[生物医药论文精品]五味子糖浆中防腐剂的防腐效力测定

五味子糖浆中防腐剂的防腐效力测定摘要目的测定五味子糖浆中防腐剂对大肠埃希菌、金黄色葡萄球菌、铜绿假单胞菌,白色念珠菌和黑曲霉的抑菌作用。方法将5种微生物接种在五味子糖浆中,经不同时间，用微生物限度检查测定其防腐效力。结果对大肠埃希菌、金黄色葡萄球菌、铜绿假单胞菌,白色念珠菌有较强的抑菌作用结论五味子糖浆中防腐剂的防腐效力符合美国药典标准。关键词五味子糖浆防腐剂防腐效力TESTONTHEANTISEPTICEFFECTSOFPRESERVATIVEINWUWEIZISYRUPABSTRACTOBJECTIVETHEANTISEPTICEFFECTSOFPRESERVATIVESINWUWEIZISYRUPONESCHERICHIACOLI,STAPHYLOCOCCUSAUREUS,PSEUDOMONASAERUGINOSA,CANDIDAALBICANSANDASPERGILLUSNIGERWERETESTEDMETHODSINOCULATE5KINDSOFMICROORGANISMSINWUWEIZISYRUP,THEABILITYOFPRESERVATIONFROMDECAYWASTESTBYMICROBIALLIMITINDIFFERENTTIMESRESULTTHATHASSTRONGERINHIBITIONEFFECTFORESCHERICHIACOLI,STAPHYLOCOCCUSAUREUS,PSEUDOMONASAERUGINOSA,CANDIDAALBICANSCONCLUSIONSTHEANTISEPTICEFFECTSOFPRESERVATIVESINWUWEIZISYRUPMETREQUIREMENTINTHEUSPVERSIONKEYWORDSWUWEIZISYRUP；PRESERVATIVE；ANTISEPTICEFFECTS为了控制药品质量，在一些制剂中加入一定量的防腐剂是常用的方法之一,中国药典2005年版对糖浆剂中防腐剂山梨酸的用量规定不得超过03G8,山梨酸G19090的G7444菌抑菌G5627G14033G994山梨酸G11468同,G16780G3822糖浆剂中用山梨酸G19090,其用量G6365山梨酸G16757,为了G13783G4531在G17837一G8999度G991是G2554有防腐效力，G12520G13785G2454G13783G7003G10498A1A0A2，对五味子糖浆中的防腐剂山梨酸G19090G17839G15904了防腐效力测定，G10628G1183G13473G3926G9911、实验材料G14841G1871G10768G14038G3533G1871G3534，G10623G10820G13430G19060G10768G14038G3533G1871G3534，G14841G1871G13917G8760G3533G1871G3534，G6925G14403G20544G981G3533G1871G3534，G6925G14403G20544G981G10768G14038G3533G1871G3534G708G3533G1871G3534G3355为G2283G1152三药G12197G6228有限G1856G2508生G1147G709；铜绿假单胞G7450菌G62G38G48G38G38G11G37G12G200G200G23G64，金黄色葡萄球菌G466CMCCB26003G467，大肠埃希菌G466CMCCB44102G467，白色念珠菌G466CMCCF98001G467，黑曲霉菌G466CMCCF98003G467G708菌种G3355为中国G2319G4410微生物菌种G1457G15267G12661G10714中G5527G6564G1391G709；五味子糖浆G708G6221G2507G726070401、070402、070501，生G1147单G1313为G7702G7531G16041G8677药G1006G709。2、实验方法21菌液的制备A1A3A2G2474大肠埃希菌、金黄色葡萄球菌、铜绿假单胞菌的G7044G21104G3533G1871物接种G14279G14841G1871G13917G8760G3533G1871G3534，经37G263G3533G18711824G4579时，G3803用。G2474白色念珠菌的G7044G21104G3533G1871物接种G14279G6925G14403G20544G981G3533G1871G3534，经25G263G3533G187124G79448G4579时，G3803用。G2474经25G263G3533G18715G7947G3837的黑曲霉菌G6925G14403G20544G981G10768G14038G7024G19766G3533G1871物，用G7092菌09G705G8707G2282G19060G9354G9094G8939G991霉菌G4406子，G3803用。22菌液浓度的测定G2010G2047G2474G990G17860菌G9094G17878量，用G7092菌09G705G8707G2282G19060G9354G9094G6365G2325G1505G13007G2027G12244G18334G2052G17878G4464的G12244G18334度,G2474G12244G18334G9094G20G80G79加入G5191G11411中，G5191G15904制G3803G1016G1022G5191G11411，G12447G2375G1554G889245G263G1343415MLG11468应的G10768G14038G3533G1871G3534，待凝固后，细菌置30G79435G263G3533G187124G79448H，真菌置23G79428G263G3533G187148G79472H，逐日点G16757结果。G6365测定的菌数结果G16757算出各菌G9094的G8999度。23防腐效力测定方法及结果G247420G80G79五味子糖浆5份,G2010G2047加入G990G17860已G3803妥的菌悬G9094各G17878量G11接种菌G9094的体积不超过G1391试G9094体积的G20G8,使G11468加后的最终含菌G8999度为G200A5A6CFU/G80G79G12，作为G1391试G9094，在20G79425G263避光密闭G1457存。G2010G2047经0、6、2G23、G238H及7、G20G23、28D等规定时间，G636522项方法测定各G1391试G9094的活菌G8999度，结果见表G20。表G20接种不同时间段各菌存活G8999度A4A7A8A9A10A11A12A13A14A15A16由表G20可知，G1391试品G1457存7G3837时，大肠埃希菌、铜绿假单胞菌和金黄色葡萄球菌已未检出；G1457存G20G23G3837时，黑曲霉菌虽G14033检出，数量已大大降低，28G3837时已未检出。3讨论31因目前我国药典未收载防腐剂效力测定法，亦G7092判断标准，本G7003G2454照美国药典对实验结果作判断，G2375在G991G2027情况G1391试G9094中的防腐剂是有效的G726在G20G23D，存活细菌G8999度减少G2052不G3822于最初活菌G8999度的0G20G8；在G20G23D，活霉菌及酵母G8999度G1457持或低于最初活霉菌及酵母G8999度；试验菌样品G6221G2507活菌G16757数G708CFU/G80G79G7090H6H2G23HG238H7DG20G23D28D大肠埃希菌070G230G202G20G200A17G23G200/070G230227G200A177G200/07050G20G23G20G200A179G200/金黄色葡萄球菌070G230G20G2007G200A1827G200A1738G200A19G232/070G230276G200A1825G200A1750G200A1958/07050G2088G200A1823G200A173G23G200A1966/铜绿假单胞菌070G230G20G208G200A1770G200A198/070G2302G209G200A1779G200A192/07050G202G20G200A1767G200A196/白色念珠菌070G230G20G206G200A18G23G23G200A17200/070G2302G206G200A186G20G200A17260/07050G20G207G200A18G23G20G200A17G20G230/黑曲霉菌070G230G20G20G20G200A1882G200A1755G200A1738G200A17G23G200220/070G2302G20G20G200A1873G200A1760G200A1737G200A176703G230/07050G20G202G200A1887G200A1770G200A1739G200A17530G2300/在28D检查周期内的其余时间，每一种G1391试G9094的微生物G8999度仍G1457持或低于指定水G5191。由G990G17860测定结果可知，五味子糖浆中的防腐剂山梨酸G19090在处方中的G8999度G991是有防腐效力的。32山梨酸G19090主要在酸G5627G9354G9094中形成G2010子态的山梨酸才G14033G17839入细胞而起抑菌作用,PH值低于G23时,山梨酸抑菌活G5627高,当PH值高于6时,抑菌活G5627低A20A21A22。五味子糖浆PH值为5左右，G10714论G990山梨酸G19090在其中亦是有效的。G12520G13785根据中国药典2005年版对五味子糖浆建G12447微生物限度检查法时，直接G2474原G9094为G1391试G9094，5种试验菌用常规法G2375可达90G8以G990，因此在本实验中所采用的测定G1391试G9094的活菌G8999度方法G708常规法G709是可G15904的，也说明使山梨酸G19090抑菌活G5627可忽略不G16757，其原因主要有G1016G1022G726一是所用G3533G1871G3534PH值为7，山梨酸G19090抑菌活G5627低；二是山梨酸G19090在G3533G1871G3534中的G8999度已非常低，不足以抑菌。33本实验结果表明，五味子糖浆G3926污染了以大肠埃希菌、金黄色葡萄球菌、铜绿假单胞菌及白色念珠菌为代表的G1972G12879微生物，存G6930G238H后，已检测不出；G3926污染了以黑曲霉为代表的霉菌，存G693028G3837后，也检测不出。G17837样的检测结果虽G9994是样品符合规定，G1306G5194不G14033真实G3332G2465G7156生G1147的G2367生G10378况，因此为了G7368G17839一G8505G1457G16789样品质量，在样品为G2334成品及G2030为成品时G2375G17839G15904微生物限度检查是G5529不可少的。了A23A24A25A26A24A25A27A28A29A30A31A32A33A34A35A36A37A38A39A40A41A42A43A44A14A45A46A47A28A48A30A38A49A50A27A51A52A15A53A54A34A55A56A56A57A38A2