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目的 :研制用于治疗糖尿病性周围神经病变的制剂 ,确定“消渴通络颗粒”工艺及质量控制 ,并进行临床观察。方法 :将中药材用适宜方法提取并进行工艺研究 ,用薄层色谱法控制质量。选用 10 0例患者 ,根据Feldman标准判断。结果 :本品制备工艺及质量可靠 ,疗效确切。结论 :消渴通络颗粒是一种可靠、稳定、有效的用于治疗气血亏虚 ,湿浊瘀阻型糖尿病周围神经病变引起的肢体麻木冷痛、灼痛 ,酸沉无力或肌肉萎缩 ,活动不利等症的中药制剂。
Objective: To develop preparations for the treatment of diabetic peripheral neuropathy, determine the “Xioke Tongluo Granules” process and quality control, and conduct clinical observation. Methods : The Chinese medicinal materials were extracted by appropriate methods and subjected to technological research. The quality was controlled by thin layer chromatography. Ten patients were selected according to the Feldman criteria. Results: The preparation process and quality of this product are reliable and the curative effect is exact. Conclusion: Xiaoke Tongluo granules is a reliable, stable and effective treatment for qi and blood deficiency, limb numbness, burning pain, weak acidity, or muscle atrophy caused by wet turbid suffocative diabetic peripheral neuropathy. Traditional Chinese medicine preparations with adverse symptoms.