مراقبة تجانس الوزن والمحتوى لأنصاف مضغوطات الفورسيميد.
Abstract
يعتبر تقسيم المضغوطات عملية شائعة في مجال اعطاء الدواء. ان هدف هذه الدراسة هو دراسة تجانس الوزن والمحتوى لأنصاف مضغوطات الفورسيميد التجارية الحاوية على خط كسر ( 40ملغ). تم الحصول على العينات التجارية من شركتين (A, B) وتم اختيار طبختين من كل شركة. في البداية تم اجراء فحص الهشاشة والقساوة واختبار تجانس الوزن والمحتوى على المضغوطات الكاملة. تمت عملية تقسيم المضغوطات باستخدام قاطعة المضغوطات، اليد، السكين ثم تطبيق اختباري تجانس الوزن والمحتوى عليها. كانت مضغوطات الشركة Aأكثر قساوة من مضغوطات الشركة B وكانت الهشاشة مقبولة في كلتا الشركتين. حققت المضغوطات الكاملة اختباري تجانس الوزن (الانحراف عن المتوسط أقل من 7.5%) والمحتوى (85-115%). نجحت الأنصاف الناتجة عن عملية الكسر بالقاطعة بينما فشلت الانصاف الناتجة عن استعمال السكين في تحقيق المتطلبات الدستورية لاختباري تجانس الوزن والمحتوى. بالنسبة لليد، كانت مضغوطات الشركة (A) صعبة الكسر وفشلت الأنصاف في الشركة ((B في تحقيق الاختبارين. The aim of this study was to check the weight and content uniformity of scored commercial furosemide half-tablets (40 mg). Two batches were selected for two companies (A, B). Firstly the whole tablets were tested for hardness, friability, weight and content uniformity. Tablet splitter, hand, and knife were used to split tablets. Weight variation and drug content of furosemide half tablets were evaluated according to the British Pharmacopoeia tests. Tablets from company (A) were more hard than tablets from company (B). The friability of the two companies had accepted values. The whole-tablets passed the weight and content tests. Using tablet splitter, the Tablets halves passed weight and content uniformity tests whereas those using knife didn’t pass. Using hand, tablets from company (A) were hard to break and halves from company (B) didn’t pass the tests.Downloads
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