复方接骨胶囊制备工艺的改进与质量控制方法探讨

The Improvement and Quality Control Method about Fufang Jiegu Capsule Preparationcraft-Discussion

目的:改进复方接骨胶囊的制备工艺和质量控制方法,探讨临床实际效果。方法:根据药物的性能,采用经醇提取,水煎煮提取,然后将提纯后中药粉碎过筛制备成胶囊。应用显微鉴别法鉴别制剂中的血竭、黄芪;用薄层色谱法鉴别制剂中的当归、川芎,桑寄生用以作为质量控制的方法,确保药物的药效。设治疗组、对照组观察临床疗效。结果:应用改进后工艺制备的药物与原来传统方法相比药物提纯度明显提高,副作用降低,两组疗效比较,差异有显著性(χ2=14.915,P<0.01)。结论:改进制备工艺后的复方接骨胶囊治疗骨折方面与传统工艺的复方接骨胶囊比较具有疗效明显、安全、无明显毒副作用,多数病人在应用药物第1个疗程即有消肿、止痛效果,是一种治疗各种部位的骨折,脱位以及身体各部位的软组织损伤的有效药物。

Objective： The improvement and quality control about the preparationcraft of Fufang Jiegu capsule, Discuss clinical actual effect. Methods ： According to medicine＇s function, abstracting by alcohol , draw by water decoct. And then make the refining medicine by crushing sieving into capsule, distinguishing Daemonorops draco BL with the microloby, Distinguishing Chinese angelica, Rhizorua chuanqiong, Chinese Taxillus Twing With thin layer color. For the method of the quality, ensuring the effect of medicine. Btfild the treatment group, the comparison group ,observes the clinical curative effect. Result： Compare the application improvement the craft preparation medicine and the original traditional method,the before medicine raise the purity, the side effect reduces, two groups of curative effects compare, the difference is obviously. Conclusion： Compare Fufang Jiegu caspsule after the preparationcraft improvement with the traditional process, curative effect remarkably, safe, and not obvious poisonous side effect, the most patients haveing used the medicine first treatment course, the swollen release, pain stop ,it is a effective medicine for fracture, dislocation, softtissue damages.