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本文试制出新处方布洛芬片剂,选择山东新华制药厂三种片剂:市售处方A、新处方片剂B和C,以及英国Boots公司的片剂D,进行体外溶出速率和人体生物利用度试验,并测定了生产A,B(和C),D片剂的布洛芬原料A′,B′,D′的粒度,比较了A′,D′的晶型。实验表明,国内外原料晶型相同,A′,B′,D′平均粒径分别为130.0,36.6,56.6μm。A与D生物不等效,B和C与D生物等效。提高国产片剂生物利用度的因素主要与原料粒度、处方组成和制备工艺有关。
This paper trial production of a new prescription ibuprofen tablets, choose Shandong Xinhua Pharmaceutical Factory three kinds of tablets: the market prescription A, the new prescription tablets B and C, and the British company Boots Tablet D, in vitro dissolution rate and human biological The degree of use test was taken and the particle size of the ibuprofen starting materials A ’, B’, and D ’used to produce A, B (and C), D tablets was measured and the crystal forms of A’ and D ’were compared. Experiments show that the domestic and foreign raw material form the same, A ’, B’, D ’average particle size was 130.0,36.6,56.6μm. A and D creatures are not equivalent, B and C are bioequivalent to D. The factors that increase the bioavailability of domestic tablets are mainly related to the particle size, prescription composition and preparation process.