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目的建立自制依普黄酮片溶出度测定方法,并与原研制剂进行溶出曲线比较,评价两者体外溶出行为的一致性。方法筛选溶出度试验参数,采用紫外-可见分光光度法在300 nm波长处测定吸光度并计算溶出度;测定自制依普黄酮片与参比制剂(OSTEN)在含2%十二烷基硫酸钠(SDS)水溶液、含2%SDS的p H=4.5乙酸盐缓冲液、含2%SDS的p H=6.8磷酸盐缓冲液、含2%SDS的0.1mol·L~(-1)盐酸溶液4种溶出介质中的溶出曲线,并进行一致性评价。结果自制片与参比制剂在上述4种溶出介质中的相似因子分别为74.57(水,2%SDS)、71.03(p H=4.5乙酸盐缓冲液,2%SDS)、74.83(p H=6.8磷酸盐缓冲液,2%SDS)、70.34(0.1 mol·L-1盐酸,2%SDS),且全部有效点的AV值均≤15.0。提示自制依普黄酮片与参比制剂体外溶出行为相似。结论建立的溶出度试验方法专属性强、灵敏、简便,能有效控制依普黄酮片的质量;自制依普黄酮片与参比制剂的体外溶出行为一致。
OBJECTIVE To establish a method for the determination of elution of ipriflavone tablets, and to compare the elution profiles with those of the original preparations, and to evaluate the consistency of in vitro dissolution behavior. Methods The parameters of dissolution test were screened, the absorbance was measured by UV - visible spectrophotometry at 300 nm and the dissolution was calculated. The results of self - made Ipflavone tablets and reference preparations (OSTEN) in 2% sodium dodecyl sulfate SDS), p H = 4.5 acetate buffer with 2% SDS, p H = 6.8 phosphate buffer with 2% SDS, 0.1 mol·L -1 hydrochloric acid solution with 2% SDS 4 Dissolution profiles in dissolution media were evaluated and conformed. Results The similarities of the self-made tablets and reference preparations in the above four dissolution media were 74.57 (water, 2% SDS), 71.03 (p H = 4.5 acetate buffer, 2% SDS), 74.83 = 6.8 phosphate buffer, 2% SDS), 70.34 (0.1 mol·L-1 hydrochloric acid, 2% SDS), and the AV values of all valid spots were all ≤15.0. Tip self-made flavanone tablets and reference preparations in vitro dissolution behavior similar. Conclusion The established dissolution test method is specific, sensitive and simple, and can effectively control the quality of epiphon flake tablets. The dissolution behavior of iproflavone tablet and reference preparation in vitro is the same.