力士樂MKD090B-058-KG1-KN保證全新原裝,沖量大促銷!德國(guó)
”這是基于傳統(tǒng)市售鋼瓶供氮工藝繁瑣、技術(shù)落后所造成的,其供氮方式凸現(xiàn)出氮?dú)饧兌鹊?、含有微生物、熱原等有害雜質(zhì)等問題。常用鋼瓶氮?dú)饧兌纫话銥?9.5%~99.9%,不能確保GMP驗(yàn)證對(duì)氮?dú)獾囊蟆H欢?,?duì)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(shí)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(shè)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(shí)施指南(21)》一書中指出:“據(jù)測(cè)定,高純氣體如99.999%以上的氮?dú)庠谳斔瓦^程中由于設(shè)計(jì)、安裝和維護(hù)管理的不當(dāng),可使氣體純度下降幾個(gè)至十個(gè)ppm,甚至可能下降一個(gè)數(shù)量級(jí)。
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中藥超微粉碎后其物理性能、化學(xué)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(jìn)一步研究。對(duì)微粉化技術(shù)在中醫(yī)臨床的應(yīng)用,有賴于中藥基礎(chǔ)和臨床研究工作的加強(qiáng)。中藥超微粉碎技術(shù)在發(fā)揮單一藥材藥效方面有很大的優(yōu)勢(shì),但對(duì)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(shí),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(dāng)與其他藥材共煎后就會(huì)產(chǎn)生很強(qiáng)的藥效,說明在煎煮過程中發(fā)生了化學(xué)變化。
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