饱和溶解度的问题？For your reference: 1. 对于一个仿制药，是选用中国药典的缓冲液，还是欧洲或是日本美国的介质配制相应pH的介质的选择依据？ You can find this brand drug is from 欧洲或是日本, 美国 and search their dissolution method. If this drug is from 美国 and dissolution is pH1.2 and 6.8 (often use), then you can follow USP to prepare your 溶出介质 and also use this buffer system to compare your dissolution profile. 2. 饱和溶解度测定的具体做法，对照的配置. 1) Follow your dissolution method, decide your溶出介质. 2) Develop your 原料 assay method (we often use HPLC method). 3) Dissolve your原料 in whatever 溶出介质you want to try to small flask to save your 原料 till can not be dissolved. 4) Stir at room temp for 24 hrs. 5) Take the supernatant, filter and run HPLC. 6) Calculate the原料concentration against working standard.查看更多
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