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黄连解毒颗粒制备工艺的改进及质量控制研究

Studies on Improvement of Huanglian-Jiedu Granules’ Preparation Process and Quality Control

【作者】 张继红

【导师】 张明军;

【作者基本信息】 湖南农业大学 , 临床兽医学, 2010, 硕士

【摘要】 黄连解毒颗粒是由黄连、黄柏、黄芩、栀子四味药味药组成的一种中草药制剂的新剂型,具有清热,解毒,消炎之功效。用于上呼吸道感染,急慢性扁桃体炎,急慢性咽喉炎等症。本研究以传统中医药理论为指导原则,运用现代制药技术,对该复方制剂中主要原药材的提取工艺、制剂的质量控制进行了系统的实验研究。根据临床用药的需要,结合处方用药的性质,确定剂型为颗粒剂。根据处方的功能主治及药物所含成分的理化性质,采用正交实验方法,以多指标综合评分筛选最佳制备工艺。醇提的最佳工艺为:用14倍量40%的乙醇溶液在80℃下煎煮3次,每次2h。对复方黄连颗粒的质量控制进行了研究。以HPLC法测定该方君药黄连所含主要有效成分小檗碱的含量,并建立了相应的测定方法和含量限度。同时在质量标准可控的基础上对该制剂进行了稳定性研究。试验结果表明,定性定量方法简便,灵敏,准确、精密,可作为该剂质量控制标准。

【Abstract】 Huanglian-jiedu granules is a new kind of Chinese herbal medicine formulation, which consists of coptis(huanglian), cork(huangbo), Scutellaria(huangqin) and gardenia(zhizi). It has the function of clearing heat, relieving toxicity and diminishing inflammations. Therefore It can be used to cure a series of diseases such as upper respiratory tract infection, acute and chronic tonsillitis, throat swelling and ache. Under the guidance of theories of traditional chinese herbal medicines, it was studied systematically on the extraction process and quality control of Huanglian-jiedu granules with modern pharmaceutical technology.Meeting the demands of clinic, taking the nature of its compositent medicines in the formula into account, the form of formula was decided as granules. According to the indicational functions and the physical and chemical properties of the compouds in the compositent medicines of the formila, orthogonal design test method was adopted to select the best preparation process by multi-index comprehensive evaluation. The best alcohol-extraction process is, decocting thrice under 80℃with 15 times of 40% ethanol solution,2 hours per time.The methods of quality control were studied and the quality standards of the material medicine and the product were estamblished. By determining the content of berberine which is the main effective ingredient of coptis with HPLC, the corresponding methods of determining content was built and the limits of content were determined. Meanwhile studies on stability were undertook. The results showed that the foregoing method was a simple, sensitive, accurate and precise method which can be used as the quality control standard of the product.

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