تُشّكل المستحضرات المُنحفة أكثر المستحضرات النباتيّة انتشاراً في العالم و سوريا على حدٍ سواء، و تسوّق على أنها مستحضرات طبيعيّة 100%، يتم الحصول عليها من مصادر مختلفة بدون وصفة طبيّة، و بالتالي تكون في كثير من الحالات غير خاضعة لأي رقابة دوائيّة، مما يجعل منها مشكلة صحيّة و اقتصادية تُهدد بلدان العالم و لا سيما النامية منها التي تفتقر عادةً إلى القوانين الناظمة لبيع و تداول هذه المستحضرات.
تمّ جمع 20 عينة من المستحضرات النباتيّة المُنحفة المنتشرة في السوق المحليّة، حيث قُسمت إلى عينات مُصنّعة محليّاً (8 عينات) و أخرى متواجدة بشكل غير شرعي ( 12 عينة )، أجري اختبار التغليف الخارجي و لصاقة التوسيم Labelling على جميع العينات، ثم فُحصت بتقنيتي الطبقة الرقيقة (Thin layer chromatography TLC) و الكروماتوغرافيا السائلة عالية الأداء (High performance liquid chromatography HPLC) للتأكد من عدم وجود السيبوترامين، إذ استخدم في الـ TLC الميتانول/ تولوين (9:1) كطور متحرك، أما بالـ HPLC استخدم الاسيتونتريل / وقاء فوسفاتي pH=5.5 (30:70) كطور متحرك، العمود BDS Hypersil C18، معدل التدفق 0.5 مل/دقيقة عند طول موجة 225nm، و حجم الحقنة 20 ميكروليتر.
أظهرت النتائج أن جميع العينات المُصنّعة محليّاً مُطابقة للدستور الأميركي USP30 و الـ GMP من حيث الغلاف الخارجي و لصاقة التوسيم و النشرة الداخلية، باستثناء عينة واحدة مُخالفة، أما المتواجدة بشكل غير شرعي، كانت جميع العينات مُطابقة للدستور و الـ GMP باستثناء 6 مخالفة، أما فيما يتعلق بفحص العينات بالـTLC و HPLC فتبيّن وجود السيبوترامين في 3 عينات مُصنّعة محليّاً من أصل 8، و تراوحت كميته بين (8-10) ملغ/الكبسولة، في حين احتوت جميع العينات غير الشرعية على مادة السيبوترامين و تراوحت كميته بين (5-26) ملغ/الكبسولة الواحدة.
Herbal slimming products are one of the most wide spreading herbal products in many countries around the world and in Syria as well, they are often advertised to contain purely natural ingredients. These products are provided by various sources and they are available over the counter, therefore, in most cases, they are not under quality control. Such these quality-uncontrolled products are considered a health and economic issue facing many countries in the world especially undeveloped countries which usually lack for regulation rules governing herbal products trading. In this study, 20 samples have been collected from the herbal slimming products available in the local market. At the beginning, these samples have been divided into locally manufactured samples (8 samples) and illegal samples (12 samples). The packaging and labeling test has been applied to all samples. Later on, these samples have been tested with TLC and HPLC to make sure they are free of Sibutramine, using in TLC Methanol/Toluene (1:9) as a mobile phase, and in HPLC Acetonitrile/phosphate buffer pH=5.5 (70:30) as a mobile phase, column BDS Hypersil C18, flow rate 0.5 ml/min and wavelength 225nm. The results of packaging and labeling test revealed that all of the locally manufactured samples are matching to the American pharmacopoeia USP30 and GMP in terms of packaging, labeling and internal leaf sheets with exception for one sample. As for illegal samples, all of them matched the pharmacopoeia and GMP with exception for 6 samples. With regards to testing the samples using TLC and HPLC, results indicated that 3 samples out of 8 locally manufactured samples contained Sibutramine with amount ranging between (8- 10) mg/capsule, while all illegal samples contained Sibutramine with amount ranging between (5-26) mg/capsule.
References used
Ariburnu, E., Uludag, M., Yalcinkaya, H., Yesilada, E. Comparative determination of Sibutramine as an adulterant in natural slimming products by HPLC and HPTLC densitometry. Journal of pharmaceutical and biomedical analysis, 2012, volume 64(65), 77-81
Bhatia, Lav., Thumar, K., Tanna, R. Determination of adulteration of anti-obesity drug in Indian herbal medicinal product: Development and validation of analytical method. Pharma analysis and Quality Assurance, 2012, Volume 3, 177-182
Chong CSY. Psychosis related to the use of Sibutramine disguised as Over-the-counter herbal weight loss remedies: a report of two patients. East Asian Arch psychiatry, 2010, Volume20, 186-189
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