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鐢典綅婊村畾娉曟祴瀹氱緹鐢叉穩绮夐挔锛堢珛宕╋級鐨勫惈閲
鍙戝竷鏃堕棿锛
2024-02-20 00:00
涓€銆佸墠瑷€
缇熺敳娣€绮夐挔锛堢珛宕╋級鏄竴绉岦/span>闃寸瀛忺/span>娣€绮夐啔锛屽寲瀛﹀紡涓裹/span>[C10H19O8Na]n 锛岀櫧鑹叉垨榛勮壊绮夋湯锛屾槸鑳芥憾浜庡喎姘达紝
鏄彉鎬ф穩绮夌殑涓€绉嶏紝灞為啔绫绘穩绮夈€傝鍝佷笌缇х敳鍩虹氦缁寸礌(CMC)鏈夌浉浼肩殑鎬ц兘锛屽叿鏈夊绋犮€佹偓娴€?/span>鍒嗘暎銆佷钩
鍖栥€佺矘缁撱€佷繚姘淬€佷繚鎶よ兌浣撶瓑澶氱鎬ц兘銆傚彲浣滀负涔冲寲鍓傘€佸绋犲墏銆佸垎鏁ｅ墏銆佺ǔ瀹氬墏銆佷笂娴嗗墏銆佹垚鑶滃墏銆佷繚 姘村墏绛夛紝骞挎硾鐢ㄤ簬鐭虫补銆佺汉缁囥€?/span> 鏃ュ寲銆佸嵎鐑熴€侀€犵焊銆佸缓绛戙€侀鍝併€佸尰鑽瓑宸ヤ笟閮ㄩ棬锛岃瑾変负"宸ヤ笟鍛崇簿"銆侟/span> 鏈瀹為獙閲囩敤JH-T7 鍏ㄨ嚜鍔ㄧ數浣嶆淮瀹氫华鎸夌収鍏剁數浣嶇獊璺冪偣纭畾缁堢偣锛屾祴瀹氬叾鍚噺锛屽苟楠岃瘉瀹為獙鏂规鐨勫彲琛孅/span>鎬с€侟/span>
浜屻€佷华鍣ㄤ笌璇曞墏
2. 1 銆佷华鍣?/span>
JH-T7 鍏ㄨ嚜鍔ㄧ數浣嶆淮瀹氫华锛岄潪姘滁/span> PH 澶嶅悎鐢垫瀬锛屽姞鐑洖娴佽缃紝鎭掓俯骞茬嚗绠便€?/span>鍒嗘瀽澶╁钩绛堻/span>
2.2 銆佽瘯鍓侟/span>
c=0. 1mol/L 鐨勯珮姘吀鏍囧噯婊村畾娑诧紝80%涔欓唶婧舵恫锛孅/span>c=0. 1mol/L 鐨勭閰伏/span>閾舵憾娑诧紝鍐伴唻閰伏/span>
涓夈€佸疄楠屾柟娉旤/span>
3. 1 銆佸疄楠岃繃绋嬶細
3. 1. 1 鍘婚櫎缇熺敳娣€绮夐挔锛堢珛宕╋級涓殑姘寲鐗?/span>
绉板彇 1g 缇熺敳娣€绮夐挔锛堢珛宕╋級缃簬骞茬嚗鐨勯敟褰㈢摱锛屽姞鍏ラ厤缃ソ鐨凕/span> 80%涔欓唶婧舵恫 50mL 锛岀敤鐜荤拑妫掓悈鎷岃繃 婊わ紝閲嶅璇ユ搷浣淈/span> 4 娆°€傚彇鏈€鍚庝竴娆¤繃婊ょ殑婊ゆ恫锛屽姞鍏ョ閰伏/span>閾舵憾娑诧紝鐪嬫槸鍚﹀彉娴戞祳銆傝嫢鍔犲叆纭濋吀閾跺悗鍙樻祽娴婏紝 鍐嶉噸澶嶄笂杩版搷浣滅户缁礂娑よ繃婊わ紝鐩磋嚦鍒板畬鍏ㄥ幓闄ゆ隘鍖栫墿锛涜嫢鍔犲叆纭濋吀閾讹紝婊ゆ恫渚濇棫娓呮緢閫忔槑锛屾棤娌夋穩浜х敓锛孅/span>
鍒欒瘉鏄庢隘鍖栫墿瀹屽叏鍘婚櫎锛屽皢鏀堕泦鐨勬护娓ｇ疆浜庡共鐕ョ锛孅/span>105鈩冧笅骞秉/span>鐕ヨ嚦鎭掗噸銆侟/span>
3. 1.2 婊村畾杩囩▼
鍙栧共鐕ュソ鐨勮瘯鏍蜂簬鐮旈挼涓矇纰庯紝绮剧‘绉板彇 0.45g(绮剧‘鑷颤/span> 0.0001g)鏀剧疆浜庡共鐕ョ殑閿ュ舰鐡朵腑锛屽姞鍏?/span> 50mL 鍐伴唻閰革紝娌告按娴村姞鐑洖娴?/span> 2 灏忔椂锛屽姞鐑畬鎴愬悗锛屾斁缃紝寰呴檷娓╄嚦瀹ゆ俯鍚庯紝杞Щ鑷冲共鐕ョ殑婊村畾鏉紝閿ュ舰鐡剁敤 鍐伴唻閰告礂娑｜/span> 3 娆★紝姣忔 5ml 锛屾礂娑插苟鍏ユ淮瀹氭澂涓紝灏嗘淮瀹氭澂鏀惧湪鐢典綅婊村畾鍙颁笂锛屽紑鍚悈鎷岋紝鎻掍笂鐢垫瀬鍜屾淮
瀹氬ご锛岃缃ソ鍙傛暟锛岀敤 0. 1mol/L 楂樻隘閰告爣鍑嗘憾娑叉淮瀹氳嚦鐢典綅绐佽穬缁堢偣锛岃涓嬬粓鐐规淮瀹欬/span>浣撶Н銆侟/span>
3.2銆佷华鍣ㄥ弬鏁?/span>
绮惧搧浠櫒 棰嗚埅鏈潵
浠櫒鍙傛暟锛屽琛?/span> 1 鎵€绀猴細
琛?/span> 1 婊村畾浠弬鏁拌缃?/span>
|
婊村畾绫诲瀷锛欬/span> |
鍔ㄦ€佹淮瀹欬/span> |
鏂规硶鍚嶏細 |
缇熺敳娣€绮夐挔鍚噺娴嬪畾 |
|
婊村畾绠′綋绉細 |
10mL |
鏍峰搧璁￠噺鍗曚綅锛欬/span> |
g |
|
宸ヤ綔鐢垫瀬锛欬/span> |
闈炴按 PH 澶嶅悎鐢垫瀬 |
鍙傛瘮鐢垫瀬锛欬/span> |
鏃燑/span> |
|
鎼呮媽閫熷害锛欬/span> |
7 |
棰勬悈鎷屾椂闂达細 |
5s |
|
鐢垫瀬骞宠 鏃堕棿锛欬/span> |
6s |
鐢垫瀬骞宠 鐢典綅锛欬/span> |
1mv |
|
婊村畾閫熷害锛欬/span> |
鎱↑/span> |
婊村畾鍓嶅钩琛＄數浣嶏細 |
6mv |
|
鏈€灏忔坊鍔犱綋绉細 |
0.02mL |
缁撴潫浣撶Н锛欬/span> |
30mL |
|
鐢典綅绐佽穬閲忥細 |
200 |
棰勬帶 mv 鍊硷細 |
鏃燑/span> |
|
鐩稿叧绯绘暟锛欬/span> |
2.299 |
缁撴灉鍗曚綅锛欬/span> |
% |
|
婊村畾鍓傚悕绉帮細 |
楂樻隘閰伏/span> |
鐞嗚娴撳害锛欬/span> |
0.1018 |
鍥涖€佺粨鏋滀笌璁ㄨ
4. 1 銆佸疄楠岀粨鏋淈/span>
鏍峰搧缁忔祴璇曪紝寰楀埌瀹為獙缁撴灉濡傝〃 2 鎵€绀猴細
琛?/span> 2 鍚噺娴嬭瘯缁撴灉
|
鏍峰搧鍚嶇О |
绉版牱閲廃/span> |
c (楂樻隘 閰伏/span>)/mol/L |
绌虹櫧浣撶Н V1/mL |
婊村畾浣撶Н V2/mL |
鍚噺 锛圏/span>%锛堻/span> |
骞冲潎閲廃/span> 锛圏/span>%锛堻/span> |
|
缇熺敳娣€绮堻/span> 閽狅紙绔嬪穿锛堻/span> |
0.46667 |
0.1018 |
0.04 |
6.009 |
2.994 |
3.028 |
|
0.47549 |
6.273 |
3.068 |
||||
|
0.52523 |
6.819 |
3.021 |
4.2 銆佹淮瀹氬浘璋包/span>
4.3 銆佺粨璁裹/span>
鏈娴嬭瘯閫氳繃鑷姩鐢典綅婊村畾浠祴瀹氱緹鐢叉穩绮夐挔锛堢珛宕╋級 鐨勫惈閲忥紝娴嬭瘯缁撴灉鍦?/span> 3.028 锛岃鏍峰搧鐨勫惈閲忕 鍚堝嚭鍦鸿姹傘€傝€屼笖浣跨敤浠櫒鍒ゆ柇鍑忓皯浜嗕汉宸ヨ宸紝澶уぇ鎻愰珮浜嗗疄楠岀殑绮惧害銆傜數浣嶆淮瀹氭硶鏄娴嬭绫绘牱鍝佸惈
閲忕殑涓嶉敊閫夋嫨銆侟/span>
鍏抽敭璇嶏細鎶樺厜浠
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