力士樂MKD090B-058-KG1-KN保證全新原裝,沖量大促銷!德國
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”這是基于傳統(tǒng)市售鋼瓶供氮工藝繁瑣、技術落后所造成的,其供氮方式凸現(xiàn)出氮氣純度低、含有微生物、熱原等有害雜質(zhì)等問題。常用鋼瓶氮氣純度一般為99.5%~99.9%,不能確保GMP驗證對氮氣的要求。然而,對無菌制品要求是無塵、無微生物和無熱原,而這正是鋼瓶供氮很難保證的。液氮在制備時雖能在純度上能符合工藝要求,但在分裝或輸送過程中,由于設備、附件、材料以及其它因素的污染,純度很容易降低。而在《藥品生產(chǎn)質(zhì)量管理規(guī)范實施指南(21)》一書中指出:“據(jù)測定,高純氣體如99.999%以上的氮氣在輸送過程中由于設計、安裝和維護管理的不當,可使氣體純度下降幾個至十個ppm,甚至可能下降一個數(shù)量級。
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中藥超微粉碎后其物理性能、化學性能、毒副作用可能發(fā)生改變,其臨床配方、劑量也可能發(fā)生變化,其制劑成型、體內(nèi)吸收、片劑硬度、崩解等,這些都有待于進一步研究。對微粉化技術在中醫(yī)臨床的應用,有賴于中藥基礎和臨床研究工作的加強。中藥超微粉碎技術在發(fā)揮單一藥材藥效方面有很大的優(yōu)勢,但對于制劑特別是傳統(tǒng)中醫(yī)方劑中需要煎煮使用的中藥,它是否適合還值得探討。許多研究證實,很多中藥煎劑中單一成分有些無藥理作用或藥理作用很小,但當與其他藥材共煎后就會產(chǎn)生很強的藥效,說明在煎煮過程中發(fā)生了化學變化。
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