【摘要】：目的根據(jù)顆粒劑的制劑特點(diǎn),探討水分(包括水分含量和水分活度)對(duì)阿莫西林克拉維酸鉀顆粒穩(wěn)定性的影響;并以穩(wěn)定性為指針,揭示阿莫西林克拉維酸鉀顆粒在制劑過程中的關(guān)鍵質(zhì)量控制屬性。方法通過高濕加速穩(wěn)定性實(shí)驗(yàn)[實(shí)驗(yàn)溫度(25±2)℃;相對(duì)濕度(75±5)%],考察阿莫西林克拉維酸鉀顆粒的水分、含量、有關(guān)物質(zhì)、晶型特征等。結(jié)果阿莫西林克拉維酸鉀顆粒的穩(wěn)定性與樣品的水分活度呈正相關(guān),與樣品的水分含量關(guān)系不大,水分活度低的樣品的穩(wěn)定性高。結(jié)論阿莫西林克拉維酸鉀顆粒的關(guān)鍵質(zhì)控屬性是水分,關(guān)鍵工藝參數(shù)是水分活度。
[Abstract]:Objective to study the effect of water (including water content and water activity) on the stability of amoxicillin clavulanate potassium granules according to the characteristics of granules. The key quality control properties of amoxicillin clavulanate potassium granules in preparation process were revealed. Methods the moisture, content, related substances and crystal form of amoxicillin clavulanate potassium granules were investigated by high humidity accelerated stability experiment [temperature (25 鹵2) 鈩，

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