrounded, trangular or polygonal with larger pits; a few layers of parenchymatous cells, inner layer of testa consists of small, slightly thick-wall cells; endospern cells contain oil droplets and aleurone grains. Raphe having vascular bundles; oil cell layer consists of one layer of rectangular oil cells containing yellowish-brown oil, with 3–5 layers of small cells lying below.

B. Thin-Layer Chromatography

Standard solution A: 1.0 mg/mL of USP Schisandrin RS (To Come) in ethanol

Standard solution B: Sonicate 0.5 g of USP Schisandra chinensis Fruit Powder RS (To Come) in 10 mL of ethanol for 10 min, centrifuge, and use the supernatant.

Sample solution: Sonicate 1.0 g of Schisandra chinensis Fruit, finely powdered, in 10.0 mL of alcohol for 10 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: 3 µL; as 8-mm bands

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

Developing solvent system: Toluene, ethyl acetate, and glacial acetic acid (23:6:1)

Developing distance: 6 cm

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, dry, and examine under UV light at 254 nm.

System suitability: Under UV light at 254 nm, the chromatogram of Standard solution B exhibits seven bands in the lower-third section; the most intense band corresponds in RF to the band due to schisandrin in the chromatogram of Standard solution A. Standard solution B also exhibits three bands in the middle-third section of the chromatogram; the most intense band with the highest RF is due to deoxyschisandrin; and two intense bands and one faint band in the upper-third section; the most intense band corresponds to γ-schisandrin.

Acceptance criteria: Under UV light at 254 nm, the Sample solution chromatogram exhibits an intense band at an RF corresponding to the band due to schisandrin in the chromatogram of Standard solution A.  The Sample solution exhibits additional bands corresponding to similar bands in the chromatogram of Standard solution B. These include six bands in the lower-third section, three bands in the middle-third section, and two intense bands and one faint band in the upper-third section. 

 

ASSAY

• Content of Lignans

To Come

  

CONTAMINANTS

• 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

 

SPECIFIC TESTS

• Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 1.0%

• Loss on Drying <731>

Analysis: Dry 2 g of Schisandra chinensis Fruit, finely powdered, at 105° for 5 h.

Acceptance criteria: NMT 16%

• Articles of Botanical Origin, Total Ash <561>: NMT 7% 

Analysis: 2 g of Schisandra chinensis Fruit, finely powdered

Acceptance criteria: NMT 7%

 

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 Schisandra chinensis Powder RS (To Come)

USP Schisandrin RS (To Come)

 
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Other Versions

Final Authorized Version 1.0
Proposed For Comment Version 0.2