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Question

新药长期毒性和“三致”试验方法之异同
在新药研究中由于试验的目的不同,长期毒性试验和突变、致畸、致癌(三致)试验的方法,从动物选择、剂量分组、给药途径、给药周期、观察指标、结果判断及评价等方面均有不同。本文仅从观察指标结果判断及评价二方面进行比较阐述。 1观察指标
1．1 长期毒性试验 一般体征、体重(每周测一次)、外观、行为、尿常规、血常规、肝肾功能及重要器官的肉眼观察和病理检查,必要时作骨髓检查,血液生化,大动物应检查心率和心电图变化。凡有可能引起眼、耳毒性的药物,应增加眼、耳毒性检查指标。有些药物尚研究对酸碱平衡、水盐代谢的影响,产生毒性反应的新药至少应对高剂量组和对照组的动物在给药期结束后继续进行观察,即最后1次给药后24小时每组处死2/3动物检测各项指标,留下1/3动物继续观察2～4周,再处死检查,以了解毒性反应的可逆程度和可能出现的延迟性毒性反应,对毒性较高、安全范围较小的特殊品种新药,如拟进行临床试验最好通过研究,找出一种解救药,备过量中毒时使用。
1．2 致突变试验 (1)哺乳动物培养细胞染色体畸变试验;每种浓度至少观察一百个中期分裂相细胞的染色体结构的异常及多倍体的出现率。(2)体内试验:①啮齿类动物微核试验:每只动物至少观察计数一千个多染红细胞,观察其微核出现的频度及多染红细胞和正成红细胞的比率。②啮齿类动物显性致死试验:交配的雌性动物在妊娠后期剖腹,观察子宫了胚胎着床数,生存胎仔数,死亡胎仔数及未着床数,显性致死率以DL表示:DL(%)=1-试验组妊娠鼠的平均生存胎仔数阴性对照组妊娠鼠的平均生存胎仔数×100%
1．3 致畸胎试验,全部动物在妊娠末期剖检,剖腹取出子宫卵巢,辨认和记录活胎数,早死胎数、晚死胎数、吸收胎数和黄体数,对活胎仔应辨别性别、称重、测量身长及尾长,仔细检查活胎仔的外观有无畸形,将每只母鼠的2/3活胎仔剥去皮肤和内脏,经脱水透吸及茜素红染色后,检查骨骼畸形,将1/3活胎仔浸入Bouin氏溶液中固定,供检查内脏畸形[8]。
1．4 致癌试验 ①预备试验:每天观察动物一般情况,每周测量动物体重,对死亡动物及试验期末的动物均需作大体解剖,并作病理解剖记录。肉眼观察,认为有病变或可疑病变的脏器进行病理组织学检查。②致癌试验:对所有动物每天应观察一般症状,开始时每周测1次体重和摄食量,第13周后,至少每4周测1次。应尽量减少肿瘤以外的死亡率。大鼠为24个月时,小鼠、地鼠18个月时,各组的存活率不少于50%,试验期末解或怀疑有血液疾患时,最好做末梢血液白血球及红血球计数。
2 结果判断及评价
2．1 长期毒性试验:第三类中药,如文献记载无毒,无十八反、十九畏配伍禁忌,双未经化学处理(水、乙醇粗提除外)的制剂,并有一定的临床资料可供借鉴,长期毒性试验可先用大鼠,给药时间为60～90天,如试验结果无明显毒性,可免做狗的长期毒性试验。

Answer 1

Long-term toxicity of new drugs and the "three to" test the similarities and differences
In trials of new drugs in the study of different purposes, the long-term toxicity tests and mutation, teratogenic, and carcinogenic (three of) the test method, from the choice of animals, dose group, route of administration, delivery cycle, observed, the result of judgement And evaluation and so on are different. This article only observed the results of judgement and evaluation described in comparison. 1 observed
1.1 long-term toxicity of the general signs, body weight (measured once a week), appearance, behavior, routine urine, blood, liver and kidney function and an important organ of the eye and pathological examination and, if necessary, for bone marrow examination, blood biochemistry, Large animals should check the heart rate and electrocardiogram changes. Where may cause eye, ear toxicity of drugs, should increase the eyes, ears toxicity indexes. Some drugs still on the acid-base balance, the impact of water and salt metabolism, toxicity of new drugs produced at least deal with high-dose group and control group of animals in the administration will continue after the end of observation, that is the last one every 24 hours after delivery Group executed 2 / 3 of animal testing indicators, leaving 1 / 3 of animals continue to observe two to four weeks, and then executed check to see the irreversible toxicity level and a possible delay of the toxicity of high toxicity, safety A smaller scope of the special varieties of new drugs, if any, to the best clinical trial conducted through research, to find a rescue medicine, by the use of excessive intoxication.
1.2 mutation test (1) mammalian cell culture chromosomal aberration test each of at least 100 medium-term observation of the splitting of the abnormal chromosome structure and the emergence of polyploid rate. (2) in test: ① rodents micro-nuclear test: each animal at least observe the counting of more than 1,000 PCE, observe its nuclear-and the frequency of PCE into cells and is the ratio of red blood cells. ② rodents dominant lethal test: the mating of the female animals in the latter part of pregnancy Caesarean section, the observation of uterine implantation of the embryo, fetal survival of Aberdeen, Aberdeen number of fetal deaths and the number of implantation, the death rate to DL dominant said: DL ( %) = 1 - pregnancy test group, the average survival of fetal mice Aberdeen negative control group of pregnant rats, the average number of live births Aberdeen × 100%
1.3 to teratogenic test, all the animals in the late Poujian pregnancy, Caesarean section the uterus removed ovarian, identify and record the number of live births, stillbirths as the number of stillbirths few nights, the number of births and yellow absorption of the number of live births in Aberdeen should identify gender, Weighing, measuring length and tail length, double-check the appearance of live births earners whether deformities, rats will each 2 / 3 of live births Tsai stripped the skin and internal organs, through absorption by dehydration and alizarin red stain, check bone deformity , 1 / 3 of live births Aberdeen immersed in Bouin's solution fixed for inspection visceral malformations [8].
① 1.4 carcinogenic test preparation test: daily observation of animals in general, the weekly animal body weight measurement, the dead animals and animal testing is required for the end of the Gross Anatomy, and autopsy records. The naked eye observation that there was suspicious lesions or lesions organ for pathological examination. ② cancer test: a day for all animals should be observed in general symptoms, measured at the start of a week, weight and food consumption, the first 13 weeks, at least every four weeks measuring 1. Should minimize the mortality rate of tumor outside. Rats for 24 months, mice, rats and 18 months, all groups of not less than 50 percent survival rate, the end of the trial or suspected blood disorder, it is best to do peripheral blood white blood cell and red blood cell count.
2 judgement and evaluation of results
2.1 long-term toxicity tests: The third category of Chinese medicine, such as documented non-toxic, non-anti-18, 19 Incompatibility fear, without a double-chemical treatment (water, ethanol extracts except) the preparation and a certain clinical Information for reference, the first long-term toxicity tests can be used rats, delivery time was 60 to 90 days, if no significant toxicity test results, the dogs do not require a long-term toxicity tests.
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感谢您为 Google 翻译提供翻译建议。我们会利用您的建议在将来更新我们的系统时提高翻译质量。 Long-term toxicity of new drugs and the "three to" test the similarities and differences <br> In trials of new drugs in the study of different purposes, the long-term toxicity tests and mutation, teratogenic, and carcinogenic (three of) the test method, from the choice of animals, dose group, route of administration, delivery cycle, observed, the result of judgement And evaluation and so on are different. This article only observed the results of judgement and evaluation described in comparison. 1 observed <br> 1.1 long-term toxicity of the general signs, body weight (measured once a week), appearance, behavior, routine urine, blood, liver and kidney function and an important organ of the eye and pathological examination and, if necessary, for bone marrow examination, blood biochemistry, Large animals should check the heart rate and electrocardiogram changes. Where may cause eye, ear toxicity of drugs, should increase the eyes, ears toxicity indexes. Some drugs still on the acid-base balance, the impact of water and salt metabolism, toxicity of new drugs produced at least deal with high-dose group and control group of animals in the administration will continue after the end of observation, that is the last one every 24 hours after delivery Group executed 2 / 3 of animal testing indicators, leaving 1 / 3 of animals continue to observe two to four weeks, and then executed check to see the irreversible toxicity level and a possible delay of the toxicity of high toxicity, safety A smaller scope of the special varieties of new drugs, if any, to the best clinical trial conducted through research, to find a rescue medicine, by the use of excessive intoxication. <br> 1.2 mutation test (1) mammalian cell culture chromosomal aberration test each of at least 100 medium-term observation of the splitting of the abnormal chromosome structure and the emergence of polyploid rate. (2) in test: ① rodents micro-nuclear test: each animal at least observe the counting of more than 1,000 PCE, observe its nuclear-and the frequency of PCE into cells and is the ratio of red blood cells. ② rodents dominant lethal test: the mating of the female animals in the latter part of pregnancy Caesarean section, the observation of uterine implantation of the embryo, fetal survival of Aberdeen, Aberdeen number of fetal deaths and the number of implantation, the death rate to DL dominant said: DL ( %) = 1 - pregnancy test group, the average survival of fetal mice Aberdeen negative control group of pregnant rats, the average number of live births Aberdeen × 100% <br> 1.3 to teratogenic test, all the animals in the late Poujian pregnancy, Caesarean section the uterus removed ovarian, identify and record the number of live births, stillbirths as the number of stillbirths few nights, the number of births and yellow absorption of the number of live births in Aberdeen should identify gender, Weighing, measuring length and tail length, double-check the appearance of live births earners whether deformities, rats will each 2 / 3 of live births Tsai stripped the skin and internal organs, through absorption by dehydration and alizarin red stain, check bone deformity , 1 / 3 of live births Aberdeen immersed in Bouin's solution fixed for inspection visceral malformations [8]. <br> ① 1.4 carcinogenic test preparation test: daily observation of animals in general, the weekly animal body weight measurement, the dead animals and animal testing is required for the end of the Gross Anatomy, and autopsy records. The naked eye observation that there was suspicious lesions or lesions organ for pathological examination. ② cancer test: a day for all animals should be observed in general symptoms, measured at the start of a week, weight and food consumption, the first 13 weeks, at least every four weeks measuring 1. Should minimize the mortality rate of tumor outside. Rats for 24 months, mice, rats and 18 months, all groups of not less than 50 percent survival rate, the end of the trial or suspected blood disorder, it is best to do peripheral blood white blood cell and red blood cell count. <br> 2 judgement and evaluation of results <br> 2.1 long-term toxicity tests: The third category of Chinese medicine, such as documented non-toxic, non-anti-18, 19 Incompatibility fear, without a double-chemical treatment (water, ethanol extracts except) the preparation and a certain clinical Information for reference, the first long-term toxicity tests can be used rats, delivery time was 60 to 90 days, if no significant toxicity test results, the dogs do not require a long-term toxicity tests.

Answer 2

Long-term toxicity of new drugs and the "three to" test the similarities and differences
In trials of new drugs in the study of different purposes, the long-term toxicity tests and mutation, teratogenic, and carcinogenic (three of) the test method, from the choice of animals, dose group, route of administration, delivery cycle, observed, the result of judgement And evaluation and so on are different. This article only observed the results of judgement and evaluation described in comparison. 1 observed
1.1 long-term toxicity of the general signs, body weight (measured once a week), appearance, behavior, routine urine, blood, liver and kidney function and an important organ of the eye and pathological examination and, if necessary, for bone marrow examination, blood biochemistry, Large animals should check the heart rate and electrocardiogram changes. Where may cause eye, ear toxicity of drugs, should increase the eyes, ears toxicity indexes. Some drugs still on the acid-base balance, the impact of water and salt metabolism, toxicity of new drugs produced at least deal with high-dose group and control group of animals in the administration will continue after the end of observation, that is the last one every 24 hours after delivery Group executed 2 / 3 of animal testing indicators, leaving 1 / 3 of animals continue to observe two to four weeks, and then executed check to see the irreversible toxicity level and a possible delay of the toxicity of high toxicity, safety Smaller scope of the special varieties of new drugs, if any, to the best clinical trial conducted through research, to find a rescue medicine, by the use of excessive intoxication.
1.2 mutation test (1) mammalian cell culture chromosomal aberration test each of at least 100 medium-term observation of the splitting of the abnormal chromosome structure and the emergence of polyploid rate. (2) in test: ① rodents micro-nuclear test: each animal at least observe the counting of more than 1,000 PCE, observe its nuclear-and the frequency of PCE into cells and is the ratio of red blood cells. ② rodents dominant lethal test: the mating of the female animals in the latter part of pregnancy Caesarean section, the observation of uterine implantation of the embryo, fetal survival of Aberdeen, Aberdeen number of fetal deaths and the number of implantation, the death rate to DL dominant said: DL ( %) = 1 - pregnancy test group, the average survival of fetal mice Aberdeen negative control group of pregnant rats, the average number of live births Aberdeen × 100%
1.3 to teratogenic test, all the animals in the late Poujian pregnancy, Caesarean section the uterus removed ovarian, identify and record the number of live births, stillbirths as the number of stillbirths few nights, the number of births and yellow absorption of the number of live births in Aberdeen should identify gender, Weighing, measuring length and tail length, double-check the appearance of live births earners whether deformities, rats will each 2 / 3 of live births Tsai stripped the skin and internal organs, through absorption by dehydration and alizarin red stain, check bone deformity , 1 / 3 of live births Aberdeen immersed in Bouin's solution fixed for inspection visceral malformations [8].
① 1.4 carcinogenic test preparation test: daily observation of animals in general, the weekly animal body weight measurement, the dead animals and animal testing is required for the end of the Gross Anatomy, and autopsy records. The naked eye observation that there was suspicious lesions or lesions organ for pathological examination. ② cancer test: a day for all animals should be observed in general symptoms, measured at the start of a week, weight and food consumption, the first 13 weeks, at least every four weeks measuring 1. Should minimize the mortality rate of tumor outside. Rats for 24 months, mice, rats and 18 months, all groups of not less than 50 percent survival rate, the end of the trial or suspected blood disorder, it is best to do peripheral blood white blood cell and red blood cell count.
2 judgement and evaluation of results
2.1 long-term toxicity tests: The third category of Chinese medicine, such as documented non-toxic, non-anti-18, 19 Incompatibility fear, without a double-chemical treatment (water, ethanol extracts except) the preparation and a certain clinical Information for reference, the first long-term toxicity tests can be used rats, delivery time was 60 to 90 days, if no significant toxicity test results, the dogs do not require a long-term toxicity tests.

Answer 3

In trials of new drugs in the study of different purposes, the long-term toxicity tests and mutation, teratogenic, and carcinogenic (three of) the test method, from the choice of animals, dose group, route of administration, delivery cycle, observed, the result of judgement And evaluation and so on are different. This article only observed the results of judgement and evaluation described in comparison. 1 observed
1.1 long-term toxicity of the general signs, body weight (measured once a week), appearance, behavior, routine urine, blood, liver and kidney function and an important organ of the eye and pathological examination and, if necessary, for bone marrow examination, blood biochemistry, Large animals should check the heart rate and electrocardiogram changes. Where may cause eye, ear toxicity of drugs, should increase the eyes, ears toxicity indexes. Some drugs still on the acid-base balance, the impact of water and salt metabolism, toxicity of new drugs produced at least deal with high-dose group and control group of animals in the administration will continue after the end of observation, that is the last one every 24 hours after delivery Group executed 2 / 3 of animal testing indicators, leaving 1 / 3 of animals continue to observe two to four weeks, and then executed check to see the irreversible toxicity level and a possible delay of the toxicity of high toxicity, safety Smaller scope of the special varieties of new drugs, if any, to the best clinical trial conducted through research, to find a rescue medicine, by the use of excessive intoxication.
1.2 mutation test (1) mammalian cell culture chromosomal aberration test each of at least 100 medium-term observation of the splitting of the abnormal chromosome structure and the emergence of polyploid rate. (2) in test: ① rodents micro-nuclear test: each animal at least observe the counting of more than 1,000 PCE, observe its nuclear-and the frequency of PCE into cells and is the ratio of red blood cells. ② rodents dominant lethal test: the mating of the female animals in the latter part of pregnancy Caesarean section, the observation of uterine implantation of the embryo, fetal survival of Aberdeen, Aberdeen number of fetal deaths and the number of implantation, the death rate to DL dominant said: DL ( %) = 1 - pregnancy test group, the average survival of fetal mice Aberdeen negative control group of pregnant rats, the average number of live births Aberdeen × 100%
1.3 to teratogenic test, all the animals in the late Poujian pregnancy, Caesarean section the uterus removed ovarian, identify and record the number of live births, stillbirths as the number of stillbirths few nights, the number of births and yellow absorption of the number of live births in Aberdeen should identify gender, Weighing, measuring length and tail length, double-check the appearance of live births earners whether deformities, rats will each 2 / 3 of live births Tsai stripped the skin and internal organs, through absorption by dehydration and alizarin red stain, check bone deformity , 1 / 3 of live births Aberdeen immersed in Bouin's solution fixed for inspection visceral malformations [8].
① 1.4 carcinogenic test preparation test: daily observation of animals in general, the weekly animal body weight measurement, the dead animals and animal testing is required for the end of the Gross Anatomy, and autopsy records. The naked eye observation that there was suspicious lesions or lesions organ for pathological examination. ② cancer test: a day for all animals should be observed in general symptoms, measured at the start of a week, weight and food consumption, the first 13 weeks, at least every four weeks measuring 1. Should minimize the mortality rate of tumor outside. Rats for 24 months, mice, rats and 18 months, all groups of not less than 50 percent survival rate, the end of the trial or suspected blood disorder, it is best to do peripheral blood white blood cell and red blood cell count.
2 judgement and evaluation of results
2.1 long-term toxicity tests: The third category of Chinese medicine, such as documented non-toxic, non-anti-18, 19 Incompatibility fear, without a double-chemical treatment (water, ethanol extracts except) the preparation and a certain clinical Information for reference, the first long-term toxicity tests can be used rats, delivery time was 60 to 90 days, if no significant toxicity test results, the dogs do not require a long-term toxicity tests.

Answer 4

厉害，这个也有人帮忙的啊！！

Answer 5

ddd