妇炎康复片备工艺及质量标准的研究.docVIP

妇炎康复片制备工艺及质量标准的研究 摘要 目的 妇炎康复片是由黄芩、赤芍等中药组成，临床用于。妇炎康复片妇炎康复片妇炎康复片妇炎康复片8倍水、提取3次、每次1h，赤芍为70%乙醇提取，8倍量，提取3次，每次1.5h，陈皮为95%乙醇提取，8倍量，提取2次，每次4h。 质量研究结果 建立了以HPLC法测定妇炎康复片中芍药苷、橙皮苷、黄芩苷含量的分析方法：以十八烷基键合硅胶为填充剂；乙腈一磷酸二氢钾水溶液(O.05 mol／L，磷酸调节pH值为3.5)为流动相；流速：0.9 mL／min；梯度洗脱：0 min，15：85；10min，15：85；15min，20：80；30min，25：75；45min，30：70；柱温：4O℃ ；进样量：10ul；检测波长：231nm。方法简单可行。 同时，按照《中国药典》2010版中药物制剂稳定性试验的相关规定，对按照本课题中制备工艺的生产的妇炎康复片成品进行长期及加速试验考察，结果良好，表明该制备工艺下的成品质量稳定。 结论 通过本课题中的相关研究，确定了妇炎康复片的最佳制备工艺，建立了控制产品质量的分析方法，产品质量稳定性良好。 关键词 妇炎康复片；制备工艺；分析方法学；稳定性考察 Abstract Objective Fuyankangfu piece by skullcap, peony, orange peel, seven Chinese herbal medicines, for the treatment of chronic pelvic inflammatory disease, cervicitis, vaginitis and other gynecological diseases. In order to better ensure a better quality of medicines, the subject is a preparation process and quality standards Fuyankangfu pieces related research laid the foundation for the future accordingly to improve the quality Fuyankangfu piece drugs. Meyhods The topic of the preparation process and quality standards Fuyankangfu pieces research. Preparation Process study Skullcap, peony, orange peel flavor three main drugs were extracted, experiments using orthogonal test method, which uses water extraction from Scutellaria adding water, water extraction time, water extraction times to inspect several factors, red peony and orange peel uses ethanol extraction, from the amount of ethanol added, multiple ethanol, ethanol extraction time, ethanol extraction times to inspect several factors to determine the optimal extraction process. Quality Standards study Refer to Chinese Pharmacopoeia the relevant provisions of the 2010 edition of Fuyankangfu sheet quality standards for research. Results Preparation Process study By orthogonal experiment were determined skullcap, peony, orange peel extraction process, skullcap for 8 times in water, extracted three times, each time 1h, TPG is 70% ethanol, eight times the amount extracted three times, every 1.5h