| الملخص | Abstract
This work has been carried out to develop national drug product contains
(70%) garlic extract as solution, it is used to treat hair loss and alopecia areata and remove dandruff.
Several formulations were prepared using different solutions bases, preservatives and humectants . Selection of best formula relied solely on physicochemical testing of sample exposed to thermal stresses.
Stability study was conducted on the product for 6 months at different temperatures to determine the expiration date and the best storage conditions.
From the study we obtained solution of good clarity.
The expiry date calculated to be not less than (2) years.
Keywords: garlic extract, solution, Hair loss, alopecia, dandruff .
Introduction
Hair loss is a common experienced by more than ( 50%) of people in the world , it is normal and it is not a disease, but become problem when person loses large amounts during washing , and result in hair loss for many reasons which may be linked to hormonal changes such as when menopausal women or polycystic ovary syndrome. Problems in the thyroid gland in the form of an increase or a lack of secretion of thyroid hormone, and this is why usually show signs and other symptoms with hair loss may be due to the side effects of certain drugs, including chemical-based medicines to treat cancer or reduced immunosuppressive medication or valporic acid. There are also genetic factors and sometimes linked with age may cause the appearance of baldness. Either some other times it may be due to alopecia areata and happen when the immune system attacks healthy body hair vs. baldness most often not be permanent. Ring worm and is one of the types of fungi that attack the scalp . Sometimes some layoffs may stimulate hair loss, also stress may stimulate hair loss. With the rise in bacterial resistance to antibiotics, there is considerable interest in the development of other classes of antimicrobials for the control of infection. Garlic (Allium sativum Linn.) has been used as medicine since ancient times and has long been known to have antibacterial, antifungal, and antiviral properties[1].
Allium is a genus of some ( 500 ) species belonging to the family Liliaceae. However only a few of these are important as food plants, notably onion, garlic, chive, leek, and rakkyo[2,3] .
Garlic contains about 1% Alliin (S-allylcysteine sulfoxide), which converts
to allicin (diallyl disulfide-oxide) in the presence of the enzyme alliinase[4].
Garlic extract solution is a generic drug not manufactured in the Iraqi factories; therefore, the aim of study is a necessity to have an Iraqi formula for this dosage form with its stability study compatible with specifications of British pharmacopeia. This study is considered one of the important documents for the purposes of registration in the ministry of health.
The formula contains garlic extract solution (70% v/v) as active ingredient.
Materials and methods :
Several formulations with different solution bases were prepared .
The formula contains: propylene glycol, preservative, odour and distilled water as inactive ingredients.
Preparation of garlic extract liquid :
Take ( 500 g) of garlic then crush with homogenizer, then put it in glass jar and fill it with one liter of distilled water, mix, then leave it standing for ten days , shake the occasionally,then filter with filter paper (18.5 cm) ,and pour into galss bottle.
Preparation of solution :
In Pyrex beaker transfer propylene glycol then heat in water bath to( 50°C) , dissolve methyl parabin and propyle parabin in it , then mix with stirrering for (15 min), mix garlic extract liquid ( 70%) with the above mixture , add the peach flavor , pineapple flavor, erythrocin and sunset yellow with mixing for (15 min), check the pH should be between ( 4 – 5.5 ) , fill in (100 ml) plastic container.
Stability study:
Stability study was conducted on the product for( six )months at different temperatures (room temperature,40,50,60 ) °C to determine the expiration date and the best storage conditions.
Method of analysis
Garlic extract solution contains alliin and allicin were measured by high pressure liquid chromatography apparatus ( HPLC) with (UV) detection at (210nm), that is special method in the laboratories of the Ministry of Science and Technology.
Results and discussion
In this study, different formulas of solutions were prepared according to the specification of British Pharmacopoeia (2013) and united state pharmacopeia (2012) . A clear orange solution of acceptable consistency was produced and the physicochemical also our formula showed excellent stability at different temperatures (R.T, 40, 50, and 60) °C.
Results of stability studies of the selected formula at different temperatures are presented in tables (2) , (3) and (4).
According to this study, the expiration date has been estimated to be not less than(2) years from the date of manufacturing at room temperature.
Table -2-The physico – chemical changes of garlic extract solution (70%w/w) with time at different temperatures.
Storage time (month) Temp.
°C %of garlic extract PH
(4-5.5) Appearance
Zero time R.T 100 5.4 Clear orange solution.
1 RT 100 5.4 = = =
40 99.8 5.4 = = =
50 99.7 5.4 = = =
60 99.6 5.4 = = =
2
RT 99.8 5.4 = = =
40 99.7 5.4 = = =
50 99.6 5.4 = = =
60 99.5 5.35 = = =
3
RT 99.7 5.4 = = =
40 99.54 5.4 = = =
50 99.4 5.35 = = =
60 99.32 5.35 = = =
4
RT 99.67 5.4 = = =
40 99.52 5.4 Deep orange solution
50 99.37 5.35 = = =
60 99.30 5.3 = = =
5
RT 99.62 5.4 Clear orange solution
40 99.49 5.4 Clear deep orange solution
50 99.35 5.35 = = =
60 99.25 5.3 = = =
6
RT 99.47 5.4 Clear orange solution
40 99.33 5.4 Clear deep orange solution
50 99.03 5.35 = = =
60 99.00 5.3 = = =
Table - 3 -The stability of garlic extract solution , concentration of garlic extract at zero time =100 % of the label amount
Concentration at
60C° % Concentration at 50C° % Concentration at
40C° % Concentration at
R.T C° % Time /day
99.6 99.7 99.8 100 30
99.5 99.6 99.7 99.8 60
99.32 99.4 99.54 99.7 90
99.30 99.37 99.52 99.67 120
99.25 99.35 99.49 99.62 150
99.00 99.03 99.33 99.47 180
Regarding the expiry date of the prepared formula we followed the Zero – order rate of reaction that is expected for kinetic garlic extract solution particularly in the first stage of reduction of concentration.
T90%=0.1C/K
Where:
C=concentration at zero time
K= rate of reaction
T= time
Table -4- The 90% at different temperature.
T90%Year T90%day Temp.
3.2 1168 R.T C°
2.8 1022 40 C°
2.4 872 50 C°
1.5 547 60 C°
Figure -1- chromatogram of alliin and allicin standard
Figure -2- chromatogram of alliin and allicin in Iraqi garlic extract
References
1-Sunaina Shetty, An in-vitro evaluation of the efficacy of garlic extract as an antimicrobial agent on periodontal pathogens: A microbiological study,an international quarterly journal of research in ayurveda, Ayu. 2013 Oct-Dec; 34(4): 445–451.
2-Eman Mohammed , Determination of Active Ingredients ( Alliin & Allicin) in Different species of Garlic Extracts By Using High Performance Liquid Chromatography,diyala journal for pure science,vol : 9 NO: 2 ,May 2013, page 70 - 81.
3-Fenwick G.R. and Hanley A.B., Crit. Rev. The genus Allium ,Part 2, Food Sci. Nutr.,22(4) (1985), 273-7.
4-Amagase H. and Petesch B.L., J. Nutr., 131(3S) (2001), 955S-62S.
5Agarwal, C.K. Therapeutic Actions of Garlic Constituents. Medicinal Research Reviews, 1996. (16), 111‐124.
6-Kim Huynh,(2009),Accelerating aging, Handbook of stability testing in pharmaceutical development,springer ,USA .
7-The British Pharmacopoeia ,The Pharmaceutical Press, London,UK,2013.
8-United state Pharmacopoeia press, 2012, U.S.P 35, U.S.A. | en_US |
