健阴灵栓的研制及临床效果观察

Preparation and Clinical Effect of Jianyinling Suppository

目的:研制健阴灵栓、考查其质量及稳定性、临床研究。方法:将处方中各药分别提取后加入栓剂基质中制成栓剂,并检查其pH、挥发油、吸收度、融变时限等质量指标,通过影响因素试验、加速试验、留样观察考查其稳定性,并对103例霉菌性阴道炎等患者进行临床观察,进行对照观察。结果:本品在35℃以下、相对湿度75%条件下质量稳定,临床总有效率94.2%。结论:该制剂的制备工艺简便,检测方法快捷,结果准确,治疗组疗效明显高于对照组,值得推广应用。

Objective:To develop Jianyinling suppository,check the quality and the stability, and observe its clinical effect.Methods:The active ingredients were extracted from the chinese traditional medicinal materials in prescription and mixed into the base of suppository to make into suppository.Then the quality targets such as pH,naphtha,absorbility,disintegration were tested,and the stability was checked through the way of factor test,acceleration test,sample observation.Its efficacy was observed in 103 patients with monilial vaginitis and the contrast was carried out between the treated group and the control group.Results:The quality and stability of the suppository we high under the temperature of 35℃ and the relative humidity of 75%. Total effective rate of 94.2% was obstained in the clinical trial.Conclusion: The fluconazole vaginal suppository can be prepared by a simple process and its content can be conveniently determined with accurate results,and the treated group has an obviously better effect than the control group. It is worthwhile to popularize and apply.