TCACM009-2016元胡止痛片产品质量标准

4.4. $ᴳ۲ᠵ⚓GB/T11—2009㐅ܦ⮰㻰݅䊣㡵$ᴳ۲⮰2䘔ឬᱛڱქfiᣔ㡼ᕓ$ᴳ۲౔䖡Ϻ《͙ࡺϦℽڝ4఩㢛M》⮰ദ⵬k᣼ܦβٯ㘍₎⬇❳ф䉔ϓ৭ᴳ۲$ᴳ۲⩝͙఩͙“⻽႒䮎͙㢛ⵀ⾢ᝬ͙㢛᫜㢛䃪䃍䄪䷄㏰᣼ܦ$ᴳ۲⩝͙ࡺ͙“㢛႒цᑾD$ᴳ۲⩝͙఩͙“⻽႒䮎͙㢛ⵀ⾢ᝬ䉋䉏䊣㡵,ᆝ͈Ⱝ⻽႒䮎㜖fiࡂᝬ、ڜጊ҇ᙴݢ䭼ژत、↋㟻Ꮳ㑄㢛͆㗍Щᰵ䭼ژत、఩㢛䯲ఎᓣу(҇ᆝ)㢛͆ᰵ䭼ژत、⇟ࢃ㓆䨼ݢ㢛㗍Щᰵ䭼ژत、ࡺ⋒̵Ή(᳏Ꮀ)㢛͆ᰵ䭼ژत、๖Ჭ䯲ఎ䛹Ꮂᵼʥ䬭㢛Jᰵ䭼ژत、νࢃḹ➕㢛͆ᰵ䭼ژत、фጉ⻪⋒ݢ㢛ᰵ䭼ژत、Ꭻጊgνᆝ4䃜台ഀ͙㢛ᰵ䭼ژत、φ჉㢛͆䯲ఎ㗍Щᰵ䭼ژत、䉡ጊ⮪□;͆䯲ఎݢ㢛㗍Щᰵ䭼ژत、冭ࢃࣆᮚݢ㢛ᰵ䭼ژत、⩄㖯∜Ꮳݢ㢛ᰵ䭼ژतふ$ᴳ۲䊣㡵㏰䉋䉏Ϧ:䃤⊣™、Ე≖ۇ$ᴳ۲䊣㡵ͧ㺭࣮̺ϦॠႻы、ᱺ⣮、ᱺӶy、㕫φ、ᝄ⮿、Ე™ࡺ、⢷ᡛ͙、ॠᓣ⊣、᪸¼㐓ᇃ䗽䱊、ᶱʥ台↋ಐࡍʥ䒵、⚶᭿ν݄ₒࢌ᜼哅、⢷ტᑦT/CACM009—元胡止痛片优质产品质量标准$ᴳ۲㻰჆βٯ㘍₎⬇❳ф䉔ϓ৭⮰䉔䛻ᴳ۲,k᠘䞠ݗ、φ䛻≷჆᫥∁ࣶڢ䭼Ꮢ$ᴳ۲䔮⩔κٯ㘍₎⬇❳ф䉔ϓ৭ᴳ۲⮰ݐ჆̷݃@Т͙⮰᲍䕆䓳$ᴳ۲⮰ᑁ⩔㔸᜼fi$ᴳ۲⮰᲍,ᄥκ$ᴳ۲⮰Ꮐ⩔᭛ᓱ̹4ᄽ⮰。᭛∔0᱋⮰ᑁ⩔@Т,ϱᝬ∔0᱋⮰❴$䔮⩔κ$ᴳ۲。܍᭛̹∔0᱋⮰ᑁ⩔@Т,k᠘ᝬᰵ⮰Ԛᩥࢁ)䔮⩔κ$ᴳ۲《͙ࡺϦℽڝ4఩㢛M》2015GBT191《k㷱ה䓼ప⹦ᴳᔃGB/T13016—2009《ᴳ۲ѿ㈧Q㑂ݢ࣋݅4㺭ⅮGBT11—2009《ᴳ۲ࡂ጑҈ᄨ݅1䘔ܲᴳ۲⮰㏿Ჰ4㑂ۅGBT200001—2002《ᴳ۲ࡂ጑҈ᠳࢃ1䘔ܲ:ᴳ۲ࡂ4Ⱔ3≧fi⮰䕆⩔䃹ⅳISO2:1996,MOD)̷݃ᱛ䄙4჆Ỳ䔮⩔κ$ᴳ۲3.3.

$ᴳ۲⊵ࣶ⮰ݮಷfi❳ݮHighgradeChinesepatent͙㢛ф䉔ϓ৭᭛ᠳ䛳⩔ф䉔͙㢛ᱼ䕿౜㢛ᱼ)4ф䉔䒱᫅ڣᰵऴ䔮⮰ݮݢ጑㞦、㫻4䓼䒿᲍Т⮰ϓ৭,ڣᰵ䉔䛻⽟჆、⫃ᩴຩ4Ⴕ2ᕓᰵԉ䯈ふ➥◥。͙㢛ф䉔ϓ৭䉔䛻Ꮐ⩔。3.ٯ㘍₎⬇❳ф䉔ϓ৭᭛ᠳ䛳⩔ф䉔䕿౜)ᐢ㘍㉎4g㟣ݢำ㔸᜼⮰͙㢛ф䉔䉔䛻⽟჆、⫃ᩴຩ4Ⴕ2ᕓᰵԉ䯈ふ➥◥。ٯ㘍₎⬇❳ф䉔ϓ৭䉔䛻ᴳ۲᜼fiݐ᫙䄑䛻⮰䛹㺭Ӊg,䄑䉔䛻ᴳ۲ͧ㺭k᠘ᐢ㘍㉎΅㉌、㉗ളⷝ4⁓ݹ㘍㉌φ䛻≷჆᫥∁4φ䛻䭼Ꮢ,ڢ͙㉗ളⷝ̺㵬ネ㜾ᑌ≧ᕓ᭪㦃Ⱔ3。4.1. ٯ㘍₎⬇❳YuanhuZhitong4.1. 䚷ᐢ㘍㉎445g,g㟣223g4.1. Бkθটंg166g,ㆵⶺ᜼㏲ㆵ,ޕ҅⮰g㟣̺䚷ᐢ㘍㉎ㆵⶺ᜼㇃ㆵ,60΅ᄻᬢ,ఊ≭᣼ं2⁍,じ—⁍3ᄻᬢ,じθ2ᄻᬢ,␐䓳,ऴᎢ␐⋞,Ꭲ≿㑕᜼⟢,ڑߌk䔜T/CACM009—㏲ㆵ,ݢ᜼䷃ㆾ,ࢷݢ᜼1000❳,k㈂Qᝂ㪰㛈Q,࢟ᓃ4.1. $৭fi㈂Q❳ᝂ㪰㛈Q❳䮐ࣧkQg᭪ḁ台㞞㜟ḁ㸼㞞;⅀仅,টp4.1. ⤲⅀,≧㵬,₎⬇。⩔κ⅀␊㵬⬬䃭⮰㗯⬇、㗭⬇、๠⬇ࣶ⬇㏻4.1. D᰹。—4~5❳—03⁍ᝂ䖡“ଢ଼4.1. 㪰㛈Q❳:⃻❳䛹026g;㪰㛈Q❳:⃻❳䛹031g;㈂Q❳:ᓯ䛹025g;ᓯ䛹030g。4.1. ჲ䬙4.2. 4211 ं$৭10❳,䮐ࣧkQ,ⵀ㏲,ߌ⩞䚳50mL,䊱ผะ⤲30ܲ䧋,␐䓳,ࡂg5gᡛᥳ᪜ܲ䧋␐䓳␐⋞㧤çfi⍏ߌⅠ䔮䛻ҫ⏢㼏ߌ≿pH9~10,⩔΅䛆ᡛᥳ᣼ं3⁍⃻10mL΅䛆⋞㧤çfi⍏ߌ⩞1mLҫ⏢㼏҈fiӇ䄁৭⏢⋞ऒंᐢ㘍㉎ᄥ⚓㢛ᱼ1g,ߌ⩞50mL,䊱ผะ30ܲ䧋,␐䓳,㜖␐⋞㧤ç冶䊣,⋞。⚓㪰ᅮ㞞䅝∁䄁侸,।ंk䔜͐⻹⏢⋞र2~3L,ݗܲ◥κस—⩔1%ⅎ⅓ࡂ䧌㘢G㪰ᅮᲫk,Б₏ጝ☣-̵⅛⩞☣-⩞䚳(7.5颐4颐1)fiᆁᐬݮ,㒚⩔ᆁᐬݮ䶰亝4ܲ䧋⮰ᆁᐬ㑤ڱ,ᆁᐬ,ंܦ,᮪ç,Бⷄ㧤⅀⚻㜟᪽◥᭪㞞⌱ᮜ。Ӈ䄁৭㞞䅝͙,౔̺ᄥ⚓㢛ᱼ㞞䅝ⰤᏀ⮰ѹ㒚k,᭪Ⱔस䷈㞞⮰᪽◥;ᡑᅩᲫk।䭰⮰ⷄg,㒚㉗โٵ▛(365nm)̷ᷬ㻲,᭪Ⱔस䷈㞞⮰㢓ٵ᪽◥。4.2.1.2 ं$৭10❳,䮐ࣧkQ,ⵀ㏲,ߌ§⇥䛆(60~90益)20mL,䊱ผะ⤲20ܲ䧋␐⋞ᡑࣽ1mL,҈fiӇ䄁৭⏢⋞。ऒंg㟣ᄥ⚓㢛ᱼ05g,स∁ݢ᜼ᄥ⚓㢛⚓㪰ᅮ㞞䅝∁䄁侸,।ंk䔜͐⻹⏢⋞र10滋L,ݗܲ◥κस—⵱㘢GF254㪰ᅮᲫk,Б§⇥䛆(60~90益)-΅䛆(3颐2)fiᆁᐬݮᆁᐬंܦ᮪çݗܲ౔㉗โٵ(254nm)4㉗โٵ(365nm)Ӈ䄁৭㞞䅝͙,౔̺ᄥ⚓㢛ᱼ㞞䅝ⰤᏀ⮰ѹ㒚k,᭪Ⱔस䷈㞞⮰᪽◥ᝂ㢓ٵ᪽◥4.2. Ꮐげऴ❳ݮ䶥̷ᰵ3⮰र䶥㻰჆4.2. 4.2.3. ⚓倄ᩴ⋞Ⱔ㞞䅝∁4.2.3.1. Б࡭K☣ദ⵱☣䩚ऴ⵱㘢fi඗ݮٱБ΅㙴fi≭fiⰤAБ06ۜ䚷䚤̵΅㘦䄯pH6.0)fi≭fiⰤB,ᠵ⚓̷Q͙⮰㻰჆䔇㵸ᷛᏒ≃㙝;ᷬ≷∎䪫280nm。ᴝ⍕35益。⤲䃦㉌΅㉌4㉗ളⷝ䃍ッᏀ̹Ѻκ6000ᬢ䬠≭fiⰤA(%≭fiⰤB(%0~35寅65寅45~50寅50寅4.2.3.1.

T/CACM009—ंᐢ㘍㉎΅㉌4㉗ളⷝᄥ⚓৭䔮䛻,㇪ჲ⼜჆,ߌ⩞䚳ݢ჆⃻1mLφ30滋g4.2.3.1. ं$৭20❳,䮐ࣧkQ,ⵀ㏲,ंㆵ᱗㏒1g,㇪ჲ⼜჆,㒚ڣඊ䩑ᒎ⨢͙,⋞-⩞䚳(1颐20)⌣ऴ⏢⋞50L,⼜჆䛹䛻,䊱ผ(ߋ⢳250W,䶽⢳40kz)30ܲᩪۣ,$⼜჆䛹䛻,⩔≿⅔⏢⋞⩞䚳(1颐20)⌣ऴ⏢⋞㶑䋟ۻ๝⮰䛹䛻,ᥳࠬ␐䓳,␐⋞25mL,㧤ç,䒘⼧㜟5mLქ䛻⨢͙,⩔⩞䚳⼬䛶㜟ݧᏒ,ᥳࠬ␐䓳。4.2.3.1. ݗܲ㇪ჲ।ंᄥ⚓৭⏢⋞4Ӈ䄁৭⏢⋞र20L,∔ڑ⋞Ⱔ㞞䅝Ж,≷჆,$৭⃻❳φ䚷ᐢ㘍㉎Бᐢ㘍㉎΅㉌(C1H5O4)4㉗ളⷝ(C1H1O5)䃍,̹ᓃᄽκ75g4100g。4.2.3. ⚓倄ᩴ⋞Ⱔ㞞䅝∁4.2.3.2. Б࡭K☣ദ⵱☣䩚ऴ⵱㘢fi඗ݮٱ΅㙴Ⅰ(47颐57)fi≭fiⰤᷬ≷∎䪫fi᪜ᠵ⁓ݹ㘍㉌䃍ッᏀ̹Ѻκ60004.2.3.2. ं⁓ݹ㘍㉌ᄥ⚓৭䔮䛻,㇪ჲ⼜჆ߌ⩞䚳ݢ჆⃻1mLφ40滋g⮰⏢⋞࢟ᓃ4.2.3.2. ं$৭20❳,䮐ࣧkQ,ⵀ㏲,ंㆵ᱗㏒1g,㇪ჲ⼜჆,㒚ڣඊ䩑ᒎ⨢͙,㇪ჲڑߌ⩞50L,⼜჆䛹䛻,䊱ผ(ߋ⢳250W,䶽⢳40kz)30ܲ䧋,ᩪۣ,$⼜჆䛹䛻,⩔⩞䚳䋟ۻ๝⮰䛹䛻,ᥳࠬ␐䓳,ं㐙␐⋞25L,㧤ç,䒘⼧㜟5Lქ䛻⨢͙,⩔⩞䚳⼬䛶ᥳࠬ␐䓳4.2.3.2. ݗܲ㇪ჲ।ंᄥ⚓৭⏢⋞4Ӈ䄁৭⏢⋞र10L,∔ڑ⋞Ⱔ㞞䅝Ж,≷჆,$৭⃻❳φg㟣Б⁓ݹ㘍㉌(C6H4O4)䃍,̹ᓃᄽκ0g。T/CACM009—参考文献 YingchunZhang,HaiyuXu,XiaomengChen,etal.Simultaneousquantificationof17constituentsfromYuanhuZhitongTabletusingrapidresolutionliquidchromatographycoupledwithatriplequadrupole2011;56(03):497-504.HaiyuXu,KeLi,YanjunChen,etal.Studyontheabsorbedfingerprint-efficacyofYuanhuZhitongTabletbasedonchemicalanalysis,vasorelaxationevaluationanddatamining[J].PLoSONE.2013;8(12):1- YeTao,HaiyuXuShanshanWangetal.Identificationoftheabsorbedconstituentsafteroraladminis鄄trationofYuanhuZhitongprescriptionextractanditspharmacokineticstudybyrapidresolutionliquidchromatography/quadrupoletimeofflightJ].JournalofChromatographyB.2013;93502):19.HaiyuXuYeTaoPengLuetal.AcomputationalDrugTargetNetworkforYuanhuZhitongPre鄄]..HaiyuXu,KeLi,YanjunChen,etal.Studyontheabsorbedfingerprint-efficacyofYuanhuZhitongTabletbasedonchemicalanalysis,vasorelaxationevaluationanddatamining[J].PlosOne.2013,8(12):1-HongweiWuWaldbauerKatharinaetal.Influenceofvinegarandwineprocessingonthealkaloidcules.2014;19(8):1148711504.vitrocoupledwithbioactivityassessmentinYuanhuZhitongpreparation[J].JournalofMedicinalPlantsResearch.2012;6(10):1941-1947. 侘ʥᑌL᭑䮢䛺ふദκ᪠ऴ㢛⤲႒も⪑⮰ٯ㘍₎⬇᫥ⵀ⾢䔇ᆁJ].㢛ᱮᔃ2015;40(06):10481054.[10⢷ᬙٵᲔ≖ۇ⢷ᲪᲪふ.ദκLTQOrbitrap⮰g㟣͙5⻹ॷય仅䅲㉌ㆧ䅝㷮㼏㻰ᒷⵀ⾢J].͙఩͙㢛ᱮᔃ2015400713341341.[11]ञ∷,䰣ν,䃤⊣™,ふ.g㟣͙3͖ͧ㺭≧ᕓ᜼ܲφ䛻≷჆ࣶڢ䉔䛻䃰Уⵀ⾢J].㢛ᱮᔃ201540(05915919.[12]侘ʥ,$ͥ,䰣ν,ふ.《͙㢛᜼᫥ݮݢ》͙φᐢ㘍㉎᫥ݮ㏰᫥㻰ᒷⵀ⾢J].͙఩͙“ദ⵬႒ᱮᔃ2014201216931696.[13]䰣νᱺٴ〛,Ე≖ۇふ.ദκ᜼ܲܲ᲼4≧ᕓ䃰У⮰ᐢ㘍㉎䚷ݢ⮰ⵀ⾢͙㡵㢛201344(2129922996.[14]ۛ䲅κჃ⌶Ე≖ۇふ.ᐢ㘍㉎͙⩋➕ⷝ᜼ܲ⮰ⵀ⾢J].͙఩჊侸᫥ݮ႒ᱮᔃ,19(06):124-[15]台᪸,䭴᭿㤸,ᑌL᭑,ふ.ٯ㘍₎⬇᫥㗌।ᩢ⋞ᄥ๓呌$ѿ㘤ͧfi㘵J].͙఩჊侸᫥