greenbook6

GREEN BOOK 6 263

260 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

GREEN BOOK 6 1

√“¬™Õ◊Ë º≈µ‘ ¿—≥±å¬“§ÿ≥¿“æ·≈–ºâŸº≈µ‘ ‡≈¡à ∑’Ë 6 æ.». 2553 ∑Ë’ª√÷°…“ 𓬮—°√∏√√¡ ∏√√¡»°— ¥‘Ï Õ∏‘∫¥°’ √¡«‘∑¬“»“ µ√å°“√·æ∑¬å π“¬π‘æπ∏å ‚æ∏Ï‘æ—≤π™—¬ √ÕßÕ∏‘∫¥’°√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 𓬠«ÿ √√≥™¬— «≤— π“¬Ë‘߇®√‘≠™—¬ √ÕßÕ∏‘∫¥°’ √¡«‘∑¬“»“ µ√å°“√·æ∑¬å π“ß®ÿ√’¿√≥å ∫ÿ≠¬«ß»å«‘‚√®πå √ÕßÕ∏‘∫¥°’ √¡«‘∑¬“»“ µ√°å “√·æ∑¬å π“ß “«π—π∑π“  ‘∑∏‘™¬— ºŸÕâ ”π«¬°“√ ”π°— ¬“·≈–«—µ∂ÿ‡ æµ¥‘ º®Ÿâ ¥— ∑” π“ß ÿ¢»√’ ÕÈ÷ß∫√‘∫Ÿ√≥å‰æ»“≈  ”π°— ¬“·≈–«—µ∂‡ÿ  æµ¥‘ π“ß “«‚ ¡¢®’ Àß…å∑Õß  ”π°— ¬“·≈–«µ— ∂ÿ‡ æµ¥‘ π“ß “«∫≠ÿ ±√°‘ “ ∫ÿ≠≠“¿‘«—≤πå  ”π°— ¬“·≈–«µ— ∂‡ÿ  æµ‘¥ π“ß “«®√‘¬“  ÿ¢º≈ »πŸ ¬«å ‘∑¬“»“ µ√°å “√·æ∑¬∑å Ë’ 7 ‡®â“¢Õß  ”π—°¬“·≈–«µ— ∂‡ÿ  æµ¥‘ °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å °√–∑√«ß “∏“√≥ ¢ÿ ®.ππ∑∫ÿ√’ ‚∑√. 0-2951-0000 µÕà 99137, 99156 ‚∑√ “√. 0-2580-5733 æ‘¡æå∑’Ë ‚√ßæ¡‘ æ å ”π—°ß“πæ√–æÿ∑∏»“ π“·Ààß™“µ‘ ‡≈¡à ∑’Ë 6 ®”π«π 5,000 ‡≈à¡ ªï∑Ëæ’ ¡‘ æå æ.». 2553 ISBN : 978-616-11-0374-3 2 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

§”π” °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å‡ªìπÀπ૬ߓπÀπË÷ß∑Ë’¡’¿“√°‘®„π°“√¥”‡π‘πß“π §âÿ¡§√ÕߺâŸ∫√‘‚¿§¥â“πº≈‘µ¿—≥±å ÿ¢¿“æ ∑—Èß„π à«π°≈“ß·≈–°√–®“¬Õ¬àŸ∑ÿ°¿“§¢Õß ª√–‡∑» §◊Õ »Ÿπ¬«å ‘∑¬“»“ µ√å°“√·æ∑¬å 14 ·Ààß ‚¥¬¥”‡ππ‘ °“√‡™Ë◊Õ¡‚¬ß°—π·≈–‡πâπ °“√¡’ à«π√à«¡¢ÕߺâŸ∫√‘‚¿§  ”À√—∫º≈‘µ¿—≥±å¬“ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å¡’√–∫∫ °“√‡Ω“Ñ √–«—ߧÿ≥¿“æ ‚¥¬¥”‡π‘π‚§√ß°“√ª√–°—π§≥ÿ ¿“欓 √à«¡°∫— ‚√ß欓∫“≈¢Õß√—∞ ∑Ë«— ª√–‡∑» ∑ Ë’ π—∫ ππÿ º≈µ‘ ¿≥— ±¬å “„π°“√µ√«® Õ∫§≥ÿ ¿“æÕ¬“à ßµàÕ‡π◊ÕË ß ·≈–®¥— „Àâ¡’ °“√‡º¬·æ√à¢âÕ¡Ÿ≈§ÿ≥¿“æ¢Õߺ≈‘µ¿—≥±å¬“‡À≈à“π—Èπ∑—Èß∑’˺à“π·≈–‰¡àºà“π‡°≥±å¡“µ√∞“π „Àâ‚√ß欓∫“≈‰¥â„™âª√–‚¬™πå ·≈–§—¥‡≈◊Õ°‡©æ“–º≈‘µ¿—≥±å¬“∑Ë’ºà“π‡°≥±å¡“µ√∞“π ¡“‡º¬·æ√à„πÀπ—ß ◊Õ‡≈à¡π’È Ÿà “∏“√≥– ∑—ÈßπÈ’‡ªìπ°“√ à߇ √‘¡„ÀâºâŸº≈‘µ‡ÀÁ𧫓¡ ”§—≠ „π°“√æ—≤π“§ÿ≥¿“æ·≈–§ß‰«â´Ë÷ߧÿ≥¿“æ∑’Ë¥’Õ¬à“ß ¡Ë”‡ ¡Õ Õ¬à“߉√°Áµ“¡¡“µ√∞“π ∑’Ë°√¡«‘∑¬“»“ µ√å°“√·æ∑¬åπ”¡“„™â„π°“√µ√«® Õ∫§ÿ≥¿“æ  à«π„À≠à‡ªìπ¡“µ√∞“π ∑Ë’√–∫ÿ‰«â„πµ”√“¬“∑’Ë√—∞¡πµ√’ª√–°“»À√◊Õ©∫—∫„À¡à°«à“ ´Ë÷ß¡’°“√ª√—∫ª√ÿßÀ—«¢âÕ„π°“√ §«∫§ÿ¡§ÿ≥¿“æ·≈–‡°≥±å¡“µ√∞“π∑Ë’∑—π ¡—¬·≈–‡¢â¡ß«¥ ∫àß∫Õ°§ÿ≥¿“扥⥒°«à“ µ”√“¬“©∫—∫‡°à“∑Ë’‡§¬„™âÕâ“ßÕ‘ß„π°“√¢È÷π∑–‡∫’¬πµ”√—∫¬“´÷Ëß¡’Õ“¬ÿµ≈Õ¥™’æ ¥—ßπÈ—π º≈‘µ¿—≥±å¬“∑Ë’ºà“π‡°≥±å¡“µ√∞“π‡À≈à“π’È ºŸâº≈‘µ “¡“√∂𔉪„™â‡ªìπ·π«∑“ß„π°“√ ª√—∫ª√ÿß∑–‡∫’¬πµ”√∫— ¬“∑’Ë¢È÷π∑–‡∫’¬π‰«â„À∑â —π ¡¬— µ“¡∑’Ë “°≈°”Àπ¥ πÕ°®“°π’È°√¡«‘∑¬“»“ µ√å°“√·æ∑¬å‰¥â¡’°“√∑∫∑«π§ÿ≥¿“æ¢Õߺ≈‘µ¿—≥±å ¬“∑Ë’‡§¬‰¥â√—∫°“√µ√«® Õ∫§ÿ≥¿“懪ìπ√–¬– √«¡∑ȗߺ≈‘µ¿—≥±å¬“∑Ë’‡§¬æ∫ªí≠À“ ‚¥¬ àÿ¡µ—«Õ¬à“ß¡“µ√«® Õ∫´”È ‡æ◊ËÕ„Àâ·πà„®«à“§ÿ≥¿“æ¢Õߺ≈‘µ¿—≥±å¬“‡À≈à“π—Èπ¬—ß§ß ¡’§ÿ≥¿“æ‰¡à‡ª≈’ˬπ·ª≈ß À√◊Õ‰¥â√—∫°“√æ—≤π“®π¡’§ÿ≥¿“æ∑Ë’ Õ¥§≈âÕß°—∫¡“µ√∞“π  “°≈ √«¡∑Èß— ‰¥ªâ √– “𧫓¡√à«¡¡◊Õ°—∫¿“§‡Õ°™π„À™â ¥‡™¬º≈‘µ¿—≥±¬å “∑∂’Ë °Ÿ  ¡ÿà µ√«® ‡æÕË◊ §π◊ „À·â °à‚√ß欓∫“≈ ∑ß—È π‡’È æÕ◊Ë „À°â “√¥”‡ππ‘ °“√ª√–°π— §≥ÿ ¿“欓∫√√≈«ÿ µ— ∂ªÿ √– ß§å ¡“°¬Ë‘ߢ÷Èπ¿“¬„µâ∑√—欓°√∑Ë’¡’Õ¬Ÿà ´Ë÷ß∑—Èߺ⟺≈‘µ·≈–ºŸâ∫√‘‚¿§‰¥â¢âÕ¡Ÿ≈∑’ˇ°’ˬ«¢âÕß·≈–  “¡“√∂𔉪„™ªâ √–‚¬™πå√«à ¡°—π‰¥â °√¡«‘∑¬“»“ µ√å°“√·æ∑¬åÀ«—߇ªìπÕ¬à“߬‘Ëß«à“‡Õ° “√ GREEN BOOK 6 π’È ®–‡ªπì ª√–‚¬™πå„π‡™ß‘ «™‘ “°“√·≈–‡ªπì ¢Õâ ¡≈Ÿ ‡°¬Ë’ «°∫— §≥ÿ ¿“æ¢Õߺ≈µ‘ ¿≥— ±¬å “∑ Ë’ “¡“√∂ π”‰ªæ‘®“√≥“„™ªâ √–‚¬™π剥âµÕà ‰ª 𓬮°— √∏√√¡ ∏√√¡»°— ¥‘Ï Õ∏∫‘ ¥°’ √¡«‘∑¬“»“ µ√°å “√·æ∑¬å GREEN BOOK 6 3

 “√∫≠— Àπ“â °µ‘ µ°‘ √√¡ª√–°“». ..........................................................................................................7 °“√®¥— ∑”√“¬™◊ËÕº≈‘µ¿—≥±å¬“§≥ÿ ¿“æ·≈–ººâŸ ≈µ‘ ‡≈¡à ∑Ë’ 6. ............................................8 Abstract.........................................................................................................................10 √“¬™◊ËÕº≈µ‘ ¿—≥±å¬“§≥ÿ ¿“æ·≈–ººâŸ ≈‘µ ®”·π°µ“¡ª√–‡¿∑¢Õ߬“. ............................11 ¬“√°— …“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈Õ◊ ¥. ........................................................................12 - Dipyridamole sterile solution ...........................................................................13 - Doxazosin mesilate tablet...............................................................................14 - Fenofibrate capsule .........................................................................................16 - Fenofibrate tablet.............................................................................................17 - Flecainide acetate tablet ..............................................................................18 - Verapamil sterile solution ................................................................................19 - Warfarin sodium tablet....................................................................................20 ¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑. .....................................................................................21 - Alprazolam tablet.............................................................................................22 - Diazepam sterile solution ................................................................................24 - Haloperidol sterile solution ..............................................................................25 - Pimozide tablet .................................................................................................26 - Sodium valproate oral solution ......................................................................27 - Sodium valproate tablet .................................................................................28 - Sodium valproate sterile powder ..................................................................30 ¬“ªØ™‘ «’ π–. ...................................................................................................................31 - Amphotericin B sterile powder ......................................................................32 - Ciprofloxacin lactate sterile solution.............................................................34 - Cefixime dry syrup ...........................................................................................36 - Cloxacilin sodium sterile powder..................................................................37 - Meropenem sterile powder ............................................................................38 - Mupirocin ointment ..........................................................................................39 - Ofloxacin tablet................................................................................................40 - Vancomycin HCl sterile powder ...................................................................43 4 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å

 “√∫≠— Àπ“â ¬“µâ“π‡™ÈÕ◊ ¡“≈“‡√’¬. ......................................................................................................45 - Quinine sulfate tablet......................................................................................46 ¬“¶“à ÀπÕπ欓∏.‘ ..........................................................................................................47 - Albendazole tablet ..........................................................................................48 - Mebendazole suspension................................................................................49 - Mebendazole tablet ........................................................................................50 ¬“√°— …“‚√§‡∫“À«“π. ....................................................................................................51 - Gliclazide modified release tablet................................................................52 - Gliclazide tablet ...............................................................................................53 - Glipizide tablet ..................................................................................................54 - Pioglitazone HCl tablet ...................................................................................56 ¬“°≈à¡ÿ  ‡µ’¬√Õ¬¥.å .........................................................................................................57 - Mometasone furoate cream..........................................................................58 ¬“·°ªâ «¥ µ“â π°“√Õ°— ‡ ∫ §≈“¬°≈“â ¡‡πÈÕ◊ . .................................................................59 - Indomethacin capsule ....................................................................................60 - Methocarbamol tablet....................................................................................62 - Piroxicam capsule ............................................................................................64 - Pizotifen maleate tablet .................................................................................65 - Tenoxicam tablet..............................................................................................66 ¬“√°— …“‚√§µ“. ..............................................................................................................67 - Acyclovir eye ointment ...................................................................................68 - Fluorometholone eye suspension...................................................................69 - Pilocarpine HCl / nitrate eye drop...............................................................70 ¬“√°— …“‚√§√–∫∫∑“߇¥‘πÀ“¬„®. ..................................................................................71 - Salbutamol sulfate tablet................................................................................72 ¬“µ“â πŒ ’ µ“¡π’ . ............................................................................................................73 - Diphenhydramine HCl capsule......................................................................74 ¬“√—°…“‚√§√–∫∫µÕà ¡‰√â∑àÕ...........................................................................................75 - Levothyroxine sodium tablet ..........................................................................76 GREEN BOOK 6 5

 “√∫≠— Àπâ“ ¬“√°— …“‚√§√–∫∫∑“߇¥π‘ Õ“À“√. ..................................................................................77 - Dicyclomine HCl tablet ...................................................................................78 «µ‘ “¡π‘ ·≈–‡°≈Õ◊ ·√à. .......................................................................................................79 - Ferrous fumarate tablet ..................................................................................80 - Folic acid tablet ...............................................................................................81 - Phytomenadione (Vitamin K1) sterile solution ............................................82 ¿“§ºπ«°. .....................................................................................................................83 - °“√®¥— ∑” GREEN BOOK 1-5 ............................................................................84 - À—«¢âÕ∑¥ Õ∫„πº≈µ‘ ¿≥— ±å¬“ ”‡√Á®√ªŸ ................................................................93 - √“¬™Ë◊ÕÀπ૬ߓπ∑Ë’√«à ¡„π‚§√ß°“√·≈– àÿ¡µ—«Õ¬“à ßµ√«®«‡‘ §√“–Àå ......................97 - ¥√√™π’ (Index) .................................................................................................103 6 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

°µ‘ µ°‘ √√¡ª√–°“» °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ¢Õ¢Õ∫§ÿ≥∫ÿ§≈“°√¢Õß‚√ß欓∫“≈  ”π—°ß“π “∏“√≥ ÿ¢®—ßÀ«—¥  ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ·≈– °√¡ π—∫ πÿπ∫√‘°“√ ÿ¢¿“æ µ≈Õ¥®πºŸâ¥”‡π‘π°“√µ√«®«‘‡§√“–Àå∑“ßÀâÕß ªØ‘∫—µ‘°“√ ”π—°¬“·≈–«—µ∂ÿ‡ æµ‘¥ ·≈–»Ÿπ¬å«‘∑¬“»“ µ√å°“√·æ∑¬å ∑Ë’„Àâ §«“¡√à«¡¡◊Õ„π°“√¥”‡π‘π‚§√ß°“√ √â“ßÀ≈—°ª√–°—π§ÿ≥¿“æ·≈–¡“µ√∞“π ∫√°‘ “√¥“â 𬓠ªßï ∫ª√–¡“≥ æ.». 2552 ®π ”‡√®Á ≈≈ÿ «à ß ‰¥¢â Õâ ¡≈Ÿ º≈µ‘ ¿≥— ±¬å “ §ÿ≥¿“æ·≈–ººâŸ ≈µ‘ ‡º¬·æ√à„π‡Õ° “√©∫∫— πÈ’ GREEN BOOK 6 7

°“√®—¥∑”√“¬™Ë◊Õº≈‘µ¿≥— ±å¬“§ÿ≥¿“æ·≈–ºŸâº≈‘µ ‡≈¡à ∑Ë’ 6 (GREEN BOOK 6) °“√§¥— ‡≈Õ◊ °º≈µ‘ ¿≥— ±¬å “∑ºË’ “à π‡°≥±¡å “µ√∞“πµ“¡µ”√“¬“∑√Ë’ ∞— ¡πµ√ª’ √–°“» À√◊Õ©∫—∫„À¡à°«à“¡“‡º¬·æ√à„πÀπ—ß ◊Õ‡≈à¡πÈ’ ‰¥â¢âÕ¡Ÿ≈®“°°“√¥”‡π‘π‚§√ß°“√ √â“ßÀ≈—° ª√–°π— §≥ÿ ¿“æ·≈–¡“µ√∞“π∫√°‘ “√¥“â 𬓠ªßï ∫ª√–¡“≥ æ.». 2552 ¢Õß°√¡«∑‘ ¬“»“ µ√å °“√·æ∑¬å ‚¥¬ ¡àÿ µ—«Õ¬“à ߺ≈µ‘ ¿—≥±å¬“®“°‚√ß欓∫“≈√∞— 352 ·Ààß µ√«®«‘‡§√“–Àå‚¥¬ ÀâÕߪؑ∫—µ‘°“√¢Õß ”π—°¬“·≈–«—µ∂ÿ‡ æµ‘¥·≈–»Ÿπ¬å«‘∑¬“»“ µ√å°“√·æ∑¬å πÕ°®“°π’È ¬—߉¥âπ”¢âÕ¡Ÿ≈®“°º≈°“√µ√«® Õ∫§ÿ≥¿“æº≈‘µ¿—≥±å¬“∑’Ë ÿà¡ ®“°√â“π¢“¬¬“ ºŸâπ”‡¢â“ À√Õ◊ ººŸâ ≈µ‘ ‚¥¬ ”π°— ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ „πª‡ï ¥¬’ «°π— ¡“‡º¬·æ√¥à «â ¬ ∑”„Àâ ‰¥¢â Õâ ¡Ÿ≈®“°·À≈àß ¡àÿ µ«— Õ¬“à ßµà“ß°—π‡æÕ◊Ë „À°â “√‡ΩÑ“√–«ß— §≥ÿ ¿“欓§√Õ∫§≈¡ÿ ¡“°¢π÷È  ”À√—∫‡°≥±å°“√§—¥‡≈◊Õ°º≈‘µ¿—≥±å¬“∑’˺à“π‡°≥±å¡“µ√∞“π¡“‡º¬·æ√àπ—Èπ ¬—ß§ß„™â‡°≥±å‡¥‘¡ §◊Õ °√≥’¬“µâπ·∫∫ ®–‰¡à°”Àπ¥®”π«π√ÿàπº≈‘µ ·≈– ”À√—∫¬“ ‡≈’¬π·∫∫µâÕß¡’º≈µ—Èß·µà 3 √ÿàπº≈‘µ¢÷Èπ‰ª·≈–ºà“π‡°≥±å¡“µ√∞“π∑ÿ°√ÿàπ °√≥’∑’˧—¥‡≈◊Õ° ‡æ’¬ß 2 √ÿàπ®–µâÕß¡’ 2 √àÿπ∑ÿ°·À≈àߺ≈‘µ·≈–‡ªìπ¬“∑’ˉ¡àæ∫ªí≠À“¥â“π§ÿ≥¿“æ ‡™àπ ªí≠À“°“√≈–≈“¬¢Õßµ—«¬“ À√◊Õªí≠À“¥â“𧫓¡§ß ¿“æ ‡ªìπµâπ  à«πº≈‘µ¿—≥±å¬“ ‡≈’¬π·∫∫∑Ë’¡’‡æ’¬ß 1 √àÿπº≈‘µ·≈–ºà“π‡°≥±å¡“µ√∞“ππ—Èπ ·¡â ‰¡à‰¥â√—∫°“√§—¥‡≈◊Õ°¡“ ‡º¬·æ√à„πÀπß—  Õ◊ ‡≈¡à πÈ’ ·µ¢à Õâ ¡≈Ÿ ‡À≈“à ππ—È ‰¥√â «∫√«¡·≈–‡º¬·æ√à„Àâ‚√ß欓∫“≈√∞— 𔉪 „™âª√–‚¬™π¥å ⫬‡™πà °—𠂧√ß°“√ªßï ∫ª√–¡“≥ æ.».2552 π’È ‰¥¡â °’ “√∑∫∑«π§≥ÿ ¿“æº≈µ‘ ¿≥— ±¬å “∑‡Ë’ §¬  ”√«®·≈«â ®”π«π 4 √“¬°“√ ‰¥â·°à Albendazole tablet, Indomethacin capsule, Piroxicam capsule ·≈– Warfarin tablet ·≈–‡§¬‡º¬·æ√à„π GREEN BOOK 3, 1, 1 ·≈– 4 µ“¡≈”¥—∫π—Èπ º≈°“√µ√«® Õ∫§≥ÿ ¿“æ´”È æ∫«à“ Albendazole tablet ·≈– Piroxicam capsule ∫“ßµ”√—∫∑Ë’‡¥‘¡‰¡àºà“π‡°≥±å¡“µ√∞“π À—«¢âÕ°“√≈–≈“¬ ¢Õßµ—«¬“ ‰¥â√—∫°“√æ—≤π“§ÿ≥¿“æ·≈–ºà“π‡°≥±å¡“µ√∞“π„π§√“«πÈ’ ·µà ”À√—∫ Indomethacin capsule ·≈– Warfarin tablet ∫“ßµ”√∫— ∑Ë’‡§¬ºà“π‡°≥±å¡“µ√∞“π æ∫§«“¡‰¡à ¡Ë”‡ ¡Õ„π°“√º≈‘µ·≈–‰¡àºà“π‡°≥±å¡“µ√∞“π„π§√“«π’È 8 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

 ”À√∫— º≈‘µ¿—≥±¬å “∑’ Ë ¡àÿ ‚¥¬ ”π°— ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ´÷Ëßµ√«® «‡‘ §√“–Àå‚¥¬ÀÕâ ߪؑ∫—µ°‘ “√¢Õß ”π—°¬“·≈–«—µ∂ÿ‡ æµ¥‘ ∑ßÈ— À¡¥ ‰¥â§¥— ‡≈◊Õ°¡“‡º¬·æ√à ®”π«π 9 √“¬°“√ ‰¥â·°à Dicyclomine HCl tablet, Diphenhydramine HCl capsule, Doxazosin mesilate tablet, Fenofibrate capsule / tablet, Levothyroxine sodium tablet, Methocarbamol tablet, Ofloxacin tablet, Pioglitazone HCl tablet ·≈– Tenoxicam tablet. °√≥’ Doxazosin mesilate tablet ∑’Ë àÿ¡®“°‚√ß欓∫“≈ „π‚§√ß°“√¢Õß °√¡«‘∑¬“»“ µ√°å “√·æ∑¬åπÈπ— µ√«®«‡‘ §√“–Àå‚¥¬ »πŸ ¬«å ∑‘ ¬“»“ µ√å°“√·æ∑¬å¢Õπ·°πà ·≈–∑’Ë àÿ¡‚¥¬ ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ µ√«®«‘‡§√“–Àå‚¥¬ ”π—°¬“·≈– «—µ∂ÿ‡ æµ‘¥ º≈°“√µ√«®«‘‡§√“–Àåæ∫«à“ µ”√—∫∑’Ë¡’ªí≠À“‰¡àºà“π‡°≥±å¡“µ√∞“π °“√≈–≈“¬¢Õßµ—«¬“ ¡’º≈ Õ¥§≈âÕß°—π∑È—ß ÕßÀâÕߪؑ∫—µ‘°“√ · ¥ß«à“‡ªìπªí≠À“¢Õß  Ÿµ√µ”√∫— ∑º’Ë Ÿâº≈µ‘ µÕâ ß«‘®—¬·≈–æ≤— π“µàÕ‰ª ®“°‡°≥±å¡“µ√∞“π„πµ”√“¬“∑’Ë√—∞¡πµ√’ª√–°“» §◊Õ USP 27, 2004 ·≈– BP 2004 ‡¡Ë◊Õ‡ª√’¬∫‡∑’¬∫°—∫ ‡°≥±å¡“µ√∞“π„πµ”√“¬“©∫—∫„À¡à°«à“ ‡™àπ USP 31, 2008  ”À√—∫√“¬°“√¬“∑Ë’µ√«® Õ∫§ÿ≥¿“æ‡À≈à“πÈ’ æ∫«à“ ‰¡à¡’§«“¡·µ°µà“ß„π à«π∑’Ë ‡ªìπ “√– ”§≠— ¬°‡«âπÀ—«¢Õâ uniformity of dosage units À√◊Õ§«“¡ ¡”Ë ‡ ¡Õ¢Õß ª√‘¡“≥µ—«¬“µàÕÀπ૬°“√„™â¬“ ‡™à𠬓‡¡Á¥ ·§ª´Ÿ≈ ¬“π”È ∑’Ë√—∫ª√–∑“πÀπ÷Ëߧ√—Èß µàÕÀπßË÷ ¿“™π–∫√√®ÿ (unit - dose container) ‡¡ËÕ◊ ‡ª√¬’ ∫‡∑’¬∫º≈®“°°“√§”π«≥„πÀ—«¢âÕ content uniformity µ“¡µ”√“¬“ USP 27 ·≈– USP 31 ∑ªË’ √∫— ‡ª≈’¬Ë π„À¡à ¢Õß°“√µ√«®«‘‡§√“–À¬å “·§ª´Ÿ≈Õπ‘ ‚¥‡¡∑“´π’ ¢Õß»Ÿπ¬«å ‘∑¬“»“ µ√°å “√·æ∑¬å∑’Ë 7 Õÿ∫≈√“™∏“π’ æ∫«à“ USP 31 ¡§’ «“¡‡¢¡â ß«¥°«à“ „π°√≥’∑Ë’§à“‡©≈Ë’¬¢Õߪ√‘¡“≥µ—«¬“ ”§—≠ (mean, _X) ¡’§à“„°≈â upper limit (110.0 % la.) À√◊Õ„°≈â lower limit (90.0% la.) ‚¥¬¬Õ¡„Àâ¡’§à“‡∫’ˬ߇∫π¡“µ√∞“π _ ·§∫°«à“„π USP 27 ·µà°√≥’∑’Ë§à“ X ¡’§à“„°≈⇧’¬ß°—∫ª√‘¡“≥µ—«¬“∑Ë’·®âß∫π©≈“° (100.0% la.) µ”√“¬“∑—Èß Õß®–¬Õ¡√—∫§à“‡∫’ˬ߇∫π¡“µ√∞“π‰¥â Ÿß°«à“°√≥’·√°·≈–‰¡à ·µ°µà“ß°π— ¡“°„π°“√º“à π‡°≥±å¡“µ√∞“π °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ¬‘π¥’√—∫øíߢâÕ§‘¥‡ÀÁπÀ√◊Õ§”·π–π”∑’ˇªìπ ª√–‚¬™πå ·≈–À“°¡’¢âÕ ß —¬ª√–°“√„¥ “¡“√∂µ‘¥µàÕ Õ∫∂“¡‰¥â∑Ë’  ”π—°¬“·≈– «—µ∂ÿ‡ æµ‘¥ µ“¡∑Ë’Õ¬àŸ„π‡Õ° “√π’È ·≈– GREEN BOOK 1-5  “¡“√∂¥Ÿ‰¥â∑’Ë http://www.dmsc.moph.go.th/webroot/drug/index.stm GREEN BOOK 6 9

Abstract In fiscal year 2009, the Department of Medical Sciences has continuously conducted the çQuality Assurance of Medicines under the Universal Health Care Coverage Schemeé. Besides, the pharmaceutical products from 352 state hospitals, this is the first opportunity that the analytical results of the sampled pharmaceutical products from drug stores, importers or manufacturers by Thai Food and Drug Administration, including dicyclomine HCl tablets, doxazosin mesilate tablets, fenofibrate capsules/tablets, levothyroxine sodium tablets, methocarbamol tablets, ofloxacin tablets, pioglitazone HCl tablets and tenoxicam tablets, were reported in this book. The analysis of al test items was performed by Bureau of Drug and Narcotic and Regional Medical Science Centers. The criterion for selecting the quality-approved products and manufacturers was that only the generic products with two to three or more production lots in compliance with the standards were published in the GREEN BOOK. On the contrary, the quality-approved innovatorûs products were noted, regardless of the sample lots received. Albendazole tablets, indomethacin capsules, piroxicam capsules and warfarin tablets were re-investigated. Some samples of albendazole tablets and piroxicam capsules, failing on the dissolution test in the GREEN BOOK 3 and 1, have passed, whereas those of indomethacin capsules and warfarin tablets, complying with the content uniformity requirement in the GREEN BOOK 1 and 4, have failed in this study. In general, USP 31, 2008 and BP 2008 employed in this study were similar to the USP 27, 2004 and BP 2004, notified by the Minister of Public Health as the official pharmacopoeia. However, a major difference between USP 31 and USP 27 is the requirement for the uniformity of dosage units. USP 27 specifies the percentage of label claim of unit-dose container for tablets and capsules as 85.0 to 115.0 %; RSD _ 6.0%. On the other hand, USP 31 requires the acceptance value of 10 dosage units to be less than or equal to 15%. The content uniformity requirement of USP 31 is considered more stringent than that of USP 27. Consequently, some samples, which conform to USP 27 standard, can not comply with USP 31 standard. The Department of Medical Sciences welcomes all comments and suggestions. For any enquiries, please contact Bureau of Drug and Narcotic, Department of Medical Sciences at the given address in this book. For details of GREEN BOOK 1-5, please visit the website of Department of Medical Sciences at http: // www.dmsc.moph.go.th/webroot/drug/index.stm 10 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

√“¬™ËÕ◊ º≈µ‘ ¿—≥±å¬“§ÿ≥¿“æ·≈–ºâºŸ ≈‘µ ®”·π°µ“¡ª√–‡¿∑¢Õ߬“ GREEN BOOK 6 11

¬“√°— …“‚√§√–∫∫À«— „®·≈–À≈Õ¥‡≈Õ◊ ¥ - Dipyridamole sterile solution - Doxazosin mesilate tablet - Fenofibrate capsule - Fenofibrate tablet - Flecainide acetate tablet - Verapamil sterile solution - Warfarin sodium tablet 12 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“√°— …“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈◊Õ¥ Dipyridamole sterile solution, 10 mg/ 2 ml À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - Chromatographic purity ºâŸº≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊ËÕºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√‘߇°Õ√å Õ‘π‡°≈‰Œ¡å 1C 29/44 (N) Persantin Boehringer Ingelheim Co.,Ltd. GREEN BOOK 6 13

¬“√—°…“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈◊Õ¥ Doxazosin mesilate tablet À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–‡¡¥Á (Content uniformity) ºâºŸ ≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊ËÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡π·Ÿ ø§‡®Õ√ßË‘ 1A 77/49 Carxasin 2 M & H Manufacturing Co.,Ltd. 1A 140/47 Cazosin 2 ¡≈‘ ≈‡‘ ¡¥ 1A 141/47 Cazosin 4 Millimed Co.,Ltd. 1C 300/47 Cardura 1 ‰ø‡´Õ√å (ª√–‡∑»‰∑¬) ®”°¥— 1C 301/47 Cardura 2 º·âŸ ∑π®”Àπ“à ¬ 1C 302/47 Cardura 4 Pfizer (Thailand) Co.,Ltd 1C 92/46(N) Cardura 5 14 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

¬“√—°…“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈Õ◊ ¥ ºâŸº≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ·√π·∫°´’Ë ·≈∫Õ√“∑Õ√ ’Ë å 1C 238/50 Dovizin 2 ª√–‡∑»Õπ‘ ‡¥¬’ Dezcard 2 Dezcard 4 Ranbaxy Laboratories Ltd., India Dozozin 2 Dozozin 4  ¬“¡‡¿ —™ 1A 293/47 Siam Bheasach Co.,Ltd. 1A 294/47 ¬‡Ÿ ¡¥“ 1A 42/46 Umeda Co.,Ltd 1A 50/46 GREEN BOOK 6 15

¬“√°— …“‚√§√–∫∫À«— „®·≈–À≈Õ¥‡≈Õ◊ ¥ Fenofibrate capsule À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π∑–‡∫¬’ πµ”√—∫¬“) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√≈å ‘π ø“√å¡“´µŸ ‘‡§≈‘ Õπ‘ ¥— µ√’ ®”°—¥ 1A 23/49 Fibril - 160 Berlin Pharmaceutical Industry Co.,Ltd. Laboratoires Fournier S.A.,France 1C 72/50 Lipanthyl -200 ∫√‘…—∑ ·Õä∫∫Õµ ‚æ√¥—° å (ª√–‡∑»‰∑¬) 1C 89/50 Lipanthyl -100 (ºâŸ·∑π®”Àπ“à ¬) 1C 90/50 Fenox -300 ¬‡Ÿ ¡¥“ 1A 420/47 Febrate - 100 Umeda Co.,Ltd 1A 421/47 Febrate - 300 ¬πŸ ´‘ π— ·≈∫Õ√“∑Õ√ ’Ë å 1A 544/41 Lexemin - 100 Unison Laboratories Co.,Ltd. 1A 346/45 Lexemin - 200 1A 543/41 Lexemin - 300 16 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å

¬“√°— …“‚√§√–∫∫À«— „®·≈–À≈Õ¥‡≈◊Õ¥ Fenofibrate film coated tablet À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π ∑–‡∫¬’ πµ”√—∫¬“) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™◊Ëպ⺟ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Advanced Pharma Co.,Ltd, India 1C 282/49 Adfen - 160 ∫. ·§ ª“Ñ ø“√å¡“´Ÿµ§‘ Õ≈ (ª√–‡∑»‰∑¬) ®”°¥— (ºâ·Ÿ ∑π®”Àπ“à ¬) 1C 148/50 Supralip NT-145 Lavoratories Fournier S.A.,France 1C 88/50 Supralip - 160 ∫√‘…∑— ·Õä∫∫Õµ ‚æ√¥°—  å (ª√–‡∑»‰∑¬) (ºâŸ·∑π®”Àπà“¬) 1C 234/40 Feno TG - 160 1A 22/51 Lexemin - 160 Lavoratories Fisons S.A.,France ∫√‘…∑— ·Õ∫ä ∫Õµ ‚æ√¥—° å (ª√–‡∑»‰∑¬) (º·âŸ ∑π®”Àπà“¬) Troikaa Parenterals, India À.®.°. ¿≠‘ ‚≠ø“√å¡“´’ (ºâ·Ÿ ∑π®”Àπ“à ¬) ¬πŸ ´‘ π— ·≈∫Õ√“∑Õ√ ’Ë å Unison Laboratories Co.,Ltd. GREEN BOOK 6 17

¬“√°— …“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈Õ◊ ¥ Flecainide acetate tablet, 100 mg À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §“à ‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈¬Ë’ (Weight variation) ºâŸº≈µ‘ ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ÕË◊ ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name 3 ‡Õ¡Á ‡Œ≈∏å 1C 149/50 (N) Tambocor 3 M Health Co.,Ltd. 18 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“√°— …“‚√§√–∫∫À«— „®·≈–À≈Õ¥‡≈Õ◊ ¥ Verapamil sterile solution À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) -  “√°Õà ‰¢â (Bacterial endotoxins, LAL) - Related substances ººŸâ ≈µ‘ ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ŒÕ´ª√î “ 1C 221/51 Verapamil Hospira Inc. GREEN BOOK 6 19

¬“√—°…“‚√§√–∫∫À—«„®·≈–À≈Õ¥‡≈Õ◊ ¥ Warfarin sodium tablet À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –‡¡¥Á (Content uniformity) ººŸâ ≈‘µ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™Õ◊Ë ºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡∫Õ√≈å π‘ ø“√¡å “´Ÿµ‡‘ §‘≈ Õ‘π¥— µ√’ 1A 362/45 Befarin 3 Berlin Pharmaceutical Industry 1A 33/46 Befarin 4 Co.,Ltd. 1A 396/45 Befarin 5 ÕÕ‰√ÕÕπ §Õ√ªå Õ‡√™πË— 1C 35/51 Orfarin 3 ª√–‡∑»øπî ·≈π¥å 1C 36/51 Orfarin 5 Orion Corporation., Finland 1A 261/50 Tufam 3 ¬πŸ ‘´π— ·≈∫Õ√“∑Õ√ ’Ë å Unison Laboratories Co.,Ltd. 20 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ - Alprazolam tablet - Diazepam sterile solution - Haloperidol sterile solution - Pimozide tablet - Sodium valproate oral solution - Sodium valproate sterile powder - Sodium valproate tablet GREEN BOOK 6 21

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Alprazolam tablet À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µà≈–‡¡Á¥ (Content uniformity) ººŸâ ≈‘µ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™Ë◊ÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name 2 ‡Õ¡Á (‡¡¥-‡¡‡°Õ√)å P1A 33/50 Anpress 0.25 2M (Med-Maker) Co.,Ltd. P1A 34/50 Xiemed 0.5 P1A 35/50 Anpress 1.0 ¡≈‘ ≈‡‘ ¡¥ Millimed Co.,Ltd. P1A 9/46 Anax 0.25 P1A 10/46 Anax 0.5 ‚¡‡¥Õ√πå ·¡πŸ Modern Manu Co.,Ltd. P1A 19/49 Moxinax 0.25 P1A 20/49 Moxinax 0.5 ‰ø‡´Õ√å (ª√–‡∑»‰∑¬) Pfizer (Thailand) Ltd. P1C 19/48 Xanax 0.25 P1C 20/48 Xanax 0.5 22 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ ºŸºâ ≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Ë◊ÕºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ø“√¡å “·≈π¥å P1A 40/44 Pharnax 0.5 Pharmaland Co.,Ltd. Alcelam 0.5 ø“√¡å “ —πµå ·≈∫Õ√“∑Õ√ ’Ë å P1A 23/49 Alcelam 1.0 Manex 0.5 Pharmasant Laboratories Co.,Ltd. P1A 24/49 Zolam 0.5 ∑’ ·¡π ø“√¡å “ P1A 21/46 Zolam 0.25 T.Man Pharma Ltd.,Part. Zolam 0.5 Anpress 0.5  À·æ∑¬å‡¿ —™ P1A 28/44 The Medicpharma Co.,Ltd. P1A 44/50 Pharnax 0.5 P1A 45/50 ¬Ÿ‚∑‡ªïô¬π P1A 4/48 Utopian Co.,Ltd. «’ ‡Õ  ø“√å¡“ P 1A 040/44 V.S.Pharma(1971) Co.,Lt d GREEN BOOK 6 23

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Diazepam sterile solution, 10 mg/2 ml À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active ingredient) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) ººâŸ ≈µ‘ ∑’ºË “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ÕË ººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name Õߧ°å “√‡¿ —™°√√¡ ‰¡à√–∫ÿ Diazepam Government Pharmaceutical Organization 24 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Haloperidol sterile solution À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) -  “√°àÕ‰¢â (Bacterial endotoxins, LAL) ºŸâº≈µ‘ ∑Ë’ºà“π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™Õ◊Ë ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õµ·≈𵑧 ·≈∫Õ√“∑Õ√ Ë’ å 1A 1188/27 Haridol-5 Atlantic Laboratories Co.,Ltd. 1A 146/31 Haridol-D 50 ·®π‡´àπ ø“√¡å “´µŸ ‘§Õ≈ ª√–‡∑»‡∫≈‡¬¬’Ë ¡ 1C 44/28 Haldol -5 Janssen Pharmaceutical, Belgium ‚¡‡¥Õ√πå ·¡πŸ 1A 2678/29 Halolop - 5 Modern Manu Co.,Ltd. 1A 211/35 Halodec - 50 ‚Õ≈π— -‡§¡‡¡¥ 1A 1201/31 Halomed - 5 Olan - Kemed Co.,Ltd. GREEN BOOK 6 25

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ Pimozide tablet À—«¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008/ BP 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –‡¡¥Á (Content uniformity) ººâŸ ≈‘µ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊Ëպ⺟ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·®π‡´àπ-´·’ ≈° 1C 106/46 Orap - 1 Janssen-Cilag Ltd. 1C 162/45 Orap forte - 4 ø“√¡å “ —πµå ·≈∫Õ√“∑Õ√’ Ë å 1A 322/38 Pizide -1 Pharmasant Laboratories Co.,Ltd. 26 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Sodium valproate oral solution, 200 mg/ml À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π BP 2004) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - Related substances ºŸºâ ≈‘µ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‚Õ≈‘§ (ª√–‡∑»‰∑¬) 1A 542/33 Depakine Olic (Thailand) Co.,Ltd. 1A 200/47 Valprocid  À·æ∑¬å‡¿ —™ The Medicpharma Co.,Ltd. GREEN BOOK 6 27

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Sodium valproate enteric coated tablet 200 mg À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π BP 2004) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §“à ‡∫ˬ’ ߇∫π®“°πÈ”Àπ°— ‡©≈ˬ’ (Weight variation) - °“√·µ°°√–®“¬µ—«¢Õ߇¡¥Á ¬“ (Disintegration) - Related substances ººâŸ ≈‘µ∑˺’ “à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈Õ◊ ° √“¬™Ë◊պ⺟ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ¥«“π´å ‡√‡¡¥’ å ª√–‡∑»Õπ‘ ‡¥¬’ 1C 372/49 Valrem Advanced Remedies Pvt.,Ltd., India Depakine ´“‚πøòï «‘π∑√Õæ Õπ‘ ¥— µ√’ ª√–‡∑»Ω√ßË— ‡»  1C 343/49 Valstal Sanofi Winthrop Industrie, France  µ—≈‡≈’¬π ·≈∫Õ√“∑Õ√Ë’ å ª√–‡∑»Õπ‘ ‡¥¬’ 1C 130/50 Stallion Laboratories Pvt.,Ltd., India 28 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

¬“√°— …“‚√§∑“ß√–∫∫ª√– “∑ ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ´π— ø“√å¡“´µŸ ‡‘ §≈‘  å Õ‘π¥ — µ√ ’ å 1C 329/49 Encorate ª√–‡∑»Õπ‘ ‡¥¬’ Sun Pharmaceutical Industries Ltd., 1C 75/49 Valparin India 1A 670/33 Desorate ∑Õ√‡å √π∑å ø“√å¡“´µŸ ‡‘ §‘≈ å ª√–‡∑»Õ‘π‡¥’¬ Torrent Pharmaceuticals Ltd., India Alkalets æÕπ¥å ‡§¡‡’ §‘≈ ª√–‡∑»‰∑¬ Pondûs Chemical Thailand R.O.P. GREEN BOOK 6 29

¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ Sodium valproate sterile powder 400 mg/4 ml À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008 under Valproic acid injection) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §«“¡‡ªπì °√¥-‡∫  (pH) ºâºŸ ≈µ‘ ∑˺’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊Ëպ⺟ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ´“‚πøïò - Õ‡«πµ ’ ª√–‡∑»Ω√—Ë߇»  1C 339/49 Depakine Sanofi - Aventis Co.,Ltd., France 30 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

¬“ªØ‘™’«π– - Amphotericin B sterile powder - Cefixime dry syrup - Ciprofloxacin lactate sterile solution - Cloxacillin sodium sterile powder - Meropenem sterile powder - Mupirocin ointment - Ofloxacin tablet - Vancomycin HCl sterile powder GREEN BOOK 6 31

¬“ªØ™‘ ’«π– Amphotericin B sterile powder, 50 mg À«— ¢âÕµ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫ˬ’ ߇∫π®“°πÈ”Àπ—°‡©≈¬Ë’ (Weight variation) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) -  “√°Õà ‰¢â (Bacterial endotoxins, LAL) ºŸâº≈µ‘ ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™ÕË◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ·Õä∫∫Õµ ·≈∫Õ√“∑Õ√Ë’ å 1C 369/48 Fungizone Abbott Laboratories Ltd. 1C 173/50 Adpho Advance Pharma Co.,Ltd. ∫. ·§ ª“Ñ ø“√¡å “´µŸ ‘§Õ≈ (ª√–‡∑»‰∑¬) 1C 135/46 Amphotericin B ®”°¥— (ºâŸ·∑π®”Àπ“à ¬) ·Õ¡∫“√“≈ ´“√“‰∫ Ambalal Sarabhai Enterprises Ltd. 32 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

¬“ªØ‘™«’ π– ºâŸº≈‘µ∑’˺“à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 1A 100/47 Amphotericin B Biolab Co.,Ltd. 1C 184/49 Ampholin ‡¡¥‘‚Õ√“≈ å ·≈∫Õ√“∑Õ√’Ë å Mediorals Laboratories Pvt.,Ltd. GREEN BOOK 6 33

¬“ªØ‘™’«π– Ciprofloxacin lactate sterile solution À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) -  “√°Õà ‰¢â (Bacterial endotoxins, LAL) - Related substances ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ËÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‰∫‡ÕÕ√å ‡Œ≈∏å ·§√å ª√–‡∑»‡¬Õ√¡—π 1C 139/31 Ciprobay Bayer Health Care Ag, Germany Ciprofloxacin ‡ø√‡´πÕ’  ÿ §“∫’ ª√–‡∑»Õπ‘ ‡¥¬’ 1C 154/49 Fresenius Kabi India Pvt.,Ltd. Ciprom-M ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√ß‘Ë 1A 110/50 Ciprovid M&H Manufacturing Co.,Ltd. ¡≈‘ ≈‡‘ ¡¥ 1A 137/47 Millimed Co.,Ltd. 34 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

¬“ªØ™‘ «’ π– ºŸºâ ≈µ‘ ∑Ë’º“à π¡“µ√∞“πµ“¡‡°≥±å§—¥‡≈◊Õ° √“¬™◊ÕË ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·√π·∫°´Ë’ ·≈∫Õ√“∑Õ√’ Ë å 1C 26/35 Cifran Ranbaxy Laboratories Ltd. 1A 557/34 Cifloxin  ¬“¡‡¿ ™— Siam Bheasach Co.,Ltd. 1C 270/49 Cifrotil ·∑‡∫≈Á∑ å (ª√–‡∑»Õ‘π‡¥¬’ ) Tablets (India) Ltd. GREEN BOOK 6 35

¬“ªØ‘™’«π– Cefixime dry syrup, 100 mg / 5 ml À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - §à“§«“¡‡ªπì °√¥ - ‡∫  (pH) - ª√‘¡“≥π”È (Water) ºâºŸ ≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Ë◊ÕººŸâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 1A 3/42(N) Cefspan Biolab Co.,Ltd. 36 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

¬“ªØ‘™«’ π– Cloxacillin sodium sterile powder, 1 g À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“𠵓¡∑–‡∫’¬π¬“) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) - §“à §«“¡‡ªπì °√¥ - ‡∫  (pH) - ª√¡‘ “≥πÈ” (Water) ººŸâ ≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√‘Ëß 1A 324/35 Cloxa M.H. M & H Manufacturing Co.,Ltd. 1A 461/49 Cloxacil in 1A 500/42 Meiclox ‚¡‡¥Õ√πå ·¡πŸ Modern Manu Co.,Ltd. 1A 2701/28 Cloxin GREEN BOOK 6 37

¬“ªØ‘™«’ π– Meropenem sterile powder, 1 g À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–‡¡¥Á (Content uniformity) - §à“§«“¡‡ªìπ°√¥ - ‡∫  (pH) - Chromatographic purity ºâŸº≈µ‘ ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈◊Õ° √“¬™◊ÕË ººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‰∫‚Õ·≈∫ 1A 11/50 (NG) Monem Biolab Co.,Ltd. ‡Õ¡Á ·Õπ¥å ‡Õ™ ·¡πŸ·ø§‡®Õ√Ëß‘ 1A 14/50 (NG) Penem M.H. M & H Manufacturing Co.,Ltd.  ¬“¡‡¿ ™— 1A 56/50 (NG) Mapenam Siam Bheasach Co.,Ltd. ´¡Ÿ µ‘ “‚¡ ø“√å¡“´µŸ ‘‡§‘≈ å 1C 189/49 (N) Meronem Sumitamo Pharmaceuticals Co.,Ltd. 38 °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å

¬“ªØ™‘ «’ π– Mupirocin ointment, 2.0 % w/w À«— ¢Õâ µ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active ingredient) ºâŸº≈µ‘ ∑’ºË à“π¡“µ√∞“πµ“¡‡°≥±å§¥— ‡≈Õ◊ ° √“¬™◊ÕË ºâŸº≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name  ¡∑‘ ‰§≈πå ∫’·™¡ 1C 149/42 Bactroban Smith Kline Beecham Co.,Ltd. 1A 1130/41 Bactex ¬Ÿ‡π’¬Ë π ¥√—° ·≈∫Õ√“µÕ√’Ë å Union Drug Laboratories Co.,Ltd. GREEN BOOK 6 39

¬“ªØ‘™’«π– Ofloxacin tablet À—«¢Õâ µ√«® Õ∫§≥ÿ ¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ºŸºâ ≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Ë◊ÕºŸºâ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ∫“ß°Õ°·≈∫ ·Õπ¥å §Õ ‡¡µ‘§ 1A 825/41 Oflocee - 100 Bangkok Lab & Cosmetics Co.,Ltd. 1A 706/43 Oflocee - 200 ™‘πµâ“ ‡∑√¥¥ß‘È 1A 906/41 Oflobac - 100 Chinta Trading Co.,Ltd. ™ÿ¡™π‡¿ —™°√√¡ 1A 1194/43 Mifloxin - 100 Community Pharmacy Public Co.,Ltd. ‡°√∑ä ‡µÕ√åø“√å¡“ 1A 301/46 Tarivid - 200 Greater Pharma Co.,Ltd. 1A 319/43 Tarivid - 300 Khandelwal Laboratories Pvt. Ltd. 1C 208/49 Ofla - 200 ∫√‘…∑— ™¡ÿ ™π‡¿ ™— °√√¡ ®”°—¥ (¡À“™π) (º·âŸ ∑π®”Àπ“à ¬) 40 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“ªØ‘™’«π– ºâºŸ ≈‘µ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™◊ËÕºŸºâ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ°“√§â“ Manufacturer Reg No. Trade name ·Õ≈ ∫’ ‡Õ  ·≈∫ 1A 945/40 Ofloxa - 200 L.B.S. Lab. Ltd. 1A 445/40 Ofloxa - 100 ‚√ßß“π‡≈»‘  ‘ßÀ凿 ™— °√√¡ 1A 448/50 Ofloxtin - 200 Lerd Singh Pharm 1A 490/50 Ofloxtin - 100 Macleods Pharmaceuticals Ltd 1C 78/51 Oflamac - 200 ∫√‘…—∑ ·Õª§“√å ø“√å¡“·≈ª (ª√–‡∑»‰∑¬) ®”°—¥ (º·âŸ ∑π®”Àπ“à ¬) 1A 730/42 Seracin - 200 1A 388/39 Seracin - 100 ¡“´“·≈∫ Masa Lab Co.,Ltd. 1A 26/47 Floxy - 200 1A 309/45 Floxy - 100 ¡≈‘ ≈‡‘ ¡¥ Mil imed Co.,Ltd. 1A 512/40 Ofacin - 200 ∫.‡¿ ™— °√√¡π§√æ≤— π“ ®”°—¥ 1A 180/42 Ofloxan - 100 Nakorn Patana Co.,Ltd. 1A 1100/40 Orivid - 100 π«‘ ‰≈øá ø“√å¡“ ®”°¥— New Life Pharma Co.,Ltd. 1A 294/38 Hyflox - 100 ø“√¡å “ —πµå ·≈∫Õ√“∑Õ√Ë’ å Pharmasant Laboratories Co.,Ltd. æÕπ¥å ‡§¡’‡§≈‘ ª√–‡∑»‰∑¬ Pondûs Chemical (Thailand) GREEN BOOK 6 41

¬“ªØ‘™’«π– Ofloxacin tablet ºâŸº≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™Õ◊Ë ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ·√π·∫°´’Ë ·≈∫Õ√“∑Õ√Ë’ å ª√–‡∑»Õ‘π‡¥¬’ 1C 340/40 Occidal - 200 Ranbaxy Laboratories Ltd. India. Õ“√å ‡Õ°Á ´ ‡¡πŸ·ø§‡®Õ√‘ß 1A 492/48 Oflox Rx - 100 R.X. Manufacturing Co., Ltd.  µ“¥“ 1C 304/49 Ofloxacin Stada VNJV Co.,Ltd Stada - 200 Àâ“ߢ“¬¬“µ√“‡®Á¥¥“« 1A 155/49 Ofloxvid -100 Seven Star Pharmaceuticals Co.,Ltd.  ¬“¡‡¿ —™ 1A 23/36 Ofloxin - 100 Siam Bheasach Co.,Ltd. 1A 340/42 Ofloxin - 200 ∑’ ‚Õ ø“√¡å “ 1A 337/38 Konovid - 200 T.O.Pharma Co.,Ltd. 1A 329/38 Konovid - 100 ¬πŸ ’§ ø“√å¡“´Ÿµ‘§Õ≈ ·≈∫œ ª√–‡∑»Õπ‘ ‡¥¬’ 1C 215/48 Oflo - 200 Unique Pharmaceutical. Lab., India ¬Ÿπ´‘ —π ·≈∫Õ√“∑Õ√Ë ’ å 1A 544/41 Lexemin - 100 Unison Laboratories Co.,Ltd. 1A 346/45 Lexemin - 200 1A 543/41 Lexemin - 300 42 °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å

¬“ªØ‘™’«π– Vancomycin HCl sterile powder, 500 mg À«— ¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active ingredient) - §à“‡∫¬Ë’ ߇∫π®“°πÈ”Àπ—°‡©≈’¬Ë (Weight variation) - §“à §«“¡‡ªìπ°√¥ - ‡∫  (pH) -  “√°àÕ‰¢â (Bacterial endotoxins, LAL) ºŸâº≈µ‘ ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™ÕË◊ ºŸâº≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Õ≈— ‡§¡ ·≈∫Õ√“∑Õ√ ’Ë å 1C 293/48 Vancogen Alkem Laboratories Ltd. 1C 82/47 Vancomycin CJ ´’ ‡® §Õ√åæÕ‡√™—Ëπ C J Corporation 1C 219/51 Vancomycin ŒÕ´ªî√“ 1C 288/47 Edicin Hospira Inc. ‡≈Á° ø“√¡å “´µŸ ‘‡§≈‘  å Lek Pharmaceuticals D.D. GREEN BOOK 6 43

¬“ªØ™‘ «’ π– ºŸâº≈µ‘ ∑’˺à“π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈◊Õ° √“¬™◊ÕË ººâŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name  ¬“¡‡¿ ™— 1A 307/47 Vancin-S Siam Bheasach Co.,Ltd. 1C 333/49 Celovan  ‰µ√¥å Õ“√傧·≈∫ Strides Arcolab Ltd. 44 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“µ“â π‡™Õ◊È ¡“≈“‡√’¬ - Quinine sulfate tablet GREEN BOOK 6 45

¬“µ“â π‡™Õ◊È ¡“≈“‡√’¬ Quinine sulfate tablet, 300 mg À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–‡¡Á¥ (Content uniformity) - Chromatographic purity ºŸºâ ≈‘µ∑º’Ë à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈◊Õ° √“¬™ÕË◊ ºâºŸ ≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name ‡¬π‡πÕ√√å “≈ ¥√°—  ‡å Œâ“ å 1A 1386/27 Genin General Drugs House Co.,Ltd. 1A 423/45 Quinine sulphate Õߧ尓√‡¿ —™°√√¡ Government Pharmaceutical 1A 2388/29 Quinine-S Organization ¬‚Ÿ ∑‡ª¬ôï π Utopian Co.,Ltd. 46 °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å

¬“¶à“ÀπÕπ欓∏‘ - Albendazole tablet - Mebendazole suspension - Mebendazole tablet GREEN BOOK 6 47

¬“¶à“ÀπÕπ欓∏‘ Albendazole tablet, 200 mg À—«¢âÕµ√«® Õ∫§ÿ≥¿“æ (¡“µ√∞“π USP 31, 2008) - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –‡¡Á¥ (Content uniformity) ºŸâº≈‘µ∑ºË’ à“π¡“µ√∞“πµ“¡‡°≥±§å —¥‡≈Õ◊ ° √“¬™Ë◊ÕººâŸ ≈µ‘ ‡≈¢∑–‡∫’¬π¬“ ™Ë◊Õ°“√§â“ Manufacturer Reg No. Trade name Õߧ°å “√‡¿ ™— °√√¡ 1A 1044/44 Falben Government Pharmaceutical Organization 1A 379/33 Albatel ∑’ ‚Õ ‡§¡‡’ §≈‘  å T.O.Chemicals (1979) Ltd. 48 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å