1、Direction For Live Combined Bifidobacterium and Lactobacillus TabletsDrug Name：General Name：Live Combined Bifidobacterium and Lactobacillus TabletsTrade Name：Golden BifidIngredient：Bifidobacterium longum，Lactobaeillus bulgaricus and Streptococcus thermophilusThree activeComponents were produced by u
2、s according to authorized manufacture procedure and identify procedureDescription：Milky white or light yellow tablet，attend by yellow speckle Indications：Golden Bifid is mainly used in the treatment of diarrhea which is due to bacteria group out of balance0f chronic diarrhea，of constipation or diarr
3、hea which is unavailing by the treatment of antibiotics drugSpecification：05gtablet no less than fifty million living Bifidobacterium，five million living Lactobacillus bulgaricus and Streptococcus thermophilusAdministration and Dosage：Orally，four tablets each time，two or three times dailyTake medici
4、ne with warmwater or warmmilkAdverse reaction：No adverse reactionPoint for attention：Cold storageSeal up for safekeeping in vacuum，Please take it as soon as possible after opening the packEarlv childhood：OrallyEarly childhood of six months，one tablet each time，two or three times daily；Six months to
5、three years oldtwo tablets each time，two or three times daily；three years to twelve years old，three tablets each timetwo or three times dailyTake medicine with warm-water or warm-milkBaby takes crushed mediclne with warm-milkElderly patients：lndiscrimination with adultDruggery reciprocity：This produ
6、ct is susceptible to Benzylpenicillin，Ampicillin sodium， Clindamycin hydrochloride，CephalothinStagger medication hoursOverdosage： During mouse toxicity experiment50 55g drug powder was perfused into stomach of a mouse per kilogramme avoirdupois，doses is 50 times of adults，observe for 1 4 days in row
7、didn t see toxicity reaction.Pharmacological and toxicological action：Pharmacological action：This product can directly replenish beneficial bacteria eauilibrate intestinal bacteria groups and restrain intestinal bacteria which do harm latently to humanToxic010gical action：We take 60 healthy Kunming
8、mouse，the weight of these mouse are between 1 8-22g and divided these mouse into 2 sets randomlyThey were infused by the stomach to medicine once everyday,glVe the medicine set this article dilution liquid 0 3ml，the amount of it is equal to take orally of this article 50-5 5gkg weightthe bland match
9、ed set gives with same quantity physiology brine，observe for 14 days in a row，and durinz the period of testing of the third day，the seventh day and the fourteenth day，live to kill the mouse to do a oath010gic sliceThe results of the experiment showed：compared with the bland matched set，the medicine
10、set had n0 adverse reactions for 14 days observation，pathologic slice ofheart， liver，spleen，kidney are much the same.Pharmacokinetics：Three kinds of bacteria which are Bifidobacterium longum，Lactobacillus bulgaricus and StreptocOCCBS thermophilus are normal physiological bacteria groups in intestine
11、s of the healthy humanThey can grow and reproduce in human intestinesStorage：Keep it in 2-8，dark and dry place双歧杆菌乳杆菌三联活菌片说明书【药品名称】通用名称：双歧杆菌乳杆菌三联活菌片商品名称：金双歧英文名称：1ive combined Bifidobac，ter 。lum and Lactobacillus tablets汉语拼音：shuangqiganjun Ruganjun Sanlian Huojunplan【成 份】 长型双歧杆菌、保加利亚乳杆菌和嗜热链球菌。三种活性成份均
12、按批准的制造及检定规程自行生产得到。【性 状】本品为乳白色或微黄色片剂，间有黄色色斑。【适 应 症 】用于治疗肠道菌群失调引起的腹泻、慢性腹泻、抗生素治疗无效的腹泻及便秘。【规 格】 0.5 克片，每片含长双歧杆菌活菌应不低于 0.510cFu，保加利亚乳杆菌和嗜热链球菌活菌均应不低于 05x10。CFU。【用法用量】口服，一次 4 片，一日 23 次。温开水或温牛奶冲服。【注意事项】1适宜于冷藏保存。2本品真空封装，开袋后应尽快服用。【儿童用药】口服，6 个月内婴儿一次 1 片，一日 23 次：6 个月至 3 岁小儿一次 2 片，一日 2-3 次；3 岁至 12 岁小儿一次 3 片，日 23
13、 次。温开水或温牛奶冲服，婴幼儿可将药片碾碎后溶于温牛奶冲服。【老年用药】与成人无差异。【药物相互作用】本品对青霉素、氨苄青霉素、氯洁霉素、先锋霉素等敏感，如同时使用请错开用药时间。【药物过量】在小鼠毒性实验中，小鼠经灌胃给药 5.0-5.5gkg 体重，剂量约是成人的 50 倍。连续观察 14 天，未见毒性反应。【药理毒理】药理作用：本品可直接补充人体正常生理细菌，调整肠道菌群平衡，抑制并清除肠道中对人具有潜在危害的细菌。毒理作用：取健康昆明种小鼠 60 只，体重 1822g，雌雄各半，随机分成 2 组，每天经口灌胃给药 1 次，给药组给予本品稀释液03ml，剂量相当口服本品 5.0-5.5gkg 体重，空白对照组给予等量生理盐水，连续观察 14 天，并在实验过程中的第 3 天、第 7 天、第 14 天活杀小鼠做病理切片。试验结果表明：本品口服给药剂量为 5.0-5.5gkg 体重时，与空白对照组相比，观察至 14 天小鼠无不良反应，心、肝、脾、肺、肾病理切片无变化。【药代动力学】本品所含三种菌，长型双歧杆菌、保加利亚乳杆菌和嗜热链球菌，皆为健康人肠道正常菌群，可在人体肠道中生长、繁殖。【贮 藏】28避光于燥处保存。毕业论文08 届石河子大学成人药剂学大专班姓名：李红梅
