妇科止血中药竭莲宫血安颗粒研制

Optimization of the preparation process of the traditional Chinese medicine Jielian Gongxuean granules for hemostasis in gynaecology

目的:考察并优化妇科止血中药竭莲宫血安颗粒的提取工艺与制剂制备工艺。方法:根据预实验结果和临床用药方法,确定醇提、水提工艺方法并进行工艺参数优选。依照现代中药制剂要求,设计并优化制剂的制备工艺。结果:醇提最佳工艺为:乙醇浓度为75%,加醇量为6倍,提取2次,每次1.5 h;水提最佳工艺为:加水量为8倍,提取2次,每次1.5 h。制剂剂型选用颗粒剂并确定了辅料配比。结论:通过本制剂的提取工艺与制备工艺的研究,证实了原药临床应用处方的工艺科学性与可行性,使制剂稳定有效。

Objective：To study and optimize the extraction and preparation process of the traditional Chi- nese medicine Jielian Gongxuean granules used for hemostasis in gynaecology. Methods：The methods of alcohol extraction and water extraction were determined and optimized in accordance with the pre-experimental results and clinical medication regimen. According to the requirements for modern products of traditional Chinese medicines, the preparation technology was designed and optimized. Results：Alcohol extraction process was as follows：ethanol concentration 75% ,6 times amount of alcohol added,2 times of extraction,1.5 h for each time;water extraction process was as follows ：8 times amount of water added,2 times of extraction, 1.5 h for each time. Granules were se- lected as the dosage form, and the ratio of pharmaceutical excipients was determined. Conclusion：Based on the study of extraction and preparation process, the scientificity and feasibility of the original prescription and process were proved.