Elaeagnus angustifolia L. Flowers soft extract valorification in a dermatological preparation note development of dermatological preparation and preliminary quality control




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FARMACIA, 2008, Vol.LVI, 2



ELAEAGNUS ANGUSTIFOLIA L. FLOWERS SOFT EXTRACT VALORIFICATION IN A DERMATOLOGICAL PREPARATION

NOTE 1. DEVELOPMENT OF DERMATOLOGICAL PREPARATION AND PRELIMINARY QUALITY CONTROL
LAURA BUCUR1, VICTORIA HÎRJĂU2, VIORICA ISTUDOR2

1„Ovidius” University Constanta, Faculty of Pharmacy, 2, Nufarului Street, Constanta

2„Carol Davila” University of Medicine and Pharmacy Bucharest, Faculty of Pharmacy, 6, Traian Vuia Street, Bucharest

*corresponding author: adrianabucur@yahoo.com
Abstract

The aim of this research was the valorification of Elaeagnus angustifolia L. flowers soft extract (A2) in a dermatological preparation. There were selected 5 ointment bases wherein blended 3% to 6% soft extract. The obtained preparation preliminary control consists of organoleptic features, homogenity and pH determinations.

The adequate blending Elaeagnus angustifolia L. flowers soft extract ointment bases are the washable ones (emulsion ointments type O/W). They have good cosmetic properties, blend the pursued soft extract quantity (6%) and allow adequate preparations (P2, P3), from the point of view of the pursued parameters.

The study continues with rheologic assays (see note 2).


Rezumat

Scopul acestui studiu a fost valorificarea extractului moale al florilor de Elaeagnus angustifolia L, pentru folosirea sa într-un produs dermatologic. Au fost selectate 5 baze de unguent, în care a fost încorporat extractul moale, în concentraţii de 3-6%. Testele preliminare de control au inclus determinări organoleptice, de omogenitate şi de pH.

Bazele de unguent adecvate acestui tip de extract sunt cele lavabile, de tip emulsie ulei în apă, având proprietăţi cosmetice bune şi capacitatea de a îngloba cantitatea necesară de extract moale de flori (6%).

Studiul de faţă va fi urmat de determinările reologice (nota 2).




  • Elaeagnus angustifolia L.

  • flowers soft extract

  • ointment bases

  • dermatological preparations

  • preliminary quality control



INTRODUCTION

The aim of this research was the valorification of Elaeagnus angustifolia L. flowers soft extract (A2), with 0.90 – 1.703% flavones and 1.066 – 1.496% poliphenols content, in a dermatological preparation. The dermatological preparation is intended to skin-deep diseases, like burns, wounds, rash, etc. because of its antimicrobial [1] and scared properties.

For obtaining the dermatological preparation, the Romanian Pharmacopoeia X-th Edition and European Pharmacopoeia stipulations were consulted for those pharmaceutical forms that consist of an ointment base and one or more active substances solution, emulsion or disperse suspension [2-7].

The ointment bases may be hydrophilic or hydrophobic, emulsion oil/ water (O/W) or water/oil (W/O), anhydrous or hydrous.



MATERIALS AND METHODS

There were selected both hydrophilic and hydrophobic ointment bases, because the flowers soft extract (A2) contains both hydrophilic (flavones, polyphenolcarboxilic acid) and hydrophobic (resins) compounds.

The resins give gummy feature to the flowers soft extract. For this reason, we used washable ointment bases [2, 3], that contain an hydrophobic substance (cetyl-stearyl alcohol) which masks soft extract gummy feature.

The ointment bases are:



  • B1 - emulgator ointment officinal in the Romanian Pharmacopoeia X-th Edition with the following formula: emulgator cetyl-stearyl alcohol 30g, liquid paraffin 35g, salve 35g;

  • B2 - emulgator ointment hydrated with 60% water [8];

  • B3 - anionic base (emulsion ointment O/W type) with the following formula: natrium laurilsulfat 1 g, cetyl-stearyl alcohol 15 g, glycerin 15 g, nypagin 0,1 g and water 68,9 g [2].

For comparative study there were selected two other bases:

  • B4 – from gels group, carbopol gel 1% with the following formula: carbopol 940 1 g, glycerin 3 g, natrium hydroxide solution 10% 3 g, preservative solution 93 g; although it has a small blending capacity (until 2%) this gel may develop this property if added 10% per emulgators [9];

  • B5 - from suction ointments group, simple ointment, officinal in the Romanian Pharmacopoeia X-th Edition, with the following formula: lanoline 10 g, salve 90 g, with high capacity of blending water or aqueous solution.

The hydrophobic bases do not blend water or aqueous solution so well. For this reason we excepted it from the studied bases group.

The bases preparation was made according to following protocol:



  • emulgator ointment (B1) - running the compounds on water pan and shaking it until homogenizing and chill;

  • emulgator ointment hydrated (B2) - 40 g emulgator ointment ran in water pan at 600C; we added 60 g warm water (at the same temperature) and shaked it until homogenizing and chill;

  • anionic base (B3) - natrium laurilsulfat dissolved in warm water; glycerin and nypagin were added and this solution was shaked slowly with cetyl-stearyl alcohol to solidification;

  • carbopol gel 1% (B4) - carbopol 940 moistened with glycerin was dispersed in preservative solution by dashing shake. We added natrium hydroxide solution 10% for neutralization of carbopol acidic groups. The dispersion was gelified at pH 6,5;

  • simple ointment (B5) - lanoline and salve were ran in a pot on water pan at 600C; when the compounds became fluid, the mixture was shaken to solidification.

The flowers soft extract was blended at cold in small sample ointment bases of 10 g. We used 3% to 6% concentrations of flowers soft extract. Initially we evaluated the aspect and the consistence of the preparations.

The ointments containing flowers soft extract need the blending at cold temperature lower than 400C, for protecting the phytocomplex and avoiding compounds degradation. The soft extract blending in ointment bases protocol is in agreement with the process of cold maceration and solvent evaporation at temperatures lower than 400C and under vacuum. The ointments were termed P1 – P5.

The preliminary control [3, 9] consists of:

- aspect evaluation: performed macroscopically, with the naked eye. According to the Romanian Pharmacopoeia X-th Edition and European Pharmacopoeia, the ointments must be homogenous and adherent to the skin. The consistence at temperature between 20-370C must have limits which assure the ointment physical stability, its application and adherention to the skin;

- smell assay: On the hand skin, the ointments must present the substances formula smell. It mustn’t present rancid or fusty smell. Colours and flavours addition is accepted only with the Health Department permission.

- homogenity evaluation (Romanian Pharmacopoeia X-th Edition): the ointments spread in thin layer on microscopic lame and examined with magnifying (4.5x) glass must have a homogenous aspect, without particles or drops jam.

- pH determination: 5 g ointment was ran on water pan. 20 ml hot water were added and strongly shaken for 1 minute. The pH of the obtained solution was determined [3].

This preliminary control was effectuated immediately after preparation and 45 days later.


RESULTS AND DISCUSSION

The obtained ointment bases have the following features:



  • B1, B2, B3 - homogenous, semisolid, white, with characteristic smell;

  • B4 - homogenous, translucent, colourless;

  • B5 - homogenous, oily, semisolid, white-yellowish, with characteristic smell.

The washable ointment bases, B1, B2, B3, tolerate soft extract blending until 6%.

The preparation P1 has a solid consistence and a non-homogenous aspect. The preparations P2 and P3 have an adequate semisolid consistence and are homogenous.

For obtaining the gel, the testing stopped at 3% soft extract concentration in B4. At this concentration the preparation has an adequate consistence and agreeable, transparence aspect (P4), but is non-homogenous. Using higher concentrations of soft extract we obtained an inadequate fluid preparation.

Soft extract blending in B5 is impossible because the phases separate. Dissolving the soft extract in ethanol 40% (solvent used for soft extract preparation) and blending it in B5, we obtained an inadequate fluid and non-homogenous preparation (P5).

The pH for all preparations correspond to the Romanian Pharmacopoeia X-th Edition stipulations which provide that ointments must have the pH between 4.5-8.5. The results of preliminary quality control are presented in table I.

This preliminary observation were similar 45 days after preparation.


CONCLUSIONS

The adequate blending Elaeagnus angustifolia L. flowers soft extract ointment bases are the washable ones (emulsion ointments type O/W). These have good cosmetic properties, blend the pursued soft extract quantity (6%) and determine adequate preparations (P2, P3).

The study continues with the rheologic control (see note 2).
Table I

The preliminary quality control results for preparations containing 3-6% soft extract in selected ointment bases




OINTMENT BASES


PREPA-RATION

CONSISTENCE AND ORGANOLEPTIC FEATURES


HOMOGE-NITY


pH

WASHBLE BASES


P1



solid consistence, brown color, specific, aromatic smell

non-homogenous


6

P2


semisolid consistence, brown color, specific, aromatic smell

homogeneous


6

P3


semisolid consistence, brown color, specific, aromatic smell

homogeneous


5.5

GELS

P4



semisolid consistence, brown color, transparency, specific, aromatic smell

non-homogenous


5.5


OILY BASES

P5



fluid consistence, brown color, specific, aromatic smell

non-homogenous


5.5



REFERENCES

  1. Bucur L., Badea V., Istudor V. - Antibacterial activity for two soft extracts of Elaeagnus angustifolia L. Archives of the Balkan Medical Union, 2006, 41 (3), 127-131

  2. Leucuţa S. – Tehnologie farmaceutică industrială, Editura Dacia, Cluj-Napoca, 2001, p. 48-58, 513-538.

  3. *** Farmacopeea Română Ediţia a X-a, Editura Medicală, Bucureşti, 1993, p. 951-952

  4. *** European Pharmacopoeia – Third Edition 1997 and Supplement 2001, Council of Europe, 67075 Strasbourg Cedex, France – 2000, p. 1664

  5. Fica C. – Îndreptar practic pentru prepararea medicamentelor, Editura Medicală, Bucureşti, 1983, p. 305-327, 347

  6. Motocescu R., Lupuleasa D. – Tehnică farmaceutică - Lucrări practice, Company Tehnoplast SRL, Bucureşti, 1987, p. 87-90

  7. Martini M.C. – Formes pharmaceutiques pour application locale, Ed. Technique et Documentation, Paris, 1996.

  8. Popovici A. – Unguente farmaceutice, Editura Medicală, 1975, p. 123-131

  9. Gafiţeanu E., Popovici I., Braha S., Matei I., Cojocaru I. – Tehnologie farmaceutică, Lucrări practice, Iaşi, 1996, vol. 3, anul IV, sem. II, ediţia a 3-a, p. 160-170




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