五種口服心血管學名藥品之品質評估

A Study on the Pharmaceutical Quality of Five Kinds of Oral Cardiovascular Products

劉瓊玉(Chiung-Yu Liu)

指導教授 ： 詹道明

高雄醫學大學/藥學院/藥學研究所/碩士(2003年)

摘要

在本研究選擇五種口服心血管藥品，包含原廠產品及學名藥品，探討其錠劑之物化性質，如錠劑厚度、硬度、脆度及崩散時間等，及錠劑之含量均一度，並進行錠劑之溶離試驗。錠劑物化性質之分析方法是依據USP 24版，BP 1999版，及中華藥典第五版收載之規範檢測。而溶離試驗以美國FDA頒佈之溶離曲線類同度方法(FDA’s Similarity factor, ƒ2 value)，探討學名藥品與原廠藥品間，體外溶離性質的相關性。
由本研究發現，錠劑之硬度及脆度與崩散時間之長短無規律之相關性；錠劑之硬度及脆度，與溶離速率之快慢，無規律之相關性；崩散時間之快慢，也與溶離速率之快慢無規律之相關性。在體外溶離試驗方面，依溶離曲線類同度方法求得之ƒ2值顯示其結果，47種學名藥品中，只有4種與原廠藥品相似(即ƒ2值>50)。

關鍵字

口服心血管藥品 ； 溶離曲線類同度 ； 學名藥品

並列摘要

In this study, five kinds of oral cardiovascular products (including innovator’s products and generic products) that are not subject to monitoring program established by the government, were evaluated for their thickness, hardness, friability, disintegration time, content uniformity and dissolution profiles as well. The methods of determination for these characteristics described in either USP 24, BP 1999 or ChP V were adopted. Consequently, the similarity between the innovator’s product and the generic product for each kind of active ingredient was evaluated by the FDA’s similarity factor (ƒ2 value).
There were no simple direct relation between the hardness, friability, disintegration time and the rate of dissolution. A ƒ2 value greater than 50 indicates that the dissolution profiles of the generic product and the corresponding innovator’s product are similar. The results show that only 4 out of 47 generic products are similar to their corresponding innovator’s products.

並列關鍵字

oral cardiovascular drugs ； similarity of dissolution profiles ； commercial products

參考文獻

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