Studies On Improvement Of Huanglian-Jiedu Granules' Preparation Process And Quality Control

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.