(2004; 358 pages)
Folium Ocimi Sancti
Folium Ocimi Sancti consists of the fresh or dried leaves of Ocimum sanctum L. (Lamiaceae) (1-3).
Moschosma tenuiflorum (L.) Heynhold, Ocimum album Blanco, O. Anisodorum Muell., O. brachiatum Hasskarl, O. flexuosum Blanco, O. frutescens Burm., O. gratissimum Lour., O. inodorum Burm., O. monachorum L., O. nelsonii Zipp ex Span., O. tenuiflorum L., O. virgatum Blanco (4).
Selected vernacular names
Badrooj, basilic des moines, bazsalikom levél, daun lampes, garden balsam, green tulsi, holy basil, huong nhu t¡ia, jagu lu myah, kamimebouki, kaphrao, kaprao, kemangi, kemangi laki, kra phrao, lampas, monk’s basil, peihan, rayhhan, reihan, sacred basil, saling-kugon, saling-kugon ma, selaseh puteh, solasi, sulasi, sursa, tamole, thulasi, tjlsi, tulashi, tulasi, tulsi (1, 4-9).
Indigenous to India and parts of north and eastern Africa, Hainan Island and Taiwan, China. It is cultivated in south-east Asia (6, 8, 10).
A herb or shrub, up to 1m high, often much branched. Stem square, lower parts sub-serrate, higher parts slightly furrowed and more densely pubescent or sub-glabrous. Leaves simple, opposite, oblong, ovate or oval-oblong, 2.7-7.5 cm long, 1-3 cm wide, with acute top, cuneate, obtuse to rounded base, margin entire, undulate or serrate, both surfaces thinly pubescent and dotted; petiole 0.2-3.0 cm long. Calyx 0.2-0.4 cm long, with or without long or short hairs, ciliate, densely glandulose; upper lip 2.0-3.5 mm long, oval short-acuminate; lower lip 1.0-2.5 mm long, dentate, teeth linear-acuminate from an equal- or unequal-sided triangular to ovate base, 2 anterior teeth equalling or slightly surpassing the upper lip; fruiting calyx not completely closed by teeth. Upper part of the corolla villous and glandulose in the upper part; lobes of upper lip rounded, lobes of lower lip obtuse to rounded. Nutlets obovoid, dark brown or black, 1-2 mm long; pericarp swells into a slimy mass when moistened (6, 8, 11, 12).
Plant material of interest: fresh or dried leaves
Leaves green to greenish-brown, 2.5-7.5 cm long, 1-3 cm wide, oblong, ovate or oval-oblong, with acute top, cuneate, obtuse to rounded base, pinnate veins, serrate or entire and undulate margin; thin but fleshy, both surfaces thinly pubescent; petiole cylindrical, 1-2 cm long, thinly pubescent (1).
Odour: characteristic, aromatic; taste: slightly pungent (1, 2).
Transverse section of the leaf through its midrib: upper epidermis consists of a layer of small, quadrangular transparent cells with thin walls and thin smooth cuticle. On tangential view, these cells are polygonal with straight or wavy walls. Lower epidermis consists of a layer of small, quadrangular transparent cells with thin walls and thin smooth cuticle. Trichomes bent, consisting of 2-6 cells; glandular trichomes short, Lamiaceae type, consisting of 1 stalk cell and 2-4 cells with rounded heads. Palisade parenchyma consists of layer of long cylindrical cells containing chlorophyll; spongy parenchyma consists of polygonal cells with thin, straight or slightly wavy side walls. Vascular bundles collateral type with collenchyma cells. Stomata diacytic, on upper and lower epidermis (1).
Powdered plant material
Upper epidermis with diacytic stomata, glandular trichomes and palisade cells; lower epidermis with diacytic stomata and underlying spongy cells; 2- and 4- celled glandular trichomes; uniseriate, multicellular trichomes with collapsed cells; lignified fibres; spiral vessels; pollen grains rare; parenchyma and collenchyma from petioles (2).
General identity tests
Macroscopic and microscopic examinations (1), and thin-layer chromatography (2).
Tests for specific microorganisms and microbial contamination limits are as described in the WHO guidelines on quality control methods for medicinal plants (13).
Not more than 13% (1).
Not more than 1% (1).
Not more than 20% (2).
Not less than 5% (1).
Not less than 5.0% (2).
Loss on drying
Not more than 14% (2).
The recommended maximum limit of aldrin and dieldrin is not more than 0.05 mg/kg (14). For other pesticides, see the European pharmacopoeia (14), and the WHO guidelines on quality control methods for medicinal plants (13) and pesticide residues (15).
For maximum limits and analysis of heavy metals, consult the WHO guidelines on quality control methods for medicinal plants (13).
Where applicable, consult the WHO guidelines on quality control methods for medicinal plants (13) for the analysis of radioactive isotopes.
Other purity tests
Chemical and foreign organic matter tests to be established in accordance with national requirements.
Contains not less than 0.5% essential oil (3). Gas chromatography and gas chromatography-mass spectroscopy methods are available for qualitative and quantitative determination of volatile constituents (16).
Major chemical constituents
The main components are tannins (4.6%) and essential oil (up to 2%) (1). The amounts of the primary constituents of the essential oil vary according to the geographical distribution and variety of the source plant material: eugenol (up to 62%), methyleugenol (up to 86%), and α- and β-caryophyllene (up to 42%). Also present are methylchavicol, linalool and 1,8-cineole (4, 16-19). The structures of the major constituents are presented below.
R = H
R = CH3
Uses supported by clinical data
None. Although there are some preliminary clinical data supporting the use of Folium Ocimi Sancti for the treatment of diabetes, further trials are needed to substantiate the data.
Uses described in pharmacopoeias and in traditional systems of medicine
Treatment of arthritis, asthma, bronchitis, common cold, diabetes, fever, influenza, peptic ulcer and rheumatism (1, 8, 20).
Uses described in folk medicine, not supported by experimental or clinical data
Treatment of earache, epilepsy, heart disease, malaria, sinusitis, snake bites, stomach ache and vomiting. Also as an anthelminthic, to stimulate lactation, to prevent hair loss, and as a tonic (7).
Intraperitoneal or intragastric administration of the fixed oil to mice (3 ml/kg body weight) significantly inhibited writhing induced by acetic acid (P < 0.01) (21). Intragastric administration of an aqueous suspension or a methanol extract of the leaves to mice (100 mg/kg body weight) showed analgesic activity in the hot-plate test (22).
A 50% ethanol extract of the leaves inhibited histamine-induced bronchospasms and pre-convulsive dyspnoea in guinea-pigs when administered by gastric lavage (200 mg/kg body weight) (23, 24). Intragastric administration of the leaf essential oil or fixed oil to guinea-pigs (0.5 ml/kg body weight) inhibited bronchospasms induced by both histamine and acetylcholine, and pre-convulsive dyspnoea (23-25).
A hydroalcoholic extract of the leaves inhibited muscle spasms induced by histamine in guinea-pig ileum, and muscle spasms induced by acetylcholine, barium and histamine in guinea-pig small intestine in vitro (26). However, an aqueous extract showed no activity in either test system (27). In another study, aqueous extracts of the leaves inhibited muscle spasms induced by acetylcholine, histamine and carbachol in rabbit intestine in vitro (28).
An ether or 95% ethanol extract of the leaves inhibited the growth in vitro of Staphylococcus aureus and S. citreus (29, 30) and of Mycobacterium tuberculosis (29, 31). A hot aqueous extract of the leaves inhibited the growth in vitro of Trichophyton mentagrophytes (32), and the growth of Aspergillus fumigatus and A. niger was inhibited in vitro when grown on agar plates containing the powdered leaves (33).
Intragastric administration of a hydroalcoholic extract of the leaves or the essential oil to rats and guinea-pigs (10 ml/kg body weight) inhibited footpad oedema induced by histamine, serotonin and carrageenan (23, 24). Intragastric administration of the fixed oil and linolenic acid extracted from the leaf to rats inhibited footpad oedema induced by prostaglandin E2, leukotriene, carrageenan and arachidonic acid (34). Intragastric administration of an aqueous leaf extract to rats (100 mg/kg body weight) inhibited footpad oedema induced by croton oil and carrageenan (22). Intraperitoneal administration of an aqueous leaf extract to rats (100 mg/kg body weight) also inhibited carrageenan-induced footpad oedema (35). A hydroalcoholic extract of the leaves inhibited the activity of prostaglandin synthetase by 88% in vitro at a concentration of 750 µg/ml (36). An aqueous leaf extract exhibited anticholinergic and antihistamine activity in guinea-pig ileum and small intestine in vitro (0.15 mg) (27).
Intragastric administration of a methanol leaf extract to rats (250mg/kg body weight) suppressed fever induced by typhoid vaccine (35). However, intragastric administration of a hydroalcoholic extract of the leaves to rabbits (10mg) did not suppress fever induced by yeast (37).
Effect on sleeping time
Intraperitoneal administration of an aqueous or 70% ethanol extract (30-40mg/kg body weight) of the leaves to mice potentiated sleeping time induced by hexobarbital and pentobarbital (28, 38).
Intragastric administration of an aqueous or methanol extract of the leaves to rats (100-500 mg/kg body weight) increased antibody titre in both sheep erythrocyte and Widal agglutination tests, thus demonstrating stimulation of the humoral immune response. The cellular immune response was also stimulated, as an increase in lymphocytosis and E-rosette formation was also seen (39). Intragastric administration of a leaf essential oil to rats (100mg/kg body weight) enhanced the titres of both anti-sheep red blood cell and IgE antibodies (40).
The effects of a leaf extract on changes in serum triiodothyronine, thyroxine and cholesterol concentrations have been investigated in mice. After 15 days of treatment (0.5 g/kg body weight, by gastric lavage), significant decreases were observed in serum thyroxine concentration, hepatic lipid peroxidation and hepatic glucose-6-phosphate activities. No marked change in serum triiodothyronine levels was noted. The activities of superoxide dismutase and superoxide catalase were increased (41).
Intragastric administration of an ethanol extract of the leaves to rats reduced the concentration of plasma corticosterone, which had risen following 30 minutes of noise (100 dB), to normal levels (42). An organic solvent extract of the leaves had significant antioxidant activity in a variety of in vitro systems (43). Intragastric administration of a 70% ethanol extract of the leaves to rats (100 mg/kg body weight) prevented ulcers induced by acetylsalicylic acid and stress (44). Administration of the dried leaves to rats similarly prevented ulcers induced by cold and acetylsalicylic acid (45). However, intragastric administration of a methanol extract of dried leaves to mice (2 g/kg body weight) did not prevent stress-induced ulcers (46).
Intragastric administration of a 50% ethanol extract of the leaves (250mg/kg body weight) to albino rats with experimentally induced hyperglycaemia reduced blood glucose levels by 30% (26, 47). Intragastric administration of the leaves (50-400 mg/kg body weight) to rats with diabetes induced by streptozocin resulted in a reduction in blood glucose levels measured after fasting (48).
Intragastric administration of eugenol (400-600mg/kg body weight) has been reported to produce liver damage in mice, whose livers were experimentally depleted of glutathione (49). It was also cytotoxic in isolated rat hepatocytes (50). However, no generalized toxicity was reported in mice after a 50% ethanol extract of the leaves was injected either intraperitoneally (1 g/kg body weight) (26) or intradermally (10 g/kg body weight) (51).
In a study without controls, oral administration of an aqueous extract of dried Folium Ocimi Sancti to 20 patients with asthma increased lung vital capacity and relieved laboured breathing (52).
Glucose and cholesterol levels
A randomized, placebo-controlled, single-blind, crossover study assessed the effects of the dried leaves on the levels of blood glucose and serum cholesterol in 40 non-insulin-dependent diabetic patients. Patients received orally 2.5 g leaves daily for 4 weeks. Blood glucose levels, measured after fasting and eating, decreased by 17.6% and 7.3% respectively. Mean total cholesterol levels also decreased slightly (by 6.5%) during the treatment period (20). No adverse effects were observed.
There are conflicting reports on the embryotoxicity of Folium Ocimi Sancti (53, 54). The use of Folium Ocimi Sancti is therefore contraindicated during pregnancy and lactation.
No information available.
One study has shown that eugenol may be hepatotoxic in mice with glutathione-depleted livers (49). Therefore, Folium Ocimi Sancti should be used with caution in patients taking drugs such as paracetamol (acetaminophen) that deplete glutathione.
Carcinogenesis, mutagenesis, impairment of fertility
A hot aqueous extract of fresh Folium Ocimi Sancti was not mutagenic in Bacillus subtilis H-17 (rec+) and M-45(rec-) at a concentration of 0.5 ml/disc (55). Intragastric administration of the leaves prevented implantation of the embryo in various animal models (54, 56). Intragastric administration of the leaves (10% of feed) to male mice inhibited spermatogenesis (57, 58).
Pregnancy: teratogenic effects
There are conflicting reports on the embryotoxicity of Folium Ocimi Sancti. In one study, a benzene leaf extract was neither teratogenic nor embryotoxic when administered intragastrically to rats (200mg/kg body weight) (53). However, another study demonstrated that aqueous or benzene extracts of the leaves were embryotoxic when administered intragastrically to rats (100-200 mg/kg body weight) (54). (See also Contraindications.)
Pregnancy: non-teratogenic effects
No information available on general precautions or precautions concerning drug and laboratory test interactions or paediatric use. Therefore, Folium Ocimi Sancti should not be administered to children without medical supervision.
No adverse reactions have been reported in clinical trials (20, 52).
Crude drug and preparations thereof (1).
(Unless otherwise indicated)
Daily dosage: 6-12 g crude drug as a decoction (8).
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