3.
丹七冠心舒半成品质量标准Quality Standard for half-finished Danqiguanxinshu
1.
稠膏：Thick Cream:
1.1
外观：棕褐色细腻粘稠的半流体，无杂质、无异物。Appearance: brown fine sticky half-liquid, no impurity, no foreign matter.
1.2
相对密度：1.35~1.40/50℃。Relative Density:1.35~1.40/50℃。（执行SOP-QC-128-01）（Executing SOP-QC-128-01）
2.
原粉：Original powder:
2.1
外观：呈浅黄棕色细粉，颜色一致，不显色斑，不出花线。Appearance：Light yellow-brown fine powder, the color is even, no spot, no thread.（取粉末少许置洁净白纸上，用药勺压平，应色泽一致，不显色斑，勺抹不出线。(Take a little powder onto clean paper, press the powder flat, the color should be even, no spot or thread should appear.）
2.2
细度：全部通过80目筛，能通过100目筛的药粉≥97% 。Fineness：all powder passes 80-hole sieve, and more than 97% can pass 100-hole sieve.
2.3
微生物限度：细菌数不得超过50个/g（执行SOP-QC-109-01）Microbe Limitation: the number of bacterium shouldn’t exceed 50/g（Executing SOP-QC-109-01）
霉菌、酵母菌数不得超过50个/g（执行SOP-QC-110-01）The number of mold and yeast shouldn’t exceed50/g（Executing SOP-QC-110-01）
3.
膏粉：Cream powder:
3.1
外观性状：颜色一致，不显色斑，不出花线。Appearance: the color is even, no spot or thread.

华译网北京翻译公司翻译过大量有关丹七冠心舒半成品质量标准的文件资料,Beijing Chinese Translation Service Company has translated many technical documents about Quality Standard for half-finished Danqiguanxinshu
4.
素片：Tablet:
4.1
外观性状：浅黄棕色的片；气微，味微苦、甜。Appearance: light yellow-brown tablet which has a little smell and tastes a little bitter or sweet.色泽均匀，完整光洁。The color is even, and the tablet is complete and smooth.
4.2
片重差异：0.3g±4%。Weight diversity: 0.3g±4%.
4.3
崩解时限：≤50分钟。Time limit for disintegration: ≤50 minute.
4.4
水分：≤6.5% 。Water:≤6.5%.
4.5
硬度：≥2kg。Hardness:≥2kg.
4.6
脆碎度：减失重量≤1%，且不得检出断裂、龟裂及粉碎的片。Friability: weight lose≤1%,and no break, crack or crushed piece should be detected.
5.
检查方法：执行有关项下的SOP。Inspection methods: to execute related SOP.
6.
贮藏：密闭，常温放置。Storage: stored in airtight container and normal temperature.

注：崩解、脆碎度的检测方法按照BP规定方法检验。Note: inspection methods for disintegration and friability are in line with those in BP.
 
1.性状：素片，呈浅黄棕色；气微，味微苦、甜。1.性状：素片，呈浅黄棕色；气微，味微苦、甜。
2.1重金属总量：不得超过10ppm（ExecutingSOP-QC-129-01）2.1重金属总量：不得超过10ppm（执行SOP-QC-129-01）
2.2微生物限度：2.2微生物限度：                                        
2.2.1细菌数：< 100个/克（执行SOP-QC-109-01）2.2.1细菌数：< 100个/克（ExecutingSOP-QC-109-01）
2.2.2霉菌、酵母菌数：<100个/克（执行SOP-QC-110-01）2.2.2霉菌、酵母菌数：<100个/克（ExecutingSOP-QC-110-01）
2.2.3大肠杆菌：不得检出（执行SOP-QC-111-01）2.2.3大肠杆菌：不得检出（ExecutingSOP-QC-111-01）
2.2.4金黄色葡萄球菌：不得检出（执行SOP-QC-166-01）2.2.4金黄色葡萄球菌：不得检出（ExecutingSOP-QC-166-01）