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starch glycolate) π“∑’ ®“°π—Èπ𔉪μÕ°Õ—¥‡ªìπ‡¡Á¥¥â«¬‡§√◊ËÕßμÕ°¬“
- §√Õ §“√凡≈‚≈ ‚´‡¥’¬¡ (croscarmel- ™π‘¥ “°‡¥’ˬ« (single punch tableting machine)
lose sodium) ‚¥¬„™â‡∫â“ (die) ¢π“¥‡ âπºà“π»Ÿπ¬å°≈“ß 10.3
- §√Õ ‚æ«‘‚¥π (crospovidone) ¡‘≈≈‘‡¡μ√ ·≈–„™â “° (punch) Àπâ“‚§âß (concave
- §Õ≈≈Õ¬¥Õ≈ ´‘≈‘°Õ𠉥ÕÕ°‰´¥å (col- shape) ´÷ËßÕ—μ√“ à«π¢Õß à«πª√–°Õ∫„πμ”√—∫¬“
loidal silicon dioxide) ‡¡Á¥· ¥ß‰«â¥—ßμ“√“ß∑’Ë 1 ‚¥¬ Ÿμ√μ”√—∫∑’Ë 1-7 ·∑π
- ·¡°π’‡´’¬¡ ‡μ’¬‡√μ (magnesium ¥â«¬ —≠≈—°…≥å F1-F7
stearate) 3. °“√∑¥ Õ∫§ÿ≥ ¡∫—μ‘∑“ß°“¬¿“æ
2. °“√‡μ√’¬¡¬“‡¡Á¥¥â«¬«‘∏’·°√πŸ≈‡ªï¬° °“√∑¥ Õ∫§ÿ≥ ¡∫—μ‘∑“ß°“¬¿“æ¢Õ߬“‡¡Á¥
º ¡ºß ¡ÿπ‰æ√μ”√—∫®‘μ√“√¡≥å°—∫Õ–«‘‡´≈ æ’ Õâ“ßÕ‘ßμ“¡‡¿ —™μ”√—∫¢Õß À√—∞Õ‡¡√‘°“ (USP 32/NF
8 9
‡Õ™ 102 ‚æ«‘‚¥π ‡§ 30 ‚´‡¥’¬¡ μ“√å™ ‰°≈‚§‡≈μ 27 , USP 33/NF 28) ·≈–‡¿ —™μ”√—∫¢ÕßÕ—ß°ƒ…
10
(À√◊Õ§√Õ §“√凡≈‚≈ ‚´‡¥’¬¡ À√◊Õ§√Õ ‚æ«‘‚¥π) (BP 2009) ‚¥¬¡’√“¬≈–‡Õ’¬¥¥—ßμàÕ‰ªπ’È
·≈–§Õ≈≈Õ¬¥Õ≈ ´‘≈‘°Õ𠉥ÕÕ°‰´¥å ¥â«¬«‘∏’ 3.1 §«“¡º—π·ª√¢ÕßπÈ”Àπ—°¬“‡¡Á¥
º ¡·∫∫‡√¢“§≥‘μ (geometric dilution) ®“°π—Èπ (weight variation)
‡μ‘¡πÈ” º ¡„À⇢⓰—π®π‡°‘¥ damp mass π”¡“ ÿ࡬“‡¡Á¥®”π«π 20 ‡¡Á¥ ™—ËßπÈ”Àπ—°·μà≈–
ºà“π·√àß¢π“¥ 18-mesh ®“°π—Èππ”·°√πŸ≈‡ªï¬°‰ª ‡¡Á¥Õ¬à“ß·¡à𬔠§”π«≥À“§à“‡©≈’ˬπÈ”Àπ—°¢Õ߬“
Õ∫∑’ËÕÿ≥À¿Ÿ¡‘ 60 Õß»“‡´≈‡´’¬ ‡ªìπ‡«≈“ 4 ™—Ë«‚¡ß ‡¡Á¥ (average weight) ·≈– à«π‡∫’ˬ߇∫π¡“μ√∞“π
·√àß·°√πŸ≈·Àâß∑’ˉ¥â ‚¥¬„™â·√àß¢π“¥ 20-mesh (standard deviation) ®“°π—Èπ§”π«≥√âÕ¬≈–¢Õß
‡μ‘¡·¡°π’‡´’¬¡ ‡μ’¬‡√μ º ¡„À⇢⓰—π‡ªìπ‡«≈“ 3 à«π‡∫’ˬ߇∫π¡“μ√∞“π —¡æ—∑∏å (relative standard
μ“√“ß∑’Ë 1 à«πª√–°Õ∫·≈–ª√‘¡“≥„π Ÿμ√¬“‡¡Á¥®“° ¡ÿπ‰æ√ (μ”√—∫®‘μ√“√¡≥å)
πÈ”Àπ—°μàÕ‡¡Á¥ (¡‘≈≈‘°√—¡)
à«πª√–°Õ∫
F1 F2 F3 F4 F5 F6 F7
ºß ¡ÿπ‰æ√ 500 500 500 500 500 500 500
Õ–«‘‡´≈ æ’‡Õ™ 102 98 85.5 111 111 111 98 98
‚æ«‘‚¥π ‡§ 30 19.5 19.5 6.5 6.5 6.5 19.5 19.5
‚´‡¥’¬¡ μ“√å™ ‰°≈‚§‡≈μ 19.5 32 19.5 - - - -
§√Õ §“√凡≈‚≈ ‚´‡¥’¬¡ - - - 19.5 - 19.5 -
§√Õ ‚æ«‘‚¥π - - - - 19.5 - 19.5
§Õ≈≈Õ¬¥Õ≈ ´‘≈‘°Õ𠉥ÕÕ°‰´¥å 6.5 6.5 6.5 6.5 6.5 6.5 6.5
·¡°π’‡´’¬¡ ‡μ’¬‡√μ 6.5 6.5 6.5 6.5 6.5 6.5 6.5
√«¡ 650 650 650 650 650 650 650