活性成分的英文

dosage strength = 每粒药含多少活性成分，5毫克，10毫克，就是两个strengths.potency = 药物的自身属性，譬如平均血药浓度10 ng/ml能导致50%的最大效应，potency就是10 ng/ml.dosage strength最权威的解释就是药物包装盒或药片上面写的标示剂量，这是法规或药物说明书中指定的药物剂量，例如每片5mg什么的。在药物的实际剂量中，这片剂可能是在5mg的5%或10%之间。有一些药物就直接写为strength，而没有dosage这个字。对这个名词的理解，只有药学专业的人员才很清楚。

牙菌斑:plaque (疾病及健康词汇: http://www.geocities.jp/ps_dictionary/medical2/102.htm)牙龈炎症gingivitis牙龈指数gingivitis index牙龈出血指数（bleeding index，BI）：检测标准testing standard适用范围Application scope牙膏toothpaste漱口水Mouthwash(Gargle, Dental water也可以的)制定本标准所参考的文献和标准Reference and criteria临床试验clinical trial活性成分Active Ingredients一般原则”（general principles）患者 suffers control对照随机randomization盲法(Blind Method)Stratified method分层功效应Effect口腔护理用品Oral & dental care Products阴性对照negative control阳性对照positive control赋形剂(excipitens).稳定性 stability生物利用度Biological Utilization药剂等效性, pharmaceutical equivalence安慰剂, placebo位点 site受试者subject成年男性和女性 male and female adults为符合纳入及排除标准的: 不能理解，抱歉，自己再改改吧！BOP Bleeding on probing颊侧buccal ridge舌侧lingualThe fourth part: Testing criteria of plaque reduction and gingivitis abating. Application scope: This criteria is applicable for the products for plaque reduction and gingivitis abating, including toothpaste, mouthwash and other products. Reference and criteria：Clinical trials of plaque reduction and gingivitis abatingFirst: General principles 1. The products containing new active ingredients or systems The effects of the products containing new active ingredients or systems for plaque reduction and gingivitis abating should be determined by two separate clinical trails. 2．The products containing the active ingredients determined by clinical trails The effects of oral & dental care products containing the active ingredients and systems determined by clinical trails for plaque reduction and gingivitis abating should be tested the equivalence between the products to be checked and the positive control products which contained the same concentration of active ingredients after choosing proper gingivitis suffers, and also should set up negative control or placebo control group. 3．The effects of the products (such as toothpaste) containing various excipitens（inactive ingredients）which may affect the activity of plaque reduction and gingivitis abating should be tested by clinical trails. 4．The biological utilization and stability of the active ingredients in the blend should be provided with available testimony by the applicant. Second: Research designs (randomization and control) Generally the blind method、the stratified method, and the dual-unit parallel observation are used as clinical research methods.Third: Testing periodThe period need for the clinical trails of plaque reduction and gingivitis abating is fairly long. Generally it should be six months, and three clinical check at least (baseline, three months, and six months).Fourth: Research objectives:The subjects should be male and female adults suffered from gingivitisGenerally the subject number should be more than 30 in a complete trail.Fifth: Checking index 1．The checking index should include acknowledged plaque index and the index which may reflect the gingivitis degree. The former includes plaque coverage (such as Quigley & Hein’s PLI modified by Turesky) or bacterium spot thickness (Silness & Löe’s PLI), stress on the observation of bacterium spots near and adjacent to the edge of the gum. If the above index is used, the reasons should be given. Record the degree of gingivitis expressed as bleeding index (BI) (Mazza), MBI, and BOP % (the percent of bleeding on probing sites to the total sites in the whole mouth after examination). The shape and color changing of gum edge and gum nipple could also be used as basic index, such as gingivitis index (GI). If other methods are used, they should have at least the same sensitivity as the above methods. 2．In principle, all the teeth in the mouth should be checked and recorded and six sites (Near-central of the buccal ridge, central of the buccal ridge, far-central of the buccal ridge, near-central of the lingual, central of the lingual, far-central of the lingual) or four sites (three sites of the buccal ridge and central of the lingual) of each tooth should be checked. The representative teeth shouldn’t be used(such as Ramfjord teeth, CPI teeth, etc).Sixth: Issue and application of products 1．The effective ingredients and concentration of the products to be checkedshould be the same as that of thepositive control products, other accessory ingredients should be the same or similar. Their appearance should be similar, if this requirement can not be achieve, then we can only fulfill the single-blind trail and issued the products by non-checkers.2. Tell the subjects about the using requirement and the attention. We should do quantification as possible, the dosage of toothpaste (such as 1 cm long, 10ml mouthwash or one cover of the bottle/time), applied times daily, duration etc. 3．The conditions should be kept identical as possible except for the testing products. If the subjects use the same toothbrush, their original brushing habits might be kept. For the following reasons: ① Even though they are taught the uniform methods, not always every person can grasp and abide them; ② we should make the experiment similar to various people in their natural lives.Seventh: Evaluation of effect1．According to medical stat. Method, we analyze the variation of the whole-mouth mean values of every index of the treatment group and the control group respectively before and after the tests, then analyzes the index variations during every period between the two groups. 2. The evaluation of the effect should be determined according to the mean value variation and block comparison of each clinical index. And all the values and stat. Results should be listed in the report, The subjective evaluated criterion should not be used alone（high effective, effective, little effective, non-effective）. In every clinical trail by comparison of the control group and the treatment group, every index reduction should meet the following conditions:[(Control-Treatment)/Control]≥15％。 3．The products for gingivitis controlling by reducing the amount of bacteric spots or change the disease caused by the bacteric spots should have significant difference.

dosage strength = 每粒药含多少活性成分，5毫克，10毫克，就是两个strengths.potency = 药物的自身属性，譬如平均血药浓度10 ng/ml能导致50%的最大效应，potency就是10 ng/ml. dosage strength最权威的解释就是药物包装盒或药片上面写的标示剂量，这是法规或药物说明书中指定的药物剂量，例如每片5mg什么的。在药物的实际剂量中，这片剂可能是在5mg的5%或10%之间。[例句]Biological and/ or immunochemical activity should be assessed using the same analytical procedures used to determine product potency.确定生物和/免疫化学活性的分析方法应当要和用来确定产品效力的分析方法一样。