發(fā)布時(shí)間：2018-04-12 11:26

  本文選題：苯磺貝他斯汀片 + 溶出度��； 參考：《中國(guó)醫(yī)藥工業(yè)雜志》2017年10期

【摘要】：建立了高效液相色譜法測(cè)定苯磺貝他斯汀片的溶出度,并進(jìn)行自制品與原研品在不同pH值溶出介質(zhì)中的溶出曲線一致性評(píng)價(jià)。采用Agilent C_8色譜柱,以0.05 mol/L磷酸二氫鉀溶液(用磷酸調(diào)至pH 3.0)∶乙腈(70∶30,含1.0 mg/ml戊烷磺酸鈉),檢測(cè)波長(zhǎng)260 nm。以鹽酸(pH 1.2)、乙酸鹽緩沖液(pH 4.5)和磷酸鹽緩沖液(pH 6.8)各900 ml為溶出介質(zhì),在轉(zhuǎn)速50 r/min下,考察自制品與原研品的溶出度,并通過(guò)計(jì)算溶出曲線相似因子(f2)評(píng)價(jià)兩者溶出行為的相似性。苯磺貝他斯汀檢測(cè)的線性范圍為3.6~18.0μg/ml;精密度、重復(fù)性和穩(wěn)定性試驗(yàn)的RSD2.0%;3種溶出介質(zhì)中的回收率分別為99.7%、100.2%和100.3%,RSD2.0%。自制品與原研品在鹽酸(pH 1.2)中30 min時(shí)的溶出度均大于95%,在3種溶出介質(zhì)中的f2值均大于65。表明自制品與原研品的體外溶出行為相似,質(zhì)量一致性良好。
[Abstract]:A high performance liquid chromatography (HPLC) method was established for the determination of dissolution of benzobestatin tablets, and the consistency of dissolution curves between self-made and original products in different pH solution was evaluated.A Agilent C8 column was used with 0.05 mol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid: acetonitrile 70: 30, containing 1.0 mg/ml sodium pentane sulfonate). The detection wavelength was 260 nm.In this paper, the dissolution rate of the self-made and the original product was investigated at a rotational speed of 50 r/min, with pH 1.2 渭 m, pH 4.5 (pH 4.5) and pH 6.8 ml, respectively, in the buffer solution of sodium hydrochloride and phosphate buffer respectively, and the dissolution rate of the prepared product and the original product were investigated at a rotational speed of 50 r/min.The similarity of dissolution behavior was evaluated by calculating the similarity factor of dissolution curve.The linear range of benzenesurastatin was 3.6 ~ 18.0 渭 g / ml, and the recoveries of RSD 2.0 and RSD 2.0 were 99.7% and 100.3%, respectively.The dissolution of both the self-made and the original product in pH 1.2) was greater than 95 at 30 min, and the F _ 2 value in the three kinds of dissolution media was higher than 65.The results showed that the dissolution behavior of the self-made product was similar to that of the original product in vitro, and the quality was consistent.
【作者單位】： 上海交通大學(xué)附屬國(guó)際和平婦幼保健院藥劑科;
【分類(lèi)號(hào)】：O657.72;TQ460.72

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本文編號(hào)：1739530