greenbook3

°√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 1

2 GREEN BOOK 3

°√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 3

√“¬™Õ◊Ë º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººâŸ ≈µ‘ ‡≈¡à ∑Ë’ 3 æ.». 2550 ∑ª’Ë √°÷ …“ πæ.‰æ®µ‘ √å «√“™‘µ Õ∏‘∫¥’°√¡«‘∑¬“»“ µ√å°“√·æ∑¬å πæ.Õ”π«¬ °“®π’ – √ÕßÕ∏‘∫¥°’ √¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å πæ.æß»æπ— ∏å «ß»å¡≥’ √ÕßÕ∏∫‘ ¥°’ √¡«‘∑¬“»“ µ√°å “√·æ∑¬å ¿°.¡“𵑠¬å Õ√ÿ≥“°Ÿ√ √ÕßÕ∏‘∫¥’°√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å ¿≠.π—π∑π“  ‘∑∏‘™¬— ‡¿ ™— °√ 9 «™ ¥â“πª√– ∑‘ ∏¿‘ “æ¢Õ߬“ ¿≠.‚√®π“ ‚°«‘∑«—≤πæß»å ºŸâÕ”π«¬°“√ ”π—°¬“·≈–«—µ∂‡ÿ  æµ¥‘ ºâŸ®—¥∑” ¿≠. ÿ¢»√’ ÕßÈ÷ ∫√∫‘ √Ÿ ≥‰å 滓≈ ‡¿ ™— °√ 8 «™ ¿≠.𥑠“æ√√≥ ‡√◊Õ߃∑∏‘ππ∑å ‡¿ ™— °√ 8 «™ ¿≠.‚ ¡»√‘ ‘ ª√–∑ª’ –®‘µµ‘ ‡¿ —™°√ 8 «™ ¿≠.¡“»«≈—¬ ≈¢‘ µ‘ ∏π‡»√…∞å ‡¿ —™°√ 5 ‡®“â ¢Õß  ”π°— ¬“·≈–«µ— ∂‡ÿ  æµ¥‘ °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å °√–∑√«ß “∏“√≥ ÿ¢ ®.ππ∑∫√ÿ ’ ‚∑√.0-2951-0000 µàÕ 99137,99156 ‚∑√ “√.0-2580-5733 æ¡‘ æ∑å Ë’ ‚√ßæ¡‘ æ¡å À“«‘∑¬“≈—¬∏√√¡»“ µ√å ‡≈à¡∑’Ë 3 ®”π«π 5,000 ‡≈¡à ªï∑’Ëæ¡‘ æå æ.».2550 ISBN : 978-974-7525-15-1 24 GREEN BOOK 3

§”π” °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ¡’§«“¡¡àÿß¡—Ëπ„π°“√¥”‡π‘π‚§√ß°“√ª√–°—π §ÿ≥¿“欓„Àâ§√Õ∫§≈ÿ¡√“¬™Ë◊Õ¬“„π∫—≠™’¬“À≈—°·Ààß™“µ‘¢Õß°√–∑√«ß “∏“√≥ ÿ¢ ‚¥¬¥”‡π‘π°“√µ√«® Õ∫§ÿ≥¿“æ·≈–§«“¡ª≈Õ¥¿—¬¢Õ߬“„π‚§√ß°“√À≈—°ª√–°—π  ÿ¢¿“æ·Ààß™“µ‘ ¥â«¬§«“¡√à«¡¡◊Õ°—∫ ”π—°ß“π “∏“√≥ ÿ¢®—ßÀ«—¥∑Ë—«ª√–‡∑» ‚√ß欓∫“≈¢Õß√—∞ ·≈– ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ ‚¥¬‚§√ß°“√¥ß— °≈“à « ‰¥â°”Àπ¥À≈—°‡°≥±å«à“ ®–„™â«‘∏’·≈–¡“µ√∞“πµ“¡µ”√“¬“©∫—∫∑’Ë√—∞¡πµ√’ª√–°“» À√◊Õ©∫—∫„À¡à°«à“‡ªìπ‡°≥±å¡“µ√∞“π ‡æË◊Õª√–‡¡‘π§ÿ≥¿“æ∫π¡“µ√∞“π‡¥’¬«°—π ∑ÿ°º≈‘µ¿—≥±å∑Ë’¡’√–∫ÿ„πµ”√“¬“  ”À√—∫º≈‘µ¿—≥±å¬“·µà≈–‡≈¢∑–‡∫’¬π∑’˺à“π°“√ µ√«®«‘‡§√“–À凢ⓡ“µ√∞“π∑ÿ°µ—«Õ¬à“ß Õ¬à“ßπâÕ¬ 3 √ÿàπ°“√º≈‘µ ®–‰¥â√—∫°“√ §—¥‡≈◊Õ°‡ªìπµ”√—∫¬“§ÿ≥¿“æ¡“‡º¬·æ√à„πÀπ—ß ◊Õ ç√“¬™◊ËÕº≈‘µ¿—≥±å¬“§ÿ≥¿“æ·≈– ºâŸº≈‘µ (GREEN BOOK)é ´Ë÷ߺ≈°“√¥”‡π‘πß“π„πªïß∫ª√–¡“≥æ.». 2545-2548 ‰¥â√«∫√«¡·≈–√“¬ß“π‰«â„πÀπ—ß Õ◊ ¥—ß°≈“à «®”π«π 2 ‡≈¡à ‚¥¬· ¥ß™ËÕ◊  “¡≠— ∑“߬“ ™◊Ëպ⟺≈‘µ ‡≈¢∑–‡∫’¬π¬“ ™◊ËÕ∑“ß°“√§â“ ¢π“¥§«“¡·√ߢÕßµ—«¬“ ”§—≠ ·≈– À—«¢âÕ∑’˵√«® Õ∫§ÿ≥¿“æ‰«â  ”À√—∫µ—«Õ¬à“ߺ‘¥¡“µ√∞“π‰¥â®—¥ àß√“¬ß“πº≈„Àâ  ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“Õ¬à“߇√àߥà«π ‡æ◊ËÕ·®âߺŸâº≈‘µæ√âÕ¡‡°Á∫µ—«Õ¬à“ß  àßµ√«®«‘‡§√“–Àå´È”°àÕ𥔇π‘π°“√µàÕ‰ª ∑È—ßπÈ’„π°“√¥”‡π‘π‚§√ß°“√¥—ß°≈à“«¡’ à«π °√–µπâÿ „Àºâ ºŸâ ≈µ‘ ¡§’ «“¡µ√–Àπ°— ·≈–√∫— º¥‘ ™Õ∫„π°“√æ≤— 𓬓·µ≈à –µ”√∫— Õ¬“à ß®√ß‘ ®ß— ¡’°“√ª√—∫ª√ÿ߇հ “√°“√¢÷Èπ∑–‡∫’¬π¬“„Àâ∑—π ¡—¬ ¡’°“√»÷°…“§«“¡§ß ¿“æ¢Õß º≈‘µ¿—≥±å¬“ ‡æ◊ËÕ„À≥⬓∑’Ë¡’§ÿ≥¿“æ  “¡“√∂·¢àߢ—π‰¥â∑—Èß„πª√–‡∑»·≈–„π√–¥—∫ ¿Ÿ¡‘¿“§Õ“‡´’¬π  ”À√∫— Àπß—  Õ◊ √“¬™ÕË◊ º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººŸâ ≈µ‘ ‡≈¡à ∑’Ë 3 (GREEN BOOK 3) πÈ’ ®—¥∑”¢÷Èπ„π·π«∑“߇¥’¬«°—π°—∫‡≈à¡ 1 ·≈– 2 ‚¥¬π”√“¬™◊ËÕµ”√—∫¬“§ÿ≥¿“æ ∑ºË’ “à π°“√µ√«®«‡‘ §√“–À„å πªßï ∫ª√–¡“≥ 2549 ¡“√“¬ß“π‰«æâ √Õâ ¡¢Õâ ¡≈Ÿ ÕπË◊ ∑‡Ë’ °¬Ë’ «¢Õâ ß ‚¥¬„π¿“§ºπ«° ‰¥â𔇠πÕ “√–§«“¡√⟇°’ˬ«°—∫ “√¡“µ√∞“𬓷≈–«—µ∂ÿ‡ æµ‘¥ ´Ë÷߇ªìπ à«π ”§—≠¬Ë‘ß„π°“√µ√«® Õ∫§ÿ≥¿“æ ·≈–°“√ —߇°µº≈‘µ¿—≥±å¬“‡æË◊Õ∫àߙȒ §«“¡‰¡§à ß ¿“æ µ≈Õ¥®π§«“¡À¡“¬¢Õß·µ≈à –À«— ¢Õâ ¢Õß°“√µ√«®«‡‘ §√“–À§å ≥ÿ ¿“æ ‡æÕË◊ ‡ªπì ª√–‚¬™πåµàÕº‡âŸ °’ˬ«¢Õâ ߥ⫬ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬åÀ«—߇ªìπÕ¬à“߬‘Ëß«à“ ¢âÕ¡Ÿ≈„πÀπ—ß ◊Õ‡≈à¡πÈ’®–‡ªìπ ª√–‚¬™πå„π°“√∫√‘∫“≈∑“߇¿ —™°√√¡·≈–‡ªìπ·π«∑“ß àŸ°“√æ—≤π“º≈‘µ¿—≥±å¬“„Àâ¡’ §ÿ≥¿“浓¡¡“µ√∞“π “°≈µÕà ‰ª ...... (𓬷æ∑¬å ‰æ®µ‘ √å «√“™µ‘ ) Õ∏∫‘ ¥°’ √¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 5

 “√∫≠— Àπ“â 7 °µ‘ µ‘°√√¡ª√–°“» 8 10 °“√®—¥∑”√“¬™Õ◊Ë º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººâŸ ≈‘µ 11 Abstract 13 14 √“¬™ÕË◊ º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººâŸ ≈µ‘ ®”·π°µ“¡ª√–‡¿∑¢Õ߬“ 15 16 ¬“ªØ™‘ ’«π– 17 18 Ampicilin and Sulbactam for Injection 20 Cefuroxime Axetil for oral Suspension 21 Cefuroxime Axetil film coated Tablet 22 Chloramphenicol sodium succinate for Injection 23 Clarithromycin Tablet 24 Doxycycline Capsule 25 Gentamycin Sulfate Injection 26 Imipenem and Cilastatin for Injection Meropenem for Injection 28 Metronidazole Tablet 29 Metronidazole Injection 30 Ofloxacin film coated Tablet 31 Vancomycin HCL Injection 32 ¬“√—°…“‚√§À«— „® ≈¥§«“¡¥π— ‚≈Àµ‘ ¬“¢—∫ª í  “«– Amiodarone HCL Tablet Amlodipine Tablet Clonidine HCl Tablet Digoxin Tablet Furosemide Injection 64 GREEN BOOK 3

 “√∫≠— Àπ“â 33 Hydralazine HCl Tablet 34 Hydrochlorothiazide Tablet 35 Spironolactone Tablet 36 Metoprolol tartrate Tablet ¬“µ“â π‡™ÕÈ◊ «—≥‚√§ ¬“¶“à ÀπÕπ欓∏‘ 39 Albendazole oral Suspension 40 Ethambutol film coated Tablet 41 Praziquantel Tablet ¬“µâ“πŒ’ µ“¡’π/¿¡Ÿ ‘·æâ 43 Azathioprine Tablet 44 Loratadine Tablet ¬“√—°…“‚√§„π√–∫∫∑“߇¥π‘ Õ“À“√ 47 Bisacodyl Tablet 48 Dicyclomine HCl film coated Tablet 49 Dicyclomine HCl Syrup 50 Loperamide HCl Capsule 51 Metoclopramide HCl Injection 52 Metoclopramide HCl Tablet 53 Sulfasalazine Tablet ¬“·°âª«¥ ≈¥‰¢â 55 Mefenamic acid Capsule ¬“√—°…“‚√§„π√–∫∫∑“߇¥π‘ À“¬„® 57 Guaifenesin Syrup 58 Guaifenesin Tablet °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 57

 “√∫≠— Àπ“â ¬“√—°…“‚√§∑“ß√–∫∫ª√– “∑ 60 Alopurinol Tablet 62 Amitriptyline HCl Tablet 63 Clomipramine HCl Tablet 64 Nortriptyline HCL Tablet 65 Probenecid Tablet 66 Selegiline HCl Tablet 69 ¬“™“ Lidocaine HCl Injection 71 ¬“µâ“π‡™◊ÕÈ ¡“‡≈‡√’¬ 73 Chloroquine phosphate Tablet 75 ¬“µâ“π‡™È◊Õ‰«√—  Zidovudine Capsule 77 78 ¬“√—°…“‚√§‡∫“À«“π 79 Insulin Injection 82 ¬“ª√–‡¿∑Õ◊ËπÊ 84 Levonorgestrel and Ethinyl estradiol Tablet 89 Peritoneal dialysis Solution 93 Sodium chloride Injection ¿“§ºπ«°  “√¡“µ√∞“𬓷≈–«—µ∂‡ÿ  æµ‘¥ °“√ ß— ‡°µº≈µ‘ ¿≥— ±¬å “‡æ◊ÕË ∫àß™§’È «“¡‰¡§à ß ¿“æ À—«¢âÕ∑¥ Õ∫„πº≈‘µ¿≥— ±¬å “ ”‡√Á®√Ÿª ¥√√™π’ (Index) 86 GREEN BOOK 3

°‘µµ‘°√√¡ª√–°“» °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ¢Õ¢Õ∫§ÿ≥ ∫ÿ§≈“°√¢Õß‚√ß欓∫“≈ ∑È—ß„π·≈–πÕ° —ß°—¥¢Õß°√–∑√«ß “∏“√≥ ÿ¢  ”π—°ß“π “∏“√≥ ÿ¢®—ßÀ«—¥  ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ √«¡∑—Èß ”π—°ß“πÀ≈—°ª√–°—π ÿ¢¿“æ ·Ààß™“µ‘ µ≈Õ¥®π∫ÿ§≈“°√¢Õß°√¡«‘∑¬“»“ µ√å°“√·æ∑¬åºŸâ¥”‡π‘π°“√µ√«® «‡‘ §√“–Àå∑„’Ë À§â «“¡√«à ¡¡Õ◊ ·≈– π∫—  ππÿ „π°“√¥”‡ππ‘ ‚§√ß°“√ª√–°π— §≥ÿ ¿“欓 ªßï ∫ª√–¡“≥ æ.». 2549 ®π ”‡√®Á ≈≈ÿ «à ß·≈–‰¥¢â Õâ ¡≈Ÿ º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈– ººâŸ ≈‘µ¡“‡º¬·æ√à„π‡Õ° “√©∫—∫πÈ’ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 79

°“√®¥— ∑”√“¬™ÕË◊ º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººŸâ ≈µ‘ ‡≈¡à ∑Ë’ 3 (GREEN BOOK 3) ¢Õâ ¡≈Ÿ „πÀπß—  Õ◊ ‡≈¡à π‰’È ¥§â ¥— ‡≈Õ◊ °¡“®“°º≈°“√µ√«® Õ∫§≥ÿ ¿“欓·ºπ ªí®®ÿ∫—π„π‚§√ß°“√ √â“ßÀ≈—°ª√–°—π§ÿ≥¿“æ·≈–¡“µ√∞“π∫√‘°“√¥â“𬓠„π ªïß∫ª√–¡“≥ 2549 ¢Õß°√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ·≈–‰¥â√—∫§«“¡√à«¡¡◊Õ „π°“√ ¡ÿà µ«— Õ¬“à ß®“°‚√ß欓∫“≈¢Õß√∞— „π ß— °¥— °√–∑√«ß “∏“√≥ ¢ÿ ∑«—Ë ª√–‡∑» ®”π«π 55 º≈µ‘ ¿≥— ±å √«¡∑—Èß ‘Èπ 1,639 µ—«Õ¬“à ß ®”·π°‡ªì𬓷ºπªí®®ÿ∫—π 50 º≈µ‘ ¿—≥±å ®”π«π 1,478 µ«— Õ¬à“ß ‚¥¬µ”√∫— „¥∑’¡Ë √’ –∫ÿ„πµ”√“¬“®–„™«â ‘∏’ ·≈–¡“µ√∞“π∑’Ë°”Àπ¥„πµ”√“¬“©∫—∫∑Ë’√—∞¡πµ√’ª√–°“»À√◊Õ©∫—∫„À¡à°«à“ „π∑°ÿ º≈µ‘ ¿≥— ±¬å “∑¡’Ë √’ ªŸ ·∫∫¬“·≈–µ«— ¬“ ”§≠— ‡À¡Õ◊ π°π— ‡æÕ◊Ë ª√–‡¡π‘ §≥ÿ ¿“æ ∫π¡“µ√∞“π‡¥¬’ «°π— ∑°ÿ ·À≈ßà º≈µ‘ ‚¥¬ÀÕâ ߪØ∫‘ µ— °‘ “√¢Õß ”π°— ¬“·≈–«µ— ∂‡ÿ  æµ¥‘ ·≈–»Ÿπ¬å«‘∑¬“»“ µ√å°“√·æ∑¬å πÕ°®“°‚§√ß°“√¥—ß°≈à“« °√¡«‘∑¬“»“ µ√å °“√·æ∑¬‰å ¥¥â ”‡ππ‘ ‚§√ß°“√√«à ¡°∫—  ¡“§¡‡¿ ™— °√√¡‚√ß欓∫“≈(ª√–‡∑»‰∑¬) ‚¥¬°“√ π—∫ ππÿ ß∫ª√–¡“≥®“°  ”π—°ß“πÀ≈°— ª√–°π—  ¢ÿ ¿“æ·Àßà ™“µ‘ ‡æÕ◊Ë  ¡ÿà µ«— Õ¬“à ߺ≈µ‘ ¿≥— ±¬å “∑‚Ë’ √ß欓∫“≈„À§â «“¡ π„®„π‡√Õ◊Ë ß§≥ÿ ¿“æÕ°’ 10 ™π¥‘ µ«— ¬“ ´Ë÷߉¥â§¥— ‡≈◊Õ°¡“‡º¬·æ√®à ”π«π 7 ™π¥‘ µ—«¬“ Õ’° 3 ™π¥‘ µ«— ¬“‰¥â·°à Carbamazepine Tablet, Warfarin sodium tablet ·≈– Omeprazole injection Õ¬„àŸ π‚§√ß°“√ √“â ßÀ≈°— ª√–°—π§≥ÿ ¿“æ·≈–¡“µ√∞“π∫√°‘ “√¥“â 𬓠ªïß∫ª√–¡“≥ 2550 ¢Õß°√¡«‘∑¬“»“ µ√°å “√·æ∑¬å ¥«â ¬‡™πà °π— ´÷ßË ®–¡’°“√ √«¡¢âÕ¡Ÿ≈‡æËÕ◊ §—¥‡≈◊Õ°‡¢â“„π GREEN BOOK ‡≈¡à µàÕ‰ª ‚¥¬„π 7 ™π¥‘ µ«— ¬“ ¥ß— °≈“à «°√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å‰¥¡â °’ “√ ¡àÿ µ«— Õ¬“à ß∫“ߺ≈µ‘ ¿≥— ±∑å ¡’Ë ‰’ ¡§à √∫ 3 √àÿπº≈µ‘ ‡æ‘¡Ë ‡µ¡‘ ·≈–À“°º≈µ‘ ¿—≥±å„¥¬ß— ‰¡¡à √’ –∫ÿ„πµ”√“¬“ ‰¥â √ÿªº≈µ“¡ ‡°≥±¡å “µ√∞“π∑ºË’ ºâŸ ≈µ‘ ‰¥¢â πÈ÷ ∑–‡∫¬’ π‰«â ´ß÷Ë Õ“®·µ°µ“à ß°π— ‡≈°Á πÕâ ¬„π·µ≈à –ººâŸ ≈µ‘  ”À√∫— ª≠í À“§≥ÿ ¿“æ¢Õߺ≈µ‘ ¿≥— ±¬å “∑æ’Ë ∫ §Õ◊ ∫“ߺ≈µ‘ ¿≥— ±¡å √’ ªŸ ·∫∫ ¬“∑‰’Ë ¡‡à À¡“– ¡µ“¡∑µË’ ”√“¬“°”Àπ¥ ‡™πà Bisacodyl Tablets ´ß÷Ë µ”√“¬“ USP 180 GREEN BOOK 3

·≈– BP °”Àπ¥„À‡â ªπì ¬“‡¡Á¥‡§≈◊Õ∫øî≈å¡ ™π¥‘ enteric ‡æÕË◊ ÕÕ°ƒ∑∏„Ï‘ π≈”‰ â ·µà¬—ß¡’°“√º≈‘µ√Ÿª·∫∫¬“‡¡Á¥‡§≈◊Õ∫πÈ”µ“≈·≈–„™â„π‚√ß欓∫“≈Õ¬àŸ ´÷Ë߇¡Ë◊Õ ∑¥ Õ∫°“√·µ°µ—«¢Õ߇¡Á¥¬“ æ∫«à“‰¡àºà“π‡°≥±åµ“¡¡“µ√∞“π¢Õ߬“‡¡Á¥ ‡§≈◊Õ∫ø≈î ¡å enteric À√Õ◊ °√≥’ Amitriptyline HCl Tablets ¡º’ ≈‘µ¿—≥±∑å Èß— ™π‘¥ ‡§≈◊Õ∫øî≈å¡·≈–‡§≈◊Õ∫πÈ”µ“≈ æ∫«à“„𬓇¡Á¥‡§≈◊Õ∫πÈ”µ“≈ º‘¥¡“µ√∞“π À«— ¢Õâ °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ‡ªπì  «à π„À≠à ‚¥¬ª√¡‘ “≥µ«— ¬“≈–≈“¬ ÕÕ°¡“πÕâ ¬°«“à ∑¡Ë’ “µ√∞“π°”Àπ¥ ´ßË÷ ‡ªπì ª≠í À“„À≠¢à Õ߬“™π¥‘ ‡§≈Õ◊ ∫πÈ”µ“≈ ∑«—Ë ‰ª ‡¡ÕË◊ Õ“¬¢ÿ Õ߬“¬“«π“π¢πÈ÷  «à 𬓇¡¥Á ‡§≈Õ◊ ∫ø≈î ¡å ‰¡æà ∫ª≠í À“°“√≈–≈“¬ ¢Õßµ«— ¬“  ”À√—∫º≈‘µ¿≥— ±¬å “ Albendazole oral suspension °“√°”Àπ¥ §à“§«“¡‡ªìπ°√¥-‡∫  (pH) ´Ë÷߇ªìπ°“√§«∫§ÿ¡§«“¡§ß ¿“æ¢Õ߬“ æ∫«à“ ººâŸ ≈µ‘ ∫“ß√“¬°”Àπ¥¡“µ√∞“π°«“â ß°«“à ∑µË’ ”√“¬“°”Àπ¥ ¥ß— ππÈ— º≈µ‘ ¿≥— ±¬å “ ¥ß— °≈à“«®ß÷ µ√«®æ∫§à“ pH Õ¬àŸπÕ°‡°≥±∑å µË’ ”√“¬“°”Àπ¥ ‡ªìπµπâ Õ¬à“߉√°Áµ“¡ ”À√—∫º≈‘µ¿—≥±å¬“∑’Ë¡’§ÿ≥¿“æ ®“°°“√„™â«‘∏’«‘‡§√“–Àå ·≈–‡°≥±å¡“µ√∞“πµ“¡µ”√“¬“©∫—∫„À¡àÊ º≈°“√µ√«® Õ∫§ÿ≥¿“ææ∫«à“ º“à π‡°≥±¡å “µ√∞“π®”π«π¡“° ´÷ËߺŸºâ ≈µ‘  “¡“√∂ª√—∫ª√ßÿ ‡Õ° “√°“√§«∫§ÿ¡ §≥ÿ ¿“æ„π∑–‡∫¬’ 𬓄À‡â ªπì ª®í ®∫ÿ π— µ“¡µ”√“¬“ ‚¥¬‰¡‡à æ¡‘Ë ¿“√–„π°“√æ≤— π“  µŸ √µ”√∫— ·µÕà ¬“à ß„¥·≈– “¡“√∂𔉪·¢ßà ¢π— „π°“√‡ πÕ¢“¬‰¥Õâ ¬“à ß¡ª’ √– ∑‘ ∏¿‘ “æ „π°“√§¥— ‡≈Õ◊ °º≈µ‘ ¿≥— ±¬å “∑ºË’ “à π‡°≥±¡å “µ√∞“π„π GREEN BOOK 3 π’È ¡’¢âÕ®”°—¥„πÀ≈“¬‡√Ë◊Õ߇πË◊Õß®“°º≈‘µ¿—≥±å¬“∫“ß™π‘¥¡’°“√„™âπâÕ¬ À√◊Õ¡’ °“√º≈µ‘ µ≈Õ¥®π°“√π”‡¢“⠇撬ߪ≈ï – 2 √ÿπà º≈‘µ ∑”„Àâ°“√ àÿ¡µ—«Õ¬à“ß∑”‰¥â ‰¡à§√∫ 3 √àÿπº≈‘µ„π™à«ß¥”‡π‘π‚§√ß°“√ ¥—ßπÈ—π°√≥’∑’Ë¡’®”π«π 2 √àÿπº≈‘µ ‡À¡◊Õπ°—π∑ÿ°º≈‘µ¿—≥±å„π√“¬°“√¬“π—ÈπÊ ·≈–‡ªìπ¬“∑’ˉ¡à¡’ªí≠À“¥â“𧫓¡ §ß ¿“æ ®–Õπÿ‚≈¡§—¥‡≈◊Õ°®“° 2 √àÿπº≈‘µÕ¬à“߇∑à“‡∑’¬¡°—π¡“‡º¬·æ√à  ”À√—∫πÈ”¬“≈â“߉µ (Peritoneal dialysis solution) ´÷Ëßµ√«® Õ∫ “√°àÕ‰¢â ‚¥¬«∏‘ ’ Bacterial Endotoxin (LAL) æ∫«“à ·µ≈à –º≈µ‘ ¿≥— ±‰å ¡æà ∫ª≠í À“ ®ß÷ §¥— ‡≈Õ◊ ° ¡“‡º¬·æ√∑à °ÿ º≈µ‘ ¿≥— ±∑å Ë’ºà“π‡°≥±å¡“µ√∞“π °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 191

Abstract Under the çQuality Assurance of Medicines under the Universal Health Care Coverage Schemeé in fiscal year 2006, the Department of Medical Sciences conducted the quality examinations nationwide of 1,639 samples from 55 products, of which 1,478 samples from 50 products were modern drugs. Apart from this program, the Department colaborated with the Association of Hospital Pharmacy (Thailand) to investigate 10 items of active pharmaceutical ingredients, with financial support from the National Health Security Office. Only seven items of ingredients and their products were inspected and reported in this Green Book 3. The remaining three, Carbamazepine Tablet, Warfarin Sodium Tablet and Omeprazole Injection, were deferred to the next Green Book. In this investigation, the methods and requirements in the latest edition of the official pharmacopoeias were followed, except for the non-official products, the ones described in their registered documents were applied to. The examples of non-compliance products included the poor disintegration or dissolution due to inappropriate dosage forms, the incorrect pH values of some oral suspensions, etc. However, most of the qualified products still could pass the pharmacopeial requirements without referring to their own requirements. This encouraged the manufacturers to update their quality control dossiers without regard to their formulation changes. Some limitations occurred for some products whose available lots were only two. The quality-approved products were then listed if they apparently showed no evidence of stability problems and all concerning companies held two lots for each product. For peritoneal dialysis solutions, it revealed that all products passed the bacterial endotoxin tests and they were reported in this Green Book. The Department of Medical Sciences wishes to record its appreciation of the services of all those who have contributed to this work. Comments, criticisms and suggestions are welcome. 102 GREEN BOOK 3

√“¬™ÕË◊ º≈µ‘ ¿≥— ±¬å “§≥ÿ ¿“æ·≈–ººâŸ ≈µ‘ ®”·π°µ“¡ª√–‡¿∑¢Õ߬“ °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 13

¬“ªØ‘™’«π– - Ampicillin and Sulbactam for Injection - Cefuroxime Axetil for Oral Suspension - Cefuroxime Axetil film coated Tablet - Chloramphenicol sodium succinate for Injection - Clarithromycin Tablet - Gentamycin Sulfate Injection - Doxycycline Capsule - Imipenem and Cilastatin for Injection - Meropenem for Injection - Metronidazole Tablet - Metronidazole Injection - Ofloxacin film coated Tablet - Vancomycin HCL Injection 124 GREEN BOOK 3

¬“ªØ‘™’«π– Ampicillin and Sulbactam for Injection ·Õ¡æ´‘ ≈‘ π‘ ·≈–´“≈·∫§·∑¡  ”À√∫— ©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content Uniformity) - ª√¡‘ “≥πÈ” (Water) - ¢π“¥ particles (Particulate Matter) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‰ø‡´Õ√å (Õµ‘ “≈’) 2C 79/47 Unasyn Pfizer Italia S.R.L., Italy 2A 8/46 Sulam  ¬“¡‡¿ —™ Siam Bheasach Co.,Ltd °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 135

¬“ªØ‘™’«π– Cefuroxime Axetil for oral Suspension ´ø’ √Ÿ Õä °´’¡ ‡Õ´∑’ ≈‘ ™π¥‘ πÈ”·¢«πµ–°Õπ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“‡∫’ˬ߇∫π®“°πÈ”Àπ°— ‡©≈¬Ë’ (Weight Variation) - §à“§«“¡‡ªìπ°√¥-‡∫  (pH) - ª√¡‘ “≥πÈ” (Water) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ·√π·∫°ä ´’Ë ·≈∫Õ√“∑Õ√’Ë å (Õ‘π‡¥’¬) 1C 27/47 Magnaspor Ranbaxy Lab. (India) (dry Syrup) 146 GREEN BOOK 3

¬“ªØ‘™’«π– Cefuroxime Axetil film coated Tablet ´’ø√Ÿ äÕ°´¡’ ‡Õ´∑’ ‘≈ ™π¥‘ ‡¡Á¥‡§≈Õ◊ ∫ø≈î å¡ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active Ingredient) - §“à ‡∫’ˬ߇∫π®“°π”È Àπ°— ‡©≈ˬ’ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - ª√¡‘ “≥πÈ” (Water) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ·√π·∫ä°´’Ë ·≈∫Õ√“∑Õ√’Ë å (Õ‘π‡¥¬’ ) 1C 222/43 Magnaspor Ranbaxy Lab. (India) Furoxime  ¬“¡‡¿ —™ 1A 131/37 Siam Bheasach Co.,Ltd °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 157

¬“ªØ™‘ ’«π– Chloramphenicol sodium succinate for Injection §≈Õ·√¡‡øππ‚‘ §≈‚´‡¥¬Ë’ ¡´§— ´‘‡π∑  ”À√—∫©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active Ingredient) - §“à ‡∫ˬ’ ߇∫π®“°π”È Àπ°— ‡©≈’¬Ë (Weight Variation) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) - ª√‘¡“≥π”È (Water) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ·Õ≈.∫’.‡Õ . ·≈∫∫Õ√“∑Õ√ ’ å 1A 922/29 Cloman L.B.S. Laboratory Ltd., Part Phenicol π‘¥â“ ø“√¡å “ Õπ‘ §Õ√åªÕ‡√™—Ëπ 1A 1125/28 Nida Pharma Incorporation Co., Ltd. Chloramphenicol ∑’.æ’.¥√—° ·≈∫∫Õ√“∑Õ√’ Ë å (1969) 1A 360/31 T.P.Drug Laboratories (1969) Co., Ltd. 168 GREEN BOOK 3

¬“ªØ™‘ ’«π– Clarithromycin Tablet §≈“√∑‘ ‚∑√¡¬— ´π‘ ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“‡∫’¬Ë ߇∫π®“°π”È Àπ°— ‡©≈ˬ’ (Weight Variation) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ·Õä∫∫Õ∑ ·≈∫∫Õ√“∑Õ√ ’ å 1C 109/41(N) Klacid MR Abbot Lab. Ltd. Clarith ·Õ≈.∫’.‡Õ  ·≈∫∫Õ√“∑Õ√ ’ å 1A 8/45 (NG) L.B.S. Laboratory Ltd., Part Crixan 250 Crixan 500 ·√π·∫ä°´Ë’ ·≈∫∫Õ√“∑Õ√Ë’ å 1C 8/47 (NG) Ranbaxy Laboratories Ltd. 1C 2/45 (NG) Fascar ¬Ÿπ’´—π 1A 9/46 (NG) Clacina Unison Laboratories Co., Ltd. Õߧ尓√‡¿ ™— °√√¡ - Government Pharm. Organization °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 179

¬“ªØ™‘ «’ π– Doxycycline Capsule ¥äÕ°´Ë’‰´§≈‘π ™π¥‘ ·§ª´≈Ÿ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à ‡∫’¬Ë ߇∫π®“°π”È Àπ°— ‡©≈¬Ë’ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - ª√‘¡“≥π”È (Water) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ∫“ß°Õ°·≈∫ ·Õπ¥å §Õ ‡¡µ§‘ 1A 595/40 Doxylcap Bangkok Lab & Cosmetic Co., Ltd. Bronmycin ‰∫‚Õ·≈∫ 1A 858/29 Biolab Co., Ltd. Doxycline ‡¬π‡πÕ√√å “≈ ¥√—Í° ‡å Œ“â  å 1A 384/27 Cin-Doxy General Drugs House Co., Ltd. ‡¡¥‘´π’ ‚ª√¥°—  å 1A 659/41 Medicine Products Co., Ltd. 1280 GREEN BOOK 3

¬“ªØ‘™«’ π– √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name 𑥓â ø“√å¡“ Õπ‘ §Õ√åªÕ‡√™—Ëπ 1A 186/35 Nadoxin Nida Pharma Incorporation Co., Ltd. Doxycine ‚Õ ∂Õ‘π‡µÕ√å ·≈∫∫Õ√“∑Õ√’ å 1A 554/38 Osoth Inter Labolatories Co., Ltd. Policycline ‚ª≈ø‘ “√¡å 1A 43/35 Doxyman Polipharm Co., Ltd. Doxyclate ∑’.·¡π ø“√¡å “ 1A 284/44 T.Man Pharma Ltd. Part. ∑.’ ‚Õ.‡§¡§’ Õ≈ å (1979) 1A 481/36 T.O. Chemicals (1979) Co., Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 2191

¬“ªØ‘™«’ π– Gentamicin Sulfate Injection ‡®πµ“¡—¬´π‘ ´≈— ‡øµ ™π‘¥©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active Ingredient) - §à“§«“¡‡ªπì °√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™È◊Õ ( Sterility Test) - Bacterial Endotoxin (LAL) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ ™— °√√¡ - Gentamicin sulfate Government Pharm. Organization π‘¥â“ ø“√¡å “ Õ‘π§Õ√åªÕ‡√™Ë—π 1A 486/27 Spectramycin inj. Nida Pharma Incorporation Co., Ltd. 202 GREEN BOOK 3

¬“ªØ™‘ «’ π– Imipenem and Cilastatin for Injection Õ¡‘ ‡‘ æπ‡π¡·≈–‰´≈“ ‡µµπ‘  ”À√—∫©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) - π”È Àπ—°À“¬‰ªÀ≈—ßÕ∫·Àßâ (Loss on drying) - Constituted solution ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡¡Õ√å§ ·Õπ¥å ‚§ 2C 64/46 Tienam Merck & Co. Inc. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 213

¬“ªØ™‘ ’«π– Meropenem for Injection ‡¡Õ‚√‡æπ‡π¡  ”À√—∫©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active Ingredient) - §à“‡∫ˬ’ ߇∫π®“°π”È Àπ—°‡©≈¬’Ë (Weight Variation) - §à“§«“¡‡ªπì °√¥-‡∫  (pH) - ª√‘¡“≥ Related Substances ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Sumitomo chemical Co., Ltd, 1C 115/42N Meronem ∫.·Õ µ√“â ‡´π‡π°â“ (ª√–‡∑»‰∑¬) 224 GREEN BOOK 3

¬“ªØ™‘ ’«π– Metronidazole Tablet (200 mg) ‡¡‚∑√𑥓‚´≈ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Assay) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–‡¡Á¥ (Content uniformity) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ —™°√√¡ 1A 150/43 Metronidazole Government Pharma. Organization Metronidazole  À·æ∑¬å‡¿ —™ 1A 1917/29 Metrolex The Medic Pharma Co., Ltd.  ¬“¡‡¿ —™ 1A 70/27 Siam Bheasach Co., Ltd. ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈°— ª√–°π—  ÿ¢¿“æ·Ààß™“µ‘ °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 235

¬“ªØ™‘ «’ π– Metronidazole Injection (500 mg /100 ml) ‡¡‚∑√𥑠“‚´≈ ™π¥‘ ©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Assay ) - §«“¡‡ªìπ°√¥-‡∫  (pH) - Bacterial Endotoxin (LAL Test) - ¢π“¥Õπ¿ÿ “§ (Particulate matter) - §«“¡ª√“»®“°‡™Õ◊È (Sterility) ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡¬π‡πÕ√å√“≈ ¥√Í°—  å‡Œ“â  å 1A 2036/30 Metrazole General Drugs House Co.,Ltd Metrogyl ‡® ∫’ ‡§¡’§Õ≈ ·Õπ¥å ø“√¡å “ (Õπ‘ ‡¥¬’ ) 1C 169/42 Metrolex J.B.Chemicals & Pharma,India Mepagyl  ¬“¡‡¿ ™— 1A 565/27 Siam Bheasach Co., Ltd. ‰∑¬π§√æ≤— π“ 1A 674/39 Thai Nakorn Patana Ltd. ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈°— ª√–°—π ¢ÿ ¿“æ·Ààß™“µ‘ 246 GREEN BOOK 3

¬“ªØ™‘ ’«π– Ofloxacin film coated Tablet (100 mg) ‚Õø≈äÕ°´“´‘π ™π‘¥‡¡Á¥‡§≈◊Õ∫ø≈î å¡ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Assay) - §«“¡·µ°µ“à ß®“°π”È Àπ—°‡¡Á¥‡©≈’ˬ (Weight variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººŸâ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ¡≈‘ ≈‡‘ ¡¥ 1A 309/45 Floxy Millimed Co.,Ltd. 1C 159/43 Occidal ·√π·∫°ä ´Ë’ ·≈∫∫Õ√“∑Õ√Ë ’ å Ranbaxy Lab.India 1A 23/36 Ofloxin  ¬“¡‡¿ ™— 1A 193/47 Viotisone Siam Bheasach Co.,Ltd. ¬Ÿπ’´—π Unison Lab.Co.,Ltd. ß∫ª√–¡“≥ :  ”π°— ß“πÀ≈°— ª√–°—π ¢ÿ ¿“æ·Ààß™“µ‘ °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 257

¬“ªØ‘™«’ π– Vancomycin HCL Injection (0.5 g/vial) ·«π‚§¡¬— ™π‘ ‰Œ‚¥√§≈Õ‰√¥å ™π‘¥©’¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§≠— (Assay) - §«“¡·µ°µà“ß®“°πÈ”Àπ—°‡¡¥Á ‡©≈ˬ’ (Weight variation) - §«“¡‡ªπì °√¥-‡∫  (pH) - §«“¡ª√“»®“°‡™ÕÈ◊ (Sterility) - Bacterial Endotoxin (LAL Test) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name CJ Corp. Kyonggi-Do, Korea 1C 82/47 Vancomycin CJ (º·Ÿâ ∑π®”Àπà“¬: ∫’‡®´’ ‡∑√¥¥È‘ß) ‡≈°Á ø“√¡å “´Ÿµ§‘ Õ≈ 1C 288/47 Edicin Lek Pharmaceuticals, Slovania Hospira, Inc., Lake Forest, USA 1C 43/49 Sterile Vancomycin HCl (ºŸâ·∑π®”Àπ“à ¬: æ·’ Õ≈ ‡Õ‡™’¬ ·ª´ø‘ î§) ß∫ª√–¡“≥ :  ”π°— ß“πÀ≈—°ª√–°π—  ÿ¢¿“æ·Ààß™“µ‘ 268 GREEN BOOK 3

¬“√°— …“‚√§À—«„® ≈¥§«“¡¥—π‚≈À‘µ ¬“¢∫— ª í  “«– - Amiodarone HCl Tablet - Amlodipine Tablet - Clonidine HCl Tablet - Digoxin Tablet - Furosemide Injection - Hydralazine HCl Tablet - Hydrochlorothiazide Tablet - Metoprolol tartrate Tablet - Spironolactone Tablet °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 279

¬“√—°…“‚√§À«— „® ≈¥§«“¡¥—π‚≈À‘µ ¬“¢—∫ª í  “«– Amiodarone HCl Tablet (200 mg) ‡Õ¡‘‚Õ¥“‚√π‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Assay) - §«“¡·µ°µà“ß®“°πÈ”Àπ—°‡¡¥Á ‡©≈ˬ’ (Weight variation) - ‡«≈“„π°“√·µ°µ«— ¢Õ߇¡Á¥¬“ (Disintegration) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name Õ≈— ø“ø“√å¡ 1C 77/42 Aratac Alphapharm, PTY, Ltd. Australia. Cardilor √‡’ ¡¥°‘ “ 1C 63/40 Cordarone Remedica Ltd., Cyprus ´“‚πøòï 1C 112/30 Sanofi Winthrop Industries, France. ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈—°ª√–°π—  ÿ¢¿“æ·Ààß™“µ‘ 2380 GREEN BOOK 3

¬“√—°…“‚√§À«— „® ≈¥§«“¡¥π— ‚≈Àµ‘ ¬“¢∫— ªí  “«– Amlodipine Tablet (5 mg) ·Õ¡‚≈¥‘ªîπ ™π¥‘ ‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Assay) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –‡¡Á¥ (Content uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡∫Õ√≈å ‘π ø“√¡å “´µŸ §‘ Õ≈ Õπ‘ ¥— µ√È’ 1A 14/43(NG) Amlopine Berlin Pharm .Indust.Ltd. Lovas ¡“´“ ·≈∫ 1A 1/47(NG) Masa Lab.Co., Ltd Norvasc ‰ø‡´Õ√å (ÕÕ ‡µ√‡≈¬’ ) 1C 199/47(N) Ambes Pfizer Australia Pty., Ltd. Õߧ尓√‡¿ ™— °√√¡ - Government Pharm. Organization ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈—°ª√–°π—  ¢ÿ ¿“æ·Ààß™“µ‘ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 2391

¬“√°— …“‚√§À—«„® ≈¥§«“¡¥—π‚≈Àµ‘ ¬“¢∫— ª í  “«– Clonidine HCL Tablet ‚§≈π‘¥π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µà≈–Àπ૬ (Content Uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‚Õ≈§‘ (ª√–‡∑»‰∑¬) 1A 277/35 Catapres 150 mcg Olic (Thailand) Ltd. ø“√å¡“ —πµå ·≈Á∫∫Õ√“µÕ√Ë’ å 1A 491/39 Hypodine Pharmasant Laboratories Co.,Ltd. 302 GREEN BOOK 3

¬“√—°…“‚√§À«— „® ≈¥§«“¡¥π— ‚≈Àµ‘ ¬“¢∫— ªí  “«– Digoxin Tablet ¥®‘ Õä °´π‘ ™π‘¥‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ«— ¬“„π·µ≈à –Àπ૬ (Content Uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ·°≈°Á ‚´ ‡«≈§—¡ ÕÕ ‡µ√‡≈¬’ 1C 92/41 Lanoxin Glaxo Wellcome Australia Ltd. 1C 40/41 Lanoxin Digoxin ‡Õ™. ‡§. ø“√å¡“´µŸ §‘ Õ≈ 1A 367/30 Grexin H.K. Pharmaceutical Co., Ltd. Cardial ø“√¡å “ π— µå ·≈Á∫∫Õ√“µÕ√Ë ’ å 1A 1197/29 Pharmasant Laboratories Co.,Ltd. Toloxin ∑.’ ·¡π ø“√å¡“ 1A 1142/30 T.Man Pharma Ltd. Part. ∑.’ ‚Õ. ø“√å¡“ 1A 559/38 T.O. Pharma Co., Ltd. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 313

¬“√°— …“‚√§À«— „® ≈¥§«“¡¥—π‚≈À‘µ ¬“¢—∫ª í  “«– Furosemide Injection ø‚Ÿ √´‰’ ¡¥å ™π‘¥©¥’ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - §“à §«“¡‡ªìπ°√¥-‡∫  (pH) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name 𑥓â ø“√¡å “ Õ‘π§Õ√ªå Õ‡√™—Ëπ 1A 270/28 Fluidsemide Nida Pharma Incorporation Co., Ltd. Furetic-s  ¬“¡‡¿ ™— 1A 81/45 Furosemide Siam Bheasach Co., Ltd. Õߧ尓√‡¿ ™— °√√¡ - Government Pharm. Organization 324 GREEN BOOK 3

¬“√—°…“‚√§À—«„® ≈¥§«“¡¥π— ‚≈À‘µ ¬“¢—∫ªí  “«– Hydralazine HCL Tablet ‰Œ¥√Õ≈≈“´π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active Ingredient) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µ≈à –Àπ૬ (Content Uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‚π«“√µå  ’ 1B 66/41 Apresoline 25 Norvartis Saglik, Turky 1C 10/48 Apresoline 25 ø“√å¡“ —πµå ·≈∫Á ∫Õ√“µÕ√Ë’ å 1A 699/38 Cesoline W Pharmasant Laboratories Co.,Ltd 1A 399/38 Cesoline Y ∑.’ ‚Õ. ø“√¡å “ 1A 645/38 Hydralazine-dragees T.O. Pharma Co., Ltd. °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 335

¬“√°— …“‚√§À«— „® ≈¥§«“¡¥—π‚≈À‘µ ¬“¢—∫ª í  “«– Hydrochlorothiazide Tablet ‰Œ‚¥√§≈Õ‚√‰∑Õ“‰´¥å ™π‘¥‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ ®Ÿ π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ—«¬“ ”§—≠ (Active Ingredient) - §à“‡∫¬’Ë ß‡∫π®“°πÈ”Àπ—°‡©≈’ˬ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡¡¥‘´π’ ‚ª√¥—° å 1A 2251/29 Hydrozide Thiazide Medicine Products Co., Ltd. Hychlorzide Hydrochlorothiazide π«‘ ‰≈øá ø“√¡å “ 1A 450/41 Hydrochlorothiazide Hydrochlorothiazide New Life Pharma Co., Ltd. Hydrochlorothiazide ø“√å¡“ π— µå ·≈Á∫∫Õ√“µÕ√Ë ’ å 1A 88/38 Pharmasant Laboratories Co.,Ltd. ∑’.‚Õ.‡§¡§’ Õ≈ å (1979) 1A 405/38 T.O. Chemicals (1979) Co., Ltd. ∑’.‚Õ. ‡¡¥ 1A 213/46 T.O. Med Co., Ltd. ∑.’ ‚Õ. ø“√å¡“ 1A 405/38 T.O. Pharma Co., Ltd. Õߧ°å “√‡¿ ™— °√√¡ 1A 139/43 Government Pharm. Organization 346 GREEN BOOK 3

¬“√°— …“‚√§À«— „® ≈¥§«“¡¥—π‚≈Àµ‘ ¬“¢∫— ªí  “«– Spironolactone Tablet  ‡æ¬’ ‚√‚π·≈§‚µπ ™π¥‘ ‡¡Á¥ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à ‡∫¬Ë’ ߇∫π®“°πÈ”Àπ—°‡©≈¬’Ë (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‡∫Õ√å≈‘π ø“√å¡“´µŸ §‘ Õ≈ Õπ‘ ¥— µ√’È 1A 202/45 Hyles 25 Berlin Pharmaceutical Industry 1A 203/45 Hyles100 Co., Ltd. Aldactone ‚Õ≈‘§ (ª√–‡∑»‰∑¬) 1A 872/27 Olic (Thailand) Ltd. Altone ø“√å¡“ —πµå ·≈Á∫∫Õ√“µÕ√Ë ’ å 1A 1627/30 Pondactone Pharmasant Laboratories Co.,Ltd. æÕπ¥å ‡§¡’§Õ≈ (ª√–‡∑»‰∑¬) 1A 279/33 Pondûs Chemical (Thailand) R.O.P. °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 357

¬“√°— …“‚√§À«— „® ≈¥§«“¡¥π— ‚≈À‘µ ¬“¢—∫ªí  “«– Metoprolol tartrate Tablet ‡¡‚∑‚æ√≈Õ≈ ∑“√å‡∑√µ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à ‡∫’ˬ߇∫π®“°πÈ”Àπ—°‡©≈Ë’¬ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡∫ ´’Ë ·Õ√Õπ 1A 1430/28 Metolol Bessy Aron Co., Ltd. Denex ¡‚’ ¥‡§¡’ 1C 165/33 Medochemie Ltd. Minax ‡¡Õ√å§ 1C 106/42 Hyperloc Merck Ltd. Melol 𥑠“â ø“√å¡“ Õπ‘ §Õ√åªÕ‡√™πË— 1A 1532/29 Nida Pharma Inc. Co., Ltd. ø“√¡å “ —πµå ·≈Á∫∫Õ√“µÕ√ ’Ë å 1A 212/31 Pharmasant Laboratories Co.,Ltd. 368 GREEN BOOK 3

¬“√—°…“‚√§À«— „® ≈¥§«“¡¥—π‚≈À‘µ ¬“¢∫— ªí  “«– √“¬™ÕË◊ ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name  ’≈¡ ‡¡¥§‘ Õ≈ 1A 873/29 Metoblock Silom Medical Co., Ltd. 1C 177/42 Metoprolol 100  µ“¥“ ø“√¡å “´Ÿµ§‘ Õ≈ Stada Pharm GMBH, 1A 303/38 Cardeloc Germany stada ∑.’ ‚Õ. ø“√å¡“ T.O. Pharma Co., Ltd. °√¡«∑‘ ¬“»“ µ√å°“√·æ∑¬å 379

¬“µ“â π‡™ÕÈ◊ «—≥‚√§ ¬“¶“à ÀπÕπ欓∏‘ - Albendazole oral Suspension - Ethambutol film coated Tablet - Praziquantel Tablet 4380 GREEN BOOK 3

¬“µ“â π‡™ÈÕ◊ «—≥‚√§ ¬“¶“à ÀπÕπ欓∏‘ Albendazole oral Suspension Õ≈— ‡∫𥓂´≈ ™π¥‘ π”È ·¢«πµ–°Õπ À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active Ingredient) - §“à §«“¡‡ªπì °√¥-‡∫  (pH) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ø“√å¡“ —πµå ·≈∫Á ∫Õ√“µÕ√ Ë’ å 1A 116/34 Alzol Pharmasant Laboratories Co.,Ltd. Zeben  ¬“¡‡¿ ™— 1A 134/33 Siam Bheasach Co., Ltd. San San ∑.’ ·¡π ø“√å¡“ 1A 705/41 Zela-C T. Man Pharma Ltd. Part. ¬Ÿπ’´—π 1A 19 / 45 Unison Laboratories Co.,Ltd °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 4391

¬“µ“â π‡™ÕÈ◊ «—≥‚√§ ¬“¶à“ÀπÕπ欓∏‘ Ethambutol film coated Tablet (400 mg) Õ’·∑¡∫Ÿ‚∑≈ ™π¥‘ ‡¡¥Á ‡§≈◊Õ∫ø≈î ¡å À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®‡Õ°≈—°…≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§—≠ (Assay) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –‡¡Á¥ (Content uniformity) - ª√¡‘ “≥ Related substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name Õߧ°å “√‡¿ —™°√√¡ 1A 318/45 Ethambutol Government Pharm. Organization Lambutol ‚√ßß“π‡¿ —™°√√¡ ·Õµ·≈πµ°‘ 1A 30/26 Tobutol Atlantic Lab.Corp.Ltd. Servambutol ‡¬π‡πÕ√√å “≈ ¥√Í—° ‡å Œ“â  å 1A 661/27 Tibitab General Drugs House Co.,Ltd ‚Õ≈‘§ (ª√–‡∑»‰∑¬) 1A 1215/41 Olic (Thailand) Ltd. ∑’.‚Õ. ø“√¡å “ 1A 487/38 T.O.Pharma Co.,Ltd ß∫ª√–¡“≥ :  ”π—°ß“πÀ≈—°ª√–°π—  ¢ÿ ¿“æ·Àßà ™“µ‘ 402 GREEN BOOK 3

¬“µ“â π‡™Õ◊È «≥— ‚√§ ¬“¶à“ÀπÕπ欓∏‘ Praziquantel Tablet ‡æ√´§‘ «Õπ‡∑≈ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®πå‡Õ°≈°— …≥å (Identification) - ª√‘¡“≥µ«— ¬“ ”§≠— (Active Ingredient) - §“à ‡∫¬Ë’ ߇∫π®“°πÈ”Àπ—°‡©≈Ë’¬ (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡°√∑ä ‡µÕ√å ø“√¡å “ 1A 283/46 Wormicide Greater Pharma Ltd. Part. Prasix ‡Õ™. ‡§. ø“√¡å “´µŸ ‘§Õ≈ 1A 1133/30 Prasikon H.K. Pharmaceutical Co., Ltd. Opticide-FC ‚ª≈ø‘ “√¡å 1A 1236/31 Polipharm Co., Ltd. Praziquantel  À·æ∑¬‡å ¿ ™— 1A 227/46 The Medic Pharma Co., Ltd. Õߧ°å “√‡¿ —™°√√¡ - Government Pharm. Organization °√¡«∑‘ ¬“»“ µ√°å “√·æ∑¬å 413

¬“µ“â πŒ’ µ“¡π’ /¿¡Ÿ ·‘ æâ - Azathioprine Tablet - Loratadine Tablet 424 GREEN BOOK 3

¬“µâ“πŒ’ µ“¡π’ /¿Ÿ¡‘·æâ Azathioprine Tablet ‡Õ´“‰∑‚Õæ√’π ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§≠— (Active Ingredient) - §“à ‡∫ˬ’ ߇∫π®“°π”È Àπ—°‡©≈¬’Ë (Weight Variation) - °“√≈–≈“¬¢Õßµ«— ¬“ (Dissolution) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µà≈–Àπ«à ¬ (Content Uniformity) ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ·°≈Á°‚´  ¡‘∏‰§≈å 1C 422/40 Imuran Imuran GlaxoSmithkline (Thailand) Ltd. 1C 279/46 Azathioprine PCH æ’´‡’ Õ™ ø“√å¡“‡§¡’ ‡π‡∏Õ√·å ≈π¥å 1C 598/30 Imuprin PCH Pharmachemie, Netherlands √’‡¡¥°‘ “ ‰´ª√ — 1C 52/46 Remedica Ltd., Limassol-Cyprus °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 435

¬“µ“â πŒ ’ µ“¡π’ /¿Ÿ¡‘·æâ Loratadine Tablet ≈Õ√“∑“¥π’ ™π¥‘ ‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ ®Ÿ πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ—«¬“ ”§—≠ (Active Ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ—«¬“„π·µà≈–Àπ«à ¬ (Content Uniformity) - ª√‘¡“≥ Related Substances ººâŸ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ∫“ß°Õ°·≈∫ ·Õπ¥å §Õ ‡¡µ§‘ 1A 945/42 Lorita Bangkok Lab & Cosmetic Co., Ltd. Clarid ‰∫‚Õ·≈∫ 1A 913/44 Loranox Biolab Co., Ltd. Carinose ‡®√‘≠‡¿ —™ 1A 458/38 Al erdine Charoen Bhaesaj Lab Co., Ltd. Clatidyne ™¡ÿ ™π‡¿ —™°√√¡ 1A 527/42 Community Pharmacy Public Co.,Ltd. ·Õ≈.∫.’ ‡Õ . ·≈∫∫Õ√“∑Õ√ ’ å 1A 401/40 L.B.S. Laboratory Ltd., Part 𑫉≈øá ø“√¡å “ 1A 803/41 New Life Pharma Co., Ltd. 446 GREEN BOOK 3

¬“µâ“πŒ’ µ“¡π’ /¿Ÿ¡·‘ æâ √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™Õ◊Ë °“√§“â Manufacturer Reg No. Trade name ‚Õ ∂Õπ‘ ‡µÕ√å ·≈∫∫Õ√“∑Õ√’ å 1A 177/47 Linityne Osoth Inter Labolatories Co.,Ltd. 1A 1072/41 Rityne Botidine 擵“√å ·≈∫ 1A 773/43 Patar Lab Ltd. Part Roletra ·√π·∫ä°´’Ë 1C 84/45 Clarityne Ranbaxy Laboratories Ltd. Fatyne ‡™Õ√ß‘Ë -æ≈“« 1C 299/32 Lorsedin Schering-Plough Labo N.V. Al er-Tab Àâ“ߢ“¬¬“ µ√“‡®Á¥¥“« 1A 1122/41 Tiradine Seven Stars Pharmaceutical Co.,Ltd. Halodin  ¬“¡‡¿ —™ 1A 12/39 Siam Bheasach Co., Ltd. Ridamin  ’≈¡ ‡¡¥‘§Õ≈ 1A 351/41 Lotidyne Silom Medical Co., Ltd. Lindine Õ—ß°ƒ…µ√“ߟ (·Õ≈.æ’) 1A 488/44 Taridine The British Dispensary (L.P.) Co., Ltd ∑.’ ‚Õ.‡§¡§’ Õ≈ å (1979) 1A 621/38 T.O. Chemicals (1979) Co., Ltd. ¬Ÿπ’´—π 1A 665/41 Unison Laboratories Co., Ltd. ¬‚Ÿ ∑‡ª¬ôï π 1A 114/42 Utopian Co., Ltd. «.’ ‡Õ . ø“√¡å “ (1971) 1A 1049/43 V.S. Pharma (1971) Co., Ltd. 1A 1091/43 °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å 457

¬“√—°…“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ - Bisacodyl Tablet - Dicyclomine HCl film coated Tablet - Dicyclomine HCl Syrup - Loperamide HCl Capsule - Metoclopramide HCl Injection - Metoclopramide HCl Tablet - Sulfasalazine Tablet 468 GREEN BOOK 3

¬“√°— …“‚√§„π√–∫∫∑“߇¥‘πÕ“À“√ Bisacodyl Tablet ∫‘ ´“‚§¥‘≈ ™π‘¥‡¡¥Á À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ‘ Ÿ®πå‡Õ°≈—°…≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§—≠ (Active Ingredient) - °“√·µ°µ—«¢Õ߇¡Á¥¬“ ·≈–ª√‘¡“≥µ—«¬“∑Ë’≈–≈“¬ (Disintegration as delayed-release for enteric coated) - §«“¡ ¡”Ë ‡ ¡Õ¢Õߪ√‘¡“≥µ—«¬“„π·µ≈à –Àπ૬ (Content Uniformity) ººŸâ ≈µ‘ ∑º’Ë “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™Õ◊Ë ººŸâ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡¡¥´‘ π’ ‚ª√¥°—  å 1A 1104/29 Bisacod Medicine Products Co.,Ltd. (Enteric sugar coated) π«‘ ‰≈øá ø“√å¡“ 1A 490/41 Bisacodyl New Life Pharma Co., Ltd. (Enteric sugar coated) ‚Õ≈‘§ (ª√–‡∑»‰∑¬) 1A 1044/41 Laxitab Olic (Thailand) Ltd. (Enteric coated) ø“√å¡“ —πµå ·≈∫Á ∫Õ√“µÕ√’ Ë å 1A 63/36 Laxcodyl Pharmasant Laboratories Co.,Ltd. (Enteric coated) Õ—ß°ƒ…µ√“ߟ (·Õ≈.æ)’ 1A 1005/28 Emulax The British Dispensary (L.P.) Co., Ltd. (Enteric coated) ‡¿ ™— °√√¡‡§∫’ ®”°—¥ 1A351/46 K.B.Biscod K.B.Pharmaceutical Co.,Ltd. (Enteric sugar coated) °√¡«‘∑¬“»“ µ√°å “√·æ∑¬å 479

¬“√°— …“‚√§„π√–∫∫∑“߇¥π‘ Õ“À“√ Dicyclomine HCL film coated Tablet ‰¥‰´‚§≈¡π’ ‰Œ‚¥√§≈Õ‰√¥å ™π¥‘ ‡¡Á¥‡§≈◊Õ∫ø≈î ¡å À«— ¢Õâ µ√«® Õ∫§≥ÿ ¿“æ - °“√µ√«®æ ‘ Ÿ®π‡å Õ°≈°— …≥å (Identification) - ª√¡‘ “≥µ«— ¬“ ”§≠— (Active Ingredient) - °“√≈–≈“¬¢Õßµ—«¬“ (Dissolution) - §«“¡ ¡Ë”‡ ¡Õ¢Õߪ√¡‘ “≥µ«— ¬“„π·µ≈à –Àπ«à ¬ (Content Uniformity) ººâŸ ≈µ‘ ∑ºË’ “à π¡“µ√∞“πµ“¡‡°≥±§å ¥— ‡≈Õ◊ ° √“¬™ÕË◊ ººâŸ ≈µ‘ ‡≈¢∑–‡∫¬’ 𬓠™ÕË◊ °“√§“â Manufacturer Reg No. Trade name ‡∫Õ√≈å ‘π ø“√å¡“´µŸ §‘ Õ≈ Õ‘π¥ — µ√È’ 1A 65/32 Dicomin Berlin Pharmaceutical Industry film coated Tablet Co., Ltd. 4580 GREEN BOOK 3