Specification – 规格
一系列的测试项目、有关的分析程序和适当的认可标准,此标准可以是数值限度、范围或所述测试项目的其它标准。它规定一套标准,物料应当符合该标准,才被认为可以用作其预期的用途。 “符合规格”表示物料按所列的分析程序测试时,会符合所列的接受标准。
Validation – 验证
为某一特定的工艺、方法或系统能够持续地产生符合既定接受标准的结果提供充分保证的文件程序。
Validation Protocol – 验证方案
说明如何进行验证和规定接受标准的书面计划。例如,生产工艺验证方案确定工艺设备、关键性工艺参数/操作范围、产品特性、取样、收集的测试数据、验证的次数,以及可接受的测试结果。
Yield, Expected – 预期产量
在以前实验室、中试规模或生产数据的基础上,预计任何适当的生产阶段的物料的量或理论产量的百分比。
Yield, Theoretical – 理论产量
根据投料量,不计任何实际生产中的损失或过失,计算任何适当的生产阶段生产的量。
主要内容:
Drug Name ,Description, Action ,Indications(适应症), Dosage and Administration ,Side Effect, Contraindications(禁忌症) ,Precautions ,Packing and Storage, Expiry Date ,Manufacturer
药品说明书:Package Insert/Insert Sheet/ Insert/Description/Instruction/Directions/ Patient Information Leaflet
正品名(国际通用名)Formal Name (Generic Name)
商品名Commodity Name/Trade Name
化学名Chemical Name
刻痕片 Scored tablets
口服剂 Oral liquid
口服溶液 Oral solution
气雾剂 Aerosol/Inhaler/Spray
长效片 Spandets
恒释片 Timed-release tablets
控释片 Controlled-release tablets
缓释片 Retard tablets
缓释胶囊 Slow-release capsule
Description/ General Description Chemical structure / Empirical formula Physical and chemical properties:
color/ taste/smell/solubility/molecular weight Composition / Chief Ingredients
给药对象:
Adults Senile patients Male Female Pregnant women Children School-age children Infants Babies Newborn babies
给药方法:
Orally/by oral route/oral administration By aerosol Subcutaneously Intra-arterially By intramuscular injection Sublingually Locally By intravenous perfusion
剂量术语:
Daily dose Single dose Initial dose/starting dose Usual dose Maximum daily dose Minimum effective dose Average maintenance dose Therapeutic dose Intermittent/spaced dose Test-dose Overdose/overdosage LD50/medial lethal dose LFD/least fatal dose The optimum daily dosage Standard/suggested/indicated/appropriate/required/desired dosage
给药时间:
Before/after meals Taken with water 30 minutes before or after the intake Treatment course The duration of treatment Treatment duration Consult your physician On medical advice Adhere to the instructions of the physician According to the doctor’s instruction Follow the prescription given by your doctor
Side Effect:
Adverse effect By-effect Reactions toxicity and untoward effects Side effects and accompanying symptoms Undesirable effects Untoward reactions Unwanted effects After effects Local reactions Side effects Side reaction Undesirable and discomforting effects Untoward symptoms Unwanted and disturbing effects
Precautions/warnings :
只限外用。For external use only
本品应吞服,不得咬碎。Swallow in tablets wholely.
避免接触眼睛和粘膜部位。Avoid contact with eyes and mucous membranes
请置于儿童拿不到的地方。Keep out of the reach of children.
Packing and Storage:
Keep in a dry place. Keep out of heat. Below 30C. Medicines should be stored with care. Store in cool dry place at room temperature. Protect/away from light Prevent moisture Tightly sealed Refrigerated storage Away from worms