中国药典附录Ⅰ(AZ)中英文对照.doc

（附录Ⅰ制剂通则） Appendix Ⅰ General Requirements for Prearations （丸剂）Ⅰ A Pills 丸剂 系指药材细粉或药材提取物加适宜的黏合剂或其他辅料制成的珠形或类球形制剂，分为蜜丸、水蜜九、水丸、糊丸、蜡丸和浓缩丸等类型。 Pills are spherical or spherical-like solid dosage forms made of finely powdered crude drugs or crude drug extracts, proper binders or other excipients. They are classified into honeyed pills, water-honeyed pills, watered pills, pasted pills, concentrated pills waxed pills and concentrated pills etc. 蜜丸 系指药材细粉以蜂蜜为黏合剂制成的丸剂。其中每丸重量在 0.5g( 含 0.5g)以上的称大蜜丸，每丸重量在0.5以下的称小蜜丸。 Honeyed pills are made of fine powder of crude drugs, using honey as binder. Among them, pills weighing more than 0.5g (including 0.5g) per pill are big honeyed pills, pills weighing less than 0.5g per pill are small honeyed pills. 水蜜丸 系指药材细粉以蜂蜜和水为黏合剂制成的丸剂。 Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders. 水丸 系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸剂。 Watered pills are made of fine powder of crude drugs, using water (or yellow rice wine, vinegar, dilute medicinal juice, dilute syrup) as binder. 糊丸 系指药材细粉以米粉、米糊或面糊等为黏合资剂制成的丸剂。 Pasted pills are made of fine powder of crude drugs, using rice powder rice-paste or flour-paste as binder. 蜡丸 系指药材细粉以蜂蜡为黏合剂制成的丸剂。 Waxed pills are made of fine powder of crude drugs, using beeswax as binder. 浓缩丸 系指药材或部分药材提取浓缩后，与适宜的辅料或其余药材细粉，以水、蜂蜜或蜂蜜和水为黏合剂制成的丸剂。根据所用黏合剂的不间，分为浓缩水丸、浓缩蜜丸和浓缩水蜜丸。 Concentrated pills are made of condensed extract of crude drugs or partial crude drugs, mixing with appropriate excipient or fine powder of other crude drugs, using water, honey or honey and water as binders. They may be classified into concentrated watered pills, concentrated honeyed pills and concentrated water-honeyed pills based upon the different binders used in the production. 丸剂在生产与贮藏期间应符合下列有关规定。 The production and storage of pills should comply with the following requirements. 一、除另有规定外，供制丸剂用的药粉应为细粉或最细粉。 1. The powdered drugs for preparing pills are fine or very fine powders, unless specified otherwise. 二、蜜