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Introduction

Domperidone Àº ÁÖ·Î Ç÷¾×-³ú À庮 ¿ÜºÎÀÇ È­Çмö¿ëü À¯¹ß ¿µ¿ª¿¡ ÀÛ¿ëÇÏ´Â Á¦ 2¼¼´ë À§Àå¿îµ¿ÃËÁøÁ¦ÀÇ ´ëÇ¥ÀûÀÎ ¾à¹°·Î, ÇÕ¼º Benzimidazole À¯µµÃ¼ÀÔ´Ï´Ù. ÀÌ´Â µµÆĹΠ¼ö¿ëü Â÷´ÜÁ¦·Î, ¸»ÃÊ µµÆĹΠ¼ö¿ëü¸¦ Â÷´ÜÇÔÀ¸·Î½á ±¸Å並 ¾ïÁ¦ÇÏ°í À§Àå ¿îµ¿¼ºÀ» Çâ»ó½ÃÅ°¸ç ÇϺΠ½Äµµ °ý¾à±Ù ¾Ð·ÂÀ» Áõ°¡½Ãŵ´Ï´Ù. Domperidone Àº ÁÖ·Î º¹ºÎ Æظ¸°¨, ½Äµµ ¿ª·ù, ±×¸®°í È­Çпä¹ýÀ¸·Î ÀÎÇÑ ±¸Åä Ä¡·á¿¡ ³Î¸® »ç¿ëµË´Ï´Ù.

Domperidone ÀÔÀÚÀÇ ¿ëÇصµ´Â ü³» Èí¼ö¿¡ Å« ¿µÇâÀ» ¹ÌÄ¡±â ¶§¹®¿¡ ÀÔÀÚ Å©±â°¡ Á¦Ç° Ç°Áú¿¡ ¹ÌÄ¡´Â ¿µÇâÀ» °ËÅäÇÏ´Â °ÍÀÌ ÇÊ¿äÇÕ´Ï´Ù. ¹èÄ¡ °£ ÀÔÀÚ Å©±â ºÐÆ÷ÀÇ Â÷ÀÌ´Â ¿ëÇصµ ¹× ü³» Èí¼ö¿¡ ºÒÀÏÄ¡¸¦ ÃÊ·¡ÇÒ ¼ö ÀÖÀ¸¸ç, ÀÌ´Â ¾à¹°ÀÇ È¿´É°ú ¾ÈÀü¼º¿¡ Á÷Á¢ÀûÀÎ ¿µÇâÀ» ¹ÌÄ¥ ¼ö ÀÖ½À´Ï´Ù. µû¶ó¼­ ÀÔÀÚ Å©±â ºÐÆ÷°¡ Á¦Ç° Ç°Áú¿¡ ¹ÌÄ¡´Â È¿°ú¿¡ ´ëÇÑ ¿¬±¸°¡ ÇʼöÀûÀÔ´Ï´Ù.

USP (¹Ì±¹ ¾àÀü) ´Â ·¹ÀÌÀú ȸÀý¹ýÀ» ÀÌ¿ëÇÑ ¿ø·áÀǾàÇ° (API) ÀÔÀÚ Å©±â ÃøÁ¤¿¡ ´ëÇÑ ¸íÈ®ÇÑ ±ÔÁ¤À» °¡Áö°í ÀÖÀ¸¸ç, ÃøÁ¤ ÀåºñÀÇ ±¸Á¶¿Í ¿ø¸®, °Ç½Ä ¹× ½À½Ä ÃøÁ¤ ¹æ¹ý¿¡ ´ëÇÑ ±¸Ã¼ÀûÀÎ ÁöħÀ» Á¦°øÇÏ°í ÀÖ½À´Ï´Ù. ±×·¯³ª ƯÁ¤ ¾à¹°¿¡ ´ëÇؼ­´Â ½À½Ä ¶Ç´Â °Ç½Ä ºÐ»ê ¹æ¹ýÀ» Æò°¡ÇÏ°í ¼±ÅÃÇÏ´Â ¹æ¹ý¿¡ ´ëÇÑ ÁöħÀÌ Á¦°øµÇÁö ¾Ê½À´Ï´Ù.

º» ³í¹®Àº USP (¹Ì±¹ ¾àÀü) ¹× ISO 13320 Ç¥ÁØ¿¡ µû¶ó Domperidone ¿ø·áÀǾàÇ° (API) ÀÇ ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ÃøÁ¤ÇÒ ¶§ ºÐ»ê ¹æ¹ýÀ» ¼±ÅÃÇÏ´Â ¹æ¹ý¿¡ ´ëÇØ Ã¼°èÀûÀÎ ¿¬±¸¸¦ ¼öÇàÇß½À´Ï´Ù.


1. Experiment

1.1 Instruments

Bettersizer 2600 laser particle size analyzer from Bettersize Instrument Ltd.
 
MS303S electronic scale from Mettler Toledo.
 
SC ultrasonic cleaner from Shanghai Shengyan Ultrasonic Instrument Co.,Ltd.

1.2 Sample and Reagents

Two sets of Domperidone API sample :
- No.1 : non-micronized sample (batch No.0068116-17);
- No.2 : micronized sample;
Tween 80 for analytical reagent; Purified water.


2. Particle size distribution measurement and method evaluation

2.1 Dry dispersion method

2.1.1 Study on the methodology of dry dispersion method

°Ç½Ä ºÐ»êÀº ºÐ¸» ÀÔÀÚ¸¦ ¾ÐÃà °ø±â·Î ¿î¹ÝÇÏ°í, ÀÔÀÚ °£ Ãæµ¹, ÀÔÀÚ¿Í ÆÄÀÌÇÁ °£ Ãæµ¹, ±×¸®°í ±â·ù Àü´ÜÀ» ÅëÇØ ºÐ»ê½ÃÅ°´Â ¹æ¹ýÀÔ´Ï´Ù. API ºÐ¸»Àº ÀÛÀº À¯±â ºÐÀÚ ÀÔÀÚ·Î ±¸¼ºµÇ¾î ÀÖÀ¸¸ç, ÀÌ´Â Àü´Ü ÀÀ·Â°ú Ãæµ¹·Î ÀÎÇØ ÆÄ¼ÕµÉ ¼ö ÀÖ½À´Ï´Ù. ¿ø·¡ ÀÔÀÚ°¡ ÆļյÇÁö ¾ÊÀº »óÅ¿¡¼­ Å« ÀÀÁýü¸¦ ºÐ»ê½ÃÅ°±â À§ÇØ, USP (¹Ì±¹ ¾àÀü) ¿¡¼­´Â ´Ù¾çÇÑ ºÐ»ê °­µµ°¡ ½ÃÇè °á°ú¿¡ ¹ÌÄ¡´Â ¿µÇâÀ» Á¶»çÇÒ °ÍÀ» ¿ä±¸ÇÏ°í ÀÖ½À´Ï´Ù. (USP 429)



°Ç½Ä ºÐ»ê ½ÇÇè¿¡¼­´Â ºÐ»ê ¾Ð·ÂÀÌ ÀÔÀÚ Å©±â ÃøÁ¤ °á°ú¿¡ ¹ÌÄ¡´Â ¿µÇâÀ» Á¶»çÇß½À´Ï´Ù.
ºÐ»ê ¾Ð·ÂÀº 0.05 MPa ¿¡¼­ 0.4 MPa ±îÁö ¹üÀ§·Î ¼³Á¤ÇÏ¿´À¸¸ç, 0.05 MPa ¸¶´Ù µ¥ÀÌÅ͸¦ ÃøÁ¤Çß½À´Ï´Ù.

- °¡·ÎÃà : ºÐ»ê ¾Ð·Â
- ¼¼·ÎÃà: ÀÔÀÚ Å©±â
- ÆĶõ °î¼±: D10
- ÁÖȲ °î¼±: D50
- ȸ»ö °î¼±: D90


Figure 1. Particle size pressure titration data of non- micronized sample


Figure 2. Particle size pressure titration data of micronized sample

ÀÌ»óÀûÀÎ ¾Ð·Â ÀûÁ¤ °î¼±¿¡¼­´Â ºÐ»ê ¾Ð·ÂÀÌ Áõ°¡ÇÔ¿¡ µû¶ó ÀÔÀÚ Å©±â°¡ Á¡Â÷ °¨¼ÒÇϸç, °î¼±Àº Á¡Â÷ ¾ÈÁ¤µÈ ±¸°£¿¡ µµ´ÞÇÕ´Ï´Ù. ¾Ð·ÂÀ» ´õ ³ôÀ̸é Å« ÀÀÁýü°¡ ´ÜÀÏ ÀÔÀÚ·Î Á¡ÁøÀûÀ¸·Î ºÐ»êµÇ¸é¼­ °î¼±ÀÌ ´õ ÇÏÇâÇÏ°Ô µË´Ï´Ù. ±×·¯³ª ¾Ð·ÂÀ» Áö³ªÄ¡°Ô ³ôÀÌ¸é ¾à¹° ÀÔÀÚ°¡ ÆÄ¼ÕµÉ ¼ö ÀÖ½À´Ï´Ù. ¹®Á¦´Â ÀÀÁýü ºÐ»ê°ú ´ÜÀÏ ÀÔÀÚ ÆÄ¼Õ »çÀÌ¿¡ ¸íÈ®ÇÑ °æ°è°¡ ¾ø±â ¶§¹®¿¡ Ãß°¡ ½ÇÇèÀÌ ÇÊ¿äÇÏ´Ù´Â Á¡ÀÔ´Ï´Ù.

Figure 2¿¡¼­´Â micronized sample ÀÇ °æ¿ì 0.2 MPa ¿¡¼­ 0.35 MPa »çÀÌ¿¡ ¸íÈ®ÇÑ stable platform (¾ÈÁ¤ Ç÷§Æû) ÀÌ ³ªÅ¸³µ½À´Ï´Ù. ¹Ý¸é, non-micronized sample ÀÇ ¾Ð·ÂÀ» Áõ°¡½Ãų ¶§´Â stable platform ÀÌ ³ªÅ¸³ªÁö ¾Ê¾ÒÀ¸¸ç, ÀÔÀÚ Å©±â°¡ Áö¼ÓÀûÀ¸·Î °¨¼ÒÇß½À´Ï´Ù. ÀÌ´Â ÀϹÝÀûÀ¸·Î ÀÔÀÚ ÆļÕÀÇ ½ÅÈ£·Î Çؼ®µË´Ï´Ù.

Ãß°¡ Áø´ÜÀ» À§ÇØ non-micronized sample ÀÇ À̹ÌÁö¸¦ Æ÷ÂøÇÑ °á°ú (Figure 3), ÇØ´ç »ùÇÃÀº ¹ÝÅõ¸íÇÑ ºÒ±ÔÄ¢ °áÁ¤ ÀÔÀÚ ÇüŸ¦ º¸¿´½À´Ï´Ù. ÀÌ·¯ÇÑ »óÅ·ΠÆÇ´ÜÇÒ ¶§, ÇØ´ç »ùÇÃÀº ½±°Ô ÆÄ¼ÕµÉ °¡´É¼ºÀÌ ÀÖ½À´Ï´Ù. °Ç½Ä ºÐ»ê ¾Ð·ÂÀ» ³ôÀϼö·Ï ÀÔÀÚ ÆļÕÀÇ À§Çèµµ Áõ°¡ÇÒ °ÍÀÔ´Ï´Ù.


Figure 3. Image of non-micronized sample

ÀûÀýÇÑ °Ç½Ä ºÐ»ê ¾Ð·ÂÀ» ´õ ÀÚ¼¼È÷ °áÁ¤Çϱâ À§ÇØ, non-micronized sample ÀÇ ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ´Ù¾çÇÑ ¾Ð·Â ÇÏ¿¡¼­ Å×½ºÆ®Çß½À´Ï´Ù (Figure 4). °á°ú¿¡ µû¸£¸é, ºÐ»ê ¾Ð·ÂÀÌ Áõ°¡ÇÔ¿¡ µû¶ó ÃÖ´ë ÀÔÀÚ Å©±â°¡ 150 - 100 ¥ìm ¿¡¼­ 30 - 20 ¥ìm ·Î °¨¼ÒÇß½À´Ï´Ù. ¶ÇÇÑ À̹ÌÁö ºÐ¼®À» ÅëÇØ ¾à 100 ¥ìm Å©±âÀÇ ¸î¸î °ÅÄ£ ÀÔÀÚ°¡ Á¸ÀçÇÔÀÌ È®ÀεǾú½À´Ï´Ù. ´õ ³ª¾Æ°¡, ÀÌ·¯ÇÑ °ÅÄ£ ÀÔÀÚµéÀº ÀÀÁýµÈ ÀÔÀÚ°¡ ¾Æ´Ï¶ó ´ÜÀÏ ÀÔÀÚ·Î ½Äº°µÉ ¼ö ÀÖ¾ú½À´Ï´Ù (Figure 5-6).
Figure 4. Particle size distribution of non-micronized sample under different pressures: red, green, navy, and cyan curve respectively represent 0.1, 0.2, 0.3, and 0.4 Mpa


Figure 5. Image of non-micronized particles


Figure 6. Image of non-micronized particles

ÃÖ´ë ÀÔÀÚ Å©±â°¡ 30 - 20 ¥ìm ¶ó´Â °ÍÀº »ç½ÇÀÌ ¾Æ´Ï¾ú½À´Ï´Ù. µû¶ó¼­ ºÐ»ê ¾Ð·ÂÀÌ 0.3 MPa ¸¦ ÃÊ°úÇßÀ» ¶§ ÀÔÀÚ°¡ ÆļյǾú´Ù°í °á·ÐÀ» ³»¸± ¼ö ÀÖ½À´Ï´Ù. ¾Ð·Â Àû ¾Ð·Â ÀûÁ¤ °î¼± (Figure 2) °ú »ùÇà ÀÚüÀÇ Ãë¾à¼ºÀ» °í·ÁÇÏ¿©, Domperidone ¿ø·áÀǾàÇ° API) ÀÇ ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ÃøÁ¤ÇÏ´Â µ¥ 0.2 MPa ÀÇ ¾Ð·ÂÀ» ¼±ÅÃÇß½À´Ï´Ù.

2.1.2 Research on the precision of dry dispersion method

À§ ½ÇÇèÀ» ¹ÙÅÁÀ¸·Î Domperidone ¿ø·áÀǾàÇ° (API) Àº 0.2 MPa ÀÇ ºÐ»ê ¾Ð·Â¿¡¼­ ÃøÁ¤µÇ¾ú½À´Ï´Ù. ±×¸² 7 °ú 8 ¿¡´Â ºñ¹ÌºÐÈ­ ¹× ¹ÌºÐÈ­ »ùÇÃÀÇ ÀÔÀÚ Å©±â ºÐÆ÷ °î¼±°ú ¹Ýº¹ ÃøÁ¤ µ¥ÀÌÅÍ°¡ ³ªÅ¸³ª ÀÖ½À´Ï´Ù.

µÎ »ùÇÃÀÇ ¹Ýº¹ ÃøÁ¤ °á°ú´Â USP (¹Ì±¹ ¾àÀü) ÀÇ ¿ä±¸ »çÇ×À» Å©°Ô ÃÊ°úÇß½À´Ï´Ù. D50 ÀÇ ÀçÇö¼ºÀº 2.1% ¹Ì¸¸À̾ú°í, D10 °ú D90 ÀÇ ÀçÇö¼ºÀº 3.5% ¹Ì¸¸À̾ú½À´Ï´Ù. ÀÌ´Â °Ç½Ä ºÐ»ê ¹æ¹ýÀÌ Domperidone API ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ÃøÁ¤ÇÏ´Â µ¥ ½Å·ÚÇÒ ¼ö ÀÖÀ½À» ÀÔÁõÇÏ´Â °ÍÀÔ´Ï´Ù.


Figure 7. Particle size distribution and repeatability of non-micronized particles (dry dispersion)


Figure 8. Particle size distribution and repeatability of micronized particles (dry dispersion)

2.2 Wet dispersion method

2.2.1 Study on the methodology of wet dispersion method

Domperidone ¿ø·áÀǾàÇ° (API) Àº ¹°¿¡ ºÒ¿ë¼ºÀÔ´Ï´Ù. °è¸éÈ°¼ºÁ¦·Î ½ÀÀ± ó¸®ÇÑ ÈÄ, »ùÇÃÀ» ±³¹Ý ¹× ÃÊÀ½ÆÄ ºÐ»êÀ» ÅëÇØ ¹°¿¡ ºÐ»ê½ÃÄ×½À´Ï´Ù. »ùÇÃÀÇ Ãë¾à¼º ¶§¹®¿¡ ºÐ»ê °­µµ´Â ³·°Ô À¯ÁöÇØ¾ß ÇÕ´Ï´Ù. µ¿½Ã¿¡, ºÐ»ê °­µµ°¡ »ùÇà ÀÔÀÚ¿¡ ¹ÌÄ¡´Â ¿µÇâÀ» Á¶»çÇϱâ À§ÇØ µÎ °¡Áö ºÐ»ê ¹æ¹ý, Áï ±³¹Ý°ú ÃÊÀ½ÆÄ ºÐ»êÀÌ °¢°¢ Àû¿ëµÇ¾ú½À´Ï´Ù (Figure 9 and 10).
Figure 9. Test sample particle size distribution under agitation only


Figure 10. Test sample particle size distribution after stir dispersion only

Figure 9 ¿Í 10 ¿¡¼­ ¾Ë ¼ö ÀÖµíÀÌ, »ùÇÃÀ» ´Ü¼øÈ÷ ±³¹ÝÇßÀ» ¶§ °á°ú°¡ ¾ÈÁ¤ÀûÀÌÁö ¾Ê¾Ò½À´Ï´Ù. ¶ÇÇÑ ½À½Ä ºÐ»êÀÇ Æ¯¼ºÀ» °í·ÁÇÒ ¶§, ¾à¹° ÀÔÀÚ°¡ ¿©ÀüÈ÷ ¼­·Î ´Þ¶óºÙÀ» ¼ö ÀÖ¾ú½À´Ï´Ù. ±×·¯³ª ³·Àº °­µµÀÇ ÃÊÀ½ÆÄ ºÐ»êÀ» Àû¿ëÇÑ ÈÄ ¾ÈÁ¤¼ºÀÌ Å©°Ô Çâ»óµÇ¾ú½À´Ï´Ù.

µ¿½Ã¿¡ ÃÊÀ½ÆÄ´Â ÀÔÀÚ Å©±â ºÐÆ÷¿¡ °ÅÀÇ ¿µÇâÀ» ¹ÌÄ¡Áö ¾Ê¾ÒÀ¸¸ç, ÁÖ·Î Å« ÀÔÀÚÀÇ ÈÄÇà Çö»ó¿¡ ¿µÇâÀ» ¹ÌÃƽÀ´Ï´Ù. ³·Àº °­µµÀÇ ÃÊÀ½ÆÄ ºÐ»ê¿¡¼­ ÃøÁ¤ °á°úÀÇ ÀçÇö¼ºÀÌ Å©°Ô °³¼±µÇ¾ú±â ¶§¹®¿¡ ÀÌÈÄÀÇ ½À½Ä ºÐ»êÀº Àú°­µµ ÃÊÀ½ÆÄ ¹æ¹ýÀ» äÅÃÇß½À´Ï´Ù.

2.2.2 Research on the precision of wet dispersion method

À§ Á¶°ÇÀ» À¯ÁöÇÑ »óÅ¿¡¼­, Àú°­µµ ÃÊÀ½ÆÄ·Î ºÐ»êÇÑ »ùÇÃÀÇ ÀÔÀÚ Å©±â ºÐÆ÷ µ¥ÀÌÅÍÀÇ Á¤¹Ðµµ¸¦ Á¶»çÇß½À´Ï´Ù.

Figure 11 °ú 12 ¿¡´Â ºñ¹ÌºÐÈ­ ¹× ¹ÌºÐÈ­ »ùÇÃÀÇ ½À½Ä ºÐ»ê¿¡ µû¸¥ ÀÔÀÚ Å©±â ºÐÆ÷¿Í ¹Ýº¹ ÃøÁ¤ µ¥ÀÌÅÍ°¡ ³ªÅ¸³ª ÀÖ½À´Ï´Ù.

°Ç½Ä ºÐ»ê°ú ºñ±³ÇßÀ» ¶§, ÀçÇö¼ºÀÌ Å©°Ô Çâ»óµÇ¾ú½À´Ï´Ù. D50 °ú D90 ÀÇ »ó´ë ÆíÂ÷´Â 0.7% ÀÌÇÏ¿´°í, D10 ÀÇ »ó´ë ÆíÂ÷´Â 2.6% ÀÌÇÏ·Î ³ªÅ¸³µ½À´Ï´Ù. ÀÌ´Â Domperidone API ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ÃøÁ¤ÇÒ ¶§ ½À½Ä ºÐ»êÀÌ °Ç½Ä ºÐ»êº¸´Ù ´õ ½Å·ÚÇÒ ¼ö ÀÖÀ½À» ÀÔÁõÇÕ´Ï´Ù.


Figure 11. Particle size distribution and repeatability of non-micronized sample (wet dispersion)


Figure 12. Particle size distribution and repeatability of micronized sample (wet dispersion)

2.3 Compare and evaluate dry and wet dispersion methods

¿ì¼±, ½ÃÇè Á¤¹Ðµµ Ãø¸é¿¡¼­ ½À½Ä ºÐ»êÀÌ °Ç½Ä ºÐ»êº¸´Ù È®¿¬È÷ ¿ì¼öÇß½À´Ï´Ù. ÀÌ´Â °Ç½Ä ºÐ»ê¿¡¼­´Â ÀÔÀÚ°¡ ½ÃÇè ±¸¿ªÀ» ÇÑ ¹ø¸¸ Åë°úÇÏ´Â ¹Ý¸é, ½À½Ä ºÐ»ê¿¡¼­´Â ¿©·¯ ¹ø Åë°úÇÏ¿© »ùÇøµ ºóµµ°¡ ´õ ³ô¾ÆÁö±â ¶§¹®ÀÔ´Ï´Ù.

µÑ°, µ¥ÀÌÅÍÀÇ »ó´ëÀû ÇÕ¸®¼º °üÁ¡¿¡¼­, ±×¸² Figure 13 °ú 14 ´Â non-micronized ¹× micronized sample ÀÇ °Ç½Ä ¹× ½À½Ä ºÐ»ê ¹æ¹ý¿¡ µû¸¥ ÀÔÀÚ Å©±â ºÐÆ÷ µ¥ÀÌÅ͸¦ º¸¿©ÁÝ´Ï´Ù. ½À½Ä ºÐ»ê ¹æ¹ý¿¡¼­´Â micronization ÀÌÈÄ ÀÔÀÚ Å©±â ºÐÆ÷ÀÇ ÇÇÅ©°¡ ´õ ÀÛÀº ÀÔÀÚ ÂÊÀ¸·Î À̵¿ÇßÀ¸¸ç, D10, D50, D90 ¸ðµÎ ´Ù¾çÇÑ Á¤µµ·Î °¨¼ÒÇß½À´Ï´Ù. ±×·¯³ª °Ç½Ä ºÐ»ê ¹æ¹ý¿¡¼­´Â ¹ÌºÐÈ­ ÀüÈÄ·Î Å« ÀÔÀÚµéÀÌ Å©°Ô º¯È­ÇÑ ¹Ý¸é, ¹Ì¼¼ ÀÔÀÚµéÀº °ÅÀÇ º¯È­ÇÏÁö ¾Ê¾Ò½À´Ï´Ù.


Figure 13. Compare particle size distribution results before and after micronization (wet dispersion)


Figure 14. Compare particle size distribution results before and after micronization (dry dispersion)


3. Conclusion

Á¾ÇÕÀûÀ¸·Î º¼ ¶§, Domperidone API ÀÔÀÚ Å©±â ºÐÆ÷ ÃøÁ¤¿¡¼­´Â °Ç½Ä ºÐ»ê°ú ½À½Ä ºÐ»ê ¹æ¹ý ¸ðµÎ ³ôÀº Á¤¹ÐµµÀÇ °á°ú¸¦ Á¦°øÇÒ ¼ö ÀÖ½À´Ï´Ù. ±×·¯³ª Domperidone API ´Â Ãë¾àÇϹǷÎ, »ùÇà ºÐ»ê¿¡ ÃæºÐÇÑ µ¥ÀÌÅÍ Áö¿øÀÌ ÇÊ¿äÇϸç, ƯÈ÷ °Ç½Ä ºÐ»ê ¹æ¹ý¿¡¼­´Â ´õ¿í ±×·¸½À´Ï´Ù.

°Ç½Ä ºÐ»ê°ú ºñ±³ÇßÀ» ¶§, ½À½Ä ºÐ»êÀº ´õ ³ªÀº ÀçÇö¼º, »ó°ü¼º, ÇÕ¸®¼ºÀ» °¡Áø µ¥ÀÌÅ͸¦ Á¦°øÇÏ´Â °ÍÀ¸·Î °üÂûµÇ¾ú½À´Ï´Ù. µû¶ó¼­ Domperidone API ÀÔÀÚ Å©±â ºÐÆ÷¸¦ ºÐ¼®ÇÏ´Â µ¥¿¡´Â ½À½Ä ºÐ»ê ¹æ¹ýÀÌ »ó´ëÀûÀ¸·Î ´õ ÇÕ¸®ÀûÀÔ´Ï´Ù.


Reference

[1] Aifen Liu. Research on gastrointestinal motility pharmaceutical [J]. China Practical Medicine, 2008, 34(3): 200-201.

[2] CHP second version appendix in 2010 [S]. Beijing: China medicine scientific press 2010:405-406.

[3] Zhukang Chen, Guiliang Chen, Huiyi Li. Research on pharmaceutical and its preparation particle size distribution analysis. [J]. CHP standard, 2012, 13(6): 405.







 
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