青黛生产工艺与质量控制研究

【作者】 廖婉；

【导师】 傅超美；

【作者基本信息】 成都中医药大学 ， 药剂学， 2008， 硕士

【摘要】 青黛为爵床科植物马蓝Baphicacanthus cusia(Nees)Bremek.、蓼科植物蓼蓝Polygonum tinctorium Ait.或十字花科植物菘蓝Isatis indigotica Fort.的叶或茎叶经加工制得的干燥粉末或团块.本课题以青黛原料药准入及产业化为目标,在传统中医药理论的指导下,对青黛的生产工艺、质量标准、稳定性等进行了较全面、深入、系统地研究。对生产工艺进行研究,显著的改变了传统工艺落后、质控方法粗糙造成的青黛质量不稳定的局面。通过实验研究确定了工艺参数,对传统工艺进行优化,得到了能够全面提高青黛产量和质量的生产工艺。制定青黛的生产工艺为:取新鲜马蓝茎叶冲洗干净后切制成10cm左右的段,加20倍量的水浸泡48小时。浸泡液先通过10目的筛网,然后再通过40目的筛网滤过除杂。于滤液中加入8%的石灰(即每100g马蓝茎叶加入8g石灰),搅拌均匀,滤过,弃去滤液,得粗靛。将粗靛加水调制成浓度为2.5%的粗靛浆,泵入青黛水飞自动分选装置,1500r/min转速下分离杂质。再将得到的青黛浆体在1000r/min转速下离心脱水得半成品,于80℃干燥12小时,粉碎过100目筛即得。为青黛的系统化研究、自动化、规模化生产奠定了理论和实践基础。对质量标准进行了系统研究,建立了青黛的质量标准草案:优化了以靛蓝、靛玉红对照品为对照的薄层色谱鉴别方法:采用高效液相色谱法,对主要有效成分靛蓝和靛玉红的含量测定方法进行了系统的方法学考察,建立了相应的测定方法,并制定了成品中靛蓝和靛玉红的含量限度,分别为靛蓝含量不得低于5.30%,靛玉红含量不得低于0.130%。最后进行了长期稳定性试验和加速稳定性试验。本课题对青黛生产工艺、质量控制进行系统研究,达到科学、可控的现代化大生产要求;完善了质量标准,保证了产品质量的安全、有效、稳定、可控。更多还原

【Abstract】 The Indigo Naturalis is dried powder or agglomerate which is processed by Baphicacanthus cusia (Nees) Bremek.、Polygonum tinctorium Ait. and Isatis indigotica Fort.. In this project, we took a comprehensive, thorough and systemic research on preparing procedure, quality criteria, stability in order to establish the quality criteria with standardization combining the theory of traditional Chinese medicine.The traditional technology is consummated and the quality unstable aspect which the method creates roughly and the traditional technology backwardness is remarkably changed . The craft parameter is determined through the experimental study. The preparing procedure which can comprehensively enhance the output and the quality of the Indigo Naturalis is obtained finally. Fresh stem and leaf of Baphicacanthus cusia (Nees) Bremek.is flushed clean and made into 10cm section, added 20 times water to soak for 48 hours. The soak is filtered and refined through the grit of 10 mu and then through the grit of 40 mu. The 8% lime is added in the filtrate (i.e. 8g lime per 100g stem and leaf of Baphicacanthus cusia (Nees) Bremek.) and then be stirred uniformly. The crude indigo can be get when the liquid is filtered and the filtrate is abandoned. The crude indigo is added the water and made into 2.5% crude indigo pastes and pumped into the levigating automatic sorted machine with the 1500r/min rotational speed to separate the impurity. Then the slurry of the Indigo Naturalis is centrifugated and dehydrated in the 1000r/min rotational speed. The intermediate product is dried in 80℃for 12 hours and pulverized through the grit of 100 mu. This project have established the theoretical and practical foundation for systematized research and the automated and formalization of the Indigo NaturalisThe quality specification has been systemic researched and the quality specification draft of the Indigo Naturalis has been established, we optimized the TLC identification with standards of indigotin and indirubin. The systemic methodology for determining the content of indigotin and indirubin by HPLC has been established and the content of indigotin cannot be lower than 5.30% and the content of indirubin cannot be lower than 0.130%. The preliminary stability test and the acceleration stability test have been carried on.In this project,the preparing procedure and the quality control have been researched, meeting objectively, scientific, controllable, the precise modernized production requirements. The quality specification has been consummated to guarante the effective, safe, controllable, stable quality of production.更多还原