摘要
目的：根据中医药理论选用活血化瘀的中药，经科学方法制成纯天然制剂，主要用于治疗冠心病心绞痛。方法：制备工艺采用水醇超滤法；ＨＰＬＣ用于药液中有效成分之一的阿魏酸含量测定和制剂稳定性考察；并对８４例冠心病心绞痛病人进行临床初步观察。结果：工艺可行稳定，制剂稳定性良好，连续考察２４个月，各项指标符合要求。含量测定方法可靠，加样回收率达９６．７４％（ＲＳＤ＝２．７％），１０批样品测定结果准确。８４例冠心病心绞痛总有效率达８６．９％，其中静息心电图改善，有效率达７７％。结论：超滤法用于中药制剂，可明显提高药液澄明度，增加制剂稳定性，延长使用限期。阿魏酸含量测定采用薄层扫描法和ＨＰＬＣ，由于ＨＰＬＣ结果贴近真实，而确定为本药含量测定方法。
OBJECTIVE:According to the traditional Chinese medical and medicinal theory removing blood stasis and promoting blood circulation,a purely natural pharmaceutica preparation was made for treating coronary heart disease with angina pectoris.METHODS:Water alcohol ultrafiltration technique was adopted in the pharmaceutical preparation.HPLC was used to determine the content of ferulic acid,one of the most effective components in Xinshu oral liquid and to investigate the stability of the preparation.To examine the therapeutic results of this preparation,we observed clinically 84 patients with coronary heart diseases associated with angina pectoris.RESULTS:Pharmaceutical preparation and its technique were proved to be good and stable.Various indexes of the preparation coincided with the requirements during twenty four months observation.The method of content determination was reliable.The average recovery rate was 96.74% (RSD=2.7%),and the results of content determination on ten samples were accurate.Of the 84 patients suffering from coronary heart diseases with angina pectoris,86.9% were improved as was shown by quiescent electrocardiogram,with an effective rate of 77%.CONCLUSION:Ultrafiltration technique obviously improved the clarity of the liquid,enhanced the stability,and delayed the expriry date.HPLC was proved to be better in determining the content of ferulic acid as compared with TLC.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1997年第1期21-23,共3页
Chinese Pharmaceutical Journal
关键词
心舒口服液
冠心病
心绞痛
中医药疗法
Xinshu oral liquid,pharmaceutical preparation technique,ferulic acid,coronary heart disease,angina pectoris
