2.7.1 who: Monographs on Selected Medicinal Plants 
Flos Chamomillae consists of the dried flowering heads of Chamomilla recutita (L.) Rauschert (Asteraceae) [2, 3, 8, 9].
Matricaria chamomilla L., M. recutita L., M. suaveolens L. [3, 98]
In most formularies and reference books, Matricaria chamomilla L. is regarded as the correct species name. However, according to the International Rules of Botanical Nomenclature, Chamomilla recutita (L.) Rauschert is the legitimate name for this species . Asteraceae are also known as Compositae.
Baboonig, babuna, babunah camornile, babunj, bunga kamil, camamilla, camomile, chamomile, camomilla, chamomille allemande, campomilla, chamomille commune, camomille sauvage, fleurs de petite camomille, flos chamomillae, German chamomile, Hungarian chamomile, Kamille, Kamillen, kamitsure, kamiture, manzanilla, manzanilla chiquita, manzanilla comun, manzanilla dulce, matricaire, matricaria flowers, pin heads, sweet false chamomille, sweet feverfew, wild chamomile [1, 3, 48, 80, 114]
Herbaceous annual; 10-30 cm in height, with erect, branching stems and alternate, tripinnately divided leaves below and bipinnately divided leaves above, both types having almost filiform lobes; the capitulum (to 1.5 cm in diameter) comprises 12-20 white ligulate florets surrounding a conical hollow receptacle on which numerous yellow tubular (disk) florets are inserted; the inflorescence is surrounded by a flattened imbricated involucre; fruit small, smooth, yellowish [3, 29, 114].
184.108.40.206 Plant Material of Interest: Flower Heads
Flos Chamomillae consists of conical flower heads, each bearing a few white ligulate florets and numerous yellowish orange to pale yellow tubular or disk florets on conical, narrow hollow receptacles with a short pedunde; disk florets are perfect and without a pappus; ray florets are pistillate, white, 3-toothed and 4-veined; involucre hemispherical, composed of 20-30 imbricate, oblanceolate, and pubescent scales; peduncles are weak brown to dusky greenish yellow, longitudinally furrowed, more or less twisted, and up to 2.5 cm long; achenes are more or less obovoid and faintly 3- to 5-ribbed; pappus none, or slightly membranous crown [5, 114].
220.127.116.11.2 Organoleptic properties
Odor is pleasant and aromatic; taste is aromatic and slightly bitter [3, 8, 9].
Receptacle and bracteoles have schizogenous secretory ducts; vascular bundles have phloem fibers; spiral, annular, and reticulate but pitted vessels; lignified cells at the bases of the ovaries are absent;
* World Health Organization.
nearly all parts of florets bear composite-type glandular hairs with short, biseriate stalk and enlarged head, formed of several tiers, each of two cells; ovary with longitudinal bands of small mucilage cells; stigma with elongated papillae at the apex; pollen grains, spherical or triangular, have numerous short spines .
Powdered Flos Chamomillae is greenish-yellow to yellowish-brown; spiny pollen grains numerous, 18-25 jm in diameter; fragments of yellow or white corolla, with polygonal, small epidermal cells having straight or slightly wavy walls, sometimes papillosed, and sometimes bearing glandular hairs of composite type; fragments of the fibrous layer of anther; fragments from ovary, with glandular hairs and rows of small mucilage cells; green fragments of parenchyma of involucre; stigma with papillae; cells of the achenes with sclariform perforations in walls; fragments of fibrovascular bundles with spiral, annular, and reticulate vessels and sclerenchyma fibers; fragments of involucral bracts with epidermis having elliptical stomata up to 30 jm in length; also vessels and fibers; occasional fiber from the stems; minute cluster crystals of calcium oxalate, up to 10 jm in diameter; fragments of lignified parenchyma of the filaments and occasional fragments of vessels [3, 29, 114].
The plant is indigenous to northern Europe and grows wild in central European countries; it is especially abundant in eastern Europe and is also found in western Asia, the Mediterranean region of northern Africa, and the United States. lt is cultivated in many countries [1, 3, 5, 6, 29, 80, 98, 108, 114].
18.104.22.168 General Identity Tests
The drug is identified by its macroscopic and microscopic characteristics, and by thin-layer chro-matography [3, 8, 9].
22.214.171.124 Purity Tests
The test for Salmonella spp. in Flos Chamomillae products should be negative. The maximum acceptable limits of other microorganisms are as follows [7, 8, 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; E. coli, 0/g or ml. Preparations for external use: aerobic bacteria, not more than 102/g or ml; fungi, not more than 102/g or ml; enterobacteria and certain Gram-negative bacteria, not more than 10Vg or ml.
126.96.36.199.2 Foreign organic matter
Not more than 10% stems and not more than 2% foreign organic matter ; no flowering heads of Anthemis cotula L. or A. nobilis L. 
188.8.131.52.6 Pesticide residues
To be established in accordance with national requirements. Normally, the maximum residue limit of aldrin and dieldrin for Flos Chamomillae 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 .
184.108.40.206.7 Heavy metals
Recommended lead and cadmium levels are no more than 10 and 0.3 mg/kg, respectively, in the final dosage form of the plant material .
For analysis of strontium-90, iodine-131, caesium-134, caesium-137, and plutonium-239, see WHO guidelines on quality control methods for medicinal plants .
220.127.116.11.9 Other tests
Chemical, dilute ethanol-soluble extractive, and water-soluble extractive tests are to be established in accordance with national requirements.
18.104.22.168 Chemical Assays
Contain not less than 0.4% v/w of essential oil [3, 8, 9]. Total volatile oil content is determined by pharmacopoeial methods [3, 8, 9].
Thin-layer [8, 9] and gas-liquid  chromatography is for volatile oil constituents, and highperformance liquid chromatography is for flavonoids [46, 92].
Flos Chamomillae contains an essential oil (0.4-1.5%), which has an intense blue color owing to its chamazulene content (1-15%). Other major constituents include a-bisabolol and related sesquiterpenes (up to 50% of the oil). Apigenin and related flavonoid glycosides constitute up to 8% (dry weight) of the drug [29, 46].
22.214.171.124 Dosage Forms
Dried flower heads, liquid extract (1:1 in 45% alcohol), tinctures, and other galenicals . Store in well-closed containers, protected from light [3, 8, 9].
126.96.36.199 Medicinal Uses
188.8.131.52.1 Uses supported by clinical data
Use for symptomatic treatment of digestive ailments such as dyspepsia, epigastric bloating, impaired digestion, and flatulence [1, 3, 5, 29, 34, 35, 114]. Infusions of camomile flowers have been used in the treatment of restlessness and in mild cases of insomnia due to nervous disorders [34, 55].
Use for inflammation and irritations of the skin and mucosa (skin cracks, bruises, frostbite, and insect bites) [29, 67], including irritations and infections of the mouth and gums, and hemorrhoids [5, 29, 34, 35, 67].
Symptomatic relief of irritations of the respiratory tract due to the common cold .
184.108.40.206.1 Uses described in pharmacopoeias and in traditional systems of medicine
Adjuvant in the treatment of minor inflammatory conditions of the gastrointestinal tract .
220.127.116.11.2 Uses described in folk medicine, not supported by experimental or clinical data
As an antibacterial and antiviral agent, an emetic, and an emmenagogue. It is also used to relieve eye strain, and to treat urinary infections and diarrhea .
Both camomile extract and (-)-a-bisabolol demonstrated antipeptic activity in vitro [68, 98, 104]. A hydroalcoholic extract of camomile inhibited the growth of Staphylococcus aureus, Streptococcus mutans, group B Streptococcus, and Streptococcus salivarius, and it had a bactericidal effect in vitro on Bacillus megatherium and Leptospira icterohaemorrhagiae . In vitro, the volatile oil of camomile also inhibited Staphylococcus aureus and Bacillus subtilis . In vitro, camomile extracts inhibited both cyclooxygenase and lipoxygenase , and thus the production of pros-taglandins and leukotrienes, known inducers of inflammation. Both bisabolol and bisabolol oxide have been shown to inhibit 5-lipoxygenase, but bisabolol was the more active of the two compounds . Numerous in vivo studies have demonstrated the anti-inflammatory effects of the drug. The anti-inflammatory effects of camomile extract, the essential oil, and the isolated constituents have been evaluated in yeast-induced fever in rats and against ultraviolet radiation-induced erythema in guinea-pig models . The principal anti-inflammatory and antispasmodic constituents of camomile appear to be the terpene compounds matricin, chamazulene, (-)-a -bisabololoxides A and B, and (-)-a -bisabolol [20, 41, 42, 51, 71, 77, 81, 107]. While matricin and (-)-a -bisabolol have been isolated from the plant, chamazulene is actually an artefact formed during the heating of the flowers when an infusion or the essential oil is prepared . The anti-inflammatory effects of these compounds in various animal models, such as inhibition of carrageenin-induced rat paw edema, have been demonstrated , although their activity was somewhat less than that of salicylamide . In the mouse model for croton oil-induced dermatitis, topical application of either the total camomile extract, or the flavonoid fraction only, was very effective in reducing inflammation . Apigenin and luteolin were more active than indometacin and phenylbutazone . Activity decreased in the following order: apigenin > luteolin > quercetin > myricetin > apigenin-7-glucoside > rutin . The spasmolytic activity of camomile has been attributed to apigenin, apigenin-7-O-glucoside [29, 77], and (-)-a-bisabolol, which have activity similar to papaverine [29, 42].
Intradermal application of liposomal apigenin-7-glucoside inhibited, in a dose-dependent manner, skin inflammations induced in rats by xanthine oxidase and cumene hydroperoxide .
Intraperitoneal administration to mice of a lyophilized infusion of camomile decreased basal motility, exploratory and motor activities, and potentiated hexobarbital-induced sleep . These results demonstrated that in mice camomile depresses the central nervous system .
A double-blind study of the therapeutic effects of a camomile extract on re-epithelialization and drying of wound weeping after dermabrasion demonstrated a statistically significant decrease in the wound size and drying tendency .
In clinical trials, topical application of a camomile extract in a cream base was found to be superior to hydrocortisone 0.25% for reducing skin inflammation . In an international multicenter trial camomile cream was compared with hydrocortisone 0.25%, fluocortin butyl ester 0.75%, and bufexamac 5% in the treatment of eczema of the extremities . The camomile cream was shown to be as effective as hydrocortisone and superior to the other two treatments, but no statistical analysis was performed. Camomile preparations have also been found to be beneficial in the treatment of radiation mucositis owing to head and neck radiation and systemic chemotherapy .
Camomile is contraindicated in patients with a known sensitivity or allergy to plants of the
Asteraceae (Compositae) such as ragweed, asters, and chrysanthemums .
No information available.
18.104.22.168.1 Carcinogenesis, mutagenesis, impairment of fertility
No mutagenic effects were found in Salmonella typhimurium strains TA 97a, TA 98, TA 100, and TA 104, with or without metabolic activation .
22.214.171.124.2 Pregnancy: teratogenic effects No adverse effects reported in vivo .
No information available concerning general precautions, drug interactions, drug and laboratory test interactions, nonteratogenic effects on pregnancy, nursing mothers, or pediatric use.
The presence of lactones in Flos Chamomillae-based preparations may cause allergic reactions in sensitive individuals, and there have been reports of contact dermatitis due to camomile preparations [47, 89, 102]. It should be noted that very few cases of allergy were specifically attributed to
German camomile . A few cases of anaphylactic reactions to the ingestion of Flos Chamomillae have also been reported [25, 36, 101].
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