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[求助]
飽和溶解度的問題
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| 在做仿制藥,與對照制劑對比溶出曲線之前,對原料的飽和溶解度進行測定。我想知道飽和溶解度測定的具體做法,對照的配置。還有,溶出介質(zhì)的選擇,對于一個仿制藥,是選用中國藥典的緩沖液,還是歐洲或是日本美國的介質(zhì)配制相應pH的介質(zhì)的選擇依據(jù)? |
新蟲 (初入文壇)
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For your reference: 1. 對于一個仿制藥,是選用中國藥典的緩沖液,還是歐洲或是日本美國的介質(zhì)配制相應pH的介質(zhì)的選擇依據(jù)? You can find this brand drug is from 歐洲或是日本, 美國 and search their dissolution method. If this drug is from 美國 and dissolution is pH1.2 and 6.8 (often use), then you can follow USP to prepare your 溶出介質(zhì) and also use this buffer system to compare your dissolution profile. 2. 飽和溶解度測定的具體做法,對照的配置. 1) Follow your dissolution method, decide your溶出介質(zhì). 2) Develop your 原料 assay method (we often use HPLC method). 3) Dissolve your原料 in whatever 溶出介質(zhì)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. |
木蟲 (正式寫手)
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