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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 investigate and optimize the extraction process and formulation preparation of Lianlian Gong Xue An Granule for gynecological hemostasis. Methods: According to the pre-experimental results and clinical medication methods, the alcohol extraction and water extraction process methods were determined and the process parameters were optimized. In accordance with the requirements of modern Chinese medicine formulations, design and optimization of preparation preparation. Results: The optimum conditions of alcohol extraction were as follows: the concentration of ethanol was 75%, the amount of alcohol was 6 times and the extraction time was 2 h, each time was 1.5 h. The optimum conditions for water extraction were as follows: adding water 8 times, extracting twice 1.5 h. Formulation formulations selected granules and determine the accessories ratio. Conclusion: Through the study of the extraction process and preparation process of the preparation, the scientific and feasible process of the clinical application of the original drug is confirmed, which makes the preparation stable and effective.