复方丹参制剂的质量评价研究 - University of Macau.DOC

应用改进的质量评价方法考察复方丹参制剂 张 烨，郑 颖*，王一涛 （澳门大学中华医药研究院，中国 澳门 999078） 关键词复方丹参制剂；质量评价；含量；溶出度；稳定性摘要目的：，为其现行质量标准改进提供参考。方法：选取水溶性部分丹参素、原儿茶醛、丹酚酸B及脂溶性部分隐丹参酮、丹参酮ⅡA共5种指标成分，对6个厂家的复方丹参制剂进行含量、溶出度和稳定性测定，比较相同制剂不同厂家、同厂家不同批次间的含量差异。以相似因子法评价溶出曲线、用动力学过程描述各指标成分含量变化规律并推算有效期。结果：6个厂家的复方丹参市售品中指标成分的含量均超出药典规定含量下限。4个厂家复方丹参片的各水溶性成分含量相差1.6-7.6倍，脂溶性成分含量相差1.4倍；2个厂家丹七片中水溶性成份含量相差2.3-8.5倍；复方丹参滴丸中指标成分含量批间RSD＜10 %。复方丹参片的水溶性成分溶出完全、但脂溶性成分未见溶出；丹七片的水溶性成分溶出不完全；复方丹参滴丸中只有原儿茶醛溶出不完全。相似因子结果表明各厂家相同制剂的指标成分间无相似溶出行为。各厂家制剂的指标成分降解均符合一级动力学过程(r2≥0.9)预测的有效期均小于年，但其中原因仍需深入探讨。结论：现行的复方丹参制剂质量标准应增加指标成分数量、增加指标成分的含量上限规定、增加溶出度和稳定性考察项目。 基金项目：澳门大学科研基金(资助号：RG088/07-08S/09R) 作者简介：张 烨（1985-），女，硕士研究生，从事中药制剂的质量评价及新剂型研究。Tel：853 E-mail：joey105@126.com *通讯作者：郑 颖（1977-），女，助理教授，药剂学博士，从事中药制剂的质量评价及新剂型研究。Tel：853 E-mail：yzheng@umac.mo 通讯地址：澳门大学中华医药研究院，3座204A室，澳门大学，澳门特别行政区Zhang Ye, Zheng Ying*, Wang Yi-tao (Institute of Chinese Medical Sciences，University of Macau，Macau SARP.R China ) KEY WORDS：Fufang Danshen products；Improved quality evaluation；Content；Dissolution；Stability ABSTRACT: AIM: To apply improved quality evaluation methods for improving current quality criteria of Fufang Danshen Products. METHODS: Considering both hydrophilic and lipophilic active components, danshensu, protocatechuic aldehyde, salvianolic acid B, cryptotanshinone and tanshinone ⅡA were selected as five markers. A HPLC method was developed to simultaneously determine their contents, which were used to compare the products from different companies, and different batches from the same company. Similarity factor method was used to evaluate the similarities of in-vitro dissolution profiles. Moreover, accelerated and long-term stability tests were performed to predict the shelf-life of Fufang Danshen products. RESULTS: All of the Fufang Danshen products passed the content requirements of Chinese pharmacopeia. However, the content variations of the hydrophilic components were much higher than those of the lipophilic components. In dissolution tests, most of the