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发表于 2015-1-4 17:17:42
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三尺之冰 发表于 2015-1-2 23:19 ![](static/image/common/back.gif)
制剂的一种分类:Control release(CR)、Extended release(ER)、Delayed release(DR),即控释、缓释和 ...
摘自药物生产手册:
Modified-release products include delayed-release products and extended-controlled-release products.
As defined in the USP, delayed-release drug products are dosage forms that release the drugs at a time later than immediately after administration (i.e., these drug products exhibit a lag time in quantifiable plasma concentrations).
Typically, coatings (e.g., enteric coatings) are intended to delay the release of medication until the dosage form passed through the acidic medium of the stomach. The in vivo tests for delayed-release drug products are similar to those for extended-release drug products. The in vitro dissolution tests for these products should document that they are stable under acidic conditions and that they release the drug only in a neutral medium (e.g., pH 6.8).
Extended-release drug products are dosage forms that allow a reduction in dosing frequency as compared with when the drug is present in an immediate-release dosage form. These drug products can also be developed to reduce fluctuations in plasma concentrations. Extended-release products can be capsules, tablets, granules, pellets, and suspensions. If any part of a drug product includes an extended-release component, the following recommendations
apply.
Controlled Release 应该是一个统称 = ER + DR + ... |
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