Andrographis paniculata WHO Monographs on Selected Medicinal Plants Volume 2

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DefinitionHerba Andrographidis consists of the dried aerial parts of Andrographis panicu-lata (Burm. f.) Nees (Acanthaceae) (1–3).

SynonymsJusticia latebrosa Russ., J. paniculata Burm. f., J. stricta Lam. ex Steud. (3, 4).

Selected vernacular namesAkar cerita bidara, alui, Andrographidis Kraut, bidara, bhoonimba, bhuinimo,bhulimb, bhuninba, charayeta, charayetha, charita, cheranta, cherota, chiraita,chiretta, chuan-hsin-lien, chuan-xın-lián, công công, faathalaaichon, fathalaai,fathalaichon, fathalaijone, halviva, herba sambiloto, hinbinkohomba, I-chien-hsi, kalafath, kalmegh, kan-jang, kariyat, khee-pang-hee, king of bitters,kiriathu, kirta, kiryata, kiryato, lanhelian, mahatikta, mahatita, naelavemu, nay-nahudandi, nelavemu, quasab-uz-zarirah, rice bitters, sambilata, sambiloto,senshinren, sinta, xuyên tâm liên, yaa kannguu yijianxi (1, 2, 5–11).

Geographical distributionWidely found and cultivated in tropical and subtropical Asia, south-east Asiaand India (6, 8, 10).

DescriptionA herbaceous annual, erect, up to 1m high; stem acutely quadrangular, muchbranched. Leaves simple, opposite, lanceolate, glabrous, 2–12cm long, 1–3cmwide; apex acute; margin entire, slightly undulate, upper leaves often bracti-form; petiole short. Inflorescence patent, terminal and axillary in panicle, 10–30mm long; bract small; pedicel short. Calyx 5-particle, small, linear. Corollatube narrow, about 6mm long; limb longer than the tube, bilabiate; upper lipoblong, white with a yellowish top; lower lip broadly cuneate, 3-lobed, whitewith violet markings. Stamens 2, inserted in the throat and far exserted; antherbasally bearded. Superior ovary, 2-celled; style far exserted. Capsule erect,linear-oblong, 1–2cm long and 2–5mm wide, compressed, longitudinally fur-rowed on broad faces, acute at both ends, thinly glandular-hairy. Seeds small,subquadrate (1–3, 5, 10).

Herba Andrographidis

Plant material of interest: dried aerial partsGeneral appearanceMixture of broken, crisp, mainly dark green lanceolate leaves and quadrangu-lar stems; capsule fruit and small flowers occasionally found (1, 3). Stem texturefragile, easily broken; leaves simple, petiole short or nearly sessile, lanceolateor ovate-lanceolate, with acuminate apex and cuneate-decurrent base, laminacrumpled and easily broken (2).

Organoleptic propertiesOdour: slight, characteristic; taste: intensely bitter (1–3, 9).

Microscopic characteristicsLeaf upper epidermis: stomata absent, glandular trichomes present, unicellularand multicellular trichomes rare, cystoliths fairly large; lithocysts large (27–30mm thick, 96–210mm long and up to 49mm wide); columnar palisade cells;collenchyma in midrib beneath epidermis; parenchyma cells spongy; vascularbundles of lignified xylem in the upper part and lignified phloem in the lowerpart; spiral, scalariform and reticulate vessels. Leaf lower epidermis: a layer ofwavy-walled cells; stomata diacytic; trichomes up to 36mm in diameter and 180mm long, and cystoliths present. Stem: epidermis has glandular and non-glan-dular trichomes. Collenchyma dense at the corners of stems; parenchyma con-tains chloroplastids. Endodermis composed of a layer of thick-walled cells.Wood with spiral, scalariform and pitted xylem vessels; pith composed of largeparenchyma cells. Small acicular crystals of calcium oxalate occur in the pithand cortical cells of stem and leaf (1–3, 8).

Powdered plant materialLeaf fragments in surface view show upper epidermis with underlying palisadeand cystoliths, lower epidermis with underlying palisade cells with stomata,cystoliths and glandular trichomes. Leaf fragments in sectional view showupper epidermis with palisade cells, spongy parenchyma cells, vascular bundles;and lower epidermis with bundles of xylem associated with fibres; fragmentsof spiral, scalariform, reticulate and pitted vessels; fragments of epidermal cellsfrom midrib; fragments of parenchyma cells in transverse and longitudinal sections. Bundles of fibres. Fragments of epidermal cells from stem withstomata, cystoliths and glandular trichomes. Scattered cystoliths; scattered uni-cellular and multicellular trichomes, mostly from epidermal cells in fruit walls;scattered glandular trichomes from bundles of fibres in fruit wall; scatteredpollen grains (1).

General identity testsMacroscopic and microscopic examinations, chemical tests, and thin-layerchromatography for the presence of diterpene lactones (1–3).


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Purity testsMicrobiologicalTests for specific microorganisms and microbial contamination limits are asdescribed in the WHO guidelines on quality control methods for medicinalplants (12).

ChemicalNot less than 6% of total diterpene lactones, calculated as andrographolide (1, 3).

Foreign organic matterNot more than 2% (1, 3).

Acid-insoluble ashNot more than 2% (1, 3).

Water-soluble extractiveNot less than 18% (1, 3).

Alcohol-soluble extractiveNot less than 13% using 85% ethanol (1, 3).

Loss on dryingNot more than 10% (1).

Pesticide residuesThe recommended maximum limit of aldrin and dieldrin is not more than 0.05mg/kg (13). For other pesticides, see the European pharmacopoeia (13), andthe WHO guidelines on quality control methods for medicinal plants (12) andpesticide residues (14).

Heavy metalsFor maximum limits and analysis of heavy metals, consult the WHO guidelineson quality control methods for medicinal plants (12).

Radioactive residuesWhere applicable, consult the WHO guidelines on quality control methods formedicinal plants (12) for the analysis of radioactive isotopes.

Other purity testsTotal ash test to be established in accordance with national requirements.

WHO monographs on selected medicinal plants

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Chemical assaysChemical and thin-layer chromatography methods are used for qualita-tive analysis of andrographolide diterpene lactones (1, 2). Titrimetric (1) andhigh-performance liquid chromatography (15) methods are available for quan-titative analysis of total diterpene lactones.

Major chemical constituentsThe major constituents are diterpene lactones (free and in glycosidic forms)including andrographolide, deoxyandrographolide, 11,12-didehydro-14-deoxy-andrographolide, neoandrographolide, andrographiside, deoxyandrographisideand andropanoside (1, 3, 6, 7, 9, 16). The structures of andrographolide andrelated diterpene lactones are presented below.


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O

OH

HO

CH2HH3C

H

HOH

CH3O

R

11 12

14O

O

CH2HH3C

H

RH

CH3O

Glc

3

OOH

HO

OHHO

Glc =

andrographolide R = H neoandrographolide R = H

andrographiside R = Glc andropanoside R = OH

3

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b-D-glucopyranosyl

Medicinal usesUses supported by clinical dataProphylaxis and symptomatic treatment of upper respiratory infections, suchas the common cold and uncomplicated sinusitis (17–19), bronchitis (6, 9) andpharyngotonsillitis (20), lower urinary tract infections (21) and acute diarrhoea(22, 23).

Uses described in pharmacopoeias and in traditional systems of medicineTreatment of bacillary dysentery, bronchitis, carbuncles, colitis, coughs, dyspepsia, fevers, hepatitis, malaria, mouth ulcers, sores, tuberculosis and venomous snake bites (1, 2, 6, 7, 10, 16, 24–27).

Uses described in folk medicine, not supported by experimental or clinical dataTreatment of colic, otitis media, vaginitis, pelvic inflammatory disease, chicken-pox, eczema and burns (6, 7).

PharmacologyExperimental pharmacologyAntibacterial activityAn ethanol extract of the leaves inhibited the growth in vitro of Escherichia coliand Staphylococcus aureus (28). A 50% methanol extract of the leaves inhibitedgrowth in vitro of Proteus vulgaris (29). However, no in vitro antibacterial activ-ity was observed when dried powder from the aerial parts was tested againstE. coli, Staphylococcus aureus, Salmonella typhi or Shigella species (30).

Anti-human immunodeficiency virus (HIV) activityAqueous extracts of the leaves inhibited HIV-1 infection and replication in thelymphoid cell line MOLT-4 (31). A hot aqueous extract of the aerial partsreduced the percentage of HIV antigen-positive H9 cells (32). Dehydroandro-grapholide inhibited HIV-1 and HIV-1 (UCD123) infection of H9 cells at 1.6mg/ml and 50mg/ml, respectively, and also inhibited HIV-1 infection ofhuman lymphocytes at 50mg/ml (33). A methanol extract of the leaves sup-pressed syncytia formation in co-cultures of uninfected and HIV-1-infectedMOLT cells (median effective dose [ED50] 70mg/ml) (34).

Immunostimulatory activity Intragastric administration of an ethanol extract of the aerial parts (25mg/kgbody weight) or purified andrographolides (1mg/kg body weight) to mice stimu-lated antibody production and the delayed-type hypersensitivity response tosheep red blood cells (35). The extract also stimulated a non-specific immuneresponse in mice, measured by macrophage migration index, phagocytosis of[14C]leucine-labelled E. coli, and proliferation of splenic lymphocytes (35). Theextract was more effective than either andrographolide or neoandrographolidealone, suggesting that other constituents may be involved in the immuno-stimulant response (35).

Antipyretic activityIntragastric administration of an ethanol extract of the aerial parts (500mg/kgbody weight) to rats decreased yeast-induced pyrexia (36). The extract wasreported to be as effective as 200mg/kg body weight of aspirin, and no toxicity was observed at doses up to 600mg/kg body weight (36). Intragastricadministration of andrographolide (100mg/kg body weight) to mice decreasedbrewer’s yeast-induced pyrexia (37). Intragastric administration of deoxy-andrographolide, andrographolide, neoandrographolide or 11,12-didehydro-14-deoxyandrographolide (100mg/kg body weight) to mice, rats or rabbitsreduced pyrexia induced by 2,4-dinitrophenol or endotoxins (6, 38).

Antidiarrhoeal activityHerba Andrographidis has antidiarrhoeal activity in situ (39, 40). An ethanol,chloroform or 1-butanol extract of the aerial parts (300mg/ml) inhibited the


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E. coli enterotoxin-induced secretory response—which causes a diarrhoeal syn-drome—in the rabbit and guinea-pig ileal loop assay (39, 40). However, anaqueous extract of the aerial parts was not active (40). The constituent diter-pene lactones, andrographolide and neoandrographolide, exhibited potent antisecretory activity in vivo against E. coli enterotoxin-induced diarrhoea (40).Andrographolide (1mg per loop) was as active as loperamide when testedagainst heat-labile E. coli enterotoxin-induced diarrhoea and more effective thanloperamide when tested against heat-stable E. coli enterotoxin-induced diar-rhoea (40). Neoandrographolide (1mg per loop) was as effective as loperamidewhen tested against heat-labile E. coli enterotoxin-induced diarrhoea andslightly less active than loperamide when tested against heat-stable E. colienterotoxin-induced diarrhoea (40). The mechanism of action involves inhibi-tion of the intestinal secretory response induced by heat-labile E. coli entero-toxins, which are known to act through the stimulation of adenylate cyclase,and by inhibition of the secretion induced by heat-stable E. coli enterotoxins,which act through the activation of guanylate cyclase (39). Incubation of murine macrophages with andrographolide (1–50mmol/l) inhibited bacterial endotoxin-induced nitrite accumulation in a concentration- and time-dependent manner. Western blot analysis demonstrated that andrographolideinhibited the expression of an inducible isoform of nitric oxide synthase linkedto endotoxin-induced circulatory shock (41).

Anti-inflammatory activityIntragastric administration of deoxyandrographolide, andrographolide, neo-andrographolide or 11,12-didehydrodeoxyandrographolide to mice inhibitedthe increase in cutaneous or peritoneal capillary permeability induced by xyleneor acetic acid, and reduced acute exudation in Selye granulocysts treated withcroton oil. 11,12-Didehydrodeoxyandrographolide had the most potent anti-inflammatory activity in vivo (6).

Antimalarial activityA 50% ethanol extract of the aerial parts inhibited the growth of Plasmodiumberghei both in vitro (100mg/ml) and in mice after intragastric administration (1g/kg body weight) (42). Intragastric administration of a 1-butanol, chloroformor ethanol–water extract of the aerial parts to Mastomys natalensis inhibited thegrowth of P. berghei at doses of 1–2g/kg body weight (43). Andrographolide (5mg/kg body weight) and neoandrographolide (2.5mg/kg body weight) werealso effective when administered by gastric lavage (43).

Antivenom activityIntraperitoneal injection of an ethanol extract of the aerial parts (25g/kg bodyweight) to mice poisoned with cobra venom markedly delayed the occurrenceof respiratory failure and death (6, 44). The same extract induced contractionsin guinea-pig ileum at concentrations of 2mg/ml. The contractions were


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enhanced by physostigmine and blocked by atropine, but were unchanged byantihistamines (44). These data suggest that extracts of the aerial parts do notmodify the activity of the nicotinic receptors but produce significant muscarinicactivity, which accounts for its antivenom effects (6, 44).

Antihepatotoxic activityThe aerial parts and their constituent andrographolides have antihepatotoxicactivity in vitro and in vivo (45–54). Intraperitoneal administration of a meth-anol extract of the aerial parts (861.3mg/kg body weight) to mice reduced hepa-totoxicity induced by carbon tetrachloride (CCl4), and reversed CCl4-inducedhistopathological changes in the liver (52). Intraperitoneal administration ofandrographolide (100mg/kg body weight) to mice inhibited the CCl4-inducedincrease in the activity of serum glutamate oxaloacetate transaminase, serumglutamate pyruvate transaminase, alkaline phosphatase, bilirubin and hepatictriglycerides (52). Intraperitoneal administration of a methanol extract of theaerial parts (500mg/kg body weight) to rats also suppressed the CCl4-inducedincrease in the activity of serum glutamate oxaloacetate transaminase, serumglutamate pyruvate transaminase, alkaline phosphatase and bilirubin (51). Intra-gastric administration of an aqueous extract of the aerial parts (500mg/kg bodyweight) to ethanol-treated rats decreased the activity of serum transaminasesand suppressed histopathological changes in the liver (49). Andrographolide,the major antihepatotoxic component of the plant, exerted a pronounced protective effect in rats against hepatotoxicity induced by CCl4 (47), D-galactosamine (54), paracetamol (48) and ethanol (49). Andrographolide wasmore effective than silymarin, the standard hepatoprotective agent (47, 48).

Clinical pharmacologyThe common coldHerba Andrographidis has been used clinically for symptomatic treatment ofthe common cold and uncomplicated sinusitis, pharyngotonsillitis, pneumoniaand bronchitis (6, 17, 18, 20). A placebo-controlled, double-blind clinical trialassessed the efficacy of a standardized extract of the aerial parts (containing4% andrographolides) for treatment of the common cold in 61 adult patients.A significant reduction (P < 0.0001) in clinical symptoms such as sore throat,tiredness, muscular ache and malaise was observed on day 4 in the groupreceiving 1200mg extract daily, as compared with the placebo group. Noadverse reactions were reported in either group (17).

A randomized, placebo-controlled, double-blind pilot trial was conductedto evaluate the efficacy of a standardized extract of the aerial parts (containing4% andrographolides) on the initial symptoms of the common cold and un-complicated sinusitis. Fifty adult patients received either 1020mg extract or aplacebo daily for 5 days. The results demonstrated that patients in the treatedgroup took less sick leave than those in the placebo group (0.21 day comparedto 0.96 day). Furthermore, 68% of treated patients felt totally recovered, as


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compared with 36% of the placebo group. Also 55% of the treated patientsthought that the course of illness was much easier than normal, as comparedwith 19% of the placebo group (18).

A randomized, placebo-controlled, double-blind study evaluated a stan-dardized extract of the aerial parts (containing 4% andrographolides) in the pro-phylaxis of the common cold in 107 schoolchildren during the winter season.The children received either 200mg extract or a placebo daily for 3 months andwere evaluated weekly by a physician. There was no difference in the occur-rence of colds between the two groups during the first 2 months of treatment.However, after the third month of treatment, there was a significant difference(P < 0.05) in the occurrence of the common cold in the treated group (30%) ascompared with the placebo group (62%) (19).

A randomized, double-blind comparison study of 152 adult patients withpharyngotonsillitis evaluated the efficacy of powdered aerial parts (6g daily)and paracetamol (1 capsule of 325mg as needed) for improving symptomatol-ogy. Baseline evaluation showed no significant difference between the twogroups. The crude drug was as effective as paracetamol in reducing the inci-dence of sore throat and fever after 3 days of treatment (20). In a study withoutcontrols, treatment of patients with a standardized extract of A. paniculata (con-taining 4% andrographolides) reduced the incidence of fever associated withthe common cold. The body temperature of patients treated with the extractwas lowered in less than 48 hours after treatment (55). This finding was con-firmed in a later study (17).

Urinary infectionsA clinical trial compared the efficacy of Herba Andrographidis, co-trimoxazole(sulfamethoxazole + trimethoprim) and norfloxacin in the prevention of urinarytract infections after extracorporeal shock wave lithotripsy. Patients received a5-day course of either Herba Andrographidis (4 tablets of 250mg, three timesdaily) or co-trimoxazole (2 tablets of 25mg, twice daily) or norfloxacin (1 tabletof 200mg, twice daily). After 1 month of treatment, urinalysis results of 100patients demonstrated that pyuria, haematuria and proteinuria were reducedin all treatment groups, and there was no significant difference between thethree treatments (21).

DysenteryThe aerial parts have been used for the treatment of acute bacillary dysenteryand enteritis (2, 6, 22, 23). In clinical studies, the combination of andro-grapholide and neoandrographolide was reported to be more effective thaneither furazolidine or chloramphenicol in the treatment of bacillary dysentery(6). A randomized, double-blind clinical study of 200 patients compared theefficacy of the powdered aerial parts with tetracycline in the treatment of acutediarrhoea and bacillary dysentery (22, 23). Patients received capsules of eitherthe aerial parts or tetracycline (both 500mg, four times daily) for 3 days. Com-pared with tetracycline, the aerial parts decreased the diarrhoea (both the fre-


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quency and amount of discharge) (22). Furthermore, the aerial parts were moreeffective in treating diarrhoea resulting from shigellosis than from cholera (22).

Infectious hepatitisAdministration of a decoction of the aerial parts to patients with infectioushepatitis was reported to provide symptomatic relief (24).

ContraindicationsHerba Andrographidis should not be used during pregnancy or lactation. Herba Andrographidis is contraindicated in cases of known allergy to plants ofthe Acanthaceae family.

WarningsDue to potential anaphylactic reactions, crude extracts of Herba Andrographidisshould not be injected (6, 56).

PrecautionsDrug interactionsExtracts of Herba Andrographidis may have a synergistic effect with isoniazid(6).

Carcinogenesis, mutagenesis, impairment of fertilityHerba Andrographidis extracts are not mutagenic in vitro (57) and have anti-mutagenic activity (58). A standardized extract of A. paniculata did not producereproductive toxicity in male rats after 60 days of intragastric administration of20–1000mg/kg body weight daily (59).

Pregnancy: teratogenic effectsSee Contraindications.

Pregnancy: non-teratogenic effectsIn vivo studies in mice and rabbits suggest that Herba Andrographidis may haveabortifacient activity (6, 60). Conversely, no interruption of pregnancy, fetalresorption or decrease in the number of live offspring was observed in preg-nant rats after intragastric administration of an extract of the aerial parts at 2g/kg body weight during the first 9 days of gestation (61). Since potentialantagonism exists between Herba Andrographidis and endogenous proges-terone, Herba Andrographidis should not be used during pregnancy (2, 61).

Nursing mothersSee Contraindications.


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Other precautionsNo information available on general precautions or precautions concerning drug and laboratory test interactions; or paediatric use. Therefore, HerbaAndrographidis should not be administered to children without medical supervision.

Adverse reactionsLarge oral doses of Herba Andrographidis may cause gastric discomfort, vom-iting and loss of appetite (6). These side-effects appear to be due to the bittertaste of andrographolide (6). Anaphylactic reactions may occur if the crude drugextract is injected (6, 56). Two cases of urticaria have been reported (18).

Dosage formsCrude drug, capsules, tablets and pills (1, 2, 6). Store in a well-closed container,protected from light and moisture.

Posology (Unless otherwise indicated)For pyrexia: a decoction from 3g crude drug, twice daily (1, 5). For the commoncold: 1.5–3.0g powdered crude drug three times daily, after meals and atbedtime (1). For diarrhoea: a decoction from 3–9g crude drug as a single doseas needed (1, 5), or two tablets of 500mg four times daily, after meals and atbedtime (5).

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Andrographis paniculata WHO Monographs on Selected Medicinal Plants Volume 2

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