發(fā)布時(shí)間：2018-03-05 02:15

  本文選題：阿司匹林腸溶片　切入點(diǎn)：質(zhì)量研究與分析　出處：《藥物分析雜志》2015年12期 　論文類型：期刊論文

【摘要】：目的:研究阿司匹林腸溶片藥物穩(wěn)定性與患者用藥情況、包裝材料和處方中高價(jià)金屬離子的相關(guān)性,并研究樣品阿司匹林腸溶片與參比制劑釋放曲線一致性,為企業(yè)提高產(chǎn)品質(zhì)量提供改進(jìn)方向。方法:以阿司匹林腸溶片含量、釋放度和有關(guān)物質(zhì)(中國(guó)藥典2010年版二部阿司匹林腸溶片方法)為考察指標(biāo),開(kāi)展Mg2+與阿司匹林穩(wěn)定性、開(kāi)瓶穩(wěn)定性(100片·瓶~(-1))、包裝材料與藥品穩(wěn)定性研究;釋放曲線研究采用光纖藥物釋放度實(shí)時(shí)測(cè)定儀,測(cè)定各廠家阿司匹林腸溶片在5種釋放介質(zhì)中的實(shí)時(shí)釋放曲線。結(jié)果:(1)阿司匹林與硬脂酸鎂按不同處方比混合,隨著放置時(shí)間的增加,游離水楊酸的含量增加,游離水楊酸增加速度與硬脂酸鎂加入量呈正相關(guān);(2)模擬患者使用方式,塑料瓶包裝的產(chǎn)品(100片·瓶~(-1))每日開(kāi)瓶3次,隨時(shí)間增加,游離水楊酸含量呈上升趨勢(shì),p H 6.8緩沖溶液中釋放度均呈下降趨勢(shì);(3)不同存放條件下,隨時(shí)間增加,鋁塑包裝產(chǎn)品的含量、游離水楊酸和釋放度均無(wú)顯著性變化,塑料瓶包裝產(chǎn)品的游離水楊酸和釋放度均有顯著性變化;(4)在p H 6.0的緩沖溶液中,參比制劑在60 min內(nèi)能夠完全釋放,部分受試制劑在2 h內(nèi)未完全釋放,在分別以2010年版中國(guó)藥典和日本橙皮書(shū)方法制備的2種p H 6.8的溶出介質(zhì)中,參比制劑均能釋放,部分受試制劑溶出行為表現(xiàn)出較大的差異。結(jié)論:阿司匹林腸溶片處方中應(yīng)避免加入硬脂酸鎂;考慮患者實(shí)際使用情況,為保證服藥期間藥品質(zhì)量,建議減少每瓶包裝量;鋁塑包裝產(chǎn)品穩(wěn)定性明顯優(yōu)于塑料瓶包裝產(chǎn)品,且不同塑料瓶包裝產(chǎn)品穩(wěn)定性有差異,建議生產(chǎn)企業(yè)選擇優(yōu)質(zhì)包材;參比制劑在大部分腸道內(nèi)均能夠進(jìn)行釋放,并且受腸道內(nèi)環(huán)境影響較小,部分企業(yè)阿司匹林腸溶片與參比制劑在釋放度行為上存在差異,企業(yè)需重視處方工藝并做進(jìn)一步研究,建議采用多條釋放曲線評(píng)價(jià)阿司匹林腸溶片的質(zhì)量。
[Abstract]:Objective: to study the relationship between drug stability of aspirin enteric-coated tablets and drug use, high valence metal ions in packaging materials and prescriptions, and to study the consistency of release curve between aspirin enteric-coated tablets and reference preparations. Methods: the contents, release and related substances of aspirin enteric-coated tablets (Chinese Pharmacopoeia, 2010) were used as the index to study the stability of Mg2 and aspirin. Open-bottle stability 100 tablets, packaging materials and drug stability study, release curve research using optical fiber drug release real-time measuring instrument, The real-time release curves of aspirin enteric-coated tablets in 5 kinds of release media were determined. Results the concentration of free salicylic acid increased with the increase of storage time, and the ratio of aspirin to magnesium stearate was mixed with different prescriptions. The increasing rate of free salicylic acid was positively correlated with the amount of magnesium stearate. The content of free salicylic acid in buffer solution of H6.8 showed a decreasing trend.) under different storage conditions, the content of free salicylic acid, free salicylic acid and release of aluminum-plastic packaging products did not change significantly with the increase of storage time. There were significant changes in free salicylic acid and release rate in plastic bottle packaging products. (4) in pH 6.0 buffer solution, the reference preparation could be completely released within 60 min, and some of the tested preparations could not be completely released within 2 h. In the dissolution media of two kinds of pH 6.8 prepared by the 2010 Chinese Pharmacopoeia and Japanese orange pericarp respectively, the reference preparation could be released. Conclusion: magnesium stearate should be avoided in the formulation of aspirin enteric-coated tablets. The stability of aluminum-plastic packaging products is obviously superior to that of plastic bottle packaging products, and the stability of different plastic bottle packaging products is different. Some enterprises have different release behavior between aspirin enteric-coated tablets and reference preparations. Enterprises should pay attention to prescription technology and do further research. It is suggested that multiple release curves be used to evaluate the quality of aspirin enteric-coated tablets.
【作者單位】： 海南省藥品檢驗(yàn)所;
【基金】：2011年國(guó)家藥品評(píng)價(jià)抽驗(yàn)項(xiàng)目(項(xiàng)目編號(hào):60) 海南省社會(huì)發(fā)展科技專項(xiàng)資金項(xiàng)目(項(xiàng)目編號(hào):SF201453)
【分類號(hào)】：R927

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