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Comparison of Dissolution Time of Sodium Ceftriaxone Preparations for Injection and Studying the Factors Affecting it

مقارنة زمن انحلال مستحضرات سفترياكسون الصوديوم المُعدَّة للإعطاء حقناً و دراسة العوامل المؤثرة عليها

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 Publication date 2016
and research's language is العربية
 Created by Shamra Editor




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The aim of this study is to compare the dissolution time of six formulations of paranteralSodium Ceftriaxonepreparation, the original product and five generic local ones. The dissolution time was measured precisely as the point at which the dried powder of Sodium Ceftriaxone preparation became a transparent solution on the addition of physiologicalsolution 0,9% of Sodium Chloride. The dissolution time of the six products were different. The measurement of infrared spectroscopy (FTIR) of different powder preparations was conducted, then the weight, the humidity and the morphology of different medical powders were studied to investigate the factors influencing the dissolution time. The difference in dissolution time between the six products was due to differences in powder characteristics such as water content, crystal shape and dimension. It was shown that one local generic product of Sodium Ceftriaxone islook like the original one.


Artificial intelligence review:
Research summary
تهدف هذه الدراسة إلى مقارنة زمن انحلال ستة مستحضرات من سفترياكسون الصوديوم المعدة للإعطاء حقناً، منها المستحضر الأصلي وخمسة مستحضرات جنيسة محلية الصنع. تم قياس زمن الانحلال بدقة عند النقطة التي تصبح فيها البودرة الدوائية لسفترياكسون الصوديوم محلولاً شفافاً بعد إضافة محلول فيزيولوجي من كلوريد الصوديوم 0.9%. أظهرت النتائج أن زمن الانحلال يختلف بين المستحضرات المدروسة. تم استخدام مطيافية الأشعة تحت الحمراء بتحويل فورييه (FTIR) لتأكيد هوية البودرة الدوائية وعدم تخربها، وكذلك تم دراسة المحتوى المائي للبودرة باستخدام تقنية التجفيف بالأشعة تحت الحمراء. وأخيراً، تمت دراسة أبعاد وأشكال البلورات في البودرة باستخدام المجهر الضوئي. أظهرت الدراسة أن الاختلاف في زمن الانحلال يعود بشكل أساسي إلى اختلافات في خصائص البودرة الدوائية كنسبة الرطوبة والشكل البلوري للجزيئات وأبعادها. وقد استطاع أحد المنتجات الوطنية الجنيسة مجاراة المنتج العالمي في زمن انحلاله والخواص الفيزيوكيميائية المختلفة للبودرة.
Critical review
دراسة نقدية: تعتبر هذه الدراسة خطوة مهمة نحو فهم العوامل المؤثرة على زمن انحلال سفترياكسون الصوديوم، إلا أن هناك بعض النقاط التي يمكن تحسينها. أولاً، كان من الأفضل تضمين عدد أكبر من المستحضرات الجنيسة المحلية لتقديم صورة أشمل عن السوق المحلية. ثانياً، لم يتم التطرق إلى تأثير درجة الحرارة على زمن الانحلال بشكل كافٍ، وهو عامل مهم يجب أخذه في الاعتبار. وأخيراً، كان من الممكن تقديم توصيات أكثر تحديداً حول كيفية تحسين خصائص البودرة الدوائية بناءً على النتائج المستخلصة من الدراسة. على الرغم من هذه النقاط، فإن الدراسة تقدم معلومات قيمة يمكن أن تكون مفيدة في تحسين جودة المستحضرات الدوائية الجنيسة.
Questions related to the research
  1. ما هو الهدف الرئيسي من هذه الدراسة؟

    الهدف الرئيسي من هذه الدراسة هو مقارنة زمن انحلال ستة مستحضرات من سفترياكسون الصوديوم المعدة للإعطاء حقناً ودراسة العوامل المؤثرة عليها.

  2. ما هي التقنيات المستخدمة في الدراسة لتحديد خصائص البودرة الدوائية؟

    تم استخدام مطيافية الأشعة تحت الحمراء بتحويل فورييه (FTIR) لتأكيد هوية البودرة الدوائية وعدم تخربها، وتقنية التجفيف بالأشعة تحت الحمراء لدراسة المحتوى المائي للبودرة، والمجهر الضوئي لدراسة أبعاد وأشكال البلورات.

  3. ما هي العوامل التي تؤثر على زمن انحلال سفترياكسون الصوديوم؟

    العوامل التي تؤثر على زمن انحلال سفترياكسون الصوديوم تشمل نسبة الرطوبة والشكل البلوري للجزيئات وأبعادها.

  4. ما هي النتائج الرئيسية التي توصلت إليها الدراسة؟

    النتائج الرئيسية هي أن زمن الانحلال يختلف بين المستحضرات المدروسة بسبب اختلافات في خصائص البودرة الدوائية، وأن أحد المنتجات الوطنية الجنيسة استطاع مجاراة المنتج العالمي في زمن انحلاله والخواص الفيزيوكيميائية المختلفة للبودرة.


References used
TANGE, M. , HATTORI, Y. , OTSUKA, M. , YOSHIDA, M., HAGINAKA, J. , UCHIDA, T. Comparison of the dissolution rate of Cefteriaxone Sodium preparations for injection. Chem. Pharm. Bull. Vol. 61, Nº 11, 2013, 1121-1129
MANDELL, GL., SANDE, MA. Antimicrobial agents: penicillins, cephalosporins, and other beta-lactam antibiotics. In Gilman AG, (Ed). Goodman and Gilman’s Pharmacological Basis of Therapeutics 8th ed. New York: Pergamon Press 1990 , 1065–1097
Clarke’s Analysis of Drugs and Poisons in pharmaceuticals, body fluids and postmortem material. London, UK, Pharmaceutical Press 2011
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