巿售Aminophyllin製劑之溶離度試驗及品質調查

INVESTIGATION ON THE DISSOLUTION AND QUALITY OF COMMERCIAL AMINOPHYLLINE PREPARATIONS

藥品在服用之後，必須先經崩散、溶離才能為人體所吸收，達到適當的血中濃度，發揮其療效，故在品質管制上，即使均一度試驗含量測定項等均符合規定，但若無適切的溶離特性，則仍無法達到良好的生體可用率而造成治療上的障礙，因此溶離度試驗在藥品之品管上日益受到重視。本局即針對此做此一品質調查，以期能提供品質現況之資料供為參考，遂於七十五年九月至七十六年二月自全省各縣市藥房抽購 Aminophylline 錠劑50件，全部檢體之溶離度試驗，按照美國藥典第二十一版 Aminophylline Tablet Dissolution 項所記載之方法予以檢驗，並參照藥典之規定測定其重量差異及崩散度。含量測定則採用液相層析法。

In order to understand the dissolution and quality of commercial aminophylline preparations. We purchased 50 samples from drugstores in Taiwan area from Sep. 1986 to Feb. 1987. For each sample, dissolution, weight variation, disintegration and identification test were performed according to the methods described in the USP XXI. A high-performance liquid chromatographic method was used to quantitate the aminophylline. The results showed that one of the samples (2.0%) can't meet the requirements of dissolution and disintegration test.