(1999; 295 pages)
Radix Paeoniae is the dried root of Paeonia lactiflora Pallas (Paeonaceae) (1, 2).1
1Paeoniae veitchii is described in the monograph "Radix Paeoniae Rubra" in the Chinese pharmacopoeia (2). Moutan Cortex, the root bark of Paeonia moutan Sims. (= P. suffruticosa Andr.) is also used in traditional medicine (3–5), and is listed as "Moutan Bark" in the Japanese pharmacopoeia (1).
Paeonia albiflora Pallas., P. edulis Salisb., P. officinalis Thunb. (5, 6).
Selected vernacular names
Báisháo, bo-báisháo, chuan-báisháo, hang-báisháo, mu-shaoyao, mudan, paeoniae alba, paeony, pai shao yao, pe-shou, peony, peony root, Pfingstrose, shakuyaku, shaoyao, syakuyaku, white peony, white-flowered peony (2, 4, 6–8).
Paeonia lactiflora Pallas is a perennial herb, 50–80 cm high, with a stout branched root. Leaves alternate and biternately compound, the ultimate segments redveined, oblong-elliptical. The leaflets are narrow-ovate or elliptical, 8–12cm long and 2–4 cm wide. The petioles are 6–10 cm long. Flowers large (5–10 cm in diameter), solitary, and red, white, or purple. Sepals 4, herbaceous, persistent. Petals 5–10, larger than sepals. Stamens numerous and anthers yellow; carpels 3–5, many-seeded. Fruit, 3–5 coriaceous few-seeded follicles. Seeds large, subglobose; testa thick (4, 6).
Plant material of interest: dried root
Radix Paeoniae is cylindrical, straight or slightly curved, two ends truncate, 5– 20cm long and 1–2.5 cm in diameter; externally light greyish brown to reddish brown, glossy or with longitudinal wrinkles, rootlet scars and occasional remains of brown cork, and with laterally elongated lenticels; texture compact, easily broken, fracture relatively even, internally whitish or pale brownish red. Cambium ring distinct and rays radial (1, 2).
Odour, slight; taste, slightly sweet at first, followed by a sour or astringent taste and a slight bitterness (1, 2).
Literature description not available; to be established in accordance with national requirements.
Powdered plant material
Light greyish brown powder; masses of gelatinized starch granules fairly abundant, 5–25µm in diameter; clusters of calcium oxalate 11–35µm in diameter, packed in parenchyma cells in rows or singly; bordered, pitted, or reticulate vessels 20–65µm in diameter, walls thickened and slightly lignified (1, 2).
China, India, and Japan (6).
General identity tests
Macroscopic, microscopic, and microchemical examinations; thin-layer chromatographic analysis for the presence of the monoterpene glycoside paeoniflorin (1, 2).
The test for Salmonella spp. in Radix Paeoniae products should be negative. The maximum acceptable limits of other microorganisms are as follows (9–11). For preparation of decoction: aerobic bacteria-not more than 107/g; fungi-not more than 105/g; Escherichia coli-not more than 102/g. Preparations for internal use: aerobic bacteria-not more than 105/g or ml; fungi-not more than 104/g or ml; enterobacteria and certain Gram-negative bacteria-not more than 103/g or ml; Escherichia coli-0/g or ml.
Not more than 6.5% (1, 2).
Not more than 0.5% (1).
To be established in accordance with national requirements. Normally, the maximum residue limit of aldrin and dieldrin for Radix Paeoniae is not more than 0.05 mg/kg (11). For other pesticides, see WHO guidelines on quality control methods for medicinal plants (9) and guidelines for predicting dietary intake of pesticide residues (12).
Recommended lead and cadmium levels are not more than 10 and 0.3mg/kg, respectively, in the final dosage form of the plant material (9).
For analysis of strontium-90, iodine-131, caesium-134, caesium-137, and plutonium-239, see WHO guidelines on quality control methods for medicinal plants (9).
Other purity tests
Alcohol-soluble extractive, chemical, foreign organic matter, moisture and water-soluble extractive tests to be established in accordance with national requirements.
Contains not less than 2.0% of paeoniflorin (1, 2), assayed by a combination of thin-layer chromatographic–spectrophotometric methods (2) or by highperformance liquid chromatography (1).
Major chemical constituents
Paeoniflorin, a monoterpene glycoside that is the major active constituent (5, 13), is present in the range of 0.05–6.01% (14, 15).
Crude plant material, powder, and decoction. Store in a ventilated dry environment protected from light (2).
Uses supported by clinical data
Uses described in pharmacopoeias and in traditional systems of medicine
As an analgesic, anti-inflammatory and antispasmodic drug in the treatment of amenorrhoea, dysmenorrhoea, and pain in the chest and abdomen (2). Radix Paeoniae is also used to treat dementia, headache, vertigo, spasm of the calf muscles (2, 4, 5), liver disease, and allergies, and as an anticoagulant (8, 13).
Uses described in folk medicine, not supported by experimental or clinical data
The treatment of atopic eczema, boils, and sores (5); to reduce fevers, induce sterility, and treat burns (8).
The primary pharmacological effects of Radix Paeoniae are antispasmodic, antiinflammatory, and analgesic. A decoction of the drug had antispasmodic effects on the ileum and uterus when administered orally to mice, rabbits, and guineapigs (13). Similar effects were observed with a methanol extract in rat uterus (16), but an ethanol extract had uterine stimulant activity in rabbits (17). Radix Paeoniae extracts tested in vitro relaxed smooth muscles in both rat stomach and uterine assays (13).
Intragastric administration of a hot-water extract of Radix Paeoniae to rats inhibited inflammation in adjuvant-induced arthritis (18) and carrageenininduced paw oedema (19). The major active constituent of the drug, paeoniflorin, a monoterpenoid glycoside, has sedative, analgesic, antipyretic, anti-inflammatory and vasodilatory effects in vivo. Hexobarbital-induced hypnosis was potentiated and acetic acid-induced writhing was inhibited in mice after intragastric administration of paeoniflorin (20, 21).
Intragastric administration of hot-water or ethanol extracts of Radix Paeoniae to rats inhibited ADP-, arachidonic acid- and collagen-induced platelet aggregation, as well as endotoxin-induced disseminated intravascular coagulation (22–24). Similar effects were observed in rabbits and mice after intraperitoneal administration of the drug (25). When tested by the standard fibrin plate method, ethanol and hot-water extracts of the drug had antifibrinolytic activity in vitro (26). Paeoniflorin had anticoagulant activity both in vitro (24), and in vivo (in mice) (27).
Intragastric administration of extracts of Radix Paeoniae protected the liver against carbon tetrachloride-induced hepatotoxicity in mice and rats (28).
Oral administration of water extracts of Radix Paeoniae or its major con- stituent, paeoniflorin, attenuated the scopolamine-induced impairment of radial maze performance in rats (29, 30). Paeoniflorin prevented the scopolamineinduced decrease in acetylcholine content in the striatum, but not in the hippocampus or cortex (30). Oral administration of paeoniflorin further attenuated learning impairment of aged rats in operant brightness discrimination tasks (31). The results of this study suggest that further research to explore the therapeutic potential of paeoniflorin in cognitive disorders such as senile dementia may be promising (31).
Reports of traditional use indicate that Radix Paeoniae may have abortifacient activity; therefore, the use of Radix Paeoniae in pregnancy is contraindicated (32).
No information available.
Radix Paeoniae should not be combined with Fritillaria verticillata, Cuscuta japonica, and Rheum officinale (7).
Carcinogenesis, mutagenesis, impairment of fertility
Hot-water or methanol extracts of Radix Paeoniae are not mutagenic in vitro (33, 34).
Pregnancy: non-teratogenic effects
Excretion of the drug into breast milk and its effects on the newborn have not been established; therefore, use of the drug during lactation is not recommended.
No information available; therefore, use of Radix Paeoniae in children is not recommended.
No information available about general precautions, drug and laboratory test interactions, or teratogenic effects on pregnancy.
No information available.
Maximum daily oral dose of crude plant material, 6–15g (2), standardized for paeoniflorin.
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