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目的:研究卡利亚营养口服液的组成、制备工艺、药效稳定性、安全性、临床疗效。方法:制备时对中药材采用特殊工艺处理提纯;药效试验采用回避性三等分迷宫灯光分辨学习的方法,检测大鼠的学习能力;稳定性采用恒温加速实验;安全性实验采用小鼠灌胃法;临床疗效是通过观察比较101名小学生及幼儿服本品前后睡眠、食欲、血红蛋白、智商、记忆力、学习成绩。结果:本品贮存2年,各项质量指标均符合标准;小鼠最大耐受量>160mg/kg;可明显提高大鼠的记忆和学习能力;对小儿增进食欲、改善睡眠、提高记忆力、升高血红蛋白均有显著效果。结论:卡利亚营养口服液处方合理,工艺可行,服用安全、有效。
Objective: To study the composition, preparation process, efficacy, safety, and clinical efficacy of Kalia nutritional oral liquid. Methods: During the preparation, the Chinese medicinal materials were purified by special techniques; the efficacy test was conducted using the avoidance three-divisional maze light-resolving learning method to detect the rat’s learning ability; the stability was accelerated by constant temperature; the safety experiment was performed by mouse irrigation. Stomach method; The clinical efficacy is through observation and comparison 101 primary school children and children before and after taking this product sleep, appetite, hemoglobin, IQ, memory, academic performance. Results: The product was stored for 2 years, the quality indicators were in line with the standard; the maximum tolerance of mice> 160mg/kg; can significantly improve the rats’ memory and learning ability; improve appetite, improve sleep, improve memory, increase in children High hemoglobin has a significant effect. Conclusion: Kariya nutrient oral liquid prescription is reasonable, process is feasible, safe and effective.