（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 condend 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 bad upon the different binders ud 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 otherwi.
二、蜜丸所用蜂蜜须经炼制后使用。按炼蜜程度分为嫩蜜、中蜜和老蜜，制备蜜丸时可根据品种、气候等具体情况选用。除另有规定外，用塑制法制备蜜丸时，炼蜜应趁热加人药粉中，混合均匀，处方中有树脂类、胶类从含挥发性成分的药味时，炼蜜应在60℃左右加人；用泛制法制备水蜜丸时，炼蜜应用沸水稀释后使用。
2. The honey ud for honeyed pills production should be procesd before using. According to the degree of processing, it can be divided into primary procesd honey, condary procesd and tertiary procesd honey, which may be lected and ud to prepare honeyed pills, depending on the climate and the varieties of honeyed pills. In preparing big and small honeyed pills by rubbing method, the procesd honey should be added to the drug powder while hot and mixed well, unless specified otherwi. If resin, gum and volatile drugs are contained in the formulation, the procesd honey should be added at about 60℃;in preparing water-honeyed pills by water spray rotating method, the procesd honey should be diluted with boiling water before using.
三、浓编丸所用药材提取物应按制法规定，采用一定的方法提取浓缩制成。
3. The extract for preparing concentrated pills should be made by extracting and concentrating according to the certain methods specified under the monograph.
四、除另有规定外，水蜜丸、水丸、浓缩水蜜丸和浓缩水丸均应在80℃以下干燥；含挥发性成分或淀粉较多的丸剂（包括糊丸）应在60℃以下干燥；不宜加热干燥的应采用其他适宜的方法干燥。
4. Unless specified otherwi, water-honeyed pills watered Pills or concentrated water-honeyed pills, concentrated Watered pills should be dried at a temperature below 80℃; pills containing large amount of volatile constituents or starch (including pasted pills) should be dried at a temperature below 60℃. Thermolabile pills should be dried with other proper methods.
五、制备蜡丸所用的蜂蜡应符合本版药典该药材项下的规定。制备时，将蜂蜡加热熔化，待冷却至60℃左右按比例加人药粉，混合均匀，趁热按塑制法制丸，并注意保温。
5. Beewax ud for producing waxed pills complies with the requirements specified under individual monograph in this pharmacopoeia. In preparing melt beewax by heating, then allow to cool to 60℃ and add drug powders proportionally, mix thoroughly and prepare the waxed pills using the kneading method while the temperature is maintained.
六、凡需包衣和打光的丸剂，应使用各品种制法项下规定的包衣材料进行包衣和打光。
6. For pills need to be coated and polished, coat with the coating materials and polish as specified under individual monograph.
七、丸剂外观应圆整均匀、色泽一致。蜜丸应细腻滋润，软硬适中。蜡丸表面应光滑无裂纹，丸内不得有蜡点和颗粒。
7. Pills should be round, integrate and uniform in appearance and colour. Big and small honeyed pills should appear fine, smooth and oily-moistened, with proper hardness. Waxed pills should be smooth in apperance without crack, and no drops or granules found inside the pills the pills.
八、除另有规定外，丸剂应密封贮存。蜡丸应密封井置阴凉干燥处贮存。
8. Unless specified otherwi, Pills should be prerved in tightly clod containers and waxed pills, in tightly clod containers and stored in a dry place.
丸剂应进行以下相应检查。
Following relevant tests should be carried out for pills.
【水分】照水分测定法（附录Ⅸ H)测定。除另有规定外，蜜丸和浓缩蜜丸中所含水分不得过15. o％；水蜜丸和浓缩水蜜丸不得过12.0％；水丸、糊丸和浓缩水丸不得过9.0％。蜡丸不检查水分。
