Abstract

Background & Objective: The aim of present study was to evaluate herbal analgesic cream containing Nigella sativa oil as an active ingredient, standardization of Nigella sativa oil and evaluation of irritation/sensitization potential of formulation.
 Material & Method: For this, HPLC analysis of oil, skin irritation test on rabbits and patch testing on human skin was conducted. HPLC analysis using C-18 column, using an isocratic mobile phase of water: methanol (10:90) at flow rate of 1 ml/inactive ingredient: thymoquinone purified from the oil was found to be 1.42g (28.4 %). Safety assessment of analgesic cream was based on Primary Dermal Irritation Index (PDII) by Draize method.
 Result: According to Draize standard scoring system of reactions PDII was found 0.04 which comes under the category of non irritant. Patch testing on human volunteers revealed that none of volunteers showed any sign of skin reactions.
 Bangladesh Journal of Medical Science Vol.19(1) 2020 p.163-168

Highlights

  • Nigella sativa, belonging to botanical family; Ranunculaceae, used as medicinal plant

  • In present work Nigella sativa oil has been used in cream formulation that is locally used for the treatment of muscular pain, inflammatory conditions, to relieve headache, neuralgic, rheumatic and other allied pains. This herbal analgesic cream is recommended in conditions like allergies, eruptions, swellings, warts and insect bite etc

  • The oil extracted from Nigella sativa seeds used as active ingredient in this formulation was standardized for its thymoquinone content by the method of Ghosheh,1999 i.e. first by extraction from oil and by using column chromatography followed by HPLC

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Summary

Introduction

Nigella sativa, belonging to botanical family; Ranunculaceae, used as medicinal plant. Standardadization and skin irritation potential of herbal analgesic cream containing Nigella sativa seed oil when given orally. Preparation of sample.[10] ml of methanol was added to 5 g of oil extracted from Nigella sativa seeds in a 25 ml flask. The emulsifier (stearic acid) and oil soluble components (cetyl alcohol, Nigella sativa oil) were dissolved and heated up to 70+5C(Part A).At the same time the aqueous phase containing water soluble components like methyl paraban, propyl paraban,propylene glycol (Part B) was heated up Tehmina Sohail, Shazia yasmeen, Hina Imran, Sadia Ferheen, Atiq-u-Rehman, Rashid Ali Khan. After 4 hours, the test and control material was removed and 1hour later the sites were examined for signs of erythema and edema at 1, 24, 48 and 72 hours according to scoring criteria for skin reactions (table 2)

Total possible score for primary irritation
Results and Discussion
Test value
Cream Base
Full Text
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