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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 develop a rectal suppository for the treatment of chronic prostatitis and observe its clinical efficacy. Methods: The total alkaloid of Sophora alopecuroides (TASa) and diclofenac as the main drug, the development of prostate Ⅰ rectal suppository; determination of TASa and diclofenac content; rectal irritation test; and the former as the suppository for the clinical observation of efficacy . Results: The linear range of TASa was 1.4 ~ 15.4 μg · ml-1, the recovery was 10 1.2%, RSD was 0.6%, and the linear range of Diclofenac was 4-14 μg · ml-1 Rate was 100.0%, RSD = 1.0%. Rectal irritation tests have shown that the formulation is non-irritating to the rectum. The clinical curative effect observed with Qianliean suppository had the same remarkable curative effect, the effective rate was 93.8% (P> 0.05). Conclusion: The preparation has reliable curative effect, controlled quality, no adverse reaction and clinical value.