药食两用中药荷叶有效成分缓释滴丸制剂工艺及其降血脂功效研究

Study on the Preparation Technology of Sustained-Release Dripping Pills and Its Effect on Lowering Blood Lipids

目的本研究旨在将药食两用中药荷叶开发研究成降脂缓释滴丸,并探究其降血脂功效。方法将荷叶提取物制成缓释滴丸,优化制剂工艺,制定质量标准。采用药效学实验方法,以高脂血症小鼠为整体模型,以总胆固醇(total cholesterol,TC)、甘油三酯(triglyceride,TG)、高密度脂蛋白(high density lipoprotein,HDL-C)含量为指标,观察比较荷叶煎剂与荷叶缓释滴丸对动物降血脂的药理作用,进一步从动物体内药理效应的比较来评价剂型工艺的科学性。结果最终确定工艺为PEG4000-SA(5∶1),药液温度为85℃~90℃之间,冷凝液温度55℃~5℃。荷叶水提物能显著降低TC、TG水平,同时增高HDL-C水平,具有显著的降血脂作用。结论通过荷叶有效组分缓释滴丸制剂工艺的系统研究,筛选并优化制剂工艺,初步制定质量控制标准,开发具有治疗又兼具保健作用的药食两用中药荷叶新制剂,为药食两用中药剂型开发提供新的思路。

OBJECTIVE To develop the lipid-lowering and slow-release dropping pills from lotus leaf,and to explore the effect of lowering blood lipid.METHODS Slow-release dripping pills were prepared from lotus leaf extract,the preparation technology was optimized and the quality standard was established.A pharmacodynamic experiment was carried out on mice with hyperlipidemia as the whole model,and the contents of Total Cholesterol(TC),Triglyceride(TG)and high density lipoprotein(HDL-C)were used as indexes.To observe and compare the pharmacological effects of Lotus leaf decoction and Lotus leaf sustained release dripping pills on reducing blood lipids in animals,and further evaluate the scientific nature of the dosage form technology from the comparison of pharmacological effects in animals.RESULTS The final process was determined to be PEG4000-SA(5∶1),the temperature of the liquid was 85℃-90℃,and the temperature of the condensate was 55℃-5℃.The water extract of lotus leaf reduced the levels of TC and TG significantly,and increased the level of HDL-C,which had a significant effect on lowering blood lipid.CONCLUSION Through the systematic study of the preparation process of the effective components of lotus leaf sustained release dripping pills,the preparation process is screened and optimized,the quality control standard is preliminarily established,and the new preparation of Chinese medicine lotus leaf with both therapeutic and health care effects is developed,providing a new idea for the development of Chinese medicine dosage forms for both medicine and food.