复方丹参肠黏附微丸中龙脑含量测定方法建立及不同剂型龙脑溶出度研究.docVIP

复方丹参肠黏附微丸中龙脑含量测定方法建立及不同剂型龙脑溶出度研究 　　[摘要]通过将冰片进行β-CD包合，制备成复方丹参肠黏附微丸，建立复方丹参肠黏附微丸中龙脑的含量测定方法，考察其体外溶出度，并与市售复方丹参片的溶出度进行对比，评价剂型设计的合理性。利用气相色谱法测定复方丹参肠黏附微丸中龙脑的含量，采用溶出度测定法第一法，分别测定复方丹参肠黏附微丸中龙脑在人工肠液的溶出度及复方丹参片中龙脑在人工胃液、人工肠液的溶出度。在该方法下测得复方丹参肠黏附微丸中龙脑的质量分数为0.79%，其体外溶出12 h内累积溶出量近70%;复方丹参片中龙脑的质量分数为0.80%，在人工肠液中，20 min内累积溶出量达60%，40 min累积溶出量达90%以上;在人工胃液中，40 min内累积溶出量不足20%，但在40～150 min累积溶出量达80%以上。结果表明，利用气相色谱法可有效测得复方丹参肠黏附微丸中龙脑的含量，与市售复方丹参片相比，复方丹参肠黏附微丸中的龙脑具有明显的缓释作用。在复方丹参肠黏附微丸中将冰片进行了包合，并制备成肠溶型制剂，在一定程度上降低了冰片对胃、肠黏膜的刺激作用，提高了药物的安全性。 　　[关键词]复方丹参肠黏附微丸;复方丹参片;龙脑;含量测定;体外溶出度 　　Determination of borneol in Fufang Danshen intestinal adhesion pellets 　　and study its in vitro dissolution in different dosage form 　　WANG Zhen， DU Shou-ying*， LU Yang*， ZHAO Zhuang， BAI Jie， LI Peng-yue， DONG Bo-yu， DU Qiu， ZHANG Lin 　　（School of Chinese Pharmacy， Beijing University of Traditional Chinese Medicine， Beijing 100102， China） 　　[Abstract]The borneol was included with β-CD and prepared Fufang Danshen intestinal adhesion pellets. GC method for determination of borneol in Fufang Danshen intestinal adhesion pellets was established to study its in vitro dissolution and make a comparison with the Fufang Danshen tablet， in this way， the rationality of dosage form was evaluated. The first method of dissolution determination was used for determining the in vitro dissolution of borneol in Fufang Danshen intestinal adhesion pellets in artificial intestinal juice， and Fufang Danshen tablet in artificial gastric juice and intestinal juice， respectively.Result shows： the concentration of borneol in Fufang Danshen intestinal adhesion pellets and Fufang Danshen tablet was 0.79% and 0.80%， respectively. Its in vitro dissolution was nearly 70% within 12 h in Fufang Danshen intestinal adhesion pellets， and in Fufang Danshen tablet， the dissolution was about 60% within 20 min and more than 90% within 40 min， and in artificial gastric juice， was less than 20% within 40 min but more than 80% till 150 min. Research suggests that in c