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1.藥劑中使用輔料的目的
①有利于制劑形態(tài)的形成
②使制備過程順利進行
③提高藥物的穩(wěn)定性
防止水解、氧化的措施：pH調(diào)節(jié)劑、抗氧劑、金屬絡合劑、將藥物制成前體藥物、將藥物制成包合物/微囊/脂質(zhì)體
④調(diào)節(jié)有效成分的作用或改善生理要求
緩釋，控釋，口感，外觀，
2.輔料在藥劑中的地位(只記最重要的內(nèi)容)
①新輔料意味著新制劑、新劑型
>>脂質(zhì)體——載體材料卵磷脂
>>微球、納米�！d體材料PLGA
>>緩控釋制劑——骨架材料HPMC
>>透皮制劑——卡波姆
②輔料不同，劑型不同，療效不同
>>速效制劑(注射劑、氣霧劑)——起效快
>>緩、控釋制劑——在體內(nèi)維持時間較普通制劑長
輔料控制釋放：定速(控釋制劑零級恒速釋藥)、定時(脈沖制劑)、定位(靶向制劑、結(jié)腸定位制劑)
>>注射劑/氣霧劑/舌下含片/透皮貼劑——避免肝臟首過效應、胃腸道pH及酶等對藥物降解及藥物對胃腸道的刺激，提高生物利用度
③輔料改變藥物的理化性質(zhì)
難溶性藥物灰黃霉素+水溶性高分子材料PEG6000制成固體分散體，藥物以微晶態(tài)、固態(tài)或不定型狀態(tài)存在，溶解度提高，吸收快，生物利用度高。
④輔料增加制劑的可接受性
味道、外觀
3.輔料舉例
(1)液體藥劑：表面活性劑、助懸劑、乳化劑——吐溫、司盤、聚乳酸(PLA)、聚乳酸-聚乙醇酸共聚物(PLGA)
(2)固體藥物：崩解劑、透皮吸收促進劑——羧甲基淀粉鈉(CMS-Na)、交聯(lián)聚維酮(PVPP)、交聯(lián)羧甲基纖維素鈉(CC-Na)、低取代羥丙基纖維素(L-HPC)、月桂氮酮(Azone)
3.輔料舉例
(1)液體藥劑：表面活性劑、助懸劑、乳化劑——吐溫、司盤、聚乳酸(PLA)、聚乳酸-聚乙醇酸共聚物(PLGA)
(2)固體藥物：崩解劑、透皮吸收促進劑——羧甲基淀粉鈉(CMS-Na)、交聯(lián)聚維酮(PVPP)、交聯(lián)羧甲基纖維素鈉(CC-Na)、低取代羥丙基纖維素(L-HPC)、月桂氮酮(Azone)
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