固肠止泻丸质量标准的研究

固肠止泻丸质量的研究 ,?G?v?J?????S?]?9?? ?9???????????r?;??r3 3.3?????????i??r,???S?S?]?J?%???2?0,?????? ???]???N?G?v?J?%?????0r,?G?v?J?[????????Ro????Rl ?9??,???g?;??r3 ???.???I [1]r???????.?O????????[M].?8??:?8????????????, 1985:1012102. [2]r??=????.???????????????????]?;??[J].?O?????? ???N????,1999,16:326. [3]r??????????????m.?O?????7??????????[S].????. ?P??:?H?????m??????,2005:????57. [4]r????T??.?O???H?????????G?J????[M].????:???? ???????G??????,1986:398. (????2008202224;????2008204223)r?r? ???????????N???M?????;?? ??????r???r??%r??????O????????????(???s712083) r???r???r?????:?;???????????????????N???????M??r3?]???M?????????????a???i???? ???i???? ????????????????????,???????[???O?????=???N???????????a???i?????????????O?? ???6??????HPLC?i??????????[C18??(4.6??250mm,5Λm),??????:????-0.05mol? L?9????????(35:65),????????:347nmr3????:????????????????97.5%,RSD=1. 25%,n=6]r3????:????????r,????r,?(???p??r,?]????????,???N???????????????N???? ??r3 r???????r?@??????????r???????, ?????????O???? ???????????????????N???M??r3????,?7???N???????M ?????????8,???????[???O?????=???N???????????a ???i?????????????O?????6??????HPLC?i?????? ????,?0??,?]???M?????????????a???i???????i???? ????????????????????,?????????????????????N?? ?M??r3???????????????N???M??????2006??11?:?m ?????????,???????????????G?2??r3 1r?????r,?????J????r????h???TLC210ATvp?? ???????????a??,SPD210Avp???i?H??????,N22000 ???a??????????r3?????6????(????071329906???i?? ?????N),????????????(????1209132200407?????i ?N),?????=????????(????1210592200403?????i ?N),?N??????????(????1209212200405?????i?N), ?????=???R??????(????1209282200403???i?????? ?N)r3???8?????????O???O???????%????????????r3?? ??????:??????????(?????O?????????????%??,???? ??060907,060908,060913)r3 2r??????J????r?2.1?????????????a???i?? ??:???????????i?9??,???????????M??????????r3?? ?????????????Mr,????????????????r,?????6???????? ???????????Mr,??????r,???????????0???M??r3???N?? ?,??22(=?=?)??????????,?9???????9?h ??????,?????J,?????1??,?]????????,????????Rf ?????pr,?c?p??????????,?????p??r3 2.2?????????=?????????a???i????:???????? ??r,????????????r,???????????????M????r,??????r,?? ??????,???????O???????????=???????????a???i?? ????r3?????9??????????,?9?h??????,?????J,?????1 ??,?]????????,?c?p??????????r3 2.3?????N???????????a???i????:???????;?? ?J?????i3g,??????20ml,???c???8????????30min, ????,????,?????T??,???@??????????1ml??????,?? ????????????;???N??????????0.3g,??????10ml,?0 ?????S????????????r3?????O???????N???????????? ?a???i??????,?????9??????????,?????h??????r3?? ?????O???????N?????????????a???i???????9?N?9?G ?e???????[?]????,????????????,????????????,?? ???????]????????,???v?2?J??r3 2.4?i???????????????;??:???N???????????a ???????[???O???????????????6?????i??r3 2.4.1???a?????J?????3?N?p????:???a??:C18?? (4.6??250mm,5Λm);??????:????-0.05mol?L?9 ????????(?N?????.PH????3.0)(35:65);????????: ??347nm;????:1.0ml?min;????????:10Λl;???f:?? ?fr3?]?????????????6????????????11000,?????O?? ???6???????r?????]??,?????????????p?????????N ?????6???????[??????,?2?????h????????r3 ???p?????.?????????????????M?????? ???????6?????????????e???????????????????? 0701?????O??2008???h29???h8?% 712 2.4.2: 0. 04585mg?ml,??????????????r3 ?M??????:?]?i??????????????????2r,4r,6r,8r, 10Λl???8?????a????,?]?i???????????????a??,???? ??????r3???????????g???M,?????????????M,?????? ???????????5??A=2214380C24663,Χ=0.9999r3?? ?J?????6?????N0.0917??0.4585Λg?.???????????? ???p????r3 2.4.3???????J???2?p????:???????????????? ??6Λl,???2????5?D,?????????6???????????????? ??598768,?????M??????RSD=1.32%r3?9???????? ?????M????,?]?i????????060913???????????????? 5??,?????????????????6?????i??????????5. 60mg?g,?????M??????RSD??1.11%r3 2.4.4?????????????M:?]?????;??,????10g?? ??????,??100ml?????O,??????2(1:100)?????? 80ml,?????[?]30min,????,?N?e????????????,?? ??,????r3?.???l????,????????1ml??????2(1: 100)??????????25ml??????????????r3 2.4.5?s???p????:???8?????2?p???????????? ??,?]?i??0r,1r,2r,4r,8r,12r,18r,24h????????10Λl,???? ?????????????]????539640,?????M????????2. 21%r3 2.4.6??????????:???N??????????,?????????? ???i?????0??????????(????060913?i??5.60mg?g) 5.0g(??6??),?]?i??????????????0.1433mg?ml?? ???6???????????????[15ml,?9?8?????a????????, ??????????,????????????1r3???????J,?h?????9?? ??????????r3 ??1r??????????????? ?H ?? ???? ??(g) ?????O?? ???6???? ?i??(mg) ???????? ?6???? ????(mg) ???????? ?6?????? ????(mg) ???? ??(%) ???? ???? ??(%) RSD (%) 152.802.154.9399.1r?r? 252.802.154.9298.6r?r? 352.802.154.8997.297.51.25 452.802.154.9097.7r?r? 552.802.154.8896.7r?r? 652.802.154.8695.8r?r? r?r?2.4.7??????????????:??????????????????7 ??,?????6?????i???N3.6??7.9mg?gr3?????????? ??,?i??????????????1g???????????i???????????6 ????(C20H17NO4??HCI)??,?2???7??3.0mgr3 3r???r???r??h???;???????????a???i?????? ???????????a?i??????????????r,????r,?????p??r,?( ???p??r,?]????????,???????????????????????N???? ???M??r3 (????2008202225;????2008204225)r?r? ???????????a???????? ?,????r???????????(????710068) r???r???r?????:???NTLC?????????O?9???S?]?????????p?H???????????]??????????? ??????? ??????;????:??????G????????,?G??R;?e??(5=?0.2)????????,????????,?????1??, Rf???3?Or3????:?h???J????????????????r,???%r,????,?????p??r3 r???????r??????, ???????????2?????? 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