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中药方制剂、生药制剂批准生产时的注意点:一般审批要求与西药制剂相同,中药方及生药制剂批准生产要特别加以注意的是: 1.销售品名中药方及生药制剂中尤其要注意的是销售名称。在决定中药方销售名称时大多数都附着处方名称或处方名称的别名。中药方的配伍成分、份量在各类药典中均有规定,从处方名称反过来可以查找该处方的成分、份量,决不允许擅自将附着的处方
The points of attention for traditional Chinese medicine preparations and biopharmaceutical preparations are as follows: The general examination and approval requirements are the same as those for western medicine preparations. Special attention should be paid to the approval of production of traditional Chinese medicines and crude drug preparations: 1. The names of the Chinese herbal medicines and crude drug preparations for sale should be especially noted. Sales name. Most of the names of prescriptions or prescriptions are aliased when deciding on the sales name of traditional Chinese medicines. The compatibility and weight of Chinese medicine prescriptions are stipulated in various pharmacopoeias. From the name of the prescription, in turn, the ingredients and serving size of the prescription can be searched.