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糖肾颗粒(简称糖肾)是浙江省中药研究所有限公司研制开发的中药、天然药第6(2)类新药,为保证其用药安全性,我们进行了大鼠4个月的长期毒性试验。试验结果表明:SD大鼠分别经...
糖肾颗粒(简称糖肾)是浙江省中药研究所有限公司研制开发的中药、天然药第6(2)类新药,为保证其用药安全性,我们进行了大鼠4个月的长期毒性试验。试验结果表明:SD大鼠分别经口给予“糖肾” 60、30和15g(生药)/(kg.d)三个剂量(简称高、中、低剂量),连续4个月,对大鼠的外观体征、活动情况等均无不良影响;大剂量和中剂量糖肾对大鼠体重增长有轻度影响,表现为高剂量和中剂量给药组大鼠在给药的一段期间(雄性大鼠2-16周,雌性大鼠2-17周)内体重增长速度慢于相应时间的对照组,但无显著性差异;给药3个月(给药中期)、对血液学、生化学指标、脏器系数检测未发现不良影响,给药各组的各项指标测定值与对照组比较及与本所建立的正常值比较均属正常;个别脏器的脏器重量、系数与相应时间的对照组比较有轻重和高低差异,但脏器外观正常,病理组织学也未见任何肉眼和镜下可见的病理形态学和组织学改变。三个阶段给药组全部所检脏器经病理组织学检查,均未有肉眼和镜下可见的任何病理形态学和组织学变化,与对照组大鼠相同。结果表明糖肾颗粒按拟定的临床服用剂量(68g生药/人/日)及疗程服用是安全的。
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The sugar kidney pellet (abbreviation sugar kidney) is the ZhejiangProvince research institute of traditional Chinese medicine limitedcompany develops the development the Chinese native medicine, thenatural medicine 6th (2) a kind of new medicine, for guaranteed itwith the medicine security, we has carried on the big mouse 4month-long long-term toxicity tests. The test result indicated that,The SD big mouse separately passes through the mouth to give "thesugar kidney" 60, 30 and 15g (crude drugs)/(kg.d) three dosage (iscalled high, center, low dosage), continuously 4 months, draft, theactive situation to the big mouse's outward appearance body and so onthe good influence; The large dose and center the dosage sugar kidneyhas the mild influence to the big mouse body weight growth, displaysfor the high dosage and center the dosage for the medicine group bigmouse in gives the medicine section of period (male big mouse 2-16week, female big mouse 2-17 week) in the body weight rate of riseslowly to the corresponding time comparison group, but does not have显著性 the difference; For the medicine 3 months (for medicineintermediate stage), to the hematology, the biochemistry study target,the internal organs coefficient examination discovery not good hasnot affected, for medicine each group's each target measured thedefinite value and the comparison group comparison and quite even isnormally with this institute establishment normal value; Theindividual internal organs internal organs weight, the coefficient andthe corresponding time comparison group compares has the weight andthe height difference, but the internal organs outward appearance isnormal, the histo-pathology has not seen under any naked eye and themirror the obviously pathology morphology and the histology change.Three stages completely examine the internal organs for the medicinegroup after the histo-pathology inspection, has not had under thenaked eye and the mirror the obviously any pathology morphology andthe histology change, is same with the comparison group big mouse. Theresult indicated the sugar kidney pellet according to draws upclinical takes the dosage (68g crude drugs/person/date) and thetreatment course takes is safe.
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