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| 个人信息 |
| 姓 名： |
夏译员 [编号]:1235 |
性 别： |
男 |
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| 擅长专业： |
医药，机械，法律，经贸，政治，互联网，林学 |
出生年月： |
1985/5/1 |
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| 民 族： |
汉族 |
所在地区： |
云南 昆明 |
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| 文化程度： |
本科 |
所学专业： |
英语 |
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| 毕业时间： |
39600 |
毕业学校： |
西南林业大学 |
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| 第一外语： |
英语 |
等级水平： |
8级 |
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| 口译等级： |
高级 |
工作经历： |
1 年 |
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| 翻译库信息 |
| 可翻译语种： |
英语 |
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| 目前所在地： |
云南 昆明 |
| 可提供服务类型： |
笔译、口译、家教 |
| 每周可提供服务时间： |
空闲时间很多，周末双休 |
| 证书信息 |
| 证书名称： |
专业八级 |
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| 获证时间： |
2008/6/1 |
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| 获得分数： |
好 |
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| 工作经历 |
| 工作时期： |
2008/3/1--2009/8/1 |
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| 公司名称： |
圣火药业集团 |
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| 公司性质： |
合资企业 |
| 所属行业： |
教育/培训 |
| 所在部门： |
国际部 |
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| 职位： |
翻译 |
| 自我评价： |
专业素质强，能准确高效率的完成任务 |
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| 笔译案例信息 |
| 案例标题： |
三七总皂苷检验操作规程 |
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| 原文： |
颁发部门：
质量保证部 标 题：
三七总皂苷检验操作规程 颁发日期：
2006年7月1日
编 号：
AO-044-03 生效日期：
2006年7月1日
编 写 人 审 核 人 批 准 人
编写日期 2006/5/6 审核日期 2006/5/7 批准日期 2006/5/8
分发部门：
质量保证部 此标准取代AO-044-02
目的：建立三七总皂苷检验的标准操作规程。
范围：适用三七总皂苷。
责任：质量保证部操作人员。
规程：
1．检验项目与限度
检验项目 单位 WS3-B-3590-2001(Z) 企业标准
性状 淡黄色无定形粉末；味苦、微甘 淡黄色无定形粉末；味苦、微甘
鉴别(1) 应呈正反应 应呈正反应
鉴别(2) 呈现与对照品保留时间一致的色谱峰 呈现与对照品保留时间一致的色谱峰
干燥失重 % ≤5.0 ≤4.8
炽灼残渣 % ≤0.5 ≤0.48
含量测定 R1 % ≥5.0 ≥5.5
Rg1 % ≥20 ≥20.5
Rb1 ≥30 ≥30.5
R1+ Rg1+ Rb1 % ≥60 ≥62
微生物限度 细菌数 个/克 <1000 <500
霉菌数 个/克 <100 <50
大肠埃希菌 不得检出 不得检出
活螨 不得检出 不得检出
2.性状 本品为淡黄色无定形粉末，味苦、微甘。
本品易溶于甲醇、乙醇和水，难溶于丙酮、乙醚和苯，易吸潮。
标 题 三七总皂苷检验操作规程
颁发部门 质量保证部 编 号 AO-044-03
3.鉴别
3.1取本品少许，置试管中，加醋酐1ml使溶解，沿试管壁滴加硫酸1～2滴，显紫红色，摇匀放置后显紫色。
3.2照[含量测定]项下方法试验，供试品色谱中应呈现与人参皂苷Rb1、人参皂苷Rg1及三七皂苷R1对照品保留时间相一致的色谱峰。
4.检查
4.1干燥失重 取本品1.0g，精密称定，置于在80℃干燥至已恒重的扁形称量瓶中，于80℃干燥至恒重，计算，即得。减失重量不得超过5.0%
4.2炽灼残渣 取本品1g，置已在700～800℃炽灼至恒重的坩埚中，缓缓炽灼至完全炭化，放冷至室温后，加入硫酸0.5ml于坩埚中使湿润，低温加热至硫酸蒸气除尽后，置700～800℃炽灼使完全炭化后，移置干燥器中冷至室温，精密称定，移置700～800℃炽灼至恒重，计算，即得。
5.2微生物限度
5.2.1 将已消毒好的用具物品搬入缓冲间，片剂盒（袋）外壁用2%来苏尔或0.1%新洁尔灭溶液擦净，再用75%酒精擦拭消毒，搬入缓冲间，打开无菌室恒温水浴锅，调节至45±1℃，继续打开紫外光灯，照射半小时。
5.2.2关闭紫外光灯30分钟后，操作人员换消毒鞋，进入缓冲间，用2%来苏尔或0.1%新洁尔灭溶液洗双手，用消毒毛巾擦干。换上无菌衣、裤、帽子、口罩及消毒鞋，将用具搬至无菌室内，关闭无菌室门；打开净化工作台，将事先融化的肉汤、虎红琼脂置45℃水浴中，备用。
5.2.3供试品的制备 取供试品2盒，用0.1%新洁尔灭和75%酒精分别擦拭盒内每版药，消毒擦干。称取供试品10g，置研钵中，以100ml稀释剂[生理盐水或磷酸盐缓冲液
标 题 三七总皂苷检验操作规程
颁发部门 质量保证部 编 号 AO-044-03
（0.1mol/L）]，分次加入研磨细匀，并转移至100ml具塞量筒中，使成1：10供试液。或将供试品和稀释剂同置匀浆仪中，以转速3000～5000转/分，开机1～2分钟。取1ml吸管1支，吸取混匀的1:10供试液1ml，在离稀释剂液面上约1cm处，沿管壁注入装有9ml的稀释剂的试管中，混匀成1:100的稀释液。照上述操作方法将1:100稀释液稀释成1：1000的稀释液。吸取1:10，1:100，各级供试液，每级注入4个平皿，1:1000注入2个，每皿各注1ml。
5.2.4吸取稀释剂2ml，分别注入两个平皿内各1ml做空白对照。
Inject diluent into 2 plates; each is 1ml for comparison
5.2.5增菌培养 取1：10供试液10ml，加入备妥的100ml胆盐乳糖增菌液内，置36±1℃培养18～24小时。取对照菌液1ml，加入备妥的100ml胆盐乳糖增菌液内，置36±1℃培养18～24小时。
5.2.6注皿与培养()
将恒温在45℃水浴中的肉汤琼脂瓶面消毒后，每100ml肉汤琼脂加入TTC 0.1ml，摇匀后，每组两皿注皿，每皿约15ml，随即转动平皿，使样液与琼脂混匀后置水平台上待凝；同时在装有1ml稀释剂的平皿内注皿，待凝。
将恒温在45℃水浴中的虎红琼脂瓶面消毒后，1、2级每级各注皿两个，每皿约15ml，随即转动平皿，使样液与琼脂混匀后置水平台上待凝，同时在装有1ml稀释剂的平皿内注皿，
待凝。
琼脂凝固后，将肉汤琼脂平板倒置30～35℃培养箱中，培养48小时，将虎红琼脂平板倒置25～28℃培养箱内，培养72±2小时。
5.2.7菌落计数、检验结果
在平板背面，正面仔细观察，用肉眼直接计数，标记或在菌落计数器上点计。
细菌菌数报告规则
若有3个稀释级的平均平板菌落数均在30～300时，采用后2个稀释级计算级间比值。
当比值≤2时，以两级的菌落数的均值为报告菌数
当比值＞2时，以低稀释级平均平板菌落数乘以稀释倍数为报告菌数。
若各稀释级平均平板菌落数均在300以上，按最高的稀释级的平均平板菌落数乘以稀释
标 题 三七总皂苷检验操作规程
颁发部门 质量保证部 编 号 AO-044-03
倍数为报告菌数，或适当增加稀释级，重作测定后报告结果。
若各稀释级的平均平板菌落数均不在30～300间，其中一稀释级的平均平板菌落数大于300，相邻稀释级的平均平板菌落数又小于30时，以最接近30或300的稀释级平均平板菌落数乘以稀释倍数为报告菌数。
若各稀释级平均平板菌落数均小于30时，按最低稀释级的平均平板菌落数乘以稀释倍数为报告菌数。
5.2.8分离培养 将增菌培养18～24小时后的胆盐乳糖液轻微摇动，以接种环沾取1～2环划线接种麦康凯琼脂平板上。置36℃±1℃培养18～24小时，观察菌落生长情况 ，大肠杆菌在麦康凯琼脂平板上的典型菌落呈桃红色或中心桃红，圆形，扁平，光滑湿润。
分离平板上无菌落或无疑似菌落生长，可作出未检出报告。
在检验过程中若发现疑似的其它规定控制菌时，亦应继续鉴定。
5.2.9染色法、染色结果
用接种环沾取无菌水，置于洁净载玻片上，再挑取少许菌苔，轻轻研开，使均匀。
自然风干或微热烤干，而后通过火焰2～3次以固定涂片。
滴加结晶紫染液，染色1分钟，水洗。
滴加碘液，媒染1分钟，水洗，甩干余水。
滴加95%乙醇脱色，约20～30秒，或将95%乙醇滴满整个涂片，立即倾去再用乙醇滴满涂片脱色10秒种，水洗，吸干。滴加沙黄复染液，染1分钟，水洗，待干。
镜检。
染色结果 革兰氏阳性菌呈紫蓝色；革兰氏阴性菌呈红色。
5.2.10生化反应
将斜面培养物接种于乳糖发酵管，置36℃±1℃培养24～48小时，观察结果。大肠杆菌应发酵乳糖并产酸产气，或产酸不产气。产酸者，以酸性复红为指示剂的培养基显红色，以溴麝香草酚蓝为指示剂的培养基显黄色。产气者，倒管内有气泡。
IMVIC试验
靛基质试验：将斜面培养物接n种于蛋白胨水培养基中，置36℃±1℃培养48±2小时。沿管壁加入柯凡克试剂0.3～0.5ml，轻微摇动，观察液面颜色，阳性反应为玫瑰红色；阴性
标 题 三七总皂苷检验操作规程
颁发部门 质量保证部 编 号 AO-044-03
反应为试剂本色。
IMVIC testing
甲基红试验：将斜面培养物接种于磷酸盐葡萄糖蛋白胨水培养基中，置36℃±1℃培养48±2小时，于每1ml培养液中加入甲基红指示剂1滴，立即观察结果，阳性反应培养液为鲜红色或桔红色；阴性反应呈黄色。
V-P试验：将斜面培养物接种于磷酸盐葡萄糖蛋白胨水培养基中，置36±1℃培养48±2小时，于每2ml培养液加入V-P试剂甲液（6%a-茶酚酒精溶液）1ml，混匀，再加V-P试剂乙液（40%KOH溶液）0.4ml，充分振摇，观察结果。阳性反应立刻或数分钟后出现红色。加试剂后4小时无红色反应为阴性，如出现红色亦应判为阳性。
柠檬酸盐利用试验：将斜面培养物接种于西蒙氏柠檬酸盐斜面，置36±1℃培养48±2
小时，观察结果。斜面有菌苔生长，培养基由绿色变为蓝色时为阳性反应；斜面无菌苔生长，培养基颜色无改变为阴性反应。
结果报告 完全符合以下结果时，判定为检出大肠杆菌
染色镜检是革兰氏阴性无芽孢杆菌；
乳糖发酵产酸产气，或产酸不产气；
IMVIC试验反应为+ + - -或- + - -。
5.2.11活螨检验 先直接检查药瓶内盖及塑料薄膜袋的内侧有无活螨，后将药品放在衬有洁净黑纸的搪瓷盘里，使成薄层，直接检查，先用肉眼观察有无疑似活螨的白点或其它颜色的点状物，再用5～10倍放大镜或双筒实体显微镜检视，有螨者，用解剖针或发丝针或小毛笔挑取活螨放在滴有一滴甘油水的载玻片上，置显微镜下观察。发现活螨者，应作检出活螨报告。
6．含量测定 照高效液相色谱法（《中国药典2005年版》一部附录ⅥD）。
6.1色谱条件与系统适应性试验 用十八烷基键合硅胶为填充剂；以流动相A：乙腈，流动相B：水，按下表进行梯度洗脱：流速每分钟为1.0ml；检测波长为203nm。理论板数按人参皂苷Rg1峰计算应不低于6000；人参皂苷Rg1峰和三七皂苷R1峰的分离度应大于1.5。
标 题 三七总皂苷检验操作规程
颁发部门 质量保证部 编 号 AO-044-03
时间（分钟） A(%) B(%)
0 20 80
20 40 60
21 20 80
26 20 80
6.2对照品溶液的制备 分别精密称取在60℃减压干燥 2小时的人参皂苷Rb1、人参皂苷Rg1、R1对照品适量，加.90%甲醇制成每1ml含人参Rb1 1.5mg、人参皂苷Rg1 1.5mg、三
七皂苷R10.4mg的混合溶液，即得。
6.3供试品溶液的制备 取本品50mg，精密称定，置10ml量瓶中，加90%甲醇溶解并稀释至刻度，摇匀，即得。
6.4测定法 分别精密吸取对照品溶液和供试品溶液各10ul，注入相色谱仪，测定峰面积，以外标法计算，即得。
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| 译文： |
Items and allow limits
Items Percentage /unit WS3-B-3590-2001(Z) Allow limits
property Intangible yellow powder bitter in taste Intangible yellow powder bitter in taste
Identification (1) positive positive
Identification (2) the same chromatographic peak as that of the control samples within same period the same chromatographic peak as that of the control samples within same period
Dried weight % ≤5.0 ≤4.8
Residues % ≤0.5 ≤0.48
Content R1 % ≥5.0 ≥5.5
Rg1 % ≥20 ≥20.5
Rb1 ≥30 ≥30.5
R1+ Rg1+ Rb1 % ≥60 ≥62
Micro organism bacterial count <1000 <500
Fungi amount <100 <50
E.coli Not detected Not detected
Live acarid Not detected Not detected
2. Nature: This product is light yellow amorphous powder, bitter in taste, soluble in methanol, ethanol and water, insoluble in acetone, ethyl ether and benzene, easy to absorb moisture.
3. Identification
3.1 some samples are obtained and put into the test tube, and 1ml acetic anhydride is added for dissolving, after that, 1 to 2 drops of sulfuric acid are dropped along the test tube wall, the solution taking on purplish red, and then turn into purple after shaking evenly.
3.2 Trial experiment is made in accordance with the Determination of Ingredients below. The chromatogram of trial samples should present the same chromatographic peak as that of the control samples, ginsenosideRb1, ginsenoside Rg1, notoginseng side R1 within same period
4. Check
4.1 After being dried, 1.0 g of samples is weighed and scaled precisely, and then put into flat weighing bottle under temperature 80℃and is dried until no weight loses.
Calculate and get results, Weight loss should be not more than 5.0%
Lose percentage(%)= lose weight/samples weight x 100%
4.2 Residues:
1 g of samples is obtained and put into the crucible with constant weight under 700-800℃, heated slowly until samples are completely carbonized and then cooled to room temperature before adding 0.5ml sulfuric acid into crucible for moisture effect, after that heated slightly until the steam of sulfuric acid moves out completely. And fully carbonization by heating under7 00-800℃, and through displacing them into desiccator for cooling to normal temperature. In the end, put into crucible again under 700-800 ℃,and heat them slowly until no weight loses. Calculate.
Residues percentage=residues weight/ samples weight X 100%
5.2Microorganism determination
5.2.1 Before the disinfected equipments are placed into the buffer, the outside of the tablets boxes or bags should be cleaned by 2% lyso or 0.1% bromo-geramine solution, and disinfected by 75% alcohol before moving to buffer, open the sterile water-bath pot with constant temperature adjusted to 45±1℃, and open the ultra-violet light for exposure for half an hour
5.2.2 After ultra-violet light is closed for 30 minutes, the staff can wear disinfected shoes and go into buffer room, then wash hands with bromo-geramine solution, use sterile towel for drying and change clothes, trouser, hats, mask ,as well as disinfected shoes, when all are finished ,move the equipments to sterile room, close the door and unfold purified working table, put the melted meat soup and Rose Bengal Agar into the water bath under 45℃
5.2.3 The preparation for testing samples:
Two boxes of samples are obtained, and cleaned by 0.1% Bromogeramine and 75% alcohol respectively, disinfected and dried in turn. 10g samples are acquired and placed into the mortar, 100ml diluent are added (normal saline or phosphate buffer （0.1mol/L）)into the mortar for grinding . When finished, it is moved to 100ml graduated container to make into 1:10 control solution. Alternatively, put both samples and diluent solution into refining equipment with rotate speed 3000-5000 running for 1-2 minutes. After that, 1ml 1:10 testing solution is absorbed by one sucker with capacity I ml. Inject 9ml diluent along the test tube wall at the place 1 cm higher than the level of the solution to make 1:100, so repeat the above procedures further make 1:1000 solution. In the end, inject 1:10, 1:100 solutions into 4 plates respectively; inject 1:1000 solution into 2 plates, each plate 1ml.
5.2.4Inject diluent solution into 2 plates; each 1ml for comparison
5.2.5 Cultivation of bacterium:
Get 10ml of 1:10 testing solution, and then add 100ml prepared Bile Lactose Broth ,cultivate under the temperature 36±1℃ for 18～24 hours.
Get the 1ml control bacterium solution, and then add 100ml prepared Bile Lactose Broth ,cultivate under the temperature 36±1℃ for 18～24 hours.
5.2.6
the bottle of bouillon agar is Disinfected under 45℃ water, and then 0.1ml TT C is added into each 100ml bouillon agar, shaking evenly. solution are distributed equally to 4 plats, each plate 15ml, each group consists of 2 plates, and then rotate the plate for better mixing before stopping them for coagulating. So does the 1ml dilunet solution.
After the bottle of Rose Bengal Agar is disinfected, and then injected into 2 groups: 1:10 1:100.
When agars are all coagulated, bouillon agar plates are upside down, and placed in cultivated boxes under 30～35℃ for 48 hours , at the same time, Rose Bengal Agar are upside down and placed in cultivated boxes under 25～28℃ for 72±2 hours
5.2.7 The calculation of colony number, results
The back and face side of plates are Observed carefully, and calculated by eye directly or marked and calculated by calculating machine
If the average colony number of the three groups is between 30～300, the ratio between latter two is usually taken
Ratio=the average colony number of higher diluent level solution by its diluent times/ the average colony number of lower diluent level solution by its diluent times
When the ratio ≤2, the average colony number of the two group is taken as reported number
When the ratio ＞2, the average colony number by the diluent times is taken as reported number
If the average colony number of those groups is more than 300, the results reported should be: the colony number of the highest diluent group multiplies the diluent times.
If the average colony number of each group is not between 30～300. of those groups , one group is more than 300,but the neighbor group is less than 30, the results should be reflected by the number ,which better close to 30 or 300 .
If the average number of each dilution plate colonies is less than 30, the number should be calculated according to number of the lowest dilution multiply the multiples of dilution level for the report.
5.2.8 Separated cultivation
the bile salt lactose solution is shaken slightly after increasing bacteria cultivation for 18～24 hours , MacConkey agar plate are inoculated with1 or 2 lines gotten by vaccination ring pads under 36 ℃ ± 1 ℃for 18 ~ 24 hours, observation of the growth of bacteria, the typical colony of E. Coli on MacConkey agar plate is pink or central pink, round, flat, smooth and moist.
If there is no colony or suspected non-Colony growth on the separated Plate, it can be reported “not detected”. On the contrary, it should be identified again
5.2.9 Staining and results
sterile water is gained with oese and placed on a clean glass slide, and then a few bacteria moss is added, gently grinded, Air-dred or slightly heated, and thenthrough the flame 2 to 3 times for fixing smears.
Dropwise crystal violet dying solution, dyeing for 1 minute, washes.
Dropwise iodine solution, 1 minutes mordant dyeing, washing,
dropwise 95% ethanol for decolorating for about 20 to 30 seconds, or dropwise 95 percent ethanol over the entire smear, and then drop ethanol immediatelyover the smear to decolorate for 10 seconds , wash, dr y. Gaza drop yellow dye complex, stained 1 min, washed, to be dried.
Microscopy.
Staining Gram-positive bacteria were blue violet; red gram-negative bac teria
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