前列腺-Ⅰ直肠栓的制备、质量控制及临床应用  

Preparation,Quality Control and Clinical Application of Qianliexina-I Suppository

作　　者：任棣[1] 常威[1] 白进良[1] 

机构地区：[1]兰州医学院第一附属医院,甘肃兰州730000

出　　处：《中国药师》2003年第1期29-31,共3页China Pharmacist

基　　金：甘肃省科技厅 2 0 0 0年科学事业费资助项目 :编号QS0 0 2 C3 3 0 10

摘　　要：目的 :研制治疗慢性前列腺炎的直肠栓并进行临床疗效观察。方法 :以苦豆子总生物碱 (TotalAlkaloidofSophoraalopecuroides ,TASa)和双氯芬酸为主药 ,研制前列腺 Ⅰ直肠栓 ;测定TASa和双氯芬酸的含量 ;做直肠刺激性试验 ;并以前列安栓作对照 ,进行临床疗效观察。结果 :TASa的线性范围为 1.4～ 15 .4 μg·ml-1;加样回收率为 10 1.2 % ,RSD =0 .6 % ;双氯芬酸的线性范围为 4～ 14 μg·ml-1,平均回收率为 10 0 .0 % ,RSD =1.0 %。直肠刺激性试验证明 ,该制剂对直肠无刺激性。临床疗效观察与前列安栓具有同样显著的疗效 ,有效率 93.8% (P >0 .0 5 )。结论 :该制剂疗效可靠 ,质量可控 ,无不良反应 ,有临床应用价值。Objective: To prepare Qianliexian I supository for treating chronic prostatitis and observe it clinical therapeutic effect. Method: Total alkaloid of sophora alopecuroides(TASa) and diclofenac sodium were served as active ingredients to prepare Qianliexian I suppository, the contents of TASa and diclofenac sodium were determined. the retum irritation tests were conducted, and observed the therapeutic effect compared with Qianliean suppository. Result: The linear range of TASa was 0.14 15.4 μg·ml -1 , standard oxymatrine's recovery was 101.2%, RSD=0.55% , the linear range of diclofenac sodium was 4 14 μg·ml -1 , average recovery was 99.95%, RSD=1.0% . Rectum irritation test showed this preparation had no irritation to rectum. It had same marked therapeutic effect compared with Qianliean suppository. The total effective rate was 93.3%( P>0.05 ). Conclusion: This preparation's therapeutic effect is reliable and quality control is feasible, adverse reactions are not found. It is worthy to popularize the application in clinical practice.

关 键 词：前列腺-I直肠栓 TASa 双氯芬酸 前列腺炎 慢性 疗效观察 

分 类 号：TQ460.6[化学工程—制药化工]