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Radix Paeoniae

Definition
Radix Paeoniae is the dried root of Paeollia filciflora Pallas (Paeonaceae).

Synonyms
Paeonia alblflora Pallas., P. edulis Salisb., P.  officinalis Thunb.

Selected vernacular names
Baishao, bo-baishao, chuan-baishao, hang-baishao, mu-shaoyao, mudan, paeoniae alba, paeony, pai shao yao, pe-shou, peony, peony root, Pfingstrose, shakuyaku, shaoyao, syakuyaku, white peony, white-flowered peony.

Description
Paeollia lactiflora Pallas is a perennial herb, 50-80cm high, with a stout branched root. Leaves alternate and biternately compound, the ultimate segments red- veined, oblong-elliptical. The leaflets are narrow-ovate or elliptical, 8-12 cm long and 2-4cm wide. The petioles are 6-10cm long. Flowers large (5-10cm 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.

Plant material of interest: dried root
General appearance

Radix Paeoniae is cylindrical, straight or slightly curved, two ends truncate, 5- 20cm long and 1-2.5cm 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.

Organoleptic properties
Odour, slight; taste, slightly sweet at first, followed bya sour or astringent taste and a slight bitterness.

Microscopic characteristics
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, 5-25Ám in diameter; clusters of calcium oxalate 11-35Ám in diameter,packed in parenchyma cells in rows or singly; bordered, pitted, or reticulate vessels 20-65Ám in diameter, walls thickened and slightly lignified.

Geographical distribution
China, India, and Japan.

General identity tests
Macroscopic, microscopic, and microchemical examinations; thin-layer chromatographic analysis for the presence of the monoterpene glycoside paeoniflorin.

Purity tests
Microbiology

The test for Salmonella spp. in Radix Paeoniae products should be negative.  The maximum acceptable limits of other microorganisms are as follows.  For preparation of decoctions: aerobic bacteria--not more than 10 7/g; fungi--not more than 10 5/g; Escherichia coli--not more than 10 2/g.  Preparations for internal use: aerobic bacteria--not more than 10 5/g or ml; fungi--not more than 10 4/g or ml; enterobacteria and certain Gram-negative bacteria--not more than 10 8/g or ml; Escherichia coli-0/g or ml.

Total Ash
Not more than 6.5%.

Acid-insoluble ash
Not more than 0.5%.

Pesticide residues
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. For other pesticides, see WHO guidelines on quality control methods for medicinal plants and guidelines for predicting dietary intake of pesticide residues.

Heavy metals
Recommended lead and cadmium levels are not more than 10 and 0.3 mg/kg. respectively, in the final dosage form of the plant material.

Radioactive residues
For analysis of strontium-90, iodinc-13l, cacsium-134, caesium-137, and plutonium-239, see WHO guidelines on quality control methods for medicinal plants.

Other purity tests
Alcohol-soluble extractive, chemical, foreign organic matter, moisturc and water-soluble extractive tests to be established in accordance with national requirements.

Chemical assays
Contains not less than 2.0% of paeoniflorin, assayed by a combination of thin-layer chromatographic-spectrophotometric methods or by high- performance liquid chromatography.

Major chemical constituents
Paeoniflorin, a mono terpene glycoside that is the major active constituent, is present in the range of 0.05-6.01%.

Dosage forms
Crude plant material, powder, and decoction. Store in a ventilated dry environment protected from light.

Medicinal uses
Uses supported by clinical data
None.

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.  Radix paeniae is also used to treat dementia, headache, vertigo, spasm of the calf muscles, liver disease, and allergies, and as an anticoagulant.

Used described in folk medicine, not supported by experimental or clinical data
The treatment of atopic eczema, boils, and sores; to reduce fevers, induce sterility, and treat burns.

Pharmacology
Experimental pharmacology
The primary pharmacological effects of Radix Paeoniae are antispasmodic, anti- inflammatory, and analgesic. A decoction of the drug had antispasmodic effects on the ileum and uterus when administered orally to mice, rabbits, and guinea-pigs. Similar effects were observed with a methanol extract in rat uterus, but an ethanol extract had uterine stimulant activity in rabbits. Radix Paeoniae extracts tested in vitro relaxed smooth muscles in both rat stomach and uterine assays.

Intragastric administration of a hot-water extract of Radix Paeoniae to rats inhibited inflammation in adjuvant-induced arthritis and carrageenin- induced paw oedema. 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.

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. Similar effects were observed in rabbits and mice after intraperitoneal administration of the drug. When tested by the standard fibrin plate method, ethanol and hot-water extracts of the drug had antifibrinolytic activity in vitro. Paeoniflorin had anticoagulant activity both in vitro, and in vivo (in mice).

Intragastric administration of extracts of Radix Paeoniae protected the liver against carbon tetrachloride-induced hepatotoxicity in mice and rats.

Oral administration of water extracts of Radix Paeoniae or its major constituent, paeoniflorin, attenuated the scopolamine-induced impairment of radial maze performance in rats. Paeoniflorin prevented the scopolamine- induced decrease in acetylcholine content in the striatum, but not in the hippocampus or cortex. Oral administration of paeoniflorin further attenuated learning impairment of aged rats in operant brightness discrimination tasks. 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.

Contraindications
Reports of traditional use indicate that Radix Paeoniae may have abortifacient activity; therefore, the use of Radix Paeoniae in pregnancy is contraindicated.

Warnings
No information available.

Precautions
Drug interactions
Radix Paeoniae should not be combined with Fritillaria vericillata, Cuscuta japonica, and Rheum officinale.

Carcinogenesis, mutagenesis, impairment of fertility
Hot-water or methanol extracts of Radix Paeoniae are not mutagenic in vitro.

Pregnancy: non-teratogenic effects
See Contraindications

Nursing mothers
Excretion of the drug into breast milk an dits effects on the newborn have not been established; therefore, use of the drug during lactation is not recommended.

Paediatric use
No information available about general precautions, drug and laboratory test interactions, or teratogenic effects on pregnancy.

Adverse reactions
No information available.

Posology
Maximum daily oral dose of crude plant material, 6-15g, standardized for paeoniflorin.

References

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