2013版BP药典中规定辛伐他汀片的溶出度试验，加二氧化锰的作用是什么?请问：“2013版BP药典中规定 辛伐他汀片 的溶出度试验，加二氧化锰的作用是什么？” 正文如下：“Dissolution Comply with the dissolution test for tablets and capsules, Appendix XII B1. TEST CONDITIONS (a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute. (b) Use 900 mL of 0.01M sodium dihydrogen orthophosphate containing 0.5% w/v of sodium dodecyl sulfate and adjusted to pH 7.0 with 1M sodium hydroxide, at a temperature of 37°, as the medium. PROCEDURE (1) After 30 minutes withdraw a 20 mL sample of the medium, filter and transfer 10 mL of the filtrate into a centrifuge tube containing 0.1 g of pre-washed manganese(IV) oxide. Shake the tube for 30 minutes, or until the manganese(IV) oxide is completely dispersed, centrifuge and measure the absorbance of the clear supernatant liquid, suitably diluted with the dissolution medium if necessary, expected to contain 0.001% w/v of Simvastatin, at the maximum at 247 nm and at the minimum at 257 nm, Appendix II B using dissolution medium that has been similarly treated with pre-washed manganese(IV) oxide in the reference cell. (2) Measure the absorbance of a 0.001% w/v solution of simvastatin BPCRS prepared by dissolving simvastatin BPCRS in the dissolution medium and treating with pre-washed manganese(IV) oxide as described above, at 247 nm and at 257 nm, using dissolution medium that has been similarly treated with pre-washed manganese(IV) oxide in the reference cell. DETERMINATION OF CONTENT Calculate the total content of simvastatin, C25H38O5, in the medium using the differences in absorbance at 247 nm and at 257 nm and using the declared content of C25H38O5 in simvastatin BPCRS. LIMITS The amount of simvastatin released is not less than 75% (Q) of the stated amount. ” 译文：“试验 溶出：按照附录Ⅻ B1中片剂和胶囊的溶出试验 试验条件 (a) 使用桨法，搅拌桨旋转50 r/min。 (b) 在37°下，用900ml含0.5%的 十二烷基硫酸钠 的0.01M 磷酸二氢钠溶液 （用1M氢氧化钠溶液调pH至7.0）为溶出介质。 操作过程： (1) 经30min后取20ml的样品，过滤转移10ml的滤液到离心管（含0.1g的二氧化锰），振摇离心管30min直至二氧化锰完全分散，离心后检测上清液的吸光度，可用溶出介质进行稀释使辛伐他汀在最大吸收247nm和最小吸收257nm的含量为0.001%，对照管/空白对照管中的溶出介质也需用二氧化锰预处理。 (2) 测0.001%的辛伐他汀BP标准品（将辛伐他汀BP标准品溶解在溶出介质并同上用二氧化锰预处理）在247nm和257nm的吸光度，空白对照管同上用二氧化锰预处理。 含量测定 计算溶出介质中的辛伐他汀含量，对比在247nm和257nm的吸收差异以及辛伐他汀BP标准品的实际装量。 限度 辛伐他汀的释放量不能低于75%。”查看更多4个回答 . 1人已关注
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