WO1997023234A1 - Procede de traitement par balanites aegyptiaca - Google Patents

Procede de traitement par balanites aegyptiaca Download PDF

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Publication number
WO1997023234A1
WO1997023234A1 PCT/SD1995/000001 SD9500001W WO9723234A1 WO 1997023234 A1 WO1997023234 A1 WO 1997023234A1 SD 9500001 W SD9500001 W SD 9500001W WO 9723234 A1 WO9723234 A1 WO 9723234A1
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WIPO (PCT)
Prior art keywords
bark
extract
aqueous extract
days
aegyptiaca
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PCT/SD1995/000001
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English (en)
Inventor
Osman Abd El Moneim Hamid
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National Research Council
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Priority to PCT/SD1995/000001 priority Critical patent/WO1997023234A1/fr
Priority to AU28744/97A priority patent/AU2874497A/en
Publication of WO1997023234A1 publication Critical patent/WO1997023234A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)

Definitions

  • Part I deals with the general introduction about Balanites aegyptiaca including its taxonomy, botanical characters, chemical constituents, medicinal folk uses and economic uses.
  • Part II includes some pharmacological and toxicological tests using B -aegyptiaca bark aqueous extract.
  • the pharmacological tests covered a number of isolated tissues (rabbit intestine, rabbit aortic strip, rat uterus, rat stomach strip, rat phrenic-nerve diaphragm preparation and perfused rabbit heart). Experiments using experimentally jaundiced rats were also carried out. Toxicity studies covered acute toxicity, lethal dose 50 and subchronic toxicity. Part lit deals with the clinical results showing the effectiveness of Balanites aegyptiaca aqueous extract (15% w/v) in treatment of infective hepatitis in adult Sudanese patients following treatment with 30 ml 3 times daily for 3 days .
  • Balanites aegyptiaca (L.) Del is one of the very useful trees in the Sudan. Various parts of the tree are pondered locally to exhibit economical importance and medicinal folkloric uses .
  • the species & family The species & family :
  • Balanites aegyptiaca (L.) Del. is the only species of the genus Balanites present in the Sudan (Andrews 1952).
  • the genus Balanites was placed in different families by various taxonomists, but recently it is recognized by Takhtajan (1969), due to its peculiarity, as the only genus in the family Balanitaceae. According to him, the classification of the family is as follows :
  • B. aegyptiaca is a large savanna tree widely distributed throughout Afrcia, a long the tropical belt from Africa in the East to Ivory Coast in the West. It is also found in the relatively drier regions of Northern Africa from Moritania to Nigeria and Ghana, to Egypt, across furniture, Saudi Arabia and India. The drier regions of Kenya, Kenya and Zaire, carry scattered open forests of B. aegyptiaca (Suliman & Jackson (1959) . In the Sudan the tree is widespread throughout the Northern and Central provinces (Wickens 1976) . Habitat :
  • the tree is common in the low Rainfall Savanna and semi-desert vegetational types (Harrison & Jackson 1958) . It grows in various soil types such as clay, dark cracking caly, sand, hard-surfaced sandy clay, etc.. It flourishes in habitats of clay soils receiving 500-1000 mm of annual rainfall as well as on sandy clay soil where rainfall exceeds 250 mm annually. However, the most luxurious Balanites forests are typically found on slightly elevated dark cracking clay under a rainfall of 500 mm and upwards annually .
  • Taxonomic desription
  • Bark rough, grey to dark brown; scales long, thick, prominent, ragged; fissures long, deep, vertical; slash pale yellow .
  • Branches & Branchlets green or greyish, stiff and brittle, drooping .
  • Leaves palmately compound, two-foliate, alternate, 2.8 -5.0 cm long, stipules absent .
  • Leaflets 2, subsessile; lamina variable : broadly elliptic, spathulate, obovate to orbicular- rhomboid; 2.5 -5.0 x1. 2-2.5 cm.
  • Petals 5
  • free, imbricate 7-10 x2-3 mm., glabrous on both surfaces .
  • drupe stone-fruit
  • oval pear-shaped, up to 5.0 ⁇ 2.5 cm. green turning yellow or brown
  • epicarp outer part, leathery, smooth or wrinkled .
  • mesocarp middle part, yellow-brown sticky flesh, oily, gummy with bittersweet taste .
  • endocarp inner part, hard-pointed, woody and surrounds the kernel .
  • Seeds ovoid, testa sub-fibrous, non-endospermic .
  • B. aegyptiaca has a high regeneration power. Regeneration is usually by seeds (Suliman & Jackson 1959) though it is a good coppicer as its cut stems profusely coppice. Its roots when exposed or injured produce aerial shoots developing into daughter plants (Amalraj 1987). The tree regenerates readily after lopping or heavily browsing, although finally acquiring adwarf bush growth form (von Maydell 1986) .
  • B. aegyptiaca propagates mainly by direct seeding, but also by root suckers and cuttings.
  • a mature tree may yield about 10,000 fruits per year. First fruit yields may be expected after 5 to 8 years. The tree can attain an age of more than 100 years (von Maydell 1986) .
  • Evergreen tree can be deciduous or partially deciduous in low rainfall areas or in the dry seasons.
  • the species is both self-and cross-compatible.
  • Cross pollination is mainly by flies and bees .
  • the fruits which are indehiscent and edible, specially the sticky mesocarp, are widely dispersed by animals, human beings & birds.
  • the endocarps are indigestible and thus will pass the intestinal tracts of the animals without losing their viability .
  • the alcoholic extract of the pulp and kernel contained sterols, terpenes and saponins as predominant compounds where as tannins, alkaloids and resins were found in slightly small amounts (Abdel Rahim et al, 1986).
  • Five saponins were isolated from the pulp and named as Balanitisins A,B,C,D and E. (Varshney et al, 1977, Varshney and Jain, 1979).
  • Two other Saponins named as Balanitisins F and G were isolated from the kernel (Varshney and Vyas, 1982).
  • the total saponin content was found to be 7.2% in the mesocarp and 6.7% in the kernel (Watt and Breyer-Brandwijk, 1962).
  • the oil extracted from the kernel constituted 44-51% w/w and is composed mainly of triglycerides and with small quantities of diglycerides, phytosterols, sterolesters and tocopherols.
  • the oil contains palmitic acid 10-12% stearic acid 9-10%, oleic acid 30-40% and linoleic acid 40-48% w/w (Abu-Al-Futuh, 1983) .
  • Leaf six flavonoid glycosides identified as quercetin 3-glucoside, quercetin 3- rutinoside, 3,7, digluscoside and 3-rhamnogalactoside of isorhamnetin, were isolated from the leaves and branches of the plant (Maksoud and El-Hadidi, 1988) .
  • Stem bark Three saponins (Yamogenin mucleus) known as Balanitisins 1, 2 and 3 were isolated from the East African specimen of B .aegyptiaca (Liu and Nakanishi, 1982).
  • Balanitisin 1 was isolated rom the stem wood of the Indian specimen (Varshney and Vyas, 1982) .
  • Balanitisins 1,2 and 3 were isolated from the East African specimen (Liu and nakanishi, 1982) and the presence of alkaloids was reported in the root bark (ElKhier, 1987) .
  • Balanitisin H was isolated from the root wood of the plant (Varshney and
  • anthelmintic purgative, boils, leucoderma, herpes, vermifuge, malaria, emetic, wounds, syphilis, colds, liver and spleen problems, aches and febrifuge.
  • stomachaches stomachaches, mental diseases, epilepsy, yellow fever, syphilis, jaundice, fumigant to heal circumcision wounds.
  • B.aegyptiaca F. Balanitaceae
  • Heglig Arabic
  • Thorn tree or Desert date English
  • the Indian tree B.roxburghii is regarded as identical to B.aegyptiaca (Hardman, 1969).
  • the tree has many folk uses in various African countries.
  • the fruit is used as fumigatory in liver diseases in Chad (Croach, 1962; Watt and Breyers-Brandwijk, 1962), and as a purgative and sucked by schools children as a confectionery in Sudan (Abu-El-Futuh, 1983).
  • the bark is used in treatment of syphillis, round worm infections and as a fish poison (Bailey, 1962).
  • the root, bark, seed kernel, fruit and branch were lethal to snails, miracidia and cercariae of schistosomes (Archibald, 1933; Watt and Breyers-Brandwijk, 1962; Bashir et al, 1984).
  • aqueous extract and saponins isolated from kernel cakes have a potent larvicidal activity (Sarroug et al., 1988) and anti-bacterial activity (Bashir et al., 1984).
  • Bashir et al., 1984 the aqueous extract of the bark is widely used as anti-jaundice.
  • the bark of B.aegyptiaca was removed, air-dried in shade, coarsely powdered and kept in air-tied containers.
  • the powder (15,30,60 g) was added to 100 ml distilled water in a 500 ml-beaker.
  • the content was boiled for 20 minutes (min), and allowed to cool, filtered through a cotton wool and refiltered using a Whatman filter paper.
  • the filterate was adjusted to 100 ml by adding distilled water. This filterate was freshly prepared everyday before experimentation .
  • the filterates were freeze-dried and the dried substance was kept in desicators. The aqueous solution of this dried substance was prepared immediately before experiments .
  • a number of isolated tissues were prepared as described by Kithchen (1984). The tissues were suspended in their corresponding physiological solutions ie, Tyrode's, Kreb's, Dejalon's or Ringer-Lock's solutions .
  • the isotonic contractions of the above tissues were recorded using T3 isotonic transducer (Bioscience, Sheerness, England) connected to MD2 Washington recorder (Bioscience) or Harvard istonic transducer (Harvard,, Kent, Englant) coupled to Harvard Universal Oscillograph (Harvard). The isometric contractions were registered using UFI isometric transducer (Bioscience) connected to MD 2 Washington recorder .
  • the 15% (w/v) aqueous extract was added (1-2 ml) to the above suspended tissues.
  • the freeze dried substance was prepared as described before and added to the isolated tissues .
  • Groups 1,2 and 3 were injected (i.p) daily for 3 days with 8 ml/kg B.W. of the aqueous bark extract of strength 15,30 and 60% (w/v), respectively.
  • Group 4 served as a control and injected similarly with distilled water (i.p) .
  • blood samples (5 ml) were taken by cardiac puncture from each rat .
  • the blood was allowed to clot and the serum was aspirated for determination of bilirubin using diazo reaction as described by Malloy and Evelyn (1937).
  • the azobilirubin produced, was measured spectrophotometrically at 540 nm.
  • the serum bilirubin content was read directly-after necessary dilution with distilled water-against standard bilirubin curve (0.I-I.6 mg/100 ml) .
  • groups 1 -3 were fed with 0.25, 0.5 and 1.0 ml of the 15% (w/v) aqueous plant extract respectively.
  • Group 4 was fed with 1.0 ml of the 30% (w/v) aqueous extract, while groups 5 and 6 were fed with 1.0 and 2.0 ml of the 60% (w/v) aqueous extract, respectively.
  • Groups 7 -10 saved as a control and fed with distilled water 0.25, 0.5, 1.0 and 2.0 ml/animal, respectively .
  • Group 1 saved as a control and fed orally with distilled water (10 ml/kg B.W.).
  • Groups 2,3 and 4 were fed orally with 65,325 and 1625 mg of the freeze-dried substance of the aqueous bark extract/kg B.W. respectively.
  • Dosing of animals in all groups was continued daily for 3 weeks.
  • a blood sample (2.0 ml) was taken from the orbital sinus at day 0 (before dosing), day 8, day 15 and day 22 of experimentation. The blood sample was immediately divided into two portions. One portion was used for haematological examinations i.e.
  • haemoglobin estimation Hb
  • packed cell volume PCV
  • WBC white blood cell count
  • RBC red blood cell count
  • the second portion of blood was centrifuged to separate plasma.
  • the total protein content g/100 ml
  • albumin g/100 ml
  • urea mg/100 ml
  • glutamate-oxaloacetate transaminase GAT U/L
  • GPT u/L glutamate-pyruvate transaminase
  • Group 1 fed with the normal Chick diet (Control group).
  • Groups 2 and 3 were fed with 2 and 10 (w/v) mixture of the powdered bark with the normal Chick diet, respectively.
  • Group 4 fed orally with the ethanolic bark extract (500 mg/kg) prepared as described before.
  • Groups 5 and 6 were injected with the ethanolic extract 50 mg/kg B.W. (i.p) and 10 mg/ kg B.W. (i.m), respectively .
  • Chicks were continued daily for 4 weeks (toxicity period) . Birds were allowed to recover for 3 weeks (recovery period). Chicks were weekly weighed and lots of 4 birds in each group were slaughtered at week 2, 4 and 7 and of treatment. Blood samples were collected for haematology and serology while the vital organs were grossly examined. The blood cellular elements, and serum constituents were determined as mentioned before ;
  • the pH of this extract was 5.50 .
  • Table 2 depicts the different values of serum bilirubin and the percentage decreases obtained following the different treatments.
  • haematological parameters (Hb, WBC, RBC, PCV) were similar in the control and treated rats. Also the plasma level of total protein, albumin, urea, GOT and GPT were similar to the control rats (Table 3).
  • Chicks fed orally with the bark powder-diet mixture (2 and 10%) showed no pathological changes and the blood cellular elements and serum constituents (GOT, total protein, albumin, globulin, bilirubin, uric acid, phosphorus and calcium) did not differ from the control (Table 4) .
  • the Chicks dosed orally with the ethanolic extract showed signs of liver toxicity (fatty vacuoles, dilated and congested sinusoid) without any significant lesions in other organs.
  • Injection of the ethanolic extracts to Chicks (50 mg/kg i.p and 10 mg/kg i.m) showed both haematoma in the liver and adhesion between abdominal and thoracic organs. There were no significant changes in the constituents of serum taken from Chicks in all groups . 4. Discussion
  • the aqueous extract of B.aegyptiaca bark did not affect the activity of the isolated tissues tested.
  • the freeze-drid substance prepared from the bark aqueous extract was also without any effect on these isolated tissues.
  • larger doses of the substance lowered significantly the contractility and the heart rate of isolated rabbit perfused heart.
  • saponins from B.roxburghii regarded by Hardman (1969) as identical to B.eagyptiaca, had no effect on the cardiovascular system of the dog (Banerji et al., 1981) .
  • the bark aqueous extracts decreased the serum bilirubin concentration of bile duct-ligated rats in a dose dependant manner. This effect was not shown in non bile duct-ligated Chicks fed with the powdered bark .
  • a rapid acute toxicity test in rats was carried out using the freeze-dried bark aqueous extract.
  • the bark like fruits of the plant, contains saponins (Archibald, 1933; Watt and Breyers-Brandwijk, 1962; Bashir et al., 1984).
  • mice orally (5440 mg freeze-dried extract/kg), i.p (1320 mg freezedried extract/kg) were 83.7 and 20.3 times greater than the dose used in Sudanese folk medicine to treat jaundice (65 mg freeze-dried extract/kg; Personel observation) .
  • the oral administration of he freeze-dried substance prepared from the bark aqueous extract to rats for 3 weeks was without any significant effect in blood cellular elements or plasma constituents, although doses used were 1 to 25 times greater than the dose used in Sudanese folk medicine to treat jaundice.
  • the extracts did not induce any teratogonic effects in new born pups .
  • Addition of the powdered bark to chick diet for 4 weeks was without effects on body weight gain, blood cellular elements or serum constituents.
  • the ethanolic extract of the powdered bark when orally administered showed signs of liver toxicity.
  • infective hepatitis The condition of infective hepatitis is endemic in the Sudan occuring mainly in sporadic form. It is usually much more severe in the adult than the child .
  • the virus is present in the blood foeces in cases in which it has been demonstrated during both the incubation period and the acute incubation phase of the disease, a carrier state may persist for some months .
  • the patients of the control group started to show improvement in the tenth day to the third week.
  • the mortality rate was 2% and the total remedy of others was delayed
  • Flavonoids ol Balanites aegyptiaca from Egypt. Plant Syst. Evol. 160, 153 -158 .

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Abstract

On a mis en évidence l'efficacité d'un extrait aqueux de l'écorce de Balanites aegyptiaca dans le traitement à la fois de l'ictère obstructif expérimental du rat et de l'hépatite infectieuse chez l'homme. On a également mis en évidence le caractère peu nocif de cet extrait aqueux. L'administration par voie intrapéritonéale de l'extrait aqueux (15 à 60 % poids/volume) à des rats aux canaux biliaires liés (c'est-à-dire des rats atteints d'ictère obstructif provoqué à des fins d'expérience), cette administration étant effectuée sur trois jours et en doses allant de 1,2 à 4,8 g d'écorce par kilo et par jour (l'équivalent de 4,91 à 29,64 mg d'extrait aqueux lyophilisé par kilo), a entraîné une réduction sensible, allant de 22 à 45,9 %, de la concentration de bilirubine dans le sang. Les valeurs de la LD50 chez les souris étaient les suivantes: 33 g d'écorce (= 1320 mg de l'extrait aqueux lyophilisé (E.A.L.)) par kilo en administration par voie intrapéritonéale; et 136 g d'écorce (= 5440 mg de l'extrait aqueux lyophilisé) par kilo en administration par voie orale. Le traitement par voie orale des rats à l'aide de 65 à 1625 mg d'E.A.L. par kilo et par jour n'a entraîné aucune variation significative des paramètres hématologiques, des différents constituants du sang, de l'activité locomotrice, du comportement ou de la respiration, car il n'a eu aucun effet au niveau des organes vitaux tels que le coeur, les poumons, les reins, la rate, le foie et le tube digestif. Aucune tératogénicité n'a été détectée chez les rats. De même, l'adjonction d'écorce pulvérulente à raison de 2 à 10 % aux aliments quotidiens habituels de poussins n'a provoqué aucune variation significative des constituants et éléments cellulaires du sang. Le traitement de 242 malades atteints d'hépatite infectieuse à l'aide de l'extrait aqueux (15 % poids/volume) en doses de 30 ml trois fois par jour pendant trois jours a eu les résultats suivants: 82 % des malades, n'ayant plus de bile dans les urines au cinquième jour, étaient complètement guéris; l'état de 11 % des malades s'est amélioré après dix jours; l'état de 6 % s'est amélioré après quinze jours; et 1 % sont décédés. Les malades ont très bien toléré le traitement et n'ont souffert d'aucun effet secondaire ni d'aucune complication.
PCT/SD1995/000001 1995-12-23 1995-12-23 Procede de traitement par balanites aegyptiaca WO1997023234A1 (fr)

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PCT/SD1995/000001 WO1997023234A1 (fr) 1995-12-23 1995-12-23 Procede de traitement par balanites aegyptiaca
AU28744/97A AU2874497A (en) 1995-12-23 1995-12-23 Balanites aegyptiaca method of treatment

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049306A1 (fr) * 1999-12-22 2001-07-12 Hamid Osman A Monieum Extraits de balanites aegyptiaca pour le traitement du vih/sida et de la leucemie
WO2010146294A1 (fr) 2009-06-17 2010-12-23 Ephyla Extrait de végétal pour la fabrication de composition de contrôle de la mélanogénèse, composition de contrôle obtenue et procédé de contrôle mettant en œuvre une telle composition
JP2015513560A (ja) * 2012-03-15 2015-05-14 ピエール、ファブレ、デルモ‐コスメティークPierre Fabredermo−Cosmetique 毛髪強度を向上させるためのバラニテス属仁の抽出物の化粧料使用
WO2019221645A3 (fr) * 2019-03-27 2022-03-03 ABDELWAHAB, Hyder Effet de balanitis aegyptiaca sur la régression de la fibrose hépatique et de la cirrhose

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GUNNAR SAMUELSON ET AL.: "INVENTORY OF PLANTS USED IN TRADITIONAL MEDICINE IN SOMALIA.", JOURNAL OF ETHNOPHARMACOLOGY, vol. 35, no. 1, October 1991 (1991-10-01), pages 25 - 63, XP000576001 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049306A1 (fr) * 1999-12-22 2001-07-12 Hamid Osman A Monieum Extraits de balanites aegyptiaca pour le traitement du vih/sida et de la leucemie
WO2010146294A1 (fr) 2009-06-17 2010-12-23 Ephyla Extrait de végétal pour la fabrication de composition de contrôle de la mélanogénèse, composition de contrôle obtenue et procédé de contrôle mettant en œuvre une telle composition
FR2946886A1 (fr) * 2009-06-17 2010-12-24 Ephyla Extrait de vegetal pour la fabrication de composition de controle de la melanogenese,composition de controle obtenue et procede de controle mettant en oeuvre une telle composition
JP2015513560A (ja) * 2012-03-15 2015-05-14 ピエール、ファブレ、デルモ‐コスメティークPierre Fabredermo−Cosmetique 毛髪強度を向上させるためのバラニテス属仁の抽出物の化粧料使用
WO2019221645A3 (fr) * 2019-03-27 2022-03-03 ABDELWAHAB, Hyder Effet de balanitis aegyptiaca sur la régression de la fibrose hépatique et de la cirrhose

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